Abstract
The additive tocopherol‐rich extracts of natural origin is a mixture of the active substances alpha‐, beta‐, gamma‐ and delta‐tocopherol. Tocopherol‐rich extracts of natural origin/delta rich is a mixture of the active substances alpha‐, beta‐, gamma‐ and delta‐tocopherol with a high concentration (>70 %) of delta‐tocopherol. Synthetic tocopherol consists of pure all‐rac‐alpha‐tocopherol. The FEEDAP Panel, in a previous opinion on the safety and efficacy of vitamin E for all animal species, has already assessed the safety of RRR‐alpha‐tocopherol and the acetate ester of all‐rac‐alpha‐tocopherol for all animal species, the consumer, the user and the environment. The FEEDAP Panel is not aware of any scientific findings in the meantime that would modify its previous conclusions. The FEEDAP Panel extended the conclusions drawn in its opinion on the safety of vitamin E (including RRR‐alpha‐tocopherol and all‐rac‐alpha‐tocopheryl acetate) to tocopherol‐rich extracts and all‐rac‐alpha‐tocopherol. Tocopherol‐rich extracts and all‐rac‐alpha‐tocopherol at use levels are safe for all animal species and the consumer. No concern for user safety is expected from the use of tocopherol‐rich extracts and all‐rac‐alpha‐tocopherol in feed. The use of tocopherol‐rich extracts and all‐rac‐alpha‐tocopherol in animal nutrition will not result in a substantial increase in concentration in the environment. Since tocopherol‐rich extracts and all‐rac‐alpha‐tocopherol are used as antioxidants in food and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.
Keywords: Synthetic alpha‐tocopherol, tocopherol‐rich extracts of natural origin, tocopherol‐rich extracts of natural origin/delta rich, vitamin E, technological additive, antioxidant, safety, efficacy
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) ; Scientific Opinion on the safety and efficacy of tocopherol‐rich extracts of natural origin, tocopherol‐rich extracts of natural origin/delta‐rich, synthetic tocopherol for all animal species. EFSA Journal 2012;10(7):2783. [14 pp.] doi: 10.2903/j.efsa.2012.2783.
Panel members: Gabriele Aquilina, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Albert Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Christer Hogstrand, the late Reinhard Kroker, Lubomir Leng, Secundino López Puente, Anne‐Katrine Lundebye Haldorsen, Alberto Mantovani, Giovanna Martelli, Miklós Mézes, Derek Renshaw, Maria Saarela, Kristen Sejrsen and Johannes Westendorf
Correspondence: feedap@efsa.europa.eu
Acknowledgement: The Panel wishes to thank the members of the Working Group on technological additives, including Carlo Nebbia, for the preparatory work on this scientific opinion.
Adoption date: 12 June 2012
Published date: 19 July 2012
Question number: EFSA‐Q‐2011‐01234
On request from: European Commission
References
- EC (European Commission) , 2003, online. Tolerable Upper Intake Level of Vitamin E. Available from ec.europa.eu/food/fs/sc/scf/out195_en.pdf
- EFSA (European Food Safety Authority) , 2006, online. Tolerable Upper Intake Levels for Vitamins and Minerals by the Scientific Panel on Dietetic products, nutrition and allergies (NDA) and Scientific Committee on Food (SCF). Available from www.efsa.europa.eu/en/scdocs/oldsc/ndaintakevitaminsminerals.htm
- EFSA (European Food Safety Authority) , 2008. Opinion on mixed tocopherols, tocotrienols tocopherol and tocotrienols as sources for vitamin E added as a nutritional substance in food supplements. The EFSA Journal, 640, 1–34. [Google Scholar]
- EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) , 2010. Scientific opinion on the safety and efficacy of vitamin e as a feed additive for all animal species. EFSA Journal 2010;8(6):1635, 28 pp. [Google Scholar]
- European Pharmacopoeia , 2010. All rac‐alpha‐tocopherol. European Pharmacopoeia 7.0, 2, 3104–3105. [Google Scholar]
- VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) , 2000. VICH Topic GL18–Impurities: residual solvents in new veterinary medicinal products, active substances and excipients. Available from www.vichsec.org/pdf/2000/Gl18_st7.pdf