ICPHSO Conference Michiko Jo 18 February 2010 Enforcement Update: Recent developments in the EU.
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Transcript of ICPHSO Conference Michiko Jo 18 February 2010 Enforcement Update: Recent developments in the EU.
2 / Doc ID: L_LIVE_EMEA1:7577679v2
© Simmons & Simmons 2009
Overview
GPSD and RAPEX: recap
Statistics
Recent developments
– New RAPEX Guidelines
– “Business Application” of GPSD
– New Legislative Framework
– Accreditation and conformity assessment
– Market surveillance and border control
– Common framework for future legislation
Regulatory trends
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© Simmons & Simmons 2009
GPSD and RAPEX: recap
Scope of GPSD (Directive 2001/95/EC)
Stakeholders
– Producers
– Distributors
– Competent authority
– National Contact Point
– The European Commission
– The General Product Safety Directive Committee
– European standardisation body
RAPEX
– Purpose
– Coverage
– Operation
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© Simmons & Simmons 2009
Statistics (2009)
Notifying Countries Countries of Origin
Other 225(13%)Unknown 124
(7%)
China including Hong Kong
1012(60%)
EU & EEA 336(20%)
Other 913(54%)
UK 104(6%)
Bulgaria 122(7%)
Greece154(9%)
Germany 185(11%)
Spain 219(13%)
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© Simmons & Simmons 2009
Statistics (2009)
Product Categories Types of Risks
Electric shock 213
(11%)Choking 261
(14%)
Injuries 405(21%)
Chemical 492(26%)
Other 341(18%)Strangulation
183(10%)
Toys 471(28%)
Clothing, textiles and
fashion items 395
(23%)
Motor vehicles 146(9%)
Electrical appliances 137
(8%)
Cosmetics 86(32%)
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© Simmons & Simmons 2009
New RAPEX Guidelines
Commission Decision 2010/15/EU
Guidelines addressed to all authorities of the Member States including market surveillance and border control authorities
Updates the guidelines adopted by Decision 2004/418/EC
Effective from 15 February 2010
Features
– New risk assessment method
– Further details of information to be notified
– Reaction/follow-up obligations of other Member States
– Withdrawal and temporary removal of notifications
– Confidentiality
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“Business Application” of GPSD
Notification obligation under Article 5(3)
Direct communication from producers/distributors to the competent authorities of all Member States concerned
An additional method of notification (not mandatory)
Practical issues
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© Simmons & Simmons 2009
New Legislative Framework
Background
Objective
Package
– Regulation (EC) No 765/2008
– Council Decision No 768/2008/EC
– Regulation (EC) No 764/2008
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Accreditation and conformity assessment
Regulation (EC) No 765/2008
Accreditation: an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity.
Accreditation system
– National level– Accreditation body– Conformity assessment body
– European level– European co-operation for Accreditation– Peer evaluation
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© Simmons & Simmons 2009
Market surveillance and border control
Regulation (EC) No 765/2008
Market surveillance: the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Community harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection.
Market surveillance framework
– Obligations of the Member States
– Measures and criteria
– Communications and information sharing
Border control v market surveillance
Amendment to the GPSD
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Common framework for the marketing of products
Council Decision 768/2008/EC
A general framework for future legislation to harmonise the conditions for the marketing of products
Contents
– General principles
– Common definitions
– Common assessment procedures
– Obligations of certain stakeholders
– Conformity assessment modules
– Notification
Example – New Toys Directive 2009/48/EC
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Regulatory Trends
Cooperation and exchange of information with wider stakeholders e.g. border control authority, non-EU/EFTA countries
Enhancement of credibility of conformity assessment/certification
Enhancement of transparency
Speed in action and information exchange
Further clarity in the rules for consistent enforcement within the EU? (but note scope for differences at national level within the EU)