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DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com ©2016/26 – DNV GL P. 1 / 18 ILPED201468EU-201626 Information leaflet on coming up changes in the European Pressure Equipment Directive (PED), version 201626 Pressure equipment for the European market This information leaflet is a common publication of the DNV GL Conformity Assessment Bodies (CAB) for PED: - Conformity Assessment Body nr. 0097 UK - Conformity Assessment Body nr. 2388 The Netherlands - Conformity Assessment Body nr. 0496 Italy - Conformity Assessment Body nr. 0575 Norway - Conformity Assessment Body nr. 2099 Denmark 1 Introduction on new PED 2014/68/EU The Pressure Equipment Directive (PED 97/23/EC) has been in place since the 29th May 2002. It will be replaced by PED 2014/68/EU as per 19 July 2016. Two main factors have enforced the new PED The basis for the determination of fluid group (1 or 2) in PED Article 9 (i.e. Directive 67/548/EEC) has been replaced by a new Classification, Labelling and Packaging Regulation as per 1 st June 2015. The “New Legal Framework:” This is a larger initiative by the European Union to bring nine EC “New Approach” directives into alignment with the “New Legal Framework,” (NLF) which was adopted in 2008. The essentials of the current PED will not change The scope of the PED The essential safety requirements (annex I) The categorisation tables (annex II) The introduction of the new PED will not act in retrospect on certificates issued under the existing PED. Article 48 states, “Certificates and decisions issued by conformity assessment bodies under Directive 97/23/EC shall be valid under this Directive.” Not only the PED changes, but also a number of other EU directives has been changed or will change, due to the new NLF, like:

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Page 1: Information leaflet on coming up changes in the ... - DNV GL leaflet new PED 201468… · DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99

DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

©2016/26 – DNV GL P. 1 / 18 ILPED201468EU-201626

Information leaflet on coming up changes in the European

Pressure Equipment Directive (PED), version 201626

Pressure equipment for the European market

This information leaflet is a common publication of the DNV GL Conformity Assessment Bodies (CAB)

for PED:

- Conformity Assessment Body nr. 0097 UK

- Conformity Assessment Body nr. 2388 The Netherlands

- Conformity Assessment Body nr. 0496 Italy

- Conformity Assessment Body nr. 0575 Norway

- Conformity Assessment Body nr. 2099 Denmark

1 Introduction on new PED 2014/68/EU

The Pressure Equipment Directive (PED 97/23/EC) has been in place since the 29th May 2002. It will be

replaced by PED 2014/68/EU as per 19 July 2016.

Two main factors have enforced the new PED

The basis for the determination of fluid group (1 or 2) in PED Article 9 (i.e. Directive

67/548/EEC) has been replaced by a new Classification, Labelling and Packaging Regulation as

per 1st June 2015.

The “New Legal Framework:” This is a larger initiative by the European Union to bring nine EC

“New Approach” directives into alignment with the “New Legal Framework,” (NLF) which was

adopted in 2008.

The essentials of the current PED will not change

The scope of the PED

The essential safety requirements (annex I)

The categorisation tables (annex II)

The introduction of the new PED will not act in retrospect on certificates issued under the existing PED.

Article 48 states, “Certificates and decisions issued by conformity assessment bodies under Directive

97/23/EC shall be valid under this Directive.”

Not only the PED changes, but also a number of other EU directives has been changed or will change,

due to the new NLF, like:

Page 2: Information leaflet on coming up changes in the ... - DNV GL leaflet new PED 201468… · DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99

DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

©2016/26 – DNV GL P. 2 / 18 ILPED201468EU-201626

Directive Products Revision

PED 97/23/EC Pressure Equipment New PED (2014/68/EU) in

force 19 July 2016

LD 95/16/EC Lifts New LD (2014/68/EU) in force

20 April 2016

R&TTE 99/5/EC Radio Equipment Replaced by new Radio

Equipment Directive

2014/53/EC in force 13 June

2016

EMC 2004/108/EC Electromagnetic Compatibility New EMC (2014/30/EU) in

force 20 April 2016

LVD 2006/95/EC Low Voltage New LVD (2014/35/EU) in

force 20 April 2016

ATEX 94/9/EC Devices in Explosive Atmosphere New ATEX (2014/34/EU) in

force 20 April 2016

RCD 94/25/EC Recreational Crafts New RCD (2013/53/EU) in

force 18 January 2016

MID 96/98/EU Measurements Instruments New MID (2014/32/EU) in

force 30 October 2016

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DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

©2016/26 – DNV GL P. 3 / 18 ILPED201468EU-201626

2 New PED Transfer process

The dates below show the two timeline steps for the introduction of the new PED.

