Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Kouba Maryline, Kos Durjava Mojca, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Aguilera Jaime, Brozzi Rosella
EFSA J. 2019 Apr 16;17(4):e05687. doi: 10.2903/j.efsa.2019.5687. eCollection 2019 Apr.
GalliPro is the trade name for a feed additive based on viable cells of a strain of intended for use as a zootechnical additive (gut flora stabiliser) in feed for chickens for fattening. The product is currently authorised for use in chickens for fattening. This opinion concerns the renewal of this authorisation. is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establish the safety for the target species, consumers and the environment. The identity of the strain present in the additive was established and evidence was provided on the lack of toxigenic potential as well as acquired antibiotic resistance determinants to antibiotics of human and veterinary importance. Accordingly, this strain is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from other components of the additive, GalliPro is considered safe for the target species, consumers and the environment. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel confirms its previous conclusions that GalliPro is safe for the target species; consumers of products from animals fed the additive and the environment. GalliPro should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the potential of GalliPro for skin and eyes irritancy and dermal sensitisation.
GalliPro是一种饲料添加剂的商品名，该添加剂基于一种特定菌株的活细胞， intended for use as a zootechnical additive (gut flora stabiliser) in feed for chickens for fattening. 该产品目前已获批准用于育肥鸡饲料。本意见涉及该授权的续期。EFSA认为该产品适用于采用合格假定安全（QPS）方法来确定对目标物种、消费者和环境的安全性。已确定了添加剂中存在的菌株的身份，并提供了证据证明其不存在产毒潜力以及对人和兽医领域重要抗生素的获得性抗生素耐药决定因素。因此，假定该菌株对目标物种、食用添加该添加剂饲料的动物产品的消费者以及环境是安全的。由于预计添加剂的其他成分不会引起担忧，因此GalliPro被认为对目标物种、消费者和环境是安全的。申请人已提供证据证明市场上现有的添加剂符合现行授权条件。饲料添加剂和动物营养产品（FEEDAP）小组确认其先前的结论，即GalliPro对目标物种、食用添加该添加剂饲料的动物产品的消费者以及环境是安全的。GalliPro应被视为一种潜在的呼吸道致敏剂。由于缺乏数据，饲料添加剂和动物营养产品小组无法就GalliPro对皮肤和眼睛的刺激性以及皮肤致敏性得出结论。 （原文中“intended for use as a zootechnical additive (gut flora stabiliser) in feed for chickens for fattening.”部分表述似乎不完整，但按照要求完整翻译了原文内容）
