Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Kouba Maryline, Fašmon Durjava Mojca, 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, Herman Lieve, Maradona Prieto Miguel, Rychen Guido, Saarela Maria, Anguita Montserrat, Galobart Jaume, Gregoretti Lucilla, Innocenti Matteo, Lopez-Galvez Gloria, Pettenati Elisa, Sofianidis Konstantinos, Brozzi Rosella, Vettori Maria Vittoria
EFSA J. 2020 Nov 12;18(11):e06282. doi: 10.2903/j.efsa.2020.6282. eCollection 2020 Nov.
Nutrase P is available in powder, granulated, thermostable granulate and liquid forms. It is based on a 6-phytase produced by a genetically modified strain of . The production strain contains four copies of the ampicillin resistance gene and one copy of a bleomycin resistance gene. Although Nutrase PTS 10,000 (thermostable granulate) and Nutrase PG 10,000 (granulate) do not raise concern regarding the presence of viable cells of the production strain and its recombinant DNA, uncertainties remain on the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder). The FEEDAP Panel cannot conclude on the safety of the additive, in any form, for the target species for which application is made due to major limitations in the study in chickens for fattening provided. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concludes that additive does not pose a toxicological safety concern regarding the consumers of the products obtained from animals receiving the additive. The additive, in its all formulations, is not a skin or eye irritant and is not dermal sensitiser. However, owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The active substance of the additive is a protein and as such would not raise concerns for the environment. Considering that the production strain harbours AMR genes and there is uncertainties regarding the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder), the Panel cannot conclude on the safety of these two formulations of the additive for the target species, consumer, user and environment. Owing to the lack of data, the FEEDAP Panel cannot conclude on the efficacy of the additive.
营养酶P有粉末状、颗粒状、热稳定颗粒状和液体状。它基于一种由基因改造菌株产生的6 - 植酸酶。生产菌株含有四个氨苄青霉素抗性基因拷贝和一个博来霉素抗性基因拷贝。尽管营养酶PTS 10,000（热稳定颗粒）和营养酶PG 10,000（颗粒）对于生产菌株及其重组DNA的活细胞存在不引起关注，但关于营养酶PL 10,000（液体）和营养酶PD 100,000（粉末）中生产菌株的活细胞和DNA的存在仍存在不确定性。由于所提供的育肥鸡研究存在重大局限性，饲料添加剂和动物营养产品委员会无法就该添加剂任何形式对其应用目标物种的安全性得出结论。考虑到生产菌株和遗传毒性研究获得的结果，该委员会得出结论，对于接受该添加剂的动物所产产品的消费者而言，该添加剂不存在毒理学安全问题。该添加剂的所有制剂均不是皮肤或眼睛刺激物，也不是皮肤致敏剂。然而，由于活性物质的蛋白质性质，应将其视为呼吸道致敏剂。该添加剂的活性物质是一种蛋白质，因此不会对环境造成担忧。考虑到生产菌株含有抗菌药物耐药性基因，且关于营养酶PL 10,000（液体）和营养酶PD 100,000（粉末）中生产菌株的活细胞和DNA的存在存在不确定性，该委员会无法就该添加剂的这两种制剂对目标物种、消费者、使用者和环境的安全性得出结论。由于缺乏数据，饲料添加剂和动物营养产品委员会无法就该添加剂的功效得出结论。