1 June 2015 Art.13 of the new PED applies (i.e.CLP)

19 July 2016 Full application of the new PED

All EU member states are required to transpose the new PED 2014/68/EU in their national legislation

before these dates.

3 Changes in brief

3.1 Economic operators The new PED defines the term “economic operators” defining roles and responsibilities as below

Manufacturer – unchanged

Authorized representative – unchanged

Importer - The importer is the economic operator established in the Union who places a product

from a third country on the Union market. The importer must ensure that the manufacturer has

correctly fulfilled his obligations. The importer is not a simple re-seller of products, but has a

key role to play in guaranteeing the compliance of imported products. He is obliged to contact

the manufacturer if the compliance with the PED requirements are doubted. He must mark the

product with his name and address. He must ensure that, while a product is under his

responsibility, storage or transport conditions do not jeopardise its compliance. He must keep a

copy of the EU Declaration of Conformity for 10 years after the product has been placed on the

market and ensure that the technical documentation can be made available to the competent

national authority upon request.

Distributor- juridical/physical person in the EU in the supply chain between any of the above

defined (both Third Country and inside the EU) and the User. Retailers, wholesalers and other

distributors in the supply chain are not required to have a direct agreement with the

manufacturer like the authorised representative. A distributor acquires products for further

distribution either from a manufacturer, from an importer, or from another distributor. However

they have an obligation to be aware of the PED requirements and their responsibility. They

must keep a copy of the manufacturer’s operation manual and the DoC.

The revision of the PED also makes clear that if an importer or distributor places pressure equipment or

assemblies on the market under their own name or trademark, or modifies the equipment in a certain

way, they will be considered manufacturer and will therefore have to take legal responsibility for the

product’s compliance including conformity assessment.

In the Netherlands the Ministry of Social Affairs has decided that a user who assembles pressure

equipment into an assembly is in effect a manufacturer. The ministry has deleted the option for

“samenbouw onder verantwoording van de gebruiker” and the user/manufacturer shall now assemble

his pressure equipment according to the new PED 2014/68/EU, have an Notified Body involved

according to a suitable conformity assessment module and CE mark the assembly.

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DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

©2016/26 – DNV GL P. 4 / 18 ILPED201468EU-201626

3.2 Conformity assessment modules The designation of some conformity assessment modules have changed ;

The old 97/23/EC The new 2014/68/EU

A1 A2

B1 B (design type)

B B (production type)

C1 C2

For each category, the following modules are available; (modules for a higher category may be used for

lower category equipment)

Category I = Module A

Category II = Modules A2, D1, E1

Category III = Modules B (design type) + D, B (design type) + F, B (production type) + E, B

(production type) + C2, H

Category IV = Modules B (production type) + D, B (production type) + F, G, H1

3.3 Fluid Classification Change The new fluid classification is effected on 1st of June 2015: Chapter 3, Article 13, “Classification of

pressure equipment.” An impact assessment by the European Commission showed that very few

substances would actually change groups in the PED because of this change. The only significant

change concerns the definition of flammable fluids, where the CLP has considered the PED definition.

The below figure from the EC study illustrates the new classification.

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DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

©2016/26 – DNV GL P. 5 / 18 ILPED201468EU-201626

3.4 Impact on Manufacturers Beside the changes in the Conformity Assessment Modules and fluid classification as described above,

the harmonized standards will increase in importance as solutions to meet the ESR must be stated by

the manufacturer if non-harmonized standards are used. This is expressed in the risk analysis

requirements, which can now be found in Annex III for each module.

