Directive 97/23/EC on Pressure Equipment (PED): Current & International Aspects

1. Directive 97/23/EC on Pressure Equipment (PED): Current & International Aspects PED Workshop, Nicosia/Cyprus, 3-5 October 2005

2. (New Approach) PED recapitulation: scope, definitions, ESRs, categories,… Problems of implementation PED: 3 years experience …

3. Technical harmonisation to support the Common Market +/- 20 sectors to date Define Essential Safety Requirements (ESRs) Establish hazard categories List Conformity Assessment Procedures Self certification / Notified Bodies Assessment Affix CE-mark Free movement within EEA Harmonised Standards to provide presumption of conformity New Approach Quo Vadis ? : “Enhancing the Implementation of the New Approach Directives” COM (2003) 240 final - 07.05.2003  New Approach

4. Ensures free movement of goods (PE), for products which fall within its scope, which meet the ESR, having completed Conformity Assessment or are Art 3.3 (SEP) equipment.  PED harmonises the previously fragmented European PE market Pressure Equipment Directive (PED)

5. PED: Scope Pressure equipment and Assemblies : - design, - manufacture, - conformity assessment Limited to: - pressure hazard - pressure greater than 0.5 bar - equipment placed on the market OR put into service - assemblies placed on the market AND put into service

6. Definitions 1- Vessel housing for containment of pressurised fluids 2- Piping pipe or system of pipes mainly for transport of fluids - includes hoses, expansion joints, fittings 3- Safety accessory protection against exceeding allowable limits 4- Pressure accessory operational function e.g. valves, fittings

7. Assemblies • Several pieces of pressure equipment, provided • the result is integrated • the result is functional • they are a whole • they are assembled by one manufacturer NOTE : a- the assembly can be built in a workshop or on-site b- there is no upper limit to an assembly c- when not placed on the market, assemblies are not covered

8. Essential Safety Requirements (ESRs) • General obligations for manufacturer • e.g. to carry out hazard analysis incl. reasonably foreseeable misuse • - to establish technical documentation file • - Design and calculation • - Manufacturing • - manufacturers capabilities • - manufacturing/joining procedures • - Materials • - Specific requirements • - for fired or otherwise heated pressure equipment • - for piping • - Specific quantitative requirements (general rule)

9. Category I : Manufacturer Self Assessment Category II, III, IV : Notified Body Assessment Categories established depending on Hazard Level 12 different CA Modules available Simplified assessment when using Harmonised Standards Conformity Assessment

10. Criteria for classification Two fluid groups - Group 1: Positive list of 7 dangerous fluid types as defined by Directive 67/548/EEC - Group 2: Other fluids Content - gaseous - liquid PS·V PS·DN

11. Determination of applicable category

12. Conformity assessment tables (A) Vessels for dangerous gases Vessels for non-dangerous liquids (Table 1) (Table 4)

13. Conformity assessment tables (B) Piping for dangerous gases Piping for non-dangerous liquids Table 6 Table 9

14. Hazard Categories for pressure equipment

15. Certification required for certain manufacturing steps Capabilities Certfication regquired Category II III IV By Qualified personnel X X X notified body for joining or Qualified joining X X X recognized third procedures party organization Qualified personnel X X recognized third for NDT party organization

16. Materials used for Cat I –IV equipment must be either : Harmonized EN Standard (material or product standard) European Approval of Material (EAM) Particular Material Appraisal (PMA) Technical documents must contain Affirmation of compliance with specification by material manufacturer Certificate of specific product control (cat II – IV) Requirements on documentation for Materials

17. European Approval for Materials (EAM) • - Technical document defining characteristics of materials • - Only for types of materials not covered by Harmonized Standards • Proposed by a Notified Body • Informal assessment by WPM possible • Possible objection by Member States and/or Commission • If objection  Committee 98/34/EC issues opinion • When published in the Official Journal  presumption of • conformity

18. First Set of EAMs on Nickel 201 published in OJ 2003/C 233/10 11 EAMS on Nickel-Chromium-Iron alloys published in OJ 2005/C 35/03 About 20 more EAMs « in the pipeline »: Nickel, nickel alloys, titanium alloys, zirkonium alloys, etc. Guiding Principles and standard form for EAMs downloadable at http://ped.eurodyn.com/materials/materials.html Orgalime support facilitating drafts of EAMs (EU contract): http://www.orgalime.org/positions/eam.htm EAMs - status

19. Harmonized Standards (ENs) • Developed Following Mandate /071 from the Commission to CEN • Designated by CEN as Candidate for Harmonisation • Substantiating the Essential Safety Requirements of the PED • Use not mandatory but providing presumption of conformity • Important examples: • EN 13445 (unfired pressure vessels), EN 13480 (piping), EN 12952 (water tube boilers), EN 12953 (shell boilers)

20. Harmonised Standards: Type 1/2 • Type 1: • - Providing a means of fulfilling at least one ESR • - Containing an Annex ZA to provide a reference between the pertaining section of the EN and the ESRs of the PED • Giving Presumption of Conformity to the addressed ESRs of the PED when published in the OJEC and transposed into national standards • Type 2: • - Not fulfilling ESRs by themselves, no publication in OJEC • But referenced from type 1 standards • Consolidated list of type 1 standards planned to be published soon => type 2 standards « erroneously » published in the past would be implicitly withdrawn

