35
EUROPEAN COMMISSION 0 Keeping European Consumers Safe 2010 Annual Report on the operation of the rapid alert system for non-food dangerous products RAPEX 2 1 0

110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 1: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

EUROPEAN COMMISSION

0

Keeping European Consumers Safe2 0 1 0 A n n u a l R e p o r t

o n t h e o p e r a t i o n o f t h e r a p i d a l e r t s y s t e mf o r n o n - f o o d d a n g e r o u s p r o d u c t s

RAPEX

2

1 0

Page 2: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

EUROPEAN COMMISSIONThe Directorate-General for Health and Consumers of the European Commission manages the rapid alert system for non-food dangerous products (RAPEX).

This report describes the activities of RAPEX in 2010.

Neither the European Commission nor any person acting on its behalf is responsible for any use that might be made of the following information.

Further information on the Directorate-General for Health and Consumers is available at:http://ec.europa.eu/dgs/health_consumer/index_en.htmThe RAPEX weekly overviews can be consulted at:http://ec.europa.eu/RAPEX

Luxembourg: Publications Offi ce of the European Union, 2011

ISBN 978-92-79-17047-8ISSN 1830-8821DOI 10.2772/16874

© European Union, 2011

Reproduction is authorised, except for commercial purposes, provided the source is acknowledged.The photos included in this publication may be reproduced within the context of this publication.For any other use, prior permission must be obtained from the copyright holder(s).

Europe Direct is a service to help you fi nd answers to your questions about the European Union

Freephone number (*):00 800 6 7 8 9 10 11

(*) Certain mobile telephone operators do not allow access to 00 800 numbers or these calls may be billed.

Keeping European Consumers Safe

2010 Annual Report on the operation of the rapid alert system

for non-food dangerous products

RAPEX

Page 3: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

4 54

Foreword

Dear readers,

It is once again an honour to present the annual activity report on the RAPEX system.

The report outlines the main developments in the fi eld of product safety in 2010, in particular the continuous improvement of cooperation between the Member States and the European Commission concerning the exchange of information on dangerous products posing serious risks.

More than 2,200 notifi cations of dangerous products were transmitted through the system, a 13% increase over the previous year. The improvement is not only quanti-tative, but also qualitative, since the number of easily traceable products – for which both the country of origin and the manufacturer are known – has increased. A better implementation of RAPEX means less dangerous products on the market.

With the new RAPEX guidelines and the accompanying risk-assessment method in place, RAPEX has become an enhanced, modern tool, making its contribution to con-sumer protection throughout Europe and helping to guarantee a fair, competitive en-vironment for businesses. With the entry into force of Regulation (EC) No 765/2008 in January 2010, the scope of the RAPEX system was extended to risks other than those affecting the health and safety of consumers (i.e. risks to health and safety in the workplace, the environment and security) and also to some products intended for professional use. The system had to adapt on the go, and I would like to praise the national market surveillance authori-ties for their efforts to meet these new challenges. Further developments are expected in the coming years, as the General Product Safety Directive, on which RAPEX is based, is itself being reviewed this year.

2010 was a successful year in terms of international cooperation on product safety. I travelled to Shanghai, China for a number of meetings including a Trilateral Summit with my Chinese and US counterparts at which all three jurisdictions pledged to strive for safer products. The year ended with International Product Safety Week in Brussels, a series of conferences gathering major players from government, consumers and business. It was also the occasion for the fi rst meeting of a recently established OECD Working Party on Consumer Product Safety.

The development of the MED-RAS platform, which establishes a rapid alert system for dangerous non-food products in the Mediterranean region uses RAPEX as a blueprint.

The achievements presented in the report would not have been possible without the daily commitment and efforts of all parties involved: the authorities in the Member States who are always open and work constructively together and the economic opera-tors who ensure the safety of the products they manufacture, import and sell. These results should make us proud and inspire us to maintain and improve our efforts to secure the safety of our consumers.

John DalliEuropean Commissioner for Health and Consumer Policy

Page 4: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

6 7

Contents

1 RAPEX activity in 2010 – executive summary .................... 92 RAPEX statistics ............................................................ 132.1 Notifications ................................................................. 13

2.1.1 Total number of notifications ......................................................................... 13

2.1.2 Notifications by notifying country .................................................................. 14

2.1.3 Notifications by product identifier .................................................................. 17

2.1.3.1 Product category of the notified product ........................................................ 17

2.1.3.2 Brand and model numbers of the notified product ........................................... 20

2.1.3.3 Country of origin of the notified product ......................................................... 21

2.1.4 Notifications by type of risk .......................................................................... 23

2.1.5 Notifications by type of measure ................................................................... 25

2.1.6 Notifications initiated by the activities of the customs authorities ...................... 28

2.2 Reactions ..................................................................... 28 2.2.1 Total number of reactions ............................................................................. 28

2.2.2 Reactions by reacting country ....................................................................... 29

2.2.3 Reactions by notified product ........................................................................ 29

2.2.4 Reactions by type of notified risk ................................................................... 32

2.2.5 Reactions by type of reaction ........................................................................ 33

2.2.6 Measures taken by reacting countries ............................................................ 34

2.3 The new notifications on professional goods and other risks .. 352.4 Reactions to the new notifications on professional goods

and other risks ............................................................. 383 Key developments in 2010 .............................................. 393.1 Enforcement ................................................................ 39

3.1.1 The new RAPEX guidelines ............................................................................ 39

3.1.2 The New Legislative Framework Regulation (Regulation 2008/765/EC) ............... 39

3.1.3 The revision of the GPSD .............................................................................. 40

3.1.4 RAPEX and other product safety indicators ..................................................... 40

3.1.4.1 Eurobarometers .......................................................................................... 40

3.1.4.2 Consumer Market Scoreboard ....................................................................... 41

3.1.4.3 Enforcement Indicators ................................................................................ 41

3.1.5 Better tools and capacity building .................................................................. 42

3.1.5.1 IT tool on risk assessment method ................................................................ 42

3.1.5.2 Market surveillance coordination and cooperation ............................................ 42

3.1.5.3 RAPEX seminars .......................................................................................... 43

3.2 Developments relating to specific products and risks .......... 43 3.2.1 Scientific opinion on food imitating products ................................................... 43

3.2.2 Study on flame retardants ............................................................................ 43

3.2.3 Outcome of the study on nano-claims ............................................................ 44

3.2.4 Measures to address risks from Dimethyl fumarate .......................................... 44

3.2.5 Personal music player standardisation ............................................................ 44

3.2.6 Lighters ...................................................................................................... 44

3.2.7 Safety of windows ........................................................................................ 45

3.2.8 Reduced ignition propensity cigarettes ........................................................... 45

3.2.9 Children′s equipment/childcare articles .......................................................... 45

3.3 Compliance by businesses .............................................. 46 3.3.1 GPSD Business Application ........................................................................... 46

3.4 International cooperation towards global governance .......... 47 3.4.1 Bilateral cooperation .................................................................................... 47

3.4.2 Trilateral cooperation (EU, USA, China) ........................................................... 49

3.4.3 Multilateral cooperation ................................................................................ 50

3.4.4 ENP and candidate countries ......................................................................... 50

4 Ongoing and future challenges ........................................ 514.1 The revision of the General Product Safety Directive .......... 514.2 RAPEX operation: extension of RAPEX to new

products and risks under the New Legislative Framework .... 514.3 GRAS – a new IT system for RAPEX ................................ 514.4 Cooperation with customs authorities ............................... 514.5 International cooperation ............................................... 525 More details about the RAPEX system .............................. 535.1 Objective ..................................................................... 535.2 The legal basis of RAPEX ................................................ 535.3 When is RAPEX used? .................................................... 54

5.3.1 RAPEX Notifications ..................................................................................... 54

5.3.2 Other types of information exchanged ............................................................ 55

5.4 How does RAPEX work? ................................................. 55 5.4.1 Role and obligations of national authorities ..................................................... 55

5.4.2 Role and obligations for producers and distributors .......................................... 56

5.5 The RAPEX website ....................................................... 586 Glossary ...................................................................... 597 National contact details .................................................. 618 Important websites ....................................................... 639 The Commission’s RAPEX Team ....................................... 65

Page 5: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

988

RAPEX activity in 2010 – executive summary

The role of RAPEX in supporting product safety

RAPEX 1 (the Community Rapid Information System for non-food dangerous prod-ucts) is a system which allows EU Member State market surveillance authorities and the European Commission to share information about dangerous products found on the European market quickly and effi ciently and to inform consumers about po-tential risks to their health and safety. RAPEX is established under Article 12 of the General Product Safety Directive (2001/95/EC) 2.

With the entry into force of Regulation (EC) No 765/2008 in January 2010, the scope of the RAPEX system was extended to risks other than those affecting the health and safety of consumers (i.e. risks to health and safety in the workplace, the envi-ronment and security) and also to some products intended for professional use.

The main objective of the RAPEX system is to ensure that only safe products are placed on the European Internal Market. Its success not only relies on close coop-eration between national market surveillance authorities and the European Com-mission, but also on appropriate legislation and rigorous enforcement, a commit-ment to safety from all economic operators in the supply chain, from design to delivery, and close cooperation between the EU and its international trading partners.

What was achieved in 2010?

In line with the trend set in recent years, the total number of measures taken against dangerous products and reported by Member States through RAPEX rose from 1,993 in 2009 to 2,244 in 2010. This represents a 13% increase.

The constant growth in the number of notifi cations is a positive sign. More notifi cations result from increased awareness and attention given to product safety by authorities and companies, the greater number of mar-ket surveillance actions carried out jointly by several na-tional authorities and the training and seminars provided by the European Commission for different stakeholders.

The most notifi ed product category this year covers clothing, textiles and fash-ion items (32%), followed closely by toys (25%). Injuries, chemical risks and strangulation were the most commonly notifi ed risks.

The number of RAPEX notifi cations concerning products of Chinese origin remains high (58%) and is mainly explained by the signifi cant market coverage of Chinese-manufactured products. The constantly improving cooperation with the Chinese authorities yielded positive returns in terms of improved traceability of products allowing more scope for corrective measures to be taken.

1

1 A detailed description of how the RAPEX system functions can be found in Chapter 5. A Glossary of the technical terms used in this report can be found in Chapter 6.

2 OJ L 22, 26.01.2010, p. 1

Page 6: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

10 11

On 7 January 2010, the Commission adopted a Decision setting safety require-ments for child-resistant window locking devices. Subsequently, the Com-mission addressed a standardisation mandate to the European Committee for Standardisation (CEN) to draw up relevant safety standards and test methods for these locks (Mandate M/465).

Work to introduce reduced ignition propensity (RIP) cigarettes in the EU, which rapidly self-extinguish when left unattended, was fi nalised within the stand-ardisation organisation concerned. The standard “EN 16156:2010 Cigarettes – Assessment of the ignition propensity – Safety requirement” was published by CEN on 17 November 2010.

On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath tubs and stands for children. This was followed by a standardisation mandate to CEN to draw up relevant standards for these three types of products (mandate M/464).

On 2 July 2010, the Commission adopted a Decision set-ting safety requirements for fi ve products common-ly used in the sleeping environment of babies and young children. These products are cot mattresses, cot bumpers, sleeping bags for ba-bies, suspended baby beds and duvets for babies. A standardisation mandate for CEN will be fi nalised in the fi rst quarter of 2011.

On 14 October 2010, the Member States voted unanimously to ap-prove a decision on the conformity of standard EN 14682:2007 on cords and drawstrings in children′s clothes with the safety requirement of the General Product Safety Directive. The Decision gives the green light to the Commission to publish the references of that standard in the Offi cial Journal of the EU.

Compliance by businesses

The “GPSD Business Application”, a new, on-line information exchange system for producers and distributors of consumer products, was launched in 2009. In 2010 it has proven to be very successful, with 133 notifi cations sent by economic opera-tors and accepted by competent national authorities across Europe.

International cooperation

On 26 October, the Health and Consumers Directorate-General organised a Con-sumer Day at the Shanghai World Expo. In conjunction with this public event, Commissioner Dalli met his counterpart AQSIQ Minister Zhi Shuping for a bilateral meeting in which they committed to further close cooperation regarding non-food consumer product safety.

This was further complemented by the holding in parallel of the second EU-US-China Trilateral Summit on Product Safety. In a joint statement, the three parties agreed on points of consensus relating to communication, cooperation and training on product safety.

Cooperation on consumer product safety between the European Commission and the United States Consumer Product Safety Commission (CPSC) remained close in 2010, involving regular information exchanges on respective regulatory frameworks, emerging risks and dangerous products.

Enforcement

2010 was the fi rst year of application of new guidelines for the management of RAPEX by the Member States and the European Commission. The guidelines iden-tify the scope of the RAPEX system, clarify the criteria for notifying measures taken against dangerous products as well as other core procedures and provide an up-dated risk assessment method for market surveillance authorities.

An information technology (IT) tool was developed to assist authorities in applying this new method.

The Commission also began investigating how to update the General Product Safety Directive, by assessing problems encountered in its application and the possible impact of proposed changes. A public consultation was carried out during the second half of 2010.

2010 saw a strong consolidation of market surveillance cooperation in the European Union. PROSAFE, an association bringing together Member State authori-ties, applied – on behalf of 21 participants – for a single joint surveillance action grant covering fi ve product groups (ladders, food-imitating child appealing prod-ucts, children′s fancy dress outfi ts, laser pointers and high-visibility clothing) and a number of cross-cutting activities. The Commission will provide a total amount of EUR 1.4 million in co-funding for this action. In addition, 15 grants were awarded for the exchange of offi cials.

