EN
The procedure for safety assessment of the substances to be used in food contact materials and articles according to the EU regulation was presented. Substances used in food contact materials and articles can not pose the risk for human health when they migrate into foodstuffs. Therefore, according to the Regulation No 1935/2004 of the European Parliament and the Council, new substances intended to be used in food contact materials and articles must undergo safety assessment provided by the European Food Safety Authority (EFSA). The safety assessment of such substance is based on the dossier containing the detailed data concerning its physical and chemical properties, intended use including quantity, technological function, microbiological properties, and results on the migration into the food or food simulants and toxicological data. The range of toxicological studies that have to be supplied for the assessment of the substance, depends on the magnitude of the migration. Generally, the higher migration is found the larger range of toxicological studies is needed for the assessment. Substances which have got the Community authorisation for plastic food contact materials are placed on the lists in the Directive 2002/72/EC. Such lists arc reviewed and undergo verification in the light of the current knowledge.