Safety evaluation of Bacillus subtilis strains

The safety of microorganisms that have been used traditionally in probiotics has been confirmed through a long period of cultural tradition and experience. Strains of species such as B. subtilis, B. licheniformis and B. sonorensis have been used extensively in (or are associated with) food processing throughout human history and ingestion of foods containing such live or dead bacteria and their metabolites has occurred over a long period of time (see: FAO Background Study Paper No. 65: http://www.fao.org/docrep/meeting/028/mg309e.pdf). So far, the safety of B. subtilis group has not been questioned in general, and reports of possible harmful effects of these microbes to the host are extremely rare. Rare cases are in fact related to “opportunistic” situations of immune compromised persons and patients at risk. On one hand, currently some authorities require proof of safety of newly isolated B. subtilis group strains before their commercialization and use in food biotechnology.