COUNCIL DIRECTIVE of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys (88/378/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100A thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas the laws, regulations and administrative provisions in force in the various Member States relating to the safety characteristics of toys differ in scope and content; whereas such disparities are liable to create barriers to trade and unequal conditions of competition within the internal market without necessarily affording consumers in the common market, especially children, effective protection against the hazards arising from the products in question;
Whereas these obstacles to the attainment of an internal market in which only sufficiently safe products would be sold should be removed; whereas, for this purpose, the marketing and free movement of toys should be made subject to uniform rules based on the objectives regarding protection of consumer health and safety as set out in the Council resolution of 23 June 1986 concerning the future orientation of the policy of the European Economic Community for the protection and promotion of consumer interests (4);
Whereas, to facilitate proof of conformity with the essential requirements, it is necessary to have harmonized standards at European level which concern, in particular, the design and composition of toys so that products complying with them may be assumed to conform to the essential requirements; whereas these standards harmonized at European level are drawn up by private bodies and must remain non-mandatory texts; whereas for that purpose the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) are recognized as the competent bodies for the adoption of harmonized standards in accordance with the general guidelines for cooperation between the Commission and those two bodies signed on 13 November 1984; whereas, for the purposes of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted by one or both of those bodies upon a remit from the Commission in accordance with the provisions of Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (5), as last amended by the Act of Accession of Spain and Portugal, and on the basis of the general guidelines;
Whereas, in accordance with the Council resolution of 7 May 1985 on a new approach to technical harmonization and standards (6), the harmonization to be achieved should consist in establishing the essential safety requirements to be satisfied by all toys if they are to be placed on the market;
Whereas, in view of the size and mobility of the toy market and the diversity of the products concerned, the scope of this Directive should be determined on the basis of a sufficiently broad definition of 'toys'; whereas, nevertheless, it should be made clear that some products are not to be regarded as toys for the purposes of this Directive either because they are not in fact intended for children or because they call for supervision or special conditions of use;
Whereas toys placed on the market should not jeopardize the safety and/or health either of users or of third parties; whereas the standard of safety of toys should be determined in relation to the criterion of the use of the product as intended, but allowance should also be made for any foreseeable use, bearing in mind the normal behaviour of children who do not generally show the same degree of care as the average adult user;
Whereas the standard of safety of the toy must be considered when it is marketed, bearing in mind the need to ensure that this standard is maintained throughout the foreseeable and normal period of use of the toy;
Whereas compliance with the essential requirements is likely to guarantee consumer health and safety; whereas all toys placed on the market must comply with these requirements and, if they do, no obstacle must be put in the way of their free movement;
Whereas toys may be presumed to comply with these essential requirements where they are in conformity with the harmonized standards, reference numbers of which have been published in the Official Journal of the European Communities;
Whereas toys that conform to a model approved by an approved body may also be regarded as complying with the essential requirements; whereas such conformity must be certified by the affixing of a European mark;
Whereas certification procedures must be established to define the way in which national approved bodies have to approve models of toys not in conformity with standards and issue type-examination certificates for them and for toys in conformity with standards, a model of which is submitted to them for approval;
Whereas adequate information for the Member States, the Commission and all the approved bodies must be provided for at the various stages of the certification and inspection procedures;
Whereas Member States must appoint bodies, called 'approved bodies', for the purposes of applying the system introduced for toys; whereas adequate information on these bodies must be provided and they must all comply with minimum criteria for their approval;
Whereas cases might arise where a toy does not satisfy the essential safety requirements; whereas, in such cases, the Member State which ascertains this fact must take all appropriate measures to withdraw the products from the market or to prohibit their being placed on the market; whereas a reason must be given for this decision and, where the reason is a shortcoming in the harmonized standards, these, or a part thereof, must be withdrawn from the list published by the Commission;
Whereas the Commission is to ensure that the harmonized European standards in all the areas covered by the essential requirements listed in Annex II are drawn up in sufficient time to enable Member States to adopt and publish the necessary provisions by 1 July 1989; whereas the national provisions adopted on the basis of this Directive should consequently become effective on 1 January 1990;
Whereas provision must be made for suitable action to be taken against anyone wrongfully affixing a mark of conformity;
Whereas checks on the safety of toys already on the market must be carried out by the competent authorities of the Member States;
Whereas, for some categories of toys that are particularly dangerous or intended for very young children, warnings or details of precautions to be taken must also be given;
Whereas the Commission must receive regular information on activities carried out under this Directive by the approved bodies;
Whereas those to whom any decision taken under this Directive is addressed must know the reason for that decision and the remedies open to them;
Whereas the opinion of the Scientific Advisory Committee for the evaluation of the toxicity and ecotoxicity of chemical compounds has been taken into account with respect to the health-based limits of bioavailability of metallic compounds in toys to children,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive shall apply to toys. A 'toy' shall mean any product or material designed or clearly intended for use in play by children of less than 14 years of age.
