Proposal for a Directive of the European Parliament and of the Council on general product safety
28. 11. 2000 EN Official Journal of the European Communities C 337 E/109 Proposal for a directive of the European Parliament and of the Council on general product safety (2000/C 337 E/15) (Text with EEA relevance) COM(2000) 139 final/2 2000/0073(COD) (Submitted by the Commission on 15 June 2000) 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, Having regard to the opinion of Committee, the Economic and Social 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 in to cover 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. lacunae and to complement provisions Whereas: (1) Under Article 16 of Council Directive 92/59/EEC of 29 June 1992 on general product safety (1), the Council was to decide, four years after the date set for the implemen- tation 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. is necessary to introduce several amendments Since it 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. (2) It is important to adopt measures with the aim of internal market, improving the the functioning of 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 legis- lation 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 legis- lation introducing a general product safety requirement, provisions on the general obligations of producers and distributors, on the enforcement of Community product (1) OJ L 228, 11. 8. 1992, p. 24. (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 these cases the even if not 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. intended for them. In all (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 the categories of consumers which can be account particularly vulnerable risks posed by the to 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, they are intended to be if used for supplying a service to consumers, as far as consumer health and safety aspects are concerned. It is necessary, 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. to achieve the objectives of in order (10) Products which are designed exclusively for professional use but have subsequently migrated to the consumer market must be subject this Directive because they can pose risks to consumer health and safety when used under reasonably foreseeable conditions. to the requirements of C 337 E/110 EN Official Journal of the European Communities 28. 11. 2000 (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. mendations or, failing those, national standards, codes of practice, the art and the safety which the state of consumers may reasonably expect. (12) out legislation sets specific Community If 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 obli- gations should not be imposed on economic operators as regards the safety requirements to which products must to be placed on the market. conform in order Accordingly, this safety requirement of the general Directive should not apply in such cases. (14) The provisions of this Directive relating to the other obli- gations of producers and distributors, the obligations and exchanges of powers of information and rapid intervention situations and confi- dentiality 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. the Member States, the (18) It is appropriate to supplement the duty to observe the safety requirement by other obligations on general economic because economic operators is necessary to prevent risks to consumers under certain circumstances. operators action by (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. in action aimed safety requirements. Both producers (20) Distributors must help in ensuring compliance with the applicable and distributors must cooperate with the competent auth- and orities certain informing conditions products regarding such information should be in the Directive application and prevent an excessive burden for the economic operators and the authorities. them when they supplied at preventing conclude to facilitate dangerous. effective risks that The are set its (15) the effective important to facilitate the general safety requirement of to is In order and consistent application of this European it Directive, 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 said be presumed to be requirement. in compliance with the establish (16) With regard to the aims of this Directive, European standards should be established by European standard- isation 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 recom- (21) In order to ensure the effective enforcement of the obli- gations 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. immediately and efficiently, (22) It is necessary in particular for the appropriate measures to include the power for Member States to organise or the withdrawal of order, dangerous products already placed on the market, to prohibit the export of dangerous products and as a last from consumers dangerous products resort should be already supplied to them. Those powers 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. to recall 28. 11. 2000 EN Official Journal of the European Communities C 337 E/111 enforcement of Community (23) The safety of consumers depends to a great extent on the safety active requirements. The Member States 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. product should, (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 such differences products, could entail unacceptable in consumer protection and constitute a disparities barrier to intra-Community trade. (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 Member States to the enforcement authorities of 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. (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) (25) In conformity with the provisions concerning the appli- cability of this Directive, the provisions relating to colla- boration between enforcement authorities should apply without prejudice to specific collaboration procedures in established under particular in the pharmaceutical sector. The European Product Safety Network should cooperate with relevant bodies in which Member States enforcement authorities covered by specific collaborate Community legislation. Systems for Interchange of Data between Administrations may be used in support of that