L 221/18 Official Journal of the European Communities 17.8.2001 COMMISSION DIRECTIVE 2001/62/EC of 9 August 2001 amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (*), and in particular Article 3 thereof, After consulting the Scientific Committee on Food, Whereas: 1) Silicones should be regarded as elastomeric materials rather than plastic materials and therefore should be deleted from the definition of plastics. The determination of a quantity of a substance in a finished material or article is simpler than the deter- mination of its specific migration level. The verification of compliance through the determination of quantity rather than specific migration level should therefore be permitted under certain conditions. 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. Recent collaborative tests indicate that there is greater variability in the results of analysis for the determination of overall migration of substances used in plastics when aqueous food simulants as well as volatile media such as isooctane, ethanol and other similar solutions are used. 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, use of which may be continued pending their evaluation by the Scientific Committee on Food and the decision on their inclusion in the Community list. On the basis of the new information available to the Scientific Committee on Food, certain monomers provi- sionally admitted at national level as well as other monomers requested for use following the adoption of () O] L 40, 11.2.1989, p. 38. (10) (12) (13) 0) Commission Directive 90/128/EEC of 23 February 1990 relating to plastic materials and articles intended to come into contact with foodstuffs (?), as last amended by Directive 1999/91/EC (})y may be included in the Community list of approved substances. For certain substances, the restrictions already estab- lished at Community level should be amended on the basis of the information available. The current total list of additives is an incomplete list inasmuch 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 only pending a decision on inclusion in the Community list. This Directive establishes specifications for only a few substances, and therefore the other substances, which may require specifications remain regulated in this respect by national laws only pending a decision at Community level. 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. In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of ensuring the free movement of plastic materials and articles intended to come into contact with foodstuffs, to lay down rules on the definition of plastics and admitted substances. This Directive confines itself to what is necessary in order to achieve the objec- tives pursued in accordance with the third paragraph of Article 5 of the Treaty. Directive 90/128/EEC should therefore be amended accordingly. The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs, (3 O] L 75, 21.3.1990, p. 19. o L3 10, 4.12.1999, p. 41.