2. The products listed in Annex I shall not be regarded as toys for the purposes of this Directive.
Article 2
1. Toys may be placed on the market only if they do not jeopardize the safety and/or health of users or third parties when they are used as intended or in a foreseeable way, bearing in mind the normal behaviour of children.
2. In the condition in which it is placed on the market, taking account of the period of foreseeable and normal use, a toy must meet the safety and health conditions laid down in this Directive.
3. For the purposes of this Directive, the expression 'placed on the market' shall cover both sale and distribution free of charge.
Article 3
Member States shall take all steps necessary to ensure that toys cannot be placed on the market unless they meet the essential safety requirements set out in Annex II.
Article 4
Member States shall not impede the placing on the market on their territory of toys which satisfy the provisions of this Directive.
Article 5
1. Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of toys bearing the EC mark provided for in Article 11, hereinafter referred to as 'EC mark', denoting conformity with the relevant national standards which transpose the harmonized standards the reference numbers of which have been published in the Official Journal of the European Communities. Member States shall publish the reference numbers of such national standards.
2. Member States shall presume that toys in respect of which the manufacturer has not applied the standards referred to in paragraph 1, or has applied them only in part, or for which no such standards exist, satisfy the essential requirements referred to in Article 3 where, after receipt of an EEC type-examination certificate, their conformity with the approved model has been certified by the affixation of the EC mark.
Article 6
1. Where a Member State or the Commission considers that the harmonized standards referred to in Article 5 (1) do not entirely satisfy the essential requirements referred to in Article 3, the Commission or the Member State shall refer the matter to the Standing Committee set up under Directive 83/189/EEC, hereinafter referred to as 'the committee', setting out its reasons. The committee shall issue an opinion as a matter of urgency.
After receiving the committee's opinion, the Commission shall notify the Member States whether or not the standards concerned or a part thereof have to be withdrawn from the publications referred to in Article 5 (1).
2. The Commission shall inform the European standardization body concerned and, if necessary, issue a new standardization brief.
Article 7
1. Where a Member State ascertains that toys bearing the EC mark which are used as intended or in accordance with Article 2 are likely to jeopardize the safety and/or health of consumers and/or third parties, it shall take all appropriate measures to withdraw the products from the market, or to prohibit or restrict their placing on the market. The Member State shall inform the Commission immediately of this measure and indicate the reasons for its decision, stating in particular whether the non-compliance results from:
(a) failure to meet the essential requirements referred to in Article 3, if the toy does not meet the standards referred to in Article 5 (1);
(b) incorrect application of the standards referred to in Article 5 (1);
(c) shortcomings in the standards referred to in Article 5 (1).
2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that any measure as referred to in paragraph 1 is justified, it shall forthwith so inform the Member State that took the action and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission, after consulting the parties concerned, shall bring the matter before the Committee within two months if the Member State which has taken the measures intends to maintain them and shall initiate the procedures referred to in Article 6.
3. Where the toy which does not comply with the requirements bears the EC mark, the competent Member State shall take appropriate measures and inform the Commission, which shall inform the other Member States.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.
Article 8
1. (a) Before being placed on the market, toys manufactured in accordance with the harmonized standards referred to in Article 5 (1) must have affixed to them the EC mark by which the manufacturer or his authorized representative established within the Community confirms that the toys comply with those standards;
(b) The manufacturer or his authorized representative established within the Community shall keep the following information available for inspection:
- a description of the means (such as the use of a test report or technical file) whereby the manufacturer ensures conformity of production with the standards referred to in Article 5 (1) and, as appropriate: an EC type-certificate drawn up by an approved body; copies of the documents the manufacturer has submitted to the approved body; a description of the means whereby the manufacturer ensures conformity with the approved model,
- the addresses of the places of manufacture and storage,
- detailed information concerning the design and manufacture.
Where neither the manufacturer nor his authorized representative are established within the Community, the above obligation to keep a dossier available shall be the responsibility of the person who places the toy on the Community market.
2. (a) Toys which do not conform in whole or in part to the standards referred to in Article 5 (1) must have affixed to them, before being placed on the market, the EC mark by which the manufacturer or his authorized representative established within the Community confirms that the toy concerned conforms to the model examined in accordance with the procedures laid down in Article 10 which an approved body has stated complies with the essential requirements referred to in Article 3;
(b) the manufacturer or his authorized representive established within the Community shall keep the following information available for inspection:
- a detailed description of manufacture,
- a description of the means (such as the use of a test report or technical file) whereby the manufacturer ensures conformity with the approved model,
- the addresses of the places of manufacture and storage,
- copies of the documents the manufacturer has submitted to an approved body in accordance with Article 10 (2),
- the test certificate for the sample or a certified copy thereof.
Where neither the manufacturer nor his authorized representative is established within the Community, the above obligation to keep a dossier available shall be the responsibility of the person who places the toy on the market in the Community.
