Vragen en antwoorden: Internationale samenwerking bij productveiligheid (en)

Met dank overgenomen van Europese Commissie (EC) i, gepubliceerd op dinsdag 26 oktober 2010.

SECTION 1 - INTERNATIONAL COOPERATION ON PRODUCT SAFETY

What is happening this week in Shanghai in relation to international co-operation on consumer product safety?

EU Health and Consumer Commissioner, John Dalli, puts consumer issues in the spotlight this week when he addresses the Consumer and Product Safety Day during the Shanghai World Expo. He will also meet with U.S. and Chinese counterparts at the second China-EU-U.S. High level Trilateral Summit on consumer product safety. Both events focus on developing a modern consumer policy and in particular stronger governance on product safety in today's global market.

The Consumer Day will include representatives from the EU institutions, consumer organisations, the European business sector and a senior representative from China's State Food and Drug Administration. The aim is to explore new opportunities to strengthen working partnerships under the theme 'better cities - better lives'.

The Trilateral Summit on product safety1 brings Mr Dalli together with his product safety counterparts Mr. Zhi Shuping, Minister of China's General Administration of Quality Supervision, Inspection and Quarantine and Mrs. Inez Moore Tenenbaum, Chairman of the U.S. Consumer Product Safety Commission. This trilateral co-operation reflects 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.

SECTION 2 - WORLD EXPO CONSUMER AND PRODUCT SAFETY DAY

Why has the Commission chosen to be part of the World Expo Shanghai?

The Commission has chosen to be part of the World Expo Shanghai as it is an opportunity to deepen the relationship between China and Europe. The China-EU relationship is vital for both partners.

Why is the consumer element so important?

The Consumer Day offers an excellent opportunity for exchanges between all the main players involved in product safety on the nature of the European regime to protect consumers. Ensuring consumers' safety is one of the collective challenges of globalisation that jurisdictions can only confront by working in international partnership. It is important to keep up the political momentum to insist that standards are high and enforced at every step along the global supply chain from factory to front door. The Consumer Day will also allow participants to get a deeper understanding of the issues at stake in consumer product safety in the EU, and to develop ideas on how to deepen co-operation to ensure product safety all along the supply chain.

What is the context?

EU-China trade has increased dramatically over recent years. China is the EU's biggest source of imports and its third export partner (EU 27 exports) after the USA and Switzerland.

Machinery, manufactured goods, office/telecommunication, textiles and clothing are among the main categories of EU imports from China.

The EU exports mainly machinery, transport equipment, chemicals, raw materials and agricultural products.

From a product safety perspective China is a major source of consumer goods, representing for example, 80 to 90% of all toys and electrical equipment sold on the European market. Products of Chinese origin also account for over 60% of all notifications through the EU's RAPEX system for dangerous consumer products.

What will the World Expo - Consumer and Product Safety Day involve?

Commissioner Dalli presents the basic principles of European Union Consumer Policy and underlines the important role of consumer policy in strengthening consumer confidence - a key pillar for growth:

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    Safety first: that all consumer products, including various categories such as toys, clothing, cosmetics, detergents, are safe;
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    Evidence-based policy making: including sound science underpinning high levels of safety, market monitoring to identify weaknesses (with follow-up either through legislation or self-regulation by industry), and where possible, moving towards international standards;
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    Enforcement and redress: The EU Rapid Alert system for dangerous consumer products (RAPEX) and RAPEX China are working well to exchange information on products posing a serious risk to consumers' health and safety. Trilateral co-operation is helping to develop a co-ordinated response across three continents;
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    Consumer involvement: Equipping consumers with clear information, to enable the best choices of products or services and supporting consumer organisations.

SECTION 3 - TRILATERAL SUMMIT ON PRODUCT SAFETY

What is the trilateral EU-U.S.-China summit on product safety about?

Commissioner Dalli will meet his 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 fostering further cooperation on product safety issues. This meeting is the second ‘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, today’s meeting is a symbol of the continuing 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. In recent 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 co-operation agreements in 20022, 20043, 20054 and January5 and September6 2006. This tripartite initiative adds to the already existing and fruitful bilateral mechanisms.

The cooperation between the EU, the US and China in a trilateral context started in September 2008, based on a joint EU-US initiative on Consumer Product Safety Compliance which took place in China. It included three one-day training seminars focused respectively on textiles, toys and electrical appliances, which brought together Chinese, EU and US regulators, businesses, standard-makers and test laboratories.

The presentations clarified the European and US safety requirements for the selected consumer products with a view to improve mutual understanding thereby ensuring safety throughout the entire supply chain. Talks also covered developments and best practices in market surveillance and consumer product safety compliance.

