RT info:eu-repo/semantics/article T1 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.) A1 Bampidis, Vasileios A1 Azimonti, Giovanna A1 Bastos, Maria de Lourdes A1 Christensen, Henrik A1 Dusemund, Birgit A1 Kouba, Maryline A1 Kos Durjava, Mojca A1 López Alonso, Marta A1 López Puente, Secundino A1 Marcon, Francesca A1 Mayo, Baltasar A1 Pechová, Alena A1 Petkova, Mariana A1 Ramos, Fernando A1 Sanz, Yolanda A1 Villa, Roberto Edoardo A1 Woutersen, Ruud A1 Cocconcelli, Pier Sandro A1 Glandorf, Boet A1 Herman, Lieve A1 Prieto Maradona, Miguel A1 Saarela, Maria A1 Anguita, Montserrat A1 Galobart, Jaume A1 Holczknecht, Orsolya A1 Manini, Paola A1 Pizzo, Fabiola A1 Tarrés‐Call, Jordi A1 Pettenati, Elisa A2 Producción Animal K1 Producción animal K1 Tecnología de los alimentos K1 Zootechnical additive K1 Gut flora stabiliser K1 Clostridium butyricum K1 Miya-Gold ® S K1 Safety K1 Renewal K1 3309 Tecnología de Los Alimentos AB [EN] The feed additive under assessment (trade name: Miya-Gold® S) is based on viable spores of Clostridium butyricum FERM BP-2789. It is authorised for use in minor avian species (excluding laying birds), weaned piglets and minor weaned porcine species, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. This opinion concerns the request for renewal of the authorisation of Miya-Gold® S for the species/categories for which an authorisation exists, the use in chickens for fattening, for which the previous authorisation had expired, and the extension of use to suckling piglets and suckling minor porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that Miya-Gold® S remains safe for the animal species/categories, the consumer and the environment under the current and previously authorised conditions of use. This conclusion applies also to the new target species for which a request of use is made. Regarding the safety for the user, the Panel concluded that the additive is not irritant to skin and eyes and that sensitisation via respiratory route cannot be excluded. There is no need for assessing the efficacy of Miya-Gold® S in the context of the renewal of the authorisation in chickens reared for laying, turkeys for fattening and reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species. The additive has the potential to be efficacious in chickens for fattening, suckling piglets and suckling minor porcine species at the level of 2.5 × 108 CFU/kg complete feedingstuff. Miya-Gold® S is compatible with decoquinate, diclazuril, lasalocid, maduramicin ammonium, narasin, narasin/nicarbazin, monensin sodium, robenidine, salinomycin sodium and semduramicin PB Wiley SN 1831-4732 LK https://hdl.handle.net/10612/21129 UL https://hdl.handle.net/10612/21129 NO Bampidis, V., Azimonti, G., Bastos, M. d. L., 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, R. E., Woutersen, R., Cocconcelli, P. S., Glandorf, B., et al. (2021). 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 Journal, 19(3). https://doi.org/10.2903/J.EFSA.2021.6450 DS BULERIA. Repositorio Institucional de la Universidad de León RD 27-jun-2024