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, Cubadda Francesco, Focks Andreas, Tosti Luca, Brozzi Rosella, Galobart Jaume, Gregoretti Lucilla, Innocenti Matteo L, Vettori Maria Vittoria, López-Gálvez Gloria
EFSA J. 2021 Mar 22;19(3):e06468. doi: 10.2903/j.efsa.2021.6468. eCollection 2021 Mar.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganese chelate of ethylenediamine (Manganese-EDA-Cl) as feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified several issues related to the data provided concerning the chemical characteristics of the additive. Based on the information provided, the FEEDAP Panel considered unlikely that the additive consists only of manganese mono-chelate of EDA, but of several coexisting (manganese) species; therefore, the FEEDAP Panel was unable to confirm the identity of the additive. The FEEDAP Panel could not evaluate the safety for target species, consumer and environment and the efficacy of the additive owing to the uncertainties and limitations identified in the studies submitted. Concerning the safety of the additive for the users, the Panel considered that handling the additive poses a risk to users by inhalation. The additive should be considered as corrosive to eyes and a skin sensitiser.
应欧盟委员会要求,欧洲食品安全局(EFSA)被要求就乙二胺锰螯合物(Manganese-EDA-Cl)作为所有动物物种饲料添加剂的安全性和有效性提供科学意见。动物饲料添加剂和产品或物质专家小组(FEEDAP)确定了与所提供的有关该添加剂化学特性的数据相关的若干问题。根据所提供的信息,FEEDAP小组认为该添加剂不太可能仅由乙二胺锰单螯合物组成,而是由几种共存的(锰)物种组成;因此,FEEDAP小组无法确认该添加剂的身份。由于所提交研究中发现的不确定性和局限性,FEEDAP小组无法评估该添加剂对目标物种、消费者和环境的安全性以及其有效性。关于该添加剂对使用者的安全性,小组认为处理该添加剂会因吸入对使用者构成风险。该添加剂应被视为对眼睛有腐蚀性且为皮肤致敏剂。