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Brussels, 08 May 2012
Questions and answers - RAPEX in 2011
1. What is RAPEX?
RAPEX is a European rapid alert system for dangerous products. It ensures that information about dangerous products withdrawn from the market and/or recalled from consumers anywhere in Europe is quickly circulated between Member States and the European Commission, so that appropriate action can be taken everywhere in the EU. Thirty 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 type of measures can be taken?
The most common measures are: ban/stop on sales; withdrawal of a dangerous product from the market or its recall from consumers; import rejection by the customs authorities.
What is covered by RAPEX?
The scope of RAPEX covers dangerous non-food products intended for consumers (e.g. a toy, a cosmetic, clothing) and for professionals (e.g. a power drill, a machine, a construction product) which pose a serious risk to various public interests, such as 'health and safety of consumers', 'environment' (risk for trees, water, air, soil, etc from dangerous chemicals contained in a product), 'health and safety at the workplace' and 'public security'.
The RAPEX system covers the majority of non-food products. Other categories of products, such as food and feed, pharmaceuticals and medical devices are excluded from its scope as they are covered by other specific alert systems, similar to RAPEX.
What are obligations of national authorities?
National authorities ensure that businesses respect their obligation to place only safe products on the market. They must designate authorities which can take measures to prevent or restrict the marketing or use of dangerous products. Each country designates a national RAPEX Contact Point which coordinates the system at national level and submits information to the Commission about dangerous products found on its own market. The information received and validated by the Commission is rapidly circulated to the national Contact Points for appropriate action. The results of these activities are reported back through the system.
What are the obligations of producers?
Producers (i.e. manufacturers and importers) are responsible for placing only safe products on the market. Once aware that a product is dangerous, a producer must immediately take measures to prevent further risks to consumers. National competent authorities must also be informed about the safety problem, 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.
2. RAPEX in 2011
What were the most significant developments in 2011?
Despite the difficult economic context, budget cuts and subsequent constraints in the national administrations, RAPEX successfully fulfilled its mission and contributed to the protection of European consumers, with 1803 measures taken against dangerous products and reported in the system by the Member States.
The main achievements were:
2011 was also a year of consolidation for the RAPEX system following both its extension to the safety of goods used in a professional context and to risks other than health and safety of consumers (e.g. risk to the environment), and the implementation of a new risk assessment method. The numerous trainings organised in 2010 by the European Commission for the national authorities brought results with a wider use of the risk assessment method and greater precision of RAPEX notifications sent in 2011.
In parallel, enhanced market surveillance activities were undertaken by national authorities through specific joint projects concerning products such as lasers pointers, ladders, visibility clothing and accessories, food-imitations and chemicals in children's fancy clothing. Furthermore, the projects on toys, sunbeds and market surveillance best practices (EMARS), drew to a close, achieving important results.
Customs authorities are increasingly involved in product safety surveillance and the number of measures initiated by the border controls and notified in RAPEX has risen steadily over the past few years.
To facilitate the fulfilment of Member States' market surveillance tasks and to ensure a harmonised approach throughout the EU, the European Commission adopted in 2011 "Guidelines for import controls in the area of product safety and compliance". These Guidelines are a concrete tool to assist customs when performing controls and to support good cooperation between customs and Market Surveillance Authorities.
What is seamless surveillance?
The EU is building a system of 'Seamless Surveillance' to ensure that unsafe products do not reach EU consumers. This involves: working on better co-operation between EU authorities; working on better risk assessment; working upstream to design out risks from the start at source; and working with customs to identify risk at point of entry.
3. RAPEX results 2011
What were the main findings in 2011?
In 2011, a total of 1.803 notifications on dangerous products posing risks to the health and safety of consumers were submitted through the RAPEX system by Member States. This constitutes 20% less notifications than in 2010 (2.244 notifications). Of the 1.803 notifications, 1.556 notifications concerned products which posed a serious risk to consumers. Other notifications refer to moderate risk or information only.
Why did the number of notifications for dangerous goods decrease in 2011?
