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INT/656 – CESE 248/2013 Annex IV (updated on 15.03.2013)

European Economic and Social Committee

Section for the Single Market, Production and Consumption

Single Market Observatory

INT/656

Annex IV

Better regulation:

implementing acts and delegated acts Rapporteur Mr Jorge Pegado Liz

Table 3 A: Relevant articles of delegating acts sorted by tables

Legislative acts under the new framework and their related delegated acts

Prepared by: Ms Ana Rojo Prada

INT/656 – CESE 248/2013 Annex IV 1

TABLE 3

RELEVANT ARTICLES OF DELEGATING ACTS SORTED BY TABLES

A) TABLE1

LEGISLATIVE ACTS UNDER THE NEW FRAMEWORK AND THEIR RELATED DELEGATED ACTS

Nr. Delegating act Relevant Articles

1. Regulation (EU) No 438/2010 of the European Parliament and of the Council of 19 May 2010 amending Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health requirements applicable to the non-commercial movement of pet

animals and amending Council Directive 92/65/EEC

Whereas: (12) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union in respect of preventive health measures regarding diseases other than rabies, and modifications of technical requirements for the identification of animals and for the anti-rabies vaccination as laid down in the Annexes inserted, in accordance with this Regulation, into Regulation (EC) No 998/2003. It is of particular importance that the Commission carry

out appropriate consultations during its preparatory work, including at expert level. Article 1 Regulation (EC) No 998/2003 is hereby amended as follows: (b) The following subparagraph is added: "In order to ensure the control of diseases other than rabies, likely to spread due to the movement of pet animals, the Commission may adopt, by means of delegated acts in accordance with Article 19b and subject to the conditions of Articles 19c and 19d, the preventive health measures referred to in point (b)(ii) of the first subparagraph. Those measures shall be scientifically justified and shall be proportionate to the risk of spreading those diseases due to such movement."; 7. The following Articles are inserted: "Article 19a 1. In order to take account of technical progress, the Commission may adopt, by means of delegated acts in accordance with Article 19b and subject to the conditions of Articles 19c and 19d, amendments to the technical requirements for the identification as laid down in Annex Ia. 2. In order to take account of scientific and technical developments regarding anti-rabies vaccination, the Commission may adopt, by means of delegated acts in accordance with Article 19b and subject to the conditions of Articles 19c and 19d, amendments to the technical requirements for the anti-rabies vaccination as laid down in Annex Ib. 3. When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Regulation. Article 19b 1. The power to adopt the delegated acts referred to in Article 5(1) and Article 19a shall be conferred on the Commission for a period of 5 years following 18 June 2010. The Commission shall make a report in respect of the delegated powers not later than 6 months before the end of the 5 year period. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 19c.

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2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 19c and 19d. Article 19c 1. The delegation of powers referred to in Article 5(1) and Article 19a may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 19d

1. The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by two months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act."; - Article 5(1): to adopt preventive health measures referred to in point (b)(ii), in order to ensure the control of diseases other than rabies, likely to spread due to the movements of pet animals.

2. Directive 2010/30/EU of the European Parliament and of the Council of 19 May 2010 on the indication by labelling and standard product information of the consumption of energy and other resources by energy-related products

Whereas: (7) The Commission should provide a priority list of energy-related products that could be covered by a delegated act under this Directive. Such a list could be included in the Working Plan referred to in Directive 2009/125/EC. (14) Energy-related products which have a significant direct or indirect impact on consumption of energy or, where relevant, of essential resources during use and which afford adequate scope for increased efficiency should be covered by a delegated act, when provision of information through labelling may stimulate end-users to purchase more efficient products. (15) In order to meet the Union climate change and energy security objectives, and given that the total energy consumed by products is expected to continue to rise in the longer term, the delegated acts under this Directive could, where relevant, also highlight on the label the high total energy consumption of the product. (16) A number of Member States have public procurement policies in place which require contracting authorities to procure energy efficient products. A number of Member States also have put in place incentives for energy efficient products. The criteria for products to be eligible for public procurement or








incentives can substantially differ from one Member State to another. To refer to performance classes as levels for particular products, as set out in delegated acts under this Directive, may reduce fragmentation of public procurement and incentives and facilitate the uptake of efficient products (19) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in respect of labelling and standard product information of the consumption of energy and other essential resources by energy-related products during use. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 2 Definitions (k) "unauthorized use of the label" means the use of the label, other than by Member State authorities or EU institutions, in a manner not provided for in this Directive or a delegated act. Article 3 Responsibilities of Member States 1. Member States shall ensure that: (b) with respect to products covered by this Directive, the display of other labels, marks, symbols or

inscriptions which do not comply with the requirements of this Directive and of the relevant delegated acts is prohibited, if such display is likely to mislead or confuse end-users with respect to the consumption of energy or, where relevant, other essential resources during use; 2. Where a Member State ascertains that a product does not comply with all the relevant requirements set out in this Directive and its delegated acts for the label and the fiche, the supplier shall be obliged to make the product compliant with those requirements under effective and proportionate conditions imposed by the Member State. Article 4 Information requirements Member States shall ensure that: (a) information relating to the consumption of electric energy, other forms of energy and where relevant other essential resources during use, and supplementary information is, in accordance with delegated acts under this Directive, brought to the attention of end-users by means of a fiche and a label related to products offered for sale, hire, hire-purchase or displayed to end-users directly or indirectly by any means of distance selling, including the Internet; (b) the information referred to in point (a) is provided in respect of built-in or installed products only where required by the applicable delegated act; (c) any advertisement for a specific model of energy-related products covered by a delegated act under this Directive includes, where energy-related or price information is disclosed, a reference to the energy efficiency class of the product; Article 5 Responsibilities of suppliers Member States shall ensure that: (a) suppliers placing on the market or putting into service products covered by a delegated act supply a label and a fiche in accordance with this Directive and the delegated act; Article 6 Responsibilities of dealers Member States shall ensure that: (b) whenever a product covered by a delegated act is displayed, dealers attach an appropriate label, in the clearly visible position specified in the applicable delegated act, and in the relevant language version.



Article 7 Distance selling and other forms of selling Where products are offered for sale, hire or hire-purchase by mail order, by catalogue, through the Internet, telemarketing or by any other means which imply that the potential end-user cannot be expected to see the product displayed, delegated acts shall make provision to ensure that potential end-users are provided with the information specified on the label for the product and in the fiche before buying the product. Delegated acts shall, where appropriate, specify the way in which the label or the fiche or the information specified on the label or in the fiche shall be displayed or provided to the potential end-user. Article 8 Free movement 1. Member States shall not prohibit, restrict or impede the placing on the market or putting into service, within their territories, of products which are covered by and comply with this Directive and the applicable delegated act. 2. Unless they have evidence to the contrary, Member States shall consider labels and fiches as

complying with the provisions of this Directive and the delegated acts. Member States shall require suppliers to provide evidence within the meaning of Article 5 concerning the accuracy of the information supplied on their labels or fiches when they have reason to suspect that such information is incorrect. Article 9 Public procurement and incentives 1. Where a product is covered by a delegated act, contracting authorities which conclude public works, supply or service contracts as referred to in Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts [8], which are not excluded by virtue of Articles 12 to 18 thereof, shall endeavour to procure only such products which comply with the criteria of having the highest performance levels and belonging to the highest energy efficiency class. Member States may also require the contracting authorities to procure only products fulfilling those criteria. Member States may make the application of those criteria subject to cost-effectiveness, economical feasibility and technical suitability and sufficient competition. 3. Where Member States provide any incentives for a product covered by a delegated act they shall aim at the highest performance levels including the highest class of energy efficiency laid down in the applicable delegated act. Taxation and fiscal measures do not constitute incentives for the purpose of this Directive. 4. Where Member States provide incentives for products, both for end-users using highly efficient products and for industries which promote and produce such products, they shall express the performance levels in terms of classes as defined in the applicable delegated act, except where they impose higher performance levels than the threshold for the highest energy efficiency class in the delegated act. Member States may impose higher performance levels than the threshold for the highest energy efficiency class in the delegated act. Article 10 Delegated acts 1. The Commission shall lay down details relating to the label and the fiche by means of delegated acts in accordance with Articles 11 to 13, relating to each type of product in accordance with this Article. Where a product meets the criteria listed in paragraph 2, it shall be covered by a delegated act in accordance with paragraph 4.



Provisions in delegated acts regarding information provided on the label and in the fiche on the consumption of energy and other essential resources during use shall enable end-users to make better informed purchasing decisions and shall enable market surveillance authorities to verify whether products comply with the information provided. Where a delegated act lays down provisions with respect to both energy efficiency and consumption of essential resources of a product, the design and content of the label shall emphasize the energy efficiency of the product. 2. The criteria referred to in paragraph 1 are the following: (a) according to most recently available figures and considering the quantities placed on the Union market, the products shall have a significant potential for saving energy and, where relevant, other essential resources; (b) products with equivalent functionality available on the market shall have a wide disparity in the relevant performance levels; (c) the Commission shall take into account relevant Union legislation and self-regulation, such as voluntary agreements, which are expected to achieve the policy objectives more quickly or at lesser

expense than mandatory requirements. 3. In preparing a draft delegated act, the Commission shall: (a) take into account those environmental parameters set out in Annex I, Part 1, to Directive 2009/125/EC which are identified as significant in the relevant implementing measure adopted under Directive 2009/125/EC and which are relevant for the end-user during use; (b) assess the impact of the act on the environment, end-users and manufacturers, including small and medium-sized enterprises (SMEs), in terms of competitiveness including on markets outside the Union, innovation, market access and costs and benefits; (c) carry out appropriate consultation with stakeholders; (d) set implementing date(s), any staged or transitional measures or periods, taking into account in particular possible impacts on SMEs or on specific product groups manufactured primarily by SMEs. 4. The delegated acts shall specify in particular: (a) the exact definition of the type of products to be included; (b) the measurement standards and methods to be used in obtaining the information referred to in Article 1(1); (c) the details of the technical documentation required pursuant to Article 5; (d) the design and content of the label referred to in Article 4, which as far as possible shall have uniform design characteristics across product groups and shall in all cases be clearly visible and legible. The format of the label shall retain as a basis the classification using letters from A to G; the steps of the classification shall correspond to significant energy and cost savings from the end-user perspective. Three additional classes may be added to the classification if required by technological progress. Those additional classes will be A+, A++, and A+++ for the most efficient class. In principle the total number of classes will be limited to seven, unless more classes are still populated. The colour scale shall consist of no more than seven different colours from dark green to red. The colour code of only the highest class shall always be dark green. If there are more than seven classes, only the red colour can be duplicated. The classification shall be reviewed in particular when a significant proportion of products on the internal market achieves the two highest energy efficiency classes and when additional savings may be achieved by further differentiating products. Detailed criteria for a possible reclassification of products are, where appropriate, to be determined on a



case-by-case basis in the relevant delegated act; (e) the location where the label shall be fixed to the product displayed and the manner in which the label and/or information are to be provided in the case of offers for sale as covered by Article 7. Where appropriate, the delegated acts may provide for the label to be attached to the product or printed on the packaging, or for the details of the labelling requirements for printing in catalogues, for distance selling and Internet sales; (f) the content and, where appropriate, the format and other details concerning the fiche or further information specified in Article 4 and Article 5(c). The information on the label shall also be included on the fiche; (g) the specific content of the label for advertising, including, as appropriate, the energy class and other relevant performance level(s) of the given product in a legible and visible form; (h) the duration of label classification(s), where appropriate, in accordance with point (d); (i) the level of accuracy in the declarations on the label and fiches; (j) the date for the evaluation and possible revision of the delegated act, taking into account the speed of technological progress.

Article 11 Exercise of the delegation 1. The powers to adopt the delegated acts referred to in Article 10 shall be conferred on the Commission for a period of five years beginning on 19 June 2010. The Commission shall make a report in respect of the delegated powers not later than six months before the end of the five-year period. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 12. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 12 and 13. Article 12 Revocation of the delegation 1. The delegation of powers referred to in Article 10 may be revoked by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 13 Objections to delegated acts 1. The European Parliament or the Council may object to the delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by two months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and enter into force on the date stated therein.



The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period, if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act. Article 14 Evaluation Not later than 31 December 2014, the Commission shall review the effectiveness of this Directive and of its delegated acts and submit a report to the European Parliament and the Council. On that occasion, the Commission shall also assess: (a) the contribution of Article 4(c) to the aim of this Directive; (b) the effectiveness of Article 9(1); (c) in the light of technical evolution and the understanding by consumers of the label layout, the need for amending Article 10(4)(d). Article 15

Penalties Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and its delegated acts, including unauthorized use of the label, and shall take the necessary measures to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. The Member States shall notify these provisions to the Commission by 20 June 2011 and shall notify the Commission without delay of any subsequent amendment affecting those provisions.

3. Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings

(32) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in respect of the adaptation to technical progress of certain parts of the general framework set out in Annex I, and in respect of the establishment of a methodology framework for calculating cost-optimal levels of minimum energy performance requirements. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 5 Calculation of cost-optimal levels of minimum energy performance requirements 1. The Commission shall establish by means of delegated acts in accordance with Articles 23, 24 and 25 by 30 June 2011 a comparative methodology framework for calculating cost-optimal levels of minimum energy performance requirements for buildings and building elements Article 18 Independent control system 2. The Member States may delegate the responsibilities for implementing the independent control systems Article 22 Adaptation of Annex I to technical progress The Commission shall adapt points 3 and 4 of Annex I to technical progress by means of delegated acts in accordance with Articles 23, 24 and 25. Article 23 Exercise of delegation 1. The powers to adopt the delegated acts referred to in Article 22 shall be conferred on the Commission for a period of five years beginning on 8 July 2010. The Commission shall make a report in respect of the






delegated powers not later than six months before the end of the five-year period. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 24. 2. Without prejudice to the deadline referred to in Article 5(1), the powers to adopt the delegated acts referred to in Article 5 shall be conferred on the Commission until 30 June 2012. 3. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 4. The powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 24 and 25. Article 24 Revocation of the delegation 1. The delegation of powers referred to in Articles 5 and 22 may be revoked by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a

reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 25 Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by two months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period, if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

ANNEX II

Independent control systems for energy performance certificates and inspection reports

1. The competent authorities or bodies to which the competent authorities have delegated the responsibility for implementing the independent control system shall make a random selection of at least a statistically significant percentage of all the energy performance certificates issued annually and subject those certificates to verification.

The verification shall be based on the options indicated below or on equivalent measures:

(a) validity check of the input data of the building used to issue the energy performance certificate and the results stated in the certificate;

(b) check of the input data and verification of the results of the energy performance certificate,



including the recommendations made;

(c) full check of the input data of the building used to issue the energy performance certificate, full verification of the results stated in the certificate, including the recommendations made, and on-site

visit of the building, if possible, to check correspondence between specifications given in the energy performance certificate and the building certified.

2. The competent authorities or bodies to which the competent authorities have delegated the responsibility for implementing the independent control system shall make a random selection of at least a statistically significant percentage of all the inspection reports issued annually and subject those reports to verification.

4. Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC

Whereas: (21) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) in respect of certain adaptations of the Annexes. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 35 Adaptation to scientific and technical progress The Commission may adopt delegated acts in accordance with Article 290 TFEU as regards adaptations of the Annexes to this Directive to scientific and technical progress, in particular taking into account amendments to the Annexes to Directive 2008/68/EC. For the delegated acts referred to in this Article, the procedures set out in Articles 36, 37 and 38 shall apply.

Article 36 Exercise of delegation 1. The powers to adopt the delegated acts referred to in Article 35 shall be conferred on the Commission for an indeterminate period of time. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and the Council. 3. The powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 37 and 38. Article 37 Revocation of the delegation 1. The delegation of power referred to in Article 35 may be revoked by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision and shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 38 Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of two months

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from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by two months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

5. Regulation (EU) No 640/2010 of the

European Parliament and of the Council of 7 July 2010 establishing a catch documentation programme for bluefin tuna Thunnus thynnus and amending Council Regulation (EC) No 1984/2003

Whereas:

(6) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union in respect of the transposition of new conservation measures adopted by ICCAT, thus updating and supplementing the Annexes to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, Article 12 Amendment of Annexes In order to apply the conservation measures adopted by ICCAT, the Commission may amend, by means of delegated acts in accordance with Article 13 and subject to the conditions set out in Articles 14 and 15, the Annexes to this Regulation. When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Regulation. Article 13 Exercise of the delegation 1. The powers to adopt delegated acts referred to in Article 12 shall be conferred on the Commission for a period of five years following 14 August 2010. The Commission shall make a report in respect of the delegated powers at the latest six months before the end of the five-year period. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 14. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 14 and 15. Article 14 Revocation of the delegation 1. The delegation of powers referred to in Article 12 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 15









Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by two months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

6. Directive 2010/45/EU of the European

Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation

Whereas:

(26) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in order to adapt the Annex. The Commission should supplement or amend the minimum data set specified in Part A of the Annex only in exceptional situations where it is justified by a serious risk to human health, and supplement or amend the complementary data set specified in Part B of the Annex in order to adapt it to scientific progress and international work carried out in the field of quality and safety of organs intended for transplantation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 24 Adaptation of the Annex The Commission may adopt delegated acts in accordance with Article 25 and subject to the conditions of Articles 26, 27 and 28 in order to: (a) supplement or amend the minimum data set specified in Part A of the Annex only in exceptional situations where it is justified by a serious risk to human health considered as such on the basis of the scientific progress; (b) supplement or amend the complementary data set specified in Part B of the Annex in order to adapt it to scientific progress and international work carried out in the field of quality and safety of organs intended for transplantation. Article 25 Exercise of the delegation 1. The power to adopt the delegated acts referred to in Article 24 shall be conferred on the Commission for a period of five years following 27 August 2010. The Commission shall make a report in respect of the delegated powers not later than six months before the end of the five-year period. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 26. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 26 and 27. 4. Where, in the case of the emergence of new serious risk to human health, imperative grounds of urgency so require, the procedure provided for in Article 28 shall apply to delegated acts adopted pursuant to Article 24(a). Article 26 Revocation of the delegation 1. The delegation of powers referred to in Article 24 may be revoked at any time by the European

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Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavor to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 27 Objection to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by two months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force

on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated Article 28 Urgency procedure 1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act adopted under this Article to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 2. The European Parliament or the Council may object to a delegated act adopted under this Article in accordance with the procedure referred to in Article 27(1). In such a case, the act shall cease to apply. The institution which objects to such a delegated act shall state its reasons therefor.

7. Directive 2010/40/EU of the European Parliament and of the Council on the framework for the deployment of Intelligent Transport Systems in the field of road transport and for interfaces with other modes of transport.

Whereas: (21) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the TFEU in respect of the adoption of specifications. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 6 Specifications 1. The Commission shall first adopt the specifications necessary to ensure the compatibility, interoperability and continuity for the deployment and operational use of ITS for the priority actions. 2. The Commission shall aim at adopting specifications for one or more of the priority actions by 27 February 2013. At the latest 12 months after the adoption of the necessary specifications for a priority action, the Commission shall, where appropriate, after conducting an impact assessment including a cost-benefit analysis, present a proposal to the European Parliament and the Council in accordance with Article 294 of the TFEU on the deployment of that priority action.









3. Once the necessary specifications for the priority actions have been adopted, the Commission shall adopt specifications ensuring compatibility, interoperability and continuity for the deployment and operational use of ITS for other actions in the priority areas. 4. Where relevant, and depending on the area covered by the specification, the specification shall include one or more of the following types of provisions: (a) functional provisions that describe the roles of the various stakeholders and the information flow between them; (b) technical provisions that provide for the technical means to fulfil the functional provisions; (c) organizational provisions that describe the procedural obligations of the various stakeholders; (d) service provisions that describe the various levels of services and their content for ITS applications and services. 5. Without prejudice to the procedures under Directive 98/34/EC the specifications shall, where appropriate, stipulate the conditions in which Member States may, after notification to the Commission, establish additional rules for the provision of ITS services on all or part of their territory, provided that those rules do not hinder interoperability.

6. The specifications shall, where appropriate, be based on any standards referred to in Article 8. The specifications shall, as appropriate, provide for conformity assessment in accordance with Decision No 768/2008/EC. The specifications shall comply with the principles set out in Annex II. 7. The Commission shall conduct an impact assessment including a cost-benefit analysis prior to the adoption of the specifications. Article 7 Delegated acts 1. The Commission may adopt delegated acts in accordance with Article 290 of the TFEU as regards specifications. When adopting such delegated acts the Commission shall act in accordance with the relevant provisions of this Directive, in particular Article 6 and Annex II. 2. A separate delegated act shall be adopted for each of the priority actions. 3. For the delegated acts referred to in this Article, the procedure set out in Articles 12, 13 and 14 shall apply. Article 12 Exercise of the delegation 1. The power to adopt the delegated acts referred to in Article 7 shall be conferred on the Commission for a period of seven years following 27 August 2010. The Commission shall make a report in respect of the delegated powers no later than six months before the end of a five year period following 27 August 2010. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 13 and 14. Article 13 Revocation of the delegation 1. The delegation of powers referred to in Article 7 may be revoked by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject



to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 14 Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by two months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.

3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

8. Regulation (EU) No 911/2010 of the European Parliament and of the Council of 22 September 2010 on the European Earth monitoring programme (GMES) and its initial operations (2011 to 2013)

Whereas: (10) For the purpose of providing for a framework ensuring full and open access to information produced by GMES services and data collected through GMES infrastructure, while providing for the necessary protection of that information and data, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) in respect of registration and licensing conditions for GMES users and of criteria for restriction of access to GMES data and information, while taking into account the data and information policies of providers of data needed for GMES, and without prejudice to national rules and procedures applicable to space and in-situ infrastructures under national control. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. (11) In order to ensure uniform conditions for implementation of this Regulation and of the delegated acts adopted on the basis of this Regulation, implementing powers should be conferred on the Commission to adopt, on the basis of the conditions and criteria established by delegated acts, specific measures on restricting access to the information produced by the GMES services and to data collected through the GMES dedicated infrastructure, including individual measures taking into account the sensitivity of the information and data in question. Implementing powers should also be conferred on the Commission to coordinate the voluntary contributions of Member States and the potential synergies with relevant national, Union and international initiatives, to set the maximum rate of co-financing for grants, to adopt measures laying down the technical requirements in order to ensure the control and integrity of the system within the GMES space component dedicated programme and to control the access to, and handling of, technologies that provide security to the GMES space component dedicated programme, and to adopt the annual work programme of GMES. According to Article 291 TFEU, rules and general principles concerning mechanisms for the control by Member States of the Commission’s exercise of its implementing powers shall be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure. Pending the adoption of that new regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [7] continues to apply, with the exception

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of the regulatory procedure with scrutiny, which is not applicable. Article 9 GMES data and information policy 2. For the purpose of providing for a framework to ensure the attainment of the GMES information and data policy objective referred to in point (b) of paragraph 1 while providing for the necessary protection of the information produced by the GMES services and of data collected through the GMES dedicated infrastructure, the Commission may adopt, by means of delegated acts in accordance with Article 10 and subject to the conditions specified in Articles 11 and 12, the following measures, taking into account the data and information policies of providers of data needed for GMES, and without prejudice to national rules and procedures applicable to space and in-situ infrastructures under national control: (a) measures establishing registration and licensing conditions for GMES users; (b) measures defining criteria for restricting access to the information produced by the GMES services and to data collected through the GMES dedicated infrastructure. Article 10 Exercise of the delegation

1. The powers to adopt the delegated acts referred to in Article 9(2) shall be conferred on the Commission until 31 December 2013. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 11 and 12. Article 11 Revocation of the delegation 1. The delegation of powers referred to in Article 9(2) may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavor to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 12 Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification. At the initiative of the European Parliament or the Council, that period shall be extended by 2 months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.



9. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes

(51) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in respect of the following: modifications of the list of species falling under the obligation of being specifically bred for use in procedures; modifications of the care and accommodation standards; modifications of methods of killing, including their specifications; modifications of the elements to be used for the establishment by Member States of requirements with regard to education, training and competence of breeders’, suppliers’ and users’ personnel; modifications of certain obligatory elements of the application for authorisation; modifications regarding the Union Reference Laboratory, its duties and tasks; as well as modifications of examples of different types of procedures assigned to each of the severity categories on the basis of factors related to the type of procedure. It is of particular importance that the Commission carry out appropriate consultation during its preparatory work, including at expert

level. Article 50 Adaptation of Annexes to technical progress In order to ensure that the provisions of Annexes I and III to VIII reflect the state of technical or scientific progress, taking into account the experience gained in the implementation of this Directive, in particular through the reporting referred to in Article 54(1), the Commission may adopt, by means of delegated acts in accordance with Article 51 and subject to the conditions laid down in Articles 52 and 53, modifications of those Annexes, with the exception of provisions of Sections I and II of Annex VIII. The dates referred to in Section B of Annex III shall not be brought forward. When adopting such delegated acts, the Commission shall act in accordance with the relevant provisions of this Directive. Article 51 Exercise of the delegation 1. The power to adopt delegated acts referred to in Article 50 shall be conferred on the Commission for a period of 8 years beginning on 9 November 2010. The Commission shall make a report in respect of the delegated power at the latest 12 months before the end of the 8-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 52. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 52 and 53. Article 52 Revocation of the delegation 1. The delegation of power referred to in Article 50 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 53 Objections to delegated acts

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1. The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by 2 months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

10. Directive 2010/65/EU of the European Parliament and of the Council of 20 October 2010 on reporting formalities for ships arriving in and/or departing from ports of the Member States and repealing Directive 2002/6/EC

Whereas: (20) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union in respect of the Annex to this Directive. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 10 Amendment procedure 1. The Commission may adopt delegated acts, in accordance with Article 290 of the Treaty on the Functioning of the European Union, as regards the Annex to this Directive, so as to ensure that account is taken of any relevant changes to the FAL forms introduced by the IMO. These amendments shall not have the effect of widening the scope of this Directive. 2. For the delegated acts referred to in this Article, the procedures set out in Articles 11, 12 and 13 shall apply. Article 11 Exercise of the delegation 1. The power to adopt the delegated acts referred to in Article 10 shall be conferred on the Commission for a period of 5 years from 18 November 2010. The Commission shall make a report in respect of the delegated powers at the latest 6 months before the end of the 5-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 12. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 12 and 13. Article 12 Revocation of the delegation 1. The delegation of powers referred to in Article 10 may be revoked by the European Parliament or by the Council at any time. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation.









3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 13 Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by 2 months. 2. Where, on expiry of the initial 2-month period or, if applicable, the extended period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of the initial 2-month period or, if applicable, the extended period where the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. Where the European Parliament or the Council objects to a delegated act, it shall not enter into force.

The institution which objects shall state the reasons for objecting to the delegated act.

11. Regulation (EU) No 995/2010 of the European Parliament and of the Council of 20 October 2010 laying down the obligations of operators who place timber and timber products on the market

Whereas: (28) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) concerning the procedures for the recognition and withdrawal of recognition of monitoring organizations, concerning further relevant risk assessment criteria that may be necessary to supplement those already provided for in this Regulation and concerning the list of timber and timber products to which this Regulation applies. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 6 Due diligence systems 3. Taking into account market developments and the experience gained in the implementation of this Regulation, in particular as identified through the exchange of information referred to in Article 13 and the reporting referred to in Article 20(3), the Commission may adopt delegated acts in accordance with Article 290 TFEU as regards further relevant risk assessment criteria that may be necessary to supplement those referred to in the second sentence of paragraph 1(b) of this Article with a view to ensuring the effectiveness of the due diligence system. For the delegated acts referred to in this paragraph the procedures set out in Articles 15, 16 and 17 shall apply. Article 8 Monitoring organizations 7. In order to supplement the procedural rules with regard to the recognition and withdrawal of recognition of monitoring organizations and, if experience so requires, to amend them, the Commission may adopt delegated acts in accordance with Article 290 TFEU, while ensuring that the recognition and withdrawal of recognition are performed in a fair and transparent manner. For the delegated acts referred to in this paragraph the procedures set out in Articles 15, 16 and 17 shall apply. Those acts shall be adopted by 3 March 2012. Article 14 Amendments of the Annex







In order to take into account, on the one hand, the experience gained in the implementation of this Regulation, in particular as identified through the reporting referred to in Article 20(3) and (4) and through the exchange of information as referred to in Article 13, and, on the other hand, developments with regard to technical characteristics, end-users and production processes of timber and timber products, the Commission may adopt delegated acts in accordance with Article 290 TFEU by amending and supplementing the list of timber and timber products set out in the Annex. Such acts shall not create a disproportionate burden on operators. For the delegated acts referred to in this Article the procedures set out in Articles 15, 16 and 17 shall apply. Article 15 Exercise of the delegation 1. The power to adopt the delegated acts referred to in Articles 6(3), 8(7) and 14 shall be conferred on the Commission for a period of seven years from 2 December 2010. The Commission shall make a report in respect of the delegated powers not later than three months before the end of a three-year period after the date of application of this Regulation. The delegation of powers shall be automatically extended

for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 16. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 16 and 17. Article 16 Revocation of the delegation 1. The delegation of powers referred to in Articles 6(3), 8(7) and 14 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 17 Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by two months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act, the act shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.



12. Regulation (EU) N° 1090/2010 of the European Parliament and of the Council amending Directive 2009/42/EC of the European Parliament and of the Council of 6 May 2009 on statistical returns in respect of carriage of goods and passengers by sea

Whereas: (8) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union in respect of certain detailed rules for implementing Directive 2009/42/EC. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 1 Directive 2009/42/EC is hereby amended as follows: (1) in Article 3(4), the second subparagraph is replaced by the following: ‘The Commission may adopt those measures by means of delegated acts in accordance with Article 10a and subject to the conditions of Articles 10b and 10c.’;

(2) in Article 4(1), the second subparagraph is replaced by the following: ‘The Commission may adopt those measures by means of delegated acts in accordance with Article 10a and subject to the conditions of Articles 10b and 10c.’; (3) in Article 5, the third paragraph is replaced by the following: ‘The Commission may adopt those measures by means of delegated acts in accordance with Article 10a and subject to the conditions of Articles 10b and 10c.’; (4) in Article 10, paragraph 3 is deleted; (5) the following Articles are inserted: ‘Article 10a Exercise of the delegation 1. The power to adopt delegated acts referred to in Article 3(4), Article 4(1) and the third paragraph of Article 5 shall be conferred on the Commission for a period of 5 years from 29 December 2010. The Commission shall draw up a report in respect of the delegated power at the latest 6 months before the end of the five-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 10b. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 10b and 10c. Article 10b Revocation of the delegation 1. The delegation of power referred to in Article 3(4), Article 4(1) and the third paragraph of Article 5 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 10c Objections to delegated acts









1. The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by 2 months. 2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to the delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.’;

13. Directive 2010/73/EU of the European Parliament and of the Council amending Directive 2003/71/EC of the European Parliament and of the Council of 4 November 2003 on the prospectus to be published when securities are offered to the public or admitted to trading and amending Directive 2001/34/EC and Directive 2004/109/EC of the European Parliament and of the Council of 15 December 2004 on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC

Whereas: (27) In order to respect the principles set out in recital 41 of Directive 2003/71/EC and to take account of the technical developments in the financial markets and to specify the requirements laid down in Directive 2003/71/EC, the Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU. In particular, delegated acts may be necessary to update the thresholds and the definitions for reduced market capitalization and SMEs established in this Directive and in Directive 2003/71/EC, and to specify the detailed content and specific form of the summary in accordance with the outcome of the debate launched by the Commission’s Communication on Packaged Retail Investment Products of 30 April 2009, aligning to the greatest extent possible the content and form of the summary for securities with that outcome, preventing the duplication of documents and potential confusion for investors as well as minimizing the costs (28) The European Parliament and the Council should have 3 months from the date of notification to object to a delegated act. At the initiative of the European Parliament or the Council, it should be possible to prolong that period by 3 months in regard to significant areas of concern. It should also be possible for the European Parliament and the Council to inform the other institutions of their intention not to raise objections. Such early approval of delegated acts is particularly appropriate when deadlines need to be met, for example where there are timetables in the basic act for the Commission to adopt delegated acts. (29) In Declaration 39 on Article 290 TFEU, annexed to the Final Act of the Intergovernmental Conference which adopted the Treaty of Lisbon, signed on 13 December 2007, the Conference took note of the Commission’s intention to continue to consult experts appointed by the Member States in the preparation of draft delegated acts in the financial services area, in accordance with its established practice. Article 1 Amendments to Directive 2003/71/EC 1. Article 1 is amended as follows: (b) the following paragraph is added: "4. In order to take account of technical developments on financial markets, including inflation, the Commission shall adopt, by means of delegated acts in accordance with Article 24a, and subject to the conditions of Articles 24b and 24c, measures concerning the adjustment of the limits referred to in points (h) and (j) of paragraph 2 of this Article."; 2. Article 2 is amended as follows:


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(c) paragraph 4 is replaced by the following: "4. In order to take account of technical developments on financial markets and to specify the requirements laid down in this Article, the Commission shall adopt, by means of delegated acts in accordance with Article 24a, and subject to the conditions of Articles 24b and 24c, the definitions referred to in paragraph 1, including the adjustment of the figures used for the definition of SMEs, and the thresholds for reduced market capitalization, taking into account the situation on different national markets, including the classification used by the operators of regulated markets, Union legislation and recommendations as well as economic developments."; 3. Article 3 is amended as follows: (b) the following paragraph is added: "4. In order to take account of technical developments on financial markets, including inflation, the Commission shall adopt, by means of delegated acts in accordance with Article 24a, and subject to the conditions of Articles 24b and 24c, measures concerning the thresholds in points (c) to (e) of paragraph 2 of this Article."; 4. Article 4 is amended as follows:

(a) in paragraph 1: (i) points (c) to (e) are replaced by the following: "(c) securities offered, allotted or to be allotted in connection with a merger or division, provided that a document is available containing information which is regarded by the competent authority as being equivalent to that of the prospectus, taking into account the requirements of Union legislation; (d) dividends paid out to existing shareholders in the form of shares of the same class as the shares in respect of which such dividends are paid, provided that a document is made available containing information on the number and nature of the shares and the reasons for and details of the offer; (e) securities offered, allotted or to be allotted to existing or former directors or employees by their employer or by an affiliated undertaking provided that the company has its head office or registered office in the Union and provided that a document is made available containing information on the number and nature of the securities and the reasons for and details of the offer."; (ii) the following subparagraphs are added: "Point (e) shall also apply to a company established outside the Union whose securities are admitted to trading either on a regulated market or on a third-country market. In the latter case, the exemption shall apply provided that adequate information, including the document referred to in point (e), is available at least in a language customary in the sphere of international finance and provided that the Commission has adopted an equivalence decision regarding the third-country market concerned. On the request of the competent authority of a Member State, the Commission shall adopt equivalence decisions in accordance with the procedure referred to in Article 24(2), stating whether the legal and supervisory framework of a third country ensures that a regulated market authorised in that third country complies with legally binding requirements which are, for the purpose of the application of the exemption under point (e), equivalent to the requirements resulting from Directive 2003/6/EC of the European Parliament and of the Council of 28 January 2003 on insider dealing and market manipulation (market abuse) [], from Title III of Directive 2004/39/EC and from Directive 2004/109/EC of the European Parliament and of the Council of 15 December 2004 on the harmonization of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market [], and which are subject to effective supervision and enforcement in that third country. That competent authority shall indicate why it considers that the legal and supervisory framework of the third country concerned is to be considered equivalent and shall provide relevant information to this end.



Such a third-country legal and supervisory framework may be considered equivalent where that framework fulfils at least the following conditions: (i) the markets are subject to authorization and to effective supervision and enforcement on an ongoing basis; (ii) the markets have clear and transparent rules regarding admission of securities to trading so that such securities are capable of being traded in a fair, orderly and efficient manner, and are freely negotiable; (iii) security issuers are subject to periodic and ongoing information requirements ensuring a high level of investor protection; and (iv) market transparency and integrity are ensured by the prevention of market abuse in the form of insider dealing and market manipulation. As regards point (e), in order to take into account the developments of financial markets, the Commission may adopt by means of delegated acts in accordance with Article 24a, and subject to the conditions of Articles 24b and 24c, measures to specify the above criteria or to add further ones to be applied in the assessment of the equivalence.

5. Article 5 is amended as follows (d) paragraph 5 is replaced by the following: "5. In order to take account of technical developments on financial markets and to specify the requirements laid down in this Article, the Commission shall adopt, by means of delegated acts in accordance with Article 24a and subject to the conditions of Articles 24b and 24c, measures relating to the following: (a) the format of the prospectus or base prospectus, the summary, final terms and supplements; and (b) the detailed content and specific form of the key information to be included in the summary. Those delegated acts shall be adopted by 1 July 2012."; 7. Article 7 is amended as follows: (a) paragraph 1 is replaced by the following: "1. Detailed delegated acts regarding the specific information which must be included in a prospectus, avoiding duplication of information when a prospectus is composed of separate documents, shall be adopted by the Commission in accordance with Article 24a and subject to the conditions of Articles 24b and 24c."; (c) paragraph 3 is replaced by the following: "3. The delegated acts referred to in paragraph 1 shall be based on the standards in the field of financial and non-financial information set out by international securities commission organizations, in particular by IOSCO and on the indicative Annexes to this Directive."; 8. Article 8 is amended as follows: (a) in the introductory part of paragraph 2 and in paragraph 3, the term "implementing measures" is replaced by "delegated acts"; (c) paragraph 4 is replaced by the following: "4. In order to take account of technical developments on financial markets and to specify the requirements laid down in this Article, the Commission shall adopt, by means of delegated acts in accordance with Article 24a and subject to the conditions of Articles 24b and 24c, measures concerning paragraph 2."; 11. Article 11 is amended as follows: (b) paragraph 3 is replaced by the following: "3. In order to take account of technical developments on financial markets and to specify the



requirements laid down in this Article, the Commission shall adopt, by means of delegated acts in accordance with Article 24a and subject to the conditions of Articles 24b and 24c, measures concerning the information to be incorporated by reference."; 13. in Article 13, paragraph 7 is replaced by the following: "7. In order to take account of technical developments on financial markets and to specify the requirements laid down in this Article, the Commission shall adopt, by means of delegated acts in accordance with Article 24a and subject to the conditions of Articles 24b and 24c, measures concerning the conditions in accordance with which time limits may be adjusted."; 14. Article 14 is amended as follows: (b) paragraph 8 is replaced by the following: "8. In order to take account of technical developments on financial markets and to specify the requirements laid down in this Article, the Commission shall adopt, by means of delegated acts in accordance with Article 24a and subject to the conditions of Articles 24b and 24c, measures concerning paragraphs 1 to 4 of this Article."; 15. in Article 15, paragraph 7 is replaced by the following:

"7. In order to take account of technical developments on financial markets and to specify the requirements laid down in this Article, the Commission shall adopt, by means of delegated acts in accordance with Article 24a and subject to the conditions of Articles 24b and 24c, measures concerning the dissemination of advertisements announcing the intention to offer securities to the public or the admission to trading on a regulated market, in particular before the prospectus has been made available to the public or before the opening of the subscription, and concerning paragraph 4 of this Article."; 19. in Article 20, the first subparagraph of paragraph 3 is replaced by the following: "3. The Commission shall adopt, by means of delegated acts in accordance with Article 24a and subject to the conditions of Articles 24b and 24c, measures to establish general equivalence criteria, based on the requirements laid down in Articles 5 and 7."; 20. in Article 21(4)(d), the words "its implementing measures" are replaced by "the delegated acts referred to therein"; 21. the following articles are inserted: "Article 24a Exercise of the delegation 1. The power to adopt delegated acts referred to in Article 1(4), Article 2(4), Article 3(4), the fifth subparagraph of Article 4(1), Article 5(5), Article 7(1), Article 8(4), Article 11(3), Article 13(7), Article 14(8), Article 15(7) and the first subparagraph of Article 20(3) shall be conferred on the Commission for a period of 4 years from 31 December 2010. The Commission shall draw up a report in respect of the delegated power at the latest 6 months before the end of the four-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 24b. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 24b and 24c. Article 24b Revocation of the delegation 1. The delegation of power referred to in Article 1(4), Article 2(4), Article 3(4), the fifth subparagraph of



Article 4(1), Article 5(5), Article 7(1), Article 8(4), Article 11(3), Article 13(7), Article 14(8), Article 15(7) or the first subparagraph of Article 20(3) may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavor to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation. 3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 24c Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of 3 months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by 3 months.

