Scientific Opinion on the safety assessment of the substance adipic acid dihydrazide, CAS No 1071-93-8, for use in food contact materials

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Acknowledgements

The Panel wishes to thank the members of the Working Group on Food Contact Materials: Mona-Lise Binderup, Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Riccardo Crebelli, Roland Franz, Nathalie Gontard, Konrad Grob, Ragna Bogen Hetland, Martine Kolf-Clauw, 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.

Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2015;13(1):3961 [8 pp.].
doi
10.2903/j.efsa.2015.3961
Possible conflict of interest
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.
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.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Bundesamt für Verbraucherschultz und Lebensmittelsicherheit, Germany
Question Number
EFSA-Q- 2013-00030
Adopted
11 December 2014
Published
13 January 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

This scientific opinion of EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the risk assessment of adipic acid dihydrazide, CAS No 1071-93-8, FCM substance No 987 for use as a crosslinker for acrylic polymer with keto side groups coated on polyolefins and adhesives in laminates made from plastics. The coating is not for direct food contact but used in inner layers of plastics laminates which are intended to be used for all types of foodstuffs at all time-temperature conditions applicable according to the laminate’s properties. Specific migration of the substance was measured from a coated low-density polyethylene (LDPE) film, the substance was not detectable (limit of detection (LOD) 0.019 mg/kg) with the food simulants 3 % acetic acid, 10 % ethanol for 10 days at 40 °C and isooctane for 2 days at 20 °C. According the in vitro and in vivo studies available the substance is not considered genotoxic. Based on an in vivo micronucleus test, the substance is not considered to be clastogenic/aneugenic under the tested conditions. The CEF Panel concluded that there is no safety concern for the consumer if the substance is used as a crosslinker for non-self-supporting coatings on plastics and not in direct contact with food. The migration of the substance should not exceed 0.050 mg/kg food.

Keywords
adipic acid dihydrazide, 1,6-dihydrazide hexanedioic acid, CAS No 1071-93-8, FCM substance No 987, food contact materials, safety assessment, evaluation
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Number of Pages
8