Scientific Opinion on the safety evaluation of the substance, Methacrylic acid, 2,3-epoxypropyl ester, copolymer with acrylic and/ or methacrylic acid alkyl (C1-C4) esters, for use in food contact materials


Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2012;10(5):2744 [13 pp.].
Possible conflict of interest
Two members 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.
Panel Members
Ulla Beckman Sundh, Mona-Lise Binderup, Leon Brimer, Laurence Castle, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean-Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana,Maria de Fátima Poças, Iona Pratt, Kettil Svensson, Fidel Toldrá, Detlef Wölfle.

The Panel wishes to thank the members of the Working Group on Food Contact Materials for the preparation of this opinion: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Roland Franz, Nathalie Gontard, Eugenia Lampi, Jean-Claude Lhuguenot, Maria Rosaria Milana, Karla Pfaff, Fatima Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the support provided to this EFSA scientific opinion.

Opinion of the Scientific Committee/Scientific Panel
On request from
Ministry of Health, Welfare and Sport, The Netherlands
Question Number
24 May 2012
Published in the EFSA Journal
31 May 2012
Last Updated
7 June 2012. This version replaces the previous one/s.
European Food Safety Authority (EFSA), Parma, Italy

This scientific opinion of  EFSA deals with the safety evaluation of the substance methacrylic acid, 2,3-epoxypropyl ester, copolymer with acrylic and/ or methacrylic acid alkyl (C1-C4) esters, REF. No 65841 and FCM Substance No 958, for use in PVC coatings for food cans. Migration tests with a representative substance, methacrylic acid, 2,3-epoxypropyl ester, copolymer with methacrylic acid, ethyl ester,  showed that migration of the monomers was not detectable (detection limit below 0.02/6 dm2) while the migration of oligomers with a molecular weight below 1000 Da was up to 0.016 mg/6 dm2. No chlorinated species were detected. The oligomeric fraction and the corresponding chlorinated oligomers were tested in three in vitro and two in vivo genotoxicity tests and they were  considred as non-genotoxic. Based on the available results of these genotoxicity tests, the Panel considered that there is no concern with respect to genotoxicity in vivo. The oligomeric fraction was also rested in a 90-day oral study in rat and the NOAEL derived was 150 mg/kg b.w. per day. The CEF Panel concluded that there is no safety concern for the consumer if the substance is used as additive up to 25 % in 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.

Methacrylic acid, 2,3-epoxypropyl ester, copolymer with acrylic and/or methacrylic acid alkyl (C1-C4) esters; Ref. No 65841 and FCM Substance No 958; Food contact materials; Safety assessment; Evaluation
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