On March 2, 2016 the European Food Safety Authority (EFSA) published two scientific opinions on the safety assessment of zinc oxide nanoparticles and α-tocopherol acetate, respectively, for use in food contact materials (FCMs).
In the first opinion, EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) assessed zinc oxide nanoparticles for use as a transparent ultraviolet light absorber in non-plasticized polymers at up to 2% by weight. Specific migration of zinc was tested from low-density polyethylene (LDPE) plaques, containing 2% of the additive, into 3% acetic acid, as well as 10% and 50% ethanol for 10 days at 60°C. Migration levels of zinc into these simulants were 2.0, 0.05, and 0.06 mg/kg, respectively. The no observed effect level (NOEL) of zinc is 50 mg/person/day, with a recommended upper limit of 25 mg/person/day. Based on the diffusional properties of nanoparticles in polymers and the solubility characteristics of zinc oxide nanoparticles, the CEF Panel concluded that the substance does not migrate in nanoform and the safety evaluation should consider migration of soluble ionic zinc. The determined migration levels of ionic zinc comply with the current specific migration limit (SML). However, in combination with dietary exposure from other sources, the recommended upper level of 25 mg/person/day could be exceeded, the CEF Panel stated. This is in line with EFSA’s previous scientific opinion on zinc oxide nanoparticles in polyolefins (FPF reported).
In the second opinion, the CEF Panel assessed α-tocopherol acetate (CAS 7695-91-2 and 58-95-7) used as an antioxidant in polyolefins intended for contact with all food types under any time and temperature conditions. The active antioxidant in the plastic is free α-tocopherol and acetate is intended to hydrolyze with moisture in situ in the plastic. Worst-case migration of the substance was calculated to be 56 mg/kg food. Hydrolysis products α-tocopherol and acetic acid are both authorized without restrictions under the plastic FMC Regulation (EU) No 10/2011 and are authorized as food additives under Regulation (EC) No 1333/2008. Therefore, the CEF Panel considers α-tocopherol acetate safe for use in polyolefins.
In a next step, the substances have to be authorized by the European Commission (EC) in order to be approved for use in FCMs. So far, only three nanomaterials (titanium nitride, carbon black, silicon dioxide) have been authorized in the EU for use in FCMs.
CEF (March 2, 2016). “Safety assessment of the substance α-tocopherol acetate for use in food contact materials.”