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European Commission


Brussels, 13 February 2013

Product Safety and Market Surveillance Package 2013 - Questions and answers

1. What does the Product Safety and Market Surveillance Package consist of?

The main elements of the Package are: a proposal for a new Regulation on Consumer Product Safety and a proposal for a single Regulation on Market Surveillance of Products. Moreover, in a multi-annual plan for market surveillance the Commission sets out 20 concrete actions how it will improve implementation of the current market surveillance rules from now until 2015. The Commission also adopted a report on the implementation of Regulation (EC) No 765/2008 on accreditation and market surveillance and a Communication on more product safety and better market surveillance in the Single Market for products that ties the whole package together.

2. Why are new rules needed and when should the proposed new rules start to apply?

The proposed new Consumer Product Safety Regulation aims at clarifying the regulatory framework for consumer products to make it fit for purpose to meet the challenges of a globalised market. It takes account of the regulatory developments in the EU during the last decade. The basic principle that all consumer products must be safe when made available on the market is kept. More emphasis is put on enhanced product identification and traceability. Also the procedures to develop new or update existing standards are significantly simplified, enhancing the role of standards in the field of consumer product safety.

The new Consumer Products Safety Regulation will complete the EU product safety framework. It will boost consumer confidence in the single market of products and ensure a level playing field for businesses.

The proposed new Market Surveillance Regulation aims at simplifying the Union framework for market surveillance of non-food products so that it works more effectively in order to protect public interests such as human health and safety or the environment. Enforcement rules that apply to products will be more uniform, market surveillance procedures streamlined and the activities of market surveillance authorities in the EU will benefit from enhanced coordination and monitoring.

The current set of market surveillance rules is fragmented and spread across several different pieces of EU legislation which causes problems for economic operators and market surveillance authorities alike. The uncertainty created by this fragmentation was criticised by the European Parliament and most stakeholders. The proposed new Market Surveillance Regulation will produce a one-tier system in which the enforcement rules are brought together in a single instrument. Thus the future Regulation will get rid of overlaps, close gaps and assimilate as far as possible the rules and procedures applicable to all non-food products. This will result in a more even application of market surveillance rules across the Member States, providing better protection for consumers and other users, more uniform trading conditions for economic operators and reduced administrative burdens. This is particularly important in the context of the economic crisis and responds to the need to make the internal market for goods more efficient and competitive.

The Commission proposals will be discussed in the European Parliament and in the Council. They are expected to come into effect from 2015.

3. What will change in a nutshell?

Today's "Product safety and market surveillance package" will enable better coordination of how authorities check products and enforce the product safety rules across the EU. In addition, the safety rules for consumer products will be clarified and strengthened:

  1. Make it easier to remove dangerous products from the market across the EU in a timely and consistent manner, when there is a need.

  2. General market surveillance and consumer safety rules for all consumer products will be aligned.

  3. Defining clearer responsibilities for manufacturers, importers and distributors when they sell consumer products.

  4. Improved traceability of consumer products throughout the supply chain – enabling a swift and effective response to safety problems (e.g. recalls).

  5. In case of known or emerging risks related to a certain type of products, reinforced controls will apply across the Union. Where products are unsafe, it will be easier to impose marketing restrictions, including their ban.

  6. Creation of a more collaborative system of market surveillance across the EU, laid down in a single set of coherent rules.

  7. Streamlined procedures concerning the notification of dangerous products, based on the synergy between the Rapid Alert Information System (RAPEX) and the Information and Communication System for Market Surveillance (ICSMS).

4. What are the benefits for consumers?

Legislation on consumer product safety requires consumer products to be safe when made available on the Union market. A set of high quality rules on the safety of products made available on the market and their traceability back to their source means more protection for consumers in the internal market.

In the same way, more coordination of the practical enforcement work is paramount to achieve a high and equal level of consumer protection across the EU.

5. How does market surveillance change?

Market surveillance authorities in the Member States will share more information between them and support each other. Information about national rules, enforcement activities and business practices will be gathered and stored in suitable IT tools easy to access. Divergences, disparities and specific needs will be identified and technical assistance offered.

The aim is to develop common practices regarding the identification and assessment of risk which should be followed across the Union. Market surveillance activities will be better coordinated and joint actions will improve their effectiveness. There should be no safe harbours for unsafe products.

The pooling of resources will help to eliminate the duplication of work and maximise the efficiency of market surveillance. Exchange of experience and information will lead to 'best practices' for the benefit of consumers, businesses and national authorities.

6. How are SME interests considered?

SMEs play a key role in shaping Europe's economy. However, the administrative burden related to market surveillance controls is generally perceived as comparatively heavier for SMEs than for major businesses.

