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Brussels, 19 April 2007
Questions and Answers on the Annual Report on the Rapid Alert System for non-food consumer products (RAPEX)
What is RAPEX?
RAPEX (Community Rapid Alert System for non-food consumer products) is a European rapid alert system for dangerous consumer products. It ensures that information about dangerous products identified by the national authorities is quickly circulated between the national authorities themselves 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 EEA countries: Iceland, Liechtenstein and Norway.
What is the legal basis for RAPEX?
The Directive on general product safety 2001/95/EC (GPSD) provides the legal framework for RAPEX. The RAPEX Guidelines 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 when the relevant 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 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 measures ordered by national authorities and measures taken voluntarily by producers and distributors (over 40% of the total in 2006) 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 a consumer product?
RAPEX is devoted to 'consumer products'. Consumer products are defined as products which are intended for consumers and products which can be used by professionals and consumers (for instance, a power drill).
The RAPEX system does not cover all consumer products. 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 is a serious risk?
A 'serious risk' is defined by the GPSD as one which requires rapid intervention by public authorities and includes risks of which the effects are not immediate. Additionally, the RAPEX system allows for the exchange of information about measures taken by national authorities in relation to products that present a moderate risk for consumers.
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. Each country participating in the RAPEX system nominates a single national RAPEX Contact Point which submits to the Commission detailed 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 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. National RAPEX Contact Points are also entitled to receive information on dangerous products directly from consumers.
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 inform national competent authorities, clearly identifying the product 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. 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.
To simplify the practical application of the notification obligation of producers and distributors, the Commission has developed an IT tool called 'Business Application', which will enable economic operators to submit notifications to the national authorities through the internet.
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 pages. These overviews provide information on the product, the nature of the risk it poses and the measures that were taken to prevent these risks. For more information, please visit: http://ec.europa.eu/ rapex.
How many dangerous products were notified in 2006 through the RAPEX system?
In 2006, 1 051 notifications were validated in the system:
The number of notifications has risen steeply over the last few years. In the second year after the entry into force of the revised GPSD in January 2004, the number of serious risk notifications has more than doubled from 388 in 2004 to 924 in 2006. Compared to 2005, 2006 saw a 32% increase in serious risk notifications.
These results can be attributed to an increased awareness of product safety by national authorities and the business sector, EU enlargement in 2004, as well as to the major role played by the Commission in promoting the development of the system and improving EU-wide cooperation.
Which EU countries notified most cases?
In 2006, all Member States of the EU (including Bulgaria and Romania) were active in the RAPEX system.
The following five countries accounted for 60% of all notifications:
Although Member State participation in the system is at present uneven, this issue is being addressed. . Moreover, when consulting these statistics, several factors such as country size, population, geographic configuration and market structures should be taken into account.
In 2006, the most active notifying countries were the same as in 2005, namely Germany, Hungary, Greece, United Kingdom and Spain. Steep increases in the number of notifications were reported for Greece, United Kingdom, Germany and Spain (in absolute numbers) and for Bulgaria, United Kingdom, Greece and Lithuania (in relative terms).
Which products are most often notified?
As in 2005, the lion's share of notifications concerned the following categories of products, which accounted for almost 75 % of all notified products:
Toys, electrical appliances and motor vehicles alone accounted for more than half of the notifications in 2006. This is in line with the previous year's results.
The main difference is that for the first time, toys took over from electrical appliances as the product category most often notified.
What are the main risks detected through the RAPEX system?
Some notifications concern products presenting more than one risk. Therefore, the total number of notified risks is higher than the total number of notifications. In 2006, 148 notifications reported more than one type of risk. The total number of notified risks was 1095 for 924 notifications.
The five main risk categories were:
These results confirm previous years' trends, whereby the risk of getting injured and the risk of getting an electric shock have been the main types of risks to which consumers have been exposed over the last few years. The five main risk categories account for 90% of all risks.
What are the risks of the three main product categories?
Each product category is likely to expose consumers to a specific type of risk. For example:
What kind of measures were taken by national authorities?
531 out of 924 serious risk notifications led to compulsory measures being ordered by the national authorities (57% of the total number). In 378 cases, the producer or distributor took voluntary measures (41%). In 15 cases, compulsory measures were complemented by voluntary corrective action. The most common measures, whether taken on a voluntary or compulsory basis, are sales bans, withdrawal from the market, informing of the consumers and recall from the consumers.
Where do most dangerous products come from?