cooperation as appropriate. sectoral Community legislation, in product sectors the Community, It is therefore necessary to provide for an adequate mechanism allowing, as a last resort, for the adoption in of measures applicable throughout 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 above- mentioned 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 such a instrument. Measures adopted under procedure are interim measures, save when they apply to of products. They should be taken by the Commission assisted by a committee composed of representatives of the Member States. individually identified products batches or (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 Commission be informed of any measure restricting the placing on the market of a product or requiring its with- drawal or recall from the market. Such measures may be the taken only in compliance with the provisions of Treaty, and in particular Articles 28, 29 and 30. the internal market, that (27) Effective safety requires supervision of product 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. (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 (1), they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision. (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 various aspects of its application may need to be discussed between experts from the different national adminis- trations in charge of enforcement and market surveillance activities. the regulatory committee. Moreover, (1) OJ L 184, 17. 7. 1999, p. 23. C 337 E/112 EN Official Journal of the European Communities 28. 11. 2000 (34) Public access to the information available to the auth- orities 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 admin- istrative provisions of the Member States concerning liability for defective products (1). (36) It is necessary for Member States to provide for appro- priate 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) the adoption of measures In addition, 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, information and exchange 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. rapid the of (39) This Directive should not affect the obligations of Member transposition and States concerning the deadlines for application of Directive 92/59/EEC, HAVE ADOPTED THIS DIRECTIVE: CHAPTER I OBJECTIVE " SCOPE " DEFINITIONS Article 1 The purpose of 1. the products referred to in Article 2(a) placed on the market are safe. this Directive is to ensure that 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: A 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; A 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: or likely, (a) product: shall mean any product which is intended for consumers, foreseeable under 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. reasonably 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; reasonably foreseeable conditions of use, (b) safe product: shall mean any product which, under normal or 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 composition, packaging, and maintenance, the product, instructions including its for assembly (ii) the effect on other products, where it is reasonably foreseeable that it will be used with other products, (iii) the presentation of the labelling, any the product, instructions for its use and disposal and any other indication or information provided by the producer and by distributors, (1) 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). (iv) the categories of consumers at risk when using the product, in particular children and the elderly, 28. 11. 2000 EN Official Journal of the European Communities C 337 E/113 (v) the services directly associated with the product supplied, when these services are provided by the producer, in particular the installing and the main- tenance 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 CunsafeD or CdangerousD; (c) Cdangerous productD: shall mean any product which does not meet the definition of Csafe productD in point (b); (d) CproducerD: shall mean: (i) the manufacturer of the product, when he is estab- lished 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 manu- if facturer is not established in the Community or, the there Community, the importer of the product, representative established no in is (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) CdistributorD: shall mean any professional in the supply chain whose activity does not affect the safety properties of a product; (f) CrecallD: shall mean any measures aimed at achieving the return of a dangerous product, reimbursement or replacement or repair, that has already been supplied or made available to consumers by the producer or distributor. for CHAPTER II GENERAL SAFETY REQUIREMENT, CONFORMITY ASSESSMENT CRITERIA AND EUROPEAN STANDARDS Article 3 Producers shall be obliged to place only safe products on 1. the market. 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 trans- posing European standards, the references of which have been published by the Commission in the Official 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. Journal of assessed having regard, where 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 to the general safety requirement conformity of a product they exist, shall be 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. Conformity of a product with the provisions mentioned 4. 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 from the market where there is evidence that, withdrawal it is dangerous to the health and despite such conformity, safety of consumers. Article 4 For the purposes of this Directive, the Commission shall 1. establish the mandates to the European standardisation 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 the Commission shall this Directive, 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 (1). The Commission shall ensure coordination with the Regulatory Committee on Consumer Product Safety referred to in Article 14(1) of this Directive. The mandates shall define the objectives that the standards to ensure that products conforming to such must meet safety standards requirement of this Directive. in compliance with the general are 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 The standards referred to in paragraph 1 shall be adopted 2. by European Standardisation bodies, in accordance with the principles contained in the general guidelines for cooperation between the Commission and those bodies. (1) OJ L 204, 21. 