Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Durjava Mojca Fašmon, 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 Debora, Herman Lieve, Maradona Miguel Prieto, Saarela Maria, Anguita Montserrat, Brozzi Rosella, Galobart Jaume, Gregoretti Lucilla, Innocenti Matteo L, López-Gálvez Gloria, Vettori Maria Vittoria, Revez Joana
EFSA J. 2021 Feb 23;19(2):e06458. doi: 10.2903/j.efsa.2021.6458. eCollection 2021 Feb.
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the ECONASE XT, an enzyme based on endo-1,4-β-xylanase produced by a genetically modified strain of CBS 114044. The additive is currently authorised for use in chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding, minor poultry species, piglets (weaned) and pigs for fattening. ECONASE XT is currently authorised in two forms, a solid and a liquid form with activities of 4,000,000 and 400,000 BXU/g, respectively. In a previous opinion, the FEEDAP Panel could not exclude the potential presence of recombinant DNA derived from the production organism in recent batches of the additive. The applicant has submitted data to support the absence of recombinant DNA derived from the production organism in recent product batches. The FEEDAP Panel confirms that the data provided support the absence of recombinant DNA of CBS 114044 in the additive and thus, no safety concern was identified.
应欧盟委员会要求,动物饲料添加剂及产品或物质专家委员会(FEEDAP)被要求就ECONASE XT提供科学意见,ECONASE XT是一种基于由转基因CBS 114044菌株产生的内切-1,4-β-木聚糖酶的酶制剂。该添加剂目前被批准用于育肥鸡、蛋用鸡、产蛋母鸡、育肥火鸡、种用火鸡、小型家禽、仔猪(断奶)和育肥猪。ECONASE XT目前有两种批准形式,固体和液体形式,活性分别为4,000,000和400,000 BXU/g。在之前的意见中,FEEDAP专家委员会无法排除近期批次添加剂中存在源自生产菌株的重组DNA的可能性。申请人已提交数据以支持近期产品批次中不存在源自生产菌株的重组DNA。FEEDAP专家委员会确认所提供的数据支持添加剂中不存在CBS 114044的重组DNA,因此,未发现安全问题。