2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to the delegated act within the period referred to in paragraph 1, it shall not enter into force. In accordance with Article 296 of the Treaty on the Functioning of the European Union, the institution which objects shall state the reasons for objecting to the delegated act.";



14. Directive 2010/76/EU of the European Parliament and of the Council amending Directives 2006/48/EC and 2006/49/EC as regards capital requirements for the trading book and for re-securitisations, and the supervisory review of remuneration policies.

Whereas: (41) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in respect of technical adjustments to Directive 2006/48/EC to clarify definitions to ensure uniform application of that Directive or to take account of developments on financial markets; to align terminology on, and frame definitions in accordance with, subsequent relevant acts; to expand the content or adapt the terminology of the list of activities subject to mutual recognition under that Directive to take account of developments on financial markets; to adjust the areas in which the competent authorities are required to exchange information; to adjust the provisions of that Directive on own funds to reflect developments in accounting standards or Union legislation, or with regard to the convergence of supervisory practices; to expand the lists of exposure classes for the purposes of the Standardised Approach or the IRB Approach to take account of developments on financial markets; to adjust certain amounts relevant to those exposure classes to take into account the effects of inflation; to adjust the list and classification of off- balance sheet items; and to adjust specific provisions and technical criteria on the treatment of counterparty credit risk, the organization and treatment of risk, the Standardised Approach and the IRB Approach, credit risk mitigation, securitisation, operational risk, review and

evaluation by the competent authorities and disclosure in order to take account of developments on financial markets or in accounting standards or Union legislation, or with regard to the convergence of supervisory practices. The Commission should also be empowered to adopt delegated acts in accordance with Article 290 TFEU in respect of measures to specify the size of sudden and unexpected changes in interest rates relevant for the purposes of the review and evaluation by the competent authorities under Directive 2006/48/EC of interest rate risk arising from non-trading activities; to prescribe a temporary reduction in the minimum level of own funds or risk weights specified under that Directive in order to take account of specific circumstances; to clarify the exemption of certain exposures from the application of provisions of that Directive on large exposures; and to adjust the criteria for the assessment by supervisors under that Directive of the suitability of a proposed acquirer for a credit institution and the financial soundness of any proposed acquisition. (42) The Commission should also be empowered to adopt delegated acts in accordance with Article 290 TFEU in respect of technical adjustments to Directive 2006/49/EC to clarify definitions to ensure uniform application of that Directive or to take account of developments on financial markets; to adjust the amounts of initial capital prescribed by certain provisions of that Directive and specific amounts relevant to the calculation of capital requirements for the trading book to take account of developments in the economic and monetary field; to adjust the categories of investment firms eligible for certain derogations to required minimum levels of own funds to take account of developments on financial markets; to clarify the requirement that investment firms hold own funds equivalent to one quarter of their fixed overheads of the preceding year to ensure uniform application of that Directive; to align terminology and definitions with subsequent relevant acts; to adjust technical provisions of that Directive on the calculation of capital requirements for various classes of risk and large exposures, on the use of internal models to calculate capital requirements and on trading in order to take account of developments on financial markets or in risk measurement or accounting standards, or in Union legislation, or which have regard to the convergence of supervisory practices; and to take account of the outcome of the review of various matters relating to the scope of Directive 2004/39/EC. (43) The European Parliament and the Council should have 3 months from the date of notification to object to a delegated act. At the initiative of the European Parliament or the Council, it should also be possible to prolong that period by 3 months. It should be possible for the European Parliament and the Council to inform the other institutions of their intention not to raise objections. Such early approval of




delegated acts is particularly appropriate when deadlines need to be met, for example where there are timetables in the basic act for the Commission to adopt delegated acts. (44) In Declaration 39 on Article 290 of the Treaty on the Functioning of the European Union, annexed to the Final Act of the Intergovernmental Conference which adopted the Treaty of Lisbon, signed on 13 December 2007, the Conference took note of the Commission’s intention to continue to consult experts appointed by the Member States in the preparation of draft delegated acts in the financial services area, in accordance with its established practice. Article 1 Amendments to Directive 2006/48/EC 12. The title of Title VI is replaced by the following: ‘DELEGATED ACTS AND POWERS OF EXECUTION’. 13. Article 150 is amended as follows: (a) paragraph 1 is replaced by the following: ‘1. Without prejudice, as regards own funds, to the proposal that the Commission is to submit pursuant to Article 62, the technical adjustments in the following areas shall be adopted by means of delegated

acts in accordance with Article 151a, and subject to the conditions of Articles 151b and 151c: (a) clarification of the definitions to ensure uniform application of this Directive; (b) clarification of the definitions in order to take account, in the application of this Directive, of developments on financial markets; (c) the alignment of terminology on, and the framing of definitions in accordance with, subsequent acts on credit institutions and related matters; (d) expansion of the content of the list referred to in Articles 23 and 24 and set out in Annex I or adaptation of the terminology used in that list to take account of developments on financial markets; (e) the areas in which the competent authorities shall exchange information as listed in Article 42; (f) technical adjustments in Articles 56 to 67 and in Article 74 as a result of developments in accounting standards or requirements which take account of Union legislation or with regard to the convergence of supervisory practices; EN 14.12.2010 Official Journal of the European Union L 329/ (g) amendment of the list of exposure classes in Articles 79 and 86 in order to take account of developments on financial markets; (h) the amount specified in Article 79(2)(c), Article 86(4)(a), Annex VII, Part 1, point 5 and Annex VII, Part 2, point 15, to take into account the effects of inflation; (i) the list and classification of off-balance sheet items in Annexes II and IV; (j) adjustment of the provisions in Annexes III and V to XII in order to take account of developments on financial markets (in particular new financial products) or in accounting standards or requirements which take account of Union legislation, or with regard to the convergence of supervisory practices. 1a. The following measures shall be adopted in accordance with the regulatory procedure referred to in Article 151(2a): (a) technical adjustments to the list in Article 2; (b) alteration of the amount of initial capital prescribed in Article 9 to take account of developments in the economic and monetary field.’; (b) paragraph 2 is amended as follows: (i) in the first subparagraph, the introductory part is replaced by the following: ‘The Commission may adopt the following measures:’; (ii) the second subparagraph is replaced by the following: ‘The measures referred to in points (a), (b), (c) and (f) of the first subparagraph shall be adopted by



means of delegated acts in accordance with Article 151a, and subject to the conditions of Articles 151b and 151c. The measures referred to in points (d) and (e) of the first subparagraph shall be adopted in accordance with the regulatory procedure referred to in Article 151(2a).’. 15. The following articles are inserted: ‘Article 151a Exercise of the delegation 1. The power to adopt delegated acts referred to in Article 150(1) and the first sentence of the second subparagraph of Article 150(2) shall be conferred on the Commission for a period of 4 years from 15 December 2010. The Commission shall draw up a report in respect of the delegated power at the latest 6 months before the end of the four-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 151b. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down

in Articles 151b and 151c. Article 151b Revocation of the delegation 1. The delegation of power referred to in Article 150(1) and the first sentence of the second subparagraph of Article 150(2) may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation. 3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 151c Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of 3 months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by 3 months. 2. If, on the expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to the delegated act within the period referred to in paragraph 1, it shall not enter into force. In accordance with Article 296 TFEU, the institution which objects shall state the reasons for objecting to the delegated act.’. Article 2 Amendments to Directive 2006/49/EC 4. The title of Section 2 of Chapter VIII is replaced by the following: ‘Delegated acts and powers of execution’.



5. Article 41(2) is replaced by the following: ‘2. The measures referred to in paragraph 1 shall be adopted by means of delegated acts in accordance with Article 42a, and subject to the conditions of Articles 42b and 42c.’. 7. The following articles are inserted: ‘Article 42a Exercise of the delegation 1. The power to adopt delegated acts referred to in Article 41 shall be conferred on the Commission for a period of 4 years from 15 December 2010. The Commission shall draw up a report in respect of the delegated power at the latest 6 months before the end of the four-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 42b. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 42b and 42c.

Article 42b Revocation of the delegation 1. The delegation of power referred to in Article 41 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation. 3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 42c Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of 3 months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by 3 months. 2. If, on the expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to the delegated act within the period referred to in paragraph 1, it shall not enter into force. In accordance with Article 296 of the Treaty on the Functioning of the European Union, the institution which objects shall state the reasons for objecting to the delegated act.’. 8. Article 47 is replaced by the following: ‘Until 30 December 2011 or any earlier date specified by the competent authorities on a case-by-case basis, institutions that have received specific risk-model recognition prior to 1 January 2007 in accordance with point 1 of Annex V may, for that existing recognition, apply points 4 and 8 of Annex VIII to Directive 93/6/EEC as those points stood prior to 1 January 2007.’.



9. The Annexes are amended as set out in Annex II to this Directive.

15. Directive 2010/78/EU of the European Parliament and of the Council amending Directives 98/26/EC, 2002/87/EC, 2003/6/EC, 2003/41/EC, 2003/71/EC, 2004/39/EC, 2004/109/EC, 2005/60/EC, 2006/48/EC, 2006/49/EC and 2009/65/EC in respect of the powers of the European Supervisory Authority (European Banking Authority), the European

Supervisory Authority (European Insurance and Occupational Pensions Authority) and the European Supervisory Authority (European Securities and Markets Authority)

Whereas: (9) The regulations establishing the ESFS provide that, in the areas specifically set out in the relevant legislation, the ESA may develop draft technical standards, to be submitted to the Commission for adoption in accordance with Articles 290 and 291 of the Treaty on the Functioning of the European Union (TFEU) by means of delegated or implementing acts. This Directive should identify a first set of such areas and should be without prejudice to adding further areas in the future. (10) The relevant legislation should define those areas where the ESA are empowered to develop draft technical standards and how they should be adopted. The relevant legislation should lay down the elements, conditions and specifications as detailed in Article 290 TFEU in the case of delegated acts.

(12) Matters subject to technical standards should be genuinely technical, where their development requires the expertise of supervisory experts. The technical standards adopted as delegated acts should further develop, specify and determine the conditions for consistent harmonisation of the rules included in basic instruments adopted by the European Parliament and the Council, supplementing or amending certain non-essential elements of the legislative act. The technical standards adopted as implementing acts should set conditions for the uniform application of legally binding Union acts. Technical standards should not involve policy choices. (23) The alignment of committee procedures to the TFEU and, in particular, to Articles 290 and 291 thereof, should be effected on a case-by-case basis. In order to take account of the technical developments in the financial markets and to specify the requirements laid down in the directives amended by this Directive, the Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU. (24) The European Parliament and the Council should have 3 months from the date of notification to object to a delegated act. At the initiative of the European Parliament or the Council, it should be possible to prolong that period by 3 months in regard to significant areas of concern. It should also be possible for the European Parliament and the Council to inform the other institutions of their intention not to raise objections. Such early approval of delegated acts is particularly appropriate when deadlines need to be met, for example where there are timetables in the basic act for the Commission to adopt delegated acts. (25) In the Declaration (No 39) on Article 290 TFEU, annexed to the Final Act of the Intergovernmental Conference which adopted the Treaty of Lisbon, the Conference took note of the Commission’s intention to continue to consult experts appointed by the Member States in the preparation of draft delegated acts in the financial services area, in accordance with its established practice Article 2 Amendments to Directive 2002/87/EC (13) In Article 20(1), the following subparagraph is added: ‘Those measures shall not include the subject matter of the power delegated and conferred on the Commission with regard to the items listed in Article 21a.’. (14) Article 21 is amended as follows: (b) paragraph 5 is replaced by the following: ‘5.By 1 December 2011 the Commission shall review Article 20 and present any appropriate legislative proposals in order to allow the full application of delegated acts under Article 290 TFEU and implementing acts under Article 291 TFEU in respect of this Directive. Without prejudice to implementing measures already adopted, the powers conferred on the Commission in Article 21 to adopt implementing measures





that remain after the entry into force of the Lisbon Treaty, shall cease to apply on 1 December 2012.’. (15) The following Article is inserted: ‘Article 21a Technical standards 1. In order to ensure consistent harmonisation of this Directive, the ESA, in accordance with Article 56 of Regulation (EU) No 1093/2010, of Regulation (EU) No 1094/2010, and of Regulation (EU) No 1095/2010 respectively may develop draft regulatory technical standards with regard to:(a) Article 2(11) in order to specify the application of Article 17 of Council Directive 78/660/EEC in the context of this Directive; (b) Article 2(17) in order to establish procedures or specify criteria for the determination of “relevant competent authorities”; (c) Article 3(5) in order to specify the alternative parameters for the identification of a financial conglomerate. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1093/2010, of Regulation (EU) No 1094/2010, and of Regulation (EU) No 1095/2010 respectively.

Article 3 Amendments to Directive 2003/6/EC (7) The following Article is inserted: ‘Article 17a By 1 December 2011 the Commission shall review Articles 1,6, 8, 14, and 16 and present any appropriate legislative proposals in order to allow the full application of the delegated acts under Article 290 TFEU and implementing acts under Article 291 TFEU in respect of this Directive. Without prejudice to implementing measures already adopted, the powers conferred on the Commission in Article 17 to adopt implementing measures that remain after the entry into force of the Lisbon Treaty shall cease to apply on 1 December 2012.’. Article 5 Amendments to Directive 2003/71/EC Directive 2003/71/EC is hereby amended as follows: (1) In Article 4, paragraph 3 is replaced by the following: ‘3. In order to ensure consistent harmonisation of this Directive, the European Supervisory Authority (European Securities and Markets Authority) (hereinafter “ESMA”)established by Regulation (EU) No 1095/2010 of the European Parliament and of the Council may develop draft regulatory technical standards to specify the exemptions concerning the points (a) to (e) of paragraph 1 and points (a)to (h) of paragraph 2. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10to 14 of Regulation (EU) No 1095/2010. (2) In Article 5(2), the following subparagraphs are added: ‘In order to ensure uniform conditions of application of this Directive and of the delegated acts adopted by the Commission in accordance with paragraph 5, ESMA shall develop draft implementing technical standards in order to ensure uniform conditions of application of the delegated acts adopted by the Commission in accordance with paragraph 5in relation to a uniform template for the presentation of the summary and to allow investors to compare the security concerned with other relevant products. Power is conferred on the Commission to adopt the implementing technical standards referred to in the



first subparagraph in accordance with Article 15 of Regulation (EU)No 1095/2010.’. (3) In Article 7, the following paragraph is added: ‘4. ESMA may develop draft implementing technical standards in order to ensure uniform conditions of application of the delegated acts adopted by the Commission in accordance with paragraph 1. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU)No 1095/2010.’. (4) In Article 8, the following paragraph is added: ‘5. ESMA may develop draft implementing technical standards to ensure uniform conditions of application of the delegated acts adopted by the Commission in accordance with paragraph 4. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU)No 1095/2010.’. (7) In Article 16, the following paragraph is added: ‘3.

In order to ensure consistent harmonisation, to specify the requirements laid down in this Article and to take account of technical developments on financial markets, ESMA shall develop draft regulatory technical standards to specify situations where a significant new factor, material mistake or inaccuracy relating to the information included in the prospectus requires a supplement to the prospectus to be published. ESMA shall submit those draft regulatory technical standards to the Commission by 1 January 2014. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10to 14 of Regulation (EU) No 1095/2010.’. (11) Article 22 is amended as follows: (c) The following paragraph is added: ‘4. In order to ensure consistent harmonisation of this Article and to take account of technical developments on financial markets, ESMA shall develop draft regulatory technical standards to specify the information required in paragraph 2. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 6 Amendments to Directive 2004/39/EC (2) In Article 7, the following paragraph is added: ‘4. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU)No 1095/2010. (11) Article 31 is amended as follows: (b) the following paragraph is added: ‘7. In order to ensure consistent harmonisation of this Article, ESMA may develop draft regulatory technical standards to specify the information to be notified in accordance with paragraphs 2, 4 and 6. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.



In order to ensure uniform conditions of application of this Article, ESMA may develop draft implementing technical standards to establish standard forms, templates and procedures for the transmission of information in accordance with paragraphs 3, 4 and 6. Power is conferred on the Commission to adopt the implementing technical standards referred to in the third subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010.’. (12) In Article 32, the following paragraph is added: ‘10. In order to ensure consistent harmonisation of this Article, ESMA may develop draft regulatory technical standards to specify the information to be notified in accordance with paragraphs 2, 4 and 9. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU)No 1095/2010. (22) Article 57 is amended as follows: (a) the existing text is renumbered as paragraph 1. (b) the following paragraphs are added:

‘2. With the objective of converging supervisory practices, ESMA shall be able to participate in the activities of the colleges of supervisors, including on-site verifications or investigations, carried out jointly by two or more competent authorities in accordance with Article 21 of Regulation (EU) No 1095/2010.3. In order to ensure consistent harmonisation of paragraph 1, ESMA may develop draft regulatory technical standards to specify the information to be exchanged between competent authorities when cooperating in supervisory activities, on-the-spot-verifications, and investigations. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation. (EU) No 1095/2010. (30) The following Article is inserted ‘Article 64a Sunset clause By 1 December 2011 the Commission shall review Articles 2, 4, 10b, 13, 15, 18, 19, 21, 22, 24 and 25, Articles 27 to 30, and Articles 40, 44, 45, 56 and 58 and present any appropriate legislative proposal in order to allow the full application of the delegated acts under Article 290TFEU and implementing acts under Article 291 TFEU in respect of this Directive. Without prejudice to implementing measures already adopted, the powers conferred on the Commission in Article 64 to adopt implementing measures that remain after the entry into force of the Lisbon Treaty on1 December 2009 shall cease to apply on 1 December2012.’. Article 7 Amendments to Directive 2004/109/EC Directive 2004/109/EC is hereby amended as follows: (1) Article 2(3) is amended as follows: (a) the first subparagraph is replaced by the following: ‘3. In order to take account of technical developments on financial markets, to specify the requirements and to ensure the uniform application of paragraph 1,the Commission shall adopt, in accordance with Article 27(2a), (2b) and (2c), and subject to the conditions of Articles 27a and 27b, measures concerning the definitions set out in paragraph 1.’. (b) the third subparagraph is replaced by the following:



‘The measures referred to in points (a) and (b) of the second subparagraph shall be laid down by means of delegated acts in accordance with Article 27(2a), (2b)and (2c), and subject to the conditions of Articles 27aand 27b.’. (2) Article 5(6) is amended as follows: (b) the third subparagraph is replaced by the following: ‘The measures referred to in point (a) shall be adopted in accordance with the regulatory procedure referred to in Article 27(2). The measures referred to in points (b)and (c) shall be laid down by means of delegated acts in accordance with Article 27(2a), (2b) and (2c), and subject to the conditions of Articles 27a and 27b.’; (c) the fourth subparagraph is replaced by the following: ‘Where appropriate, the Commission may also adapt the five-year period referred to in paragraph 1 by means of a delegated act in accordance with Article 27(2a),(2b) and (2c), and subject to the conditions of Articles 27a and 27b.’. (3) Article 9(7) is amended as follows: (a) the first subparagraph is replaced by the following:

‘7. The Commission shall adopt, by means of delegated acts in accordance with Article 27(2a), (2b)and (2c), and subject to the conditions of Articles 27aand 27b, measures in order to take account of technical developments on financial markets and to specify the requirements laid down in paragraphs 2, 4 and 5.’. (b) the second subparagraph is replaced by the following: ‘The Commission shall specify, by means of delegated acts in accordance with Article 27(2a), (2b) and (2c),and subject to the conditions of Articles 27a and 27b,the maximum length of the “short settlement cycle” referred to in paragraph 4 of this Article, as well as the appropriate control mechanisms by the competent authority of the home Member State.’ (5) Article 13 is amended as follows: (a) in paragraph 2: (i) the first subparagraph is replaced by the following: ‘2. The Commission shall adopt, by means of delegated acts in accordance with Article 27(2a),(2b) and (2c), and subject to the conditions of Articles 27a and 27b, measures in order to take account of technical developments on financial markets and to specify the requirements laid down in paragraph 1. It shall in particular determine:’; (6) Article 14(2) is replaced by the following: ‘2. The Commission shall adopt, by means of delegated acts in accordance with Article 27(2a), (2b) and (2c), and subject to the conditions of Articles 27a and 27b, measures in order to take account of technical developments on financial markets and to specify the requirements laid down in paragraph 1.’. (7) Article 17(4) is replaced by the following: ‘4. The Commission shall adopt, by means of delegated acts in accordance with Article 27(2a), (2b) and (2c), and subject to the conditions of Articles 27a and 27b, measures in order to take account of technical developments on financial markets, to take account of developments in information and communication technology and to specify the requirements laid down in paragraphs 1, 2 and 3. The Commission shall, in particular, specify the types of financial institution through which a shareholder may exercise the financial rights provided for in paragraph 2(c).’.



(8) Article 18(5) is replaced by the following: ‘5. The Commission shall adopt, by means of delegated acts in accordance with Article 27(2a), (2b) and (2c), and subject to the conditions of Articles 27a and 27b, measures in order to take account of technical developments on financial markets, to take account of developments in information and communication technology and to specify the requirements laid down in paragraphs 1 to 4. The Commission shall, in particular, specify the types of financial institution through which a debt security holder may exercise the financial rights provided for in paragraph 2(c).’. (9) Article 19(4) is replaced by the following: ‘4. The Commission shall adopt, by means of delegated acts in accordance with Article 27(2a), (2b) and (2c), and subject to the conditions of Articles 27a and 27b, measures in order to specify the requirements laid down in paragraphs 1, 2 and 3. (10) Article 21(4) is replaced by the following: ‘4.

The Commission shall adopt, by means of delegated acts in accordance with Article 27(2a), (2b) and (2c), and subject to the conditions of Articles 27a and 27b, measures to take account of technical developments on financial markets, to take account of developments in information and communication technology and to specify the requirements laid down in paragraphs 1, 2 and 3. The Commission shall, in particular, specify:(a) minimum standards for the dissemination of regulated information, as referred to in paragraph 1; (b) minimum standards for the central storage mechanism as referred to in paragraph 2. The Commission may also specify and update a list of media for the dissemination of information to the public.’ (12) Article 23 is amended as follows: (b) paragraph 4 is replaced by the following: ‘4. In order to ensure the uniform conditions of application of paragraph 1, the Commission shall adopt, in accordance with the procedure referred to in Article 27(2), implementing measures:(i) setting up a mechanism ensuring the establishment of equivalence of information required under this Directive, including financial statements and information, required under the law, regulations or administrative provisions of a third country; (ii) stating that, by reason of its domestic law, regulations, administrative provisions, or of the practices or procedures based on the international standards set by international organizations, the third country where the issuer is registered ensures the equivalence of the information requirements provided for in this Directive. In the context of point (ii) of the first subparagraph, the Commission shall also adopt, by means of delegated acts in accordance with Article 27(2a), (2b) and (2c),and subject to the conditions of Articles 27a and 27b,measures concerning the assessment of standards relevant to the issuers of more than one country. The Commission shall, in accordance with the procedure referred to in Article 27(2), take the necessary decisions on the equivalence of accounting standards which are used by third-country issuers under the conditions set out in Article 30(3). If the Commission decides that the accounting standards of a third country are not equivalent, it may allow the issuers concerned to continue using such accounting standards during an appropriate transitional period.



In the context of the third subparagraph, the Commission shall also adopt, by means of delegated acts in accordance with Article 27(2a), (2b) and (2c), and subject to the conditions of Articles 27a and 27b, measures aimed at establishing general equivalence criteria regarding accounting standards relevant to issuers of more than one country.’. (c) paragraph 5 is replaced by the following: ‘5. In order to specify the requirements laid down in paragraph 2, the Commission may adopt, by means of delegated acts in accordance with Article 27(2a), (2b)and (2c), and subject to the conditions of Articles 27aand 27b, measures defining the type of information disclosed in a third country that is of importance to the public in the Union.’. (d) in paragraph 7, the second subparagraph is replaced by the following: ‘The Commission shall also adopt, by means of delegated acts in accordance with Article 27(2a), (2b)and (2c), and subject to the conditions of Articles 27aand 27b, measures aimed at establishing general equivalence criteria for the purpose of the first subparagraph.’. (16) The title of Chapter VI is replaced by the following:

‘DELEGATED ACTS AND IMPLEMENTING MEASURES’. (17) Article 27 is amended as follows: (a) paragraph 2a is replaced by the following: ‘2a. The power to adopt the delegated acts referred to in Article 2(3), Article 5(6), Article 9(7), Article 12(8),Article 13(2), Article 14(2), Article 17(4), Article 18(5),Article 19(4), Article 21(4), Article 23(4), Article 23(5)and Article 23(7) shall be conferred on the Commission for a period of 4 years from 4 January 2011. The Commission shall draw up a report in respect of delegated power at the latest 6 months before the end of the four-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 27a.’. (b) the following paragraphs are inserted: ‘2b. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.2c. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 27a and 27b.’. (18) The following Articles are inserted: ‘Article 27a Revocation of the delegation1. The delegation of power referred to in Article 2(3),Article 5(6), Article 9(7), Article 12(8), Article 13(2),Article 14(2), Article 17(4), Article 18(5), Article 19(4)Article 21(4), Article 23(4), Article 23(5) and Article 23(7)may be revoked at any time by the European Parliament or by the Council.2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation.3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force .It shall be published in the Official Journal of the European Union. Article 27b



Objections to delegated acts1. The European Parliament or the Council may object to a delegated act within a period of 3 months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by 3 months.2. If, on the expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to a delegated act within the period referred to in paragraph 1, it shall not enter into force. In accordance with Article 296 TFEU, the institution which objects shall state the reasons for objecting to the delegated act.’. Article 8 Amendments to Directive 2005/60/EC

(5) In Article 34, the following paragraph is added: ‘3. In order to ensure consistent harmonisation and to take account of technical developments in the fight against money laundering and terrorist financing, the ESA, taking into account the existing framework and cooperating, as appropriate, with other relevant Union bodies in that field, may develop draft regulatory technical standards in accordance with Article 56 of Regulation (EU) No 1093/2010, of Regulation (EU) No 1094/2010 and of Regulation (EU)No 1095/2010 respectively, to specify the minimum content of the communication referred to in paragraph 2. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU)No 1093/2010.’. (7) The title of Chapter VI is replaced by the following: ‘DELEGATED ACTS AND IMPLEMENTING MEASURES’ (8) Article 40 is amended as follows: (ii) the second subparagraph is replaced by the following: ‘The measures shall be adopted by means of delegated acts in accordance with Article 41(2a), (2b)and (2c), and subject to the conditions of Articles 41a and 41b.’; (b) in paragraph 3, the second subparagraph is replaced by the following: ‘The measures shall be adopted by means of delegated acts in accordance with Article 41(2a), (2b) and (2c),and subject to the conditions of Articles 41a and 41b.’. (9) Article 41 is amended as follows: (b) paragraph 2a is replaced by the following: ‘2a. The power to adopt delegated acts referred to in Article 40 shall be conferred on the Commission for a period of 4 years from 4 January 2011. The Commission shall draw up a report in respect of the delegated power at the latest 6 months before the end of the four-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 41a.’; (c) the following paragraphs are inserted: ‘2b. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European



Parliament and to the Council.2c. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 41a and 41b.’; (10) The following Articles are inserted: ‘Article 41a Revocation of the delegation1. The delegation of power referred to in Article 40 maybe revoked at any time by the European Parliament or by theCouncil.2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation.3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or on a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 41b

Objections to delegated acts1. The European Parliament or the Council may object to a delegated act within a period of 3 months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by 3months.2. If, on the expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to a delegated act within the period referred to in paragraph 1, it shall not enter into force. In accordance with Article 296 TFEU, the institution which objects shall state the reasons for objecting to the delegated act.’. Article 9 Amendments to Directive 2006/48/EC Directive 2006/48/EC is hereby amended as follows: (1) Article 6 is amended as follows: (b) the following paragraphs are added: ‘2. In order to ensure consistent harmonisation ofthis Article, EBA may develop draft regulatory technicalstandards:(a) on the information to be provided to the competent authorities in the application for the authorisation of credit institutions, including theprogramme of operations provided for in Article 7; (b) specifying the conditions to comply with therequirement set out in Article 8; (c) specifying the requirements applicable to shareholders and members with qualifying holdings, aswell as to specify obstacles which may preventeffective exercise of the supervisory functions ofthe competent authority, as provided for inArticle 12. Power is delegated to the Commission to adopt theregulatory technical standards referred to in points (a),(b) and (c) of the first subparagraph in accordance withthe procedure laid down in Articles (5) In Article 19, the following paragraph is added: ‘9.



In order to ensure consistent harmonisation of this Article, EBA may develop draft regulatory technical standards to establish an exhaustive list of information, referred to in Article 19a (4), to be included by proposed acquirers in their notification, without prejudice to paragraph 3 of this Article. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU)No 1093/2010. In order to ensure uniform conditions of application of this Directive, EBA may develop draft implementing technical standards to establish common procedures, forms and templates for the consultation process between the relevant competent authorities as referred to in Article 19b. Power is conferred on the Commission to adopt the implementing technical standards referred to in the third subparagraph in accordance with Article 15 of Regulation (EU)No 1093/2010.’. (6) In Article 22, the following paragraph is added: ‘3. In order to specify the requirements laid down in this Article and to ensure the convergence of supervisory practices, EBA may develop draft regulatory technical standards to specify the arrangements, processes and mechanisms referred to in paragraph 1, in accordance with the principles of proportionality

and comprehensiveness set out in paragraph 2. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10to 14 of Regulation (EU) No 1093/2010.’. (7) In Article 25, the following paragraph is added: ‘Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10to 14 of Regulation (EU) No 1093/2010. Power is also conferred on the Commission to adopt the implementing technical standards referred to in the second subparagraph in accordance with Article 15 of Regulation(EU) No 1093/2010.’. (8) In Article 26, the following paragraph is added: ‘5. In order to ensure consistent harmonisation of this Article, EBA shall develop draft regulatory technical standards to specify the information to be notified in accordance with this Article. In order to ensure uniform conditions of application of this Article, EBA shall develop draft implementing technical standards to establish standard forms, templates and procedures for such notification. EBA shall submit those draft technical standards to the Commission by 1 January 2014. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10to 14 of Regulation (EU) No 1093/2010. Power is also conferred on the Commission to adopt the implementing technical standards referred to in the second subparagraph in accordance with Article 15 of Regulation (EU) No 1093/2010.’. (9) In Article 28, the following paragraph is added: ‘4. In order to ensure consistent harmonisation of this Article, EBA shall develop draft regulatory technical standards to specify the information to be notified in accordance with this Article. In order to ensure uniform conditions of application of this Article, EBA shall develop draft implementing technical standards to establish standard forms, templates and procedures for such notification. EBA shall submit those draft technical standards to the Commission by 1 January 2014. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first



subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010. Power is also conferred on the Commission to adopt the implementing technical standards referred to in the second subparagraph in accordance with Article 15 of Regulation (EU) No 1093/2010.’. (14) In Article 42, the following paragraphs are added: ‘The competent authorities may refer to EBA situations where a request for collaboration, in particular to exchange information, has been rejected or has not been acted upon within a reasonable time. Without prejudice to Article 258of the Treaty on the Functioning of the European Union(TFEU), EBA may, in situations referred to in the first sentence, act in accordance with the powers conferred on it under Article 19 of Regulation (EU) No 1093/2010. In order to ensure consistent harmonisation of this Article, EBA shall develop draft regulatory technical standards to specify the information contained in this Article. In order to ensure uniform conditions of application of this Article, EBA shall develop draft implementing technical standards to establish standard forms, templates and procedures for the information sharing requirements which are likely to facilitate the monitoring of credit institutions. EBA shall submit those draft technical standards to the Commission by 1 January 2014.

Power is delegated to the Commission to adopt the regulatory technical standards referred to in the third paragraph in accordance with the procedure laid down in Articles 10to 14 of Regulation (EU) No 1093/2010. (15) Article 42a is amended as follows: (b) in paragraph 3, the following subparagraphs are added: ‘In order to ensure consistent harmonisation of this Article, EBA may develop draft regulatory technical standards in order to specify general conditions for the functioning of colleges of supervisors. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the fourth subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU)No 1093/2010. In order to ensure uniform conditions of application of this Article, EBA may develop draft implementing technical standards in order to determine the operational functioning of colleges of supervisors. Power is conferred on the Commission to adopt the implementing technical standards referred to in the sixth subparagraph in accordance with Article 15 of Regulation (EU) No 1093/2010.’. (20) Article 63a is amended as follows: (a) paragraph 4 is replaced by the following: ‘4. The provisions governing the instrument shall provide for principal, unpaid interest or dividend to be such as to absorb losses and to not hinder the recapitalisation of the credit institution through appropriate mechanisms, as developed by EBA under paragraph 6’; (b) paragraph 6 is replaced by the following: ‘6. In order to ensure consistent harmonisation and to ensure the convergence of supervisory practices, EBA shall develop draft regulatory technical standards to specify the requirements applicable to the instruments referred to in paragraph 1 of this Article EBA shall submit those draft regulatory technical standards to the Commission by 1 January 2014. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1093/2010. EBA shall also issue guidelines in relation to instruments referred to in point (a) of the first paragraph of Article 57.



EBA shall monitor the application of those guidelines (22) In Article 81(2) the following subparagraphs are added: ‘In order to ensure consistent harmonisation of this Article, EBA, in consultation with the European Supervisory Authority (European Securities and Markets Authority) (hereinafter “ESMA”), established by Regulation (EU) No 1095/2010 of the European Parliament and of the Council, shall develop draft regulatory technical standards to specify the assessment methodology relating to credit assessments. EBA shall submit those draft regulatory technical standards to the Commission by 1 January 2014. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the second subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1093/2010. (23) In Article 84(2), the following subparagraphs are added: ‘In order to ensure consistent harmonisation of this Article, EBA may develop draft regulatory technical standards to specify the assessment methodology under which the competent authorities permit credit institutions to use the IRB approach. Power is delegated to the Commission to adopt the regulatory technical standards referred to in point (a)

of the first subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1093/2010.’. (24) In Article 97(2), the following subparagraphs are added: ‘In order to ensure consistent harmonisation of this Article, EBA, in consultation with ESMA, shall develop draft regulatory technical standards to specify the assessment methodology relating to credit assessments. EBA shall submit those draft regulatory technical standards to the Commission by1 January 2014. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the second subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1093/2010.’. (25) In Article 105(1), the following subparagraphs are added: ‘In order to ensure consistent harmonisation of this Article, EBA may develop draft regulatory technical standards to specify the assessment methodology under which the competent authorities permit credit institutions to use Advanced Measurement Approaches. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the second subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1093/2010.’. (26) In Article 106(2), the second subparagraph is replaced by the following: ‘In order to ensure consistent harmonisation of this paragraph, EBA shall develop draft regulatory technical standards in order to specify the exemptions in points (c) and (d) as well as to specify the conditions used to determine the existence of a group of connected clients, as stated in paragraph 3. EBA shall submit those draft regulatory technical standards to the Commission by 1 January 2014. Power is delegated to the Commission to adopt the regulatory technical standards referred to the second subparagraph in accordance with the procedure laid down in Articles 10to 14 of Regulation (EU) No 1093/2010.’. (29) Article 122a(10) is replaced by the following: ‘10. EBA shall report to the Commission annually on the compliance with this Article by the competent authorities. In order to ensure consistent harmonisation of this Article, EBA shall develop draft regulatory technical



standards for the convergence of supervisory practices with regard to this Article, including the measures taken in case of breach of the due diligence and risk management obligations. EBA shall submit those draft regulatory technical standards to the Commission by 1 January 2014. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the second subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation (EU) No 1093/2010.’. (30) In Article 124, the following paragraph is added: ‘6. In order to ensure consistent harmonisation of this Article, EBA may develop draft regulatory technical standards to specify this Article and a common risk assessment procedure and methodology. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10to 14 of Regulation (EU) No 1093/2010.’. (35) Article 131a is amended as follows: (a) paragraph 1 is replaced by the following:

‘1. The consolidating supervisor shall establish colleges of supervisors to facilitate the exercise of the tasks referred to in Article 129 and Article 130(1) and subject to the confidentiality requirements of paragraph 2of this Article and compatibility with Union law, ensure appropriate coordination and cooperation with relevant third-country competent authorities where appropriate. EBA shall contribute to promoting and monitoring the efficient, effective and consistent functioning of colleges of supervisors referred to in this Article in accordance with Article 21 of Regulation (EU) No 1093/2010. To that end, EBA shall participate as it deems appropriate and shall be considered as a competent authority for that purpose. Colleges of supervisors shall provide a framework for the consolidating Supervisor, EBA and the other competent authorities concerned to carry out the following tasks:(a) exchanging information among themselves and with EBA in accordance with Article 21 of Regulation (EU) No 1093/2010; (b) agreeing on voluntary entrustment of tasks and voluntary delegation of responsibilities where appropriate; (c) determining supervisory examination programmes based on a risk assessment of the group in accordance with Article 124; (d) increasing the efficiency of supervision by removing unnecessary duplication of supervisory requirements, including in relation to the information requests referred to in Article 130(2) and Article 132(2); (e) consistently applying the prudential requirements under this Directive across all entities within a banking group without prejudice to the options and discretions available in Union legislation; (f) applying Article 129(1)(c) taking into account the work of other forums that may be established in that area. The competent authorities participating in the colleges of supervisors and EBA shall cooperate closely. The confidentiality requirements under Chapter 1, Section 2shall not prevent the competent authorities from exchanging confidential information within colleges of supervisors. The establishment and functioning of colleges of supervisors shall not affect the rights and responsibilities of the competent authorities under this Directive.’; (b) in paragraph 2: (i) the second subparagraph is replaced by the following:



‘In order to ensure consistent harmonisation of this Article, EBA may develop draft regulatory technical standards in order to specify general conditions of functioning of the colleges of supervisors. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the second subparagraph in accordance with the procedure laid down in Articles 10 to 14 of Regulation(EU) No1093/2010. Article 10 Amendments to Directive 2006/49/EC Directive 2006/49/EC is hereby amended as follows: (1) In Article 18, the following paragraph is added: ‘5. The European Supervisory Authority (European Banking Authority) (hereinafter “EBA”) established by Regulation(EU) No 1093/2010 of the European Parliament and of the Council, may develop draft regulatory technical standards to specify the assessment methodology under which competent authorities permit institutions to use internal models for the purposes of calculating capital requirements under this Directive.

Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10to 14 of Regulation (EU) No 1093/2010. Article 11 Amendments to Directive 2009/65/EC Directive 2009/65/EC is hereby amended as follows: (1) In Article 5, the following paragraph is added: ‘8. In order to ensure consistent harmonisation of this Article the European Supervisory Authority (European Securities and Markets Authority) (hereinafter “ESMA”), established by Regulation (EU) No 1095/2010 of the European Parliament and of the Council may develop draft regulatory technical standards to specify the information to be provided to the competent authorities in the application for authorisation of a UCITS. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with the procedure laid down in Articles 10to 14 of Regulation (EU) No 1095/2010. (5) In Article 11, the following paragraph is added: ‘3. In order to ensure consistent harmonisation of this Directive, ESMA may develop draft regulatory technical standards to establish an exhaustive list of information, as provided for in this Article, with reference to Article 10b(4)of Directive 2004/39/EC, to be included by proposed acquirers in their notification, without prejudice to Article 10a(2)of that Directive. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. (6) Article 12 is amended as follows: (a) paragraph 3 is amended as follows: (i) the first subparagraph is replaced by the following: ‘3. Without prejudice to Article 116, the Commission shall adopt, by means of delegated acts in accordance with Article 112(2), (3) and (4), and subject to the conditions of Articles 112aand 112b, measures



specifying the procedures and arrangements as referred to under point (a) of the second subparagraph of paragraph 1 and the structures and organisational requirements to minimise conflicts of interests as referred to under point (b)of the second subparagraph of paragraph 1.’; (b) the following paragraph is added: ‘4. In order to ensure uniform conditions of application of this Article, ESMA may develop draft implementing technical standards to determine the conditions of applications of the delegated acts adopted by the Commission regarding the procedures, arrangements, structures and organisational requirements referred to in paragraph 3. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010.’. (7) Article 14 is amended as follows: (a) paragraph 2 is amended as follows: (i) in the first subparagraph, the introductory part is replaced by the following: ‘2.

