LEGISLATIVE GUIDELINE FOR ECOLOGICAL AGRICULTURE IN THE

EUROPEAN UNION Authors: - CHIEF COORD. DR. STOLERU VASILE -USAMV IASI - DR. ENG. ALDESCU TEODORA - MAPDR - PROF. DR. GRADINARIU GICA- USAMV IASI - PROF. DR. JITAREANU GERARD - USAMV IASI - PROF. DR. MUNTEANU NECULAI - USAMV IASI - PROF. DR. ISTRATE MIHAI - USAMV IASI - ENG. VRABIE IURIE - UNCALNIS UNGHENI

Project implemented by: The University of Agricultural Sciences and Veterinary Medicine Iasi

2009

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CONTENTS

1. Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 ………………………………….……………………….… 5 TITLE I ……………………………………...………………………….…… 11 TITLE II ………………………………………………………………….….. 15 TITLE III …………………………………………………………….………. 19 CHAP.I. …………………………………………………………....…… 19 CHAP.II. ……………………………………………………….….….… 20 CHAP.III. ……………………………………………..………….…...… 30 CHAP.IV. ……………..……………………………………….…..….… 31 CHAP.V. ………………………………………………….….……….… 33 TITLE IV ………………………………………………………….…………. 35 TITLE V ………………………………………………………..……………. 38 TITLE VI ………………………………………………………………….…. 43 TITLE VIII ……………………………………………………………...……. 46 2. Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control …..……………..…….…………….…….…. 52 TITLE I ………………………………...……………………………….…… 60 TITLE II ……………………………………………………...……………… 61 CHAP.I. ………………………………………………...……….……… 61 CHAP.II. ………………….…………………………………….….…… 63 CHAP.III. ……………………………………………………….…….… 75 CHAP.IV. ……………………………………………………….….…… 78 CHAP.V. …………………………………………………………….….. 82 CHAP.VI. ………………………………………………………….….… 84 CHAP.VII. …………………………………………………….……....… 90 TITLE III ……………………………………………………………….…..… 93 CHAP.I. ………………………………………………………….....…… 93 CHAP.II. …………………………………………………………..….… 93 CHAP.III. …………………………………………………………..…… 94 TITLE IV ……………………………………………………………….….… 96 CHAP.I. …………………………………………………………....…… 96 CHAP.II. ………………………………………………………………. 100 CHAP.III. ……………………………………………...………….…… 101 CHAP.IV. ………………………………………………………...….… 103 CHAP.V. ……………………………………………………..……...… 104 CHAP.VI. ………………………………………………………...….… 105 CHAP.VII. ……………………………………………………..…….… 106 CHAP.VIII. ……………………………………………………….….… 107 TITLE V ………………………………………………………………….… 109 CHAP.I. …………………………………………………….…………. 109 CHAP.II. ………………………………………………………………. 110 ANNEX I ……………………………………………………..………... 113 ANNEX II ……………………………………………………………… 115 ANNEX III …………………………………………………………...… 117 ANNEX IV ……….………………………………………………..…… 118 ANNEX V ……………………………………………………………… 118

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ANNEX VI …………………………………………………………...… 122 ANNEX VII …………………………………………………………..… 124 ANNEX VIII …….……………………………………………………… 124 ANNEX IX ………………………………………………………...…… 128 ANNEX X ……………………………………………………..…..…… 129 ANNEX XI …………………………………………….…………..…… 129 ANNEX XII ………………………………………………………..…… 134 ANNEX XIII ………………………………………………………….… 134 ANNEX XIV ………………………………………………………….… 135 3. Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market sur-veillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 ……………………………………………………..……….…...……… 142 CHAP.I. …………………………………………………….………..… 151 CHAP.II. …………………………………………………...…….….… 153 CHAP.III. ………………………………………………………....…… 159 CHAP.IV. ………………………………………………………....…… 168 CHAP.V. ………………………………………………………….…… 168 CHAP.VI. ………………………………………………………...….… 172 ANNEX I …………………………………………..………………...… 174 ANNEX II ……………………………………………………………… 174 4. Council Regulation (EC) No 967/2008 of 29 September 2008 amending Regu-lation (EC) No 834/2007 on organic production and labelling of organic products …………………………………………………...…………………….…...…... 175 5. Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as re-gards the arrangements for imports of organic products from third countries .. 177 TITLE I ……………………………………………………………….….… 179 TITLE II …………………………………………………………….……… 180 CHAP.I. …………………………………………………….…….…… 180 CHAP.II. ………………………………………………….………....… 184 TITLE III ………………………………………………………….….…...… 184 CHAP.I. …………………………………………………….……..…… 184 CHAP.II. …………………………………………...……….…….…… 187 CHAP.III. …………………………………………………...……….… 190 TITLE IV ………………………………………………………….……...… 195 TITLE V ………………………………………………………….…….....… 197 ANNEX I …………………………………………..………………...… 199 ANNEX II ……………………………..……………..………………… 199 ANNEX III ………………………………………..…….……………… 200 ANNEX IV …………………………………………..……….………… 204 ANNEX V …………………………………………..………..………… 204 ANNEX VI …………………………………………..………….……… 207 ANNEX VII …………………………………………..………………… 209 6. Commission Regulation (EC) No 1254/2008 of 15 December 2008 amending Regulation (EC) No 889/2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of or-ganic products with regard to organic production, labelling and control …..… 210 7. Commission Regulation (EC) No 710/2008 of 24 July 2008 setting the weighting coefficients to be used in calculating the Community market price for pig carcases for the 2008/2009 marketing year …………………………...….. 214

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Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 Whereas:

(1) Organic production is an overall system of farm management and food production that combines best environmental practices, a high level of biodiversity, the preser-vation of natural resources, the application of high animal welfare standards and a production method in line with the preference of certain consumers for pro-ducts produced using natu-ral substances and proce-sses. The organic produc-tion method thus plays a dual societal role, where it on the one hand provides for a specific market responding to a consumer demand for organic products, and on the other hand delivers public goods contributing to the protection of the environment and animal welfare, as well as to rural development.

(2) The share of the organic agricultural sector is on the increase in most Member States. Growth in consumer demand in recent years is particularly remarkable. Recent reforms of the common agricultural policy, with its emphasis on market-orientation and the supply of quality products to meet consumer demands, are likely to further stimulate the market in organic produce. Against this background the legislation on organic production plays an increasingly important role in the agricultural policy framework and is closely related to developments in the agricultural markets.

(3) The Community legal framework governing the sector of organic production should pursue the objective of ensuring fair competition and a proper functioning of the internal market in organic products, and of maintaining and justifying consumer confidence in products labelled as organic. It should further aim at providing conditions under which this sector can progress in line with production and market developments.

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(4) The Communication from the Commission to the Council and the European Parliament on a European Action Plan for Organic Food and Farming proposes to improve and reinforce the Community's organic farming standards and import and inspection requirements. In its conclusions of 18 October 2004, the Council called on the Commission to review the Community legal framework in this field with a view to ensure simplification and overall coherence and in particular to establish principles encouraging harmonisation of standards and, where possible, to reduce the level of detail.

(5) It is therefore appropriate to define more explicitly the objectives, principles and rules applicable to organic production, in order to contribute to transparency and consumer confidence as well as to a harmonised perception of the concept of organic production.

(6) To that end, Council Regulation (EEC) No 2092/91 of 24 June 1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs [2] should be repealed and replaced by a new regulation.

(7) A general Community framework of organic production rules should be established with regard to plant, livestock, and aquaculture production, including rules for the collection of wild plants and seaweeds, rules on conversion, as well as rules on the production of processed food, including wine, and feed and organic yeast. The Commission should authorise the use of products and substances and decide on methods to be used in organic farming and in the processing of organic food.

(8) The development of organic production should be facilitated further, in particular by fostering the use of new techniques and substances better suited to organic production.

(9) Genetically modified organisms (GMOs) and products produced from or by GMOs are incompatible with the concept of organic production and consumers' perception of organic products. They should therefore not be used in organic farming or in the processing of organic products.

(10) The aim is to have the lowest possible presence of GMOs in organic products. The existing labelling thresholds represent ceilings which are exclusively linked to the adventitious and technically unavoidable presence of GMOs.

(11) Organic farming should primarily rely on renewable resources within locally organised agricultural systems. In order to minimise the use of non-renewable resources, wastes and by-products of plant and animal origin should be recycled to return nutrients to the land.

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(12) Organic plant production should contribute to maintaining and enhancing soil fertility as well as to preventing soil erosion. Plants should preferably be fed through the soil eco-system and not through soluble fertilisers added to the soil.

(13) The essential elements of the organic plant production management system are soil fertility management, choice of species and varieties, multiannual crop rotation, recycling organic materials and cultivation techniques. Additional fertilisers, soil conditioners and plant protection products should only be used if they are compatible with the objectives and principles of organic production.

(14) Livestock production is fundamental to the organisation of agricultural production on organic holdings in so far as it provides the necessary organic matter and nutrients for cultivated land and accordingly contributes towards soil improvement and the development of sustainable agriculture.

(15) In order to avoid environmental pollution, in particular of natural resources such as the soil and water, organic production of livestock should in principle provide for a close relationship between such production and the land, suitable multiannual rotation systems and the feeding of livestock with organic-farming crop products produced on the holding itself or on neighbouring organic holdings.

(16) As organic stock farming is a land-related activity animals should have, whenever possible, access to open air or grazing areas.

(17) Organic stock farming should respect high animal welfare standards and meet animals' species-specific behavioural needs while animal-health management should be based on disease prevention. In this respect, particular attention should be paid to housing conditions, husbandry practices and stocking densities. Moreover, the choice of breeds should take account of their capacity to adapt to local conditions. The implementing rules for livestock production and aquaculture production should at least ensure compliance with the provisions of the European Convention for the Protection of Animals kept for Farming purposes and the subsequent recommendations by its standing committee (T-AP).

(18) The organic livestock production system should aim at completing the production cycles of the different livestock species with organically reared animals. It should therefore encourage the increase of the gene pool of organic animals, improve self reliance and thus ensure the development of the sector.

(19) Organic processed products should be produced by the use of processing methods which guarantee that the organic integrity and vital

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qualities of the product are maintained through all stages of the production chain.

(20) Processed food should be labelled as organic only where all or almost all the ingredients of agricultural origin are organic. However, special labelling provisions should be laid down for processed foods which include agricultural ingredients that cannot be obtained organically, as it is the case for products of hunting and fishing. Moreover, for the purpose of consumer information, transparency in the market and to stimulate the use of organic ingredients, it should also be made possible to refer to organic production in the ingredients list under certain conditions.

(21) It is appropriate to provide for flexibility as regards the application of production rules, so as to make it possible to adapt organic standards and requirements to local climatic or geographic conditions, specific husbandry practices and stages of development. This should allow for the application of exceptional rules, but only within the limits of specific conditions laid down in Community legislation.

(22) It is important to maintain consumer confidence in organic products. Exceptions from the requirements applicable to organic production should therefore be strictly limited to cases where the application of exceptional rules is deemed to be justified.

(23) For the sake of consumer protection and fair competition, the terms used to indicate organic products should be protected from being used on non-organic products throughout the Community and independently of the language used. The protection should also apply to the usual derivatives or diminutives of those terms, whether they are used alone or combined.

(24) In order to create clarity for consumers throughout the Community market, the EU-logo should be made obligatory for all organic pre-packaged food produced within the Community. It should otherwise be possible to use the EU-logo on a voluntary basis in the case of non pre-packaged organic products produced within the Community or any organic products imported from third countries.

(25) It is however considered appropriate to limit the use of the EU-logo to products which contain only, or almost only, organic ingredients in order not to mislead consumers as to the organic nature of the entire product. It should therefore not be allowed to use it in the labelling of in-conversion products or processed foodstuffs of which less than 95 % of its ingredients of agricultural origin are organic.

(26) The EU-logo should under no circumstances prevent the simultaneous use of national or private logos.

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(27) Moreover, for the sake of avoiding deceptive practices and any possible confusion amongst consumers on the Community or non-Community origin of the product, whenever the EU-logo is used, consumers should be informed about the place were the agricultural raw materials of which the product is composed have been farmed.

(28) The Community rules should promote a harmonised concept of organic production. The competent authorities, control authorities and control bodies should refrain from any conduct that might create obstacles to the free movement of compliant products that have been certified by an authority or body located in another Member State. They should in particular not impose any additional controls or financial burdens.

(29) For the sake of consistency with Community legislation in other fields, in the case of plant and livestock production, Member States should be allowed to apply within their own territories, national production rules which are stricter than the Community organic production rules, provided that these national rules also apply to non-organic production and are otherwise in conformity with Community law.

(30) The use of GMOs in organic production is prohibited. For the sake of clarity and coherence, it should not be possible to label a product as organic where it has to be labelled as containing GMOs, consisting of GMOs or produced from GMOs.

(31) In order to ensure that organic products are produced in accordance with the requirements laid down under the Community legal framework on organic production, activities performed by operators at all stages of production, preparation and distribution of organic products should be submitted to a control system set up and managed in conformity with the rules laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules [3].

(32) It might in some cases appear disproportionate to apply notification and control requirements to certain types of retail operators, such as those who sell products directly to the final consumer or user. It is therefore appropriate to allow Member States to exempt such operators from these requirements. However, in order to avoid fraud it is necessary to exclude from the exemption those retail operators who produce, prepare or store products other than in connection with the point of sale, or who import organic products or who have contracted out the aforesaid activities to a third party.

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(33) Organic products imported into the European Community should be allowed to be placed on the Community market as organic, where they have been produced in accordance with production rules and subject to control arrangements that are in compliance with or equivalent to those laid down in Community legislation. In addition, the products imported under an equivalent system should be covered by a certificate issued by the competent authority, or recognised control authority or body of the third country concerned.

(34) The assessment of equivalency with regard to imported products should take into account the international standards laid down in Codex Alimentarius.

(35) It is considered appropriate to maintain the list of third countries recognised by the Commission as having production standards and control arrangement which are equivalent to those provided for in Community legislation. For third countries which are not included in that list, the Commission should set up a list of control authorities and control bodies recognised as being competent for the task of ensuring controls and certification in third countries concerned.

(36) Relevant statistical information should be collected in order to obtain reliable data needed for the implementation and follow-up of this Regulation and as a tool for producers, market operators and policy makers. The statistical information needed should be defined within the context of the Community Statistical Programme.

(37) This Regulation should apply from a date which gives the Commission sufficient time to adopt the measures necessary for its implementation.

(38) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [4].

(39) The dynamic evolution of the organic sector, certain highly sensitive issues linked to the organic production method and the need to ensure a smooth functioning of the internal market and control system makes it appropriate to provide for a future review of the Community rules on organic farming, taking into account the experience gained from the application of these rules.

(40) Pending the adoption of detailed Community production rules for certain animal species and aquatic plants and micro-algae, Member States should have the possibility to provide for the application of national

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standards or, in the absence thereof, private standards accepted or recognised by the Member States,

HAS ADOPTED THIS REGULATION:

TITLE I AIM, SCOPE AND DEFINITIONS Article 1 Aim and scope 1. This Regulation provides the basis for the sustainable development of organic production while ensuring the effective functioning of the internal market, guaranteeing fair competition, ensuring consumer confidence and protecting consumer interests.

It establishes common objectives and principles to underpin the rules set out under this Regulation concerning:

(a) all stages of production, preparation and distribution of organic products and their control;

(b) the use of indications referring to organic production in labelling and advertising.

2. This Regulation shall apply to the following products originating from agriculture, including aqua-culture, where such pro-ducts are placed on the market or are intended to be placed on the market:

(a) live or unprocessed agricultural products;

(b) processed agricultural products for use as food;

(c) feed;

(d) vegetative propagating material and seeds for cultivation.

The products of hunting and fishing of wild animals shall not be considered as organic production.

This Regulation shall also apply to yeasts used as food or feed.

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3. This Regulation shall apply to any operator involved in activities, at any stage of production, preparation and distribution, relating to the products set out in paragraph 2.

However, mass catering operations shall not be subject to this Regulation. Member States may apply national rules or, in the absence thereof, private standards, on labelling and control of products originating from mass catering operations, in so far as the said rules comply with Community Law.

4. This Regulation shall apply without prejudice to other community provisions or national provisions, in conformity with Community law concerning products specified in this Article, such as provisions governing the production, preparation, marketing, labelling and control, including legislation on foodstuffs and animal nutrition.

Article 2 Definitions For the purposes of this Regulation, the following definitions shall apply:

(a) "organic production" means the use of the production method compliant with the rules established in this Regulation, at all stages of production, preparation and distribution;

(b) "stages of production, preparation and distribution" means any stage from and including the primary production of an organic product up to and including its storage, processing, transport, sale or supply to the final consumer, and where relevant labelling, advertising, import, export and subcontracting activities;

(c) "organic" means coming from or related to organic production;

(d) "operator" means the natural or legal persons responsible for ensuring that the requirements of this Regulation are met within the organic business under their control;

(e) "plant production" means production of agricultural crop products including harvesting of wild plant products for commercial purposes;

(f) "livestock production" means the production of domestic or domesticated

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terrestrial animals (including insects);

(g) the definition of "aquaculture" is that given in Council Regulation (EC) No 1198/2006 of 27 July 2006 on the European Fisheries Fund [5];

(h) "conversion" means the transition from non organic to organic farming within a given period of time, during which the provisions concerning the organic production have been applied;

(i) "preparation" means the operations of preserving and/or processing of organic products, including slaughter and cutting for livestock products, and also packaging, labelling and/or alterations made to the labelling concerning the organic production method;

(j) the definitions of "food", "feed" and "placing on the market" are those given in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [6];

(k) "labelling" means any terms, words, particulars, trade marks, brand name, pictorial matter or symbol relating to and placed on any packaging, document, notice, label, board, ring or collar accompanying or referring to a product;

(l) the definition of "pre-packaged foodstuff" is that given in Article 1(3)(b) of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs [7];

(m) "advertising" means any representation to the public, by any means other than a label, that is intended or is likely to influence and shape attitude, beliefs and behaviours in order to promote directly or indirectly the sale of organic products;

(n) "competent authority" means the central authority of a Member State competent for the organisation of official controls in the field of organic production in accordance with the provisions set out under this Regulation, or any other authority on which that competence has been conferred to; it shall also include, where appropriate, the corresponding authority of a third country;

(o) "control authority" means a public administrative organisation of a Member State to which the competent authority has conferred, in whole or in part, its competence for the inspection and certification in the field of organic production in accordance with the provisions set out under this Regulation; it shall also include, where appropriate, the corresponding

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authority of a third country or the corresponding authority operating in a third country;

(p) "control body" means an independent private third party carrying out inspection and certification in the field of organic production in accordance with the provisions set out under this Regulation; it shall also include, where appropriate, the corresponding body of a third country or the corresponding body operating in a third country;

(q) "mark of conformity" means the assertion of conformity to a particular set of standards or other normative documents in the form of a mark;

(r) the definition of "ingredients" is that given in Article 6(4) of Directive 2000/13/EC;

(s) the definition of "plant protection products" is that given in Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [8];

(t) the definition of "Genetically modified organism (GMO)" is that given in Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC [9] and which is not obtained through the techniques of genetic modifications listed in Annex I.B of that Directive;

(u) "produced from GMOs" means derived in whole or in part from GMOs but not containing or consisting of GMOs;

(v) "produced by GMOs" means derived by using a GMO as the last living organism in the production process, but not containing or consisting of GMOs nor produced from GMOs;

(w) the definition of "feed additives" is that given in Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [10];

(x) "equivalent", in describing different systems or measures, means that they are capable of meeting the same objectives and principles by applying rules which ensure the same level of assurance of conformity;

(y) "processing aid" means any substance not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or their ingredients, to fulfil a certain technological purpose during treatment or processing and which may result in the unintentional but technically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not present

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any health risk and do not have any technological effect on the finished product;

(z) the definition of "ionising radiation" is that given in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation [11] and as restricted by Article 1(2) of Directive 1999/2/EC of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation [12].

(aa) "mass catering operations" means the preparation of organic products in restaurants, hospitals, canteens and other similar food business at the point of sale or delivery to the final consumer.

TITLE II OBJECTIVES AND PRINCIPLES FOR ORGANIC PRODUCTION Article 3 Objectives Organic production shall pursue the following general objectives:

(a) establish a sustainable management system for agriculture that:

(i) respects nature's systems and cycles and sustains and enhances the health of soil, water, plants and animals and the balance between them;

(ii) contributes to a high level of biological diversity;

(iii) makes responsible use of energy and the natural resources, such as water, soil, organic matter and air;

(iv) respects high animal welfare standards and in particular meets animals’ species-specific behavioural needs;

(b) aim at producing products of high quality;

(c) aim at producing a wide variety of foods and other agricultural products that respond to con-sumers’ demand for goods produced by the use of processes that do not harm the environment, human

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health, plant health or animal health and welfare.

Article 4 Overall principles Organic production shall be based on the following principles:

(a) the appropriate design and management of biological processes based on ecological systems using natural resources which are internal to the system by methods that:

(i) use living organisms and mechanical production methods;

(ii) practice land-related crop cultivation and livestock production or practice aquaculture which complies with the principle of sustainable exploitation of fisheries;

(iii) exclude the use of GMOs and products produced from or by GMOs with the exception of veterinary medicinal products;

(iv) are based on risk assessment, and the use of precautionary and preventive measures, when appropriate;

(b) the restriction of the use of external inputs. Where external inputs are required or the appropriate management practices and methods referred to in paragraph (a) do not exist, these shall be limited to:

(i) inputs from organic production;

(ii) natural or naturally-derived substances;

(iii) low solubility mineral fertilisers;

(c) the strict limitation of the use of chemically synthesised inputs to exceptional cases these being:

(i) where the appropriate

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management practices do not exist; and

(ii) the external inputs referred to in paragraph (b) are not available on the market; or

(iii) where the use of external inputs referred to in paragraph (b) contributes to unacceptable environmental impacts;

(d) the adaptation, where necessary, and within the framework of this Regulation, of the rules of organic production taking account of sanitary status, regional differences in climate and local conditions, stages of development and specific husbandry practices.

Article 5 Specific principles applicable to farming In addition to the overall principles set out in Article 4, organic farming shall be based on the following specific principles:

(a) the maintenance and enhancement of soil life and natural soil fertility, soil stability and soil biodiversity preventing and combating soil compaction and soil erosion, and the nourishing of plants primarily through the soil ecosystem;

(b) the minimisation of the use of non-renewable resources and off-farm inputs;

(c) the recycling of wastes and by-products of plant and animal origin as input in plant and livestock production;

(d) taking account of the local or regional ecological balance when taking production decisions;

(e) the maintenance of animal health by encouraging the natural immunological defence of the animal, as well as the selection of appropriate breeds and husbandry practices;

(f) the maintenance of plant health by preventative measures, such as the choice of appropriate species and varieties resistant to pests and diseases, appropriate crop rotations, mechanical and physical methods and the protection of natural enemies of pests;

(g) the practice of site-adapted and land-related livestock production;

(h) the observance of a high level of animal welfare respecting species-specific needs;

(i) the production of products of organic livestock from animals that have been raised on organic holdings since birth or hatching and throughout their life;

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(j) the choice of breeds having regard to the capacity of animals to adapt to local conditions, their vitality and their resistance to disease or health problems;

(k) the feeding of livestock with organic feed composed of agricultural ingredients from organic farming and of natural non-agricultural substances;

(l) the application of animal husbandry practices, which enhance the immune system and strengthen the natural defence against diseases, in particular including regular exercise and access to open air areas and pastureland where appropriate;

(m) the exclusion of rearing artificially induced polyploid animals;

(n) the maintenance of the biodiversity of natural aquatic ecosystems, the continuing health of the aquatic environment and the quality of surrounding aquatic and terrestrial ecosystems in aquaculture production;

(o) the feeding of aquatic organisms with feed from sustainable exploitation of fisheries as defined in Article 3 of Council Regulation (EC) No 2371/2002 of 20 December 2002 on the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy [13] or with organic feed composed of agricultural ingredients from organic farming and of natural non-agricultural substances.

Article 6 Specific principles applicable to processing of organic food In addition to the overall principles set out in Article 4, the production of processed organic food shall be based on the following specific principles:

(a) the production of organic food from organic agricultural ingredients, except where an ingredient is not available on the market in organic form;

(b) the restriction of the use of food additives, of non organic ingredients with mainly technological and sensory functions and of micronutrients and processing aids, so that they are used to a minimum extent and only in case of essential technological need or for particular nutritional purposes;

(c) the exclusion of substances and processing methods that might be misleading regarding the true nature of the product;

(d) the processing of food with care, preferably with the use of biological, mechanical and physical methods.

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Article 7 Specific principles applicable to processing of organic feed In addition to the overall principles set out in Article 4, the production of processed organic feed shall be based on the following specific principles:

(a) the production of organic feed from organic feed materials, except where a feed material is not available on the market in organic form;

(b) the restriction of the use of feed additives and processing aids to a minimum extent and only in case of essential technological or zootechnical needs or for particular nutritional purposes;

(c) the exclusion of substances and processing methods that might be misleading as to the true nature of the product;

(d) the processing of feed with care, preferably with the use of biological, mechanical and physical methods.

TITLE III PRODUCTION RULES CHAPTER 1 General production rules Article 8 General requirements Operators shall comply with the production rules set out in this Title and with the implementing rules provided for in Article 38(a).

Article 9

Prohibition on the use of GMOs

1. GMOs and products produced from or by GMOs shall not be used as food, feed, processing aids, plant protection products, fertilisers, soil conditioners, seeds, vegetative propagating material, micro-organisms and animals in organic production.

2. For the purpose of the prohibition referred to in paragraph 1 concerning GMOs or products produced from GMOs for food and feed, operators may rely on the labels accompanying a product or any other accompanying document, affixed or provided pursuant to Directive 2001/18/EC, Regulation (EC) 1829/2003 of the European Parliament and the Council of 22 September 2003 on genetically modified food and feed [14] or Regulation (EC) 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms.

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Operators may assume that no GMOs or products produced from GMOs have been used in the manufacture of purchased food and feed products when the latter are not labelled, or accompanied by a document, pursuant to those Regulations, unless they have obtained other information indicating that labelling of the products in question is not in conformity with those Regulations.

3. For the purpose of the prohibition referred to in paragraph 1, with regard to products not being food or feed, or products produced by GMOs, operators using such non-organic products purchased from third parties shall require the vendor to confirm that the products supplied have not been produced from or by GMOs.

4. The Commission shall decide on measures implementing the prohibition on the use of GMOs and products produced from or by GMOs in accordance with the procedure referred to in Article 37(2).

Article 10 Prohibition on the use of ionising radiation The use of ionising radiation for the treatment of organic food or feed, or of raw materials used in organic food or feed is prohibited.

CHAPTER 2 Farm production Article 11 General farm production rules The entire agricultural holding shall be managed in compliance with the requirements applicable to organic production.

However, in accordance with specific conditions to be laid down in accordance with the procedure referred to in Article 37(2), a holding may be split up into clearly separated units or aquaculture production sites which are not all managed under organic production. As regards animals, different species shall be involved. As regards aquaculture the same species may be involved, provided that there is adequate separation between the production sites. As regards plants, different varieties that can be easily differentiated shall be involved.

Where, in accordance with the second subparagraph, not all units of a holding are used for organic production, the operator shall keep the land, animals, and products used for, or produced by, the organic units separate from those used for, or produced by, the non-organic units and keep adequate records to show the separation.

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Article 12 Plant production rules 1. In addition to the general farm production rules laid down in Article 11, the following rules shall apply to organic plant production:

(a) organic plant production shall use tillage and cultivation practices that maintain or increase soil organic matter, enhance soil stability and soil biodiversity, and prevent soil compaction and soil erosion;

(b) the fertility and biological activity of the soil shall be maintained and increased by multiannual crop rotation including legumes and other green manure crops, and by the application of livestock manure or organic material, both preferably composted, from organic production;

(c) the use of biodynamic preparations is allowed;

(d) in addition, fertilisers and soil conditioners may only be used if they have been authorised for use in organic production under Article 16;

(e) mineral nitrogen fertilisers shall not be used;

(f) all plant production techniques used shall prevent or minimise any contribution to the contamination of the environment;

(g) the prevention of damage caused by pests, diseases and weeds shall rely primarily on the protection by natural enemies, the choice of species and varieties, crop rotation, cultivation techniques and thermal processes;

(h) in the case of an established threat to a crop, plant protection products may only be used if they have been authorised for use in organic production under Article 16;

(i) for the production of products other than seed and vegetative propagating material only organically produced seed and propagating material shall be used. To this end, the mother plant in the case of seeds and the parent plant in the case of vegetative propagating material shall have been produced in accordance with the rules laid down in this Regulation for at least one generation, or, in the case of perennial crops, two growing seasons;

(j) products for cleaning and disinfection in plant production shall be used only if they have been authorised for use in organic production under Article 16.

2. The collection of wild plants and parts thereof, growing naturally in natural areas, forests and agricultural areas is considered an organic production method provided that:

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(a) those areas have not, for a period of at least three years before the collection, received treatment with products other than those authorised for use in organic production under Article 16;

(b) the collection does not affect the stability of the natural habitat or the maintenance of the species in the collection area.

3. The measures necessary for the implementation of the production rules contained in this Article shall be adopted in accordance with the procedure referred to in Article 37(2).

Article 13 Production rules for seaweed 1. The collection of wild seaweeds and parts thereof, growing naturally in the sea, is considered as an organic production method provided that:

(a) the growing areas are of high ecological quality as defined by Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy [15] and, pending its implementation, of a quality equivalent to designated waters under Directive 2006/113/EC of the European Parliament and of the Council of 12 December 2006 on the quality required of shellfish waters [16], and are not unsuitable from a health point of view. Pending more detailed rules to be introduced in implementing legislation, wild edible seaweeds shall not be collected in areas which would not meet the criteria for Class A or Class B areas as defined in Annex II of Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption [17];

(b) the collection does not affect the long term stability of the natural habitat or the maintenance of the species in the collection area.

2. The farming of seaweeds shall take place in coastal areas with environmental and health characteristics at least equivalent to those

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outlined in paragraph 1 in order to be considered organic. In addition to this:

(a) sustainable practices shall be used in all stages of production, from collection of juvenile seaweed to harvesting;

(b) to ensure that a wide gene-pool is maintained, the collection of juvenile seaweed in the wild should take place on a regular basis to supplement indoor culture stock;

(c) fertilisers shall not be used except in indoor facilities and only if they have been authorised for use in organic production for this purpose under Article 16.

3. The measures necessary for the implementation of production rules contained in this Article shall be adopted in accordance with the procedure referred to in Article 37(2).

Article 14 Livestock production rules 1. In addition to the general farm production rules laid down in Article 11, the following rules shall apply to livestock production:

(a) with regard to the origin of the animals:

(i) organic livestock shall be born and raised on organic holdings;

(ii) for breeding purposes, non-organically raised animals may be brought onto a holding under specific conditions. Such animals and their products may be deemed organic after compliance with the conversion period referred to in Article 17(1)(c);

(iii) animals existing on the holding at the beginning of the conversion period and their products may be deemed organic after compliance with the conversion period referred to in Article 17(1)(c);

(b) with regard to husbandry practices and housing conditions:

(i) personnel keeping animals shall possess the necessary basic knowledge and skills as regards the health and the welfare needs of the animals;

(ii) husbandry practices, including stocking densities, and housing conditions shall ensure that the developmental, physiological and ethological needs of animals are met;

(iii) the livestock shall have permanent access to open air areas, preferably pasture, whenever weather conditions and the state of the ground allow this unless restrictions and obligations related to the protection of human and animal health are imposed on the basis of Community legislation;

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(iv) the number of livestock shall be limited with a view to minimising overgrazing, poaching of soil, erosion, or pollution caused by animals or by the spreading of their manure;

(v) organic livestock shall be kept separate from other livestock. However, grazing of common land by organic animals and of organic land by non-organic animals is permitted under certain restrictive conditions;

(vi) tethering or isolation of livestock shall be prohibited, unless for individual animals for a limited period of time, and in so far as this is justified for safety, welfare or veterinary reasons;

(vii) duration of transport of livestock shall be minimised;

(viii) any suffering, including mutilation, shall be kept to a minimum during the entire life of the animal, including at the time of slaughter;

(ix) apiaries shall be placed in areas which ensure nectar and pollen sources consisting essentially of organically produced crops or, as appropriate, of spontaneous vegetation or non-organically managed forests or crops that are only treated with low environmental impact methods. Apiaries shall be kept at sufficient distance from sources that may lead to the contamination of beekeeping products or to the poor health of the bees;

(x) hives and materials used in beekeeping shall be mainly made of natural materials;

(xi) the destruction of bees in the combs as a method associated with the harvesting of beekeeping products is prohibited;

(c) with regard to breeding:

(i) reproduction shall use natural methods. Artificial insemination is however allowed;

(ii) reproduction shall not be induced by treatment with hormones or similar substances, unless as a form of veterinary therapeutic treatment in case of an individual animal;

(iii) other forms of artificial reproduction, such as cloning and embryo transfer, shall not be used;

(iv) appropriate breeds shall be chosen. The choice of breeds shall also contribute to the prevention of any suffering and to avoiding the need for the mutilation of animals;

(d) with regard to feed:

(i) primarily obtaining feed for livestock from the holding where the animals are kept or from other organic holdings in the same region;

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(ii) livestock shall be fed with organic feed that meets the animal's nutritional requirements at the various stages of its development. A part of the ration may contain feed from holdings which are in conversion to organic farming;

(iii) with the exception of bees, livestock shall have permanent access to pasture or roughage;

(iv) non organic feed materials from plant origin, feed materials from animal and mineral origin, feed additives, certain products used in animal nutrition and processing aids shall be used only if they have been authorised for use in organic production under Article 16;

(v) growth promoters and synthetic amino-acids shall not be used;

(vi) suckling mammals shall be fed with natural, preferably maternal, milk;

(e) with regard to disease prevention and veterinary treatment:

(i) disease prevention shall be based on breed and strain selection, husbandry management practices, high quality feed and exercise, appropriate stocking density and adequate and appropriate housing maintained in hygienic conditions;

(ii) disease shall be treated immediately to avoid suffering to the animal; chemically synthesised allopathic veterinary medicinal products including antibiotics may be used where necessary and under strict conditions, when the use of phytotherapeutic, homeopathic and other products is inappropriate. In particular restrictions with respect to courses of treatment and withdrawal periods shall be defined;

(iii) the use of immunological veterinary medicines is allowed;

(iv) treatments related to the protection of human and animal health imposed on the basis of Community legislation shall be allowed;

(f) with regard to cleaning and disinfection, products for cleaning and disinfection in livestock buildings and installations, shall be used only if they have been authorised for use in organic production under Article 16.

2. The measures and conditions necessary for the implementation of the production rules contained in this Article shall be adopted in accordance with the procedure referred to in Article 37(2).

Article 15 Production rules for aquaculture animals 1. In addition to the general farm production rules laid down in Article 11, the following rules shall apply to aquaculture animal production:

(a) with regard to the origin of the aquaculture animals:

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(i) organic aquaculture shall be based on the rearing of young stock originating from organic broodstock and organic holdings;

(ii) when young stock from organic broodstock or holdings are not available, non-organically produced animals may be brought onto a holding under specific conditions;

(b) with regard to husbandry practices:

(i) personnel keeping animals shall possess the necessary basic knowledge and skills as regards the health and the welfare needs of the animals;

(ii) husbandry practices, including feeding, design of installations, stocking densities and water quality shall ensure that the developmental, physiological and behavioural needs of animals are met;

(iii) husbandry practices shall minimise negative environmental impact from the holding, including the escape of farmed stock;

(iv) organic animals shall be kept separate from other aquaculture animals;

(v) transport shall ensure that the welfare of animals is maintained;

(vi) any suffering of the animals including the time of slaughtering shall be kept to a minimum;

(c) with regard to breeding:

(i) artificial induction of polyploidy, artificial hybridisation, cloning and production of monosex strains, except by hand sorting, shall not be used;

(ii) the appropriate strains shall be chosen;

(iii) species-specific conditions for broodstock management, breeding and juvenile production shall be established;

(d) with regard to feed for fish and crustaceans:

(i) animals shall be fed with feed that meets the animal's nutritional requirements at the various stages of its development;

(ii) the plant fraction of feed shall originate from organic production and the feed fraction derived from aquatic animals shall originate from sustainable exploitation of fisheries;

(iii) in the case of non-organic feed materials from plant origin, feed materials from animal and mineral origin, feed additives, certain products used in animal nutrition and processing aids shall be used only if they have been authorised for use in organic production under Article 16;

(iv) growth promoters and synthetic amino-acids shall not be used;

(e) with regard to bivalve molluscs and other species which are not fed by man but feed on natural plankton:

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(i) such filter-feeding animals shall receive all their nutritional requirements from nature except in the case of juveniles reared in hatcheries and nurseries;

(ii) they shall be grown in waters which meet the criteria for Class A or Class B areas as defined in Annex II of Regulation (EC) No 854/2004;

(iii) the growing areas shall be of high ecological quality as defined by Directive 2000/60/EC and, pending its implementation of a quality equivalent to designated waters under Directive 2006/113/EC;

(f) with regard to disease prevention and veterinary treatment:

(i) disease prevention shall be based on keeping the animals in optimal conditions by appropriate siting, optimal design of the holdings, the application of good husbandry and management practices, including regular cleaning and disinfection of premises, high quality feed, appropriate stocking density, and breed and strain selection;

(ii) disease shall be treated immediately to avoid suffering to the animal; chemically synthesised allopathic veterinary medicinal products including antibiotics may be used where necessary and under strict conditions, when the use of phytotherapeutic, homeopathic and other products is inappropriate. In particular restrictions with respect to courses of treatment and withdrawal periods shall be defined;

(iii) the use of immunological veterinary medicines is allowed;

(iv) treatments related to the protection of human and animal health imposed on the basis of Community legislation shall be allowed.

(g) With regard to cleaning and disinfection, products for cleaning and disinfection in ponds, cages, buildings and installations, shall be used only if they have been authorised for use in organic production under Article 16.

2. The measures and conditions necessary for the implementation of the production rules contained in this Article shall be adopted in accordance with the procedure referred to in Article 37(2).

Article 16 Products and substances used in farming and criteria for their authorisation 1. The Commission shall, in accordance with the procedure referred to in Article 37(2), authorise for use in organic production and include in a restricted list the products and substances, which may be used in organic farming for the following purposes:

(a) as plant protection products;

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(b) as fertilisers and soil conditioners;

(c) as non-organic feed materials from plant origin, feed material from animal and mineral origin and certain substances used in animal nutrition;

(d) as feed additives and processing aids;

(e) as products for cleaning and disinfection of ponds, cages, buildings and installations for animal production;

(f) as products for cleaning and disinfection of buildings and installations used for plant production, including storage on an agricultural holding.

Products and substances contained in the restricted list may only be used in so far as the corresponding use is authorised in general agriculture in the Member States concerned in accordance with the relevant Community provisions or national provisions in conformity with Community law.

2. The authorisation of the products and substances referred to in paragraph 1 is subject to the objectives and principles laid down in Title II and the following general and specific criteria which shall be evaluated as a whole:

(a) their use is necessary for sustained production and essential for its intended use;

(b) all products and substances shall be of plant, animal, microbial or mineral origin except where products or substances from such sources are not available in sufficient quantities or qualities or if alternatives are not available;

(c) in the case of products referred to in paragraph 1(a), the following shall apply:

(i) their use is essential for the control of a harmful organism or a particular disease for which other biological, physical or breeding alternatives or cultivation practices or other effective management practices are not available;

(ii) if products are not of plant, animal, microbial or mineral origin and are not identical to their natural form, they may be authorised only if their conditions for use preclude any direct contact with the edible parts of the crop;

(d) in the case of products referred to in paragraph 1(b), their use is essential for obtaining or maintaining the fertility of the soil or to fulfil specific nutrition requirements of crops, or specific soil-conditioning purposes;

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(e) in the case of products referred to in paragraph 1(c) and (d), the following shall apply:

(i) they are necessary to maintain animal health, animal welfare and vitality and contribute to an appropriate diet fulfilling the physiological and behavioural needs of the species concerned or it would be impossible to produce or preserve such feed without having recourse to such substances;

(ii) feed of mineral origin, trace elements, vitamins or provitamins shall be of natural origin. In case these substances are unavailable, chemically well-defined analogic substances may be authorised for use in organic production.

3. (a) The Commission may, in accordance with the procedure referred to in Article 37(2), lay down conditions and limits as regards the agricultural products to which the products and substances referred to in paragraph 1 can be applied to, the application method, the dosage, the time limits for use and the contact with agricultural products and, if necessary, decide on the withdrawal of these products and substances.

(b) Where a Member State considers that a product or substance should be added to, or withdrawn from the list referred to in paragraph 1, or that the specifications of use mentioned in subparagraph (a) should be amended, the Member State shall ensure that a dossier giving the reasons for the inclusion, withdrawal or amendments is sent officially to the Commission and to the Member States.

Requests for amendment or withdrawal, as well as decisions thereon, shall be published.

(c) Products and substances used before adoption of this Regulation for purposes corresponding to those laid down in paragraph 1 of this Article, may continue to be used after said adoption. The Commission may in any case withdraw such products or substances in accordance with Article 37(2).

4. Member States may regulate, within their territory, the use of products and substances in organic farming for purposes different than those mentioned in paragraph 1 provided their use is subject to objectives and principles laid down in Title II and the general and specific criteria set out in paragraph 2, and in so far as it respects Community law. The Member State concerned shall inform other Member States and the Commission of such national rules.

5. The use of products and substances not covered under paragraph 1 and 4, and subject to the objectives and principles laid down in Title II and the general criteria in this Article, shall be allowed in organic farming.

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Article 17 Conversion 1. The following rules shall apply to a farm on which organic production is started:

(a) the conversion period shall start at the earliest when the operator has notified his activity to the competent authorities and subjected his holding to the control system in accordance with Article 28(1);

(b) during the conversion period all rules established by this Regulation shall apply;

(c) conversion periods specific to the type of crop or animal production shall be defined;

(d) on a holding or unit partly under organic production and partly in conversion to organic production, the operator shall keep the organically produced and in-conversion products separate and the animals separate or readily separable and keep adequate records to show the separation;

(e) in order to determine the conversion period referred to above, a period immediately preceding the date of the start of the conversion period, may be taken into account, in so far as certain conditions concur;

(f) animals and animal products produced during the conversion period referred to in subparagraph (c) shall not be marketed with the indications referred to in Articles 23 and 24 used in the labelling and advertising of products.

2. The measures and conditions necessary for the implementation of the rules contained in this Article, and in particular the periods referred to in paragraph 1(c) to (f) shall be defined in accordance with the procedure referred to in Article 37(2).

CHAPTER 3 Production of processed feed Article 18 General rules on the production of processed feed 1. Production of processed organic feed shall be kept separate in time or space from production of processed non organic feed.

2. Organic feed materials, or feed materials from production in conversion, shall not enter simultaneously with the same feed materials produced by non organic means into the composition of the organic feed product.

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3. Any feed materials used or processed in organic production shall not have been processed with the aid of chemically synthesised solvents.

4. Substances and techniques that reconstitute properties that are lost in the processing and storage of organic feed, that correct the results of negligence in the processing or that otherwise may be misleading as to the true nature of these products shall not be used.

5. The measures and conditions necessary for the implementation of the production rules contained in this Article shall be adopted in accordance with the procedure referred to in Article 37(2).

CHAPTER 4 Production of processed food Article 19 General rules on the production of processed food 1. The preparation of processed organic food shall be kept separate in time or space from non-organic food.

2. The following conditions shall apply to the composition of organic processed food:

(a) the product shall be produced mainly from ingredients of agricultural origin; in order to determine whether a product is produced mainly from ingredients of agricultural origin added water and cooking salt shall not be taken into account;

(b) only additives, processing aids, flavourings, water, salt, preparations of micro-organisms and enzymes, minerals, trace elements, vitamins, as well as amino acids and other micronutrients in foodstuffs for particular nutritional uses may be used, and only in so far as they have been authorised for use in organic production in accordance with Article 21;

(c) non-organic agricultural ingredients may be used only if they have been authorised for use in organic production in accordance with Article 21 or have been provisionally authorised by a Member State;

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(d) an organic ingredient shall not be present together with the same ingredient in non-organic form or an ingredient in conversion;

(e) food produced from in-conversion crops shall contain only one crop ingredient of agricultural origin.

3. Substances and techniques that reconstitute properties that are lost in the processing and storage of organic food, that correct the results of negligence in the processing of these products or that otherwise may be misleading as to the true nature of these products shall not be used.

The measures necessary for the implementation of the production rules contained in this Article, and in particular regarding processing methods and the conditions for the provisional authorisation by Member States mentioned in paragraph 2(c), shall be adopted in accordance with the procedure referred to in Article 37(2).

Article 20 General rules on the production of organic yeast 1. For the production of organic yeast only organically produced substrates shall be used. Other products and substances may only be used in so far as they have been authorised for use in organic production in accordance with Article 21.

2. Organic yeast shall not be present in organic food or feed together with non-organic yeast.

3. Detailed production rules may be laid down in accordance with the procedure referred to in Article 37(2).

Article 21 Criteria for certain products and substances in processing 1. The authorisation of products and substances for use in organic production and their inclusion in a restricted list of the products and substances referred to in Article 19(2)(b) and (c) shall be subject to the objectives and principles laid down in Title II and the following criteria, which shall be evaluated as a whole:

(i) alternatives authorised in accordance with this chapter are not available;

(ii) without having recourse to them, it would be impossible to produce or preserve the food or to fulfil given dietary requirements provided for on the basis of the Community legislation.

In addition, the products and substances referred to in Article 19(2)(b) are to be found in nature and may have undergone only mechanical, physical, biological, enzymatic or microbial processes, except where such products

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and substances from such sources are not available in sufficient quantities or qualities on the market.

2. The Commission shall, in accordance with the procedure referred to in Article 37(2), decide on the authorisation of the products and substances and their inclusion in the restricted list referred to in paragraph 1 of this Article and lay down specific conditions and limits for their use, and, if necessary, on the withdrawal of products.

Where a Member State considers that a product or substance should be added to, or withdrawn from the list referred to in paragraph 1, or that the specifications of use mentioned in this paragraph should be amended, the Member State shall ensure that a dossier giving the reasons for the inclusion, withdrawal or amendments is sent officially to the Commission and to the Member States.

Requests for amendment or withdrawal, as well as decisions thereon, shall be published.

Products and substances used before adoption of this Regulation and falling under Article 19(2)(b) and (c) may continue to be used after the said adoption. The Commission may, in any case, withdraw such products or substances in accordance with Article 37(2).

CHAPTER 5 Flexibility Article 22 Exceptional production rules 1. The Commission may, in accordance with the procedure referred to in Article 37(2) and the conditions set out in paragraph 2 of this Article and subject to the objectives and principles laid down in Title II, provide for the granting of exceptions from the production rules laid down in Chapters 1 to 4.

2. Exceptions as referred to in paragraph 1 shall be kept to a minimum and, where appropriate, limited in time and may only be provided for in the following cases:

(a) where they are necessary in order to ensure that organic production can be initiated or maintained on holdings confronted with climatic, geographical or structural constraints;

(b) where it is necessary in order to ensure access to feed, seed and vegetative propagating material, live animals and other farm inputs, where such inputs are not available on the market in organic form;

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(c) where it is necessary in order to ensure access to ingredients of agricultural origin, where such ingredients are not available on the market in organic form;

(d) where they are necessary in order to solve specific problems related to the management of organic livestock;

(e) where they are necessary with regard to the use of specific products and substances in the processing referred to in Article 19(2)(b) in order to ensure production of well established food products in organic form;

(f) where temporary measures are necessary in order to allow organic production to continue or recommence in the case of catastrophic circumstances;

(g) where it is necessary to use food additives and other substances as set out in Article 19(2)(b) or feed additives and other substances as set out in Article 16(1)(d) and such substances are not available on the market other than produced by GMOs;

(h) where the use of food additives and other substances as set out in Article 19(2)(b) or feed additives as set out in Article 16(1)(d) is required on the basis of Community law or national law.

3. The Commission may in accordance with the procedure referred to in Article 37(2) lay down specific conditions for the application of exceptions provided for under paragraph 1.

TITLE IV LABELLING Article 23 Use of terms referring to organic production 1. For the purposes of this Regulation a product shall be regarded as bearing terms referring to the organic production method where, in the labelling, advertising material or commercial documents, such a product, its

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ingredients or feed materials are described in terms suggesting to the purchaser that the product, its ingredients or feed materials have been obtained in accordance with the rules laid down in this Regulation. In particular, the terms listed in the Annex, their derivatives or diminutives, such as "bio" and "eco", alone or combined, may be used throughout the Community and in any Community language for the labelling and advertising of products which satisfy the requirements set out under or pursuant to this Regulation.

In the labelling and advertising of live or unprocessed agricultural products terms referring to the organic production method may be used only where, in addition, all the ingredients of that product have also been produced in accordance with the requirements laid down in this Regulation.

2. The terms referred to in paragraph 1 shall not be used anywhere in the Community and in any Community language for the labelling, advertising and commercial documents of a product which does not satisfy the requirements set out under this Regulation, unless they are not applied to agricultural products in food or feed or clearly have no connection with organic production.

Furthermore, any terms, including terms used in trademarks, or practices used in labelling or advertising liable to mislead the consumer or user by suggesting that a product or its ingredients satisfy the requirements set out under this Regulation shall not be used.

3. The terms referred to in paragraph 1 shall not be used for a product for which it has to be indicated in the labelling or advertising that it contains GMOs, consists of GMOs or is produced from GMOs according to Community provisions.

4. As regards processed food, the terms referred to in paragraph 1 may be used:

(a) in the sales description, provided that:

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(i) the processed food complies with Article 19;

(ii) at least 95 % by weight, of its ingredients of agricultural origin are organic;

(b) only in the list of ingredients, provided that the food complies with Article 19(1), 19(2)(a), 19(2)(b) and 19(2)(d);

(c) in the list of ingredients and in the same visual field as the sales description, provided that:

(i) the main ingredient is a product of hunting or fishing;

(ii) it contains other ingredients of agricultural origin that are all organic;

(iii) the food complies with Article 19(1), 19(2)(a), 19(2)(b) and 19(2)(d).

The list of ingredients shall indicate which ingredients are organic.

In the case where points (b) and (c) of this paragraph apply, the references to the organic production method may only appear in relation to the organic ingredients and the list of ingredients shall include an indication of the total percentage of organic ingredients in proportion to the total quantity of ingredients of agricultural origin.

The terms and the indication of percentage referred to in the previous subparagraph shall appear in the same colour, identical size and style of lettering as the other indications in the list of ingredients.

5. Member States shall take the measures necessary to ensure compliance with this Article.

6. The Commission may in accordance

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with the procedure referred to in Article 37(2) adapt the list of terms set out in the Annex.

Article 24 Compulsory indications 1. Where terms as referred to in Article 23(1) are used:

(a) the code number referred to in Article 27(10) of the control authority or control body to which the operator who has carried out the most recent production or preparation operation is subject, shall also appear in the labelling;

(b) the Community logo referred to in Article 25(1) as regards pre-packaged food shall also appear on the packaging;

(c) where the Community logo is used, an indication of the place where the agricultural raw materials of which the product is composed have been farmed, shall also appear in the same visual field as the logo and shall take one of the following forms, as appropriate:

- "EU Agriculture", where the agricultural raw material has been farmed in the EU,

- "non-EU Agriculture", where the agricultural raw material has been farmed in third countries,

- "EU/non-EU Agriculture", where part of the agricultural raw materials has been farmed in the Community and a part of it has been farmed in a third country.

The abovementioned indication "EU" or "non-EU" may be replaced or supplemented by a country in the case where all agricultural raw materials of which the product is composed have been farmed in that country.

For the abovementioned "EU" or "non-EU" indication, small quantities by weight of ingredients may be disregarded provided that the total quantity of the disregarded ingredients does not exceed 2 % of the total quantity by weight of raw materials of agricultural origin.

The abovementioned "EU" or "non-EU" indication shall not appear in a colour, size and style of lettering more prominent than the sales description of the product.

The use of the Community logo as referred to in Article 25(1) and the indication referred to in the first subparagraph shall be optional for products imported from third countries. However, where the Community logo as referred to in Article 25(1) appears in the labelling, the indication referred to in the first subparagraph shall also appear in the labelling.

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2. The indications referred to in paragraph 1 shall be marked in a conspicuous place in such a way as to be easily visible, clearly legible and indelible.

3. The Commission shall, in accordance with the procedure referred to in Article 37(2), lay down specific criteria as regards the presentation, composition and size of the indications referred to in paragraph 1(a) and (c).

Article 25 Organic production logos 1. The Community organic production logo may be used in the labelling, presentation and advertising of products which satisfy the requirements set out under this Regulation.

The Community logo shall not be used in the case of in-conversion products and food as referred to in Article 23(4)(b) and (c).

2. National and private logos may be used in the labelling, presentation and advertising of products which satisfy the requirements set out under this Regulation.

3. The Commission shall, in accordance with the procedure referred to in Article 37(2), lay down specific criteria as regards presentation, composition, size and design of the Community logo.

Article 26 Specific labelling requirements The Commission shall in accordance with the procedure referred to in Article 37(2) establish specific labelling and composition requirements applicable to:

(a) organic feed;

(b) in-conversion products of plant origin;

(c) vegetative propagating material and seeds for cultivation.

TITLE V CONTROLS Article 27 Control system 1. Member States shall set up a system of controls and designate one or more competent authorities responsible for controls in respect of the obligations established by this Regulation in conformity with Regulation (EC) No 882/2004.

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2. In addition to the conditions laid down in Regulation (EC) No 882/2004, the control system set up under this Regulation shall comprise at least the application of precautionary and control measures to be adopted by the Commission in accordance with the procedure referred to in Article 37(2).

3. In the context of this Regulation the nature and frequency of the controls shall be determined on the basis of an assessment of the risk of occurrence of irregularities and infringements as regards compliance with the requirements laid down in this Regulation. In any case, all operators with the exception of wholesalers dealing only with pre-packaged products and operators selling to the final consumer or user as described in Article 28(2), shall be subject to a verification of compliance at least once a year.

4. The competent authority may:

(a) confer its control competences to one or more other control authorities. Control authorities shall offer adequate guarantees of objectivity and impartiality, and have at their disposal the qualified staff and resources necessary to carry out their functions;

(b) delegate control tasks to one or more control bodies. In that case, the Member States shall designate authorities responsible for the approval and supervision of such bodies.

5. The competent authority may delegate control tasks to a particular control body only if the conditions laid down in Article 5(2) of Regulation (EC) No 882/2004 are satisfied, and in particular where:

(a) there is an accurate description of the tasks that the control body may carry out and of the conditions under which it may carry them out;

(b) there is proof that the control body:

(i) has the expertise, equipment and infrastructure required to carry out the tasks delegated to it;

(iii) has a sufficient number of suitable qualified and experienced staff; and

(iii) is impartial and free from any conflict of interest as regards the exercise of the tasks delegated to it;

(c) the control body is accredited to the most recently notified version, by a publication in the C series of the Official Journal of the European Union, of European Standard EN 45011 or ISO Guide 65 (General requirements for bodies operating product certification systems), and is approved by the competent authorities;

(d) the control body communicates the results of the controls carried out to the competent authority on a regular basis and whenever the competent

40

authority so requests. If the results of the controls indicate non-compliance or point to the likelihood of non-compliance, the control body shall immediately inform the competent authority;

(e) there is an effective coordination between the delegating competent authority and the control body.

6. In addition to the provisions of paragraph 5, the competent authority shall take into account the following criteria whilst approving a control body:

(a) the standard control procedure to be followed, containing a detailed description of the control measures and precautions that the body undertakes to impose on operators subject to its control;

(b) the measures that the control body intends to apply where irregularities and/or infringements are found.

7. The competent authorities may not delegate the following tasks to the control bodies;

(a) the supervision and audit of other control bodies;

(b) the competence to grant exceptions, as referred to in Article 22, unless this is provided for in the specific conditions laid down by the Commission in accordance with Article 22(3).

8. In accordance with Article 5(3) of Regulation (EC) No 882/2004, competent authorities delegating control tasks to control bodies shall organise audits or inspections of control bodies as necessary. If, as a result of an audit or an inspection, it appears that such bodies are failing to carry out properly the tasks delegated to them, the delegating competent authority may withdraw the delegation. It shall withdraw it without delay if the control body fails to take appropriate and timely remedial action.

9. In addition to the provisions of paragraph 8, the competent authority shall:

(a) ensure that the controls carried out by the control body are objective and independent;

(b) verify the effectiveness of its controls;

(c) take cognisance of any irregularities or infringements found and corrective measures applied;

(d) withdraw approval of that body where it fails to satisfy the requirements referred to in (a) and (b) or no longer fulfils the criteria indicated in paragraph 5, 6 or fails to satisfy the requirements laid down in paragraphs 11, 12 and 14.

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10. Member States shall attribute a code number to each control authority or control body performing control tasks as referred to in paragraph 4.

11. Control authorities and control bodies shall give the competent authorities access to their offices and facilities and provide any information and assistance deemed necessary by the competent authorities for the fulfilment of their obligations according to this Article.

12. The control authorities and control bodies shall ensure that at least the precautionary and control measures referred to in paragraph 2 are applied to operators subject to their control.

13. Member States shall ensure that the control system as set up allows for the traceability of each product at all stages of production, preparation and distribution in accordance with Article 18 of Regulation (EC) No 178/2002, in particular, in order to give consumers guarantees that organic products have been produced in compliance with the requirements set out in this Regulation.

14. By 31 January each year at the latest the control authorities and control bodies shall transmit to the competent authorities a list of the operators which were subject to their controls on 31 December of the previous year. A summary report of the control activities carried out during the previous year shall be provided by 31 March each year.

Article 28 Adherence to the control system 1. Any operator who produces, prepares, stores, or imports from a third country products in the meaning of Article 1(2) or who places such products on the market shall, prior to placing on the market of any products as organic or in conversion to organic:

(a) notify his activity to the competent authorities of the Member State where the activity is carried out;

(b) submit his undertaking to the control system referred to in Article 27.

The first subparagraph shall apply also to exporters who export products produced in compliance with the production rules laid down in this Regulation.

Where an operator contracts out any of the activities to a third party, that operator shall nonetheless be subject to the requirements referred to in points (a) and (b), and the subcontracted activities shall be subject to the control system.

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2. Member States may exempt from the application of this Article operators who sell products directly to the final consumer or user provided they do not produce, prepare, store other than in connection with the point of sale or import such products from a third country or have not contracted out such activities to a third party.

3. Member States shall designate an authority or approve a body for the reception of such notifications.

4. Member States shall ensure that any operator who complies with the rules of this Regulation, and who pays a reasonable fee as a contribution to the control expenses, is entitled to be covered by the control system.

5. The control authorities and control bodies shall keep an updated list containing the names and addresses of operators under their control. This list shall be made available to the interested parties.

6. The Commission, in accordance with the procedure referred to in Article 37(2), shall adopt implementing rules to provide details of the notification and submission procedure referred to in paragraph 1 of this Article in particular with regard to the information included in the notification referred to in paragraph 1(a) of this Article.

Article 29 Documentary evidence 1. The control authorities and the control bodies referred to in Article 27(4) shall provide documentary evidence to any such operator who is subject to their controls and who in the sphere of his activities, meets the requirements laid down in this Regulation. The documentary evidence shall at least permit the identification of the operator and the type or range of products as well as the period of validity.

2. The operator shall verify the documentary evidence of his suppliers.

3. The form of the documentary evidence referred to in paragraph 1 shall be drawn up in accordance with the procedure referred to in Article 37(2), taking into account the advantages of electronic certification.

Article 30 Measures in case of infringements and irregularities 1. Where an irregularity is found as regards compliance with the requirements laid down in this Regulation, the control authority or control body shall ensure that no reference to the organic production method is made in the labelling and advertising of the entire lot or production run affected by this irregularity, where this would be proportionate to the

43

relevance of the requirement that has been violated and to the nature and particular circumstances of the irregular activities.

Where a severe infringement or an infringement with prolonged effect is found, the control authority or control body shall prohibit the operator concerned from marketing products which refer to the organic production method in the labelling and advertising for a period to be agreed with the competent authority of the Member State.

2. Information on cases of irregularities or infringements affecting the organic status of a product shall be immediately communicated between the control bodies, control authorities, competent authorities and Member States concerned and, where appropriate, to the Commission.

The level of communication shall depend on the severity and the extent of the irregularity or infringement found.

The Commission may, in accordance with the procedure referred to in Article 37(2), lay down specifications regarding the form and modalities of such communications.

Article 31 Exchange of information Upon a request duly justified by the necessity to guarantee that a product has been produced in accordance with this Regulation, the competent authorities, control authorities and the control bodies shall exchange relevant information on the results of their controls with other competent authorities, control authorities and control bodies. They may also exchange such information on their own initiative.

TITLE VI TRADE WITH THIRD COUNTRIES Article 32 Import of compliant products 1. A product imported from a third country may be placed on the Community market as organic provided that:

(a) the product complies with the

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provisions set out in Titles II, III and IV as well as with the implementing rules affecting its production adopted pursuant to this Regulation;

(b) all operators, including the exporters, have been subject to control by a control authority or control body recognised in accordance with paragraph 2;

(c) the operators concerned shall be able to provide at any time, to the importers or the national authorities, documentary evidence as referred to in Article 29, permitting the identification of the operator who carried out the last operation and the verification of compliance by that operator with points (a) and (b), issued by the control authority or control body referred to in point (b).

2. The Commission shall, in accordance with the procedure referred to in Article 37(2), recognise the control authorities and control bodies referred to in paragraph 1(b) of this Article, including control authorities and control bodies as referred to in Article 27, which are competent to carry out controls and to issue the documentary evidence referred to in paragraph 1(c) of this Article in third countries, and establish a list of these control authorities and control bodies.

The control bodies shall be accredited to the most recently notified version, by a publication in the C series of the Official Journal of the European Union, of European Standard EN 45011 or ISO Guide 65 (General requirements for bodies operating product certification systems). The control bodies shall undergo regular on-the-spot evaluation, surveillance and multiannual re-assessment of their activities by the accreditation body.

When examining requests for recognition, the Commission shall invite the control authority or control body to supply all the necessary information. The Commission may also entrust experts with the task of examining on-the-spot the rules of production and the control activities carried out in the third country by the control authority or control body concerned.

The recognised control bodies or control authorities shall provide the assessment reports issued by the accreditation body or, as appropriate, the competent authority on the regular on-the-spot evaluation, surveillance and multiannual re-assessment of their activities.

Based on the assessment reports, the Commission assisted by the Member States shall ensure appropriate supervision of the recognised control authorities and control bodies by regularly reviewing their recognition. The nature of the supervision shall be determined on the basis of an assessment of the risk of the occurrence of irregularities or infringements of the provisions set out in this Regulation.

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Article 33 Import of products providing equivalent guarantees 1. A product imported from a third country may also be placed on the Community market as organic provided that:

(a) the product has been produced in accordance with production rules equivalent to those referred to in Titles III and IV;

(b) the operators have been subject to control measures of equivalent effectiveness to those referred to in Title V and such control measures have been permanently and effectively applied;

(c) the operators at all stages of production, preparation and distribution in the third country have submitted their activities to a control system recognised in accordance with paragraph 2 or to a control authority or control body recognised in accordance with paragraph 3;

(d) the product is covered by a certificate of inspection issued by the competent authorities, control authorities or control bodies of the third country recognised in accordance with paragraph 2, or by a control authority or control body recognised in accordance with paragraph 3, which confirms that the product satisfies the conditions set out in this paragraph.

The original of the certificate referred to in this paragraph shall accompany the goods to the premises of the first consignee; thereafter the importer must keep the certificate at the disposal of the control authority or the control body for not less than two years.

2. The Commission may, in accordance with the procedure referred to in Article 37(2), recognise the third countries whose system of production complies with principles and production rules equivalent to those laid down in Titles II, III and IV and whose control measures are of equivalent effectiveness to those laid down in Title V, and establish a list of these countries. The assessment of equivalency shall take into account Codex Alimentarius guidelines CAC/GL 32.

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When examining requests for recognition, the Commission shall invite the third country to supply all the necessary information. The Commission may entrust experts with the task of examining on-the-spot the rules of production and the control measures of the third country concerned.

By 31 March of each year, the recognised third countries shall send a concise annual report to the Commission regarding the implementation and the enforcement of the control measures established in the third country.

Based on the information in these annual reports, the Commission assisted by the Member States ensures appropriate supervision of the recognised third countries by regularly reviewing their recognition. The nature of the supervision shall be determined on the basis of an assessment of the risk of the occurrence of irregularities or infringements of the provisions set out in this Regulation.

3. For products not imported under Article 32 and not imported from a third country which is recognised under paragraph 2 of this Article, the Commission may, in accordance with the procedure referred to in Article 37(2), recognise the control authorities and control bodies, including control authorities and control bodies as referred to in Article 27, competent to carry out controls and issue certificates in third countries for the purpose of paragraph 1, and establish a list of these control authorities and control bodies. The assessment of equivalency shall take into account Codex Alimentarius guidelines CAC/GL 32.

The Commission shall examine any request for recognition lodged by a control authority or control body in a third country.

When examining requests for recognition, the Commission shall invite the control authority or control body to supply all the necessary information. The control body or the control authority shall undergo regular on-the-spot evaluation, surveillance and multiannual re-assessment of their activities by an accreditation body or, as appropriate, by a competent authority. The Commission may also entrust experts with the task of examining on-the-spot the rules of production and the control measures carried out in the third country by the control authority or control body concerned.

The recognised control bodies or control authorities shall provide the assessment reports issued by the accreditation body or, as appropriate, the competent authority on the regular on-the-spot evaluation, surveillance and multiannual re-assessment of their activities.

Based on these assessment reports, the Commission assisted by the Member States shall ensure appropriate supervision of recognised control authorities and control bodies by regularly reviewing their recognition. The

47

nature of the supervision shall be determined on the basis of an assessment of the risk of the occurrence of irregularities or infringements of the provisions set out in this Regulation.

TITLE VII FINAL AND TRANSITIONAL RULES Article 34 Free movement of organic products 1. Competent authorities, control authorities and control bodies may not, on grounds relating to the method of production, to the labelling or to the presentation of that method, prohibit or restrict the marketing of organic products controlled by another control authority or control body located in another Member State, in so far as those products meet the requirements of this Regulation. In particular, no additional controls or financial burdens in addition to those foreseen in Title V of this Regulation may be imposed.

2. Member States may apply stricter rules within their territory to organic plant and livestock production, where these rules are also applicable to non-organic production and provided that they are in conformity with Community law and do not prohibit or restrict the marketing of organic products produced outside the territory of the Member State concerned.

Article 35 Transmission of information to the Commission Members States shall regularly transmit the following information to the Commission:

(a) the names and addresses of the competent authorities and where appropriate their code numbers and their marks of conformity;

(b) lists of control authorities and bodies and their code numbers and, where appropriate, their marks of conformity. The Commission shall publish regularly the list of control authorities and bodies.

Article 36 Statistical information Member States shall transmit to the Commission the statistical information necessary for the implementation and follow-up of this Regulation. This statistical information shall be defined within the context of the Community Statistical Programme.

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Article 37 Committee on organic production 1. The Commission shall be assisted by a regulatory Committee on organic production.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.

The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.

Article 38 Implementing rules The Commission shall, in accordance with the procedure referred to in Article 37(2), and subject to the objectives and principles laid down in Title II, adopt detailed rules for the application of this Regulation. These shall include in particular the following:

(a) detailed rules as regards the production rules laid down in Title III, in particular as regards the specific requirements and conditions to be respected by operators;

(b) detailed rules as regards the labelling rules laid down in Title IV;

(c) detailed rules as regards the control system established under Title V, in particular as regards minimum control requirements, supervision and audit, the specific criteria for delegation of tasks to private control bodies the criteria for approval and withdrawal of such bodies and the documentary evidence referred to in Article 29;

(d) detailed rules as regards the rules on imports from third countries laid down in Title VI, in particular as regards the criteria and procedures to be followed with regard to the recognition under Article 32 and 33 of third countries and control bodies, including the publication of lists of recognised third countries and control bodies, and as regards the certificate referred to in Article 33(1) point (d) taking into account the advantages of electronic certification;

(e) detailed rules as regards the free movement of organic products laid down in Article 34 and the transmission of information to the Commission in Article 35.

Article 39 Repeal of Regulation (EEC) No 2092/91 1. Regulation (EEC) No 2092/91 is hereby repealed as from 1 January 2009.

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2. References to the repealed Regulation (EEC) No 2092/91 shall be construed as references to this Regulation.

Article 40 Transitional measures Where necessary, measures to facilitate the transition from the rules established by Regulation (EEC) No 2092/91 to this Regulation shall be adopted in accordance with the procedure referred to in Article 37(2).

Article 41 Report to the Council 1. By 31 December 2011, the Commission shall submit a report to the Council.

2. The report shall, in particular, review the experience gained from the application of this Regulation and consider in particular the following issues:

(a) the scope of this Regulation, in particular as regards organic food prepared by mass caterers;

(b) the prohibition on the use of GMOs, including the availability of products not produced by GMOs, the vendor declaration, the feasibility of specific tolerance thresholds and their impact on the organic sector;

(c) the functioning of the internal market and controls system, assessing in particular that the established practices do not lead to unfair competition or barriers to the production and marketing of organic products.

3. The Commission shall, if appropriate, accompany the report with relevant proposals.

Article 42 Entry into force and application This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Union.

For certain animal species, certain aquatic plants and certain micro algae, where the detailed production rules are not laid down, the rules provided for labelling in Article 23 and for the controls in Title V shall apply. Pending the inclusion of detailed production rules, national rules or, in the absence thereof, private standards accepted or recognised by the Member States shall apply.

It shall apply as from 1 January 2009.

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This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Luxembourg, 28 June 2007.

For the Council

The President

S. Gabriel

[1] Opinion delivered on 22 May 2007 (not yet published in the Official Journal).

[2] OJ L 198, 22.7.1991, p. 1. Regulation as last amended by Commission Regulation (EC) No 394/2007 (OJ L 98, 13.4.2007, p. 3).

[3] OJ L 165, 30.4.2004, p. 1. Corrected by OJ L 191, 28.5.2004, p. 1.

[4] OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

[5] OJ L 223, 15.8.2006, p. 1.

[6] OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).

[7] OJ L 109, 6.5.2000, p. 29. Directive as last amended by Commission Directive 2006/142/EC (OJ L 368, 23.12.2006, p. 110).

[8] OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/31/EC (OJ L 140, 1.6.2007, p. 44).

[9] OJ L 106, 17.4.2001, p. 1. Regulation as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

[10] OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

[11] OJ L 159, 29.6.1996, p. 1.

[12] OJ L 66, 13.3.1999, p. 16. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

[13] OJ L 358, 31.12.2002, p. 59.

[14] OJ L 268, 18.10.2003, p. 1. Regulation as amended by Commission Regulation (EC) No 1981/2006 (OJ L 368, 23.12.2006, p. 99).

[15] OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).

[16] OJ L 376, 27.12.2006, p. 14.

[17] OJ L 139, 30.4.2004, p. 206. Corrected version in OJ L 226, 25.6.2004, p. 83.

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ANNEX TERMS REFERRED TO IN ARTICLE 23(1)

BG: биологичен.

ES: ecológico, biológico.

CS: ekologické, biologické.

DA: økologisk.

DE: ökologisch, biologisch.

ET: mahe, ökoloogiline.

EL: βιολογικό.

EN: organic.

FR: biologique.

GA: orgánach.

IT: biologico.

LV: bioloģisks, ekoloģisks.

LT: ekologiškas.

LU: biologesch.

HU: ökológiai.

MT: organiku.

NL: biologisch.

PL: ekologiczne.

PT: biológico.

RO: ecologic.

SK: ekologické, biologické.

SL: ekološki.

FI: luonnonmukainen.

SV: ekologisk.

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Managed by the Publications Office Important legal notice

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Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control

Official Journal L 250 , 18/09/2008 P. 0001 - 0084

Commission Regulation (EC) No 889/2008

of 5 September 2008

laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 [1], and in particular Article 9(4), the second paragraph of Article 11 Articles 12(3), 14(2), 16(3)(c), 17(2) and 18(5), the second subparagraph of Article 19(3), Articles 21(2), 22(1), 24(3), 25(3), 26, 28(6), 29(3) and 38(a), (b), (c) and (e), and Article 40 thereof,

Whereas:

(1) Regulation (EC) No 834/2007, and in particular Titles III, IV and V thereof, lay down basic requirements with regard to production, labelling and control of organic products in the plant and livestock sector. Detailed rules for the implementation of those requirements should be laid down.

(2) The evolution of new detailed production rules on certain animal species, organic aquaculture, seaweed and yeasts used as food or feed on community level will require more time and therefore should be elaborated in a subsequent procedure. It is therefore appropriate to exclude those products from the scope of this Regulation. However, as regards certain livestock species, aquaculture products and seaweed, the Community rules provided for production, controls and labelling should apply mutatis mutandis to those products, in accordance with Article 42 of Regulation (EC) No 834/2007.

(3) Certain definitions should be laid down in order to avoid ambiguities and to guarantee the uniform application of the organic production rules.

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(4) Organic plant production is based on nourishing the plants primarily through the soil ecosystem. Therefore hydroponic cultivation, where plants grow with their roots in an inert medium feed with soluble minerals and nutrients, should not be allowed.

(5) Organic plant production involves varied cultivation practices and limited use of fertilisers and conditioners of low solubility, therefore these practices should be specified. In particular, conditions for the use of certain non-synthetic products should be laid down.

(6) The use of pesticides, which may have detrimental effects on the environment or result in the presence of residues in agricultural products, should be significantly restricted. Preference should be given to the application of preventive measures in pest, disease and weed control. In addition, conditions for the use of certain plant protection products should be laid down.

(7) For the purpose of organic farming, the use of certain plant protection products, fertilisers, soil conditioners, as well as certain non-organic feed materials, feed additives and feed processing aids and certain products used for cleaning and disinfection was allowed under Council Regulation (EEC) No 2092/91 [2] under well-defined conditions. For the sake of ensuring the continuity of organic farming the products and substances in question should, in accordance with the provisions laid down in Article 16(3)(c) of Regulation (EC) No 834/2007, continue to be allowed. Moreover, for the sake of clarity, it is appropriate to list in the Annexes to this Regulation the products and substances which had been allowed under Regulation (EEC) No 2092/91. Other products and substances may be added to these lists in the future under a different legal basis, namely Article 16(1) of Regulation (EC) No 834/2007. It is therefore appropriate to identify the distinct status of each category of products and substances by means of a symbol in the list.

(8) The holistic approach of organic farming requires a livestock production related to the land, where the produced manure is used to nourish the crop production. Since livestock farming always implies the management of agricultural land, provision should be made to prohibit landless livestock production. In organic livestock production the choice of breeds should take account of their capacity to adapt to local conditions, their vitality and their resistance to disease and a wide biological diversity should be encouraged.

(9) Under certain circumstances operators may face difficulties in obtaining organic breeding animals from a reduced gene pool, which would hamper the development of the sector. Therefore the possibility of bringing a

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limited number of non-organic animals onto a farm for breeding purposes should be provided for.

(10) Organic stock farming should ensure that specific behavioural needs of animals are met. In this regard, housing for all species of livestock should satisfy the needs of the animals concerned as regards ventilation, light, space and comfort and sufficient area should accordingly be provided to permit ample freedom of movement for each animal and to develop the animal's natural social behaviour. Specific housing conditions and husbandry practices with regard to certain animals, including bees, should be laid down. These specific housing conditions should serve a high level of animal welfare, which is a priority in organic livestock farming and therefore may go beyond Community welfare standards which apply to farming in general. Organic husbandry practices should prevent poultry from being reared too quickly. Therefore specific provisions to avoid intensive rearing methods should be laid down. In particular poultry shall either be reared until they reach a minimum age or else shall come from slow-growing poultry strains, so that in either case there is no incentive to use intensive rearing methods.

(11) In most cases, livestock should have permanent access to open air areas for grazing, weather conditions permitting, and such open air areas should in principle be organised under an appropriate system of rotation.

(12) In order to avoid environmental pollution of natural resources such as soil and water by nutrients, an upper limit for the use of manure per hectare and for keeping livestock per hectare should be set. This limit should be related to the nitrogen content of the manure.

(13) Mutilations which lead to stress, harm, disease or the suffering of animals should be banned. However, specific operations essential to certain types of production and for the sake of security for animals and human beings may be permitted under restricted conditions.

(14) Livestock should be fed on grass, fodder and feedingstuffs produced in accordance with the rules of organic farming, preferably coming from the own holding, by taking into account their physiological needs. In addition, in order to provide for the basic nutritional requirements of livestock, certain minerals, trace elements and vitamins may need to be used under well-defined conditions.

(15) Since the existing regional differences in the possibility for organic ruminants to obtain the necessary essential vitamins A, D and E through their feed rations, as regards climate and available sources of feed, are

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expected to persist, the use of such vitamins for ruminants should be allowed.

(16) Animal-health management should mainly be based on prevention of disease. In addition specific cleaning and disinfection measures should be applied.

(17) The preventive use of chemically-synthesised allopathic medicinal products is not permitted in organic farming. However, in the event of a sickness or injury of an animal requiring an immediate treatment, the use of chemically-synthesised allopathic medicinal products should be limited to a strict minimum. Furthermore, in order to guarantee the integrity of organic production for consumers it should be possible to take restrictive measures such as doubling the withdrawal period after use of chemically synthesised allopathic medicinal products.

(18) Specific rules for disease prevention and veterinary treatment in beekeeping should be laid down.

(19) Provision should be made to require operators producing feed or food to take account of appropriate procedures based on a systematic identification of critical processing steps in order to ensure that the produced processed products comply with the organic production rules.

(20) Certain non-organic products and substances are needed in order to ensure the production of certain processed organic food and feed. The harmonization of wine processing rules on Community level will require more time. Therefore the mentioned products should be excluded for wine processing until, in a subsequent procedure, specific rules are laid down.

(21) For the purpose of processing organic food, the use of certain ingredients of non-agricultural origin, certain food processing aid and certain non-organic ingredients of agricultural origin was allowed under Regulation (EEC) No 2092/91 under well-defined conditions. For the sake of ensuring the continuity of organic farming the products and substances in question should, in accordance with the provisions laid down in Article 21(2) of Regulation (EC) No 834/2007, continue to be allowed. Moreover, for the sake of clarity, it is appropriate to list in the Annexes to this Regulation the products and substances which had been allowed under Regulation (EEC) No 2092/91. Other products and substances may be added to these lists in the future under a different legal basis, namely Article 21(2) of Regulation (EC) No 834/2007. It is therefore appropriate to identify the distinct status of each category of products and substances by means of a symbol in the list.

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(22) Under certain conditions organic products and non-organic products can be collected and transported simultaneously. In order to duly separate organic from non-organic products during handling and to avoid any commingling specific provisions should be laid down.

(23) The conversion to the organic production method requires certain periods of adaptation of all means in use. Depending on the previous farm production, specific time periods for the various production sectors should be laid down.

(24) In accordance with Article 22 of Regulation (EC) No 834/2007, specific conditions for the application of exceptions provided for in that Article should be laid down. It is appropriate to set out such conditions with regard to the non availability of organic animals, feed, beeswax, seeds and seed potatoes and organic ingredients as well as to specific problems related to the livestock management and in the case of catastrophic circumstances.

(25) Geographical and structural differences in agriculture and climatic constraints may hamper the development of organic production in certain regions and therefore call for exceptions for certain practices as regards the characteristics of livestock buildings and installations. Therefore tethering of animals should, under well-defined conditions, be allowed in holdings which, due to their geographical location and structural constraints, in particular with regard to mountainous areas, are of small size, and only where it is not possible to keep the cattle in groups appropriate to their behavioural needs.

(26) For the purpose of ensuring the development of an incipient organic livestock sector, several temporary derogations as regards tethering of animals, housing conditions for animals and stocking densities were granted under Regulation (EEC) No 2092/91. These derogations should, on a transitional basis, be maintained until their expiry date, in order not to disrupt the organic livestock sector.

(27) Considering the importance of pollination of the organic beekeeping sector it should be possible to grant exceptions permitting the parallel production of organic and non-organic beekeeping unit on the same farm.

(28) Under certain circumstances, farmers may experience difficulty in securing supplies of organically reared livestock and organic feedingstuffs and therefore authorisation should be granted for a limited number of non-organically produced farm input to be used in restricted quantities.

(29) Major efforts have been undertaken by producers involved in organic production for the development of the production of organic seeds and

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vegetative materials in order to establish a broad choice of plant varieties of plant species for which organic seeds and vegetative propagating material is available. However, currently for many species there is still not enough organic seed and vegetative propagating material available and, in those cases, the use of non-organic seed and vegetative propagating material should be allowed.

(30) In order to help operators to find organic seed and seed potatoes, each Member State should ensure that a database is set up that contains the varieties of which organic seed and seed potatoes are available on the market.

(31) The management of adult bovine animals may endanger the keeper and other persons handling the animals. Therefore provision should be made to allow for exceptions to be granted during the final fattening phase of mammals, in particular with regard to bovine animals.

(32) Catastrophic circumstances or widespread animal or plant diseases may have serious effects on the organic production in the regions concerned. Appropriate measures need to be taken to ensure the maintenance of farming or even the reestablishment of farming. Therefore the supply of non-organic animals, or non-organic feed should be made possible for a limited period in the affected areas.

(33) In accordance with Articles 24(3) and 25(3) of Regulation (EC) No 834/2007, specific criteria as regards the presentation, composition, size and design of the Community logo, as well as the presentation and composition of the code number of the control authority or control body and of the indication of the place where the agricultural product has been farmed should be laid down.

