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, HavingregardtotheTreatyestablishingtheEuropean Community, HavingregardtoCouncilDirective89/109/EECof21 December 1988 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, After consulting the Scientific Committee on Food, Whereas: (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 amended; for reasons of clarity and rationality, it should therefore be consolidated. (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 endanger human health or bring about an unacceptable change in the composition of the foodstuffs. (3)In order to achieve this objective in the case of plastic 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. (4)The scope of this Directive must coincide with that of Council Directive 82/711/EEC (4). (5)Since the rules established in this Directive are not suitable for ion-exchange resins, these materials and arti- cles will be covered by a subsequent specific Directive. (6)Silicones should be regarded as elastomeric materials rather than plastic materials and therefore should be excluded from the definition of plastic. (7)The establishment of a list of approved substances 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- tive 89/109/EEC. (8)Besides the monomers and other starting substances fully evaluated and authorised at Community level, there are also monomers and starting substances evaluated and 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 inclusion in the Community list; this Directive will accordingly be extended in due course to the substances and sectors provisionally excluded. (9)The current list of additives is an incomplete list inas- much as it does not contain all the substances which are currently accepted in one or more Member States; accordingly, these substances continue to be regulated by national laws pending a decision on inclusion in the Community list. (10)This Directive establishes specifications for only a few substances. The other substances, which may require specifications, therefore remain regulated in this respect by national laws pending a decision at Community level. (11)For certain additives the restrictions established in this Directive cannot yet be applied in all situations pending the collection and evaluation of all the data needed for a better estimation of the exposure of the consumer in some specific situations; therefore, these additives appear in a list other than that of the additives fully regulated at Community level. (12)Directive 82/711/EEC lays down the basic rules neces- sary for testing migration of the constituents of plastic materials and articles and Council Directive 85/572/ EEC (5) establishes the list of simulants to be used in the migration tests. (13)The determination of a quantity of a substance in a finished material or article is simpler than the determina- tion of its specific migration level. The verification of compliance through the determination of quantity rather thanspecificmigrationlevelshouldthereforebe permitted under certain conditions. (14)For certain types of plastics the availability of generally recognised diffusion models based on experimental data allows the estimation of the migration level of a substance under certain conditions, therefore avoiding complex, costly and time-consuming testing. 15.8.2002L 220/18Official Journal of the European CommunitiesEN (1) OJ L 40, 11.2.1989, p. 38. (2) OJ L 75, 21.3.1990, corrected by OJ L 349, 13.12.1990, p. 26. (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)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. (16)Council Directive 78/142/EEC (1) lays down limits for the quantity of vinyl chloride present in plas