With the proposals adopted today, the Commission does not suggest that SMEs could produce or distribute less safe products, but it proposes a simplified and coherent set of rules that makes compliance easier, especially for SMEs. The Commission is committed to providing guidance and useful information to companies and other interested parties on the interpretation and application of the new product safety and market surveillance rules.

7. What new obligations are there for manufacturers and importers?

Manufacturers and importers are responsible for placing only safe products on the market. They will be asked to provide appropriate information on the product allowing its identification and traceability, including information on the product's origin.

The indication of origin supplements the basic traceability requirements concerning the name and address of the manufacturer. In particular, the indication of the country of origin helps to identify the actual place of manufacture in all those cases where the manufacturer cannot be contacted or its given address is different from the actual place of manufacture. Such information can facilitate the task of market surveillance authorities in tracing the product back to the actual place of manufacture and enable contacts with the authorities of the countries of origin in the framework of bilateral or multilateral cooperation on consumer product safety for appropriate follow up actions

The requirements are the same throughout the Union and provide an equal level playing field.

8. What are the new obligations of distributors?

Distributors, such as wholesalers and retailers, must check that the manufacturer or importer has duly labelled the product before selling it to their clients or offering it for sale in their shops.

9. What are the new obligations of national authorities?

The information-sharing and cooperation amongst national authorities is enhanced. For example, national authorities must respond to requests of mutual assistance from their counterparts in other Member States.

The obligation to carry out market surveillance on an adequate scale is reinforced and where necessary specific sampling and testing obligations can be adopted where the risks relating to a category of products so justifies.

10. What is covered by the market surveillance legislation and RAPEX?

The Rapid Alert Information System (RAPEX) is moved from the current General Product Safety Directive to the future Market Surveillance Regulation in order to assimilate as far as possible the rules and procedures applicable to all products in case of risk. The Regulation will cover the large majority of non-food products, with limited exceptions, such as pharmaceuticals and medical devices as they are covered by other specific surveillance systems.

11. How do Member States share market surveillance findings between them? What is new regarding RAPEX?

At present, two separate procedures operate, sometimes in parallel, which requires Member States to notify to the Commission and the other Member States certain market surveillance action taken at national level. Under the future Market Surveillance Regulation the two procedures become a single procedural flow with certain events triggering a single notification to the other Member States and the Commission (made using either the proven RAPEX rapid alert system or the Information and Communication System for Market Surveillance in accordance with the distinction made in this Regulation). Member States can thus use the information collected by other countries' authorities and avoid double work.

12. How will the package simplify EU legislation?

The number of pieces of legislation will be reduced because the state-of-the-art Consumer Product Safety Regulation will replace Directive 87/357/EEC on food-imitating products and Directive 2001/95/EC on general product safety that are both outdated. Moreover, the market surveillance rules spread across numerous legal texts will be merged into one regulation. Simpler legislation and more uniform rules are good for businesses and will improve fair play among them. Problems as criticised by the European Parliament and other stakeholders will no longer exist.

13. Will legislative overlaps be abolished?

The proposed Market Surveillance Regulation will dispense with the distinction between consumer and professional products for market surveillance purposes. It will also avoid making a distinction between harmonised products and non-harmonised products except where this is unavoidable in applying certain specific provisions. To the greatest extent possible the applicable rules are the same for all non-food products.

14. How will the new legislation be made more accessible and user friendly?

The new Regulation sets out the whole process of a market surveillance exercise in a chronological, sequential manner. It presents a chain of events, incorporating relevant provisions on natural justice aspects, publication of information, notification etc. at each stage of the procedure. This approach substantially improves the accessibility, transparency and user-friendliness of the legislation, and hence its effectiveness.

15. What can already be done now?

One of the key parts of the package is the multi-annual plan for market surveillance consisting of individual actions that the Commission will undertake over the next three years to improve market surveillance for products in the EU. With this plan the Commission aims to fill gaps and make the surveillance of the single market for products (with the exception of food, feed and medicines) more efficient and operational by assisting Member States Authorities in undertaking their tasks. The objective of these actions are as follows :

a. Sharing information avoids duplication of work

  1. Facilitating the 'portability' of test reports: Sharing information between market surveillance authorities and with customs across the EU is essential to avoid duplication work. Therefore the Commission will promote the use of results of tests already performed in one Member State by other Member States and will also facilitate their distribution via Information and Communication System for Market Surveillance (ICSMS)1. The system will be developed further to collect, store and exchange information and best practices among all the actors directly concerned including publication of test results, results of joint actions, guidelines and guidance for training of market surveillance authorities, case studies, statistics and overall information on market surveillance for products.

