Villa Roberto Edoardo, Azimonti Giovanna, Bonos Eleftherios, Christensen Henrik, Durjava Mojca, Dusemund Birgit, Gehring Ronette, Glandorf Boet, Kouba Maryline, López-Alonso Marta, Marcon Francesca, Nebbia Carlo, Pechová Alena, Prieto-Maradona Miguel, Röhe Ilen, Theodoridou Katerina, Woutersen Ruud, Anguita Montserrat, Brozzi Rosella, Galobart Jaume, Innocenti Matteo L, Pagés Daniel
EFSA J. 2024 Nov 13;22(11):e9075. doi: 10.2903/j.efsa.2024.9075. eCollection 2024 Nov.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a preparation of CNCM I-1077 as a zootechnical feed additive for several animal species. The additive, existing in a not-coated and a coated form, is currently authorised for use in feed for calves, cattle for fattening, dairy cows, dairy goats and dairy sheep, lambs, all minor ruminant species for fattening and rearing, horses and camelids for fattening and rearing. This application regards the request for the extension of use in all ruminants and camelids reared for milk production/suckling/reproduction, all minor (young) ruminant species and camelids for fattening and Equidae other than horses, and the modification of the authorisation for lambs to reduce the minimum use level. The identity of the active agent as was confirmed. Based on the qualified presumption of safety approach and since no concerns are expected from other components, the additive is considered safe for the target species, consumers and the environment. The not-coated form of the additive is not irritant to skin or eyes. The additive in both formulations should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. No conclusion could be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The additive has the potential to be efficacious when used in feed for all ruminants and camelids reared for milk production/suckling/reproduction at the minimum proposed use level of 5 × 10 CFU (colony forming unit)/kg complete feed, all minor (young) ruminant species and camelids for fattening and lambs at 1 × 10 CFU/kg complete feed, and in all Equidae species other than horses at 3 × 10 CFU/kg complete feed.
应欧盟委员会的要求，欧洲食品安全局（EFSA）被要求就CNCM I-1077制剂作为几种动物的动物营养饲料添加剂的安全性和有效性发表科学意见。该添加剂有未包被和包被两种形式，目前已被批准用于犊牛、育肥牛、奶牛、奶山羊、奶绵羊、羔羊、所有育肥和饲养的小型反刍动物、育肥和饲养的马及骆驼科动物的饲料中。本申请涉及将其使用范围扩大至所有用于产奶/哺乳/繁殖的反刍动物和骆驼科动物、所有育肥的小型（幼龄）反刍动物和骆驼科动物以及除马以外的马科动物，并修改羔羊的批准使用量以降低最低使用水平。活性成分的身份已得到确认。基于安全合格假定方法，且预计其他成分不会引起担忧，该添加剂对目标物种、消费者和环境被认为是安全的。该添加剂的未包被形式对皮肤或眼睛无刺激性。两种制剂形式的添加剂均应被视为皮肤和呼吸道致敏剂，通过皮肤和呼吸道的任何接触都被视为有风险。由于缺乏数据，无法就该添加剂包被形式的眼刺激潜力得出结论。当以建议的最低使用水平使用时，该添加剂在用于所有用于产奶/哺乳/繁殖的反刍动物和骆驼科动物的饲料中（5×10 CFU（菌落形成单位）/千克全价饲料）、所有育肥的小型（幼龄）反刍动物和骆驼科动物以及羔羊（1×10 CFU/千克全价饲料）、除马以外的所有马科动物（3×10 CFU/千克全价饲料）时，有可能具有功效。
