Risk assessment of food contact materials.

Food Contact Materials (FCMs), such as plastics, papers, ceramics and inks used in food packaging, containers, kitchen utensils and tableware are subject to scrutiny due to their potential to release toxic compounds into food. In the European Union, materials and articles intended for contact with food must adhere to stringent safety regulations and novel materials not explicitly covered by existing legislation require individual risk assessment. This project focused on the assessment of the genotoxic potential of two substances used in FCMs, specifically neodecanoic acid (NDA) and di(2-ethylhexyl) phthalate (DEHP), for which data gaps have been identified in genotoxicity studies. NDA was selected because it was re-evaluated due to the intention to approve its use in printing inks for FCMs. For DEHP, various studies on genotoxicity are available, which, however, differ in their outcome. DEHP is commonly used as a plasticiser to enhance the flexibility, transparency, durability of plastics and is ubiquitously detected in daily life. The present study followed the EFSA strategy for the assessment of genotoxicity applying in vitro methods in bacterial and mammalian cells as well as in silico approaches. In this context, aneuploidy, a thresholded genotoxic effect, received particular attention since few indications are available on the aneugenic activity of FCMs. The results showed significant findings that require further investigation.