The European Commission organised RAPEX training seminars for national mar-ket surveillance and customs authorities in order to strengthen their knowledge of the RAPEX system and to improve the overall enforcement capacity of the Member States. In 2010, seminars were held in Spain, Denmark, Ireland, Iceland, Malta, Poland, Italy, Portugal, Norway, Hungary, Slovenia and Sweden.

Developments relating to specifi c products and risks

In December 2010, the Scientifi c Committee on Consumer Safety (SCCS) adopted a draft opinion on the potential health risks posed by chemical consumer prod-ucts resembling food and/or having child-appealing properties. Stakehold-ers were invited to comment through an online public consultation.

The Commission also sponsored a study on fl ame retardants. The aim was to identify fl ame retardants in consumer products used in the domestic environment, to assess human exposure to fl ame retardants and to draft tentative risk assess-ments. A second study, on so-called nano-claims, was aimed at improving general knowledge about the nature of this technology and the usefulness of “nano” labels on products.

Following the mandate that was sent to the Electrical Standardisation Committee (CENELEC) on 28 September 2009, work continued during 2010 on the development of a revised European safety standard to provide protection against excessive

sound pressure levels from personal music players.

In early 2010, Decision 2006/502/EC prohibiting the sale of non-child resistant and novelty lighters to consumers

was prolonged for the fourth time, thereby extending its validity until 11 May 2011.

The validity of Decision 2009/251/EC, which requires Member States to ensure that any con-sumer product containing Dimethyl fumarate

(DMF) – an anti-mould chemical substance that is strongly sensitising – is not placed or made avail-

able on the market, was extended by one year in early 2010. A permanent measure is being prepared under the REACH legislation.

Page 7: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

12 13

2

2,500

2,000

1,500

1,000

500

0 Serious risk Other risk levels For info

1,963

38243

All notificationsSerious risk notifications

2,500

2,000

1,500

1,000

500

0 2003 2004 2005 2006 2007 2008 2009 2010

67139

468

847

1,051

1,605

1,8661,993

2,244

388

701

924

1,3551,545

1,699

1,963

RAPEX statistics2.1 Notifications

2.1.1 Total number of notifications

Situation in 2010

In 2010, the European Commission distributed through the RAPEX system 2,244 notifi cations on consumer products posing serious risks to health and safety:

1,963• of these notifi cations were distributed to Member States as notifi cations under Article 12 of the GPSD and Article 22 of Regulation 765/2008. (These are preventive or restrictive measures on products presenting a serious risk to the health and safety of consumers either taken by national authorities or carried out voluntarily by economic operators, e.g. stopping or banning of sales, withdrawals from the market, recalls from consumers);

38 notifi cations were distributed to Member States under Article 11 of the GPSD • and Article 23 of Regulation 765/2008. (These are measures taken by national authorities with regard to products posing risks classifi ed as less than serious);

243 notifi cations were distributed to Member States for information purposes, • as they did not qualify for distribution under the above-mentioned legal bases.

Figure 1 – Total number of notifi cations

Figure 2 – Number of notifi cations 2003–2010

Comparison with previous years

The Commission hosted the third International Consumer Product Safety Week in Brussels on 1–3 December 2010. The event brought together regulators, business representatives, consumer organisations, standardisation bodies and aca-demics for a series of intense discussions. The 2010 edition involved sessions on the forthcoming revision of the General Product Safety Directive, a seminar on risk assessment, held under the auspices of the EMARS II project, as well as an inter-national day that involved meetings of the ICPSC and the OECD. The OECD meet-ing was the fi rst of its new working party on consumer product safety, which was launched in July 2010.

Finally, the Commission launched the MED-RAS project aiming to facilitate the es-tablishment of a rapid alert system for dangerous non-food products in the Medi-terranean region. Six Southern Mediterranean partners – Egypt, Israel, Jordan, Lebanon, Morocco and Tunisia participated in the work of an expert group steering the project and committed to exchange information through the system.

Page 8: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

14 15

250

200

150

100

50

0

Bel

gium

Bul

garia

Cze

ch R

epub

lic

Den

mar

k

Ger

man

y

Esto

nia

Irel

and

Gre

ece

Spa

in

Fran

ce

Ital

y

Cyp

rus

Latv

ia

Lith

uani

a

Luxe

mbo

urg

Hun

gary

Mal

ta

Net

herlan

ds

Aust

ria

Pola

nd

Port

ugal

Rom

ania

Slov

enia

Slov

akia

Finl

and

Swed

en

Uni

ted

Kin

gdom

Icel

and

Liec

hten

stei

n

Nor

way

5

44

28

88

119

146

159

2316

204192

251314

178

191

19

3829

68

39

20 20

62

9888

1000

27

12%

10%

8%

6%

4%

2%

0%

Ger

man

y

Bul

garia

Hun

gary

Cyp

rus

Gre

ece

Spa

in

Fran

ce

Finl

and

Ital

y

Uni

ted

Kin

gdom

Pola

nd

Slo

vaki

a

Lith

uani

a

Port

ugal

Net

herlan

ds

Aus

tria

Latv

ia

Sw

eden

Den

mar

k

Irel

and

Rom

ania

Slo

veni

a

Mal

ta

Esto

nia

Bel

gium

Cze

ch R

epub

lic

Nor

way

Luxe

mbo

urg

Icel

and

Liec

hten

stei

n

3%3%

2%2% 2%

1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1% 1%0%

0% 0%

4%4%5%

6%

7%

8%

10%

9%

10%

10%

Figure 3 – Number of notifi cations by notifying country (absolute values)

Figure 4 – Notifi cations by notifying country (%)

The total number of notifi cations validated by the European Commission has risen steadily over the past several years, increasing more than fourfold for instance between 2004 (468) and 2010 (2,244).

In 2010, the total number of notifi cations rose by 13% (2,244 notifi cations, up from in 2009). This annual change has been positive since 2004: 81% in 2005, 24% in 2006, 53% in 2007, 16% in 2008 and 7% in 2009.3

The number of notifi cations of products presenting a serious risk (i.e. under Article 12 of the GPSD and Article 22 of Regulation 765/2008) has grown by 16% compared to 2009 (1,963 compared to 1,699). In 2009, the number of Article 12 notifi cations had increased by 10% compared to 2008.

This growth is due to the increased awareness and attention given to product safety by national authorities and the business sector, more frequent and more effective controls of consumer products on the market, joint market surveillance actions car-ried out by national authorities and, fi nally, to the many training actions and semi-nars provided by the European Commission for different stakeholders.

The number of notifi cations distributed for information purposes only has decreased by 14% compared to 2009 (243 notifi cations compared to 283). This is a result mainly of the fact that notifi cations submitted by Member States to the Com-mission are constantly improving in quality. In particular, the notifi ed products and the risks they pose were better identifi ed, meaning that other Member States could undertake necessary follow-up activities with regard to these products.

In the following charts, the fi gures concern only notifi cations on consumer products posing a serious risk distributed through RAPEX under Article 12 of the GPSD and Article 22 of Regulation 765/2008. Notifi cations distrib-uted under Article 11 of the GPSD and Article 23 of Regulation 765/2008 and notifi cations sent for information purposes are not covered.

2.1.2 Notifications by notifying country

In 2010, 27 EU Member States and Norway sent notifi cations through the RAPEX system. Two participating countries (Iceland and Liechtenstein) did not submit any notifi cations.

The following fi ve most frequently notifying countries accounted for 47% of all notifi cations:

Germany (204 notifi cations, 10%), •

Bulgaria (192 notifi cations, 10%), •

Hungary (191 notifi cations, 10%), •

Cyprus (178 notifi cations, 9%), •

Greece (159 notifi cations, 8%).•

3 The more dramatic increases in 2004 and 2007 are fuelled in part by the enlargements of those years.

Page 9: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

16 17

250

200

150

100

50

0

Bel

gium

Bul

garia

Cze

ch R

epub

lic

Den

mar

k

Ger

man

y

Esto

nia

Irel

and

Gre

ece

Spa

in

Fran

ce

Ital

y

Cyp

rus

Latv

ia

Lith

uani

a

Luxe

mbo

urg

Hun

gary

Mal

ta

Net

herlan

ds

Aus

tria

Pola

nd

Port

ugal

Rom

ania

Slo

veni

a

Slo

vaki

a

Finl

and

Sw

eden

Uni

ted

Kin

gdom

EEA c

ount

ries

1517

3

14

43

89

122

192

50

3032

13

23

9

32

15

163

187204205

20 2013

16

33

2320

115

132

154159

163

146

88

119

51

4338

33

10

44

1316

2831

35

44

2 30

1 1

1419

48

73

38

131721

29

43

68

18

8

1727 27

3339

16

40

20 20

62 61

58

15

88

12

10

3829

27

84

98 100

87

104

8887

114

140

114

102

33

5

109

129

191

119

2713

76

88

103

220

108

178

23

2007200820092010

Other53%

Germany10%

Bulgaria10%

Hungary10%

Cyprus9%

Greece8%

Other53%

Spain13%

Germany11%

Greece9%

Bulgaria7%

Hungary7%

Figure 6 – The fi ve most frequently notifying countries in 2010

Figure 5 – Number of notifi cations by notifying country: comparison with previous years

Comparison with previous years

In 2010, half of the countries increased their activities, notifying more dangerous products than in 2009. This year, the gap between the countries with the highest and the lowest number of notifi cations remained almost the same as in 2009. This is refl ected in the fact that the total share of the fi ve most frequently notifying coun-tries (i.e. Germany, Bulgaria, Hungary, Cyprus and Greece) is still 47% as in 2009.

Figure 7 – The fi ve most frequently notifying countries in 2009

It should be stressed that RAPEX statistics do not refl ect all market surveillance activities carried out in Member States. Legitimate reasons may exist for the fact that some measures taken against dangerous products in Member States do not result in notifi cations sent to the RAPEX system. The participation rate of coun-tries in RAPEX is the result of various factors such as the different way in which the national market surveillance networks are organised, the different size of the countries, and the different production and market structures that exist across the EU. The European Commission has undertaken several actions in 2010 in order to facilitate the participation of Member States in RAPEX, including the publication of the new RAPEX Guidelines, the development of a new risk assessment application and the organisation of RAPEX seminars.

2.1.3 Notifications by product identifier

2.1.3.1 Product category of the notified product

The product categories most frequently notifi ed through the RAPEX system in 2010 were:

Clothing, textiles and fashion items (625 notifi cations, 32%), •

Toys (488 notifi cations, 25%), •

Motor vehicles (175 notifi cations, 9%), •

Electrical appliances (158 notifi cations, 8%), •

Childcare articles and children′s equipment (72 notifi cations, 4%).•

These categories of consumer products accounted for almost 80% of all products notifi ed in 2010. This year the product category “Clothing, textiles and fashion items” was the most notifi ed (32%), closely followed by “Toys” (25%). Both cat-egories account together for more than half (57%) of all notifi cations distributed through the RAPEX system in 2010.

A signifi cant increase in the number of RAPEX notifi cations on clothing, textiles and fashion items results mainly from enhanced market surveillance activities under-taken by national authorities following, in particular, the adoption of Commission Decision 2009/251/EC on DMF 4 which is a strong novel sensitizer found to have been used as an anti-mould treatment especially in shoes, some textiles and furni-ture. A second, equally important factor leading to the prominence of this category in the fi ndings of non-compliance was the launch of the joint market surveillance action on cords and drawstrings in children′s clothing, which saw the participation of nine Member States. This proves that risk-focused Community level measures and joint prioritisation of certain types of products in the surveillance actions taken by Member States result in well spent resources in terms of fi nding dangerous prod-ucts that could be harmful to consumers.

4 OJ L 74, 20.3.2009, p. 32 –34

Page 10: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

18 19

700

600

500

400

300

200

100

0

Che

mic

al p

rodu

cts

Chi

ldca

re a

rtic

les

and

child

ren′

s eq

uipm

ent

Clo

thin

g, t

extile

san

d fa

shio

n item

sCom

mun

icat

ion

and

med

ia e

quip

men

t

Cos

met

ics

Dec

orat

ive

articl

es

Elec

tric

al a

pplia

nces

Food

-im

itat

ing

prod

ucts

Furn

itur

e

Gad

gets

Gas

app

lianc

es

Han

d to

ols

Hob

by/s

port

seq

uipm

ent

Jew

elle

ryKitch

en/c

ooki

ngac

cess

orie

s

Lase

r po

inte

rs

Ligh

ters

Ligh

ting

cha

ins

Ligh

ting

equ

ipm

ent

Mac

hine

ry

Mot

or v

ehic

les

Oth

er

Prot

ective

equ

ipm

ent

Rec

reat

iona

l cra

fts

Sta

tion

ery

Toys

29

72

625

6

66

10

158

51

12 4 8 1

42

7 5 1535

2348

1733 29

3 1

488

175

35%

30%

25%

20%

15%

10%

5%

0%

Clo

thin

g, t

extile

s an

d fa

shio

n item

s

Toys

Mot

or v

ehic

les

Elec

tric

al a

pplia

nces

Chi

ldca

re a

rtic

les

and

child

ren′

s eq

uipm

ent

Cos

met

ics

Food

-im

itat

ing

prod

ucts

Ligh

ting

equ

ipm

ent

Hob

by/s

port

s eq

uipm

ent

Ligh

ters

Oth

er

Che

mic

al p

rodu

cts

Prot

ective

equ

ipm

ent

Ligh

ting

cha

ins

Mac

hine

ry

Lase

r po

inte

rs

Furn

itur

e

Dec

orat

ive

articl

es

Gas

app

lianc

es

Jew

elle

ry

Com

mun

icat

ion

and

med

ia e

quip

men

tKitch

en/c

ooki

ng

acce

ssor

ies

Gad

gets

Rec

reat

iona

l cra

fts

Han

d to

ols

Sta

tion

ery

32%

25%

9%8%

4% 3%3% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 0% 0% 0% 0% 0% 0% 0% 0%

