Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Fašmon Durjava Mojca, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto E, Woutersen Ruud, Cubadda Francesco, Focks Andreas, Tosti Luca, Anguita Montserrat, Brozzi Rosella, Galobart Jaume, Innocenti Matteo L, López-Gálvez Gloria, Sofianidis Konstantinos, Vettori Maria Vittoria, Gregoretti Lucilla
EFSA J. 2021 Apr 28;19(4):e06541. doi: 10.2903/j.efsa.2021.6541. eCollection 2021 Apr.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper chelate of ethylenediamine (Copper-EDA-Cl) as a feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) identified several issues related to the data provided concerning the chemical characteristics of the additive and, based on the information provided from an dissociation study, considered it unlikely that the additive consists only of copper mono-chelate of EDA but of several coexisting (copper) species. Therefore, in the absence of adequate experimental data and owing to the uncertainties identified, the Panel cannot conclude on its identity and characterisation of the additive. The FEEDAP Panel concludes that the additive is safe for chickens for fattening and reared for laying/breeding but cannot conclude on the safety for other animal species/categories. The FEEDAP Panel cannot conclude on the safety of the additive for the consumer or the environment. The FEEDAP Panel concludes that handling the additive poses a risk to users by inhalation. The additive should be considered as non-irritant for the skin but corrosive for the eyes and a skin sensitiser. The Panel notes the uncertainties on the genotoxicity potential of the additive that might have an impact on the conclusions on the safety for the user. The FEEDAP Panel concludes that the additive is efficacious in providing copper to meet the nutritional requirements of this trace element in all animal species.
应欧盟委员会要求，欧洲食品安全局（EFSA）被要求就乙二胺铜螯合物（Copper-EDA-Cl）作为所有动物物种饲料添加剂的安全性和有效性发表科学意见。动物饲料添加剂和产品或物质专家小组（FEEDAP小组）发现了与所提供的添加剂化学特性数据相关的几个问题，并根据解离研究提供的信息，认为该添加剂不太可能仅由乙二胺的单铜螯合物组成，而是由几种共存的（铜）物种组成。因此，由于缺乏足够的实验数据以及存在的不确定性，该小组无法就添加剂的身份和特性得出结论。FEEDAP小组得出结论，该添加剂对育肥鸡和产蛋/种用鸡是安全的，但无法就对其他动物物种/类别是否安全得出结论。FEEDAP小组无法就该添加剂对消费者或环境的安全性得出结论。FEEDAP小组得出结论，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皮肤无刺激性，但对眼睛有腐蚀性且是皮肤致敏剂。该小组指出添加剂遗传毒性潜力方面的不确定性，这可能会影响对使用者安全性的结论。FEEDAP小组得出结论，该添加剂在为所有动物物种提供铜以满足该微量元素的营养需求方面是有效的。
