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Document 52000PC0139

Proposal for a Directive of the European Parliament and of the Council on general product safety

/* COM/2000/0139 final - COD 2000/0073 */

OJ C 337E , 28.11.2000, p. 109–121 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)

52000PC0139

Proposal for a Directive of the European Parliament and of the Council on general product safety /* COM/2000/0139 final - COD 2000/0073 */

Official Journal C 337 E , 28/11/2000 P. 0109 - 0121


Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on general product safety

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. Introduction

2. Reasons, objectives and main elements of the proposal

3. Subsidiarity

4. Economic aspects and impact on SMEs

5. Consultations

6. Contents of the proposal

1. Introduction

Council Directive 92/59/EEC on general product safety (GPSD) was adopted on 29 June 1992 and was to be applied by the Member States at the latest by 29 June 1994. The Directive was based on Article 100A (now Article 95) and was adopted, before the entry into force of the Maastricht Treaty, in cooperation with the European Parliament.

Article 16 of the Directive states that:

"Four years from the date referred to in Article 17(1), on the basis of a Commission report on the experience acquired, together with appropriate proposals, the Council shall decide whether to adjust this Directive, in particular with a view to extending its scope as laid down in Article 1(1) and Article 2(a), and whether the provisions of Title V should be amended".

The Commission has conducted an in-depth review and assessment of the implementation and practical application of the Directive.

A report on the main findings of this review is presented separately to the European Parliament and the Council. In addition, full details are available in a study report (available on http://europa.eu.int/comm/dgs/health_consumer/index), which has been carried out for the Commission by the "Centre du droit de la Consommation" of the Université Catholique de Louvain.

Improvements in consumer health and safety represent one of the political priorities announced by the Commission. This proposal is framed within the actions intended to achieve this objective. The General Product Safety Directive and other Directives related to product safety have established an elevated level of consumer protection in the European Union. Nevertheless, recent crises in the food sector and certain weaknesses in the safety of industrial products have demonstrated the need to reinforce the present legal regime. Experience so far has shown some weaknesses in the provisions of the Directive, which have limited the achievement of its objectives and, in addition, some consumer protection needs which are not sufficiently addressed in the Directive as it presently stands.

Statistics which have been collected through the European Home and Leisure Accidents Surveillance System (EHLASS) [1], the European global system for collecting uniform data on consumer accidents, indicated a high number of fatalities due to these types of accidents, part of which are related to the use of consumer products. The annual number of fatalities in the Union during home and leisure activities was (in 1996) 83 000, while approximately 6 000 die at the workplace and 45 000 in traffic accidents. Home and leisure accidents are the most important cause of death for persons under 35 years of age. However, it is important to note that these figures also include accidents which may not necessarily involve dangerous products within the meaning of the present Directive.

[1] Now part of the Injury Prevention Programme in the framework for action in the field of public health (1999-2003).

Food safety is already regulated by a body of specific Community legislation. Nevertheless, at present, food safety issues are managed within the same institutional framework as other consumer products. However, the White Paper on Food Safety foresees that the proposed Food Safety Authority will in future assist the Commission on all product safety issues in relation to food. In particular, it is envisaged that the food notifications which are now made using the Rapid Exchange of Information System will accordingly fall under the ambit of this Authority, thus reducing the scope of the GPSD.

The proposal for revision of the Directive presented here is intended to address, as appropriate, both the issues mentioned in Article 16 above and the weaknesses and additional needs identified in the review, with the aim of contributing to the achievement of a high level of consumer health and safety protection.

Aims and scope of the existing general product safety Directive

The Directive regulates the safety of consumer products and aims at ensuring that products placed on the market are safe. The products covered are those intended for consumers or likely to be used by consumers, supplied in the course of a commercial activity. This includes new, used and reconditioned products, with the exception of antiques and products sold with a view to being reconditioned, provided that the supplier informs the consumer of this fact. A generic definition of "safe product" has been provided.

The overall aim of this Directive is to harmonise the measures of the Member States aimed at imposing a general obligation to market only safe products, to ensure both a consistent and high level of protection of consumer health and safety throughout the EC and the proper functioning of the internal market.

According to the preamble of the Directive, a broadly based, legislative framework of a horizontal nature is needed to cover products not covered by specific, sectoral Community legislation as well as to "cover lacunae in existing or forthcoming specific legislation".

Therefore, the Directive is intended as a complement to sectoral Community legislation to:

- cover products which are not subject to sectoral legislation;

- also cover products that are subject to sectoral legislation (existing and forthcoming), for the categories of risks, safety aspects, and administrative and control requirements, which are not addressed in such sectoral legislation.

However, the preamble of the Directive clarifies that when there are rules involving total harmonisation which lay down obligations regarding product safety, further obligations on the placing on the market of the products covered by such rules should not be imposed on economic operators. This is in particular the case of products covered by the "new approach" Directives. Moreover, Article 1 states that "where specific rules of Community law contain provisions governing only certain aspects of product safety or categories of risks for the products concerned, those are the provisions which shall apply to the products concerned with regard to the relevant safety aspects or risks".

Main contents of the existing general product safety Directive

In summary, Directive 92/59/EEC includes the following main provisions:

Obligations for producers:

- to place only safe products on the market;

- to provide consumers with the relevant information to assess the risks associated with a product;

- to adopt measures to ensure that they will be informed of risks posed by the products which they supply, and to take action to prevent those risks, including withdrawal of products when necessary.

Obligations for distributors:

- not to supply products which they know or should have presumed to be dangerous;

- to collaborate in the monitoring of the safety of products they supply and in action to prevent any risks posed by such products.

Definition of criteria for assessing product safety and deciding under which conditions a product should be deemed to be safe

- products conforming to specific rules of national law of the Member State in which they circulate are deemed to be in compliance with the general safety requirement of the GPSD;

- in the other cases, the safety of a product must be assessed having regard to European or national voluntary standards, Community technical specifications, codes of good practice, the state of the art and expectations of consumers.

Obligations of the Member States:

- to take measures to make producers and distributors comply with their obligations. This includes in particular establishing or designating market surveillance authorities empowered to adopt a range of control and enforcement measures and to impose sanctions in the event of failure to comply with the obligations of the Directive;

- to notify the Commission of the measures they take restricting the marketing of products or imposing their withdrawal from the market. The Commission will then examine the reasons for the measures and inform all Member States when it concludes that a measure is justified;

- to ensure that their officials and agents do not disclose information covered by professional secrecy, obtained for the purposes of the Directive, except for information relating to the safety of a product which must be made public in order to protect the health and safety of persons. This also applies to Commission officials.

Establishment of a rapid exchange of information system (RAPEX) for products posing a serious and immediate risk

Under this system, when a Member State adopts or decides to adopt emergency measures to prevent, restrict or impose specific conditions on the marketing or use of products posing a serious and immediate risk, it must notify the Commission which, in turn, will inform the other Member States. Details of the functioning of the system are set out in an Annex to the Directive.

Procedures for Community-wide measures

The Commission, assisted by a Committee, may adopt temporary, Community-wide measures concerning products posing a serious and immediate risk, subject to a number of substantive and procedural conditions.

Committee

A regulatory Committee is in charge of assisting the Commission on adaptations to the Annex, related to RAPEX procedures, and in the adoption of Community measures in case of emergency situations.

Review of the implementation of the General Product Safety Directive

In Article 16 of Directive 92/59/EEC reference is made, with a view to revising the Directive, to its scope (Articles 1(1) and 2(a)) and to emergency situations and action at Community level (Title V).

The Commission decided to postpone the presentation of a proposal for the revision of the Directive in order to acquire more experience, ensure a better preparation and, in particular, complete a study on the implementation of the GPSD.

As mentioned above, a study on the legal and practical application of the GPSD, including the identification of problem areas and conclusions on the need for amendment, was completed in October 1999 by the "Centre du Droit de la Consommation" of the Louvain University. This study covered all EU Member States and in addition, Norway and Iceland in the EEA.

Extensive consultations have been held by the Commission on the revision of the Directive, as presented in detail in paragraph 5 below.

An assessment of the functioning of the RAPEX, an important element of the Directive, has been completed by the Commission with interviews in all Member States. The main results of these visits are presented in the Commission report to the European Parliament and the Council on the experience acquired with the application of the Directive.

2. reasons, objectives and main elements of the proposal

In order to fulfil its general objective, the Directive is intended to create a horizontal regulatory framework to complete and complement sectoral product safety Community legislation.

While the overall approach of the Directive has turned out to be fundamentally sound and does not need substantial revision, its objectives have not been fully achieved because of some lack of clarity, weakness or lacunae in certain of its provisions.

More specifically the following needs and objectives have been identified for the revision.

2.1. Relationship between the GPSD and sectoral Community legislation

The aim of the GPSD was to introduce a horizontal regulatory framework for all consumer products to cover products not subject to specific Community legislation, but also to fill gaps in such legislation. As previously explained, the GPSD not only sets a general safety requirement for consumer products, but it also introduces additional requirements for producers and distributors, provisions on control and enforcement, notification systems (in particular the RAPEX) and Community-wide action in particular cases.

The review of the application of the GPSD has shown that there has been some uncertainty, disagreement or lack of awareness on the applicability of certain provisions of the GPSD in the case of products covered by sectoral legislation.

Some Member States have considered that certain of the provisions of the GPSD do not apply in the case of products covered by sectoral legislation, in spite of the fact that such legislation does not include equivalent provisions.

In particular, several Community Directives setting safety requirements for certain categories of products do not establish obligations for producers and distributors as in Article 3(2) and 3(3) of the GPSD, provisions on market surveillance, on notification under a rapid alert system and for Community emergency measures. As a consequence of the divergent application of the GPSD as a complement to sectoral legislation, these important aspects of product safety are not treated in a consistent way throughout the Community. This situation needs to be rectified, taking also into account that these are aspects on which improvement, reinforcement and additions to the GPSD are necessary and they would have little effect if their applicability to all consumer products were not guaranteed.

The unclear formulation of Article 1 of the GPSD should be adapted to provide clarity and legal certainty on the applicability of the various provisions of the GPSD in the different cases.

The situation should therefore be clarified as follows:

- All the provisions of the GPSD apply in the case of consumer products not covered by any sectoral Community legislation concerning their safety;

- In the case of products covered by the specific safety requirements of sectoral Community legislation, these requirements replace the general safety requirement, the definition of "safe" product and the conformity criteria of the GPSD for the products concerned. However, if these requirements cover only certain safety aspects of the products concerned, the general safety requirement, the definition of "safe" product and the conformity criteria of the GPSD apply to the remaining aspects. All the provisions of the GPSD other than the general safety requirement (in short: additional obligations of producers and distributors, market surveillance, RAPEX, measures at Community level) apply without prejudice to specific provisions in sectoral legislation;

- The Community legislation aimed at "total safety" (legislation harmonising all the safety requirements which are considered to be relevant for a product category), in particular the directives of the "new approach type", are assumed by definition to set safety requirements covering all the safety aspects which must be taken into account for ensuring the safety of the product considered. Products in conformity with these requirements must circulate freely in the internal market, subject to the application of the conformity assessment procedures of the relevant directives. Therefore, these "essential safety requirements" are the only safety requirements applicable in the case of products covered by such directives. The general safety requirement, the definition of "safe product" and the conformity criteria of the GPSD, do not apply in this case. As above, the other provisions of the GPSD do apply in this case, without prejudice to any specific requirements for the same aspects established in the sectoral legislation applicable.