In 2011, for the first time since the start of the operation of the current RAPEX system (in 2004), the total number of notifications decreased by 20% (1803 notifications, down from 2244 in 2010). This is compared with annual increases of 81% in 2005, 24% in 2006, 53% in 2007, 16% in 2008, 7% in 2009 and 13% in 2010. While this decrease, which occurred mainly in the first quarter of the year, might be also in part to budget cuts and subsequent resource constraints in the national administrations, it must be noted that the RAPEX system has now reached a level of stability and maturity and that the more active use of the risk assessment guidelines has lead to the streamlining of notifications, with improvements in their quality.
Member States are also using the system more efficiently since it is now clearer where and how it is most relevant to act. Particular attention is given to providing more detailed information in the system such as details regarding economic operators, which allows the authorities to better trace the products.
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:
In 2011, 16 countries1 notified fewer dangerous products than in 2010.
The most frequently notified products in 2011 were:
These categories of products accounted for almost 75% of all products posing serious risk notified in 2011. Decreases in comparison with last year relate mostly to clothing, toys and food-imitating products.
What are the main risks detected through the RAPEX system?
The risk categories most often notified, which accounted for 84% of all alerts on products posing a serious risk, were:
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 may be many reasons why some Member States may have more notifications than others: large market, large import volumes, well-developed surveillance mechanisms, 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.
What measures did the national authorities take in response to the dangerous goods that they found?
The most frequently taken measures with regard to dangerous consumer products in 2011 were: withdrawal from the market, sales ban, recall from consumers, import rejected by the customs authorities, and corrective actions.
Where did the largest amount of dangerous products come in from 2011?
According to the RAPEX Report (and taking into account additional information received in 2012), the majority of dangerous products posing serious risks to the health and safety of consumers notified through RAPEX came from outside the EU – (China, Turkey).
China (including Hong Kong) was indicated as a country of origin for 54% (839 notifications) of notified products.
Dangerous products of European origin accounted for 293 notifications (19%), including 44 products of French origin (3%), 43 products of German origin (3%) and 32 products of Italian origin (2%). The figures show that attention needs to be given to informing European manufacturers and importers on the safety requirements applying to consumer products. Trainings have been organized in particular in the toy sector.
In 2011, the number of cases with an unidentified country of origin has decreased to 8% (128 notifications) from 10% (201 notifications) in 2010. This figure should be seen as a significant improvement in the operation of the RAPEX system, in particular compared to the 2004 figures when it was as high as 23%. 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.
Is there an increase in the number of notifications on products of Chinese origin?
No, on the contrary, there was a decrease in the number of consumer products (posing a serious risk to the health and safety of consumers) of Chinese origin notified via RAPEX in 2011 - to 54% from 58% in 2010. In total 839 notifications concerned products manufactured in China (including Hong Kong).
This still very high number is must be considered in the context of the significant market penetration of Chinese-manufactured consumer products in European markets. Products are checked according to the same, stringent safety requirements regardless of their origin, usually based on typical risks associated with the product category. The consistent intensification of contacts with the Chinese administration and businesses is yielding significant returns in terms of improved product identification and traceability for corrective measures and this will continue.
4. Safety at Source
Is 'safety at source’ a primary objective?
Yes. Research shows that one of the largest causes of product recalls are design defects. This means that the product was unsafe due to the faulty design and not because of some error in the manufacturing of the product.
Companies responsible for the design of the product must make sure they do their homework and design out safety risks from the start. This will significantly improve the chances of producing safe products.
It is important to reach out to manufacturers to help them know what requirements they are expected to meet, to know the risks associated with certain products and to understand the importance of design assessments and risk analysis. Manufacturers must ensure that suppliers are trustworthy and provide safe materials and components. They have to control incoming supplies to ensure they don’t contain unwanted substances. They need to manage the quality of the manufacturing process and check the final products coming off the conveyor belt. Work must move forward in this direction, for example: continuing to offer hands-on training on the responsibilities of manufacturers; develop broad advice to economic operators; look at trends in common weaknesses in products and share this with partners so that guidance can be given to economic operators on how to avoid these in the future.
