Pressure Equipment Workshop Romania – Session I Introduction to PED and related standards

1. Pressure Equipment Workshop Romania – Session I Introduction to PED and related standards in the context of the New Approach Ed Haynes, February 2007

2. Scope of presentation • The 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. The “New Approach” New Approach to Technical Harmonisation and Standards

4. New Approach: Background & overview • Access to Community Market (EEA) • Competitiveness encouraged • Technical harmonisation to support the common market • 19 sectors to date • Essential (Health and Safety) Requirements (ESRs) • Conformity to be established to ESRs • Conformity assessment procedures relate to risks • Manufacturer’s responsibility • CE marking of products placed on the market • Self certification / Notified Bodies Assessment • Various intervention mechanisms for authorities • Harmonised Standards provide presumption of conformity

5. New Approach (2) • Regulates risks, and not products • More than 1 risk related directive may apply to the same product • Regulation based on risk management instead of technical solutions • Regulation introduces a wide flexibility for manufacturers, in choice of technological means of meeting ESRs, and conformity assessment 

6. New Approach (3) • Use of European standards giving presumption of conformity; however use of ENs is voluntary • Authorities accept that conformity assessment can be carried out on their behalf by independent bodies • Conformity assessment procedures reflect risk categories • Manufacturers can call upon any Notified Body from throughout the European Union • Conformity assessment always covers design and production, but may be in two stages • Choice between product or quality assurance route

7. The Manufacturer • The person who is responsible for designing and manufacturing a product, with a view to placing it on the Community market, on his own behalf. • Has an obligation to ensure that product is designed and manufactured, and its conformity assessed, all to the Essential Requirements in applicable New Approach directives. • May use finished products, ready-made parts or components, or may subcontract these tasks. However, he must always retain the overall control and have the necessary competence to take the responsibility for the product.

8. The Authorised Representative • Any natural or legal person appointed by the manufacturer to act on his behalf. • Must be established inside the Community. • May be addressed by authorities of the Member States instead of the manufacturer with regard to obligations under a New Approach directive. • Manufacturer remains generally responsible for actions carried out by an authorised representative on his behalf.

9. Legislation and European and National level • Timely transposition of Directives into national law • Complaints and own initiatives • Safeguard clause (98/34 Committee) (See some examples later in this presentation)

10. Review of the New Approach • After 20 years the New Approach is being reviewed to assess its effectiveness and to identify possible improvements • Review is expected to be published at the end of 2007. Timescale for implementation (?) • Aspects considered include Accreditation, Safeguard clauses and Rapid Information Exchange, Technical harmonisation, CE marking and Conformity assessment (QA)

11. Review of the New Approach:(my own impressions) The New Approach is considered a success • The principles it embodies are broadly confirmed • Some changes and enhancements are likely • There is potential for some broadening in the global context • Safeguards must continue for specialist areas

12. The Pressure Sector • Sizeable market in Europe (€ billions) • Covers a wide variety of products • Previously heavily regulated at national level with deeply rooted “national” codes • Dates back to the Industrial Revolution • Related to worker and consumer safety • A technically complex subject • Some indications of concern at global level

13. New Approach - Pressure • In accordance with the principles of the “New Approach”, the design and the manufacture of pressure equipment are subject to essential safety requirements. • This means that Member States cannot prohibit, restrict or impede the placing on the market or putting into service of pressure equipment complying with the provisions of the Directive (bearing the CE marking).

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

15. PED The Pressure Equipment Directive 97/23/EC of the European Parliament on the approximation of the laws of the Member States concerning pressure equipment “Done at Brussels 29 May 1997. For the European Parliament (President). For the Council (President)”

16. 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

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

18. 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

19. PED: Scope Pressure equipment and Assemblies : - design, - manufacture, - conformity assessment Limited to: - pressure hazard - pressure greater than 0.5 bar (gauge or 1.5 bar absolute) - equipment placed on the market OR put into service - assemblies placed on the market AND put intoservice

20. 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

21. 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

22. Essential Safety Requirements (ESRs) • General obligations for manufacturer (Prelim and ESR 1) e.g. carry out hazard analysis incl. reasonably foreseeable misuse; • (i) eliminate hazards (ii) protect against them (iii) advise residual hazards • - 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)

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

24. 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

25. Determination of applicable category

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

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

28. Hazard Categories for PE

29. 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

30. Documentation requirements for materials Materials used for Cat I – IV equipment must be in one of the following forms: • Harmonised EN 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)

31. Materials issues: EN/ASME/ASTM PED Annex I clause 4.1 (a) emphasises ductility and toughness, quantified in clause 7.5. • European materials have guaranteed properties of strength [room (and elevated) temperature], ductility and toughness (transverse direction). • American materials standards do not always state these properties and they are not guaranteed. Levels of C, S (and P) are not consistent with good impact properties expected in Europe.

