Council Directive

of 19 December 1985

laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs

(85/572/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 82/711/EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs1, and in particular Article 2 (3) thereof,

Having regard to the proposal from the Commission2,

Having regard to the opinion of the European Parliament3,

Having regard to the opinion of the Economic and Social Committee4,

Whereas, by virtue of Article 2 (3) of, together with the first indent of Chapter 1 (2) of the Annex to Directive 82/711/EEC, appropriate simulants to carry out migration tests should be indicated for plastic materials and articles intended to come into contact with a single foodstuff or a specific group of foodstuffs;

Whereas the possibility should not be excluded, where necessary, of making use of methods for testing migration other than those laid down in this Directive;

Whereas, in determining appropriate simulants, account must be taken in particular of the chemical composition of the foodstuff and its physical properties;

Whereas, for some foodstuffs containing fat, the result obtained in migration tests with the simulant is higher than that obtained in migration tests with the foodstuff itself and whereas therefore the result should be corrected by applying a ‘reduction factor’ appropriate to the particular situation; whereas in certain specific cases, particularly that of materials and objects in contact with foodstuffs with fatty substances on the surface, the existence of appropriate methods of analysis is essential for implementation of this Directive;

Whereas the adaptation of this Directive to technical progress constitutes an implementing measure, the adoption of which, in order to simplify and accelerate the procedure, should in principle 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/EEC5,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Pursuant to Article 2 (3) of Directive 82/711/EEC, the simulants to be used for testing migration of the constituents of plastic materials and articles intended to come into contact with a single foodstuff or specific group of foodstuffs and the concentration of these simulants shall be those indicated in the Annex.

Article 2

Notwithstanding Article 1, the list of substances or materials whose use is authorized to the exclusion of all others may lay down procedures testing migration of particular constituents of plastic materials and articles which differ from those laid down in the Annex where this is appropriate.

Article 3

Adaptations to be made to the Annex to this Directive in the light of progress in scientific and technical knowledge shall be adopted in accordance with the procedure laid down in Article 10 of Directive 76/893/EEC6.

Article 4

Member States shall take all measures necessary to comply with this Directive not later than such time as they take the measures to implement Directive 82/711/EEC

Article 5

This Directive is addressed to the Member States.

ANNEX

Annotations:

F1The food simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with a single food or specific groups of foods are set out in point 3 of Annex III to Commission Regulation (EU) No 10/2011.