EuropeAid /114385/D/SV/CY Project

Assessment and administration capacity building for the harmonisation with the New Approach directives

SEMINAR on New Approach Directives

February 16+17, 2004 in Nicosia

ATEX Directive

PED Pressure Equipment directive

97/23/EEC
The views expressed in this publication do not necessarily reflect the views of the European Commission.

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Contents EC-Directives according to 95EEC

Aim of EC-Directives

Pressure Equipment Directive (97/23/EG)

Aim of Directives according to 95 EEC Free movement Transition period Conformity assessment

Guidelines on the Pressure Equipment Directive

Grouping of Guidelines Examples

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Problematic points in the application of the PED

The term Manufacturer Sound engineering practice Risk analysis Materials for Pressure Equipment European approval of materials Harmonised European Standards Operating instructions Transitional period for PED application

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Aim of Directives according to 95 EEC Directives according to 95 EEC (former 100a EEC) are to
ensure free movement of goods in the Common European Market. remove barriers to free trade in the internal market by harmonization of national legislation in the EU Member states.

Pressure Equipment is placed on the common market by the manufacturer or his authorized representative established within the Community.

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Free Movement (Article 4 PED) Member States shall not, on ground of the hazards due to pressure, prohibit, restrict or impede the placing on the market or putting into service under the conditions specified by the manufacturer of pressure equipment or assemblies referred to in Article 1 which comply with the Directive and bear the CE marking indicating that they have undergone conformity assessment in accordance with Article 10.

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Transitional provisions (Article 20 PED) Clause (1): Member States shall apply such provisions as from 29 November 1999. Clause (3) : Member States must permit the placing on the market of pressure equipment and assemblies which comply with the regulations in force in their territory at the date of application of the Directive until 29 May 2002, and permit such equipment to put into service beyond that date.

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Transitional period for the application of the PED In the transitional period (from 29 May 1997 to 29 May 2002) the manufacturer of a pressure equipment or an assembly is free to chose between the application of the new law and the old law (Article 20). In case of choosing the old law the manufacturer should mention it in the user instructions. After the transition period pressure equipment manufactured according to the old law the item needs to be reassessed to comply with the requirements of the PED may not placed on the market in the European Economic Area (EEA) and Switzerland.

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Conformity assessment (Article 10 PED) Before placing on the market, the manufacturer shall subject each item of equipment to one of the conformity assessment procedures described in Annex III, according to the conditions given in this Article. The conformity assessment procedures to be applied to an item of pressure equipment with a view to affixing the CE marking shall be determined by the category, as defined in Article 9, in which the equipment is classified.

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives Categories for unfired pressure vessels for liquids of fluid Group 2 (PED Annex II Diagram 4)

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Guidelines on the PED The Commissions Working Group Pressure (WGP) comprise
representatives of the EU-Member States and representatives of European Organisations, e.g. ORGALIME, CEOC; CEFIC, CECT, EBA.

The guidelines are the consensus of WGP on the correct interpretation of the PED text; There is no legal binding effect of the guidelines; The guidelines are published by the EU Member states and the European Organisations involved.

NOTE: Guidelines are available from www.http://ped.eurodyn.com

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Grouping of Guidelines on the PED 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Scope and exclusions Classification and categories Assemblies Conformity assessment procedures Interpretation of essential safety requirements on design Interpretation of essential safety requirements on fabrication Interpretation of essential safety requirements on materials Interpretation of other essential safety requirements Miscellaneous Horizontal questions

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives WPG 1/3 as an example Guideline related to: Article 1 Question: Are replacements, repairs or modifications of pressure equipment in use covered by the directive? Answer: 1. Entire change: the complete replacement of an item of pressure equipment by an new one is covered by the PED. 2. Repairs are not covered by the PED but are covered by national regulations (if any). 3. Pressure equipment which have been subject to important modifications that change its original characteristics , purpose and/or type after it has been put into service has to be considered as a new product covered by the directive. This has to be assessed by a case by case basis. Reason: The directive applies only to the first placing on the market and putting into service. See blue guide chapter 2.1.

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives WPG 3/2 as an example Guideline related to: Article 1.2 and 3. 2 Question: Are joining operations on site covered by the PED? Answer: For the joining on site of components or equipment, two cases have to be considered: 1. Joining of component parts: joining of component parts to comprise an item of pressure equipment is subject to the requirements of the Directive. The manufacturer -even he is the user- has the responsibility that the resulting item of pressure equipment is in compliance with the Directive. 2. Joining of items of pressure equipment: The joining is not covered by the PED if it is carried out to constitute an installation under the responsibility of the user but remain covered by national rules.

