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) l

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 <i>Bacillus subtilis</i> CBS 148232, and viable spores of <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) 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 <i>B. velezensis</i> NRRL B-50508, <i>B. velezensis</i> NRRL B-50509 and <i>B. subtilis</i> NRRL B-50510 in animal nutrition is safe for the target species, consumers and the environment. Similarly, the Panel concluded that the use of <i>B. subtilis</i> 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<sup>8</sup> colony forming units (CFU)/kg complete feed.

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Publication Details

Journal
EFSA Journal
Published
2025-02-01
DOI
https://doi.org/10.2903/j.efsa.2025.9265
Citations
2
Primary Topic
Agricultural safety and regulations
Type
article
Field-Weighted Citation Impact
2.32
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article

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) l

Vasileios Bampidis, Ilen Röhe, Alena Pechová, Eleftherios Bonos et al.
2 citations
EFSA Journal
Agricultural safety and regulations
2.32
article

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) l

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

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 <i>Bacillus subtilis</i> CBS 148232, and viable spores of <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) 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 <i>B. velezensis</i> NRRL B-50508, <i>B. velezensis</i> NRRL B-50509 and <i>B. subtilis</i> NRRL B-50510 in animal nutrition is safe for the target species, consumers and the environment. Similarly, the Panel concluded that the use of <i>B. subtilis</i> 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<sup>8</sup> colony forming units (CFU)/kg complete feed.

EFSA JournalVol. 23(2)
Openalex Percentile: Top 14%
Agricultural safety and regulations
2.32
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