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.