2.2. Scope of the General Product Safety Directive

Under the present formulation, only products intended for, or likely to be used by consumers, supplied in the course of a commercial activity, are included in the scope of the Directive.

The possible inclusion of services within the scope of the Directive has been suggested and considered. Services are increasingly important for the internal market and some services involve significant safety aspects. Certain Member States have included services in their legislation transposing Directive 92/59/EEC.

Discussions on the subject have shown the importance and urgent need to consider Community action on service safety. The Commission has launched action in order to prepare as soon as possible specific proposals in this area. Work in progress is aimed at identifying the priority sectors, and the best approach for Community action on service safety (general regulatory framework or legislation in specific sectors; approach based on safety requirements or the liability of providers or both, etc.).

At this stage, pending completion of the examination in progress, it is proposed to limit the extension of the scope of the GPSD to products related to services. This would cover:

- products which are supplied to consumers, or used by consumers, in the course of a service;

- products used to provide a service, as far as their intrinsic consumer safety aspects are concerned.

In both cases, significant safety aspects are involved, which are becoming more relevant with the development of the service sector (for example: tourist services, fitness centres, etc.).

The scope of the Directive should also be clarified in order to ensure that products not intended for consumers, but likely to be used by them under reasonably foreseeable conditions are subject to the requirements of the Directive. The objective is in particular to avoid that "professional" products "migrate" to consumer markets without the appropriate adaptations, protective and control measures.

2.3. Obligations of producers and distributors

The GPSD establishes obligations for producers and also sets out other obligations for distributors, as explained above.

Experience has demonstrated a need to complete these obligations for producers and distributors with regard to some aspects.

Producers and distributors can in some cases determine by tests or safety assessments or conclude after receiving and examining complaints or external information, that products that they supply or have supplied are dangerous and take action in order to prevent risks to consumers. In such cases, producers and distributors are obliged in some countries outside the EU (in particular the USA and Australia), to immediately notify the authorities of their findings and of the measures taken by them. This information may be very important for market surveillance authorities to trace the products under consideration, verify whether other products present the same risk, take any necessary measure and inform the authorities of the other Member States as appropriate. However, Community legislation and the national legislation of several Member States does not include an obligation to inform the authorities in such cases. This obligation should be included in the GPSD to contribute to reinforce the effectiveness of market surveillance in the Community. The conditions under which such notifications must be presented and their content, should be defined in a clear way in order to prevent an excessive burden for economic operators and the administrations.

More generally, recent events have shown the importance of close and effective collaboration between producers, distributors and national authorities, in particular for managing crises. Such cooperation is essential in rapidly tracing dangerous products during emergency situations and organising their withdrawal. A general obligation for producers and distributors to collaborate with the authorities in such cases should apply throughout the Community. Procedures should also be foreseen in order to facilitate a dialogue between economic operators and the authorities on product safety issues.

The GPSD provides for the withdrawal from the market, by producers, of dangerous products when necessary to prevent risks to consumers. In such cases, the products under consideration are withdrawn from shops and stores in the distribution chain. The stocks of products in the shops may not be sold and must be removed, and those not yet in the distribution chain may not leave the stores of producers or importers. However, the GPSD does not make provisions for the recall by producers and distributors for replacement, repair or reimbursement of dangerous products already sold, or otherwise supplied to consumers in order to ensure consumer safety. Moreover, it is necessary in some cases that producers warn consumers of the risks posed by products that have already been sold to them. The legal provisions and practice of the Member States in respect of these aspects are uneven. The GPSD should be amended in order to introduce consistent provisions in this area.

2.4. Conformity assessment criteria and product safety standards

Article 4 of Directive 92/59/EEC states that, unless specific relevant regulatory requirements exist at Community or national level, the safety of a product must be assessed taking into account:

- national standards transposing European standards, or

- Community technical specifications, or

- national standards, or

- codes of good practices in respect of health and safety in the sector concerned, or

- the state of the art technology and the level of safety which consumers may reasonably expect.

When a product is in compliance with specific national regulatory requirements applicable in the Member State in which it is placed on the market, it is deemed to be "safe" according to the provision of the Directive. In the absence of such requirements, the abovementioned non-binding specifications have to be taken into account in vetting the product. The Directive seems to establish a hierarchical order among the specifications mentioned in the list.

Experience has shown that the potential of the Directive for ensuring a consistent, high level of protection throughout the EU and the proper functioning of the internal market is limited by the way in which conformity assessment criteria are defined and the lack of a clearly defined legal status for them.

In particular, European standards do not confer a "presumption of conformity" under this Directive, unlike the counterpart, harmonised standards under the "new approach" directives.

The nature, status and practical relevance of the other documents or references mentioned in Article 4 is open to interpretation.

Standardisation mandates for the European standardisation bodies to produce standards under this Directive are not mentioned and publication in the OPEC of the references of these standards is not foreseen.

The lack of "status" of European standards under this Directive has weakened its credibility as an effective instrument for ensuring harmonization.

Often manufacturers of certain categories of products have requested the adoption of specific Directives for their products, in spite of the fact that the products considered were covered by Directive 92/59/EEC and specific European standards.

On the side of both industry and consumers, the need for additional sectoral legislation is often felt as the Directive is not always considered sufficient for the objectives of consumer protection and the internal market.

It would clearly not be possible to introduce into the Directive itself detailed safety requirements covering in a sufficient manner all the products falling within its wide scope. Therefore, it is essential to strengthen the role of European standards in establishing the conformity of products to the general safety requirement of the Directive. In this way, the GPSD could provide a framework for ensuring a sufficient degree of harmonisation in consumer safety requirements, for the product groups most relevant for consumer safety, and the functioning of the internal market, with a flexible approach while avoiding the need for a proliferation of sectoral legislation. The revision should permit that products in compliance with European standards established by European standardisation bodies under mandate from the Commission, whose references are published in the Official Journal of the European Communities, be presumed in conformity with the safety requirements of the Directive.

The procedure foreseen in Directive 98/34/EC will apply for the establishment of standardisation mandates under the GPSD. The Commission will be assisted by the Committee of Directive 98/34/EEC. The same procedure will also apply for the possible publication of certain existing standards of the appropriate quality.

In addition, the Commission, as foreseen in the Treaty, may adopt recommendations addressed to the Member States. Such recommendations can be used, for the aims of the GPSD, to establish guidelines for the assessment of product safety to facilitate effective and consistent implementation of the Directive in respect of certain products and categories of risks. These recommendations could be established in particular for facilitating the application of the GPSD to certain products, pending the adoption of specific standards for them or when standards are not deemed to be necessary or appropriate.

A "safeguard clause" procedure should be included in the GPSD in order to allow the Member States and the Commission to intervene if a standard does not provide the required level of protection.

2.5. Market surveillance and enforcement powers

Directive 92/59/EEC sets out "the obligations and powers of the Member States" in relation to market surveillance and enforcement of the requirements of the Directive.

Market surveillance and the establishment and application of enforcement powers are of the utmost importance to ensure the effective and consistent implementation of Community requirements concerning consumer product safety at large. However, experience has shown uneven enforcement of the GPSD and other relevant product safety legislation due to disparities in the effectiveness of the control and enforcement systems put in place in the Member States.

Moreover, sanctions are often not dissuasive enough or not applied and therefore do not always represent an effective means of ensuring compliance.

Finally, whereas the internal EU market for consumer products is now open and integrated, market surveillance is still fragmented, with too little collaboration between the relevant authorities of the Member States.

Therefore, there is a need for more stringent Community provisions on market surveillance and enforcement powers to:

- ensure that effective, proportional and dissuasive sanctions are applied as necessary;

- ensure that systematic and coordinated market surveillance approaches are put in place by all Member States aiming at comparable levels of effectiveness and able to guarantee a high level of consumer protection;

- ensure that the market surveillance systems work in a transparent manner and are open to consumers and other stakeholders;

- provide for a periodic assessment by the Commission of the results achieved by the market surveillance systems of the Member States, as part of a broader assessment of the functioning of the GPSD;

- set-up a framework for systematic collaboration between the enforcement authorities of the Member States, with the participation of the Commission. To this end, a European Product Safety Network should be established to promote, at operational level, exchange of information on risk assessment, test methods, etc, and facilitate the execution of joint projects and activities;

- encourage the Member States to use the most recent scientific developments;

- reinforce the enforcement powers of competent authorities in particular in relation to:

- the prohibition on export of dangerous products to non-member countries;

- recall of dangerous products already supplied to consumers, and adequate consumer information on the risks posed by them;

- temporary prohibition of the placing on the market of certain products, pending verification and assessment of their risks;

- rapid action, in case of serious risks requiring immediate or rapid intervention, and removal of limitations on the circulation of information on such risks for the aims of the GPSD.

2.6. Notification and exchange of information

Under the GPSD, Member States must notify the Commission of measures taken which restrict the placing on the market, or require the withdrawal, of a product or product batch. In the case of products posing a serious and immediate risk, the information on such measures, taken or decided by a Member State, is rapidly transmitted by the Commission to all Member States (RAPEX system). Such notifications are not required in the case of risks which have only a local effect.

Apart from the notifications presented under RAPEX, the Commission must hold consultations with the interested parties, assess the justification of each measure and inform all Member States of its conclusions if it considers that the measure is justified.

The experience with the notification requirements has shown a need for streamlining and reinforcing certain of the relevant provisions.

It should be clarified that notification requirements cover measures related to both individual products (products of a specific brand and type) or batches of such products, and categories of products, i.e. all products serving the same or similar functions and posing a given risk.

In future, measures related to risk which are deemed to be only local should also be notified, while indicating in the notification the limited effect, because it is in many cases difficult to exclude any future occurrence of a similar risk in another Member State.

The heavy consultation and assessment procedure by the Commission foreseen in Article 7 of the GPSD, should be simplified to allow for rapid information of all the Member States on measures which the Commission considers to be justified.

The RAPEX system should be revised as follows:

- Voluntary action instigated by or agreed with the authorities should also be notified. In fact, in many cases such voluntary action prevents the need for mandatory measures by removing the risk in question. Information to all Member States on such action is necessary for the effective and consistent enforcement of the Directive.

- Measures or action to be notified are those related to serious risks for the health and safety of consumers which require rapid intervention. The concept of "immediate risk" has appeared, in the light of experience, to be a source of confusion and legal uncertainty. No clear and common EU definition has emerged and therefore this concept is of little use in practice, even complicating decisions on the necessary protective action.

