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 Edoardo, Woutersen Ruud, Brozzi Rosella, Galobart Jaume, Gregoretti Lucilla, Innocenti Matteo L, Vettori Maria Vittoria, López-Gálvez Gloria
EFSA J. 2021 Nov 5;19(11):e06894. doi: 10.2903/j.efsa.2021.6894. eCollection 2021 Nov.
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 iron (II) chelate of amino acids hydrate for all animal species, brand name Availa Fe, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein and with a minimum content of 9% iron. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to include a minimum specification for free amino acids of 18%; (iii) to introduce a tighter specification on the mineral content (iron), with an inclusion level of 9-10%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2017/2330. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust, it is not possible to make the assessment of the exposure by inhalation.
应欧盟委员会的要求，动物饲料添加剂及产品或物质专家委员会（FEEDAP）被要求根据提交的关于修改添加剂授权条款的档案，就品牌名为Availa Fe的氨基酸水合铁（II）螯合物对所有动物物种的安全性和有效性发表科学意见。该添加剂目前被授权使用源自大豆蛋白的氨基酸，且铁含量最低为9%。申请人提议：（i）纳入其他来源的氨基酸，如水解玉米蛋白粉、水解马铃薯蛋白和水解家禽羽毛粉；（ii）纳入游离氨基酸最低规格为18%的要求；（iii）对矿物质含量（铁）引入更严格的规格，添加水平为9-10%。使用不同提议的水解蛋白来源生产的添加剂符合欧盟委员会法规（EU）2017/2330规定的规格。FEEDAP专家委员会认为，使用不同提议的水解蛋白来源（即大豆、羽毛粉、马铃薯和玉米蛋白粉）不会改变先前评估中就该添加剂对目标物种、消费者、环境的安全性和有效性得出的结论。关于对使用者的安全性，该添加剂应被视为皮肤和眼睛刺激物以及皮肤致敏剂。该添加剂有很高的扬尘可能性；然而，由于缺乏粉尘中锌浓度的数据，无法对吸入暴露进行评估。
