Scientific Opinion on the safety and efficacy of vitamin E as a feed additive for all animal species

Following a request from European Commission, the European Food Safety Authority was asked to deliver a scientific opinion on the safety and efficacy of vitamin E as a feed additive for all animal species. Vitamin E is a well-established micro-nutrient for all animal species. Vitamin E-based additives are globally used in animal nutrition, and have been for decades, to prevent vitamin E deficiency. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) examined data from three active substances (all-rac-α-tocopheryl acetate, RRR-α-tocopheryl acetate and RRR-α-tocopherol) currently authorised as vitamin E. The biopotency of these forms is different: one International Unit (IU) of vitamin E is defined as 1 mg all-rac-α-tocopheryl acetate, as 0.74 mg of RRR-α-tocopheryl acetate and as 0.67 mg of RRR-α-tocopherol. The additives described containing those forms of vitamin E do not present major stability or homogeneity issues. However, sensitivity to light and moisture, as well as to oxygen and heat for RRR-preparations, must be appropriately managed in order to maintain the amount of vitamin E nominally available to farm animals. Vitamin E at the current use levels is safe for all animal species. Information on hypervitaminosis E is not sufficiently consistent to derive a maximum content for vitamin E in feedingstuffs, based on safety for target species. A conservative consumer exposure assessment indicates that the UL (300 mg α-tocopherol equivalents/day) is not exceeded even assuming high background intake and levels in animal feeds far higher than practical use. The FEEDAP Panel concludes that the use of vitamin E at practical use levels is safe for the consumer. No concern for user safety is expected from the use of the active substances vitamin E in feed additives. However, to draw conclusions on the final formulated additives, specific studies would be required. Vitamin E occurs in nature and its use in animal nutrition will not result in a substantial increase in concentration in the environment. Therefore, no concern for the environment is expected. All-rac-α-tocopheryl acetate, RRR-α-tocopherol and RRR-α-tocopheryl acetate are efficacious in all animal species in satisfying the requirements for vitamin E. The FEEDAP Panel makes specific recommendations concerning (i) labelling of vitamin E in IU, (ii) restricting the use of oily RRR-α-tocopherol to premixture manufacturers, (iii) the introduction of a recommended maximum of 200 IU vitamin E/kg complete feedingstuffs, (iv) the specification of the additives.