There can be a variety of situations necessitating rapid intervention. The concepts of "immediate risk" and "emergency measures" do not always apply to such situations and may in some cases distort the perception of the safety issues considered as well as creating an unjustified and extreme concern.

- The role of the Commission needs to be clarified. It is not possible for the Commission to complete its own assessment of the risk posed by a product within the deadlines foreseen for circulating the information to all Member States. Therefore, the initial assessment by the Commission will be limited to verifying compliance with the requirements established by the revised GPSD for the functioning of RAPEX, in particular the inclusion of adequate information on the risk in question, measures taken and their justifications.

- It should be possible to open the RAPEX system to allow for the participation of non-EU countries or international organisations, on the basis of reciprocity, under appropriate conditions. This could be achieved through specific agreements between the EC and these countries or organisations. The benefit would be a broader coverage of risks and dangerous products, and more effective protective action.

- The Annex to the Directive, introducing requirements on the operation of the RAPEX system, should provide for the establishment by the Commission, assisted by an Advisory Committee, of operational guidelines aimed at facilitating the effective functioning of the system.

2.7. Rapid action at Community level

The GPSD provides for the adoption by the Commission (assisted by the Emergencies Committee) of decisions requiring Member States to take temporary measures in case of products posing a serious and immediate risk, under a number of substantive and procedural conditions.

The conditions for these decisions are very restrictive. It has been difficult in practice to reach agreement on the use of this procedure.

The main needs for the improvement of the mechanism of rapid measures at Community level are the following:

- It should be clarified that such decisions may be taken when there is a need for rapid action.

- For the reasons explained above, the reference to the concept of immediate risk, which cannot be defined and therefore creates legal uncertainty, should be deleted.

- The validity of these decisions should be extended from the present three months to one year. The measures would be periodically reviewed and renewed as appropriate. In this way the excessive administrative burden caused by the present very limited validity would be eliminated.

- Measures concerning a specific product or batch of products should have unlimited validity. It is, in fact, impractical and inappropriate to confirm by Council and European Parliament directives or decisions measures concerning individual products, or batches of products, of specific brands and types.

- The conditions for adopting decisions under this procedure should be simplified. The necessary conditions motivating a rapid measure at Community level under this procedure are in fact: the divergence between the Member States on the measures to deal with the risk considered, the absence of specific procedures for rapid Community action for the products considered and the existence of a situation where the risk can be eliminated more effectively by Community action to ensure a consistent level of protection and the proper functioning of the internal market. On the contrary, the condition that the information on the risks can only be provided by a Member State conflicts with the realities of the global market, the growing importance of independent scientific advice and the part played by consumer organisations. Finally, the requirement that at least one Member State has decided measures in respect of the product considered is not compatible with the need for rapid action, whereas the requirement that a Member State requests a Commission decision overlaps with the Committee procedure foreseen for its adoption.

- Finally, the imposition of a period of ten days for applying any measures decided under this procedure is impractical. It should be possible to adapt the period foreseen to the specific cases considered.

- There is a risk that products which have been subject to a Community decision temporarily or permanently prohibiting them from being placed on the Community market or which have been withdrawn from the market or recalled from the consumers are exported from the Community to non-EU countries. The present GPSD does not prevent such an export.

The authorities of certain Member States are particularly concerned about the destination of stocks of products that they have ordered to be withdrawn from the market because of the risks for the health and safety of consumers. Some Member States have therefore introduced a ban on export of dangerous products, in particular to prevent stocks withdrawn from their market from being sold on the external markets.

Consumers all over the world have the right to expect that products, which have been prohibited from being placed on the Community market, are not exported to the them. In addition there is a risk that prohibited products which have been exported cold be re-imported to the EU-market.

It is therefore proposed to prohibit the export to non-EU countries of products which have been subject to a Community decision temporarily or permanently prohibiting it from being placed on the Community market or which have been withdrawn from the market or recalled from the consumers. The responsibility to ensure compliance with this obligation will be incumbent on producers and exporters. The authorities should intervene in case of infringement.

2.8. Committees

Under the GPSD, the Commission is assisted by a regulatory Committee of representatives of the Member States. The Committee is consulted on the decisions mentioned in Article 9 of the Directive and on the amendments to the Annex.

The Committee is referred to in the Directive as the "Emergencies Committee"(in spite of the fact that the Commission decisions concerning products posing "serious and immediate risks" are not explicitly restricted to emergencies).

The "Emergencies Committee" should be renamed as the "Regulatory Consumer Product Safety Committee" in order to better reflect its tasks. The procedures for the consultation of this Committee should be put in line with the rules for the exercise of implementing powers conferred on the Commission, set out by Council Decision 1999/468/EC.

The Commission considers that an Advisory Consumer Product Safety Committee will be useful to examine any question concerning the application of this Directive (rapid measures excepted), in particular issues related to enforcement and market surveillance activities. Members of this committee will be experts from the different national administrations competent for consumer safety.

Moreover, a need has appeared in practice for a forum where all aspects of the application of the Directive could be discussed and appropriate collaboration promoted between all the interested parties. The Commission intends therefore to introduce in the rules of procedure of the Advisory Consumer Product Safety Committee the possibility to consult, the stakeholders, the relevant standardization and technical bodies and other experts according to the subjects being considered.

Finally, a close cooperation should be ensured between the Consumer Product Safety Committees and the other Committees established by specific rules of Community law to assist the Commission as regards the health and safety aspects of the products concerned.

2.9. Confidentiality

The present provisions of the GPSD concerning confidentiality have not ensured an approach throughout the EU sufficiently consistent for the aims of the Directive.

In some cases, information that is considered confidential in one Member State must be made public under the openness requirements of other Member States. This creates difficulties regarding the circulation, use and disclosure to the public of information on risks and dangerous products, in particular within the framework of the RAPEX system.

The provisions of the GPSD should be clarified further in order to achieve a common approach to information management in this area. Protection should be restricted to professional secrecy, whereas the information on product risks available to the authorities not covered by such secrecy should be available to the public.

3. subsidiarity

The General Product Safety Directive was adopted in 1992 as part of the programme aimed at establishing the internal market by 31 December 1992. It was specifically intended to prevent possible barriers to trade and distortion of competition within the internal market associated with disparities between horizontal product safety legislation of the Member States. In accordance with the Treaty provisions, in particular Article 100A (now Article 95), this was to be achieved by setting requirements aiming at a high level of consumer health and safety protection.

The aims of the General Product Safety Directive fall within the fundamental competencies of the European Community and by definition can only be achieved by measures at Community level.

All the amendments proposed are aimed at reinforcing the effectiveness of the Directive and ensuring a more consistent implementation of its provisions.

As far as the market surveillance provisions are concerned, it should be observed that it is primarily for the Member States to decide the approach and measures to be put in place to ensure that producers and distributors comply with their obligations under the Directive. These measures will need to take into account the internal institutional arrangements and administrative practices of the Member States.

However, if the market surveillance systems and enforcement approaches put in place are not sufficiently effective, the objectives of the Directive cannot be attained. Moreover, weaknesses in the enforcement activities of a Member State can, under certain circumstances, affect the safety of consumers in other Member States. Experience has shown that in such cases, consumer confidence can be compromised throughout the EU and entire economic sectors can be disrupted.

It is therefore necessary to better define the obligations facing Member States concerning the establishment of the appropriate enforcement means and procedures. Such obligations should not, however, interfere with internal institutional structures, administrative practices and the distribution of competencies among the institutional and administrative levels and sectors within the Member States.

Therefore, the relevant new provisions related to market surveillance and enforcement powers are formulated in a generic way, compatible with the various internal conditions of the Member States.

4. economic aspects and impact on small and medium-sized enterprises (smes)

Several of the new or modified provisions introduced by the proposed revision are of an administrative nature (such as those concerning the reinforcement of market surveillance, better collaboration between Member States, improvement to the RAPEX system, etc.) and have no impact on economic operators.

Certain other amendments only aim at clarifying the present text to ensure a more effective and consistent implementation (for instance the amendments concerning the scope of the Directive, its relationships with other Directives, etc.). Also, in this case, there is no impact of the amendments on economic operators.

However, a few proposed amendments may well have economic implications for businesses:

- the obligation of producers and distributors to inform the authorities when they conclude that a product that they supply is dangerous;

- the obligation of producers and distributors to collaborate with the authorities in order to prevent risks to consumer health and safety;

- the obligation to recall dangerous products, when necessary in order to prevent risks;

- the prohibition on the export to non-EU countries of dangerous products.

All these obligations, except the last one, apply only in the case where economic operators have placed on the market a dangerous product, in breach of the fundamental obligation to market only safe products. Producers and distributors can therefore prevent or at least minimise economic consequences of these obligations by carefully assessing the risks of their products before their placing on the market, which is an obligation under the present Directive.

It is not possible to estimate how frequently there will be a need to apply these obligations: all will depend on the care taken by the relevant economic operators to supply only safe products. Equally, the economic implications of each of the provisions considered will depend on the nature and circumstances of non-compliance and therefore no meaningful estimate can be carried out beforehand.

The obligation of producers and distributors to inform the authorities when they conclude that a product that they supply is dangerous, is already applied in certain non-EU countries, in particular the US. It is equally applied to European firms operating on the markets of these non-EU countries and there is no evidence of an excessive burden.

The costs associated with the obligation to collaborate with the authorities, in particular in the case of crises, like those recently experienced in the food sector, should be seen in the context of the broader economic consequences that failure to deal rapidly and effectively with consumer risks in such cases may have. Clearly, each of these cases involves specific aspects and no a priori quantification of costs and benefits is possible.

The same applies to recall of products already supplied to consumers. The cost of a recall will vary, depending on factors such as geographical spread, number of products sold, value of the products, etc. The benefits of timely recalls in economic terms will include reduced liabilities for the producers.

Finally, there is no data on the type and number of dangerous products exported, or which might in future be exported to non-EU countries. The potential market lost by European producers, and the benefits deriving from the proposed prohibition of such exports, cannot be evaluated.

It should be borne in mind that any increased costs associated with the new obligations for SMEs will solely occur when a product is found not to comply with the safety requirements of the Directive. Therefore, the vast majority of businesses will only experience the following benefits as a result of the revision of the Directive.

First, businesses which do not respect their obligations to protect consumer health and safety, may have an unfair advantage over those that do, if enforcement is not effective. More effective market surveillance will reduce such unfair competition between businesses within the internal market and also in the context of the globalisation of trade.

Secondly, increased collaboration with market surveillance authorities could help small and medium-sized firms. Where an unsafe product is supplied by SMEs, national authorities should cooperate closely with them to ensure that appropriate actions or measures are taken to deal with the problem.