(34) In accordance with Article 26 of Regulation (EC) No 834/2007, specific requirements for the labelling of organic feed should be laid down taking into account the varieties and composition of feed and the horizontal labelling provisions applicable to feed.

(35) In addition to the control system based on the Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules [3] specific control measures should be laid down. In particular, detailed requirements with regard to all stages of production, preparation and distribution related to organic products.

(36) Notifications of information by the Member States to the Commission must enable it to use the information sent directly and as effectively as

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possible for the management of statistical information and referential data. To achieve this objective, all information to be made available or to be communicated between the Member States and the Commission should be sent electronically or in digital form.

(37) Exchanges of information and documents between the Commission and the Member States, and the provision and notification of information from the Member States to the Commission are generally carried out electronically or in digital form. In order to improve the way such exchanges of information under organic production rules are dealt with and to extend their use, it is necessary to adapt the existing computer systems or set up new ones. Provision should be made for this to be done by the Commission and implemented after informing the Member States via the Committee on organic production.

(38) The conditions under which information is processed by these computer systems and the form and content of documents which have to be communicated under Regulation (EC) No 834/2007 have to be adjusted frequently in line with changes to the applicable rules or management requirements. Uniform presentation of the documents to be sent in by the Member States is also necessary. To achieve these objectives and to simplify procedures and ensure that the computer systems concerned can be made operational immediately, the form and content of the documents should be laid down on the basis of models or questionnaires, which should be adapted and updated by the Commission after informing the Committee on organic production.

(39) Transitional measures should be laid down, for certain provisions established under Regulation (EEC) No 2092/91, in order not to jeopardize the continuity of the organic production.

(40) Commission Regulation (EEC) No 207/93 of 29 January 1993 defining the content of Annex VI to Regulation (EEC) No 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs and laying down detailed rules for implementing the provisions of Article 5(4) thereto [4] Commission Regulation (EC) No 1452/2003 of 14 August 2003 maintaining the derogation provided for in Article 6(3)(a) of Council Regulation (EEC) No 2092/91 with regard to certain species of seed and vegetative propagating material and laying down procedural rules and criteria relating to that derogation [5] and Commission Regulation (EC) No 223/2003 of 5 February 2003 on labelling requirements related to the organic production method for feedingstuffs, compound feedingstuffs and feed materials and

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amending Council Regulation (EEC) No 2092/91 [6] should be repealed and replaced by a new Regulation.

(41) Regulation (EEC) No 2092/91 is repealed by Regulation (EC) No 834/2007 with effect from 1 January 2009. However, many of its provisions should, with some adaptation, continue to apply and should therefore be adopted in the framework of this Regulation. For the sake of clarity it is appropriate to set out the correlation between those provisions of Regulation (EEC) No 2092/91 and the provisions of this Regulation.

(42) The measures provided for in this Regulation are in accordance with the opinion of the regulatory Committee on organic production,

HAS ADOPTED THIS REGULATION: Content Title I Introductory provisions Title II Rules on production, processing, packaging, transport and storage of products Chapter 1 Plant production Chapter 2 Livestock production Section 1 Origin of animals Section 2 Livestock housing and husbandry practices Section 3 Feed Section 4 Disease prevention and veterinary treatment Chapter 3 Processed products Chapter 4 Collection, packaging, transport, storage of products Chapter 5 Conversion rules Chapter 6 Exceptional production rules Section 1 Climatic, geographical or structural constraints Section 2 Non-availability of organic farm input Section 3 Specific management problems in organic livestock Section 4 Catastrophic circumstances Chapter 7 Seed data base Title III Labelling Chapter 1 Community logo Chapter 2 Specific labelling requirements for feed Chapter 3 Other specific labelling requirements Title IV Controls Chapter 1 Minimum control requirements Chapter 2 Control requirements for plants and plant products Chapter 3 Control requirements for livestock and livestock products Chapter 4 Control requirements for preparation of products Chapter 5 Control requirements for imports

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Chapter 6 Control requirements for units using contracts to third parties Chapter 7 Control requirements for units preparing feed Chapter 8 Infringements and exchange of information Title V Transmission of information to the Commission, transitional and final provisions Chapter 1 Transmission of information to the Commission Chapter 2 Transitional and final provisions

TITLE I INTRODUCTORY PROVISIONS Article 1 Subject matter and scope 1. This Regulation lays down specific rules on organic production, labelling and control in respect of products referred to in Article 1(2) of Regulation (EC) No 834/2007.

2. This Regulation shall not apply to the following products:

(a) products originating from aquaculture;

(b) seaweed;

(c) livestock species other than those referred to in Article 7;

(d) yeasts used as food or feed.

However, Title II, Title III and Title IV shall apply mutatis mutandis to products referred to in points (a), (b) and (c) of the first subparagraph until detailed production rules for those products are laid down on the basis of Regulation (EC) No 834/2007.

Article 2 Definitions In addition to the definitions laid down in Article 2 of Regulation (EC) No 834/2007, the following definitions shall apply for the purposes of this Regulation:

(a) "non-organic": means not coming from or not related to a production in accordance to Regulation (EC) No 834/2007 and this Regulation;

(b) "veterinary medicinal products": means products as defined in Article 1(2) of Directive 2001/82/EC of the European Parliament and of the Council [7] concerning the Community code relating to veterinary medicinal products

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(c) "importer": means the natural or legal person within the community who presents a consignment for release for free circulation into the Community, either in person, or through a representative;

(d) "first consignee" means the natural or legal person to whom the imported consignment is delivered and who will receive it for further preparation and/or marketing;

(e) "holding" means all the production units operated under a single management for the purpose of producing agricultural products;

(f) "production unit" meaning all assets to be used for a production sector such as production premises, land parcels, pasturages, open air areas, livestock buildings, the premises for the storage of crops, crop products, livestock products, raw materials and any other input relevant for this specific production sector;

(g) "hydroponic production" means the method of growing plants with their roots in a mineral nutrient solution only or in an inert medium, such as perlite, gravel or mineral wool to which a nutrient solution is added;

(h) "veterinary treatment" means all courses of a curative or preventive treatment against one occurrence of a specific disease;

(i) "in-conversion feedingstuffs" means feedingstuffs produced during the conversion period to organic production, with the exclusion of those harvested in the 12 months following the beginning of the conversion as referred to in Article 17(1)(a) of Regulation (EC) No 834/2007.

TITLE II RULES ON PRODUCTION, PROCESSING, PACKAGING, TRANSPORT AND STORAGE OF ORGANIC PRODUCTS CHAPTER 1 Plant Production Article 3 Soil management and fertilisation 1. Where the nutritional needs of plants cannot be met by measures provided for in Article 12(1)(a), (b) and (c) of Regulation (EC) No 834/2007, only fertilisers and soil conditioners referred to in Annex I to this Regulation may be used in organic production and only to the extent necessary. Operators shall keep documentary evidence of the need to use the product.

2. The total amount of livestock manure, as defined in Council Directive 91/676/EEC [8] concerning the protection of waters against pollution

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caused by nitrates from agricultural sources, applied on the holding may not exceed 170 kg of nitrogen per year/hectare of agricultural area used. This limit shall only apply to the use of farmyard manure, dried farmyard manure and dehydrated poultry manure, composted animal excrements, including poultry manure, composted farmyard manure and liquid animal excrements.

3. Organic-production holdings may establish written cooperation agreements exclusively with other holdings and enterprises which comply with the organic production rules, with the intention of spreading surplus manure from organic production. The maximum limit as referred to in paragraph 2, shall be calculated on the basis of all of the organic-production units involved in such cooperation.

4. Appropriate preparations of micro-organisms may be used to improve the overall condition of the soil or the availability of nutrients in the soil or in the crops.

5. For compost activation appropriate plant-based preparations or preparations of micro-organisms may be used.

Article 4 Prohibition of hydroponic production Hydroponic production is prohibited.

Article 5 Pest, disease and weed management 1. Where plants cannot be adequately protected from pests and diseases by measures provided for in Article 12 (1)(a), (b), (c) and (g) of Regulation (EC) No 834/2007, only products referred to in Annex II to this Regulation may be used in organic production. Operators shall keep documentary evidence of the need to use the product.

2. For products used in traps and dispensers, except pheromone dispensers, the traps and/or dispensers, shall prevent the substances from being released into the environment and prevent contact between the substances and the crops being cultivated. The traps shall be collected after use and disposed off safely.

Article 6 Specific rules on mushroom production For production of mushrooms, substrates may be used, if they are composed only of the following components:

(a) farmyard manure and animal excrements:

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(i) either from holdings producing according to the organic production method;

(ii) or referred to in Annex I, only when the product referred to in point (i) is not available; and when they do not exceed 25 % of the weight of total components of the substrate, excluding the covering material and any added water, before composting;

(b) products of agricultural origin, other than those referred to in point (a), from holdings producing according to organic production method;

(c) peat not chemically treated;

(d) wood, not treated with chemical products after felling;

(e) mineral products referred to in Annex I, water and soil.

CHAPTER 2 Livestock production Article 7 Scope This Chapter lays down detailed production rules for the following species: bovine including bubalus and bison, equidae, porcine, ovine, caprine, poultry (species as mentioned in Annex III) and bees.

Section 1 Origin of animals Article 8 Origin of organic animals 1. In the choice of breeds or strains, account shall be taken of the capacity of animals to adapt to local conditions, their vitality and their resistance to disease. In addition, breeds or strains of animals shall be selected to avoid specific diseases or health problems associated with some breeds or strains used in intensive production, such as porcine stress syndrome, PSE Syndrome (pale-soft-exudative), sudden death, spontaneous abortion and difficult births requiring caesarean operations. Preference is to be given to indigenous breeds and strains.

2. For bees, preference shall be given to the use of Apis mellifera and their local ecotypes.

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Article 9 Origin of non-organic animals 1. In accordance with Article 14(1)(a)(ii) of Regulation (EC) No 834/2007, non-organic animals may be brought onto a holding for breeding purposes, only when organic animals are not available in sufficient number and subject to the conditions provided for in paragraphs 2 to 5 of this Article.

2. Non-organic young mammals, when a herd or flock is constituted for the first time, shall be reared in accordance with the organic production rules immediately after they are weaned. Moreover, the following restrictions shall apply at the date on which the animals enter the herd:

(a) buffalo, calves and foals shall be less than six months old;

(b) lambs and kids shall be less than 60 days old;

(c) piglets shall weigh less than 35 kg.

3. Non-organic adult male and nulliparous female mammals, for the renewal of a herd or flock, shall be reared subsequently in accordance with the organic production rules. Moreover, the number of female mammals is subject to the following restrictions per year:

(a) up to a maximum of 10 % of adult equine or bovine, including bubalus and bison species, livestock and 20 % of the adult porcine, ovine and caprine livestock, as female animals;

(b) for units with less than 10 equine or bovine animals, or with less than five porcine, ovine or caprine animals any renewal as mentioned above shall be limited to a maximum of one animal per year.

This provision of this paragraph will be reviewed in 2012 with a view to phase it out.

4. The percentages referred to in paragraph 3 may be increased up to 40 %, subject to prior authorisation by the competent authority, in the following special cases:

(a) when a major extension to the farm is undertaken;

(b) when a breed is changed;

(c) when a new livestock specialisation is initiated;

(d) when breeds are in danger of being lost to farming as laid down in Annex IV to Commission Regulation (EC) No 1974/2006 [9] and in that case animals of those breeds must not necessarily be nulliparous.

5. For the renovation of apiaries, 10 % per year of the queen bees and swarms may be replaced by non-organic queen bees and swarms in the

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organic production unit provided that the queen bees and swarms are placed in hives with combs or comb foundations coming from organic production units.

Section 2 Livestock housing and husbandry practices Article 10 Rules pertaining to housing conditions 1. Insulation, heating and ventilation of the building shall ensure that air circulation, dust level, temperature, relative air humidity and gas concentration, are kept within limits which are not harmful to the animals. The building shall permit plentiful natural ventilation and light to enter.

2. Housing for livestock shall not be mandatory in areas with appropriate climatic conditions to enable animals to live outdoors.

3. The stocking density in buildings shall provide for the comfort, the well being and the species-specific needs of the animals which, in particular, shall depend on the species, the breed and the age of the animals. It shall also take account of the behavioural needs of the animals, which depend in particular on the size of the group and the animals' sex. The density shall ensure the animals' welfare by providing them with sufficient space to stand naturally, lie down easily, turn round, groom themselves, assume all natural postures and make all natural movements such as stretching and wing flapping.

4. The minimum surface for indoor and outdoor areas, and other characteristics of housing for different species and categories of animals, are laid down in Annex III.

Article 11 Specific housing conditions and husbandry practices for mammals 1. Livestock housing shall have smooth, but not slippery floors. At least half of the indoor surface area as specified in Annex III shall be solid, that is, not of slatted or of grid construction.

2. The housing shall be provided with a comfortable, clean and dry laying/rest area of sufficient size, consisting of a solid construction which is not slatted. Ample dry bedding strewn with litter material shall be provided in the rest area. The litter shall comprise straw or other suitable natural material. The litter may be improved and enriched with any mineral product listed in Annex I.

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3. Notwithstanding Article 3(3) of Council Directive 91/629/EEC [10] the housing of calves in individual boxes shall be forbidden after the age of one week.

4. Notwithstanding Article 3(8) of Council Directive 91/630/EEC [11] sows shall be kept in groups, except in the last stages of pregnancy and during the suckling period.

5. Piglets shall not be kept on flat decks or in piglet cages.

6. Exercise areas shall permit dunging and rooting by porcine animals. For the purposes of rooting different substrates can be used.

Article 12 Specific housing conditions and husbandry practices for poultry 1. Poultry shall not be kept in cages.

2. Water fowl shall have access to a stream, pond, lake or a pool whenever the weather and hygienic conditions permit in order to respect their species-specific needs and animal welfare requirements.

3. Buildings for all poultry shall meet the following conditions:

(a) at least one third of the floor area shall be solid, that is, not of slatted or of grid construction, and covered with a litter material such as straw, wood shavings, sand or turf;

(b) in poultry houses for laying hens, a sufficiently large part of the floor area available to the hens shall be available for the collection of bird droppings;

(c) they shall have perches of a size and number commensurate with the size of the group and of the birds as laid down in Annex III.

(d) they shall have exit/entry pop-holes of a size adequate for the birds, and these pop-holes shall have a combined length of at least 4 m per 100 m2 area of the house available to the birds;

(e) each poultry house shall not contain more than:

(i) 4800 chickens,

(ii) 3000 laying hens,

(iii) 5200 guinea fowl,

(iv) 4000 female Muscovy or Peking ducks or 3200 male Muscovy or Peking ducks or other ducks,

(v) 2500 capons, geese or turkeys;

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(f) the total usable area of poultry houses for meat production on any single unit, shall not exceed 1600 m2;

(g) poultry houses shall be constructed in a manner allowing all birds easy access to open air area.

4. Natural light may be supplemented by artificial means to provide a maximum of 16 hours light per day with a continuous nocturnal rest period without artificial light of at least eight hours.

5. To prevent the use of intensive rearing methods, poultry shall either be reared until they reach a minimum age or else shall come from slow-growing poultry strains. Where slow-growing poultry strains are not used by the operator the following minimum age at slaughter shall be:

(a) 81 days for chickens,

(b) 150 days for capons,

(c) 49 days for Peking ducks,

(d) 70 days for female Muscovy ducks,

(e) 84 days for male Muscovy ducks,

(f) 92 days for Mallard ducks,

(g) 94 days for guinea fowl,

(h) 140 days for male turkeys and roasting geese and

(i) 100 days for female turkeys.

The competent authority shall define the criteria of slow-growing strains or draw up a list thereof and provide this information to operators, other Member States and the Commission.

Article 13 Specific requirements and housing conditions in beekeeping 1. The siting of the apiaries shall be such that, within a radius of 3 km from the apiary site, nectar and pollen sources consist essentially of organically produced crops and/or spontaneous vegetation and/or crops treated with low environmental impact methods equivalent to those as described in Article 36 of Council Regulation (EC) No 1698/2005 [12] or in Article 22 of Council Regulation 1257/1999 [13] which cannot affect the qualification of beekeeping production as being organic. The above mentioned requirements do not apply where flowering is not taking place, or the hives are dormant.

2. The Member States may designate regions or areas where beekeeping complying with organic production rules is not practicable.

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3. The hives shall be made basically of natural materials presenting no risk of contamination to the environment or the apiculture products.

4. The bees wax for new foundations shall come from organic production units.

5. Without prejudice to Article 25, only natural products such as propolis, wax and plant oils can be used in the hives.

6. The use of chemical synthetic repellents is prohibited during honey extractions operations.

7. The use of brood combs is prohibited for honey extraction.

Article 14 Access to open air areas 1. Open air areas may be partially covered.

2. In accordance with Article 14(1)(b)(iii) of Regulation (EC) No 834/2007 herbivores shall have access to pasturage for grazing whenever conditions allow.

3. In cases where herbivores have access to pasturage during the grazing period and where the winter-housing system gives freedom of movement to the animals, the obligation to provide open air areas during the winter months may be waived.

4. Notwithstanding paragraph 2, bulls over one year old shall have access to pasturage or an open air area.

5. Poultry shall have access to an open air area for at least one third of their life.

6. Open air areas for poultry shall be mainly covered with vegetation and be provided with protective facilities and permit fowl to have easy access to adequate numbers of drinking and feeding troughs.

7. Where poultry are kept indoors due to restrictions or obligations imposed on the basis of Community legislation, they shall permanently have access to sufficient quantities of roughage and suitable material in order to meet their ethological needs.

Article 15 Stocking density 1. The total stocking density shall be such as not to exceed the limit of 170 kg of nitrogen per year and hectare of agricultural area as referred to in Article 3(2).

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2. To determine the appropriate density of livestock referred to above, the competent authority shall set out the livestock units equivalent to the above limit, taking as a guideline, the figures laid down in Annex IV or the relevant national provisions adopted pursuant to Directive 91/676/EEC.

Article 16 Prohibition of landless livestock production Landless livestock production, by which the operator of the livestock does not manage agricultural land and/or has not established a written cooperation agreement with another operator according to Article 3(3), is prohibited.

Article 17 Simultaneous production of organic and non-organic livestock 1. Non organic livestock may be present on the holding provided they are reared on units where the buildings and parcels are separated clearly from the units producing in accordance with the organic production rules and a different species is involved.

2. Non-organic livestock may use organic pasturage for a limited period of time each year, provided that such animals come from a farming system as defined in paragraph 3(b) and that organic animals are not present at the same time on that pasture.

3. Organic animals may be grazed on common land, providing that:

(a) the land has not been treated with products not authorised for organic production for at least three years;

(b) any non-organic animals which use the land concerned are derived from a farming system equivalent to those as described in Article 36 of Regulation (EC) No 1698/2005 or in Article 22 of Regulation 1257/1999;

(c) any livestock products from organic animals, whilst using this land, shall not be regarded as being from organic-production, unless adequate segregation from non-organic animals can be proved.

4. During the period of transhumance animals may graze on non-organic land when they are being moved on foot from one grazing area to another. The uptake of non-organic feed, in the form of grass and other vegetation on which the animals graze, during this period shall not exceed 10 % of the total feed ration per year. This figure shall be calculated as a percentage of the dry matter of feedingstuffs from agricultural origin.

5. Operators shall keep documentary evidence of the use of provisions referred to in this Article.

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Article 18 Management of animals 1. Operations such as attaching elastic bands to the tails of sheep, tail-docking, cutting of teeth, trimming of beaks and dehorning shall not be carried out routinely in organic farming. However, some of these operations may be authorised by the competent authority for reasons of safety or if they are intended to improve the health, welfare or hygiene of the livestock on a case-by-case basis.

Any suffering to the animals shall be reduced to a minimum by applying adequate anaesthesia and/or analgesia and by carrying out the operation only at the most appropriate age by qualified personnel.

2. Physical castration is allowed in order to maintain the quality of products and traditional production practices but only under the conditions set out in the second subparagraph of paragraph 1.

3. Mutilation such as clipping the wings of queen bees is prohibited.

4. Loading and unloading of animals shall be carried out without the use of any type of electrical stimulation to coerce the animals. The use of allopathic tranquillisers, prior to or during transport, is prohibited.

Section 3 Feed Article 19 Feed from own holding or from other organic holdings 1. In the case of herbivores, except during the period each year when the animals are under transhumance subject to Article 17(4), at least 50 % of the feed shall come from the farm unit itself or in case this is not feasible, be produced in cooperation with other organic farms primarily in the same region.

2. In the case of bees, at the end of the production season hives shall be left with sufficient reserves of honey and pollen to survive the winter.

3. The feeding of bee colonies shall only be permitted where the survival of the hives is endangered due to climatic conditions and only between the last honey harvest and 15 days before the start of the next nectar or honeydew flow period. Feeding shall be with organic honey, organic sugar syrup, or organic sugar.

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Article 20 Feed meeting animals' nutritional requirements 1. All young mammals shall be fed on maternal milk in preference to natural milk, for a minimum period of three months for bovines including bubalus and bison species and equidae, 45 days for sheep and goats and 40 days for pigs.

2. Rearing systems for herbivores are to be based on maximum use of grazing pasturage according to the availability of pastures in the different periods of the year. At least 60 % of the dry matter in daily rations of herbivores shall consist of roughage, fresh or dried fodder, or silage. A reduction to 50 % for animals in dairy production for a maximum period of three months in early lactation is allowed.

3. Roughage, fresh or dried fodder, or silage shall be added to the daily ration for pigs and poultry.

4. The keeping of livestock in conditions, or on a diet, which may encourage anaemia, is prohibited.

5. Fattening practices shall be reversible at any stage of the rearing process. Force-feeding is forbidden.

Article 21 In-conversion feed 1. Up to 30 % of the feed formula of rations on average may comprise in-conversion feedingstuffs. When the in-conversion feedingstuffs come from a unit of the holding itself, this percentage may be increased to 60 %.

2. Up to 20 % of the total average amount of feedingstuffs fed to the livestock may originate from the grazing or harvesting of permanent pastures or perennial forage parcels in their first year of conversion, provided that they are part of the holding itself and have not been part of an organic production unit of that holding in the last five years. When both in-conversion feedingstuffs and feedingstuffs from parcels in their first year of conversion are being used, the total combined percentage of such feedingstuffs shall not exceed the maximum percentages fixed in paragraph 1.

3. The figures in paragraph 1 and 2 shall be calculated annually as a percentage of the dry matter of feedingstuffs of plant origin.

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Article 22 Products and substances referred to in Article 14(1)(d)(iv) of Regulation (EC) No 834/2007 1. Non-organic feed materials of plant and animal origin may be used in organic production subject to the restrictions laid down in Article 43 and only if they are listed in Annex V and the restrictions laid down therein are complied with.

2. Organic feed materials of animal origin, and feed materials of mineral origin may be used in organic production and only if they are listed in Annex V and the restrictions laid down therein are complied with.

3. Products and by-products from fisheries may be used in organic production only if they are listed in Annex V and the restrictions laid down therein are complied with.

4. Feed additives, certain products used in animal nutrition and processing aids may be used in organic production only if they are listed in Annex VI and the restrictions laid down therein are complied with.

Section 4 Disease prevention and veterinary treatment Article 23 Disease prevention 1. The use of chemically synthesised allopathic veterinary medicinal products or antibiotics for preventive treatment is prohibited, without prejudice to Article 24(3).

2. The use of substances to promote growth or production (including antibiotics, coccidiostatics and other artificial aids for growth promotion purposes) and the use of hormones or similar substances to control reproduction or for other purposes (e.g. induction or synchronisation of oestrus), is prohibited.

3. Where livestock is obtained from non-organic units, special measures such as screening tests or quarantine periods may apply, depending on local circumstances.

4. Housing, pens, equipment and utensils shall be properly cleaned and disinfected to prevent cross-infection and the build-up of disease carrying organisms. Faeces, urine and uneaten or spilt feed shall be removed as often as necessary to minimise smell and to avoid attracting insects or rodents.

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For the purpose of Article 14(1)(f) of Regulation (EC) No 834/2007, only products listed in Annex VII may be used for cleaning and disinfection of livestock buildings installations and utensils. Rodenticides (to be used only in traps), and the products listed in Annex II, can be used for the elimination of insects and other pests in buildings and other installations where livestock is kept.

5. Buildings shall be emptied of livestock between each batch of poultry reared. The buildings and fittings shall be cleaned and disinfected during this time. In addition, when the rearing of each batch of poultry has been completed, runs shall be left empty to allow vegetation to grow back. Member States shall establish the period for which runs must be empty. The operator shall keep documentary evidence of the application of this period. These requirements shall not apply where poultry is not reared in batches, is not kept in runs and is free to roam, throughout the day.

Article 24 Veterinary treatment 1. Where despite preventive measures to ensure animal health as laid down in Article 14(1)(e)(i) of Regulation (EC) No 834/2007 animals become sick or injured they shall be treated immediately, if necessary in isolation and in suitable housing.

2. Phytotherapeutic, homoepathic products, trace elements and products listed in Annex V, part 3 and in Annex VI, part 1.1. shall be used in preference to chemically-synthesized allopathic veterinary treatment or antibiotics, provided that their therapeutic effect is effective for the species of animal, and the condition for which the treatment is intended.

3. If the use of measures referred to in paragraph 1 and 2 is not effective in combating illness or injury, and if treatment is essential to avoid suffering or distress of the animal, chemically-synthesised allopathic veterinary medicinal products or antibiotics may be used under the responsibility of a veterinarian.

4. With the exception of vaccinations, treatments for parasites and compulsory eradication schemes where an animal or group of animals receive more than three courses of treatments with chemically-synthesised allopathic veterinary medicinal products or antibiotics within 12 months, or more than one course of treatment if their productive lifecycle is less than one year, the livestock concerned, or produce derived from them, may not be sold as organic products, and the livestock shall undergo the conversion periods laid down in Article 38(1).

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Records of documented evidence of the occurrence of such circumstances shall be kept for the control body or control authority.

5. The withdrawal period between the last administration of an allopathic veterinary medicinal product to an animal under normal conditions of use, and the production of organically produced foodstuffs from such animals, is to be twice the legal withdrawal period as referred to in Article 11 of Directive 2001/82/EC or, in a case in which this period is not specified, 48 hours.

Article 25 Specific rules on disease prevention and veterinary treatment in beekeeping 1. For the purposes of protecting frames, hives and combs, in particular from pests, only rodenticides (to be used only in traps), and appropriate products listed in Annex II, are permitted.

2. Physical treatments for disinfection of apiaries such as steam or direct flame are permitted.

3. The practice of destroying the male brood is permitted only to isolate the infestation of Varroa destructor.

4. If despite all preventive measures, the colonies become sick or infested, they shall be treated immediately and, if necessary, the colonies can be placed in isolation apiaries.

5. Veterinary medicinal products may be used in organic beekeeping in so far as the corresponding use is authorised in the Member State in accordance with the relevant Community provisions or national provisions in conformity with Community law.

6. Formic acid, lactic acid, acetic acid and oxalic acid as well as menthol, thymol, eucalyptol or camphor may be used in cases of infestation with Varroa destructor.

7. If a treatment is applied with chemically synthesised allopathic products, during such a period, the colonies treated shall be placed in isolation apiaries and all the wax shall be replaced with wax coming from organic beekeeping. Subsequently, the conversion period of one year laid down in Article 38(3) will apply to those colonies.

8. The requirements laid down in paragraph 7 shall not apply to products listed in paragraph 6.

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CHAPTER 3 Processed products Article 26 Rules for the production of processed feed and food 1. Additives, processing aids and other substances and ingredients used for processing food or feed and any processing practice applied, such as smoking, shall respect the principles of good manufacturing practice.

2. Operators producing processed feed or food shall establish and update appropriate procedures based on a systematic identification of critical processing steps.

3. The application of the procedures referred to in paragraph 2 shall guarantee at all times that the produced processed products comply with the organic production rules.

4. Operators shall comply with and implement the procedures referred to in paragraph 2. In particular, operators shall:

(a) take precautionary measures to avoid the risk of contamination by unauthorised substances or products;

(b) implement suitable cleaning measures, monitor their effectiveness and record these operations;

(c) guarantee that non-organic products are not placed on the market with an indication referring to the organic production method.

5. Further to the provisions laid down in paragraphs 2 and 4, when non-organic products are also prepared or stored in the preparation unit concerned, the operator shall:

(a) carry out the operations continuously until the complete run has been dealt with, separated by place or time from similar operations performed on non-organic products;

(b) store organic products, before and after the operations, separate by place or time from non-organic products;

(c) inform the control authority or control body thereof and keep available an updated register of all operations and quantities processed;

(d) take the necessary measures to ensure identification of lots and to avoid mixtures or exchanges with non-organic products;

(e) carry out operations on organic products only after suitable cleaning of the production equipment.

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Article 27 Use of certain products and substances in processing of food 1. For the purpose of Article 19(2)(b) of Regulation (EC) No 834/2007, only the following substances can be used in the processing of organic food, with the exception of wine:

(a) substances listed in Annex VIII to this Regulation;

(b) preparations of micro-organisms and enzymes normally used in food processing;

(c) substances, and products as defined in Articles 1(2)(b)(i) and 1(2)(c) of Council Directive 88/388/EEC [14] labelled as natural flavouring substances or natural flavouring preparations, according to Articles 9(1)(d) and (2) of that Directive.

(d) colours for stamping meat and eggshells in accordance with, respectively, Article 2(8) and Article 2(9) of European Parliament and Council Directive 94/36/EC [15];

(e) drinking water and salt (with sodium chloride or potassium chloride as basic components) generally used in food processing;

(f) minerals (trace elements included), vitamins, aminoacids, and micronutrients, only authorised as far their use is legally required in the foodstuffs in which they are incorporated.

2. For the purpose of the calculation referred to in Article 23(4)(a)(ii) of Regulation (EC) No 834/2007,

(a) food additives listed in Annex VIII and marked with an asterisk in the column of the additive code number, shall be calculated as ingredients of agricultural origin;

(b) preparations and substances referred to in paragraph (1)(b),(c),(d),(e) and (f) of this Article and substances not marked with an asterisk in the column of the additive code number shall not be calculated as ingredients of agricultural origin.

3. The use of the following substances listed in Annex VIII shall be re-examined before 31 December 2010:

(a) Sodium nitrite and potassium nitrate in Section A with a view to withdrawing these additives;

(b) Sulphur dioxide and potassium metabisulphite in Section A;

(c) Hydrochloric acid in Section B for the processing of Gouda, Edam and Maasdammer cheeses, Boerenkaas, Friese, and Leidse Nagelkaas.

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The re-examination referred to in point (a) shall take account of the efforts made by Member States to find safe alternatives to nitrites/nitrates and in establishing educational programmes in alternative processing methods and hygiene for organic meat processors/manufacturers.

Article 28 Use of certain non-organic ingredients of agricultural origin in processing food For the purpose of Article 19(2)(c) of Regulation (EC) No 834/2007, non-organic agricultural ingredients listed in Annex IX to this Regulation can be used in the processing of organic food.

Article 29 Authorisation of non-organic food ingredients of agricultu-ral origin by Member State 1. Where an ingredient of agricultural origin is not included in Annex IX to this Regulation, that ingredient may only be used under the following conditions:

(a) the operator has notified to the competent authority of the Member State all the requisite evidence showing that the ingredient concerned is not produced in sufficient quantity in the Community in accordance with the organic production rules or cannot be imported from third countries;

(b) the competent authority of the Member State has provisionally authorised, the use for a maximum period of 12 months after having verified that the operator has undertaken the necessary contacts with suppliers in the Community to ensure himself of the unavailability of the ingredients concerned with the required quality requirements;

(c) no decision has been taken, in accordance with the provisions of paragraphs 3 or 4 that a granted authorisation with regard to the ingredient concerned shall be withdrawn.

The Member State may prolong the authorisation provided for in point (b) a maximum of three times for 12 months each.

2. Where an authorisation as referred to in paragraph 1 has been granted, the Member State shall immediately notify to the other Member States and to the Commission, the following information:

(a) the date of the authorisation and in case of a prolonged authorisation, the date of the first authorisation;

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(b) the name, address, telephone, and where relevant, fax and e-mail of the holder of the authorisation; the name and address of the contact point of the authority which granted the authorisation;

(c) the name and, where necessary, the precise description and quality requirements of the ingredient of agricultural origin concerned;

(d) the type of products for the preparation of which the requested ingredient is necessary;

(e) the quantities that are required and the justification for those quantities;

(f) the reasons for, and expected period of, the shortage;

(g) the date on which the Member State sends this notification to the other Member States and the Commission. The Commission and/or Member States may make this information available to the public.

3. Where a Member State submits comments to the Commission and to the Member State which granted the authorisation, which show that supplies are available during the period of the shortage, the Member State shall consider withdrawal of the authorisation or reducing the envisaged period of validity, and shall inform the Commission and the other Member States of the measures it has taken or will take, within 15 working days from the date of receipt of the information.

4. At the request of a Member State or at the Commission's initiative, the matter shall be submitted for examination to the Committee set up in accordance with Article 37 of Regulation (EC) No 834/2007. It may be decided, in accordance with the procedure laid down in paragraph 2 of that Article, that a previously granted authorisation shall be withdrawn or its period of validity amended, or where appropriate, that the ingredient concerned shall be included in Annex IX to this Regulation.

5. In case of an extension as referred to in the second subparagraph of paragraph 1, the procedures of paragraphs 2 and 3 shall apply.

CHAPTER 4 Collection, packaging, transport and storage of products Article 30 Collection of products and transport to preparation units Operators may carry out simultaneous collection of organic and non-organic products, only where appropriate measures are taken to prevent any possible mixture or exchange with non-organic products and to ensure the identification of the organic products. The operator shall keep the

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information relating to collection days, hours, circuit and date and time of reception of the products available to the control body or control authority.

Article 31 Packaging and transport of products to other operators or units 1. Operators shall ensure that organic products are transported to other units, including wholesalers and retailers, only in appropriate packaging, containers or vehicles closed in such a manner that substitution of the content cannot be achieved without manipulation or damage of the seal and provided with a label stating, without prejudice to any other indications required by law:

(a) the name and address of the operator and, where different, of the owner or seller of the product;

(b) the name of the product or a description of the compound feedingstuff accompanied by a reference to the organic production method;

(c) the name and/or the code number of the control body or authority to which the operator is subject; and

(d) where relevant, the lot identification mark according to a marking system either approved at national level or agreed with the control body or authority and which permits to link the lot with the accounts referred to in Article 66.

The information referred to in points (a) to (d) of the first subparagraph may also be presented on an accompanying document, if such a document can be undeniably linked with the packaging, container or vehicular transport of the product. This accompanying document shall include information on the supplier and/or the transporter.

2. The closing of packaging, containers or vehicles shall not be required where:

(a) transportation is direct between an operator and another operator who are both subject to the organic control system, and

(b) the products are accompanied by a document giving the information required under paragraph 1, and

(c) both the expediting and the receiving operators shall keep documentary records of such transport operations available for the control body or control authority of such transport operations.

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Article 32 Special rules for transporting feed to other production/pre-paration units or storage premises In addition to the provisions of Article 31, when transporting feed to other production or preparation units or storage premises, operators shall ensure that the following conditions are met:

(a) during transport, organically-produced feed, in-conversion feed, and non-organic feed shall be effectively physically separated;

(b) the vehicles and/or containers which have transported non-organic products are used to transport organic products provided that:

(i) suitable cleaning measures, the effectiveness of which has been checked, have been carried out before commencing the transport of organic products; operators shall record these operations,

(ii) all appropriate measures are implemented, depending on the risks evaluated in accordance with Article 88(3) and, where necessary, operators shall guarantee that non-organic products cannot be placed on the market with an indication referring to organic production,

(iii) the operator shall keep documentary records of such transport operations available for the control body or control authority;

(c) the transport of finished organic feed shall be separated physically or in time from the transport of other finished products;

(d) during transport, the quantity of products at the start and each individual quantity delivered in the course of a delivery round shall be recorded.

Article 33 Reception of products from other units and other operators On receipt of an organic product, the operator shall check the closing of the packaging or container where it is required and the presence of the indications provided to in Article 31.

The operator shall crosscheck the information on the label referred to in Article 31 with the information on the accompanying documents. The result of these verifications shall be explicitly mentioned in the documentary accounts referred to in Article 66.

Article 34 Special rules for the reception of products from a third country

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Organic products shall be imported from a third country in appropriate packaging or containers, closed in a manner preventing substitution of the content and provided with identification of the exporter and with any other marks and numbers serving to identify the lot and with the certificate of control for import from third countries as appropriate.

On receipt of an organic product, imported from a third country, the first consignee shall check the closing of the packaging or container and, in the case of products imported in accordance with Article 33 of Regulation (EC) No 834/2007, shall check that the certificate mentioned in that Article covers the type of product contained in the consignment. The result of this verification shall be explicitly mentioned in the documentary accounts referred to in Article 66 of this Regulation.

Article 35 Storage of products 1. For the storage of products, areas shall be managed in such a way as to ensure identification of lots and to avoid any mixing with or contamination by products and/or substances not in compliance with the organic production rules. Organic products shall be clearly identifiable at all times.

2. In case of organic plant and livestock production units, storage of input products other than those authorised under this Regulation is prohibited in the production unit.

3. The storage of allopathic veterinary medicinal products and antibiotics is permitted on holdings provided that they have been prescribed by a veterinarian in connection with treatment as referred to in Article 14(1)(e)(ii) of Regulation (EC) No 834/2007, that they are stored in a supervised location and that they are entered in the livestock record as referred to in Article 76 of this Regulation.

4. In case where operators handle both non-organic products and organic products and the latter are stored in storage facilities in which also other agricultural products or foodstuffs are stored:

(a) the organic products shall be kept separate from the other agricultural products and/or foodstuffs;

(b) every measure shall be taken to ensure identification of consignments and to avoid mixtures or exchanges with non-organic products;

(c) suitable cleaning measures, the effectiveness of which has been checked, have been carried out before the storage of organic products; operators shall record these operations.

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CHAPTER 5 Conversion rules Article 36 Plant and plant products 1. For plants and plant products to be considered organic, the production rules as referred to in Articles 9, 10, 11 and 12 of Regulation (EC) No 834/2007 and Chapter 1 of this Regulation and where applicable the exceptional production rules in Chapter 6 of this Regulation must have been applied on the parcels during a conversion period of at least two years before sowing, or, in the case of grassland or perennial forage, at least two years before its use as feed from organic farming, or, in the case of perennial crops other than forage, at least three years before the first harvest of organic products.

2. The competent authority may decide to recognise retroactively as being part of the conversion period any previous period in which:

(a) the land parcels were subject of measures defined in a programme implemented pursuant to Regulations (EC) No 1257/99, (EC) No 1698/2005, or in another official programme, provided that the measures concerned ensure that products not authorised for organic production have not been used on those parcels, or

(b) the parcels were natural or agricultural areas which were not treated with products not authorised for organic production.

The period referred to in point (b) of the first subparagraph can be taken into consideration retroactively only where satisfactory proof has been furnished to the competent authority allowing it to satisfy itself that the conditions were met for a period of at least three years.

3. The competent authority may decide, in certain cases, where the land had been contaminated with products not authorised for organic production, to extend the conversion period beyond the period referred to in paragraph 1.

4. In the case of parcels which have already been converted to or were in the process of conversion to organic farming, and which are treated with a product not authorised for organic production, the Member State may shorten the conversion period referred to in paragraph 1 in the following two cases:

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(a) parcels treated with a product not authorised for organic production as part of a compulsory disease or pest control measure imposed by the competent authority of the Member State;

(b) parcels treated with a product not authorised for organic production as part of scientific tests approved by the competent authority of the Member State.

In the cases provided for in points (a) and (b) of the first subparagraph, the length of the conversion period shall be fixed taking into account of the following factors:

(a) the process of degradation of the product concerned shall guarantee, at the end of the conversion period, an insignificant level of residues in the soil and, in the case of a perennial crop, in the plant;

(b) the harvest following the treatment may not be sold with reference to organic production methods.

The Member State concerned shall inform the other Member States and the Commission of its decision to require compulsory measures.

Article 37 Specific conversion rules for land associated with organic livestock production 1. The conversion rules as referred to in Article 36 of this Regulation shall apply to the whole area of the production unit on which animal feed is produced.

2. Notwithstanding the provisions in paragraph 1, the conversion period may be reduced to one year for pasturages and open air areas used by non-herbivore species. This period may be reduced to six months where the land concerned has not during the last year, received treatments with products not authorised for organic production.