This 'outreach' was followed by a high level trilateral meeting, which took place on 17 November 2008 in Brussels, where the participants agreed on a joint statement focusing on enhanced cooperation and specific actions to be carried out. For more information about the meeting and the full text of the joint statement, please see:

http://ec.europa.eu/consumers/safety/int_coop/trilateral_en.htm

Over the past two years, many of the actions set out in the 2008 joint statement have been followed up:

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    On traceability, a seminar on product traceability and tracking labels was organised in October 2009 in Stockholm.
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    On toy safety, a study was undertaken by ANEC to compare the requirements in the different standards and present options for further convergence.
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    On children's products, the trilateral partners regularly update each other on policy intentions and regulatory developments.

What are the objectives of trilateral co-operation at this point in time?

Joint action by the largest markets in the world in terms of production and sale of consumer products is unique and vital. Much has been achieved through the trilateral process, in terms of outreach to manufacturers and understanding by all three authorities of the importance of product safety. And so the time is right to intensify the work. This would involve for example to reinforce bilateral co-operation mechanisms; to develop a 'seamless surveillance' model of checks on traded goods with export and import authorities working jointly with product safety officials; and taking action to deliver policy advice to economic operators to improve their level of awareness of safety requirements.

What are the priority areas for action which were agreed at the trilateral summit today?

The trilateral priority areas for action agreed are set out in the joint press statement, and relate to:

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    product traceability,
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    convergence of safety requirements,
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    advice to manufacturers
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    developing the 'seamless surveillance' concept

What is meant by 'policy advice to economic operators?

Efficiency is essential in product safety. Authorities, therefore, need to make the most effective use of all of the information they have under their control.

Currently, the RAPEX-China system only deals with specific cases. In the future, the EU would like to see all trilateral participants, looking at trends visible through RAPEX-China or comparable systems and using them as the basis for advice to economic operators about upcoming problems.

An example of where this has happened - on an ad hoc basis - in the past is the case of products containing the biocide dimethylfumarate (DMF). Over a number of years a large number of consumers experienced serious health problems as a result of coming into contact with mainly leather products containing DMF. Problems included skin itching, irritation, redness, burns and, in some cases, acute respiratory difficult.

While the Commission eventually banned DMF in consumer products, that was not before AQSIQ took action of its own, by issuing two notices:

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    One, on 4 August 2008, requested manufacturers to stop using DMF as leather fungicide in furniture production;
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    A second, on 25 November 2008, requested manufacturers to stop using DMF as leather fungicide in exported consumer products.

In the future the EU would like to see this type of action adopted more systematically. One current example could be the issue of cords and drawstrings in children's clothing. EU authorities are encountering a vast number of such unsafe products on the market. Many of these have Chinese origin. The US is facing similar challenges.

While to some extent this type of work would be bilateral in nature, many of the products will be sold on more than one of the three markets. Accordingly, it would be useful to share these trends and the action taken in a trilateral context. The notices would also be used improve awareness among importers of upcoming issues.

What is seamless surveillance?

Seamless surveillance is the concept of linking product safety controls along the product supply chain, i.e. from factory to front door. It involves cooperation between authorities responsible for controlling exports, customs authorities and product safety authorities in countries of origin and consumption.

Why is this necessary?

With increasing global trade and growing complexity of product supply chains, effective enforcement of product safety legislation can no longer rely only on checks once products are on the shelves. Controlling product safety upstream, i.e. during design, sourcing, manufacturing and shipping, is essential to protect our consumers against unsafe products.

Is this already happening?

Not really. Diverse legislative requirements, different enforcement systems, and the complexity and geographical spread of the product supply chain all conspire against joined-up controls. Despite increasing cooperation between surveillance authorities, more needs to be done to link the enforcement efforts.

What are you doing to get there?

This trilateral process is an excellent vehicle for discussing the principles of cooperative enforcement and procedures that could make it happen in practice. That means we will be looking for concrete steps that might be taken toward this goal.

SECTION 4 - BILATERAL CO-OPERATION DEVELOPMENTS

What is the RAPEX system?

RAPEX (EU Rapid Alert System for non-food consumer products) is a Community rapid information system for dangerous consumer products. It ensures that information about dangerous products identified by the national authorities is quickly circulated between the national authorities and the European Commission, with the aim of preventing or restricting the selling of these products on the European market. 30 countries currently participate in the system; all the European Union countries and the European Economic Area (EEA) countries: Iceland, Liechtenstein and Norway. More information about the RAPEX system can be found at: MEMO/10/130

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 is RAPEX-China?

The 2009 RAPEX statistics show that around 60% of all unsafe products found on the European market come from China. To address the issue of dangerous Chinese imports and tackle the safety problems at source, the Commission created an IT application '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 regarding unsafe products. AQSIQ committed to a system of quarterly reporting on Chinese enforcement actions.

