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一种由蛋白酶以及NRRL B - 50508、NRRL B - 50509和NRRL B - 50510(Syncra® SWI 201 TPT)组成的饲料添加剂对育肥猪和其他生长阶段猪种(丹麦丹尼斯克(英国)有限公司)的安全性和有效性。

Safety and efficacy of a feed additive consisting of protease and NRRL B-50508, NRRL B-50509 and NRRL B-50510 (Syncra® SWI 201 TPT) for pigs for fattening and other growing porcine species (Danisco (UK) ltd.).

作者信息

Villa Roberto Edoardo, Azimonti Giovanna, Bonos Eleftherios, Christensen Henrik, Durjava Mojca, Dusemund Birgit, Gehring Ronette, Glandorf Boet, Kouba Maryline, López-Alonso Marta, Marcon Francesca, Nebbia Carlo, Pechová Alena, Prieto-Maradona Miguel, Röhe Ilen, Theodoridou Katerina, Bampidis Vasileios, Woutersen Ruud, Anguita Montserrat, Galobart Jaume, Innocenti Matteo L, Casanova Jordi Ortuño, Pettenati Elisa, Brozzi Rosella

出版信息

EFSA J. 2025 Feb 27;23(2):e9265. doi: 10.2903/j.efsa.2025.9265. eCollection 2025 Feb.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product consisting of the protease produced with the genetically modified strain CBS 148232, and viable spores of NRRL B-50508, NRRL B-50509 and NRRL B-50510 (Syncra® SWI 201 TPT) as a zootechnical feed additive for pigs for fattening and other growing porcine species. The FEEDAP Panel concludes that the use of the active agents NRRL B-50508, NRRL B-50509 and NRRL B-50510 in animal nutrition is safe for the target species, consumers and the environment. Similarly, the Panel concluded that the use of CBS 148232 as a production strain of the protease present in the final product does not raise safety concerns. No viable cells and no DNA of this strain were detected in the intermediate concentrates used to formulate the final additive. Based on the results obtained in a tolerance trial in weaned piglets, the FEEDAP Panel concluded that Syncra® SWI 201 TPT is safe for pigs for fattening and other growing porcine species at the proposed conditions of use. Syncra® SWI 201 TPT is not irritant to the eyes or the skin but should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The additive does not raise safety concerns for the environment. Syncra® SWI 201 TPT has the potential to be efficacious when supplemented in the feed of pigs for fattening and other minor porcine species at the same physiological stage at 5000 protease units (U)/kg and 1.5 × 10 colony forming units (CFU)/kg complete feed.

摘要

应欧盟委员会的要求,欧洲食品安全局(EFSA)被要求就一种产品的安全性和有效性发表科学意见,该产品由用转基因菌株CBS 148232生产的蛋白酶以及NRRL B - 50508、NRRL B - 50509和NRRL B - 50510(Syncra® SWI 201 TPT)的活孢子组成,用作育肥猪和其他生长猪种的动物营养饲料添加剂。动物饲料添加剂和产品授权小组(FEEDAP小组)得出结论,NRRL B - 50508、NRRL B - 50509和NRRL B - 50510活性剂在动物营养中的使用对目标物种、消费者和环境是安全的。同样,该小组得出结论,使用CBS 148232作为最终产品中蛋白酶的生产菌株不会引发安全问题。在用于配制最终添加剂的中间浓缩物中未检测到该菌株的活细胞和DNA。根据在断奶仔猪耐受性试验中获得的结果,FEEDAP小组得出结论,在建议的使用条件下,Syncra® SWI 201 TPT对育肥猪和其他生长猪种是安全的。Syncra® SWI 201 TPT对眼睛或皮肤无刺激性,但应被视为皮肤和呼吸道致敏剂,任何通过皮肤和呼吸道的接触都被视为有风险。该添加剂对环境不会引发安全问题。当以5000蛋白酶单位(U)/千克和1.5×10菌落形成单位(CFU)/千克全价饲料添加到处于相同生理阶段的育肥猪和其他小型猪种的饲料中时,Syncra® SWI 201 TPT有可能有效。

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