Without prejudice to Article 116, the Commission shall adopt, by means of delegated acts in accordance with Article 112(2), (3) and (4), and subject to the conditions of Articles 112aand 112b, measures with a view to ensuring that the management company complies with the duties set out in paragraph 1, in particular to:’; (b) the following paragraph is added: ‘3. In order to ensure uniform conditions of application of this Article, ESMA may develop draft implementing technical standards to determine the delegated acts adopted by the Commission regarding the criteria, principles and steps referred to in paragraph 2. (8) In Article 17, the following paragraph is added: ‘10. In order to ensure consistent harmonisation of this Article ESMA may develop draft regulatory technical standards to specify the information to be notified in accordance with paragraphs 1, 2, 3, 8 and 9. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU)No 1095/2010. In order to ensure uniform conditions of application of this Article, ESMA may develop draft implementing technical standards to establish standard forms, templates and procedures for the transmission of information in accordance with paragraphs 3 and 9. (9) In Article 18, the following paragraph is added: ‘5. In order to ensure consistent harmonisation of this Article ESMA may develop draft regulatory technical standards to specify the information to be notified in accordance with paragraphs 1, 2 and 4. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. (12) Article 23(6) is amended as follows: (a) the first subparagraph is replaced by the following: ‘6. The Commission may adopt, by means of delegated acts in accordance with Article 112(2), (3)and (4), and subject to the conditions of Articles 112aand 112b, measures in relation to the measures to betaken by a depositary in order to fulfil its duties regarding a UCITS managed by a management company



established in another Member State, including the particulars that need to be included in the standard agreement to be used by the depositary and the management company in accordance with paragraph 5.’; (13) In Article 29, the following paragraphs are added: ‘5. In order to ensure consistent harmonisation of this Directive, ESMA may develop draft regulatory technical standards to specify:(a) the information to be provided to the competent authorities in the application for the authorisation of the investment company, including the programme of operations; and (b) the obstacles which may prevent effective exercise ofthe supervisory functions of the competent authority under paragraph 1(c). Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. (15) Article 33(6) is amended as follows: (a) the first subparagraph is replaced by the following: ‘6.

The Commission may adopt, by means of delegated acts in accordance with Article 112(2), (3)and (4), and subject to the conditions of Articles 112aand 112b, measures in relation to the measures to betaken by a depositary in order to fulfil its duties regarding a UCITS managed by a management company established in another Member State, including the particulars that need to be included in the standard agreement to be used by the depositary and the management company in accordance with paragraph 5.’; (16) Article 43 is amended as follows: (a) in paragraph 5: (i) the first subparagraph is replaced by the following: ‘5. The Commission may adopt, by means of delegated acts in accordance with Article 112(2),(3) and (4), and subject to the conditions of Articles 112a and 112b, measures specifying the detailed content, format and method by which to provide the information referred to in paragraphs 1and 3.’; (b) the following paragraph is added: ‘6. In order to ensure uniform conditions of application of this Article, ESMA may develop draft implementing technical standards to determine the conditions of applications of the delegated acts adopted by the Commission regarding the content, format and method by which the information referred to in paragraphs 1 and 3 of this Article is to be provided. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010.’. (17) In Article 50, the following paragraph is added: ‘4. In order to ensure consistent harmonisation of this Article ESMA may develop draft regulatory technical standards to specify the provisions concerning the categories of assets in which UCITS can invest in accordance with this Article and with delegated acts adopted by the Commission which relate to such provisions. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.’. (18) Article 51 is amended as follows:



(b) paragraph 4 is replaced by the following: ‘4. Without prejudice to Article 116, the Commission shall adopt, by means of delegated acts in accordance with Article 112(2), (3) and (4), and subject to the conditions of Articles 112a and 112b, measures specifying the following:(a) criteria for assessing the adequacy of the risk management process employed by the management company in accordance with the first subparagraph of paragraph 1; (b) detailed rules regarding the accurate and independent assessment of the value of OTC derivatives; and (c) detailed rules regarding the content of and procedure to be followed for communicating the information referred to in the third subparagraph of paragraph 1 to the competent authorities of the management company’s home Member State.’; (c) the following paragraph is added: ‘5. In order to ensure uniform conditions of application of this Article, ESMA may develop draft implementing

technical standards to determine the conditions of application of the delegated acts adopted by the Commission regarding the criteria and rules referred to in paragraph 4. (20) Article 60 is amended as follows: (a) in paragraph 6: (i) in the first subparagraph, the introductory part is replaced by the following: ‘6. The Commission may adopt, by means of delegated acts in accordance with Article 112(2),(3) and (4), and subject to the conditions of Articles 112a and 112b, measures specifying:’; (b) the following paragraph is added: ‘7. In order to ensure uniform conditions of application of this Article, ESMA may develop draft implementing technical standards to determine the conditions of application of the delegated acts adopted by the Commission regarding the agreement, measures and procedures referred to in paragraph 6. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with the Article 15 of Regulation (EU) No 1095/2010.’. (21) Article 61 is amended as follows: (a) paragraph 3 is replaced by the following: ‘3. The Commission may adopt, by means of delegated acts in accordance with Article 112(2), (3)and (4), and subject to the conditions of Articles 112aand 112b, measures further specifying the following:(a) the particulars that need to be included in the agreement referred to in paragraph 1; and (b) the types of irregularities referred to in paragraph 2which are deemed to have a negative impact on the feeder UCITS.’. (b) the following paragraph is added: ‘4. In order to ensure uniform conditions of application of this Article, ESMA may develop draft implementing technical standards to determine the conditions of application of the delegated acts adopted by the Commission regarding the agreement, measures and types of irregularities referred to in paragraph 3.



Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010.’. (22) Article 62(4) is replaced by the following: ‘4. The Commission may adopt, by means of delegated acts in accordance with Article 112(2), (3) and (4), and subject to the conditions of Articles 112a and 112b, measures specifying the content of the agreement referred to in the first subparagraph of paragraph 1.’. (23) Article 64 is amended as follows: (a) paragraph 4 is replaced by the following: ‘4. The Commission may adopt, by means of delegated acts in accordance with Article 112(2), (3)and (4), and subject to the conditions of Articles 112aand 112b, measures specifying:(a) the format and the manner in which to provide the information referred to in paragraph 1; or (b) in the event that the feeder UCITS transfers all or parts of its assets to the master UCITS in exchange for units, the procedure for valuing and auditing such a contribution in kind and the role of the depositary

of the feeder UCITS in that process.’. (b) the following paragraph is added: ‘5. In order to ensure uniform conditions of application in which the information is provided, ESMA may develop draft implementing technical standards to determine the conditions of application of the delegated acts adopted by the Commission regarding the format and the manner of the information provided and procedure referred to in paragraph 4. Power is conferred on the Commission to adopt the implementing technical standards referred to in the first subparagraph in accordance with Article 15 of Regulation (EU) No 1095/2010.’. (24) In Article 69, the following paragraph is added: ‘5. In order to ensure consistent harmonisation of this Article, ESMA may develop draft regulatory technical standards to specify the provisions concerning the content of the prospectus, the annual report and the half-yearly report as laid down in Annex I, and the format of those documents. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU)No 1095/2010.’. (25) In Article 75, paragraph 4 is replaced by the following: ‘4. The Commission may adopt, by means of delegated acts in accordance with Article 112(2), (3) and (4), and subject to the conditions of Articles 112a and 112b, measures which define the specific conditions which need to be met when providing the prospectus in a durable medium other than paper or by means of a website which does not constitute a durable medium.’. (26) Article 78 is amended as follows: (a) paragraph 7 is replaced by the following: ‘7. The Commission shall adopt, by means of delegated acts in accordance with Article 112(2), (3)and (4), and subject to the conditions of Articles 112aand 112b, measures which define the following:(a) the detailed and exhaustive content of the key investor information to be provided to investors as referred to in paragraphs 2, 3 and 4; (b) the detailed and exhaustive content of the key investor information to be provided to investors in



the following specific cases: (i) for UCITS having different investment compartments, the key investor information to be provided to investors subscribing to a specific investment compartment, including how to pass from one investment compartment into another and the costs related thereto, (ii) for UCITS offering different share classes, the key investor information to be provided to investors subscribing to a specific share class, (iii) for fund of funds structures, the key investor information to be provided to investors subscribing to a UCITS, which invests itself in other UCITS or other collective investment undertakings referred to in Article 50(1)(e), (iv) for master-feeder structures, the key investor information to be provided to investors subscribing to a feeder UCITS, (v) for structured, capital protected and other comparable UCITS, the key investor information to be provided to investors in relation to the special characteristics of such UCITS; and (c) the specific details of the format and presentation of the key investor information to be provided to investors as referred to in paragraph 5.’;

(27) Article 81(2) is replaced by the following: ‘2. The Commission may adopt, by means of delegated acts in accordance with Article 112(2), (3) and (4), and subject to the conditions of Articles 112a and 112b, measures which define the specific conditions which need to be met when providing key investor information in a durable medium other than on paper or by means of a website which does not constitute a durable medium.’. (28) In Article 83, the following paragraph is added: ‘3. In order to ensure consistent harmonisation of this Article, ESMA may develop draft regulatory technical standards to specify the requirements of this Article relating to borrowing. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010.’. (29) In Article 84, the following paragraph is added: ‘4. In order to ensure consistent harmonisation of this Article, ESMA may develop draft regulatory technical standards to specify the conditions which need to be met by the UCITS after the adoption of the temporary suspension of there-purchase or redemption of the units of the UCITS as referred to in paragraph 2(a), once the suspension has been decided. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU)No 1095/2010.’. (30) Article 95 is replaced by the following: ‘Article 951. The Commission may adopt, by means of delegated acts in accordance with Article 112(2), (3) and (4), and subject to the conditions of Articles 112a and 112b, measures specifying: (a) the scope of the information referred to in Article 91(3); (b) the facilitation of access for the competent authorities of the UCITS host Member States to the information or documents referred to in Article 93(1), (2) and (3) in accordance with Article 93(7) (37) The title of chapter XIII is replaced by the following: ‘DELEGATED ACTS AND POWERS OF EXECUTION’ (38) Article 111 is replaced by the following:



‘Article 111 The Commission may adopt technical amendments to this Directive in the following areas:(a) clarification of the definitions in order to ensure consistent harmonisation and uniform application of this Directive throughout the Union; or (b) alignment of terminology and the framing of definitions in accordance with subsequent acts on UCITS and related matters. The measures referred to in the first subparagraph shall be adopted by means of delegated acts in accordance with Article 112(2), (3) and (4), and subject to the conditions of Articles 112a and 112b.’. (39) Article 112 is replaced by the following: ‘Article 1121. The Commission shall be assisted by the European Securities Committee established by Commission Decision2001/528/EC.2. The power to adopt the delegated acts referred to in Articles 12, 14, 23, 33, 43, 51, 60, 61, 62, 64, 75, 78, 81,95 and 111 shall be conferred on the Commission for a period of 4 years from 4 January 2011. The Commission shall draw up a report in respect of delegated powers at the latest 6 months before the

end of the four-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes them in accordance with Article 112a.3. As soon as it adopts a delegated act, the Commission shall notify the European Parliament and the Council thereofsimultaneously.4. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 112a and 112b.’. (40) The following Articles are inserted: ‘Article 112a Revocation of the delegation1. The delegation of power referred to in Articles 12, 14, 23, 33, 43, 51, 60, 61, 62, 64, 75, 78, 81, 95 and 111 maybe revoked at any time by the European Parliament or by theCouncil.2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation.3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 112b Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of 3 months from the date of notification. At the initiative of the European Parliament or the Council that period may be extended by 3 months. 2. If, on the expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the



Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to a delegated act within the period referred to in paragraph 1, it shall not enter into force. In accordance with Article 296 TFEU, the institution which objects shall state the reasons for objecting to the delegated act.’. Following the Lamfalussy architecture, these delegated acts are adopted by the Commission following a special procedure.

16. REGULATION (EU) No 649/2012 of the European Parliament and of the Council concerning the export and import of dangerous chemicals (recast)

Whereas: (23) In order to adapt this Regulation to technical progress, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of inclusion of chemicals in Part 1 or 2 of Annex I and other amendments to that Annex, inclusion of chemicals in Part 1 or 2 of Annex V and other amendments to that Annex, and

amendments to Annexes II, III, IV and VI. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. Article 23 Updating annexes 4. In order to adapt this Regulation to technical progress, the Commission shall be empowered to adopt delegated acts in accordance with Article 26 concerning the following measures: (a) inclusion of a chemical in Part 1 or 2 of Annex I pursuant to paragraph 2 of this Article following final regulatory action at Union level, and other amendments of Annex I, including modifications to existing entries; (b) inclusion of a chemical that is subject to Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants ( 1 ) in Part 1 of Annex V; (c) inclusion of a chemical already subject to an export ban at Union level in Part 2 of Annex V; (d) modifications to existing entries in Annex V; (e) amendments of Annexes II, III, IV and VI. Article 26 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 23(4) shall be conferred on the Commission for a period of five years from 1 March 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension no later than three months before the end of each period. 3. The delegation of power referred to in Article 23(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 23(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification




of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

17. Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC

(23) The Commission should endorse those draft regulatory technical standards by means of delegated acts under Article 290 TFEU in order to give them binding legal effect. They should be subject to amendment only in very restricted and extraordinary circumstances, since the Authority is the actor in close contact with and knowing best the daily functioning of financial markets. Draft regulatory technical standards would be subject to amendment if they were incompatible with Union law, did not respect the principle of proportionality or ran counter to the fundamental principles of the internal market for financial services as reflected in the acquis of Union financial services legislation. The Commission should not change the content of the draft regulatory technical standards prepared by the Authority without prior

coordination with the Authority. To ensure a smooth and expeditious adoption process for those standards, the Commission’s decision to endorse draft regulatory technical standards should be subject to a time limit. (24) Given the technical expertise of the Authority in the areas where regulatory technical standards should be developed, note should be taken of the Commission’s stated intention to rely, as a rule, on the draft regulatory technical standards submitted to it by the Authority in view of the adoption of the corresponding delegated acts. However, in cases where the Authority fails to submit a draft regulatory technical standard within the time limits set out by the relevant legislative act, it should be ensured that the result of the exercise of delegated power is actually achieved, and the efficiency of the decision-making process be maintained. In those cases, the Commission should therefore be empowered to adopt regulatory technical standards in the absence of a draft by the Authority. Article 10 Regulatory technical standards 1. Where the European Parliament and the Council delegate power to the Commission to adopt regulatory technical standards by means of delegated acts under Article 290 TFEU in order to ensure consistent harmonisation in the areas specifically set out in the legislative acts referred to in Article 1(2), the Authority may develop draft regulatory technical standards. The Authority shall submit its draft standards to the Commission for endorsement. Regulatory technical standards shall be technical, shall not imply strategic decisions or policy choices and their content shall be delimited by the legislative acts on which they are based. Before submitting them to the Commission, the Authority shall conduct open public consultations on draft regulatory technical standards and analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft regulatory technical standards concerned or in relation to the particular urgency of the matter. The Authority shall also request the opinion of the Securities and Markets Stakeholder Group referred to in Article 37. Where the Authority submits a draft regulatory technical standard, the Commission shall immediately forward it to the European Parliament and the Council. Within 3 months of receipt of a draft regulatory technical standard, the Commission shall decide whether to endorse it. The Commission may endorse the draft regulatory technical standards in part only, or with amendments, where the Union’s interests so require. Where the Commission intends not to endorse a draft regulatory technical standard or to endorse it in part or with amendments, it shall send the draft regulatory technical standard back to the Authority, explaining why it does not endorse it, or, as the case may be, explaining the reasons for its amendments. Within a period of 6 weeks, the Authority may amend the draft regulatory technical standard on the basis




of the Commission’s proposed amendments and resubmit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council. If, on the expiry of that six-week period, the Authority has not submitted an amended draft regulatory technical standard, or has submitted a draft regulatory technical standard that is not amended in a way consistent with the Commission’s proposed amendments, the Commission may adopt the regulatory technical standard with the amendments it considers relevant, or reject it. The Commission may not change the content of a draft regulatory technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article. The Commission may not change the content of a draft regulatory technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article. 2. Where the Authority has not submitted a draft regulatory technical standard within the time limit set out in the legislative acts referred to in Article 1(2), the Commission may request such a draft within a new time limit.3. Only where the Authority does not submit a draft regulatory technical standard to the Commission within

the time limits in accordance with paragraph 2, may the Commission adopt a regulatory technical standard by means of a delegated act without a draft from the Authority. Article 11 Exercise of the delegation 1. The power to adopt regulatory technical standards referred to in Article 10 shall be conferred on the Commission for a period of 4 years from 16 December 2010. The Commission shall draw up a report in respect of the delegated power not later than 6 months before the end of the four-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 14.2. As soon as it adopts a regulatory technical standard, the Commission shall notify it simultaneously to the European Parliament and to the Council.3. The power to adopt regulatory technical standards is conferred on the Commission subject to the conditions laid down in Articles 12 to 14. Article 12 Revocation of the delegation1. The delegation of power referred to in Article 10 may be revoked at any time by the European Parliament or by the Council.2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation.3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the regulatory technical standards already in force. It shall be published in the Official Journal of the European Union Following the Lamfalussy architecture, these delegated acts are adopted by the Commission following a special procedure.

18. Regulation (EU) No 1094/2010 of the European Parliament and of the Council of 24 November 2010 establishing a

Whereas: (22) The Commission should endorse those draft regulatory technical standards by means of delegated acts under Article 290 TFEU in order to give them binding legal effect. They should be subject to

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:331:0048:0083:EN:pdf



European Supervisory Authority (European Insurance and Occupational Pensions Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/79/EC

amendment only in very restricted and extraordinary circumstances, since the Authority is the actor in close contact with and knowing best the daily functioning of financial markets. Draft regulatory technical standards would be subject to amendment if they were incompatible with Union law, did not respect the principle of proportionality or ran counter to the fundamental principles of the internal market for financial services as reflected in the acquis of Union financial services legislation. The Commission should not change the content of the draft regulatory technical standards prepared by the Authority without prior coordination with the Authority. To ensure a smooth and expeditious adoption process for those standards, the Commission’s decision to endorse draft regulatory technical standards should be subject to a time limit. (23) Given the technical expertise of the Authority in the areas where regulatory technical standards should be developed, note should be taken of the Commission’s stated intention to rely, as a rule, on the draft regulatory technical standards submitted to it by the Authority in view of the adoption of the corresponding delegated acts. However, in cases where the Authority fails to submit a draft regulatory technical standard within the time limits set out by the relevant legislative act, it should be ensured that the result of the exercise of delegated power is actually achieved, and the efficiency of the decision-

making process be maintained. In those cases, the Commission should therefore be empowered to adopt regulatory technical standards in the absence of a draft by the Authority. Article 10 Regulatory technical standards 1. Where the European Parliament and the Council delegate power to the Commission to adopt regulatory technical standards by means of delegated acts under Article 290 TFEU in order to ensure consistent harmonisation in the areas specifically set out in the legislative acts referred to in Article 1(2), the Authority may develop draft regulatory technical standards. The Authority shall submit its draft standards to the Commission for endorsement. Regulatory technical standards shall be technical, shall not imply strategic decisions or policy choices and their content shall be delimited by the legislative acts on which they are based. Before submitting them to the Commission, the Authority shall conduct open public consultations on draft regulatory technical standards and analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft regulatory technical standards concerned or in relation to the particular urgency of the matter. The Authority shall also request the opinion of the relevant stakeholder group referred to in Article 37. Where the Authority submits a draft regulatory technical standard, the Commission shall immediately forward it to the European Parliament and the Council. Within 3 months of receipt of a draft regulatory technical standard, the Commission shall decide whether to endorse it. The Commission may endorse the draft regulatory technical standards in part only, or with amendments, where the Union’s interests so require. Where the Commission intends not to endorse a draft regulatory technical standard, or to endorse it in part or with amendments, it shall send the draft regulatory technical standard back to the Authority, explaining why it does not endorse it, or, as the case may be, explaining the reasons for its amendments. Within a period of 6 weeks, the Authority may amend the draft regulatory technical standard on the basis of the Commission’s proposed amendments and resubmit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council. If, on the expiry of that six-week period, the Authority has not submitted an amended draft regulatory technical standard, or has submitted a draft regulatory technical standard that is not amended in a way



consistent with the Commission’s proposed amendments, the Commission may adopt the regulatory technical standard with the amendments it considers relevant or reject it. The Commission may not change the content of a draft regulatory technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article. 2. Where the Authority has not submitted a draft regulatory technical standard within the time limit set out in the legislative acts referred to in Article 1(2), the Commission may request such a draft within a new time limit.3. Only where the Authority does not submit a draft regulatory technical standard to the Commission within the time limits in accordance with paragraph 2, may the Commission adopt a regulatory technical standard by means of a delegated act without a draft from the Authority. The Commission shall conduct open public consultations on draft regulatory technical standards and analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft regulatory technical standards concerned or in relation to the particular urgency of the matter. The Commission shall also request the opinion or advice of the relevant stakeholder group referred to in Article 37.

The Commission shall immediately forward the draft regulatory technical standard to the European Parliament and the Council. The Commission shall send its draft regulatory technical standard to the Authority. Within a period of 6 weeks, the Authority may amend the draft regulatory technical standard and submit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council. If, on the expiry of the six-week period referred to in the fourth subparagraph, the Authority has not submitted an amended draft regulatory technical standard, the Commission may adopt the regulatory technical standard. If the Authority has submitted an amended draft regulatory technical standard within the six-week period, the Commission may amend the draft regulatory technical standard on the basis of the Authority’s proposed amendments or adopt the regulatory technical standard with the amendments it considers relevant. The Commission shall not change the content of the draft regulatory technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article. 4. The regulatory technical standards shall be adopted by means of regulations or decisions. They shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. Article 11 Exercise of the delegation1. The power to adopt regulatory technical standards referred to in Article 10 shall be conferred on the Commission for a period of four years from 16 December 2010. The Commission shall draw up a report in respect of the delegated power not later than 6 months before the end of the four-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 14.2. As soon as it adopts a regulatory technical standard, the Commission shall notify it simultaneously to the European Parliament and to the Council.3. The power to adopt regulatory technical standards is conferred on the Commission subject to the conditions laid down in Articles 12 to 14. Article 12 Revocation of the delegation1.



The delegation of power referred to in Article 10 may be revoked at any time by the European Parliament or by the Council.2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation 3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the regulatory technical standards already in force. It shall be published in the Official Journal of the European Union Following the Lamfalussy architecture, these delegated acts are adopted by the Commission following a special procedure.

19. Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC

Whereas: (23) The Commission should endorse those draft regulatory technical standards by means of delegated acts pursuant to Article 290 TFEU in order to give them binding legal effect. They should be subject to amendment only in very restricted and extraordinary circumstances, since the Authority is the actor in close contact with and knowing best the daily functioning of financial markets. Draft regulatory technical standards would be subject to amendment if they were incompatible with Union law, did not respect the principle of proportionality or ran counter to the fundamental principles of the internal market for financial services as reflected in the acquis of Union financial services legislation. The Commission should not change the content of the draft regulatory technical standards prepared by the Authority without prior coordination with the Authority. To ensure a smooth and expeditious adoption process for those standards, the Commission’s decision to endorse draft regulatory technical standards should be subject to a time limit (24) Given the technical expertise of the Authority in the areas where regulatory technical standards should be developed, note should be taken of the Commission’s stated intention to rely, as a rule, on the draft regulatory technical standards submitted to it by the Authority in view of the adoption of the corresponding delegated acts. However, in cases where the Authority fails to submit a draft regulatory technical standard within the time limits set out by the relevant legislative act, it should be ensured that the result of the exercise of delegated power is actually achieved, and the efficiency of the decision-making process be maintained. In those cases, the Commission should therefore be empowered to adopt regulatory technical standards in the absence of a draft by the Authority. Article 10 Regulatory technical standards 1. Where the European Parliament and the Council delegate power to the Commission to adopt regulatory technical standards by means of delegated acts pursuant to Article 290 TFEU in order to ensure consistent harmonisation in the areas specifically set out in the legislative acts referred to in Article 1(2), the Authority may develop draft regulatory technical standards. The Authority shall submit its draft standards to the Commission for endorsement. Regulatory technical standards shall be technical, shall not imply strategic decisions or policy choices and their content shall be delimited by the legislative acts on which they are based. Before submitting them to the Commission, the Authority shall conduct open public consultations on draft regulatory technical standards and analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft regulatory technical standards concerned or in relation to the particular urgency of the matter. The Authority shall




also request the opinion of the Banking Stakeholder Group referred to in Article 37. Where the Authority submits a draft regulatory technical standard, the Commission shall immediately forward it to the European Parliament and the Council. Within 3 months of receipt of a draft regulatory technical standard, the Commission shall decide whether to endorse it. The Commission may endorse the draft regulatory technical standards in part only, or with amendments, where the Union’s interests so require. Where the Commission intends not to endorse a draft regulatory technical standard or to endorse it in part or with amendments, it shall send the draft regulatory technical standard back to the Authority, explaining why it does not endorse it, or, as the case may be, explaining the reasons for its amendments. Within a period of 6 weeks, the Authority may amend the draft regulatory technical standard on the basis of the Commission’s proposed amendments and resubmit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council. If, on the expiry of that six-week period, the Authority has not submitted an amended draft regulatory technical standard, or has submitted a draft regulatory technical standard that is not amended in a way

consistent with the Commission’s proposed amendments, the Commission may adopt the regulatory technical standard with the amendments it considers relevant, or reject it. The Commission may not change the content of a draft regulatory technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article. 3. Only where the Authority does not submit a draft regulatory technical standard to the Commission within the time limits in accordance with paragraph 2, may the Commission adopt a regulatory technical standard by means of a delegated act without a draft from the Authority. The Commission shall conduct open public consultations on draft regulatory technical standards and analyse the potential related costs and benefits, unless such consultations and analyses are disproportionate in relation to the scope and impact of the draft regulatory technical standards concerned or in relation to the particular urgency of the matter. The Commission shall also request the opinion or advice of the Banking Stakeholder Group referred to in Article 37. The Commission shall immediately forward the draft regulatory technical standard to the European Parliament and the Council. The Commission shall send its draft regulatory technical standard to the Authority. Within a period of 6 weeks, the Authority may amend the draft regulatory technical standard and submit it in the form of a formal opinion to the Commission. The Authority shall send a copy of its formal opinion to the European Parliament and to the Council. If on the expiry of the six-week period referred to in the fourth subparagraph, the Authority has not submitted an amended draft regulatory technical standard, the Commission may adopt the regulatory technical standard. If the Authority has submitted an amended draft regulatory technical standard within the six-week period, the Commission may amend the draft regulatory technical standard on the basis of the Authority’s proposed amendments or adopt the regulatory technical standard with the amendments it considers relevant. The Commission shall not change the content of the draft regulatory technical standard prepared by the Authority without prior coordination with the Authority, as set out in this Article. Article 11 Exercise of the delegation 1. The power to adopt regulatory technical standards referred to in Article 10 shall be conferred on the Commission for a period of 4 years from 16 December 2010. The Commission shall draw up a report in



respect of the delegated power not later than 6 months before the end of the 4-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 14. 2. As soon as it adopts a regulatory technical standard, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt regulatory technical standards is conferred on the Commission subject to the conditions laid down in Articles 12 to 14.

Article 12

Revocation of the delegation

1. The delegation of power referred to in Article 10 may be revoked at any time by the European Parliament or by the Council.

2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation.

3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the regulatory technical standards already in force. It shall be published in the Official Journal of the European Union.

Following the Lamfalussy architecture, these delegated acts are adopted by the Commission following a special procedure.

20. Directive 2010/75/EU of the European Parliament and of the Council on industrial emissions (integrated pollution prevention and control) (Recast)

Whereas: (40) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in respect of the setting of the date from which continuous measurements of emissions into the air of heavy metals and dioxins and furans are to be carried out, and the adaptation of certain parts of Annexes V, VI and VII to scientific and technical progress. In the case of waste incineration plants and waste co-incineration plants, this may include, inter alia, the establishment of criteria to allow derogations from continuous monitoring of total dust emissions. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 48 Monitoring of emissions 1. Member States shall ensure that the monitoring of emissions is carried out in accordance with Parts 6 and 7 of Annex VI.2.

The installation and functioning of the automated measuring systems shall be subject to control and to annual surveillance tests as set out in point 1 of Part 6 of Annex VI.3. The competent authority shall determine the location of the sampling or measurement points to be used for monitoring ofemissions.4. All monitoring results shall be recorded, processed and presented in such a way as to enable the competent authority to verify compliance with the operating conditions and emission limit values which are included in the permit.5. As soon as appropriate measurement techniques are available within the Union, the Commission shall, by means of delegated acts in accordance with Article 76 and subject to the conditions laid down in Articles 77 and 78, set the date from which continuous measurements of emissions into the air of heavy metals




and dioxins and furans are to be carried out. Article 74 Amendments of Annexes In order to allow the provisions of this Directive to be adapted to scientific and technical progress on the basis of best available techniques, the Commission shall adopt delegated acts in accordance with Article 76 and subject to the conditions laid down in Articles 77 and 78 as regards the adaptation of Parts 3 and 4 of Annex V, Parts 2, 6, 7 and 8 of Annex VI and Parts 5, 6, 7 and 8of Annex VII to such scientific and technical progress. Article 76 Exercise of the delegation1. The power to adopt the delegated acts referred to in Article 48(5) and Article 74 shall be conferred on the Commission for a period of 5 years from 6 January 2011. The Commission shall draw up a report in respect of the delegated power at the latest 6 months before the end of the five-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 77.2.

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to theCouncil.3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 77 and 78. Article 77 Revocation of the delegation1. The delegation of power referred to in Article 48(5) and Article 74 may be revoked at any time by the European Parliament or by the Council.2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation and possible reasons for a revocation.3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or on a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 78 Objections to delegated acts1. The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by 2 months. 2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to the delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.



21. Regulation (EU) No 1236/2010 of the European Parliament and of the Council of 15 December 2010 laying down a scheme of control and enforcement applicable in the area covered by the Convention on future multilateral cooperation in the North-East Atlantic fisheries and repealing Council Regulation (EC) No 2791/1999

Whereas: (12) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) in respect of detailed rules concerning lists of the fishery resources to be notified, procedures for prior notification of entry into port and for the cancellation thereof as well as authorisation to land or tranship. The Commission should also be empowered to adopt delegated acts in respect of the incorporation into Union law of future amendments of those measures of the Scheme which form the subject matter of certain expressly defined non-essential elements of this Regulation and which become binding upon the Union in accordance with the terms of the Convention. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.

Article 46 Delegation of powers 1. The Commission may adopt, by means of delegated acts in accordance with Article 47 and subject to the conditions of Articles 48 and 49 the detailed rules for the application of Article 25, as well as the list of fishery resources referred to in Article 10(1) and detailed rules on the notification and cancellation procedures, including periods, as referred to in the second subparagraph of Article 24(4). 2. When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Regulation. Article 47 Exercise of the delegation 1. The power to adopt delegated acts referred to in Article 46 shall be conferred on the Commission for a period of 3 years from 1 January 2011. The Commission shall make a report in respect of the delegated powers at the latest 6 months before the end of the three-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 48. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 48 and 49. Article 48 Revocation of the delegation 1. The delegation of power referred to in Article 46 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 49 Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification.










At the initiative of the European Parliament or the Council this period shall be extended by 2 months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act. Article 51 Procedure for amendments As far as is necessary, in order to incorporate into Union law amendments to the existing provisions of the Scheme which become obligatory for the Union, the Commission may amend the provisions of this Regulation by means of delegated acts in accordance with Article 47 and subject to the conditions set out in Articles 48 and 49, concerning:

(a) participation of Contracting Parties in the fishery in the Regulatory area as referred to in Article 5; (b) removal and disposal of fixed gear and the retrieval of lost gear as referred to in Articles 6 and 7; (c) use of VMS as referred to in Article 11; (d) cooperation and communication of information to the NEAFC Secretary as referred to in Article 12; (e) requirements for separate stowage and labelling of frozen fishery resources as referred to in Articles 14 and 15; (f) assignment of NEAFC inspectors as referred to in Article 16; (g) measures to promote compliance with the Scheme by non-Contracting Party fishing vessels under Chapter VI; (h) the list of regulated resources set out in the Annex. When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Regulation. Appendix Statements on Article 51 "The European Parliament, the Council and the Commission note that any of the provisions of a non-essential character of the basic legislative act, which now are listed under Article 51 of the Regulation (delegation of powers), can become at any time in the future a significant element of the existing NEAFC control scheme from a political point of view, in which case the European Parliament, the Council and the Commission recall that either of the legislators, the Council or the European Parliament, can immediately exercise either the right to object to a draft Commission delegated act or the right to revoke the delegated powers as provided under Article 48 and Article 49 of the Regulation respectively." "The Council and the Parliament agree that the inclusion of any provision of the NEAFC control scheme into this Regulation as a non-essential element, now listed under Article 51, does not imply per se that such provisions will automatically be considered by the legislators to be of a non-essential character in any future Regulations." "The European Parliament, the Council and the Commission declare that the provisions of this Regulation shall be without prejudice to any future position of the institutions as regards the implementation of Article 290 TFEU or individual legislative acts containing such provisions."

22. Regulation (EU) No 1235/2010 of the Whereas:




European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products

(26) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in order to supplement the provisions in point (cc) of Article 9(4) and in point (b) of Article 10a(1) of Regulation (EC) No 726/2004. The Commission should be empowered to adopt supplementary measures laying down the situations in which post-authorisation efficacy studies may be required. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 1 Amendments to Regulation (EC) No 726/2004 Regulation (EC) No 726/2004 is hereby amended as follows: 2. Article 9(4) is amended as follows: (b) the following points are inserted: ‘(ca) details of any recommended measures for ensuring the safe use of the medicinal product to be included in the risk management system; (cb) if appropriate, details of any recommended obligation to conduct post-authorisation safety studies or to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter

than those referred to in Chapter 3; (cc) if appropriate, details of any recommended obligation to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed. Such an obligation to conduct such studies shall be based on the delegated acts adopted pursuant to Article 10b while taking into account the scientific guidance referred to in Article 108a of Directive 2001/83/EC;’; 3. Article 10 is amended as follows: (b) to conduct a post-authorisation efficacy study when the understanding of the disease or the clinical methodology indicate that previous efficacy evaluations might have to be revised significantly. The obligation to conduct the post-authorisation efficacy study shall be based on the delegated acts adopted pursuant to Article 10b while taking into account the scientific guidance referred to in Article 108a of Directive 2001/83/EC. Article 10b 1. In order to determine the situations in which post- authorisation efficacy studies may be required under point (cc) of Article 9(4) and point (b) of Article 10a(1) of this Regulation, the Commission may adopt, by means of delegated acts in accordance with Article 87b, and subject to the conditions of Articles 87c and 87d, measures supplementing the provisions in point (cc) of Article 9(4) and point (b) of Article 10a(1). 2. When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Regulation.’; 21. the following Articles are inserted: Article 87b 1. The power to adopt the delegated acts referred to in Article 10b shall be conferred on the Commission for a period of 5 years from 1 January 2011. The Commission shall draw up a report in respect of the delegated powers not later than 6 months before the end of the 5 year period. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 87c. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down



in Articles 87c and 87d. Article 87c 1. The delegation of powers referred to in Article 10b may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 87d 1. The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by 2 months.

2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to the delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.’.

23. Directive 2010/84/EU of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use

Whereas: (36) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in order to supplement the provisions in Articles 21a and 22a of Directive 2001/83/EC. The Commission should be empowered to adopt supplementary measures laying down the situations in which post-authorisation efficacy studies may be required. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 1 Amendments to Directive 2001/83/EC 8. The following Article is inserted: ‘Article 21a In addition to the provisions laid down in Article 19, a marketing authorisation for a medicinal product may be granted subject to one or more of the following conditions: (a) to take certain measures for ensuring the safe use of the medicinal product to be included in the risk management system; (b) to conduct post-authorisation safety studies; (c) to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter than those referred to in Title IX; (d) any other conditions or restrictions with regard to the safe and effective use of the medicinal product; (e) the existence of an adequate pharmacovigilance system; (f) to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been




marketed. Such an obligation to conduct such studies shall be based on the delegated acts adopted pursuant to Article 22b while taking into account the scientific guidance referred to in Article 108a. The marketing authorisation shall lay down deadlines for the fulfilment of these conditions where necessary.’. 10. The following Articles are inserted: ‘Article 22a 1. After the granting of a marketing authorisation, the national competent authority may impose an obligation on the marketing authorisation holder: (a) to conduct a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product. If the same concerns apply to more than one medicinal product, the national competent authority shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study; (b) to conduct a post-authorisation efficacy study when the understanding of the disease or the clinical methodology indicate that previous efficacy evaluations might have to be revised significantly. The

obligation to conduct the post-authorisation efficacy study shall be based on the delegated acts adopted pursuant to Article 22b while taking into account the scientific guidance referred to in Article 108a. Article 22b 1. In order to determine the situations in which post- authorisation efficacy studies may be required under Articles 21a and 22a of this Directive, the Commission may adopt, by means of delegated acts in accordance with Article 121a, and subject to the conditions of Articles 121b and 121c, measures supplementing the provisions in Articles 21a and 22a. 2. When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Directive. 20. Title IX is replaced by the following: ‘TITLE IX CHAPTER 5 Implementation, Delegation and Guidance Article 108 In order to harmonise the performance of the pharmacovigilance activities provided for in this Directive, the Commission shall adopt implementing measures in the following areas for which pharmacovigilance activities are provided for in Article 8(3), and in Articles 101, 104, 104a, 107, 107a, 107b, 107h, 107n and 107p: (a) the content and maintenance of the pharmacovigilance system master file kept by the marketing authorisation holder; (b) the minimum requirements for the quality system for the performance of pharmacovigilance activities by the national competent authorities and the marketing authorisation holder; (c) the use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities; (d) the minimum requirements for the monitoring of data in the Eudravigilance database to determine whether there are new risks or whether risks have changed; (e) the format and content of the electronic transmission of suspected adverse reactions by Member States and the marketing authorisation holder; (f) the format and content of electronic periodic safety update reports and risk management plans; (g) the format of protocols, abstracts and final study reports for the post-authorisation safety studies.



Those measures shall take account of the work on international harmonisation carried out in the area of pharmacovigilance and shall, where necessary, be revised to take account of technical and scientific progress. Those measures shall be adopted in accordance with the regulatory procedure referred to in Article 121(2). 24. The following Articles are inserted: ‘Article 121a 1. The power to adopt the delegated acts referred to in Article 22b shall be conferred on the Commission for a period of 5 years from 20 January 2011. The Commission shall draw up a report in respect of the delegated powers not later than 6 months before the end of the 5 year period. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 121b. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 121b and 121c.

