The need to revise the Technical Guidance on the assessment of the toxigenic potential of Bacillus species used in animal nutrition

The first guidance for applicants on how to assess toxigenic potential of species of the genus Bacillus was developed by the then Scientific Committee on Animal Nutrition (SCAN) and published in 2000 with the title Opinion on the Safety of use of Bacillus species in Animal Nutrition (EC, 2000). The SCAN guidance took as its basis the then existing knowledge on the structure and biogenesis of toxins produced by B. cereus, assuming that toxins found in other Bacillus species would have sufficiently similar properties to be detected by the methods developed for the Bacillus cereus group. Since the SCAN Opinion was published it became apparent that the few reports of B. cereus-like enterotoxins occurring in species other than those of the B. cereus group and cited in the SCAN Opinion were likely to have resulted from a misidentification of the strain involved (From et al., 2005). The few incidents of food poisoning investigated where non-B. cereus group strains were determined to be the causative organism suggested an association with heat-stable surfactins and similar cyclic lipopeptides with surfactin activity rather than the enterotoxins typical of B. cereus. As hazards of this nature were not considered in the original SCAN Opinion, the FEEDAP Panel undertook a revision, also taking the opportunity to adopt this revision document as part of its technical guidance provided to applicants seeking authorisation of feed additives (EFSA FEEDAP Panel, 2011). The data requirements proposed for species belonging to the B. cereus group in the revised opinion was essentially unchanged other than requiring a full genome sequence analysis. The bulk of the changes introduced involved a substantial revision of the sections dealing with species other than those of the B. cereus group, with a shift to the detection of a capacity for the production of surfactins.