FAQ on EU's Product Safety Efforts

November 18, 2008 // Published as a news service by IHS

RELATED CONTENT
 Engineering Standards Collections
 Toy Safety Standards
 Toy Safety News

TRILATERAL SUMMIT ON PRODUCT SAFETY

Why is the trilateral EU-U.S.-China summit on product safety so important?
On Nov. 17, Meglena Kuneva, European Commission (EC) consumer commissioner met with her high-level U.S. and Chinese counterparts to discuss how product safety can be improved and ensured throughout the global supply chain, with the aim of laying a firm basis for further cooperation on product safety issues.

This meeting was of particular significance given that it is the first trilateral gathering of the partners at this level. While bilateral mechanisms are in place and sufficiently established to execute the deepening collaboration between the three sides, the Nov. 17 meeting is a symbol of the commitment to that collaboration at the highest level.

What cooperation has there been between the EU, U.S. and China on product safety to date?
Product safety is an area of mutual concern for the three parties and in the past years, all have made significant efforts toward making consumer products safer and have established effective mechanisms for close cooperation.

Positive developments have been made since the signing of various cooperation agreements in 2002^[1], 2004^[2], 2005^[3] and January^[4] and September^[5] 2006.

This tripartite initiative adds to the already existing and fruitful bilateral mechanisms. The trilateral summit follows a joint EU-U.S.-China initiative on consumer product safety compliance that took place in China in September 2008.

At a political level, Kuneva visited China in 2007 and 2008 to discuss progress with the Chinese authorities and stress the need for continuous efforts.

Work between the EU and U.S. authorities on product safety has been moving forwards, particularly through bilateral meetings between Kuneva and Nancy Nord, chairman of the Consumer Product Safety Commission (CPSC) in Brussels and Washington, as well as through regular meetings of the Transatlantic Economic Council (TEC).

EU-U.S. cooperation was intensified also by the parallel in-depth "stocktaking" exercises that were carried out by EU and U.S. authorities in autumn 2007, following the "summer of recalls," to review existing product safety controls.

Considering the interdependence in this area, safety of consumer products is an established common concern, and moving to the next level in cooperation and adding tripartite initiatives to the existing bilateral contacts was therefore a logical step.

There are already concrete results achieved from reinforced cooperation between the EC and the Chinese authorities using modern methods and tools such as the exchanges from the EU's Rapid Alert System for dangerous consumer products (RAPEX).

There has been an increase in the training seminars and technical assistance to provide the Chinese authorities with the necessary specific information to track down and investigate alerts of dangerous products.

There is continuous contact and good cooperation between the EC and the U.S. authorities, in particular the CPSC. This is largely based on "Guidelines for information exchange and on administrative cooperation" between the CPSC and the Directorate-General for Health and Consumers of the EC, agreed upon in February 2005, which allow for regular exchanges of information and establish a series of joint initiatives to help safeguard consumers' health and safety.

These bilateral dialogues will be pursued further and intensified.

What are the main issues discussed at the trilateral summit?
The following issues were discussed on Nov. 17:

• The latest developments in the three jurisdictions, including the new U.S. legislation on product safety, the EU framework for toy safety and children's product safety and the Chinese new toy legislation and broader framework for ensuring the safety of exported consumer products.
• How to build and extend trilateral collaboration.
• The specific actions that need to be developed, including the following: ideas for global consumer product traceability; potential convergence of toy safety standards; closer collaboration in children's products safety; sharing of experience and expertise.

COOPERATION DEVELOPMENTS

Why is international cooperation on product traceability so important?
Product traceability serves to identify economic operators involved in the entire supply chain for consumer goods. With this information, corrective measures can be put in place effectively. Traceability has steadily grown in importance due to the integration and globalization of markets and global sourcing of products.

As the journey from the factory floor to the store shelf often spans the globe, ensuring the safety in the whole supply chain has become more challenging. High-profile alerts on non-food consumer goods worldwide have recently highlighted the need for better traceability, also to ensure effective recall procedures.

What tools and structures are in place to enable better traceability of the global production and supply chain?
The General Product Safety Directive, directive 2001/95/EC, contains general obligations for producers to keep information necessary for tracing the origin of a product or to display the identity of the producer or details of the production batch on the packaging of the product.

