Ch. Hansen had sought approval of the product as a gut flora stabilizer for both weaned piglets and minor porcine species. It has not been previously authorized as a feed additive in the EU.
The additive is aimed at both supplementation in feed and use in drinking water for the target animals. It exists in two forms, EB15 and EB15 10, which contain the bacterium in concentrations of 1.25 × 109 CFU/g additive and 1.25 × 1010 CFU/g additive, respectively.
The European Food Safety Authority (EFSA) said B. subtilis is suitable for the qualified presumption of safety (QPS) approach to establishing safety,
“In the view of the FEEDAP Panel, the identity of the active agent is established as B. subtilis and the toxigenic potential and the antibiotic resistance qualifications have been met.”
It concluded, therefore, that both the strain and the additive are safe for the target species, consumer and the environment.
Chr. Hansen submitted six efficacy studies.
In all four studies considered, EFSA said supplementation of EB15 led to a numerical greater weight gain, however, reaching significance only in one case.
The risk assessor said feed to gain ratio was significantly improved in two studies, while mortality in the treatment group was also significantly lower in one study. It said significant differences on fecal scores were observed only in one study, and significant effects were found only in two studies.
“Therefore, there is insufficient evidence to conclude on the efficacy of EB15 in weaned piglets,” noted the opinion of the FEEDAP panel.
The full opinion can be read here.