Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Fašmon Durjava Mojca, Kouba Maryline, López-Alonso Marta, Puente Secundino López, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Dierick Noël, Saarela Maria, Brozzi Rosella, Pettenati Elisa, Anguita Montserrat
EFSA J. 2023 Feb 16;21(2):e07816. doi: 10.2903/j.efsa.2023.7816. eCollection 2023 Feb.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo-1,4-beta-xylanase produced by ATCC PTA-5588, protease produced by CBS 148232, and alpha-amylase produced by ATCC SD-6525, Axtra® XAP 104 TPT, for chickens for fattening, laying hens and minor poultry species. In the previous assessment, a series of shortcomings did not allow to conclude on the safety of the product. The shortcomings included uncertainty on the presence of viable cells of one of the production strains; uncertainty on the identity of the production strains of the ■■■■■ used in the manufacturing process of the protease and their presence in the final additive; and uncertainty about the test item used for the toxicological testing of the xylanase. Moreover, the Panel could not conclude on the efficacy in laying hens. The applicant submitted some new information to address some of the limitations previously identified. Moreover, the applicant declared a change in the production strain of the protease, substituting ATCC SD-2107 for CBS 148232. The Panel concluded that the additive is safe for the target species at the recommended use level (1,000 xylanase U, 100 amylase U and 2,000 protease U per kg feed). The additive is safe for the consumers of food products obtained from animals fed with the additive and raises no concerns for the environment. The Panel could not conclude on the skin/eye irritancy potential of the additive nor on its dermal sensitisation potential. Owing to the proteinaceous nature of the active substances, the additive is considered a respiratory sensitiser. The additive is efficacious in chickens for fattening, chickens reared for laying and minor poultry species up to the point of lay at the level of 2,000 xylanase U, 200 amylase U and 4,000 protease U per kg feed (double the minimum recommended use level). Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for laying hens.
应欧盟委员会的要求，欧洲食品安全局被要求就由ATCC PTA - 5588生产的内切 - 1,4 - β - 木聚糖酶、由CBS 148232生产的蛋白酶以及由ATCC SD - 6525生产的α - 淀粉酶（Axtra® XAP 104 TPT）对育肥鸡、产蛋鸡和小型家禽品种的安全性和有效性发表科学意见。在先前的评估中，一系列缺陷使得无法就该产品的安全性得出结论。这些缺陷包括生产菌株之一活细胞存在情况的不确定性；蛋白酶生产过程中使用的■■■■■生产菌株的身份及其在最终添加剂中的存在情况的不确定性；以及木聚糖酶毒理学测试所用测试项目的不确定性。此外，专家小组无法就该添加剂对产蛋鸡的有效性得出结论。申请人提交了一些新信息以解决先前确定的一些局限性。此外，申请人宣布蛋白酶的生产菌株发生了变化，用ATCC SD - 2107替代了CBS 148232。专家小组得出结论，该添加剂在推荐使用水平（每千克饲料1000木聚糖酶单位、100淀粉酶单位和2000蛋白酶单位）下对目标物种是安全的。该添加剂对食用添加了该添加剂的动物所产食品的消费者是安全的，并且对环境没有影响。专家小组无法就该添加剂的皮肤/眼睛刺激性潜力及其皮肤致敏潜力得出结论。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。该添加剂在每千克饲料含有2000木聚糖酶单位、200淀粉酶单位和4000蛋白酶单位（最低推荐使用水平的两倍）时，对育肥鸡、用于产蛋的饲养鸡和小型家禽品种直至产蛋点是有效的。由于缺乏足够的数据，专家小组无法就该添加剂对产蛋鸡的有效性得出结论。