Article 38 Livestock and livestock products 1. Where non-organic livestock has been brought onto a holding in accordance with Article 14(1)(a)(ii) of Regulation (EC) No 834/2007 and Article 9 and/or Article 42 of this Regulation and if livestock products are to be sold as organic products, the production rules as referred to in Articles 9, 10, 11 and 14 of Regulation (EC) No 834/2007 and in Chapter 2 of Title II and where applicable in Article 42 of this Regulation must have been applied for at least:

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(a) 12 months in the case of equidae and bovines, including bubalus and bison species, for meat production, and in any case at least three quarters of their lifetime;

(b) six months in the case of small ruminants and pigs and animals for milk production;

(c) 10 weeks for poultry for meat production, brought in before they are three days old;

(d) six weeks in the case of poultry for egg production.

2. Where non-organic animals exist on a holding at the beginning of the conversion period in accordance with Article 14(1)(a)(iii) of Regulation (EC) No 834/2007 their products may be deemed organic if there is simultaneous conversion of the complete production unit, including livestock, pasturage and/or any land used for animal feed. The total combined conversion period for both existing animals and their offspring, pasturage and/or any land used for animal feed, may be reduced to 24 months, if the animals are mainly fed with products from the production unit.

3. Beekeeping products can be sold with references to the organic production method only when the organic production rules have been complied with for at least one year.

4. The conversion period for apiaries does not apply in the case of application of Article 9(5) of this Regulation.

5. During the conversion period the wax shall be replaced with wax coming from organic beekeeping.

CHAPTER 6 Exceptional production rules Section 1 Exceptional production rules related to climatic, geographical or structural constraints in accordance with Article 22(2)(a) of Regulation (EC) No 834/2007 Article 39 Tethering of animals Where the conditions laid down in Article 22(2)(a) of Regulation (EC) No 834/2007 apply, competent authorities may authorise cattle in small holdings to be tethered if it is not possible to keep the cattle in groups appropriate to their behaviour requirements, provided they have access to

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pastures during the grazing period according to Article 14(2), and at least twice a week access to open air areas when grazing is not possible.

Article 40 Parallel production 1. Where the conditions laid down in Article 22(2)(a) of Regulation (EC) No 834/2007 apply, a producer may run organic and non-organic production units in the same area:

(a) in the case of the production of perennial crops, which require a cultivation period of at least three years, where varieties cannot be easily differentiated, provided the following conditions are met:

(i) the production in question forms part of a conversion plan in respect of which the producer gives a firm undertaking and which provides for the beginning of the conversion of the last part of the area concerned to organic production in the shortest possible period which may not in any event exceed a maximum of five years;

(ii) appropriate measures have been taken to ensure the permanent separation of the products obtained from each unit concerned;

(iii) the control authority or control body is notified of the harvest of each of the products concerned at least 48 hours in advance;

(iv) upon completion of the harvest, the producer informs the control authority or control body of the exact quantities harvested on the units concerned and of the measures applied to separate the products;

(v) the conversion plan and the control measures referred to in Chapter 1 and 2 of Title IV have been approved by the competent authority; this approval shall be confirmed each year after the start of the conversion plan;

(b) in the case of areas intended for agricultural research or formal education agreed by the Member States' competent authorities and provided the conditions set out in point (a)(ii)(iii)(iv) and the relevant part of point (v) are met;

(c) in the case of production of seed, vegetative propagating material and transplants and provided the conditions set out in point (a)(ii)(iii)(iv) and the relevant part of point (v) are met;

(d) in the case of grassland exclusively used for grazing.

2. The competent authority may authorise holdings carrying out agricultural research or formal education to rear organic and non-organic livestock of the same species, where the following conditions are met:

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(a) appropriate measures, notified in advance to the control authority or control body, have been taken in order to guarantee the permanent separation between livestock, livestock products, manure and feedingstuffs of each of the units;

(b) the producer informs the control authority or control body in advance of any delivery or selling of the livestock or livestock products;

(c) the operator informs the control authority or control body of the exact quantities produced in the units together with all characteristics permitting the identification of the products and confirms that the measures taken to separate the products have been applied.

Article 41 Management of beekeeping units for the purpose of pollination Where the conditions laid down in Article 22(2)(a) of Regulation (EC) No 834/2007 apply, for the purpose of pollination actions an operator may run organic and non-organic beekeeping units on the same holding, provided that all the requirements of the organic production rules are fulfilled, with the exception of the provisions for the siting of the apiaries. In that case the product cannot be sold as organic.

The operator shall keep documentary evidence of the use of this provision.

Section 2 Exceptional production rules related to non-availability of organic farm inputs in accordance with Article 22(2)(b) of Regulation (EC) No 834/2007 Article 42 Use of non-organic animals Where the conditions laid down in Article 22(2)(b) of Regulation (EC) No 834/2007 apply, and with prior authorisation of the competent authority,

(a) when a flock is constituted for the first time, renewed or reconstituted and organically reared poultry are not available in sufficient numbers, non-organically reared poultry may be brought into an organic poultry production unit, provided that the pullets for the production of eggs and poultry for meat production are less than three days old;

(b) non-organically reared pullets for egg production of not more than 18 weeks may be brought into an organic livestock unit until 31 December 2011, when organically reared pullets are not available and provided that the relevant provisions laid down in Section 3 and 4 of Chapter 2 are complied with.

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Article 43 Use of non-organic feed of agricultural origin Where the conditions laid down in Article 22(2)(b) of Regulation (EC) No 834/2007 apply, the use of a limited proportion of non-organic feed of plant and animal origin is allowed where farmers are unable to obtain feed exclusively from organic production. The maximum percentage of non-organic feed authorised per period of 12 months for species other than herbivores shall be:

(a) 10 % during the period from 1 January 2009 to 31 December 2009;

(b) 5 % during the period from 1 January 2010 to 31 December 2011.

The figures shall be calculated annually as a percentage of the dry matter of feed from agricultural origin. The maximum percentage authorised of non-organic feed in the daily ration shall be 25 % calculated as a percentage of the dry matter.

The operator shall keep documentary evidence of the need for the use of this provision.

Article 44 Use of non-organic beeswax In the case of new installations or during the conversion period, non-organic beeswax may be used only

(a) where beeswax from organic beekeeping is not available on the market;

(b) where it is proven free of contamination by substances not authorised for organic production; and

(c) provided that it comes from the cap.

Article 45

Use of seed or vegetative propagating material not obtained by the organic production method

1. Where the conditions laid down in Article 22(2)(b) of Regulation (EC) No 834/2007 apply,

(a) seed and vegetative propagating material from a production unit in conversion to organic farming may be used,

(b) where point (a) is not applicable, Member States may authorise the use of non-organic seed or vegetative propagating material if not available from organic production. However, for the use of non-organic seed and seed potatoes the following paragraphs (2) to (9) apply.

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2. Non-organic seed and seed potatoes may be used, provided that the seed or seed potatoes are not treated with plant protection products, other than those authorised for treatment of seed in accordance with Article 5(1), unless chemical treatment is prescribed in accordance with Council Directive 2000/29/EC [16] for phytosanitary purposes by the competent authority of the Member State for all varieties of a given species in the area where the seed or seed potatoes are to be used.

3. Species for which it is established that organically produced seed or seed potatoes are available in sufficient quantities and for a significant number of varieties in all parts of the Community are set out in Annex X.

The species listed in Annex X may not be subject of authorisations pursuant to paragraph 1(b), unless these are justified by one of the purposes referred to in paragraph 5(d).

4. Member States may delegate the responsibility for granting the authorisation referred to in paragraph 1(b) to another public administration under their supervision or to the control authorities or control bodies referred to in Article 27 of Regulation (EC) No 834/2007.

5. Authorisation to use seed or seed potatoes not obtained by the organic production method may only be granted in the following cases:

(a) where no variety of the species which the user wants to obtain is registered in the database referred to in Article 48;

(b) where no supplier, meaning an operator who markets seed or seed potatoes to other operators, is able to deliver the seed or seed potatoes before sowing or planting in situations where the user has ordered the seed or seed potatoes in reasonable time;

(c) where the variety which the user wants to obtain is not registered in the database referred to in Article 48, and the user is able to demonstrate that none of the registered alternatives of the same species are appropriate and that the authorisation therefore is significant for his production;

(d) where it is justified for use in research, test in small-scale field trials or for variety conservation purposes agreed by the competent authority of the Member State.

6. The authorisation shall be granted before the sowing of the crop.

7. The authorisation shall be granted only to individual users for one season at a time and the authority or body responsible for the authorisations shall register the quantities of seed or seed potatoes authorised.

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8. By way of derogation from paragraph 7, the competent authority of the Member State may grant to all users a general authorisation:

(a) for a given species when and in so far as the condition laid down in paragraph 5(a) is fulfilled;

(b) for a given variety when and in so far as the conditions laid down in paragraph 5(c) are fulfilled.

The authorisations referred to in the first subparagraph shall be clearly indicated in the database referred to in Article 48.

9. Authorisation may only be granted during periods for which the database is updated in accordance with Article 49(3).

Section 3 Exceptional production rules related to specific management problems in organic livestock in accordance with Article 22(2)(d) of Regulation (EC) No 834/2007 Article 46 Specific management problems in organic livestock The final fattening phase of adult bovines for meat production may take place indoors, provided that this indoors period does not exceed one fifth of their lifetime and in any case for a maximum period of three months.

Section 4 Exceptional production rules related to catastrophic circumstances in accordance with Article 22(2)(f) of Regulation (EC) No 834/2007 Article 47 Catastrophic circumstances The competent authority may authorise on a temporary basis:

(a) in the case of high mortality of animals caused by health or catastrophic circumstances, the renewal or reconstitution of the herd or flock with non-organic animals, when organically reared animals are not available;

(b) in case of high mortality of bees caused by health or catastrophic circumstances, the reconstitution of the apiaries with non-organic bees, when organic apiaries are not available;

(c) the use of non-organic feedingstuffs for a limited period and in relation to a specific area by individual operators, when forage production is lost or when restrictions are imposed, in particular as a result of exceptional

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meteorological conditions, the outbreak of infectious diseases, the contamination with toxic substances, or as a consequence of fires;

(d) the feeding of bees with organic honey, organic sugar or organic sugar syrup in case of long lasting exceptional weather conditions or catastrophic circumstances, which hamper the nectar or honeydew production.

Upon approval by the competent authority, the individual operators shall keep documentary evidence of the use of the above exceptions. Member States shall inform each other and the Commission on the exceptions they have granted under point (c) of the first subparagraph within 1 month from its approval.

CHAPTER 7 Seed data base Article 48 Database 1. Each Member State shall ensure that a computerised database is established for the listing of the varieties for which seed or seed potatoes obtained by the organic production method are available on its territory.

2. The database shall be managed either by the competent authority of the Member State or by an authority or body designated for this purpose by the Member State, hereinafter referred to as "manager of the database". Member States may also designate an authority or a private body in another country.

3. Each Member State shall inform the Commission and the other Member States of the authority or private body designated to manage the database.

Article 49 Registration 1. Varieties for which seed or seed potatoes produced by the organic production method are available shall be registered in the database referred to in Article 48 at the request of the supplier.

2. Any variety which has not been registered in the database shall be considered as unavailable with regard to Article 45(5).

3. Each Member State shall decide in which period of the year the database has to be regularly updated for each species or group of species cultivated on its territory. The database shall hold information with regard to that decision.

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Article 50 Conditions for registration 1. For registration, the supplier shall:

(a) demonstrate that he or the last operator, in cases where the supplier is only dealing with pre-packaged seed or seed potatoes, has been subject to the control system referred to in Article 27 of Regulation (EC) No 834/2007;

(b) demonstrate that the seed or seed potatoes to be placed on the market comply with the general requirements applicable to seed and seed potatoes;

(c) make available all the information required under Article 51 of this Regulation, and undertake to update this information at the request of the manager of the database or whenever such updating is necessary to ensure that the information remains reliable.

2. The manager of the database may, with the approval by the competent authority of the Member State, refuse a supplier's application for registration or delete a previously accepted registration if the supplier does not comply with the requirements set out in paragraph 1.

Article 51 Registered information 1. For each registered variety and for each supplier, the database referred to in Article 48 shall contain at least the following information:

(a) the scientific name of the species and the variety denomination;

(b) the name and contact details of the supplier or his representative;

(c) the area where the supplier can deliver the seed or seed potatoes to the user in the usual time needed for the delivery;

(d) the country or region in which the variety is tested and approved for the purpose of the common catalogues of varieties of agricultural plant species and vegetable species as defined in Council Directives 2002/53/EC on the common catalogue of varieties of agricultural plant species [17] and 2002/55/EC on the marketing of vegetable seed [18];

(e) the date from which the seed or seed potatoes will be available;

(f) the name and/or code number of the control authority or control body in charge of the control of the operator as referred to in Article 27 of Regulation (EC) No 834/2007.

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2. The supplier shall immediately inform the manager of the database if any of the registered varieties are no longer available. The amendments shall be recorded in the database.

3. Besides the information specified in paragraph 1, the database shall contain a list of the species listed in Annex X.

Article 52 Access to information 1. The information in the database referred to in Article 48 shall be available through the Internet, free of cost, to the users of seed or seed potatoes and to the public. Member States may decide that any user who has notified its activity in accordance with Article 28(1)(a) of Regulation (EC) No 834/2007 may obtain, on request, an extract of data concerning one or several groups of species from the database manager.

2. The Member States shall ensure that all users referred to in paragraph 1 are informed, at least once a year, about the system and how to obtain the information in the database.

Article 53 Registration fee Each registration may be subject to the levying of a fee, which shall represent the cost of inserting and maintaining the information in the database referred to in Article 48. The competent authority of the Member State shall approve the amount of the fee charged by the manager of the database.

Article 54 Annual report 1. The authorities or bodies designated to grant authorisations in accordance with Article 45 shall register all authorisations, and shall make this information available in a report to the competent authority of the Member State and to the manager of the database.

The report shall contain, for each species concerned by an authorisation according to Article 45(5), the following information:

(a) the scientific name of the species and the variety denomination;

(b) the justification for the authorisation indicated by a reference to Article 45(5)(a), (b), (c) or (d);

(c) the total number of authorisations;

(d) the total quantity of seed or seed potatoes involved;

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(e) the chemical treatment for phytosanitary purposes, as referred to in Article 45(2).

2. For authorisations according to Article 45(8) the report shall contain the information referred to in point (a) of the second subparagraph of paragraph 1 of this Article and the period for which the authorisations were in force.

Article 55 Summary report The competent authority of the Member State shall, before 31 March each year, collect the reports and send a summary report covering all authorisations of the Member State from the previous calendar year to the Commission and to the other Member States. The report shall cover the information specified in Article 54. The information shall be published in the database referred to in Article 48. The competent authority may delegate the task of collecting the reports to the manager of the database.

Article 56 Information upon request Upon request from a Member State or the Commission, detailed information on authorisations granted in individual cases shall be made available to other Member States or to the Commission.

TITLE III LABELLING CHAPTER 1 Community Logo Article 57 Community logo In accordance with Article 25(3) of Regulation (EC) No 834/2007, the Community logo shall follow the model in Annex XI to this Regulation.

The Community logo shall be used in accordance with the technical reproduction rules laid down in Annex XI to this Regulation.

Article 58 Conditions for the use of the code number and place of origin 1. The indication of the code number of the control authority or control body referred to in Article 24(1)(a) of Regulation (EC) 834/2007 shall,

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(a) start with the acronym identifying the Member State or the third country, as referred to in the international standard for the two letter country codes under ISO 3166 (Codes for the representation of names of countries and their subdivisions);

(b) include a term which establishes a link with the organic production method, as referred to in Article 23(1) of Regulation (EC) No 834/2007;

(c) include a reference number to be decided by the competent authority; and

(d) be placed immediately below the Community logo, where the Community logo is used in the labelling.

2. The indication of the place where the agricultural raw materials of which the products is composed have been farmed, as referred to in Article 24(1)(c) of Regulation (EC) 834/2007, shall be placed immediately below the code number referred to in paragraph 1.

CHAPTER 2 Specific labelling requirements for feed Article 59 Scope, use of trade marks and sales descriptions This Chapter shall not apply to pet food and feed for fur animals or feed for aquaculture animals.

The trade marks and sales descriptions bearing an indication referred to in Article 23(1) of Regulation (EC) No 834/2007 may be used only if at least 95 % of the product's dry matter is comprised of feed material from the organic production method.

Article 60 Indications on processed feed 1. Without prejudice to Articles 61 and 59, second paragraph of this Regulation, the terms referred to in Article 23(1) of Regulation (EC) 834/2007 may be used on processed feed provided that:

(a) the processed feed complies with the provisions of Regulation (EC) 834/2007 and in particular with Article 14(1) (d) (iv) and (v) and Article 18 thereof;

(b) the processed feed complies with the provisions of this Regulation and in particular with Articles 22 and 26 thereof;

(c) at least 95 % of the product's dry matter is organic.

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2. Subject to the requirements laid down in points (a) and (b) of paragraph 1, the following statement is permitted in the case of products comprising variable quantities of feed materials from the organic production method and/or feed materials from products in conversion to organic farming and/or non-organic materials:

"may be used in organic production in accordance with Regulations (EC) 834/2007 and (EC) 889/2008"

Article 61 Conditions for the use of indications on processed feed 1. The indication provided for in Article 60 shall be:

(a) separate from the wording referred to in Article 5 of Council Directive 79/373/EEC [19] or in Article 5(1) of Council Directive 96/25/EC [20];

(b) presented in a colour, format or character font that does not draw more attention to it than to the description or name of the animal feedingstuff referred to in Article 5(1)(a) of Directive 79/373/EEC or in Article 5(1)(b) of Directive 96/25/EC respectively;

(c) accompanied, in the same field of vision, by an indication by weight of dry matter referring:

(i) to the percentage of feed material(s) from the organic production method;

(ii) to the percentage of feed material(s) from products in conversion to organic farming;

(iii) to the percentage of feed material(s) not covered by points (i) and (ii);

(iv) to the total percentage of animal feed of agricultural origin;

(d) accompanied by a list of names of feed materials from the organic production method;

(e) accompanied by a list of names of feed materials from products in conversion to organic production.

2. The indication provided for in Article 60 may be also accompanied by a reference to the requirement to use the feedingstuffs in accordance with Articles 21 and 22.

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CHAPTER 3 Other specific labelling requirements Article 62 In-conversion products of plant origin In-conversion products of plant origin may bear the indication "product under conversion to organic farming" provided that:

(a) a conversion period of at least 12 months before the harvest has been complied with;

(b) the indication shall appear in a colour, size and style of lettering which is not more prominent than the sales description of the product, the entire indication shall have the same size of letters;

(c) the product contains only one crop ingredient of agricultural origin;

(d) the indication is linked to the code number of the control body or control authority as referred to in Article 27(10) of Regulation 834/2007.

TITLE IV CONTROLS CHAPTER 1 Minimum control requirements Article 63 Control arrangements and undertaking by the operator 1. When the control arrangements are first implemented, the operator shall draw up and subsequently maintain:

(a) a full description of the unit and/or premises and/or activity;

(b) all the practical measures to be taken at the level of the unit and/or premises and/or activity to ensure compliance with the organic production rules;

(c) the precautionary measures to be taken in order to reduce the risk of contamination by unauthorised products or substances and the cleaning measures to be taken in storage places and throughout the operator's production chain.

Where appropriate, the description and measures provided for in the first subparagraph may be part of a quality system as set up by the operator.

2. The description and the measures referred to in paragraph 1 shall be contained in a declaration, signed by the responsible operator. In addition, this declaration shall include an undertaking by the operator:

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(a) to perform the operations in accordance with the organic production rules;

(b) to accept, in the event of infringement or irregularities, the enforcement of the measures of the organic production rules;

(c) to undertake to inform in writing the buyers of the product in order to ensure that the indications referring to the organic production method are removed from this production.

The declaration provided for in the first subparagraph shall be verified by the control body or control authority that issues a report identifying the possible deficiencies and non-compliances with the organic production rules. The operator shall countersign this report and take the necessary corrective measures.

3. For the application of Article 28(1) of Regulation (EC) No 834/2007 the operator shall notify the following information to the competent authority:

(a) Name and address of operator;

(b) Location of premises and, where appropriate, parcels (land register data) where operations are carried out;

(c) Nature of operations and products;

(d) Undertaking by the operator to carry out the operation in accordance with the provision laid down in Regulation (EC) No 834/2007 and this Regulation;

(e) In the case of an agricultural holding, the date on which the producer ceased to apply products not authorised for organic production on the parcels concerned;

(f) The name of the approved body to which the operator entrusted control of his undertaking, where the Member State has implemented the control system by approving such bodies.

Article 64 Modification of control arrangements The operator responsible shall notify any change in the description or of the measures referred to in Article 63 and in the initial control arrangements set out in Articles 70, 74, 80, 82, 86 and 88 to the control authority or control body in due time.

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Article 65 Control visits 1. The control authority or control body shall carry out at least once a year a physical inspection of all operators.

2. The control authority or control body may take samples for testing of products not authorised for organic production or for checking production techniques not in conformity with the organic production rules. Samples may also be taken and analysed for detecting possible contamination by products not authorised for organic production. However, such analysis shall be carried out where the use of products not authorised for organic production is suspected.

3. A control report shall be drawn up after each visit, countersigned by the operator of the unit or his representative.

4. Moreover, the control authority or control body shall carry out random control visits, primarily unannounced, based on the general evaluation of the risk of non-compliance with the organic production rules, taking into account at least the results of previous controls, the quantity of products concerned and the risk for exchange of products.

Article 66 Documentary accounts 1. Stock and financial records shall be kept in the unit or premises and shall enable the operator to identify and the control authority or control body to verify:

(a) the supplier and, where different, the seller, or the exporter of the products;

(b) the nature and the quantities of organic products delivered to the unit and, where relevant, of all materials bought and the use of such materials, and, where relevant, the composition of the compound feedingstuffs;

(c) the nature and the quantities of organic products held in storage at the premises;

(d) the nature, the quantities and the consignees and, where different, the buyers, other than the final consumers, of any products which have left the unit or the first consignee's premises or storage facilities;

(e) in case of operators who do not store or physically handle such organic products, the nature and the quantities of organic products bought and sold, and the suppliers, and where different, the sellers or the exporters and the buyers, and where different, the consignees.

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2. The documentary accounts shall also comprise the results of the verification at reception of organic products and any other information required by the control authority or control body for the purpose of proper control. The data in the accounts shall be documented with appropriate justification documents. The accounts shall demonstrate the balance between the input and the output.

3. Where an operator runs several production units in the same area, the units for non organic products, together with storage premises for input products must also be subject to the minimum control requirements.

Article 67 Access to facilities 1. The operator shall:

(a) give the control authority or control body, for control purposes, access to all parts of the unit and all premises, as well as to the accounts and relevant supporting documents;

(b) provide the control authority or control body with any information reasonably necessary for the purposes of the control;

(c) submit, when requested by the control authority or control body, the results of its own quality assurance programmes.

2. In addition to the requirements set out in paragraph 1, importers and first consignees shall submit the information on imported consignments referred to in Article 84.

Article 68 Documentary evidence For the purpose of the application of Article 29(1) of Regulation (EC) No 834/2007 the control authorities and the control bodies shall use the model of the documentary evidence set out in Annex XII to this Regulation.

Article 69

Vendor declaration

For the purpose of the application of Article 9(3) of Regulation (EC) No 834/2007 the vendor declaration that products supplied have not been produced from or by GMOs may follow the model set out in Annex XIII to this Regulation.

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CHAPTER 2 Specific control requirements for plants and plant products from farm production or collection Article 70 Control arrangements 1. The full description of the unit referred to in Article 63(1)(a) shall:

(a) be drawn up even where the operator limits his activity to the collection of wild plants;

(b) indicate the storage and production premises and land parcels and/or collection areas and, where applicable, premises where certain processing and/or packaging operations take place; and

(c) specify the date of the last application on the parcels and/or collection areas concerned of products, the use of which is not compatible with the organic production rules.

2. In case of collection of wild plants, the practical measures referred to in Article 63(1)(b) shall include any guarantees given by third parties which the operator can provide to ensure that the provisions of Article 12(2) of Regulation (EC) No 834/2007 are complied with.

Article 71 Communications Each year, before the date indicated by the control authority or control body, the operator shall notify the control authority or control body of its schedule of production of crop products, giving a breakdown by parcel.

Article 72

Plant production records

Plant production records shall be compiled in the form of a register and kept available to the control authorities or bodies at all times at the premises of the holding. In addition to Article 71 such records shall provide at least the following information:

(a) as regards the use of fertiliser: date of application, type and amount of fertiliser, parcels concerned;

(b) as regards the use of plant protection products: reason and date of treatment, type of product, method of treatment;

(c) as regards purchase of farm inputs: date, type and amount of purchased product;

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(d) as regards harvest: date, type and amount of organic or in conversion crop production.

Article 73 Several production units run by the same operator Where an operator runs several production units in the same area, the units producing non-organic crops, together with storage premises for farm input products shall also be subject to the general and the specific control requirements laid down in Chapter 1 and this Chapter of this Title.

CHAPTER 3 Control requirements for livestock and livestock products produced by animal husbandry Article 74 Control arrangements 1. When the control system applying specifically to livestock production is first implemented, the full description of the unit referred to in Article 63(1)(a) shall include:

(a) a full description of the livestock buildings, pasturage, open air areas, etc., and, where applicable, the premises for the storage, packaging and processing of livestock, livestock products, raw materials and inputs;

(b) a full description of the installations for the storage of livestock manure.

2. The practical measures referred to in Article 63(1)(b) shall include:

(a) a plan for spreading manure agreed with the control body or authority, together with a full description of the areas given over to crop production;

(b) where appropriate, as regards the spreading of manure, the written arrangements with other holdings as referred to in Article 3(3) complying with the provisions of the organic production rules;

(c) a management plan for the organic-production livestock unit.

Article 75 Identification of livestock The livestock shall be identified permanently using techniques adapted to each species, individually in the case of large mammals and individually or by batch in the case of poultry and small mammals.

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Article 76 Livestock records Livestock records shall be compiled in the form of a register and kept available to the control authorities or bodies at all times at the premises of the holding. Such records shall provide a full description of the herd or flock management system comprising at least the following information:

(a) as regards animals arriving at the holding: origin and date of arrival, conversion period, identification mark and veterinary record;

(b) as regards livestock leaving the holding: age, number of heads, weight in case of slaughter, identification mark and destination;

(c) details of any animals lost and reasons thereof;

(d) as regards feed: type, including feed supplements, proportions of various ingredients of rations and periods of access to free-range areas, periods of transhumance where restrictions apply;

(e) as regards disease prevention and treatment and veterinary care: date of treatment, details of the diagnosis, the posology; type of treatment product, the indication of the active pharmacological substances involved method of treatment and veterinary prescription for veterinary care with reasons and withdrawal periods applying before livestock products can be marketed labelled as organic.

Article 77 Control measures on veterinary medicinal products for livestock Whenever veterinary medicinal products are used the information according to Article 76(e) is to be declared to the control authority or body before the livestock or livestock products are marketed as organically produced. Livestock treated shall be clearly identified, individually in the case of large animals; individually, or by batch, or by hive, in the case of poultry, small animals and bees.

Article 78 Specific control measures on beekeeping 1. A map on an appropriate scale listing the location of hives shall be provided to the control authority or control body by the beekeeper. Where no areas are identified in accordance with Article 13(2), the beekeeper shall provide the control authority or control body with appropriate documentation and evidence, including suitable analyses if necessary, that the areas accessible to his colonies meet the conditions required in this Regulation.

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2. The following information shall be entered in the register of the apiary with regard to the use of feeding: type of product, dates, quantities and hives where it is used.

3. Whenever veterinary medicinal products are to be used, the type of product, including the indication of the active pharmacological substance, together with details of the diagnosis, the posology, the method of administration, the duration of the treatment and the legal withdrawal period shall be recorded clearly and declared to the control body or authority before the products are marketed as organically produced.

4. The zone where the apiary is situated shall be registered together with the identification of the hives. The control body or authority shall be informed of the moving of apiaries by a deadline agreed on with the control authority or body.

5. Particular care shall be taken to ensure adequate extraction, processing and storage of beekeeping products. All the measures to comply with this requirement shall be recorded.

6. The removals of the supers and the honey extraction operations shall be entered in the register of the apiary.

Article 79 Several production units run by the same operator Where an operator manages several production units, as provided for in Articles 17(1), 40 and 41, the units which produce non-organic livestock or non-organic livestock products shall also be subject to the control system as laid down in Chapter 1 and this Chapter of this Title.

CHAPTER 4 Control requirements for units for preparation of plant and livestock products and foodstuffs composed of plant and livestock products Article 80 Control arrangements In the case of a unit involved in the preparation for its own account or for account of a third party, and including in particular units involved in packaging and/or re-packaging of such products or units involved in labelling and/or re-labelling of such products, the full description of the unit referred to in Article 63(1)(a) shall show the facilities used for the reception, the processing, packaging, labelling and storage of agricultural

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products before and after the operations concerning them, as well as the procedures for the transport of the products.

CHAPTER 5 Control requirements for imports of plants, plant products, livestock, livestock products and foodstuffs comprising plant and/or livestock products, animal feedingstuffs, compound feedingstuffs and feed materials from third countries Article 81 Scope This Chapter applies to any operator involved, as importer and/or as first consignee, in the import and/or reception, for its own account or for account of another operator, of organic products.

Article 82 Control arrangements 1. In the case of the importer, the full description of the unit referred to in Article 63(1)(a) shall include the importer's premises and of his import activities, indicating the points of entry of the products into the Community and any other facilities the importer intends to use for the storage of the imported products pending their delivery to the first consignee.

In addition, the declaration referred to in Article 63(2) shall include an undertaking by the importer to ensure that any facilities that the importer will use for storage of products are submitted to control, to be carried out either by the control body or control authority or, when these storage facilities are situated in another Member State or region, by a control body or authority approved for control in that Member State or region.

2. In the case of the first consignee, the full description of the unit referred to in Article 63(1)(a) shall show the facilities used for the reception and storage.

3. Where the importer and the first consignee are the same legal person and operate in one single unit, the reports referred to in the second subparagraph of Article 63(2) may be formalised within one single report.

Article 83 Documentary accounts The importer and the first consignee shall keep separate stock and financial records, unless where they are operating in one single unit.

On request of the control authority or control body, any details on the transport arrangements from the exporter in the third country to the first

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consignee and, from the first consignee's premises or storage facilities to the consignees within the Community shall be provided.

Article 84 Information on imported consignments The importer shall, in due time, inform the control body or control authority of each consignment to be imported into the Community, providing:

(a) the name and address of the first consignee;

(b) any details the control body or authority may reasonably require,

(i) in case of products imported in accordance with Article 32 of Regulation (EC) No 834/2007, the documentary evidence referred to in that Article;

(ii) in case of products imported in accordance with Article 33 of Regulation (EC) No 834/2007, a copy of the certificate of inspection referred to in that Article.

On the request of the control body or control authority of the importer, the latter shall forward the information referred to in the first paragraph to the control body or control authority of the first consignee.

Article 85 Control visits The control authority or control body shall check the documentary accounts referred to in Article 83 of this Regulation and the certificate referred to in Article 33(1)(d) of Regulation (EC) No 834/2007 or the documentary evidence referred to in Article 32(1)(c) of the latter Regulation.

Where the importer performs the import operations by different units or premises, he shall make available on request the reports referred to in the second subparagraph of Article 63(2) of this Regulation for each of these facilities.

CHAPTER 6 Control requirements for units involved in the production, preparation or import of organic products and which have contracted out to third parties in part or in total the actual operations concerned Article 86 Control arrangements With regard to the operations, which are contracted out to third parties, the full description of the unit referred to in Article 63(1)(a) shall include:

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(a) a list of the subcontractors with a description of their activities and an indication of the control bodies or authorities to which they are subject;

(b) written agreement by the subcontractors that their holding will be subject to the control regime of Title V of Regulation (EC) No 834/2007;

(c) all the practical measures, including inter alia an appropriate system of documentary accounts, to be taken at the level of the unit to ensure that the products the operator places on the market can be traced to, as appropriate, their suppliers, sellers, consignees and buyers.

CHAPTER 7 Control requirements for units preparing feed Article 87 Scope This Chapter applies to any unit involved in the preparation of products referred to in Article 1(2)(c) of Regulation (EC) No 834/2007 on its own account or on behalf of a third party.

Article 88 Control arrangements 1. The full description of the unit referred to in Article 63(1)(a) shall indicate:

(a) the facilities used for the reception, preparation and storage of the products intended for animal feed before and after the operations concerning them;

(b) the facilities used for the storage of other products used to prepare feedingstuffs;

(c) the facilities used to store products for cleaning and disinfection;

(d) where necessary, the description of the compound feedingstuff that the operator intends to produce, in accordance with Article 5(1)(a) of Directive 79/373/EEC, and the livestock species or class for which the compound feedingstuff is intended;

(e) where necessary, the name of the feed materials that the operator intends to prepare.

2. The measures to be taken by operators, as referred to in Article 63(1)(b), to guarantee compliance with the organic production rules shall include the indications of measures referred to in Article 26.

3. The control authority or control body shall use these measures to carry out a general evaluation of the risks attendant on each preparation unit

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and to draw up a control plan. This control plan shall provide for a minimum number of random samples depending on the potential risks.

Article 89 Documentary accounts For the purposes of proper control of the operations, the documentary accounts referred to in Article 66 shall include information on the origin, nature and quantities of feed materials, additives, sales and finished products.

Article 90 Control visits The control visit referred to in Article 65 shall comprise a full physical inspection of all premises. Moreover, the control authority or control body shall make targeted visits based on a general evaluation of the potential risks of non-compliance with the organic production rules.

The control body or authority shall pay particular attention to the critical control points pointed out for the operator, with a view to establishing whether the surveillance and checking operations are carried out correctly.

All the premises used by the operator for the conduct of his activities may be checked as frequently as the attendant risks warrant.

CHAPTER 8 Infringements and exchange of information Article 91 Measures in case of suspicion of infringements and irregularities 1. Where an operator considers or suspects that a product which he has produced, prepared, imported or that he has received from another operator, is not in compliance with organic production rules, he shall initiate procedures either to withdraw from this product any reference to the organic production method or to separate and identify the product. He may only put it into processing or packaging or on the market after elimination of that doubt, unless it is placed on the market without indication referring to the organic production method. In case of such doubt, the operator shall immediately inform the control body or authority. The control authority or control body may require that the product cannot be placed on the market with indications referring to the organic production method until it is satisfied, by the information received from the operator or from other sources, that the doubt has been eliminated.

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2. Where a control authority or control body has a substantiated suspicion that an operator intends to place on the market a product not in compliance with the organic production rules but bearing a reference to the organic production method, this control authority or control body can require that the operator may provisionally not market the product with this reference for a time period to be set by that control authority or control body. Before taking such a decision, the control authority or control body shall allow the operator to comment. This decision shall be supplemented by the obligation to withdraw from this product any reference to the organic production method if the control authority or control body is sure that the product does not fulfil the requirements of organic production.

However, if the suspicion is not confirmed within the said time period, the decision referred to in the first subparagraph shall be cancelled not later than the expiry of that time period. The operator shall cooperate fully with the control body or authority in resolving the suspicion.

3. Member States shall take whatever measures and sanctions are required to prevent fraudulent use of the indications referred to in Title IV of Regulation (EC) No 834/2007 and Title III and/or Annex XI of this Regulation.

Article 92

Exchange of information

1. Where the operator and his subcontractors are checked by different control authorities or control bodies, the declaration referred to in Article 63(2) shall include an agreement by the operator on his behalf and that of his subcontractors, that the different control bodies or control authorities can exchange information on the operations under their control and on the way this exchange of information can be implemented.

2. Where a Member State finds irregularities or infringements relating to the application of this Regulation in a product coming from another Member State and bearing indications as referred to in Title IV of Regulation (EC) No 834/2007 and Title III and/or Annex XI of this Regulation, it shall inform the Member State which designated the control body or control authority and the Commission thereby.

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TITLE V TRANSMISSION OF INFORMATION TO THE COMMISSION, TRANSITIONAL AND FINAL PROVISIONS CHAPTER 1 Transmission of information to the Commission Article 93 Statistical information 1. Member States shall provide the Commission with the annual statistical information on organic production referred to in Article 36 of Regulation (EC) No 834/2007 by using the computer system enabling electronic exchanges of documents and information made available by the Commission (Eurostat) before 1 July each year.

2. The statistical information referred to in paragraph 1 shall comprise, in particular the following data:

(a) the number of organic producers, processors, importers and exporters;

(b) the organic crop production and crop area under conversion and under organic production;

(c) the organic livestock numbers and the organic animal products;

(d) the data on organic industrial production by type of activities.

3. For the transmission of the statistical information referred to in paragraphs 1 and 2, Member States shall use the Single Entry point provided by the Commission (Eurostat).

4. The provisions relating to the characteristics of statistical data and metadata shall be defined within the context of the Community Statistical Programme on the basis of models or questionnaires made available via the system referred to in paragraph 1.

Article 94 Other information 1. Member States shall provide the Commission with the following information by using the computer system enabling electronic exchanges of documents and information made available by the Commission (DG Agriculture and rural development) for information other than statistical information:

(a) before 1 January 2009, the information referred to in Article 35(a) of Regulation (EC) No 834/2007 and afterwards each modification when that appears;

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(b) by 31 March each year, the information referred to in Article 35(b) of Regulation (EC) No 834/2007, as regards control authorities and bodies approved on 31 December of the previous year,

(c) before 1 July each year, all other information required or needed in accordance with this Regulation.

2. The data shall be communicated, entered and updated in the system referred to in paragraph 1 under the responsibility of the competent authority as referred to in Article 35 of Regulation (EC) No 834/2007, by the authority itself or by the body to which that function has been delegated.

3. The provisions relating to the characteristics of data and metadata shall be defined on the basis of models or questionnaires made available via the system referred to in paragraph 1.

CHAPTER 2 Transitional and final provisions Article 95 Transitional measures 1. For a transitional period expiring on 31 December 2010, cattle may be tethered in buildings already existing before 24 August 2000, provided that regular exercise is provided and rearing takes place in line with animal welfare requirements with comfortably littered areas as well as individual management and provided that the competent authority has authorised this measure. The competent authority may continue authorising this measure upon request of individual operators for its application in a limited period ending before the 31 December 2013, under the additional condition that the controls visits referred to in Article 65(1) are carried out at least twice a year.

2. The competent authority may authorise, for a transitional period expiring on 31 December 2010, the exceptions concerning housing conditions and stocking density granted to livestock producing holdings on the basis of the derogation provided for in part B, paragraph 8.5.1 of Annex I to Regulation (EEC) No 2092/91. The operators benefiting from this extension shall present a plan to the control authority or control body, containing the description of arrangements which are intended to ensure compliance with the provisions of the organic production rules by the end of the transitional period. The competent authority may continue authorising this measure upon request of individual operators for its application in a limited period ending before the 31 December 2013, under the additional condition that

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the controls visits referred to in Article 65(1) are carried out at least twice a year.

3. For a transition period expiring 31 December 2010 the final fattening phase of sheep and pigs for meat production as laid down under point 8.3.4 of Annex I.B of Regulation (EEC) No 2092/91 may take place indoors under the condition that the controls visits referred to in Article 65(1) are carried out at least twice a year.

4. The castration of piglets may be carried out without the application of anaesthesia and/or analgesia during a transition period expiring on 31 December 2011.

5. Pending the inclusion of detailed processing rules for pet food, national rules or in the absence thereof, private standards accepted or recognised by the Member States shall apply.

6. For the purpose of Article 12(1)(j) of Regulation (EC) No 834/2007 and pending the inclusion of specific substances according to Article 16(f) of that Regulation, only products authorised by the competent authorities may be used.

7. Authorisations of non-organic ingredients of agricultural origin granted by Member States under Regulation (EEC) No 207/93 may be deemed granted as under this Regulation. However, authorisations granted in accordance with Article 3(6) of the former Regulation shall expire on 31 December 2009.

8. For a transitional period expiring on the 1 July 2010, the operators may continue to use in the labelling the provisions as laid down in Regulation (EEC) No 2092/91 for:

(i) the system for calculation the percentage of organic ingredients of food;

(ii) the code number and/or the name of the control body or control authority.

9. Stocks of products produced, packaged and labelled before 1 January 2009 in accordance with Regulation (EEC) No 2092/91 may continue to be brought on the market bearing terms referring to organic production until stocks are exhausted.

10. Packaging material in accordance with Regulation (EEC) No 2092/91 may continue to be used for products brought to the market bearing terms referring to organic production until 1 January 2012, where the product otherwise complies with the requirements of Regulation (EC) 834/2007.

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Article 96 Repeal Regulations (EEC) No 207/93, (EC) No 223/2003 and (EC) No 1452/2003 are repealed.

References to the repealed Regulations and to Regulation (EEC) No 2092/91 shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex XIV.

Article 97 Entry into force and application This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union.

It shall apply as from 1 January 2009.

However, paragraph 2(a) of Article 27 and Article 58 shall apply as of 1 July 2010.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 September 2008.

For the Commission

Mariann Fischer Boel

Member of the Commission

[1] OJ L 189, 20.7.2007, p. 1.

[2] OJ L198, 22.7.1991, p. 1.

