Safety assessment of the substance a-tocoferol acetate for use in food contact materials. EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

This scientific opinion of the EFSA Panel on food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety assessment of a-tocopherol acetate, CAS Nos 7695-91-2 and 58-95-7, and FCM No 1055, as an antioxidant for its use in polyolefins intendedd for contact with all food types under any time and temperature conditions. The acetate is intended to hydrolyse with moisture in situ in the plastic and the active antioxidant in the plastic is the free a-tocopherol. Based on an assumption of total mass transfer for the maximum level of 650 mg/kg plastic, the worst-case migration of the substance was calculated to be 56 mg/kg food. The substance readily hydrolyses into a-tocopherol and acetic acid, which are both authorised without restrictions under Regulation (EU) No 10/2011. The CEF Panel concluded therefore that the use of the substance in polyolefins does not raise a safety concern.

Before a substance is authorised to be used in food contact materials and is included in a positive list EFSA’s opinion on its safety is required.

According to the applicant, the substance a-tocopherol acetate is intended to be used as an antioxidant in moulded polyolefin food contact plastics such as storage bins, bulk containers, and samll and large food storage tanks.

The synthetic dl-for (all-rac-mixture) of the substance has the CAS No 7695-91-2 abd cibsusts if 8 stereoisomers. The d-form (2R,4’R,8’R stereoisomer) derived from the naturally occurring d-a-tocopherol has the CAS No 58-95-7. It is used at a purity of minimum 96.5%. The substance shows thermal stability up to 240ºC and starts to decompose at this temperature.
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