on Pressure Equipment (PED): Past experience and future challenges Directive 97/23/EC on Pressure Equipment (PED): Past experience and future challenges Pressure Equipment Workshop, Warsaw 24-25 June 2004

PED: Two years experience and new momenta (New Approach) PED recapitulation: scope, definitions, ESRs, categories Experiences and outlook: standardisation, notified bodies, market surveillance Current hot topics

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 to provide presumption of conformity New Approach Quo Vadis ? : “Enhancing the Implementation of the New Approach Directives” COM (2003) 240 final - 07.05.2003 

Pressure Equipment Directive (PED) 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

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

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

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

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)

Conformity Assessment 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

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

Determination of applicable category Classification Group I fluid Group II fluid vessels gaseous Table 1 Table 2 liquid Table 3 Table 4 piping Table 6 Table 7 Table 8 Table 9 Pressure accessories volume according to table 1-4 DN according to table 6-9 Safety general Category IV specific Category of respective equipment Assemblies According to highest element (except safety acc.)

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

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

Hazard Categories for pressure equipment Category ESRs CA Modules CE mark I apply A Yes II A1, D1, E1 III B1 + D, B + E, H B1 + F, B + C1 IV B + D, H1 B + F, G (3.3) SEP None NO

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

Requirements on documentation for Materials 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)

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 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

European Approval for Materials First Set of EAMs on Nickel 201 published in OJ 2003/C 233/10, see reference list at http://europa.eu.int/comm/enterprise/pressure_equipment/index.htm Four other EAMs (nickel alloys) sent out for consultation, more « 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

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)

Harmonised Standards: Type 1/2 - 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

Harmonised Standards: Challenges Situation in some Member States is 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, i.e. European industry: economically efficient and safe ENs ENs competitive with other standards on an international level

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

Notified Bodies & RTPOs: Problems 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

Notified Bodies Forum (NBF) Forum of all notified bodies, RTPOs and user inspectorates in the pressure sector => participation strongly encouraged Purpose: to exchange information and to co-ordinate the consistent implementation of the PED in different Member States in collaboration with WPG/WGP Rotating chair held by notified body representatives, financed by the 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

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 define additional measures for workers protection, where needed

Market Surveillance Important element of the New Approach 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 labeling, documentation

Market Surveillance: Safeguard Clause Detection of product on the market which is not safe to be used/dangerous Clarification between market surveillance and manufacturer/authorized representative/importer If danger persist : withdrawal from the market and notification to Commission and Member States Investigation by the Commission Commission Decision

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 (at present UK), 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

Hot Topics : National vs. EU regulations 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) … 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

Hot Topics: User Inspectorates (UIs) Member States - may notify UIs for the carrying out of conformity assessment for Modules A1, C1, F and G - having notified UIs, MS must accept the use of pressure equipment on their territory which has been assessed by a “foreign” UI User Inspectorates - must fulfil the criteria in Annex V - work exclusively for the group of which they are part No CE-marking!

Hot Topics: User Inspectorates (UIs) Commission must report on PED article 14 on UIs until 29 May 2005: UIs to be abandoned? Scope of UIs to be extended? Acceptance of UIs to become mandatory for all Member States?

Hot Topics : Future of SPVD Commission must report on the future of the Simple Pressure Vessels Directive (SPVD) until 29 May 2005: To be “fully” integrated into PED? Integration into PED with “special” provisions for SPVs? No change?

Hot Topics : Reports of the Commission Steps (for SPVD & UIs): Public enquiry via web-based questionnaire to be launched in July 2004 Summary of results in November Further discussion with Member States and stakeholder groups Report of the Commission in May 2005

Further information Commission web-site : http://ped.eurodyn.com PED WGP Guidelines National Authorities Euro Info Centers Industry Associations Notified Bodies Directive text itself