Scientific Opinion on the safety assessment of the substance, 5‐norbornene‐2, 3‐dicarboxylic anhydride, CAS No 826‐62‐0, for use in food contact materials
2014; Wiley; Volume: 12; Issue: 6 Linguagem: Inglês
10.2903/j.efsa.2014.3714
ISSN1831-4732
Autores Tópico(s)Agricultural safety and regulations
ResumoEFSA JournalVolume 12, Issue 6 3714 OpinionOpen Access Scientific Opinion on the safety assessment of the substance, 5-norbornene-2, 3-dicarboxylic anhydride, CAS No 826-62-0, for use in food contact materials EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)Search for more papers by this author EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)Search for more papers by this author First published: 04 June 2014 https://doi.org/10.2903/j.efsa.2014.3714Citations: 2 Panel members: 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, Martine Kolf-Clauw, 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. Correspondence: fip@efsa.europa.eu Acknowledgement: The Panel wishes to thank the members of the Working Group on Food Contact Materials: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Alessandro Di Domenico, Roland Franz, Nathalie Gontard, Ragna Bogen Hetland, 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. Adoption date: 20 May 2014 Published date: 4 June 2014 Question number: EFSA-Q-2011-01059 On request from: Ministry of Health, Welfare and Sport, the Netherlands AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the risk assessment of 5-norbornene-2, 3-dicarboxylic anhydride CAS 826-62-0, FCM substance No 978, for a co-monomer in polyester based coatings for metal cans. Based on the residual content of the substance in the final coating, the calculated worst case migration of the two isomers of the substance and their hydrolysis products was 27 µg/kg food. From the same experiment the overall migration was 24 mg/kg food. LMWF was found to make up 8.8 mg/kg food, out of this the LMWF which contains the substance was 1.54 mg/kg food. Based on negative results from two in vivo genotoxicity tests, the Panel considered that the substance and the LMWF oligomers containing the substance moieties are non-genotoxic. The systemic toxicity of the substance-containing LMWF oligomers was assessed in a subchronic oral rat study. The comparison between the NOAEL, derived from this study and a daily intake gives a large margin of safety. The CEF Panel concluded that the substance 5-norbornene-2, 3-dicarboxylic anhydride is not of a safety concern for the consumer if it is used as a co-monomer in polyester based can coatings at levels of up to 18.3 weight % of the final dry coating, in contact with all food excluding beverages, at sterilization conditions and long term contact. Migration of the substance and its hydrolysis products should in total not exceed 50 µg/kg food. Citing Literature Volume12, Issue6June 20143714 ReferencesRelatedInformation
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