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Stefano SoroHead of Product Safety Unit Health and Consumers DGEuropean Commission
‘RAPEX’European Rapid Alert System
for Dangerous Consumer Products
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
OBJECTIVE
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
LEGAL FRAMEWORK
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
• 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”
RAPEX NOTIFICATION CRITERIA
RAPEX WEBSITE
Information to the public on dangerous products:
Weekly overviews of RAPEX notifications on products posing serious risks Latest safety newsContact details of the RAPEX Contact PointsLegal documents and guidelines
www.ec.europa.eu/rapex
Bilateral cooperationChina – AQSIQ, EU-China High Level Dialogue; product safety on the agendaU.S. - CPSC, US-EU Transatlantic Economic Council; focus on product/import safety
Trilateral co-operationJoint China-U.S.-EU InitiativeHigh-Level Trilateral EU-China-U.S. Summit
Multilateral co-operationOECD; Roundtable on Product Safety, CCPICPSC / ICPHSO: Multilateral cooperation between regulatorsISO/COPOLCO: International standardisation
INTERNATIONAL COOPERATION
System operational since May 2006 – allows AQSIQ to tackle safety issues at sourceFeedback from AQSIQ every 3 months RAPEX – China WG meetingsAQSIQ reporting
7 reports between September 2006 and August 2008
Average of 80 investigations per quarter (peak in summer 2007 with 184 investigations)
“RAPEX-CHINA” application
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
The lack of measures in the remaining cases was mostly due to incorrect or insufficient information on the Chinese manufacturers
“RAPEX-CHINA” application
599 NOTIFICATIONS
MEASURES ADOPTED – 303 (51%)
MEASURES NOT ADOPTED – 296 (49%)
EXPORT STOPPED BY AQSIQ OR BY MANUFACTURER – 157
(26%)
STRENGTHENED SUPERVISION - 78 (13%)
MANUFACTURER COULD NOT BE FOUND – 154
(26%)
DIFFERENT RISK ASSESSMENT– 25(4%)
OTHER- 117(19%)
CORRECTIVE ACTIONS – 59 (10%)
OTHER – 9(2%)
• 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 ELEMENTS
Number of notifications 2002 - 2008
168 139
468
847
1051
1605
1798
0
400
800
1200
1600
2000
2002 2003 2004 2005 2006 2007 2008
2008 data is based on an extrapolation of data for the first 9 months of the year
RAPEX STATISTICS
Notifications by product category January-October 2008
421
150 14097 80 65 51 47 39 33 21 20 19 18 18 17 8 8 7 7 6 5 5 5 3
0
50
100
150
200
250
300
350
400
450 Toys: 33%
Electrical appliances: 12%
Motor vehicles: 11%
Clothing, textiles, fashion items: 8%
Childcare articles and children’s equipment: 6%
Toys: 33%
Electrical appliances: 12%
Motor vehicles: 11%
Clothing, textiles, fashion items: 8%
Childcare articles and children’s equipment: 6%
RAPEX STATISTICS
Notifications by type of risk January-October 2008
314
275248 242
161
89 87
34 27 20 12 11 9 4 1 10
50
100
150
200
250
300
350
Inju
ries
Chem
ical
Chokin
g
Electr
ic sh
ock
Fire
Burns
Suffo
catio
n
Damag
e to
hea
ring
Strang
ulatio
nCut
s
Micr
obio
logica
l
Damag
e to
sigh
t
Health
risk
/ ot
her
Drownin
g
Explo
sion
Oth
er
Injuries: 20%
Chemical: 18%
Choking: 16%
Electric shock: 16%
Fire: 10%
Injuries: 20%
Chemical: 18%
Choking: 16%
Electric shock: 16%
Fire: 10%
RAPEX STATISTICS
Notifications by country of origin January-October 2008
714
140
7248 37 27 27 25 20 17 16 14 14 13 10 10 9 8 7 6 5 4 4 4 4 3 3 3 3 3 3 3 3 2 2 1 1 1 1 1 1 1
0
100
200
300
400
500
600
700
800
China: 55%
Unknown: 11%
Germany: 6%
Italy: 4%
Hong Kong: 3%
China: 55%
Unknown: 11%
Germany: 6%
Italy: 4%
Hong Kong: 3%
RAPEX STATISTICS
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
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
New Risk Assessment Guidelines
Stefano SoroHead of Product Safety UnitHealth and Consumers DG
European CommissionOffice B232 6/116, 1049 Brussels, Belgium
[email protected]+ 32.2.296.75.43
CONTACT DETAILS