Safety and efficacy of Bacillus subtilis PB6 (Bacillus subtilis ATCC PTA‐6737) as a feed additive for sows

Abstract

Bacillus subtilis PB6 is a feed additive based on viable spores of a strain of Bacillus subtilis. EFSA has already issued several opinions on the safety and efficacy of the additive when used in the feed for a number of avian and porcine species/categories. The applicant is now seeking authorisation for use in sows in order to have benefits in piglets. In the course of previous assessments, no evidence of a toxigenic potential or resistance to relevant antibiotics was found. Consequently, the strain of B. subtilis in the additive, following the qualified presumption of safety approach to safety assessment, is presumed safe for target animals including sows and their offspring, consumers and the environment. In a previous assessment, it was also concluded that the additive is not a skin/eye irritant or a skin sensitiser and that there were no concerns on respiratory sensitisation. The use of the additive with feed for sows is considered unlikely to introduce hazards for users of the product not already considered. Five studies are described in which groups of sows given the additive for a minimum period from the last 3 weeks of pregnancy, throughout farrowing and lactation, until weaning of piglets were compared with a control group. In only two of five studies, there was a significant beneficial effect seen in terms of piglet performance. However, when data from the four similar were pooled and analysed, significant increases in weaned weight and average daily gain were indicated for piglets from sows given the additive. Consequently, the FEEDAP Panel concludes that Bacillus subtilis PB6 when added to diets of sows from 3 weeks before parturition until weaning of piglets at a dose of 1 9 10 8 CFU/kg complete feed has the potential to improve the growth of piglets from birth to weaning.

Bacillus subtilis QST 713 Supplementation during Late Gestation in Gilts Reduces Stillbirth and Increases Piglet Birth Weight

“…The increased NBA in the treatment group was in agreement with some previous findings [ 5 , 8 , 9 ]. However, many other studies reported nonsignificant effect of probiotic supplementation on this criterion [ 4 , 6 , 7 , 10 , 14 – 20 ]. The positive effect of the probiotic supplementation on NBA may be partly attributable to the fact that it reduced stillbirth rate.…”

“…It is interesting that Bacillus subtilis QST 713 increased both litter size/NBA and birth weight despite the fact that birth weight is negatively associated with litter size [ 25 , 26 ]. Some previous studies failed to find any beneficial effects of probiotic supplementation at late gestation on birth weight of piglets [ 7 – 9 , 20 ] while other studies even found a reduced birth weight in the probiotic supplementation group where litter and/or NBA increased in comparison with that in the control [ 5 , 14 ]. Two previous studies found that birth weight was increased while litter sizes were unaltered when probiotic was supplemented throughout 2 successive estrus cycles [ 27 ] or late gestation [ 28 ].…”

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)

“…For the present dossier, the applicant states that no adverse events have been reported since the market authorisation of the additive (2013). 28 In the previous assessments (EFSA FEEDAP Panel, 2012a, 2013, 2017a, 2020, 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).…”

“…EFSA has issued several opinions on the safety and efficacy of Bacillus velezensis 3 ATCC PTA‐6737 ( Bacillus subtilis PB6) as a feed additive for different species: chickens for fattening (EFSA FEEDAP Panel, 2009 ), chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches (EFSA FEEDAP Panel, 2011 ), weaned piglets and weaned minor porcine species (EFSA FEEDAP Panel, 2012a ), turkeys for fattening and turkeys reared for breeding (EFSA FEEDAP Panel, 2013 ), laying hens, other minor laying poultry birds (EFSA FEEDAP Panel, 2015 ) and sows (EFSA FEEDAP Panel, 2017a ).…”

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.)

“…In the previous assessments (EFSA FEEDAP Panel, 2012, 2013, 2017a, PB6 (B. velezensis PTA-6737) was presumed safe for the target species, consumers and the environment based on the qualified presumption of safety (QPS) approach. In a recent opinion (EFSA FEEDAP Panel, 2020) and in the current assessment, the active agent has been reclassified as B. velezensis and its taxonomical identity and its compliance with the QPS qualifications confirmed.…”