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives WPG 3/2 as an example (concluded) If the joining is carried out under the responsibility of a manufacturer to constitute an assembly covered by the definition given in Article 1.2.1.5, this assembly must fulfil the requirements of the Directive. Reason: The fifth recital in the Directive says: This Directive does not cover the assembly of pressure equipment on the site and under the responsibility of the user, as in the case of industrial installations. NOTES:
1. The definition of assembly in Article 1.2.1.5 is limited to those assemblies assembled by a manufacturer. When items of pressure equipment or assemblies are being put together by a user, to avoid confusion, the term installation is used. See also guideline 3/8

2.

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives The term Manufacturer EN 764-3 Manufacturer: Individual or organisation that is responsible for the design, fabrication, testing, inspection and installation of pressure equipment and assemblies where relevant:
NOTE 1: The manufacturer may subcontract one or more of the above mentioned tasks under his responsibility. NOTE 2: In EU Member states the manufacturer is responsible for compliance with the Pressure Equipment Directive 97/23/EC. For those manufacturers outside the EU their authorized representative inside the EU assumes this

responsibility. Commissions Working Group Pressure 1-1999:

Manufacturer can be each, who is capable and willing to overtake this task.

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Sound engineering practice Pressure equipment and/or assemblies ... designed and manufactured in accordance with the sound engineering practice of a Member State in order to ensure save use (Article 3.3). Guideline 9/1: Sound engineering practice means, ... that such equipment is designed taking in account all relevant factors influencing its safety. Furthermore, such equipment is manufactured, verified and delivered with instructions for use in order to ensure its safety during its intended life, when used in foreseeable or reasonably foreseeable conditions. The manufacturer is responsible for the application of sound engineering practice.

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives General risk analysis The manufacturer is under an obligation to analyse the hazards in order to identify those which apply to his equipment and to meet the requirements of all relevant directives: e.g. risk in account of:
pressure
Pressure Equipment Directive

moving elements
Machinery Directive Low Voltage Directive Electromagnet Compatibility Directive Explosion Protection Directive

electrical current electromagnetic influences potentially explosive atmospheres

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Risk analysis for pressure equipment The manufacturer is under an obligation to analyse the hazards in order to identify those which apply to his equipment in account of pressure; he must then design and construct it taking account of his analysis (Annex 1, Preliminary observations number 3).

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Risk analysis for pressure equipment (conclusion) In choosing the most appropriate solutions, the manufacturer must apply the principles set out below in the following order:
eliminate or reduce hazards as far as reasonable practical, apply appropriate protection measures against hazards which cannot be eliminated, where appropriate, inform user of residual hazards and indicate whether it is necessary to take appropriate special measures to reduce the risk at the time of installation and/or use (Annex 1, number 1.2)-

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Materials for Pressure Equipment The manufacturer must provide in his technical documentation elements relating to compliance with the material specifications of the Directive in one of the following forms:
by using materials which comply with harmonized standards , by using materials covered by a European approval of pressure equipment materials in accordance with Article 11. by using a particular material appraisal.

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Materials for Pressure Equipment (concluded) The equipment manufacturer must take appropriate measures to ensure that the material used conforms with the required specifications. For the main pressure-bearing parts of equipment in categories II, III and IV, this must take the form of a certificate of specific product control. Where a material manufacturer has a appropriate qualityassurance system, ... the manufacturer are presumed to certify conformity with the relevant requirements of this section.

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

European approvals for materials (Article 1, 2.9) European approval for materials means a technical document defining characteristics of materials intended for repeated use in the manufacture of pressure equipment which are not covered by any harmonized standard.

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Harmonized European Standards Harmonized European Standards are prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. After formal adoption by the European Commission they are published in the Official Journal of the Commission. The mandate is mentioned in the foreword of a harmonized standard. The user of a harmonized European Standard may presume conformity with the Essential Safety Requirements of the Pressure Equipment Directive (presumption of conformity).

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

Operating instructions (Annex I, Number 3.4) When pressure equipment is placed on the market, it must be accompanied, as far as relevant, with instructions for the user, containing all the necessary information for:
mounting including assembling of different pieces of pressure equipment putting into service use maintenance including checks by the user

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives

EuropeAid/114385/D/SV/CY Assessment and administration capacity building for the harmonisation with the New Approach Directives