Scientific Opinion on the safety evaluation of the substance, 4-acrylamido-4-methyl-2-pentanone, CAS No 2873-97-4, for use in food contact materials

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the risk assessment of 4-acrylamido-4-methyl-2-pentanone, Chemical Abstracts Service (CAS) No 2873-97-4, Food Contact Materials (FCM) substance No 986, for use as a comonomer for acrylic copolymers with keto side groups in non-self-supporting coatings on plastics. The keto groups are introduced into the polymer chain in order to render the copolymer curable by adipic acid dihydrazide (ADH). The coating is not expected to be used in direct contact with food but used in inner layers of plastics laminates that are intended to be used for all types of foodstuffs at all time–temperature conditions applicable according to the laminate’s properties. Specific migration of the substance was measured from a coated low-density polyethylene film. The substance was not detectable (limits of detection 0.001–0.014 mg/kg) with the food simulants 3 % acetic acid, 10 % ethanol, 95 % ethanol for 10 days at 40 °C and isooctane for 2 days at 20 °C. Based on the results of the available studies, the substance does not give rise to concerns for genotoxicity. The substance was also studied for neurotoxicity in vitro and in vivo. The Panel concluded that there is no evidence for neurotoxicity in vivo. The CEF Panel concluded that the substance, 4-acrylamido-4-methyl-2-pentanone, is not of safety concern for the consumer if it is used as a comonomer in acrylic copolymers to introduce keto side groups, which are crosslinked by adipic dihydrazide (ADH) in non-self-supporting coatings on plastics and not in direct contact with food. The migration of the substance should not exceed 0.050 mg/kg food.