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

Stefano.Soro@ec.europa.eu+ 32.2.296.75.43

CONTACT DETAILS