The CEF Panel received a request from the Ministry for Health, Welfare and Sports, the Netherlands, for safety evaluation of a substance following a corresponding application from the company The Valspar Corporation, UK.
The safety evaluation of the substance methacrylic acid, 2,3-epoxypropyl ester, copolymer with acrylic and/or methacrylic acid alkyl (C1-C4) esters, with the REF. No 65841, FCM Substance No 958, is requested for use as additive up to 25 % in organosol (PVC) coatings for contact with all types of foodstuffs except for beer and beverages under all conditions of time and temperature including sterilisation followed by long term storage. The methacrylic acid, 2,3-epoxypropyl ester contains an oxirane ring which reacts with (scavenges) any hydrogen chloride generated from the PVC during the thermal processing of the coating, forming corresponding chlorinated moieties.
Migration and toxicity tests were submitted for a single polymeric additive (acronym EMA-GMA), methacrylic acid, 2,3-epoxypropyl ester (GMA) (20 %), copolymer with methacrylic acid, ethyl ester (synonym ethyl methacrylate, acronym EMA) (80%) which is considered representative of the copolymers of GMA with acrylic and methacrylic acids alkyl (C1-C4) esters.
The migration of residual monomers (EMA, GMA and hydrolysis product of GMA) was not detectable in the intended conditions of use while the migration of low molecular weight oligomers (less than 1000 Da) containing the GMA unit was up to 0.016 mg/6 dm2. Chlorinated species were not detected in this fraction.
Based on the available results of three in vitro and two in vivo genotoxicity tests, the Panel considered that that there is no concern with respect to genotoxicity in vivo of the oligomeric fraction below 1000 Da, o-EMA-GMA, and the corresponding chlorinated oligomers, o-EMA-GMA.HCl.
A NOAEL of 150 mg/kg b.w. per day was derived for o–EMA-GMA, based on a 90-day oral rat study.
The CEF Panel concluded that there is no safety concern for the consumer if the substance is used only as additive up to 25 % in PVC coatings, for contact with all types of foodstuffs except beer and beverages, under all conditions of time and temperature including sterilisation followed by long term storage.