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, Galobart Jaume, Vettori Maria Vittoria, Brozzi Rosella
EFSA J. 2021 Nov 8;19(11):e06903. doi: 10.2903/j.efsa.2021.6903. eCollection 2021 Nov.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of DSM 15544 (Calsporin) when used as a feed additive for piglets (suckling and weaned), pigs for fattening, sows in order to have benefit in piglets, ornamental fish, dogs and all avian species. The additive is authorised for use in sows, suckling and weaned piglets, pigs for fattening, chickens for fattening, laying hens, ornamental fish and dogs. With this application the company requested a new authorisation for all avian species and the modification of the current authorisations as regards the strain taxonomy from DSM 15544 to DSM 15544. The FEEDAP Panel concluded that the active agent of Calsporin should be taxonomically designated as DSM 15544. The Panel also concluded that Calsporin is presumed safe for the target species, consumers and the environment. Calsporin is not a dermal/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. Calsporin when supplemented at 3 × 10 CFU/kg complete feed has the potential to be efficacious in all avian species for rearing, fattening, laying and breeding purposes.
应欧盟委员会的要求，欧洲食品安全局被要求就DSM 15544（钙卫宝）用作仔猪（哺乳和断奶）、育肥猪、母猪的饲料添加剂时的安全性和有效性发表科学意见，以便使其对仔猪、观赏鱼、犬类和所有禽类有益。该添加剂已被批准用于母猪、哺乳和断奶仔猪、育肥猪、育肥鸡、蛋鸡、观赏鱼和犬类。通过此次申请，该公司请求对所有禽类给予新的批准，并将当前批准中的菌株分类从DSM 15544修改为DSM 15544。饲料添加剂和动物营养产品专家小组得出结论，钙卫宝的活性成分应在分类学上指定为DSM 15544。该小组还得出结论，钙卫宝对目标物种、消费者和环境被认为是安全的。钙卫宝不是皮肤/眼睛刺激物或皮肤致敏剂，但应被视为呼吸道致敏剂。当在全价饲料中以3×10 CFU/kg的剂量添加时，钙卫宝有可能对所有禽类的饲养、育肥、产蛋和繁殖目的有效。