7. 1998, p. 37. Directive as amended by Directive 98/48/EC (OJ L 217, 5. 8. 1998, p. 18). C 337 E/114 EN Official Journal of the European Communities 28. 11. 2000 The Commission, after consulting the Committee estab- 3. lished 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 Standard- isation bodies before the entry into force of this Directive. safety general 4. Where a Member State or the Commission considers that a European standard referred to in Article 3(2) does not satisfy the the requirement of Commission or the Member State shall refer the matter to the Committee established by Directive 98/34/EC, setting out the its Commission shall notify the Member States whether or not the to be withdrawn from publication as referred to in Article 3(2) of this Directive. receiving the Committee’s opinion, standard concerned or this Directive, reasons. After thereof has a part 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 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. risks, that they have placed on the market 3. Producers and distributors shall immediately inform the competent authorities of the Member States if they conclude that a product is dangerous. They shall in particular inform the authorities of to consumers. Specific the action taken to prevent 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). risks CHAPTER III OTHER OBLIGATIONS OF PRODUCERS AND OBLIGATIONS OF DISTRIBUTORS Article 5 1. Within the limits of their respective activities, producers information to shall provide consumers with the relevant enable them to assess in a product inherent the normal or reasonably foreseeable period of throughout its use, where such risks are not immediately obvious without adequate warnings, and to take precautions against those risks. the 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 appro- priate action including, if necessary to avoid these risks, with- drawing 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 distributors informed of such monitoring. complaints made keeping and 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 4. their Producers and distributors, within the limits of respective activities, shall collaborate with the competent auth- orities, 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, for dialogue with the producers and distributors concerned on issues related to consumer product safety enforcement. including procedures CHAPTER IV SPECIFIC OBLIGATIONS AND POWERS OF THE MEMBER STATES Article 6 States shall comply with and 1. Member distributors this Directive in such a way that products placed on the market are safe. that obligations producers under ensure their 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. The Member States shall define the tasks, organisation 3. and powers of the various the authorities competent 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. for 28. 11. 2000 EN Official Journal of the European Communities C 337 E/115 Article 7 to infringements of lay down the rules on penalties The Member States shall applicable 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. to the The Member States 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. shall notify those provisions Article 8 1. In order to achieve the objectives of this Directive and in particular for the purposes of Article 6, the competent auth- orities 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: same aims, Directive, is not satisfactory or is insufficient. in conformity to their obligation under this In particular, the competent authorities shall have the 2. to apply necessary powers and take the necessary action, with due those mentioned in paragraph 1(d) to (h), in the case of products posing a serious risk which requires rapid intervention. appropriate measures rapidity among 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; (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; (c) any other person, where necessary, with regard to coop- eration in action taken to avoid risks arising from a product. (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 suitable to ensure product warnings be affixed regarding the risks which the product may present; safety and requiring that 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. In order to achieve the objective referred to in paragraph 2. 1, the Member States shall ensure that appropriate and effective means and procedures are put in place, which may include in particular: (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; (a) the establishment, periodical updating and implementation surveillance programmes by categories of of sectoral products or risks; (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; (b) the follow-up and updating of scientific knowledge concerning the safety of products publicly available, peri- odical reports on surveillance activities, findings and results achieved; (c) periodical reviewing and assessments of the functioning of the if necessary, revision of the surveillance approach and organi- sation put in place. control activities and their effectiveness, and, (h) organising or ordering, the effective and immediate with- drawal 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, in cases where action by producers and distributors to the if necessary, 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. C 337 E/116 EN Official Journal of the European Communities 28. 11. 