21. Standardisation: Challenges (1) • New Approach grants certain « privileges » to key players • like national standard organisations and notified bodies and • in turn defines a few simple principles: • National standard organisations are obliged to withdraw documents conflicting with ENs (98/34/EC) and • National regulation must not discriminate certain solutions

22. Standardisation: Challenges (2) • But: • National standard organisations continue to maintain their national codes to the detriment of ENs, e.g. xy5500, xy2790: economically short-sighted thinking, conflict of interest, inefficient use of resources • National regulations on in-service inspection and/or operation of pressure equipment, etc. favour local codes, discriminate ENs • National (quasi-)monopolies for inspection services & economic interests of monopoly holders => local code favoured, ENs discriminated

23. Standardisation: Challenges (3) • What to do: • Promote European standardisation • Legal measures, e.g. infringement procedures • CEN structure, role of national standard bodies ??? • Interest of all players, i.e. European industry: • economically efficient and safe ENs • ENs competitive with other standards on an international level • In a harmonised internal market without a guaranteed position • « at home » no national European standard can compete on an international level in the long term!

24. Notified Bodies & RTPOs: Facts • Notified by individual Member States to the Commission and other Member States => must be subject to law of a Member State • Member States have to assess integrity, independence and technical competence • Involved in conformity assessment of category II, III, IV pressure equipment • Heterogeneous manufacturer/user structure => in practice notified bodies/RTPOs are often the single most important element ensuring the safety of pressure equipment • PED annex IV stipulates minimum criteria for notified bodies/RTPOS, Member States may apply additional criteria, e.g. Notified Bodies must be free from financial inducements, related e.g. to standardisation (PED annex IV)

25. Notified Bodies: Challenges • Manufacturers pay for services => potential conflicts of interest • Manufacturers “shopping around” for cheapest solution => quality of conformity assessment may deteriorate • Different technical performances of notified bodies/RTPOs • Surveillance of notified bodies/RTPOs by Member States needs to be improved • Subsidiaries of notified bodies in third countries : technical expertise, training, responsibility, surveillance,…? • Most identified problems with the safety of products point also to related problems with notified bodies! • Attachment to former national legislation and/or interests in national/ private “standardisation” => discrimination of “alternatives” like ENs • Local incumbents create barriers for “foreign” notified bodies, e.g. by using tasks under national competence

26. Market Surveillance • Member States must take measures to ensure market surveillance • Verification of meeting of the ESRs and other requirements when appropriate • Ensure that products do not endanger health and safety of persons and where appropriate domestic animals or property • Pressure Sector: awareness needs to be raised but Member States are awakening now! • Most identified problems are with relatively cheap mass products (simple pressure vessels, pressure cookers) => “small” risk per item may generate a substantial risk for accidents due to the large number of products • Sometimes responsibilities (manufacturer, distributor, authorized representative) difficult to identify, e.g. insufficient labelling, documentation

27. Administrative Co-operation • ADCO groups WPA & WGA established in 2004 • Comprises representatives from public administrations only • Information exchange, co-operation, common concepts and actions for the surveillance/designation of products and notified bodies • Chaired by Member States and supported by the Commission • Regular meetings, web-based communication platforms (Circa, ICSMS) • Now: “constitution” established => deal with individual cases ! • ADCO approach may be extended with the revision of New Approach

28. National vs. EU regulations: Challenges • Interfaces of national and European competences: • “Placing on the market” vs. • operation (e.g. attended/unattended operation) • initial in-service inspection • regular in-service inspection • non-pressure related aspects of pressure equipment (e.g. fire extinguishers, environment,…) • … • Sometimes clear separation is difficult: • => Tendency of Member State authorities and “national” competent bodies to impose additional requirements, which may infringe articles 4, 5 of the PED

29. International Aspects • Pressure equipment « talks » with the US: • Started in 2002 with US « attack » on certain PED provisions considered to conflict with ASME • Exchange of various letters • Two face-to-face meetings in Washington and Paris (in 2004) • Issues (examples): • - « secluded » ASME based US system vs. international collaboration, e.g. at ISO => pilot project on common material testing standards • Compliance of ASME with PED ESRs on materials • Qualification of welding/NDT personnel/procedures

30. International Aspects • EU / China dialogue: • Co-operation agreement signed on Commissioner/Minister level in 2003 • Meeting with AQSIQ representatives in November 2004 in Brussels • Follow up meeting & forum on pressure equipment in November 2005 in Beijing • Issues at stake: • - New Chinese legislation: transparency & availability of documents • - Compliance when using « non-Chinese » standards • - Facilitate Manufacturer Licensing, e.g. by AQSIQ office in Europe, • use of European labs/bodies, re-use of PED quality system elements • - Collaboration at ISO, use of international standards in China • (- Safety of Chinese products placed on European market)

31. New Commission web-site : http://europa.eu.int/comm/enterprise/pressure_equipment/ped/index_en.html PED WGP Guidelines National Authorities Industry Associations Notified Bodies Directive text itself Further information & The End