[3] OJ L 165, 30.4.2004, p. 1. Corrected by OJ L 191, 28.5.2004, p. 1.

[4] OJ L 25, 2.2.1993, p. 5.

[5] OJ L 206, 15.8.2003, p. 17.

[6] OJ L 31, 6.2.2003, p. 3.

[7] OJ L 311, 28.11.2001, p. 1.

[8] OJ L 375, 31.12.1991, p. 1.

[9] OJ L 368, 23.12.2006, p. 15.

[10] OJ L 340, 11.12.1991, p. 28.

[11] OJ L 340, 11.12.1991, p. 33.

[12] OJ L 277, 21.10.2005, p. 1.

[13] OJ L 160, 26.6.1999, p. 80.

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[14] OJ L 184, 15.7.1988, p. 61.

[15] OJ L 237, 10.9.1994, p. 13.

[16] OJ L 169, 10.7.2000, p. 1.

[17] OJ L 193, 20.7.2002, p. 1.

[18] OJ L 193, 20.7.2002, p. 33.

[19] OJ L 86, 6.4.1979, p. 30.

[20] OJ L 125, 23.5.1996, p. 35.

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ANNEX I Fertilisers and soil conditioners referred to in Article 3(1) Note: A : authorised under Regulation (EEC) No 2092/91 and carried over by Article 16(3)(c) of Regulation (EC) No 834/2007 B : authorised under Regulation (EC) No 834/2007 Authorisation | Name | Description, compositional requirements, conditions for use | A | Compound products or products containing only materials listed hereunder: Farmyard manure | Product comprising a mixture of animal excrements and vegetable matter (animal bedding). Factory farming origin forbidden | A | Dried farmyard manure and dehydrated poultry manure | Factory farming origin forbidden | A | Composted animal excrements, including poultry manure and composted farmyard manure included | Factory farming origin forbidden | A | Liquid animal excrements | Use after controlled fermentation and/or appropriate dilution Factory farming origin forbidden | A | Composted or fermented household waste | Product obtained from source separated household waste, which has been submitted to composting or to anaerobic fermentation for biogas production Only vegetable and animal household waste Only when produced in a closed and monitored collection system, accepted by the Member State Maximum concentrations in mg/kg of dry matter: cadmium: 0,7; copper: 70; nickel: 25; lead: 45; zinc: 200; mercury: 0,4; chromium (total): 70; chromium (VI): 0 | A | Peat | Use limited to horticulture (market gardening, floriculture, arboriculture, nursery) | A | Mushroom culture wastes | The initial composition of the substrate shall be limited to products of this Annex | A | Dejecta of worms (vermicompost) and insects | |

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A | Guano | | A | Composted or fermented mixture of vegetable matter | Product obtained from mixtures of vegetable matter, which have been submitted to composting or to anaerobic fermentation for biogas production | A | Products or by-products of animal origin as below: blood mealhoof mealhorn mealbone meal or degelatinized bone mealfish mealmeat mealfeather, hair and "chiquette" mealwoolfurhairdairy products | Maximum concentration in mg/kg of dry matter of chromium (VI): 0 | A | Products and by-products of plant origin for fertilisers | Examples: oilseed cake meal, cocoa husks, malt culms | A | Seaweeds and seaweed products | As far as directly obtained by: (i)physical processes including dehydration, freezing and grinding(ii)extraction with water or aqueous acid and/or alkaline solution(iii)fermentation | A | Sawdust and wood chips | Wood not chemically treated after felling | A | Composted bark | Wood not chemically treated after felling | A | Wood ash | From wood not chemically treated after felling | A | Soft ground rock phosphate | Product as specified in point 7 of Annex IA.2. to Regulation (EC) No 2003/2003 of the European Parliament and of the Council [1] relating to fertilisers , 7 Cadmium content less than or equal to 90 mg/kg of P205 | A | Aluminium-calcium phosphate | Product as specified in point 6 of Annex IA.2. of Regulation 2003/2003, Cadmium content less than or equal to 90 mg/kg of P205 Use limited to basic soils (pH > 7,5) | A | Basic slag | Products as specified in point 1 of Annex IA.2. of Regulation 2003/2003 | A | Crude potassium salt or kainit | Products as specified in point 1 of Annex IA.3. of Regulation 2003/2003 | A | Potassium sulphate, possibly containing magnesium salt | Product obtained from crude potassium salt by a physical extraction process, containing possibly also magnesium salts | A | Stillage and stillage extract | Ammonium stillage excluded | A | Calcium carbonate (chalk, marl, ground limestone, Breton ameliorant, (maerl), phosphate chalk) | Only of natural origin | A | Magnesium and calcium carbonate | Only of natural origin e.g. magnesian chalk, ground magnesium, limestone | A | Magnesium sulphate (kieserite) | Only of natural origin | A | Calcium chloride solution | Foliar treatment of apple trees, after identification of deficit of calcium | A | Calcium sulphate (gypsum) | Products as specified in point 1 of Annex ID. of Regulation 2003/2003 Only of natural origin |

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A | Industrial lime from sugar production | By-product of sugar production from sugar beet | A | Industrial lime from vacuum salt production | By-product of the vacuum salt production from brine found in mountains | A | Elemental sulphur | Products as specified in Annex ID.3 of Regulation 2003/2003 | A | Trace elements | Inorganic micronutrients listed in part E of Annex I to Regulation 2003/2003 | A | Sodium chloride | Only mined salt | A | Stone meal and clays | | [1] OJ L 304, 21.11.2003, p. 1. -------------------------------------------------- ANNEX II Pesticides — plant protection products referred to in Article 5(1) Note: A : authorised under Regulation (EEC) No 2092/91 and carried over by Article 16(3)(c) of Regulation (EC) No 834/2007 B : authorised under Regulation (EC) No 834/2007 1. Substances of crop or animal origin Authorisation | Name | Description, compositional requirement, conditions for use | A | Azadirachtin extracted from Azadirachta indica (Neem tree) | Insecticide | A | Beeswax | Pruning agent | A | Gelatine | Insecticide | A | Hydrolysed proteins. | Attractant, only in authorized applications in combination with other appropriate products of this list | A | Lecithin | Fungicide | A | Plant oils (e.g. mint oil, pine oil, caraway oil). | Insecticide, acaricide, fungicide and sprout inhibitor. | A | Pyrethrins extracted from Chrysanthemum cinerariaefolium | Insecticide | A | Quassia extracted from Quassia amara | Insecticide, repellent | A | Rotenone extracted from Derris spp. and Lonchocarpus spp. and Terphrosia spp. | Insecticide | 2. Micro-organisms used for biological pest and disease control Authorisation | Name | Description, compositional requirement, conditions for use | A | Micro-organisms (bacteria, viruses and fungi) | | 3. Substances produced by micro-organisms

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Authorisation | Name | Description, compositional requirement, conditions for use | A | Spinosad | Insecticide Only where measures are taken to minimize the risk to key parasitoids and to minimize the risk of development of resistance | 4. Substances to be used in traps and/or dispensers Authorisation | Name | Description, compositional requirement, conditions for use | A | Diammonium phosphate | Attractant, only in traps | A | Pheromones | Attractant; sexual behaviour disrupter; only in traps and dispensers | A | Pyrethroids (only deltamethrin or lambdacyhalothrin) | Insecticide; only in traps with specific attractants; only against Bactrocera oleae and Ceratitis capitata Wied. | 5. Preparations to be surface-spread between cultivated plants Authorisation | Name | Description, compositional requirement, conditions for use | A | Ferric phosphate (iron (III) orthophosphate) | Molluscicide | 6. Other substances from traditional use in organic farming Authorisation | Name | Description, compositional requirement, conditions for use | A | Copper in the form of copper hydroxide, copper oxychloride, (tribasic) copper sulphate, cuprous oxide, copper octanoate | Fungicide. up to 6 kg copper per ha per year For perennial crops, Member States may, by derogation from the previous paragraph, provide that the 6 kg copper limit can be exceeded in a given year provided that the average quantity actually used over a 5-year period consisting of that year and of the four preceding years does not exceed 6 kg | A | Ethylene | Degreening bananas, kiwis and kakis; Degreening of citrus fruit only as part of a strategy for the prevention of fruit fly damage in citrus; Flower induction of pineapple; sprouting inhibition in potatoes and onions | A | Fatty acid potassium salt (soft soap) | Insecticide | A | Potassium aluminium (aluminium sulphate) (Kalinite) | Prevention of ripening of bananas | A | Lime sulphur (calcium polysulphide) | Fungicide, insecticide, acaricide | A | Paraffin oil | Insecticide, acaricide | A | Mineral oils | Insecticide, fungicide; only in fruit trees, vines, olive trees and tropical crops (e.g. bananas); | A | Potassium permanganate | Fungicide, bactericide; only in fruit trees, olive trees and vines. |

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A | Quartz sand | Repellent | A | Sulphur | Fungicide, acaricide, repellent | 7. Other substances Authorisation | Name | Description, compositional requirement, conitions for use | A | Calcium hydroxide | Fungicide Only in fruit trees, including nurseries, to control Nectria galligena | A | Potassium bicarbonate | Fungicide | -------------------------------------------------- ANNEX III Minimum surface areas indoors and outdoors and other characteristics of housing in the different species and types of production referred to in Article 10(4) 1. Bovines, equidae, ovine, caprine and porcine | Indoors area (net area available to animals) | Outdoors area (exercise area, excluding pasturage) | | Live weight minimum (kg) | M2/head | M2/head | Breeding and fattening bovine and equidae | up to 100 | 1,5 | 1,1 | up to 200 | 2,5 | 1,9 | up to 350 | 4,0 | 3 | over 350 | 5 with a minimum of 1 m2/100 kg | 3,7 with a minimum of 0,75 m2/100 kg | Dairy cows | | 6 | 4,5 | Bulls for breeding | | 10 | 30 | Sheep and goats | | 1,5 sheep/goat | 2,5 | | 0,35 lamb/kid | 0,5 | Farrowing sows with piglets up to 40 days | | 7,5 sow | 2,5 | Fattening pigs | up to 50 | 0,8 | 0,6 | up to 85 | 1,1 | 0,8 | up to 110 | 1,3 | 1 | Piglets | over 40 days and up to 30 kg | 0,6 | 0,4 | Brood pigs | | 2,5 female | 1,9 | | 6 male If pens are used for natural service: 10 m2/boar | 8,0 | 2. Poultry | Indoors area (net area available to animals) | Outdoors area (m2 of area available in rotation/head) | | No animals/m2 | cm perch/animal | nest | Laying hens | 6 | 18 | 7 laying hens per nest or in case of common nest 120 cm2/bird | 4, provided that the limit of 170 kg of N/ha/year is not exceeded |

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Fattening poultry (in fixed housing) | 10 with a maximum of 21 kg liveweight/m2 | 20 (for guinea fowl only) | | 4 broilers and guinea fowl 4,5 ducks 10 turkey 15 geese In all the species mentioned above the limit of 170 kg of N/ha/year is not exceeded | Fattening poultry in mobile housing | 16 [1] in mobile poultry houses with a maximum of 30 kg liveweight/m2 | | | 2,5, provided that the limit of 170 kg of N/ha/year is not exceeded | [1] Only in the case of mobile houses not exceeding 150 m2 floor space. -------------------------------------------------- ANNEX IV Maximum number of animals per hectare referred to in Article 15 (2) Class or species | Maximum number of animals per ha equivalent to 170 kg N/ha/year | Equines over six months old | 2 | Calves for fattening | 5 | Other bovine animals less than one year old | 5 | Male bovine animals from one to less than two years old | 3,3 | Female bovine animals from one to less than two years old | 3,3 | Male bovine animals two years old or over | 2 | Breeding heifers | 2,5 | Heifers for fattening | 2,5 | Dairy cows | 2 | Cull dairy cows | 2 | Other cows | 2,5 | Female breeding rabbits | 100 | Ewes | 13,3 | Goats | 13,3 | Piglets | 74 | Breeding sows | 6,5 | Pigs for fattening | 14 | Other pigs | 14 | Table chickens | 580 | Laying hens | 230 | -------------------------------------------------- ANNEX V Feed materials referred to in Article 22(1), (2) and (3) 1. NON-ORGANIC FEED MATERIALS OF PLANT ORIGIN 1.1. Cereals, grains, their products and by-products: - Oats as grains, flakes, middlings, hulls and bran - Barley as grains, protein and middlings - Rice germ expeller

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- Millet as grains - Rye as grains and middlings - Sorghum as grains - Wheat as grains, middlings, bran, gluten feed, gluten and germ - Spelt as grains - Triticale as grains - Maize as grains, bran, middlings, germ expeller and gluten - Malt culms - Brewers' grains 1.2. Oil seeds, oil fruits, their products and by-products: - Rape seed, expeller and hulls - Soya bean as bean, toasted, expeller and hulls - Sunflower seed as seed and expeller - Cotton as seed and seed expeller - Linseed as seed and expeller - Sesame seed as expeller - Palm kernels as expeller - Pumpkin seed as expeller - Olives, olive pulp - Vegetable oils (from physical extraction). 1.3. Legume seeds, their product and by-products: - Chickpeas as seeds, middlings and bran - Ervil as seeds, middlings and bran - Chickling vetch as seeds submitted to heat treatment, middlings and bran - Peas as seeds, middlings, and bran - Broad beans as seeds, middlings and bran - Horse beans as seeds middlings and bran - Vetches as seeds, middlings and bran - Lupin as seeds, middlings and bran 1.4. Tuber, roots, their products and by-products: - Sugar beet pulp - Potato - Sweet potato as tuber - Potato pulp (by-product of the extraction of potato starch) - Potato starch - Potato protein - Manioc. 1.5. Other seeds and fruits, their products and by-products: - Carob - Carob pods and meals thereof - Pumpkins,

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- Citrus pulp - Apples, quinces, pears, peaches, figs, grapes and pulps thereof - Chestnuts - Walnut expeller - Hazelnut expeller - Cocoa husks and expeller - Acorns. 1.6. Forages and roughages: - Lucerne - Lucerne meal - Clover - Clover meal - Grass (obtained from forage plants) - Grass meal - Hay - Silage - Straw of cereals - Root vegetables for foraging 1.7. Other plants, their products and by-products: - Molasses - Seaweed meal (obtained by drying and crushing seaweed and washed to reduce iodine content) - Powders and extracts of plants - Plant protein extracts (solely provided to young animals) - Spices - Herbs 2. FEED MATERIALS OF ANIMAL ORIGIN 2.1. Milk and milk products: - Raw milk - Milk powder - Skimmed milk, skimmed-milk powder, - Buttermilk, buttermilk powder - Whey, whey powder, whey powder low in sugar, whey protein powder (extracted by physical treatment) - Casein powder - Lactose powder - Curd and sour milk 2.2. Fish, other marine animals, their products and by-products: Under the following restrictions: Products origin only from sustainable fisheries and to be used only for species other than herbivores - Fish

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- Fish oil and cod-liver oil not refined - Fish molluscan or crustacean autolysates - Hydrolysate and proteolysates obtained by an enzyme action, whether or not in soluble form, solely provided to young animals - Fish meal 2.3. Egg and egg products - Eggs and egg products for use as poultry feed, primarily from the same holding. 3. FEED MATERIALS OF MINERAL ORIGIN 3.1. Sodium: - unrefined sea salt - coarse rock salt - sodium sulphate - sodium carbonate - sodium bicarbonate - sodium chloride 3.2. Potassium: - potassium chloride 3.3. Calcium: - lithotamnion and maerl - shells of aquatic animals (including cuttlefish bones) - calcium carbonate - calcium lactate - calcium gluconate 3.4. Phosphorus: - defluorinated dicalcium phosphate - defluorinated monocalcium phosphate - monosodium phosphate - calcium-magnesium phosphate - calcium-sodium phosphate 3.5. Magnesium: - magnesium oxide (anhydrous magnesia) - magnesium sulphate - magnesium chloride - magnesium carbonate - magnesium phosphate 3.6. Sulphur: - sodium sulphate. --------------------------------------------------

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ANNEX VI Feed additives and certain substances used as in animal nutrition referred to in Article 22(4) 1. FEED ADDITIVES Additives listed must have been approved under Regulation (EC) No 1831/2003 of the European Parliament and of the Council [1] on additives for use in animal nutrition 1.1. Nutritional additives (a) Vitamins - Vitamins derived from raw materials occurring naturally in feedingstuffs; - Synthetic vitamins identical to natural vitamins for monogastric animals; - Synthetic vitamins A, D, and E identical to natural vitamins for ruminants with prior authorisation of the Member States based on the assessment of the possibility for organic ruminants to obtain the necessary quantities of the said vitamins through their feed rations. (b) Trace elements E1 | Iron: | | ferrous (II) carbonate | | ferrous (II) sulphate monohydrate and/or heptahydrate | | ferric (III) oxide; | E2 | Iodine: | | calcium iodate, anhydrous | | calcium iodate, hexahydrate | | sodium iodide; | E3 | Cobalt: | | cobaltous (II) sulphate monohydrate and/or heptahydrate | | basic cobaltous (II) carbonate, monohydrate; | E4 | Copper: | | copper (II) oxide | | basic copper (II) carbonate, monohydrate | | copper (II) sulphate, pentahydrate; | E5 | Manganese: | | manganous (II) carbonate | | manganous oxide and manganic oxide | | manganous (II) sulfate, mono- and/or tetrahydrate; | E6 | Zinc: | | zinc carbonate | | zinc oxide | | zinc sulphate mono- and/or heptahydrate; | E7 | Molybdenum: | | ammonium molybdate, sodium molybdate; |

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E8 | Selenium: | | sodium selenate | | sodium selenite. | 1.2. Zoo-technical additives Enzymes and micro-organisms 1.3. Technological additives (a) Preservatives E 200 | Sorbic acid | E 236 | Formic acid [**] | E 260 | Acetic acid [**] | E 270 | Lactic acid [**] | E 280 | Propionic acid [**] | E 330 | Citric acid. | (b) Antioxidant substances E 306 — Tocopherol-rich extracts of natural origin used as an antioxidant (c) Binders and anti-caking agents E 470 | Calcium stearate of natural origin | E 551b | Colloidal silica | E 551c | Kieselgur | E 558 | Bentonite | E 559 | Kaolinitic clays | E 560 | Natural mixtures of stearites and chlorite | E 561 | Vermiculite | E 562 | Sepiolite | E 599 | Perlite. | (d) Silage additives Enzymes, yeasts and bacteria can be used as silage additives The use of lactic, formic, propionic and acetic acid in the production of silage shall only be permitted when weather conditions do not allow for adequate fermentation 2. CERTAIN SUBSTANCES USED IN ANIMAL NUTRITION Substance listed must have been approved under Council Directive 82/471/EEC concerning certain products used in animal nutrition [3] Yeasts: Saccharomyces cerevisiae Saccharomyces carlsbergiensis 3. SUBSTANCES FOR SILAGE PRODUCTION - sea salt - coarse rock salt - whey - sugar

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- sugar beet pulp - cereal flour - molasses [1] OJ L 268, 18.10.2003, p. 29. [**] For silage: only when weather conditions do not allow for adequate fermentation. [3] OJ L 213, 21.7.1982, p. 8. -------------------------------------------------- ANNEX VII Products for cleaning and disinfection referred to in Article 23 (4) Products for cleaning and disinfection of buildings and installations for animal production: - Potassium and sodium soap - Water and steam - Milk of lime - Lime - Quicklime - Sodium hypochlorite (e.g. as liquid bleach) - Caustic soda - Caustic potash - Hydrogen peroxide - Natural essences of plants - Citric, peracetic acid, formic, lactic, oxalic and acetic acid - Alcohol - Nitric acid (dairy equipment) - Phosporic acid (dairy equipment) - Formaldehyde - Cleaning and disinfection products for teats and milking facilities - Sodium carbonate -------------------------------------------------- ANNEX VIII Certain products and substances for use in production of processed organic food referred to in Article 27(1)(a) Note: A : authorised under Regulation (EEC) No 2092/91 and carried over by Article 21(2) of Regulation (EC) No 834/2007 B : authorised under Regulation (EC) No 834/2007 SECTION A — FOOD ADDITIVES, INCLUDING CARRIERS For the purpose of the calculation referred to in Article 23(4)(a)(ii) of Regulation (EC) No 834/2007, food additives marked with an asterisk in the

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column of the code number, shall be calculated as ingredients of agricultural origin. Authorisation | Code | Name | Preparation of foodstuffs of | Specific conditions | plant origin | animal origin | A | E 153 | Vegetable carbon | | X | Ashy goat cheese Morbier cheese | A | E 160b* | Annatto, Bixin, Norbixin | | X | Red Leicester cheese Double Gloucester cheese Cheddar Mimolette cheese | A | E 170 | Calcium carbonate | X | X | Shall not be used for colouring or calcium enrichment of products | A | E 220 Or | Sulphur dioxide | X | X | In fruit wines [****] without added sugar (including cider and perry) or in mead: 50 mg [*****] | | E 224 | Potassium metabisulphite | X | X | For cider and perry prepared with addition of sugars or juice concentrate after fermentation: 100 mg [*****] | | | | | | | A | E 250 or | Sodium nitrite | | X | For meat products [1]: | | E 252 | Potassium nitrate | | X | For E 250: indicative ingoing amount expressed as NaNO2: 80 mg/kg For E 252: indicative ingoing amount expressed as NaNO3: 80 mg/kg For E 250: maximum residual amount expressed as NaNO2: 50 mg/kg For E 252: maximum residual amount expressed as NaNO3: 50 mg/kg | A | E 270 | Lactic acid | X | X | | A | E 290 | Carbon dioxide | X | X | | A | E 296 | Malic acid | X | | | A | E 300 | Ascorbic acid | X | X | Meat products [2] | A | E 301 | Sodium ascorbate | | X | Meat products [2] in connection with nitrates and nitrites | A | E 306* | Tocopherol-rich extract | X | X | Anti-oxidant for fats and oils | A | E 322* | Lecithins | X | X | Milk products [2] | A | E 325 | Sodium lactate | | X | Milk-based and meat products | A | E 330 | Citric acid | X | | | A | E 331 | Sodium citrates | | X | | A | E 333 | Calcium citrates | X | | | A | E 334 | Tartaric acid (L(+)–) | X | | | A | E 335 | Sodium tartrates | X | | | A | E 336 | Potassium tartrates | X | | | A | E 341 (i) | Monocalcium-phosphate | X | | Raising agent for self raising flour | A | E 400 | Alginic acid | X | X | Milk-based products [2] | A | E 401 | Sodium alginate | X | X | Milk-based products [2] |

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A | E 402 | Potassium alginate | X | X | Milk-based products [2] | A | E 406 | Agar | X | X | Milk-based and meat products [2] | A | E 407 | Carrageenan | X | X | Milk-based products [2] | A | E 410* | Locust bean gum | X | X | | A | E 412* | Guar gum | X | X | | A | E 414* | Arabic gum | X | X | | A | E 415 | Xanthan gum | X | X | | A | E 422 | Glycerol | X | | For plant extracts | A | E 440 (i)* | Pectin | X | X | Milk-based products [2] | A | E 464 | Hydroxypropyl methyl cellulose | X | X | Encapsulation material for capsules | A | E 500 | Sodium carbonates | X | X | "Dulce de leche" [3] and soured-cream butter and sour milk cheese [2] | A | E 501 | Potassium carbonates | X | | | A | E 503 | Ammonium carbonates | X | | | A | E 504 | Magnesium carbonates | X | | | A | E 509 | Calcium chloride | | X | Milk coagulation | A | E 516 | Calcium sulphate | X | | Carrier | A | E 524 | Sodium hydroxide | X | | Surface treatment of "Laugengebäck" | A | E 551 | Silicon dioxide | X | | Anti-caking agent for herbs and spices | A | E 553b | Talc | X | X | Coating agent for meat products | A | E 938 | Argon | X | X | | A | E 939 | Helium | X | X | | A | E 941 | Nitrogen | X | X | | A | E 948 | Oxygen | X | X | | SECTION B — PROCESSING AIDS AND OTHER PRODUCTS, WHICH MAY BE USED FOR PROCESSING OF INGREDIENTS OF AGRICULTURAL ORIGIN FROM ORGANIC PRODUCTION Note: A : authorised under Regulation (EEC) No 2092/91 and carried over by Article 21(2) of Regulation (EC) No 834/2007 B : authorised under Regulation (EC) No 834/2007 Authorisation | Name | Preparation of foodstuffs of plant origin | Preparation of foodstuffs of animal origin | Specific conditions | A | Water | X | X | Drinking water within the meaning of Council Directive 98/83/EC | A | Calcium chloride | X | | Coagulation agent | A | Calcium carbonate | X | | | | Calcium hydroxide | X | | | A | Calcium sulphate | X | | Coagulation agent |

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A | Magnesium chloride (or nigari) | X | | Coagulation agent | A | Potassium carbonate | X | | Drying of grapes | A | Sodium carbonate | X | | Sugar(s) production | A | Lactic acid | | X | For the regulation of the pH of the brine bath in cheese production [6] | A | Citric acid | X | X | For the regulation of the pH of the brine bath in cheese production [6] Oil production and hydrolysis of starch [7] | A | Sodium hydroxide | X | | Sugar(s) production Oil production from rape seed (Brassica spp) | A | Sulphuric acid | X | X | Gelatine production [6] Sugar(s) production [7] | A | Hydrochloric acid | | X | Gelatine production For the regulation of the pH of the brine bath in the processing of Gouda-, Edam and Maasdammer cheeses, Boerenkaas, Friese and Leidse Nagelkaas | A | Ammonium hydroxide | | X | Gelatine production | A | Hydrogen peroxide | | X | Gelatine production | A | Carbon dioxide | X | X | | A | Nitrogen | X | X | | A | Ethanol | X | X | Solvent | A | Tannic acid | X | | Filtration aid | A | | | | | A | Egg white albumen | X | | | A | Casein | X | | | A | Gelatin | X | | | A | Isinglass | X | | | A | Vegetable oils | X | X | Greasing, releasing or anti-foaming agent | A | Silicon dioxide gel or colloidal solution | X | | | A | Activated carbon | X | | | A | Talc | X | | In compliance with the specific purity criteria for food additive E 553b | A | Bentonite | X | X | Sticking agent for mead [6] In compliance with the specific purity criteria for food additive E 558 | A | Kaolin | X | X | Propolis [6] In compliance with the specific purity criteria for food additive E 559 | A | Celluose | X | X | Gelatine production [6] | A | Diatomaceous earth | X | X | Gelatine production [6] | A | Perlite | X | X | Gelatine production [6] | A | Hazelnut shells | X | | | A | Rice meal | X | | | A | Beeswax | X | | Releasing agent | A | Carnauba wax | X | | Releasing agent |

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[1] This additive can only be used, if it has been demonstrated to the satisfaction of the competent authority that no technological alternative, giving the same guarantees and/or allowing to maintain the specific features of the product, is available. [2] The restriction concerns only animal products. [3] "Dulce de leche" or "Confiture de lait" refers to a soft, luscious, brown cream, made of sweetened, thickened milk. [****] In this context, "fruit wine" is defined as wine made from fruits other than grapes. [*****] Maximum levels available from all sources, expressed as SO2 in mg/l. [6] The restriction concerns only animal products. [7] The restriction concerns only plant products. -------------------------------------------------- ANNEX IX Ingredients of agricultural origin which have not been produced organically referred to in Article 28 1. UNPROCESSED VEGETABLE PRODUCTS AS WELL AS PRODUCTS DERIVED THEREFROM BY PROCESSES 1.1. Edible fruits, nuts and seeds: acorns | Quercus spp. | cola nuts | Cola acuminata | gooseberries | Ribes uva-crispa | maracujas (passion fruit) | Passiflora edulis | raspberries (dried) | Rubus idaeus | red currants (dried) | Ribes rubrum | 1.2. Edible spices and herbs: pepper (Peruvian) | Schinus molle L. | horseradish seeds | Armoracia rusticana | lesser galanga | Alpinia officinarum | safflower flowers | Carthamus tinctorius | watercress herb | Nasturtium officinale | 1.3. Miscellaneous: Algae, including seaweed, permitted in non-organic foodstuffs preparation 2. VEGETABLE PRODUCTS 2.1. Fats and oils whether or not refined, but not chemically modified, derived from plants other than: cocoa | Theobroma cacao | coconut | Cocos nucifera | olive | Olea europaea | sunflower | Helianthus annuus |

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palm | Elaeis guineensis | rape | Brassica napus, rapa | safflower | Carthamus tinctorius | sesame | Sesamum indicum | soya | Glycine max | 2.2. The following sugars, starches and other products from cereals and tubers: - fructose - rice paper - unleavened bread paper - starch from rice and waxy maize, not chemically modified 2.3. Miscellaneous: - pea protein Pisum spp. - rum, only obtained from cane sugar juice - kirsch prepared on the basis of fruits and flavourings as referred to in Article 27(1)(c). 3. ANIMAL PRODUCTS aquatic organisms, not originating from aquaculture, and permitted in no-organic foodstuffs preparation - gelatin - whey powder "herasuola" - casings -------------------------------------------------- ANNEX X Species for which organically produced seed or seed potatoes are available in sufficient quantities and for a significant number of varieties in all parts of the Community referred to in Article 45(3) -------------------------------------------------- ANNEX XI Community logo, referred to in Article 57 A. A COMMUNITY LOGO 1. Conditions with regard to the presentation and use of the Community Logo 1.1. The Community logo referred to above shall comprise of the models in part B.2 of this Annex. 1.2. The indications that must be included in the logo are listed in part B.3 of this Annex. It is possible to combine the logo with the indication mentioned in the Annex Council Regulation (EC) No 834/2007. 1.3. To use the Community logo and the indications referred to in part B.3 of this Annex, the technical reproduction rules laid down in the graphic manual in part B.4 of this Annex must be complied with.

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B.2. Models Español | Čeština | Dansk | +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ | | | Deutsch | Deutsch | Eesti keel | +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ | | | Eesti keel | Eλλαδα | English | +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ | | | Français | Italiano | Latviešu valoda | +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ | | | Lietuvių kalba | Magyar | Malti | +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ | | | Nederlands | Polski | Português | +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ | | | Slovenčina (slovenský jazyk) | Slovenščina (slovenski jezik) | Suomi | +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ | | | Svenska | Български | Română | +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ | | |

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Nederlands/Français | Suomi/Svenska | Français/Deutsch | +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ | | | B.3. Indications to be inserted in the Community logo B.3.1. Single indications: BG: БИОЛОГИЧНО ЗЕМЕДЕЛИЕ ES: AGRICULTURA ECOLÓGICA CS: EKOLOGICKÉ ZEMĚDĚLSTVÍ DA: ØKOLOGISK JORDBRUG DE: BIOLOGISCHE LANDWIRTSCHAFT, ÖKOLOGISCHER LANDBAU ET: MAHEPÕLLUMAJANDUS, ÖKOLOOGILINE PÕLLUMAJANDUS EL: ΒΙΟΛΟΓΙΚΗ ΓΕΩΡΓΙΑ EN: ORGANIC FARMING FR: AGRICULTURE BIOLOGIQUE IT: AGRICOLTURA BIOLOGICA LV: BIOLOĞISKĀ LAUKSAIMNIECĪBA LT: EKOLOGINIS ŽEMĖS ŪKIS HU: ÖKOLÓGIAI GAZDÁLKODÁS MT: AGRIKULTURA ORGANIKA NL: BIOLOGISCHE LANDBOUW PL: ROLNICTWO EKOLOGICZNE PT: AGRICULTURA BIOLÓGICA RO: AGRICULTURĂ ECOLOGICĂ SK: EKOLOGICKÉ POĽNOHOSPODÁRSTVO SL: EKOLOŠKO KMETIJSTVO FI: LUONNONMUKAINEN MAATALOUSTUOTANTO SV: EKOLOGISKT JORDBRUK B.3.2. Combination of two indications: Combinations of two indications referring to the languages mentioned under B.3.1. are authorised, subject of being developed in accordance with the following examples: NL/FR: BIOLOGISCHE LANDBOUW — AGRICULTURE BIOLOGIQUE FI/SV: LUONNONMUKAINEN MAATALOUSTUOTANTO — EKOLOGISKT JORDBRUK FR/DE: AGRICULTURE BIOLOGIQUE — BIOLOGISCHE LANDWIRTSCHAFT B.4. Graphic manual CONTENTS 1. Introduction 2. General use of the logo

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2.1. Coloured logo (reference colours) 2.2. Single-colour logo: logo in black and white 2.3. Contrast with background colours 2.4. Typography 2.5. Language 2.6. Reduction sizes 2.7. Particular conditions to use the logo 3. Original Bromides 3.1. Two-colour selection 3.2. Outlines 3.3. Single-colour: logo in black and white 3.4. Colour samples sheets 1. INTRODUCTION The graphic manual is an instrument for the operators to reproduce the logo. 2. GENERAL USE OF THE LOGO 2.1. Coloured logo (reference colours) When the coloured logo is used, this logo must appear in colour by using direct colours (Pantone) or a four-coloured process. The reference colours are indicated herunder. Logo in pantone +++++ TIFF +++++ Logo in four-colour process +++++ TIFF +++++ 2.2. Single-colour logo: logo in black and white The logo in black and white can be used as shown: +++++ TIFF +++++ 2.3. Contrast with background colours If the logo is used in colour on coloured backgrounds which makes it difficult to read, use a delimiting outer circle around the logo to improve its contrast with the background colours as shown: Logo in coloured background +++++ TIFF +++++ 2.4. Typography Use Frutiger or Myriad bold condensed in capitals for the wording. The letter size of the wording shall be reduced according to the norms set down in Section 2.6 2.5. Language You are free to use the language version or versions of your choice according to the specifications indicated in B.3. 2.6. Reduction sizes

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If the application of the logo on different types of labelling makes reduction necessary, the minimum size shall be: (a) For a logo with a single indication: minimum size 20 mm diameter. +++++ TIFF +++++ (b) For a logo with a combination of two indications: minimum size 40 mm diameter. +++++ TIFF +++++ 2.7. Particular conditions to use the logo The use of the logo serves to confer specific value to the products. The most effective application of the logo is therefore in colour, since it will thus have a greater presence and be recognised more easily and quickly by the consumer. The use of the logo using a single colour (black and white) as established in Section 2.2 is only recommended in cases where its application in colour is not practical. 3. ORIGINAL BROMIDES 3.1. Two-colour selection - Single indication in all the languages - The examples of the language combinations referred to in B.3.2 +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ - The examples of the language combinations referred to in B.3.2 +++++ TIFF +++++ +++++ TIFF +++++ +++++ TIFF +++++ 3.2. Outlines +++++ TIFF +++++ 3.3. Single-colour: logo in black and white +++++ TIFF +++++ 3.4. Colour sample sheets PANTONE REFLEX BLUE +++++ TIFF +++++

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PANTONE 367 +++++ TIFF +++++ -------------------------------------------------- ANNEX XII Model of documentary evidence to the operator according to Article 29(1) of Regulation (EC) No 834/2007 referred to in Article 68 of this Regulation Documentary evidence to the operator according to Article 29(1) of Regulation (EC) No 834/2007 Document Number: | Name and address of operator: main activity (producer, processor, importer, etc): | Name, address and code number of control body/authority: | Product groups/Activity: Plant and plant products:Livestock and livestock products:Processed products: | defined as: organic production, in-conversion products; and also non-organic production where parallel production/processing pursuant to Article 11 of Regulation (EC) No 834/2007 occurs | Validity period: Plant products from …to… Livestock products from …to… Processed products from …to… | Date of control(s): | This document has been issued on the basis of Article 29(1) of Regulation (EC) No 834/2007 and of Regulation (EC) No 889/2008. The declared operator has submitted his activities under control, and meets the requirements laid down in the named Regulations. Date, place: Signature on behalf of the issuing control body/authority: | -------------------------------------------------- ANNEX XIII Model of a vendor declaration referred to in Article 69 Vendor declaration according to Article 9(3) of Council Regulation (EC) No 834/2007 | Name, address of vendor: | | Identification (e.g. lot or stock number): | Product name: | Components: (Specify all components existing in the product/used the last in the production process) ……………… ……………… ……………… ……………… ……………… | I declare that this product was manufactured neither "from" nor "by" GMOs as those terms are used in Articles 2 and 9 of Council Regulation (EC) No 834/2007. I do not have any information which could suggest that this statement is inaccurate. Thus, I declare that the above named product complies with Article 9 of Regulation (EC) No 834/2007 regarding the prohibition on the use of GMOs. I undertake to inform our customer and its control body/authority immediately if this declaration is withdrawn or modified, or if any information comes to light which would undermine its

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accuracy. I authorise the control body or control authority, as defined in Article 2 of Council Regulation (EC) No 834/2007, which supervises our customer to examine the accuracy of this declaration and if necessary to take samples for analytic proof. I also accept that this task may be carried out by an independent institution which has been appointed in writing by the control body. The undersigned takes responsibility for the accuracy of this declaration. | Country, place, date, signature of vendor: | Company stamp of vendor (if appropriate): | -------------------------------------------------- ANNEX XIV Correlation Table referred to in Article 96 Regulation (EEC) No 2092/91 | (1)Regulation (EC) No 207/93(2)Regulation (EC) No 223/2003(3)Regulation (EC) No 1452/2003 | This Regulation | — | | Article 1 | — | | Article 2(a) | Article 4(15) | | Article 2(b) | Annex III, C (first indent) | | Article 2(c) | Annex III, C (second indent) | | Article 2(d) | — | | Article 2(e) | — | | Article 2(f) | — | | Article 2(g) | — | | Article 2(h) | Article 4(24) | | Article 2(i) | — | | Article 3(1) | Annex I.B, 7.1 and 7.2 | | Article 3(2) | Annex I.B, 7.4 | | Article 3(3) | Annex I.A, 2.4 | | Article 3(4) | Annex I.A, 2.3 | | Article 3(5) | — | | Article 4 | Article 6(1), Annex I.A, 3 | | Article 5 | Annex I.A, 5 | | Article 6 | Annex I.B and C (titles) | | Article 7 | Annex I.B, 3.1 | | Article 8(1) | Annex I.C, 3.1 | | Article 8(2) | Annex I.B, 3.4, 3.8, 3.9, 3.10, 3.11 | | Article 9(1) to (4) | Annex I.C, 3.6 | | Article 9(5) | Annex I.B, 8.1.1 | | Article 10(1) | Annex I.B, 8.2.1 | | Article 10(2) | Annex I.B, 8.2.2 | | Article 10(3) | Annex I.B, 8.2.3 | | Article 10(4) |

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Annex I.B, 8.3.5 | | Article 11(1) | Annex I.B, 8.3.6 | | Article 11(2) | Annex I.B, 8.3.7 | | Article 11(3) | Annex I.B, 8.3.8 | | Article 11(4), (5) | Annex I.B, 6.1.9, 8.4.1 to 8.4.5 | | Article 12(1) to (4) | Annex I.B, 6.1.9 | | Article 12(5) | Annex I.C, 4, 8.1 to 8.5 | | Article 13 | Annex I.B, 8.1.2 | | Article 14 | Annex I.B, 7.1, 7.2 | | Article 15 | Annex I.B, 1.2 | | Article 16 | Annex I.B, 1.6 | | Article 17(1) | Annex I.B, 1.7 | | Article 17(2) | Annex I.B, 1.8 | | Article 17(3) | Annex I.B, 4.10 | | Article 17(4) | Annex I.B, 6.1.2 | | Article 18(1) | Annex I.B, 6.1.3 | | Article 18(2) | Annex I.C, 7.2 | | Article 18(3) | Annex I.B, 6.2.1 | | Article 18(4) | Annex I.B, 4.3 | | Article 19(1) | Annex I.C, 5.1, 5.2 | | Article 19(2) to (4) | Annex I.B, 4.1, 4.5, 4.7 and 4.11 | | Article 20 | Annex I.B, 4.4 | | Article 21 | Article 7 | | Article 22 | Annex I.B, 3.13, 5.4, 8.2.5 and 8.4.6 | | Article 23 | Annex I.B, 5.3, 5.4, 5.7 and 5.8 | | Article 24 | Annex I.C, 6 | | Article 25 | Annex III, E.3 and B | | Article 26 | Article 5(3) and Annex VI, part A and B | | Article 27 | Article 5(3) | | Article 28 | Article 5(3) | (1): Article 3 | Article 29 | Annex III, B.3 | | Article 30 | Annex III.7 | | Article 31 | Annex III, E.5 | | Article 32 | Annex III.7a | | Article 33 | Annex III, C.6 | | Article 34 | Annex III.8 and A.2.5 | | Article 35 | Annex I.A, 1.1 to 1.4 | | Article 36 | Annex I.B, 2.1.2 | | Article 37 | Annex I.B, 2.1.1, 2.2.1,2.3 and Annex I.C, 2.1, 2.3 | | Article 38 | Annex I.B, 6.1.6 | | Article 39 | Annex III, A1.3 and b | | Article 40 |

