The New Legislative Framework Helsinki, 10 September 2008

1. The New Legislative Framework Helsinki, 10 September 2008 European Commission Directorate General for Enterprise and Industry Unit C1: Regulatory approach for the free circulation of goods Doris Gradenegger

2. Timeframe / Process • Proposals were adopted by the Commission on 14 February 2007 • COREPER adoption 13 February 2008 • EP Plenary 21 February 2008 • Adoption by the Council 23 June 2008 • OJ L 218, p. 30 (Regulation 765/2008), p. 82 (Decision 768/2008) • Entry into force 1 January 2010

3. Why did we propose the New Framework? New Approach directives are not all functioning in the same way in all Member States • Incoherent definitions/lack of definitions • Unclear obligations for economic operators • Abuse of CE marking • Ad-hoc variants of modules • Differing criteria for notified bodies • Uneven level of market surveillance

4. Why did we propose the New Framework? • More than a NA review • Legal framework for the marketing of goods

5. Complementary legislative tools REGULATION • Accreditation • Market surveillance - internal - imported products • CE marking Applicable as from 01/01/2010 DECISION sui generis • Definitions • Obligations for economic operators • Notified Bodies • Conformity assessment procedures • Safeguard mechanisms • CE marking TOOLBOX

6. The technique • Split into two instruments for legal reasons: Two different addressees: MS and legislator • Regulation applies as it stands • Alignment of sectoral Directives (currently toys Directive) to Decision Art 2: “Legislation shall have recourse to the general principles and … reference provisions”

7. Regulation - Scope Accreditation • Accreditation relating to conformity assessment Market surveillance • Products = Substances, preparations and goods produced through a manufacturing process, except food, feed, human blood and tissues, living plants and animals Border controls • ALL products covered by Community harmonisation legislation

8. Regulation - Scope For the first time: Community rules on accreditation and market surveillance  Coherence throughout the EU

9. Market surveillance - Exemptions • Exemptions via product definition • Food and feed, human blood and tissues, living plants and animals • Exemptions via lex specialis (“Regulation applies insofar as there are no specific provisions …”) • Pharmaceuticals • Drug precursors • Civil aviation • Motor vehicles • Medical devices • Authorities may take more specific measures as provided for in GPSD (Consumer products)

10. Regulation - Exemptions BORDER CONTROLS • Specific provisions relating to the organisation of border controls of specific products prevail

11. Market surveillance - Main elements I Common minimum requirements in all Member States • Organisational/operational requirements • Infrastructures, resources and powers • Adequate checks – internally and at borders

12. Market surveillance - Main elements II - Ensure recall/withdrawal of products posing a serious risk, use RAPEX (Art 12 GPSD) • Hear operator (10 days, except urgency) • Measures: • Proportionate • well founded • appeal possible • Destruction of products • Ensure follow up of complaints and accidents

13. Market surveillance - Main elements III • Co-operation mechanism - National level - Community level • Improvement of safeguard clause mechanism & information procedure in Decision

14. Border controls - Main elements • Customs obliged to carry out checks at borders on an adequate scale • Suspension of release for free circulation if product • is not properly marked or • presents a serious risk • Inform market surveillance authorities • Destruction of products

15. Accreditation Accreditation = a third-party attestation attesting the competence of a conformity assessment body to carry out specific conformity assessment tasks

16. Why introduce Accreditation? • Currently operates in all Member States, however due to lack of common rules: • Different approaches to accreditation • Differing systems with uneven rigour • Need to introduce a framework for accreditation and to lay down principles for its operation and organisation at Community level to ensure uniform application

17. Accreditation - Requirements Accreditation bodies should: • Be completely independent from commercial motivations; • Be independent and impartial; • NOT be involved in conformity assessment activities for which they accredit other bodies; • Demonstrate a high level of competence via participation in the EA (European co-operation for accreditation) peer evaluation system.

