Safety and efficacy of BioPlus 2B® (Bacillus subtilis DSM 5750 and Bacillus licheniformis DSM 5749) as a feed additive for sows, piglets, pigs for fattening, turkeys for fattening and calves

zootechnical additive, Bacillus subtilis and Bacillus licheniformis, piglets, pigs for fattening, sows, turkeys for fattening, calves for rearing
First published in the EFSA Journal
12 September 2016
Adopted
12 July 2016
Type
Scientific Opinion

Abstract

BioPlus 2B® is a preparation of Bacillus subtilis and Bacillus licheniformis authorised for use with piglets, pigs and turkeys for fattening, sows and calves. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to re-evaluate the additive when used in feeds for these species and to assess a new use in water for drinking. The additive subject of the evaluation is BioPlus 2B® 10, a formulation 10-fold more concentrated than that currently authorised. The active agents have been identified as strains of B. licheniformis and B. subtilis; they are susceptible to relevant antibiotics and do not show toxigenic potential. Consequently, they meet the qualifications required by the qualified presumption of safety (QPS) approach and are presumed safe for the target species, consumers and the environment. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy of the additive to skin and eyes or its dermal sensitisation. The dustiness of BioPlus 2B® 10 indicated a potential for users to be exposed via inhalation. Given the proteinaceous nature of the active agents, the additive should be considered as a potential respiratory sensitiser. BioPlus 2B® and BioPlus 2B® 10 are considered equivalent when used to deliver the same dose. BioPlus 2B® has the potential to improve performance of piglets (weaned and suckling plus weaned), pigs for fattening, sows and calves for rearing at a minimum dose of 1.3 × 109 colony forming units (CFU)/kg complete feed or when used in water for drinking at an equivalent dose of 6.5 × 108 CFU/L water. The additive has the potential to reduce mortality of piglets when used over a complete reproductive cycle of sows. No conclusion could be drawn on the efficacy of BioPlus 2B® for turkeys for fattening.

Panel members at the time of adoption

Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2016.4558
EFSA Journal 2016;14(9):4558
Question Number
On request from
European Commission