Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Fašmon 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, Dierick Noël, Martelli Giovanna, Galobart Jaume, Ortuño Jordi, Anguita Montserrat
EFSA J. 2022 May 9;20(5):e07251. doi: 10.2903/j.efsa.2022.7251. eCollection 2022 May.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ROVABIO ADVANCE (liquid and solid) which contains endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase. The enzymes present in the additive are produced by two strains of , one of them genetically modified. The additive is intended to be used as a feed additive for weaned piglets and pigs for fattening. Viable cells of the production strains and DNA of the genetically modified strain were not detected in the fermentation product used to formulate the additive. Based on the results of a tolerance trial in weaned piglets, the FEEDAP Panel concluded that ROVABIO ADVANCE is safe for weaned piglets under the recommended conditions of use. This conclusion was extended to pigs for fattening. Based on the outcome of the toxicological studies performed, the Panel concluded that the additive is of no concern regarding consumer safety. ROVABIO ADVANCE is not irritant to the skin or eyes but it is a skin and respiratory sensitiser. No risks to the environment are expected from the use of the additive in animal nutrition. Owing to the lack of sufficient data, the FEEDAP Panel could not conclude on the efficacy of ROVABIO ADVANCE.
应欧盟委员会的要求,欧洲食品安全局(EFSA)被要求就含有内切-1,4-β-木聚糖酶和内切-1,3(4)-β-葡聚糖酶的ROVABIO ADVANCE(液体和固体)的安全性和有效性发表科学意见。该添加剂中存在的酶由两种菌株产生,其中一种是转基因菌株。该添加剂旨在用作断奶仔猪和育肥猪的饲料添加剂。在用于配制该添加剂的发酵产品中未检测到生产菌株的活细胞和转基因菌株的DNA。根据断奶仔猪耐受性试验的结果,饲料添加剂和动物营养产品专家委员会(FEEDAP Panel)得出结论,在推荐的使用条件下,ROVABIO ADVANCE对断奶仔猪是安全的。这一结论也适用于育肥猪。根据所进行的毒理学研究结果,专家委员会得出结论,该添加剂对消费者安全不构成担忧。ROVABIO ADVANCE对皮肤或眼睛无刺激性,但它是一种皮肤和呼吸道致敏剂。在动物营养中使用该添加剂预计不会对环境造成风险。由于缺乏足够的数据,饲料添加剂和动物营养产品专家委员会无法就ROVABIO ADVANCE的有效性得出结论。