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, Galobart Jaume, Tarrés-Call Jordi, Pettenati Elisa, Ortuño Jordi
EFSA J. 2023 Apr 21;21(4):e07954. doi: 10.2903/j.efsa.2023.7954. eCollection 2023 Apr.
Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the feed additive containing endo-1,4-β-glucanase produced by IMI 360748 (Hostazym® C). The product is authorised as a zootechnical additive (functional group: digestibility enhancers) for use in chickens for fattening, minor poultry species for fattening and weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation for the use in those species/categories, and the extension of use to chickens reared for laying, turkeys reared for breeding, minor poultry species reared for laying or breeding, ornamental birds and suckling piglets. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that the additive is safe for the target species, the consumers, and the environment under the authorised conditions of use. This conclusion also applies to the target species for which a request for an extension of use is made. The additive is considered not a skin corrosive or eye irritant, but it should be considered a skin sensitiser. The Panel cannot conclude on the potential of the additive to be a skin irritant. Due to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The Panel considers that the additive has the potential to be efficacious at 500 CU/kg complete feed in all poultry for fattening, reared for laying or breeding, and ornamental birds, and at 350 CU/kg complete feed in piglets (weaned and suckling, for the period in which solid feed is given).
应欧盟委员会的要求，欧洲食品安全局动物饲料添加剂及产品或物质专家小组（FEEDAP）被要求就含有由IMI 360748生产的内切-1,4-β-葡聚糖酶的饲料添加剂（Hostazym® C）的安全性和有效性发表科学意见。该产品被授权作为一种畜牧技术添加剂（功能组：消化率增强剂），用于育肥鸡、育肥小型家禽品种和断奶仔猪。本科学意见涉及在这些物种/类别中使用的授权续期请求，以及将使用范围扩大到产蛋鸡、种用火鸡、产蛋或育种的小型家禽品种、观赏鸟和哺乳仔猪的请求。申请人提供了证据，证明市场上现有的添加剂符合授权条件。没有新的证据会导致专家小组重新考虑之前的结论，即在授权使用条件下，该添加剂对目标物种、消费者和环境是安全的。这一结论也适用于提出使用范围扩大请求的目标物种。该添加剂被认为不是皮肤腐蚀剂或眼睛刺激物，但应被视为皮肤致敏剂。专家小组无法就该添加剂是否具有皮肤刺激性得出结论。由于活性物质的蛋白质性质，该添加剂被认为是一种呼吸道致敏剂。专家小组认为，该添加剂在育肥、产蛋或育种的所有家禽以及观赏鸟的全价饲料中添加500 CU/kg时具有潜在的有效性，在仔猪（断奶和哺乳，在提供固体饲料的期间）的全价饲料中添加350 CU/kg时具有潜在的有效性。
