‘RAPEX’
European Rapid Alert System for
Dangerous Consumer Products
Stefano Soro
Head of Product Safety Unit
Health and Consumers DG
European Commission
OBJECTIVE
to provide a rapid exchange of information
between European countries and European
Commission about measures and actions taken
in relation to consumer products posing a serious
risk to the health and safety of consumers
LEGAL FRAMEWORK
RAPEX was established under the General
Product Safety Directive (2001/95/EC)
Applies to consumer products
Provides general safety requirements
Provides conformity assessment criteria
Imposes obligations on producers & distributors,
European countries and European Commission
Establishes RAPEX
RAPEX Guidelines – define the operation of the
RAPEX system (2004/418/EC)
RAPEX MEMBERS
30 European countries:
27 Member States of the European Union
3 EFTA/EEA countries
(no internal borders + harmonized requirements for products)
Access to RAPEX is open to third countries under
conditions specified in the GPSD.
RAPEX NETWORKS
RAPEX Contact Points network at the European
level:
30 RAPEX Contact Points
1 single Contact Point per Member State
National RAPEX networks in Member States.
They include:
RAPEX Contact Point
Market surveillance authorities
Customs authorities
RAPEX NOTIFICATION CRITERIA
Non-food consumer product
Serious risks to the health and safety of
consumers
Restrictive and preventive measures adopted by
authorities (“obligatory measures”) or by
economic operators (“voluntary measures”)
“Cross border effect”
www.ec.europa.eu/rapex
RAPEX WEBSITE
Information to the public on dangerous
products:
Weekly overviews of RAPEX notifications on products
posing serious risks
Latest safety news
Contact details of the RAPEX Contact Points
Legal documents and guidelines
INTERNATIONAL COOPERATION
Bilateral cooperation
China – AQSIQ, EU-China High Level Dialogue;
product safety on the agenda
U.S. - CPSC, US-EU Transatlantic Economic
Council; focus on product/import safety
Trilateral co-operation
Joint China-U.S.-EU Initiative
High-Level Trilateral EU-China-U.S. Summit
Multilateral co-operation
OECD; Roundtable on Product Safety, CCP
ICPSC / ICPHSO: Multilateral cooperation
between regulators
ISO/COPOLCO: International standardisation
“RAPEX-CHINA” application
System operational since May 2006 – allows
AQSIQ to tackle safety issues at source
Feedback from AQSIQ every 3 months
RAPEX – China WG meetings
AQSIQ reporting
7 reports between September 2006 and August
2008
Average of 80 investigations per quarter (peak
in summer 2007 with 184 investigations)
599 NOTIFICATIONS
“RAPEX-CHINA” application
MEASURES ADOPTED – 303
(51%)
EXPORT STOPPED BY AQSIQ OR
BY MANUFACTURER – 157
(26%)
MEASURES NOT ADOPTED – 296
(49%)
MANUFACTURER COULD
NOT BE FOUND – 154
(26%)
AQSIQ has so far investigated 599 cases
In 51% of cases this has resulted in corrective
action, such as export bans and strengthened
supervision over Chinese companies
STRENGTHENED SUPERVISION - 78
(13%)
DIFFERENT RISK ASSESSMENT– 25
(4%)
CORRECTIVE ACTIONS – 59
(10%)
OTHER- 117
(19%)
The lack of measures in the remaining cases was
mostly due to incorrect or insufficient
information on the Chinese manufacturers
OTHER – 9
(2%)
RAPEX ELEMENTS
Legal framework (GPSD, Guidelines)
Online application ‘REIS’
RAPEX Contact Points Network at the EU level
National RAPEX networks at the MS level
Commission RAPEX Team
RAPEX Contact Points Working Group
International cooperation
RAPEX website
RAPEX publications
Program of seminars and trainings
RAPEX STATISTICS
Number of notifications 2002 - 2008
2000
1798
1605
1600
1200
1051
847
800
2008 data is based on
an extrapolation of data
for the first 9 months of
the year
468
400
168
139
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2006
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RAPEX STATISTICS
Notifications by product category January-October 2008
450
250
200
150
100
50
421
Toys: 33%
400
350
Electrical appliances: 12%
300
Motor vehicles: 11%
Clothing, textiles, fashion items: 8%
150 140
Childcare articles and children’s equipment: 6%
97
80
65
51
47
39
33
21
20
19
18
18
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RAPEX STATISTICS
Notifications by type of risk January-October 2008
350
300
Injuries: 20%
314
Chemical: 18%
275
248
250
Choking: 16%
242
200
Electric shock: 16%
Fire: 10%
161
150
89
100
87
34
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27
20
12
11
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RAPEX STATISTICS
China: 55%
Unknown: 11%
Germany: 6%
Italy: 4%
Hong Kong: 3%
PLANS FOR 2009
New RAPEX Guidelines !
to clarify the scope of RAPEX
to better explain the notification criteria
to introduce new provisions on languages
to better regulate RAPEX procedures (e.g. follow
up to suspended notifications)
to explain rules on confidentiality
...
PLANS FOR 2009
New Risk Assessment Guidelines !
Process (1/3)
To eliminate diverging risk assessment results
9 WG meetings 2006 - 2008 + Stakeholder
Workshop Dec 2007
Public internet consultation Aug – Oct 2008
10th and final meeting in Dec 2008
1
... OJ L 208, 10.6.2004, p. 73.
New Risk Assessment Guidelines
Changes (2/3)
Develop an injury scenario: "Let the accident
happen."
Combine the severity of consumer's injury with
its probability: Read the risk level from a table.
Develop further injury scenarios -> further risks:
Highest risk = risk of the product
New Risk Assessment Guidelines
Advantages (3/3)
More transparent -> More consensus
Better separation of hazard and probability
Examples and assistance provided by tables
CONTACT DETAILS
Stefano Soro
Head of Product Safety Unit
Health and Consumers DG
European Commission
Office B232 6/116, 1049 Brussels, Belgium
[email protected]
+ 32.2.296.75.43
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