Clothing, textiles and fashion items32%

Other23%

Toys25%

Motor vehicles9%

Electrical appliances8%

Childcare articles and children′s equipment

4%

Toys28%Other

27%

Clothing, textiles and fashion items23%Motor vehicles

9%

Electrical appliances8%

Cosmetics5%

Figure 9 – Notifi cations by product category (%)

Figure 8 – Number of notifi cations by product category (absolute values) Figure 10 – The fi ve most frequently notifi ed product categories in 2010

Figure 11 – The fi ve most frequently notifi ed product categories in 2009

Page 11: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

20 21

Brand Known + Type/number of model KnownBrand Unknown + Type/number of model KnownBrand Known + Type/number of model UnknownBrand Unknown + Type/number of model Unknown

1%9%

6%

84%

Arg

entina

Aus

tria

Ban

glad

esh

Bel

gium

Bra

zil

Bul

garia

Can

ada

Chi

naCoc

os (

Keel

ing)

Isl

ands

Côt

e d'

Ivoi

reCyp

rus

Cze

ch R

epub

licD

enm

ark

Esto

nia

Finl

and

Fran

ceG

erm

any

Gre

ece

Gua

tem

ala

Hun

gary

Indi

aIn

done

sia

Isra

elIt

aly

Japa

nKo

rea

Lith

uani

aM

alay

sia

Mex

ico

Mor

occo

Net

herlan

dsN

iger

iaN

orth

Kor

eaN

orw

ayPh

ilipp

ines

Pola

ndPo

rtug

alRom

ania

Rus

sia

Slo

vaki

aSpa

inSri L

anka

Sw

eden

Sw

itze

rlan

dSyr

iaTa

iwan

Thai

land

Tuni

sia

Turk

eyU

krai

neU

nite

d Ara

b Em

irat

esU

nite

d Kin

gdom

Uni

ted

Sta

tes

Unk

now

nVie

tnam

1,200

1,000

800

600

400

200

04 4 17

1,134

36 3651

3463

4 1 12 6 1 8 5 1 1 1 1 1 6 4 230

222

1 12111

73

31 119

43

5

201

334

1571 1 7 2 8 3 2 21 11 8

Figure 13 – Notifi cations of which brand and model numbers are known/unknown (%)

Figure 12 – Number of notifi cations of which brand and model numbers are known/unknown

Type/number of model Known

Type/number of model Unknown

Total

Brand Known 1,651 175 1,826

Brand Unknown 121 16 137

1,772 191 1,963

2.1.3.2 Brand and model numbers of the notified product

1,651 notifi cations validated in 2010 (84%) concerned products for which both the brand and the type/model number were known, which ensures a better identifi ca-tion and therefore traceability of the notifi ed products. In 15% of the cases, either the brand or the type/model number was known. Only in 16 cases (1%) were both the brand and the type/model number unknown.

Figure 14 – Number of notifi cations by country of origin of the notifi ed product

2.1.3.3 Country of origin of the notified product

In 58% of all notifi cations sent through the RAPEX system in 2010 (i.e. 1,134 noti-fi cations), the country of origin of the notifi ed products was China (including Hong Kong). The high number of RAPEX notifi cations concerning Chinese products re-sults from the signifi cant market penetration of Chinese-manufactured consumer products in European markets. Products of all origins are checked according to the same, stringent safety requirements, usually based on risks associated with the product category or typical hazards. The constant intensifi cation of our contacts with the Chinese administration and businesses is yielding signifi cant returns in terms of improved product identifi cation and tracing for corrective measures.

338 notifi cations (17% of all notifi cations sent through RAPEX) concerned products originating from the 27 EU Member States and 3 EFTA/EEA countries. This is con-sistent with the data from previous years (20% in 2009, 20% in 2008, 22% in 2007 and 21% in 2006).

201 notifi cations (10% of all notifi cations sent through RAPEX) contained no infor-mation about the country of origin of the notifi ed product. Even though this fi gure is slightly higher than the 7% recorded in 2009, it remains a very low level, given that in 2004 the number of cases with an unidentifi ed country of origin was as high as 23%. The overall drop indicates that the market surveillance authorities in Eu-rope are increasingly aware of the importance of fi nding identifi cation data that is helpful to partner authorities in other Member States and ultimately in the country of origin of the product.

Market surveillance authorities are able to take corrective measures if both the country of origin and the brand are known. Since this was the case for only 84% of products notifi ed in 2010 there is still room for improvement in educating manufac-turers and importers on the importance of traceability in the supply chain.

Page 12: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

22 23

Chi

naU

nkno

wn

Turk

eyG

erm

any

Ital

yU

nite

d Sta

tes

Fran

ceIn

dia

Japa

nPo

land

Spa

inSw

eden

Taiw

anU

nite

d Kin

gdom

Bul

garia

Net

herlan

dsBan

glad

esh

Thai

land

Bel

gium

Cze

ch R

epub

licM

alay

sia

Côt

e d'

Ivoi

reH

unga

ryKo

rea

Rom

ania

Mex

ico

Vie

tnam

Aus

tria

Bra

zil

Gre

ece

Rus

sia

Den

mar

kPh

ilipp

ines

Ukr

aine

Cyp

rus

Esto

nia

Finl

and

Indo

nesi

aSlo

vaki

aSri L

anka

Arg

entina

Can

ada

Coc

os (

Keel

ing)

Isl

ands

Gua

tem

ala

Isra

elLi

thua

nia

Mor

occo

Nig

eria

Nor

th K

orea

Nor

way

Port

ugal

Sw

itze

rlan

dSyr

iaTu

nisi

aU

nite

d Ara

b Em

irat

es

70%

60%

50%

40%

30%

20%

10%

0%

10%

4%3%

3%2%2%

2%2%

2%2%1%

1%1%

1%1%

1%1%

0%0%

0%0%

0%0%

0%0%

0%0%

0%0%

0%0%

0%0%

0%0%

0%0%

0%0%

0%0%

0%0%

0%0%

0%0%

0%0%

0%0%

0%0%

0%

58%

Other15%

China, including Hong Kong58%

Unknown10%

EU-27 and EEA countries17%

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0% 2004 2005 2006 2007 2008 2009 2010

38%

27%

OtherUnknown

EU-25/27 and EEAChina, including Hong Kong

20% 21%

20% 17%

13% 13%

13%

22%

11%

10%

20%

11%

23%

12%

49% 49% 52%59%

13%

7%

20%

60%

15%

10%

17%

58%

Figure 16 – Notifications by country of origin of the notified product (%)

Figure 15 – Notifi cations by country of origin of the notifi ed product (%) Figure 17 – Notifications by country of origin of the notified product (%) – comparison previous years

2.1.4 Notifications by type of risk

The fi ve most frequently notifi ed risk categories were:

Injuries (550 notifi cations, 24%),•

Chemical (439 notifi cations, 19%), •

Strangulation (356 notifi cations, 16%),•

Choking (330 notifi cations, 14%), •

Electric shock (197 notifi cations, 9%). •

These fi ve risk categories account for 82% of all notifi ed risks.

It should be noted that some RAPEX notifi cations concern products presenting more than just one risk. For example, a toy can pose a choking risk due to small parts and, simultaneously, a chemical risk due to excessive levels of a restricted substance. The total number of notifi ed risks is accordingly higher than the total number of notifi cations.

On the basis of RAPEX data it can also be concluded that each product category is likely to expose consumers to specifi c types of risk. For example, the main risks arising when playing with unsafe toys are choking (often associated with the pres-ence of small parts) and reactions to chemicals (often associated with high levels of chemical substances such as phthalates, lead and other heavy metals), while the most common risk for electrical products is electric shock, often combined with the risk of fi re.

Page 13: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

24 2524

600

500

400

300

200

100

0

Bur

ns

Che

mic

al

Cho

king

Cut

s

Dam

age

to h

earing

Dam

age

to s

ight

Dro

wni

ng

Elec

tric

sho

ck

Fire

Hea

lth

risk

Inju

ries

Mic

robi

olog

ical

Str

angu

lation

Suf

foca

tion

439

84

330

1330 45

6

197175

2 1740

356

550

30%

25%

20%

15%

10%

5%

0%

Inju

ries

Che

mic

al

Str

angu

lation

Cho

king

Elec

tric

sho

ck

Fire

Bur

ns

Dam

age

to s

ight

Suf

foca

tion

Dam

age

to h

earing

Mic

robi

olog

ical

Cut

s

Dro

wni

ng

Hea

lth

risk

19%

24%

16%14%

9%8%

4%2% 2% 1% 1% 0%0%1%

Injuries24%

Other18%

Chemical19%

Strangulation16%

Choking14%

Electric shock9%

Chemical26%

Other18%

Injuries21%

Choking14%

Electric shock11%

Strangulation10%

Figure 20 – The fi ve most frequently notifi ed types of risk in 2010

2.1.5 Notifications by type of measure

1,163 of the 1,963 RAPEX serious risk notifi cations were of compulsory preventive and restrictive measures ordered by national authorities (60% of the total). In 755 notifi ed cases (38%), economic operators took preventive and restrictive measures on a ‘voluntary’ basis, i.e. they complied with their legal obligations without the for-mal intervention of a national authority. In 45 cases (2%), ‘voluntary’ actions were complemented by compulsory measures taken by the national authority. In this situation, even though an economic operator has ceased selling a product, national authorities still believe further action needs to be taken and accordingly order that the product be withdrawn from the market or recalled from consumers who have already bought it.

Figure 21 – The five most frequently notified types of risk in 2009

Figure 18 – Number of notifi cations by type of risk (absolute values)

Figure 19 – Notifi cations by type of risk (%)

Page 14: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

26 27

1,400

1,200

1,000

800

600

400

200

0 Compulsory measures Voluntary measures Compulsory and voluntary

1,163

755

45

Voluntary measures38%

Compulsory and voluntary2%

Compulsory measures60%

Figure 22 – Number of notifi cations by type of measure (absolute values)

Figure 23 – Notifi cations by type of measure (%)

Figure 24 – Number of notifi cations by type of measure per country (absolute values)

Jan–Dec 2010

Belgium 2 12 14

Bulgaria 186 6 192

Czech Republic 12 1 13

Denmark 1 21 3 25

Germany 27 170 7 204

Estonia 14 2 16

Ireland 2 21 23

Greece 111 48 159

Spain 128 18 146

France 12 106 1 119

Italy 85 1 2 88

Cyprus 132 34 12 178

Latvia 4 24 28

Lithuania 40 4 44

Luxembourg 5 5

Hungary 189 1 1 191

Malta 1 17 1 19

Netherlands 20 18 38

Austria 7 22 29

Poland 15 52 1 68

Portugal 11 28 39

Romania 20 20

Slovenia 1 19 20

Slovakia 36 18 8 62

Finland 66 30 2 98

Sweden 5 22 27

United Kingdom 24 57 7 88

Iceland 0

Liechtenstein 0

Norway 7 3 10

1,163 755 45 1,963

Compulsorymeasures

Voluntarymeasures

Compulsoryand voluntary

Total

Page 15: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

28 29

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

57%

41%

53%

44%

2% 3%

60%

38%

2%

47%

50%

3%

50%

48%

2%

Compulsory and voluntaryVoluntary measuresCompulsory measures

2006 2007 2008 2009 2010

200

180

160

140

120

100

80

60

40

20

0

Bel

gium

Bul

garia

Cze

ch R

epub

licD

enm

ark

Ger

man

y

Esto

nia

Irel

and

Gre

ece

Spa

in

Fran

ce

Ital

y

Cyp

rus

Latv

iaLi

thua

nia

Luxe

mbo

urg

Hun

gary

Mal

ta

Net

herlan

ds

Aus

tria

Pola

nd

Port

ugal

Rom

ania

Slo

veni

aSlo

vaki

a

Finl

and

Sw

eden

Uni

ted

Kin

gdom

Icel

and

Liec

hten

stei

n

Nor

way

2 1

12

1 2

147

27

2

126 8 4

40

5 1

20

715

1120

11 2

36

5

24

0 07

2

66

38

189

132128

111

186

85

62

Compulsory, allCompulsory by customs authorities

Figure 25 – Notifi cations by type of measure (%) – comparison previous years

Figure 26 – Number of notifi cations concerning compulsory measures initiated by the customs authorities (absolute values)

Comparison with previous years

The share of cases in which measures have been initiated by the authorities grew slightly in 2010 (from 53% to 60%), continuing a trend observed since 2008. Six out of ten measures are now ordered by the authorities.

2.1.6 Notifications initiated by the activities of the customs authorities

In 2010, 129 notifi cations concerned measures that were adopted by customs authorities, representing 11% of the total of 1,163 compulsory measures taken. These consisted mainly of rejections of imports.

The Member State fi gures for this category of notifi cations may appear to indicate that customs authorities are more active in tackling imports of dangerous products in some countries than others. However, this does not give a full picture of the activity of customs authorities across the EU, since in many other countries meas-ures in which customs has played an important role are in fact taken directly by market surveillance authorities themselves, acting in liaison with customs.

2.2 Reactions

2.2.1 Total number of reactions

In 2010, EU Member States and the EFTA/EEA countries sent a total of 2,154 reac-tions to all notifi cations distributed through RAPEX. 2,111 reactions were sent in response to notifi cations for serious risk (98%); 12 reactions concerned notifi ca-tions of products with lower risk levels (1%); and 31 reactions were sent in relation to notifi cations sent for information only (1%).

843 of the serious notifi cations submitted under Article 12 of the GPSD/Article 22 of the Regulation 765/2008 (i.e. 43%) received at least one reaction.