32. 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 • Publication in the Official Journal gives presumption of • conformity

33. E A Ms • For Guiding Principles PE 01-01 and standard form see http://ec.europa.eu/enterprise/pressure_equipment/ped/materials/materials_en.html • First four EAMs on Nickel 201 published in OJ 2003/C233/10 • 11 other alloys were published in OJ 2005/35/6 – see http://ec.europa.eu/enterprise/pressure_equipment/eam_published.htm • More EAMs are in the pipeline but the total number is relatively low

34. 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 provide 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)

35. Harmonised Standards • Type 1: • - Provide a means of fulfilling at least one ESR • Contain an annex Z 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 cited in the OJEU. • List of standards recently published in OJ on 2006-12-19 C311/31 to C 311/44 - Seehttp://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/equippre.html

36. Harmonised Standards: Challenges • Avoiding situations detrimental to European standardisation: • National standard organisations are obliged to withdraw documents conflicting with ENs (98/34/EC) and • 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

37. PED Annex Z “Once this standard is cited in the OJ under [the] Directive and [it] has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements [of the] Directive and associated EFTA regulations.”

38. Shell boilers EN 12953-3 Table ZA.1(extract) Design & calculation for pressure parts

39. Valves prEN 12516-1 Table ZA.1 (extract)Shell design strength – tabulation method

40. Question 1 Can we use standards other than EN in pressure equipment? Answer YES as long as the manufacturer meets the essential safety requirements in the PED. [Commercial considerations may apply ie. the overall cost may be greater]

41. Question 2 How do I know that AD 2000, CODAP, PD5500, ASME or other non-EN standard meets the Essential Safety Requirements? Answer You do not know, unless the manufacturer: • reviews his arrangements for complying with ESRs and • the Notified Body accepts this, where it is involved in Conformity Assessment.

42. Question 3 Does this mean that the manufacturer takes on additional responsibility by not using EN? Answer YES – other standards do not confer Presumption of Conformity with the ESRs.

43. 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 PE in categories II, III, IV. Since users are not specifically involved, and the manufacturer is responsible for safety, Notified Bodies/RTPOs activities are the next most important for safety. PED annex IV stipulates minimum criteria for Notified Bodies/RTPOs, Member States may apply additional criteria, but not restricting trade.

44. 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. • Member States to improve surveillance of notified bodies/RTPOs

45. Conformity Assessment 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 or remain as a CABF Recommendation. Web-based communication platform, contact: jochem.grassmuck@vdtuev.de

46. Consistency in interpretation and application of the PED • Standards • Guidance documents developed by WGP/WPG • Other technical documents, e.g. ASME code? • General guidance e.g. Blue Guide • Participation in Working Groups • Conformity Assessment Bodies Forum • WGA: Working Group Admin Cooperation • WG6 (precursor to 98/34)

47. Market Surveillance (1) • Pressure equipment and assemblies within the scope of the Directive must be safe when placed on the market and put into service • Member States • must take steps to ensure that pressure equipment cannot be placed on the market if, when installed, maintained or used, it endangers the health and safety of persons, domestic animals or property. • define additional measures for workers protection, where needed. • verify that ESRs and other requirements are met, when appropriate.

48. Market Surveillance (2) • Availability of sufficient resources at national level • Data analysis and strategic market surveillance • Proper enforcement policy • Exchange of information and communication protocols • Mutual assistance and cross border activities • WGA: Working Group Admin Cooperation

49. Market Surveillance (3) • 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 difficult to distinguish responsibilities amongst manufacturer, distributor, authorized representative, e.g. insufficient labeling, access to documentation

50. Market Surveillance: Safeguard Clause • Detection of product on the market which is not safe to be used and/or is dangerous (normally by a national authority) • Clarification between or amongst market surveillance and manufacturer/authorized representative/importer • If danger persists: withdraw product from the market, notify the Commission and other Member States • Investigation by the Commission • Commission Decision