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, Dierick Noël, Herman Lieve, Martelli Giovanna, Galobart Jaume, Anguita Montserrat
EFSA J. 2021 Nov 8;19(11):e06906. doi: 10.2903/j.efsa.2021.6906. eCollection 2021 Nov.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an endo-1,4-β-xylanase (Beltherm MP/ML), produced by a genetically-modified strain, as a zootechnical additive for laying hens, minor poultry species and all avian species. The additive is authorised for use in feed for poultry species for fattening or reared for laying/breeding, weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive for those species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). The current application is for an extension of use of the additive. No viable cells were detected in the additive, but the data provided to support the absence of DNA in the additive was not sufficient to conclude on the absence of recombinant DNA in the additive. However, the Panel concluded that no safety concerns would arise from the presence of DNA from the production strain in the additive. In the current assessment, the FEEDAP Panel concluded that the additive is safe for all avian species at the recommended level of 100 ADXU/kg feed. Similarly, the FEEDAP Panel concluded that Beltherm MP/ML is safe for the consumer and the environment. Concerning the user safety, the FEEDAP Panel concluded that the additive is not toxic by inhalation or irritant for skin or eyes, but it is considered a potential dermal and a respiratory sensitiser. In a previous opinion, the efficacy of the additive in poultry species for fattening was shown. However, owing to the insufficient data submitted in previous and current assessments, the Panel could not conclude on the efficacy of the product for the target species for which the application was made.
应欧盟委员会要求，欧洲食品安全局（EFSA）被要求就一种由转基因菌株生产的内切 - 1,4 - β - 木聚糖酶（Beltherm MP/ML）作为蛋鸡、小型家禽品种和所有禽类的动物技术添加剂的安全性和有效性发表科学意见。该添加剂已被批准用于育肥或产蛋/繁殖的家禽品种饲料、断奶仔猪、育肥猪和育肥小型猪品种饲料。此前，EFSA动物饲料添加剂和产品或物质专家小组（FEEDAP小组）已对该添加剂在这些物种中的安全性和有效性进行了评估。本次申请是该添加剂的用途扩展。在添加剂中未检测到活细胞，但所提供的支持添加剂中不存在DNA的数据不足以得出添加剂中不存在重组DNA的结论。然而，该小组得出结论，添加剂中存在生产菌株的DNA不会引发安全问题。在当前评估中，FEEDAP小组得出结论，在推荐添加水平为100 ADXU/kg饲料时，该添加剂对所有禽类品种都是安全的。同样，FEEDAP小组得出结论，Beltherm MP/ML对消费者和环境是安全的。关于使用者安全，FEEDAP小组得出结论，该添加剂吸入无毒，对皮肤或眼睛无刺激性，但被认为是一种潜在的皮肤和呼吸道致敏剂。在之前的一份意见中，已表明该添加剂在育肥家禽品种中的有效性。然而，由于之前和当前评估中提交的数据不足，该小组无法就该产品在所申请的目标物种中的有效性得出结论。