3. In the event of non-observance of the obligations laid down in paragraphs 1 (b) and 2 (b), the competent Member State shall take appropriate measures to ensure that those obligations are observed.
Where non-observance of the obligations is obvious, it may in particular require the manufacturer or his authorized representative established within the Community to have a test performed at his own expense within a specified period by an approved body in order to verify compliance with the harmonized standards and essential safety requirements.
Article 9
1. The minimum criteria which Member States must meet in order to appoint the approved bodies referred to in this Directive are contained in Annex III.
2. Each Member State shall notify the Commission of the approved bodies responsible for carrying out the EC type-examination referred to in Articles 8 (2) and 10. The Commission shall publish a list of these bodies, with the distinguishing numbers it has given them, in the Official Journal of the European Communities for information and shall be responsible for updating it.
3. A Member State which has approved a body shall withdraw approval if it finds that the body no longer meets the criteria listed in Annex III. It shall forthwith inform the Commission thereof.
Article 10
1. EC type-examination is the procedure by which an approved body ascertains and certifies that a model of a toy satisfies the essential requirements referred to in Article 3.
2. The application for EC type-examination shall be lodged with an approved body by the manufacturer or by his authorized representative established within the Community.
The application shall include:
- a description of the toy,
- the name and address of the manufacturer or of his authorized representative or representatives, and the place of manufacture of the toy,
- comprehensive manufacturing and design data; and shall be accompanied by a model of the toy to be manufactured.
3. The approved body shall carry out the EC type-examination in the manner described below:
- it shall examine the documents supplied by the applicant and establish whether they are in order,
- it shall check that the toy would not jeopardize safety and/or health, as provided for in Article 2,
- it shall carry out the appropriate examinations and tests - using as far as possible the harmonized standards referred to in Article 5 (1) - in order to check whether the model meets the essential requirements referred to in Article 3,
- it may ask for further examples of the model.
4. If the model complies with the essential requirements referred to in Article 3, the approved body shall draw up an EC type-examination certificate which shall be notified to the applicant. This certificate shall state the conclusions of the examination, indicate any conditions attaching to it and be accompanied by the descriptions and drawings of the approved toy.
The Commission, the other approved bodies and the other Member States may obtain on request a copy of the certificate and, on reasoned request, a copy of the design and manufacturing schedule and the reports on the examinations and tests carried out.
5. An approved body which refuses to issue an EC type-examination certificate shall so inform the Member State which approved it and the Commission, giving the reasons for refusal.
Article 11
1. The EC mark referred to in Articles 5, 7 and 8 and the name and/or trade name and/or mark and address of the manufacturer or his authorized representative or the importer into the Community shall as a rule be affixed either to the toy or on the packaging in a visible, easily legible and indelible form. In the case of small toys and toys consisting of small parts these particulars may be affixed in the same way to the packaging, to a label or to a leaflet. Where the said particulars are not affixed to the toy, the consumer's attention must be drawn to the advisability of keeping them.
2. The EC mark shall consist of the symbol 'CE'.
3. The affixing to toys of marks or inscriptions that are likely to be confused with the EC mark shall be prohibited.
4. The particulars referred to in paragraph 1 may be abbreviated provided that the abbreviation enables the manufacturer, his authorized representative or the importer into the Community to be identified.
5. Annex IV sets out the warnings and indications of precautions to be taken during use that have to be given for certain toys. Member States may require that these warnings and precautions, or some of them, together with the information specified in paragraph 4, be given in their own national language or languages when the toys are placed on the market.
Article 12
1. Member States shall take the necessary measures to ensure that sample checks are carried out on toys which are on their market, so as to verify their conformity with this Directive.
The authority responsible for inspection:
- shall obtain access, on request, to the place of manufacture or storage and to the information referred to in Article 8 (1) (b) and (2) (b),
- may ask the manufacturer, his authorized representative or the person responsible for marketing the toy established within the Community to supply the information as provided for in Article 8 (1) (b) and (2) (b) within a period specified by the Member State,
- may select a sample and take it away for examination and testing.
2. Every three years, Member States shall send the Commission a report on the application of this Directive.
3. The Member States and the Commission shall take the necessary measures to guarantee confidentiality with regard to the forwarding of the copies relating to the EC type-examination referred to in Article 10 (4).
Article 13
Member States shall regularly inform the Commission of the activities carried out in pursuance of this Directive by the bodies they have approved so that the Commission may ensure that the inspection procedures are implemented correctly and without discrimination.
Article 14
Any decision taken pursuant to this Directive and involving restrictions on the placing of the toy on the market shall state the exact grounds on which it is based. It shall be notified at the earliest opportunity to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member State in question and of the time limits applying to such remedies.
Article 15
1. Member States shall adopt and publish by 30 June 1989 the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
They shall apply these provisions from 1 January 1990.
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.
Article 16
This Directive is addressed to the Member States.
Done at Brussels, 3 May 1988.