Safety assessment of the mixture of methyl-branched and linear C14–C18 alkanamides, derived from fatty acids, for use in food contact materials
Note: The full opinion will be published in accordance with Article 10(6) of Regulation (EC) No 1935/2004 once the decision on confidentiality, in line with Article 20(3) of the Regulation, will be received from the European Commission. The following information has been provided under the confidentiality framework and has been redacted awaiting the decision of the Commission: the level of the components in the applied substance; the identity and level of impurities in the applied substance; and results of the in vitro hydrolysis studies on the applied substance.
This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the mixture of methyl-branched and linear C14–C18 alkanamides, derived from fatty acids, for use in food contact materials as a slip or release agent at up to 1% w/w in polyolefins. The final materials are intended for contact with foodstuffs other than fatty foods for long-term storage at room temperature including short heating. No thermal degradation of the substance is expected under manufacturing process conditions of polyolefins. Specific migration from low-density polyethylene (LDPE) made with 0.37% of the substance into 3% acetic acid and 10% ethanol was up to 0.68 mg/kg. Based on negative results in a bacterial mutation test and in an in vivo micronucleus test, there was no evidence of a genotoxic potential of the substance. Impurities were determined and the main ones were tested in a bacterial mutation test giving negative results. Along with the negative results from the in vivo micronucleus test on the substance containing the impurities, there was no evidence of a genotoxic potential of the impurities. Based on a 28-day study on the substance, the Panel noted that there is sufficient margin of safety between the no observed adverse effect level (NOAEL) and the maximum exposure of consumers that could occur at a migration level of 5 mg/kg food, to cover uncertainties about toxic effects due to potential accumulation of slowly hydrolysed branched amide species of the substance during chronic exposure. The CEF Panel concluded that the substance is not of safety concern for consumers if it is used in the manufacture of polyolefin articles intended for contact with all foodstuffs other than fatty foods and the migration does not exceed 5 mg/kg food. The 5 mg/kg food migration should not apply to n-stearamide.