As indicated under para 3.1 the user assembling pressure equipment into an integrated whole (pressure

system) will be seen as ‘manufacturer’.

The content of a Declaration of Conformity in Annex IV is also expressed more in detail.

3.5 Impact on Conformity Assessment Bodies The new PED lists Notified Bodies, Recognised Third Party Organisations and User Inspectorates as

‘Conformity Assessment Bodies’ (CAB).

The horizontal requirements on Conformity Assessment Bodies will be implemented in the new PED.

This includes stricter connection to accreditation and more focus on personnel competences at the

Conformity Assessment.

4 Changes in detail

For those interested in a more detailed analysis of the consequences of the introduction of the new PED,

a transfer list in the new PED provides guidance on how the PED 97/23/EC is transferred to the new

PED 2014/68/EU.

In appendix I of this leaflet a table is included showing which new PED articles were covered by the PED

97/23/EC, including a specification of the changes.

Practical changes to the PED are covered in this chapter.

4.1 Changes in fluid categorisation (art 13) as per 1st June 2015 Fluid groups 1 and 2 of PED 97/23/EC will remain. However the base for Group classification will be

changed as the old Dangerous Substances directive – 67/548/EEC - is being replaced by the new CLP

legislation. In practice these changes only concerns some toxic fluids and flammable liquids with a flash

point between 21 and 23 centigrade.

Working Group Pressure Guideline WPG B-01 is providing some guidance as well.

4.2 Module A1 into new PED Module A2 Monitoring of final assessment is to be performed at random intervals.

4.3 Module C1 into new PED Module C2 Same change as for Module A1 into A2.

4.4 Module B into new Module B (production type) Same approach as under the old PED. Requirements to CAB have some modifications.

4.5 Module B1 into new Module B (design type) Most remarkable is that B1 is integrated with module B and the new module B is split up in

B (production type) and B (design type). For the B (design type) certificate, no prototype testing is

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DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

©2016/26 – DNV GL P. 6 / 18 ILPED201468EU-201626

required, the validity is ten years and the technical file is to be stored another 10 years. Modules B and

B1 are both Type Examinations.

4.6 Other Product modules and Quality System Modules The content of the product modules F and G and the quality modules D, D1, E, E1, H and H1 do not

contain noticeable changes.

4.7 EU Declaration of Conformity The minimum content of the EU Declaration of Conformity (DoC) is described in more detail in Annex IV

of the PED. It is expected that a number of manufacturers should review the content of their DoC and

update accordingly, in order to comply with PED 2014/68/EU requirements. This can be combined with

the introduction of the new PED Directive number on the DoC.

4.8 Nameplate with CE marking The text of the new PED requires the full postal address of the manufacturer to be available on the

nameplate. Please note that our Notified body number has changed to 2388 (see chapter 8) this

number should follow the CE marking.

5 Consequences of the new PED on new and running projects

5.1 New projects New PED art 13 has been in effect as per 1st of June 2015.

5.1.1 Quality System Modules

Applications will be assessed according PED 97/23/EC until July 18th 2016 and, when not finished on

July 19th 2016, will be continued and certified according PED 2014/68/EU. All reporting and

assessments performed under PED 97/23/EC remain valid under PED 2014/68/EU. Issuing a

Declaration of Conformity or Certificate of Conformity according 2014/68/EU before 19 July 2016 is not

allowed.

Issued Certificates according PED 97/23/EC before 19 July 2016 remain valid after this date for PED

2014/68/EU.

5.1.2 Product Modules

Applications will be assessed according PED 97/23/EC until 18 July 2016 and, when not finished on 19

July 2016, will be continued and certified according PED 2014/68/EU. All reporting and assessments

performed under PED 97/23/EC remains valid under PED 2014/68/EU. Issuing Declaration of

Conformity (manufacturer) and Certificate of Conformity (by CAB) according 2014/68/EU before 19 July

2016 is not allowed.

Issued Certificates according PED 97/23/EC (before 19 July 2016) remain valid after this date. Meaning

old and New PED modules can be combined after 19 July 2016, i.e. Module B (97/23/EC) with module D

(2014/68/EU).

