Villa Roberto Edoardo, Azimonti Giovanna, Bonos Eleftherios, Christensen Henrik, Durjava Mojca, Dusemund Birgit, Gehring Ronette, Glandorf Boet, Kouba Maryline, López-Alonso Marta, Marcon Francesca, Nebbia Carlo, Pechová Alena, Prieto-Maradona Miguel, Röhe Ilen, Theodoridou Katerina, Alija-Novo Natalia, Anguita Montserrat, Cionci Nicole Bozzi, Brozzi Rosella, Innocenti Matteo Lorenzo, Ortuño Jordi, Pettenati Elisa, Pizzo Fabiola, Valeri Piera, García-Cazorla Yolanda
EFSA J. 2024 Oct 24;22(10):e9025. doi: 10.2903/j.efsa.2024.9025. eCollection 2024 Oct.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product containing endo-1,4-β-xylanase (ECONASE® XT) as a zootechnical feed additive (digestibility enhancer) for pigs for fattening, laying hens and minor poultry species. ECONASE® XT is available in two liquid and three solid forms and is produced with a genetically modified strain of (CBS 114044). The FEEDAP Panel concluded that the genetic modification of the production strain does not raise any safety concerns, and viable cells of the production strain and its DNA were not detected in the final products. The Panel also concluded that ECONASE® XT is safe for pigs for fattening, laying hens and minor poultry species at the proposed conditions of use. The use of the additive raises no safety concerns for the consumers of products derived from animals fed with the additive or for the environment. The liquid and solid forms of ECONASE® XT are non-irritant to the skin, but only the liquid forms were confirmed as non-irritant to the eyes and not dermal sensitisers. The Panel could not conclude on the irritation potential to the eyes and the dermal sensitisation potential for the solid forms. Due to the proteinaceous nature of the active substance, the additive is considered to be a respiratory sensitiser. The additive has the potential to be efficacious in pigs for fattening at 20,000 BXU/kg complete feed, in all laying poultry species at 12,000 BXU/kg complete feed and in minor poultry species other than laying birds at 8000 BXU/kg complete feed.
应欧盟委员会的要求,欧洲食品安全局被要求就一种含有内切-1,4-β-木聚糖酶(ECONASE® XT)作为育肥猪、产蛋鸡和小型家禽品种的动物营养饲料添加剂(消化率增强剂)的产品的安全性和有效性发表科学意见。ECONASE® XT有两种液体形式和三种固体形式,由一种转基因的 (CBS 114044)菌株生产。饲料添加剂和动物营养产品专家小组得出结论,生产菌株的基因改造不会引发任何安全问题,且在最终产品中未检测到生产菌株的活细胞及其DNA。该小组还得出结论,在建议的使用条件下,ECONASE® XT对育肥猪、产蛋鸡和小型家禽品种是安全的。使用该添加剂对食用添加该添加剂的动物产品的消费者或环境不存在安全问题。ECONASE® XT的液体和固体形式对皮肤无刺激性,但仅液体形式被确认为对眼睛无刺激性且不是皮肤致敏剂。该小组无法就固体形式对眼睛的刺激潜力和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。该添加剂在育肥猪的全价饲料中添加量为20,000 BXU/kg、在所有产蛋家禽品种的全价饲料中添加量为12,000 BXU/kg以及在非产蛋小型家禽品种的全价饲料中添加量为8000 BXU/kg时可能有效。