Directive 97/23/ECon Pressure Equipment (PED):

International aspects and current developments

Pressure Equipment Workshop, Bratislava April 2005

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

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 

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

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

Recital

Recital 5 Items and assemblies

Recital 14 Essential Safety Requirements

and Final assessment

Recital 16 CEN, CENELEC Harmonised Standards

Recital 19 Conformity Assessment

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

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

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

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

- 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)

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

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

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.)

Vessels for dangerous gases Vessels for non-dangerous liquids (Table 1) (Table 4)

Conformity assessment tables (A)

Piping for dangerous gases Piping for non-dangerous liquids Table 6 Table 9

Conformity assessment tables (B)

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

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

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)

- 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)

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

• 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)

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

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

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

•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

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)

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

Notified Bodies Forum (CABF)

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

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

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

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

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

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

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

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