The EFSA panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) said ethylene glycol dipalmitate (EGDP) is not of safety concern for consumers for use in food contact materials (FCMs) based on certain conditions.
It gave the all clear provided the fatty acid precursor is from edible fats or oils using conventionally applied procedures, and any impurities in the ethylene glycol are under control of the producer.
As this depends on the process to produce the ethylene glycol, controls must come from the producer in line with good manufacturing practice.
The safety assessment was for its use as a processing aid at concentrations of up to 2% in plastics, acting as a lubricant to improve injection moulding and distribution of additives in the polymer melt.
It should be included in the group total specific migration limit (SML(T)) of 30 mg/kg expressed as ethylene glycol, said the panel in its scientific opinion.
Emery Oleochemicals application
The request from the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany followed an application by Emery Oleochemicals.
The substance has not been evaluated before but palmitic acid and ethylene glycol, which are used in the production of EGDP, are listed in Regulation (EU) 10/2011.
Concentration of EGDP used varies from 0.1 to 2% w/w, depending on the polymer type.
Polymers listed for application are polyvinyl chloride (PVC), polyethylene terephthalate, polyamide, polycarbonate, polyolefins (polyethylene, polypropylene), polyoxymethylene, polylactic acid and styrene butadiene rubber.
Materials and articles are intended to be used in contact with all types of food without restrictions on temperature or duration.
No upper temperature limit during use is specified, but the processing temperature of some polymers containing the substance is likely to exceed 220 °C.
Migration and toxicity
Specific migration of the substance was determined using simulants in non-plasticised PVC containing 1% EGDP.
Migration was 26mg/kg for 0.1% EGDP in low-density polyethylene using conservative modelling.
Since the level of EGDP used can be higher overall migration limit may be exceeded.
However, the CEF panel noted migration would be limited by the generic specific migration limit of 60mg/kg food and has to be controlled by the user.
No toxicological data were provided for EGDP by the applicant. However, data was submitted for similar ethylene and propylene glycol fatty acid esters for ‘read across’.
Based on the structural similarities and toxicokinetic considerations the panel said this was accepted.
Three limited bacterial gene mutation tests and a mammalian gene mutation test were carried out. Based on ‘read across’, the panel considered there is no indication of genotoxic potential of EGDP.
Two 90-day oral toxicity studies on similar substances using rats showed no adverse effects; so, based on ‘read across’ from these structural homologues, no sub-chronic toxicity of EGDP is expected at relevant doses (i.e. <1 000 mg/kg bw/day).