Brussels, 15 April 2010
1. COMMUNITY RAPID INFORMATION SYSTEM FOR DANGEROUS PRODUCTS (RAPEX)
What is RAPEX?
RAPEX is a Community rapid alert system for dangerous products. It ensures that information about dangerous products withdrawn from the EU market and/or recalled from consumers is quickly circulated between Member States and the European Commission, with the aim of preventing or restricting the selling of these products on the market. 30 countries currently participate in the system. The participating countries are all the European Union countries and the EFTA/EEA countries: Iceland, Liechtenstein and Norway.
What is the legal basis for RAPEX?
The General Product Safety Directive (2001/95/EC, GPSD)1 and, as of 1 January 2010, the Regulation setting out requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (Regulation 765/2008)2 provide the legal framework for RAPEX.
The RAPEX Guidelines (2010/15/EU) 3 complement the GPSD by defining the key aspects of the operation of the RAPEX system. The Guidelines were drawn up by the Commission in close cooperation with the countries participating in the system.
When is RAPEX used?
According to the GPSD and the Regulation 765/2008, national authorities notify the Commission, via the RAPEX system, of measures taken to prevent or restrict the marketing or use of non-food products posing a serious risk to various public interests, mainly the health and safety of consumers, environment, and public security. This obligation is laid down in Article 12 of the GPSD and Article 22 of the Regulation 765/2008.
What type of measures can be taken?
Both preventive and restrictive measures ordered by national authorities and measures taken voluntarily by producers and distributors (44% of the total in 2009) are covered by RAPEX. The most common measures are a ban/stop on sales, withdrawal of a dangerous product from the market, providing information to consumers about the risks related to the use of the product, or recall of a dangerous product from consumers.
What is covered by RAPEX?
On 1 January 2010, the scope of RAPEX was extended to cover also 'non-consumer' products and risks to other public interests than 'health and safety of consumers'.
RAPEX applies now to both 'consumer' and 'non-consumer' products .The RAPEX system covers the majority of products, but certain categories of products are excluded from its scope. For example, for food and feed, a specific alert system (RASFF), similar to RAPEX, is in place. Specific systems are in place also for medical devices and pharmaceuticals.
RAPEX applies to products posing risks to various public interests, such as 'health and safety of consumers', 'environment', 'health and safety at the workplace' and 'public security'.
Where can I find updated RAPEX information on-line?
The Commission publishes weekly overviews of RAPEX notifications on products posing a serious risk to consumers on its RAPEX internet page. These overviews provide information on the notified product, the nature of the risk it poses and the measures that were taken to prevent these risks. For more information, please visit: www.ec.europa.eu/rapex .
What are the role and obligations of national authorities?
National authorities ensure that businesses respect their obligation to place only safe products on the market. To this end, they must designate market surveillance authorities with necessary powers to take measures to prevent or restrict the marketing or use of dangerous products. Competent national authorities must take appropriate measures if they find dangerous consumer products on the market, where a producer or a distributor has not taken corrective action voluntarily.
Furthermore, each country participating in the RAPEX system nominates a single national RAPEX Contact Point which submits to the Commission information about dangerous products found on its own market.
The information received and validated by the Commission is rapidly circulated to the national Contact Points in all countries participating in the system. These then ensure that their respective national authorities check whether the product in question is present on their market and take appropriate actions. 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.
What are the role and obligations of producers and distributors?
Producers and distributors have to ensure that only safe products are put on the market. Therefore, once they become aware that a product is dangerous, they must immediately take measures to prevent further risks to consumers. Furthermore, they must inform national competent authorities, clearly identifying the product in question, the risks it poses and the information necessary to trace it. This information is then conveyed via the RAPEX system to the Commission and other countries participating in the RAPEX system if the product poses a serious risk.
How can I find specific information on the notifications submitted by a particular Member State?
There is a search database on the RAPEX home-page, where a keyword can be entered and all related notifications will be listed. For example, if "Germany" is put in as the keyword, all notifications submitted by the German authorities since 2005 will be shown. Equally, a particular product (e.g. vehicle) or third country name can be put into the search tool to find information on the related number of notifications. See: www.ec.europa.eu/rapex .
How is information about the risks related to the use of a product provided to consumers?
Consumers can learn about the risks posed by a product, either from the company which sold the product, the national enforcement authority, the Commission, and/or from the media.
In most cases, information is provided to the consumer in one of the following ways: warnings posted on the company's, enforcement authority's or Commission's websites; recall notices published in newspapers and magazines and/or posters displayed in shops. For recalls of products, where purchase requires registration of consumer's contact details (ex. motor vehicles) consumers are notified about the safety problems by individual letters sent by companies.
What are the most significant developments with regard to RAPEX which took place in 2009 and 2010?
First of all, the scope of RAPEX was extended to cover new products and new risks. As of 1 January 2010 (when the Regulation 765/2008 came into force) RAPEX applies to both 'consumer' and 'professional' products, and to new risks to public interests other than 'health and safety of consumers', such as 'environment', 'health and safety at the workplace' and 'public security'.
