On February 27, 2017 the European Food Safety Authority’s (EFSA) Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids (CEF Panel) published a scientific opinion on the safety assessment of the mixture of methyl-branched and linear C14–C18 alkanamides, derived from fatty acids (from now on referred to as ‘the substance’), for use in food contact materials (FCMs). The substance is intended for use as a slip or release agent at up to 1% weight per weight (w/w) in polyolefins, for contact with non-fatty foodstuffs for long-term storage at room temperature including short heating. The CEF Panel noted that no thermal degradation of the substance is expected under manufacturing process conditions of polyolefins. Specific migration from low-density polyethylene (LDPE), containing 0.37% of the substance, into 3% acetic acid and 10% ethanol was measured to be up to 0.68 mg/kg. A bacterial mutation test and an in vivo micronucleus test indicated no evidence of genotoxic potential of the substance. Also, there was no evidence of genotoxic potential of the substance’s impurities. A 28-day oral toxicity study on the substance was performed in rats at different dose levels and a no observed adverse effect level (NOAEL) of 300 mg/kg bodyweight per day was determined. The CEF Panel considered the margin of safety between the NOAEL and a maximum exposure of consumers at a migration level of 5 mg/kg food to be sufficient, therefore not requiring a subchronic toxicity study and covering uncertainties about toxic effects due to potential accumulation of slowly hydrolyzed branched amide species during chronic exposure. The CEF Panel concluded that the mixture of methyl-branched and linear C14–C18 alkanamides, derived from fatty acids, is safe for consumers if used as described. The CEF Panel noted that the 5 mg/kg food migration should not apply to n-stearamide.
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CEF (February 27, 2017). “Safety assessment of the mixture of methyl-branched and linear C14–C18 alkanamides, derived from fatty acids, for use in food contact materials.”
Chemical Watch (March 3, 2017). “EFSA panel clears fatty alkanamides for FCMs.“