18. Accreditation – Main principles = Last level of control • No competition between accreditors and between accreditors and accredited CABs • ONE national accreditation body per Member State • Public authority activity • Peer evaluation • Cooperation between national accreditation bodies and EA

19. Decision – toolbox for future legislation • General principles – NA approach technique, conformity assessment … • Definitions • Obligations of economic operators • Notified bodies, notification • Safeguard procedure • CE marking

20. Why harmonise definitions and obligations? • Different Directives use terms differently • Some Directives have no definitions at all • Obligations of economic operators are not consistent throughout sectoral legislation ->Lack of clarity/legal security

21. Definitions • Economic operators • Making available on the market • Placing on the market • ...

22. Obligations I • Economic operators are responsible for the compliance of the product in relation to their role in the supply and distribution chain • Only manufacturer has detailed knowledge of design and production process -> Distinguish between manufacturer and operators further down the chain: conformity assessment is responsibility of manufacturer alone

23. Obligations importer • Need to ensure compliance of third country products -> IMPORTER to ensure that • manufacturer has carried out conformity assessment • manufacturer has drawn up the technical documentation • product bears conformity mark -> Indication of importer’s name and address

24. Obligations distributor • DISTRIBUTOR to act with due care • Ensure presence of conformity marking and required documents

25. Traceability • Each operator shall be able to identify to market surveillance authorities • Any operator who has supplied them with a product • Any operator to whom they have supplied a product

26. Why strengthen requirements for Notified Bodies? Notification is a Member State responsibility • Currently different requirements for notification in different Member States • NBs do not apply conformity assessment in an equal manner => Need to create a level playing field for both notified bodies and manufacturers

27. Notification • Ensure full technical competence • Requirements for notifying authorities • Requirements / obligations for NBs • Subsidiaries and sub-contracting • Accredited in-house bodies • Procedure – electronic notification • Challenge of competence – de-notification

28. Safeguard procedures • Two phases: • MS informs MS and COM about specific measure taken • If all MS agree: all MS to take measure; measure is deemed to be justified • If objections are raised: COM to decide whether measure is justified after consulting MS and operator, depending on the decision: • Measure to be withdrawn or • other MS have to ensure that product is withdrawn

29. CE marking in the New Legal Framework Strengthening the marking In Decision (rules on affixing) and Regulation (general principles incl. pictogram) • Clarify role and significance • Manufacturer’s responsibility • The ONLY conformity mark • Rules and conditions for its affixing • Community collective trade mark • MS to ensure correct implementation

30. What’s next? Alignment of sectoral Directives • By issue? • Separate Directives? • Groups of Directives? • Omnibus?  to be decided within the next months

31. European Consumer Safety Mark Regulation on accreditation and market surveillance • Co-decision procedure – discussed by EP in 2007 • Summer 2007: Mattel recall case – “unsafe” toys bearing CE marking • criticism of CE marking • “CE is misleading the consumer as CE does not in all cases require 3rd party certification but only manufacturer’s declaration which is not reliable.” • “CE marking does not mean safety.”

32. Safety of products • Safety requirements in legislation • Quality of the manufacturer • Quality of controls and testing • Quality of surveillance by public authorities If there is a weak link in the chain, the chain breaks down.

33. European Parliament Regulation on accreditation and market surveillance • Recital introduced by EP: COM to provide an in-depth analysis on the feasibility of a consumer safety mark, if necessary followed by a legislative proposal

34. Timeframe • Web-Questionnaire • Consumers • Enterprises • Market surveillance authorities • Consultation closed 6 June • Trends … • Feedback to EP end of September

35. Issues to be clarified … additional mark, possibly involving third party certification • BENEFIT for consumers? - safer products - need to understand the meaning • ACCEPTANCE by consumers? • awareness/recognition • (higher) price • BENEFIT or BURDEN for enterprises? - competitive advantage/disadvantage - procedures • SMEs?

36. Issues to be clarified • Scope • ALL consumer products? • selected products? --> selection criteria? • Relation to existing marks • Voluntary or obligatory • Enforcement, ownership

37. Thank you for your attention!