In the following charts, the fi gures only concern reactions to notifi cations for serious risk (2,111 reactions).

2.2.2 Reactions by reacting country

In 2010, all Member States, plus Norway and Iceland, sent reactions to RAPEX noti-fi cations. Only Liechtenstein did not send a reaction to any RAPEX notifi cations.

The following fi ve countries accounted for 40% of all reactions:

Netherlands (276 reactions, 13%), •

Sweden (159 reactions, 8%), •

Portugal (157 reactions, 7%), •

Hungary (133 reactions, 6%), •

Denmark (132 reactions, 6%).•

2.2.3 Reactions by notified product

Notifi cations concerning motor vehicles generated the most reactions (66%). Almost 90% of all reactions concerned RAPEX notifi cations related to the following fi ve product categories:

Motor vehicles (1,386 reactions, 66%), •

Toys (237 reactions, 11%), •

Childcare articles and children′s equipment (88 reactions, 4%),•

Electrical appliances (83 reactions, 4%), •

Clothing, textiles and fashion items (76 reactions, 4%).•

Page 16: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

30 31

300

250

200

150

100

50

0

Bel

gium

Bul

garia

Cze

ch R

epub

lic

Den

mar

k

Ger

man

y

Esto

nia

Irel

and

Gre

ece

Spa

in

Fran

ce

Ital

y

Cyp

rus

Latv

ia

Lith

uani

a

Luxe

mbo

urg

Hun

gary

Mal

ta

Net

herlan

ds

Aus

tria

Pola

nd

Port

ugal

Rom

ania

Slo

veni

a

Slo

vaki

a

Finl

and

Sw

eden

Uni

ted

Kin

gdom

Icel

and

Liec

hten

stei

n

Nor

way

22 20

89

118

31

95 9782

29

88

12 12

45

12

57

17

73

133

157

276

118

312 14

3644

0

128

159

132

14%

12%

10%

8%

6%

4%

2%

0%

Net

herlan

ds

Sw

eden

Port

ugal

Hun

gary

Den

mar

k

Finl

and

Ger

man

y

Slo

veni

a

Gre

ece

Irel

and

Bul

garia

Ital

y

Spa

in

Pola

nd

Mal

ta

Lith

uani

a

Nor

way

Icel

and

Esto

nia

Fran

ce

Bel

gium

Cze

ch R

epub

lic

Aus

tria

Uni

ted

Kin

gdom

Cyp

rus

Latv

ia

Luxe

mbo

urg

Slo

vaki

a

Rom

ania

Liec

hten

stei

n

13%

7%8%

6% 6%6% 6%

6% 5% 5% 4% 4%4%

3%2%

2% 1%3%

1%2%

1%1% 1% 1% 1%0%0%

1% 1%

6%

1,600

1,400

1,200

1,000

800

600

400

200

0

Che

mic

al p

rodu

cts

Chi

ldca

re a

rtic

les

and

child

ren′

s eq

uipm

ent

Clo

thin

g, t

extile

s an

d f

ashi

on it

ems

Com

mun

icat

ion

and

med

ia e

quip

men

t

Cos

met

ics

Dec

orat

ive

articl

es

Elec

tric

al a

pplia

nces

Food

-im

itat

ing

prod

ucts

Furn

itur

e

Gad

gets

Gas

app

lianc

es

Han

d to

ols

Hob

by/s

port

s eq

uipm

ent

Jew

elle

ry

Lase

r po

inte

rs

Ligh

ters

Ligh

ting

cha

ins

Ligh

ting

equ

ipm

ent

Mac

hine

ry

Mot

or v

ehic

les

Oth

er

Prot

ective

equ

ipm

ent

Rec

reat

iona

l cra

fts

Sta

tion

ery

Toys

227688

42 1283

26 6 5 3 1 4 6 2 13 12 10 10 5 1

237

1

1,386

4416

70%

60%

50%

40%

30%

20%

10%

0%

Mot

or v

ehic

les

Toys

Chi

ldca

re a

rtic

les

and

chi

ldre

n′s

equi

pmen

t

Elec

tric

al a

pplia

nces

Clo

thin

g, t

extile

s an

d f

ashi

on it

ems

Hob

by/s

port

s eq

uipm

ent

Cos

met

ics

Food

-im

itat

ing

prod

ucts

Che

mic

al p

rodu

cts

Com

mun

icat

ion

and

med

ia e

quip

men

t

Ligh

ting

equ

ipm

ent

Mac

hine

ry

Dec

orat

ive

articl

es

Oth

er

Prot

ective

equ

ipm

ent

Furn

itur

e

Ligh

ters

Gad

gets

Rec

reat

iona

l cra

fts

Lase

r po

inte

rs

Gas

app

lianc

es

Ligh

ting

cha

ins

Han

d to

ols

Jew

elle

ry

Sta

tion

ery

66%

4%

11%

4% 4%2% 2% 1% 1% 1% 1% 1% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0%0% 0%1%

Figure 27 – Number of reactions by reacting country (absolute values)

Figure 28 – Reactions by reacting country (%)

Figure 29 – Number of reactions by product category of the original notifi cation (absolute values)

Figure 30 – Reactions by product category of the original notifi cation (%)

Page 17: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

32 33

1,400

1,200

1,000

800

600

400

200

0

Bur

ns

Che

mic

al

Cho

king

Cut

s

Dam

age

to h

earing

Dam

age

to s

ight

Dro

wni

ng

Elec

tric

sho

ck

Fire

Hea

lth

risk

Inju

ries

Mic

robi

olog

ical

Str

angu

lation

Suf

foca

tion

58

174181

8 14 7 49

341

3 5 40 28

1,303

10

70%

60%

50%

40%

30%

20%

10%

0%

Inju

ries

Fire

Che

mic

al

Cho

king

Bur

ns

Elec

tric

sho

ck

Str

angu

lation

Suf

foca

tion

Dam

age

to s

ight

Cut

s

Dam

age

to h

earing

Dro

wni

ng

Mic

robi

olog

ical

Hea

lth

risk

59%

8%

15%

3% 2% 2% 1% 1% 0% 0% 0% 0%0%

8%

2,500

2,000

1,500

500

0

1,924

70 74 43

Found on national market

Not found on national market

Additional info requested or provided

Disagree withoriginal notification

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

91%

3% 4% 2%

Found on national market

Not found on national market

Additional info requested or provided

Disagree withoriginal notification

2.2.5 Reactions by type of reaction

In the majority of reactions received (1,924 reactions, 91%), Member States stated that the notifi ed product was found on their market and that adequate preventive or restrictive measures were adopted at national level. In 74 reactions (4%), the reacting country requested or provided additional information on the case. In 43 reactions (2%), the reacting country did not agree with the information provided in the notifi cation, mainly with the conclusions of the risk assessment presented by the notifying Member State. In 70 reactions (3%), Member States informed the Commission that the notifi ed product was not found on their markets.

2.2.4 Reactions by type of notified risk

More than half of the reactions received were sent in response to notifi cations about consumer products posing a risk of injuries (1,303 reactions, 59%) or a risk of fi re (341 reactions, 15%). These two risks are clearly linked to motor vehicles, which accounted for 66% of all reactions received.

The fi ve risk categories most frequently included in the reactions were:

Injuries (1,303 reactions, 59%), •

Fire (341 reactions, 15%), •

Chemical (181 reactions, 8%), •

Choking (174 reactions, 8%), •

Burns (58 reactions, 3%).•

Some reactions concerned products that present more than one risk: therefore the total number of risks associated with the reactions (2,221) is higher than the total number of reactions submitted for serious risk (2,111).

Figure 31 – Number of reactions by type of risk of the original notification (absolute values)

Figure 32 – Reactions by type of risk of the original notifi cation (%)

Figure 33 – Number of reactions by type of reaction (absolute values)

Figure 34 – Reactions by type of reaction (%)

Page 18: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

34 35

2,000

1,800

1,600

1,400

1,200

1,000

800

600

400

200

0

85

1,821

8 10

Compulsory measures

Voluntary measures

Compulsory and voluntary measures

No measures indicated

Compulsory measures

Voluntary measures

Compulsory and voluntary measures

No measures indicated

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

4%

95%

0% 1%

10

9

8

7

6

5

4

3

2

1

0 Serious risk Other risk levels For info

7

6

7

2.2.6 Measures taken by reacting countries

In the majority of cases in which the reacting country found the notifi ed product on its national market (1,924 reactions), the measures taken were also indicated. In 85 cases (4%), those measures were taken by the national authorities (compulsory measures) and in 1,821 cases (95%) they were taken by the economic operators (voluntary measures). In 8 cases (0.4%), it was indicated that compulsory as well as voluntary measures were taken. In 10 cases (0.6%), no measures were indicated.

As explained later in this report, the RAPEX website now mentions the countries which found the product on their market and took restrictive measures next to each notifi cation.

Figure 35 – Reactions by measures taken when notifi ed products were found on the national market (absolute values)

Figure 36 – Reactions by measures taken in the case the products were found on the national market (%)

Figure 37 – Total number of notifi cations on professional goods and risks other than health and safety

2.3 The new notifications on professional goods and other risks

Following the entry into force of Regulation 765/2008 in January 2010, the Mem-ber States have been using RAPEX to notify additional types of market surveil-lance measures to the Commission. These include measures taken with regard to the safety of goods used in a professional context (i.e. not by consumers) and measures taken to address risks to public interests other than health and safety (environmental or security risks, for example), whether the products are used in a professional context or by consumers. In this fi rst year of the application of Regula-tion 765/2008, a total of 20 notifi cations were distributed:

Seven of these notifi cations relate to products presenting serious risks and • were therefore distributed to Member States as notifi cations under Article 22 of Regulation 765/2008;

Six notifi cations relate to products presenting only a moderate risk and so • were distributed to Member States under Article 23 of Regulation 765/2008;

Seven notifi cations were distributed to Member States simply for information • purposes, as while they did not fulfi l the criteria of either Article 22 or Article 23 of the regulation, the information they contained was deemed of interest to market surveillance authorities.

As regards the seven notifi cations concerning products presenting serious risks, the distribution of the relevant risk categories was as follows:

Environmental (4 notifi cations, 57%), •

Health & safety (3 notifi cations, 43%).•

The specifi c environmental risks covered by notifi cations were chemical pollution and CO2 emissions. Health and safety aspects related mainly to products consid-ered as professional goods (e.g. mobile phones for use in potentially explosive atmospheres and fertilisers).

Page 19: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

36 37

Environment57%

Health & Safety43%

Germany43%

Finland43%

Netherlands14%

China29%

Netherlands29%

France14%

Germany14%

Turkey14%

Consumer products57%

Professional products43%

Figure 38 – Notifi cations by type of risk

Figure 39 – Notifi cations by notifying country

Figure 40 – Notifi cations by country of origin of the notifi ed product

Figure 41 – Notifi cations by type of product (consumer/professional)

The notifi cations were sent by the following 3 EU Member States:

Germany (3 notifi cations, 43%),•

Finland (3 notifi cations, 43%),•

The Netherlands (1 notifi cation, 14%).•

The product categories notifi ed were:

Stationery (1 notifi cation, 14%),•

Chemical products (1 notifi cation, 14%),•

Electrical appliances (1 notifi cation, 14%),•

Motor vehicles (1 notifi cation, 14%),•

Childcare articles and children′s equipment (1 notifi cation, 14%),•

Other (2 notifi cations, 29%).•

In two of the notifi cations of products presenting a serious risk, China was indicated as a country of origin. In two others the country of origin was the Netherlands. The remaining three notifi cations (29%) concerned, respectively, products originating from France, Germany and Turkey.

The seven notifi cations for serious risk which were validated in 2010 concerned both consumer (4 notifi cations) and professional (3 notifi cations) products.

Three of the notifi cations concerned compulsory preventive and restrictive meas-ures ordered by the national authorities (43%). In two notifi ed cases (29%), eco-nomic operators took the necessary preventive and restrictive measures on a vol-untary basis. In two cases (29%), compulsory measures were accompanied by voluntary measures taken by an economic operator.

Page 20: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

38 39

3Compulsory measures

42%

Compulsory and voluntary29%

Voluntary measures29%

Key developments in 2010

3.1 Enforcement

An effective enforcement of product safety legislation plays a key role in ensuring that European citizens are and feel protected against serious risks and threats that they cannot tackle as individuals.

National market surveillance authorities and the European Commission cooperate at European level to ensure that only safe products have access to the Single Mar-ket and its 500 million consumers.

3.1.1 The new RAPEX guidelines

2010 was the fi rst year of application of the new guidelines for the management of RAPEX and the notifi cation procedure established under Article 11 of Directive 2001/95/EC 5. The guidelines are laid down in Commission Decision 2010/15/EU, adopted by the Commission on 16 December 2009.

The guidelines provide greater precision on the scope of the RAPEX system, clarify its notifi cation criteria and defi ne various stages and aspects of the notifi cation and reaction procedures. They also regulate essential aspects of the system which had not previously been subject to specifi c rules, such as permanent withdrawal of notifi cations from the system, temporary removal of notifi cations from the RAPEX website and rules on challenging the risk assessments presented in notifi cations.

The new guidelines were thoroughly discussed with Member States, who have not encountered major problems with their application. The most challenging element is the new risk assessment guidelines for consumer products. National experts ex-perienced diffi culties in estimating the probabilities of injuries, in particular.

In 2011 the Commission will continue to monitor the application of the RAPEX guidelines and the risk assessment method. If any major problems are identifi ed, the Commission will consider a partial revision.