Finally, the proposal also aims to clarify the safety requirements applicable to products. The new "status" that the proposal will give to European standards, coupled with the possible use of Commission recommendations setting guidelines on risk assessment, will help provide clear references points for business in defining a safe product. This will assist businesses and particularly SMEs in placing products the internal market.

Common assessment criteria and product safety standards will permit businesses to compete on a level playing field by ensuring them equal opportunities. Increased use of European standards should be linked to the reinforcement of market surveillance.

5. consultations

The organisations consulted about the proposal and who have outlined their main views are: European Association for the Coordination of Consumer representation in standardisation (ANEC), European Consumers' Organisation (BEUC), Confederation of British Industry (CBI), European Chemical Industry Council (CEFIC), European Committee for Standardization (CEN), European Trade Union Confederation (CES/ETUC), Confederation of Family Organisations in the European Union (COFACE), The Retail, Wholesale and international trade representation to the European Union (EUROCOMMERCE), European Community of Consumer Cooperatives (EUROCOOP), Institut Européen Interregional de la Consommation (IEIC), Liaison group of the European Mechanical, Electrical, Electronic and Metalworking industries (ORGALIME), Product Safety Enforcement Forum of Europe (PROSAFE), Union européenne de l'Artisanat et des PME (UEAPME) and Union of industrial and employers' confederations of Europe (UNICE).

The Commission's intention has been to involve as many relevant stakeholders as possible during the preparatory stages of its proposal. Government experts, Consumer Organisations, European standardisation bodies and ANEC have all been consulted on several occasions within the framework of the Consumer Safety Working Party. The objective has been to assess the current application of the General Product Safety Directive and discuss any necessary changes and suitable provisions that should be included in its revision.

A discussion paper entitled, "Review and revision of Directive 92/59/EEC (General Product Safety)" has been widely distributed and published on the Internet. This document was used during a meeting which included all stakeholders held on 24 June 1999. In January 2000, a second consultation meeting focused on a draft text of the revised Directive.

In December 1999, the Economic and Social Committee issued an Opinion, on its own initiative, on General Product Safety. In addition, the "Centre du Droit de la Consommation" of Louvain University has consulted stakeholders to carry out a study on product safety. The different positions obtained on the main issues of the proposal are summarised hereafter.

Extension of the scope: the commercial sector does not oppose the inclusion of products intended for use in the context of consumer services as long as such products are directly relevant to consumer health and safety. The industrial sector's opinion is that products supplied in the context of services are already covered. The view expressed by consumers representatives was that time had now created a more positive attitude to initiatives in the service sector.

Industry insists that the Directive's present wording already covers "migrated" products. However, the commercial sector has reservations regarding the inclusion of such products. Consumer representatives, however, welcomed the proposal to cover product migration.

Industry associations stressed that any change in the present text should be justified by the experience acquired and avoid to create confusion with other Community legislation.

Conformity assessment criteria and safety standards: the idea of strengthening the role of European standards has been welcomed. Consumer and industry organisations requested to participate in the procedure for establishing mandates for the European standardisation bodies to raise quality and transparency in the preparation and adoption of such mandates.

Obligations of producers and distributors: economic operators stressed that further obligations should not be imposed unless it was clear that an increased level of safety would result. They were worried that the imposition of an obligation to notify the authorities when they conclude that a product is dangerous could result in costly bureaucratic burden. Industry wished it to be clarified that the recall of products should only be used as a last resort.

Market surveillance and collaboration between authorities: a general consensus exists regarding the need to strengthen the present market surveillance regime. The importance of clearer obligations for Member States was stressed by participants. Consumers require protection, while businesses need the reassurance that enforcement officers can ensure fair and free trade.

Several organisations underscored the need for a coherent approach to enforcement between the sectorial legislation and the GPSD.

Rapid exchange of information system: both consumer organisations and economic operators are in favour of improving the RAPEX system. They recognise the utility of having clear and detailed data regarding a notified product as well as the importance of following up the notifications made by the Member States. Consumer and Industry representatives called for the information notified under this system and the Commission opinions to be made publicly available.

Emergency measures at Community level: stakeholders agree with the utility of Community emergency measures. It was a generally held opinion that the procedural conditions required under Article 9 are currently an obstacle to the adoption of emergency measures.

Industry insisted that the present three month validity period of any emergency decision should be maintained. Also it expressed the opinion that the concept of "serious and immediate risk" was already well established in some Member States. However, the need to differentiate between emergency action involving an immediate risk and an action taken to combat long-term risks, while incorporating the precautionary principle, was underlined.

Ban of export of dangerous products: the point raised by Industry during consultations was the need to make a distinction between a product not "deemed safe" within the terms of the Directive and a product which is dangerous. In some cases, standards in other countries may differ from those within the EU but not in a way which makes products that conform to them unsafe.

Consumer organisations called for a ban with no exemptions and highlighted the contradiction between the stated need to ban such exports as a general principle and the suggestion that some flexibility could be considered under certain circumstances.

Confidentiality: consumer associations find transparency to be essential in assuring consumer safety. Therefore, they support the inclusion of transparency as a general principle in the field of consumer health and safety, and that secrecy should be limited to exceptional cases.

Industry does not question that the public should be informed where there is a risk, but the necessity for public information must be weighed against industry's need for commercial confidentiality.

6. contents of the proposal

This proposal concerns an EEA matter and should therefore extend to the EEA.

The amendments proposed with reference to the existing text are identified by underlining.

Article 1 concerns the main objective of the Directive. It also clarifies the relationships between the General Product Safety Directive (GPSD) and other sectoral Community legislation containing provisions on safety aspects of certain products.

Article 2 provides the definitions of the concepts used in the GPSD. All products supplied or made available to consumers through the normal commercial retail networks and by service providers are covered by the GPSD. It includes also services if associated with the product supplied.

Article 3 obliges producers to market only safe products. It provides criteria for assessing the conformity of a product with the general safety requirement and allows products in compliance with European standards established under certain conditions, to benefit from a presumption of conformity.

Article 4 the Commission will introduce mandates to the European standardisation bodies to elaborate standards for the purposes of this Directive. Publication of the references of these standards may be withdrawn if they are subsequently deemed to provide an insufficient level of safety.

Article 5 presents the different obligations of producers and distributors, inter alia, to inform and collaborate with the authorities, warn consumers as well as recalling dangerous products as a last resort. Additionally they should inform their respective national authorities of any voluntary measures they have taken.

Article 6 establishes the obligation of the Member States to guarantee and monitor that producers and distributors comply with their obligations. Member States must detail and communicate to the Commission the operational organisation of market surveillance and ensure coordination and collaboration between the various authorities responsible.

Article 7 establishes the obligation for the Member States to lay down rules on penalties.

Article 8 describes the measures to be adopted by the Member States in achieving the objectives of this Directive. In particular, the Member States shall have the power to rapidly enforce rapid measures when necessary and prohibit exports of certain products.

Article 9 concerns the basic generic requirements for a structured and transparent approach to the operation of market surveillance systems taking into account best practices. It includes the preparation of annual surveillance programmes and reports, procedures for dealing with complaints and control activities.

Articles 10 establishes the European Product Safety Network aimed to strength collaboration between the enforcement authorities and bodies of the Member States and facilitate the exchange of information and expertise.

Article 11 details the notification and exchanges of information procedure. Member States shall notify the Commission when they take measures that restrict the free marketing of products. The Commission shall distribute this information unless it considers the measure to be unjustified. In this case the Commission informs the Member State that initiated the action of its decision.

Article 12 provides for a rapid exchange of information system among Member States and the Commission concerning products that present a serious risk which requires rapid intervention and measures taken by producers, distributors and public authorities to deal with it. Participation in this system may be open to non-EU countries.

Article 13 details the rapid measures at Community level and conditions for their adoption. Two types of measures are envisaged: measures of a permanent nature concerning individual products and measures for certain products posing a serious risk valid for one year, renewable on an annual basis. It additionally establishes the obligations of Member States in implementing decisions adopted under this procedure. The export of banned products will be prohibited.

Article 14 defines the provisions establishing a Regulatory Consumer Product Safety Committee, in charge of assisting the Commission in the adoption of rapid measures.

Article 15 establishes a Consumer Product Safety Committee, of an advisory nature, to examine any question concerning the application of this Directive, rapid measures excepted.

Article 16 defines the limits of the confidentiality requirements in relation to protection of consumer health and safety and protects professional secrecy in duly justified cases.

Article 17 clarifies that the application of this Directive shall be without prejudice to Directive 85/374/EEC concerning liability for defective products.

Article 18 requires Member States to justify and notify to the party concerned their measures, including those in relation to the recall of products or the ban on the export of a dangerous product. They shall inform the parties concerned regarding the remedies available, time-limits and ensure that competent courts can review the measure.

Article 19 requires the European Commission to submit a report on the implementation of the Directive and on the functioning of market surveillance in the Member States to the European Parliament and the Council every three years.

Article 20 provides for the transposition and entry into force of this Directive.

Article 21 repeals the former Directive 92/59/EEC.

Article 22 addresses this Directive to the Member States.

Annex I provides for specific requirements for the information to given by producers and distributors to authorities if they become aware that a product that they supply is dangerous.

Annex II details the procedures for the application of the Community system for the rapid exchange of information set up in Article 13.

Annex III establishes the obligation of Member States concerning the deadline for transposition and for application of Directive 92/59/EEC.

Annex IV consists of a comparison table between the provisions of Directive 92/59/EEC and its revised version.

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on general product safety

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission [2],

[2] OJ C

Having regard to the opinion of the Economic and Social Committee [3],

[3] OJ C

Whereas:

(1) Under Article 16 of Council Directive 92/59/EEC of 29 June 1992 on general product safety [4], the Council was to decide, four years after the date set for the implementation of the Directive, on the basis of a report of the Commission on the experience acquired, together with appropriate proposals, whether to adjust the Directive. Since it is necessary to introduce several amendments into the Directive, in order to complete, reinforce or clarify certain of its provisions in the light of experience as well as new and relevant developments on consumer product safety, Directive 92/59/EEC should be recast in the interest of clarity.

[4] OJ L 228, 11.8.1992, p. 24.

(2) It is important to adopt measures with the aim of improving the functioning of the internal market, comprising an area without internal frontiers in which the free movement of goods, persons, services and capital is assured.

(3) In the absence of Community provisions, horizontal legislation of the Member States on product safety, imposing in particular a general obligation on economic operators to market only safe products, might differ in the level of protection afforded to persons. Such disparities, and the absence of horizontal legislation in certain Member States, would be liable to create barriers to trade and distortion competition within the internal market.

(4) In order to ensure a high level of consumer protection, the Community must contribute to protecting the health and safety of consumers. Horizontal Community legislation introducing a general product safety requirement, provisions on the general obligations of producers and distributors, on the enforcement of Community product safety requirements and for rapid exchange of information and action at Community level in certain cases, should contribute to that aim.

