The New Legislative Framework Rita L’Abbate Unit C1: Regulatory approach for the free movement of goods

Overview The New Legislative Framework (NLF) Implementation phase… The Regulation The Decision Implementation phase…

New Legislative Framework - Texts OJ L218 - 13.08.08 : Regulation 765/2008/EC - requirements for accreditation and market surveillance relating to the marketing of products Decision 768/2008/EC - a common framework for the marketing of products

Timeframe/Process Adoption : 9 July 2008 Publication in OJEU – 13 August 2008 Entry into force 20 days after publication Date of application of Regulation 765/2008 is 1 Jan 2010 Decision ‘sui generis’ = by issue/by sector

Why did we propose the review? Experience shows Directives do not function in the same way in all Member States …. Different levels of controls in Member States Unequal treatment, distortion of competition Many non conforming products bearing CE marking Lack of trust in marking Different ways of controlling notified bodies - no transparency Differing definitions, unclear obligations for importers distributors…

Main elements covered by the Review Market surveillance Accreditation - Notified Bodies Role and significance of CE marking Common definitions & obligations Safeguard clause

NLF- 2 Complementary legislative tools REGULATION Accreditation Market Surveillance Internal Imported products General principles Financing elements Applicable 1 Jan 2010 DECISION Definitions Obligations for economic operators Conformity Assessment Procedures marking Notified bodies Safeguard mechanisms Basis for future legislation

The Regulation & the Decision Covers elements not already included in sectoral legislation Creates direct rights and obligations for Member States and individuals Becomes law in all Member States on 1 January 2010 Member States need to be ready to apply DECISION Covers elements already included in legislation Sui Generis Decision -applies to EU legislator, Commitment No immediate effects for Member States or individuals Better Regulation tool: model Articles - “toolbox” Applies to new legislation or revisions of legislation

Regulation –main objectives Accreditation Enhance mutual confidence in certificates and quality of conformity assessment bodies Common transparent rules for assessing the competence of conformity assessment bodies Market surveillance Make our internal market legislation more effective by ensuring better control of this legislation Ensure equal conditions for economic operators Common minimum requirements Enhanced cooperation and information exchange amongst market surveillance authorities of MS

Regulation – Accreditation (1) Objectives are to create confidence in accredited certificates thus establishing trust in the market place to ensure ONE accreditation certificate for whole territory of EU to introduce a horizontal framework for accreditation and to lay down principles for its operation and organisation at Community level to ensure uniform application

Regulation – Accreditation (2) Accreditation = Assessment of competence of conformity assessment bodies (laboratories, testing and inspection bodies..) Scope: no exemptions – accreditation of all conformity assessment bodies Organisational framework: no general obligation to be accredited Single accreditation body per Member State

Regulation – Accreditation (3) Accreditation - a public authority activity No competition Accreditation in the Member State of establishment Requirements for accreditation bodies Peer evaluation EA (European co-operation for accreditation)

Regulation – market surveillance (1) Scope “harmonised products” exceptions: food, feed, human blood, cells, tissues and agricultural products lex specialis

Regulation – market surveillance (2) Organisational requirements Infrastructures, resources, powers complaint procedures, monitoring of accidents Market surveillance programmes

Regulation – market surveillance (3) Surveillance measures appropriate product checks on “adequate scale” Right to enter premises, ask for documentation Warning of users

Regulation – market surveillance (4) Restrictive measures Withdrawal/recall products posing a “serious risk” Rapid information of all Member States Hear economic operator Possibility to destroy products Penalties

Regulation – market surveillance (5) Communication and co-ordination Exchange of information Rapid information on dangerous products Comprehensive database Cooperation Obligation to cooperate with other MS Mutual assistance Joint initiatives, training programmes, sharing of resources

Regulation – market surveillance (6) Control of products entering the Community Customs must carry out checks at external borders on an adequate scale Suspension of release for free circulation if product is not properly marked presents a serious risk Information of market surveillance authorities Possibility of destruction

Regulation – CE marking marking – General principles Complementary to rules in legislation Only on products for which affixing is foreseen in legislation Affixing = responsibility for conformity Relationship to other marks Obligation for MS to protect marking

Decision – toolbox for future legislation General principles and reference provisions for the drawing up of Community harmonisation General guidelines for legislator Essential requirements instead of technical details Choice of conformity assessment procedures Model provisions

Decision – model articles (1) Definitions placing on the market, manufacturer, importer, etc Obligations of economic operators Differentiation according to role Manufacturer, Authorised representative Importers and distributors NEW! Traceability provisions

Decision – model articles (2) Conformity assessment Marking Rules and conditions for affixing – form of the marking

Decision – model articles (3) Notified Bodies Requirements for notifying authorities Notification criteria/ role of accreditation Notification process – electronic notification Obligation of notified bodies Subsidiaries and sub-contracting Control requirements COMM/MS de-notification Co-ordination GNBs

Decision – model articles (4) Safeguard clause procedure Notification of measure – time for objections No objections – all MS must take relevant action Objection: Matter decided at EU level – Commission decision

Implementation phase - priorities Regulation – 1 January 2010 Accreditation – relationship with EA Market surveillance Information exchange systems (RAPEX and database) Lex specialis – how does it work? Guidelines: e.g. market surveillance programmes Decision “automatic” alignment of legislation under review (e.g. toys safety) Alignment of legislation not up for review?

Web site addresses New Legal Framework: New internal market package: http://ec.europa.eu/enterprise/newapproach/ review_en.htm New internal market package: http://ec.europa.eu/enterprise/regulation/internal_market_package/index_en.htm Questions: Entr-reg-approach-for-free-circ@ec.europa.eu

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