3.1.2 The New Legislative Framework Regulation (Regulation 2008/765/EC) 6

Regulation 2008/765/EC became applicable on 1 January 2010 and introduces bet-ter rules on market surveillance for products subject to specifi c requirements under EU legislation (e.g. toys, electrical products, machinery). It aims to protect con-sumers and professionals from dangerous products and to ensure compliance of products with all requirements contained in sectoral directives The Regulation rec-ognizes the importance of the RAPEX system and extends its scope to professional products and to products presenting a serious risk to public interests other than the health and safety of consumers (e.g. risks to the environment).

The Regulation also involves customs authorities in the enforcement of EU product legislation by laying down a clear obligation for them to carry out controls of the safety aspects of products imported from third countries.

Figure 42 – Notifi cations by type of measure

2.4 Reactions to the new notifications on professional goods and other risks

In 2010, Member States sent four reactions to all notifi cations not relating to the health and safety of consumers. Two reactions, from Bulgaria and Denmark, were sent to Article 22 notifi cations and two reactions, from Finland and the Nether-lands, were sent to notifi cations distributed for information. The reactions con-cerned mainly notifi cations on motor vehicles and childcare articles & children′s equipment. The reactions were sent in response to notifi cations on products posing risks to the environment and health & safety.

Conclusion

In 2010, most notifi cations were related either to a serious risk for the environment posed by a consumer product or a health and safety risk linked to a professional product. Notifi cations received concerned both professional and consumer products almost equally.

It is expected that the number of notifi cations concerning professional products or products posing risks other than risks to the health and safety of consumers, will increase in 2011, as Member States gain experience with the application of Regula-tion 765/2008.

5 OJ L 22, 26.01.2010, p. 16 Regulation 2008/765/EC setting out the requirements for accreditation and market surveillance relating to the

marketing of products and repealing Regulation (EEC) No 339/93

Page 21: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

40 41

The surveys showed that 20% of consumers (compared to 25% in 2009) and 16% of retailers (similar to the percentage in 2009) thought that a signifi cant number of non-food consumer products sold in Europe were unsafe. There were big dif-ferences between Member States, with the best perceived safety levels occurring in Luxembourg, the Netherlands and Ireland. On average, 9% of the respondents stated that they had been personally affected by a recall of non-food products.

A majority of the retailers in the EU felt well-informed about the rules and regula-tions relating to product safety and more than 4 out of 10 (42%) retailers of con-sumer products declared that they had carried out tests in the past two years to make sure that none of the products they were selling were unsafe.

A majority of retailers in all countries agreed that national public authorities actively monitor and ensure compliance with product safety legislation in their sec-tor. 7% said they were aware that their competitors knowingly sold unsafe products in the past year.

3.1.4.2 Consumer Market Scoreboard

In 2010, the Commission published the 3rd and 4th editions of the “Consumer Mar-kets Scoreboard” 8, a publication that monitors the performance of markets in terms of economic and social outcomes for the consumers.

The 3rd edition of the Scoreboard, “Consumers at Home in the Internal Market” was mainly focused on measuring the integration of the Single Market for retail sales and on benchmarking national consumer environments. Product safety was one of the key areas addressed, as it plays an important role in building consumer welfare and confi dence. The main conclusion drawn, on the basis of broad range of indicators, was that diffi cult economic conditions have had a big impact on national consumer environments, leading consumers to feel generally less secure.

The 4th edition of the scoreboard, “Making Markets Work for Consumers” was large-ly dedicated to comparing and ranking as many as 50 different goods and services markets according to the way they serve European citizens. This was based on several key indicators including comparability of prices, consumer trust, consumer satisfaction, consumer complaints and the ease of switching providers.

3.1.4.3 Enforcement Indicators

One of the main roles for the European Commission, as coordinator of product safety enforcement across the EU, is to monitor Member States compliance with their obligations under the EU’s law and treaties. To do this, the Commission needs to be well informed about the enforcement activities and capabilities in each Mem-ber State.

As follow-up to an initiative from 2008 and on consideration of recommendations given in 2009 by Member State experts, the Commission set up a data collection mechanism for indicators of enforcement levels. This allows it to make an annual collection of relevant data regarding product safety enforcement work carried out in the Member States.

These key indicators point out both the input (available resources) as well as the output (checks, results, corrective actions) of national authorities responsible for enforcing product safety laws.

The main objective is to develop a base of knowledge in this fi eld, giving all parties involved the possibility to learn more about what is being done in different Member States. All data collected is shared with Member States, while the most relevant indicators are also available to the public via the Consumer Market Scoreboard.

3.1.3 The revision of the GPSD

Based on the conclusions of the 2009 Report on the implementation of the General Product Safety Directive and taking into account the new obligations set out in Regulation (EC) No 765/2008, the Commission started work in 2010 to identify ways to modernise the General Product Safety Directive.

The Commission started by assessing the scope of problems encountered in the Directive′s application and the possible impacts of a number of potential chang-es. Four main areas for improvement were identifi ed: (i) procedures for issuing standardisation mandates under the GPSD, (ii) harmonisation of Member State safety evaluations, (iii) market surveillance cooperation and coordination, including the functioning of RAPEX and (iv) alignment with the New Legislative Framework. A public consultation covering these areas was carried out during the summer of 2010. In its consultation the Commission sought feedback through dedicated ques-tionnaires and consultation papers.

Fifty-fi ve different authorities at national level replied to the questionnaires, from all EU Member States except one, as well as Norway, Iceland and Switzerland. Various other stakeholders, including more than thirty business associa-tions, seventeen consumer organisations, and over fi fty indi-vidual economic operators (including several SMEs) contrib-uted to the consultation. In total, 305 replies were received to the nine online questionnaires. In addition, thirteen busi-ness and consumer organisations provided separate posi-tion papers In addition, a number of direct exchanges with stakeholders (both business and consumers) were held.

As far as the functioning of RAPEX is concerned, the re-sults of the public consultation showed that many Member States still had diffi culties complying fully with their obli-gations under the RAPEX system. In particular, many high-lighted problems in notifying the Commission of preventive and restrictive measures and in ensuring follow-up action to notifi cations distributed through the RAPEX system. The main reasons given were insuffi cient human and fi nancial resources, an overly complex notifi cation procedure and in-suffi ciently detailed data provided in RAPEX notifi cations.

Other stakeholders overwhelmingly see the positive role of the RAPEX system in the product safety area and consider that it contributes to better protecting con-sumers throughout the EU.

More detailed information about the results of this public consultation can be found at the following website:

http://ec.europa.eu/consumers/safety/prod_legis/GPSD_consultation/GPSD_Results/index_en.htm

The public consultation culminated in an international stakeholder conference on 1 December 2010 in which the Commission received feedback from stakeholders on key conclusions of the public consultation.

3.1.4 RAPEX and other product safety indicators

3.1.4.1 Eurobarometers 7

In 2010, the Commission ran two Eurobarometer surveys that included product safety issues, consulting consumers and retailers about their perception of con-sumer law enforcement in Europe. These surveys provided indications about aware-ness and knowledge of product safety laws, complaints, perceived compliance, and market surveillance activities.

7 http://ec.europa.eu/consumers/strategy/facts_eurobar_en.htm 8 http://ec.europa.eu/consumers/strategy/facts_en.htm

Page 22: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

42 43

Helmets

The eleven participating Member States examined 367 models of skiing, cycling, children and horse riding helmets and 40 of them were tested in the laboratory against the requirements of the relevant European standards. The results showed that 63% of the examined helmets did not comply with the requirements of the standards concerning marking and instructions for use.

In addition, sixteen out of the 40 helmets tested did not fulfi l at least one of the fol-lowing criteria: shock absorption capability, strength and effectiveness of retention and resistance to penetration requirements. No relationship could be established between the price of the helmet and compliance. In some cases, models with a low or even very low price were compliant, while models positioned at the top end of the price range were not.

3.1.5.3 RAPEX seminars

The European Commission organises RAPEX seminars for national market surveil-lance and customs authorities to strengthen their knowledge of the RAPEX system and improve the overall enforcement capacity of the Member States.

In 2010, seminars were held in Spain, Denmark, Ireland, Iceland, Malta, Poland, Italy, Portugal, Norway, Hungary, Slovenia and Sweden. Besides explaining the functioning of the RAPEX system and the implementation of the GPSD, an impor-tant part of the seminars was the application of the new risk assessment guidelines. Practical exercises were organised so that the participants gained hands-on experi-ence with the use of the new online tool for carrying out risk assessments.

3.2 Developments relating to specific products and risks

3.2.1 Scientific opinion on food imitating products

In December 2010, the Scientifi c Committee on Consumer Safety (SCCS) adopted a draft opinion on the potential health risks posed by chemical consumer products resembling food and/or having child-appealing characteristics. Stakeholders were invited to comment through an online public consultation that ran until 11 Febru-ary 2011.

Some chemical consumer products, such as shower gels, shampoos, body lotions, and soaps, resemble items of food and/or appeal to children because of their colour, appearance, smell or other characteristics. As a result, consumers, especially vul-nerable groups such as young children or the elderly may put them in their mouths and potentially swallow them.

The two main reasons for asking the SCCS to assess the risk from accidental inges-tion of food-resembling and child-appealing chemical consumer products were the diffi culties observed in determining their potential health risks and the need for a common approach to the assessment of their safety across the EU.

Despite the lack of available data on both the frequency and effects of accidentally ingesting consumer products resembling food and/or having child-appealing prop-erties, the SCCS opinion provides several elements that can be used in risk assess-ments of these products.

3.2.2 Study on flame retardants

In 2010 the Commission provided support for a study on fl ame retardants. The aims were to identify fl ame retardant chemicals present in consumer products used in domestic environments, assess human exposure to them and draft tentative risk assessments. The study identifi ed 41 fl ame retardants used in approximately seven hundred applications. Some of the substances had been assessed previously for human health and environmental risks in EU and UK risk assessment reports. For the others, toxicological data were collected and evaluated. Finally all substances

3.1.5 Better tools and capacity building

3.1.5.1 IT tool on risk assessment method

The risk assessment method published in early 2010 as part of the RAPEX Guide-lines was increasingly applied by market surveillance authorities. It provided more transparency and consistency when establishing the level of risk. A related IT tool was made available: http://europa.eu/sanco/rag/

3.1.5.2 Market surveillance coordination and cooperation9

2010 saw a signifi cant consolidation of market surveillance cooperation in the European Union. PROSAFE, whose members are national market surveillance au-thorities from across the EU, applied for a single joint surveillance action grant covering fi ve product groups (i.e. ladders, food-imitating child appealing products, children′s fancy dresses, laser pointers and high-visibility clothing) and a number of horizontal activities. The Commission awarded EUR 1.4 million in co-funding to the action, which will involve 21 Member States. 15 grants were awarded for exchanges of offi cials.

Four ongoing joint surveillance actions drew to a close with excellent results:

Cords and drawstrings in children′s clothing

The eleven participating Member States compared over 16,000 pieces of clothing against the requirements of European Standard EN 14682, resulting in more than 400 RAPEX notifi cations. More than 2,000 garments did not comply with at least with one of the requirements of the standards. The majority of the non-compliant garments (70%) were for children under 7 years of age. Non-compliant garments can expose young children to very serious risks. The joint action also led to the production of a short check-list and a training video to assist market surveillance inspectors, manufacturers and importers in identifying problems with children′s clothing.

Baby walkers

Market surveillance authorities in twelve Member States tested 36 differ-ent models of baby walker to assess their compliance with the relevant standard EN 1273: 2005. Nineteen (53%) were found to comply with the requirements, which include stability (dynamic, static), step-falling test, the strength and durability, folding mechanisms and parking devices. However, seventeen of the tested models (47%) failed to meet at least one of these important requirements. The joint action also took into consideration products sold online.

Child appealing appliances

During the course of 2010, a joint market surveillance action on household electrical appliances with child appealing designs was carried out by thirteen

Member States, with the objective of creating a common understanding of the characteristics that make appliances child appealing.

On the basis of the research work undertaken, including a literature review and child observation studies, the various characteristics that are appealing to children were identifi ed. It was concluded that one of the most signifi cant characteristics which affects the attraction of an appliance to children is the function of the appliance.

The outputs of the project were an evaluation tool and an inventory of appliances that are considered to be child appealing. The fi nal versions of these will be submit-ted to the Low Voltage Directive Administrative Co-operation Working Group in early 2011 with a view to their endorsement.

9 http://ec.europa.eu/consumers/safety/projects/market_surveillance_enforcement_en.htm#surveillance_enforcement

Page 23: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

44 45

were grouped according to their safety profi les. The study also investigated fi re statistics in the Member States, in particular the number of fi re deaths, and their possible link to the stringency of regulatory requirements on fi re safety.

3.2.3 Outcome of the study on nano-claims

A 2010 study showed that producers often displayed the term “nano” on the label or the website of a product in order to differentiate it from competing products and attract consumers’ attention. In some cases, however, producers deleted this “nano-claim”, considering that it may hinder sales. Furthermore, producers used terms such as “nanomaterials” and “nanotechnology” interchangeably. Finally, on some products, the label “nano” referred to something very small or thin, such as a very thin nano-structured layer applied by a leather care cream after application. Limited analyses of nano-labelled products showed that nano-materials may be present, or not. The main conclusion was that “nano” labels are not used consist-ently and often provide no reliable information to consumers.

3.2.4 Measures to address risks from Dimethyl fumarate

Decision 2009/251/EC adopted on 17 March 2009 required Member States to ensure that any consumer product containing Dimethyl fumarate (DMF), an anti-mould chemical substance that is strongly sensitising and can cause severe skin lesions, is not placed or made available on the market. The validity of the Decision was extended in 2010 for a further year (Commission Decision 2010/153/EU). A perma-nent measure is being prepared under the REACH legislation.