2000 Article 10 Article 12 1. The Commission shall promote the establishment and operation of a European Product Safety Network between the authorities of for market surveillance of consumer products and involving also the Commission. the Member States competent The Network shall cooperate with relevant bodies in 2. product sectors covered by the legislation referred to in Article 1(2) and shall have as its objectives, in particular, to facilitate: 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. (a) the exchange of information on risk assessment, dangerous products, the recent scientific developments as well as other aspects relevant for control activities; test methods and results, (b) the establishment and execution of joint surveillance and testing projects; (c) the exchange of expertise and best practices and colla- boration in training activities; (d) coordination at Community level of and recall of dangerous products. tracing, withdrawal CHAPTER V EXCHANGES OF INFORMATION AND RAPID INTERVENTION SITUATIONS Article 11 from consumers of 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 those products already supplied, as provided for in Article 8(1)(d) to (h), the Member State shall, to the extent that such notifi- required under Article 12 or any specific cation is not Community 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. inform the Commission of legislation, 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 estab- lished 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. On receiving this information, 2. the Commission shall check whether it complies with the requirements applicable to the to the functioning of RAPEX, and shall other Member States, which, immediately in turn, inform the Commission of any measures adopted. forward it shall 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). Access to RAPEX may be open to candidate countries, 4. third countries or international organisations, within the framework of agreements between the Community and those to countries modalities defined in these agreements. Any such agreements shall be based on reciprocity and include provisions on confi- dentiality corresponding to those applicable in the Community. organisations, international according or 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. The Commission shall 2. 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, immediately inform the Member State which initiated the action. it shall Article 13 If the Commission becomes aware of a serious risk from 1. 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; 28. 11. 2000 EN Official Journal of the European Communities C 337 E/117 (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 The Advisory Committee on Consumer Product Safety 3. shall also assist the Commission in examining any question concerning the application of in particular issues related to enforcement and market surveillance activities. this Directive, (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 func- tioning 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. Export 3. 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. The competent authorities responsible for carrying out 5. 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 The Commission shall be assisted by a Regulatory composed of Product the Member States and chaired by a 1. Committee on Consumer representatives of representative of the Commission. Safety, 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 represen- tatives of the Member States and chaired by the representative of the Commission. CHAPTER VII MISCELLANEOUS AND FINAL PROVISIONS Article 16 Information available to the authorities of the Member 1. to consumer the Commission relating to risks States or in general be health and safety posed by products shall 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. to disclose However, the Member States and the Commission shall take the steps necessary to ensure that their officials and agents are the required not purposes of this Directive which, by its nature, is covered by professional for information relating to the safety properties of products in which must be made public if circumstances so require, order to protect the health and safety of consumers. information obtained for justified cases, in duly secrecy except Protection of professional secrecy shall not prevent the 2. dissemination to the competent authorities of information relevant for ensuring the effectiveness of market surveillance and receiving information covered by professional secrecy shall ensure its protection. enforcement authorities activities. The Article 17 This Directive 85/374/EEC. shall be without prejudice to Directive 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. 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. 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. C 337 E/118 EN Official Journal of the European Communities 28. 11. 2000 its from the Measures requiring the withdrawal of a product market or into take consideration the need to encourage distributors, users and consumers such measures. to contribute to the implementation of from consumers recall shall 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. Any decision taken by virtue of 3. this Directive and involving restrictions on the placing of a product on the from the market or its market or requiring its withdrawal 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 implemen- tation of this Directive to the European Parliament and the Council. The report shall in particular include information on the 2. 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 the approaches, systems and relevant in particular 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 issues, 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 to the obligations of January 2003 without prejudice 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. 28. 11. 2000 EN Official Journal of the European Communities C 337 E/119 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: A the details that permit a precise identification of the product or product batch in question; A full description of the risk posed by the products concerned; A all available information, useful to trace the product; A 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 notifi- cation 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. C 337 E/120 EN Official Journal of the European Communities 28. 11. 2000 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 or 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 circum- stances 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. 28. 11. 2000 EN Official Journal of the European Communities C 337 E/121 ANNEX IV CORRELATION TABLE This Directive Directive 92/59/EEC 1 2 3 4 5 6 7 8 9 10 11 12 13 14 and 15 16 17 18 19 20 21 22 Annex I Annex II Annex III Annex IV 1 2 4 A 3 5 5, second paragraph 6 A A 7 8 9 10 12 13 14 15 17 18 19 A Annex A A