According to 14 follow-up reports received from AQSIQ:

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    Chinese authorities investigated and where necessary adopted measures in relation to 1324 RAPEX notifications,
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    Chinese authorities investigate on average 95 RAPEX every three months;
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    Export bans (410 cases) and strengthened supervision over Chinese companies involved in manufacturing and/or exporting to the EU of dangerous goods (172 cases), are the most frequently adopted measures by AQSIQ.

Traceability, i.e. the ability to find the manufacturer/exporter in the supply chain, still remains the biggest challenge in the operation of the RAPEX-China system. In many cases, no measures were adopted by AQSIQ due to different reasons, such as: (a) information on the Chinese manufacturer/exporter provided by the Member States was inaccurate (b) Chinese company claimed that it had never been involved in the manufacturing or export of a notified product, (c) Chinese company has not kept orders, contracts, invoices and other documents which could prove its role in the manufacturing and/or exporting process, (d) Chinese company has changed its address and (e) due to "multiple trade relations" AQSIQ could not establish which of the involved companies holds responsibility.

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. It also allows DG SANCO and AQSIQ to discuss EU safety requirements and standards, as well as risk assessment, in the context of concrete cases thereby raising awareness and promoting mutual understanding. The next meeting of the RAPEX China Working Group, also involving many EU Member States, will take place the day before the trilateral, on 25 October 2010 in Shanghai.

What tools and structures are in place to enable better traceability of the global production and supply chain?

The General Product Safety 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 7% of RAPEX notifications concerning products posing a serious risk for which the country of origin is unknown, there is still scope for improvement.

Further improvement has come as a result of the New Legal Framework Decision 768/2008/EC, which set out the indication of the name and the address of the manufacturer and the importer as a general principle for Community harmonisation legislation.

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.

Over the past years, there have been several training seminars for businesses and government officials. Early next year, the European Commission will again travel to China to inform and train manufacturers about the implications of the new toy safety rules in Europe.

These activities are supported through the EU-China Trade Project (EUCTP), which provides funding and expertise for the EU's outreach efforts in China (More information about the EUCTP can be found on: http://www.euchinawto.org/)

SECTION 5 - MEMORANDUM OF UNDERSTANDING

What is the EU-China Memorandum of Understanding?

A Memorandum of Understanding (MoU) on general product safety between DG SANCO and the Chinese General Administration for Quality Supervision, Inspection and Quarantine (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.

How has the Memorandum of Understanding been strengthened since it was first signed?

The MoU has been 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 to the Member States and stakeholders in the cooperation framework. For the full text of the updated MoU please see:

ec.europa.eu/consumers/safety/int_coop/docs/memorandum_china_annexes.pdf

SECTION 6 - OTHER SELECTED EU PRODUCT SAFETY ACTIVITIES

What work has the Commission done with business to boost the level of product safety?

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 makes 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. For more information please visit:

http://ec.europa.eu/consumers/safety/rapex/guidelines_business_en.htm

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 Commission detailed information about dangerous products found on its own market.

How is the safety of cosmetics ensured in the EU and China?

In December 2009, almost on the same day, China and the European Union each published a major new piece of cosmetics legislation: the Chinese Cosmetics Administrative Application & Acceptance Rules and the EU Cosmetics Regulation. Although there are differences in the regulatory approach, both pieces of legislation ultimately have the same objective: A high level of consumer protection, by allowing safe products to quickly enter the market and ensuring that unsafe products do not reach the market (or are quickly detected and removed).

How to define this safety? How to ensure safety? How to control safety? These are the key questions facing the legislators, control bodies and companies, irrespective of the legislative system in which they operate.

For more than seven months, no single new cosmetic products from the EU have passed through the Chinese registration process. This is not because these products are not safe - they are acceptable according to the high safety and regulatory standards of the EU but simply, because there is a lack of clarity on the requirements that need to be fulfilled.

The EU-China Seminar on Safety Assessment of Cosmetic Products and their Ingredients to be held in Beijing on 27 October should bring together regulatory experts from the competent authorities, control bodies and industry of the EU and China. The seminar is an example of the long standing history of collaboration between the EU and China on consumer safety topics.

The event will allow a better understanding of safety assessment definitions and practices relating to cosmetic ingredients and products. It will also identify possible ways in which the new regulatory texts can be ‘translated’ into smooth daily practice in the trade of cosmetic products between the two regions.

1 :

Trilateral Summit between the product safety authorities of: China (AQSIQ - Administration of Quality Supervision, Inspection, and Quarantine), the US (CPSC -Consumer Product Safety Commission) and the EU (Health and Consumers Directorate General)

2 :

The Industrial Products and WTO/TBT Consultation Mechanism between the Directorate-General for Enterprise and Industry of the European Commission and the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (October 2002).

3 :

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).

4 :

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

5 :

The Memorandum of Understanding on Administrative Cooperation Arrangement between Directorate-General for Health and Consumer Protection of the European Commission and the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (from January 2006; updated by joint statement today).

6 :

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