Additives for use in animal nutrition are regulated under Regulation (EC) No. 1831/2003. The scope of this paper addresses the specific microbiological issues relevant to a microbial feed additive, containing a Bacillus spp. and uses as an example a product with the trade name, Calsporin. Bacillus subtilis C-3102 is the active ingredient in Calsporin and is added to animal feed to favourably affect animal production and performance (growth and feed efficiency), by modulating the gastrointestinal flora. It is not the purpose of this review to present the raw data for Calsporin but rather to use Calsporin as an example of the type of data required by the European regulatory authorities. At the time of preparation of this manuscript Calsporin has yet to be reviewed by the authorities. The regulatory system under the auspices of the EFSA FEEDAP Panel is clearly attempting to move in line with development of scientific opinion and is to be applauded for such efforts. Bacteria do need to be regulated, and the regulations clearly provide adequate and appropriate protection to human health and to environmental considerations.