Scientific Opinion on the safety assessment of the substance, furan-2,5-dicarboxylic acid, CAS No 3238-40-2, for use in food contact materials

Tabs

Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2014;12(10):3866 [8 pp.].
doi
10.2903/j.efsa.2014.3866
Panel members at the time of adoption
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, 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: Laurence Castle, Riccardo Crebelli, Alessandro di Domenico, Roland Franz, Nathalie Gontard, Ragna Bogen Hetland, Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima Tavares 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
Member State - United Kingdom
Question Number
EFSA-Q-2014-00013
Adopted
24 September 2014
Published
20 October 2014
Last Updated
25 February 2015. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (231.22 KB)
Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the substance furan-2,5-dicarboxylic acid (FDCA) with CAS No 3238-40-2 and FCM substance No 01031, for use as a monomer with ethylene glycol to produce polyethylene furanoate (PEF) polymer. Final articles are intended to be used in contact with all types of foodstuffs and storage under any condition of time and temperature. Based on the residual content in the plastic, specific migration of the substance was calculated to be up to 0.12 mg/kg food when assuming total mass transfer. Concerning the migration of oligomers, the sum of all species that had a low molecular weight, contained the FDCA unit, and migrated into food simulants under test conditions of 10 days at 60 °C, was estimated to be up to 0.060 mg/kg food as derived from the migration into 20 % ethanol, which was considered representative and still conservative for the intended use. Based on three negative in vitro tests, the Panel considered that there is no concern with respect to genotoxicity. From a 90-day oral toxicity study in rat, it was concluded that the NOAEL was 300 mg FDCA/kg bw/day. The substance does not raise concern for accumulation in man. The Panel concluded that the substance furan-2,5-dicarboxylic acid does not raise a safety concern for the consumer when used as a monomer in the production of polyethylene furanoate (PEF) polymer and the migration of the substance itself does not exceed 5 mg/kg food. However, considering the lack of data demonstrating that the migrating oligomers and reaction products are hydrolysed in vivo back to their starting substances, the CEF Panel furthermore concluded that migration of oligomers less than 1000 Da should not exceed 50 µg/kg food (expressed as FDCA).

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 Food Standards Agency, United Kingdom, for safety assessment of the substance furan-2,5-dicarboxylic acid (FDSA) following a corresponding application from YXY Technologies B.V., The Netherlands.

FDCA is a monomer intended to manufacture PEF polymer with ethylene glycol as co-monomer. The PEF polymer is intended to be used in contact with all types of foodstuffs and storage under any condition of time and temperature.

Specific migration was estimated based on an assumption of 100 % mass transfer of the residual content of FDCA in PEF polymer and this provided an estimate of 0.12 mg/kg food. Overall migration was performed with 3 % acetic acid, 10, 20, 50 and 95 % ethanol and iso-octane food simulants for 10 days at 60 °C. All results were below the limit of detection of 6 mg/kg food. Concerning the migration of oligomers, using the same test conditions, the sum of all migrating species that had a low molecular weight and contained the FDCA unit was estimated to be 1.5 mg/kg food (into 95 % ethanol), 0.54  

(50 % ethanol), 0.060 (20 % ethanol), 0.021 (10 % ethanol) and 0.011 mg/kg (3 % acetic acid).  Due to swelling effects that are known to occur when polyesters are in contact with higher ethanol levels the migration values from the 95% and 50% ethanol tests were considered as too severe and the 20 % ethanol test was taken as more representative and still conservative for the intended use. The substance did not induce gene mutations in bacteria and mammalian cells, and did not induce chromosomal aberrations in human peripheral lymphocytes. Based on three negative in vitro tests, the Panel considered that there is no concern with respect to genotoxicity. From a 90-day oral toxicity study in rats, a NOAEL of 300 mg FDCA/kg bw/day was derived based on a reduction of body weight and effects on adrenal glands.

Therefore the CEF Panel concluded that the substance furan-2,5-dicarboxylic acid (FDCA) does not raise a safety concern for the consumer when the substance is used as a monomer in the production of polyethylene furanoate (PEF) polymer  and the migration of the substance itself does not exceed 5 mg/kg food. However, considering the lack of data demonstrating that the migrating oligomers and reaction products are hydrolysed in vivo back to their starting substances, the CEF Panel furthermore concluded that migration of the oligomers less than 1000 Da should not exceed 50 µg/kg food (expressed as FDCA).

Keywords
furan-2,5-dicarboxylic acid, CAS No 3238-40-2, FCM substance No 01031, food contact materials, plastics, polyesters, safety assessment
Print on demand
Number of Pages
8