Erik HanssonDG Health and Consumer Protection(DG SANCO)European Commission

Developments on product safety in the EU

The New General Product Safety Directive (2001/95/EC) -in force since 15 January 2004

For consumer products not regulated by specific legislation (exist for toys, electrical products, machinery, foodstuffs, cosmetics etc)

Product safety requirements

For (nearly) all consumer products: Safety management requirements for producers and distributors Market surveillance obligations for Member States RAPEX-system

Guidance document on SANCO website:

http://ec.europa.eu/consumers/cons_safe/prod_safe/other_EU/cons_prod_en.htm

Developments on product safety in the EU

Safety management requirements for producers and distributors

Monitor and follow up safety Traceability Take appropriate actions Notify authorities

Developments on product safety in the EU

Notification duty for producers and distributorsKnowing or ought to know product placed on the market poses risk to the consumerNotify all Member States where the product has been placed on the market Exceptions, form and guidance in Guidelines published on DG SANCO website.IT application for notifications available autumn 2006

Guidance document on SANCO website: http://ec.europa.eu/comm/consumers/cons_safe/prod_safe/gpsd/guidelines_en.htm

Developments on product safety in the EU

Control of transpositionNew RAPEX-systemNetwork set-upConsultations on standards and consumer participationGuidance documentsBetter transparency

Follow-up actions on community level:

Developments on product safety in the EU

Decisions on new obligatory requirements

CR-lighters

Developments on product safety in the EU

Rapid Alerts (RAPEX) in 2005

Notifications from Member States on measures ordered by authorities or voluntary measures by business concerning consumer products causing a serious risk

Excludes: foodstuffs, pharmaceuticals, medical devices.

Link: Overviews of RAPEX notifications:

http://ec.europa.eu/comm/dgs/health_consumer/dyna/rapex/rapex_archives.cfm

Developments on product safety in the EU

Authority A Authority B

Authority C Authority D

Contact points in Member States

DG A DG B

DG C DG D

DGHealth and Consumer Protection

Developments on product safety in the EU

RAPEX notifications 2002 - 2005

168139

468

847

84 67

388

701

0

100

200

300

400

500

600

700

800

900

2001 2002 2003 2004 2005

Art. 11+12+ INFO

Art. 12

Developments on product safety in the EU

Categories of products notified under Article 12(1st January - 31th August 2006)

Lighting equipments

8% Motor vehicles

14%

Electric appliances

21%

Toys23%

Origin of the products notified under Article 12(1st January - 31th August 2006)

Unknown14%

EU 25 & EFTA/EEA countries

23%

China(Incl. Hong Kong)

50%

Origin of the products notified under Article 12 in

EU 25 & EFTA/EEA and Acceding countries(1st January - 31th August 2006)

30

28

21

15

11

8

7

4

3

3

2

2

1

1

1

1

0 5 10 15 20 25 30 35

Germany

Italy

United Kingdom

Spain

France

The Netherlands

Poland

Sweden

Czech Republic

Switzerland

Austria

Greece

Belgium

Finland

Portugal

Roumania

Article 12 notifications by Member State(1st January - 31th August 2006)

9993

6362

5531

292524

2011

9999

7765543332111

0 20 40 60 80 100 120

GermanyHungary

United KingdomGreece

SpainFinland

LithuaniaFrance

Slovakia Czech Republic

IrelandBulgariaPortugalSweden

The NetherlandsBelgium

PolandRomania

CyprusItaly

EstoniaAustriaLatvia

Slovenia Norway

DenmarkLuxembourg

Malta

Notifications by participating countries[1]

[1] We have taken account only the notifications validated by

the Commission and consequently transmitted to

Member state

138

101

31

154164

0 5 3

0

20

40

60

80

100

120

140

160

180

Withdrawalfrom market

Recall ofproduct

Ban on sale Publicwarning

Measures adopted for Article 12 notifications(1st January - 31th August 2006)

obligatory

voluntary

Member States co-operation

NetworkJoint actionsIT-systems for communication between Member States - ICSMSBest practice market surveillance project – PROSAFE

Developments on product safety in the EU

International co-operationUSA – CPSCChina - AQSIQICPSC

Follow up on non compliances (RAPEX)Training and information for manufacturersEmerging risksInternational standardisation – ISO/COPOLCO

Developments on product safety in the EU

General principles for sector legislation (New Approach)Application of GPSDRisk assessment guidelinesInjury data collectionChemRisk

Developments on product safety in the EU

Reviews

The future…

Developed enforcement co-operation and customs control Business monitoring and follow up Mandatory product specific technical requirements under GPSD

Developments on product safety in the EU

Guidance documents:

Borderline to sectoral directivesBusiness notification dutyRAPEX operation

Developments on product safety in the EU

« Product safety in Europe – A guide to corrective action including recalls »

Consensus document representing best practiceAvailable on Commission website

Developments on product safety in the EU

http://ec.europa.eu/comm/consumers/

Consumer safety:Products and Services

Developments on product safety in the EU