The number of RAPEX notifications in which the product was untraceable has decreased in comparison with previous years. However, with 10% of RAPEX notifications (RAPEX statistics from January to September 2008) concerning products posing a serious risk for which the country of origin is unknown, there is still scope for improvement.

The statistics from the regular quarterly reports from China since autumn 2007 under the China-RAPEX system have also made it clear that problems with traceability - not being able to trace back the manufacturer of products - is a major reason why Chinese authorities cannot take corrective actions or stop dangerous goods at the source.

The reports indicate that the lack of corrective measures from the Chinese authorities in 49% of the investigated cases was often due to the fact that China's General Administration for Quality Supervision, Inspection and Quarantine (AQSIQ) could not, for many different reasons, find the Chinese companies responsible for the manufacturing and/or exporting of the notified dangerous goods to the EU.

Further improvement can be expected as a result of the recently adopted New Legal Framework Decision 768/2008/EC, which sets out the indication of the name and the address of the manufacturer and the importer as a general principle for European Community harmonization legislation. However, significant efforts are needed to ensure effective international traceability.

What further measures can be taken to strengthen traceability?
The EU-China Trade Project has recently undertaken a study to investigate the commercial, technical, legal and political feasibility of a post-manufacturing traceability system along the supply chain between China and the EU.

Such a system would cover product quality, safety, authenticity, compliance and other issues. The EC is currently studying the results and will start discussions with its Chinese counterparts to see whether and how practical progress towards such a system could be made.

This topic will also be discussed during the third EU-China Market Surveillance Seminar scheduled for Nov. 21 in Brussels.

What concrete measures has China taken to improve product safety since the 2007 recalls and what is the EC's assessment of the progress?
In response to the 2007 toy recalls and following Kuneva's visit in July 2007, the Chinese government agreed to step up its controls in key areas.

Firstly, this resulted in an immediate strengthening of its existing inspection and export control regime for toys, which includes export licensing, manufacturer auditing and classification, first item registration, video surveillance, batch testing and training. Moreover, the Chinese government audited most of the Chinese export licensed manufacturers and revoked the export license of 701 companies.

Secondly, to give more visibility to their reinforced efforts, AQSIQ agreed to quarterly reporting on its follow-up to the RAPEX-China notifications. This system allows the Chinese authorities to take corrective action at the source to stop dangerous goods from reaching the EU market.

Since the launch of RAPEX-China in 2006, the Chinese authorities have investigated 599 RAPEX notifications. After a peak in investigations following the high-profile recalls in the summer of 2007, its efforts have now stabilized with an average of 80 notifications per three-month reporting period.

Out of 599 notifications, AQSIQ investigations have resulted in corrective action, such as export bans and strengthened supervision over Chinese companies, in 51% of the cases. The lack of measures in 49% of the investigated cases was often due to the fact that AQSIQ could not, for many different reasons, find the Chinese companies responsible for the manufacturing and/or exporting of the notified dangerous goods to the EU.

The RAPEX-China system has been instrumental in laying the foundations of a market-surveillance culture in China and setting the blueprint for a Chinese domestic alert system, which is now operational. It also allows the EC and AQSIQ to discuss EU safety requirements and standards, as well as risk assessment, in the context of concrete cases, thereby raising awareness of the obligations and promoting mutual understanding.

Overall, there is genuine progress being made in China in the field of product safety and the EC will seek to ensure that this effort is maintained. The full impact of tighter safety measures and controls should become more apparent with time, so long as product safety is kept as an uncompromised priority in China.

What support has the EU provided to China in improving its product safety?
The EU has kept in close contact with the Chinese authorities to provide any support possible when it comes to improving product safety. Education on European product safety rules and their implementation is an effective way of promoting product safety and one that is likely to yield the most long-lasting results.

There were a series of training seminars to businesses in Beijing, Guangzhou and Shanghai focusing, respectively, on textiles, toys and electrical appliances, and more will follow soon when the revised Toys Directive, directive 88/378/EEC is finally approved.

What is RAPEX and "RAPEX-China"?
EU's Rapid Alert System for dangerous consumer products is a European Community system that ensures information about dangerous products identified by national authorities is quickly circulated between the national authorities and the EC, with the aim of preventing or restricting the selling of these products on the European market.

