Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, 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, Anguita Montserrat, Brozzi Rosella, Ortuño Jordi, Pettenati Elisa, Tarrés-Call Jordi, García-Cazorla Yolanda
EFSA J. 2023 Aug 14;21(8):e08175. doi: 10.2903/j.efsa.2023.8175. eCollection 2023 Aug.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Agal-Pro BL/BL-L®. The additive is a preparation of alpha-galactosidase produced by a genetically modified strain of (CBS 615.94) and endo-1,4-beta-glucanase produced by a non-genetically modified strain of (CBS 120604). It is intended to be used as a zootechnical additive (functional group: digestibility enhancers) in chickens for fattening in its solid and liquid forms (Agal-Pro BL® and Agal-Pro BL-L®), and in minor poultry species for fattening and chickens reared for laying only in its solid form (Agal-Pro BL®). The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for the target animals, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive is considered an irritant to the skin and eyes and a dermal sensitiser. Due to the proteinaceous nature of the active substances, it should be considered a respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
应欧盟委员会的要求,欧洲食品安全局被要求就Agal-Pro BL/BL-L®续展申请的评估提供科学意见。该添加剂是由转基因的米曲霉(CBS 615.94)菌株产生的α-半乳糖苷酶和由非转基因的米曲霉(CBS 120604)菌株产生的内切-1,4-β-葡聚糖酶的制剂。它拟用作育肥鸡的动物营养添加剂(功能组:消化率增强剂),有固体和液体两种形式(Agal-Pro BL®和Agal-Pro BL-L®),而对于小型家禽品种,仅固体形式(Agal-Pro BL®)用于育肥和蛋鸡饲养。申请人已提供证据证明目前市场上的添加剂符合现有授权条件。没有新的证据会导致饲料添加剂和动物营养产品委员会重新考虑其先前的结论。因此,委员会得出结论,在授权使用条件下,该添加剂对目标动物、消费者和环境仍然是安全的。关于用户安全,该添加剂被认为对皮肤和眼睛有刺激性,是一种皮肤致敏剂。由于活性物质的蛋白质性质,应将其视为呼吸道致敏剂。在授权续展时无需评估该添加剂的功效。