5.1.3 Particular Material Appraisals

PMA’s issued before 19 July 2016, based on PED 97/23/EC remain valid under the new PED.

5.1.4 Welding approvals

An approval on WPQR’s and WPQ’s issued before 19 July 2016, based on PED 97/23/EC remain valid

under the new PED.

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DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

©2016/26 – DNV GL P. 7 / 18 ILPED201468EU-201626

5.2 Ongoing projects on 1 June 2015 and on 19 July 2016

5.2.1 Quality System Modules

Applications will be assessed according PED 97/23/EC until 18 July 2016 and will be continued and

certified according PED 2014/68/EU. All reporting and assessments performed under PED 97/23/EC

remain valid under PED 2014/68/EU. Issuing Declaration of Conformity (manufacturer) and Certificate

of Conformity (by CAB) according 2014/68/EU before 19 July 2016 is not allowed.

Issued Certificates according PED 97/23/EC before 19 July 2016 remain valid after this date.

5.2.2 Product Modules

Applications will be assessed according PED 97/23/EC until 18 July 2016 and will be continued and

certified according PED 2014/68/EU. All reporting and assessments performed under PED 97/23/EC

remains valid under PED 2014/68/EU. Issuing Declaration of Conformity (manufacturer) and Certificate

of Conformity (by CAB) according 2014/68/EU before 19 July 2016 is not allowed.

Issued Certificates according PED 97/23/EC before 19 July 2016 remain valid after this date.

A Manufacturer issuing a Declaration of Conformity after the transfer should make a reference to Art.48

resp. Art.41 if the DoC is based on Certificates issued before the transfer.

6 Appendix on changes New/Old PED

Appendix 1 to this leaflet provides cross references between the new and the old PED.

7 Disclaimer

This leaflet is assembled by DNV GL to provide guidance to clients on the introduction of the

new PED 2014/68/EU. Interpretation of the Directive itself is not the responsibility of DNV GL.

DNV GL does not accept any liability or responsibility for loss or damages resulting from any

use of this document. DNV GL holds all rights to this information leaflet, including copyright.

8 Transition of Conformity Assessment Body number (2388)

By transition of the Notification for PED from Det Norske Veritas B.V. – PCNL to DNV GL

Business Assurance B.V. and the introduction of the new PED 2014/68/EU the Conformity

Assessment Body number will change from 0427 into 2388 as per 19 July 2016.

9 Your contact in DNV GL

For further information please contact the respective DNV GL PED Conformity Assessment

Bodies (CAB) in UK (CAB 0097), Netherlands (CAB 2388), Italy (CAB 0496), Norway (CAB

0575) and Denmark (CAB 2099).

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DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

©2016/26 – DNV GL P. 8 / 18 ILPED201468EU-201626

For any question or comment or if you do not want to receive information by DNV GL please revert to:

DNV GL Business Assurance B.V.

Conformity Body for Pressure Equipment Directive no. 2388

Zwolseweg 1

NL - 2994 LB Barendrecht

E-mail: [email protected]

Contact person: Chris van den Berg – Technical Manager

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DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

©2016/26 – DNV GL P. 9 / 18 ILPED201468EU-201626

Appendix I

Pressure Equipment Directive PED 2014/68/EU versus 97/23/EC

2014/68/EU of 15 May 2014 97/23/EC of 29 May 1997 Modification

Art Lid Text Art Lid Text

Preamble THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee ( 1 ), Acting in accordance with the ordinary legislative procedure ( 2 ), etc, etc

Preamble THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposals from the Commission (1), Having regard to the Opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 4 February 1997, etc, etc

A number of preambule items are modified. Take notice of them.