What other controls are possible in the journey from ‘factory to front door’?
Importers also have an important responsibility – they need to inform their suppliers about the requirements applicable to the products they wish to import. They also need to check that the products they receive indeed comply with these requirements. The sheer volume of sales (e.g. over the internet) make this difficult for everyone concerned and there needs to be more information, training and guidance in this regard.
There must be effective, proportionate and dissuasive penalties for importers who repeatedly ignore the rules. This is important to protect consumers and also to protect legitimate businesses that invest in product safety.
5. Safety at point of entry – cooperation with customs
What in particular is being done at point of entry?
In the last years more attention has been paid upstream including with customs authorities and this work represents important progress. Market surveillance authorities continue to develop this co-operation with customs authorities who play an important role in the area of product safety. Their responsibility for import controls put them in a prime position to assess whether products to be placed on the market are safe.
Can you explain how RAPEX is linked to work at customs?
There is a requirement at EU level that customs authorities co-operate with market surveillance authorities. In some countries there is very direct involvement in product safety checks. In 2011, there were notifications in RAPEX from seven countries where measures had been adopted directly or initiated by customs authorities (Spain, Finland, Portugal, United Kingdom, Italy, Germany and Netherlands). This stops the dangerous products already at the border, making the enforcement system more efficient.
Over the past few years the links have been developed between RAPEX and RIF2 (customs alert) systems.
Which customs authorities are most active?
Customs authorities are increasingly active and notifying through RAPEX more often.
In 2011, in total 153 notifications were initiated by customs authorities, of which 136 were on serious risk (9% of the total notifications on serious risk and 15% of the total compulsory measures taken).
Spain and Finland are the countries with the highest number of RAPEX notifications initiated by customs authorities (69 and 37 notifications). The top categories for these notifications were: toys, cosmetics; electrical appliances and equipment; and clothing, textiles and fashion items.
6. Cooperation with China
The EU and China are the biggest trade partners in the World; China is the EU's first supplier and its second customer after the USA. The EU is China's first customer and second supplier after Japan.
The Commission has been working ever more closely with the Chinese authorities and this co-operation is yielding good results. This co-operation is developed around the following:
- trilateral co-operation EU-US-China.
- joint action
Trilateral cooperation in the product safety area between the US, the EU and China started in 2008. While the EU and the US represent the word's largest markets for consumer products, China is one of the major producers. Trilateral discussions help to build trust and to develop a coordinated response to the challenges faced in addressing product safety concerns.
The last (second) High-Level EU-China-US Trilateral Meeting took place in 2010 in Shanghai where the parties agreed on the importance of keeping product safety on the political agenda, recognising that open markets can only be built on strong and secure management of global product supply chains. Trilateral priority areas for action were agreed, including on product traceability, convergence of safety requirements, advice to manufacturers and joint enforcement actions.
The next High-Level EU-China-US Trilateral Meeting on Consumer Product Safety is planned for 27-29 June 2012 in Washington DC.
The European and Chinese authorities have just launched the first joint project which is a significant step forward in building cooperation and the concept of "seamless surveillance".
The aim is to establish seamless surveillance between the EU and China. This would cover the length of the industrial chain, from the product manufacturer all the way to the consumer, and bridging any gaps, improving the quality of checks and controls both in China and in the EU, in order to effectively protect consumers' safety and health. The aim is to become more effective and efficient in the work done to ensure that unsafe products can no longer enter the EU market.
What is the "RAPEX-CHINA" application?
The RAPEX-China application was established in 2006 in the framework of the Memorandum of Understanding (MoU) on general product safety between DG SANCO and the Chinese authority responsible for product safety in China - the General Administration for Quality Supervision, Inspection and Quarantine (AQSIQ).
Through the RAPEX-China application, the Commission submits information to AQSIQ about dangerous products of Chinese origin found on the EU market and notified through RAPEX. This information 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?