(5) It is very difficult to adopt Community legislation for every product which exists or which may be developed. There is a need for a broad-based, legislative framework of a horizontal nature to deal with such products, and also to cover lacunae and to complement provisions in existing or forthcoming specific legislation, in particular with a view to ensuring a high level of protection of safety and health of persons, as required by Article 95 of the Treaty.

(6) It is therefore necessary to establish at Community level a general safety requirement for any product placed on the market, or otherwise supplied or made available to consumers, intended for consumers, or likely to be used by consumers under reasonably foreseeable conditions even if not intended for them. In all these cases the products under consideration can pose risks for the health and safety of consumers which must be prevented. Certain second-hand goods should nevertheless be excluded by their very nature.

(7) The provisions of this Directive should apply to products irrespective of the selling techniques including distance and electronic selling.

(8) The safety of products should be assessed taking into account the categories of consumers which can be particularly vulnerable to the risks posed by the products under consideration, in particular children and the elderly.

(9) Production equipment, capital goods and other products used in the context of a trade or business should be covered by this Directive, if they are intended to be used for supplying a service to consumers, as far as consumer health and safety aspects are concerned. It is necessary, in order to achieve the objectives of this Directive, that manufacturers ensure that such products do not pose risks for the safety of consumers when used under normal or reasonably foreseeable conditions by service providers.

(10) Products which are designed exclusively for professional use but have subsequently migrated to the consumer market must be subject to the requirements of this Directive because they can pose risks to consumer health and safety when used under reasonably foreseeable conditions.

(11) In the absence of more specific safety provisions, within the framework of Community legislation covering the products concerned, all the provisions of this Directive are to apply in order to ensure consumer health and safety.

(12) If specific Community legislation sets out safety requirements covering only certain safety aspects or categories of risks with regard to the products concerned, the obligations of economic operators in respect of the safety requirements, including data generation, hazard identification and risk assessment, should be determined by those provisions of the specific legislation, while the general safety requirement of this Directive should apply to the other aspects.

(13) Where there are specific rules of Community law of the total harmonisation type, in particular those adopted on the basis of the new approach, which lay down the safety requirements applicable to certain products, further obligations should not be imposed on economic operators as regards the safety requirements to which products must conform in order to be placed on the market. Accordingly, the general safety requirement of this Directive should not apply in such cases.

(14) The provisions of this Directive relating to the other obligations of producers and distributors, the obligations and powers of the Member States, the exchanges of information and rapid intervention situations and confidentiality should apply in the case of products covered by specific rules of Community law, without prejudice to any specific requirements on the same aspects in such rules.

(15) In order to facilitate the effective and consistent application of the general safety requirement of this Directive, it is important to establish European voluntary standards covering certain products and risks in such a way that a product which conforms to a national standard transposing a European standard is to be presumed to be in compliance with the said requirement.

(16) With regard to the aims of this Directive, European standards should be established by European standardisation bodies, under mandates set by the Commission assisted by a Committee. The mandates should indicate the objectives that the standards must meet in order to ensure that products in compliance with the standards fulfil the general safety requirement.

(17) In the absence of specific regulations and when the European standards established under mandates set by the Commission are not available or recourse is not made to them, the safety of products should be assessed taking into account national standards transposing any other relevant European standards, Commission recommendations or, failing those, national standards, codes of practice, the state of the art and the safety which consumers may reasonably expect.

(18) It is appropriate to supplement the duty to observe the general safety requirement by other obligations on economic operators because action by economic operators is necessary to prevent risks to consumers under certain circumstances.

(19) The additional obligations on producers should include the duty to adopt measures, commensurate with the characteristics of the products, enabling them to be informed of the risks that these products may present, to supply consumers with information enabling them to assess and prevent risks, to warn consumers of the risks posed by dangerous products already supplied to them, to withdraw those products from the market, and, as a last resort, to recall those products when necessary.

(20) Distributors must help in ensuring compliance with the applicable safety requirements. Both producers and distributors must cooperate with the competent authorities in action aimed at preventing risks and informing them when they conclude that certain products supplied are dangerous. The conditions regarding such information should be set in the Directive to facilitate its effective application and prevent an excessive burden for the economic operators and the authorities.

(21) In order to ensure the effective enforcement of the obligations incumbent on producers and distributors, the Member States must establish or designate authorities which are responsible for monitoring product safety and have powers to take appropriate measures, including the power to apply effective proportionate and dissuasive penalties, and ensure appropriate coordination between the various designated authorities.

(22) It is necessary in particular for the appropriate measures to include the power for Member States to organise or order, immediately and efficiently, the withdrawal of dangerous products already placed on the market, to prohibit the export of dangerous products and as a last resort to recall from consumers dangerous products already supplied to them. Those powers should be applied when producers and distributors fail to prevent risks to consumers in accordance with their obligations. Where necessary, the appropriate powers and procedures must be available to the authorities to decide and apply any necessary measures rapidly.

(23) The safety of consumers depends to a great extent on the active enforcement of Community product safety requirements. The Member States should, therefore, establish systematic approaches to ensure the effectiveness of market surveillance and other enforcement activities and should ensure their openness to the public and interested parties.

(24) Collaboration between the enforcement authorities of the Member States is necessary in ensuring the protection objectives of this Directive. It is, therefore, appropriate to establish a European Product Safety Network between the enforcement authorities of the Member States to facilitate collaboration at operational level on market surveillance and other enforcement activities, in particular risk assessment, testing of products, exchange of expertise and scientific knowledge, execution of joint surveillance projects and tracing, withdrawing or recalling dangerous products. That Network should involve the authorities in charge of the specific products and risks concerned.

(25) In conformity with the provisions concerning the applicability of this Directive, the provisions relating to collaboration between enforcement authorities should apply without prejudice to specific collaboration procedures established under sectoral Community legislation, in particular in the pharmaceutical sector. The European Product Safety Network should cooperate with relevant bodies in which Member States enforcement authorities collaborate in product sectors covered by specific Community legislation. Systems for Interchange of Data between Administrations may be used in support of that cooperation as appropriate.

(26) It is necessary, for the purpose of ensuring a consistent, high level of consumer health and safety protection and preserving the unity of the internal market, that the Commission be informed of any measure restricting the placing on the market of a product or requiring its withdrawal or recall from the market. Such measures may be taken only in compliance with the provisions of the Treaty, and in particular Articles 28, 29 and 30.

(27) Effective supervision of product safety requires the setting-up at national and Community levels of a system of rapid exchange of information in situations of serious risk requiring rapid intervention in respect of the safety of a product. It is also appropriate for this Directive to set out detailed procedures for the operation of the system and to give the Commission, assisted by an advisory committee, power to adapt them.

(28) It is primarily for Member States, in compliance with the Treaty and in particular with Articles 28, 29 and 30 thereof, to take appropriate measures with regard to dangerous products located within their territory.

(29) However, if the Member States differ as regards the approach to dealing with the risk posed by certain products, such differences could entail unacceptable disparities in consumer protection and constitute a barrier to intra-Community trade.

(30) It may be necessary to deal with serious product-safety problems requiring rapid intervention which affect or could affect, in the immediate future, all or a significant part of the Community and which, in view of the nature of the safety problem posed by the product, cannot be dealt with effectively in a manner commensurate with the degree of urgency of the problem under the procedures laid down in the specific rules of Community law applicable to the products or category of products in question.

(31) It is therefore necessary to provide for an adequate mechanism allowing, as a last resort, for the adoption of measures applicable throughout the Community, in the form of a decision addressed to the Member States, to cope with situations created by products presenting a serious risk and requiring rapid intervention in the abovementioned circumstances and accordingly to ban their export. Such a decision is not of direct application to economic operators and must be incorporated into a national instrument. Measures adopted under such a procedure are interim measures, save when they apply to individually identified products or batches of products. They should be taken by the Commission assisted by a committee composed of representatives of the Member States.

(32) Since such rapid intervention measures necessary for the implementation of this Directive are measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [5], they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision.

[5] OJ L 184, 17.7.1999, p. 23.

(33) In accordance with Article 2 of Decision 1999/468/EC, the other measures necessary for the implementation of this Directive should be adopted by use of the advisory procedure provided for in Article 3 of that Decision. An Advisory Committee on Consumer Product Safety should therefore be created without prejudice to the competence of the regulatory committee. Moreover, the various aspects of its application may need to be discussed between experts from the different national administrations in charge of enforcement and market surveillance activities.

(34) Public access to the information available to the authorities on product safety should be ensured. However professional secrecy, as referred to in Article 287 of the Treaty, must be protected in a way which is compatible with the need to ensure the effectiveness of market surveillance activities and of protection measures.

(35) This Directive should not affect victims' rights within the meaning of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products [6].

[6] OJ L 210, 7.8.1985, p. 29. Directive as amended by Directive 1999/34/EC of the European Parliament and of the Council (OJ L 141, 4.6.1999, p. 20).

(36) It is necessary for Member States to provide for appropriate means of redress before the competent courts in respect of measures taken by the competent authorities which restrict the placing on the market of a product or require its withdrawal or recall.

(37) In addition, the adoption of measures concerning imported products with a view to preventing risks to the safety and health of persons must comply with the Community's international obligations.

(38) The Commission should periodically examine how this Directive is applied and the results obtained, in particular in relation to the functioning of market surveillance systems, the rapid exchange of information and measures at Community level, together with other issues relevant for consumer product safety in the Community, and present reports to the European Parliament and the Council on the subject.

(39) This Directive should not affect the obligations of Member States concerning the deadlines for transposition and application of Directive 92/59/EEC,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

Objective - Scope - Definitions

Article 1

1. The purpose of this Directive is to ensure that the products referred to in Article 2(a) placed on the market are safe.

2. This Directive shall apply only in so far as there are no specific provisions in rules of Community law governing the safety of the products concerned.

In particular, where products are subject to safety requirements imposed by Community legislation specific to those products:

- Articles 2, 3 and 4 of this Directive shall not apply to those products in so far as concerns the risks or categories of risks regulated by the specific legislation;

- the other Articles of this Directive shall apply in so far as there are no specific provisions in that legislation governing the aspects covered by the said Articles of this Directive.

Article 2

For the purposes of this Directive:

(a) "product" shall mean any product which is intended for consumers, or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them, and is supplied or made available, whether for consideration or not, in the course of a commercial activity and whether new, used or reconditioned.

This definition includes products used to provide a service, in so far as consumer product safety aspects under reasonably foreseeable conditions of use of those products are concerned.

It does not include second-hand products supplied as antiques or as products to be repaired or reconditioned prior to being used, provided that the supplier clearly informs the person to whom he supplies the product to that effect;

(b) "safe product" shall mean any product which, under normal or reasonably foreseeable conditions of use, including duration, does not present any risk or only the minimum risks compatible with the product's use, considered as acceptable and consistent with a high level of protection for the safety and health of persons, taking into account the following points in particular:

(i) the characteristics of the product, including its composition, packaging, instructions for assembly and maintenance,

(ii) the effect on other products, where it is reasonably foreseeable that it will be used with other products,

(iii) the presentation of the product, the labelling, any instructions for its use and disposal and any other indication or information provided by the producer and by distributors,

(iv) the categories of consumers at risk when using the product, in particular children and the elderly,

(v) the services directly associated with the product supplied, when these services are provided by the producer, in particular the installing and the maintenance of the product.

