Bampidis Vasileios, Azimonti Giovanna, de Lourdes Bastos Maria, 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, Anguita Montserrat, Galobart Jaume, Manini Paola, Pizzo Fabiola, Tarrés-Call Jordi, Pettenati Elisa, Holczknecht Orsolya
EFSA J. 2019 Jul 24;17(7):e05781. doi: 10.2903/j.efsa.2019.5781. eCollection 2019 Jul.
Following a request from the European Commission, the 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 Bergazym P100 (endo-1,4-β-xylanase, produced by a non-genetically modified strain of ) as a feed additive for other birds for fattening, ornamental birds and other growing Suidae. Considering the high margin of safety observed in the tolerance studies in chickens for fattening and in weaned piglets, and that the recommended level is the same, the Panel extrapolates the conclusions reached in chickens for fattening to all poultry species for fattening and ornamental birds and extrapolates the conclusions reached in weaned piglets to other growing Suidae species. Therefore, Bergazym P100 containing endo-1,4-β-xylanase as active substance is considered safe in other birds for fattening, ornamental birds and other growing Suidae at the recommended dose of 1,500 EPU/kg feed. The additive is considered safe for the consumer and the environment. The additive is not irritant to the eyes and the skin, but it is considered a potential skin and respiratory sensitiser. The additive has the potential to be efficacious as a zootechnical additive, functional group 'digestibility enhancers', in other birds for fattening, ornamental birds and other growing Suidae at the recommended dose of 1,500 EPU/kg feed.
应欧盟委员会的要求，动物饲料添加剂及产品或物质专家委员会（FEEDAP）被要求就Bergazym P100（由非转基因菌株生产的内切-1,4-β-木聚糖酶）作为育肥其他禽类、观赏鸟及其他生长猪科动物的饲料添加剂的安全性和有效性发表科学意见。考虑到在育肥鸡和断奶仔猪的耐受性研究中观察到的高安全边际，且推荐水平相同，专家委员会将育肥鸡得出的结论外推至所有育肥禽类和观赏鸟，并将断奶仔猪得出的结论外推至其他生长猪科动物。因此，以内切-1,4-β-木聚糖酶为活性物质的Bergazym P100在推荐剂量为1500 EPU/kg饲料时，被认为对育肥其他禽类、观赏鸟及其他生长猪科动物是安全的。该添加剂被认为对消费者和环境是安全的。该添加剂对眼睛和皮肤无刺激性，但被认为是一种潜在的皮肤和呼吸道致敏剂。该添加剂在推荐剂量为1500 EPU/kg饲料时，作为动物技术添加剂（功能组为“消化率增强剂”），对育肥其他禽类、观赏鸟及其他生长猪科动物有潜在的有效性。
