Workshop on the Implementation of the PED

1. Enterprise Directorate-General European Commission Workshop on the Implementation of the PED Bratislava 11, 12 and 13 April 2005 Market Surveillance Cornelis Brekelmans

2. Enterprise Directorate-General European Commission Main challenges for the New Approach • How to implement in a coherent way a common legal framework through 25 different national administrations ? • How to ensure consistent safety levels between Member States ? • How to ensure consistent conformity assessment and market surveillance ? • How to build trust and confidence ?

3. Enterprise Directorate-General European Commission Responsibilities of Manufacturer and authorities • The Directive leaves an important responsibility to manufacturers and Notified Bodies, in particular as there is no prior market approval mechanism • At the same time, Member States remain responsible for safety on the national market and the directives therefore create various intervention mechanisms

4. Enterprise Directorate-General European Commission “Intervention” mechanisms for authorities • Overall responsibility for ensuring proper implementation • Appointment and monitoring of notified bodies • Recognized third party organisation, user inspectorates • Market surveillance; Verification of documents kept by the manufacturer • Wrongly affixed CE marking • Safeguard clause • Formal objection to standards • Reclassification • EAM

5. Enterprise Directorate-General European Commission Market Surveillance Member States are obliged to implement a market surveillance policy, in order to verify compliance with ESR and other relevant provisions of directives, so as to ensure • equivalent levels of protection of citizens and other legitimate interests throughout the Union • a fair level playing field amongst economic operators

6. Enterprise Directorate-General European Commission Market Surveillance • Proper enforcement policy through law and administrative provisions • Availability of sufficient human and financial resources at national level • Avoid conflicts of interest in relation to Notified Bodies • Keep in mind the European dimension: • Exchange of information and communication protocols • Mutual assistance and cross border activities • Data analysis and strategic market surveillance WGA • Working Group Administrative Cooperation

7. Enterprise Directorate-General European Commission Market Surveillance There are different means or levels of market surveillance: • Monitoring of products placed on the market; verification of EC declaration of conformity and relevant technical documentation • Corrective action through safeguard clause, action on undue CE marking, • Information exchange with European counterparts • Additional measures in relation to worker protection under national law („use“ related); • Warn general public where risks for health/safety exist

8. Enterprise Directorate-General European Commission Market Surveillance Different situations can occur, • Properly CE marked products that (nevertheless) present a risk • Products not CE marked that should have been • Undue CE marked products • Products marked on basis of PED not covered by PED • Pre-PED products for which the corrective action has also an effect on CE marked products • Presenting a risk • Presenting a potential risk • Non-conformity without presenting a (potential) risk

9. Enterprise Directorate-General European Commission Safeguard clause • Notification of national measure must also occur when this measure concerns non-CE marked products that can have an impact on CE marked products. • “liable to endanger the safety of persons, and where appropriate, domestic animals and property” In first instance, the measure is product and not manufacturer related ! • Quid products that should have CE marking but do not….: general enforcement clause

10. Enterprise Directorate-General European Commission Safeguard clause Authorities have a significant margin of appreciation: • All appropriate (sufficient and proportionate) measures • To withdraw, prohibit placing on the market and putting into service or use • Restrict free movement (……?) “Qui peut le plus, peut le moins”

11. Enterprise Directorate-General European Commission Safeguard clause Basis for action: • Failure to satisfy essential requirements • Incorrect application of harmonized standards • Shortcomings in harmonized standards • Shortcoming in EAM

12. Enterprise Directorate-General European Commission Safeguard clause Commission’s intervention is intended to • Verify correct implementation of Community law with respect to a product that in principle meets European requirements • Come to a European wide solution, protecting interests at the European level • Allow the “competent” Member State to take appropriate action against the person who affixed the CE marking, informing Commission and other Member States: after Commission evaluation the product related procedure becomes a manufacturer related procedure, dealt with by another authority, on behalf of all

13. Enterprise Directorate-General European Commission Safeguard clauses Be careful…… • Safeguard procedures do not replace a fast mutual information exchange system. If need be, information via RAPEX, ICSMS, ICSMS,etc. to be given in parallel to the safeguard procedure! • A safeguard procedure launched by one Member State does not/may imply that any other Member State has to react as well on the same product on its own territory! • Member States remain responsible for safety on their national market, not the Commission! • Eventually, one Member State will address the manufacturer, on behalf of all

14. Enterprise Directorate-General European Commission

15. Enterprise Directorate-General European Commission Wrongly affixed CE marking. • The product wearing the CE marking is not covered by the Directive • Not all requirements to affix the CE marking have been met

16. Enterprise Directorate-General European Commission Wrongly affixed CE marking. • manufacturer or authorized representative shall be obliged to to make product conform and to end infringement under the conditions imposed by the Member States • When non-conformity persist, the Member States must take all appropriate action to restrict or prohibit placing or withdraw it from the market • Member States must inform all other Member States and Commission