Some 30 countries currently participate in the system - all the EU countries plus the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway.

To address the issue of dangerous Chinese imports and tackle the safety problems at the source, the EC created an application known as "RAPEX-China: in May 2006 to provide AQSIQ with access to RAPEX notifications concerning dangerous Chinese products found in the EU.

This allows AQSIQ to directly follow up on notifications, take corrective action at the source and stop the future supply of the notified products into the EU. This is essential, as around half of the dangerous consumer products detected in RAPEX are coming from China.

What are the overall trends in RAPEX notifications?
Between January and September 2008, a total of 1,347 notifications were submitted through the RAPEX system by member states and EFTA/EEA countries. Of these, 1,099 notifications concerned products that posed a serious risk to consumers.

If EU member states maintain their current participation in the system, approximately 1,800 notifications will be sent through RAPEX in 2008 (1,605 notifications were sent in 2007).

So far, the most active countries in 2008 were:

• Germany (161 notifications, 15%)
• Spain (116 notifications, 11%)
• Slovakia (96 notifications, 9%)
• Poland (90 notifications, 8%)
• Greece (86 notifications, 8%)

There have been no significant changes with regard to types of consumer goods notified through the system. The three most frequently notified products in the first nine months of 2008 were the same as in 2007 and included:

• Toys with 366 notifications (33%)
• Motor vehicles with 133 notifications (12%)
• Electrical appliances with 126 notifications (11%)

What percentage of dangerous products in RAPEX come from China?
Over 50% of dangerous products notified during the first nine months of 2008 originated from China (615 notifications, 56%). This represents an increase over the same period in 2007, when 472 reported cases (47%) had China as the country of origin.

This increase was partially caused by the fact that many of the products that had been notified in the past from unknown origin were, due to more effective market surveillance activities, notified in 2008 as products from Chinese origin.

Over 220 notifications (20%) submitted so far in 2008 concerned products originating from EU member states. In total, 19 member states of the EU were reported as the country of origin for the notified products.

This indicates a slight decrease compared to the same period in 2007, when 239 notifications concerned products originating from member states and the EEA-countries (24%).

These numbers show that the national 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.

What is happening in the U.S.?
The new Consumer Product Safety Improvement Act, adopted on Aug. 14, 2008, provides the Consumer Product Safety Commission (CPSC) with new tasks and powers, introduces a general conformity certification requirement for all consumer products and various new requirements for toys and children's products, including bans on lead and phthalates, new safety standards and test procedures, product tracking labels and mandatory third-party testing for certain children's products.

Regarding the EU relations with the U.S., the Transatlantic Economic Council (TEC) of Nov. 9, 2007 took in its joint statement the objective to enhance cooperation on import safety. To follow-up this objective, a joint EU-U.S. report, "Towards enhanced cooperation between the EU and the U.S. on the safety of imported products," was prepared and its conclusions were endorsed at the following TEC on May 13, 2008.

Following the recommendation contained in the report, the CPSC and the EC have increased their cooperation efforts in the area of consumer product safety, as well as set up a Toy Safety Working Group to function as a focal point to discuss toy import safety-related matters. The talks have increased mutual understanding and allowed to identify points for further discussion.

What is the EU-China memorandum of understanding?
A Memorandum of understanding (MoU) on general product safety between the EU's Health and Consumers Directorate-General (DG SANCO) and the Chinese AQSIQ was first signed in January 2006.

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 is also the basis for the RAPEX-China system.

The full text of the MoU is available at the following web site:
http://ec.europa.eu/consumers/cons_safe/prod_safe/memorandum_china.pdf.

How has the memorandum of understanding been strengthened in the agreement signed on Nov. 17?
The MoU was strengthened and updated in view of the significant progress made over the last three years in the cooperation with China.

The updated MoU includes clearer reference to the RAPEX-China system and the roles in this respect of both sides, provides for more opportunities to cooperate - for example, by undertaking joint enforcement actions - mentions the established working groups between the EC and AQSIQ and clarifies the confidentiality understanding regarding the exchange of information.

Moreover, it foresees a role for the EU member states and stakeholders in the cooperation framework.

