Safety and efficacy of a feed additive consisting of Bacillus subtilis FERM BP-07462, Enterococcus lactis FERM BP-10867 and Clostridium butyricum FERM BP-10866 (BIO-THREE®) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, all avian species for rearing/fattening to slaughter and all avian species reared for laying or breeding to point of lay (TOA BIOPHARMA Co., Ltd.)
- PMID: 35757152
- PMCID: PMC9201748
- DOI: 10.2903/j.efsa.2022.7342
Safety and efficacy of a feed additive consisting of Bacillus subtilis FERM BP-07462, Enterococcus lactis FERM BP-10867 and Clostridium butyricum FERM BP-10866 (BIO-THREE®) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, all avian species for rearing/fattening to slaughter and all avian species reared for laying or breeding to point of lay (TOA BIOPHARMA Co., Ltd.)
Abstract
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of BIO-THREE® when used as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, all avian species for rearing/fattening to slaughter and all avian species reared for laying or breeding to point of lay. The product under assessment is based on viable cells/spores of Bacillus subtilis FERM BP-07462, Enterococcus lactis FERM BP-10867 and Clostridium butyricum FERM BP-10866. Based on the tolerance study provided, the Panel concluded that the additive is safe for the target species under the conditions of use. The additive is safe for the consumers of products derived from animals receiving the additive. The additive is not irritant to skin and eyes. The additive is a respiratory sensitiser. No conclusions could be drawn on its potential to be a skin sensitiser. The use of the product as a feed additive is of no concern for the environment. The FEEDAP Panel was not in the position to conclude on the efficacy of BIO-THREE® for the target species. BIO-THREE® is compatible with diclazuril, decoquinate and halofuginone. No conclusions could be drawn on the compatibility of BIO-THREE® with monensin sodium, salinomycin sodium, narasin, robenidine hydrochloride and maduramicin ammonium.
Keywords: Bacillus subtilis FERM BP‐07462; Clostridium butyricum FERM BP‐10866; Enterococcus lactis FERM BP‐10867; efficacy; gut flora stabilisers; safety; zootechnical additives.
© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.
Similar articles
-
Efficacy of a feed additive consisting of Bacillus subtilis FERM BP-07462, Enterococcus lactis FERM BP-10867 and Clostridium butyricum FERM BP-10866 (BIO-THREE®) for chickens for fattening and reared for laying, turkeys for fattening and reared for breeding, and all avian species for rearing/fattening or reared for laying/breeding (TOA BIOPHARMA Co., Ltd.).EFSA J. 2023 Nov 8;21(11):e08343. doi: 10.2903/j.efsa.2023.8343. eCollection 2023 Nov. EFSA J. 2023. PMID: 38027428 Free PMC article.
-
Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP-2789 (Miya-Gold® S) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), piglets (suckling and weaned) and minor porcine species (Miyarisan Pharmaceutical Co. Ltd.).EFSA J. 2021 Mar 8;19(3):e06450. doi: 10.2903/j.efsa.2021.6450. eCollection 2021 Mar. EFSA J. 2021. PMID: 33732396 Free PMC article.
-
Efficacy of a feed additive consisting of Bacillus velezensisNITE BP-01844 (BA-KING®) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and all avian species for fattening, or rearing to slaughter or point of lay including non-food producing species (Toa Biopharma Co., Ltd.).EFSA J. 2023 Jun 8;21(6):e08053. doi: 10.2903/j.efsa.2023.8053. eCollection 2023 Jun. EFSA J. 2023. PMID: 37304354 Free PMC article.
-
Safety and efficacy of a feed additive consisting of Bacillus velezensis NITE BP-01844 (BA-KING®) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and all avian species for fattening, or rearing to slaughter or point of lay including non-food producing species (Toa Biopharma Co., Ltd.).EFSA J. 2022 Feb 25;20(2):e07152. doi: 10.2903/j.efsa.2022.7152. eCollection 2022 Feb. EFSA J. 2022. PMID: 35237356 Free PMC article.
-
Safety and efficacy of a feed additive consisting of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 (Biomin® C5) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening and reared for laying/breeding (Biomin GmbH).EFSA J. 2023 Oct 19;21(10):e08354. doi: 10.2903/j.efsa.2023.8354. eCollection 2023 Oct. EFSA J. 2023. PMID: 37869252 Free PMC article.
Cited by
-
Efficacy of a feed additive consisting of Bacillus subtilis FERM BP-07462, Enterococcus lactis FERM BP-10867 and Clostridium butyricum FERM BP-10866 (BIO-THREE®) for chickens for fattening and reared for laying, turkeys for fattening and reared for breeding, and all avian species for rearing/fattening or reared for laying/breeding (TOA BIOPHARMA Co., Ltd.).EFSA J. 2023 Nov 8;21(11):e08343. doi: 10.2903/j.efsa.2023.8343. eCollection 2023 Nov. EFSA J. 2023. PMID: 38027428 Free PMC article.
References
-
- Belloso Daza MV, Cortimiglia C, Bassi D and Cocconcelli PS, 2021. Genome‐based studies indicate that the Enterococcus faecium Clade B strains belong to Enterococcus lactis species and lack of the hospital infection associated markers. International Journal of Systematic and Evolutionary Microbiology, 71. 10.1099/ijsem.0.004948 - DOI - PubMed
-
- EFSA (European Food Safety Authority) , 2007. Opinion of the Scientific Committee on a request from EFSA on the introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA. EFSA Journal 2007;587, 16 pp. 10.2903/j.efsa.2007.587 - DOI
-
- EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards) , Koutsoumanis K, Allende A, Alvarez‐Ordóñez A, Bolton D, Bover‐Cid S, Chemaly M, Davies R, De Cesare A, Hilbert F, Lindqvist R, Nauta M, Peixe L, Ru G, Simmons M, Skandamis P, Suffredini E, Cocconcelli PS, Fernández Escámez PS, Maradona MP, Querol A, Suarez JE, Sundh I, Vlak J, Barizzone F, Correia S and Herman L, 2020. Scientific Opinion on the update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA (2017–2019). EFSA Journal 2020;18(2):5966, 56 pp. 10.2903/j.efsa.2020.5966 - DOI - PMC - PubMed
-
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , 2012. Guidance on studies concerning the safety of use of the additive for users/workers. EFSA Journal 2012;10(1):2539, 5 pp. 10.2903/j.efsa.2012.2539 - DOI
-
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Bampidis V, Bastos M, Christensen H, Dusemund B, Kouba M, Kos Durjava M, López‐Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Brock T, de Knecht J, Kolar B, van Beelen P, Padovani L, Tarrés‐Call J, Vettori MV and Azimonti G, 2019. Guidance on the assessment of the safety of feed additives for the environment. EFSA Journal 2019;17(4):5648, 78 pp. 10.2903/j.efsa.2019.5648 - DOI - PMC - PubMed