CHAPTER 1 - GENERAL PROVISIONS

1 1 Scope 1 1 Scope and definitions Equal

1 2 This Directive shall not apply to: Etc, etc

1 3 The following are excluded from the scope of this Directive: Etc, etc

Text modified. Equal consequences

2 1-14 Definitions 1 2 For the purposes of this Directive: [definitions] Nearly equal

15-32 Definitions New

3 Making available on the market and putting into service 2 Market surveillance Text modified. Equal consequences

4 Technical requirements 3 Technical requirements Text modified. Equal consequences

5 1 Free movement 4 1 Free movement Text modified. Equal consequences

5 2 Free movement 14 2 Free movement User inspectorate specified here as well. Equal consequences

5 3 Free movement 4 2 Free movement Text modified. Equal consequences

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DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

©2016/26 – DNV GL P. 10 / 18 ILPED201468EU-201626

CHAPTER 2 - OBLIGATIONS OF ECONOMIC OPERATORS

6 Obligations of manufacturers New

7 Authorised representatives New

8 Obligations of importers New

9 Obligations of distributors New

10 Cases in which obligations of manufacturers apply to importers and distributors

New

11 Identification of economic operators New

5 Presumption of conformity Removed

6 Committee on technical standards and regulations Removed

8 Safeguard clause Removed

CHAPTER 3 - CONFORMITY AND CLASSIFICATION OF PRESSURE EQUIPMENT AND ASSEMBLIES

12 1 Presumption of conformity New, noted.

12 2 Presumption of conformity 11 4 European approval for materials Rewritten

13 1 Classification of pressure equipment 9 1 Classification of pressure equipment Revised.

9 2 Classification of pressure equipment Removed

13 1a Classification of pressure equipment New. I.c.w. Regulation 1272/2008.

13 1b Classification of pressure equipment 9 2 Classification of pressure equipment Revised.

13 2 Classification of pressure equipment 9 3 Classification of pressure equipment Nearly equal

14 Conformity assessment procedures 10 Conformity assessment Modified. Several Modules have new name and are modified:A2, B, C2. See Annex III for the modification of the Modules itself.

15 1 European approval for materials 11 1 European approval for materials Text modified. Equal consequences

15 2 European approval for materials 11 2 European approval for materials Text modified. Equal consequences

15 3 European approval for materials 11 3 European approval for materials Text modified. Equal consequences

15 4 European approval for materials New

15 5 European approval for materials 11 5 European approval for materials Text modified. Equal consequences

15 6 European approval for materials New

12 Notified bodies Removed

13 Recognized third-party organizations Removed

16 1 User inspectorates 14 1 User inspectorates Text modified. Equal consequences

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DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

©2016/26 – DNV GL P. 11 / 18 ILPED201468EU-201626

16 2-7 User inspectorates 14 3-8 User inspectorates Text modified. Equal consequences

14 9-10 User inspectorates Removed

17 EU Declaration of conformity New

18 General principles of the CE marking New

CHAPTER 4 - NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

15 1 CE marking Removed

19 1 Rules and conditions for affixing the CE marking 15 2 CE marking Text modified. Equal consequences

19 2 Rules and conditions for affixing the CE marking 15 3 CE marking Text modified. Equal consequences

15 4-5 CE marking Removed

19 3-6 Rules and conditions for affixing the CE marking New

20 Notification New

21 Notifying authorities New

22 Requirements relating to notifying authorities New

23 Information obligation on notifying authorities New

24 Requirements relating to notified bodies and recognised third-party organisations

New. Requirements to Notified Bodies are made more explicit.

25 Requirements relating to user inspectorates New

26 Presumption of conformity of conformity assessment bodies New. Definition of Presumption of Conformity.

27 Subsidiaries of and subcontracting by conformity assessment bodies

New. Requirements to subcontract at Notified Bodies are made more explicit.

28 Application for notification New. Application requirements(Renewal application!). Accrediation or evidence compliance with accreditation standard is a pre-requisite.

29 Notification procedure New. Procedure.

30 Identification numbers and lists of notified bodies New, noted.

31 Lists of recognised third-party organisations and user inspectorates

New, noted.

32 Changes to notifications New, noted.

33 Challenge of the competence of notified bodies, recognised third party organisations and user inspectorates

New, noted.

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DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

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34 Operational obligations of notified bodies, user inspectorates and recognised third party organisations

New. Requirements to obligation at Notified Bodies are made more explicit.

35 Appeal against decisions of notified bodies, recognised third party organisations and user inspectorates

New. Requirements on Appeal at Notified Bodies are made more explicit.

