Scientific Opinion on the safety of “Methyl Vinyl Ether-Maleic Anhydride Copolymer” (chewing gum base ingredient) as a Novel Food ingredient
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of “methyl vinyl ether-maleic anhydride copolymer (Gantrez SF)” as a novel food ingredient in the context of Regulation (EC) No 258/97. The novel food ingredient Gantrez SF is an anhydrous copolymer formed by the reaction of methyl vinyl ether (MVE) and maleic anhydride (MAN) under appropriate conditions. The Panel considers that the information provided on the specifications, stability and production process do not raise safety concerns. An estimated daily intake (EDI) for Gantrez SF associated with its use in chewing gum may be calculated based on the maximum concentration (2 %) of Gantrez SF in finished chewing gum, and on the level at which chewing gum is consumed. Based on data from the United Kingdom, a high intake estimate of 280 mg Gantrez SF per day was derived. The Panel notes that the NOAEL of 1.8 and 2.1 g/kg bw per day Gantrez SF for male and female rats, respectively, which was derived from a 90-day subchronic toxicity study, is about 500-fold above this conservative intake estimate. The Panel has no safety concerns regarding genotoxicity and the low molecular weight components. The Panel concludes that the novel food ingredient, methyl vinyl ether-maleic anhydride copolymer (Gantrez SF), is safe under the proposed uses and use levels.