24. Directive 2011/61/EU of the European Parliament and of the Council of 8 June 2011 on Alternative Investment Fund Managers and amending Directives 2003/41/EC and 2009/65/EC and Regulations (EC) No 1060/2009 and (EU) No 1095/2010

Whereas: 4) This Directive aims to provide for an internal market for AIFMs and a harmonised and stringent regulatory and supervisory framework for the activities within the Union of all AIFMs, including those which have their registered office in a Member State (EU AIFMs) and those which have their registered office in a third country (non-EU AIFMs). As the practical consequences and possible difficulties resulting from a harmonised regulatory framework and an internal market for non- EU AIFMs performing management and/or marketing activities within the Union and EU AIFMs managing non-EU alternative investment funds (AIFs), are uncertain and difficult to predict due to the lack of previous experience in this regard, a review mechanism should be provided for. It is intended that, after a transitional period of 2 years, a harmonised passport regime become applicable to non-EU AIFMs performing management and/or marketing activities within the Union and EU AIFMs managing non-EU AIFs after the entry into force of a delegated act by the Commission in this regard. It is intended that the harmonised regime, during a further transitional period of 3 years, co-exist with the national regimes of the Member States subject to certain minimum harmonised conditions. After that 3-year period of co-existence, it is intended that the national regimes be brought to an end on the entry into force of a further delegated act by the Commission. (35) The depositary should have its registered office or a branch in the same country as the AIF. It should be possible for a non-EU AIF to have a depositary established in the relevant third country only if certain additional conditions are met. On the basis of the criteria set out in delegated acts, the Commission should be empowered to adopt implementing measures, stating that prudential regulation and supervision of a third country have the same effect as Union law and are effectively enforced. Further, the mediation procedure set out in Article 19 of Regulation (EU) No 1095/2010 should apply in the event that competent authorities disagree on the correct application of the other additional conditions. Alternatively, for non-EU AIFs, the depositary should also be able to be established in the home Member State or in the Member State of reference of the AIFM managing the AIF. (62) After the entry into force of a delegated act adopted by the Commission in this regard, which will, in principle, taking into account the advice provided by ESMA, occur 2 years after the deadline for transposition of this Directive, authorised EU AIFMs intending to market non-EU AIFs to professional investors in their home Member State and/or in other Member States should be allowed to do so with a passport in so far as they comply with this Directive. That right should be subject to notification




procedures and conditions in relation to the third country of the non-EU AIF. (64) After the entry into force of a delegated act adopted by the Commission in that regard, which will, in principle, taking into account advice given by ESMA, occur 2 years after the deadline for transposition of this Directive, a basic principle of this Directive should be that a non- EU AIFM is to benefit from the rights conferred under this Directive, such as to market units or shares of AIFs throughout the Union with a passport, subject to its compliance with this Directive. This should ensure a level playing field between EU and non-EU AIFMs. This Directive therefore provides for an authorisation applicable to non-EU AIFMs which will become applicable after the entry into force of the delegated act adopted by the Commission in this regard. To ensure that such compliance is enforced, the competent authorities of a Member State should enforce compliance with this Directive. For such non-EU AIFMs the competent supervisory authorities should be the competent authorities of the Member State of reference, as defined in this Directive. (69) During a transitional period which will, in principle, taking into account ESMA’s advice, be brought to an end by means of a delegated act 3 years after the establishment of the passport for non-EU AIFMs, a non-EU AIFM intending to market AIFs in certain Member States only and without such a passport should

also be permitted to do so by the relevant Member States, but only in so far as certain minimum conditions are met. Those non-EU AIFMs should be subject at least to rules similar to those applicable to EU AIFMs managing EU AIFs with respect to the disclosure to investors. In order to facilitate the monitoring of systemic risk those non-EU AIFMs should also be subject to reporting obligations vis- à-vis the competent authorities of the Member State in which AIFs are marketed. Such AIFMs should therefore comply with the transparency requirements laid down in this Directive and the obligations on AIFMs managing AIFs which acquire control of non-listed companies and issuers. Further, appropriate cooperation arrangements for the purpose of systemic risk oversight and in line with international standards should be in place between the competent authorities of the Member States where the AIFs are marketed, if applicable, the competent authorities of the EU AIFs concerned and the supervisory authorities of the third country where the non-EU AIFM is established and, if applicable, the supervisory authorities of the third country where the non-EU AIF is established in order to ensure an efficient exchange of information that allows competent authorities of the relevant Member States to carry out their duties in accordance with this Directive. The cooperation arrangements should not be used as a barrier to impede third country funds from being marketed in a Member State. Finally, the third country where the non- EU AIFM or the non-EU AIF is established should not be listed as a Non-Cooperative Country and Territory by FATF. (78) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU where expressly provided for in this Directive. In particular, the Commission should be empowered to adopt delegated acts to specify the methods of leverage as defined in this Directive, including any financial and/or legal structures involving third parties controlled by the relevant AIF where those structures are specifically set up to directly or indirectly create leverage at the level of the AIF. In particular for private equity and venture capital funds this means that leverage that exists at the level of a portfolio company is not intended to be included when referring to such financial or legal structures. (79) Delegated acts should also be adopted to specify how to calculate the thresholds for the lighter regime and how to treat AIFMs whose assets under management, including any assets acquired through use of leverage, in one and the same calendar year occasionally exceed and/or fall below the relevant threshold; to specify the obligations to register for the AIFMs falling below the thresholds and to provide information in order to effectively monitor systemic risk and the obligation for such AIFMs to notify the relevant competent authorities where they no longer fulfil the conditions for application of the lighter



regime. (80) Delegated acts should also be adopted to clarify the methods of leverage, including any financial and/or legal structures involving third parties controlled by the relevant AIF and how leverage is to be calculated; to specify the risks the additional own funds or the professional indemnity insurance must cover, the conditions for determining the appropriateness of additional own funds or the coverage of the professional indemnity insurance, and the manner of determining ongoing adjustments of the additional own funds or of the coverage of the professional indemnity insurance. Delegated acts should also be adopted to specify the criteria to be used by competent authorities to assess whether AIFMs comply with their obligations as regards their conduct of business, their obligation to act in the best interests of the AIFs or the investors of the AIFs they manage and the integrity of the market; to have and employ effectively the resources and procedures that are necessary for the proper performance of their business activities; to take all reasonable steps to avoid conflicts of interest and, where such conflicts cannot be avoided, to identify, manage and monitor, and where applicable, disclose, those conflicts of interest in order to prevent them from adversely affecting the interests of the AIFs and their investors and to ensure that the AIFs they manage are fairly treated; to comply with all regulatory requirements applicable to the

conduct of their business activities so as to promote the best interests of the AIFs or the investors of the AIFs they manage and the integrity of the market; and to treat all AIF investors fairly. (81) Delegated acts should also be adopted to specify the type of conflicts of interest AIFMs have to identify, as well as the reasonable steps AIFMs are expected to take in terms of structures and organisational and administrative procedures in order to identify, prevent, manage, monitor and disclose conflicts of interest. Delegated acts should also be adopted to specify the risk management functions to be employed; the appropriate frequency for review of the risk management system; how the risk management function should be functionally and hierarchically separated from the operating units, including the portfolio management function; the specific safeguards against conflicts of interest; and the risk management requirements to be employed by AIFMs. Delegated acts should also be adopted to specify the liquidity management systems and procedures that AIFMs should employ and the alignment of the investment strategy, liquidity profile and redemption policy. Delegated acts should also be adopted to specify the requirements that the originators, the sponsors or the original lenders of securitisation instruments have to meet in order for an AIFM to be allowed to invest in such instruments issued after 1 January 2011. (82) Delegated acts should also be adopted to specify the requirements that AIFMs have to comply with when investing in such securitisation instruments; to specify administrative and accounting procedures, control and safeguard arrangements for electronic data processing and adequate internal control mechanisms; to specify the procedures for the proper valuation of the assets and the calculation of the net asset value per unit or share of the AIF, the professional guarantees the external valuer must be able to provide, and the frequency for valuation appropriate for open-ended AIFs (83) Delegated acts should also be adopted to specify the conditions subject to which the delegation of AIFM functions should be approved and the conditions subject to which the AIFM has delegated its functions to the extent that it becomes a letter-box entity and can no longer be considered to be the manager of the AIF; as regards depositaries, to specify the criteria for assessing that the prudential regulation and supervision of third countries where the depositaries are established have the same effect as Union law and are effectively enforced, the particulars that need to be included in the standard agreement, the conditions for performing the depositary functions, including the type of financial instruments that should be included in the scope of the depositary’s custody duties, the conditions subject to which the depositary may exercise its custody duties over financial instruments registered with



a central depositary and the conditions subject to which the depositary should safekeep the financial instruments issued in a nominative form and registered with an issuer or a registrar, the due diligence duties of depositaries, the segregation obligation, the conditions subject to and circumstances in which financial instruments held in custody should be considered as lost, what is to be understood by external events beyond reasonable control, the consequences of which would have been unavoidable despite all reasonable efforts to the contrary, and the conditions subject to and circumstances in which there is an objective reason to contract a discharge of liability. Delegated acts should also be adopted to specify the content and format of the annual report that AIFMs have to make available for each AIF they manage and to specify the disclosure obligations of AIFMs to investors and reporting requirements to competent authorities as well as their frequency. (84) Delegated acts should also be adopted to specify when leverage is considered to be employed on a substantial basis and the principles competent authorities should use when considering imposing limits to the level of leverage that an AIFM can apply. Delegated acts should also be adopted to specify the cooperation arrangements in relation to non-EU AIFMs and/or non-EU AIFs in order to design a common framework to facilitate the establishment of those cooperation arrangements with third countries.

Delegated acts should also be adopted to specify the content of exchange of information regarding AIFMs between competent authorities and the provision of certain information to ESMA. (85) Depending on the advice of ESMA in this regard and the criteria set out in this Directive, a delegated act should also be adopted in order to extend the passport to EU AIFMs marketing non-EU AIFs in the Union and to non- EU AIFMs managing and/or marketing AIFs in the Union, and another delegated act should be adopted to terminate the application of national private placement regimes in this regard. (86) The European Parliament and the Council should have 3 months from the date of notification to object to a delegated act. At the initiative of the European Parliament or the Council, it should be possible to prolong that period by 3 months in regard to significant areas of concern. It should also be possible for the European Parliament and the Council to inform the other institutions of their intention not to raise objections. Such early approval of delegated acts is particularly important where deadlines need to be met, for example to allow Member States to transpose delegated acts within the transposition period laid down in this Directive, where relevant. (87) In the Declaration on Article 290 of the Treaty on the Functioning of the European Union, annexed to the Final Act of the Intergovernmental Conference which adopted the Treaty of Lisbon, the Conference took note of the Commission’s intention to consult experts appointed by the Member States in the preparation of draft delegated acts in the financial services area, in accordance with its established practice. (88) 2 years after the deadline for transposition of this Directive, ESMA should issue an opinion on the functioning of the passport then in force and on the functioning of national private placement regimes. It should also issue advice on the extension of the passport to EU AIFMs marketing non-EU AIFs in the Union and to non- EU AIFMs managing and/or marketing AIFs in the Union. The Commission should adopt a delegated act within 3 months after having received that opinion and advice from ESMA and taking into account the criteria listed in, and the objectives of, this Directive, inter alia, regarding the internal market, investor protection and the effective monitoring of systemic risk, specifying the date when the rules relating to the extension of the passport provided for in this Directive should become applicable in all Member States. (90) 3 years after the entry into force of the delegated act pursuant to which the passport is to apply to all AIFMs, ESMA should issue an opinion on the functioning of the passport then in force and on the functioning of national private placement regimes. It should also issue advice on the termination of those



national regimes. The Commission should adopt a delegated act within 3 months of receipt of the opinion and advice from ESMA, taking into account the criteria listed in, and the objectives of, this Directive, inter alia, relating to the internal market, investor protection and the effective monitoring of systemic risk, specifying the date when the national regimes referred to in this Directive should be brought to an end in all Member States. Article 3 Exemptions 6. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying: (a) how the thresholds referred to in paragraph 2 are to be calculated and the treatment of AIFMs which manage AIFs whose assets under management, including any assets acquired through the use of leverage, occasionally exceed and/or fall below the relevant threshold in the same calendar year; (b) the obligation to register and to provide information in order to allow effective monitoring of systemic risk as set out in paragraph 3; and (c) the obligation to notify competent authorities as set out in paragraph 3.

Article 4 Definitions 3. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying: (a) the methods of leverage, as defined in point (v) of paragraph 1, including any financial and/or legal structures involving third parties controlled by the relevant AIF; and (b) how leverage is to be calculated. 4. The European Supervisory Authority (European Securities and Markets Authority) (ESMA) shall develop draft regulatory technical standards to determine types of AIFMs, where relevant in the application of this Directive, and to ensure uniform conditions of application of this Directive. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010 Article 7 Application for authorisation 2. Member States shall require that an AIFM applying for an authorisation shall provide the following information relating to the AIFM to the competent authorities of its home Member State: (a) information on the persons effectively conducting the business of the AIFM; (b) information on the identities of the AIFM’s shareholders or members, whether direct or indirect, natural or legal persons, that have qualifying holdings and on the amounts of those holdings; (c) a programme of activity setting out the organisational structure of the AIFM, including information on how the AIFM intends to comply with its obligations under Chapters II, III, IV, and, where applicable, Chapters V, VI, VII and VIII; (d) information on the remuneration policies and practices pursuant to Article 13; (e) information on arrangements made for the delegation and sub-delegation to third parties of functions as referred to in Article 20. 6. In order to ensure consistent harmonisation of this Article, ESMA may develop draft regulatory technical standards to specify the information to be provided to the competent authorities in the application for the authorisation of the AIFM, including the programme of activity. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first



subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 8 Conditions for granting authorisation 6. In order to ensure consistent harmonisation of this Article, ESMA may develop draft regulatory technical standards to specify the: (a) requirements applicable to the AIFMs under paragraph 3; (b) requirements applicable to shareholders and members with qualifying holdings referred to in point (d) of paragraph 1; (c) obstacles which may prevent effective exercise of the supervisory functions of the competent authorities. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 9 Initial capital and own funds 9. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to

the conditions of Articles 57 and 58, measures in relation to paragraph 7 of this Article specifying: (a) the risks the additional own funds or the professional indemnity insurance must cover; (b) the conditions for determining the appropriateness of additional own funds or the coverage of the professional indemnity insurance; and (c) the manner of determining ongoing adjustments of the additional own funds or of the coverage of the professional indemnity insurance. 10. With the exception of paragraphs 7 and 8 and of the delegated acts adopted pursuant to paragraph 9, this Article shall not apply to AIFMs which are also UCITS management companies. Article 12 General principles 3. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying the criteria to be used by the relevant competent authorities to assess whether AIFMs comply with their obligations under paragraph 1. Article 14 Conflicts of interest 4. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying: (a) the types of conflicts of interest as referred to in paragraph 1; (b) the reasonable steps AIFMs are expected to take in terms of structures and organisational and administrative procedures in order to identify, prevent, manage, monitor and disclose conflicts of interest. Article 15 Risk management 5. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying: (a) the risk management systems to be employed by AIFMs in relation to the risks which they incur on behalf of the AIFs that they manage; (b) the appropriate frequency of review of the risk management system; (c) how the risk management function is to be functionally and hierarchically separated from the operating units, including the portfolio management function; (d) specific safeguards against conflicts of interest referred to in the second subparagraph of paragraph



1; (e) the requirements referred to in paragraph 3. Article 16 Liquidity management 3. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying: (a) the liquidity management systems and procedures; and (b) the alignment of the investment strategy, liquidity profile and redemption policy set out in paragraph 2. Article 17 Investment in securitisation positions In order to ensure cross-sectoral consistency and to remove misalignment between the interest of firms that repackage loans into tradable securities and originators within the meaning of point (41) of Article 4 of Directive 2006/48/EC, and AIFMs that invest in those securities or other financial instruments on behalf of AIFs, the Commission shall adopt, by means of delegated acts in accordance with Article 56 and

subject to the conditions of Articles 57 and 58, measures laying down the requirements in the following areas: (a) the requirements that need to be met by the originator, the sponsor or the original lender, in order for an AIFM to be allowed to invest in securities or other financial instruments of this type issued after 1 January 2011 on behalf of AIFs, including requirements that ensure that the originator, the sponsor or the original lender retains a net economic interest of not less than 5 %; (b) qualitative requirements that must be met by AIFMs which invest in these securities or other financial instruments on behalf of one or more AIFs. Article 18 General principles 1. Member States shall require that AIFMs use, at all times, adequate and appropriate human and technical resources that are necessary for the proper management of AIFs. In particular, the competent authorities of the home Member State of the AIFM, having regard also to the nature of the AIFs managed by the AIFM, shall require that the AIFM has sound administrative and accounting procedures, control and safeguard arrangements for electronic data processing and adequate internal control mechanisms including, in particular, rules for personal transactions by its employees or for the holding or management of investments in order to invest on its own account and ensuring, at least, that each transaction involving the AIFs may be reconstructed according to its origin, the parties to it, its nature, and the time and place at which it was effected and that the assets of the AIFs managed by the AIFM are invested in accordance with the AIF rules or instruments of incorporation and the legal provisions in force. 2. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying the procedures and arrangements as referred to in paragraph 1. Article 19 Valuation 5. Where an external valuer performs the valuation function, the AIFM shall demonstrate that: (a) the external valuer is subject to mandatory professional registration recognised by law or to legal or regulatory provisions or rules of professional conduct; (b) the external valuer can provide sufficient professional guarantees to be able to perform effectively the



relevant valuation function in accordance with paragraphs 1, 2 and 3; and (c) the appointment of the external valuer complies with the requirements of Article 20(1) and (2) and the delegated acts adopted pursuant to Article 20(7). 6. The appointed external valuer shall not delegate the valuation function to a third party. 11. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying: (a) the criteria concerning the procedures for the proper valuation of the assets and the calculation of the net asset value per unit or share; (b) the professional guarantees the external valuer must be able to provide to effectively perform the valuation function; (c) the frequency of valuation carried out by open-ended AIFs which is both appropriate to the assets held by the AIF and its issuance and redemption policy. Article 20 Delegation 1. AIFMs which intend to delegate to third parties the task of carrying out functions on their behalf shall

notify the competent authorities of their home Member State before the delegation arrangements become effective. The following conditions shall be met: (a) the AIFM must be able to justify its entire delegation structure on objective reasons; (b) the delegate must dispose of sufficient resources to perform the respective tasks and the persons who effectively conduct the business of the delegate must be of sufficiently good repute and sufficiently experienced; (c) where the delegation concerns portfolio management or risk management, it must be conferred only on undertakings which are authorised or registered for the purpose of asset management and subject to supervision or, where that condition cannot be met, only subject to prior approval by the competent authorities of the home Member State of the AIFM; (d) where the delegation concerns portfolio management or risk management and is conferred on a third-country undertaking, in addition to the requirements in point (c), cooperation between the competent authorities of the home Member State of the AIFM and the supervisory authority of the undertaking must be ensured; (e) the delegation must not prevent the effectiveness of supervision of the AIFM, and, in particular, must not prevent the AIFM from acting, or the AIF from being managed, in the best interests of its investors; (f) the AIFM must be able to demonstrate that the delegate is qualified and capable of undertaking the functions in question, that it was selected with all due care and that the AIFM is in a position to monitor effectively at any time the delegated activity, to give at any time further instructions to the delegate and to withdraw the delegation with immediate effect when this is in the interest of investors. The AIFM shall review the services provided by each delegate on an ongoing basis. 2. No delegation of portfolio management or risk management shall be conferred on: (a) the depositary or a delegate of the depositary; or (b) any other entity whose interests may conflict with those of the AIFM or the investors of the AIF, unless such entity has functionally and hierarchically separated the performance of its portfolio management or risk management tasks from its other potentially conflicting tasks, and the potential conflicts of interest are properly identified, managed, monitored and disclosed to the investors of the AIF. 4. The third party may sub-delegate any of the functions delegated to it provided that the following conditions are met: (a) the AIFM consented prior to the sub-delegation;



(b) the AIFM notified the competent authorities of its home Member State before the sub-delegation arrangements become effective; (c) the conditions set out in paragraph 1, on the understanding that all references to the ‘delegate’ are read as references to the ‘sub-delegate’. 5. No sub-delegation of portfolio management or risk management shall be conferred on: (a) the depositary or a delegate of the depositary; or (b) any other entity whose interests may conflict with those of the AIFM or the investors of the AIF, unless such entity has functionally and hierarchically separated the performance of its portfolio management or risk management tasks from its other potentially conflicting tasks, and the potential conflicts of interest are properly identified, managed, monitored and disclosed to the investors of the AIF. The relevant delegate shall review the services provided by each sub-delegate on an ongoing basis. 6. Where the sub-delegate further delegates any of the functions delegated to it, the conditions set out in paragraph 4 shall apply mutatis mutandis 7. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying:

(a) the conditions for fulfilling the requirements set out in paragraphs 1, 2, 4 and 5; (b) the conditions under which the AIFM shall be deemed to have delegated its functions to the extent that it becomes a letter-box entity and can no longer be considered to be the manager of the AIF as set out in paragraph 3. Article 21 Depositary 17. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying: (a) the particulars that need to be included in the written contract referred to in paragraph 2; (b) general criteria for assessing whether the prudential regulation and supervision of third countries as referred to in point (b) of paragraph 6 have the same effect as Union law and are effectively enforced; (c) the conditions for performing the depositary functions pursuant to paragraphs 7, 8 and 9, including: (i) the type of financial instruments to be included in the scope of the depositary’s custody duties in accordance with point (a) of paragraph 8; (ii) the conditions subject to which the depositary is able to exercise its custody duties over financial instruments registered with a central depositary; and (iii) the conditions subject to which the depositary is to safekeep the financial instruments issued in a nominative form and registered with an issuer or a registrar, in accordance with point (b) of paragraph 8; (d) the due diligence duties of depositaries pursuant to point (c) of paragraph 11; (e) the segregation obligation pursuant to point (d)(iii) of paragraph 11; (f) the conditions subject to which and circumstances in which financial instruments held in custody are to be considered as lost; (g) what is to be understood by external events beyond reasonable control, the consequences of which would have been unavoidable despite all reasonable efforts to the contrary pursuant to paragraph 12; (h) the conditions subject to which and circumstances in which there is an objective reason to contract a discharge pursuant to paragraph 13. Article 22 Annual report 4. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying the content and format of the annual report.



Those measures shall be adapted to the type of AIF to which they apply. Article 23 Disclosure to investors 6. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying the disclosure obligations of AIFMs referred to in paragraphs 4 and 5, including the frequency of the disclosure referred to in paragraph 5. Those measures shall be adapted to the type of AIFM to which they apply. Article 25 Use of information by competent authorities, supervisory cooperation and limits to leverage 9. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures setting out principles specifying the circumstances in which competent authorities apply the provisions set out in paragraph 3, taking into account different strategies of AIFs, different market conditions in which AIFs operate and possible pro-cyclical effects of applying those provisions. Article 33

Conditions for managing EU AIFs established in other Member States 7. In order to ensure consistent harmonisation of this Article, ESMA may develop draft regulatory technical standards to specify the information to be notified in accordance with paragraphs 2 and 3. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 34 Conditions for EU AIFMs which manage non-EU AIFs which are not marketed in Member States 2. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures regarding the cooperation arrangements referred to in paragraph 1 in order to design a common framework to facilitate the establishment of those cooperation arrangements with third countries. 11. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures regarding the cooperation arrangements referred to in point (a) of paragraph 2 in order to design a common framework to facilitate the establishment of those cooperation arrangements with third countries. 13. ESMA shall develop draft regulatory technical standards to determine the minimum content of the cooperation arrangements referred to in point (a) of paragraph 2 so as to ensure that both the competent authorities of the home and the host Member States receive sufficient information in order to be able to exercise their supervisory and investigatory powers under this Directive. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Article 10 to 14 of Regulation (EU) No 1095/2010. 14. In order to ensure consistent harmonisation of this Article, ESMA shall develop draft regulatory technical standards to specify the procedures for coordination and exchange of information between the competent authority of the home Member State and the competent authorities of the host Member States of the AIFM. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 36 Conditions for the marketing in Member States without a passport of non-EU AIFs managed by an EU AIFM



3. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures regarding the cooperation arrangements referred to in paragraph 1 in order to design a common framework to facilitate the establishment of those cooperation arrangements with third countries. Article 37 Authorisation of non-EU AIFMs intending to manage EU AIFs and/or market AIFs managed by them in the Union in accordance with Article 39 or 40 15. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures regarding the cooperation arrangements referred to in point (d) of paragraph 7 in order to design a common framework to facilitate the establishment of those cooperation arrangements with third countries. 17. ESMA shall develop draft regulatory technical standards to determine the minimum content of the cooperation arrangements referred to in point (d) of paragraph 7 so as to ensure that the competent authorities of the Member State of reference and the competent authorities of the host Member States receive sufficient information in order to be able to exercise their supervisory and investigatory powers

under this Directive. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 23. In order to ensure the uniform application of this Article, ESMA shall develop draft regulatory technical standards on the following: (a) the manner in which an AIFM must comply with the requirements laid down in this Directive, taking into account that the AIFM is established in a third country and, in particular, the presentation of the information required in Articles 22 to 24; (b) the conditions under which the law to which a non-EU AIFM or a non-EU AIF is subject is considered to provide for an equivalent rule having the same regulatory purpose and offering the same level of protection to the relevant investors. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Article 10 to 14 of Regulation (EU) No 1095/2010. Article 40 Conditions for the marketing in the Union with a passport of non-EU AIFs managed by a non-EU AIFM 11. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures regarding the cooperation arrangements referred to in point (a) of paragraph 2 in order to design a common framework to facilitate the establishment of those cooperation arrangements with third countries. 13. ESMA shall develop draft regulatory technical standards to determine the minimum content of the cooperation arrangements referred to in point (a) of paragraph 2 so as to ensure that the competent authorities of the Member State of reference and the competent authorities of the host Member States receive sufficient information in order to be able to exercise their supervisory and investigatory powers under this Directive. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 14. In order to ensure consistent harmonisation of this Article, ESMA shall develop draft regulatory technical standards to specify the procedures for coordination and exchange of information between the competent authority of the Member State of reference and the competent authorities of the host Member



States of the AIFM. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 41 Conditions for managing AIFs established in Member States other than the Member State of reference by non- EU AIFMs 7. In order to ensure consistent harmonisation of this Article, ESMA may develop draft regulatory technical standards to specify the information to be notified in accordance with paragraphs 2 and 3. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 42 Conditions for the marketing in Member States without a passport of AIFs managed by a non-EU AIFM 3. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures regarding the cooperation arrangements referred to in

paragraph 1 in order to design a common framework to facilitate the establishment of those cooperation arrangements with third countries. Article 53 Exchange of information relating to the potential systemic consequences of AIFM activity 1. The competent authorities of the Member States responsible for the authorisation and/or supervision of AIFMs under this Directive shall communicate information to the competent authorities of other Member States where this is relevant for monitoring and responding to the potential implications of the activities of individual AIFMs or AIFMs collectively for the stability of systemically relevant financial institutions and the orderly functioning of markets on which AIFMs are active. ESMA and the ESRB shall also be informed and shall forward this information to the competent authorities of the other Member States. 3. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying the content of the information to be exchanged pursuant to paragraph 1. Article 56 Exercise of the delegation 1. The powers to adopt delegated acts referred to in Articles 3, 4, 9, 12, 14 to 25, 34 to 37, 40, 42, 53, 67 and 68 shall be conferred on the Commission for a period of 4 years from 21 July 2011. The Commission shall draw up a report in respect of the delegated powers no later than 6 months before the end of the 4-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 57. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The powers to adopt delegated acts are conferred on the Commission subject to the conditions of Articles 57 and 58. Article 57 Revocation of the delegation 1. The delegation of power referred to in Articles 3, 4, 9, 12, 14 to 25, 34 to 37, 40, 42, 53, 67 and 68 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a



reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation and the possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 58 Objections to delegated acts 1. The European Parliament and the Council may object to a delegated act within a period of 3 months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by 3 months. 2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if, upon a justified request by the Commission, the European Parliament

and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to the adopted delegated act within the period referred to in paragraph 1, it shall not enter into force. In accordance with Article 296 TFEU, the institution which objects shall state the reasons for objecting to the delegated act. Article 63 Amendments to Directive 2009/65/EC Directive 2009/65/EC is amended as follows: (1) the following Article is inserted: ‘Article 50a In order to ensure cross-sectoral consistency and to remove misalignment between the interest of firms that repackage loans into tradable securities and other financial instruments (originators) and UCITS that invest in those securities or other financial instruments, the Commission shall adopt, by means of delegated acts in accordance with Article 112a and subject to conditions of Articles 112b and 112c, measures laying down the requirements in the following areas: (a) the requirements that need to be met by the originator in order for a UCITS to be allowed to invest in securities or other financial instruments of this type issued after 1 January 2011, including requirements that ensure that the originator retains a net economic interest of not less than 5 %; (b) qualitative requirements that must be met by UCITS which invest in those securities or other financial instruments.’; (2) Article 112(2) is replaced by the following: ‘2. The power to adopt the delegated acts referred to in Articles 12, 14, 23, 33, 43, 51, 60, 61, 62, 64, 75, 78, 81, 95 and 111 shall be conferred on the Commission for a period of 4 years from 4 January 2011. The power to adopt the delegated acts referred to in Article 50a shall be conferred on the Commission for a period of 4 years from 21 July 2011. The Commission shall draw up a report in respect of delegated powers at the latest 6 months before the end of the 4-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes them in accordance with Article 112a.’; (3) Article 112a(1) is replaced by the following: ‘1. The delegation of power referred to in Articles 12, 14, 23, 33, 43, 50a, 51, 60, 61, 62, 64, 75, 78, 81, 95 and 111 may be revoked at any time by the European Parliament or by the Council.’.



Article 66 Transposition 4. Member States shall ensure that the laws, regulations and administrative provisions adopted by them in compliance with Articles 36 and 42 cease to apply in accordance with the delegated act adopted by the Commission pursuant to Article 68(6) and on the date specified therein. Article 67 Delegated act on the application of Article 35 and Articles 37 to 41 5. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying the contents of the information to be provided pursuant to paragraph 2. 6. The Commission shall adopt a delegated act within 3 months after having received positive advice and an opinion from ESMA, and taking into account the criteria listed in paragraph 2 and the objectives of this Directive, such as those relating to the internal market, investor protection and the effective monitoring of systemic risk, in accordance with Article 56 and subject to the conditions of Articles 57 and 58, specifying the date when the rules set out in Article 35 and Articles 37 to 41 become applicable in all

Member States. If there is objection to the delegated act referred to in the first subparagraph in accordance with Article 58, the Commission shall re-adopt the delegated act pursuant to which the rules set out in Article 35 and Articles 37 to 41 shall become applicable in all Member States, in accordance with Article 56 and subject to the conditions of Articles 57 and 58, at a later stage which seems appropriate to it, taking into account the criteria listed in paragraph 2 and the objectives of this Directive, such as those relating to the internal market, investor protection and the effective monitoring of systemic risk. Article 68 Delegated act on the termination of the application of Articles 36 and 42 1. 3 years after the entry into force of the delegated act referred to in Article 67(6) pursuant to which the rules set out in Article 35 and Articles 37 to 41 have become applicable in all Member States, ESMA shall issue to the European Parliament, the Council and the Commission: (a) an opinion on the functioning of the passport for EU AIFMs marketing non-EU AIFs in the Union pursuant to Article 35 and for non-EU AIFMs managing and/or marketing AIFs in the Union pursuant to Articles 37 to 41, and on the functioning of the marketing of non-EU AIFs by EU AIFMs in the Member States and the management and/or marketing of AIFs by non-EU AIFMs in the Member States pursuant to the applicable national regimes as set out in Articles 36 and 42; and (b) advice on the termination of the existence of the national regimes set out in Articles 36 and 42 in parallel with the existence of the passport in accordance with the rules set out in Article 35 and Articles 37 to 41. 3. To that end, as from the entry into force of the delegated act referred to in Article 67(6) and until the issuance of the ESMA opinion referred to in point (a) of paragraph 1 of this Article, the competent authorities shall, quarterly, provide ESMA with information on the AIFMs that are managing and/or marketing AIFs under their supervision, either under the application of the passport regime provided for in this Directive, or under their national regimes 5. The Commission shall adopt, by means of delegated acts in accordance with Article 56 and subject to the conditions of Articles 57 and 58, measures specifying the contents of the information to be provided pursuant to paragraph 2. 6. The Commission shall adopt a delegated act within 3 months after having received positive advice and an opinion from ESMA and taking into account the criteria listed in paragraph 2 and the objectives of this



Directive, such as those relating to the internal market, investor protection and the effective monitoring of systemic risk, in accordance with Article 56 and subject to the conditions of Articles 57 and 58, specifying the date when the national regimes set out in Articles 36 and 42 are to be terminated and the passport regime provided for in Article 35 and Articles 37 to 41 shall become the sole and mandatory regime applicable in all Member States If there is objection to the delegated act referred to in the first subparagraph in accordance with Article 58, the Commission shall re-adopt the delegated act pursuant to which the national regimes set out in Articles 36 and 42 are to be terminated and the passport regime provided for in Article 35 and Articles 37 to 41 shall become the sole and mandatory regime applicable in all Member States, in accordance with Article 56 and subject to the conditions of Articles 57 and 58, at a later stage which seems appropriate to it, taking into account the criteria listed in paragraph 2 and the objectives of this Directive, such as those relating to the internal market, investor protection and the effective monitoring of systemic risk.

25. Regulation (EU) No 304/2011 of the European Parliament and of the Council of 9 March 2011 amending Council Regulation (EC) No 708/2007 concerning use of alien and locally absent species in aquaculture

Whereas: (6) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) in order to adapt Annexes I, II and III to technical and scientific progress, to amend Annex IV in order to add species to that Annex and to adopt specifications for the conditions necessary for adding species to Annex IV. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 1 Regulation (EC) No 708/2007 is hereby amended as follows: 6. Article 24 is replaced by the following: ‘Article 24 Amendments of Annexes and detailed rules 1. The Commission may, by means of delegated acts in accordance with Article 24a and subject to the conditions laid down in Articles 24b and 24c: (a) amend Annexes I, II and III to this Regulation in order to adapt them to technical and scientific progress; (b) adopt specifications for the conditions necessary for adding species to Annex IV, as provided for in paragraph 3; and (c) add species to Annex IV where the conditions provided for in paragraph 3 and their further specifications are complied with. 2. When adopting delegated acts as referred to in paragraph 1, the Commission shall act in accordance with this Regulation. 7. the following Articles are inserted: ‘Article 24a Exercise of the delegation 1. The power to adopt the delegated acts referred to in Article 24 shall be conferred on the Commission for a period of 5 years from 24 April 2011. The Commission shall make a report in respect of the delegated power at the latest 6 months before the end of the 5-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 24b. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.




3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 24b and 24c. Article 24b Revocation of the delegation 1. The delegation of power referred to in Article 24 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 24c Objections to delegated acts

1. The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification. At the initiative of the European Parliament or the Council, that period shall be extended by 2 months. 2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to the delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.’;

26. Regulation (EU) No 513/2011 of the European Parliament and of the Council of 11 May 2011 amending Regulation (EC) No 1060/2009 of the European Parliament and of the Council of 16 September 2009 on credit rating agencies

Whereas: (15) The competent authorities should communicate any information required pursuant to Regulation (EC) No 1060/2009 and assist and cooperate with ESMA. ESMA and the competent authorities should also cooperate closely with the sectoral competent authorities responsible for supervision of the undertakings referred to in Article 4(1) of Regulation (EC) No 1060/2009. ESMA should be able to delegate specific supervisory tasks to the competent authority of a Member State, for instance where a supervisory task requires knowledge and experience with respect to local conditions, which are more easily available at national level. The kind of tasks that it should be possible to delegate include the carrying out of specific investigatory tasks and on-site inspections. Prior to the delegation of tasks, ESMA should consult the relevant competent authority about the detailed conditions relating to such delegation of tasks, including the scope of the task to be delegated, the timetable for the performance of the task, and the transmission of necessary information by and to ESMA. ESMA should compensate the competent authorities for carrying out a delegated task in accordance with a regulation on fees to be adopted by the Commission by means of a delegated act. ESMA should not be able to delegate the power to adopt decisions on registration.






(29) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in order to specify further or amend the criteria for assessing the equivalence of the regulatory and supervisory framework of a third country in order to take into account developments on financial markets, to adopt a regulation on fees and detailed rules concerning fines and periodic penalty payments, and to amend the Annexes to Regulation (EC) No 1060/2009. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. (30) When preparing and drawing up delegated acts, the Commission should ensure the early and ongoing transmission of information on relevant documents to the European Parliament and the Council. (31) The European Parliament and the Council should have three months from the date of notification to object to a delegated act. On the initiative of the European Parliament or the Council, it should be possible to prolong that period by three months in regard to significant areas of concern. It should also be possible for the European Parliament and the Council to inform the other institutions of their intention not

to raise objections. Such early approval of delegated acts is particularly appropriate when deadlines need to be met, for example where there are timetables in the basic act for the Commission to adopt delegated acts. (32) In the Declaration on Article 290 of the Treaty on the Functioning of the European Union, annexed to the Final Act of the Intergovernmental Conference which adopted the Treaty of Lisbon, the Conference took note of the Commission's intention to continue to consult experts appointed by the Member States in the preparation of draft delegated acts in the financial services area, in accordance with its established practice. Article 1 Amendments Regulation (EC) No 1060/2009 is hereby amended as follows: (3) Article 5 is amended as follows: (d) paragraph 5 is deleted; (e) in paragraph 6, the third subparagraph is replaced by the following: ‘In order to take account of developments on financial markets, the Commission shall adopt, by means of delegated acts in accordance with Article 38a, and subject to the conditions of Articles 38b and 38c, measures to specify further or amend the criteria set out in points (a), (b) and (c) of the second subparagraph of this paragraph.’; (9) Articles 15 to 21 are replaced by the following: Article 19 Registration and supervisory fees 2. The Commission shall adopt the regulation on fees referred to in the first subparagraph by means of a delegated act in accordance with Article 38a and subject to the conditions of Articles 38b and 38c. (11) Articles 23 to 27 are replaced by the following: Article 23e



Procedural rules for taking supervisory measures and imposing fines 7. The Commission shall adopt further rules of procedure for the exercise of the power to impose fines or periodic penalty payments, including provisions on rights of defence, temporal provisions, and the collection of fines or periodic penalty payments, and shall adopt detailed rules on the limitation periods for the imposition and enforcement of penalties. The rules referred to in the first subparagraph shall be adopted by means of delegated acts in accordance with Article 38a and subject to the conditions of Articles 38b and 38c. (19) Article 37 is replaced by the following: ‘Article 37 Amendments to Annexes In order to take account of developments, including international developments, on financial markets, in particular in relation to new financial instruments, the Commission may adopt, by means of delegated acts in accordance with Article 38a and subject to the conditions of Articles 38b and 38c, measures to amend the Annexes, excluding Annex III.’;

(21) the following Articles are inserted: ‘Article 38a Exercise of the delegation 1. The power to adopt delegated acts referred to in the third subparagraph of Article 5(6), Article 19(2), Article 23e(7) and Article 37 shall be conferred on the Commission for a period of four years from 1 June 2011. The Commission shall draw up a report in respect of the delegated power at the latest six months before the end of the four-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 38b. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 38b and 38c. Article 38b Revocation of the delegation 1. The delegation of power referred to in the third subparagraph of Article 5(6), Article 19(2), Article 23e(7) and Article 37 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation. 3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 38c Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of three months from the date of notification.



