On September 29 and November 18, 2015 the European Food Safety Authority’s (EFSA) Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids (CEF Panel) published scientific opinions on the safety assessment of three substances for use in food contact materials (FCMs).
2,4-di-tert-amylphenol (CAS 120-95-6) is an impurity and hydrolysis product of the substance phosphorous acid mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters which was previously evaluated by the CEF Panel for its use as an antioxidant in all polymers. Based on migration testing, in vitro genotoxicity tests, and an oral toxicity study in rats, the CEF Panel concluded that 2,4-di-tert-amylphenol is safe if its migration is below 1 mg/kg food and is included in the current 5 mg/kg food restriction for the antioxidant it stems from, expressed as the sum of the phosphite and phosphate forms of the substance and 4-tert-amylphenol.
Montmorillonite clay modified by dimethyldialkyl(C16-C18)ammonium chloride (no CAS number available) is intended for use as an additive in ethylene-based polymers for sealing layers in long-term storage of dry foods at room or refrigerated temperatures. Dimethyl(C16-C18)amines and 1-chloroalkanes were identified as impurities from the modifier. Considering migration testing and genotoxicity studies of the additive and its impurities, the CEF Panel concluded that montmorillonite clay modified by dimethyldialkyl(C16-C18)ammonium chloride is safe for the intended use and migration of the sum of 1-chlorohexadecane and 1-chlorooctadecane should be below 0.05 mg/kg food.
4-acrylamido-4-methyl-2-pentanone (CAS 2873-97-4) is intended for use as a minor comonomer for acrylic copolymers with keto side groups for non-self-supporting coatings on polyolefins used in laminates made from plastics. Based on migration testing, available genotoxicity studies, and in vitro and in vivo neurotoxicity tests, the CEF Panel concluded that 4-acrylamido-4-methyl-2-pentanone is safe for the intended use and migration of the substance should be below 0.050 mg/kg food.
CEF (September 29, 2015). “Safety assessment of the substance 2,4-di-tert-amylphenol, impurity and hydrolysis product of the substance phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters, for use in food contact materials.”