Bampidis Vasileios, Azimonti Giovanna, de Lourdes Bastos Maria, Christensen Henrik, Durjava Mojca, Dusemund Birgit, 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, Anguita Montserrat, Brozzi Rosella, García-Cazorla Yolanda, Ortuño Jordi, Pettenati Elisa, Vettori Maria Vittoria, Revez Joana
EFSA J. 2023 Feb 24;21(2):e07878. doi: 10.2903/j.efsa.2023.7878. 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-β-d-mannanase (Hemicell® HT/HT-L) produced by a genetically-modified strain of (DSM 33618) as a zootechnical feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, piglets (weaned) and minor porcine species. The production strain was obtained from a recipient strain that has been evaluated previously by EFSA and considered to be safe. The genetic modification does not raise safety concerns and there were no antibiotic resistance genes from the genetic modification in the production strain. Viable cells and the DNA of the production strain were not found in the intermediate product used to formulate the additive. Hemicell® HT/HT-L produced by DSM 33618 is considered safe for the above-mentioned target species at the intended conditions of use. The use of Hemicell® HT/HT-L as a feed additive raises no concerns for the consumer or for the environment. Hemicell® HT/HT-L is not irritant to the skin and eyes but is regarded as a dermal sensitiser and a potential respiratory sensitiser. The additive has a potential to be efficacious at 32,000 U/kg in chickens for fattening, chickens reared for laying, minor poultry species for fattening or reared for laying/breeding, pigs for fattening and minor porcine species, and at 48,000 U/kg in turkeys for fattening, turkeys reared for breeding and weaned piglets.
应欧盟委员会的要求,欧洲食品安全局(EFSA)被要求就由转基因菌株(DSM 33618)生产的内切-1,4-β-D-甘露聚糖酶(Hemicell® HT/HT-L)作为育肥鸡和火鸡、产蛋鸡、种用火鸡、接近产蛋期的小型家禽、育肥猪、断奶仔猪及小型猪种的畜牧饲料添加剂的安全性和有效性发表科学意见。生产菌株源自一种受体菌株,该受体菌株此前已由EFSA评估并认为是安全的。基因改造不存在安全问题,生产菌株中不存在来自基因改造的抗生素抗性基因。用于配制添加剂的中间产品中未发现生产菌株的活细胞和DNA。在预期使用条件下,DSM 33618生产的Hemicell® HT/HT-L被认为对上述目标物种是安全的。使用Hemicell® HT/HT-L作为饲料添加剂对消费者或环境不存在问题。Hemicell® HT/HT-L对皮肤和眼睛无刺激性,但被视为皮肤致敏剂和潜在的呼吸道致敏剂。该添加剂在育肥鸡、产蛋鸡、育肥或产蛋/育种的小型家禽、育肥猪及小型猪种中,以32,000 U/kg的添加量可能有效;在育肥火鸡、种用火鸡及断奶仔猪中,以48,000 U/kg的添加量可能有效。