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 Fernand, 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 Dec 9;19(12):e06979. doi: 10.2903/j.efsa.2021.6979. eCollection 2021 Dec.
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 selenium-enriched yeast ( CNCM I-3060) 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 as selenomethionine produced by CNCM I-3060 as a nutritional additive (compound of trace elements) with a minimum selenium content of 2,000 mg/kg. The applicant proposed the inclusion of an additional formulation with a minimum content of selenium in the additive of 3,000 mg/kg. Considering (i) that the main changes in the manufacturing of the product compared to the former application involve the drying phase (spray-drying vs drum drying), which has led to slightly different values of the dusting potential and particle size, and (ii) the conditions of use already authorised, the FEEDAP Panel stated that the modification requested would only affect the safety for the target animals and the users, without impacting the safety for the consumers, safety for the environment or the efficacy of the additive. The FEEDAP Panel concluded that there are no concerns for the safety of the target animals based on its previous assessment and an additional study on homogeneity of the additive. The additive is hazardous by inhalation, is not irritant for the eyes, skin and is not a dermal sensitiser.
应欧盟委员会要求，动物饲料添加剂及产品或物质专家小组（FEEDAP）被要求根据提交的关于修改该添加剂授权条款的档案，就富硒酵母（CNCM I-3060）对所有动物物种的安全性和有效性发表科学意见。该添加剂目前被批准为由CNCM I-3060生产的硒代蛋氨酸作为营养添加剂（微量元素化合物），最低硒含量为2000毫克/千克。申请人提议在添加剂中纳入一种最低硒含量为3000毫克/千克的额外配方。考虑到（i）与先前申请相比，该产品生产过程中的主要变化涉及干燥阶段（喷雾干燥与滚筒干燥），这导致了粉尘潜在性和粒径略有不同的值，以及（ii）已批准的使用条件，FEEDAP专家小组表示，所要求的修改仅会影响目标动物和使用者的安全性，而不会影响消费者的安全性、环境安全性或添加剂的有效性。FEEDAP专家小组根据其先前的评估以及对添加剂均匀性的一项补充研究得出结论，目标动物的安全性不存在问题。该添加剂吸入有害，对眼睛、皮肤无刺激性，也不是皮肤致敏剂。
