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COMMISSION DIRECTIVE
of 23 February 1990
relating to plastics materials and articles intended to come into contact with foodstuffs
(90/128/EEC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 89/109/EEC of 21 December 1989 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,
Whereas Article 2 of Directive 89/109/EEC lays down that materials and articles, in their finished state, 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 plastics materials and articles, a suitable instrument is a specific Directive within the meaning of Article 3 of Directive 89/109/EEC, the general provisions of which are also applicable to the case in question;
Whereas the scope of this Directive must coincide with that of Council Directive 82/711/EEC (2);
Whereas since the rules established in this Directive are not suitable for ion-exchange resins, these materials and articles will be covered by a subsequent specific Directive;
Whereas the establishment of a list of approved substances accompanied by a limit an overall migration and, where necessary, by other specific restrictions will be sufficient to achieve the objective laid down in Article 2 of Directive 89/109/EEC;
Whereas the stage reached in the work at Community level does not yet permit adoption of a complete list of the authorized substances applicable to all types of plastics materials and articles and therefore the substances which are currently used in at least one Member State can continue to be used pending a decision on inclusion in the Community list; whereas this Directive will accordingly be extended in due course to the substances and sectors provisionally excluded;
Whereas the overall migration limit is a measure of the inertness of the material and prevents an unacceptable change in the composition of the foodstuffs, and, moreover, reduces the need for a large number of specific migration limits or other restrictions, thus giving effective control;
Whereas Directive 82/711/EEC lays down the basic rules necessary for testing migration of the constituents of plastics materials and articles and Council Directive 85/572/EEC (3) establishes the list of simulants to be used in the migration tests;
Whereas Council Directive 78/142/EEC (1) lays down limits for the quantity of vinyl chloride present in plastics materials and articles prepared with this substance and for the quantity of vinyl chloride released by these materials and articles, and Directives 80/766/EEC (2) and 81/432/EEC (3) establish the Community methods of analysis for controlling these limits;
Whereas Commission Directive 80/590/EEC (4) determines the symbol that may accompany any material and article intended to come into contact with foodstuffs;
Whereas in view of potential liability, there is a need for the written declaration provided for in Article 6 (5) of Directive 89/109/EEC whenever professional use is made of plastics materials and articles which are not by their nature clearly intended for food use;
Whereas, in accordance with Article 3 of Directive 89/109/EEC, the Scientific Committee for Food has been consulted on the provisions liable to affect public health;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive is a specific Directive within the meaning of Article 3 of Directive 89/109/EEC.
2. This Directive shall apply to plastics materials and articles and parts thereof:
(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,
which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs and are intended for that purpose.
3. For the purposes of this Directive, 'plastics' shall mean the organic macromolecular compounds obtained by polymerization, polycondensation, polyaddition or any other similar process from molecules with a lower molecular weight or by chemical alteration of natural macromolecules. Silicones and other similar macromolecular compounds shall also be regarded as plastics. Other substances or matter may be added to such macromolecular compounds.
However, the following shall not be regarded as plastics:
(i) varnished or unvarnished regenerated cellulose film, covered by Council Directive 83/229/EEC (5), as amended by Directive 86/388/EEC (6);
(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:
- paraffin waxes, including synthetic paraffin waxes, and/or micro-crystalline waxes,
- mixtures of the waxes listed in the first indent with each other and/or with plastics;
(v) ion-exchange resins.
4. This Directive shall not apply, until further action by the Commission, to materials and articles composed of two or more layers, one or more of which does not consist exclusively of plastics, even if the one intended to come into direct contact with foodstuffs does consist exclusively of plastics.
Article 2
Plastics materials and articles shall not transfer their constituents to foodstuffs in quantities exceeding 10 milligrams per square decimetre of surface area of material or article (mg/dm2) (overall migration limit). However, this limit shall be 60 milligrams of the constituents released per kilogram of foodstuff (mg/kg) in the following cases:
(a) articles which are containers or are comparable to containers or which can be filled, with a capacity of not less than 500 millilitres (ml) and not more than 10 litres (l);
(b) articles which can be filled and for which it is impracticable to estimate the surface area in contact with foodstuffs;
(c) caps, gaskets, stoppers or similar devices for sealing.
Article 3
1. Only those monomers and other starting substances listed in Annex II, Sections A and B may be used for the manufacture of plastics materials and articles subject to the restrictions specified.
2. From the date of notification of this Directive, the list in Annex II, Section A may be amended:
- either by adding substances listed in Annex 2, Section B, according to the criteria in Annex II of Directive 89/109/EEC, or
- by including 'new substances', i.e. substances which are listed neither in Section A nor in Section B of Annex 2, according to Article 3 of Directive 89/109/EEC.
3. From the date of notification of this Directive no Member State shall authorize any new substance for use within its territory except under the procedure in Article 4 of Directive 89/109/EEC.
4. As from 1 January 1993, only those monomers and other starting substances listed in Annex II, Section A shall be used for the manufacture of plastics materials and articles, subject to the restrictions specified therein. However, before 1 January 1992 it may be decided that, in some justified cases, for certain substances listed in Annex II, section B, this time limit will be postponed.
5. However the lists appearing in Annex II, Sections A and B do not yet include monomers and other starting substances used only in the manufacture of:
- surface coatings obtained from resinous or polymerized products in liquid, powder or dispersion form, such as varnishes, lacquers, paints, etc.,
- silicones,
- epoxy resins,
- products obtained by means of bacterial fermentation,
- adhesives and adhesion promoters,
- printing inks.
Article 4
The specific migration limits in the list set out in Annex II are expressed in mg/kg. However, such limits are expressed in mg/dm2 in the following cases:
(a) articles which are containers or are comparable to containers or which can be filled, with a capacity of less than 500 ml or more than 10 l;
(b) sheet, film or other materials which cannot be filled or for which it is impracticable to estimate the relationship between the surface area of such materials and the quantity of foodstuff in contact therewith.
In these cases, the limits set out in Annex II, expressed in mg/kg shall be divided by the conventional conversion factor of 6 in order to express them in mg/dm2.
Article 5
1. Verification of compliance with the migration limits shall be carried out in accordance with the rules laid down in Directives 82/711/EEC and 85/572/EEC and the further provisions set out in Annex I.
2. The verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if it can be established that compliance with the overall migration limit laid down in Article 2 implies that the specific migration limits are not exceeded.
Article 6
1. At the marketing stages other than the retail stages, the plastics materials and articles which are intended to be placed in contact with foodstuffs shall be accompanied by a written declaration in accordance with Article 6 (5) of Directive 89/109/EEC.
2. Paragraph 1 does not apply to plastics materials and articles which by their nature are clearly intended to come into contact with foodstuffs.
Article 7
1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1990. They shall forthwith inform the Commission thereof.
2. Member States shall:
- permit the trade in and use of plastics materials and articles complying with this Directive before 1 January 1991,
- prohibit trade in and use of plastics materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive as from 1 January 1993.
Article 8
This Directive is addressed to the Member States.
Done at Brussels, 23 February 1990.