Download - Directive 97/23/EC on Pressure Equipment (PED): International aspects and current developments
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Directive 97/23/ECon Pressure Equipment (PED):
International aspects and current developments
Pressure Equipment Workshop, Bratislava April 2005
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Scope of presentation
1) Link to presentation on New Approach
2) Recapitulation: PED scope, definitions, ESRs, categories, illustrating progress in understanding and clarification
3) Experience and developments: standardisation, notified bodies, market surveillance
4) Current topics from Europe and beyond
- all with an International flavour and indication of developments
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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
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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
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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
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Recital
Recital 5 Items and assemblies
Recital 14 Essential Safety Requirements
and Final assessment
Recital 16 CEN, CENELEC Harmonised Standards
Recital 19 Conformity Assessment
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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
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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
PED: Scope
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1- Vessel housing for containment of pressurised fluids
2- Pipingpipe or system of pipes mainly for transport of fluids – includes hoses, expansion joints, fittings
3- Safety accessoryprotects against exceeding allowable limits
4- Pressure accessory
operational function e.g. valves, fittings
Definitions
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Several pieces of pressure equipment, provided1. the result is integrated2. the result is functional3. they are a whole4. they are assembled by one manufacturer
NOTES: a- the assembly can be built in a workshop or on-siteb- there is no upper limit to an assemblyc- when not placed on the market, assemblies are not covered
Assemblies
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- 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)
Essential Safety Requirements (ESRs)
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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
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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
Criteria for classification
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Determination of applicable categoryClassification Group 1 fluid Group 2 fluid
vessels gaseous Table 1 Table 2
liquid Table 3 Table 4
piping gaseous Table 6 Table 7
liquid Table 8 Table 9
Pressure
accessories
volume according to table 1-4
DN according to table 6-9
Safety
accessories
general Category IV
specific Category of respective equipment
Assemblies According to highest element (except safety acc.)
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Vessels for dangerous gases Vessels for non-dangerous liquids (Table 1) (Table 4)
Conformity assessment tables (A)
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Piping for dangerous gases Piping for non-dangerous liquids Table 6 Table 9
Conformity assessment tables (B)
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Hazard Categories for PE
Category ESRs CA Modules CE mark I apply A Yes
II apply A1, D1, E1 Yes
III apply B1 + D, B + E, H B1 + F, B + C1
Yes
IV apply B + D, H1 B + F, G
Yes
(3.3) SEP None NO
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Capabilities Certification required 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
Certification for certain manufacturing activities
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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)
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- 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
European Approval for Materials (EAM)
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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
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• Developed following CommissionDeveloped following Commission mandate M/071 to CENmandate M/071 to CEN
• Designated by CEN as candidate for harmonisationDesignated by CEN as candidate for harmonisation
• Substantiating the Essential Safety Requirements of the PEDSubstantiating the Essential Safety Requirements of the PED
• Use not mandatory but providing presumption of conformityUse not mandatory but providing presumption of conformity • Important examples of product standards:Important examples of product standards:
EN 13445 (unfired pressure vessels), EN 13480 (piping), EN 13445 (unfired pressure vessels), EN 13480 (piping), EN 12952 (water tube boilers), EN 12953 (shell boilers)EN 12952 (water tube boilers), EN 12953 (shell boilers)
Harmonised Standards (ENs)
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Type 1: Type 1: - Provide a means of fulfilling at least one ESR- Provide a means of fulfilling at least one ESR-Contain an Annex ZA to provide a reference between the Contain an Annex ZA to provide a reference between the pertaining section of the EN and the ESRs of the PEDpertaining section of the EN and the ESRs of the PED- Give Presumption of Conformity to those ESRs of the PED Give Presumption of Conformity to those ESRs of the PED which are addressed, when the standard is published in the which are addressed, when the standard is published in the OJEC.OJEC.
Type 2:Type 2:- Not fulfilling ESRs by themselves, no publication in OJEC- Not fulfilling ESRs by themselves, no publication in OJEC- usually referenced from type 1 standardsusually referenced from type 1 standards
Consolidated list of standards to be published in OJEC soonConsolidated list of standards to be published in OJEC soon
Harmonised Standards: Types 1, 2
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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 solutionsInterest of all players, including European industry:• economically efficient and safe ENs • ENs competitive with other standards internationally
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Individual Member States notify the 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
Notified Bodies & RTPOs: Facts
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•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
Notified Bodies & RTPOs: Problems
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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
Notified Bodies & RTPOs: Problems (ctd)
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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: [email protected]
Notified Bodies Forum (CABF)
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Member States: Member States: mustmust take measures to ensure market surveillance take measures to ensure market surveillance
verify that ESRs and other requirements are met, when appropriateverify that ESRs and other requirements are met, when appropriate
ensure that products do not endanger health and safety of persons ensure that products do not endanger health and safety of persons and where appropriate domestic animals or propertyand where appropriate domestic animals or property
define additional measures for workers protection, where neededdefine additional measures for workers protection, where needed
Market Surveillance
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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
Market Surveillance
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Detection of product on the market which is not safe to be Detection of product on the market which is not safe to be used and/or is dangerousused and/or is dangerous
Clarification between market surveillance and Clarification between market surveillance and manufacturer/authorized representative/importermanufacturer/authorized representative/importer
If danger persists : withdraw from the market and notify the If danger persists : withdraw from the market and notify the Commission and Member StatesCommission and Member States
Investigation by the CommissionInvestigation by the Commission
Commission DecisionCommission Decision
Market Surveillance: Safeguard Clause
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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
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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
Topic : National vs. EU regulations
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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
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Current topics : Liaison on tradeRelations 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
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Further information
Commission “eurodyn” and “Europa” web-sites:http://ped.eurodyn.comhttp://europa.eu.int/comm/enterprise/pressure_equipment
Directive text itselfPED WGP Guidelines (hypertext linked to PED)National AuthoritiesEuro Info CentersIndustry AssociationsNotified Bodies