The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be 'unsafe' or 'dangerous';

(c) "dangerous product" shall mean any product which does not meet the definition of 'safe product' in point (b);

(d) "producer" shall mean:

(i) the manufacturer of the product, when he is established in the Community, and any other person presenting himself as the manufacturer by affixing to the product his name, trade mark or other distinctive mark, or the person who reconditions the product,

(ii) the manufacturer's representative, when the manufacturer is not established in the Community or, if there is no representative established in the Community, the importer of the product,

(iii) other professionals in the supply chain, in so far as their activities may affect the safety properties of a product placed on the market;

(e) "distributor" shall mean any professional in the supply chain whose activity does not affect the safety properties of a product;

(f) "recall" shall mean any measures aimed at achieving the return of a dangerous product, for reimbursement or replacement or repair, that has already been supplied or made available to consumers by the producer or distributor.

CHAPTER II

General safety requirement, conformity assessment criteria and European standards

Article 3

1. Producers shall be obliged to place only safe products on the market.

2. Where there are no specific Community provisions governing the safety of the products in question, a product shall be deemed safe when it conforms to the specific rules of national law of the Member State in whose territory the product is lawfully produced or marketed, such rules being drawn up in conformity with the Treaty, and in particular Articles 28 and 30 thereof, and laying down the health and safety requirements which the product must satisfy in order to be marketed. The product shall be deemed safe in so far as the aspects covered by the rules of national law are concerned.

Products in conformity with voluntary national standards transposing European standards, the references of which have been published by the Commission in the Official Journal of the European Communities in accordance with Article 4 shall be presumed to be in conformity with the general safety requirement of this Directive, in so far as the aspects covered by those standards are concerned. The Member States shall publish the references of such national standards.

3. In the absence of specific rules or national standards transposing European standards as referred to in paragraph 2 or when recourse is not made to such standards, the conformity of a product to the general safety requirement shall be assessed having regard, where they exist, to voluntary national standards giving effect to other relevant European standards, to Commission recommendations setting guidelines on product safety assessment or, failing these, to standards drawn up in the Member State in which the product is lawfully produced or marketed, to the codes of good practice in respect of health and safety in the sector concerned or to the state of the art and technology and to the safety which consumers may reasonably expect.

4. Conformity of a product with the provisions mentioned in paragraphs 2 or 3, shall not bar the competent authorities of the Member States from taking appropriate measures to impose restrictions on its being placed on the market or to require its withdrawal from the market where there is evidence that, despite such conformity, it is dangerous to the health and safety of consumers.

Article 4

1. For the purposes of this Directive, the Commission shall establish the mandates to the European standardization bodies and publish in the Official Journal of the European Communities the references of European standards. Where there is evidence that a standard does not ensure compliance with the general safety requirement of this Directive, the Commission shall withdraw such publication in whole or in part, in accordance with paragraph 4.

The mandates shall be established in accordance with Directive 98/34/EC of the European Parliament and of the Council [7]. The Commission shall ensure coordination with the Regulatory Committee on Consumer Product Safety referred to in Article 14(1) of this Directive.

[7] OJ L 204, 21.7.1998, p. 37. Directive as amended by Directive 98/48/EC (OJ L 217, 5.8.1998, p. 18).

The mandates shall define the objectives that the standards must meet to ensure that products conforming to such standards are in compliance with the general safety requirement of this Directive.

2. The standards referred to in paragraph 1 shall be adopted by European Standardization Bodies, in accordance with the principles contained in the general guidelines for cooperation between the Commission and those Bodies.

3. The Commission, after consulting the Committee established by Article 5 of Directive 98/34/EC, may decide to publish in the Official Journal of the European Communities the references of European standards relating to products covered by this Directive which were adopted by European Standardisation Bodies before the entry into force of this Directive.

4. Where a Member State or the Commission considers that a European standard referred to in Article 3(2) does not satisfy the general safety requirement of this Directive, the Commission or the Member State shall refer the matter to the Committee established by Directive 98/34/EC, setting out its reasons. After receiving the Committee's opinion, the Commission shall notify the Member States whether or not the standard concerned or a part thereof has to be withdrawn from publication as referred to in Article 3(2) of this Directive.

CHAPTER III

Other obligations of producers and obligations of distributors

Article 5

1. Within the limits of their respective activities, producers shall provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warnings, and to take precautions against those risks.

Provision of warnings does not, however, exempt any person from compliance with the other requirements laid down in this Directive.

Also within the limits of their respective activities, producers shall adopt measures commensurate with the characteristics of the products which they supply, to enable them to be informed of risks which these products might present and to take appropriate action including, if necessary to avoid these risks, withdrawing the products in question from the market, adequately and effectively warning consumers of the risks posed by the products, or, in the last resort, recalling from consumers products already supplied to them when other measures would not suffice to prevent the risks involved.

The measures shall for example include, whenever appropriate, marking of the products or product batches in such a way that they can be identified, sample testing of marketed products, investigating complaints made and keeping distributors informed of such monitoring.

2. Distributors shall be required to act with due care to help to ensure compliance with the applicable safety requirements, in particular by not supplying products which they know or should have presumed, on the basis of the information in their possession and as professionals, do not comply with those requirements. Moreover, within the limits of their respective activities, they shall participate in monitoring the safety of products placed on the market, especially by passing on information on product risks, safeguarding and providing documentation necessary for tracing the origin of products, and cooperating in the action taken by producers and competent authorities to avoid the risks.

3. Producers and distributors shall immediately inform the competent authorities of the Member States if they conclude that a product that they have placed on the market is dangerous. They shall in particular inform the authorities of the action taken to prevent risks to consumers. Specific requirements for this information are set out in Annex I. They shall be adapted by the Commission acting in accordance with the procedure referred to in Article 15(2).

4. Producers and distributors, within the limits of their respective activities, shall collaborate with the competent authorities, at the request of the latter, on action taken to avoid the risks posed by products which they supply or have supplied. The competent authorities shall define the procedures for such collaboration, including procedures for dialogue with the producers and distributors concerned on issues related to consumer product safety enforcement.

CHAPTER IV

Specific obligations and powers of the Member States

Article 6

1. Member States shall ensure that producers and distributors comply with their obligations under this Directive in such a way that products placed on the market are safe.

2. In particular, Member States shall establish or nominate authorities competent to monitor the compliance of products with the obligation to place only safe products on the market and arrange for such authorities to have the necessary powers and responsibility to take the appropriate measures incumbent upon them under this Directive.

3. The Member States shall define the tasks, organisation and powers of the authorities competent for the various product categories, risk aspects and surveillance activities, as well as the appropriate arrangements for the exchange of information, coordination and collaboration between such authorities and shall notify the Commission thereof, as well as any subsequent modification thereto. The Commission shall pass on such information to the other Member States.

Article 7

The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by the date specified in Article 20(1) at the latest and shall also notify it, without delay, of any subsequent amendment affecting them.

Article 8

1. In order to achieve the objectives of this Directive and in particular for the purposes of Article 6, the competent authorities of the Member States shall have the necessary powers, and take the necessary action in accordance with the degree of risk and in conformity with the Treaty, and in particular Articles 28 and 30 thereof, to adopt appropriate measures with a view to:

(a) organising appropriate checks on the safety properties of products, even after their being placed on the market as being safe, on an adequate scale, up to the final stage of use or consumption;

(b) requiring all necessary information from the parties concerned;

(c) taking samples of products and subjecting them to safety checks;

(d) subjecting product marketing to prior conditions designed to ensure product safety and requiring that suitable warnings be affixed regarding the risks which the product may present;

(e) making arrangements to ensure that persons who might be exposed to a risk from certain products are informed in good time and in a suitable manner of the said risk by, inter alia, the publication of special warnings;

(f) temporarily prohibiting, for the period required to carry out the various checks, verifications or safety assessments, anyone from supplying, offering to supply or exhibiting, certain products whenever there are precise and consistent indications that they could be dangerous;

(g) prohibiting the placing on the market of dangerous products and establishing the accompanying measures needed to ensure that the ban is complied with;

(h) organising or ordering, the effective and immediate withdrawal of dangerous products already on the market, the warning of consumers on the risks posed by dangerous products, the recalling from consumers of those products already supplied, and the destruction of the products in question under appropriate conditions, if necessary, in cases where action by producers and distributors to the same aims, in conformity to their obligation under this Directive, is not satisfactory or is insufficient.

2. In particular, the competent authorities shall have the necessary powers and take the necessary action, to apply with due rapidity appropriate measures among those mentioned in paragraph 1(d) to (h), in the case of products posing a serious risk which requires rapid intervention.

3. The measures to be taken by the competent authorities under paragraphs 1 and 2 shall be addressed, as appropriate, to:

(a) the producer;

(b) within the limits of their respective activities, distributors and in particular the party responsible for the first stage of distribution on the national market;

(c) any other person, where necessary, with regard to cooperation in action taken to avoid risks arising from a product.

Article 9

1. The approaches established by the Member States for operating effective market surveillance, including the working procedures and the procedures for exchanging information and coordination and collaboration between the various authorities concerned, shall aim at guaranteeing a high level of consumer health and safety protection.

2. In order to achieve the objective referred to in paragraph 1, the Member States shall ensure that appropriate and effective means and procedures are put in place, which may include in particular:

(a) the establishment, periodical updating and implementation of sectoral surveillance programmes by categories of products or risks;

(b) the follow-up and updating of scientific knowledge concerning the safety of products publicly available, periodical reports on surveillance activities, findings and results achieved;

(c) periodical reviewing and assessments of the functioning of the control activities and their effectiveness, and, if necessary, revision of the surveillance approach and organisation put in place.

3. The Member States shall ensure that consumers and other interested parties may present complaints to the competent authorities on product safety and on surveillance and control activities and that these complaints are considered, followed up as appropriate and answered. The Member States shall actively inform consumers and the other interested parties of the procedures established to that end.

Article 10

1. The Commission shall promote the establishment and operation of a European Product Safety Network between the authorities of the Member States competent for market surveillance of consumer products and involving also the Commission.

2. The Network shall cooperate with relevant bodies in product sectors covered by the legislation referred to in Article 1(2) and shall have as its objectives, in particular, to facilitate:

(a) the exchange of information on risk assessment, dangerous products, test methods and results, the recent scientific developments as well as other aspects relevant for control activities;

(b) the establishment and execution of joint surveillance and testing projects;

(c) the exchange of expertise and best practices and collaboration in training activities;

(d) coordination at Community level of tracing, withdrawal and recall of dangerous products.

