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

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

3. New Legislative Framework - Texts
OJ L :
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

4. 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

5. 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…

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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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)

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

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

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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

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

23. 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

24. 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

25. 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?

26. Web site addresses New Legal Framework: New internal market package:
review_en.htm
New internal market package:
Questions:

27. THANK YOU
FOR YOUR ATTENTION