Assessment on the Safety and Efficacy of a Feed Additive Consisting of a Protease (Subtilisin EC 3.4.21.62) and <i>Bacillus Velezensis</i> NRRL B-50508, <i>B. Velezensis</i> NRRL B-50509 and <i>B. Subtilis</i> NRRL B-50510 (Syncra® SWI 201 TPT) for P

An application was submitted to the Food Standards Agency and Food Standards Scotland in October 2024 from Genencor International B.V. (“the applicant”) on behalf of Danisco (UK) ltd. for the new authorisation of an additive consisting of the subtilisin EC 3.4.21.62 (hereafter referred to as 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), under the category ‘zootechnical additive’, functional group ‘digestibility enhancers’ for pigs for fattening and other growing porcine species. In 2025, the European Food Safety Authority (EFSA) published a scientific opinion on the safety and efficacy of a feed additive consisting of a 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. The FEEDAP Panel concluded that the use of a genetically modified protease production strain B. subtilis CBS 148232 does not raise safety concerns. Neither DNA nor viable cells of this strain were detected in the intermediate concentrates used to formulate the final additive. In addition, 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. The FEEDAP Panel concluded that the additive is safe for pigs for fattening and other growing porcine species at the proposed conditions of use and does not raise safety concerns for the environment. Furthermore, the FEEDAP Panel concluded that the additive is not irritant to the skin and eyes but should be considered a respiratory and skin sensitiser, and any exposure through respiratory tract and skin is considered a risk. When supplemented in the feed of pigs for fattening and other minor porcine species at the same physiological stage at 5,000 protease units (U)/kg and 1.5x10 8 colony forming units (CFU)/kg complete feed, Syncra® SWI 201 TPT has the potential to be efficacious. The FSA and FSS have reviewed the applicant’s authorisation application, supporting documentation, and other regulators’ risk assessments, most notably the EFSA risk assessment opinion, and considers sufficient evidence has been demonstrated to conclude without the need for further questions or risk assessment.