5-norbornene-2,3-dicarboxylic anhydride

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Article
5-norbornene-2,3-dicarboxylic anhydride, CAS number 826-62-0, FCM substance No 978, food contact materials, safety assessment, evaluation
First published in the EFSA Journal
4 June 2014
Adopted
20 May 2014
Type
Opinion of the Scientific Committee/Scientific Panel
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.

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, 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.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2014.3714
EFSA Journal 2014;12(6):3714 [9 pp.].
Question Number
On request from
Ministry of Health, Welfare and Sport, the Netherlands
Competing interests
One member of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests.
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Number of Pages
9