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

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 Bacillus subtilis CBS 148232, and viable spores of Bacillus velezensis NRRL B-50508, B. velezensis NRRL B-50509 and B. subtilis 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 B. velezensis NRRL B-50508, B. velezensis NRRL B-50509 and B. subtilis NRRL B-50510 in animal nutrition is safe for the target species, consumers and the environment. Similarly, the Panel concluded that the use of B. subtilis 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 × 10⁸ colony forming units (CFU)/kg complete feed.