36 Information obligation on notified bodies, recognised third party organisations and user inspectorates

New. Some additional info to be provided to Notifying authorities.

37 Exchange of experience New. For member states

38 Coordination of notified bodies, recognised third-party organisations and user inspectorates

New. For Commission and Member states

16 Unduly affixed CE marking Removed

17 Member States Removed

18 Decisions entailing refusal or restriction Removed

CHAPTER 5 - UNION MARKET SURVEILLANCE, CONTROL OF PRESSURE EQUIPMENT AND ASSEMBLIES ENTERING THE UNION MARKET, AND UNION SAFEGUARD PROCEDURE

39 Union market surveillance and control of pressure equipment and assemblies entering the Union market

New. For Commission and Member states

40 Procedure for dealing with pressure equipment or assemblies presenting a risk at national level

New. For Member states

41 Union safeguard procedure New. For Commission and Member states

42 Compliant pressure equipment or assemblies which present a risk

New. For Commission and Member states

43 Formal non-compliance New. For Commission and Member states

CHAPTER 6 - COMMITTEE PROCEDURE AND DELEGATED ACTS

44 1 Committee procedure 7 2 Committee on Pressure Equipment Text modified. Equal consequences

44 2-5 Committee procedure New. For Commission

44 5,1stp Committee procedure New. For Commission

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DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

©2016/26 – DNV GL P. 13 / 18 ILPED201468EU-201626

44 5,2ndp Committee procedure 7 4 Committee on Pressure Equipment Text modified. Equal consequences

45 Delegated power 7 1 Committee on Pressure Equipment Text modified. Equal consequences

7 3 Committee on Pressure Equipment Removed

46 Exercise of the delegation New. For Commission

CHAPTER 7 - TRANSITIONAL AND FINAL PROVISIONS

47 Penalties New

19 Repeal Removed

20 1-2 Transposition and transitional provisions Removed

48 1 Transitional provisions 20 3 Transposition and transitional provisions Revised, noted.

48 2-3 Transitional provisions New, noted

49 Transposition New. - Article 13 to be implemented 28 February 2015 in National Legislation by Member states, entrance date 1 June 2015. - New PED 2014/68/EU to be implemented July 18th 2016 in National Legislation by Member States, entrance date July 19th 2016 .

50 Repeal New. Confirmation of repeals old PED parts.

51 Entry into force and application New. Entrance date new PED Directive (17 July 2014). Noted

52 Addressees 21 Addressees of the Directive Addressed to member states as PED to be implemented in National Legislations.

ANNEX I - ESSENTIAL SAFETY REQUIREMENTS

ANNEX I - ESSENTIAL SAFETY REQUIREMENTS

0 PRELIMINARY OBSERVATIONS No relevant changes

1 GENERAL No relevant changes

2 DESIGN

2.1 General No relevant changes

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DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

