Directive 97/23/EC on Pressure Equipment (PED): International aspects and current developments

1. Directive 97/23/EC on Pressure Equipment (PED): International aspects and current developments Pressure Equipment Workshop, Bratislava April 2005

2. Scope of presentation • Link to presentation on New Approach • Recapitulation: PED scope, definitions, ESRs, categories, illustrating progress in understanding and clarification • Experience and developments: standardisation, notified bodies, market surveillance • Current topics from Europe and beyond - all with an International flavour and indication of developments

3. New Approach • Technical harmonisation to support the Common Market • 19 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 provide presumption of conformity

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

5. PED 97/23/EC Recital - 27 “Whereas” clauses set the scene 21 Articles 7 Annexes: ESR, Graphs, Modules, Criteria for Notified Bodies, Recognised Third Party Organisations and User Inspectorates, “CE” Marking, and Declaration of Conformity

6. Recital Recital 5 Items and assemblies Recital 14 Essential Safety Requirements and Final assessment Recital 16 CEN, CENELEC Harmonised Standards Recital 19 Conformity Assessment

7. Articles Article 1 Scope and definitions – next 3 slides Article 2 Market surveillance – later in my talk Article 3 Technical Requirements - Annex I Essential Safety Requirements Article 8 Safeguard clause Article 10 Conformity Assessment Article 15 CE Marking – indicates legal declaration

8. 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 intoservice

9. 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 protects against exceeding allowable limits 4- Pressure accessory operational function e.g. valves, fittings

10. 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 NOTES: 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

11. Essential Safety Requirements (ESRs) • General obligations for manufacturer (Prelim and ESR 1) • e.g. carry out hazard analysis incl. reasonably foreseeable misuse • - to establish technical documentation file • - Design and calculation (ESR 2) • - Manufacturing (ESR 3) • - manufacturers capabilities, manufacturing/joining procedures • - Materials (ESR 4) • Specific requirements (ESRs 5, 6, 7): • fired or otherwise heated pressure equipment, - piping, and • specific quantitative requirements (general rule)

12. Conformity Assessment • Categories depend on Hazard Level • Cat I: Self Assessment by Manufacturer • Cats II, III, IV: Notified Body also assesses • 12 different CA Modules available • Simplified assessment when using Harmonised Standards, particularly in design

13. 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 Physical state of fluid - gaseous, - liquid Indication of stored “energy” PS·V or PS·DN (piping etc

14. Determination of applicable category

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

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

17. Hazard Categories for PE

18. Certification for certain manufacturing activities Capabilities Certification required Category II III IV By Qualified personnel X X X notified body for joining or Qualified joining X X Xrecognized third proceduresparty organization Qualified personnel X Xrecognized third for NDTparty organization

19. Documentation requirements for materials Materials used for Cat I – IV equipment must be either : • Harmonised 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)

20. European Approval for Materials (EAM) • - Technical document defining characteristics of materials • - Only for types of materials not covered by Harmonised Standards • proposed by a Notified Body • possible objection by Member States and/or Commission • If objection raised, Committee 98/34/EC issues opinion • when published in the Official Journal gives presumption of • conformity

21. E A Ms • First four EAMs on Nickel 201 published in OJ 2003/C233/10, 11 other nickel alloys were published in OJ 2005/35/6 - see http://europa.eu.int/comm/enterprise/pressure_equipment/index.htm • More EAMs are in the pipeline • Guiding Principles and standard form downloadable at http://ped.eurodyn.com/materials/materials.html • Orgalime support facilitating drafts of EAMs (EU contract): http://www.orgalime.org/positions/eam.htm

22. Harmonised Standards (ENs) • Developed following Commissionmandate M/071 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 of product standards: • EN 13445 (unfired pressure vessels), EN 13480 (piping), • EN 12952 (water tube boilers), EN 12953 (shell boilers)

23. Harmonised Standards: Types 1, 2 • Type 1: • - Provide a means of fulfilling at least one ESR • Contain an Annex ZA to provide a reference between the pertaining section of the EN and the ESRs of the PED • Give Presumption of Conformity to those ESRs of the PED which are addressed, when the standard is published in the OJEC. • Type 2: • - Not fulfilling ESRs by themselves, no publication in OJEC • usually referenced from type 1 standards • Consolidated list of standards to be published in OJEC soon

