Scientific Opinion on the safety assessment of the substance perfluoromethyl perfluorovinylether, CAS No 1187-93-5, for use in food contact materials

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2015;13(7):4171 [8 pp.].
doi
10.2903/j.efsa.2015.4171
Panel members at the time of adoption
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Food Contact Materials: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Roland Franz, Konrad Grob, Martine Kolf-Clauw, Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle, for the preparatory work on this scientific opinion and EFSA staff member Joaquim Maia for the support provided to this scientific output.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Ministry of Health, Welfare and Sports - the Netherlands
Question Number
EFSA-Q-2014-00314
Adopted
23 June 2015
Published in the EFSA Journal
14 July 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety re-evaluation of perfluoromethyl perfluorovinylether, CAS No 1187-93-5 and FCM No 391, as a co-monomer for fluoro- and perfluoropolymers. The polymers are intended to be used for the production of O-rings, gaskets and seals for repeated use in food processing applications that may contact all types of food at temperatures ranging from low up to 200 °C, from a few minutes to hours. The worst-case specific migration of the substance was estimated to be lower than 0.07 µg/kg food, based on its residual amount in a perfluoropolymer sample containing the maximum level of use of perfluoromethyl perfluorovinylether. The migration of volatile and semivolatile substances was estimated to be lower than 0.07 µg/kg food and lower than 1 µg/kg food, respectively. Overall migration was calculated under repeat use conditions, and was 4 µg/kg in 3 % acetic acid, 3 µg/kg in 20 % ethanol and 9 µg/kg in olive oil. No oligomers below 1 500 Da were detected. Based on toxicological data available and evaluated in 2001 (SCF) and 2004 (EFSA), the CEF Panel concluded that the substance is not of genotoxic concern. Therefore, the CEF Panel concluded that the substance is not of safety concern for the consumer if it is used as a co-monomer for fluoro- and perfluoropolymers intended for repeated use applications where the contact ratio is 1 dm2 surface in contact with not less than 150 kg food.

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Number of Pages
8