3.2.5 Personal music player standardisation

Following the mandate sent to the Electrical Standardisation Committee (CENELEC) in September 2009, work continued during 2010 on the development of a revised European safety standard to provide protection against excessive sound pressure levels from personal music players.

The approach adopted by CENELEC is based on an average sound level limit of 85 dBA. This is a level that is considered to be safe under all conditions of use. There is the possibility however for the user to choose to override the limit so that the sound level can be increased up to a maximum average of 100 dBA. In this case the user has to be provided with warnings about the risks which are repeated after each 20 hours of listening time.

The fi nal outcome of the work was a draft amendment to two existing standards approved at the end of 2010. It is expected to be published by CENELEC in early 2011.

In 2011, the working group will start on the next step of the mandated work, the development of smart solutions based on the measurement of sound dose.

3.2.6 Lighters

In early 2010, Decision 2006/502/EC prohibiting the sale of non-child resistant and novelty lighters to consumers was prolonged for the fourth time, extending its validity until 11 May 2011.

Throughout the year CEN made good progress with the revision of EN 13869, the standard for lighters, fi nalising the short term elements of the mandated work by changing the defi nition of lighters and replacing the term ‘novelty’ with ‘child appealing’. However, work on replacing the child panel test with technical param-eters has not yet started, prompting another prolongation of the decision in 2011.

3.2.7 Safety of windows

On 7 January 2010 the Commission adopted a decision setting out safety require-ments for child-resistant window locking devices.10 Subsequently, the Com-mission addressed a standardisation mandate to CEN to draw up relevant safety standards and test methods for these locks (Mandate M/465).

The safety of corded window coverings such as blinds or draperies was the topic of several discussions with Member Sates, standardisation experts and consumers’ representatives throughout 2010, further to a number of fatalities involving young children who strangled in the cords. A draft decision setting safety requirements is due to be submitted for formal vote by Member States in the fi rst quarter of 2011. The purpose of this decision is to strengthen the requirements of standard EN 13120: 2009 for internal blinds and draw up new standards for corded window coverings in general, to eliminate the risks of strangulation and internal asphyxia-tion of children.

3.2.8 Reduced ignition propensity cigarettes

Reduced ignition propensity (RIP) cigarettes rapidly self-extinguish when left un-attended. Introducing such cigarettes in the EU would reduce the number of fi res caused by cigarettes and could save an estimated 500 to 700 human lives every year. The work of standardisation organisations for such introduction was fi nalised in the course of 2010, and CEN published standard EN 16156:2010 “Cigarettes – Assessment of the ignition propensity – Safety requirement” on 17 November. The publication of a reference to the new standard in the Offi cial Journal, thus providing the presumption of safety for all cigarettes manufactured in compliance with the standard, is planned for November 2011.

3.2.9 Children′s equipment/childcare articles

On 6 January 2010 the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath tubs and stands for children.11 On that basis, the Commission addressed a standardisation mandate to CEN to draw up standards for these three products (man-date M/464).

On 2 July 2010 the Commission adopted a Decision set-ting safety requirements for fi ve products commonly used in the sleep environment of babies and young chil-dren.12 These products are cot mattresses, cot bumpers, sleeping bags for babies, suspended baby beds, duvets for babies. A standardisation mandate will be formally ad-dressed to CEN in the fi rst quarter of 2011.

On 14 October 2010, Member States voted unanimously to approve a decision on the conformity of standard EN 14682:2007 on cords and drawstrings in children clothes with the safety requirement of Directive 2001/95. The decision gives the green light to the Commission to publish the references of that standard in the Of-fi cial Journal of the EU.

In December 2010 the Commission signed a contract with an external consultant to carry out a study that includes risk assessments and the identifi cation of essential safety requirements for 11 products commonly used for child and baby care, for which there are no European standards or for which the existing relevant standard does not cover the risks adequately. Some of the products concerned are children shoes, bibs, soft slings, baby feeders, nursery pillows. The study is due to be concluded in September 2011.

10 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:004:0091:0093:EN:PDF 11 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:003:0023:0029:EN:PDF12 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:170:0039:0048:EN:PDF

Page 24: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

46 47

90

80

70

60

50

40

30

20

10

0

Bel

gium

Bul

garia

Cze

ch R

epub

lic

Den

mar

k

Ger

man

y

Esto

nia

Irel

and

Gre

ece

Spa

in

Fran

ce

Ital

y

Cyp

rus

Latv

ia

Lith

uani

a

Luxe

mbo

urg

Hun

gary

Mal

ta

Net

herlan

ds

Aus

tria

Pola

nd

Port

ugal

Rom

ania

Slo

veni

a

Slo

vaki

a

Finl

and

Sw

eden

Uni

ted

Kin

gdom

Icel

and

Liec

hten

stei

n

Nor

way

43

29

13

44

18 16

30

52

83

39

16 1712

21

13

33

2624

32

53

1612

21

40

17

32

8

30

41

35

35

30

25

20

15

10

5

0

Elec

tric

al a

pplia

nces

Mot

or v

ehic

les

Oth

er

Toys

Chi

ldca

re a

rtic

les

Hob

by/s

port

s eq

uipm

ent

Furn

itur

e

Clo

thin

g

Com

pute

r ha

rdw

are

Gas

app

lianc

es

Con

stru

ctio

n pr

oduc

ts

31

3

26

15

20

11

455

9

4

3.4 International cooperation towards global governance

3.4.1 Bilateral cooperation

While this section describes in more detail the cooperation with certain countries, the Commission is also engaged in dialogue with many other countries and regional organisa-tions which are not specifi cally mentioned here.

China

In October, the Directorate General for Health and Consum-ers organised a Consumer Day during the Shanghai World Expo. 140 participants heard speeches from Commissioner John Dalli and Director General Paola Testori Coggi, as well as product safety experts from industry and consumer or-ganisations.

In conjunction with this public event, Commissioner Dalli met his counterpart AQSIQ Minister Zhi Shuping for a bi-lateral meeting in which they committed to further close cooperation regarding non-food consumer product safety, building on the already excellent efforts in this area.

In November, the Commission hosted a delegation from AQSIQ Defective Product Administrative Centre for a series of meetings on product safety, the RAPEX sys-tem and European efforts to collect injury and accident data involving consumer products.

RAPEX-China

The RAPEX-CHINA system, established in 2006, provides real time information to the Chinese authorities on all products of Chinese origin notifi ed through RAPEX. To date, the Chinese authorities (General Administration of Quality Supervision, Inspection and Quarantine – AQSIQ) have submitted 15 quarterly reports to DG SANCO on enforcement actions carried out in response to RAPEX notifi cations ex-changed via the system.

3.3 Compliance by businesses

3.3.1 GPSD Business Application

Since May 2009, producers and distributors have been able to notify the national authorities of the Member States and EFTA/EEA countries about dangerous prod-ucts through the on-line GPSD Business Application.

The purpose of the application is to simplify the procedure for producers and dis-tributors to fulfi l their legal obligation to notify the national authorities of any dan-gerous consumer products placed on the EU market. Its advantage is that produc-ers and distributors can alert all countries concerned at the same time through one notifi cation, thus simplifying and speeding up the process. Access to the secure online database where all the notifi cations are stored is restricted to the com-petent national authorities only. Neither competitors nor consumers can view its contents.

Since its launch, the GPSD Business Application has proven successful. In 2010, 133 notifi cations (including updates) sent through the application by producers and distributors were accepted by the competent national authorities. This constitutes an increase of 202% compared to 2009 (44 notifi cations).

In 2010, all the Member States and EFTA/EEA countries received notifi cations via the application. France, Netherlands, Spain, Germany, and Belgium are the most frequently notifi ed Member States.

Figure 43 – Number of notifi cations received by country

Figure 44 – Number of notifi cations by product category

The data provided through the application by producers and distributors was usual-ly complete and of high quality. The notifi cations submitted contained the required detailed information regarding a) the product identifi cation, b) the risks posed by the product, c) the importers and distributors responsible for marketing and dis-tributing the product on the EU market, d) action taken to protect consumers and e) the incidents reported and complaints received.

For additional information on the GPSD Business Application, including a manual explaining how to prepare and submit a notifi cation and a list of frequently asked questions, please visit the Commission′s website: http://ec.europa.eu/consumers/safety/rapex/guidelines_business_en.htm

Page 25: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

48 49

Figure 45 – Actions taken by AQSIQ (total fi gures)

1,386 NOTIFICATIONS

MEASURES ADOPTED – 795 (57 %)

MEASURES NOT ADOPTED – 591 (43 %)

EXPORT STOPPED BY AQSIQ OR BY MANUFACTURER

– 421 (30 %)

STRENGTHENED SUPERVISION – 176 (13 %)

MANUFACTURER COULD NOT BE FOUND

– 308 (22 %)

DIFFERENT RISK ASSESSMENT – 51 (4 %)

OTHER– 232 (17 %)

CORRECTIVE ACTIONS – 171 (12 %)

OTHER – 27 (3 %)

During the period between 2006 and 2010, AQSIQ has investigated and, where necessary, adopted measures in relation to 1,386 RAPEX notifi cations. Analyses of the reports received show that, on average, AQSIQ investigates 92 RAPEX cases over a three-month period.

United States

Cooperation on consumer product safety between the European Commission and the United States Consumer Product Safety Commission (CPSC) remained close in 2010, involving regular information exchange on respective regulatory frameworks, emerging risks and dangerous products.

The toy safety working group established between the Commission and the CPSC met twice, discussing matters common to the US and the EU in the toy safety area. Given that the group also works on childcare articles other than toys, the group has now been renamed, becoming the Working Group on the Safety of Toys and Other Children′s Products.

The Commission and the CPSC also sought to make a structural improvement to the relationship through negotiations, which kicked off in 2010, for an agreement on cooperation and information exchange in product safety. The negotiations aim to:

establish a regular dialogue and co-operation on issues of common interest • and formalise the already ongoing informal dialogue with the US authorities in the product safety area;

ensure, via cooperation and exchange of information, better protection for • consumers both in the European Union and the United States of America.

Japan

Closer contacts with Japan took place mainly in the context of multilateral discus-sions. This created an opportunity to share information about the technical param-eters for test methods of the child-resistance of lighters, where Japan has made important progress.

3.4.2 Trilateral cooperation (EU, USA, China)

The trilateral relationship between the European Union, China and the United States is at the core of international work on product safety. While the EU and the US represent the world’s largest markets for consumer products, China is one of the major producers. Cooperative work between authorities responsible for consumer product safety in all three jurisdictions is therefore vital.

In 2010, the second Trilateral Summit on Product Safety took place on 25 and 26 October in Shanghai, China. At the summit, Commissioner Dalli discussed develop-ments and projects for product safety with his counterparts Mr. Zhi Shuping, Minis-ter of AQSIQ and the Hon. Mrs. Inez Tenenbaum, Chairman of the CPSC.

The three parties agreed, in a joint statement, on points of consensus relating to communication, cooperation and training on product safety. They also under-took to agree, within six months, a number of specifi c actions to implement these points. Also highlighted was the importance of a seamless surveillance approach to safety throughout the supply chain and an improved follow-up on specifi c issues that arise.

The summit was complemented by two side-events. The public session of the sum-mit, which brought together offi cials, private sector representatives, consumer or-ganisations and academics from all three jurisdictions, took place on 25 October in Shanghai and discussed major current product safety issues. In addition, the Euro-pean Commission and the CPSC held a joint training seminar on product design and risk analysis for an audience of Chinese manufacturers, authorities and students in Suzhou on 22 October.

Challenges

Traceability has remained the biggest challenge in the operation of the RAPEX-CHINA system over its three years of running. In 591 cases (43% of the total) AQSIQ was not able to fi nd the responsible Chinese companies and thus could not adopt appropriate restrictive measures. Assessment of AQSIQ’s reports suggests the following reasons for this situation: (a) limited resources do not always allow national authorities to thoroughly investigate the identity of the product, (b) the information about the Chinese companies submitted by Member States is incorrect or inaccurate, (c) the Chinese company denies its role in the production or export of the product and does not keep any orders, contracts, invoices or other documents which could prove its involvement, (d) change of address or bankruptcy of the Chi-nese company, (e) the complexity of relations between the Chinese authorities and economic operators.

Reports also show malpractice and negligence on behalf of certain European im-porters. Based on the feedback received from AQSIQ, it can be concluded that some of the dangerous products subject to AQSIQ′s investigations were manufac-tured by Chinese companies according to improper specifi cations provided by EU importers. Furthermore, in many cases, EU importers have not specifi ed any safety requirements for purchased products, have not requested any tests before shipping products to the EU or have not had products posing risks to consumers approved before shipping them to the EU. These examples show that both the Commission services and the Member States need to continue their efforts in informing compa-nies of their obligations under product safety legislation.

Page 26: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

50 51

4Ongoing and future challenges

4.1 The revision of the General Product Safety Directive

The Commission will fi nish its work on the impact assessment linked to the revision of the General Product Safety Directive in close cooperation with concerned stake-holders. The main objective of the revision is to present a coherent set of rules for both economic operators and market surveillance authorities in the area of product safety. It expects to adopt a proposal for a new legislative instrument, which will be submitted to the European Parliament and the Council, by the end of 2011.

4.2 RAPEX operation: extension of RAPEX to new products and risks under the New Legislative Framework

The main challenge is integrating the new notifi cations – i.e. of measures taken against consumer and non-consumer products which pose non-safety risks, such as environmental or security risks – required by the New Legislative Framework. To achieve this, the RAPEX notifi cation criteria and the risk assessment methodology are being adapted to these new risks and products.