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Annex I.C, 1.3 | | Article 41 | Annex I.B, 3.4 (first indent and 3.6(b)) | | Article 42 | Annex I.B, 4.8 | | Article 43 | Annex I.C, 8.3 | | Article 44 | Article 6(3) | | Article 45 | | (3): Article 1(1), (2) | Article 45(1), (2) | | (3): Article 3(a) | Article 45(1) | | (3): Article 4 | Article 45(3) | | (3): Article 5(1) | Article 45(4) | | (3): Article 5(2) | Article 45(5) | | (3): Article 5(3) | Article 45(6) | | (3): Article 5(4) | Article 45(7) | | (3): Article 5(5) | Article 45(8) | Annex I.B, 8.3.4 | | Article 46 | Annex I.B, 3.6(a) | | Article 47(1) | Annex I.B, 4.9 | | Article 47(2) | Annex I.C, 3.5 | | Article 47(3) | | (3): Article 6 | Article 48 | | (3): Article 7 | Article 49 | | (3): Article 8(1) | Article 50(1) | | (3): Article 8(2) | Article 50(2) | | (3): Article 9(1) | Article 51(1) | | (3): Article 9(2), (3) | Article 51(2) | | | Article 51(3) | | (3): Article 10 | Article 52 | | (3): Article 11 | Article 53 | | (3): Article 12(1) | Article 54(1) | | (3): Article 12(2) | Article 54(2) | | (3): Article 13 | Article 55 | | (3): Article 14 | Article 56 | | | Article 57 | | | Article 58 | | (2): Article 1 and Article 5 | Article 59 | | (2): Article 5 and 3 | Article 60 | | (2): Article 4 | Article 61 | Article 5(5) | | Article 62 | Annex III.3 | | Article 63 | Annex III.4 | | Article 64 | Annex III.5 | | Article 65 | Annex III.6 | | Article 66 | Annex III.10 | | Article 67 |

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— | | Article 68 | — | | Article 69 | Annex III, A.1. | | Article 70 | Annex III, A.1.2. | | Article 71 | — | | Article 72 | Annex III, A.1.3 | | Article 73 | Annex III, A.2.1 | | Article 74 | Annex III, A.2.2 | | Article 75 | Annex III, A.2.3 | | Article 76 | Annex I.B, 5.6 | | Article 77 | Annex I.C, 5.5,6.7,7.7,7.8 | | Article 78 | Annex III, A.2.4 | | Article 79 | Annex III, B.1 | | Article 80 | Annex III, C | | Article 81 | Annex III, C.1 | | Article 82 | Annex III, C.2 | | Article 83 | Annex III, C.3 | | Article 84 | Annex III, C.5 | | Article 85 | Annex III, D | | Article 86 | Annex III, E | | Article 87 | Annex III, E.1 | | Article 88 | Annex III, E.2 | | Article 89 | Annex III, E.4 | | Article 90 | Annex III, 9 | | Article 91 | Annex III, 11 | | Article 92 | | | Article 93 | — | | Article 94 | Annex I.B, 6.1.5 | | Article 95(1) | Annex I.B, 8.5.1 | | Article 95(2) | — | | Article 95(3)-(8) | — | | Article 95 | — | | Article 96 | — | | Article 97 | Annex II, part A | | Annex I | Annex II, part B | | Annex II | Annex VIII | | Annex III | Annex VII | | Annex IV | Annex II, part C | | Annex V | Annex II, part D | | Annex VI | Annex II, part E | | Annex VII | Annex VI, part A and B | | Annex VIII |

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Annex VI, part C | | Annex IX | — | | Annex X | — | | Annex XI | — | | Annex XIII | — | | Annex IX | -------------------------------------------------- Important legal notice

2008/889/EC: Commission Decision of 18 November 2008 amending Decisions 2002/747/EC, 2003/31/EC, 2005/342/EC, 2005/344/EC and 2005/360/EC in order to prolong the validity of the ecological criteria for the award of the Community eco-label to certain products (notified under document number C(2008) 6941) (Text with EEA relevance)

Official Journal L 318 , 28/11/2008 P. 0012 - 0013

Commission Decision of 18 November 2008 amending Decisions 2002/747/EC, 2003/31/EC, 2005/342/EC, 2005/344/EC and 2005/360/EC in order to prolong the validity of the ecological criteria for the award of the Community eco-label to certain products (notified under document number C(2008) 6941) (Text with EEA relevance) (2008/889/EC) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme [1], and in particular the second subparagraph of Article 6(1) thereof, After consulting the European Union Eco-labelling Board, Whereas: (1) Commission Decision 2002/747/EC of 9 September 2002 establishing revised ecological criteria for the award of the Community eco-label to light bulbs and amending Decision 1999/568/EC [2] expires on 28 February 2009. (2) Commission Decision 2003/31/EC of 29 November 2002 establishing revised ecological criteria for the award of the Community eco-label to

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detergents for dishwashers and amending Decision 1999/427/EC [3] expires on 31 December 2008. (3) Commission Decision 2005/342/EC of 23 March 2005 establishing revised ecological criteria for the award of the Community eco-label to hand dishwashing detergents [4] expires on 31 December 2008. (4) Commission Decision 2005/344/EC of 23 March 2005 establishing ecological criteria for the award of the Community eco-label to all purpose cleaners and cleaners for sanitary facilities [5] expires on 31 December 2008. (5) Commission Decision 2005/360/EC of 26 April 2005 establishing ecological criteria and the related assessment and verification requirements for the award of the Community eco-label to lubricants [6] expires on 31 May 2009. (6) Pursuant to Regulation (EC) No 1980/2000 a timely review has been carried out of the ecological criteria, as well as of the related assessment and verification requirements, established by those Decisions. (7) Given the different stages of the revision process for these Decisions it is appropriate to prolong the period of validity of the ecological criteria and the requirements for Decisions 2003/31/EC, 2005/342/EC and 2005/344/EC for a period of 24 months, and Decision 2002/747/EC and Decision 2005/360/EC for a period of 14 months. (8) Since the review obligation pursuant to Regulation (EC) No 1980/2000 concerns only the ecological criteria and assessment and verification requirements, it is appropriate that Decisions 2002/747/EC, 2003/31/EC, 2005/342/EC, 2005/344/EC and 2005/360/EC remain in effect. (9) Decisions 2002/747/EC, 2003/31/EC, 2005/342/EC, 2005/344/EC and 2005/360/EC should therefore be amended accordingly. (10) The measures provided for in this Decision are in accordance with the opinion of the Committee instituted by Article 17 of Regulation (EC) No 1980/2000, HAS ADOPTED THIS DECISION: Article 1 Article 5 of Decision 2002/747/EC is replaced by the following: "Article 5 The ecological criteria for the product group "light bulbs", as well as the related assessment and verification requirements, shall be valid until 30 April 2010." Article 2 Article 5 of Decision 2003/31/EC is replaced by the following: "Article 5

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The ecological criteria for the product group "detergents for dishwashers", as well as the related assessment and verification requirements, shall be valid until 31 December 2010." Article 3 Article 3 of Decision 2005/342/EC is replaced by the following: "Article 3 The ecological criteria for the product group "hand dishwashing detergents", as well as the related assessment and verification requirements, shall be valid until 31 December 2010." Article 4 Article 3 of Decision 2005/344/EC is replaced by the following: "Article 3 The ecological criteria for the product group "all purpose cleaners and cleaners for sanitary facilities", as well as the related assessment and verification requirements, shall be valid until 31 December 2010." Article 5 Article 4 of Decision 2005/360/EC is replaced by the following: "Article 4 The ecological criteria for the product group "lubricants", and the related assessment and verification requirements, shall be valid until 31 July 2010." Article 6 This Decision is addressed to the Member States. Done at Brussels, 18 November 2008. For the Commission Stavros Dimas Member of the Commission [1] OJ L 237, 21.9.2000, p. 1. [2] OJ L 242, 10.9.2002, p. 44. [3] OJ L 9, 15.1.2003, p. 11. [4] OJ L 115, 4.5.2005, p. 9. [5] OJ L 115, 4.5.2005, p. 42. [6] OJ L 118, 5.5.2005, p. 26. --------------------------------------------------

Managed by the Publications Office Important legal notice

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Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Articles 95 and 133 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee [1], After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty [2], Whereas: (1) It is necessary to ensure that products benefiting from the free movement of goods within the Community fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety at the workplace, protection of consumers, protection of the environment and security, while ensuring that the free movement of products is not restricted to any extent greater than that which is allowed under Community harmonisation legislation or any other relevant Community rules. Provision should, therefore, be made for rules on accreditation, market surveillance, controls of products from third countries and the CE marking. (2) It is necessary to establish an overall framework of rules and principles in relation to accreditation and market surveillance. That framework should not affect the substantive rules of existing legislation setting out the provisions to be observed for the purpose of protecting public interests such as health, safety and protection of consumers and of the environment, but should aim at enhancing their operation. (3) This Regulation should be seen as complementary to Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products [3]. (4) It is very difficult to adopt Community legislation for every product which exists or which may be developed; there is a need for a broad-based, legislative framework of a horizontal nature to deal with such products, to cover lacunae, in particular pending revision of existing

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specific legislation, and to complement provisions in existing or future specific legislation, in particular with a view to ensuring a high level of protection of health, safety, the environment and consumers, as required by Article 95 of the Treaty. (5) The framework for market surveillance established by this Regulation should complement and strengthen existing provisions in Community harmonisation legislation relating to market surveillance and the enforcement of such provisions. However, in accordance with the principle of lex specialis, this Regulation should apply only in so far as there are no specific provisions with the same objective, nature or effect in other existing or future rules of Community harmonisation legislation. Examples can be found in the following sectors: drug precursors, medical devices, medicinal products for human and veterinary use, motor vehicles and aviation. The corresponding provisions of this Regulation should not therefore apply in the areas covered by such specific provisions. (6) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety [4] established rules to ensure the safety of consumer products. Market surveillance authorities should have the possibility of taking the more specific measures available to them under that Directive. (7) However, in order to achieve a higher level of safety for consumer products, the market surveillance mechanisms provided for in Directive 2001/95/EC should be reinforced as regards products presenting a serious risk, in accordance with the principles established by this Regulation. Directive 2001/95/EC should therefore be amended accordingly. (8) Accreditation is part of an overall system, including conformity assessment and market surveillance, designed to assess and ensure conformity with the applicable requirements. (9) The particular value of accreditation lies in the fact that it provides an authoritative statement of the technical competence of bodies whose task is to ensure conformity with the applicable requirements. (10) Accreditation, though so far not regulated at Community level, is carried out in all Member States. The lack of common rules for that activity has resulted in different approaches and differing systems throughout the Community, with the result that the degree of rigour applied in the performance of accreditation has varied between Member States. It is therefore necessary to develop a comprehensive framework for accreditation and to lay down at Community level the principles for its operation and organisation. (11) The establishment of a uniform national accreditation body should be without prejudice to the allocation of functions within Member States.

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(12) Where Community harmonisation legislation provides for the selection of conformity assessment bodies for its implementation, transparent accreditation, as provided for in this Regulation, ensuring the necessary level of confidence in conformity certificates, should be considered by the national public authorities throughout the Community the preferred means of demonstrating the technical competence of those bodies. However, national authorities may consider that they possess the appropriate means of carrying out this evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements. (13) A system of accreditation which functions by reference to binding rules helps to strengthen mutual confidence between Member States as regards the competence of conformity assessment bodies and consequently the certificates and test reports issued by them. It thereby enhances the principle of mutual recognition and therefore the provisions of this Regulation on accreditation should apply in relation to bodies carrying out conformity assessments in both the regulated and the non-regulated areas. The issue at stake is the quality of certificates and test reports irrespective of whether they fall within the regulated or the non-regulated area, and no distinction should therefore be made between those areas. (14) For the purposes of this Regulation, not-for-profit operation by a national accreditation body should be understood as an activity that is not intended to add any gain to the resources of the body's owners or members. While national accreditation bodies do not have the objective of maximising or distributing profits, they may provide services in return for payment, or receive income. Any excess revenue that results from such services may be used for investment to develop their activities further, as long as it is in line with their main activities. It should accordingly be emphasised that the primary objective of national accreditation bodies should be to support or engage actively in activities that are not intended to produce any gain. (15) Since the purpose of accreditation is to provide an authoritative statement of the competence of a body to perform conformity assessment activities, Member States should not maintain more than one national accreditation body and should ensure that that body is organised in such a way as to safeguard the objectivity and impartiality of its activities. Such national accreditation bodies should operate independently of commercial

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conformity assessment activities. It is therefore appropriate to provide that Member States ensure that, in the performance of their tasks, national accreditation bodies are deemed to exercise public authority, irrespective of their legal status. (16) For the assessment and continued monitoring of the competence of a conformity assessment body, it is essential to determine its technological knowledge and experience and its ability to carry out assessment. It is therefore necessary that the national accreditation body possess the relevant knowledge, competence and means for the proper performance of its tasks. (17) Accreditation should in principle be operated as a self-supporting activity. Member States should ensure that financial support exists for the fulfilment of special tasks. (18) In those cases where it is not economically meaningful or sustainable for a Member State to establish a national accreditation body, that Member State should have recourse to the national accreditation body of another Member State and should be encouraged to have such recourse to the fullest extent possible. (19) Competition between national accreditation bodies could lead to the commercialisation of their activity, which would be incompatible with their role as the last level of control in the conformity assessment chain. The objective of this Regulation is to ensure that, within the European Union, one accreditation certificate is sufficient for the whole territory of the Union, and to avoid multiple accreditation, which is added cost without added value. National accreditation bodies may find themselves in competition on the markets of third countries, but that must have no effect on their activities inside the Community, or on the cooperation and peer evaluation activities organised by the body recognised under this Regulation. (20) In order to avoid multiple accreditation, to enhance acceptance and recognition of accreditation certificates and to carry out effective monitoring of accredited conformity assessment bodies, conformity assessment bodies should request accreditation by the national accreditation body of the Member State in which they are established. Nevertheless, it is necessary to ensure that a conformity assessment body is able to request accreditation in another Member State in the event that there is no national accreditation body in its own Member State or where the national accreditation body is not competent to provide the accreditation services requested. In such cases, appropriate cooperation and exchange of information between national accreditation bodies should be established.

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(21) In order to ensure that national accreditation bodies fulfil the requirements and obligations provided for in this Regulation, it is important that Member States support the proper functioning of the accreditation system, monitor their national accreditation bodies regularly and take appropriate corrective measures within a reasonable timeframe where necessary. (22) In order to ensure the equivalence of the level of competence of conformity assessment bodies, to facilitate mutual recognition and to promote the overall acceptance of accreditation certificates and conformity assessment results issued by accredited bodies, it is necessary that national accreditation bodies operate a rigorous and transparent peer evaluation system and regularly undergo such evaluation. (23) This Regulation should provide for the recognition of a single organisation at European level in respect of certain functions in the field of accreditation. The European cooperation for Accreditation (the EA), whose main mission is to promote a transparent and quality-led system for the evaluation of the competence of conformity assessment bodies throughout Europe, manages a peer evaluation system among national accreditation bodies from the Member States and other European countries. That system has proved to be efficient and to provide mutual confidence. The EA should, therefore, be the first body recognised under this Regulation and Member States should ensure that their national accreditation bodies seek and maintain membership of the EA for as long as it is so recognised. At the same time, the possibility of changing the relevant body recognised under this Regulation should be provided for, in case there is a need for it in the future. (24) Effective cooperation among national accreditation bodies is essential for the proper implementation of peer evaluation and with regard to cross-border accreditation. In the interests of transparency, it is, therefore, necessary to provide for an obligation on national accreditation bodies to exchange information among themselves and to provide the national authorities and the Commission with relevant information. Updated and accurate information concerning the availability of accreditation activities operated by national accreditation bodies should also be made public and, therefore, accessible, in particular to conformity assessment bodies. (25) Sectoral accreditation schemes should cover the fields of activity where general requirements for the competence of conformity assessment bodies are not sufficient to ensure the necessary level of protection where specific detailed technology or health and safety-related requirements are imposed. Given the fact that the EA has at its disposal a broad range of

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technical expertise, it should be requested to develop such schemes, especially for areas covered by Community legislation. (26) For the purpose of ensuring the equivalent and consistent enforcement of Community harmonisation legislation, this Regulation introduces a Community market surveillance framework, defining minimum requirements against the background of the objectives to be achieved by Member States and a framework for administrative cooperation including the exchange of information among Member States. (27) In the case of economic operators in possession of test reports or certificates attesting conformity issued by an accredited conformity assessment body, where the relevant Community harmonisation legislation does not require such reports or certificates, market surveillance authorities should take due account of them when performing checks on product characteristics. (28) Cooperation between competent authorities at national level and across borders in exchanging information, investigating infringements and taking action to bring about their cessation, even before the placing on the market of dangerous products, by reinforcing measures to identify them, mainly in seaports, is essential to the protection of health and safety and to guaranteeing the smooth functioning of the internal market. National consumer protection authorities should cooperate, at national level, with national market surveillance authorities and should exchange information with them relating to products which they suspect present a risk. (29) Risk assessment should take all relevant data into account, including, where available, data on risks that have materialised with respect to the product in question. Account should also be taken of any measures that may have been taken by the economic operators concerned to alleviate the risks. (30) Situations of serious risk posed by a product require rapid intervention, which may entail the withdrawal of the product, its recall or the prohibition of its being made available on the market. In those situations it is necessary to have access to a system of rapid exchange of information between Member States and the Commission. The system provided for in Article 12 of Directive 2001/95/EC has proved its effectiveness and efficiency in the field of consumer products. To avoid unnecessary duplication, that system should be used for the purposes of this Regulation. Moreover, coherent market surveillance throughout the Community requires a comprehensive exchange of information on national activities in this context which goes beyond this system. (31) Information exchanged between competent authorities should be subject to the strictest guarantees of confidentiality and professional

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secrecy and be handled in accordance with rules on confidentiality pursuant to the applicable national law or, as regards the Commission, Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents [5], in order to ensure that investigations are not compromised and that the reputations of economic operators are not prejudiced. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [6] and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data [7] apply in the context of this Regulation. (32) Community harmonisation legislation provides for specific procedures establishing whether or not a national measure restricting the free movement of a product is justified (safeguard clause procedures). Those procedures apply following a rapid exchange of information on products presenting a serious risk. (33) Points of entry at the external borders are well placed to detect unsafe non-conforming products or products to which the CE marking has been affixed falsely or in a misleading manner even before they are placed on the market. An obligation on authorities in charge of the control of products entering the Community market to execute checks on an adequate scale can therefore contribute to a safer market place. In order to increase the effectiveness of such checks, those authorities should receive all the necessary information concerning dangerous non-conforming products from the market surveillance authorities well in advance. (34) Council Regulation (EEC) No 339/93 of 8 February 1993 on checks for conformity with the rules on product safety in the case of products imported from third countries [8] lays down rules regarding the suspension of the release of products by customs authorities and provides for further measures including the involvement of market surveillance authorities. It is therefore appropriate that those provisions, including the involvement of market surveillance authorities, be incorporated in this Regulation. (35) Experience has shown that products which are not released are often re-exported and subsequently enter the Community market at other points of entry, thus undermining the customs authorities' efforts. Market surveillance authorities should therefore be given the means of proceeding with the destruction of products if they deem it appropriate.

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(36) Within one year of the publication of this Regulation in the Official Journal of the European Union, the Commission should present an in-depth analysis in the realm of consumer safety markings, followed by legislative proposals where necessary. (37) The CE marking, indicating the conformity of a product, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking should be set out in this Regulation so as to make them immediately applicable and to simplify future legislation. (38) The CE marking should be the only marking of conformity indicating that a product is in conformity with Community harmonisation legislation. However, other markings may be used as long as they contribute to the improvement of consumer protection and are not covered by Community harmonisation legislation. (39) It is necessary for Member States to provide for appropriate means of redress in the competent courts and tribunals in respect of measures taken by the competent authorities which restrict the placing on the market of a product or which require its withdrawal or recall. (40) Member States may find it useful to establish cooperation with the stakeholders concerned, including sectoral professional organisations and consumer organisations, in order to take advantage of available market intelligence when establishing, implementing and updating market surveillance programmes. (41) The Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive and could be increased if the relevant economic operator has previously committed a similar infringement of the provisions of this Regulation. (42) In order to achieve the objectives of this Regulation, it is necessary for the Community to contribute to the financing of activities required to implement policies in the field of accreditation and market surveillance. Financing should be provided in the form of grants to the body recognised under this Regulation without a call for proposals, in the form of grants after a call for proposals, or by the award of contracts to that or to other bodies, depending on the nature of the activity to be financed and in accordance with Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities [9] (the Financial Regulation). (43) For some specialised tasks, such as the production and revision of sectoral accreditation schemes, and for other tasks related to the

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verification of the technical competence and the facilities of laboratories and certification or inspection bodies, the EA should initially be eligible for Community financing, since it is well adapted to providing the necessary technical expertise in this respect. (44) Given the role of the body recognised under this Regulation in the peer evaluation of accreditation bodies and its ability to assist the Member States with the management of that peer evaluation, the Commission should be in a position to provide grants for the functioning of the secretariat of the body recognised under this Regulation, which should provide ongoing support for accreditation activities at Community level. (45) A partnership agreement should be signed, in accordance with the provisions of the Financial Regulation, between the Commission and the body recognised under this Regulation in order to fix the administrative and financial rules on the financing of accreditation activities. (46) In addition, financing should also be available to bodies other than the body recognised under this Regulation for other activities in the field of conformity assessment, metrology, accreditation and market surveillance, such as the drawing-up and updating of guidelines, inter-comparison activities linked to the operation of safeguard clauses, preliminary or ancillary activities in connection with the implementation of Community legislation in those areas and programmes of technical assistance and cooperation with third countries as well as the enhancement of policies in those areas at Community and international level. (47) This Regulation respects the fundamental rights and observes the principles reflected in the Charter of Fundamental Rights of the European Union. (48) Since the objective of this Regulation, namely to ensure that products on the market covered by Community legislation fulfil requirements providing a high level of protection of health and safety and other public interests while guaranteeing the functioning of the internal market by providing a framework for accreditation and market surveillance, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, HAVE ADOPTED THIS REGULATION:

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CHAPTER I GENERAL PROVISIONS Article 1 Subject matter and scope 1. This Regulation lays down rules on the organisation and operation of accreditation of conformity assessment bodies performing conformity assessment activities. 2. This Regulation provides a framework for the market surveillance of products to ensure that those products fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety at the workplace, the protection of consumers, protection of the environment and security. 3. This Regulation provides a framework for controls on products from third countries. 4. This Regulation lays down the general principles of the CE marking. Article 2 Definitions For the purposes of this Regulation the following definitions shall apply: 1. "making available on the market" shall mean any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge; 2. "placing on the market" shall mean the first making available of a product on the Community market; 3. "manufacturer" shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark; 4. "authorised representative" shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under the relevant Community legislation; 5. "importer" shall mean any natural or legal person established within the Community who places a product from a third country on the Community market; 6. "distributor" shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market; 7. "economic operators" shall mean the manufacturer, the authorised representative, the importer and the distributor; 8. "technical specification" shall mean a document that prescribes technical requirements to be fulfilled by a product, process or service;

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9. "harmonised standard" shall mean a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services [10] on the basis of a request made by the Commission in accordance with Article 6 of that Directive; 10. "accreditation" shall mean an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity; 11. "national accreditation body" shall mean the sole body in a Member State that performs accreditation with authority derived from the State; 12. "conformity assessment" shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled; 13. "conformity assessment body" shall mean a body that performs conformity assessment activities including calibration, testing, certification and inspection; 14. "recall" shall mean any measure aimed at achieving the return of a product that has already been made available to the end user; 15. "withdrawal" shall mean any measure aimed at preventing a product in the supply chain from being made available on the market; 16. "peer evaluation" shall mean a process for the assessment of a national accreditation body by other national accreditation bodies, carried out in accordance with the requirements of this Regulation, and, where applicable, additional sectoral technical specifications; 17. "market surveillance" shall mean the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Community harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection; 18. "market surveillance authority" shall mean an authority of a Member State responsible for carrying out market surveillance on its territory; 19. "release for free circulation" shall mean the procedure laid down in Article 79 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code [11]; 20. "CE marking" shall mean a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing;

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21. "Community harmonisation legislation" shall mean any Community legislation harmonising the conditions for the marketing of products. CHAPTER II ACCREDITATION Article 3 Scope This Chapter shall apply to accreditation, used on a compulsory or voluntary basis, relating to conformity assessment, whether that assessment is compulsory or not, and irrespective of the legal status of the body performing the accreditation. Article 4 General principles 1. Each Member State shall appoint a single national accreditation body. 2. Where a Member State considers that it is not economically meaningful or sustainable to have a national accreditation body or to provide certain accreditation services, it shall, as far as possible, have recourse to the national accreditation body of another Member State. 3. A Member State shall inform the Commission and the other Member States where, in accordance with paragraph 2, recourse is had to the national accreditation body of another Member State. 4. On the basis of the information referred to in paragraph 3 and Article 12, the Commission shall draw up and update a list of national accreditation bodies which it shall make publicly available. 5. Where accreditation is not operated directly by the public authorities themselves, a Member State shall entrust its national accreditation body with the operation of accreditation as a public authority activity and grant it formal recognition. 6. The responsibilities and tasks of the national accreditation body shall be clearly distinguished from those of other national authorities. 7. The national accreditation body shall operate on a not-for-profit basis. 8. The national accreditation body shall not offer or provide any activities or services that conformity assessment bodies provide, nor shall it provide consultancy services, own shares in or otherwise have a financial or managerial interest in a conformity assessment body. 9. Each Member State shall ensure that its national accreditation body has the appropriate financial and personnel resources for the proper performance of its tasks, including the fulfilment of special tasks, such as

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activities for European and international accreditation cooperation and activities that are required to support public policy and which are not self-financing. 10. The national accreditation body shall be a member of the body recognised under Article 14. 11. National accreditation bodies shall establish and maintain appropriate structures to ensure the effective and balanced involvement of all interested parties within both their organisations and the body recognised under Article 14. Article 5 Operation of accreditation 1. A national accreditation body shall, when requested by a conformity assessment body, evaluate whether that conformity assessment body is competent to carry out a specific conformity assessment activity. Where it is found to be competent, the national accreditation body shall issue an accreditation certificate to that effect. 2. When a Member State decides not to use accreditation, it shall provide the Commission and the other Member States with all the documentary evidence necessary for the verification of the competence of the conformity assessment bodies it selects for the implementation of the Community harmonisation legislation in question. 3. National accreditation bodies shall monitor the conformity assessment bodies to which they have issued an accreditation certificate. 4. Where a national accreditation body ascertains that a conformity assessment body which has received an accreditation certificate is no longer competent to carry out a specific conformity assessment activity or has committed a serious breach of its obligations, that accreditation body shall take all appropriate measures within a reasonable timeframe to restrict, suspend or withdraw the accreditation certificate. 5. Member States shall establish procedures for the resolution of appeals, including, where appropriate, legal remedies against accreditation decisions or the absence thereof. Article 6 Principle of non-competition 1. National accreditation bodies shall not compete with conformity assessment bodies. 2. National accreditation bodies shall not compete with other national accreditation bodies.

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3. National accreditation bodies shall be permitted to operate across national borders, within the territory of another Member State, either at the request of a conformity assessment body in the circumstances set out in Article 7(1), or, if they are asked to do so by a national accreditation body in accordance with Article 7(3), in cooperation with the national accreditation body of that Member State. Article 7 Cross-border accreditation 1. Where a conformity assessment body requests accreditation it shall do so with the national accreditation body of the Member State in which it is established or with the national accreditation body to which that Member State has had recourse in accordance with Article 4(2). However, a conformity assessment body may request accreditation by a national accreditation body other than those referred to in the first subparagraph in any one of the following situations: (a) where the Member State in which it is established has decided not to establish a national accreditation body and has not had recourse to the national accreditation body of another Member State in accordance with Article 4(2); (b) where the national accreditation bodies referred to in the first subparagraph do not perform accreditation in respect of the conformity assessment activities for which accreditation is sought; (c) where the national accreditation bodies referred to in the first subparagraph have not successfully undergone peer evaluation under Article 10 in respect of the conformity assessment activities for which accreditation is sought. 2. Where a national accreditation body receives a request pursuant to paragraph 1(b) or (c), it shall inform the national accreditation body of the Member State in which the requesting conformity assessment body is established. In such cases, the national accreditation body of the Member State in which the requesting conformity assessment body is established may participate as an observer. 3. A national accreditation body may request another national accreditation body to carry out part of the assessment activity. In such a case, the accreditation certificate shall be issued by the requesting body. Article 8 Requirements for national accreditation bodies A national accreditation body shall fulfil the following requirements:

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1. it shall be organised in such a manner as to make it independent of the conformity assessment bodies it assesses and of commercial pressures, and to ensure that no conflicts of interest with conformity assessment bodies occur; 2. it shall be organised and operated so as to safeguard the objectivity and impartiality of its activities; 3. it shall ensure that each decision relating to the attestation of competence is taken by competent persons different from those who carried out the assessment; 4. it shall have adequate arrangements to safeguard the confidentiality of the information obtained; 5. it shall identify the conformity assessment activities for which it is competent to perform accreditation, referring, where appropriate, to relevant Community or national legislation and standards; 6. it shall set up the procedures necessary to ensure efficient management and appropriate internal controls; 7. it shall have a number of competent personnel at its disposal sufficient for the proper performance of its tasks; 8. it shall document the duties, responsibilities and authorities of personnel who could affect the quality of the assessment and of the attestation of competence; 9. it shall establish, implement and maintain procedures for monitoring the performance and competence of the personnel involved; 10. it shall verify that conformity assessments are carried out in an appropriate manner, meaning that unnecessary burdens are not imposed on undertakings and that due account is taken of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process; 11. it shall publish audited annual accounts prepared in accordance with generally accepted accounting principles. Article 9 Compliance with requirements 1. Where a national accreditation body does not meet the requirements of this Regulation or fails to fulfil its obligations hereunder, the Member State concerned shall take appropriate corrective action or shall ensure that such corrective action is taken, and shall inform the Commission thereof. 2. Member States shall monitor their national accreditation bodies at regular intervals in order to ensure that they fulfil the requirements laid down in Article 8 on a continuing basis.

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3. Member States shall take the utmost account of the results of peer evaluation under Article 10 when carrying out the monitoring referred to in paragraph 2 of this Article. 4. National accreditation bodies shall have in place the necessary procedures to deal with complaints against the conformity assessment bodies they have accredited. Article 10 Peer evaluation 1. National accreditation bodies shall subject themselves to peer evaluation organised by the body recognised under Article 14. 2. Stakeholders shall have the right to participate in the system set up for the supervision of peer evaluation activities, but not in individual peer evaluation procedures. 3. Member States shall ensure that their national accreditation bodies regularly undergo peer evaluation as required by paragraph 1. 4. Peer evaluation shall be operated on the basis of sound and transparent evaluation criteria and procedures, in particular concerning structural, human resource and process requirements, confidentiality and complaints. Appropriate appeal procedures against decisions taken as a result of such evaluation shall be provided for. 5. Peer evaluation shall ascertain whether the national accreditation bodies meet the requirements laid down in Article 8, taking into account the relevant harmonised standards referred to in Article 11. 6. The outcome of peer evaluation shall be published and communicated by the body recognised under Article 14 to all Member States and the Commission. 7. The Commission shall, in cooperation with the Member States, oversee the rules and the proper functioning of the peer evaluation system. Article 11 Presumption of conformity for national accreditation bodies 1. National accreditation bodies that demonstrate conformity with the criteria laid down in the relevant harmonised standard, the reference of which has been published in the Official Journal of the European Union, by having successfully undergone peer evaluation under Article 10 shall be presumed to fulfil the requirements laid down in Article 8. 2. National authorities shall recognise the equivalence of the services delivered by those accreditation bodies which have successfully undergone peer evaluation under Article 10, and thereby accept, on the basis of the presumption referred to in paragraph 1 of this Article, the accreditation

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certificates of those bodies and the attestations issued by the conformity assessment bodies accredited by them. Article 12 Information obligation 1. Each national accreditation body shall inform the other national accreditation bodies of the conformity assessment activities in respect of which it operates accreditation and of any changes thereto. 2. Each Member State shall inform the Commission and the body recognised under Article 14 of the identity of its national accreditation body and of all conformity assessment activities in respect of which that body operates accreditation in support of Community harmonisation legislation, and of any changes thereto. 3. Each national accreditation body shall regularly make publicly available information concerning the results of its peer evaluation, the conformity assessment activities in respect of which it operates accreditation and any changes thereto. Article 13 Requests to the body recognised under Article 14 1. The Commission may, after consulting the Committee set up by Article 5 of Directive 98/34/EC, request the body recognised under Article 14 to contribute to the development, maintenance and implementation of accreditation in the Community. 2. The Commission may also, following the procedure laid down in paragraph 1: (a) request the body recognised under Article 14 to lay down evaluation criteria and procedures for peer evaluation and to develop sectoral accreditation schemes; (b) accept any existing scheme that already lays down evaluation criteria and procedures for peer evaluation. 3. The Commission shall ensure that sectoral schemes identify the technical specifications necessary to meet the level of competence required by Community harmonisation legislation in fields with specific requirements relating to technology, health and safety or environment related requirements or any other aspect of public interest protection. Article 14 European accreditation infrastructure 1. The Commission shall, after consulting the Member States, recognise a body which satisfies the requirements set out in Annex I to this Regulation.

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2. A body which is to be recognised pursuant to paragraph 1 shall conclude an agreement with the Commission. That agreement shall specify, inter alia, the detailed tasks of the body, funding provisions and provisions for its supervision. Both the Commission and the body shall be able to terminate the agreement without cause at the expiry of a reasonable period of notice to be defined therein. 3. The Commission and the body shall make the agreement public. 4. The Commission shall communicate the recognition of a body pursuant to paragraph 1 to the Member States and to national accreditation bodies. 5. The Commission may not recognise more than one body at a time. 6. The first body recognised under this Regulation shall be the European cooperation for accreditation, provided that it has concluded an agreement as specified in paragraph 2.

CHAPTER III COMMUNITY MARKET SURVEILLANCE FRAMEWORK AND CONTROLS OF PRODUCTS ENTERING THE COMMUNITY MARKET SECTION 1 General provisions Article 15 Scope 1. Articles 16 to 26 shall apply to products covered by Community harmonisation legislation. 2. Each of the provisions of Articles 16 to 26 shall apply in so far as there are no specific provisions with the same objective in Community harmonisation legislation. 3. The application of this Regulation shall not prevent market surveillance authorities from taking more specific measures as provided for in Directive 2001/95/EC. 4. For the purposes of Articles 16 to 26, a "product" shall mean a substance, preparation or good produced through a manufacturing process other than food, feed, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction. 5. Articles 27, 28 and 29 shall apply to all products covered by Community legislation in so far as other Community legislation does not contain specific provisions relating to the organisation of border controls.

Article 16 General requirements 1. Member States shall organise and carry out market surveillance as provided for in this Chapter.

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2. Market surveillance shall ensure that products covered by Community harmonisation legislation which, when used in accordance with their intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained, are liable to compromise the health or safety of users, or which otherwise do not conform to applicable requirements set out in Community harmonisation legislation are withdrawn or their being made available on the market is prohibited or restricted and that the public, the Commission and the other Member States are informed accordingly. 3. National market surveillance infrastructures and programmes shall ensure that effective measures can be taken in relation to any product category subject to Community harmonisation legislation. 4. Market surveillance shall cover products assembled or manufactured for the manufacturer's own use where Community harmonisation legislation provides that its provisions shall apply to such products. SECTION 2 Community market surveillance framework Article 17 Information obligations 1. Member States shall inform the Commission of their market surveillance authorities and their areas of competence. The Commission shall transmit that information to the other Member States. 2. Member States shall ensure that the public is aware of the existence, responsibilities and identity of national market surveillance authorities, and of how those authorities may be contacted. Article 18 Obligations of the Member States as regards organisation 1. Member States shall establish appropriate communication and coordination mechanisms between their market surveillance authorities. 2. Member States shall establish adequate procedures in order to: (a) follow up complaints or reports on issues relating to risks arising in connection with products subject to Community harmonisation legislation; (b) monitor accidents and harm to health which are suspected to have been caused by those products; (c) verify that corrective action has been taken; and (d) follow up scientific and technical knowledge concerning safety issues.

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3. Member States shall entrust market surveillance authorities with the powers, resources and knowledge necessary for the proper performance of their tasks. 4. Member States shall ensure that market surveillance authorities exercise their powers in accordance with the principle of proportionality. 5. Member States shall establish, implement and periodically update their market surveillance programmes. Member States shall draw up either a general market surveillance programme or sector specific programmes, covering the sectors in which they conduct market surveillance, communicate those programmes to the other Member States and the Commission and make them available to the public, by way of electronic communication and, where appropriate, by other means. The first such communication shall be effected by 1 January 2010. Subsequent updates of the programmes shall be made public in the same manner. Member States may cooperate with all relevant stakeholders to those ends. 6. Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every fourth year and the results thereof shall be communicated to the other Member States and the Commission and be made available to the public, by way of electronic communication and, where appropriate, by other means. Article 19 Market surveillance measures 1. Market surveillance authorities shall perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks on the basis of adequate samples. When doing so they shall take account of established principles of risk assessment, complaints and other information. Market surveillance authorities may require economic operators to make such documentation and information available as appear to them to be necessary for the purpose of carrying out their activities, and, where it is necessary and justified, enter the premises of economic operators and take the necessary samples of products. They may destroy or otherwise render inoperable products presenting a serious risk where they deem it necessary. Where economic operators present test reports or certificates attesting conformity issued by an accredited conformity assessment body, market surveillance authorities shall take due account of such reports or certificates.

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2. Market surveillance authorities shall take appropriate measures to alert users within their territories within an adequate timeframe of hazards they have identified relating to any product so as to reduce the risk of injury or other damage. They shall cooperate with economic operators regarding actions which could prevent or reduce risks caused by products made available by those operators. 3. Where the market surveillance authorities of one Member State decide to withdraw a product manufactured in another Member State, they shall inform the economic operator concerned at the address indicated on the product in question or in the documentation accompanying that product. 4. Market surveillance authorities shall carry out their duties independently, impartially and without bias. 5. Market surveillance authorities shall observe confidentiality where necessary in order to protect commercial secrets or to preserve personal data pursuant to national legislation, subject to the requirement that information be made public under this Regulation to the fullest extent necessary in order to protect the interests of users in the Community. Article 20 Products presenting a serious risk 1. Member States shall ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on their market is prohibited, and that the Commission is informed without delay thereof, in accordance with Article 22. 2. The decision whether or not a product represents a serious risk shall be based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering that a product presents a serious risk. Article 21 Restrictive measures 1. Member States shall ensure that any measure taken, pursuant to the relevant Community harmonisation legislation, to prohibit or restrict the product's being made available on the market, to withdraw it from the market or to recall it, is proportionate and states the exact grounds on which it is based.

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2. Such measures shall be communicated without delay to the relevant economic operator, which shall at the same time be informed of the remedies available under the law of the Member State concerned and of the time limits to which such remedies are subject. 3. Prior to the adoption of a measure referred to in paragraph 1, the economic operator concerned shall be given the opportunity to be heard within an appropriate period of not less than 10 days, unless such consultation is not possible because of the urgency of the measure to be taken, as justified by health or safety requirements or other grounds relating to the public interests covered by the relevant Community harmonisation legislation. If action has been taken without the operator's being heard, the operator shall be given the opportunity to be heard as soon as possible and the action taken shall be reviewed promptly thereafter. 4. Any measure referred to in paragraph 1 shall be promptly withdrawn or amended upon the economic operator's demonstrating that he has taken effective action. Article 22 Exchange of information — Community Rapid Information System 1. Where a Member State takes or intends to take a measure in accordance with Article 20 and considers that the reasons which prompted the measure or the effects of the measure go beyond its territory, it shall immediately notify the Commission of that measure, in accordance with paragraph 4 of this Article. It shall also inform the Commission without delay of the modification or withdrawal of any such measure. 2. If a product presenting a serious risk has been made available on the market, Member States shall notify the Commission of any voluntary measures taken and communicated by an economic operator. 3. The information provided in accordance with paragraphs 1 and 2 shall include all available details, in particular the data necessary for the identification of the product, the origin and the supply chain of the product, the related risk, the nature and the duration of the national measure taken and any voluntary measures taken by economic operators. 4. For the purposes of paragraphs 1, 2 and 3, the market surveillance and information exchange system provided for in Article 12 of Directive 2001/95/EC shall be used. Paragraphs 2, 3 and 4 of Article 12 of that Directive shall apply mutatis mutandis.

