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Safety and efficacy of a feed additive consisting of tocopheryl phosphate mixture (TPM) for all animal species (Avecho biotechnology limited)

on the Wiley Online Library

Metadata

Panel members at the time of adoption

Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fašmon Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Legal notice: Relevant information or parts of this scientific output have been blackened in accordance with the European Commission decision on the confidentiality requests formulated by the applicant and further confidentiality requests formulated by the applicant for which a decision by the European Commission is pending. The blackened text will be subject to review once the full decision on the confidentiality requests is adopted by the European Commission. The full output was shared with the European Commission, EU Member States and the applicant.

Abstract

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.