ICPHSO Conference Michiko Jo 18 February 2010 Enforcement Update: Recent developments in the EU.

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



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



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%)



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%)



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



“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



New Legislative Framework

Background

Objective

Package

– Regulation (EC) No 765/2008

– Council Decision No 768/2008/EC

– Regulation (EC) No 764/2008



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



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



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



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)



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ICPHSO Conference Michiko Jo 18 February 2010 Enforcement Update: Recent developments in the EU.

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