©2016/26 – DNV GL P. 14 / 18 ILPED201468EU-201626

2.2 Design for adequate strength No relevant changes

2.3 Provisions to ensure safe handling and operation No relevant changes

2.4 Means of examination No relevant changes

2.5 Means of draining and venting No relevant changes

2.6 Corrosion or other chemical attack No relevant changes

2.7 Wear No relevant changes

2.8 Assemblies No relevant changes

2.9 Provisions for filling and discharge No relevant changes

2.10 Protection against exceeding the allowable limits of pressure equipment

No relevant changes

2.11 Safety accessories No relevant changes

2.12 External fire No relevant changes

3 MANUFACTURING

3.1 Manufacturing procedures No relevant changes

3.2 Final assessment No relevant changes

3.3 Marking and labelling No relevant changes

3.4 Operating instructions No relevant changes

4 MATERIALS

4.1 Materials for pressurised parts No relevant changes

4.2 The pressure equipment manufacturer No relevant changes

4.3 Materials used No relevant changes

SPECIFIC PRESSURE EQUIPMENT REQUIREMENTS

5 FIRED OR OTHERWISE HEATED PRESSURE EQUIPMENT WITH A RISK OF OVERHEATING AS REFERRED TO IN ARTICLE 4(1)

No relevant changes

6 PIPING AS REFERRED TO IN ARTICLE 4(1)© No relevant changes

7 SPECIFIC QUANTITATIVE REQUIREMENTS FOR CERTAIN PRESSURE EQUIPMENT

7.1 Allowable stresses No relevant changes

7.2 Joint coefficients No relevant changes

7.3 Pressure limiting devices, particularly for pressure vessels No relevant changes

7.4 Hydrostatic test pressure No relevant changes

7.5 Material characteristics No relevant changes

ANNEX II - CONFORMITY ASSESSMENT TABLES

ANNEX II - CONFORMITY ASSESSMENT TABLES

1 Modules No relevant changes

2 Safety Accessories No relevant changes

3 Pressure Accessories No relevant changes

4 Tables (9x) No relevant changes

ANNEX III - CONFORMITY ASSESSMENT PROCEDURES

ANNEX III - CONFORMITY ASSESSMENT PROCEDURES

Introductory wording Introductory wording No relevant changes

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©2016/26 – DNV GL P. 15 / 18 ILPED201468EU-201626

1 MODULE A: (INTERNAL PRODUCTION CONTROL) MODULE A: (INTERNAL PRODUCTION CONTROL)

1 Procedure No relevant changes

2 Technical documentation No relevant changes

3 Manufacturing No relevant changes

4 CE marking and EU declaration of conformity No relevant changes

5 Authorised representative No relevant changes

2 MODULE A2: INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM INTERVALS

MODULE A1: internal manufacturing checks with monitoring of the final assessment)

1 Procedure Revised

2 Technical documentation Revised

3 Manufacturing Revised

4 Final assessment and pressure equipment checks Revised

5 CE marking and EU declaration of conformity Revised

6 Authorised representative Revised

3 MODULE B: EU-TYPE EXAMINATION

3.1 EU-Type examination – Production Type MODULE B: EU-TYPE EXAMINATION

1 Explanation Revised

2 Procedure Revised

3 Manufacturer Revised

4 Notified Body Revised

5 Notified Body Evaluation Report Revised

6 EU Type-Examination Certificate Revised

7 Remain Type-Examination valid Revised

8 Inform Notifying Authority Revised

9 Archiving Application and Certification documents by Notified Body

Revised

10 Authorised representative Revised

3.2 EU-Type examination – Design Type MODULE B1: EC design-examination

1 Explanation Revised

2 Procedure Revised

3 Manufacturer Revised

4 Notified Body Revised

5 Notified Body Evaluation Report Revised

6 EU Type-Examination Certificate - 10 years Revised

7 Remain Type-Examination valid Revised

8 Inform Notifying Authority Revised

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©2016/26 – DNV GL P. 16 / 18 ILPED201468EU-201626

9 Archiving Application and Certification documents by Notified Body

Revised

10 Authorised representative Revised

4 MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM INTERVALS

MODULE C1: conformity to type)

1 Procedure Revised

2 Manufacturing Revised

3 Final assessment and pressure equipment checks Revised

4 CE marking and EU declaration of conformity Revised

5 Authorised representative Revised

5 MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

MODULE D: production quality assurance

1 Procedure No relevant changes

2 Manufacturing No relevant changes

3 Quality system No relevant changes

4 Surveillance under the responsibility of the notified body No relevant changes

5 CE marking and EU declaration of conformity No relevant changes

6 Archiving by manufacturer No relevant changes

7 Inform Notifying Authority Revised

8 Authorised representative No relevant changes

6 MODULE D1: QUALITY ASSURANCE OF THE PRODUCTION PROCESS

MODULE D1: production quality assurance

1 Procedure No relevant changes

2 Technical documentation No relevant changes

3 Archiving by manufacturer No relevant changes

4 Manufacturing No relevant changes

5 Quality system No relevant changes

6 Surveillance under the responsibility of the notified body No relevant changes

7 CE marking and EU declaration of conformity No relevant changes

8 Archiving by manufacturer No relevant changes

9 Inform Notifying Authority Revised

10 Authorised representative No relevant changes

7 MODULE E: CONFORMITY TO TYPE BASED ON PRESSURE EQUIPMENT QUALITY ASSURANCE

MODULE E: product quality assurance

1 Procedure No relevant changes

2 Manufacturing No relevant changes

3 Quality system No relevant changes

4 Surveillance under the responsibility of the notified body No relevant changes

5 CE marking and EU declaration of conformity No relevant changes

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©2016/26 – DNV GL P. 17 / 18 ILPED201468EU-201626