Secondly, on 16 December 2009 the Commission adopted the new RAPEX Guidelines (Decision 2010/15/EU) which will significantly improve the operation of the system. The new RAPEX Guidelines also provide a new, upgraded risk assessment method for consumer products which will greatly facilitate the work of the market surveillance authorities in terms of accuracy, efficiency and speed.
Furthermore, as of May 2009, the Commission publishes on the RAPEX website (www.ec.europa.eu/rapex) information about Member States which have found a dangerous product on their market which has already been notified and have taken appropriate measures (i.e. submitted a reaction to a RAPEX notification). This information is available in the RAPEX weekly overviews in the column 'Products were found and measures were taken also in'. This new function on the RAPEX website gives a better view on the overall level of enforcement, including the follow-up given by national market surveillance authorities to RAPEX notifications. .
Finally, in May 2009, the Commission launched the 'Business Application' which allows companies to notify online to competent authorities of Member States their recall campaigns carried out with regard to dangerous products they placed on the EU market. The new online system will make it possible for businesses to alert all Member States concerned at the same time in one step, simplifying and speeding up the process. This in turn is in the critical interest of any consumers who might be at risk from such products.
2. RAPEX DATA 2009
How many dangerous products were notified in 2009 through the RAPEX system?
In 2009, a total of 1993 notifications were submitted thought the RAPEX system by Member States and EFTA/EEA countries. This constitutes 7% more notifications than in 2008 (1866 notifications). Of these, 1699 notifications concerned products which posed a serious risk to consumers.
Which EU countries notified most cases?
The following five Member States accounted for 47% of all RAPEX notifications on products posing a serious risk to the health and safety of consumers last year:
Spain (220 notifications, 13%),
Germany (187 notifications, 11%),
Greece (154 notifications, 9%),
Bulgaria (122 notifications, 7%),
Hungary (119 notifications, 7%),
In 2009, 15 countries increased their activity in the RAPEX system.
Which products were most often notified?
The most frequently notified products in 2009 were:
toys (472 notifications, 28%),
clothing, textile and fashion items (395 notifications, 23%),
motor vehicles (146 notifications, 9%),
electrical appliances (138 notifications, 8%),
cosmetics (86 notifications, 5%).
These categories of products accounted for almost 73% of all products posing serious risk notified in 2009.
What are the main risks detected through the RAPEX system?
The most often notified risks categories, which accounted for 82% of all alerts on products posing a serious risk, were:
chemical (493 notifications, 26%),
injuries (405 notifications, 21%),
choking (261 notifications, 14%),
electric shock (214 notifications, 11%),
strangulation (182 notifications, 10%).
Chemical: for example, a product containing dimethylfumarate (DMF), a mould-proof agent used in consumer products made from leather (mainly shoes, textiles and furniture) which is strongly sensitising on contact with the skin.
Injuries: for example toys and childcare articles, such as toy guns with darts, cots, high chairs, swings and children's playpens. The most common problems were sharp edges, insufficient stability or presence of openings where children could trap their legs, hands or head.
Choking: the overwhelming majority of s the notified cases with a choking risk concerned toys for small children (below 36 months) which contained small elements which children could put into their mouth, swallow and choke.
Electric shock: for example, technical defects in electrical appliances which lead to a risk of electric shock were: accessible live parts, insufficient insulation of wires, improper attachment of wires, or inappropriate size of a plug.
Strangulation: for example, cords in the neck/hood area of clothes for children under 7 years, which can get caught in playground equipment causing strangulation.
(One of the factors which led to the high number of notifications in 2009 on products posing a risk of strangulation was the launch of a joint market surveillance action on cords and drawstrings in children’s clothing (results published 15/3/2010). In the framework of that project, national enforcement authorities from nine Member States withdrew from the market hundreds of non-compliant cloths which due to cords in the hood and waist area posed a serous risk of injury, especially to children below 7 years.
What measures did the national authorities take in response to the dangerous goods that they found?
When reporting through the RAPEX system, Member States must give details of the restrictive measures which they ordered in response to the identified risk ('compulsory measures'), as well as any preventive actions taken by economic operators on their own initiative ('voluntary measures'). Of the 1699 notifications for products posing a serious risk, 901 concerned compulsory measures ordered by the national authorities (53%), 752 were where economic operators took 'voluntary measures' (44%), while in 46 cases, compulsory measures were complemented by corrective actions by economic operators (3%).
The most frequently taken measures with regard to dangerous consumer products in 2009 were: sales ban, withdrawal from the market, recall from consumers and corrective actions. Where did the largest amount of dangerous products come from in 2009?
Most dangerous products notified through RAPEX come from outside the EU – (China, Turkey, Taiwan).
China (including Hong Kong) was indicated as a country of origin for more than half (60% / 1013 notifications) of notified products. Other third countries involved in notifications were, e.g.: Turkey (48 notifications, 3%), Taiwan (36 notifications, 2%) and the USA (33 notifications, 2%).
