Brussels, 20 April 2009
1. RAPID ALERT SYSTEM FOR DANGEROUS PRODUCTS (RAPEX)
What is RAPEX?
RAPEX is a Community rapid alert system for dangerous non-food consumer 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 It ensures that information about dangerous products withdrawn from the EU market and/or recalled from consumers is quickly circulated between Member States and the European Commission, with the aim of preventing or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) provides the legal framework for RAPEX. The RAPEX Guidelines (2004/418/EC)  complement the GPSD by defining the key aspects of the operation of the RAPEX system. The Guidelines were drawn up by the Commission in cooperation with the countries participating in the system. Although some specific consumer products (like toys, cosmetics, electrical appliances, personal protective equipment, machinery, motor vehicles, etc.) are covered by sector-specific Directives, the RAPEX requirements in the GPSD apply also to these products as these Directives do not provide for a similar rapid information exchange system.
When is RAPEX used?
According to the GPSD, national authorities notify the Commission, via the RAPEX system, of measures taken to prevent or restrict the marketing or use of non-food consumer products posing a serious risk to the health and safety of consumers. This obligation is laid down in Article 12 of the GPSD.
What type of measures can be taken?
Both preventive and restrictive measures ordered by national authorities and measures taken voluntarily by producers and distributors (48% of the total in 2008) 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?
RAPEX is devoted to 'consumer products' which can be used by professionals and consumers (for instance, a power drill, a lamp or a toy). The RAPEX system covers the majority of consumer 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.
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, which is not subject to voluntary actions taken by a producer or a distributor.
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.
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 .
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 .
2. RAPEX DATA 2008
How many dangerous products were notified in 2008 through the RAPEX system?
In 2008, a total of 1866 notifications were submitted thought the RAPEX system by Member States and EFTA/EEA countries. This constitutes 16% more notifications than in 2007 (1605 notifications). Of these, 1545 notifications concerned products which posed a serious risk to consumers.
Which EU countries notified most cases?
The following five Member States accounted for 50% of all RAPEX notifications on products posing a serious risk to the health and safety of consumers last year:
In 2008, 12 countries increased their activity in the RAPEX system.
Which products were most often notified?
The most frequently notified products in 2008 were:
These categories of products accounted for almost 68% of all products posing serious risk notified in 2008.
What are the main risks detected through the RAPEX system?
The most often notified risks categories, which accounted for 80% of all alerts on products posing a serious risk, were:
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 1545 notifications for products posing a serious risk, 775 concerned compulsory measures ordered by the national authorities (50%), 736 were where economic operators took 'voluntary measures' (48%), while in 34 cases, compulsory measures were complemented by corrective actions by economic operators (2%).
Where did the largest amount of dangerous products come from in 2007?
China (including Hong Kong) was indicated as a country of origin for more than half (59% / 909 notifications) of notified products. Other third countries involved in notifications were, e.g.: Turkey (33 notifications, 2%) and the USA (29 notifications, 2%).
Products of European origin accounted for 313 notifications (20%), including 82 products of German origin (5%), 57 products of Italian origin (4%), 30 products of French origin (2%) and 23 products of British origin (1%). These fairly high numbers show that the national enforcement authorities should focus their activities not only on products coming from third countries but also closely monitor the safety of consumer goods manufactured in the EU. It also shows that further attention needs to be given to the education of the European manufacturers and distributors on the safety requirements applying to consumer products.
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 or that the European market surveillance system is working less effectively. 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.
3. RAPEX-CHINA: IMPROVING CONTROLS ON CHINESE PRODUCTS
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 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.
One important measure in this context is that 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.
Why did the Commission and AQSIQ decide to sign an upgraded Memorandum of Understanding on cooperation arrangements in 2008?
The extended MoU (signed on 17 November 2008) strengthens the original version in view of the significant progress made in cooperation with China over the last three years, by including a clearer reference to the "RAPEX-CHINA" system and the role of both sides in this respect. It also provides for further opportunities to cooperate, for example by undertaking joint enforcement actions, mentions the established working groups between the Commission and AQSIQ, and clarifies the confidentiality understanding regarding the exchange of information. Moreover, it foresees a role for Member States and stakeholders in the cooperation framework.
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 (upgraded in 2008), 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.
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 the follow-up actions with regard to 669 RAPEX notifications. Analysis of 8 quarterly follow-up reports received so far from AQSIQ shows that over a three-month period AQSIQ investigates on average 80 RAPEX cases. In 352 cases (53%) investigations resulted in preventive or restrictive measures being adopted either by AQSIQ or voluntarily by the Chinese manufacturer/exporter, while in 317 cases (47%) no measures were taken mainly due to insufficiently detailed information on the Chinese company provided by the EU.
When was the last quarterly follow-up report provided by AQSIQ, and what were the main findings?
The most recent (8th) report was provided to the Commission in January 2008, and covers the AQSIQ's investigations from September to November 2008. In that period, AQSIQ has investigated a total of 86 RAPEX notifications, 70 of which were completed before the submission of the report. In 49 of these cases (70%), measures such as export bans, corrective actions and stronger supervision, were enacted to prevent the export of dangerous goods to the EU. The next quarterly report is due in April 2009. Brief analyses of the quarterly reports are made available at: http://ec.europa.eu/consumers/safety/rapex/index_en.htm.
In addition to the upgraded MoU, what other important developments in the cooperation with China took place in 2008?
In September 2008, the Commission and the US Consumer Product Safety Commission (CPSC), together with AQSIQ, conducted a serious of joint outreach seminars in China on EU and US safety requirements for clothing, toys and electrical appliances, with a view to promoting respect of the applicable safety requirements and further enhancing the safety of imported products.
These seminars were followed by a high-level EU-CHINA-US trilateral meeting hosted by Commissioner Kuneva in Brussels on 17 November 2008, to further the common agenda and to send a strong political signal of the determination of all sides to keep product safety at the top of the international political agenda, recognising that open markets can only be built on strong and secure management of global product supply chains. The parties agreed to priority areas for action, including product traceability and cooperation on safety standards for toys and children's products.
 OJ L 11, 15.01.2002, p.4
 OJ L 151, 30.04.2004, p. 83