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, Cocconcelli Pier Sandro, Glandorf Boet, Gropp Jűrgen, Prieto Maradona Miguel, Rychen Guido, Saarela Maria, Anguita Montserrat, Galobart Jaume, Pettenati Elisa, Tarrés-Call Jordi
EFSA J. 2021 Apr 28;19(4):e06536. doi: 10.2903/j.efsa.2021.6536. eCollection 2021 Apr.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ECONASE XT (endo-1,4-β-xylanase) produced by a genetically modified strain of (CBS 140027) as a zootechnical feed additive for piglets (weaned), pigs for fattening, chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding and minor poultry species. The recipient strain and the production strain CBS 140027 are considered safe. The additive is safe for chickens for fattening and weaned piglets at the maximum recommended doses (16,000 and 24,000 BXU/kg feed, respectively) with a wide margin of safety (100-fold and 50-fold, respectively). These conclusions are extended to chickens reared for laying and to pigs for fattening at 16,000 and 24,000 BXU/kg feed, respectively. The additive is safe for turkeys for fattening or reared for breeding at 16,000 BXU/kg feed. The FEEDAP Panel cannot conclude on the safety of the additive for laying hens and for minor poultry species for laying at the proposed conditions of use. The information provided does not allow to conclude on the safety of the use of ECONASE XT P/L produced by CBS 140027 in animal nutrition for the consumers. The use of the additive under assessment in animal nutrition does not raise safety concerns for the environment. ECONASE XT L is non-irritant to the skin or to the eyes. In absence of data, the FEEDAP Panel cannot conclude on the potential of the solid product to be irritant to skin and eyes and on the potential of the additive in all forms to be a dermal sensitiser. All forms of the additive should be considered as respiratory sensitisers. All forms of the additive are considered efficacious at the minimum recommended levels for the target species.
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（CBS 140027）生产的ECONASE XT（内切-1,4-β-木聚糖酶）作为仔猪（断奶）、育肥猪、育肥鸡、蛋鸡、产蛋母鸡、育肥火鸡、种用火鸡和小型家禽品种的动物营养饲料添加剂的安全性和有效性发表科学意见。受体菌株和生产菌株CBS 140027被认为是安全的。该添加剂在最大推荐剂量（分别为16,000和24,000 BXU/kg饲料）下对育肥鸡和断奶仔猪是安全的，安全系数较大（分别为100倍和50倍）。这些结论分别扩展到产蛋鸡和16,000和24,000 BXU/kg饲料的育肥猪。该添加剂在16,000 BXU/kg饲料下对育肥火鸡或种用火鸡是安全的。饲料添加剂专家委员会无法就该添加剂在所提议的使用条件下对产蛋母鸡和小型产蛋家禽品种的安全性得出结论。所提供的信息无法就CBS 140027生产的ECONASE XT P/L在动物营养中供消费者使用的安全性得出结论。在动物营养中评估使用该添加剂对环境不存在安全问题。ECONASE XT L对皮肤和眼睛无刺激性。由于缺乏数据，饲料添加剂专家委员会无法就固体产品对皮肤和眼睛的潜在刺激性以及添加剂所有形式的潜在皮肤致敏性得出结论。添加剂的所有形式都应被视为呼吸道致敏剂。添加剂的所有形式在目标物种的最低推荐水平下都被认为是有效的。