At the initiative of the European Parliament or the Council that period shall be extended by three months. 2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to the delegated act within the period referred to in paragraph 1, it shall not enter into force. In accordance with Article 296 of the Treaty on the Functioning of the European Union, the institution which objects shall state the reasons for objecting to the delegated act.’;

27. Regulation (EU) No 211/2011 of the European Parliament and of the Council of 16 February 2011 on the citizens’ initiative

(24) In order to address future adaptation needs, the Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU for the purpose of amending the Annexes to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 5 Procedures and conditions for the collection of statements of support 4. Member States shall forward to the Commission any changes to the information set out in Annex III. Taking into account those changes, the Commission may adopt, by means of delegated acts, in accordance with Article 17 and subject to the conditions of Articles 18 and 19, amendments to Annex III. Article 7 Minimum number of signatories per Member State 3. The Commission shall adopt, by means of delegated acts, in accordance with Article 17 and subject to the conditions of Articles 18 and 19, appropriate adjustments to Annex I in order to reflect any modification in the composition of the European Parliament. Article 16 Amendment of the Annexes The Commission may adopt, by means of delegated acts in accordance with Article 17 and subject to the conditions of Articles 18 and 19, amendments to the Annexes to this Regulation within the scope of the relevant provisions of this Regulation. Article 17 Exercise of the delegation 1. The power to adopt the delegated acts referred to in Article 16 shall be conferred on the Commission for an indeterminate period of time. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 18 and 19. Article 18 Revocation of the delegation 1. The delegation of power referred to in Article 16 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a




reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 19 Objections to delegated acts 1. The European Parliament or the Council may object to the delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by two months. 2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the

Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to a delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act

28. Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC

Whereas: Article 16 Amendment of the Annexes The Commission may adopt, by means of delegated acts in accordance with Article 17 and subject to the conditions of Articles 18 and 19, amendments to the Annexes to this Regulation within the scope of the relevant provisions of this Regulation. Article 17 Exercise of the delegation 1. The power to adopt the delegated acts referred to in Article 16 shall be conferred on the Commission for an indeterminate period of time. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 18 and 19. Article 18 Revocation of the delegation 1. The delegation of power referred to in Article 16 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 19




Objections to delegated acts 1. The European Parliament or the Council may object to the delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by two months. 2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to a delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act. (52) In particular, the Commission should be empowered to adopt delegated acts outlining the conditions

for the use of websites to make available the declaration of performance. Article 3 Basic requirements for construction works and essential characteristics of construction products 3. For specific families of construction products covered by a harmonised standard, the Commission shall, where appropriate and in relation to their intended uses as defined in harmonised standards, determine by means of delegated acts in accordance with Article 60, those essential characteristics for which the manufacturer shall declare the performance of the product when it is placed on the market. Article 7 Supply of the declaration of performance 3. By way of derogation from paragraphs 1 and 2, the copy of the declaration of performance may be made available on a web site in accordance with conditions to be established by the Commission by means of delegated acts in accordance with Article 60. Such conditions shall, inter alia, guarantee that the Article 11 Obligations of manufacturers 2. Manufacturers shall keep the technical documentation and the declaration of performance for a period of 10 years after the construction product has been placed on the market. Where appropriate, the Commission may, by means of delegated acts in accordance with Article 60, amend that period for families of construction products on the basis of the expected life or part played by the construction product in the construction works Article 19 European Assessment Document



3. The Commission may adopt delegated acts in accordance with Article 60 to amend Annex II and establish supplementary procedural rules for the development and adoption of a European Assessment Document. Article 27 Levels or classes of performance 1. The Commission may adopt delegated acts in accordance with Article 60, to establish classes of performance in relation to the essential characteristics of construction products. Article 28 Assessment and verification of constancy of performance 2. By means of delegated acts in accordance with Article 60, the Commission shall establish and may revise, taking into account in particular the effect on the health and safety of people, and on the environment, which system or systems are applicable to a given construction product or family of construction products or a given essential characteristic. In doing so, the Commission shall also take into

account the documented experiences forwarded by national authorities with regard to market surveillance. Article 60 Delegated acts For the purposes of achieving the objectives of this Regulation, in particular removing and avoiding restrictions on making construction products available on the market, the following matters shall be delegated to the Commission in accordance with Article 61, and subject to the conditions laid down in Articles 62 and 63: (a) the determination, where appropriate, of the essential characteristics or threshold levels within specific families of construction products, in relation to which, in accordance with Articles 3 to 6, the manufacturer shall declare, in relation to their intended use, by levels or classes, or in a description, the performance of the manufacturer’s product when it is placed on the market; (b) the conditions on which a declaration of performance may be electronically processed, in order to make it available on a web site in accordance with Article 7; (c) the amendment of the period for which the manufacturer shall keep the technical documentation and the declaration of performance after the construction product has been placed on the market, in accordance with Article 11, based on the expected life or the part played by the construction product in the construction works; (d) the amendment of Annex II and where necessary the adoption of supplementary procedural rules in accordance with Article 19(3) in order to ensure compliance with the principles in Article 20, or the application in practice of the procedures set out in Article 21; (e) the adaptation of Annex III, table 1 of Annex IV, and Annex V in response to technical progress; (f) the establishment and adaptation of classes of performance in response to technical progress in accordance with Article 27(1); (g) the conditions on which a construction product shall be deemed to satisfy a certain level or class of performance without testing or without further testing in accordance with Article 27(5), provided that the fulfilment of the basic requirements for construction works is not thereby jeopardised; (h) the adaptation, establishment and revision of the systems of assessment and verification of constancy of performance in accordance with Article 28, relating to a given product, a given product family or a



given essential characteristic, and in accordance with: (i) the importance of the part played by the product or those essential characteristics with respect to the basic requirements for construction works; (ii) the nature of the product; Article 61 Exercise of the delegation 1. The power to adopt delegated acts referred to in Article 60 shall be conferred on the Commission for a period of 5 years from 24 April 2011. The Commission shall draw up a report in respect of the delegated power at the latest 6 months before the end of the 5-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 62. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down

in Articles 62 and 63. Article 62 Revocation of the delegation 1. The delegation of power referred to in Article 60 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 63 Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of 3 months from the date of notification. At the initiative of the European Parliament or the Council, that period shall be extended by 3 months. 2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to a delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

29. Directive 2011/24/EU of the European Parliament and of the Council of 9 March

Whereas: (60) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU




2011 on the application of patients’ rights in cross-border healthcare

in respect of measures that would exclude specific categories of medicinal products or medical devices from the recognition of prescriptions, as provided for in this Directive. In order to identify the reference networks which should benefit from support by the Commission, the Commission should also be empowered to adopt delegated acts in respect of the criteria and conditions that European reference networks have to fulfil. (61) It is of particular importance that, when empowered to adopt delegated acts in accordance with Article 290 TFEU, the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 11 Recognition of prescriptions issued in another Member State 1. If a medicinal product is authorised to be marketed on their territory, in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004, Member States shall ensure that prescriptions issued for such a product in another Member State for a named patient can be dispensed on their territory in

compliance with their national legislation in force, and that any restrictions on recognition of individual prescriptions are prohibited unless such restrictions are: (a) limited to what is necessary and proportionate to safeguard human health, and non-discriminatory; or (b) based on legitimate and justified doubts about the authenticity, content or comprehensibility of an individual prescription. The recognition of such prescriptions shall not affect national rules governing prescribing and dispensing, if those rules are compatible with Union law, including generic or other substitution. The recognition of prescriptions shall not affect the rules on reimbursement of medicinal products. Reimbursement of costs of medicinal products is covered by Chapter III of this Directive. In particular, the recognition of prescriptions shall not affect a pharmacist’s right, by virtue of national rules, to refuse, for ethical reasons, to dispense a product that was prescribed in another Member State, where the pharmacist would have the right to refuse to dispense, had the prescription been issued in the Member State of affiliation. The Member State of affiliation shall take all necessary measures, in addition to the recognition of the prescription, in order to ensure continuity of treatment in cases where a prescription is issued in the Member State of treatment for medicinal products or medical devices available in the Member State of affiliation and where dispensing is sought in the Member State of affiliation. This paragraph shall also apply to medical devices that are legally placed on the market in the respective Member State. 5. For the purpose of paragraph 1, the Commission shall also adopt, by means of delegated acts in accordance with Article 17 and subject to the conditions of Articles 18 and 19 and no later than 25 October 2012 measures to exclude specific categories of medicinal products or medical devices from the recognition of prescriptions provided for under this Article, where necessary in order to safeguard public health. Article 12 European reference networks 4. For the purposes of paragraph 1, the Commission shall: (a) adopt a list of specific criteria and conditions that the European reference networks must fulfil and the



conditions and criteria required from healthcare providers wishing to join the European reference network. These criteria and conditions shall ensure, inter alia, that European reference networks: (i) have knowledge and expertise to diagnose, follow-up and manage patients with evidence of good outcomes, as far as applicable; (ii) follow a multi-disciplinary approach; (iii) offer a high level of expertise and have the capacity to produce good practice guidelines and to implement outcome measures and quality control; (iv) make a contribution to research; (v) organise teaching and training activities; and (vi) collaborate closely with other centres of expertise and networks at national and international level; 5. The Commission shall adopt the measures referred to in paragraph 4(a) by means of delegated acts in accordance with Article 17 and subject to the conditions of Articles 18 and 19. The measures referred to in points (b) and (c) of paragraph 4 shall be adopted in accordance with the regulatory procedure referred to in Article 16(2).

Article 17 Exercise of the delegation 1. The powers to adopt delegated acts referred to in Articles 11(5) and 12(5) shall be conferred on the Commission for a period of 5 years from 24 April 2011. The Commission shall make a report in respect of the delegated powers not later than 6 months before the end of the five-year period. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 18. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 18 and 19. Article 18 Revocation of the delegation 1. The delegation of power referred to in Articles 11(5) and 12(5) may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 19 Objections to delegated acts 1. The European Parliament or the Council may object to the delegated act within a period of 2 months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by 2 months. 2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and



shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

30. Regulation (EU) No 510/2011 of the European Parliament and of the Council of 11 May 2011 setting emission performance standards for new light commercial vehicles as part of the Union’s integrated

approach to reduce CO2 emissions from light-duty vehicles

Whereas: (33) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU to amend the monitoring and reporting requirements laid down in Annex II in the light of the experience

of the application of this Regulation, to adjust the figure of M0 referred to in Annex I to the average mass of new light commercial vehicles in the previous three calendar years, to establish rules regarding the interpretation of the eligibility criteria for derogations, on the content of applications for a derogation and on the content and assessment of programmes for the reduction of specific emissions of CO2, as well as to adapt the formulae set out in Annex I in order to reflect any change in the regulatory test procedure for the measurement of specific CO2 emissions. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 8 Monitoring and reporting of average emissions 9. The Commission shall adopt detailed rules for the monitoring and reporting of data under this Article and for the application of Annex II. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2). In order to take account of experience gained from the application of this Regulation, the Commission may amend Annex II by means of delegated acts in accordance with Article 15, and subject to the conditions laid down in Articles 16 and 17. Article 11 Derogations for certain manufacturers . An application for a derogation from the specific emissions target calculated in accordance with Annex I may be made by a manufacturer of fewer than 22000 new light commercial vehicles registered in the Union per calendar year, and which: (a) is not part of a group of connected manufacturers; or (b) is part of a group of connected manufacturers that is responsible in total for fewer than 22000 new light commercial vehicles registered in the Union per calendar year; or (c) is part of a group of connected manufacturers but operates its own production facilities and design centre. 2. A derogation applied for under paragraph 1 may be granted for a maximum period of five calendar years. An application shall be made to the Commission and shall include: (a) the name of, and contact person for, the manufacturer; (b) evidence that the manufacturer is eligible for a derogation under paragraph 1; (c) details of the light commercial vehicles which it manufactures including the mass and specific emissions of CO2 of those light commercial vehicles; and (d) a specific emissions target consistent with its reduction potential, including the economic and









technological potential to reduce its specific emissions of CO2 and taking into account the characteristics of the market for the type of light commercial vehicle manufactured. 3. Where the Commission considers that the manufacturer is eligible for a derogation applied for under paragraph 1 and is satisfied that the specific emissions target proposed by the manufacturer is consistent with its reduction potential, including the economic and technological potential to reduce its specific emissions of CO2, and taking into account the characteristics of the market for the type of light commercial vehicle manufactured, the Commission shall grant a derogation to the manufacturer. The derogation shall apply from 1 January of the year following the date of granting of the derogation. 4. A manufacturer which is subject to derogation in accordance with this Article shall notify the Commission immediately of any change which affects or may affect its eligibility for a derogation. 5. Where the Commission considers, whether on the basis of a notification under paragraph 4 or otherwise, that a manufacturer is no longer eligible for the derogation, it shall revoke the derogation with effect from 1 January of the next calendar year and shall notify the manufacturer thereof. 6. Where the manufacturer does not attain its specific emissions target, the Commission shall impose the excess emissions premium on the manufacturer, as set out in Article 9.

7. The Commission shall adopt rules to supplement paragraphs 1 to 6 of this Article, inter alia, on the interpretation of the eligibility criteria for derogations, on the content of applications, and on the content and assessment of programmes for the reduction of specific emissions of CO2, by means of delegated acts in accordance with Article 15, and subject to the conditions laid down in Articles 16 and 17. Article 13 Review and report 5. By 31 October 2016, and every three years thereafter, the Commission shall amend Annex I by means of delegated acts in accordance with Article 15, and subject to the conditions laid down in Articles 16 and 17, to adjust the figure M0, referred to therein, to the average mass of new light commercial vehicles in the previous three calendar years. Those adjustments shall take effect for the first time on 1 January 2018 and every three years thereafter. 6. The Commission shall include light commercial vehicles in the review of the procedures for measuring CO2 emissions in accordance with Article 13(3) of Regulation (EC) No 443/2009. From the date of application of the revised procedure for the measuring of CO2 emissions, innovative technologies shall no longer be approved under the procedure set out in Article 12. The Commission shall include light commercial vehicles in the review of Directive 2007/46/EC in accordance with Article 13(4) of Regulation (EC) No 443/2009. In order to reflect any change in the regulatory test procedure for the measurement of specific CO2 emissions, the Commission shall adapt the formulae set out in Annex I by means of delegated acts in accordance with Article 15, and subject to the conditions laid down in Articles 16 and 17. Article 15 Exercise of the delegation 1. The power to adopt delegated acts referred to in the second subparagraph of Article 8(9), Article 11(7), Article 13(5) and the fourth subparagraph of Article 13(6), shall be conferred on the Commission for a period of five years from 3 June 2011. The Commission shall draw up a report in respect of the delegated power at the latest six months before the end of the five-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 16.



2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 16 and 17. Article 16 Revocation of the delegation 1. The delegation of power referred to in the second subparagraph of Article 8(9), Article 11(7), Article 13(5) and the fourth subparagraph of Article 13(6) may be revoked at any time by the European Parliament or the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke a delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the

delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 17 Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by two months. 2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If either the European Parliament or the Council objects to the delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

31. Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products

(11) Safety features for medicinal products should be harmonised within the Union in order to take account of new risk profiles, while ensuring the functioning of the internal market for medicinal products. Those safety features should allow verification of the authenticity and identification of individual packs, and provide evidence of tampering. The scope of these safety features should take due account of the particularities of certain medicinal products or categories of medicinal products, such as generic medicinal products. Medicinal products subject to prescription should as a general rule bear the safety features. However, in view of the risk of falsification and the risk arising from falsification of medicinal products or categories of medicinal products there should be the possibility to exclude certain medicinal products or categories of medicinal products subject to prescription from the requirement to bear the safety features by way of a delegated act, following a risk assessment. Safety features should not be introduced for medicinal products or categories of medicinal products not subject to prescription unless, by way of exception, an assessment shows the risk of falsification, which leads to serious consequences. Those medicinal products should accordingly be listed in a delegated act.

http://ec.europa.eu/health/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf



(30) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in order to supplement the provisions of Directive 2001/83/EC, as amended by this Directive, concerning good manufacturing and distribution practices for active substances, concerning detailed rules for medicinal products introduced into the Union without being imported and concerning safety features. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council (32) The safety features for medicinal products introduced under this Directive require substantial adaptations to manufacturing processes. In order to enable manufacturers to make those adaptations, the time limits for the application of the provisions on the safety features should be sufficiently long and should be calculated as from the date of publication in the Official Journal of the European Union of the delegated acts setting out detailed rules in relation to those safety features. It should also be taken into account that some Member States already have a national system in place. Those Member States should

be granted an additional transitional period for adapting to the harmonised Union system. (36) Directive 2001/83/EC was recently amended by Directive 2010/84/EU ( 3 ) as regards pharmacovigilance. That Directive, inter alia, amended Article 111 with regard to inspections and Article 116 with regard to the suspension and revocation and variation of marketing authorisations under certain circumstances. Furthermore, it inserted provisions on delegated acts in Articles 121a, 121b and 121c of Directive 2001/83/EC. This Directive requires some further and complementary changes to those Articles of Directive 2001/83/EC Article 1 Directive 2001/83/EC is hereby amended as follows: (7) in Article 47, the third and fourth paragraphs are replaced by the following: ‘The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c, the principles and guidelines of good manufacturing practice for active substances referred to in the first paragraph of point (f) of Article 46 and in Article 46b. The principles of good distribution practices for active substances referred to in the first paragraph of point (f) of Article 46 shall be adopted by the Commission in the form of guidelines. The Commission shall adopt guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients referred to in the second paragraph of point (f) of Article 46.’; (8) the following Article is inserted: ‘Article 47a 1. The safety features referred to in point (o) of Article 54 shall not be removed or covered, either fully or partially, unless the following conditions are fulfilled: (a) the manufacturing authorisation holder verifies, prior to partly or fully removing or covering those safety features, that the medicinal product concerned is authentic and that it has not been tampered with; (b) the manufacturing authorisation holder complies with point (o) of Article 54 by replacing those safety



features with safety features which are equivalent as regards the possibility to verify the authenticity, identification and to provide evidence of tampering of the medicinal product. Such replacement shall be conducted without opening the immediate packaging as defined in point 23 of Article 1. Safety features shall be considered equivalent if they: (i) comply with the requirements set out in the delegated acts adopted pursuant to Article 54a(2); and (ii) are equally effective in enabling the verification of authenticity and identification of medicinal products and in providing evidence of tampering with medicinal products; (c) the replacement of the safety features is conducted in accordance with applicable good manufacturing practice for medicinal products; and (d) the replacement of the safety features is subject to supervision by the competent authority. 2. Manufacturing authorisation holders, including those performing the activities referred to in paragraph 1 of this Article, shall be regarded as producers and therefore held liable for damages in the cases and under the conditions set forth in Directive 85/374/EEC.’; (10) the following Articles are inserted:

‘Article 52a 8. This Article shall be without prejudice to Article 111. Article 52b 1. Notwithstanding Article 2(1), and without prejudice to Title VII, Member States shall take the necessary measures in order to prevent medicinal products that are introduced into the Union, but are not intended to be placed on the market of the Union, from entering into circulation if there are sufficient grounds to suspect that those products are falsified. 2. In order to establish what the necessary measures referred to in paragraph 1 of this Article are, the Commission may adopt, by means of delegated acts in accordance with Article 121a, and subject to the conditions laid down in Articles 121b and 121c, measures supplementing paragraph 1 of this Article as regards the criteria to be considered and the verifications to be made when assessing the potential falsified character of medicinal products introduced into the Union but not intended to be placed on the market.’; (12) the following Article is inserted: ‘Article 54a 1. Medicinal products subject to prescription shall bear the safety features referred to in point (o) of Article 54, unless they have been listed in accordance with the procedure pursuant to point (b) of paragraph 2 of this Article. Medicinal products not subject to prescription shall not bear the safety features referred to in point (o) of Article 54, unless, by way of exception, they have been listed in accordance with the procedure pursuant to point (b) of paragraph 2 of this Article, after having been assessed to be at risk of falsification. 2. The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c, measures supplementing point (o) of Article 54 with the objective of establishing the detailed rules for the safety features referred to in point (o) of Article 54. Those delegated acts shall set out: (a) the characteristics and technical specifications of the unique identifier of the safety features referred to in point (o) of Article 54 that enables the authenticity of medicinal products to be verified and individual packs to be identified. When establishing the safety features due consideration shall be given to



their cost-effectiveness; (b) the lists containing the medicinal products or product categories which, in the case of medicinal products subject to prescription shall not bear the safety features, and in the case of medicinal products not subject to prescription shall bear the safety features referred to in point (o) of Article 54. Those lists shall be established considering the risk of and the risk arising from falsification relating to medicinal products or categories of medicinal products. To this end, at least the following criteria shall be applied: (i) the price and sales volume of the medicinal product; (ii) the number and frequency of previous cases of falsified medicinal products being reported within the Union and in third countries and the evolution of the number and frequency of such cases to date; (iii) the specific characteristics of the medicinal products concerned; (iv) the severity of the conditions intended to be treated; (v) other potential risks to public health;EN L 174/80 Official Journal of the European Union 1.7.2011 (c) the procedures for the notification to the Commission provided for in paragraph 4 and a rapid system for evaluating and deciding on such notification for the purpose of applying point (b); (d) the modalities for the verification of the safety features referred to in point (o) of Article 54 by the

manufacturers, wholesalers, pharmacists and persons authorised or entitled to supply medicinal products to the public and by the competent authorities. Those modalities shall allow the verification of the authenticity of each supplied pack of the medicinal products bearing the safety features referred to in point (o) of Article 54 and determine the extent of such verification. When establishing those modalities, the particular characteristics of the supply chains in Member States, and the need to ensure that the impact of verification measures on particular actors in the supply chains is proportionate, shall be taken into account; (e) provisions on the establishment, management and accessibility of the repositories system in which information on the safety features, enabling the verification of the authenticity and identification of medicinal products, as provided for in point (o) of Article 54, shall be contained. The costs of the repositories system shall be borne by the manufacturing authorisation holders of medicinal products bearing the safety features. 3. When adopting the measures referred to in paragraph 2, the Commission shall take due account of at least the following: (a) the protection of personal data as provided for in Union law; (b) the legitimate interests to protect information of a commercially confidential nature; (c) the ownership and confidentiality of the data generated by the use of the safety features; and (d) the cost-effectiveness of the measures. 4. The national competent authorities shall notify the Commission of non-prescription medicinal products which they judge to be at risk of falsification and may inform the Commission of medicinal products which they deem not to be at risk according to the criteria set out in point (b) of paragraph 2 of this Article. 5. Member States may, for the purposes of reimbursement or pharmacovigilance, extend the scope of application of the unique identifier referred to in point (o) of Article 54 to any medicinal product subject to prescription or subject to reimbursement. Member States may, for the purposes of reimbursement, pharmacovigilance or pharmacoepidemiology, use the information contained in the repositories system referred to in point (e) of paragraph 2 of this Article. Member States may, for the purposes of patient safety, extend the scope of application of the anti-tampering device referred to in point (o) of Article 54 to any medicinal product.’; (17) Article 80 is amended as follows:



(a) the following point is inserted: ‘(ca) they must verify that the medicinal products received are not falsified by checking the safety features on the outer packaging, in accordance with the requirements laid down in the delegated acts referred to in Article 54a(2);’; Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 2 January 2013. They shall forthwith inform the Commission thereof. 2. Member States shall apply those measures from 2 January 2013. However, the Member States shall apply: (b) the provisions necessary to comply with points 8, 9, 11 and 12 of Article 1 of this Directive from 3 years after the date of publication of the delegated acts referred to in point 12 of Article 1 of this Directive. Nevertheless, Member States which, on 21 July 2011, have systems in place for the purpose referred to in point 11 of Article 1 of this Directive shall apply the provisions necessary to comply with points 8, 9, 11

and 12 of Article 1 of this Directive at the latest from 6 years after the date of application of the delegated acts referred to in point 12 of Article 1 of this Directive; Article 3 At the latest 5 years after the date of application of the delegated acts referred to in Article 54a(2) of Directive 2001/83/EC as inserted by this Directive, the Commission shall submit a report to the European Parliament and to the Council containing the following: (a) a description, where possible including quantitative data, of the trends in the falsification of medicinal products in terms of: categories of medicinal products affected, distribution channels including sale at a distance to the public by means of information society services, the Member States concerned, the nature of the falsifications, and the regions of provenance of these products; and (b) an evaluation of the contribution of the measures provided for in this Directive regarding the prevention of the entry of falsified medicinal products in the legal supply chain. That evaluation shall in particular assess point (o) of Article 54 and Article 54a of Directive 2001/83/EC as inserted by this Directive. Article 4 In order to adopt the delegated acts referred to in Article 54a(2) of Directive 2001/83/EC as inserted by this Directive, the Commission shall perform a study assessing at least the following aspects: (a) the technical options for the unique identifier of the safety features referred to in point (o) of Article 54 of Directive 2001/83/EC as inserted by this Directive; (b) the options for the extent and the modalities of verification of the authenticity of the medicinal product bearing the safety features. This assessment shall take into account the particular characteristics of the supply chains in the Member States; (c) the technical options for establishing and managing the repositories system, referred to in point (e) of Article 54a(2) of Directive 2001/83/EC as inserted by this Directive. The study shall, for each of the options, assess benefits, costs and cost-effectiveness.

32. Directive 2011/76/EU of the European Parliament and of the Council of

Whereas: (39) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the




27 September 2011 amending Directive 1999/62/EC on the charging of heavy goods vehicles for the use of certain infrastructures

Treaty on the Functioning of the European Union in respect of certain adaptations of the Annexes. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 1 Directive 1999/62/EC is hereby amended as follows: (5) Articles 9b and 9c are replaced by the following: Article 9d The Commission shall adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union as regards: — the adaptation of Annex 0 to the Union acquis, — the adaptation of the formulas of sections 4.1 and 4.2 of Annex IIIa to scientific and technical progress. The procedures set out in Articles 9e, 9f and 9g shall apply to the delegated acts referred to in this Article. Article 9e

1. The power to adopt the delegated acts referred to in Article 9d shall be conferred on the Commission for an indeterminate period of time. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 9f and 9g. Article 9f 1. The delegation of power referred to in Article 9d may be revoked by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the power specified in that decision and shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 9g 1. The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by two months. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

33. Regulation (EU) No 691/2011 of the European Parliament and of the Council of

Whereas: (22) The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the




6 July 2011 on European environmental economic accounts

European Union should be delegated to the Commission for the purpose of adjusting the modules to environmental, economic and technical developments, as well as providing methodological guidance. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council. Article 3 Modules 3. The Commission shall be empowered to adopt delegated acts, where necessary to take account of environmental, economic and technical developments, in accordance with Article 9: (a) to provide methodological guidance; and (b) to update the Annexes referred to in paragraph 1 as regards the information referred to in paragraph 2(c) to (e). In exercising its power pursuant to this paragraph, the Commission shall ensure that its delegated acts

do not impose significant additional administrative burdens on the Member States and on the respondent units Article 9 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power referred to in Article 3(3) shall be conferred on the Commission for a period of 5 years from 11 August 2011. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Article 3(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 3(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or the Council.

34. Regulation (EU) No 692/2011 of the European Parliament and of the Council of 6 July 2011 concerning European statistics on tourism and repealing Council Directive 95/57/EC

Whereas: (12) In order to take account of economic, social and technical developments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of adapting the deadlines for data transmission and the Annexes, except for the optional nature of the required data and the limitation of the scope as defined in the Annexes. The Commission should also be empowered to adapt the definitions to the changes in international definitions.




It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council. Article 2 Definitions 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 11 concerning amendments to the definitions in paragraph 1 of this Article for the purpose of adapting those definitions to changes to international definitions. Article 3 Subjects covered and characteristics of the required data 2. The Commission shall be empowered to adopt, where necessary, delegated acts in accordance with Article 11 concerning adaptation of the Annexes, except for the optional nature of the required data and to the limitation of the scope as defined in the Annexes in order to take account of economic, social or technical developments. In exercising its power pursuant to this provision, the Commission shall ensure

that any delegated acts adopted do not impose significant additional administrative burdens on the Member States and on the respondents. Article 9 Transmission of data 4. Member States shall transmit: (a) the annual data listed in Sections 1 and 2 of Annex I within 6 months after the end of the reference period, unless otherwise specified in Annex I; (b) the monthly data listed in Section 2 of Annex I within 3 months after the end of the reference period; (c) the rapid key indicators relating to nights spent by residents and non-residents in tourist accommodation establishments, as listed in Section 2 of Annex I, within 8 weeks after the end of the reference period; (d) the data listed in Section 4 of Annex I within 9 months after the end of the reference period, if the Member State concerned opts in favour of transmitting them; (e) the data listed in Annex II within 6 months after the end of the reference period. 5. The Commission shall be empowered to adopt, where necessary, delegated acts in accordance with Article 11 concerning amendments to the transmission deadlines laid down in paragraph 4 of this Article in order to take account of economic, social or technical developments. Any such amendments shall take into account the existing data collection practices in the Member States Article 11 Exercise of the delegation 1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power referred to in Articles 2(2), 3(2) and 9(5) shall be conferred on the Commission for a period of 5 years from 11 August 2011. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Articles 2(2), 3(2) and 9(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the



Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 2(2), 3(2) and 9(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or the Council.

35. Directive 2011/89/EU of the European Parliament and of the Council of 16 November 2011 amending Directives 98/78/EC, 2002/87/EC, 2006/48/EC and 2009/138/EC as regards the supplementary supervision of financial entities in a financial conglomerate Text with EEA relevance

Whereas: (15) In order to improve the supplementary supervision of financial entities in a financial conglomerate, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of technical adaptations to be made to Directive 2002/87/EC as regards the definitions, the alignment of terminology and the calculation methods set out in that Directive. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council. Article 1 Amendments to Directive 98/78/EC (3) the following Article is inserted: ‘Article 2a Level of application with regard to mixed financial holding companies Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010, of Regulation (EU) No 1094/2010 and of Regulation (EU) No 1095/2010 respectively. Article 2 Amendments to Directive 2002/87/EC (17) the title of Chapter III is replaced by the following: ‘DELEGATED ACTS AND IMPLEMENTING MEASURES’; (18) Article 20 is replaced by the following: ‘Article 20 Powers conferred on the Commission The Commission shall be empowered to adopt delegated acts in accordance with Article 21c concerning the technical adaptations to be made to this Directive in the following areas: (a) a more precise formulation of the definitions laid down in Article 2 in order to take account of developments in financial markets for the application of this Directive; (b) the alignment of terminology and the framing of definitions in this Directive in accordance with subsequent Union acts on regulated entities and related matters; (c) a more precise definition of the calculation methods set out in Annex I in order to take account of developments on financial markets and prudential techniques. Those measures shall not include the subject matter of the power delegated to and conferred on the


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Commission with regard to the items listed in Article 21a.’; (19) in Article 21, paragraphs 2, 3 and 5 are deleted; (20) Article 21a is amended as follows: (a) in the first subparagraph of paragraph 1, the following point is added: ‘(d) Article 6(2) in order to ensure a uniform format (with instructions) for, and determine the frequency of and, where appropriate, the dates for reporting.’; (b) the following paragraph is inserted: ‘1a. In order to ensure consistent application of Articles 2, 7 and 8 and Annex II, the ESA shall, through the Joint Committee, develop draft regulatory technical standards to establish a more precise formulation of the definitions set out in Article 2 and to coordinate the provisions adopted pursuant to Articles 7 and 8 and Annex II. The Joint Committee shall submit those draft regulatory technical standards to the Commission by 1 January 2015. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010, of Regulation (EU)

No 1094/2010 and of Regulation (EU) No 1095/2010 respectively.’; (c) the following paragraph is added: ‘3. Within two years of the adoption of any implementing technical standards in accordance with paragraph 2(a), Member States shall require a uniform format for and shall determine the frequency of, and the dates for, reporting of the calculations referred to in this Article.’; (21) the following Articles are inserted in Chapter III: ‘Article 21c Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power referred to in Article 20 shall be conferred on the Commission for a period of four years from 9 December 2011. The Commission shall draw up a report in respect of the delegated power at the latest six months before the end of the four-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 20 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or on a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 20 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three months of the notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or the Council.’; Article 3 Amendments to Directive 2006/48/EC

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(8) the following Article is inserted: ‘Article 72a 1. Where a mixed financial holding company is subject to equivalent provisions under this Directive and under Directive 2002/87/EC, in particular in terms of risk- based supervision, the consolidating supervisor may, after consulting the other competent authorities responsible for the supervision of subsidiaries, apply only the relevant provision of Directive 2002/87/EC to that mixed financial holding company. 2. Where a mixed financial holding company is subject to equivalent provisions under this Directive and under Directive 2009/138/EC, in particular in terms of risk- based supervision, the consolidating supervisor may, in agreement with the group supervisor in the insurance sector, apply to that mixed financial holding company only the provision of the Directive relating to the most significant financial sector as determined under Article 3(2) of Directive 2002/87/EC. 3. The consolidating supervisor shall inform EBA and the European Supervisory Authority (European Insurance and Occupational Pensions Authority) established by Regulation (EU) No 1094/2010 of the European Parliament and of the Council (*) (EIOPA) of the decisions taken under paragraphs 1 and 2 of this Article. EBA, EIOPA and the European Supervisory Authority (European Securities and Markets

Authority) established by Regulation (EU) No 1095/2010 of the European Parliament and of the Council (**) (ESMA) shall, through the Joint Committee of the European Supervisory Authorities (Joint Committee), develop guidelines aimed at converging supervisory practices and shall develop draft regulatory technical standards, which they shall submit to the Commission within three years of the adoption of the guidelines. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010, of Regulation (EU) No 1094/2010 and of Regulation (EU) No 1095/2010 respectively. Article 4 Amendments to Directive 2009/138/EC (2) in Article 213, paragraphs 2 and 3 are replaced by the following: 6. The group supervisor shall inform the European Supervisory Authority (European Banking Authority) established by Regulation (EU) No 1093/2010 of the European Parliament and of the Council (*) (EBA) and the European Supervisory Authority (European Insurance and Occupational Pensions Authority) established by Regulation (EU) No 1094/2010 of the European Parliament and of the Council (EIOPA) (**) of the decisions taken under paragraphs 4 and 5. EBA, EIOPA and the European Supervisory Authority (European Securities and Markets Authority) established by Regulation (EU) No 1095/2010 (***) (ESMA) shall, through the Joint Committee of the European Supervisory Authorities (Joint Committee), develop guidelines aimed at converging supervisory practices and shall develop draft regulatory technical standards, which they shall submit to the Commission within three years of the adoption of those guidelines. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010, of Regulation (EU) No 1094/2010 and of Regulation (EU) No 1095/2010 respectively. Article 5 Review The Commission shall fully review Directive 2002/87/EC, including the delegated and implementing acts adopted pursuant thereto. Following that review, the Commission shall send a report to the European Parliament and to the Council by 31 December 2012, addressing, in particular, the scope of that Directive, including whether the scope should be extended by reviewing Article 3, and the application of

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that Directive to non-regulated entities, in particular special purpose vehicles. The report shall also cover the identification criteria of financial conglomerates owned by wider non-financial groups, whose total activities in the banking sector, insurance sector and investment services sector are materially relevant in the internal market for financial services.

36. Regulation (EU) No 1173/2011 of the European Parliament and of the Council of 16 November 2011 on the effective enforcement of budgetary surveillance in the euro area

Whereas: (17) In order to supplement the rules on calculation of the fines for manipulation of statistics as well as the rules on the procedure to be followed by the Commission for the investigation of such actions, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of detailed criteria for establishing the amount of the fine and for conducting the Commission’s investigations. It is of particular importance that the Commission carry out appropriate consultations

during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council. Article 8 Sanctions concerning the manipulation of statistics 1. The Council, acting on a recommendation by the Commission, may decide to impose a fine on a Member State that intentionally or by serious negligence misrepresents deficit and debt data relevant for the application of Articles 121 or 126 TFEU, or for the application of the Protocol on the excessive deficit procedure annexed to the TEU and to the TFEU. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 11 concerning: (a) detailed criteria establishing the amount of the fine referred to in paragraph 1; (b) detailed rules concerning the procedures for the investigations referred to in paragraph 3, the associated measures and the reporting on the investigations; (c) detailed rules of procedure aimed at guaranteeing the rights of the defence, access to the file, legal representation, confidentiality and provisions as to timing and the collection of the fines referred to in paragraph 1. Article 11 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 8(4) shall be conferred on the Commission for a period of 3 years from 13 December 2011. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of that 3-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Article 8(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.


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5. A delegated act adopted pursuant to Article 8(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.

37. Regulation (EU) No 1233/2011 of the European Parliament and of the Council of 16 November 2011 on the application of certain guidelines in the field of officially supported export credits and repealing

Council Decisions 2001/76/EC and 2001/77/EC

Whereas: (14) In order to smoothly and promptly incorporate into Union legislation the amendments to the guidelines set out in the Arrangement as agreed upon by the Participants to the Arrangement, the Commission should adopt delegated acts to amend Annex II where this is necessary. Therefore the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union

should be delegated to the Commission in respect of amendments to the guidelines as agreed upon by the Participants to the Arrangement. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council, Article 2 Delegation of power The Commission shall adopt delegated acts in accordance with Article 3 to amend Annex II as a result of amendments to the guidelines agreed upon by the Participants to the Arrangement. Where, in the case of amendments to Annex II as a result of amendments to the guidelines agreed upon by the Participants to the Arrangement, imperative grounds of urgency so require, the procedure provided for in Article 4 shall apply to delegated acts adopted pursuant to this Article. Article 3 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 2 shall be conferred on the Commission for an indeterminate period of time from 9 December 2011. 3. The delegation of power referred to in Article 2 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 2 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 2 months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council. Article 4 Urgency procedure 1. Delegated acts adopted pursuant to this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to


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the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 3(5). In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or by the Council.

38. Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing

Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004

Whereas: (58) The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of, inter alia, the availability of certain mandatory particulars by means other than on the package or on the label, the list of foods not required to bear a list of ingredients, the re-examination of the list of substances or products causing allergies or intolerances, or the list of nutrients that may be declared on a voluntary basis. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when

preparing and drawing up delegated acts, should ensure simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. Article 9 List of mandatory particulars 1. In accordance with Articles 10 to 35 and subject to the exceptions contained in this Chapter, indication of the following particulars shall be mandatory: (a) the name of the food; (b) the list of ingredients; (c) any ingredient or processing aid listed in Annex II or derived from a substance or product listed in Annex II causing allergies or intolerances used in the manufacture or preparation of a food and still present in the finished product, even if in an altered form; (d) the quantity of certain ingredients or categories of ingredients; (e) the net quantity of the food; (f) the date of minimum durability or the ‘use by’ date; (g) any special storage conditions and/or conditions of use; (h) the name or business name and address of the food business operator referred to in Article 8(1); (i) the country of origin or place of provenance where provided for in Article 26; (j) instructions for use where it would be difficult to make appropriate use of the food in the absence of such instructions; (k) with respect to beverages containing more than 1,2 % by volume of alcohol, the actual alcoholic strength by volume; (l) a nutrition declaration. 3. Where the Commission adopts delegated and implementing acts referred to in this Article, the particulars referred to in paragraph 1 may alternatively be expressed by means of pictograms or symbols instead of words or numbers. In order to ensure that consumers benefit from other means of expression of mandatory food information than words and numbers, and provided that the same level of information as with words and numbers is ensured, the Commission, taking into account evidence of uniform consumer understanding, may establish, by means of delegated acts in accordance with Article 51, the criteria subject to which one or more particulars referred to in paragraph 1 may be expressed by pictograms or symbols instead of words or numbers. Article 10


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Additional mandatory particulars for specific types or categories of foods 1. In addition to the particulars listed in Article 9(1), additional mandatory particulars for specific types or categories of foods are laid down in Annex III. 2. In order to ensure consumer information with respect to specific types or categories of foods and to take account of technical progress, scientific developments, the protection of consumers’ health or the safe use of a food, the Commission may amend Annex III by means of delegated acts, in accordance with Article 51. Where, in the case of the emergence of a risk to consumers’ health, imperative grounds of urgency so require, the procedure provided for in Article 52 shall apply to delegated acts adopted pursuant to this Article. Article 12 Availability and placement of mandatory food information 3. In order to ensure that consumers benefit from other means of provision of mandatory food information better adapted for certain mandatory particulars, and provided that the same level of information as by means of the package or the label is ensured, the Commission, taking into account

evidence of uniform consumer understanding and of the wide use of these means by consumers, may establish, by means of delegated acts in accordance with Article 51, criteria subject to which certain mandatory particulars may be expressed by means other than on the package or on the label. Article 13 Presentation of mandatory particulars 4. For the purpose of achieving the objectives of this Regulation, the Commission shall, by means of delegated acts in accordance with Article 51, establish rules for legibility. For the same purpose as referred to in the first subparagraph, the Commission may, by means of delegated acts in accordance with Article 51, extend the requirements under paragraph 5 of this Article to additional mandatory particulars for specific types or categories of foods. Article 18 List of ingredients 5. For the purposes of achieving the objectives of this Regulation, the Commission shall, by means of delegated acts in accordance with Article 51, adjust and adapt the definition of engineered nanomaterials referred to in point (t) of Article 2(2) to technical and scientific progress or to definitions agreed at international level. Article 19 Omission of the list of ingredients 1. The following foods shall not be required to bear a list of ingredients: (a) fresh fruit and vegetables, including potatoes, which have not been peeled, cut or similarly treated; (b) carbonated water, the description of which indicates that it has been carbonated; (c) fermentation vinegars derived exclusively from a single basic product, provided that no other ingredient has been added; (d) cheese, butter, fermented milk and cream, to which no ingredient has been added other than lactic products, food enzymes and micro-organism cultures essential to manufacture, or in the case of cheese other than fresh cheese and processed cheese the salt needed for its manufacture; (e) foods consisting of a single ingredient, where: (i) the name of the food is identical to the ingredient name; or (ii) the name of the food enables the nature of the ingredient to be clearly identified. 2. In order to take into account the relevance for the consumer of a list of ingredients for specific types or

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categories of foods, the Commission may, in exceptional cases, by means of delegated acts, in accordance with Article 51, supplement paragraph 1 of this Article, provided that omissions do not result in the final consumer or mass caterers being inadequately informed. Article 21 Labelling of certain substances or products causing allergies or intolerances 2. In order to ensure better information for consumers and to take account of the most recent scientific progress and technical knowledge, the Commission shall systematically re- examine and, where necessary, update the list in Annex II by means of delegated acts, in accordance with Article 51. Where, in the case of the emergence of a risk to consumers’ health, imperative grounds of urgency so require, the procedure provided for in Article 52 shall apply to delegated acts adopted pursuant to this Article. Article 23 Net quantity 2. In order to ensure a better understanding by the consumer of the food information on the labelling, the Commission may establish for certain specified foods, by means of delegated acts, in accordance with

Article 51, a manner for the expression of the net quantity other than the one laid down in paragraph 1 of this Article. Article 30 Content 2. The content of the mandatory nutrition declaration referred to in paragraph 1 may be supplemented with an indication of the amounts of one or more of the following: (a) mono-unsaturates; (b) polyunsaturates; (c) polyols; (d) starch; (e) fibre; (f) any of the vitamins or minerals listed in point 1 of Part A of Annex XIII, and present in significant amounts as defined in point 2 of Part A of Annex XIII. 3. Where the labelling of a prepacked food provides the mandatory nutrition declaration referred to in paragraph 1, the following information may be repeated thereon: (a) the energy value; or (b) the energy value together with the amounts of fat, saturates, sugars, and salt. 4. By way of derogation from Article 36(1), where the labelling of the products referred to in Article 16(4) provides a nutrition declaration, the content of the declaration may be limited to the energy value only. 5. Without prejudice to Article 44 and by way of derogation from Article 36(1), where the labelling of the products referred to in Article 44(1) provides a nutrition declaration, the content of that declaration may be limited only to: (a) the energy value; or (b) the energy value together with the amounts of fat, saturates, sugars, and salt. 6. In order to take account of the relevance of particulars referred to in paragraphs 2 to 5 of this Article for the information of consumers, the Commission may, by means of delegated acts, in accordance with Article 51, amend the lists in paragraphs 2 to 5 of this Article, by adding or removing particulars. Article 31 Calculation 2. The Commission may adopt, by means of delegated acts, in accordance with Article 51, conversion

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factors for the vitamins and minerals referred to in point 1 of Part A of Annex XIII, in order to calculate more precisely the content of such vitamins and minerals in foods. Those conversion factors shall be added to Annex XIV. Article 36 Applicable requirements 3. The Commission shall adopt implementing acts on the application of the requirements referred to in paragraph 2 of this Article to the following voluntary food information: (a) information on the possible and unintentional presence in food of substances or products causing allergies or intolerances; (b) information related to suitability of a food for vegetarians or vegans; and (c) the indication of reference intakes for specific population groups in addition to the reference intakes set out in Annex XIII. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(2). 4. In order to ensure that consumers are appropriately informed, where voluntary food information is

provided by food business operators on a divergent basis which might mislead or confuse the consumer, the Commission may, by means of delegated acts, in accordance with Article 51, provide for additional cases of provision of voluntary food information to the ones referred to in paragraph 3 of this Article. Article 46 Amendments to the Annexes In order to take into account technical progress, scientific developments, consumers’ health, or consumers’ need for information, and subject to the provisions of Article 10(2) and Article 21(2) relating to the amendments to Annexes II and III, the Commission may, by means of delegated acts in accordance with Article 51, amend the Annexes to this Regulation Article 47 Transitional period for and date of application of implementing measures or delegated acts 1. Without prejudice to paragraph 2 of this Article, in exercising the powers conferred by this Regulation to adopt measures by means of implementing acts in accordance with the examination procedure referred to in Article 48(2) or by means of delegated acts in accordance with Article 51 the Commission shall: (a) establish an appropriate transitional period for application of the new measures, during which foods bearing labels not complying with the new measures may be placed on the market and after which stocks of such foods that have been placed on the market before the end of the transitional period may continue to be sold until exhausted; and (b) ensure that those measures apply as from 1 April in any calendar year. 2. Paragraph 1 shall not apply in cases of urgency where the purpose of the measures referred to in that paragraph is the protection of human health. Article 51 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 9(3), Article 10(2), Article 12(3), Article 13(4), Article 18(5), Article 19(2), Article 21(2), Article 23(2), Article 30(6), Article 31(2), Article 36(4) and Article 46 shall be conferred on the Commission for a period of 5 years after 12 December 2011. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before

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the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Article 9(3), Article 10(2), Article 12(3), Article 13(4), Article 18(5), Article 19(2), Article 21(2), Article 23(2), Article 30(6), Article 31(2), Article 36(4) and Article 46 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or on a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 9(3), Article 10(2), Article 12(3), Article 13(4), Article 18(5), Article 19(2), Article 21(2), Article 23(2), Article 30(6), Article 31(2), Article 36(4) and Article 46 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council

or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council. Article 52 Urgency procedure 1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 51(5). In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or by the Council.

