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Abstract Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of RRR‐alpha‐tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applican...
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Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of all-rac-alpha-tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant pro...
Abstract Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of all‐rac‐alpha‐tocopheryl acetate (vitamin E) as a feed additive for all animal species. The appl...
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Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of tocopheryl phosphate mixture (TPM) as nutritional feed additive for all animal species. The additive has not been authorised for use in animal nutrition. TPM is produced by chemical synthesis and is a mixture of two different phosphorylated tocopheryl compounds in approximate 2:1 weight ratio: all-rac-α-tocopheryl di-hydrogen phosphate (TP) and all-rac-di-α-tocopheryl hydrogen phosphate (T2P). It is intended to be used as nutritional additive (as a source of vitamin E) in feed for all animal species and categories. Considering the limited information on the ADMER for the components of the additive and the uncertainties on the potential aneugenicity and clastogenicity of the additive, the Panel cannot conclude on the safety of the additive for the target species and for the consumer. TPM is not a skin irritant nor a skin sensitiser but should be considered irritant to the eyes and the upper respiratory tract. Owing to the uncertainty on the potential aneugenicity and clastogenicity of the additive, it is not possible to conclude on safety for the user. The FEEDAP Panel cannot conclude on the safety of TPM for the environment due to lack of data on environmental impact of T2P. TPM is a bioavailable source of α-tocopherol. The data available, however, do not allow the Panel to establish the relative bioequivalence of TPM as vitamin E. Therefore, the Panel is not in the position to conclude on the efficacy of TPM for all animal species.
Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of all-rac-alpha-tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of all-rac-alpha-tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance; however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of all-rac-alpha-tocopheryl acetate in the context of the renewal of the authorisation.
