THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 76/893/EEC of 23 November 1976 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs ( 1 ), and in particular Article 3 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament ( 2 ),

Having regard to the opinion of the Economic and Social Committee ( 3 ),

Whereas Article 2 of Directive 76/893/EEC laid down inter alia that materials and articles must not transfer their constituents to foodstuffs in quantities which could endanger human health or bring about an unacceptable change in the composition of the foodstuffs;

Whereas in order to achieve this objective in the case of plastic materials the suitable instrument is a specific directive within the meaning of Article 3 of Directive 76/893/EEC, the general rules of which shall also be applicable to the case in question;

Whereas, given the complexity of the problem, the Directive should initially be limited to fixing the basic rules for verification of constituent migration; whereas further directives, to be adopted in accordance with the procedure laid down in Article 10 of Directive 76/893/EEC, will establish the methods of analysis necessary for the verification of such migration;

Whereas this Directive does not affect all aspects of plastic materials and articles; whereas it is therefore necessary to authorize the Member States, on the one hand, not to impose the labelling particulars laid down in Article 7 of Directive 76/893/EEC in accordance with paragraphs 4 and 5 of that Article and, on the other hand, to prohibit the marketing of materials and articles which, although conforming with the standards laid down by that Directive, do not comply with national provisions regarding other possible standards referred to in Article 3 or in the absence of these, with Article 2 of the Directive in question;

Whereas, in view of the analytical difficulties connected with the determination of the migration levels in food products, conventional tests should be chosen (liquids capable of simulating the attack on foodstuffs and standard test conditions) in order to reproduce, as far as possible, the migration phenomena which may occur in contact between the article and the foodstuff;

Whereas if such tests subsequently prove not to reflect reality Member States should be authorized to amend them provisionally, pending a Community decision;

Whereas, in the current state of analytical techniques, it is not possible to determine all the conditions under which conventional migration tests should be performed on materials and articles consisting of two or more layers, one or more of which does not consist entirely of plastics; whereas a decision on the application of this Directive to such materials and articles should therefore be taken at a later date;

Whereas the adaptation of this Directive to technical progress is an implementing measure; whereas, in order to simplify and accelerate the procedure, this should be the responsibility of the Commission;

Whereas in all cases in which the Council confers on the Commission authority to implement the provisions relating to plastic materials and articles intended to come into contact with foodstuffs, a procedure should be laid down establishing close cooperation between Member States and the Commission within the Standing Committee for Foodstuffs set up under Decision 69/414/EEC ( 4 ),

HAS ADOPTED THIS DIRECTIVE:

(a) consisting exclusively of plastics, or

(b) composed of two or more layers of materials, each consisting exclusively of plastics, which are bound together by means of adhesives or by any other means,

(i) varnished or unvarnished regenerated cellulose film;

(ii) elastomers and natural and synthetic rubber;

(iii) paper and paperboard, whether modified or not by the addition of plastics;

(iv) surface coatings obtained from:

(a) However, where a Member State, as a result of new information or of a reassessment of existing information made since this Directive was adopted, has detailed grounds for establishing that for a given plastic material or article the basic rules laid down in the Annex for migration tests are technically unsuitable or because the actual conditions of use are basically different from the test conditions specified in the table in the Annex, that Member State may, within its territory and only for the particular case, temporarily suspend application of the basic rules referred to in the Annex and permit the use of more appropriate basic rules. It shall immediately inform the other Member States and the Commission thereof and give the reasons for its decision.

(b) The Commission shall examine, as soon as possible, the reasons given by the Member States concerned and shall consult the Member States within the Standing Committee for Foodstuffs and shall then deliver its opinion forthwith and amend this Directive, if necessary. In that case, the Member State which has adopted the more appropriate basic rules may retain them until the said amendments enter into force.

1. ‘Migration tests’ for the determination of specific and overall migration shall be carried out using the ‘food simulants’ laid down in Chapter I of this Annex and under ‘conventional migration test conditions’ specified in Chapter II of this Annex.

2. ‘Substitute tests’ which use the ‘test media’ under the ‘conventional substitute test conditions’ as set out in Chapter III shall be carried out if the migration test using the fatty food simulants (see Chapter I) is not feasible for technical reasons connected with the method of analysis.

3. ‘Alternative tests’ indicated in Chapter IV are permissible instead of migration tests with fatty food simulant when the conditions specified in Chapter IV are fulfilled.

4. In all three cases it is permissible:

— 3 % acetic acid (w/v) in aqueous solution,

— 10 % ethanol (v/v) in aqueous solution,

— rectified olive oil (‘reference simulant D’).

(a) when the material or article is already in contact with a known foodstuff;

(b) when the material or article is accompanied, according to the rules of Article 6 of Directive 89/109/EEC, by a specific indication stating with which food types described in Table 1 it may or may not be used, for example ‘only for aqueous foods’;

(c) when the material or article is accompanied, according to the rules of Article 6 of Directive 89/109/EEC, by a specific indication stating with which foodstuff(s) or group(s) of foodstuffs mentioned in Directive 85/572/EEC they may or may not be used. This indication shall be expressed: