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, Mayo Baltasar, Anguita Monsterrat, Bozzi Cionci Nicole, Brozzi Rosella, Galobart Jaume, Innocenti Matteo L, Pettenati Elisa, Pizzo Fabiola, Amaduzzi Angelica
EFSA J. 2025 Jun 18;23(6):e9463. doi: 10.2903/j.efsa.2025.9463. eCollection 2025 Jun.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of 6-phytase produced with a genetically modified strain of (CBS 126897) (Quantum® Blue) as a zootechnical feed additive for poultry, piglets, pigs for fattening and sows, other porcine species and ornamental birds. The additive is currently authorised for use in feed for laying birds, poultry other than laying birds, weaned piglets, pigs for fattening and sows. This scientific opinion concerns the request for the renewal of the authorisation of the additive for these species and the extension of use to suckling piglets and other porcine species and ornamental birds. The additive is available in two solid (Quantum® Blue 5 G and 40 P) and two liquid formulations (Quantum® Blue 5 and 10 L). Some changes in the composition of the product have been implemented since the first authorisation. The applicant provided evidence that the additive complies with the terms of the authorisation. The FEEDAP Panel concluded that all formulations of the additive remain safe for the target species, consumers and the environment, and that the extension of use to the new species would not affect these conclusions. Regarding user safety, all the forms of the additive should be considered as respiratory sensitisers. The solid forms of the additive are dust free; therefore, the exposure of users through inhalation is unlikely. No specific information was submitted for the four formulations of the additive under assessment regarding their potential to be skin and eye irritants and skin sensitisers. In the absence of data, the FEEDAP Panel is not in the position to conclude on the potential of the additive to be skin and eye irritants or skin sensitisers. There is no need for the assessment of efficacy in poultry, weaned piglets, pigs for fattening and sows in the context of the renewal of the authorisation. The FEEDAP Panel considers that the additive has the potential to be efficacious in ornamental birds at 250 FTU/kg complete feed and in suckling piglets and in suckling and weaned piglets of minor porcine species at 500 FTU/kg and in minor porcine species for fattening/reared for reproduction and reproductive animals at 250 FTU/kg complete feed.
应欧盟委员会的要求，欧洲食品安全局被要求就一种饲料添加剂的安全性和有效性提供科学意见。该添加剂由用转基因的解脂耶氏酵母菌株（CBS 126897）（量子蓝）生产的6-植酸酶组成，用作家禽、仔猪、育肥猪、母猪、其他猪种和观赏鸟的动物营养饲料添加剂。该添加剂目前已被批准用于蛋鸡、非蛋鸡家禽、断奶仔猪、育肥猪和母猪的饲料中。本科学意见涉及对该添加剂在这些物种上的授权续期申请以及将其使用范围扩展至哺乳仔猪、其他猪种和观赏鸟的请求。该添加剂有两种固体剂型（量子蓝5G和40P）和两种液体剂型（量子蓝5L和10L）。自首次授权以来，产品成分已发生一些变化。申请人提供了证据证明该添加剂符合授权条款。动物饲料添加剂和产品委员会得出结论，该添加剂的所有剂型对目标物种、消费者和环境仍然是安全的，并且将使用范围扩展至新物种不会影响这些结论。关于使用者安全，该添加剂的所有形式都应被视为呼吸道致敏剂。该添加剂的固体形式无粉尘；因此，使用者通过吸入接触的可能性不大。对于正在评估的该添加剂的四种剂型，未提交关于其作为皮肤和眼睛刺激物以及皮肤致敏剂潜力的具体信息。在缺乏数据的情况下，动物饲料添加剂和产品委员会无法就该添加剂作为皮肤和眼睛刺激物或皮肤致敏剂的潜力得出结论。在授权续期的背景下，无需对家禽、断奶仔猪、育肥猪和母猪进行功效评估。动物饲料添加剂和产品委员会认为，该添加剂在全价饲料中添加250酶活性单位/千克时对观赏鸟、在全价饲料中添加500酶活性单位/千克时对哺乳仔猪以及小型猪种的哺乳和断奶仔猪、在全价饲料中添加250酶活性单位/千克时对小型育肥猪/种猪和繁殖动物有潜在的功效。
