The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) said the substance is not of safety concern when used under certain conditions in its scientific opinion.
EFSA was asked by the Ministry of Health, Welfare and Sports, the Netherlands, to re-evaluate the safety of perfluoromethyl perfluorovinylether (MVE) because Solvay Specialty Polymers proposed extended use.
The company said MVE is intended to be used as a co-monomer for fluoro- and perfluoropolymers in amounts up to 45%.
Use of polymers
The polymers will be for production of O-rings, gaskets and seals for repeated use in food processing applications where the contact ratio is 1 dm2 of surface in contact with not less than 150kg food.
They may contact all types of food at temperatures ranging from low up to 200 °C, from a few minutes to hours.
It is noted that some perfluorinated compounds may show a high potential for accumulation but the proposed conditions of repeated use and contact ratio (1 dm2 surface in contact with not less than 150 kg food) would lead to a negligible migration, said the panel.
The substance was evaluated by the Scientific Committee on Food (SCF, 2001) and EFSA (2004) as a co-monomer used in the polymerisation process of fluoropolymers, intended for anti-stick coating applications in articles for repeated use.
Based on these evaluations the panel said it is not of genotoxic concern.
Worst-case specific migration 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 MVE.
Migration of volatile and semi-volatile 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, said the panel.
The substance is listed under FCM substance No 391 in Commission Regulation (EU) 10/2011 with a Specific Migration Limit (SML) of 0.05 mg/kg and restriction ‘Only to be used in anti-stick coatings’.
Initial application was in April 2014, with more data submitted in September and March 2015.