Safety assessment of the substance α-tocopherol acetate for use in food contact materials


Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2016;14(3):4412 [7 pp.].
Panel members at the time of adoption
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu.
The Panel wishes to thank the members of the Working Group on Food Contact Materials: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Roland Franz, Konrad Grob, Martine Kolf-Clauw, Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima Tavares Poças, Kettil Svensson and Detlef Wölfle for the preparatory work on this scientific output and EFSA staff member: Katharina Volk for the support provided to this scientific output. 
Opinion of the Scientific Committee/Scientific Panel
On request from
Food Standards Agency, United Kingdom
Question Number
10 February 2016
Published in the EFSA Journal
2 March 2016
European Food Safety Authority (EFSA), Parma, Italy
This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety assessment of α-tocopherol acetate, CAS Nos 7695-91-2 and 58-95-7, and FCM No 1055, as an antioxidant for its use in polyolefins intended 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 α-tocopherol. Based on an assumption of total mass transfer for the maximum use 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 α-tocopherol and acetic acid, which are both authorised without restrictions under Regulation (EU) No 10/2011. dl-α-Tocopherol and acetic acid are authorised food additives under Regulation (EC) No 1333/2008 and toxicological data were available for tocopherols that were evaluated as food additives in 2015 (EFSA ANS Panel, 2015). The CEF Panel concluded therefore that the use of the substance in polyolefins does not raise a safety concern. 
α-tocopherol acetate, CAS No 7695-91-2 and 58-95-7, vitamin E, antioxidant, plastics, polyolefins
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