Products of European origin accounted for 337 notifications (20%), including 70 products of German origin (4%), 68 products of Italian origin (4%), 30 products of French origin (2%) and 24 products of Polish origin (1%). All other products came from the other Member States combined. National enforcement authorities therefore focus their activities not only on products coming from third countries but also closely monitor the safety of consumer goods manufactured in the EU. The figures show that attention needs to be given to the education of the European manufacturers and distributors on the safety requirements applying to consumer products.
In 2009, the number of cases with an unidentified country of origin has decreased to 7% (124 notifications) from 10% in 2008 and 23% in 2004. This figure should be seen as a significant improvement in the operation of the RAPEX system. It is also an indicator that the market surveillance authorities in Europe are increasingly attentive, not only to getting dangerous products off the shop shelves, but also to tracing dangerous products back to their source. Checking the traceability data is helpful to authorities in other countries and ultimately in finding the country of origin and final source of the product.
Why have notifications for dangerous goods increased every year?
The increase in the number of notifications transmitted through the RAPEX system does not mean that there are more dangerous goods on the European market. On the contrary, these results can be ascribed to increasing 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 carried out by national authorities, the EU enlargement in 2004 and 2007 and finally to several training actions and seminars provided by the European Commission for different stakeholders.
What does it show when a country makes a lot of notifications – is it that there are more dangerous products on that particular market?
The number of notifications made by a particular Member State cannot be directly linked to the level of safety of the products on its market. There are many reasons why some Member States may have more notifications than others: very effective surveillance mechanisms, big market, large import volumes etc. In general, it follows that the European countries which have the biggest markets and the greatest number of imported goods, and which also have the highest number of inspectors, find more dangerous goods and thus notify through RAPEX more often than smaller countries.
Is there an increase in the number of notifications on products of Chinese origin?
In total, 1013 notifications on products posing a serious risk sent through the RAPEX system in 2009 concerned products manufactured in China (including Hong Kong). The number of products of Chinese origin notified via RAPEX increased in 2009 to 60% from 59% in 2008. This is a smaller increase than that recorded from 2007 to 2008 (which was a 7% increase from 52% to 59%). Such increases should be seen in the context of a number of factors, such as: increasing imports of goods to the EU from China, focus of enforcement actions taken at the national level on products of Chinese origin, more effective cooperation between the EU and China and more accurate data on the country of origin of notified products provided through RAPEX.
What is the "RAPEX-CHINA" application?
In January 2006, a Memorandum of Understanding (MoU) on general product safety was signed between DG SANCO and the Chinese General Administration for Quality Supervision, Inspection and Quarantine (AQSIQ) the authority responsible for product safety in China. The MoU establishes a framework for better communication and collaboration between both regulators and specifically seeks to support the Chinese authorities in their efforts to ensure product safety, particularly for consumer goods exported to the EU. The MoU was upgraded in November 2008 to strengthen its original version and to provide for further opportunities to cooperate.
In the framework of the MoU, RAPEX information on products of Chinese origin is now made available to AQSIQ through the on-line "RAPEX-CHINA" application. This allows the Chinese authorities to follow up directly on notifications regarding unsafe products coming from their territory and identify areas where the safety standards are weaker.
Does the Commission get feedback on how the Chinese authorities follow up on the information sent through the "RAPEX-CHINA" application?
As part of the 2006 Memorandum of Understanding, AQSIQ agreed to provide the Commission with information on the conclusions of the follow up actions undertaken with regard to the data provided through the "RAPEX-CHINA" system. There is agreement on a quarterly reporting to the Commission. The information provided in this report allows the Commission to monitor and analyse the follow-up market surveillance activities carried out by the Chinese authorities on their territory, and allows both parties to identify and address weak points in their cooperation systems. So far, 11 quarterly reports have been provided to the Commission.
How many RAPEX notifications has AQSIQ investigated since the establishment of the "RAPEX-CHINA" application?
Since the establishment of the "RAPEX-CHINA" application, AQSIQ has ensured follow-up actions with regard to 1007 RAPEX notifications. Analysis of 11 quarterly follow-up reports received so far from AQSIQ shows that over a three-month period AQSIQ investigates on average 91 RAPEX cases. In 566 cases (56%) investigations resulted in preventive or restrictive measures being adopted either by AQSIQ or voluntarily by the Chinese manufacturer/exporter (ex. export stop or strengthened supervision), while in 441 cases (44%) no measures were taken mainly due to insufficiently detailed information on the Chinese company responsible for manufacturing and/or exporting products to the EU.
3. BUSINESS APPLICATION
4. JOINT ENFORCEMENT ACTION ON TOYS
5. JOINT ENFORCEMENT ACTION ON SUNBEDS
OJ L 11, 15.01.2002, p.4
OJ L 218, 13.8.2008, p. 30
OJ L 22, 26.01.2010, p. 1