Scientific Opinion on the safety assessment of the substance adipic acid dihydrazide, CAS No 1071-93-8, for use in food contact materials

Abstract

This scientific opinion of EFSA's Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the risk assessment of adipic acid dihydrazide, CAS No 1071-93-8, FCM substance No 987 for use as a crosslinker for acrylic polymer with keto side groups coated on polyolefins and adhesives in laminates made from plastics. The coating is not for direct food contact but used in inner layers of plastics laminates which 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 (LDPE) film, the substance was not detectable (limit of detection (LOD) 0.019 mg/kg) with the food simulants 3 % acetic acid, 10 % ethanol for 10 days at 40 °C and isooctane for 2 days at 20 °C. According the in vitro and in vivo studies available the substance is not considered genotoxic. Based on an in vivo micronucleus test, the substance is not considered to be clastogenic/aneugenic under the tested conditions. The CEF Panel concluded that there is no safety concern for the consumer if the substance is used as a crosslinker for 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.