4.3 GRAS – a new IT system for RAPEX

The Commission is fi nalising the development of the fi rst version of a new IT application for the RAPEX system. GRAS-RAPEX, as it will be known, will replace the current REIS application, which has been in use since 2004. It is expected that GRAS-RAPEX will facilitate the participation of a greater number of authorities with RAPEX and speed up the daily work.

Due to the recent developments in the product safety area, and particularly (a) the adoption of the new RAPEX guidelines, (b) the extension of the scope of RAPEX to professional products and to other risks than health and safety of consumers and (c) a further increase in the number of notifi cations, the delivery of GRAS-RAPEX has become urgent. Efforts are being made in order to hand over the application to the national enforcement authorities without further delays.

4.4 Cooperation with customs authorities

With the entry into force of the New Legislative Framework on 1 January 2010, the involvement of customs authorities in the enforcement of product safety legislation was put on a stronger footing. This has necessitated further cooperation between responsible authorities (Market Surveillance and Customs) during the control proc-ess to insure that illegal and unsafe products are not allowed to be placed on the EU market.

To facilitate this process, the Commission brought together Member State experts from customs as well as market surveillance authorities to develop practical guide-lines for the implementation of the legislative requirements. This work will fi nish in early 2011, after which the implementation at national level will be launched, taking into account the recommendations described in the guidelines.

3.4.3 Multilateral cooperation

International Product Safety Week

The Commission hosted the third, biannual International Consumer Product Safety Week in Brussels on 1–3 December, 2010. The event gathered regulators, business representatives, consumer organisations, standardisation bodies and academics interested in product safety for a series of intense discussions. The 2010 edition included a session on the forthcoming revision of the General Product Safety Direc-tive, a seminar on risk assessment held under the auspices of the EMARS II project as well as an international day that involved meetings of the ICPSC and the OECD (see below).

ICPSC

The International Consumer Product Safety Caucus (ICPSC) is an informal network bringing together regulatory and enforcement agencies around the world, with the aim of facilitating the exchange of information on consumer product safety issues and strengthening international cooperation in this area.

In 2010, the ICPSC followed up its efforts regarding product traceability with a seminar held during the spring meeting of the International Consumer Product Health and Safety Organisation (ICPHSO). Moreover, on the initiative of the Com-mission and US Consumer Product Safety Commission (CPSC) it decided to launch a pilot project to identify a minimum set of traceability information for a specifi c consumer product and test the practical implementation of this data set across the supply chain.

The ICPSC met in Brussels on 2 December 2010 focussing on taking forward previous recommendations on product traceability and international standards harmonisation. At this meeting, it was also agreed that DG SANCO would assume the chairmanship and secretariat of the network for the next term.

OECD Roundtable

2010 saw the creation of a working party on consumer product safety at the OECD. The working party, which held its fi rst formal meeting in Brussels on 2 December 2010, includes authorities from a broad range of OECD and non-OECD member countries. An action plan has been developed to guide initial work, with an initial focus on the exchange of information between product safety authorities. A DG SANCO representative was selected as one of the working party’s vice-chairs and thus a bureau member.

3.4.4 ENP and candidate countries

The Commission provides technical assistance in the product safety area to can-didate countries, potential EU accession countries and interested European Neigh-bourhood Policy (ENP) countries.

In 2009, the Commission launched the MED-RAS project aimed at facilitating the establishment in the Mediterranean region of a rapid alert system for dangerous non-food products. Six Southern Mediterranean partners – Egypt, Israel, Jordan, Lebanon, Morocco and Tunisia participate in the work of an expert group that steers the project and have committed to exchange information through the system. Once established, the system will be open to all Southern Mediterranean countries as well as all other countries covered by the European Neighbourhood Policy.

The MED-RAS system will be totally separate from the RAPEX system. However, it will be organised and function according to rules similar to those which govern RAPEX. The expert group is currently fi nalising its work on these guidelines. Pro-vided the software application is established in 2011, the system could begin to operate from as soon as 2012.

Page 27: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

52 53

5More details about the RAPEX system

4.5 International cooperation

The internationalisation of the supply chain for consumer products sold in the EU means that the international dimension of product safety is continually increasing in importance. International cooperation between product safety authorities, there-fore, needs to intensify. The Commission is consistently increasing its involvement in international activities through participation in initiatives such as the ICPSC, the OECD working party on consumer product safety, the EU-China-US trilateral proc-ess and the proliferation of bilateral cooperation arrangements.

Future work will focus on a number of common themes:

Information exchange and follow-up actions•

Improving mechanisms to disseminate relevant, accurate and timely information among product safety authorities will be vital to ensuring that the fi nite resources available to ensure consumer safety are used in the most effective manner. Greater information exchange will permit authorities to reach consumers and economic operators they would not otherwise be able to reach.

Shared information includes data on product recalls, new scientifi c information on emerging risks as well as best practice in regulatory or enforcement initiatives. The ultimate goal, which remains unfeasible in the short term, would be a form of seam-less surveillance of the supply chain, from factory to consumer.

This work is at the heart of the EU′s activities in the OECD and bilaterally with the US and China and will continue to play a role in the future.

Traceability •

Product traceability remains a key issue in efforts to improve consumer safety, both in terms of letting consumers who have purchased a dangerous product know of the risks and remedies associated with it and in terms of identifying the econom-ic operators responsible for the manufacture, importation or distribution of such products. The EU′s international cooperative work on traceability, notably in the ICPSC, is looking at how current and future tracking technologies can be deployed to enhance safety.

Harmonisation of safety requirements•

Legislation and standards affecting product safety differ widely across the world and this is one factor that complicates international cooperation. Different

levels of protection can mean that products may be deemed unsafe in one jurisdiction while they continue to be sold on other markets,

meaning consumers are not equally protected and permitting regulatory arbitrage by economic operators. On another

level, when the same product is designed and manufac-tured in one location but sold in many other jurisdictions the complexity of the of the combined and differing safety requirements applicable may act as a disincentive to en-suring compliance and safety.

The EU is working with the United States, Australia and Canada on a pilot project on harmonisation of safety requirements which will seek to develop com-mon content of standards pertaining to three du-rable children′s products. The ultimate aim of the

project is a single global standard in each case.

5.1 Objective

The main objective of RAPEX is to ensure that information about dangerous non-food consumer and professional products found in one Member State is rapidly circulated among all the other national authorities and sent to the European Com-mission for follow-up, with the aim of preventing the supply of these products to consumers and professional users.

This European level coordination adds value to the surveillance and enforcement actions taken at national level and increases the overall safety of consumer goods placed on the European market. Thirty countries currently participate in the sys-tem, including all EU Member States and the EFTA/EEA countries: Iceland, Liech-tenstein and Norway.

5.2 The legal basis of RAPEX

As of January 2010, two acts, i.e. Directive 2001/95/EC on general product safety13 (GPSD) and Regulation No 765/2008 setting out the requirements for accredita-tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 14 (Regulation 765/2008), provide the legal framework for RAPEX. In addition, in 2010 the Commission introduced new RAPEX Guidelines (Decision 2010/15/EU) 15, which aim to facilitate the effective and consistent applica-tion of the provisions related to the notifi cation procedure.16

The RAPEX system is used to exchange information on dangerous, non-food, con-sumer and professional products, including those covered by “sectoral” Directives (e.g. toys, cosmetics, electrical appliances, personal protective equipment, ma-chinery, motor vehicles), which pose a serious risk to various public interests such as the health and safety of consumers, health and safety in the work place, the environment, energy effi ciency and public security.

While the RAPEX system allows for a rapid exchange of information on dangerous products in order to protect the public interest, some of these “sectoral” Directives also foresee a procedure known as the “Safeguard Clause” procedure. This allows the Commission to check if national measures that restrict the free movement of products are justifi ed and thus ensure an equal level of public interest protection across the EU.

The GPSD is available at:http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32001L0095:EN:NOT

Regulation 765/2008 is available at:http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0030:0047:en:PDF

The RAPEX Guidelines are available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32004D0418R(01):EN:HTML

13 OJ L 11, 15.1.2002, p. 414 OJ L 218, 13.8.2008, p. 3015 OJ L 151, 30.04.2004, p. 8316 For more information on the new RAPEX Guidelines please see Chapter 3.1.1

Page 28: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

54 55

What is a serious risk?

Products notifi ed through the RAPEX system have to pose a serious risk to the public interest. A serious risk is defi ned as one which requires rapid intervention by the public authorities, and it includes risks with effects that are not immediate. The national authorities are obliged to assess the risks posed by a product they intend to notify using the most suitable method (including the risk assessment method provided in the RAPEX Guidelines), since only those products which pose a serious risk are required to be notifi ed through RAPEX.

What is the cross-border effect?

National authorities of Member States exchange information about dangerous prod-ucts through RAPEX only if there is evidence or reasonable suspicion that these products can be found on the markets of at least two countries participating in the system.

5.3.2 Other types of information exchanged

Under the GPSD and Regulation 765/2008, Member States also exchange other types of information about dangerous products with the Commission. For example, measures ordered by the national authorities in relation to products that present only a moderate risk for consumers. These notifi cations come under Article 11 of the GPSD and Article 23 of the Regulation 765/2008.

Furthermore, Member States exchange information on products posing risks which, nevertheless, cannot be correctly identifi ed by national authorities due to insuffi -cient product identifi cation (i.e. the brand, model number, pictures of the product and/or its packaging are not available). These notifi cations are distributed for infor-mation purposes only.

Sectoral legislation relevant to consumer protection includes:

Toy Safety Directive 2009/48/EC which replaces Directive 88/378/EEC,•

Low Voltage Directive 2006/95/EC,•

Machinery Directive 98/37/EC,•

Cosmetics Directive 76/768/EEC (Cosmetic regulation 1223/2009 adopted in 2009),•

Motor Vehicles Directive 70/156/EEC,•

Personal Protective Equipment Directive 89/686/EEC.•

5.3 When is RAPEX used?

5.3.1 RAPEX Notifications

According to the GPSD and Regulation 765/2008, the national authorities of Mem-ber States notify the European Commission, via the RAPEX system, of those meas-ures taken to prevent or restrict the marketing or use of products posing a serious risk to the public interest and which may be available in more than two European countries. This obligation is laid down in Article 12 of the GPSD and Article 22 of Regulation 765/2008 (see box under point 5.3.2).

What products are concerned by measures notifi ed?

Since the adoption of the GPSD in 2004, RAPEX has applied only to non-food con-sumer products. However, following the entry into force of Regulation 765/2008 (on 1 January 2010) the scope of the RAPEX system was extended and thus it also applies to non-food professional products.

RAPEX covers products that are made available to users, including prod-ucts provided to consumers in the context of a service, such as, for

example, hairdryers in hotels and sunbeds if operated by the consumer.

The most frequently notifi ed products are: toys, clothing, motor vehicles, electrical applianc-

es, cosmetics, children′s equipment, lighting equipment and hobby/sports equipment.

The RAPEX system does not cover all prod-ucts. Certain products such as food, feed,

medical devices and pharmaceuticals are ex-cluded from the scope of RAPEX because infor-

mation about such products is exchanged through specifi c alert systems established at European level. For

example, the Rapid Alert System for Food and Feed (RASFF) is used to exchange information about dangerous food and feed.

What measures can be taken?

Member States notify through RAPEX dangerous consumer products that were sub-ject both to measures ordered by national authorities and/or actions taken volun-tarily by producers and distributors to meet their obligations under the law. The most common measures are sales bans, withdrawal of dangerous products from the market and recalls of dangerous products from consumers.

Sectoral Directives are available on the EUR-Lex website: http://eur-lex.europa.eu/Two guidance documents clarify the relationship between the GPSD and the sectoral Directives. These are available at: http://ec.europa.eu/consumers/safety/rapex/key_docs_en.htm

5.4 How does RAPEX work?

The RAPEX system relies on close cooperation between the European Commission and the national authorities of the Member States.

5.4.1 Role and obligations of national authorities

Each Member State has designated competent market surveillance authorities and granted them the necessary powers to take measures in order to prevent or restrict the marketing or use of dangerous products. More specifi cally, the national authori-ties are competent to take samples of products placed on the market, to test them in laboratories and – in cases where these products pose risks to the public inter-est – order producers and distributors to stop their sale, withdraw them from the market and/or recall them.

In addition, each country participating in the system has also established a single RAPEX Contact Point, which coordinates the operation of the RAPEX system at national level.

Information exchanged through RAPEX

RAPEX notifi cationsNotifi cation under Article 12 of the GPSD/Article 22 of the Regulation 765/2008: • notifi cations of measures ordered by the national authorities, or actions taken voluntarily by producers or distributors in relation to products presenting a serious risk.

Other informationNotifi cations under Article 11 of the GPSD/Article 23 of the Regulation 765/2008: • notifi cations of measures ordered by the national authorities in relation to products presenting a moderate risk.

Notifi cations for information: • notifi cations of measures ordered by the national authorities, or actions taken voluntarily by producers or distributors in relation to dangerous products, disseminated for information purposes only due to insuffi cient product identifi cation.

Page 29: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

56 57

When the national authorities or a producer/distributor take measures which pre-vent or restrict the marketing or use of a product posing serious risks to the public interest, the RAPEX Contact Point submits the following information and details about the product to the Commission by means of a standard notifi cation form:

product identifi cation – name, brand, model, description, picture;•

risks posed by the product – type of risk, results of laboratory tests and risk • assessment;

measures adopted to prevent risks – type of measure, scope, duration, date of • entry into force;

distribution channels of the notifi ed product – manufacturer, exporter, importer, • distributors and countries of destination.

The Commission examines the information provided with regard to its compliance with the GPSD, Regulation 765/2008 and the RAPEX Guidelines, and checks its completeness. The result of this process is called “validation”. A notifi cation is not validated if another country has already notifi ed measures against the same prod-uct and same risk – i.e. if the RAPEX network has already been alerted.