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Article 23 General information support system 1. The Commission shall develop and maintain a general archiving and exchange of information system, using electronic means, on issues relating to market surveillance activities, programmes and related information on non-compliance with Community harmonisation legislation. The system shall appropriately reflect notifications and information provided under Article 22. 2. For the purposes of paragraph 1, Member States shall provide the Commission with information at their disposal and not already provided under Article 22 on products presenting a risk regarding, in particular, identification of risks, results of testing carried out, provisional restrictive measures taken, contacts with the economic operators concerned and justification for action or inaction. 3. Without prejudice to Article 19(5) or to national legislation in the area of confidentiality, the safeguarding of confidentiality with regard to the information content shall be ensured. The protection of confidentiality shall not prevent the dissemination to market surveillance authorities of information relevant to ensuring the effectiveness of market surveillance activities. Article 24 Principles of cooperation between the Member States and the Commission 1. Member States shall ensure efficient cooperation and exchange of information between their market surveillance authorities and those of the other Member States and between their own authorities and the Commission and the relevant Community agencies regarding their market surveillance programmes and all issues relating to products presenting risks. 2. For the purposes of paragraph 1, the market surveillance authorities of one Member State shall give the market surveillance authorities of other Member States assistance on an adequate scale by supplying information or documentation, by carrying out appropriate investigations or any other appropriate measure and by participating in investigations initiated in other Member States. 3. The Commission shall collect and organise such data on national market surveillance measures as will enable it to fulfil its obligations. 4. Any information provided by an economic operator under Article 21(3) or otherwise shall be included when the reporting Member State notifies other Member States and the Commission of its findings and actions. Any

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subsequent information shall be clearly identified as relating to the information already provided. Article 25 Sharing of resources 1. Market surveillance initiatives designed to share resources and expertise between the competent authorities of the Member States may be set up by the Commission or the Member States concerned. Such initiatives shall be coordinated by the Commission. 2. For the purposes of paragraph 1, the Commission shall, in cooperation with the Member States: (a) develop and organise training programmes and exchanges of national officials; (b) develop, organise and set up programmes for the exchange of experience, information and best practice, programmes and actions for common projects, information campaigns, joint visit programmes and the consequent sharing of resources. 3. Member States shall ensure that their competent authorities participate fully in the activities referred to in paragraph 2, where appropriate. Article 26 Cooperation with the competent authorities of third countries 1. Market surveillance authorities may cooperate with the competent authorities of third countries with a view to exchanging information and technical support, promoting and facilitating access to European systems and promoting activities relating to conformity assessment, market surveillance and accreditation. The Commission shall, in cooperation with Member States, develop appropriate programmes for that purpose. 2. Cooperation with the competent authorities of third countries shall take the form of, inter alia, the activities referred to in Article 25(2). Member States shall ensure that their competent authorities participate fully in those activities. SECTION 3 Controls of products entering the Community market Article 27 Controls of products entering the Community market 1. The authorities of the Member States in charge of the control of products entering the Community market shall have the powers and

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resources necessary for the proper performance of their tasks. They shall carry out appropriate checks on the characteristics of products on an adequate scale, in accordance with the principles set out in Article 19(1), before those products are released for free circulation. 2. Where in a Member State more than one authority is responsible for market surveillance or external border controls, those authorities shall cooperate with each other, by sharing information relevant to their functions and otherwise as appropriate. 3. The authorities in charge of external border controls shall suspend release of a product for free circulation on the Community market when any of the following findings are made in the course of the checks referred to in paragraph 1: (a) the product displays characteristics which give cause to believe that the product, when properly installed, maintained and used, presents a serious risk to health, safety, the environment or any other public interest referred to in Article 1; (b) the product is not accompanied by the written or electronic documentation required by the relevant Community harmonisation legislation or is not marked in accordance with that legislation; (c) the CE marking has been affixed to the product in a false or misleading manner. The authorities in charge of external border controls shall immediately notify the market surveillance authorities of any such suspension. 4. In the case of perishable products, the authorities in charge of external border controls shall, as far as possible, seek to ensure that any requirements they may impose with regard to the storage of products or the parking of vehicles used for transport are not incompatible with the preservation of those products. 5. For the purposes of this Section, Article 24 shall apply in respect of authorities in charge of external border controls, without prejudice to the application of Community law providing for more specific systems of cooperation between those authorities. Article 28 Release of products 1. A product the release of which has been suspended by the authorities in charge of external border controls pursuant to Article 27 shall be released if, within three working days of the suspension of release, those authorities have not been notified of any action taken by the market surveillance authorities, and provided that all the other requirements and formalities pertaining to such release have been fulfilled.

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2. Where the market surveillance authorities find that the product in question does not present a serious risk to health and safety or cannot be regarded as being in breach of Community harmonisation legislation, that product shall be released, provided that all the other requirements and formalities pertaining to such release have been fulfilled. Article 29 National measures 1. Where the market surveillance authorities find that a product presents a serious risk, they shall take measures to prohibit that product from being placed on the market and shall require the authorities in charge of external border controls to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document or, where data processing is carried out electronically, in the data-processing system itself: "Dangerous product — release for free circulation not authorised — Regulation (EC) No 765/2008". 2. Where the market surveillance authorities find that a product does not comply with Community harmonisation legislation, they shall take appropriate action, which may, if necessary, include prohibiting the product's being placed on the market. Where placing on the market is prohibited pursuant to the first subparagraph, the market surveillance authorities shall require the authorities in charge of external border controls not to release the product for free circulation and to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document or, where data processing is carried out electronically, in the data-processing system itself: "Product not in conformity — release for free circulation not authorised — Regulation (EC) No 765/2008". 3. Where that product is subsequently declared for a customs procedure other than release for free circulation and provided that the market surveillance authorities do not object, the endorsements set out in paragraphs 1 and 2 shall also be included, under the same conditions, on the documents used in connection with that procedure. 4. Member States' authorities may destroy or otherwise render inoperable products presenting a serious risk where they deem it necessary and proportionate. 5. Market surveillance authorities shall provide authorities in charge of external border controls with information on product categories in which a

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serious risk or non-compliance within the meaning of paragraphs 1 and 2 has been identified. CHAPTER IV CE MARKING Article 30 General principles of the CE marking 1. The CE marking shall be affixed only by the manufacturer or his authorised representative. 2. The CE marking as presented in Annex II shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product. 3. By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing. 4. The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonisation legislation providing for its affixing. 5. The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired. 6. Without prejudice to Article 41, Member States shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use. CHAPTER V COMMUNITY FINANCING Article 31 Body pursuing an aim of general European interest The body recognised under Article 14 shall be considered a body pursuing an aim of general European interest within the meaning of Article 162 of Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002

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laying down detailed rules for the implementation of Regulation (EC, Euratom) No 1605/2002 [12]. Article 32 Activities eligible for Community financing 1. The Community may finance the following activities in connection with the application of this Regulation: (a) the production and revision of sectoral accreditation schemes referred to in Article 13(3); (b) the activities of the secretariat of the body recognised under Article 14, such as the coordination of accreditation activities, the processing of technical work linked to the operation of the peer evaluation system, the provision of interested parties with information and the participation of the body in the activities of international organisations in the field of accreditation; (c) the drawing up and updating of contributions to guidelines in the fields of accreditation, notification to the Commission of conformity assessment bodies, conformity assessment and market surveillance; (d) inter-comparison activities linked to the operation of safeguard clauses; (e) the making available to the Commission of technical expertise for the purpose of assisting the Commission in its implementation of market surveillance administrative cooperation, including the financing of administrative cooperation groups, market surveillance decisions and safeguard clause cases; (f) the performance of preliminary or ancillary work in connection with the implementation of the conformity assessment, metrology, accreditation and market surveillance activities linked to the implementation of Community legislation, such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits, research work, the development and maintenance of databases, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work, as well as European market surveillance campaigns and similar activities; (g) activities carried out under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of European conformity assessment, market surveillance and accreditation policies and systems among interested parties in the Community and at international level. 2. The activities referred to in paragraph 1(a) shall be eligible for Community financing only if the Committee set up by Article 5 of Directive 98/34/EC has been consulted on the requests to be submitted to the body recognised under Article 14 of this Regulation.

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Article 33 Bodies eligible for Community financing Community financing may be granted to the body recognised under Article 14 for the implementation of the activities set out in Article 32. However, Community financing may also be granted to other bodies for the carrying out of the activities set out in Article 32, except those set out in paragraph 1(a) and (b) of that Article. Article 34 Financing The appropriations allocated to the activities referred to in this Regulation shall be determined each year by the budgetary authority within the limits of the financial framework in force. Article 35 Financing arrangements 1. Community financing shall be provided: (a) without a call for proposals, to the body recognised under Article 14 to carry out those activities referred to in Article 32(1)(a) to (g) for which grants can be awarded in accordance with the Financial Regulation; (b) in the form of grants after a call for proposals, or by public procurement procedures, to other bodies to carry out the activities referred to in Article 32(1)(c) to (g). 2. The activities of the secretariat of the body recognised under Article 14 referred to in Article 32(1)(b) may be financed on the basis of operating grants. In the event of renewal, the operating grants shall not be decreased automatically. 3. Grant agreements may authorise flat-rate cover of the beneficiary's overheads up to a maximum of 10 % of total eligible direct costs for actions, except where the beneficiary's indirect costs are covered through an operating grant financed from the Community budget. 4. The common cooperation objectives and the administrative and financial conditions relating to the grants awarded to the body recognised under Article 14 may be defined in a framework partnership agreement signed by the Commission and that body, in accordance with the Financial Regulation and Regulation (EC, Euratom) No 2342/2002. The European Parliament and the Council shall be informed of the conclusion of any such agreement.

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Article 36 Management and monitoring 1. The appropriations determined by the budgetary authority for the financing of conformity assessment, accreditation and market surveillance activities may also cover administrative expenses relating to preparation, monitoring, inspection, auditing and evaluation which are directly necessary for the achievement of the objectives of this Regulation, and in particular studies, meetings, information and publication activities, expenses relating to informatics networks for the exchange of information and any other expenditure on administrative and technical assistance which the Commission may use for conformity assessment and accreditation activities. 2. The Commission shall evaluate the relevance of the conformity assessment, accreditation and market surveillance activities that receive Community financing in the light of the requirements of Community policies and legislation, and inform the European Parliament and the Council of the outcome of that evaluation by 1 January 2013 and every five years thereafter. Article 37 Protection of the Community's financial interests 1. The Commission shall ensure that, when the activities financed under this Regulation are implemented, the Community's financial interests are protected by the application of preventive measures against fraud, corruption and other illegal activities, by effective checks and by the recovery of amounts unduly paid and, if irregularities are detected, by effective, proportionate and dissuasive penalties, in accordance with Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests [13], Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities [14] and Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) [15]. 2. For the purposes of the Community activities financed under this Regulation, the notion of irregularity referred to in Article 1(2) of Regulation (EC, Euratom) No 2988/95 shall mean any infringement of a provision of Community law or any breach of a contractual obligation resulting from an act or omission by an economic operator which has, or

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would have, the effect of prejudicing the general budget of the European Union or budgets managed by it by an unjustified item of expenditure. 3. Any agreements and contracts resulting from this Regulation shall provide for monitoring and financial control by the Commission or any representative which it authorises and for audits by the Court of Auditors, which may be conducted on the spot if necessary. CHAPTER VI FINAL PROVISIONS Article 38 Technical guidelines In order to facilitate the implementation of this Regulation, the Commission shall draw up non-binding guidelines in consultation with stakeholders. Article 39 Transitional provision Accreditation certificates issued before 1 January 2010 may remain valid until the date of their expiry, but no later than 31 December 2014. This Regulation shall, however, apply in the case of their extension or renewal. Article 40 Review and reporting By 2 September 2013, the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation, of Directive 2001/95/EC and of any other relevant Community instrument addressing market surveillance. That report shall, in particular, analyse the consistency of Community rules in the field of market surveillance. If appropriate, it shall be accompanied by proposals to amend and/or consolidate the instruments concerned, in the interests of better regulation and simplification. It shall include an evaluation of the extension of the scope of Chapter III of this Regulation to all products. By 1 January 2013, and every five years thereafter, the Commission, in cooperation with the Member States, shall produce and submit to the European Parliament and to the Council a report on the implementation of this Regulation. Article 41 Penalties The Member States shall lay down rules on penalties for economic operators, which may include criminal sanctions for serious infringements,

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applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive and may be increased if the relevant economic operator has previously committed a similar infringement of the provisions of this Regulation. The Member States shall notify the Commission of those provisions by 1 January 2010 and shall notify it without delay of any subsequent amendment affecting them. Article 42 Amendment to Directive 2001/95/EC Article 8(3) of Directive 2001/95/EC shall be replaced by the following: "3. In the case of products posing a serious risk, the competent authorities shall with due dispatch take the appropriate measures referred to in paragraph 1(b) to (f). The existence of a serious risk shall be determined by the Member States, assessing each individual case on its merits and taking into account the guidelines referred to in point 8 of Annex II.". Article 43 Repeal Regulation (EEC) No 339/93 is hereby repealed with effect from 1 January 2010. References to the repealed Regulation shall be construed as references to this Regulation. Article 44 Entry into force This Regulation shall enter into force on the 20th day after its publication in the Official Journal of the European Union. It shall apply from 1 January 2010. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 9 July 2008. For the European Parliament The President H.-G. Pöttering For the Council The President J.-P. Jouyet [1] OJ C 120, 16.5.2008, p. 1.

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[2] Opinion of the European Parliament of 21 February 2008 (not yet published in the Official Journal) and Council Decision of 23 June 2008. [3] See page 82 of this Official Journal. [4] OJ L 11, 15.1.2002, p. 4. [5] OJ L 145, 31.5.2001, p. 43. [6] OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1). [7] OJ L 8, 12.1.2001, p. 1. [8] OJ L 40, 17.2.1993, p. 1. Regulation as last amended by Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1). [9] OJ L 248, 16.9.2002, p. 1. Regulation as last amended by Regulation (EC) No 1525/2007 (OJ L 343, 27.12.2007, p. 9). [10] OJ L 204, 21.7.1998, p. 37. Directive as last amended by Council Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81). [11] OJ L 302, 19.10.1992, p. 1. Regulation as last amended by Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1). [12] OJ L 357, 31.12.2002, p. 1. Regulation as last amended by Regulation (EC, Euratom) No 478/2007 (OJ L 111, 28.4.2007, p. 13). [13] OJ L 312, 23.12.1995, p. 1. [14] OJ L 292, 15.11.1996, p. 2. [15] OJ L 136, 31.5.1999, p. 1. -------------------------------------------------- ANNEX I Requirements applicable to the body to be recognised under Article 14 1. The body recognised under Article 14 of the Regulation (the body), shall be established within the Community. 2. Under the body's constitution, national accreditation bodies from within the Community shall be entitled to be members of it, provided that they comply with the rules and objectives of the body and with the other conditions set out herein and as agreed with the Commission in the framework agreement. 3. The body shall consult all relevant stakeholders. 4. The body shall provide its members with peer evaluation services satisfying the requirements of Articles 10 and 11. 5. The body shall cooperate with the Commission in accordance with this Regulation. -------------------------------------------------- ANNEX II CE marking

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1. The CE marking shall consist of the initials "CE" taking the following form: +++++ TIFF +++++ 2. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing in paragraph 1 shall be respected. 3. Where specific legislation does not impose specific dimensions, the CE marking shall be at least 5 mm high. --------------------------------------------------

Council Regulation (EC) No 967/2008 of 29 September 2008 amending Regulation (EC) No 834/2007 on organic production and labelling of organic products

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 37(2) thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Parliament, Whereas: (1) Council Regulation (EC) No 834/2007 [1] has introduced rules for compulsory indications to be used on organic products, which, from 1 January 2009, includes the use of the Community logo on pre-packaged food, in accordance with Article 24(1)(b) of that Regulation. (2) It has appeared that the Community logo in place pursuant to Annex V to Council Regulation (EEC) No 2092/91 of 24 June 1991 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs [2] could be confused with other logos in place for protected geographical indications and protected designations of origin, pursuant to Commission Regulation (EC) No 1898/2006 of 14 December 2006 laying down detailed rules of implementation of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs [3] and the logo for traditional specialities guaranteed, defined by Commission Regulation (EC) No 1216/2007 of 18 October 2007 laying down detailed rules for the implementation of Council Regulation (EC) No 509/2006 on agricultural products and foodstuffs as traditional specialities guaranteed [4]. (3) It is important for the perception of consumers to ensure an informative labelling with a distinctive and appealing Community logo, which symbolises organic production and clearly identifies the products.

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The design of such a Community logo requires a certain time period to be developed and to be made known to the public. (4) In order to avoid unnecessary financial and organisational burdens on operators, the compulsory use of the Community logo should be postponed for the time needed to create the new Community logo. This decision does not prevent operators from using, on a voluntary basis, the current logo defined in Annex V to Regulation (EEC) No 2092/91. (5) Regulation (EC) No 834/2007 should therefore be amended accordingly, HAS ADOPTED THIS REGULATION: Article 1 The following paragraph shall be added to Article 42 of Regulation (EC) No 834/2007: "However, Article 24(1)(b) and (c) shall apply as from 1 July 2010." Article 2 This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 29 September 2008. For the Council The President M. Barnier [1] OJ L 189, 20.7.2007, p. 1. [2] OJ L 198, 22.7.1991, p. 1. [3] OJ L 369, 23.12.2006, p. 1. [4] OJ L 275, 19.10.2007, p. 3. --------------------------------------------------

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Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries

THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 [1], and in particular Article 33(2), Article 38(d) and Article 40 thereof, Whereas: (1) Articles 32 and 33 of Regulation (EC) No 834/2007 lay down general provisions for import of organic products. With a view to guarantee that these provisions will be applied in a correct and uniform way, detailed rules and procedures for the application of those provisions should be laid down. (2) As substantial experience has been built up since 1992 with the import of products providing equivalent guarantees, a relatively short period should be given to control bodies and control authorities to request their inclusion in the list for the purpose of equivalence in accordance with Article 33 of Regulation (EC) No 834/2007. However, as there is no experience with the direct application of Community rules on organic production and labelling of organic products outside the territory of the Community, more time should be given to control bodies and control authorities wishing to request their inclusion in the list for the purpose of compliance in accordance with Article 32 of Regulation (EC) No 834/2007. Therefore a longer period should be provided for sending in the requests and for examining them. (3) For products imported according to Article 32 of Regulation (EC) No 834/2007, the operators concerned should be able to provide documentary evidence. It is necessary to establish a model for this documentary evidence. Products imported according to Article 33 of Regulation (EC) No 834/2007 should be covered by a certificate of inspection. It is necessary to lay down detailed rules with regard to the issuing of this certificate. Moreover, a procedure in order to coordinate at Community level certain controls on products imported from third countries which are intended to be marketed in the Community as organic should be laid down. (4) Argentina, Australia, Costa Rica, India, Israel, New Zealand and Switzerland were previously listed as third countries from which imported products could be marketed in the Community as organic, under Commission Regulation (EC) No 345/2008 of 17 April 2008 laying down

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detailed rules for implementing the arrangements for imports from third countries provided for in Council Regulation (EEC) No 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs [2]. The Commission has re-examined the situation of those countries according to the criteria set out in Regulation (EC) No 834/2007, taking into consideration the production rules applied and the experience gained with the import of organic products from these third countries as previously listed under Article 11(1) of Council Regulation (EEC) No 2092/2091. On this basis it is concluded that the conditions for inclusion of Argentina, Australia, Costa Rica, India, Israel, and New Zealand in the list of third countries for equivalency according to Article 33(1) of Regulation (EC) No 834/2007 are fulfilled. (5) The European Community and the Swiss Confederation have concluded an Agreement on trade in agricultural products [3] approved by Decision 2002/309/EC of the Council and of the Commission [4]. Annex 9 to that Agreement covers organically produced agricultural products and foodstuffs and sets out that the Parties must take the necessary measures so that organic products complying with each other’s laws and regulations can be imported and placed on the market. For the sake of clarity, Switzerland should also be listed in the list of third countries for equivalency according to Article 33(1) of Regulation (EC) No 834/2007. (6) Member States’ authorities have acquired substantial experience and expertise in the field of granting access for organic imported goods into the territory of the Community. To establish and maintain the lists of third countries and control bodies and control authorities, this experience should be used and the Commission should be able to take account of reports from Member States and other experts. The tasks involved should be divided in a just and proportionate way. (7) Provision should also be made for transitional measures applicable to third country applications received by the Commission before 1 January 2009, the date from which Regulation (EC) No 834/2007 applies. (8) In order not to disrupt international trade, and to facilitate the transition between the rules established by Regulation (EEC) No 2092/2091 and those established by Regulation (EC) No 834/2007, it is necessary to extend the possibility of Member States to continue to grant authorisations to importers on a case by case basis for placing on the Community market of products until the measures necessary for the functioning of the new import rules have been put in place, in particular as regards the recognition of control bodies and control authorities referred to in Article 33(3) of Regulation (EC) No 834/2007. This possibility should be gradually phased

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out as the list of control bodies referred to in that Article is being established. (9) In order to improve transparency and guarantee the application of this Regulation, an electronic system for exchange of information between the Commission, the Member States, the third countries, and the control bodies and control authorities should be foreseen. (10) The detailed rules laid down in this Regulation replace those laid down in Commission Regulation (EC) No 345/2008 and in Commission Regulation (EC) No 605/2008 of 20 June 2008 laying down detailed rules for implementing the provisions concerning the certificate of inspection for imports from third countries under Article 11 of Council Regulation (EEC) No 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs [5]. Those Regulations should therefore be repealed and replaced by a new Regulation. (11) The measures provided for in this Regulation are in accordance with the opinion of the regulatory Committee on organic production, HAS ADOPTED THIS REGULATION: TITLE I INTRODUCTORY PROVISIONS Article 1 Subject matter This Regulation lays down the detailed rules for the import of compliant products and the import of products providing equivalent guarantees as provided for in Articles 32 and 33 of Regulation (EC) No 834/2007. Article 2 Definitions For the purposes of this Regulation: 1. "certificate of inspection": means the certificate of inspection referred to in Article 33(1)(d) of Regulation (EC) No 834/2007 covering one consignment; 2. "documentary evidence": means the document referred to in Article 68 of Commission Regulation (EC) No 889/2008 [6] and in Article 6 of this Regulation, for which the model is set out in Annex II to this Regulation; 3. "consignment": means a quantity of products under one or more Combined Nomenclature codes, covered by a single certificate of inspection, conveyed by the same means of transport and imported from the same third country;

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4. "first consignee": means the natural or legal person as defined in Article 2(d) of Regulation (EC) No 889/2008; 5. "verification of the consignment": means the verification by the relevant Member States’ authorities of the certificate of inspection to satisfy Article 13 of this Regulation, and, where these authorities consider appropriate, of the products, in relation to the requirements of Regulation (EC) No 834/2007, of Regulation (EC) No 889/2008 and of this Regulation; 6. "relevant Member States authorities": means the customs authorities or other authorities, designated by the Member States; 7. "assessment report": means the assessment report referred to in Articles 32(2) and 33(3) of Regulation (EC) No 834/2007 drawn up by an independent third party fulfilling the requirements of ISO Standard 17011 or by a relevant competent authority, which includes information on document reviews, including the descriptions referred to in Articles 4(3)(b) and 11(3)(b) of this Regulation, on office audits, including critical locations and on risk-oriented witness audits conducted in representative third countries. TITLE II IMPORT OF COMPLIANT PRODUCTS CHAPTER 1 List of recognised control bodies and control authorities for the purpose of compliance Article 3 Compilation and content of the list of recognised control bodies and control authorities for the purpose of compliance 1. The Commission shall draw up a list of control bodies and control authorities, recognised for the purpose of compliance in accordance with Article 32(2) of Regulation (EC) No 834/2007. The list shall be published in Annex I to this Regulation. The procedures for drawing up and amending the list are defined in Articles 4, 16 and 17 of this Regulation. The list shall be made available to the public on the Internet in accordance with Articles 16(4) and 17 of this Regulation. 2. The list shall contain all the information necessary in respect of each control body or control authority to allow verifying whether products placed on the Community market have been controlled by a control body or authority recognised in accordance with Article 32(2) of Regulation (EC) No 834/2007 and in particular: (a) the name and address of the control body or control authority, including e-mail and Internet address and their code number;

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(b) the third countries concerned and in which the products have their origin; (c) the product categories concerned for each third country; (d) the duration of the inclusion in the list; (e) the Internet address where the list of operators subject to the control system can be found, including their certification status and the product categories concerned, as well as suspended and decertified operators and products. Article 4 Procedure for requesting inclusion in the list of recognised control bodies and control authorities for the purpose of compliance 1. The Commission shall consider whether to recognise and include a control body or control authority in the list provided for in Article 3 upon receipt of a request for inclusion in this list from the representative of the control body or control authority concerned. Only complete requests that have been received before 31 October 2011 shall be considered, on the basis of the model of application made available by the Commission in accordance with Article 17(2), for the drawing up of the first list. For the following calendar years, only complete requests that have been received before 31 October of each year shall be considered. 2. The request can be introduced by control bodies and control authorities established in the Community or in a third country. 3. The request shall consist of a technical dossier, which shall comprise all the information needed for the Commission to ensure that the conditions set out in Article 32(1) and (2) of Regulation (EC) No 834/2007 are met for all organic products intended for export to the Community, namely: (a) an overview of the activities of the control body or control authority in the third country or third countries concerned, including an estimate of the number of operators involved and an indication of the expected nature and quantities of agricultural products and foodstuffs originated from the third country or third countries concerned and intended for export to the Community under the rules set out in Article 32(1) and (2) of Regulation (EC) No 834/2007; (b) a detailed description of how Titles II, III and IV of Regulation (EC) No 834/2007 as well as the provisions of Regulation (EC) No 889/2008 have been implemented in the third country or in each of the third countries concerned; (c) a copy of the assessment report as set out in the fourth subparagraph of Article 32(2) of Regulation (EC) No 834/2007:

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(i) proving that the control body or control authority has been satisfactorily assessed on its ability to meet the conditions set out in Article 32(1) and (2) of Regulation (EC) No 834/2007; (ii) giving guarantees on the elements referred to in Article 27(2), (3), (5), (6) and (12) of Regulation (EC) No 834/2007; (iii) ensuring that the control body or control authority meets the control requirements and precautionary measures set out in Title IV of Regulation (EC) No 889/2008; and (iv) confirming that it has effectively implemented its control activities according to these conditions and requirements; (d) proof that the control body or authority has notified its activities to the authorities of the third country concerned and its undertaking to respect the legal requirements imposed on it by the authorities of the third country concerned; (e) the website address where the list of operators subject to the control system can be found, as well as a contact point where information is readily available on their certification status, the product categories concerned, as well as suspended and decertified operators and products; (f) an undertaking to comply with the provisions of Article 5 of this Regulation; (g) any other information deemed relevant by the control body or control authority or by the Commission. 4. When examining a request for inclusion in the list of control body or control authority, and also any time after its inclusion, the Commission may request any further information, including the presentation of one or more on-the-spot examination reports established by independent experts. Furthermore, the Commission may, based on risk-assessment and in case of suspected irregularities, organise an on-the-spot examination by experts it designates. 5. The Commission shall assess whether the technical dossier referred to in paragraph 3 and the information referred to in paragraph 4 are satisfactory and may subsequently decide to recognise and include a control body or control authority in the list. The decision shall be taken in accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007. Article 5 Management and review of the list of recognised control bodies and control authorities for the purpose of compliance 1. A control body or control authority may only be included in the list referred to in Article 3 when it fulfils the following obligations:

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(a) if, after the control body or control authority has been included in the list, any changes are made to the measures applied by the control body or control authority, that control body or control authority shall notify the Commission thereof; requests to amend the information in respect of a control body or control authority referred to in Article 3(2) shall also be notified to the Commission; (b) a control body or control authority included in the list shall keep available and communicate at first request all information related to its control activities in the third country; it shall give access to its offices and facilities to experts designated by the Commission; (c) by 31 March every year, the control body or control authority shall send a concise annual report to the Commission; the annual report shall update the information of the technical dossier referred to in Article 4(3); it shall describe in particular the control activities carried out by the control body or control authority in the third countries during the previous year, the results obtained, the irregularities and infringements observed and the corrective measures taken; it shall furthermore contain the most recent assessment report or update of such report, which shall contain the results of the regular on-the-spot evaluation, surveillance and multiannual reassessment as referred to in Article 32(2) of Regulation (EC) No 834/2007; the Commission may request any other information deemed necessary; (d) in the light of any information received, the Commission may at any time amend the specifications relating to the control body or control authority and may suspend the entry of that body or authority in the list referred to in Article 3; a similar decision may also be made where a control body or authority has not supplied information required or where it has not agreed to an on-the-spot examination; (e) the control body or control authority shall make available to interested parties, on an Internet website, a continuously updated list of operators and products certified as organic. 2. If a control body or a control authority does not send the annual report, referred to in paragraph 1(c), does not keep available or does not communicate all information related to its technical dossier, control system or updated list of operators and products certified as organic, or does not agree to an on-the-spot examination, after request by the Commission within a period which the Commission shall determine according to the severity of the problem and which generally may not be less than 30 days, that control body or control authority may be withdrawn from the list of control bodies and control authorities, in accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007.

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If a control body or a control authority fails to take appropriate and timely remedial action, the Commission shall withdraw it from the list without delay. CHAPTER 2 Documentary evidence required for import of compliant products Article 6 Documentary evidence 1. The documentary evidence required for import of compliant products referred to in Article 32(1)(c) of Regulation (EC) No 834/2007, shall, in accordance with Article 17(2) of this Regulation, be established on the basis of the model set out in Annex II to this Regulation and contain at least all the elements that are part of that model. 2. The original documentary evidence shall be established by a control authority or the control body which has been recognised for issuing that documentary by a decision as referred to in Article 4. 3. The authority or body issuing the documentary evidence shall follow the rules established in accordance with Article 17(2) and in the model, notes and guidelines made available by the Commission via the computer system enabling electronic exchange of documents referred to in Article 17(1). TITLE III IMPORT OF PRODUCTS PROVIDING EQUIVALENT GUARANTEES CHAPTER 1 List of recognised third countries Article 7 Compilation and content of the list of third countries 1. The Commission shall establish a list of recognised third countries in accordance with Article 33(2) of Regulation (EC) No 834/2007. The list of recognised countries is set out in Annex III to this Regulation. The procedures for drawing up and amending the list are defined in Articles 8 and 16 of this Regulation. Amendments to the list shall be made available to the public on the Internet in accordance with Articles 16(4) and 17 of this Regulation. 2. The list shall contain all the information necessary in respect of each third country to allow verifying whether products placed on the Community market have been subject to the control system of the third country

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recognised in accordance with Article 33(2) of Regulation (EC) No 834/2007 and in particular: (a) the product categories concerned; (b) the origin of the products; (c) a reference to the production standards applied in the third country; (d) the competent authority in the third country responsible for the control system, its address, including e-mail and Internet addresses; (e) the control authority or authorities in the third country and/or the control body or bodies recognised by the said competent authority to carry out controls, their addresses, including, when appropriate, e-mail and Internet addresses; (f) the authority or authorities or the control body or bodies responsible in the third country for issuing certificates with a view to importing into the Community, their addresses and their code numbers and, when appropriate, their e-mail and Internet addresses; (g) the duration of the inclusion in the list. Article 8 Procedure for requesting inclusion in the list of third countries 1. The Commission shall consider whether to include a third country in the list provided for in Article 7 upon receipt of a request for inclusion, from the representative of the third country concerned. 2. The Commission shall only be required to consider a request for inclusion which meets the following preconditions. The request for inclusion shall be completed by a technical dossier, which shall comprise all the information needed for the Commission to ensure that the conditions set out in Article 33(1) of Regulation (EC) No 834/2007 are met for products intended for export to the Community, namely: (a) general information on the development of organic production in the third country, the products produced, the area in cultivation, the production regions, the number of producers, the food processing taking place; (b) an indication of the expected nature and quantities of organic agricultural products and foodstuffs intended for export to the Community; (c) the production standards applied in the third country as well as an assessment of their equivalence to the standards applied in the Community; (d) the control system applied in the third country, including the monitoring and supervisory activities carried out by the competent authorities in the third country, as well as an assessment of its equivalent effectiveness when compared to the control system applied in the Community;

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(e) the Internet or other address where the list of operators subject to the control system can be found, as well as a contact point where information is readily available on their certification status and the product categories concerned; (f) the information the third country proposes to include in the list as referred to in Article 7; (g) an undertaking to comply with the provisions of Article 9; (h) any other information deemed relevant by the third country or by the Commission. 3. When examining a request for inclusion in the list of recognised third countries, and also any time after its inclusion, the Commission may request any further information, including the presentation of one or more on-the-spot examination reports established by independent experts. Furthermore, the Commission may, based on risk-assessment and in case of suspected irregularities organise an on-the-spot examination by experts it designates. 4. The Commission shall assess whether the technical dossier referred to in paragraph 2 and the information referred to in paragraph 3 are satisfactory and may subsequently decide to recognise and include a third country in the list. The decision shall be taken in accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007. Article 9 Management and review of the list of third countries 1. The Commission shall only be required to consider a request for inclusion when the third country undertakes to accept the following conditions: (a) if, after a third country has been included in the list, any changes are made to the measures in force in the third country or their implementation and in particular to its control system, that third country shall notify the Commission thereof; requests to amend the information in respect of a third country referred to in Article 7(2) shall also be notified to the Commission; (b) the annual report referred to in Article 33(2) of Regulation (EC) No 834/2007 shall update the information of the technical dossier referred to in Article 8(2) of this Regulation; it shall describe in particular the monitoring and supervisory activities carried out by the competent authority of the third country, the results obtained and the corrective measures taken; (c) in the light of any information received, the Commission may at any time amend the specifications relating to the third country and may

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suspend the entry of that country from the list referred to in Article 7; a similar decision may also be made where a third country has not supplied information required or where it has not agreed to an on-the-spot examination. 2. If a third country does not send the annual report, referred to Article 33(2) of Regulation (EC) No 834/2007, does not keep available or does not communicate all information related to its technical dossier or control system or does not agree to an on-the-spot examination, after request by the Commission within a period which the Commission shall determine according to the severity of the problem and which generally may not be less than 30 days, that third country may be withdrawn from the list, in accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007. CHAPTER 2 List of recognised control bodies and control authorities for the purpose of equivalence Article 10 Compilation and content of the list of recognised control bodies and control authorities for the purpose of equivalence 1. The Commission shall draw up a list of control bodies and control authorities, recognised for the purpose of equivalence in accordance with Article 33(3) of Regulation (EC) No 834/2007. The list shall be published in Annex IV to this Regulation. The procedures for drawing up and amending the list are defined in Articles 11, 16 and 17 of this Regulation. The list shall be made available to the public on the Internet in accordance with Articles 16(4) and 17 of this Regulation. 2. The list shall contain all the information necessary in respect of each control body or authority to allow verifying whether products placed on the Community market have been controlled by a control body or authority recognised in accordance with Article 33(3) of Regulation (EC) No 834/2007 and in particular: (a) the name, address and code number of the control body or authority, and, when appropriate, its e-mail and Internet address; (b) the third countries not listed in the list provided for in Article 7 where the products have their origin; (c) the product categories concerned for each third country; (d) the duration of the inclusion in the list; and (e) the Internet website where the list of operators subject to the control system can be found, as well as a contact point where information is

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readily available on their certification status, the product categories concerned, as well as suspended and decertified operators and products. 3. By way of derogation from paragraph 2(b), those products originating from third countries listed in the list of recognised third countries as referred to in Article 7 which belong to a category which is not referred to in that list may be listed in the list provided for in this Article. Article 11 Procedure for requesting inclusion in the list of recognised control bodies and control authorities for the purpose of equivalence 1. The Commission shall consider whether to include a control body or control authority in the list provided for in Article 10 upon receipt of a request for inclusion from the representative of the control body or control authority concerned on the basis of the model of application made available by the Commission in accordance with Article 17(2). Only complete requests that have been received by 31 October 2009 shall be considered for the drawing up of the first list. For the following calendar years, the Commission shall undertake regular updates of the list as appropriate on the basis of complete requests that have been received before 31 October of each year. 2. The request can be introduced by control bodies and control authorities established in the Community or in a third country. 3. The request for inclusion shall consist of a technical dossier, which shall comprise all the information needed for the Commission to ensure that the conditions set out in Article 33(3) of Regulation (EC) No 834/2007 are met for products intended for export to the Community, namely: (a) an overview of the activities of the control body or control authority in the third country or third countries, including an estimate of the number of operators involved and the expected nature and quantities of agricultural products and foodstuffs intended for export to the Community under the rules set out in Article 33(1) and (3) of Regulation (EC) No 834/2007; (b) a description of the production standards and control measures applied in the third countries, including an assessment of the equivalence of these standards and measures with Titles III, IV and V of Regulation (EC) No 834/2007 as well as with the associated implementing rules laid down in Regulation (EC) No 889/2008; (c) a copy of the assessment report as set out in the fourth subparagraph of Article 33(3) of Regulation (EC) No 834/2007: (i) proving that the control body or control authority has been satisfactorily assessed on its ability to meet the conditions set out in Article 33(1) and (3) of Regulation (EC) No 834/2007;

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(ii) confirming that it has effectively implemented its activities according to those conditions; and (iii) demonstrating and confirming the equivalence of the production standards and control measures referred to in subparagraph (b) of this paragraph; (d) proof that the control body or control authority has notified its activities to the authorities of each of the third countries concerned and its undertaking to respect the legal requirements imposed on it by the authorities of each of the third countries concerned; (e) the Internet website where the list of operators subject to the control system can be found, as well as a contact point where information is readily available on their certification status, the product categories concerned, as well as suspended and decertified operators and products; (f) an undertaking to comply with the provisions of Article 12; (g) any other information deemed relevant by the control body or control authority or by the Commission. 4. When examining a request for inclusion in the list of control body or control authority, and also any time after its inclusion, the Commission may request any further information, including the presentation of one or more on-the-spot examination reports established by independent expert. Furthermore, the Commission may organise an on-the-spot examination by experts it designates on a risk-based approach and in case of suspected irregularities. 5. The Commission shall assess whether the technical dossier referred to in paragraph 2 and the information referred to in paragraph 3 are satisfactory and may subsequently decide to recognise and include a control body or control authority in the list. The decision shall be taken in accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007. Article 12 Management and review of the list of control bodies and control authorities for the purpose of equivalence 1. A control body or control authority may only be included in the list referred to in Article 10 when it fulfils the following obligations: (a) if, after a control body or control authority has been included in the list, any changes are made to the measures applied by the control body or control authority, that control body or control authority shall notify the Commission thereof; requests to amend the information in respect of a control body or authority referred to in Article 10(2), shall also be notified to the Commission;

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(b) by 31 March every year, the control body or control authority shall send a concise annual report to the Commission. The annual report shall update the information of the technical dossier referred to in Article 11(3); it shall describe in particular the control activities carried out by the control body or control authority in the third countries in the previous year, the results obtained, the irregularities and infringements observed and the corrective measures taken; It shall furthermore contain the most recent assessment report or update of such report, which shall contain the results of the regular on-the-spot evaluation, surveillance and multiannual reassessment as referred to in Article 33(3) of Regulation (EC) No 834/2007; the Commission may request any other information deemed necessary; (c) in the light of any information received, the Commission may at any time amend the specifications relating to the control body or control authority and may suspend the entry of that body or authority from the list referred to in Article 10; a similar decision may also be made where a control body or control authority has not supplied information required or where it has not agreed to an on-the-spot examination; (d) the control body or control authority shall make available to interested parties, by electronic means, a continuously updated list of operators, and of products certified as organic. 2. If a control body or a control authority does not send the annual report, referred to in paragraph 1(b), does not keep available or does not communicate all information related to its technical dossier, control system or updated list of operators and products certified as organic, or does not agree to an on-the-spot examination, after request by the Commission within a period which the Commission shall determine according to the severity of the problem and which generally may not be less than 30 days, that control body or control authority may be withdrawn from the list of control bodies and control authorities, in accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007. If a control body or a control authority fails to take appropriate and timely remedial action, the Commission shall withdraw it from the list without delay. CHAPTER 3 Release for free circulation of products imported in accordance with Article 33 of Regulation (EC) No 834/2007 Article 13 Certificate of inspection

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1. The release for free circulation in the Community of a consignment of products referred to in Article 1(2) of Regulation (EC) No 834/2007 and imported in accordance with Article 33 of that Regulation shall be conditional on: (a) the submission of an original certificate of inspection to the relevant Member State’s authority; and (b) on the verification of the consignment by the relevant Member State’s authority and the endorsement of the certificate of inspection in accordance with paragraph 8 of this Article. 2. The original certificate of inspection shall be established in accordance with Article 17(2) and paragraphs 3 to 7 of this Article, on the basis of the model and the notes set out in Annex V. The model notes, together with guidelines referred to in Article 17(2), shall be made available by the Commission via the computer system enabling electronic exchange of documents referred to in Article 17. 3. To be accepted, the certificate of inspection must have been issued by: (a) the control authority or control body which has been accepted for issuing the certificate of inspection, as referred to in Article 7(2), from a third country recognised under Article 8(4); or (b) the control authority or control body in the third country listed for the third country concerned recognised under Article 11(5). 4. The authority or body issuing the certificate of inspection shall only issue the certificate of inspection and endorse the declaration in box 15 of the certificate, after: (a) it has carried out a documentary check on the basis of all relevant inspection documents, including in particular the production plan for the products concerned, transport documents and commercial documents; and (b) it has either made a physical check of the consignment, or it has received an explicit declaration of the exporter declaring that the consignment concerned has been produced and/or prepared in accordance with Article 33 of Regulation (EC) No 834/2007; it shall carry out a risk-oriented verification of the credibility of this declaration. It shall furthermore give a serial number to each issued certificate and keep a register of the delivered certificates in chronological order. 5. The certificate of inspection shall be drawn up in one of the official languages of the Community and filled in, except for the stamps and signatures, either entirely in capital letters or entirely in typescript. The certificate of inspection shall be in one of the official languages of the Member State of destination. Where necessary, the relevant Member State’s authorities may request a translation of the certificate of inspection in one of its official languages.

