Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Fašmon 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, Glandorf Boet, Brantom Paul, Anguita Montserrat, Galobart Jaume, Manini Paola, Ortuño Jordi, Pettenati Elisa, Pizzo Fabiola, Tarrés Jordi, Revez Joana
EFSA J. 2022 Jul 21;20(7):e07439. doi: 10.2903/j.efsa.2022.7439. eCollection 2022 Jul.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo-1,4-β-xylanase produced by ATCC PTA-127053 (Xygest™ HT) as a zootechnical feed additive for poultry. The production strain is genetically modified. No viable cells nor recombinant DNA of the production strain were detected in the final product. Therefore, the Panel concluded that the additive does not pose any safety concern regarding the production strain. The FEEDAP Panel concluded that Xygest™ HT is considered safe for chickens for fattening at 30,000 U/kg and in laying hens at 45,000 U/kg, with a wide margin of safety. These conclusions can be extended to chickens reared for laying/breeding and extrapolated to all poultry species for fattening and reared for laying/breeding and to ornamental birds. The conclusions on laying hens are extrapolated to all laying poultry species. The use of Xygest™ HT in animal nutrition is of no concern for consumer safety and this feed additive is considered safe for the environment. The Panel also concluded that Xygest™ HT is not irritant to the eyes and skin but should be considered a dermal and a respiratory sensitiser. The Panel concluded that the additive Xygest™ HT has a potential to be efficacious for laying hens under the proposed conditions of use and this conclusion can also be extrapolated to all laying poultry species. The Panel could not conclude on the efficacy of the product for chickens for fattening due to insufficient data.
应欧盟委员会要求,欧洲食品安全局(EFSA)被要求就ATCC PTA - 127053(Xygest™ HT)生产的内切 - 1,4 - β - 木聚糖酶作为家禽饲养用饲料添加剂的安全性和有效性发表科学意见。生产菌株经过基因改造。在最终产品中未检测到生产菌株的活细胞或重组DNA。因此,专家小组得出结论,该添加剂在生产菌株方面不存在任何安全问题。饲料添加剂和动物营养产品(FEEDAP)专家小组得出结论,Xygest™ HT对于育肥鸡在30,000 U/kg以及产蛋鸡在45,000 U/kg的添加量下被认为是安全的,且具有较大的安全边际。这些结论可以扩展到用于产蛋/育种的鸡,并外推到所有用于育肥和产蛋/育种的家禽品种以及观赏鸟。关于产蛋鸡的结论可外推到所有产蛋家禽品种。Xygest™ HT在动物营养中的使用对消费者安全没有影响,并且该饲料添加剂被认为对环境是安全的。专家小组还得出结论,Xygest™ HT对眼睛和皮肤无刺激性,但应被视为皮肤和呼吸道致敏剂。专家小组得出结论,在提议的使用条件下,添加剂Xygest™ HT对产蛋鸡有潜在的有效性,并且这一结论也可以外推到所有产蛋家禽品种。由于数据不足,专家小组无法就该产品对育肥鸡的有效性得出结论。