CHAPTER V

Exchanges of information and rapid intervention situations

Article 11

1. Where a Member State takes measures which restrict the placing on the market of products or require their withdrawal from the market, or the recall from consumers of those products already supplied, as provided for in Article 8(1)(d) to (h), the Member State shall, to the extent that such notification is not required under Article 12 or any specific Community legislation, inform the Commission of the measures, specifying its reasons for adopting them. Where the notifying Member State considers that the measures relate to an event which is local in effect and in any case limited to its territory, the notification will specify it. It shall also inform the Commission of any modification or withdrawal of such measures.

The guidelines referred to in Annex II, point 8, shall define the contents and standard form for the notifications provided for in this Article. In particular the guidelines shall provide criteria for determining which measures related to purely local events must not be notified because they are not relevant for the aims of this Article.

2. The Commission shall forward the notification to the other Member States, unless it concludes, after examination, that the measure does not comply with Community law. In such a case, it shall immediately inform the Member State which initiated the action.

Article 12

1. Where a Member State adopts or decides to adopt, recommend or agree with manufacturers, importers and distributors, whether on a compulsory or voluntary basis, measures or actions to prevent, restrict or impose specific conditions on the possible marketing or use, within its own territory, of products by reason of a serious risk for the health and safety of consumers which requires rapid intervention, it shall immediately inform the Commission thereof through the Community Rapid Information System (RAPEX). The Member States shall also inform the Commission without delay of any modification or withdrawal of such measures or actions.

If the notifying Member State considers that the effects of the risk do not or cannot go beyond its territory, the notification shall indicate it taking into account the relevant criteria established in the guidelines referred to in Annex II, point 8.

Without prejudice to the first subparagraph, Member States may pass on to the Commission any information in their possession regarding the existence of a serious risk requiring rapid intervention before deciding to adopt the measures or action in question.

2. On receiving this information, the Commission shall check whether it complies with the requirements applicable to the functioning of RAPEX, and shall forward it to the other Member States, which, in turn, shall immediately inform the Commission of any measures adopted.

3. Detailed procedures for RAPEX are set out in Annex II. They shall be adapted by the Commission in accordance with the procedure referred to in Article 15(2).

4. Access to RAPEX may be open to candidate countries, third countries or international organisations, within the framework of agreements between the Community and those countries or international organisations, according to modalities defined in these agreements. Any such agreements shall be based on reciprocity and include provisions on confidentiality corresponding to those applicable in the Community.

Article 13

1. If the Commission becomes aware of a serious risk from certain products to the health and safety of consumers in various Member States requiring rapid action, it may, after consulting the Member States, adopt a decision, in accordance with the procedure laid down in Article 14(1), requiring Member States to take measures from among those listed in Article 8(1)(d) to (h) if:

(a) Member States differ on the approach to deal with the risk;

(b) the risk cannot be dealt with, in view of the nature of the safety issue posed by the product and in a manner compatible with the degree of urgency of the case, under other procedures laid down by the specific Community legislation applicable to the products concerned; and

(c) the risk can be eliminated effectively only by adopting appropriate measures applicable at Community level, in order to ensure a consistent and high level of protection of the health and safety of consumers and the proper functioning of the internal market.

2. Decisions referred to in paragraph 1 shall be valid for a period not exceeding one year and may be confirmed, under the same procedure, for additional periods of one year.

However, decisions concerning specific, individually identified products or batches of products, shall be valid without a time-limit.

3. Export from the Community of products for which Member States have been required to take measures among those listed in Article 8(1)(f), (g) and (h) shall be prohibited.

4. The Member States shall take all necessary measures to implement the decisions referred to in paragraph 1 within less than 10 days, unless a different period is specified in those decisions.

5. The competent authorities responsible for carrying out the measures referred to in paragraph 1 shall, within one month, give the parties concerned an opportunity to submit their views and shall inform the Commission accordingly.

CHAPTER VI

Committee procedures

Article 14

1. The Commission shall be assisted by a Regulatory Committee on Consumer Product Safety, composed of representatives of the Member States and chaired by a representative of the Commission.

2. In cases where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7(3) and Article 8 thereof. The period provided for in Article 5(6) of Decision 1999/468/EC shall be fifteen days.

Article 15

1. The Commission shall be assisted by an Advisory Committee on Consumer Product Safety composed of representatives of the Member States and chaired by the representative of the Commission.

2. Where reference is made to this paragraph, the advisory procedure laid down in Article 3 of Decision 1999/468/EC shall apply, in compliance with Article 7(3) and Article 8 thereof.

3. The Advisory Committee on Consumer Product Safety shall also assist the Commission in examining any question concerning the application of this Directive, in particular issues related to enforcement and market surveillance activities.

CHAPTER VII

Miscellaneous and final provisions

Article 16

1. Information available to the authorities of the Member States or the Commission relating to risks to consumer health and safety posed by products shall in general be available to the public. In particular the public shall have access to information on product identification, the nature of the risk and the measures taken.

However, the Member States and the Commission shall take the steps necessary to ensure that their officials and agents are required not to disclose information obtained for the purposes of this Directive which, by its nature, is covered by professional secrecy in duly justified cases, except for information relating to the safety properties of products which must be made public if circumstances so require, in order to protect the health and safety of consumers.

2. Protection of professional secrecy shall not prevent the dissemination to the competent authorities of information relevant for ensuring the effectiveness of market surveillance and enforcement activities. The authorities receiving information covered by professional secrecy shall ensure its protection.

Article 17

This Directive shall be without prejudice to Directive 85/374/EEC.

Article 18

1. Any measure adopted under this Directive and involving restrictions on the placing of a product on the market, or requiring its withdrawal from the market, or its recall from consumers must state the appropriate reasons on which it is based. It shall be notified as soon as possible to the party concerned and shall indicate the remedies available under the provisions in force in the Member State in question and the time limits applying to such remedies.

The parties concerned shall, whenever feasible, be given an opportunity to submit their views before the adoption of the measure. If this has not been done in advance because of the urgency of the measures to be taken, such opportunity shall be given in due course after the measure has been implemented.

Measures requiring the withdrawal of a product from the market or its recall from consumers shall take into consideration the need to encourage distributors, users and consumers to contribute to the implementation of such measures.

2. Member States shall ensure that any measure taken by the competent authorities involving restrictions on the placing of a product on the market or requiring its withdrawal from the market or recall from consumers can be challenged before the competent courts.

3. Any decision taken by virtue of this Directive and involving restrictions on the placing of a product on the market or requiring its withdrawal from the market or its recall from consumers shall be without prejudice to assessment of the liability of the party concerned, in the light of the national criminal law applying in the case in question.

Article 19

1. Every three years following the date referred to in Article 20(1), the Commission shall submit a report on the implementation of this Directive to the European Parliament and the Council.

2. The report shall in particular include information on the safety of consumer products, the functioning of market surveillance, standardisation work, the functioning of RAPEX and Community measures taken on the basis of Article 13. To this end the Commission shall conduct assessments of the relevant issues, in particular the approaches, systems and practices put in place in the Member States, in the light of the requirements of this Directive and the other Community legislation relating to product safety. The Member States shall provide the Commission with all the necessary assistance and information for performing the assessments and preparing the reports.

Article 20

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 1 January 2003. They shall forthwith inform the Commission thereof.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive.

Article 21

Directive 92/59/EEC is hereby repealed with effect from 1 January 2003 without prejudice to the obligations of Member States concerning the deadlines for transposition and for application of the repealed Directive as indicated in Annex III.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IV.

Article 22

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

ANNEX I REQUIREMENTS CONCERNING INFORMATION ON DANGEROUS PRODUCTS TO BE PROVIDED TO COMPETENT AUTHORITIES BY PRODUCERS AND DISTRIBUTORS

1. The Information must be provided in cases where producers or distributors conclude, based on data, test results or other information which become available to them, that a product which they supply is not safe, within the meaning of Article 2(b) or, as appropriate, in the light of the specific safety requirements set in rules of Community law applicable to the product considered.

2. This requirement applies in the case of product lines or batches, not for individual dangerous products.

3. The information to be provided shall include at least:

- the details that permit a precise identification of the product or product batch in question;

- full description of the risk posed by the products concerned;

- all available information, useful to trace the product;

- description of action taken to prevent risks to consumers.

4. The information shall be provided to the authorities designated for that purpose in the Member States where the products in question are or have been placed on the market or otherwise supplied to consumers.

ANNEX II PROCEDURES FOR THE APPLICATION OF THE COMMUNITY RAPID INFORMATION SYSTEM (RAPEX) PROVIDED FOR IN ARTICLE 13 AND GUIDELINES FOR NOTIFICATIONS REFERRED TO IN ARTICLES 12 AND 13

1. The system covers products as defined in Article 2(a) of this Directive that present a serious risk to the health and safety of consumers which requires rapid intervention.

Pharmaceuticals, which come under Directives 75/319/EEC and 81/851/EEC, are excluded from the application of the RAPEX system.

2. The system is essentially aimed at a rapid exchange of information in the event of a serious risk to the health and safety of consumers requiring rapid intervention. In this regard, the national authorities will judge each individual case on its merits taking into account the guidelines referred to in point 8 which will define specific criteria for identifying serious risks requiring rapid intervention.

3. Member States notifying under Article 12 of this Directive shall give all available details. In particular, the notification shall contain the information stipulated in the guidelines referred to in point 8 and at least:

(a) information to identify the product;

(b) a description of the danger involved, including a summary of the results of any tests/analyses and of their conclusions which are relevant to assessing the level of risk;

(c) the nature and the duration of the measures or action taken or decided on, if applicable;

(d) information on supply chains and distribution of the product.

Such information must be transmitted, using the special standard notification form and by the means stipulated in the guidelines referred to in point 8.

When the measure notified pursuant to Article 11 or Article 12 seeks to limit the marketing or use of a chemical substance or preparation, the Member States shall provide as soon as possible either a summary or the references of the relevant data relating to the substance or preparation considered and to known and available substitutes, where such information is available. They will also communicate the anticipated effects of the measure on consumer health and safety together with the assessment of the risk carried out in accordance with the general principles for the risk evaluation of chemical substances as referred to in Article 10(4) of Regulation (EEC) No 793/93 in the case of an existing substance or in Article 3(2) of Directive 67/548/EEC in the case of a new substance. The guidelines referred to in point 8 shall define the details and procedures for the information requested in that respect.

4. When a Member State has informed the Commission, according to Article 12(1), third subparagraph, about a serious risk, before deciding to adopt measures it must inform the Commission within a deadline of 45 days whether it confirms of modifies this information.5. The Commission shall verify, in the shortest time possible, the conformity with the provisions of this Directive of the information received under this rapid information system and, when it considers it to be necessary and in order to assess product safety, may carry out an investigation of its own motion. In the case of such an investigation Member States shall supply the Commission with the requested information to the best of their ability.

