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
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
First published in the EFSA Journal:
18 November 2015
27 October 2015
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.
© European Food Safety Authority, 2015
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.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
fip [at] efsa.europa.eu
EFSA Journal 2015;13(11):4283 [8 pp.].
On request from:
Bundesamt für Verbraucherschultz und Lebensmittelsicherheit, Germany
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.