Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Durjava Mojca Fašmon, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Bories Georges, Gropp Jürgen, Anguita Montserrat, Galobart Jaume, Holczknecht Orsolya, Tarrés-Call Jordi, Pettenati Elisa, Pizzo Fabiola, Vettori Maria Vittoria, Manini Paola
EFSA J. 2021 Apr 19;19(4):e06533. doi: 10.2903/j.efsa.2021.6533. eCollection 2021 Apr.
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.
应欧盟委员会的要求，欧洲食品安全局动物饲料添加剂和产品或物质专家小组（FEEDAP）被要求就所有动物物种使用的饲料添加剂全消旋α-生育酚醋酸酯（维生素E）的授权续期申请评估发表科学意见。申请人提供的数据表明，目前市场上的添加剂符合授权条件。FEEDAP专家小组确认，在当前授权使用条件下使用全消旋α-生育酚醋酸酯对目标物种、消费者和环境是安全的。预计使用该活性物质不会对使用者安全造成担忧，然而，由于缺乏信息，FEEDAP专家小组无法就其皮肤致敏潜力得出结论。要就最终配制添加剂对使用者的安全性得出结论，需要进行具体研究。在授权续期的背景下，无需评估全消旋α-生育酚醋酸酯的功效。
