1. The New Legislative Framework Miniseminar New Legal Framework Reykjavík, 10 December 2008
Doris Gradenegger
Unit C1: Regulatory Approach for the Free Circulation of Goods

2. References NLF
OJ L 218
P Regulation 765/2008 on accreditation and market surveillance,
P Decision 768/ common framework for the marketing of products
Applicability: Regulation 1 January 2010, Decision to be used as from now on

3. Review of the New Approach
New Approach – essential requirements rather than detailed technical specifications
More than a NA review
New Legal Framework

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

5. Why two instruments?  Legal reasons
Regulation
Addressed to MS
Covers elements not already included in existing legislation
Applicable as from 01/01/2010
Decision sui generis
Addressed to legislator
Not possible to change existing legislation via a single regulation (legal security)
Covers elements already included in existing legislation (e.g. NBs, safeguard clause)
TOOLBOX

6. The Technique Regulation applies as it stands from 1/1/2010
Decision = toolbox for new legislation and revision of existing legislation
Art 2: “Legislation shall have recourse to the general principles and … reference provisions”
Deviation possible if appropriate due to specificities of the sector; to be justified
Alignment of sectoral Directives (currently toys Directive) to Decision

7. Regulation - the Scope Accreditation Market surveillance
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. Market surveillance - Exemptions
Exemptions via product definition Art 15(4)
Food and feed, human blood and tissues, living plants and animals
Exemptions via lex specialis Art 15 (2) (“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) - Art 15(3)

9. Border Controls - Exemptions
Specific provisions relating to the organisation of border controls of specific products prevail (e.g. endangered species)

10. 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

11. Market surveillance – Main elements II
Ensure recall/withdrawal of products posing a serious risk - rapid information system (Art 22)
Hear operator (10 days, except urgency)
Measures:
Proportionate
well founded
appeal possible
Destruction of products
Ensure follow up of complaints and accidents

12. Market surveillance – Main elements III
Co-operation mechanism
National level
Community level
Improvement of safeguard clause mechanism & information procedure (in Decision)

13. 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

14. Decision – toolbox for future legislation
General principles – NA approach technique, conformity assessment …
Definitions
Obligations of economic operators
Requirements for notified bodies, notifying authorities
Safeguard procedure
CE marking

15. 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

16. Obligations
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

17. Obligations Importer I
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

18. Obligations Importer II
If reason to believe that product not in conformity:
not allowed to place it on the market
inform manufacturer + authorities
sample testing, investigate complaints and recalls + inform distributors
If reason to believe that product already on market not in conformity: corrective action
Provide information to authorities upon reasoned request

19. Obligations Distributor
Distributor to act with due care
Ensure presence of conformity marking and required documents
If reason to believe that product is not compliant: not allowed to make product available on the market
If product already on the market: ensure corrective action is taken, if risk: inform authorities
Provide information to authorities upon reasoned request

20. 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

21. Safeguard procedure 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

22. Notified Bodies Requirements for notifying authorities
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

23. CE marking Strengthening the CE 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

24. Study on a consumer safety mark
No support from stakeholders
rather enforce the existing system (NLF!) – market surveillance and border controls

25. By issue? Separate Directives? Groups of Directives? Omnibus?
What’s next?
Alignment of sectoral Directives
By issue?
Separate Directives?
Groups of Directives?
Omnibus?
 to be decided soon

26. Thank you for your attention!