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, Svensson Kettil, Zeljezic Davor, Anguita Montserrat, Brozzi Rosella, Galobart Jaume, Ortuño Jordi, Revez Joana, Tarrés-Call Jordi, Pettenati Elisa
EFSA J. 2022 Jul 25;20(7):e07428. doi: 10.2903/j.efsa.2022.7428. eCollection 2022 Jul.
Following a request from the European Commission, the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the product containing endo-1,4-β-xylanase produced by DSM 33574 (Xylamax) as a zootechnical additive in chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay. 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. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the Panel concluded that Xylamax is safe for all poultry species for fattening or reared to the point of lay. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concluded that the additive is safe for the consumers. The Panel also concluded that Xylamax is not irritant to the skin but should be considered a potential eye irritant and a respiratory sensitiser. No conclusions could be drawn on the potential of the additive to cause skin sensitisation. The use of the product as a feed additive is of no concern for the environment. The FEEDAP Panel concluded that the additive has the potential to be efficacious at 10,000 XU/kg feed in chickens for fattening. This conclusion was extended/extrapolated to chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay.
应欧盟委员会的要求，欧洲食品安全局动物饲料添加剂和产品（FEEDAP）专家小组被要求就DSM 33574（Xylamax）生产的含内切-1,4-β-木聚糖酶的产品作为育肥鸡、产蛋/种用鸡、育肥火鸡、种用火鸡以及育肥或饲养至产蛋阶段的小型家禽品种的畜牧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，该添加剂对生产菌株不存在任何安全问题。基于大鼠亚慢性口服毒性研究确定的未观察到不良影响水平，专家小组得出结论，Xylamax对所有育肥或饲养至产蛋阶段的家禽品种都是安全的。考虑到生产菌株和遗传毒性研究结果，专家小组得出结论，该添加剂对消费者是安全的。专家小组还得出结论，Xylamax对皮肤无刺激性，但应被视为潜在的眼刺激物和呼吸道致敏剂。关于该添加剂引起皮肤致敏的可能性无法得出结论。该产品作为饲料添加剂的使用对环境无影响。FEEDAP专家小组得出结论，该添加剂在育肥鸡饲料中添加量为10,000 XU/kg时具有有效性。这一结论扩展/外推至产蛋/种用鸡、育肥火鸡、种用火鸡以及育肥或饲养至产蛋阶段的小型家禽品种。