Cooperation in the framework of the RAPEX-China system is well-established, as AQSIQ submits quarterly reports to the Commission with the conclusions of the follow up actions undertaken with regard to the data provided through the "RAPEX-CHINA" system.
The information provided in the reports allows the Commission and Member States to monitor and analyse the follow-up market surveillance activities carried out by the Chinese authorities on their territory, and as a consequence allows them to identify and address weak points in the cooperation system. So far, 19 quarterly reports have been provided to the Commission.
How many RAPEX notifications has AQSIQ investigated since the establishment of the "RAPEX-CHINA" application?
AQSIQ has ensured follow-up action with regard to 1752 RAPEX notifications. Analysis of 19 quarterly follow-up reports received so far from AQSIQ shows that over a three-month period AQSIQ investigates on average 92 RAPEX cases. In 985 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 767 cases (44%) no measures were taken mainly due to the fact that the Chinese company responsible for manufacturing and/or exporting products to the EU could not be found.
7. RAPEX data 2011: Safety of goods in a professional context and other risks
In 2011, Member States submitted 25 notifications on restrictive measures taken with regard to the safety of goods used in a professional context ( e.g. a feed mixer used in agriculture, posing a risk of injury to the user), and to address risks other than health and safety of consumers (e.g. plastic bags with cadmium posing a risk to the environment).
8. GPSD business application
What is the "GPSD Business Application"?
The "GPSD Business Application" is an on-line application that was established (in May 2009) by the European Commission to facilitate businesses' obligation to notify Member States' competent authorities of dangerous products made available to consumers on the EU market. Businesses can use this application – instead of traditional methods such as e-mail or fax, to submit their notifications on dangerous products to national authorities of all 27 EU Member States and 3 countries that are parties to the European Economic Area (EEA). Using this application, they can also notify all Member States at the same time.
When do businesses have to notify dangerous consumer products to national authorities of Member States?
Once a company becomes aware that a product poses a risk to the health and safety of consumers, they must immediately take measures to prevent these risks. 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 should be sent to competent authorities in all Member States where the product in question has been marketed.
Is the GPSD Business Application working well?
Yes; since its launch, the GPSD Business Application has proven successful. In 2011, 215 notifications (including updates) sent through the application by producers and distributors were accepted by the competent national authorities. This constitutes an increase of 62% compared to 2010 (133 notifications).
Which products were most frequently notified?
Notifications submitted by producers and distributors concerned: electrical appliances, motor vehicles, toys, children's products and hobby/sport equipment.
Are the 'GPSD Business Application' notifications forwarded via RAPEX?
Yes, once a national authority has confirmed the risk and the corrective measures, the notification is conveyed via the RAPEX system to the Commission and other countries participating in the RAPEX system.
For more information on the GPSD Business Application:
9. Other policy development impacting RAPEX
What is the impact of the new Toy Safety Directive on the functioning of the RAPEX system?
The new Toys Safety Directive (2009/48/EC) is applicable since in 2011. It improved the existing rules for the marketing of toys that are produced in and imported into the EU with a view to reducing toy related accidents and achieving long-term health benefits. Member States have to ensure that market surveillance authorities perform adequate checks both at the EU external borders and within the Union itself, as well as conducting visits at the premises of economic operators that will ensure the immediate confiscation of toys presenting a serious risk. It also strengthened the obligations of manufacturers, distributors, and importers. Before placing a new toy on the market, manufacturers have to identify the hazards and the potential exposure to children in a mandatory safety assessment. Manufacturers are also obliged to ensure traceability of the toy by indicating the name, address and number of the item.
Awareness-raising on the new requirements is very important and toys are likely to remain a focus area for market surveillance.
For more information:
Weekly RAPEX reports or specific data:
RAPEX national contact points: http://ec.europa.eu/consumers/safety/rapex/index_en.htm
For further information on the impact of the new toys Directive:
Belgium, Bulgaria, Germany, Greece, France, Italy, Cyprus, Lithuania, Hungary, Malta, Austria, Poland, Slovakia, Finland, Sweden and Norway.
RIF = Risk Information System in the customs area