The People's Republic of China was the country of origin for notified products in almost half of all cases (440 notifications, 48%). This is mainly due to the large number of products imported to the European Union from China. 195 notifications (21%) concerned products originating in the 25 EU countries.
The number of notifications concerning products of unknown origin was fairly high, totalling 159 notifications (17%). This high percentage is a limiting factor in assessing the presence of dangerous products in the EU. However, a slight improvement can be noted compared to the previous year when 20% of notifications concerned products of unknown origin.
What were the most important developments in EU product safety policy in 2006?
Globalisation is leading to growing international trade in consumer products. This development increases the need to improve cooperation regarding the identification of unsafe products, and to ensure that producers across the world are aware of the relevant safety requirements and apply them in practice. In 2006, the European Union made significant steps forward in co-operation with its two main trading partners; the United States and China.
The People's Republic of China
In January 2006, the Commission and the Chinese government signed a Memorandum of Understanding with the objective of establishing better communication and collaboration on consumer product safety and to support Chinese authorities in their efforts to ensure product safety, in particular for consumer products exported to the EU. The Memorandum puts in place a number of practical measures, including joint meetings, exchanges of information and follow-up on emerging safety issues. One measure taken in May 2006 is that RAPEX information concerning products of Chinese origin has been made available on a read-only basis to the Chinese government, thereby allowing immediate follow-up on notifications regarding unsafe products.
In addition to this general framework, a specific Roadmap for safer toys was signed in September 2006. This agreement aims at ensuring that toys exported from China to the EU are safe and outlines a strategy for improving the safety of toys manufactured in China. The Roadmap, supported by both the European and Chinese toy manufacturers' associations, includes practical measures regarding training and technical assistance, exchanges of RAPEX information between the EU and the Chinese authorities, and tracing, feedback and follow-up mechanisms for dangerous products. It also contains a commitment from the Chinese authorities to strengthen inspection and supervision of toys exported to Europe.
European and United States regulators face many similar challenges regarding product safety. Many products are common to both markets, so a product identified as dangerous on one market could still be circulating on the other. Exchanging information on product recalls, emerging health and safety issues and standardisation activities can help both sides improve the effectiveness of their activities. In the context of specific Guidelines, already agreed in February 2005, last year saw increased co-operation on a number of issues of mutual interest, including on specific products such as child resistant lighters and lead in children's products. The EU and USA also joined forces to spur the further development of the International Consumer Product Safety Caucus, a forum for the exchange of information on product safety issues between a broader group of regulators, including China, Japan, Australia, South Korea, Mexico, Canada, Turkey and others.
What were among the main issues of concern in terms of product safety in 2006?
After several years of discussion, in May last year the Commission adopted a Decision requiring Member States to ensure that, as of 11 March 2007, cigarette lighters are child-resistant when placed on the EU market.
From the same date, the Decision also prohibited the placing on the market of lighters which resemble objects such as toys, food and mobile phones (so-called 'novelty lighters') that are particularly attractive to children. Certain lighters are excluded from the scope of the Decision, but must comply with the general safety requirements for these products. Similar requirements have already been in place in the USA, Canada, Australia and New Zealand since the mid-nineties. They have proved instrumental in saving a significant number of lives, and in particular children's lives.
In the first half of 2006, the Commission was alerted to the increasing numbers of cheap, unsafe mini-motorbikes being imported into the EU and resulting in a significant number of RAPEX notifications. These products are reduced-scale copies of normal motorbikes with internal combustion engines. Several Member States reported serious design and construction defects in such products, which on some occasions had caused serious accidents. In response, the Commission requested the Member States to take all necessary urgent measures to protect the safety of consumers, including the withdrawal from the market of unsafe products to prevent further accidents. Many countries responded to this request, thereby significantly improving the safety of the users of these products.
How will the Commission upgrade the RAPEX system in 2007?
One of the key developments for RAPEX in 2007 will be the implementation of the so-called GRAS (Generic Rapid Alert System) platform. This new IT system will function as a common basis for all rapid alert systems managed by the Directorate-General for Health and Consumer Protection, and will cover, in particular, biological and chemical risks, food and feed, as well as dangerous non-food consumer products. GRAS will ensure a more efficient operation of RAPEX and should result in a higher number of notifications in 2007.
For more information please visit:
European Commission's Directorate-General for Health and Consumer Protection:
Business notifications: http://ec.europa.eu/consumers/cons_safe/prod_safe/gpsd/guidelines_en.htm
() OJ L 11, 15.1.2002, p. 4.