Market surveillance under the General Product Safety Directive (GPSD) Erik Hansson European Commission DG Health and Consumer Protection.

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Transcript Market surveillance under the General Product Safety Directive (GPSD) Erik Hansson European Commission DG Health and Consumer Protection.

Market surveillance
under the General
Product Safety
Directive (GPSD)
Erik Hansson
European Commission
DG Health and Consumer
Protection
The General Product
Safety Directive
(GPSD)
Applies to consumer products
Waives for requirements on same
aspects in specific legislation
Business-obligations
Produce and sell only safe products
Monitor and follow up safety – trace,
take actions and notify
Co-operate with authorities
Member-States
obligations
Control: market surveillance and
enforcement
Reporting
Co-operation
European Commission
obligations
Monitor
Support
Recognise standards
Rapid EU decisions
Ensuring the safety of
consumer products
Pre-market (preventive)
Conformity assessment requirements for
many products falling under sectoral
legislation
Post-market (reparative)
Monitoring and safety management
requirements in GPSD
Organisation of Market
Surveillance in Member States
Geographical
National
Regional
Local
Type of product
The essential market
surveillance requirements of
the GPSD
Somebody to do the job
Defined tasks and organisation
Investigation powers
Encourage voluntary actions
Powers to require corrective actions
Sanctions
The Essential operational
requirements of the GPSD
Surveillance programmes
Cooperation arrangements
Scientific and technical knowledge
Complaints and notification procedures
Evaluation and review
Transparency
Citizens right to know
Except
Professional secrecy
Investigation secrets
Commission support
Networking
Information exchange
Tracing and recall
Exchange of expertise and best
practices
Commission support
Joint surveillance projects
Specific products
Communication systems (ICSMS)
Injury data registration
Best practice in market surveillance
(PROSAFE)
Commission control
Continuos
Information exchange, RAPEX, complaints,
etc.
Regular Commission reports
In depth assessment
Rapid Alerts (RAPEX)
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/ra
pex_archives.cfm
Authority A
Authority B
Contact points in
Member States
Authority D
Authority C
DG A
DG C
DG
Health and
Consumer
Protection
DG B
DG D
RAPEX notifications
2002 - 2005
900
847
800
701
700
600
500
468
400
Art . 11+12+ INFO
Art . 12
388
300
200
100
168
84
139
67
0
2001
2002
2003
2004
2005
Categories of products notified under Article 12
(1st January - 31th August 2006)
Toys
23%
Lighting
equipments
8%
Motor
vehicles
14%
Electric
appliances
21%
Products notified under Article 12 by nature of the risk
(1st January - 31th August 2006)
Chemical
8%
Injury
25%
Choking/
Suffocation
16%
Fire risk/burns
18%
Electric shock
23%
Measures adopted for Article 12 notifications
(1st January - 31th August 2006)
180
160
154
164
138
140
120
101
100
obligatory
80
voluntary
60
31
40
20
0
5
3
0
Withdrawal
from market
Recall of
product
Ban on sale
Public
warning
Origin of the products notified under Article 12
(1st January - 31th August 2006)
Unknow n
14%
EU 25 & EFTA/EEA
countries
23%
China
(Incl. Hong Kong)
50%
International co-operation
USA – CPSC
China - AQSIQ
ICPSC
International standardisation –
ISO/COPOLCO
Guidance documents:
Borderline to sectoral directives
Business notification duty
RAPEX operation
Recall guideline
http://ec.europa.eu/comm/consumers/
• Consumer safety:
• Products and services