39. Regulation (EU) No 1214/2011 of the European Parliament and of the Council of 16 November 2011 on the professional cross-border transport of euro cash by road between euro-area Member States "

Whereas: (20) In order to take into account technological progress and possible new European standards, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of the amendment of the technical rules on standards in regard to the IBNS, the armouring of CIT vehicles, bulletproof vests and weapons strong-boxes. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level and of the social partners. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. Article 27 Amendment of technical rules The Commission shall be empowered to adopt delegated acts in accordance with Article 28 concerning amendments to Annex II and to the technical rules on the standards applicable to the armouring of CIT vehicles and to bulletproof vests referred to in Articles 16, 17, 18 and 20, and to weapons strong-boxes referred to in Article 6(2), with a view to taking into account technological progress and possible new European standards. Article 28 Exercise of the delegation


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1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 27 shall be conferred on the Commission for an indeterminate period of time from 30 November 2012. 3. The delegation of power referred to in Article 27 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified therein. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or on a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 27 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 3 months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That

period shall be extended by 3 months at the initiative of the European Parliament or of the Council.

40. Directive 2011/82/EU of the European Parliament and of the Council of 25 October 2011 facilitating the crossborder exchange of information on road safety related traffic offences

Whereas: (24) In order to achieve the objective of exchange of information between Member States through interoperable means, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of taking into account relevant changes to Decision 2008/615/JHA and Decision 2008/616/JHA or where required by legal acts of the Union directly relevant for the update of Annex I. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council. Article 9 Delegated acts The Commission shall be empowered to adopt delegated acts in accordance with Article 10 concerning the update of Annex I in the light of technical progress to take into account relevant changes to Decision 2008/615/JHA and Decision 2008/616/JHA or where required by legal acts of the Union directly relevant for the update of Annex I. Article 10 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power referred to in Article 9 shall be conferred on the Commission for a period of five years from 6 November 2011. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 9 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of


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any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 9 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

41. Regulation (EU) No 1227/2011 of the European Parliament and of the Council of

25 October 2011 on wholesale energy market integrity and transparency

Whereas: (16) As financial markets develop, the concepts of market abuse applying to those markets will be

adapted. In order to ensure the necessary flexibility to respond quickly to these developments therefore, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of technical updating of the definitions of inside information and market manipulation for the purpose of ensuring coherence with other relevant Union legislation in the fields of financial services and energy. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission should, when preparing and drawing up delegated acts, ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council. Article 6 Technical updating of definitions of inside information and market manipulation 1. The Commission shall be empowered to adopt delegated acts in accordance with Article 20 in order to: (a) align the definitions set out in points (1), (2), (3) and (5) of Article 2 for the purpose of ensuring coherence with other relevant Union legislation in the fields of financial services and energy; and (b) update those definitions for the sole purpose of taking into account future developments on wholesale energy markets. 2. The delegated acts referred to in paragraph 1 shall take into account at least: (a) the specific functioning of wholesale energy markets, including the specificities of electricity and gas markets, and the interaction between commodity markets and derivative markets; (b) the potential for manipulation across borders, between electricity and gas markets and across commodity markets and derivative markets; (c) the potential impact on wholesale energy market prices of actual or planned production, consumption, use of transmission, or use of storage capacity; and (d) network codes and framework guidelines adopted in accordance with Regulations (EC) No 714/2009 and (EC) No 715/2009. Article 13 Implementation of prohibitions against market abuse 2. The investigatory and enforcement powers referred to in paragraph 1 shall be limited to the aim of the investigation. They shall be exercised in conformity with national law and include the right to: (e) require the cessation of any practice that is contrary to this Regulation or delegated acts or implementing acts adopted on the basis thereof; Article 20 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.


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2. The power to adopt delegated acts referred to in Article 6 shall be conferred on the Commission for a period of 5 years from 28 December 2011. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Article 6 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 6 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the

European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or the Council.

42. Decision No 1104/2011/EU of the European Parliament and of the Council of 25 October 2011 on the rules for access to the public regulated service provided by the global navigation satellite system established under the Galileo programme

Whereas: (20) The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the common minimum standards in the areas set out in the Annex and, if necessary, to update and amend it in order to take into account the developments in the Galileo programme. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. Article 8 Common minimum standards 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 11 concerning the adoption of the common minimum standards for the areas set out in the Annex and, if necessary, amendments updating the Annex to take account of developments in the Galileo programme, in particular with regard to technology and changes in security needs. Article 11 Exercise of delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 8(2) shall be conferred on the Commission for a period of five years from 5 November 2011. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. 3. The delegation of power referred to in Article 8(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European


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Parliament and to the Council. 5. A delegated act adopted pursuant to Article 8(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. ANNEX Common minimum standards 1. As regards Article 5(4), the common minimum standards for the use of the PRS cover the following areas: (i) PRS user group organisation; (ii) definition and management of access rights for PRS users and user groups of PRS participants; (iii) distribution of PRS keys and related classified information between the GSMC and the competent PRS authorities;

(iv) distribution of PRS keys and related classified information to the users; (v) security management, including security incidents, and risk assessment for PRS receivers and associated classified technology and information; (vi) reporting of detected potentially harmful electromagnetic interference affecting the PRS; (vii) operational concepts and procedures for PRS receivers. 2. As regards Article 5(5), the common minimum standards for the development and manufacture of PRS receivers or security modules cover the following areas: (i) PRS user segment authorisation; (ii) security of PRS receivers and PRS technology during research, development, and manufacturing phases; (iii) PRS receiver and PRS technology integration; (iv) protection profile for PRS receivers, security modules, and material using PRS technology. 3. As regards Article 5(6) and Article 9, the common minimum standards for export restrictions cover the following areas: (i) authorised PRS participants; (ii) export of PRS-related material and technology. 4. As regards Article 5(7), the common minimum standards for the links between the GSMC and the competent PRS

43. Decision No 1080/2011/EU of the European Parliament and of the Council of 25 October 2011 granting an EU guarantee to the European Investment Bank against losses under loans and loan guarantees for projects outside the Union and repealing Decision No 633/2009/EC

Whereas: (10) In order to reflect significant policy developments, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending Annex III to this Decision. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. Article 4 Countries covered 1. The list of countries potentially eligible for EIB financing under EU guarantee is set out in Annex II. The list of countries eligible for EIB financing under EU guarantee is set out in Annex III and shall include no countries other than those listed in Annex II. For countries not listed in Annex II, eligibility for EIB


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financing under EU guarantee shall be decided on a case-by-case basis in accordance with the ordinary legislative procedure. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 5 concerning amendments to Annex III. The Commission’s decisions shall be based on an overall economic and political assessment, including aspects related to the democracy, human rights and fundamental freedoms as well as the relevant European Parliament resolutions and Council decisions and conclusions. Delegated acts amending Annex III shall not affect the EU guarantee coverage of EIB financing operations signed before the entry into force of those delegated acts. 3. The EU guarantee shall cover only EIB financing operations carried out in eligible countries that have concluded a framework agreement with the EIB establishing the legal conditions under which such operations are to be carried out. 4. The EU guarantee shall not cover EIB financing operations in a specific country with which the agreement concerning such operations has been signed after that country’s accession to the Union. Article 5

Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 4 shall be conferred on the Commission for an indeterminate period of time from 30 October 2011. 3. The delegation of power referred to in Article 4 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 4 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

44. Regulation (EU) No 258/2012 of the European Parliament and of the Council of 14 March 2012 implementing Article 10 of the United Nations’ Firearms Protocol and establishing export authorisation, import and transit measures for firearms, their parts and components and ammunition

Whereas: (14) In order to maintain the list of firearms, their parts and essential components and ammunition for which an authorisation is required under this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of aligning Annex I to this Regulation to Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff ( 3 ), and to Annex I to Directive 91/477/EEC. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.


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Article 5 The Commission shall be empowered to adopt delegated acts in accordance with Article 6 to amend Annex I on the basis of the amendments to Annex I to Regulation (EEC) No 2658/87, and on the basis of the amendments to Annex I to Directive 91/477/EEC. Article 6 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 5 shall be conferred on the Commission for an indeterminate period of time. 3. The delegation of power referred to in Article 5 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 5 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. ANNEX I ( 1 ) List of firearms, their parts and essential components and ammunition

45. Regulation (EU) No 1343/2011 of the European Parliament and of the Council of 13 December 2011 on certain provisions for fishing in the GFCM (General Fisheries Commission for the Mediterranean) Agreement area and amending Council Regulation (EC) No 1967/2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea

Whereas: (15) In order to ensure that the Union continues to fulfil its obligations under the GFCM Agreement, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the implementation in Union law of amendments, which have become binding on the Union, to existing GFCM measures which have already been implemented in Union law, as regards the provision to the Executive Secretary of the GFCM of information on minimum mesh size in the Black Sea; the transmission to the Executive Secretary of the GFCM of the list of authorised vessels for the purpose of the GFCM Register; port state measures; cooperation, information and reporting; the table, map and geographic coordinates of the GFCM Geographical Sub-Areas; port state inspection procedures for vessels; and GFCM statistical matrices. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council, Article 26 Delegation of powers As far as is necessary, in order to implement in Union law amendments that become obligatory for the Union to existing GFCM measures that have already been implemented in Union law, the Commission shall be empowered to adopt delegated acts, in accordance with Article 27, in order to amend the provisions of this Regulation in respect of the following: (a) the provision to the Executive Secretary of the GFCM of information under Article 15(4);


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(b) the transmission of the list of authorised vessels to the Executive Secretary of the GFCM under Article 17; (c) port state measures set out in Articles 18 to 22; (d) cooperation, information and reporting set out in Articles 23 and 24; (e) the table, the map and the geographical coordinates of GFCM Geographical Sub-Areas (GSAs) set out in Annex I; (f) port state inspection procedures for vessels set out in Annex II; and (g) GFCM statistical matrices set out in Annex III. Article 27 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 26 shall be conferred on the Commission for a period of 3 years from 19 January 2012. The Commission shall draw up a report in respect of the delegation of power not later than 6 months before the end of the three-year period. The delegation of

power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of powers referred to in Article 26 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 26 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.

46. Regulation (EU) No 1337/2011 of the European Parliament and of the Council of 13 December 2011 concerning European statistics on permanent crops and repealing Council Regulation (EEC) No 357/79 and Directive 2001/109/EC of the European Parliament and of the Council

Whereas: (15) In order to take into account economic and technical developments, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the breakdowns of species by groups, density classes and age classes set out in Annex I and the variables/characteristics, size classes, degree of specialisation and vine varieties set out in Annex II, except in respect of the optional nature of the required information. It is of particular importance that the Commission carry out the appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. Article 4 Data production 3. In order to take into account economic and technical developments, the Commission shall be empowered to adopt delegated acts in accordance with Article 11 concerning the amendment of: — the breakdowns of species by groups, density classes and age classes set out in Annex I, and — the variables/characteristics, size classes, degree of specialisation and vine varieties set out in Annex II,


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except in respect of the optional nature of the required information. In exercising this power, the Commission shall ensure that the delegated acts do not impose a significant additional administrative burden on the Member States and on the respondents. Article 11 Exercise of delegation 1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 4(3) and Article 13 shall be conferred on the Commission for a period of 5 years from 31 December 2011. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Article 4(3) and Article 13 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the

Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 4(3) and Article 13 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council. Article 13 Review By 31 December 2018 and every 5 years thereafter, the Commission shall review the functioning of this Regulation. In the context of this review, the Commission shall assess whether it is necessary to produce all the data referred to in Article 4. Where the Commission considers that some of those data are no longer required, it shall be empowered to adopt delegated acts in accordance with Article 11 that delete certain data from Annexes I and II.

47. Regulation (EU) No 1336/2011 of the European Parliament and of the Council of 13 December 2011 amending Council Regulation (EC) No 1215/2009 introducing exceptional trade measures for countries and territories participating in or linked to the European Union’s Stabilisation and Association process

Whereas: (9) In order to adopt the provisions necessary for the application of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the necessary amendments and technical adjustments to Annexes I and II following amendments to the Combined Nomenclature codes and to the TARIC subdivisions, as well as the necessary adjustments following the granting of trade preferences under other arrangements between the Union and the countries and territories referred to in this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. Article 1


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Regulation (EC) No 1215/2009 is amended as follows: (5) Article 7 is replaced by the following: ‘Article 7 Conferral of powers The Commission shall be empowered to adopt delegated acts in accordance with Article 7a concerning: (a) necessary amendments and technical adjustments to Annexes I and II following amendments to the Combined Nomenclature codes and to the TARIC subdivisions; (b) necessary adjustments following the granting of trade preferences under other arrangements between the Union and the countries and territories referred to in Article 1.’; (6) the following Article is inserted: ‘Article 7a Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 7 shall be conferred on the Commission until

the date of expiry of this Regulation. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before that date. 3. The power to adopt delegated acts referred to in Article 7 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 7 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.’;

48. Regulation (EU) No 70/2012 of the European Parliament and of the Council of 18 January 2012 on statistical returns in respect of the carriage of goods by road

Whereas: (10) In order to take account of economic and technical developments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of updating Part 1 of Annex I, except for any modifications to the optional nature of the required information, and adapting Annexes II to VII. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. Article 3 Data collection 4. The Commission shall be empowered to adopt, where necessary, delegated acts in accordance with Article 8 concerning the updating of Part 1 of Annex I, solely in order to take account of economic and technical developments, except for any modifications to the optional nature of the required information. The Commission shall also be empowered to adopt, where necessary, delegated acts in accordance with Article 8 concerning the adaptation of Annexes II to VII to take account of economic and technical


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developments. In exercising its power pursuant to this paragraph, the Commission shall ensure that any delegated acts adopted do not impose significant additional administrative burdens on the Member States and on the respondents. Article 8 Exercise of the delegation 1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 3(4) shall be conferred on the Commission for a period of 5 years from 23 February 2012. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Article 3(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power

specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 3(4) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 2 months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.

49. DIRECTIVE 2012/19/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 Waste electrical and electronic equipment WEEE (repeal. Directive 2002/96/EC). Recast

Whereas: (31) In order to address difficulties faced by Member States in achieving the collection rates, to take into account technical and scientific progress and to supplement the provisions on fulfilment of recovery targets, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of transitional adjustments for certain Member States, adaptation to technical and scientific progress and the adoption of detailed rules on WEEE exported out of the Union counting towards the fulfilment of recovery targets. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. Article 7 Collection rate 1. Without prejudice to Article 5(1), each Member State shall ensure the implementation of the ‘producer responsibility’ principle and, on that basis, that a minimum collection rate is achieved annually. From 2016, the minimum collection rate shall be 45 % calculated on the basis of the total weight of WEEE collected in accordance with Articles 5 and 6 in a given year in the Member State concerned, expressed as a percentage of the average weight of EEE placed on the market in the three preceding years in that Member State. Member States shall ensure that the volume of WEEE collected evolves gradually during


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the period from 2016 to 2019, unless the collection rate laid down in the second subparagraph has already been achieved. From 2019, the minimum collection rate to be achieved annually shall be 65 % of the average weight of EEE placed on the market in the three preceding years in the Member State concerned, or alternatively 85 % of WEEE generated on the territory of that Member State. Until 31 December 2015, a rate of separate collection of at least 4 kilograms on average per inhabitant per year of WEEE from private households or the same amount of weight of WEEE as was collected in that Member State on average in the three preceding years, whichever is greater, shall continue to apply. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 20 laying down the necessary transitional adjustments in order to address difficulties faced by Member States in adhering to the requirements laid down in paragraph 1. Article 8 Proper treatment 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 20 concerning the amendment of Annex VII in order to introduce other treatment technologies that ensure at least the

same level of protection for human health and the environment. The Commission shall evaluate, as a matter of priority, whether the entries regarding printed circuit boards for mobile phones and liquid crystal displays need to be amended. The Commission is invited to evaluate whether amendments to Annex VII are necessary to address nanomaterials contained in EEE. Article 10 Shipments of WEEE 2. WEEE exported out of the Union shall only count towards the fulfilment of obligations and targets set out in Article 11 of this Directive if, in compliance with Regulations (EC) No 1013/2006 and (EC) No 1418/2007, the exporter can prove that the treatment took place in conditions that are equivalent to the requirements of this Directive. 3. The Commission shall, not later than 14 February 2014, adopt delegated acts, in accordance with Article 20, laying down detailed rules supplementing those in paragraph 2 of this Article, in particular the criteria for the assessment of equivalent conditions. Article 19 Adaptation to scientific and technical progress The Commission shall be empowered to adopt delegated acts in accordance with Article 20 concerning the amendments necessary in order to adapt Article 16(5) and Annexes IV, VII, VIII and IX to scientific and technical progress. When amending Annex VII, the exemptions granted under Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment ( 3 ) shall be taken into consideration. Before the Annexes are amended, the Commission shall, inter alia, consult producers of EEE, recyclers, treatment operators and environmental organisations and employees’ and consumer associations. Article 20 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 7(4), Article 8(4), Article 10(3) and Article 19 shall be conferred on the Commission for a period of five years from 13 August 2012. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration,

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unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 7(4), Article 8(4), Article 10(3) and Article 19 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 7(4), Article 8(4), Article 10(3) and Article 19 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

50. Regulation (EU) No 236/2012 of the European Parliament and of the Council on Short Selling and certain aspects of credit default swaps

Whereas: (43) The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of details concerning calculating short positions, where a natural or legal person has an uncovered position in a credit default swap, notification or disclosure thresholds and further specification of criteria and factors for determining in which cases an adverse event or development creates a serious threat to financial stability or to market confidence in a Member State or the Union. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at the level of experts of the relevant institutions, authorities and agencies, where appropriate. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (46) Since some Member States have already put in place restrictions on short selling and since this Regulation provides for delegated acts and binding technical standards which should be adopted before it can be usefully applied, it is necessary to provide for a sufficient period of time for transitional purposes. Since it is essential to specify, before 1 November 2012, key non- essential elements which will facilitate compliance by market participants with this Regulation and enforcement by competent authorities, it is also necessary to provide the Commission with the means to adopt the technical standards and delegated acts before that date, ARTICLE2 DEFINITIONS 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 42 specifying the definitions laid down in paragraph 1 of this Article, in particular specifying when a natural or legal person is considered to own a financial instrument for the purposes of the definition of short sale in point (b) of paragraph 1. Article 3 Short and long positions 7. The Commission shall be empowered to adopt delegated acts in accordance with Article 42 specifying: (a) cases in which a natural or legal person is considered to hold a share or debt instrument for the purposes of paragraph 2; (b) cases in which a natural or legal person has a net short position for the purposes of paragraphs 4 and


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5 and the method of calculation of such position; (c) the method of calculating positions for the purposes of paragraphs 3, 4 and 5 when different entities in a group have long or short positions or for fund management activities relating to separate funds. For the purposes of point (c) of the first subparagraph, the method of calculation shall take into account, in particular, whether different investment strategies are pursued in relation to a particular issuer through more than one separate fund managed by the same fund manager, whether the same investment strategy is pursued in relation to a particular issuer through more than one fund, and whether more than one portfolio within the same entity is managed on a discretionary basis pursuing the same investment strategy in relation to a particular issuer. Article 4 Uncovered position in a sovereign credit default swap 1. For the purposes of this Regulation, a natural or legal person shall be considered to have an uncovered position in a sovereign credit default swap where the sovereign credit default swap does not serve to hedge against: (a) the risk of default of the issuer where the natural or legal person has a long position in the sovereign

debt of that issuer to which the sovereign credit default swap relates; or (b) the risk of a decline of the value of the sovereign debt where the natural or legal person holds assets or is subject to liabilities, including but not limited to financial contracts, a portfolio of assets or financial obligations the value of which is correlated to the value of the sovereign debt. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 42 specifying, for the purposes of paragraph 1 of this Article: (a) cases in which a sovereign credit default swap transaction is considered to be hedging against a default risk or the risk of a decline of the value of the sovereign debt, and the method of calculation of an uncovered position in a sovereign credit default swap; (b) the method of calculating positions where different entities in a group have long or short positions or for fund management activities relating to separate funds. Article 5 Notification to competent authorities of significant net short positions in shares 2. A relevant notification threshold is a percentage that equals 0,2 % of the issued share capital of the company concerned and each 0,1 % above that. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 42 modifying the thresholds referred to in paragraph 2 of this Article, taking into account the developments in financial markets. Article 6 Public disclosure of significant net short positions in shares 2. A relevant publication threshold is a percentage that equals 0,5 % of the issued share capital of the company concerned and each 0,1 % above that. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 42 modifying the thresholds referred to in paragraph 2 of this Article, taking into account the developments in financial markets. Article 7 Notification to competent authorities of significant net short positions in sovereign debt 2. The relevant notification thresholds shall consist of an initial amount and then additional incremental levels in relation to each sovereign issuer, as specified in the measures taken by the Commission in accordance with paragraph 3. ESMA shall publish on its website the notification thresholds for each

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Member State. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 42 specifying the amounts and incremental levels referred to in paragraph 2 of this Article. Article 9 Method of notification and disclosure 5. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the details of the information to be provided for the purposes of paragraph 1. ESMA shall submit those draft regulatory technical standards to the Commission by 31 March 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 11 Information to be provided to ESMA 3. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the details of the information to be provided in accordance with paragraphs 1 and 2. ESMA shall submit those draft regulatory technical standards to the Commission by 31 March 2012.

Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 13 Restrictions on uncovered short sales in sovereign debt 4. The Commission shall adopt delegated acts in accordance with Article 42 specifying the parameters and methods for calculating the threshold of liquidity referred to in paragraph 3 of this Article in relation to issued sovereign debt. Article 16 Exemption where the principal trading venue is in a third country 3. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the method for calculation of the turnover to determine the principal venue for the trading of a share. ESMA shall submit those draft regulatory technical standards to the Commission by 31 March 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 23 Power to restrict short selling of financial instruments temporarily in the case of a significant fall in price 6. ESMA may issue and send to the Commission an opinion on adjusting the threshold referred to in paragraph 5, taking into account the developments in financial markets. The Commission shall be empowered to adopt delegated acts in accordance with Article 42 modifying the thresholds referred to in paragraph 5 of this Article, taking into account the developments in financial markets. 7. The Commission shall adopt delegated acts in accordance with Article 42 specifying what constitutes a significant fall in value for financial instruments other than liquid shares, taking into account the specificities of each class of financial instrument and the differences of volatility. 8. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the method of calculation of the 10 % fall for liquid shares and of the fall in value specified by the Commission as referred to in paragraph 7.

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ESMA shall submit those draft regulatory technical standards to the Commission by 31 March 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 30 Further specification of adverse events or developments The Commission shall be empowered to adopt delegated acts in accordance with Article 42 specifying criteria and factors to be taken into account by the competent authorities and by ESMA in determining in which cases the adverse events or developments referred to in Articles 18 to 21 and Article 27 and the threats referred to in point (a) of Article 28(2) arise. Article 42 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 2(2), Article 3(7), Article 4(2), Article 5(4),

Article 6(4), Article 7(3), Article 17(2), Article 23(5) and Article 30 shall be conferred on the Commission for an indeterminate period of time. 3. The delegation of power referred to in Article 2(2), Article 3(7), Article 4(2), Article 5(4), Article 6(4), Article 7(3), Article 17(2), Article 23(5) and Article 30 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. The decision to revoke shall take effect on the day following its publication in the Official Journal of the European Union or on a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 2(2), Article 3(7), Article 4(2), Article 5(4), Article 6(4), Article 7(3), Article 17(2), Article 23(5) and Article 30 shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of 3 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 3 months at the initiative of the European Parliament or of the Council. Article 43 Deadline for the adoption of delegated acts The Commission shall adopt the delegated acts under Article 2(2), Article 3(7), Article 4(2), Article 5(4), Article 6(4), Article 7(3), Article 17(2), Article 23(5) and Article 30 by 31 March 2012. The Commission may extend the deadline referred to in the first paragraph by 6 months.

51. Regulation (EU) No 261/2012 of the European Parliament and of the Council amending Council Regulation (EC) No 1234/2007 as regards contractual relations in the milk and milk products sector

Whereas (23) In order to ensure that the objectives and responsibilities of producer organisations and associations of producer organisations in the milk and milk products sector are clearly defined, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the conditions for the recognition of transnational producer organisations and transnational associations of producer organisations, the rules on the establishment and the conditions of administrative assistance in the case of transnational cooperation and the calculation of the volume of raw milk covered by negotiations by a producer organisation. It is of particular importance that the Commission carry out







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appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (3) in Chapter II of Title II of Part II, the following Section is inserted: Article 126e Commission powers in relation to producer organisations and interbranch organisations in the milk and milk products sector 1. In order to ensure that the objectives and responsibilities of producer organisations and associations of producer organisations in the milk and milk products sector are clearly defined, so as to contribute to the effectiveness of the actions of such organisations without imposing an undue burden, the Commission shall be empowered to adopt delegated acts in accordance with Article 196a which lay down: (a) the conditions for recognising transnational producer organisations and transnational associations of producer organisations; (b) rules relating to the establishment and the conditions of administrative assistance to be given by the relevant competent authorities in the case of transnational cooperation;

(c) additional rules regarding the calculation of the volume of raw milk covered by the negotiations referred to in Article 126c(2)(c) and Article 126c(3). (8) in Chapter I of Part VII, the following Articles are added: ‘Article 196a Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 126e(1) shall be conferred on the Commission for a period of 5 years from 2 April 2012. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Article 126e(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 126e(1) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.

52. REGULATION (EU) No 260/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 March 2012 establishing technical and business requirements for credit transfers and direct debits in euro and

Whereas: (30) In order to ensure that the technical requirements for credit transfers and direct debits in euro remain up to date, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of those technical requirements. In the Declaration (No 39) on Article 290 TFEU, annexed to the Final Act of the Intergovernmental Conference which adopted the Treaty of Lisbon,






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amending Regulation (EC) No 924/2009 (Text with EEA relevance)

the Conference took note of the Commission’s intention to continue to consult experts appointed by the Member States in the preparation of draft delegated acts in the financial services area, in accordance with its established practice. It is of particular importance that the Commission carry out appropriate and transparent consultation during its preparatory work, including with the ECB and all relevant stakeholders. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council. Article 13 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 14 to amend the Annex, in order to take account of technical progress and market developments. Article 14 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 13 shall be conferred on the Commission for a period of 5 years from 31 March 2012. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Article 13 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or on a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 13 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 3 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 3 months at the initiative of the European Parliament or the Council.

53. Directive 2012/12/EU of the European Parliament and of the Council amending Council Directive 2001/112/EC relating to fruit juices and certain similar products intended for human consumption

Whereas: (4) In order to bring the Annexes to Directive 2001/112/EC into line with developments in relevant international standards and to take into account technical progress, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending those Annexes, with the exception of Part I of Annex I, and of Annex II. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. Article 1 Amendments to Directive 2001/112/EC (6) Article 7 is replaced by the following: ‘Article 7









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In order to bring the Annexes to this Directive into line with developments in relevant international standards and to take into account technical progress, the Commission shall be empowered to adopt delegated acts in accordance with Article 7a to amend the Annexes to this Directive, with the exception of Part I of Annex I, and of Annex II.’; (7) the following Article is inserted: ‘Article 7a 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 7 shall be conferred on the Commission for a period of five years from 28 October 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 7 may be revoked at any time by the European Parliament or by the Council.

A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 7 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’;

54. Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products

Whereas: (72) In order to supplement or amend this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of certain non-essential elements of this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (73) The Commission should adopt immediately applicable delegated acts where, in duly justified cases relating to the restriction of an active substance in Annex I or to the removal of an active substance from that Annex, imperative grounds of urgency so require Article 3 Definitions 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 83 in order to adapt the definition of nanomaterial set out in point (z) of paragraph 1 of this Article in view of technical and scientific progress and taking into account the Recommendation 2011/696/EU. Article 5 Exclusion criteria 3. No later than 13 December 2013, the Commission shall adopt delegated acts in accordance with Article 83 specifying scientific criteria for the determination of endocrine-disrupting properties.






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Pending the adoption of those criteria, active substances that are classified in accordance with Regulation (EC) No 1272/2008 as, or meet the criteria to be classified as, carcinogen category 2 and toxic for reproduction category 2, shall be considered as having endocrine-disrupting properties. Substances such as those that are classified in accordance with Regulation (EC) No 1272/2008 as, or that meet the criteria to be classified as, toxic for reproduction category 2 and that have toxic effects on the endocrine organs, may be considered as having endocrine-disrupting properties. Article 6 Data requirements for an application 2. Notwithstanding paragraph 1, the applicant need not provide data as part of the dossiers required under points (a) and (b) of paragraph 1 where any of the following applies: (a) the data are not necessary owing to the exposure associated with the proposed uses; 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying criteria for determining what constitutes adequate justification to adapt the data requirements under paragraph 1 of this Article on the grounds referred to in point (a) of paragraph 2 of this Article. Article 21

Waiving of data requirements 1. By way of derogation from Article 20, the applicant need not provide data required under that Article where any of the following applies: (a) the data are not necessary owing to the exposure associated with the proposed uses; 3. In order to ensure the harmonised application of paragraph 1(a) of this Article, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying criteria for defining when the exposure associated with the proposed uses would justify adapting the data requirements of Article 20. Article 23 Comparative assessment of biocidal products 5. Where the comparative assessment involves a question which, by reason of its scale or consequences, would be better addressed at Union level, in particular where it is relevant to two or more competent authorities, the receiving competent authority may refer the question to the Commission for a decision. The Commission shall adopt that decision by means of implementing acts in accordance with the examination procedure referred to in Article 82(3). The Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying the criteria for determining when comparative assessments involve questions better addressed at Union level and the procedures for such comparative assessments. Article 28 Amendment of Annex I 1. The Commission shall be empowered to adopt delegated acts in accordance with Article 83 amending Annex I, after receiving the opinion of the Agency, in order to include active substances provided that there is evidence that they do not give rise to concern according to paragraph 2 of this Article. 2. Active substances give rise to concern where: (a) they meet the criteria for classification according to Regulation (EC) No 1272/2008 as: — explosive/highly flammable, — organic peroxide, — acutely toxic of category 1, 2 or 3, — corrosive of category 1A, 1B or 1C, — respiratory sensitiser,

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— skin sensitiser, — germ cell mutagen of category 1 or 2; — carcinogen of category 1 or 2, — human reproductive toxicant of category 1 or 2 or with effects on or via lactation, — specific target organ toxicant by single or repeated exposure, or — toxic to aquatic life of acute category 1; (b) they fulfil any of the substitution criteria set out in Article 10(1); or (c) they have neurotoxic or immunotoxic properties. Active substances also give rise to concern, even if none of the specific criteria in points (a) to (c) are met, where a level of concern equivalent to that arising from points (a) to (c) can be reasonably demonstrated based on reliable information. 3. The Commission shall also be empowered to adopt delegated acts in accordance with Article 83 amending Annex I, after receiving the opinion of the Agency, in order to restrict or to remove the entry for an active substance if there is evidence that biocidal products containing that substance do not, in certain circumstances, satisfy the conditions set out in paragraph 1 of this Article or in Article 25. Where

imperative grounds of urgency so require, the procedure provided for in Article 84 shall apply to delegated acts adopted pursuant to this paragraph. 4. The Commission shall apply paragraph 1 or 3 at its own initiative or at the request of an economic operator or a Member State providing the necessary evidence as referred to in those paragraphs. Whenever the Commission amends Annex I it shall adopt a separate delegated act in respect of each substance. Article 40 Supplementary rules and technical guidance notes The Commission shall be empowered to adopt delegated acts in accordance with Article 83 laying down supplementary rules for the renewal of authorisations subject to mutual recognition. The Commission shall also draw up technical guidance notes to facilitate the implementation of this Chapter and, in particular, Articles 37 and 39. Article 56 Research and development 1. By way of derogation from Article 17, an experiment or a test for the purposes of research or development involving an unauthorised biocidal product or a non-approved active substance intended exclusively for use in a biocidal product (‘experiment’ or ‘test’) may take place only under the conditions laid down in this Article. Persons carrying out an experiment or test shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data, quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance, and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment. They shall make this information available to the competent authority on request. 2. Any person intending to carry out an experiment or test that may involve, or result in, release of the biocidal product into the environment shall first notify the competent authority of the Member State where the experiment or test will occur. The notification shall include the identity of the biocidal product or active substance, labelling data and quantities supplied, and all available data on possible effects on human or animal health or impact on the environment. The person concerned shall make available any other information requested by the competent authorities. In the absence of an opinion from the competent authority within 45 days of the notification referred to in

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the first subparagraph, the notified experiment or test may take place. 3. If the experiments or tests could have harmful effects, whether immediate or delayed, on the health of humans, particularly of vulnerable groups, or animals, or any unacceptable adverse effect on humans, animals or the environment, the relevant competent authority of the Member State concerned may prohibit them or allow them subject to such conditions as it considers necessary to prevent those consequences. The competent authority shall, without delay, inform the Commission and other competent authorities of its decision. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying detailed rules supplementing this Article.

