Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, 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, Herman Lieve, Louro Maria Henriqueta, Alija Novo Natalia, Anguita Montserrat, Manini Paola, Casanova Jordi Ortuño, Pettenati Elisa, Pizzo Fabiola, Brozzi Rosella
EFSA J. 2023 Aug 10;21(8):e08163. doi: 10.2903/j.efsa.2023.8163. eCollection 2023 Aug.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a protease (ProAct 360) produced by a genetically modified strain of (DSM 33099) as a zootechnical feed additive for poultry species for fattening or reared for laying/breeding. The production strain and its recombinant DNA were not detected in an intermediate concentrated product representative of the final formulation. The final product did not trigger a safety concern with regard to the genetic modification. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that ProAct 360 is considered safe for all growing poultry species at the recommended inclusion level of 30,000 NFP/kg complete feed. The use ProAct 360 as a feed additive did not give rise to concerns for the consumers or the environment. The additive is not an eye or a dermal irritant but should be considered a respiratory sensitiser. In the absence of data, no conclusions could be reached on the skin sensitisation potential of the additive. The FEEDAP Panel concluded that the additive has the potential to be efficacious at 30,000 NFP/kg complete feed for all poultry species for fattening or reared for laying/breeding.
应欧盟委员会的要求,欧洲食品安全局(EFSA)被要求就一种由转基因的嗜热栖热放线菌(DSM 33099)菌株产生的蛋白酶(ProAct 360)作为育肥或产蛋/育种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。在代表最终配方的中间浓缩产品中未检测到生产菌株及其重组DNA。最终产品在转基因方面未引发安全问题。动物饲料添加剂和产品或物质专家小组(FEEDAP)得出结论,在全价饲料中推荐添加水平为30,000 NFP/kg时,ProAct 360对所有生长阶段的家禽品种被认为是安全的。使用ProAct 360作为饲料添加剂不会引起消费者或环境方面的担忧。该添加剂不是眼睛或皮肤刺激物,但应被视为呼吸道致敏剂。由于缺乏数据,无法就该添加剂的皮肤致敏潜力得出结论。FEEDAP专家小组得出结论,在全价饲料中添加水平为30,000 NFP/kg时,该添加剂对所有育肥或产蛋/育种家禽品种具有潜在的有效性。