INTERNATIONAL PRODUCT SAFETY WEEK

The International Product Safety Week, hosted by the EC in Brussels Nov. 17-21, is a series of events bringing together a broad range of consumer product safety professionals from around the globe, representing regulators, business, consumer organizations, standard makers and test laboratories.

The aim is to convene in one place at the same time the main global actors working in the product safety field with a view to raising the level of cooperation and achievement in product safety on the global market and ensuring safety throughout the entire supply chain.

The week begins with the signing of an upgraded memorandum of understanding on cooperation arrangements between the EC and the AQSIQ and the high-level tripartite summit between the EU, the U.S. and China.

These events will be followed by a series of meetings throughout the week in which experts from a broad range of organizations involved in consumer product safety share expertise and practical experience, including:

• International Consumer Product Health and Safety Caucus (ICPSC) - Regulators from ICPSC will meet to discuss cooperation and mutual challenges in the global governance of product safety. The ICPSC is a platform to facilitate the exchange of information on consumer product safety issues between government authorities in the area of governmental policy, legislation and market surveillance.

• International Consumer Product Health and Safety Organisation (ICPHSO) - This organization, which is dedicated to the health and safety issues related to consumer products manufactured and marketed in the global marketplace, will hold a European meeting and training symposium. ICPHSO provides a forum for the exchange of ideas and sharing of information among government, industry, trade associations, consumer organizations, legal representatives, academia, standards makers and interested individuals.

• PROSAFE - This informal network of member state authorities will hold its closing conference on the Enhancing Market Surveillance through Best Practice (EMARS) project, which aims to ensure a basic level of expertise and practical experience in the market surveillance organizations of member states within the EEA.

• EU-China Regulators Working Group - This group will meet regarding the rapid alert system for unsafe products and the related exchange of information between the EC and China (RAPEX-China).

• Third EU-China Market Surveillance Seminar - This seminar will address the latest developments in Europe in market surveillance under the General Product Safety Directive, the EU New Legislative Framework and relevant developments in China. This year's seminar focuses on product traceability in global supply chains.

OTHER EU PRODUCT SAFETY ACTIVITIES

What measures have been taken to improve the EU's product safety system in 2008?
The 2008 legislative measures to improve the EU's product safety system included:

• In January, the EC adopted a proposal to revise the 20-year-old Toys Directive. The revision has a threefold objective: to have new and higher safety requirements to cope with identified hazards, to strengthen manufacturers' and importers' responsibility for the marketing of toys and to enhance market surveillance and customs controls by the member states.

• In April, the EC adopted Decision 2008/329/EC, which requires member states to ensure that, as of July 21, 2008, magnetic toys placed on the EU market must carry warning labels. The decision covers all toys that contain or consist of loose or detachable magnets, or magnetic components of such size and shape that they can be swallowed by children. Magnets are an emerging risk; in the course of the last few years, they have become smaller, more powerful and more easily detachable.

• In March, the EC decision banning the sale of non-child resistant and novelty lighters to consumers started to apply in full. The decision enhanced consumer safety by requiring that, as 11 March 11, 2008, cigarette lighters that are dangerous to children could no longer be sold to European consumers.

• On July 9, 2008, the New Legislative Framework for marketing of products consisting of Regulation 765/2008/EC and Decision 768/2008/EC was adopted. The package strengthens and modernizes the conditions for placing a wide range of industrial products on the EU market and lays down horizontal provisions on market surveillance and controls of products entering into the EU.

• Finally, to achieve progress in the area of children's product safety beyond toys, EU member states agreed on Nov. 7, 2008 to publish the reference of the European baby walker standard in the Official Journal, thereby turning it into a harmonized standard under the GPSD guiding production and compliance checks. This publication is imminent.

Non-legislative actions included:

• Awarding financial contributions of € 2.6 million to four cross-border market surveillance actions by EU member states. These so-called "joint actions" focus on toys for children under three years, addressing magnets, small parts and heavy metals; sun beds and solarium services addressing the new limits for UV radiation; cords and drawstrings on children's clothing addressing the strangulation risk of such products; and EMARS 2.

• Examining possible measures that could be taken to better protect children and adolescents from exposure to noise from personal music players and other similar devices.

