Scientific Opinion on the safety evaluation of the substance, 4-acrylamido-4-methyl-2-pentanone, CAS No 2873-97-4, 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 2015;13(11):4283 [8 pp.].
doi
10.2903/j.efsa.2015.4283
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, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu. 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.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Food Contact Materials: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Roland Franz, Konrad Grob, Martine Kolf-Clauw, Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima Poças, Kettil Svensson and Detlef Wölfle for the preparatory work on this scientific opinion.

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.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Bundesamt für Verbraucherschultz und Lebensmittelsicherheit, Germany
Question Number
EFSA-Q-2013-00031
Adopted
27 October 2015
Published
18 November 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the risk assessment of 4-acrylamido-4-methyl-2-pentanone, Chemical Abstracts Service (CAS) No 2873-97-4, Food Contact Materials (FCM) substance No 986, for use as a comonomer for acrylic copolymers with keto side groups in non-self-supporting coatings on plastics. The keto groups are introduced into the polymer chain in order to render the copolymer curable by adipic acid dihydrazide (ADH). The coating is not expected to be used in direct contact with food but used in inner layers of plastics laminates that 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 film. The substance was not detectable (limits of detection 0.001–0.014 mg/kg) with the food simulants 3 % acetic acid, 10 % ethanol, 95 % ethanol for 10 days at 40 °C and isooctane for 2 days at 20 °C. Based on the results of the available studies, the substance does not give rise to concerns for genotoxicity. The substance was also studied for neurotoxicity in vitro and in vivo. The Panel concluded that there is no evidence for neurotoxicity in vivo. The CEF Panel concluded that the substance, 4-acrylamido-4-methyl-2-pentanone, is not of safety concern for the consumer if it is used as a comonomer in acrylic copolymers to introduce keto side groups, which are crosslinked by adipic dihydrazide (ADH) in 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.

Summary

Within the general task of evaluating substances intended for use in materials in contact with food in accordance with 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 EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) received a request from a competent Member State Authority for safety evaluation of a substance following a corresponding application from BASF SE.

The safety assessment of 4-acrylamido-4-methyl-2-pentanone (CAS No 2873-97-4 and FCM substance No 986) was requested. The substance is intended to be used as a minor comonomer for acrylic copolymers with keto side groups for non-self-supporting coatings on polyolefins used in laminates made from plastics. The coating is not used in direct food contact but applied in inner layers of plastics laminates that are intended to be used for all types of foodstuffs at all time–temperature conditions applicable according to the laminate’s properties.

The substance starts to decompose at temperatures above 130 °C. Maximum process temperature is 100 °C.

Specific migration of the substance was measured from a coated low-density polyethylene (LDPE) film with the non-coated LDPE side in contact with the food simulants 3 % acetic acid, 10 % ethanol, 95 % ethanol for 10 days at 40 °C and isooctane for 2 days at 20 °C. Under these conditions the substance was not detectable in any of the food simulants (limits of detection 0.001 mg/kg to 0.014 mg/kg). Overall migration into 95 % ethanol and isooctane was measured against a blank LDPE sample, which was not coated on the non-contact side. No significant differences between the test samples and the blank were found for any of the tested simulants, which means the coating layer did not influence the overall migration value. No additional oligomers, compared with the blank LDPE, were detected by liquid chromatography–mass spectrometry analysis on the isooctane overall migration solution.

The substance was tested in bacteria and was not considered to be mutagenic. In addition, no indication of mutagenicity was observed in mammalian cells. The chromosome damage potential of the substance was studied in vitro and in vivo. Based on the negative results of both studies, the substance is considered to be not clastogenic/aneugenic under the test conditions used. Based on the evidence available, the substance does not give rise to concerns for genotoxicity. The substance was also studied for neurotoxicity in vitro and in vivo. No evidence for neurotoxicity in vivo was observed.

The CEF Panel, having considered the above-mentioned data, concluded that the substance, 4-acrylamido-4-methyl-2-pentanone, is not a safety concern for the consumer if it is used as a comonomer in acrylic copolymers to introduce keto side groups, which are crosslinked by adipic dihydrazide (ADH) in 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
N-(1,1-dimethyl-3-oxobutyl)acrylamide, 4-acrylamido-4-methyl-2-pentanone, CAS No 2873-97-4, FCM substance No 986, food contact materials, safety assessment, evaluation
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Number of Pages
8