L 220/18EN Official Journal of the European Communities 15.8.2002 COMMISSION DIRECTIVE 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, (8) Besides the monomers and other starting substances fully evaluated and authorised at Community level, there are Having regard to the Treaty establishing the European also monomers and starting substances evaluated and Community, authorised in at least one Member State which may continue to be used pending their evaluation by the Scientific Committee on Food and the decision on their Having regard to Council Directive 89/109/EEC of 21 inclusion in the Community list; this Directive will December 1988 on the approximation of the laws of the accordingly be extended in due course to the substances Member States relating to materials and articles intended to and sectors provisionally excluded. come into contact with foodstuffs (1), and in particular Article 3 thereof, (9) The current list of additives is an incomplete list inas- After consulting the Scientific Committee on Food, much as it does not contain all the substances which are currently accepted in one or more Member States; Whereas: accordingly, these substances continue to be regulated by national laws pending a decision on inclusion in the Community list. (1) Commission Directive 90/128/EEC of 23 February 1990 relating to plastic materials and articles intended to come into contact with foodstuffs (2), as last amended by Direc- tive 2002/17/EC (3), has been frequently and substantially (10) This Directive establishes specifications for only a few amended; for reasons of clarity and rationality, it should substances. The other substances, which may require therefore be consolidated. specifications, therefore remain regulated in this respect by national laws pending a decision at Community level. (2) Article 2 of Directive 89/109/EEC lays down that mate- rials and articles, in their finished state, must not transfer their constituents to foodstuffs in quantities which could (11) For certain additives the restrictions established in this endanger human health or bring about an unacceptable Directive cannot yet be applied in all situations pending change in the composition of the foodstuffs. the collection and evaluation of all the data needed for a better estimation of the exposure of the consumer in (3) In order to achieve this objective in the case of plastic some specific situations; therefore, these additives appear materials and articles, a suitable instrument is a specific in a list other than that of the additives fully regulated at Directive within the meaning of Article 3 of Directive Community level. 89/109/EEC, the general provisions of which are also applicable to the case in question. (12) Directive 82/711/EEC lays down the basic rules neces- (4) The scope of this Directive must coincide with that of sary for testing migration of the constituents of plastic Council Directive 82/711/EEC (4). materials and articles and Council Directive 85/572/ EEC (5) establishes the list of simulants to be used in the (5) Since the rules established in this Directive are not migration tests. suitable for ion-exchange resins, these materials and arti- cles will be covered by a subsequent specific Directive. (13) The determination of a quantity of a substance in a (6) Silicones should be regarded as elastomeric materials finished material or article is simpler than the determina- rather than plastic materials and therefore should be tion of its specific migration level. The verification of excluded from the definition of plastic. compliance through the determination of quantity rather than specific migration level should therefore be (7) The establishment of a list of approved substances permitted under certain conditions. accompanied by a limit on overall migration and, where necessary, by other specific restrictions will be sufficient to achieve the objective laid down in Article 2 of Direc- (14) For certain types of plastics the availability of generally tive 89/109/EEC. recognised diffusion models based on experimental data allows the estimation of the migration level of a (1) OJ L 40, 11.2.1989, p. 38. substance under certain conditions, therefore avoiding 2 ( ) OJ L 75, 21.3.1990, corrected by OJ L 349, 13.12.1990, p. 26. complex, costly and time-consuming testing. (3) OJ L 58, 28.2.2002, p. 19. (4) OJ L 297, 23.10.1982, p. 26. Directive as last amended by Directive 97/48/EC (OJ L 222, 12.8.1997, p. 10). (5) OJ L 372, 31.12.1985, p. 14. 15.8.2002 EN Official Journal of the European Communities L 220/19 (15) The overall migration limit is a measure of the inertness (b) composed of two or more layers of materials, each of the material and prevents an unacceptable change in consisting exclusively of plastics, which are bound together the composition of the foodstuffs, and, moreover, by means of adhesives or by any other means, reduces the need for a large number of specific migration limits or other restrictions, thus giving effective control. which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs are intended (16) Council Directive 78/142/EEC (1) lays down limits for for that purpose. the quantity of vinyl chloride present in plastic materials and articles prepared with this substance and for the 3. For the purposes of this Directive, ‘plastics’ shall mean the quantity of vinyl chloride released by these materials and organic macromolecular compounds obtained by polymerisa- articles, and Commission Directives 80/766/EEC (2) and tion, polycondensation, polyaddition or any other similar 81/432/EEC (3) establish the Community methods of process from molecules with a lower molecular weight or by analysis for controlling these limits. chemical alteration of natural macromolecules. Other substances or matter may be added to such macromolecular (17) In view of potential liability, there is a need for the compounds. written declaration provided for in Article 6(5) of Direc- tive 89/109/EEC whenever professional use is made of plastic materials and articles which are not by their However, the following shall not be regarded as ‘plastics’: nature clearly intended for food use. (a) varnished or unvarnished regenerated cellulose film, (18) Commission Directive 80/590/EEC (4) determines the covered by Commission Directive 93/10/EEC (5); symbol that may accompany any material and article intended to come into contact with foodstuffs. (b) elastomers and natural and synthetic rubber; (19) In accordance with the principle of proportionality, it is (c) paper and paperboard, whether modified or not by the necessary and appropriate for the achievement of the addition of plastics; basic objective of ensuring the free movement of plastic materials and articles intended to come into contact with (d) surface coatings obtained from: foodstuffs, to lay down rules on the definition of plastics — paraffin waxes, including synthetic paraffin waxes, and/ and permitted substances. This Directive confines itself or micro-crystalline waxes, to what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of — mixtures of the waxes listed in the first indent with each Article 5 of the Treaty. other and/or with plastics, (20) In accordance with Article 3 of Directive 89/109/EEC, (e) ion-exchange resins; the Scientific Committee on Food has been consulted on the provisions liable to affect public health. (f) silicones. (21) The measures provided for in this Directive are in accor- 4. This Directive shall not apply, until further action by the dance with the opinion of the Standing Committee on Commission, to materials and articles composed of two or the Food Chain and Animal Health. more layers, one or more of which does not consist exclusively of plastics, even if the one intended to come into direct contact (22) This Directive should be without prejudice to the dead- with foodstuffs does consist exclusively of plastics. lines set out in Annex VII, Part B within which the Member States are to comply with Directive 90/128/ EEC, and the acts amending it, Article 2 Plastic materials and articles shall not transfer their constituents HAS ADOPTED THIS DIRECTIVE: 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 Article 1 the constituents released per kilogram of foodstuff (mg/kg) in the following cases: 1. This Directive is a specific Directive within the meaning of Article 3 of Directive 89/109/EEC. (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); 2. This Directive shall apply to plastic materials and articles and parts thereof: (b) articles which can be filled and for which it is impracticable (a) consisting exclusively of plastics; or to estimate the surface area in contact with foodstuffs; (c) caps, gaskets, stoppers or similar devices for sealing. (1) OJ L 44, 15.2.1978, p. 15. (2) OJ L 213, 16.8.1980, p. 42. (3) OJ L 167, 24.6.1981, p. 6. (5) OJ L 93, 17.4.1993, p. 27. Directive amended by Directive 93/111/ (4) OJ L 151, 19.6.1980, p. 21. EC (OJ L 310, 14.12.1993, p. 41). L 220/20EN Official Journal of the European Communities 15.8.2002 Article 3 2. The meaning of the numbers between brackets appearing in the column ‘Restrictions and/or specifications’ is explained in 1.