55. Regulation (EU) No 648/2012 of the European Parliament

and of the Council on OTC derivatives, central counterparties and trade repositories

Whereas: (80) ESMA should be able to delegate specific supervisory tasks to the competent authority of a Member

State, for instance where a supervisory task requires knowledge and experience with respect to local conditions, which are more easily available at national level. ESMA should be able to delegate the carrying out of specific investigatory tasks and on-site inspections. Prior to the delegation of tasks, ESMA should consult the relevant competent authority about the detailed conditions relating to such delegation of tasks, including the scope of the task to be delegated, the timetable for the performance of the task, and the transmission of necessary information by and to ESMA. ESMA should compensate the competent authorities for carrying out a delegated task in accordance with a regulation on fees to be adopted by the Commission by means of a delegated act. ESMA should not be able to delegate the power to adopt decisions on registration. (91) The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of amendments to the list of entities exempt from this Regulation, further rules of procedure relating to the imposition of fines or periodic penalty payments, including provisions on the rights of the defence, time limits, the collection of fines or periodic penalty payments and the limitation periods for the imposition and enforcement of penalty payments or fines; measures to amend Annex II in order to take account of developments in the financial markets; the further specification of the type of fees, the matters for which fees are due, the amount of the fees and the manner in which they are to be paid. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (92) In order to ensure consistent harmonisation, power should be delegated to the Commission to adopt the ESAs’ draft regulatory technical standards in accordance with Articles 10 to 14 of Regulations (EU) No 1093/2010, (EU) No 1094/2010 and (EU) No 1095/2010 for the application, for the purposes of this Regulation, of points (4) to (10) of Section C of Annex I to Directive 2004/39/EC and in order to specify: the OTC derivative contracts that are considered to have a direct, substantial and foreseeable effect within the Union or the cases where it is necessary or appropriate to prevent the evasion of any provision of this Regulation; the types of indirect contractual arrangements that meet the conditions set out in this Regulation; the classes of OTC derivative contracts that should be subject to the clearing obligation, the date or dates from which the clearing obligation is to take effect, including any phase-in, the categories of counterparties to which the clearing obligation applies, and the minimum remaining maturity of the OTC derivative contracts entered into or novated before the date on which the clearing obligation takes effect; the details to be included in a competent authority’s notification to ESMA of its authorisation of a CCP to clear a class of OTC derivative contract; particular classes of OTC derivative contracts, the degree of standardisation of the contractual terms and operational processes, the volume and the liquidity, and the






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availability of fair, reliable and generally accepted pricing information; the details to be included in ESMA’s register of classes of OTC derivative contracts subject to the clearing obligation; the details and type of the reports for the different classes of derivatives; criteria to determine which OTC derivative contracts are objectively measurable as reducing risks directly relating to the commercial activity or treasury financing activity and values of the clearing thresholds, the procedures and the arrangements in regard to risk- mitigation techniques for OTC derivative contracts not cleared by a CCP; the risk-management procedures, including the required levels and type of collateral and segregation arrangements and the required level of capital; the notion of liquidity fragmentation; requirements regarding the capital, retained earnings and reserves of CCPs; the minimum content of the rules and governance arrangements for CCPs; the details of the records and information to be retained by CCPs; the minimum content and requirements for CCPs’ business continuity policies and disaster recovery plans; the appropriate percentage and time horizons for the liquidation period and the calculation of historical volatility to be considered for the different classes of financial instruments taking into account the objective to limit pro-cyclicality and the conditions under which portfolio margining practices can be implemented; the framework for defining extreme but plausible market conditions which should be used

when defining the size of the default fund and the resources of CCPs; the methodology for calculating and maintaining the amount of CCPs’ own resources; the type of collateral that could be considered highly liquid, such as cash, gold, government and high-quality corporate bonds, covered bonds and the haircuts and the conditions under which commercial bank guarantees can be accepted as collateral; the financial instruments that can be considered highly liquid, bearing minimal credit and market risk, highly secured arrangements and concentration limits; the type of stress tests to be undertaken by CCPs for different classes of financial instruments and portfolios, the involvement of clearing members or other parties in the tests, the frequency and timing of the tests and the key information that the CCP is to disclose on its risk-management model and assumptions adopted to perform the stress tests; the details of the application by trade repositories for registration with ESMA; the frequency and the detail in which trade repositories are to disclose information relating to aggregate positions by class of OTC derivative contract; and the operational standards required in order to aggregate and compare data across repositories. (93) Any obligation imposed by this Regulation which is to be further developed by means of delegated or implementing acts adopted under Article 290 or 291 TFEU should be understood as applying only from the date on which those acts take effect. Article 1 Subject matter and scope 4. This Regulation shall not apply to: (a) the members of the ESCB and other Member States’ bodies performing similar functions and other Union public bodies charged with or intervening in the management of the public debt; (b) the Bank for International Settlements. 6. The Commission shall be empowered to adopt delegated acts in accordance with Article 82 to amend the list set out in paragraph 4 of this Article. To that end, by 17 November 2012 the Commission shall present to the European Parliament and the Council a report assessing the international treatment of public bodies charged with or intervening in the management of the public debt and central banks. Article 4 Clearing obligation 4. In order to ensure consistent application of this Article ESMA shall develop draft regulatory technical

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standards specifying the contracts that are considered to have a direct, substantial and foreseeable effect within the Union or the cases where it is necessary or appropriate to prevent the evasion of any provision of this Regulation as referred to in paragraph 1(a)(v), and the types of indirect contractual arrangements that meet the conditions referred to in the second subparagraph of paragraph 3. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 5 Clearing obligation procedure 1. Where a competent authority authorises a CCP to clear a class of OTC derivatives under Article 14 or 15, it shall immediately notify ESMA of that authorisation. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the details to be included in the notifications referred to in the first subparagraph. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the

second subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 2. Within six months of receiving notification in accordance with paragraph 1 or accomplishing a procedure for recognition set out in Article 25, ESMA shall, after conducting a public consultation and after consulting the ESRB and, where appropriate, the competent authorities of third countries, develop and submit to the Commission for endorsement draft regulatory technical standards specifying the following: (a) the class of OTC derivatives that should be subject to the clearing obligation referred to in Article 4; (b) the date or dates from which the clearing obligation takes effect, including any phase in and the categories of counterparties to which the obligation applies; and (c) the minimum remaining maturity of the OTC derivative contracts referred to in Article 4(1)(b)(ii). Power is delegated to the Commission to adopt regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. 4. With the overarching aim of reducing systemic risk, the draft regulatory technical standards for the part referred to in paragraph 2(a) shall take into consideration the following criteria: (a) the degree of standardisation of the contractual terms and operational processes of the relevant class of OTC derivatives; (b) the volume and liquidity of the relevant class of OTC derivatives; (c) the availability of fair, reliable and generally accepted pricing information in the relevant class of OTC derivatives. In preparing those draft regulatory technical standards, ESMA may take into consideration the interconnectedness between counterparties using the relevant classes of OTC derivatives, the anticipated impact on the levels of counterparty credit risk between counterparties as well as the impact on competition across the Union. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards further specifying the criteria referred to in points (a), (b) and (c) of the first subparagraph. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt regulatory technical standards referred to in the third subparagraph of this paragraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 6 Public register

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4. In order to ensure consistent application of this Article, ESMA may develop draft regulatory technical standards specifying the details to be included in the public register referred to in paragraph 1. ESMA shall submit any such draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 7 Access to a CCP 5. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the notion of liquidity fragmentation. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 9 Reporting obligation

5. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the details and type of the reports referred to in paragraphs 1 and 3 for the different classes of derivatives. The reports referred to in paragraphs 1 and 3 shall specify at least: (a) the parties to the derivative contract and, where different, the beneficiary of the rights and obligations arising from it; (b) the main characteristics of the derivative contracts, including their type, underlying maturity, notional value, price, and settlement date. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010 Article 10 Non-financial counterparties 4. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards, after consulting the ESRB and other relevant authorities, specifying: (a) criteria for establishing which OTC derivative contracts are objectively measurable as reducing risks directly relating to the commercial activity or treasury financing activity referred to in paragraph 3; and (b) values of the clearing thresholds, which are determined taking into account the systemic relevance of the sum of net positions and exposures per counterparty and per class of OTC derivatives. After conducting an open public consultation, ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 11 Risk-mitigation techniques for OTC derivative contracts not cleared by a CCP 14. In order to ensure consistent application of this Article, ESMA shall draft regulatory technical standards specifying: (a) the procedures and arrangements referred to in paragraph 1; (b) the market conditions that prevent marking-to-market and the criteria for using marking-to-model referred to in paragraph 2;

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(c) the details of the exempted intragroup transactions to be included in the notification referred to in paragraphs 7, 9 and 10; (d) the details of the information on exempted intragroup transactions referred to in paragraph 11; (e) the contracts that are considered to have a direct, substantial and foreseeable effect within the Union or the cases where it is necessary or appropriate to prevent the evasion of any provision of this Regulation as referred to in paragraph 12; ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with 15. In order to ensure consistent application of this Article, the ESAs shall develop common draft regulatory technical standards specifying: (a) the risk-management procedures, including the levels and type of collateral and segregation arrangements, required for compliance with paragraph 3; (b) the level of capital required for compliance with paragraph 4; (c) the procedures for the counterparties and the relevant competent authorities to be followed when

applying exemptions under paragraphs 6 to 10; (d) the applicable criteria referred to in paragraphs 5 to 10 including in particular what should be considered as practical or legal impediment to the prompt transfer of own funds and repayment of liabilities between the counterparties. The ESAs shall submit those common draft regulatory technical standards to the Commission by 30 September 2012. Depending on the legal nature of the counterparty, power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with either Articles 10 to 14 of Regulations (EU) No 1093/2010, (EU) No 1094/2010 or (EU) No 1095/2010. Article 16 Capital requirements 3. In order to ensure consistent application of this Article, EBA shall, in close cooperation with the ESCB and after consulting ESMA, develop draft regulatory technical standards specifying requirements regarding the capital, retained earnings and reserves of a CCP referred to in paragraph 2. EBA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1093/2010. Article 18 College 6. In order to ensure the consistent and coherent functioning of colleges across the Union, ESMA shall develop draft regulatory technical standards specifying the conditions under which the Union currencies referred to in paragraph 2(h) are to be considered as the most relevant and the details of the practical arrangements referred to in paragraph 5. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 25 Recognition of a third-country CCP 8. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the information that the applicant CCP shall provide ESMA in its application for

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recognition. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 26 General provisions 9. In order to ensure consistent application of this Article, ESMA, after consulting the members of the ESCB, shall develop draft regulatory technical standards specifying the minimum content of the rules and governance arrangements referred to in paragraphs 1 to 8. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 29 Record keeping 4. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical

standards specifying the details of the records and information to be retained as referred to in paragraphs 1 to 3. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 34 Business continuity 3. In order to ensure consistent application of this Article, ESMA shall, after consulting the members of the ESCB, develop draft regulatory technical standards specifying the minimum content and requirements of the business continuity policy and of the disaster recovery plan. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 41 Margin requirements 5. In order to ensure consistent application of this Article, ESMA shall, after consulting EBA and the ESCB, develop draft regulatory technical standards specifying the appropriate percentage and time horizons for the liquidation period and the calculation of historical volatility, as referred to in paragraph 1, to be considered for the different classes of financial instruments, taking into account the objective to limit procyclicality, and the conditions under which portfolio margining practices referred to in paragraph 4 can be implemented. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 42 Default fund 5. In order to ensure consistent application of this Article, ESMA shall, in close cooperation with the ESCB and after consulting EBA, develop draft regulatory technical standards specifying the framework for defining extreme but plausible market conditions referred to in paragraph 3, that should be used when defining the size of the default fund and the other financial resources referred to in Article 43.

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ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 44 Liquidity risk controls 2. In order to ensure consistent application of this Article, ESMA shall, after consulting the relevant authorities and the members of the ESCB, develop draft regulatory technical standards specifying the framework for managing the liquidity risk that CCPs are to withstand in accordance with paragraph 1. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 45 Default waterfall 5. In order to ensure consistent application of this Article, ESMA, shall, after consulting the relevant competent authorities and the members of the ESCB, develop draft regulatory technical standards

specifying the methodology for calculation and maintenance of the amount of the CCP’s own resources to be used in accordance with paragraph 4. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 46 Collateral requirements 3. In order to ensure consistent application of this Article, ESMA shall, after consulting EBA, the ESRB and the ESCB, develop draft regulatory technical standards specifying: (a) the type of collateral that could be considered highly liquid, such as cash, gold, government and high-quality corporate bonds and covered bonds; (b) the haircuts referred to in paragraph 1; and (c) the conditions under which commercial bank guarantees may be accepted as collateral under paragraph 1. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 47 Investment policy 8. In order to ensure consistent application of this Article, ESMA shall, after consulting EBA and the ESCB, develop draft regulatory technical standards specifying the financial instruments that can be considered highly liquid, bearing minimal credit and market risk as referred to in paragraph 1, the highly secured arrangements referred to in paragraphs 3 and 4 and the concentration limits referred to in paragraph 7. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 49 Review of models, stress testing and back testing 4. In order to ensure consistent application of this Article, ESMA shall, after consulting EBA, other relevant competent authorities and the members of the ESCB, develop draft regulatory technical

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standards specifying: (a) the type of tests to be undertaken for different classes of financial instruments and portfolios; (b) the involvement of clearing members or other parties in the tests; (c) the frequency of the tests; (d) the time horizons of the tests; (e) the key information referred to in paragraph 3. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 56 Application for registration 3. In order to ensure consistent application of this Article, ESMA shall develop draft regulatory technical standards specifying the details of the application for registration referred to in paragraph 1. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first

subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 64 Procedural rules for taking supervisory measures and imposing fines 7. The Commission shall adopt further rules of procedure for the exercise of the power to impose fines or periodic penalty payments, including provisions on the rights of the defence, temporal provisions, and the collection of fines or periodic penalty payments, and shall adopt detailed rules on the limitation periods for the imposition and enforcement of penalties. The rules referred to in the first subparagraph shall be adopted by means of delegated acts in accordance with Article 82. Article 70 Amendments to Annex II In order to take account of developments on financial markets the Commission shall be empowered to adopt delegated acts in accordance with Article 82 concerning measures to amend Annex II. Article 72 Supervisory fees 1. ESMA shall charge fees to the trade repositories in accordance with this Regulation and in accordance with the delegated acts adopted pursuant to paragraph 3. Those fees shall fully cover ESMA’s necessary expenditure relating to the registration and supervision of trade repositories and the reimbursement of any costs that the competent authorities may incur carrying out work pursuant to this Regulation in particular as a result of any delegation of tasks in accordance with Article 74. 2. The amount of a fee charged to a trade repository shall cover all administrative costs incurred by ESMA for its registration and supervision activities and be proportionate to the turnover of the trade repository concerned. 3. The Commission shall adopt a delegated act in accordance with Article 82 to specify further the type of fees, the matters for which fees are due, the amount of the fees and the manner in which they are to be paid. Article 81 Transparency and data availability 5. In order to ensure consistent application of this Article, ESMA shall, after consulting the members of the ESCB, develop draft regulatory technical standards specifying the frequency and the details of the

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information referred to in paragraphs 1 and 3 as well as operational standards required in order to aggregate and compare data across repositories and for the entities referred to in paragraph 3 to have access to information as necessary. Those draft regulatory technical standards shall aim to ensure that the information published under paragraph 1 is not capable of identifying a party to any contract. ESMA shall submit those draft regulatory technical standards to the Commission by 30 September 2012. Power is delegated to the Commission to adopt the regulatory technical standards referred to in the first subparagraph in accordance with Articles 10 to 14 of Regulation (EU) No 1095/2010. Article 82 Exercise of the delegation 1. The power to adopt delegated acts is conferred to the Commission subject to the conditions laid down in this Article. 2. The delegation of power referred to in Article 1(6), Article 64(7), Article 70, Article 72(3) and Article 85(2) shall be conferred to the Commission for an indeterminate period of time. 3. Before adopting a delegated act, the Commission shall endeavour to consult ESMA. 4. A delegation of power referred to in Article 1(6), Article 64(7), Article 70, Article 72(3) and Article

85(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. The decision to revoke shall take effect on the day following that of its publication in the Official Journal of the European Union or on a later date specified therein. It shall not affect the validity of any delegated acts already in force. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 1(6), Article 64(7), Article 70, Article 72(3) and Article 85(2) shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of three months of notification of the act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament or the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council. Article 85 Reports and review 2. By 17 August 2014, the Commission shall prepare a report, after consulting ESMA and EIOPA, assessing the progress and effort made by CCPs in developing technical solutions for the transfer by pension scheme arrangements of non-cash collateral as variation margins, as well as the need for any measures to facilitate such solution. If the Commission considers that the necessary effort to develop appropriate technical solutions has not been made and that the adverse effect of centrally clearing derivative contracts on the retirement benefits of future pensioners remain unchanged, it shall be empowered to adopt delegated acts in accordance with Article 82 to extend the three-year period referred to in Article 89(1) once by two years and once by one year.

56. Directive 2012/18/EU of the European Parliament and of the Council on control of major-accident hazards involving dangerous substances

Whereas: (27) In order to take into account technical developments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be

delegated to the Commission in respect of amending Annexes II to VI to adapt them to technical progress. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when





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preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

Article 25 Amendment of Annexes The Commission shall be empowered to adopt delegated acts in accordance with Article 26 in order to adapt Annexes II to VI to technical progress. Such adaptations shall not result in substantial changes in the obligations of the Member States and the operators as laid down in this Directive

Article 26

Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 25 shall be conferred on the Commission for a period of five years from 13 August 2012. The Commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the

five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than four months before the end of each period. 3. The delegation of power referred to in Article 25 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the

delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date

specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 25 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the

expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

57. REGULATION (EU) No 978/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 applying a scheme of generalised tariff preferences and repealing Council Regulation (EC) No 732/2008

Whereas: (26) In order to achieve a balance between the need for better targeting, greater coherence and transparency on the one hand, and better promoting sustainable development and good governance through a unilateral trade preference scheme on the other hand, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amendments to the Annexes to this Regulation and temporary withdrawals of tariff preferences due to failure to adhere to the principles of sustainable development and good governance, as well as procedural rules regarding the submission of applications for the tariff preferences granted under the special incentive arrangement for sustainable development and good governance, the conduct of a temporary withdrawal and safeguard

http://trade.ec.europa.eu/doclib/docs/2012/october/tradoc_150025.pdf





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investigations in order to establish uniform and detailed technical arrangements. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (27) In order to provide a stable framework for economic operators, the power to adopt an act in accordance with Article 290 TFEU should be delegated to the Commission in respect of repealing a decision on temporary withdrawal under the urgency procedure before that decision to temporarily withdraw tariff preferences takes effect, where the reasons justifying temporary withdrawal no longer apply. Article 3 1. A list of eligible countries is established in Annex I. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 36 to amend Annex I to take account of changes in the international status or classification of countries. 3. The Commission shall notify an eligible country concerned of any relevant changes in its status under

the scheme. Article 5 1. A list of GSP beneficiary countries meeting the criteria laid down in Article 4 is established in Annex II. 2. By 1 January of each year following the entry into force of this Regulation the Commission shall review Annex II. To provide a GSP beneficiary country and economic operators with time for orderly adaptation to the change in the country’s status under the scheme: (a) the decision to remove a beneficiary country from the list of GSP beneficiary countries, in accordance with paragraph 3 of this Article and on the basis of point (a) of Article 4(1), shall apply as from one year after the date of entry into force of that decision; (b) the decision to remove a beneficiary country from the list of GSP beneficiary countries, in accordance with paragraph 3 of this Article and on the basis of point (b) of Article 4(1), shall apply as from two years after the date of application of a preferential market access arrangement. 3. For the purposes of paragraphs 1 and 2 of this Article the Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to amend Annex II on the basis of the criteria laid down in Article 4. Article 8 6. Where Annex II is amended in accordance with the criteria laid down in Article 4, the Commission shall be empowered to adopt delegated acts in accordance with Article 36 to amend Annex VI in order to adjust the modalities listed in that Annex so as to maintain proportionally the same weight of the graduated product sections as defined in paragraph 1 of this Article. Article 9 2. Where Annex II is amended, the Commission shall be empowered to adopt delegated acts in accordance with Article 36 to amend Annex VII in order to review the vulnerability threshold listed in point 1(b) of Annex VII so as to maintain proportionally the same weight of the vulnerability threshold as calculated in accordance with Annex VII. Article 10 4. After examining the request, the Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to establish or to amend Annex III in order to grant a requesting country the special incentive arrangement for sustainable development and good governance by adding that country to the list of GSP+ beneficiary countries.

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5. Where a GSP+ beneficiary country no longer fulfils the conditions referred to in points (a) or (c) of Article 9(1), or withdraws any of its binding undertakings referred to in points (d), (e) and (f) of Article 9(1), the Commission shall be empowered to adopt a delegated act, in accordance with Article 36, to amend Annex III in order to remove that country from the list of GSP+ beneficiary countries. 6. The Commission shall notify the requesting country of a decision taken in accordance with paragraphs 4 and 5 of this Article after Annex III is amended and published in the Official Journal of the European Union. Where the requesting country is granted the special incentive arrangement, it shall be informed of the date on which the respective delegated act enters into force. 7. The Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to establish rules related to the procedure for granting the special incentive arrangement for sustainable development and good governance in particular with respect to deadlines and the submission and processing of requests. Article 11 2. The Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to amend Annex IX to take into account amendments to the Combined Nomenclature affecting the products listed

in that Annex. Article 15 9. Where the Commission considers that the findings justify temporary withdrawal for the reasons referred to in paragraph 1 of this Article, it shall be empowered, in accordance with Article 36, to adopt delegated acts to amend Annex III in order to temporarily withdraw the tariff preferences provided under the special incentive arrangement for sustainable development and good governance referred to in point (b) of Article 1(2). 10. Where the Commission decides on temporary withdrawal, such delegated act shall take effect six months after its adoption. 11. Where the reasons justifying temporary withdrawal no longer apply before the delegated act referred to in paragraph 9 of this Article takes effect, the Commission shall be empowered to repeal the adopted act to temporarily withdraw tariff preferences in accordance with the urgency procedure referred to in Article 37. 12. The Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to establish rules related to the procedure for temporary withdrawal of the special incentive arrangement for sustainable development and good governance in particular with respect to deadlines, rights of parties, confidentiality and review. Article 16 Where the Commission finds that the reasons justifying a temporary withdrawal of the tariff preferences, as referred to in Article 15(1), no longer apply, it shall be empowered to adopt delegated acts, in accordance with Article 36, to amend Annex III in order to reinstate the tariff preferences provided under the special incentive arrangement for sustainable development and good governance. Article 17 2. The Commission shall continuously review the list of EBA beneficiary countries on the basis of the most recent available data. Where an EBA beneficiary country no longer fulfils the conditions referred to in paragraph 1 of this Article, the Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to amend Annex IV in order to remove the country from the list of EBA beneficiary countries following a transitional period of three years as from the date on which the delegated act entered into force 3. Pending the identification by the UN of a newly independent country as a least-developed country, the

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Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to amend Annex IV as an interim measure so as to include such a country in the list of EBA beneficiary countries. If such a newly independent country is not identified by the UN as a least-developed country during the first available review of the category of least-developed countries, the Commission shall be empowered to adopt delegated acts forthwith, in accordance with Article 36, to amend Annex IV in order to remove such a country from that Annex, without granting the transitional period referred to in paragraph 2 of this Article. Article19 1. The preferential arrangements referred to in Article 1(2) may be withdrawn temporarily, in respect of all or of certain products originating in a beneficiary country, for any of the following reasons: (a) serious and systematic violation of principles laid down in the conventions listed in Part A of Annex VIII; (b) export of goods made by prison labour; (c) serious shortcomings in customs controls on the export or transit of drugs (illicit substances or precursors), or failure to comply with international conventions on anti-terrorism and money laundering;

(d) serious and systematic unfair trading practices including those affecting the supply of raw materials, which have an adverse effect on the Union industry and which have not been addressed by the beneficiary country. For those unfair trading practices, which are prohibited or actionable under the WTO Agreements, the application of this Article shall be based on a previous determination to that effect by the competent WTO body; (e) serious and systematic infringement of the objectives adopted by Regional Fishery Organisations or any international arrangements to which the Union is a party concerning the conservation and management of fishery resources. 10. Where the Commission considers that the findings justify temporary withdrawal for the reasons referred to in paragraph 1 of this Article, it shall be empowered, in accordance with Article 36, to adopt delegated acts to amend Annexes II, III or IV, whichever is applicable, in order to temporarily withdraw the tariff preferences provided under the preferential arrangements referred to in Article 1(2). 13. Where the reasons justifying temporary withdrawal no longer apply before the delegated act referred to in paragraph 10 of this Article takes effect, the Commission shall be empowered to repeal the adopted act to temporarily withdraw the tariff preferences in accordance with the urgency procedure referred to in Article 37. 14. The Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to establish rules related to the procedure for temporary withdrawal of all arrangements in particular with respect to deadlines, rights of parties, confidentiality and review. Article 20 Where the Commission finds that the reasons justifying a temporary withdrawal of the tariff preferences as referred to in Article 19(1) no longer apply, it shall be empowered to adopt delegated acts, in accordance with Article 36 to amend Annexes II, III or IV, whichever is applicable, in order to reinstate the tariff preferences provided under the preferential arrangements referred to in Article 1(2). Article 22 4. The Commission shall be empowered to adopt delegated acts, in accordance with Article 36, to establish rules related to the procedure for adopting general safeguard measures in particular with respect to deadlines, rights of parties, confidentiality, disclosure, verification, visits and review. Article 36 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down

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in this Article. 2. The power to adopt delegated acts referred to in Articles 3, 5, 6, 8, 9, 10, 11, 15, 16, 17, 19, 20 and 22 shall be conferred to the Commission for an indeterminate period of time from 20 November 2012. 3. The delegation of powers referred to in Articles 3, 5, 6, 8, 9, 10, 11, 15, 16, 17, 19, 20 or 22 may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 3, 5, 6, 8, 9, 10, 11, 15, 16, 17, 19, 20 or 22 shall enter into force only if no objection has been expressed by either the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European

Parliament or the Council. Article 37 1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act adopted under this Article to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 36(5). In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or the Council. ANNEX VII Modalities for the application of Chapter III of this Regulation 3. For the purposes of Article 11, the data to be used in application of point 1 of this Annex are those available on 1 September of the year preceding the year when the delegated act referred to in Article 11(2) is adopted.

58. REGULATION (EU) No 1025/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council

Whereas: (46) In order to update the list of European standardisation organisations and to adapt the criteria for organisations representing SMEs and societal stakeholders to further developments as regards their non-profit making nature and representativity, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amendments to the Annexes to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. Article 12 Notification of stakeholder organisations The Commission shall establish a notification system for all stakeholders, including European standardisation organisations and European stakeholder organisations receiving Union financing in accordance with this Regulation in order to ensure proper consultation and market relevance prior to: (e) adopting delegated acts referred to in Article 20 Article 20












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Delegated acts The Commission shall be empowered to adopt delegated acts in accordance with Article 21 concerning amendments to the Annexes, in order to: (a) update the list of European standardisation organisations set out in Annex I to take into account changes in their name or structure; (b) adapt the criteria for European stakeholder organisations set out in Annex III to this Regulation to further developments as regards their non-profit making nature and representativity. Such adaptations shall not have the effect of creating any new criteria or abolishing any existing criteria or category of organisation. Article 21 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 20 shall be conferred on the Commission for a period of five years from 1 January 2013. The Commission shall draw up a report in respect of the

delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before 3. The delegation of power referred to in Article 20 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 20 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

59. DIRECTIVE 2012/27/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC

Whereas: (61) In order to permit adaptation to technical progress and changes in the distribution of energy sources, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the review of the harmonised efficiency reference values laid down on the basis of Directive 2004/8/EC and in respect of the values, calculation methods, default primary energy coefficient and requirements in the Annexes to this Directive. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council. Article 8 Energy audits and energy management systems 5. Energy audits shall be considered as fulfilling the requirements of paragraph 4 when they are carried out in an independent manner, on the basis of minimum criteria based on Annex VI, and implemented

http://www.emissions-euets.com/attachments/301_Energy%20Efficiency%20Directive%202012_27.pdf






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under voluntary agreements concluded between organisations of stakeholders and an appointed body and supervised by the Member State concerned, or other bodies to which the competent authorities have delegated the responsibility concerned, or by the Commission. Article 14 Promotion of efficiency in heating and cooling 10. On the basis of the harmonised efficiency reference values referred to in point (f) of Annex II, Member States shall ensure that the origin of electricity produced from high- efficiency cogeneration can be guaranteed according to objective, transparent and non-discriminatory criteria laid down by each Member State. They shall ensure that this guarantee of origin complies with the requirements and contains at least the information specified in Annex X. Member States shall mutually recognise their guarantees of origin, exclusively as proof of the information referred to in this paragraph. Any refusal to recognise a guarantee of origin as such proof, in particular for reasons relating to the prevention of fraud, must be based on objective, transparent and non-discriminatory criteria. Member States shall notify the Commission of such refusal and its justification. In the event of refusal to recognise a guarantee of origin, the Commission may adopt a decision to compel the refusing party to recognise it, in particular with

regard to objective, transparent and non- discriminatory criteria on which such recognition is based. The Commission shall be empowered to review, by means of delegated acts in accordance with Article 23 of this Directive, the harmonised efficiency reference values laid down in Commission Implementing Decision 2011/877/EU ( 1 ) on the basis of Directive 2004/8/EC by 31 December 2014. Article 22 Delegated acts 1. The Commission shall be empowered to adopt delegated acts in accordance with Article 23 to review the harmonised efficiency reference values referred to in the second subparagraph of Article 14(10). 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 23 to adapt to technical progress the values, calculation methods, default primary energy coefficient and requirements in Annexes I, II, III, IV, V, VII, VIII, IX, X and XII. Article 23 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 22 shall be conferred on the Commission for a period of five years from 4 December 2012. 3. The delegation of power referred to in Article 22 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.EN 14.11.2012 Official Journal of the European Union L 315/25 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 22 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

60. REGULATION (EU) No 1029/2012 OF THE Whereas:


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EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 introducing emergency autonomous trade preferences for Pakistan

(19) In order to make the necessary technical adaptations to the list of goods for which the autonomous trade preferences apply and to remove products from the scope of this Regulation where volumes of imports covered by this Regulation increase beyond certain levels, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending Annexes I and II to reflect changes in the combined nomenclature and to remove products from the scope of this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (20) In order to address without delay significantly increased imports of the products exempted from customs duties when imported into the Union and which may have an adverse impact upon Union producers, the Commission should adopt delegated acts removing products from the scope of this Regulation under the urgency procedure. Article 4 Removal of products from the scope of this Regulation

1. Where, in the calendar year 2012 or 2013, imports based on customs import data for a product originating from Pakistan and included in Annex I increase, in volume, by 25 % or more, as compared to the average of the years 2009 to 2011, that product shall be removed from the scope of this Regulation for the remainder of that year. For the purposes of this paragraph, the Commission shall be empowered to adopt delegated acts, in accordance with Article 6, to amend Annex I to remove that product from the scope of this Regulation for the remainder of that year. 2. Upon the entry into force of the delegated act, imports of the product referred to in paragraph 1 shall be subject to ‘most- favoured-nation’ or other applicable duties. Article 5 Technical adjustments to the Annexes The Commission shall be empowered to adopt delegated acts in accordance with Article 6 to amend the Annexes in order to incorporate amendments and technical adjustments made necessary by amendments to the Combined Nomenclature and to the TARIC subdivisions. Article 6 Exercise of the delegation 1. The power to adopt the delegated acts referred to in Articles 4 and 5 is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 4 and 5 shall be conferred on the Commission for the period of application of this Regulation. 3. The delegation of power referred to in Articles 4 and 5 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 4 and 5 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not





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object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. Article 7 Urgency procedure 1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 6(5). In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or by the Council.

61. REGULATION (EU, EURATOM) No 966/2012 OF

THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002

Whereas:

(5) Regulation (EC, Euratom) No 1605/2002 was confined to stating broad budgetary principles and financial rules in line with the Treaties while the implementing provisions were laid down in Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Council Regulation (EC, Euratom) No 1605/2002 ( 4 ) in order to produce a better hierarchy of rules and make Regulation (EC, Euratom) No 1605/2002 easier to read. Under Article 290 TFEU a legislative act may delegate to the Commission the power to adopt non-legislative acts only to supplement or amend certain non-essential elements of that legislative act. As a consequence, some provisions laid down in Regulation (EC, Euratom) No 2342/2002, should be incorporated into this Regulation (74) In order to supplement and amend certain aspects of this Regulation the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. The content and scope of each delegation is set out in detail in the relevant Articles. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work for delegated acts, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure the simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council. (76) Transitional provisions should be set out. This Regulation should only apply following the adoption of the delegated acts, containing the rules of application, which are expected to enter into force in December 2012. In order to avoid the application of this Regulation in the last month of the year, it is appropriate to defer its application to 1 January 2013. Moreover, in order to ensure coherence with the sector-specific rules, it is appropriate to defer application of the provisions on the methods of implementation and financial instruments to 1 January 2014. Finally, in order to allow for their application already to the 2012 budget, it is appropriate that the provisions on the transfer of payment appropriations for Structural Funds for the end of the year apply from the date of entry into force of this Regulation. (77) This Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union in order to allow for the timely adoption of the delegated acts under this Regulation. The timely entry into force of this Regulation is necessary for the application of the rules set out in the delegated acts from 1 January 2013, in order to avoid the difficulties linked to a modification of financial rules during the financial year Article 3 Compliance of secondary legislation with this Regulation 1. Provisions concerning the implementation of the revenue and expenditure of the budget, and contained in a basic act, shall respect the budgetary principles set out in Title II of Part One. 2. Without prejudice to paragraph 1, any proposal or amendment to a proposal submitted to the






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legislative authority containing derogations from provisions other than those in Title II of Part One or from delegated acts adopted pursuant to this Regulation shall clearly indicate such derogations and shall state the specific reasons justifying them in the recitals and in the explanatory memorandum of such proposals. Article 8 Specific rules on the principles of unity and budgetary accuracy 4. Interest generated by pre-financing payments made from the budget shall not be due to the Union except as otherwise provided for in the delegation agreements, with the exception of those agreements concluded with third countries or the bodies they have designated. In cases in which it is provided for, such interest shall either be re-used for the corresponding action, deducted from payment requests in accordance with point (c) of the first subparagraph of Article 23(1) or recovered. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the accounting of interest generated by pre-financing payments. Article 11 Accounting for revenue and appropriations

3. The appropriations authorised for a financial year shall be used solely to cover expenditure committed and paid in that financial year and to cover amounts due against commitments from preceding financial years. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules for appropriations for the financial year. Article 13 Cancellation and carry-over of appropriations 7. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules for the cancellation and carry-over of appropriations. Article 19 Use of euro 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the rate of conversion between euro and other currencies. Article 21 Assigned revenue 6. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning the establishment of the structure to accommodate external and internal assigned revenue and the provision of the corresponding appropriations, and concerning rules for the contribution from Member States to research programmes. Furthermore, the Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning the proceeds of sanctions imposed pursuant to Article 126(11) TFEU, and concerning assigned revenue resulting from the participation of EFTA states in certain Union programmes. Article 22 Donations 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the acceptance of donations made to the Union. Article 23 Rules on deductions and exchange rate adjustments 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the accounts for recoverable taxes.

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Article 25 Transfers by institutions other than the Commission 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the calculation of percentages of transfers by institutions other than the Commission. Article 26 Transfers by the Commission 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the calculation of percentages of internal transfers by the Commission, and grounds for transfer requests. Article 29 Transfers subject to special provisions 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on requests for transfers from the Emergency Aid Reserve. Article 30

Principles of economy, efficiency and effectiveness 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on ex ante, mid-term and ex post evaluations. Article 31 Compulsory financial statement 1. Any proposal or initiative submitted to the legislative authority by the Commission, the High Representative of the Union for Foreign Affairs and Security Policy (the "High Representative") or by a Member State, which may have an impact on the budget, including changes in the number of posts, shall be accompanied by a financial statement and by an ex-ante evaluation as provided for in Article 30(4). Any amendment to a proposal or initiative submitted to the legislative authority which may have appreciable implications for the budget, including changes in the number of posts, shall be accompanied by a financial statement prepared by the institution proposing the amendment. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the requirements of the financial statement. Article 34 Publication of accounts, budgets and reports 1. The budget shall be established and implemented and the accounts presented in accordance with the principle of transparency. 2. The President of the European Parliament shall have the budget and any amending budget, as definitively adopted, published in the Official Journal of the European Union. The budgets shall be published within three months of the date on which they are declared definitively adopted. The consolidated annual accounts and the report on budgetary and financial management drawn up by each institution shall be published in the Official Journal of the European Union. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the provisional publication of the budget Article 35 Publication of information on recipients and other information 3. This information shall be made available with due observance of the requirements of confidentiality and security, in particular the protection of personal data.

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Where natural persons are concerned, the publication shall be limited to the name and locality of the recipient, the amount awarded and the purpose of the award.The disclosure of those data shall be based on relevant criteria such as the periodicity of award, or the type or importance of the award. The criteria for disclosure and the level of detail published shall take into account the specificities of the sector and of each method of implementation. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning the establishment of detailed rules on the publication of information on recipients. Where applicable, the level of detail and criteria shall be defined in the relevant sector-specific rules. Article 38 Draft budget 2. In order to provide more precise and reliable forecasts of the budgetary implications of legislation in force and of pending legislative proposals, the Commission shall attach to the draft budget a financial programming for the following years. The financial programming shall be updated after the adoption of the budget, to incorporate the results of the budgetary procedure and any other relevant decisions.

The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on financial programming. Article 41 Draft amending budgets 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on draft amending budgets. Article 44 Budget nomenclature 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the classification of the budget. Article 49 Presentation of the budget 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning the presentation of the budget, including a definition of actual expenditure in the last financial year for which the accounts have been closed, budget remarks and the establishment plans. Article 53 Budget implementation in accordance with the principle of sound financial management 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the implementation of the budget in accordance with the principle of sound financial management, and on information on transfers of personal data for audit purposes. Article 54 Basic act and exceptions 2. By way of derogation from paragraph 1 the following may be implemented without a basic act provided the actions which they are intended to finance fall within the competences of the Union: (c) appropriations for preparatory measures in the field of Title V of the TEU. Such measures shall be limited to a short period of time and shall be designed to establish the conditions for Union action in fulfilment of the objectives of the CFSP and for the adoption of the necessary legal instruments. For the purpose of Union crisis management operations, preparatory measures shall be designed, inter alia, to assess the operational requirements, to provide for a rapid initial deployment of resources, or to establish the conditions on the ground for the launching of the operation.

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Preparatory measures shall be agreed by the Council, on a proposal by the High Representative. In order to ensure the rapid implementation of preparatory measures, the High Representative shall inform the European Parliament and the Commission as early as possible of the Council's intention to launch a preparatory measure and, in particular, of the estimated resources required for this purpose. The Commission shall take all the measures necessary to ensure a rapid disbursement of the funds. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules for the financing of preparatory measures in the field of the CFSP; (d) appropriations for one-off actions, or even actions for an indefinite duration, carried out by the Commission by virtue of tasks resulting from its prerogatives at institutional level pursuant to the TFEU and the Euratom Treaty, other than its right of legislative initiative referred to in point (b), and under specific powers directly conferred on it by those Treaties, a list of which is to be given in the delegated acts adopted pursuant to this Regulation; 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the basic act and the exceptions enumerated in paragraph 2 of this Article Article 57

Conflict of interests 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 setting out what is likely to constitute a conflict of interests together with the procedure to be followed in such cases. Article 58 Methods of implementation of the budget 8. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the methods of implementation of the budget, including direct management, the exercise of powers delegated to executive agencies, and specific provisions for indirect management with international organisations, with bodies referred to in Articles 208 and 209, with public law bodies or bodies governed by private law with a public service mission, with bodies governed by the private law of a Member State and entrusted with the implementation of a public-private partnership and with persons entrusted with the implementation of specific actions in the CFSP. Article 59 Shared management with Member States 8. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on shared management with Member States, including the compilation of a register of bodies responsible for the management and control of Union funds, and on measures to promote best practices Article 60 Indirect management 8. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on indirect management, including the establishment of the conditions under indirect management according to which the systems, rules and procedures of entities and persons are to be equivalent to those of the Commission, management declarations and compliance statements, and the procedures for the examination and acceptance of the accounts and the exclusion from Union financing of expenditure incurredin breach of the applicable rules. Article 61 Ex ante assessments and delegation agreements 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the ex ante assessment of rules and procedures under indirect management

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and the content of delegation agreements. Article 62 Executive agencies 1. The Commission may delegate powers to the executive agencies to implement all or part of a Union programme or project, on its behalf and under its responsibility, in accordance with Council Regulation (EC) No 58/2003 of 19 December 2002 laying down the statute for executive agencies to be entrusted with certain tasks in the management of Community programmes ( 1 ). The executive agencies shall be created by means of a Commission Decision and shall be legal persons under Union law. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the exercise of powers delegated to the executive agencies. Article 63 Limits to delegation of powers 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on entrusting tasks to certain external private sector entities or bodies in accordance with the procurement rules set out in Title V of Part One.

Article 64 Segregation of duties 1. The duties of authorising officer and accounting officer shall be segregated and mutually exclusive. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the rights and obligations of all financial actors. Article 65 The authorising officer 10. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the assistance provided to authorising officers responsible and the internal provisions governing delegations. Article 66 Powers and duties of the authorising officer 10. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on ex ante and ex post controls, the keeping of supporting documents, on the code of professional standards, the failure of the authorising officer to act, transmission of information to the accounting officer, and reports on negotiated procedures. Article 68 Powers and duties of the accounting officer 9. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the powers and duties of the accounting officer, including his or her appointment and termination of duties, his or her opinion on accounting and inventory systems, treasury and bank account management, signatures on accounts, management of account balances, transfer and conversion operations, methods of payment, legal entity files and the keeping of supporting documents. Article 69 Powers which may be delegated by the accounting officer 1. The accounting officer may, in the performance of his or her duties, delegate certain tasks to subordinate staff. The instrument of delegation shall set out those tasks. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on persons empowered to administer accounts in a local unit.

