On February 18, 2015 the European Food Safety Authority (EFSA) published two scientific opinions dealing with the safety assessment of new food contact substances. The first substance, ethylene glycol dipalmitate (EGDP, CAS 624-03-3), assessed by the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was approved for use as a processing aid at concentrations of up to 2% in various types of plastics. Although toxicological data were not provided for EGDP, data were submitted for structurally similar substances, namely, ethylene and propylene glycol fatty acid esters for read-across. The read-across assessment performed showed no evidence of subchronic and developmental toxicity as well as genotoxicity for EGDP. Migration of EGDP is limited by the generic specific migration limit (SML(T)) of 30 mg/kg food expressed as ethylene glycol. The second opinion deals with the safety assessment of fatty acids, C16–18 saturated, hexaesters with dipentaerythritol (FADP) for use as a processing agent at up to 1.5% in various types of plastics. CEF notes that migration of the substance is limited by the generic SML(T) of 60 mg/kg food. As in the case of EGDP, toxicological data from structurally similar substances were submitted for read-across. Based on the data provided for pentaerythritol fatty acids, the CEF Panel has no concern regarding both the mutagenic and accumulation potential of FADP. The CEF panel concluded that both substances do not give rise to safety concerns for consumers for the proposed uses and use levels.
CEF (February 18, 2015). “Scientific Opinion on the safety assessment of the substance ethylene glycol dipalmitate, CAS No 624-03-3, for use in food contact materials.” EFSA Journal 2015;13(2): 4019.
CEF (February 18, 2015). “Scientific Opinion on the safety assessment of the substance fatty acids, C16–18 saturated, hexaesters with dipentaerythritol for use in food contact materials.” EFSA Journal 2015;13(2):4021.