Scientific Opinion on the safety assessment of the substance, Perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt, CAS No 1190931-27-1, 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 2014;12(6):3718 [9 pp.].
doi
10.2903/j.efsa.2014.3718
Panel members at the time of adoption
Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq (until july 2013), Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Poças, Iona Pratt †, Kettil Svensson, Fidel Toldrá and Detlef Wölfle.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Food Contact Materials: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Roland Franz, Nathalie Gontard, Ragna Bogen Hetland, Eugenia Lampi, Jean-Claude Lhuguenot (until November 2012), Maria Rosaria Milana, Maria de Fátima Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the preparatory work on this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Ministry of Health, Welfare and Sports, The Hague
Question Number
EFSA-Q-2013-00363
Adopted
20 May 2014
Published
6 June 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

This scientific opinion of EFSA deals with the safety assessment of perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt, CAS No 1190931-27-1, for use as a polymer production aid during the manufacture of fluoropolymers. Specific migration of the substance was not determined. The specific migration of the substance and the two degradation products in polytetrafluoroethylene film were determined and the maximum potential migrations were 0.4 μg/kg food. The CEF Panel concluded there is no safety concern for the consumer if the substance is only to be used as a polymer production aid during the manufacture of fluoropolymers which are produced under high temperature conditions of at least 370 °C and intended for repeated use in contact with all types of foodstuffs under all contact conditions.

Summary

Within the general task of evaluating substances intended for use in materials in contact with food according to the Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with foodstuffs, the CEF Panel received a request from the Ministry of Health, Welfare and Sports, The Hague, for safety assessment of the substance perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt, following a corresponding application submitted on behalf of Solvay Solexis SpA.

The safety assessment of perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt, CAS No 1190931-27-1, (FCM substance No 1045), was requested for use as a polymer production aid during the manufacture of fluoropolymers which are produced under high temperature conditions of at least 370 °C and intended for repeated use in contact with all types of foodstuffs under all contact conditions.

Due to the high temperatures (ranging from 380 to 420 °C) applied for manufacture of food contact articles it can be expected that both the substance itself as well as the decomposition products are efficiently removed during thermal processing (high temperature extrusion, baking or sintering) and not present anymore in the final food contact articles.

Specific migration of the substance was not determined. The worst case residual content in polytetrafluoroethylene (PTFE) film manufactured at a low processing temperature was determined and migration was calculated assuming 100 % transfer. The substance was not detectable in the polymer film at a detection limit of 0.06 μg/g; this corresponds to a maximum migration of 0.4 μg/kg food. The two decomposition products were not detectable indicating a maximum potential migration of 0.4 μg/kg food. The calculated migration values obtained from the residual concentration determinations relate to a single use application. Since the final food contact materials and articles are intended for repeated use, the migration, if any, would occur even at a lower level at each usage.

The substance perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt, was tested in three in vitro genotoxicity tests and in one in vivo genotoxicity test. The substance did not induce gene mutations in bacteria nor in mouse lymphoma cells. The substance did not induce chromosome aberrations in bone marrow cells of the rat, when administered at the highest tolerated dose (1250 mg/kg bw). The main decomposition product did not induce mutations in bacteria and did not induce micronuclei when tested in vitro in Chinese hamster V79 cells.

Based on the results of the in vitro and in vivo genotoxicity tests a weak clastogenic potential cannot fully be excluded. However, in absence of genotoxicity of other perfluorinated compounds and since the substance and its decomposition products completely disappear during the production process, there is no safety concern.

It is noted that some perfluorinated compounds may show a high potential for accumulation in man. However the proposed conditions of use would lead to a negligible migration. Under these conditions the Panel has no indication for safety concern for this substance.

The CEF Panel having considered the above-mentioned data concluded that the substance perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt, is not of a safety concern for the consumer if the substance is only to be used as a polymer production aid during the manufacture of fluoropolymers which are produced under high temperature conditions of at least 370 °C. The final materials and articles are intended for repeated use in contact with all types of foodstuffs under all contact conditions.

Keywords
perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]} ammonium salt, CAS 1190931-27-1, acetic acid 2,2-difluoro-2-[[2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy]- ammonium salt, FCM 1045, food contact materials, safety assessment
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Number of Pages
9