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Article 70 Imprest accounts 1. Imprest accounts may be set up for the collection of revenue other than own resources and for the payment of small sums as defined in the delegated acts adopted pursuant to this Regulation. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning the conditions for imprest accounts, including maximum amounts to be paid by imprest administrators and rules also for external actions, including rules regarding the choice of imprest administrators, the endowment of imprest accounts, checks by authorising and accounting officers and the respect of procurement procedures. Furthermore, the Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the creation of imprest accounts and imprest administrators in Union Delegations. Article 72 Liability of the authorising officer for illegal activity, fraud or corruption 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the liability of the authorising officers, the accounting officers and the

imprest administrators in the event of illegal activity, fraud or corruption. Article 73 Rules applicable to authorising officers 8. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules applicable to authorising officers by delegation, including confirmation of instructions and the role of the Financial Irregularities Panel. Article 74 Rules applicable to accounting officers 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the liability of accounting officers in the event of other forms of misconduct. Article 75 Rules applicable to imprest administrators 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the liability of imprest administrators in the event of other forms of misconduct. Article 76 Own resources 1. An estimate of revenue constituted by own resources, as referred to in Decision 2007/436/EC, Euratom, shall be entered in the budget in euro. It shall be made available in accordance with Regulation (EC, Euratom) No 1150/2000. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules applicable to own resources. Article 77 Estimate of amounts receivable 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the estimate of amounts receivable. Article 78 Establishment of amounts receivable 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the establishment of amounts receivable, including procedures and

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supporting documents, and of default interest. Article 79 Authorisation of recovery 2. The institution may formally establish an amount as being receivable from persons other than Member States by means of a decision which shall be enforceable within the meaning of Article 299 TFEU. If the efficient and timely protection of the Union's financial interests so requires, the Commission may also, in exceptional circumstances, adopt such an enforceable decision for the benefit of other institutions at their request with respect to claims arising in relation to staff to whom the Staff Regulations apply. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the establishment of the recovery order. Article 81 Limitation period 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the limitation period. Article 83

Fines, penalties and accrued interest imposed by the Commission 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the amounts received by way of fines, penalties and accrued interest. Article 84 Financing decisions 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on financing decisions. Article 85 Types of commitments 1. A budgetary commitment is the operation by which the appropriation necessary to cover subsequent payments to honour legal commitments is reserved. A legal commitment is the act whereby the authorising officer enters into or establishes an obligation which results in a charge. Budgetary commitments and legal commitments shall be adopted by the same authorising officer, except in duly justified cases as provided for in the delegated acts adopted pursuant to this Regulation. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the types of commitment, adoption of global commitments, single signature, and administrative expenditure covered by provisional commitments. Article 86 Rules applicable to commitments 6. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on budgetary and legal commitments including registration of individual commitments. Article 87 Checks applicable to commitments 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the checks applicable to commitments. Article 88 Validation of expenditure 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210

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concerning the establishment of detailed rules on validation of expenditure, including passing for payment of staff expenditure and for interim and balance payments of procurement contracts and grants, certified correct for pre-financing payments, and "passed for payment" and "certified correct" forms Article 89 Authorisation of expenditure 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the authorisation of expenditure, including the establishment of mandatory details for payment orders, and on checks by the authorising officer of payment orders. Article 90 Types of payments 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the types of payments and supporting documents Article 92 Time limits 6. The Commission shall be empowered to adopt delegated acts in accordance with Article 210

concerning detailed rules on time limits for payment and on the specification of the circumstances in which creditors in receipt of a late payment are entitled to receive default interest charged to the line from which the principal was paid. Article 93 Electronic management of operations 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the electronic management of operations. Article 98 Appointment of the internal auditor 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the appointment of the internal auditor. Article 99 Powers and duties of the internal auditor 7. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the powers and duties of the internal auditor. Article 100 Independence of the internal auditor 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the independence and the liability of the internal auditor, including the right for the internal auditor to bring an action before the Court of Justice of the European Union. Article 101 Definition of public contracts 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the definition and scope of procurement contracts, including framework contracts and specific contracts. Article 103 Publication of public contracts 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the requirements for the advertising of contracts and publication of notices. Article 104

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Procurement procedures 1. Procurement procedures shall take one of the following forms: (a) the open procedure; (b) the restricted procedure; (c) contests; (d) the negotiated procedure; (e) the competitive dialogue. Where a public contract or a framework contract is of interest to two or more institutions, executive agencies or bodies referred to in Article 208 and 209, and whenever there is a possibility for realising efficiency gains, the contracting authorities concerned shall seek to carry out the procurement procedure on an interinstitutional basis. Where a public contract or framework contract is necessary for the implementation of a joint action between an institution and one or more contracting authorities from Member States, the procurement procedure may be carried out jointly by the institution and the contracting authorities, in certain situations, which are to be specified in the delegated acts adopted pursuant to this Regulation.

2. For contracts where the value exceeds the thresholds provided for in Articles 118 or 190, use of the negotiated procedure shall be authorised only in cases provided for in the delegated acts adopted pursuant to this Regulation. 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the types of procurement procedure, joint procurement, low value contracts and payment against invoices. Article 105 Content of tender documents Tender documents shall give a full, clear and precise description of the subject of the contract and specify the exclusion, selection and award criteria applicable to the contract. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the content of tender documents, including the possibility of, and the conditions for, revision of the price and the technical specifications. Article 106 Exclusion criteria applicable for participation in procurement procedures 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on: (a) the exclusion criteria applicable for participation in calls for tenders, including rules on illegal activities giving rise to exclusion; (b) what evidence may be satisfactory to show that an exclusion situation does not exist; (c) the duration of an exclusion. Such exclusion shall not exceed 10 years. Article 107 Exclusion criteria applicable to awards 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the exclusion criteria applicable during the procurement procedure, and the establishment of what evidence may be considered satisfactory to show that an exclusion situation does not exist. Furthermore, the Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning the duration of an exclusion. Article 108

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Central exclusion database 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the central exclusion database, including the definition of standardised procedures and technical specifications for the operation of the database. Article 109 Administrative and financial penalties 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on different administrative and financial penalties for tenderers or candidates who have made false declarations, have made substantial errors, have committed irregularities or fraud or have been found in serious breach of their contractual obligations. Article 110 Award criteria for contracts 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning the specification of the selection criteria and the award criteria. Furthermore, the Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning the documents

that give proof of economic and financial capacity and the evidence of technical and professional capacity and detailed rules on electronic auctions and abnormally low tenders. Article 111 Submission of tenders 6. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the submission of tenders and the establishment of the time limits for receipt of tenders and requests to participate, the time allowed for access to invitation to tender documents and the time limits in urgent cases. Furthermore, the Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning the different methods of communication and detailed rules on the possibility of a tender guarantee, the opening of tenders, the requests to participate and the Committee for the evaluation of tenders and requests to participate. Article 112 Principles of equal treatment and transparency 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the principles of equal treatment and transparency. Furthermore, the Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning the contact that is allowed between contracting authorities and tenderers during the contract award procedure, the minimum requirements of the written record of an evaluation and the minimum details of the decision taken by the contracting authority. Article 113 The award decision 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the award decision and the signature and implementation of the contract. Article 114 Cancellation of the procurement procedure The contracting authority may, before the contract is signed, either abandon the procurement or cancel the award procedure without the candidates or tenderers being entitled to claim any compensation. The decision shall be justified and be brought to the attention of the candidates or tenderers. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the cancellation of the procurement procedure.

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Article 115 Guarantees Other than in the case of low value contracts, the contracting authority may, if it deems it appropriate and proportionate on a case-by-case basis and subject to a risk-analysis, require contractors to lodge a guarantee in order to: (a) ensure full performance of the contract, or (b) limit the financial risks connected with payment of pre- financing. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules, including criteria for risk analysis, on the guarantees that are required from contractors. Article 116 Errors, irregularities and fraud in the procedure 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the suspension of a contract in the event of errors, irregularities and fraud. Article 117 The contracting authority

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the delegation of the function of contracting authority, including the identification of the appropriate levels for the calculation of thresholds. Article 118 Thresholds applicable 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the thresholds applicable, separate contracts and contracts with lots, estimating the value of certain contracts, and the standstill period before the signature of the contract. Article 119 Rules on participation in tendering procedures 1. Participation in tendering procedures shall be open on equal terms to all natural and legal persons coming within the scope of the Treaties and to all natural and legal persons in a third country which has a special agreement with the Union in the field of public procurement under the conditions laid down in that agreement. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the evidence to be provided in relation to access to contracts. Article 121 Scope of grants 1. Grants are direct financial contributions, by way of donation, from the budget in order to finance any of the following: (a) an action intended to help achieve a Union policy objective; (b) the functioning of a body which pursues an aim of general Union interest or has an objective forming part of, and supporting, a Union policy ('operating grants'). Grants shall be covered either by a written agreement or by a Commission decision notified to the successful applicant of a grant. The Commission may establish secure electronic systems for exchanges with the beneficiaries. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning the detailed specification of the scope of grants, and concerning rules determining whether grant agreements or grant decisions are to be used. Furthermore, the Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning details of the electronic exchange system,

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including the conditions under which documents submitted by means of such systems, including grant agreements, are to be deemed originals and to have been signed, and the use of framework partnerships. Article 122 Beneficiaries 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning the minimum content of grant agreements or decisions, in particular, where a grant is awarded to several entities, the specific obligations of the coordinator, if any, and of the other beneficiaries, the applicable responsibility regime and the conditions for adding or removing a beneficiary. Article 123 Forms of grants 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning rules for the different forms of grants, including low value grants. Article 124 Lump sums, unit costs and flat-rate financing

6. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules regarding lump sums, unit costs and flat-rate financing. Article 125 General principles applicable to grants 8. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 complementing the general principles applicable to grants, including the no-profit principle and the co-financing principle. Furthermore, the Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning the definition of technical assistance. Article 126 Eligible costs 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning further specifications on eligible costs. Article 128 Transparency 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the requirements regarding the work programme, the content of calls for proposals, the exceptions to calls for proposals, information for applicants and ex post publication. Article 129 Principle of non-cumulative award 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the principle of the non-cumulative award of grants. Article 130 Principle of non-retroactivity 1. A grant may be awarded for an action which has already begun provided that the applicant can demonstrate the need for starting the action priorto signature of the grant agreement or notification of the grant decision. In such cases, costs eligible for financing shall not have been incurred prior to the date of submission of the grant application, except in duly justified exceptional cases as provided for in the basic act or in the event of extreme urgency for crisis management aid, civil protection operations and humanitarian aid operations, or in situations of imminent or immediate danger threatening to escalate into armed conflict

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or to destabilise a country, whereby an early engagement by the Union would be of major importance in promoting conflict prevention. No grant may be awarded retroactively for actions already completed. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the principle of non-retroactivity Article 131 Applications for grants 6. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the arrangements for grant applications, evidence of not falling within an exclusion situation, applicants without legal personality, legal persons forming one applicant, financial and administrative penalties, eligibility criteria and low value grants. Article 132 Selection and award criteria 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on selection and award criteria.

Article 133 Evaluation procedure 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the evaluation and award of grants and information to applicants. Article 134 Pre-financing guarantee 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the pre-financing guarantee. Article 135 Payment of grants and controls 9. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules for the payment of grants and controls, including rules concerning supporting documents and the suspension and reduction of grants. Article 137 Implementation contracts and financial support to third parties 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on implementation contracts and financial support to third parties. Article 138 General rules 6. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on prizes, including programming, rules of contest, ex post publication, evaluation, information and notification of winners. Article 139 Scope 6. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on financial instruments, including the selection of entities entrusted with the implementation of financial instruments, the content of delegation agreements, management costs and fees, the specific rules for fiduciary accounts, the direct implementation of the financial instruments and the selection of managers, of financial intermediaries and of final recipients Article 140

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Principles and conditions applicable to financial instruments 13. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the implementation of financial instruments, including the conditions for their use, the leverage effect, the ex-ante evaluation, the monitoring and the treatment of contributions from the Funds referred to in Article 175. Article 141 Structure of the accounts 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the report on budgetary and financial management. Article 144 Accounting principles 2. The Commission shall be empowered to adopt delegated acts concerning the establishment of the framework for the implementation by the accounting officer of his or her tasks under this Article and Articles 145, 146, 148, 151, 154, 156 and 157. Article 181

Research funds 1. Parts One and Three shall apply to research and technological development appropriations, except as otherwise provided in this Title. Such appropriations shall be entered either in one of the titles of the budget relating to the policy areas linked to "Indirect research" and "Direct research" or in a chapter relating to research activities in another title. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on types of operations under research Article 183 Joint Research Centre 1. The Joint Research Centre (JRC) may receive funding charged to appropriations entered outside the titles and the chapters referred to in Article 181(1) in respect of its participation in procurement and grant procedures following Titles V and VI of Part One, and financed in whole or in part from the budget. For the purposes of the participation in the procurement and grant procedures, the JRC shall be considered as a legal person established in a Member State. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the JRC. Article 184 External actions 1. Parts One and Three shall apply to external actions financed from the budget, except as otherwise provided in this Title. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the actions which may be financed under external actions. Article 186 Use of budget support 1. Where provided for in the relevant basic acts, the Commission may provide budget support to a beneficiary third country if that country's management of public finances is sufficiently transparent, reliable and effective. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the use of budget support and on the obligations of recipients. Article 187

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Union trust funds for external actions 9. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the management, reporting and governance of trust funds for external actions. Article 188 Implementation of external actions through indirect management 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the implementation of external actions through indirect management. Article 189 Financing agreements on the implementation of external actions 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on financing agreements concerning the implementation of external actions. Article 190 External action procurement 1. The Commission shall be empowered to adopt delegated acts in accordance with Article 210

concerning detailed rules on external action procurement. 2. The provisions of Chapter 1 of Title V of Part One relating to the general provisions on procurement shall be applicable to contracts covered by this Title subject to the special provisions relating to thresholds and the arrangements for awarding external contracts to be laid down in the delegated acts adopted pursuant to this Regulation. The contracting authorities for the purposes of this Chapter shall be: (a) the Commission on behalf of, and for the account of, one or more third countries; (b) entities and persons referred to in Article 185 and entrusted with the corresponding budget implementation tasks. Article 191 Rules on participation in tendering procedures 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the participation in tendering procedures. Article 192 Full financing of an external action An action may be financed in full by the budget only where this is essential for it to be carried out. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the full financing of an external action. Article 193 Applicable rules for external action grants Grant procedures to be applied in indirect management by the entities referred to in Article 185 shall be laid down in the agreements concluded between the Commission and those entities. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on grant procedures applicable under indirect management. Article 195 The European Offices 1. "European offices", for the purposes of this Title, are the administrative structures set up by one or more institutions to perform specific cross-cutting tasks. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the scope of the European offices and the delegations by the institutions to the European offices.

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Article 196 Appropriations regarding the European offices 1. The appropriations for each European office, the total amount of which shall be entered in a specific budget line within the section of the budget relating to the Commission, shall be set out in detail in an Annex to that section. The Annex shall take the form of a statement of revenue and expenditure, subdivided in the same way as the sections of the budget. The appropriations entered in that Annex shall cover all the financial requirements of each European office in the performance of its duties on behalf of the institutions. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the appropriations for the European offices, including the delegation of certain tasks by the accounting officer, treasury and bank accounts. Article 199 Delegation of authorising officer powers for interinstitutional European offices 1. Each institution may delegate authorising officer powers to the director of an interinstitutional

European office for the management of appropriations entered in its section and shall set the limits and conditions for this delegation of powers. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the delegation of authorising officer powers to the director of an interinstitutional European office. Article 201 General provisions 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on the scope of administrative appropriations and rent guarantees. Article 203 Specific provisions regarding administrative appropriations 1. Administrative appropriations shall be non-differentiated appropriations. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on specific administrative appropriations, including buildings and advances to staff members of the institutions. Article 204 Remunerated external experts The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on remunerated external experts, including a specific procedure for the selection of natural persons as remunerated external experts, for assisting the institutions in the evaluation o Article 205 Transitional provisions 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning detailed rules on transitional provisions. Article 207 Thresholds and amounts The Commission shall be empowered to adopt delegated acts in accordance with Article 210 concerning all the thresholds and amounts laid down in this Regulation, without prejudice to Article 118. Article 208 Framework financial regulation for bodies set up under the TFEU and the Euratom Treaty

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1. The Commission shall be empowered to adopt a framework financial Regulation by means of a delegated act in accordance with Article 210 for bodies which are set up under the TFEU and the Euratom Treaty and which have legal personality and receive contributions charged to the budget. The framework financial regulation shall be based on the principles and rules set out in this Regulation. The financial rules of those bodies shall not depart from the framework financial regulation except where their specific needs so require and with the Commission's prior consent. Article 209 Model Financial Regulation for public-private partnership bodies The bodies having legal personality set up by a basic act and entrusted with the implementation of a public-private partnership shall adopt their financial rules. Those rules shall include a set of principles necessary to ensure sound financial management of Union funds. The Commission shall be empowered to adopt a model financial regulation by means of a delegated act in accordance with Article 210 which shall lay down the principles necessary to ensure sound financial management of Union funds and which shall be based on Article 60.

The financial rules of those bodies shall not depart from the model financial regulation except where their specific needs so require and with the Commission's prior consent. Article 210 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power referred to in Articles 8, 11, 13, 19, 21, 22, 23, 25, 26, 29, 30, 31, 34, 35, 38, 41, 44, 49, 53, 54, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 68, 69, 70, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 83, 84, 85, 86, 87, 88, 89, 90, 92, 93, 98, 99, 100, 101, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 121, 122, 123, 124, 125, 126, 128, 129, 130, 131, 132, 133, 134, 135, 137, 138, 139, 140, 142, 144, 181, 183, 184, 186, 187, 188, 189, 190, 191, 192, 193, 195, 196, 199, 201, 203, 204, 205, 207, 208 and 209 shall be conferred on the Commission up to the end of the first post-2013 multiannual financial framework referred to in Article 312 TFEU. The Commission shall draw up a report in respect of the delegation of power not later than two years before the end of the first post-2013 multiannual financial framework. The delegation of power shall be tacitly extended for periods corresponding to subsequent multiannual financial frameworks, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period of validity of the corresponding multiannual financial framework. 3. The delegation of power referred to in Articles 8, 11, 13, 19, 21, 22, 23, 25, 26, 29, 30, 31, 34, 35, 38, 41, 44, 49, 53, 54, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 68, 69, 70, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 83, 84, 85, 86, 87, 88, 89, 90, 92, 93, 98, 99, 100, 101, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 121, 122, 123, 124, 125, 126, 128, 129, 130, 131, 132, 133, 134, 135, 137, 138, 139, 140, 142, 144, 181, 183, 184, 186, 187, 188, 189, 190, 191, 192, 193, 195, 196, 199, 201, 203, 204, 205, 207, 208 and 209 may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

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5. A delegated act adopted pursuant to Articles 8, 11, 13, 19, 21, 22, 23, 25, 26, 29, 30, 31, 34, 35, 38, 41, 44, 49, 53, 54, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 68, 69, 70, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 83, 84, 85, 86, 87, 88, 89, 90, 92, 93, 98, 99, 100, 101, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 121, 122, 123, 124, 125, 126, 128, 129, 130, 131, 132, 133, 134, 135, 137, 138, 139, 140, 142, 144, 181, 183, 184, 186, 187, 188, 189, 190, 191, 192, 193, 195, 196, 199, 201, 203, 204, 205, 207, 208 and 209 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council.

62. Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs

Whereas: (63) In order to supplement or amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of supplementing the list of products set out in Annex I to this Regulation; establishing the restrictions and derogations with regard to the sourcing of feed in the case of a designation of origin; establishing restrictions and derogations with regard to the slaughtering of live animals or with regard to the sourcing of raw materials; laying down rules which limit the information contained in the product specification; establishing the Union symbols; laying down additional transitional rules in order to protect the rights and legitimate interests of producers or stakeholders concerned; laying down further details on the eligibility criteria for the names of traditional specialities guaranteed; laying down detailed rules relating to the criteria for optional quality terms; reserving an additional optional quality term, laying down its conditions of use and amending those conditions; laying down derogations to the use of the term "mountain product" and establishing the methods of production, and other criteria relevant for the application of that optional quality term, in particular, laying down the conditions under which raw materials or feedstuffs are permitted to come from outside the mountain areas; laying down additional rules for determining the generic status of terms in the Union; laying down rules for determining the use of the name of a plant variety or of an animal breed; defining the rules for carrying out the national objection procedure for joint applications concerning more than one national territory; and for complementing the rules of the application process, the opposition process, the amendment application process and the cancellation process in general. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. Article 2 Scope 1. This Regulation covers agricultural products intended for human consumption listed in Annex I to the Treaty and other agricultural products and foodstuffs listed in Annex I to this Regulation. In order to take into account international commitments or new production methods or material, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, supplementing the list of products set out in Annex I to this Regulation. Such products shall be closely linked to agricultural products or to the rural economy. Article 5 Requirements for designations of origin and geographical indications 4. In order to take into account the specific character of production of products of animal origin, the





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Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning restrictions and derogations with regard to the sourcing of feed in the case of a designation of origin. In addition, in order to take into account the specific character of certain products or areas, the Commission shall be empowered to adopt delegated acts in accordance with Article 56, concerning restrictions and derogations with regard to the slaughtering of live animals or with regard to the sourcing of raw materials. These restrictions and derogations shall, based on objective criteria, take into account quality or usage and recognised know-how or natural factors. Article 7 Product specification 2. In order to ensure that product specifications provide relevant and succinct information, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down rules which limit the information contained in the specification referred to in paragraph 1 of this Article, where such a limitation is necessary to avoid excessively voluminous applications for registration. The Commission may adopt implementing acts laying down rules on the form of the specification. Those

implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). Article 12 Names, symbols and indications 7. In order to ensure that the appropriate information is communicated to the consumer, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, establishing the Union symbols. Article 16 Transitional provisions 2. In order to protect the rights and legitimate interests of producers or stakeholders concerned, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning additional transitional rules. Article 18 Criteria 5. In order to ensure the smooth functioning of the scheme, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning further details of the eligibility criteria laid down in this Article. Article 19 Product specification 2. In order to ensure that product specifications provide relevant and succinct information, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down rules which limit the information contained in the specification referred to in paragraph 1 of this Article, where such a limitation is necessary to avoid excessively voluminous applications for registration. The Commission may adopt implementing acts laying down rules on the form of the specification. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 57(2). Article 23 Names, symbol and indication 4. In order to ensure that the appropriate information is communicated to the consumer, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, establishing the Union symbol

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Article 25 Transitional provisions 3. In order to protect the rights and legitimate interests of producers or stakeholders concerned, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down additional transitional rules. Article 29 Optional quality terms 4. In order to take into account the specific character of certain sectors as well as consumer expectations, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down detailed rules relating to the criteria referred to in paragraph 1 of this Article. 6. When adopting delegated and implementing acts in accordance with paragraphs 4 and 5 of this Article, the Commission shall take account of any relevant international standards. Article 30 Reservation and amendment 1. In order to take account of the expectations of consumers, developments in scientific and technical

knowledge, the market situation, and developments in marketing standards and in international standards, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, reserving an additional optional quality term and laying down its conditions of use. 2. In duly justified cases and in order to take into account the appropriate use of the additional optional quality term, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down amendments to the conditions of use referred to in paragraph 1 of this Article. Article 31 Mountain product 3. In duly justified cases and in order to take into account natural constraints affecting agricultural production in mountain areas, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down derogations from the conditions of use referred to in paragraph 1 of this Article. In particular, the Commission shall be empowered to adopt a delegated act laying down the conditions under which raw materials or feedstuffs are permitted to come from outside the mountain areas, the conditions under which the processing of products is permitted to take place outside of the mountain areas in a geographical area to be defined, and the definition of that geographical area. 4. In order to take into account natural constraints affecting agricultural production in mountain areas, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning the establishment of the methods of production, and other criteria relevant for the application of the optional quality term established in paragraph 1 of this Article. Article 41 Generic terms 3. In order to fully protect the rights of interested parties, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, laying down additional rules for determining the generic status of terms referred to in paragraph 1 of this Article. Article 42 Plant varieties and animal breeds 2. In order to further clarify the extent of rights and freedoms of food business operators to use the name of a plant variety or of an animal breed referred to in paragraph 1 of this Article, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, concerning rules for determining the use of such names.

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Article 49 Application for registration of names 7. In order to facilitate the application process, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, defining the rules for carrying out the national objection procedure for joint applications concerning more than one national territory and complementing the rules of the application process. Article 51 Opposition procedure 6. In order to establish clear procedures and deadlines for opposition, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, complementing the rules of the opposition procedure. Article 53 Amendment to a product specification 3. In order to facilitate the administrative process of an amendment application, including where the amendment does not involve any change to the single document and where it concerns a temporary

change in the specification resulting from the imposition of obligatory sanitary or phytosanitary measures by the public authorities, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56, complementing the rules of the amendment application process. Article 54 Cancellation 2. In order to ensure legal certainty that all parties have the opportunity to defend their rights and legitimate interests, the Commission shall be empowered to adopt delegated acts, in accordance with Article 56 complementing the rules regarding the cancellation process. Article 56 Exercise of the delegation 1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in the second subparagraph of Article 2(1), Article 5(4), the first subparagraph of Article 7(2), the first subparagraph of Article 12(5), Article 16(2), Article 18(5), the first subparagraph of Article 19(2), the first subparagraph of Article 23(4), Article 25(3), Article 29(4), Article 30, Article 31(3) and (4), Article 41(3), Article 42(2), the first subparagraph of Article 49(7), the first subparagraph of Article 51(6), the first subparagraph of Article 53(3) and the first subparagraph of Article 54(2) shall be conferred on the Commission for a period of five years from 3 January 2013. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in the second subparagraph of Article 2(1), Article 5(4), the first subparagraph of Article 7(2), the first subparagraph of Article 12(5), Article 16(2), Article 18(5), the first subparagraph of Article 19(2), the first subparagraph of Article 23(4), Article 25(3), Article 29(4), Article 30, Article 31(3) and (4), Article 41(3), Article 42(2), the first subparagraph of Article 49(7), the first subparagraph of Article 51(6), the first subparagraph of Article 53(3) and the first subparagraph of Article 54(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date

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specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to the second subparagraph of Article 2(1), Article 5(4), the first subparagraph of Article 7(2), the first subparagraph of Article 12(5), Article 16(2), Article 18(5), the first subparagraph of Article 19(2), the first subparagraph of Article 23(4), Article 25(3), Article 29(4), Article 30, Article 31(3) and (4), Article 41(3), Article 42(2), the first subparagraph of Article 49(7), the first subparagraph of Article 51(6), the first subparagraph of Article 53(3) and the first subparagraph of Article 54(2) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

63. Regulation (EU) No 260/2012 of the European Parliament and of the Council of 14 March 2012 establishing technical and business requirements for credit transfers and direct debits in euro and amending Regulation (EC) No 924/2009 Text with EEA relevance

Whereas: (30) In order to ensure that the technical requirements for credit transfers and direct debits in euro remain up to date, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of those technical requirements. In the Declaration (No 39) on Article 290 TFEU, annexed to the Final Act of the Intergovernmental Conference which adopted the Treaty of Lisbon, the Conference took note of the Commission’s intention to continue to consult experts appointed by the Member States in the preparation of draft delegated acts in the financial services area, in accordance with its established practice. It is of particular importance that the Commission carry out appropriate and transparent consultation during its preparatory work, including with the ECB and all relevant stakeholders. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council Article 13 Delegation of power The Commission shall be empowered to adopt delegated acts in accordance with Article 14 to amend the Annex, in order to take account of technical progress and market developments. Article 14 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 13 shall be conferred on the Commission for a period of 5 years from 31 March 2012. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Article 13 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or on a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.







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5. A delegated act adopted pursuant to Article 13 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 3 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 3 months at the initiative of the European Parliament or the Council.

64. Regulation (EU) No 1227/2011 of the European Parliament and of the Council of 25 October 2011 on wholesale energy market integrity and transparency Text with EEA relevance

Whereas: (16) As financial markets develop, the concepts of market abuse applying to those markets will be adapted. In order to ensure the necessary flexibility to respond quickly to these developments therefore, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of technical updating of the definitions of inside information and market manipulation for the purpose of ensuring coherence with other relevant Union

legislation in the fields of financial services and energy. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission should, when preparing and drawing up delegated acts, ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council. Article 6 Technical updating of definitions of inside information and market manipulation 1. The Commission shall be empowered to adopt delegated acts in accordance with Article 20 in order to: (a) align the definitions set out in points (1), (2), (3) and (5) of Article 2 for the purpose of ensuring coherence with other relevant Union legislation in the fields of financial services and energy; and (b) update those definitions for the sole purpose of taking into account future developments on wholesale energy markets. 2. The delegated acts referred to in paragraph 1 shall take into account at least: (a) the specific functioning of wholesale energy markets, including the specificities of electricity and gas markets, and the interaction between commodity markets and derivative markets; (b) the potential for manipulation across borders, between electricity and gas markets and across commodity markets and derivative markets; (c) the potential impact on wholesale energy market prices of actual or planned production, consumption, use of transmission, or use of storage capacity; and (d) network codes and framework guidelines adopted in accordance with Regulations (EC) No 714/2009 and (EC) No 715/2009. Article 20 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 6 shall be conferred on the Commission for a period of 5 years from 28 December 2011. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Article 6 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.





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4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 6 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or the Council.

65. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous

substances in electrical and electronic equipment (recast)

Whereas: (25) For the purposes of achieving the objectives of this Directive the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union in respect of amendments to Annex II, detailed rules for complying with maximum concentration

values, and the adaptation of Annexes III and IV to technical and scientific progress. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. Article 4 Prevention 2. For the purposes of this Directive, no more than the maximum concentration value by weight in homogeneous materials as specified in Annex II shall be tolerated. The Commission shall adopt, by means of delegated acts in accordance with Article 20 and subject to the conditions laid down in Articles 21 and 22, detailed rules for complying with these maximum concentration values taking into account, inter alia, surface coatings Article 5 Adaptation of the Annexes to scientific and technical progress 1. For the purposes of adapting Annexes III and IV to scientific and technical progress, and in order to achieve the objectives set out in Article 1, the Commission shall adopt by means of individual delegated acts in accordance with Article 20 and subject to the conditions laid down in Articles 21 and 22, the following measures: (a) inclusion of materials and components of EEE for specific applications in the lists in Annexes III and IV, provided that such inclusion does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 and where any of the following conditions is fulfilled: — their elimination or substitution via design changes or materials and components which do not require any of the materials or substances listed in Annex II is scientifically or technically impracticable, — the reliability of substitutes is not ensured, — the total negative environmental, health and consumer safety impacts caused by substitution are likely to outweigh the total environmental, health and consumer safety benefits thereof. Decisions on the inclusion of materials and components of EEE in the lists in Annexes III and IV and on the duration of any exemptions shall take into account the availability of substitutes and the socioeconomic impact of substitution. Decisions on the duration of any exemptions shall take into account any potential adverse impacts on innovation. Life-cycle thinking on the overall impacts of the exemption shall apply, where relevant; (b) deletion of materials and components of EEE from the lists in Annexes III and IV where the conditions set out in point (a) are no longer fulfilled. Article 6 Review and amendment of list of restricted substances in Annex II 3. The measures referred to in this Article shall be adopted by the Commission by means of delegated


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acts in accordance with Article 20 and subject to the conditions laid down in Articles 21 and 22. Article 20 Exercise of the delegation 1. The powers to adopt the delegated acts referred to in Article 4(2), Article 5(1) and Article 6 shall be conferred on the Commission for a period of 5 years from 21 July 2011. The Commission shall draw up a report in respect of delegated powers at the latest 6 months before the end of the 5 year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 21. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 21 and 22. Article 21 Revocation of the delegation 1. The delegation of power referred to in Article 4(2), Article 5(1) and Article 6 may be revoked at any

time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 22 Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification. At the initiative of the European Parliament or the Council that period shall be extended by 2 months. 2. If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.

66. Council Regulation (EU) No 973/2010 of 25 October 2010 temporarily suspending the autonomous Common Customs Tariff duties on imports of certain industrial products into the autonomous regions of the Azores and Madeira

Whereas: (9) Amendments to the Combined Nomenclature may not give rise to any substantive changes to the nature of the suspension of duties. The Commission should therefore be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union for the purpose of making necessary amendments and technical adaptations to the list of goods for which a suspension applies, Article 6 When necessary the Commission may adopt by means of delegated acts in accordance with Article 7 and subject to the conditions of Articles 8 and 9 such amendments and technical adaptations to Annexes I and II as are required as a consequence of amendments to the Combined Nomenclature.


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Article 7 1. The powers to adopt the delegated acts referred to in Article 6 shall be conferred on the Commission for an indeterminate period. 2. As soon as it adopts a delegated act, the Commission shall notify it to the Council. 3. The powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 8 and 9. Article 8 1. The delegation of power referred to in Article 6 may be revoked by the Council. 2. Where the Council has commenced an internal procedure for deciding whether to revoke the delegation of powers, it shall endeavour to inform the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.

Article 9 1. The Council may object to the delegated act within a period of three months from the date of notification. 2. If, on expiry of that period, the Council has not objected to the delegated act, or if, before that date, the Council informs the Commission that it has decided not to raise objections, the delegated act shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein. 3. If the Council objects to the adopted delegated act, it shall not enter into force. The Council shall state the reasons for objecting to the delegated act. Article 10 The European Parliament shall be informed of the adoption of delegated acts by the Commission, of any objection formulated to them, or of the revocation of the delegation of powers by the Council.

67. Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC Text with EEA relevance

whereas (23) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty in respect of the adoption of criteria for derogations and amendments to the Annexes of this Directive. Article 4 Derogation and safeguard clauses 1. Where it is demonstrated, on the basis of the criteria referred to in paragraph 4 of this Article, that particular substances covered by Parts 1 or 2 of Annex I are incapable of creating a major accident hazard, in particular due to their physical form, properties, classification, concentration or generic packaging, the Commission may list those substances in Part 3 of Annex I by delegated acts in accordance with Article 24. 4. By 30 June 2013, the Commission shall adopt delegated acts in accordance with Article 24, to establish criteria to be used for the purposes of paragraphs 1 and 3 of this Article respectively, and to amend Annex VII accordingly. 5. Where a Member State considers that a dangerous substance not listed in Parts 1 or 2 of Annex I, presents a major-accident hazard, it may take appropriate measures and shall notify the Commission. The Commission shall inform the forum referred to in Article 17(2) of notifications made pursuant to the






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first subparagraph of this paragraph. Where appropriate, the Commission may list the substances referred to in the first subparagraph of this paragraph in Part 1 or Part 2 of Annex I by delegated acts in accordance with Article 24. Article 23 Amendment of Annexes Without prejudice to Article 4, in order to adapt Annexes I to VII to technical progress, the Commission shall adopt delegated acts in accordance with Article 24. Article 24 Exercise of the delegation 1. The powers to adopt the delegated acts referred to in Articles 4 and 23 shall be conferred on the Commission for an indeterminate period of time. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 3. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down

in Articles 25 and 26. Article 25 Revocation of the delegation 1. The delegation of powers referred to in Article 24 may be revoked at any time by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, stating the delegated powers which could be subject to revocation and the reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union. Article 26 Objections to delegated acts 1. The European Parliament and the Council may object to the delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by one month. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein. The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European parliament and the Council have both informed the Commission of their intention not to raise objections. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act

68. REGULATION (EU) No 1007/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 September 2011 on textile fibre names and related labelling and

Whereas: (24) The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the adoption of technical criteria and procedural rules for the authorisation of higher tolerances, the amendment of Annexes II, IV, V, VI,





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marking of the fibre composition of textile products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC of the European Parliament and of the Council

VII, VIII and IX in order to adapt them to technical progress and the amendment of Annex I in order to include new textile fibre names in the list set out in that Annex. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. Article 20 Tolerances 5. In the case of particular textile products for which the manufacturing process requires tolerances higher than those laid down in paragraphs 2 and 3, the Commission may authorise higher tolerances. Prior to placing the textile product on the market, the manufacturer shall submit a request for authorisation by the Commission providing sufficient reasons for and evidence of the exceptional manufacturing circumstances. The authorisation may only be granted in exceptional cases and where adequate justification is provided by the manufacturer. If appropriate, the Commission shall adopt, by means of delegated acts in accordance with Article 22, technical criteria and procedural rules for the application of this paragraph.

Article 21 Delegated acts 1. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 concerning the adoption of technical criteria and procedural rules for the application of Article 20(5), amendments to Annexes II, IV, V, VI, VII, VIII and IX, in order to take account of technical progress, and amendments to Annex I in order to include, pursuant to Article 6, new textile fibre names in the list set out in that Annex. 2. When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Regulation. Article 22 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 20(5) and Article 21 shall be conferred on the Commission for a period of five years from 7 November 2011. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 20(5) and Article 21 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following its publication in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 20(5) and Article 21 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of





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the Council.

69. Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters

Whereas: (37) In order to ensure that the certificates to be used in connection with the recognition or enforcement of judgments, authentic instruments and court settlements under this Regulation are kept up-to-date, the power to adopt acts in accordance with Article 290 of the TFEU should be delegated to the Commission in respect of amendments to Annexes I and II to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.

The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council Article 77 The Commission shall be empowered to adopt delegated acts in accordance with Article 78 concerning the amendment of Annexes I and II. Article 78 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 77 shall be conferred on the Commission for an indeterminate period of time from 9 January 2013. 3. The delegation of power referred to in Article 77 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 77 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. ANNEX I CERTIFICATE CONCERNING A JUDGMENT IN CIVIL AND COMMERCIAL MATTERS ANNEX II CERTIFICATE CONCERNING AN AUTHENTIC INSTRUMENT/COURT SETTLEMENT (1) IN CIVIL AND COMMERCIAL MATTERS

70. Regulation (EU) No 259/2012 of the European Parliament and of the Council of 14 March 2012 amending Regulation (EC) No 648/2004 as regards the use of phosphates and other phosphorus compounds in consumer laundry detergents and consumer automatic dishwasher detergents Text with

Whereas: (8) In order to adapt Regulation (EC) No 648/2004 to scientific and technical progress, to introduce provisions on solvent-based detergents and in order to introduce appropriate individual risk-based concentration limits for fragrance allergens, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amendments to the Annexes to that Regulation that are necessary to meet those objectives. It is of











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EEA relevance particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. (7) Articles 13 and 14 are replaced by the following: "Article 13 Adaptation of Annexes 1. The Commission shall be empowered to adopt delegated acts in accordance with Article 13a in order to introduce amendments necessary for adapting Annexes I to IV, VII and VIII to scientific and technical progress. The Commission shall, wherever possible, use European standards. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 13a in order to introduce amendments to the Annexes of this Regulation regarding solvent-based detergents. 3. Where individual risk-based concentration limits for the fragrance allergens are established by the Scientific Committee on Consumer Safety, the Commission shall adopt delegated acts in accordance with

Article 13a in order to adapt the limit of 0,01 % set out in section A of Annex VII accordingly. Article 13a Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 13 shall be conferred on the Commission for a period of 5 years from 19 April 2012. By 19 July 2016, the Commission shall draw up a report in respect of the delegation of power. The delegation of power shall be tacitly extended for further periods of 5 years, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each such period. 3. The delegation of power referred to in Article 13 may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 13 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or the Council.

71. REGULATION (EU) No 530/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2012 on the accelerated phasing-in of double-hull or equivalent design requirements for single-hull oil tankers

Whereas: (21) It is very unlikely that the IMO would modify the content of the relevant Regulations in MARPOL 73/78 and Resolutions MEPC 111(50) and 94(46) adopted by the MEPC referred to in this Regulation. However, non- substantial amendments, such as renumbering, could be introduced in those texts. In order to keep this Regulation updated with the most recent developments of relevant international law, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission only in respect of such amendments in so far as they do








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not broaden the scope of this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council, Article 10 Amendment procedure 1. The Commission shall be empowered to adopt delegated acts in accordance with Article 11 concerning the alignment of the references in this Regulation to the non-substantial amendments, such as renumbering, adopted by the IMO to the Regulations of Annex I to MARPOL 73/78, as well as to Resolutions MEPC 111(50) and 94(46) as amended by Resolutions MEPC 99(48) and 112(50), in so far as such amendments do not broaden the scope of this Regulation. Article 11 Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this article.

2. The power to adopt the delegated acts referred to in Article 10(1) shall be conferred on the Commission for a period of five years from 20 July 2012. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 10(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 10(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

72. Directive 2012/35/EU of the European Parliament and of the Council of 21 November 2012 amending Directive 2008/106/EC on the minimum level of training of seafarers

Whereas (12) In order to gather data on the seafaring profession in line with its evolution and with that of technology, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of adaptations of Annex V of Directive 2008/106/EC. The use of such delegated acts should be limited to cases in which amendments to the STCW Convention and Code require changes to that Annex. Additionally, such delegated acts should not modify the provisions on anonymising data referred to in that Annex. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and the Council.

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(22) Article 27 is replaced by the following: "Article 27 Amendment The Commission shall be empowered to adopt delegated acts, in accordance with Article 27a, amending Annex V to this Directive with respect to specific and relevant content and details of the information that needs to be reported by Member States provided that such acts are limited to taking into account the amendments to the STCW Convention and Code and respect the safeguards on data protection. Such delegated acts shall not change the provisions of anonymisation of data as required by Article 25a(3)."; (23) the following Article is inserted: "Article 27a Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power referred to in Article 27 shall be conferred on the Commission for a period of

five years from 3 January 2013. The Commission shall draw up a report in respect of the delegation of power not later than 4 April 2017. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 27 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 27 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council.";

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