6 Archiving by manufacturer No relevant changes

7 Inform Notifying Authority Revised

8 Authorised representative No relevant changes

8 MODULE E1: QUALITY ASSURANCE OF FINAL PRESSURE EQUIPMENT INSPECTION AND TESTING

MODULE E1: product quality assurance

1 Procedure No relevant changes

2 Technical documentation No relevant changes

3 Archiving by manufacturer No relevant changes

4 Manufacturing No relevant changes

5 Quality system No relevant changes

6 Surveillance under the responsibility of the notified body No relevant changes

7 CE marking and EU declaration of conformity No relevant changes

8 Archiving by manufacturer No relevant changes

9 Inform Notifying Authority Revised

10 Authorised representative No relevant changes

9 MODULE F: CONFORMITY TO TYPE BASED ON PRESSURE EQUIPMENT VERIFICATION

MODULE F: product verification

1 Procedure No relevant changes

2 Manufacturing No relevant changes

3 Verification No relevant changes

4 Verification of conformity by examination and testing of every item of pressure equipment

No relevant changes

5 CE marking and EU declaration of conformity No relevant changes

6 Affix Notified Body number during manufacturing No relevant changes

7 Authorised representative No relevant changes

10 MODULE G: CONFORMITY BASED ON UNIT VERIFICATION MODULE G: EC unit verification

1 Procedure No relevant changes

2 Technical documentation No relevant changes

3 Manufacturing No relevant changes

4 Verification No relevant changes

5 CE marking and EU declaration of conformity No relevant changes

6 Authorised representative No relevant changes

11 MODULE H: CONFORMITY BASED ON FULL QUALITY ASSURANCE

MODULE H: full quality assurance

1 Procedure No relevant changes

2 Manufacturing No relevant changes

3 Quality system No relevant changes

4 Surveillance under the responsibility of the notified body No relevant changes

5 CE marking and EU declaration of conformity No relevant changes

6 Archiving by manufacturer No relevant changes

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DNV GL Headquarters, Veritasveien 1, P.O.Box 300, 1322 Høvik, Norway. Tel: +47 67 57 99 00. www.dnvgl.com

©2016/26 – DNV GL P. 18 / 18 ILPED201468EU-201626

7 Inform Notifying Authority Revised

8 Authorised representative No relevant changes

12 MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION

MODULE H1: full quality assurance with design examination and special surveillance of the final assessment

1 Procedure No relevant changes

2 Manufacturing No relevant changes

3 Quality system No relevant changes

4 Design examination No relevant changes

5 Surveillance under the responsibility of the notified body No relevant changes

6 CE marking and EU declaration of conformity No relevant changes

7 Inform Notifying Authority Revised

8 Authorised representative No relevant changes

ANNEX IV - MINIMUM CRITERIA TO BE MET WHEN DESIGNATING THE NOTIFIED BODIES REFERRED TO IN ARTICLE 12 AND THE RECOGNIZED THIRD-PARTY ORGANIZATIONS REFERRED TO IN ARTICLE 13

Removed

ANNEX V - CRITERIA TO BE MET WHEN AUTHORIZING USER INSPECTORATES REFERRED TO IN ARTICLE 14

Removed

ANNEX VI - CE MARKING Removed

ANNEX IV - EU DECLARATION OF CONFORMITY (No XXXX) ( 1 )

ANNEX VII - DECLARATION OF CONFORMITY

1 - 8 Content requirement DoC example adjusted

ANNEX V PART A - Repealed Directive with list of the successive amendments thereto

New. Noted

PART B - Time-limit for transposition into national law and date of application

New. Noted

ANNEX VI - CORRELATION TABLE

97/23/EC and 2014/68/EU New. Noted