If the examination conducted by the Commission leads to validation, information is circulated to the RAPEX Contact Points in all countries participating in the system. RAPEX Contact Points then forward this information to their competent national authorities, who then check whether the notifi ed product is present on the market and if necessary take appropriate action. The results of these market surveillance activities, including additional information relevant for other national authorities, are then reported back to the Commission through the RAPEX system. These feed-back messages are called “reactions”.

5.4.2 Role and obligations for producers and distributors

The RAPEX system is also used to exchange information about the preventive or restrictive actions taken voluntarily by producers and distributors in relation to dangerous products which they may have placed on the market. Voluntary action in this context means measures taken without the intervention of the public authority.

Producers and distributors are in a prime position to assess wheth-er products they place on the market are dangerous because, as professionals, they should have information about the product and have contact with consumers. Therefore, once they become aware that a product is dangerous, they must immediately inform the competent authorities in their country, clearly identifying the prod-uct in question, the risks it poses and the information necessary to trace it. They must also inform the authorities of any measures taken to prevent further risks to consumers. First contact with the national authorities should be established as soon as possible and if needed even before all the required information is available.

Producer/distributor

Competent Authority

RAPEX Contact Point in Member State ‘A’

EUROPEAN COMMISSION

Competent Authority

RAPEX Contact Point in Member State ‘B’

RAPEX Contact Point in Member State ‘C’

Producer/distributor

Informs the Commission – through RAPEX – about the preventive or restrictive measures taken by national authorities or ‘voluntar-ily’ by a producer/distributor in relation to a dangerous product

Competent AuthorityCompetent Authority

Analyses, validates and distributes informa-tion received through RAPEX to RAPEX Con-tact Points in all participating countries

Forwards information from the Commission to the competent authorities and from the national authorities to the Commission

Checks if notifi ed products are found on the national market; collects information about notifi ed products; and provides the results of the market surveillance activities to the RAPEX Contact Point

A notifi cation consists of information provided by Member States concerning measures or actions taken for products presenting a serious or a moderate risk to the public interests.

A reaction is information provided by Member States in response to a “validated” notifi cation. A reaction normally contains information about the presence of the notifi ed product in other Member States and the measures taken therein.

Figure 46 – RAPEX network

This information is then conveyed to the Commission by the RAPEX Contact Point via the RAPEX system, and subsequently to the other countries participating in the RAPEX system.

The obligation of economic operators to inform the authorities about dangerous products is a key element in the market monitoring procedure. National authorities are able to monitor whether the companies have taken appropriate measures to address the risks posed by dangerous products and to assess whether additional measures are necessary.

57

Page 30: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

58 59

6AQSIQ General Administration for Quality Supervision, In-

spection and Quarantine of the People's Republic of China

Article 11/Article 23 notifi cation Notifi cation of measures or actions taken for products presenting a moderate risk according either to Article 11 of the GPSD or Article 23 of Regulation 765

Article 12/Article 22 notifi cation Notifi cation of measures or actions taken for products presenting a serious risk according either to Article 12 of the GPSD or Article 22 of Regulation 765

Compulsory measures Measures ordered by national authorities (e.g. ban of sales, informing consumers, withdrawal from the market, recall from consumers) or by the customs authorities (e.g. rejection of import)

CPSC United States Consumer Product Safety Commission

EEA countries (as used in this report) countries that are members of the European Economic Area (EEA) but are not mem-bers of the European Union, namely Norway, Iceland and Liechtenstein

EU-27 All EU countries

Notifi cation for information Notifi cation of measures or actions taken which the Commission disseminated to the National Contact Points for information only because they do not fall under the scope of Article 12 (or Article 22) or Article 11 (or Article 23) of the GPSD (or of Regulation 765)

GRAS Generic Rapid Alert System, a general IT platform for all rapid alert systems of the Directorate-General for Health and Consumers

National Contact Point Representative of the network of all national market surveillance authorities considered by the European Commission as the single contact point for that country

Reaction Information provided by Member States in response to a “validated” notifi cation. A reaction normally con-tains information about the presence of the notifi ed product in other Member States and the measures taken therein

Voluntary measures Corrective measures voluntarily taken by the pro-ducer or distributor (e.g. stop of sales, informing consumers, withdrawal from the market, recall from consumers) on the business' own initiative, without the intervention of a public authority

Glossary

To simplify the practical application of the notifi cation obligation of producers and distributors, the Commission has developed an online application called the GPSD Business Application, which enables economic operators to submit notifi cations Europe-wide to national authorities via the Internet. For more information on the application, see Chapter 3.2.2.

The fi gure below illustrates cooperation between the European Commission, the national RAPEX Contact Points and national market surveillance authorities.

5.5 The RAPEX website

The Commission publishes weekly overviews of RAPEX notifi cations on products posing serious risks to consumers, as well as product safety news and infor-mation about major events held in the consumer arena, on the RAPEX website: http://ec.europa.eu/rapex

RAPEX weekly overviews provide information on the product, the nature of the risk posed and the measures taken to prevent these risks. This information enables consumers to check whether the products they use or plan to purchase have been subject to RAPEX notifi cations.

In 2009, the Commission also started publishing in the RAPEX weekly overviews information regarding the Member States’ reactions to the initial product notifi -cations.

Page 31: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

60 61

7National RAPEX Contact Points

A list of the contact details of the national RAPEX Contact Points is available at: http://ec.europa.eu/consumers/safety/rapex/index_en.htm

Product safety information for consumers per country

AustriaMinistry of Social Affairs and Consumer Protection www.produktsicherheit.gv.atAustrian Consumers Information Association (Verein für Konsumenteninformation) www.konsument.atAustrian Road Safety (Kuratorium für Verkehrssicherheit) www.kfv.atGroße schützen Kleine (regional initiative for child safety) www.grosse-schuetzen-kleine.at

Belgiumwww.economie.fgov.be

BulgariaMinistry of Economy, Energy and Tourism – in charge of consumer protection www.mi.government.bgCommission for Consumer Protection www.kzp.bg

CyprusMinistry of Commerce, Industry and Tourism – Competition and Consumers Protection Service www.mcit.gov.cy

Czech RepublicMinistry of Industry and Trade www.mpo.czCzech Trade Inspection www.coi.czState Health Institute www.szu.czConsumers Defence Association – SOS www.consumers.cz

DenmarkInformationscenter for miljø og sundhed www.miljoeogsundhed.dk/default.aspx?node=281The Danish Consumer Council www.forbrugerraadet.dk/english/

EstoniaConsumer Protection Board www.tarbijakaitseamet.ee

FinlandFinnish Safety and Chemicals Agency (Tukes) www.tukes.fi

FranceDirection Générale de la Concurrence, de la Consommation et de la Répression des Fraudes (DGCCRF) http://www.dgccrf.bercy.gouv.fr/

GermanyFederal Institute for Occupational Safety and Health (RAPEX contact point) www.baua.deFederal Offi ce of Consumer Protection and Food Safety (single contact point for cosmetics and daily commodities) www.bvl.bund.de

Greecewww.efpolis.gr

HungaryHungarian Authority for Consumer Protection www.nfh.huCentral database on unsafe and prohibited products www.piacfelugyelet.hu

National contact details

Page 32: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

62 63

8IcelandNeytendastofa/Consumer Agency www.neytendastofa.is

IrelandNational Consumer Agency www.nca.ie – e-mail: [email protected] and Safety Authority www.hsa.ieIrish Water Safety www.iws.ie

ItalyMinistero dello Sviluppo Economico, Direzione Generale Armonizzazione Mercate e Tutela dei Consumatori, Uffi cio D4 Sicurezza prodotti www.sviluppoeconomico.gov.it

Latviawww.ptac.gov.lv

LiechtensteinAmt für Handel und Transport (Offi ce of Trade and Transport) www.aht.llv.li

LithuaniaState Consumer Rights Protection Authority of Lithuania www.vartotojoteises.ltState Non Food Products Inspectorate www.inspekcija.lt

LuxembourgILNAS (Institut luxembourgeois de la normalisation, de l’accréditation, de la sécurité et qualité des produits et services) www.ilnas.lu

Maltawww.msa.org.mt/marketsurveillance/index.html

NetherlandsDe nieuwe Voedsel en Waren Autoriteit (Dutch Food and Consumer Product Safety Authority) www.vwa.nl – e-mail: [email protected]

NorwayDirectorate for Civil Protection and Emergency Planning www.dsb.no

Polandwww.uokik.gov.pl

PortugalDirecção-Geral do Consumidor (Directorate General for Consumers) www.consumidor.pt

RomaniaNational Authority for Consumer Protection www.anpc.gov.ro

SlovakiaMinistry of Economy of the Slovak Republic www.mhsr.skSlovak Trade Inspection www.soi.skPublic Health Institute of the Slovak Republic www.uvzsr.sk

SloveniaMarket Inspectorate of the Republic of Slovenia www.ti.gov.si/en/Health Inspectorate of the Republic of Slovenia www.mz.gov.si/en/National Chemicals Bureau of the Republic of Slovenia www.uk.gov.si

SpainInstituto Nacional del Consumo www.consumo-inc.es/Seguridad/home.htm

SwedenSwedish Consumer Agency www.konsumentverket.se

United KingdomDepartment for Business, Innovation and Skills www.bis.gov.uk

European Commission

RAPEX: http://ec.europa.eu/rapex

Business application: http://ec.europa.eu/consumers/safety/rapex/guidelines_business_en.htm

EU Commission, Directorate-General for Health and Consumers:http://ec.europa.eu/dgs/health_consumer/index_en.htm

EU Commission, Directorate for Consumer Affairs: http://ec.europa.eu/consumers/index_en.htm

EU Commissioner for Consumer Affairs, Mr John Dalli: http://ec.europa.eu/commission_2010-2014/dalli/index_en.htm

EU Commission, Directorate-General for Enterprise and Industry – Single market for goods: Regulatory policy: common rules for productshttp://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/index_en.htm

EU Commission, Directorate-General for Taxation and Customs Union: http://ec.europa.eu/taxation_customs/index_en.htm

Specifi c products

Lighters: http://ec.europa.eu/consumers/safety/prod_legis/prod_legislation_lighters_en.htm

Toys: http://ec.europa.eu/enterprise/toys/index_en.htm

Dimethylfumarate (DMF): http://ec.europa.eu/consumers/safety/projects/index_en.htm#dmf

Personal music players: http://ec.europa.eu/consumers/safety/projects/index_en.htm#mp3

Consumer product safety regulation/enforcement agencies

CPSC (US Consumer Product Safety Commission): http://www.cpsc.gov/

AQSIQ (China Administration for Quality Supervision, Inspection and Quarantine): http://english.aqsiq.gov.cn/

Health Canada: http://www.hc-sc.gc.ca/

NITE (Japan, National Institute of Technology and Evaluation): http://www.nite.go.jp/index-e.html

Important websites

Page 33: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

64 65

9KATS (Korean Agency for Technology & Standards): http://www.kats.go.kr/english/home/home.asp?OlapCode=ATSU15

FCAB (Switzerland, Federal Consumer Affairs Bureau): http://www.konsum.admin.ch/

Product Recalls Australia: http://www.recalls.gov.au/content/index.phtml/itemId/952401

International consumer safety organisations

ICPHSO (International Consumer Product Health and Safety Organization): http://www.icphso.org/

ICPSC (International Consumer Product Safety Caucus): http://www.icpsc.org/

Market surveillance

PROSAFE: http://www.prosafe.org/

EMARS: http://www.emars.eu/

ICSMS: https://www.icsms.org/icsms/App/index.jsp

Standardisation

ANEC: http://www.anec.org/anec.asp

CEN: http://www.cen.eu/cenorm/homepage.htm

Cenelec: http://www.cenelec.eu/Cenelec/Homepage.htm

ETSI: http://www.etsi.org/WebSite/homepage.aspx

The Commission’s RAPEX Team can be contacted at:

European CommissionDirectorate-General for Health and Consumers RAPEX Team B232 06/114Rue Breydel 4B – 1049 Brussels

E-Mail: [email protected].: (+32-2) 295 23 43Fax: (+32-2) 299 86 37Mobile phone: (+32-498) 98 04 77 (for use only in case of an emergency during weekends and holidays)

The Commission’s RAPEX Team

Page 34: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

How to obtain EU publications

Free publications:• via EU Bookshop (http://bookshop.europa.eu);• at the European Commission’s representations or delegations.

You can obtain their contact details by linking http://ec.europa.euor by sending a fax to +352 2929-42758.

Publications for sale:• via EU Bookshop (http://bookshop.europa.eu);• Priced subscriptions (Official Journal of the EU, Legal cases of the Court of Justice as

well as certain periodicals edited by the European Commission) can be ordered from one of our sales agents.You can obtain their contact details by linking http://bookshop.europa.eu, or by sending a fax to +352 2929-42758.

European Commission, 2011

Keeping European Consumers Safe 2010 Annual Report on the operation of the rapid alert system for non-food dangerous products

Luxembourg: Publications Offi ce of the European Union

2010 – 68 pp. – 21.0 x 29.7 cmISBN 978-92-79-17047-8ISSN 1830-8821DOI 10.2772/16874

Page 35: 110310 DGSanco Rapex Br EN dm - European Commission€¦ · On 6 January 2010, the Commission adopted a Decision setting safety requirements for bath rings, bathing aids and bath

ND

-AE-11-001-EN

-C

Keeping European Consumers Safe2 0 1 0 A n n u a l R e p o r t

o n t h e o p e r a t i o n o f t h e r a p i d a l e r t s y s t e mf o r n o n - f o o d d a n g e r o u s p r o d u c t s

RAPEX