Safety and efficacy of a feed additive consisting of Bacillus velezensis ATCC PTA‐6737 (Bacillus velezensis PB6) for turkeys for fattening, turkeys reared for breeding, laying hens, minor poultry species for laying, piglets (weaned), weaned minor porcine species and sows (Kemin Europe N.V.)

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Bacillus subtilis ATCC PTA‐6737 (Bacillus subtilis PB6) when used as a feed additive for turkeys for fattening, turkeys reared for breeding, laying hens, minor poultry species for laying, piglets (weaned), weaned minor porcine species and sows. With this application, the company requested the modification of the current authorisations as regards the strain taxonomy from B. subtilis ATCC PTA‐6737 to Bacillus velezensis ATCC PTA‐6737. The FEEDAP Panel concluded that the active agent of B. subtilis PB6 should be taxonomically designated as B. velezensis ATCC PTA‐6737. The Panel also concluded that Bacillus velezensis PB6 is presumed safe for the target species, consumers and the environment and is not a dermal/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. The Panel reiterated the previous conclusions reached on the efficacy of the additive when used with the target species.

Assessment of the feed additive consisting of Bacillus velezensis ATCC PTA‐6737 (PB6) for turkeys for fattening and turkeys reared for breeding for the renewal of its authorisation and the modification of the conditions of the authorisation for other growing poultry species (Kemin Europe N.V)

“…In the previous assessments (EFSA FEEDAP Panel, 2012a , 2013 , 2017a , 2020 , 2022 ), the active agent B. velezensis ATCC PTA‐6737 was presumed safe for the target species, consumers and the environment based on the qualified presumption of safety (QPS) approach (EFSA, 2007 ; EFSA BIOHAZ Panel, 2023 ).…”

“…In 2022, the FEEDAP Panel concluded that the additive is non‐irritant to skin and eyes or a dermal sensitiser, but it should be considered a respiratory sensitiser (EFSA FEEDAP Panel, 2022 ). The Panel notes that the OECD test guidelines available at present are designed to assess the skin sensitisation potential of chemical substances only and that, currently, no validated assays for assessing the sensitisation potential of microorganisms are available.…”

“…An opinion on the compatibility of Bacillus velezensis ATCC PTA‐6737 with coccidiostats was also published in 2010 (EFSA FEEDAP Panel, 2010 ) and an opinion with the modification of the species designation from Bacillus subtilis ATCC PTA‐6737 to Bacillus velezensis ATCC PTA‐6737 (EFSA FEEDAP Panel, 2022 ).…”

Safety and efficacy of a feed additive consisting of Bacillus velezensis ATCC PTA‐6737 (PB6) for the renewal of the authorisations in weaned piglets, weaned minor porcine species and sows and the extension of use to all Suidae (Kemin Europe N.V)

“…In 2022, the FEEDAP Panel concluded that the additive was non‐irritant to skin and eyes or a dermal sensitiser, but it should be considered a respiratory sensitiser (EFSA FEEDAP Panel, 2022 ). The Panel notes that the OECD test guidelines available at present are designed to assess the skin sensitisation potential of chemical substances only and that currently no validated assays for assessing the sensitisation potential of microorganisms are available.…”

“…An opinion on the compatibility of Bacillus subtilis PB6 ( Bacillus subtilis ATCC PTA‐6737) with coccidiostats was also published in 2010 (EFSA FEEDAP Panel, 2010 ) and recently, an opinion with the modification of the strain designation from Bacillus subtilis ATCC PTA‐6737 to Bacillus velezensis ATCC PTA‐6737 (EFSA FEEDAP Panel, 2022 ).…”