The New Legislative Framework

1
The New Legislative Framework

• Jacques McMillan
• Head Of Unit
• DG Enterprise and Industry
• Regulatory approach for the free movement of goods

2
The New Legislative Framework

• Present Situation
• Some 700 old approach texts
• 25 New approach texts
• Missing chapters
• Incoherence
• Confusion

3
The New Legislative Framework

• LEVEL OF SAFETY
• QUALITY OF PRODUCTS
• QUALITY OF OPERATORS
• QUALITY OF 3RD PARTIES
• QUALITY OF ACCREDITATION
• QUALITY OF MARKET SURVEILLANCE
• QUALITY OF CONTROLS OF 3RD COUNTRIES
• --------------------------------------------------
  ------------------
• SAFE PRODUCTS
• --------------------------------------------------
  ------------------
• (CE MARKING)

4
The New Legislative Framework

• 2007 PROPOSALS
• Overall coverage NEW/OLD
• Missing chapters
• Coherence for existing legislation
• Consumer industrial products
• Standardisation unchanged
• Horizontal texts with no direct modification of
  existing legislation
• DECISION/REGULATION

5
The New Legislative Framework

• DECISION (sui generis)
• Framework instructions for legislator
  reference articles
• Definitions obligations for operators
  traceability of products
• Notification process
• Conformity assessment procedures rules
• CE marking
• Safeguard mechanisms

6
The New Legislative Framework

• REGULATION
• Accreditation
• Obligations for MS the system
• Obligations for accreditation bodies
• Role of EA peer evaluation
• Link to EU legislation

7
The New Legislative Framework

• REGULATION
• Market surveillance Member States
• Obligation to withdraw dangerous products
• Obligation to have the powers, authority means
  (even to destroy)
• Obligation to inform
• Obligation to organise cooperation between
  authorities
• Role of customs/control of products from 3rd
  countries

8
The New Legislative Framework

• REGULATION
• Market surveillance Commission
• Follow up coordinate national implementation
• Coordinate national infrastructures programmes
• Rapid information system
• Overall database

9
SCOPE - DECISION

• Sui generis
• Excluded feed/food, cosmetics, tobacco, plant
  health protection, human blood tissues,
  medicinal products human veterinary, chemicals
• Need adaptations medical devices, construction
  products marine equipment

10
SCOPE - REGULATION

• Accreditation
• Products services
• Market Surveillance
• Exclusions for food - feed, human blood,
• cells, tissues agricultural products via
• the product definition in Article 15.
• Exception does not cover border controls
• Lex specialis - pharmaceuticals, aviation,
• drug precursors, medical devices motor
• vehicles given as examples in recitals
• CE marking

11
The New Legislative Framework

• Timetable
• Adoption Commission14 Feb 2007
• Adoption Council/EP 9 July 2008
• Entry into force 20 days after pub
• Publication 13 August 2008
• Regulation applicable from 1/01/2010
• Implementing measures
• Review of sectoral directives?

12
New Legislative Framework

• Regulation (EC) 765/2008 of EP CS of 9 July
  2008 for accreditation market surveillance
  (OJ L218/30 of 13/08/2008)
• Decision (EC) 768/2008 of EP CS of 9 July 2008
  on common framework for the marketing of products
  (OJ L218/82 of 13/08/2008)
• Regulation (EC) 764/2008 of EP CS of 9 July
  2008procedures for application of certain
  natioanl technical rules to products marketed in
  another Member State (OJ L218/21 of 13/08/2008)