On November 25, 2014 the European Food Safety Authority (EFSA) published a scientific opinion considering the substance dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene (CAS 287916-86-3) safe for use in food contact materials (FCMs). The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) concluded that it is safe for consumers at a maximum used level up to 20 % w/w in contact with dry foods. The substance is used as a polymeric antistatic additive in hydrophobic plastics, mainly in polyethylene (PE) and polypropylene (PP). The additive is a self-standing polymer whose five starting substances have already undergone toxicological evaluation. They are listed in the Annex I of the Plastics Regulation (EU) No 10/2011. Migration tests gave no detectable migration of the low molecular weight oligomeric fraction less than 1000 Dalton. Neither the starting substances nor the additive itself displayed genotoxicity in vitro.
CEF (November 25, 2014). “Scientific Opinion on the safety assessment of the substance, dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene, CAS No 287916-86-3, for use in food contact materials.” EFSA Journal 12, 11, 3909