  2. Synergies between both systems: The Commission will ensure synergies between the Rapex Information System (GRAS-RAPEX)2 and ICSMS. In addition the Commission will examine the feasibility of a public Consumer Product Safety Information Database, which could include a platform for complaints and injuries.

  3. A EU general risk assessment methodology for products: The Commission will complete and update the general risk assessment methodology3 so that they cover all risks. A more effective and efficient risk assessment will avoid double work for assessment of the other risks.

b. More efficient cooperation throughout the EU

There is a need for more cross-border cooperation on market surveillance in order to ensure the sharing of information on inspection results and to avoid the repetition of tests. Consequently this group of actions includes:

Coordination of cross-border surveillance activities: The Commission will prepare the creation of an Executive Secretariat that will assist the EU Market Surveillance Forum to facilitate the coherent implementation of the activities covered by this plan or in the relevant EU legislation. This will facilitate and ensure better results with fewer resources in which all actors can have confidence. It will contribute to ensuring consistent and efficient implementation and enforcement of EU provisions.

Joint enforcement actions will pool resources: The Commission will support joint enforcement actions, allowing market surveillance authorities and customs to pool resources and expertise and to apply SME-friendly methods (information will be made available electronically and rules will be made more uniform, accessible and user friendly). Exchanges of officials between Member States to share and gain experience are also planned.

Closer European cooperation on market surveillance will reduce administrative burden: The Commission will support the better functioning of the informal and sectorial 'Administrative Cooperation' groups (ADCOs), with a view to reduce the administrative burden and costs.

Products sold on-line: short, simple and clear common rules. The Commission intends to study the ways in which e-shops operate, in particular if products are distributed to the final consumer directly from third countries. It will be completed by clear rules for products sold online, guidance, collection of information and education of relevant parties (authorities, economic operators and consumers).

c. Continuous European dialogue with stakeholders – Listening to SMEs

A continuous European dialogue with all stakeholders will be launched involving all parties in the supply chain, and especially small and medium-sized enterprises (SMEs). For them the administrative burden coping with market surveillance controls is comparatively heavier than for major businesses. Market surveillance authorities should involve them more closely in identifying problems, listing categories of products that need closer attention and finding effective solutions. This dialogue is essential, as participants know the products and the risks that they can present to users. From its part the Commission will contribute with feedback, input and suggestions on market surveillance in the EU. This will help to identify new needs for market surveillance and should address the specific concerns of consumers, SMEs and other businesses.

d. Improving supply chain supervision: all parties have a role to play

Market surveillance is the responsibility of the relevant national market surveillance authorities. However, all parties in the supply chain, including businesses and consumers, have a role to play.

  1. Improving product traceability in the supply chain: With a view to improve the identification of actors in the supply chain, the Commission will speed up its work to improve product traceability. It comprises evaluation of the recommendations of the "Expert Group on Product Traceability" and up-to-date guidance, taking into account the specific needs of SMEs.

  2. Including non-harmonised categories of products in safety tests: Within the EU, products are traditionally subdivided into 'consumer' or 'professional', and 'harmonised' or 'non-harmonised' categories. The safety requirements for consumer products that are not yet harmonised will be further strengthened by the proposal for a Consumer Products Safety Regulation. In this respect the Commission will initiate study of the safety aspects of professional, non-harmonised products, i.e. products that are not subject to European rules on safety or other essential requirements, and the corresponding difficulties for market surveillance authorities. This will help businesses to better trade such goods in the internal market.

e. More safety and less unfair competition: More and better controls on products entering the EU

Controls at borders should be organised and performed in the same way as within the EU, since checks performed at the first point of entry or during the declaration of goods for release for free circulation prevent the spread of dangerous products on the EU market.

Improve the efficiency of border safety controls: The Commission will support the implementation of uniform rules4 in order to assist Member Sates' customs controls and to improve cooperation between customs and market surveillance authorities. Actions envisaged include data collection on control results and joint enforcement actions. They will also allow customs authorities to have an overview of the market surveillance objectives and organisation at national and EU levels, with specific reference to the treatment of SMEs. In addition the Commission will support to improve the efficiency of border safety and compliance controls through better coordination, shared activities, good cooperation and exchange of information.

A common risk approach to customs controls: Appropriate risk management is a prerequisite for efficient import controls5. The Commission, together with the Member States, will set up a common risk approach for product safety and compliance controls on imported products. This includes the development of common criteria for risk assessment as part of the customs control systems and methods of exchange of information between customs and Market Surveillance Authorities for managing risk at the point of import.

For more information:


Weekly RAPEX reports or specific data:


3 :

Available in the RAPEX Guidelines (OJEU No L 22 of 26.01.2010)

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