Scientific Opinion on the safety assessment of the substance ethylene-vinyl acetate copolymer wax, CAS No 24937-78-8 for use in food contact materials
Competing interests: One member of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests.
This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the polymeric additive ethylene-vinyl acetate copolymer wax, CAS No 24937-78-8, FCM substance No 00969 for use as a dispersing agent, lubricant, pigment carrier, and/or a processing aid in the production of plastic materials made from polymers such as polyethylene (PE), polypropylene (PP) or polyethylene terephthalate (PET). Final articles are intended for repeated contact with all types of foodstuffs at any conditions of time and temperature. The copolymer has a weight-averaged molecular weight higher than 6 000 Da and the low molecular weight fraction (LMWF) below 1 000 Da was estimated to be below 10 % w/w The copolymer starts decomposing at temperatures above 230 °C, which is above the maximum process temperature of PE and PP but it is below the maximum process temperature of PET. The Panel considered that in the absence of information on possible thermal decomposition products, the use of the substance in PET should be excluded. The specific migration of the LMFW from polyolefins was conservatively estimated to be up to approximately 5.8 mg/kg food. There is no evidence of genotoxicity of ethylene-vinyl acetate copolymer wax. A 120 day oral toxicity study in rats showed no indication of accumulation. Therefore, the CEF Panel concluded that the substance ethylene-vinyl acetate copolymer wax does not raise a safety concern for the consumer if it is used as additive up to 2 % in polyolefins and the migration of low molecular weight oligomeric fraction below 1 000 Da does not exceed 5 mg/kg food.