24. Harmonised Standards: Challenges • Some situations are detrimental to European standardisation: • National standard organisations are obliged to withdraw documents conflicting with ENs (98/34/EC) and • Notified Bodies must be free from financial inducements, related e.g. to standardisation (PED annex IV) • National regulation must not discriminate certain solutions • Interest of all players, including European industry: • economically efficient and safe ENs • ENs competitive with other standards internationally

25. Notified Bodies & RTPOs: Facts Individual Member States notifythe Commission and other Member States => Notified Bodies must be subject to laws of a Member State Member States have to assess integrity, independence and technical competence of candidates Involved in conformity assessment of category II, III, IV PE Heterogeneous manufacturer/user structure => in practice Notified Bodies/RTPOs often the single most important element ensuring safety PED annex IV stipulates minimum criteria for Notified Bodies/RTPOs, Member States may apply additional criteria, but not restricting trade

26. Notified Bodies & RTPOs: Problems • Manufacturers: • pay for services - potential for conflict of interest • shop around for cheapest solution – • quality of conformity assessment may deteriorate as a result • Varying technical performance of notified bodies/RTPOs • Questions about subsidiaries of notified bodies in third countries include: technical expertise, training, responsibility, surveillance etc. • So far, most identified problems with the safety of products also point to related problems with Notified Bodies! • Member States to improve surveillance of notified bodies/RTPOs

27. Notified Bodies & RTPOs: Problems (ctd) Attachment to former national legislation and/or interests in national/ private “standardisation” may result in discrimination of “alternatives” like ENs Local incumbents create barriers for “foreign” notified bodies, e.g. by using tasks under national competence

28. Notified Bodies Forum (CABF) Forum of all notified bodies, RTPOs and user inspectorates in the pressure sector: participation in this forum is strongly encouraged Purpose: to exchange information and co-ordinate consistent implementation of PED in Member States in collaboration with WPG/WGP Rotating chair by notified body representatives, financed by Commission, attended by various “observers” (Commission, CEN, industry, users,…) Technical Response Group (TRG) : drafts internal guidance documents on certain technical/legal questions that may also lead to a WPG/WGP guideline Web-based communication platform, contact: jochem.grassmuck@vdtuev.de

29. Market Surveillance • Member States: • must take measures to ensure market surveillance • verify that ESRs and other requirements are met, when appropriate • ensure that products do not endanger health and safety of persons and where appropriate domestic animals or property • define additional measures for workers protection, where needed

30. Market Surveillance • Important element of the New Approach • Pressure Sector: awareness needs to be raised but Member States generally understand their responsibilities and becoming more involved • Most identified problems are with relatively cheap mass products (simple pressure vessels, pressure cookers) However, a “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 labeling, documentation

31. Market Surveillance: Safeguard Clause • Detection of product on the market which is not safe to be used and/or is dangerous • Clarification between market surveillance and manufacturer/authorized representative/importer • If danger persists : withdraw from the market and notify the Commission and Member States • Investigation by the Commission • Commission Decision

32. Administrative Co-operation • Individual Member States have limited resources but collective strength • ADCO groups WPA & WGA established in 2004 • Comprise 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, 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

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

34. Topics : Reports of the Commission • Review of New Approach – mentioned in this talk • SPVD 87/404 and User Inspectorates – PED Article 14: • Public enquiry via web-based questionnaire July 2004 • Summary of results in November 2004 • Further discussion with Member States and stakeholder groups • Reports due middle of 2005

35. Current topics : Liaison on trade Relations with some trading sectors: US Department of Commerce, May and Sept 2004 Meeting with Chinese delegation, November 2004 Common themes and outcomes: to promote understanding of differences in requirements to facilitate access of European industry to foreign markets, e.g. (i) solving problems related to implicit technical barriers of trade (ii) making foreign legislation more accessible and transparent unity of regulation in Europe, replacing fragmented approach

36. Further information Commission “eurodyn” and “Europa” web-sites: http://ped.eurodyn.com http://europa.eu.int/comm/enterprise/pressure_equipment Directive text itself PED WGP Guidelines (hypertext linked to PED) National Authorities Euro Info Centers Industry Associations Notified Bodies