Scientific Opinion on the safety of “Methyl Vinyl Ether-Maleic Anhydride Copolymer” (chewing gum base ingredient) as a Novel Food ingredient

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2013;11(10):3423 [17 pp.].
doi
10.2903/j.efsa.2013.3423
Panel members at the time of adoption
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen
Acknowledgements

The Panel wishes to thank the members of the Working Group on Novel Foods: Paul Brantom, Karl-Heinz Engel, Marina Heinonen, Hannu Korhonen, Rosangela Marchelli, Bevan Moseley, Monika Neuhäuser-Berthold, Annette Pöting, Morten Poulsen, Seppo Salminen, Josef Schlatter, Hendrik Van Loveren and Hans Verhagen for the preparatory work on this scientific opinion, and EFSA staff: Wolfgang Gelbmann for the support provided to this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2012-00653
Adopted
10 October 2013
Published in the EFSA Journal
25 October 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

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.

Keywords
chewing gum, Gantrez SF, copolymer, methyl vinyl ether, maleic anhydride, dilauroyl peroxide
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Number of Pages
17