17. Enterprise Directorate-General European Commission RAPEX. • Aimed at rapid exchange of information in the event of a serious risk to health or safety of persons • Notification to Commission concerns identification of product, description of risk, the measures taken or decided, information on supply chains and distribution • Commission informs other Member States and verifies conformity with Directive; can take additional measures at EU level • Notification under RAPEX does not exclude notification under PED : they serve different purposes • Restrictive measures on pressure equipment are to be introduced and assessed only under the PED/SPVD

18. Enterprise Directorate-General European Commission ADministrative COoperation (ADCO): Article 17 sets an obligation for Member States to cooperate • ADCO-Group WPA & WGA established in 2004 • Representatives of public administrations • Tasks and objectives for authorities involved in market surveillance and monitoring of Notified Bodies: - Exchange of information - Development of common concepts - Common actions, sharing work

19. Enterprise Directorate-General European Commission “ADCOtools“: • Regular meetings in Brussels, in relation with meetings of the Working Group Pressure • Electronic communication platform through CIRCA • Use RAPEX and ICSMS Systems (http://www.icsms.org/) – • Pro-active market surveillance action Union-wide • ………….

20. Enterprise Directorate-General European Commission Lessons to be learnt from previous or current safeguard procedures: • compressed air tank. (Austria) (Commission opinion has been adopted endorsing the safeguard clause) • respiratory apparatus comprising multiple non-metallic bottles of compressed air. (France) (under examination) • liquefied petroleum gas (LPG) tanks. (Finland) (under examination)

21. Enterprise Directorate-General European Commission Simple Pressure Vessels • Simple Pressure Vessel, 24L/8bar. • Manufactured by a Chinese company, Xinlei • Distributed in several EU countries by a German company as part of a compressor • Notified body has a subsidiairy in China • Problem identified: welding and peaking

22. Enterprise Directorate-General European Commission SPV • ban on the placing on the market of the simple pressure vessel whether as a separate product or as a part of an assembly • vessels systematically do not comply with the essential requirements set out in section 2 of Annex I to the Directive due to lack of penetration in longitudinal and circular welds and peaking (i.e. a lack of roundness) of the cylindrical section as a result of the failure to master welding and weld preparation techniques. • the entire production of this pressure vessel model is affected by a systematic defect • technically impossible to refurbish the vessels in such a way as to bring them into conformity with the provisions of the Directive.

23. Enterprise Directorate-General European Commission SPV • the manufacturer, the notified body and the importer recognised that systematic problems occurred until April 2003 • steps had been taken to modify the product and the production process (issue of a new EC type examination certificate and new identification number of the assembly)

24. Enterprise Directorate-General European Commission SPV Issues to be discussed: • Understanding of Essential Requirements • Notified bodies and control of their subsidiaries • Monitoring of Notified Bodies and their subsidiaries • Only one country introduced safeguard clause • National measures that remain limited to the national market • Importance to follow Directive’s procedures • Distributor/importer assimilated to manufacturer • Administrative cooperation and exchange of information • Role of the Commission

25. Enterprise Directorate-General European Commission LPG tanks Finland identified faults at the vessel ends located at the curvature of the knuckle of approximately 4—5 mm, identified by visual examination and measurement: - The shape of dished ends does not meet the requirements of the standard EN 13445–3, paragraph 7.5.3.1 or the AD- Merkblatt 2000 B3; The dished ends cannot be calculated according to these equations. - The shape of dished ends does not meet the requirements of the standard EN 13445–4, paragraph 5.4.4. The local irregularities are larger than 2 %.

26. Enterprise Directorate-General European Commission LPG According to Member State, the alleged local irregularities of the dished ends constitute a violation of essential requirement 3.1.1 of Annex I to the Directive, which may cause a dangerous in-service failure and thus endanger the safety of people.

27. Enterprise Directorate-General European Commission LPG Issues to be discussed • Role of Notified Bodies • Compliance with B + F module • Conformity with standards • Manufacturer’ declaration that product has been withdrawn form a specific national market • Declaration of conformity • Technical file • Withdrawal of ED Declaration of conformity • Role of administrative cooperation and exchange of information

28. Enterprise Directorate-General European Commission Respiratory apparatus • respiratory apparatus comprising a number of non-metallic bottles of compressed air. • Design allows for rapid release of pressure between bottles • compressed air bottles made of a composite material lined with a thermoplastic material, that appear particularly sensitive to increases in temperature which may ensue from rapid pressurisation.

29. Enterprise Directorate-General European Commission Respiratory apparatus • Problem identified by Member State: ignition hazard due to rapid release of fluids between bottles that may lead to local increase of temperature • A ministerial decree imposes permanent communication between bottles to address the risk identified

30. Enterprise Directorate-General European Commission Respiratory apparatus Issues to be discussed • Accidents occurred with non CE marked, pre-PED equipment • Design principles at stake that also concern PED CE marked equipment • Role of Member States in addressing technical issues • Role of standards bodies, Notified Bodies Forum

31. Enterprise Directorate-General European Commission Further information • Commission web-site : http://ped.eurodyn.com • Blue Guide • PED WGP Guidelines • Directive text itself