• A report on "Evaluating Business Safety Measures in the Toy Supply Chain," as a follow-up to the EC's product safety stocktaking review in autumn 2007.

• Standardization mandates to the European Committee for Standardization (CEN) for child-resistant lighters and reduced ignition propensity cigarettes.

• A study to prepare for mandates in the area of childcare articles and children's products.

What is the EMARS project?
Enhancing Market Surveillance through Best Practice is a PROSAFE project that aims to ensure a basic level of expertise and practical experience in most of the market surveillance organizations of member states within the EEA. In particular, the project seeks to establish:

• A more coordinated and well-established best practice technique in the area of market surveillance between various member states.
• A more balanced and fair market surveillance strategy throughout the single market.
• A basic knowledge base, a handbook to best practices in market surveillance and a handbook of risk assessment, which - hopefully - are accepted not only by the network and GPSD Committee but also by other related ADCO groups, as well as consumer and business representatives.

The EMARS project will finish at the end of 2008, when a follow-up project (EMARS 2) will commence to take forward the results during the first phase. EMARS 2 aims to further strengthen cooperation between member states on consumer product safety, including through the continuation of a rapid advice forum, extension of the knowledge base, updating the handbooks, establishment of a EU-wide training program for market surveillance inspectors and coordination of authorities input into standardization.

What work has the EC done with industry to boost the level of product safety?
Following the 2007 recalls, the EC's focus over the past year has been on the toy sector.

Kuneva agreed with the European toy industry on a voluntary agreement, in which industry engaged in a common mission to spread best safety practices. The EC is currently working on an agreement with toy importers and retailers to engage them more actively in measures to improve the safety of toys on the European market.

Furthermore, in June the EC presented a report by independent experts entitled "Evaluating Business Safety Measures in the Toy Supply Chain," which represents the results of a five-month analysis of product safety measures in the toy supply chain. The main conclusion of the research was to underline that product safety cannot be guaranteed by final product testing alone, but that it has to be a key part of the "quality culture" of an organization and needs to be embedded in the entire product supply chain.

Amongst the key conclusions, the report found that it is the smaller players in the market, such as small European importers and traders and small Chinese manufacturers, that tend to be the weak link in the product safety chain. A second area where weaknesses have been detected is in relation to the expertise available within member states' enforcement practices and the role of the testing laboratories.

The report sets out a series of practical recommendations addressed to each of the stakeholders in the supply chain to strengthen safety controls. For more information, see IP/08/879 and MEMO/08/364.

What is the role of member states in ensuring that the high level of product safety is met in the EU?
Under the General Product Safety Directive, member states have the obligation to 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 EC detailed information about dangerous products found on its own market.

What concrete developments are already planned for 2009?
In the next year, the EC will propose mandates for drafting standards for children's products (other than toys) for which there are currently no standards. For example, the EC is well aware that many accidents, sometimes fatal, involving babies and toddlers happen in the cot. This is why the EC will propose new standards for products used for sleeping or in association with the cot or the crib, such as cot-bumpers and sleeping bags.

Another dangerous area is bathing. Bath rings, bath aids and also products combining a changing mat with a bath will be drawn under standardization.

Finally, the EC will also request the revision of existing standards to cover new risks that are not addressed in the current version, such as high-chairs.

^[1] The Industrial Products and WTO/TBT Consultation Mechanism between the Directorate-General for Enterprise and Industry of the EC and the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (October 2002).

^[2] The Memorandum of Understanding on Cooperation between the U.S. Consumer Product Safety Commission and the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (April 2004).

^[3] Guidelines for information exchange and on administrative cooperation between the U.S. Consumer Product Safety Commission and the Directorate-General for Health and Consumers of the EC (February 2005).

^[4] The Memorandum of Understanding on Administrative Cooperation Arrangement between Directorate-General for Health and Consumer Protection of the EC and the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (from January 2006; updated by joint statement on Nov. 17, 2008).

^[5] The Guideline for Action on Co-operation for Strengthening EU-China Toys Safety between the Directorate-General for Enterprise and Industry of the EC, the Directorate-General for Health and Consumer Protection of the EC and the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (September 2006).

Source: European Commission.