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Uncertified alterations or erasures shall invalidate the certificate. 6. The certificate of inspection shall be made in one single original. The first consignee or, where relevant, the importer may make a copy for the purpose of informing the control authorities and control bodies in accordance with Article 83 of Regulation (EC) No 889/2008. Any such copy shall carry the indication "COPY" or "DUPLICATE" printed or stamped thereon. 7. For products imported under the transitional rules stipulated in Article 19 of this Regulation, the following shall apply: (a) the certificate of inspection referred to in paragraph 3(b) shall, at the time it is submitted in accordance with paragraph 1, include in box 16 the declaration of the competent authority in the Member State which granted the authorisation according to the procedure provided for in Article 19; (b) the competent authority in the Member State which granted the authorisation may delegate the competence for the declaration in box 16 to the control authority or control body inspecting the importer in accordance with the control measures set out in Title V of Regulation (EC) No 834/2007, or to the authorities defined as the Member State’s relevant authorities; (c) the declaration in box 16 is not required: (i) when the importer presents an original document, issued by the competent authority of the Member State which granted the authorisation in accordance with Article 19 of this Regulation, demonstrating that the consignment is covered by that authorisation; or (ii) when the Member State’s authority, which granted the authorisation referred to in Article 19, has given satisfactory evidence that the consignment is covered by that authorisation, directly to the authority in charge of the verification of the consignment; this procedure of direct information is optional for the Member State which granted the authorisation; (d) the document giving the evidence required in points c(i) and (ii), shall include: (i) the reference number of the import authorisation and the date of expiration of the authorisation; (ii) the name and address of the importer; (iii) the third country of origin; (iv) the details of the issuing body or authority, and, where different, the details of the inspection body or authority in the third country; (v) the names of the products concerned.

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8. At the verification of a consignment, the original certificate of inspection shall be endorsed by the relevant Member State’s authorities in box 17 and returned to the person who submitted the certificate. 9. The first consignee shall, at the reception of the consignment, complete box 18 of the original of the certificate of inspection, to certify that the reception of the consignment has been carried out in accordance with Article 34 of Regulation (EC) No 889/2008. The first consignee shall then send the original of the certificate to the importer mentioned in box 11 of the certificate, for the purpose of the requirement laid down in the second subparagraph of Article 33(1) of Regulation (EC) No 834/2007, unless the certificate has to further accompany the consignment referred to in paragraph 1 of this Article. 10. The certificate of inspection may be established by electronic means, using the method made available to the control authorities or control bodies by the Member State concerned. The competent authorities of the Member States may require that the electronic certificate of inspection be accompanied by an advance electronic signature within the meaning of Article 2(2) of Directive 1999/93/EC of the European Parliament and of the Council [7]. In all other cases, the competent authorities shall require an electronic signature offering equivalent assurances with regard to the functionalities attributed to a signature by applying the same rules and conditions as these defined in the Commission’s provisions on electronic and digitised documents, set out by Commission Decision 2004/563/EC, Euratom [8]. Article 14 Special customs procedures 1. Where a consignment coming from a third country is assigned to customs warehousing or inward processing in the form of a system of suspension as provided for in Council Regulation (EEC) No 2913/92 [9], and subject to one or more preparations as defined in Article 2(i) of Regulation (EC) No 834/2007, the consignment shall be subject, before the first preparation is carried out, to the measures referred to in Article 13(1) of this Regulation. The preparation may include operations such as: (a) packaging or repackaging; or (b) labelling concerning the presentation of the organic production method. After this preparation, the endorsed original of the certificate of inspection shall accompany the consignment, and shall be presented to the relevant Member State’s authority, which shall verify the consignment for the purpose of its release for free circulation.

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After this procedure, the original of the certificate of inspection shall, where relevant, be returned to the importer of the consignment, referred to in box 11 of the certificate to fulfil the requirement laid down in the second subparagraph of Article 33(1) of Regulation (EC) No 834/2007. 2. Where, under a suspensive customs procedure pursuant to Regulation (EEC) No 2913/92, a consignment coming from a third country is intended to be submitted in a Member State, before its release for free circulation in the Community, to a splitting into different batches, the consignment shall be subject, before this splitting is carried out, to the measures referred to in Article 13(1) of this Regulation. For each of the batches which results from the splitting, an extract of the certificate of inspection shall be submitted to the relevant Member State’s authority, in accordance with the model and the notes set out in Annex VI. The extract from the certificate of inspection shall be endorsed by the relevant Member State’s authorities in box 14. A copy of each endorsed extract from the certificate of inspection shall be kept together with the original certificate of inspection by the person identified as the original importer of the consignment and mentioned in box 11 of the certificate of inspection. This copy shall carry the indication "COPY" or "DUPLICATE" printed or stamped thereon. After the splitting, the endorsed original of each extract of the certificate of inspection shall accompany the batch concerned, and shall be presented to the relevant Member State’s authority, which shall verify the batch concerned for the purpose of its release for free circulation. The consignee of a batch shall, at the reception thereof complete the original of the extract of the certificate of inspection in box 15, in order to certify that the reception of the batch has been carried out in accordance with Article 34 of Regulation (EC) No 889/2008. The consignee of a batch shall keep the extract of the certificate of inspection at the disposal of the control authorities and/or control bodies for not less than two years. 3. The preparation and splitting operations referred to in paragraphs 1 and 2 shall be carried out in accordance with the relevant provisions set out in Title V of Regulation (EC) No 834/2007 and in Title IV of Regulation (EC) No 889/2008. Article 15 Non-compliant products Without prejudice to any measures or actions taken in accordance with Article 30 of Regulation (EC) No 834/2007 and/or Article 85 of Regulation (EC) No 889/2008, the release for free circulation in the Community of

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products not in conformity with the requirements of that Regulation shall be conditional on the removal of references to organic production from the labelling, advertising and accompanying documents. TITLE IV COMMON RULES Article 16 Assessment of the requests and publication of the lists 1. The Commission shall examine the requests received in accordance with Articles 4, 8 and 11 with the assistance of the Committee on organic production, referred to in Article 37(1) of Regulation (EC) No 834/2007 (hereafter called "the Committee"). For this purposes the Committee shall adopt specific internal rules of procedure. In order to assist the Commission with the examination of the requests and with the management and review of the lists, the Commission shall set up an expert group consisting of governmental and private experts. 2. For each request received, and after appropriate consultation with Member States in accordance with the specific internal rules of procedure, the Commission shall nominate two Member States to act as co-reporters. The Commission shall divide the requests between the Member States proportionally with the number of votes of each Member State in the Committee on organic production. The co-reporting Member States shall examine the documentation and information as set out in Articles 4, 8 and 11 related to the request and shall draw up a report. For the management and review of the lists, they shall also examine the annual reports and any other information referred to in Articles 5, 9 and 12 related to the entries on the lists. 3. Taking into account the result of the examination by the co-reporting Member States, the Commission shall decide, in accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007, on the recognition of third countries, control bodies or control authorities, their inclusion on the lists or any modification of the lists, including the attribution of a code number to those bodies and authorities. The decisions shall be published in the Official Journal of the European Union. 4. The Commission shall make the lists available to the public by any appropriate technical means, including publication on the Internet. Article 17 Communication

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1. When transmitting documents or other information referred to in Articles 32 and 33 of Regulation (EC) No 834/2007 and in this Regulation to the Commission or the Member States, the competent authorities of third countries, the control authorities or the control bodies shall use electronic transmission. When specific electronic transmission systems are made available by the Commission or the Member States, they shall use these systems. The Commission and the Member States shall also use these systems to provide each other with concerned documents. 2. For the form and content of documents and information referred to in Articles 32 and 33 of Regulation (EC) No 834/2007 and in this Regulation, the Commission shall set out guidelines, models and questionnaires where appropriate and make them available in the computer system referred to in paragraph 1 of this Article. These guidelines, models and questionnaires shall be adapted and updated by the Commission, after having informed the Member States and the competent authorities of third countries, as well as the control authorities and control bodies recognised in accordance with this Regulation. 3. The computer system provided for in paragraph 1 shall be able to collect the requests, documents and information referred to in this Regulation where appropriate, including the authorisations granted pursuant to Article 19. 4. The supporting documents referred to in Articles 32 and 33 of Regulation (EC) No 834/2007 and in this Regulation, in particular in Articles 4, 8 and 11, shall be kept by the competent authorities of third countries, the control authorities or the control bodies at the disposal of the Commission and the Member States for at least three years following the year in which the controls took place or the certificates of inspection and documentary evidence were delivered. 5. Where a document or procedure provided for in Articles 32 and 33 of Regulation (EC) No 834/2007 or in the detailed rules for its application requires the signature of an authorised person or the approval of a person at one or more of the stages of that procedure, the computer systems set up for the communication of those documents must make it possible to identify each person unambiguously and provide reasonable assurance that the contents of the documents, including as regards the stages of the procedure, cannot be altered, in accordance with Community legislation, and in particular with Commission Decision 2004/563/EC, Euratom.

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TITLE V FINAL AND TRANSITIONAL RULES Article 18 Transitional rules on the list of third countries Requests for inclusion from third countries submitted in accordance with Article 2 of Regulation (EC) No 345/2008 before the 1 January 2009 shall be treated as applications under Article 8 of this Regulation. The first list of recognised countries shall include Argentina, Australia, Costa Rica, India, Israel, New Zealand and Switzerland. It shall not contain the code numbers referred to in Article 7(2)(f) of this Regulation. These code numbers shall be added before 1 July 2010 by updating the list in accordance with Article 17(2). Article 19 Transitional rules on equivalent import of products not originating in listed third countries 1. In accordance with Article 40 of Regulation (EC) No 834/2007 the competent authority of a Member State may authorise importers in that Member State, where the importer has notified his activity in accordance with Article 28 of that Regulation, to place on the market products imported from third countries which are not included in the list referred to in Article 33(2) of that Regulation, provided that the importer provides sufficient evidence showing that the conditions referred to in Article 33(1)(a) and (b) of that Regulation are satisfied. Where, having first allowed the importer or any other person concerned to comment, the Member State considers that those conditions are no longer satisfied, it shall withdraw the authorisation. Authorisations shall expire at the latest 24 months after the publication of the first list of control bodies and control authorities recognised pursuant to Article 10 of this Regulation. The imported product shall be covered by a certificate of inspection as set out in Article 13, issued by the control authority or the control body which has been accepted for issuing the certificate of inspection by the competent authority of the authorising Member State. The original of the certificate must accompany the goods to the premises of the first consignee. Thereafter the importer must keep the certificate at the disposal of the control body and, as appropriate the control authority, for not less than two years.

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2. Each Member State shall inform the other Member States and the Commission of each authorisation granted pursuant to this Article, including information on the production standards and control arrangements concerned. 3. At the request of a Member State or at the Commission’s initiative, an authorisation granted pursuant to this Article shall be examined by the Committee on organic production. If this examination discloses that the conditions referred to in Article 33(1)(a) and (b) of Regulation (EC) No 834/2007 are not satisfied, the Commission shall require the Member State which granted the authorisation to withdraw it. 4. Member States may no longer grant the authorisations referred to in paragraph 1 of this Article from the date of 12 months after the publication of the first list of control bodies and control authorities referred to in Article 11(5) except if the imported products in question are goods whose production in the third country was controlled by a control body or control authority not on the list set up in accordance with Article 10. 5. Member States shall no longer grant any authorisation referred to in paragraph 1 from 1 January 2013. 6. Any authorisation to market products imported from a third country which had, prior to 31 December 2008 been granted to an importer by the Competent Authority of a Member State under Article 11(6) of Regulation (EEC) No 2092/91 shall expire on 31 December 2009 at the latest. Article 20 Repeal Regulations (EC) No 345/2008 and (EC) No 605/2008 are repealed. References to the repealed Regulations shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VII. Article 21 Entry into force This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Union. It shall apply as from 1 January 2009. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 8 December 2008. For the Commission Mariann Fischer Boel Member of the Commission

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[1] OJ L 189, 20.7.2007, p. 1. [2] OJ L 108, 18.4.2008, p. 8. [3] OJ L 114, 30.4.2002, p. 132. [4] OJ L 114, 30.4.2002, p. 1. [5] OJ L 166, 27.6.2008, p. 3. [6] OJ L 250, 18.9.2008, p. 1. [7] OJ L 13, 19.1.2000, p. 12. [8] OJ L 251, 27.7.2004, p. 9. [9] OJ L 302, 19.10.1992, p. 1. -------------------------------------------------- ANNEX I LIST OF CONTROL BODIES AND CONTROL AUTHORITIES FOR THE PURPOSE OF COMPLIANCE AND RELEVANT SPECIFICATIONS REFERRED TO IN ARTICLE 3 -------------------------------------------------- ANNEX II MODEL OF THE DOCUMENTARY EVIDENCE referred to in Article 6(1) Documentary evidence to the operator according to Articles 32(1)(c) and 29(1) of Regulation (EC) No 834/2007, required for import of compliant products in accordance with Article 6 of Regulation (EC) No 1235/2008 1. Document number: 2. Name and address of operator: main activity (producer, processor, importer, etc.): 3. Name, address and code number of control body/authority: 4. Product groups/activity: Plant and plant products: Livestock and livestock products: Processed products: 5. defined as: organic production, in-conversion products, and also non-organic production, where parallel production/processing pursuant to Article 11 of Regulation (EC) No 834/2007 occurs 6. Validity period: 7. Date of control(s): Plant products from to Livestock products from to Processed products from to 8. This document has been issued in accordance with Articles 32(1)(c) and 29(1) of Regulation (EC) No 834/2007 and Article 6 of Regulation (EC) No

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1235/2008. The declared operator has submitted his activities under control, and meets the requirements laid down in the named Regulations. Date, place: Signature on behalf of the issuing control body/authority: +++++ TIFF +++++ ANNEX III LIST OF THIRD COUNTRIES AND RELEVANT SPECIFICATIONS REFERRED TO IN ARTICLE 7 ARGENTINA 1. Product categories : (a) live or unprocessed agricultural products and vegetative propagating material and seeds for cultivation with the exception of: - livestock and livestock products, bearing or intended to bear indications referring to conversion; (b) processed agricultural products for use as food with the exception of: - livestock products bearing or intended to bear indications referring to conversion. 2. Origin : products of category 1(a) and organically produced ingredients in products of category 1(b) that have been produced in Argentina. 3. Production standards : Ley 25 127 sobre "Producción ecológica, biológica y orgánica". 4. Competent authority : Servicio Nacional de Sanidad y Calidad Agroalimentaria SENASA, www.senasa.gov.ar 5. Control bodies : - Food Safety SA, www.foodsafety.com.ar - Instituto Argentino para la Certificación y Promoción de Productos Agropecuarios Orgánicos SRL (Argencert), www.argencert.com - Letis SA, www.letis.com.ar - Organización Internacional Agropecuaria (OIA), www.oia.com.ar 6. Certificate issuing bodies : as at point 5. 7. Duration of the inclusion : 30 June 2013. AUSTRALIA 1. Product categories : (a) unprocessed crop products and vegetative propagating material and seeds for cultivation; (b) processed agricultural products for use as food composed essentially of one or more ingredients of plant origin. 2. Origin : products of category 1(a) and organically grown ingredients in products of category 1(b) that have been grown in Australia.

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3. Production standards : National standard for organic and bio-dynamic produce. 4. Competent authority : Australian Quarantine and Inspection Service AQIS, www.aqis.gov.au 5. Control bodies and authorities : - Australian Certified Organic Pty. Ltd., www.australianorganic.com.au - Australian Quarantine and Inspection Service (AQIS), www.aqis.gov.au - Bio-dynamic Research Institute (BDRI), www.demeter.org.au - National Association of Sustainable Agriculture, Australia (NASAA), www.nasaa.com.au - Organic Food Chain Pty Ltd (OFC), www.organicfoodchain.com.au 6. Certificate issuing bodies and authorities : as at point 5. 7. Duration of the inclusion : 30 June 2013. COSTA RICA 1. Product categories : (a) unprocessed crop products and vegetative propagating material and seeds for cultivation; (b) processed crop products for use as food. 2. Origin : products of category 1(a) and organically produced ingredients in products of category 1(b) that have been produced in Costa Rica. 3. Production standards : Reglamento sobre la agricultura orgánica. 4. Competent authority : Servicio Fitosanitario del Estado, Ministerio de Agricultura y Ganadería, www.protecnet.go.cr/SFE/Organica.htm 5. Control bodies : - BCS Oko-Garantie, www.bcs-oeko.com - Eco-LOGICA, www.eco-logica.com 6. Certificate issuing authority : Ministerio de Agricultura y Ganadería. 7. Duration of the inclusion : 30 June 2011. INDIA 1. Product categories : (a) unprocessed crop and vegetative propagating material and seeds for cultivation; (b) processed agricultural products for use as food composed essentially of one or more ingredients of plant origin. 2. Origin : products of category 1(a) and organically grown ingredients in products of category 1(b) that have been grown in India. 3. Production standards : National Programme for Organic Production. 4. Competent authority : Agricultural and Processed Food Export Development Authority APEDA, www.apeda.com/organic 5. Control bodies and authorities : - APOF Organic Certification Agency (AOCA), www.aoca.in

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- Bureau Veritas Certification India Pvt. Ltd, www.bureauveritas.co.in - Control Union Certifications, www.controlunion.com - Ecocert SA (India Branch Office), www.ecocert.in - IMO Control Private Limited, www.imo.ch - Indian Organic Certification Agency (Indocert), www.indocert.org - Lacon Quality Certification Pvt. Ltd, www.laconindia.com - Natural Organic Certification Association, www.nocaindia.com - OneCert Asia Agri Certification private Limited, www.onecertasia.in - SGS India Pvt. Ltd, www.in.sgs.com - Uttaranchal State Organic Certification Agency (USOCA), www.organicuttarakhand.org/products_certification.htm - Rajasthan Organic Certification Agency (ROCA), http://www.rajasthankrishi.gov.in/Departments/SeedCert/index_eng.asp 6. Certificate issuing bodies and authorities : as at point 5. 7. Duration of the inclusion : 30 June 2009. ISRAEL 1. Product categories : (a) unprocessed crop products and vegetative propagating material and seeds for cultivation; (b) processed agricultural products for use as food composed essentially of one or more ingredients of plant origin. 2. Origin : products of category 1(a) and organically produced ingredients in products of category 1(b) that have been produced in Israel or that have been imported into Israel: - either from the Community, - or from a third country in the framework of a regime which is recognised as equivalent in accordance with the provisions of Article 33(2) of Regulation (EC) No 834/2007. 3. Production standards : National Standard for organically grown plants and their products. 4. Competent authority : Plant Protection and Inspection Services (PPIS), www.ppis.moag.gov.il 5. Control bodies and authorities : - Agrior Ltd.-Organic Inspection & Certification, www.agrior.co.il - IQC Institute of Quality & Control, www.iqc.co.il - Plant Protection and Inspection Services (PPIS), www.ppis.moag.gov.il - Skal Israel Inspection & Certification, www.skal.co.il 6. Certificate issuing bodies and authorities : as at point 5. 7. Duration of the inclusion : 30 June 2013. SWITZERLAND

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1. Product categories : live or unprocessed agricultural products and vegetative propagating material, processed agricultural products for use as food, feed and seeds for cultivation with the exception of: - products produced during the conversion period and products containing an ingredient of agricultural origin produced during the conversion period. 2. Origin : products and organically produced ingredients in products that have been produced in Switzerland or that have been imported into Switzerland: - either from the Community, - or from a third country for which Switzerland has recognised that the products have been produced and controlled in that third country to rules equivalent to those laid down in the Swiss legislation. 3. Production standards : Ordinance on organic farming and the labelling of organically produced plant products and foodstuffs. 4. Competent authority : Federal Office for Agriculture FOAG, http://www.blw.admin.ch/themen/00013/00085/00092/index.html?lang=en 5. Control bodies : - Bio Test Agro (BTA), www.bio-test-agro.ch - bio.inspecta AG, www.bio-inspecta.ch - Institut für Marktökologie (IMO); www.imo.ch - ProCert Safety AG, www.procert.ch 6. Certificate issuing bodies : as at point 5. 7. Duration of the inclusion : 30 June 2013. NEW ZEALAND 1. Product categories : (a) live or unprocessed agricultural products and vegetative propagating material and seeds for cultivation, with the exception of: - livestock and livestock products bearing or intended to bear indications referring to conversion, - products from aquaculture; (b) processed agricultural products for use as food with the exception of: - livestock products bearing or intended to bear indications referring to conversion, - products containing products from aquaculture. 2. Origin : products of category 1(a) and organically produced ingredients in products of category 1(b) that have been produced in New Zealand or that have been imported into New Zealand: - either from the Community,

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- or from a third country within the framework of a regime which is recognised as equivalent in accordance with the provisions of Article 33(2) of Regulation (EC) No 834/2007, - or from a third country whose rules of production and inspection system have been recognised as equivalent to the MAF Food Official Organic Assurance Programme on the basis of assurances and information provided by this country’s competent authority in accordance with the provisions established by MAF and provided that only organically produced ingredients intended to be incorporated, up to a maximum of 5 % of products of agricultural origin, in products of category 1(b) prepared in New Zealand are imported. 3. Production standards : NZFSA Technical Rules for Organic Production. 4. Competent authority : New Zealand Food Safety Authority NZFSA, http://www.nzfsa.govt.nz/organics/ 5. Control bodies : - AsureQuality, www.organiccertification.co.nz - BIO-GRO New Zealand, www.bio-gro.co.nz 6. Certificate issuing authority : Ministry of Agriculture and Forestry (MAF) — New Zealand Food Safety Authority (NZFSA). 7. Duration of the inclusion : 30 June 2011. -------------------------------------------------- ANNEX IV LIST OF CONTROL BODIES AND CONTROL AUTHORITIES FOR THE PURPOSE OF EQUIVALENCE AND RELEVANT SPECIFICATIONS REFERRED TO IN ARTICLE 10 -------------------------------------------------- ANNEX V MODEL OF THE CERTIFICATE OF INSPECTION for import of products from organic production into the European Community referred to in Article 13 The model of the certificate is determined with regard to: - the text, - the format, on one single sheet, - the layout and the dimensions of the boxes. CERTIFICATE OF INSPECTION FOR IMPORT OF PRODUCTS FROM ORGANIC PRODUCTION INTO THE EUROPEAN COMMUNITY 1. Issuing body or authority (name and address) 2. Council Regulation (EC) No 834/2007, Article 33(2) or Article 33(3) or Commission Regulation (EC) No 1235/2008, Article 19 3. Serial number of the certificate of inspection 4. Reference No authorisation under Article 19

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5. Exporter (name and address) 6. Control body or control authority (name and address) 7. Producer or preparer of the product (name and address) 8. Country of dispatch 9. Country of destination 10. First consignee in the Community (name and address) 11. Name and address of the importer 12. Marks and numbers. Container No(s). Number and kind. Trade name of the product 13. CN codes 14. Declared quantity 15. Declaration of body or authority issuing the certificate referred to in box 1. This is to certify that this certificate has been issued on the basis of the checks required under Article 13(4) of Regulation (EC) No 1235/2008 and that the products designated above have been obtained in accordance with rules of production and inspection of the organic production method which are considered equivalent in accordance with the provisions of Regulation (EC) No 834/2007. Date Name and signature of authorised person Stamp of issuing authority or body +++++ TIFF +++++ 16. Declaration of the competent authority of the Member State of the European Union who granted the authorisation or its designate. This is to certify that the products designated above have been authorised for marketing in the European Community in accordance with the procedure of Article 19 of Regulation (EC) No 1235/2008, under the authorisation number mentioned in box 4. Date Name and signature of the authorised person Stamp of the competent authority or its designate in the Member State 17. Verification of the consignment by the relevant authority of the Member State. Member State: … Import registration (type, number, date and office of the customs declaration): … Date: … Name and signature of authorised person Stamp 18. Declaration of the first consignee.

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This is to certify that the reception of the goods has been carried out in accordance with the provisions of Article 34 of Regulation (EC) No 889/2008. Name of the company Date Name and signature of the authorised person +++++ TIFF +++++ Notes Box 1: authority or body or other designated authority or body as referred to in Article 13(3) of Regulation (EC) No 1235/2008. This body also completes box 3 and box 15. Box 2: this box indicates the EC Regulations which are relevant for the issue and use of this certificate; indicate he relevant provision. Box 3: the serial number of the certificate given by the issuing body or authority in accordance with Article 13(4) of Regulation (EC) No 1235/2008. Box 4: the authorisation number in case of import under Article 19. This box is completed by the issuing body, or when the information is not yet available at the time the issuing body endorses box 15, by the importer. Box 5: name and address of the exporter. Box 6: control body or authority for monitoring compliance of the last operation (production, preparation, including packaging and labelling) with the rules of the organic production methods in the third country of dispatch. Box 7: operator who carried out the last operation (production, preparation, including packaging and labelling) on the consignment in the third country mentioned in box 8. Box 9: country of destination means the country of the first consignee in the Community. Box 10: name and address of the first consignee of the consignment in the Community. The first consignee shall mean the natural or legal person where the consignment is delivered and where it will be handled for further preparation and/or marketing. The first consignee shall also complete box 18. Box 11: name and address of the importer. The importer shall mean the natural or legal person within the European Community who presents the consignment for release for free circulation into the European Community, either on its own, or through a representative. Box 13: Combined Nomenclature codes for the products concerned. Box 14: declared quantity, expressed in appropriate units (kg of net mass, litre, etc.).

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Box 15: declaration of body or authority issuing the certificate. The signature and the stamp must be in a colour different to that of the printing. Box 16: only for imports under the procedure laid down in Article 19 of Regulation (EC) No 1235/2008. To be completed by the competent authority in the Member State which granted the authorisation, or by the delegated body or authority in case of delegation in accordance with Article 13(7)(b) of Regulation (EC) No 1235/2008. Not to be completed where the derogation of Article 13(7)(c) of Regulation (EC) No 1235/2008 applies. Box 17: shall be completed by the relevant Member State's authority either at the verification of the consignment in accordance with Article 13(1), or before the preparation or splitting operation in the circumstances referred to in Article 14 of Regulation (EC) No 1235/2008. Box 18: shall be filled in by the first consignee at the reception of the products, when he has carried out the checks provided for in Article 34 of Regulation (EC) No 889/2008. +++++ TIFF +++++ -------------------------------------------------- ANNEX VI MODEL OF THE EXTRACT OF THE CERTIFICATE OF INSPECTION referred to in Article 14 The model of the extract is determined with regard to: - the text, - the format, - the layout and the dimensions of the boxes. EXTRACT No … OF THE CERTIFICATE OF INSPECTION FOR IMPORT OF PRODUCTS FROM ORGANIC PRODUCTION INTO THE EUROPEAN COMMUNITY 1. Body or authority having issued the underlying certificate of inspection (name and address) 2. Council Regulation (EC) No 834/2007, Article 33(2) or Article 33(3) or Commission Regulation (EC) No 1235/2008, Article 19 3. Serial number of the underlying certificate of inspection 4. Reference No authorisation under Article 19 5. Operator having split the original consignment into batches (name and address) 6. Control body or control authority (name and address) 7. Name and address of the importer of the original consignment 8. Country of dispatch of the original consignment 9. Total declared quantity of the original consignment 10. Consignee of the batch obtained from splitting (name and address)

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11. Marks and numbers. Container No(s). Number and kind. Trade name of the batch. 12. CN code 13. Declared quantity of the batch 14. Declaration of the relevant authority of the Member State endorsing the extract of the certificate. This extract corresponds to the batch described above and obtained by the splitting of a consignment which is covered by an original certificate of inspection with the serial number mentioned in box 3: Member State: … Date: … Name and signature of authorised person Stamp 15. Declaration of the consignee of the batch This is to certify that the reception of the batch has been carried out in accordance with Article 33 of Regulation (EC) No 889/2008. Name of the company Date: Name and signature of authorised person +++++ TIFF +++++ Notes Extract No …: the extract number corresponds to the number of the batch obtained from the splitting of the original consignment. Box 1: name of body or authority in the third country having issued the underlying certificate of inspection. Box 2: this box indicates the EC Regulations which are relevant for the issue of this extract; indicate the relevant provision under which the underlying consignment was imported, see box 2 of the underlying certificate of inspection. Box 3: the serial number of the underlying certificate which was given by the issuing body or authority in accordance with Article 13(4) of Regulation (EC) No 1235/2008. Box 4: reference No of the authorisation granted under Article 19 of Regulation (EC) No 1235/2008, see box 4 of the underlying certificate of inspection. Box 6: Control body or control authority in charge of controlling the operator having split the consignment. Boxes 7, 8, 9: see relevant information on the underlying certificate of inspection. Box 10: consignee of the batch (obtained from the splitting) in the European Community.

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Box 12: Combined Nomenclature codes for the batch of the products concerned. Box 13: declared quantity, expressed in appropriate units (kg of net mass, litre, etc.). Box 14: shall be completed by the relevant Member State's authority for each of the batches resulting from the splitting operation referred to in Article 14(2) of Regulation (EC) No 1235/2008.

Box 15: shall be filled up at the reception of the batch, when the consignee has carried out the checks provided for in Article 33 of Regulation (EC) No 889/2008.

+++++ TIFF +++++ -------------------------------------------------- ANNEX VII Correlation Table referred to in Article 20 Regulation (EC) No 345/2008 | Regulation (EC) No 605/2008 | This Regulation | — | Article 1(1) | Article 1 | — | Article 1(2) | — | — | Article 2, introductory words and point 1 | Article 2, introductory words and point 1 | | — | Article 2, point 2 | | Article 2, point 2 | Article 2, point 3 | | Article 2, point 3 | Article 2, point 4 | | Article 2, point 4 | — | | Article 2, point 5 | Article 2, point 5 | — | — | Article 3 | — | — | Article 4 | — | — | Article 5 | — | — | Article 6 | Article 1 | — | Article 7 | Article 2(1) | — | Article 8(1) | Article 2(2) | — | Article 8(2) | Article 2(3) | — | Article 8(3) | Article 2(4) | — | Article 8(3) and 9(2) | — | — | Article 8(4) | Article 2(5) | | Article 9(1) | Article 2(6) | | Article 9(3) and 9(4) | — | — | Article 10 | — | — | Article 11 |

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— | — | Article 12 | — | Articles 3 and 4 | Article 13 | — | Article 5 | Article 14 | — | Article 6 | Article 15 | — | — | Article 16 | — | — | Article 17 | — | Article 7(1) | — | — | Article 7(2) | — | — | — | Article 18 | — | — | Article 19 | Article 3 | Article 8 | Article 20 | Article 4 | Article 9 | Article 21 | Annex II | — | — | — | — | Annex I | — | — | Annex II | Annex I | — | Annex III | — | — | Annex IV | — | Annex I | Annex V | — | Annex II | Annex VI | Annex III | Annex IV | Annex VII | --------------------------------------------------

Commission Regulation (EC) No 1254/2008 of 15 December 2008 amending Regulation (EC) No 889/2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control

THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 [1], and in particular Article 20(3), Article 21(2), Article 22(2) and Article 38(a) thereof, Whereas: (1) Regulation (EC) No 834/2007, and in particular Article 20 thereof, lays down basic requirements for the production of organic yeast. Detailed rules for the implementation of those requirements should be laid down in Commission Regulation (EC) No 889/2008 [2].

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(2) Since provisions for the production of organic yeast should be introduced, the scope of Regulation (EC) No 889/2008 should now also encompass yeasts used as food and feed. (3) With a view to help organic farmers to find adequate feed supply for their animals and to facilitate conversion of organic area, in order to meet rising consumer demand for organic products, it is appropriate to allow the use of up to 100 % in-conversion feedingstuffs, produced on the farmers’ own holding, in the feed ration of organic animals. (4) According to Annex VI(B) to Council Regulation (EEC) No 2092/91 [3] only enzymes normally used as processing aids were allowed to be used in organic processing, enzymes used as food additives would have to be in the list of authorised food additives of Annex VI(A)(A.1) to that Regulation. It is necessary to re-introduce this provision in the new implementing rules. (5) Since yeast is not considered as an agricultural product within the meaning of Article 32(3) of the Treaty and in order to allow the labelling of organic yeast as organic, it is necessary to amend the provision on the calculation of ingredients. However, the calculation of yeast and yeast products as agricultural ingredients will be obligatory as of 31 December 2013. This time period is necessary for the industry to be able to adjust. (6) The decorative colouring of boiled eggs is traditional in certain regions of the European Union at a certain period of the year, and as organic eggs may also be coloured and placed on the market, certain Member States lodged a request to allow colours for this purpose, a panel of independent experts was examining certain colours and different other substances for disinfecting and conserving the boiled eggs [4] and concluded that a number of natural colours could be authorised, as well as synthetic forms of iron oxides and iron hydroxides on a temporary basis. Given the local and seasonal character of the production it is however appropriate to give to competent authorities the capacity to give relevant authorisations. (7) As recommended by a panel for organic yeast [5] several products and substances that are necessary for the production of organic yeast, yeast confections and formulations should be authorised under Article 21 of Regulation (EC) No 834/2007. Article 20 of that Regulation provides that only organically produced substrates are to be used for the production of organic yeast and organic yeast should not be present in organic food or feed together with non-organic yeast. However, the panel of experts has in its conclusions of 10 July 2008 recommended temporarily allowing 5 % non-organic yeast extract, until organic yeast extract is available, as additional substrate for the production of organic yeast as a source of nitrogen, phosphor, vitamins and minerals. In accordance to the flexibility

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rules under Article 22(2)(e) of that Regulation 5 % non-organic yeast extract should be authorised for the production of organic yeast. (8) Regulation (EC) No 889/2008 should therefore be amended accordingly. (9) The amendments should apply from the date of application of Regulation (EC) No 889/2008. (10) The measures provided for in this Regulation are in accordance with the opinion of the Regulatory Committee on Organic Production, HAS ADOPTED THIS REGULATION: Article 1 Regulation (EC) No 889/2008 is amended as follows: 1. In Article 1(2), point (d) is deleted. 2. In Article 21, paragraph 1 is replaced by the following: "1. Up to 30 % of the feed formula of rations on average may comprise in-conversion feedingstuffs. When the in-conversion feedingstuffs come from a unit of the holding itself, this percentage may be increased to 100 %." 3. Article 27 is amended as follows: (a) in paragraph 1(b), the following sentence is added: "however, enzymes to be used as food additives have to be listed in Annex VIII, Section A."; (b) in paragraph 2, the following point (c) is added: "(c) yeast and yeast products shall be calculated as ingredients of agricultural origin as of 31 December 2013."; (c) the following paragraph 4 is added: "4. For the traditional decorative colouring of the shell of boiled eggs produced with the intention to place them on the market at a given period of the year, the competent authority may authorise for the period referred to above, the use of natural colours and natural coating substances. The authorisation may comprise synthetic forms of iron oxides and iron hydroxides until 31 December 2013. Authorisations shall be notified to the Commission and the Member States." 4. The following Article 27a is inserted: "Article 27a For the purpose of the application of Article 20(1) of Regulation (EC) No 834/2007, the following substances may be used in the production, confection and formulation of yeast: (a) substances listed in Annex VIII, Section C to this Regulation; (b) products and substances referred to in Article 27(1)(b) and (e) of this Regulation." 5. In Chapter 6 of Title II, the following Section 3a is inserted:

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"Section 3a Exceptional production rules with regard to the use of specific products and substances in the processing in accordance with Article 22(2)(e) of Regulation (EC) No 834/2007 Article 46a Addition of non-organic yeast extract Where the conditions laid down in Article 22(2)(e) of Regulation (EC) No 834/2007 apply, the addition of up to 5 % non-organic yeast extract or autolysate to the substrate (calculated in dry matter) is allowed for the production of organic yeast, where operators are unable to obtain yeast extract or autolysate from organic production. The availability of organic yeast extract or autolysate shall be re-examined by 31 December 2013 with a view to withdrawing this provision." 6. Annex VIII is amended in accordance with the Annex to this Regulation. Article 2 This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Union. It shall apply from 1 January 2009. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 15 December 2008. For the Commission Mariann Fischer Boel Member of the Commission [1] OJ L 189, 20.7.2007, p. 1. [2] OJ L 250, 18.9.2008, p. 1. [3] OJ L 198, 22.7.1991, p. 1. Regulation (EEC) No 2092/91 is repealed and replaced by Regulation (EC) No 834/2007 as from 1 January 2009. [4] Recommendations from the Group of Independent Experts concerning "an application for eggshell colouring agents for organic Easter eggs" www.organic-farming.europa.eu [5] Recommendations from the Group of Independent Experts on "Provisions on organic yeast" www.organic-farming.europa.eu -------------------------------------------------- ANNEX Annex VIII to Regulation (EC) No 889/2008 is amended as follows: 1. the title of Annex VIII is replaced by the following: "Certain products and substances for use in production of processed organic food, yeast and yeast products referred to in Article 27(1)(a) and Article 27a(a)";

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2. the following Section C is added: "SECTION C — PROCESSING AIDS FOR THE PRODUCTION OF YEAST AND YEAST PRODUCTS Name | Primary yeast | Yeast confections/formulations | Specific conditions | Calcium chloride | X | | | Carbon dioxide | X | X | | Citric acid | X | | For the regulation of the pH in yeast production | Lactic acid | X | | For the regulation of the pH in yeast production | Nitrogen | X | X | | Oxygen | X | X | | Potato starch | X | X | For filtering | Sodium carbonate | X | X | For the regulation of the pH | Vegetable oils | X | X | Greasing, releasing or anti-foaming agent" | --------------------------------------------------

Commission Regulation (EC) No 710/2008 of 24 July 2008 setting the weighting coefficients to be used in calculating the Community market price for pig carcases for the 2008/2009 marketing year

THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) [1], and in particular Article 43 thereof,

Whereas:

(1) The Community market price for pig carcases, as referred to in Articles 17 and 37 of Regulation (EC) No 1234/2007, must be established by weighting the prices recorded in each Member State by coefficients expressing the relative size of the pig population of each Member State. (2) These coefficients should be determined on the basis of the number of pigs counted at the beginning of December each year in accordance with

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Council Directive 93/23/EEC of 1 June 1993 on the statistical surveys to be carried out on pig production [2]. (3) In view of the results of the December 2007 census, new weighting coefficients should be set for the 2008/2009 marketing year and Commission Regulation (EC) No 846/2007 [3] should be repealed. (4) Since the 2008/2009 marketing year begins on 1 July 2008, this Regulation should be applicable as of that date. (5) The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets, HAS ADOPTED THIS REGULATION: Article 1 The weighting coefficients referred to in Articles 17 and 37 of Regulation (EC) No 1234/2007 shall be as set out in the Annex hereto. Article 2 Regulation (EC) No 846/2007 is hereby repealed. Article 3 This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union. It shall apply from 1 July 2008. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24 July 2008. For the Commission Mariann Fischer Boel Member of the Commission [1] OJ L 299, 16.11.2007, p. 1. Regulation as last amended by Commission Regulation (EC) No 510/2008 (OJ L 149, 7.6.2008, p. 61). [2] OJ L 149, 21.6.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). [3] OJ L 187, 19.7.2007, p. 3. -------------------------------------------------- ANNEX Weighting coefficients to be used in calculating the Community market price for pig carcases for the 2008/2009 marketing year Articles 17 and 37 of Regulation (EC) No 1234/2007

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Belgium | 3,9 % | Bulgaria | 0,6 % | Czech Republic | 1,7 % | Denmark | 8,2 % | Germany | 16,9 % | Estonia | 0,2 % | Greece | 0,6 % | Spain | 16,3 % | France | 9,4 % | Ireland | 1,0 % | Italy | 5,8 % | Cyprus | 0,3 % | Latvia | 0,3 % | Lithuania | 0,6 % | Luxembourg | 0,05 % | Hungary | 2,4 % | Malta | 0,05 % | Netherlands | 7,3 % | Austria | 2,0 % | Poland | 11,0 % | Portugal | 1,5 % | Romania | 4,1 % | Slovenia | 0,3 % | Slovakia | 0,6 % | Finland | 0,9 % | Sweden | 1,1 % | United Kingdom | 2,9 % | --------------------------------------------------