[Role of the EFSA in risk management system regarding food contact materials and articles].

The role of the European Food Safety Authority (EFSA) in the risk management system regarding food contact materials and articles is related with the risk assessment of the substances for the European Commission. General rules for the authorisation of substances used in materials and articles intended to contact with food is established in the Regulation (EC) no 1935/2004. For the evaluation of substances their toxicological properties and magnitude of migration into food simulants is taken into account. Toxicological studies include the mutagenicity tests, oral toxicity studies, carcinogenicity, reproduction and also studies on absorption, distribution, metabolism and excretion of the substance and other studies when needed. The set of the relevant toxicological data for substance depends on the magnitude of migration. In the case of positive opinion by EFSA the substance appears on the Community list of authorised substances. Sometimes, the earlier evaluated and authorized substances must undergo re-evaluation due to their new toxicological properties or as a result of a presence in the food of their earlier unknown decomposition products. Examples of the selected substances which underwent re-evaluation by EFSA in the light of the current toxicological knowledge and the relevant activities undertaken by the European Commission have been presented.