6. Upon receipt of a notification the Member States are requested, to inform the Commission, at the latest within the set period of time stipulated in the guidelines referred to at point 8, of the following:

(a) whether the product has been marketed in their territory and if they have adopted or intend to adopt the same or different measure(s) or action(s) adapted to their own circumstances or they consider it is not necessary to adopt measure(s) or action(s) for the product concerned in view of their own circumstances and explain why;

(b) supplementary information they have obtained on the danger involved, including the results of any tests/analyses carried out to assess the level of risk;

(c) whether they disagree with the measure(s) or action(s) in question and explain why;

(d) whether they consider that no follow-up is necessary and they explain why;

(e) whether it is unnecessary to adopt measures or take action for the products concerned under their circumstances and why.

The guidelines referred to in point 8 shall specify how to deal with notifications concerning risks which are considered by the Member State notifying not to go beyond its territory.

7. Member States shall immediately inform the Commission of any modification, or withdrawal of the measure(s) or action(s) in question.

8. Guidelines concerning the operation of the exchange of information system by the Commission and the Member States, shall be prepared and regularly up-dated by the Commission assisted by the Advisory Committee set up under Article 15(1).

9. The Commission may inform the national contact points regarding products posing risks requiring rapid action, imported to or exported from the European Community and the European Economic Area.

10. The responsibility for the accuracy of the information provided and the liability for it lie with the notifying Member State.

11. The Commission shall ensure the proper functioning of the system.

ANNEX III REPEALED DIRECTIVE AND DEADLINES FOR TRANSPOSITION INTO NATIONAL LAW AND FOR APPLICATION

Repealed Directive (referred to in Article 21): Council Directive 92/59/EEC; Deadlines for transposition and for application (referred to in Article 21): 29 June 1994.

ANNEX IV

CORRELATION TABLE

This Directive

// Directive 92/59/EEC

1 // 1

2 // 2

3 // 4

4 // --

5 // 3

6 // 5

7 // 5, second paragraph

8 // 6

9 // --

10 // --

11 // 7

12 // 8

13 // 9

14 and 15 // 10

16 // 12

17 // 13

18 // 14

19 // 15

20 // 17

21 // 18

22 // 19

// --

Annex I // --

Annex II // Annex

Annex III // --

Annex IV // --

FINANCIAL STATEMENT

DATE:

1. BUDGET HEADING APPROPRIATIONS:

B5-100

2. TITLE

Proposal for a Directive of the European Parliament and of the Council on general product safety (replacing Council Directive 92/59/EEC of 29 June 1992 on general product safety)

3. LEGAL BASIS

Articles 95 of the Treaty.

4. DESCRIPTION OF OPERATION

The General Product Safety Directive was adopted in 1992 as part of the programme aimed at establishing the internal market by 31 December 1992. While the overall approach of the Directive has turned out to be fundamentally sound and does not need substantial revision, its objectives have not been fully achieved because of a lack of clarity, weakness or lacunae in certain of its provisions.

All the amendments proposed in the revised text are aimed at reinforcing the effectiveness of the Directive and ensuring a more consistent implementation of its provisions.

5. CLASSIFICATION OF EXPENDITURE OR REVENUE

Non-compulsory expenditure

Differentiated appropriations

6. TYPE OF EXPENDITURE OR REVENUE

Refer to cost items of point 7.2.

Consumer Product Safety Committees: travel expenses of the representatives of the Member States.

- Assessment of European Standards (EN): Staff. One Commission official working on standardisation assisted by two consultants.

- Report to EP and Council: Staff. One Commission official drafting a report about the functioning of the Directive assisted by one consultant.

- Notification system: Staff. One Commission official managing the exchange of information system.

7. FINANCIAL IMPACT

7.1 Method of calculating total cost of operation (relation between individual and total costs)

The total cost of the action has been estimated taking into account:

- the costs that the implementation of the present Directive implies for the Commission,

- the costs (staff and consultants) that the new activities introduced in the amended text of the Directive will create.

The cost of the staff has been calculated on the basis of the annual average cost of a post in 1999 (EUR 95 524). The cost of the assistance has been estimated as an average of previous similar services.

7.2 Itemised breakdown of cost

Commitment appropriations EUR million (at current prices)

>TABLE POSITION>

8. FRAUD PREVENTION MEASURES

- Specific control measures envisaged

9. ELEMENTS OF COST-EFFECTIVENESS ANALYSIS

9.1 Specific and quantified objectives; target population

- Specific objectives:

To ensure that only safe products are placed on the internal market and to assure a high level of consumer safety and protection.

The target population will be all European Union consumers who will benefit from improved products being produced and distributed on the internal market. Increased market surveillance will benefit European producers by preventing unfair competition from businesses that do not respect their obligations to protect consumer health and safety.

9.2 Grounds for the operation

The Member States have requested that the Commission take a more active role in the rapid alert system foreseen under the Directive. Further, the Member States support the requirement for a report to be made every three years on the implementation of the Directive at national level as well as the suggested use of the Emergency Committee (Consumer Product Safety Committees in the revised text) in assisting the Commission on the application of this Directive.

The Directive will build upon established procedures, making them more efficient, while this will also prove more cost effective than installing an entirely new procedure. Increased efficiency at Commission level in the operation of the rapid alert system will improve the follow-up on alert notifications and the quality of the information sent via the system.

The new "status" that the proposal will give to European standards, will help provide clear reference points for businesses in defining a safe product. Common assessment criteria and product safety standards will permit businesses to compete on a level playing field by ensuring that they have equal opportunities.

The revised Directive builds on established procedures at Community and national levels. Cooperation between national administrations in the field of market surveillance has been carried out in other Community initiatives such as the Mutual Joint Visit Programme.

The improvement of the RAPEX system will make the exchange of information more rapid, allowing earlier preventative action. The increased scope for promoting the use of European standards will give producers greater certainty that their products comply with the relevant safety requirements.

The responsibilities of the new Food Safety Authority will affect the scope of the rapid alert system. When this happens, the number of notifications sent via the system will reduce.

9.3 Monitoring and evaluation of the operation

- Performance indicators selected

Improvements in the performance of the RAPEX system should be apparent in the response times necessary for taking measures to deal with notifications regarding defective products.

The report foreseen in Article 17 will include information on the safety of consumer products, the functioning of market surveillance, standardisation work, the functioning of the rapid exchange of information system and Community measures taken on the basis of Article 12. To this end, the Commission will conduct assessments of the relevant issues, in particular the approaches, systems and practices put in place in the Member States, in the light of the requirements of this Directive and the other Community legislation related to product safety.

The results of the report produced every three years will be assessed by the Commission and the Member States and submitted to the European Parliament and the Council. Any modifications required can be reviewed on this basis.

10. ADMINISTRATIVE EXPENDITURE (SECTION III, PART A OF THE BUDGET)

Actual mobilization of the necessary administrative resources will depend on the Commission's annual decision on the allocation of resources, taking into account the number of staff and additional amounts authorized by the budgetary authority.

10.1 Effect on the number of posts

>TABLE POSITION>

10.2 Overall financial impact of additional human resources

EUR

>TABLE POSITION>

10.3 Increase in other administrative expenditure as a result of the operation

EUR

>TABLE POSITION>

Any supplementary needs will have to be found within the overall financial envelope which each year is granted to DG SANCO.

IMPACT ASSESSMENT FORM THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE TO SMALL AND MEDIUM-SIZED ENTERPRISES (SMEs)

TITLE OF PROPOSAL

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on general product safety (replacing Council Directive 92/59/EEC of 29 June 1992 on general product safety).

DOCUMENT REFERENCE NUMBER

xxxxxxxxxx

THE PROPOSAL

1. Taking into account of the principle of subsidiarity, why is Community legislation necessary in this area and what are its main aims-

The General Product Safety Directive was adopted in 1992 as part of the programme aimed at establishing by 31 December 1992, the internal market. The aims and motivations of the General Product Safety Directive, which remain unchanged, fall within the fundamental competencies of the European Community.

All the amendments proposed in the revised text are aimed at reinforcing the effectiveness of the Directive and ensuring a more consistent implementation of its provisions.

The absence of efficient market surveillance in one Member State can have negative consequences at European level for the functioning of the Internal Market, for business competitiveness and consumers protection. The experience has shown certain weakness and lacunae in Community product safety legislation and its enforcement. This situation calls for improved Community provisions aimed at guaranteeing the protection of consumers and the proper functioning of the market.

The modifications envisaged are compatible with the need to respect the prerogative of Member States in deciding their own internal institutional and administrative arrangements and business regimes.

THE IMPACT ON BUSINESS

2. Who will be affected by the proposal-

The proposal will not significantly modify the implications for business compared with the present Directive. All business sectors and all sizes of businesses related to the production, distribution and trade of consumer products are interested. The proposed Directive will also apply to business which use or supply products in the provision of services to consumers.

The proposal has a similar impact over the entire Community. It is not aimed at any particular region.

3. What will business have to do to comply with the proposal-

The main new additional obligations for business will be:

Obligations for producers:

to effectively warn consumers of the risks posed by those products already supplied to them, and when necessary and as a last resort recall such products in order to avoid such risks.

Obligations for distributors:

to collaborate in tracing of the products they supply and to co-operate in any risk avoidance action;

Obligations for producers and distributors:

to inform the competent authorities if they conclude that a product which they supply is dangerous. Specific information requirements are provided in Annex I.

to collaborate, in accordance with the requests of competent authorities, in taking action to avoid any risks posed by the products they supply.

not to export to non-Member States dangerous products subject to a Community decision prohibiting them from being placed on the Community market or which have been withdrawn from the market or recalled from the consumers.

However, it should be noted that the increased costs associated with the new obligations for SMEs will solely occur when a product in found not to comply with the safety requirements of the Directive.

4. What economic effects is the proposal likely to have-

This proposal will facilitate an effective and consistent framework for ensuring protection of consumer health and safety, and an equal treatment of producers, importers and distributors.

Certain provisions of the proposal will improve businesses' competitiveness. At present businesses which do not respect their obligations to protect consumer health and safety, have an unfair advantage over those that do. More effective market surveillance will reduce such unfair competition between businesses within the internal market and also in the context of the globalisation of World trade. Business could also gain a marketing advantage in terms of the increased safety that their product offers.

The new "status" that the proposal will give to European standards, will help provide clear references points for business in defining a safe product. This in turn, will assist businesses and particularly SMEs in penetrating the internal market as the manufacturing and technical standards that need to be attained will cover a wider range of products. Common assessment criteria and product safety standards will permit businesses to compete on a level playing field by ensuring them equal opportunities.

5. Does the proposal contain measures to take account of the specific situation of small and medium-sized firms (reduced or different requirements, etc.)-

The scope of the proposal is entirely horizontal and its provisions are generic. Therefore, it does not contain measures specifically aimed at or adapted for small and medium-sized firms.

CONSULTATION

6. Organisations that have been consulted about the proposal and who have outlined their main points.

See Chapter 5.

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