Scientific Opinion on the safety and efficacy of Bacillus subtilis KCCM 10673P and Aspergillus oryzae KCTC 10258BP as feed additives for all animal species

PepSoyGen-C is described as pure cultures of Aspergillus oryzae and Bacillus subtilis added simultaneously to feed materials to reduce antinutritional factors. The applicant is seeking its authorisation as a technological additive, under a newly proposed, currently non-existent functional group, “substances for the reduction of anti-nutritional factors”. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that the two microbial cultures should be regarded as two independent feed additives that are the subject of the evaluation. The additives are poorly characterised. The inclusion level is likely to be 2 % by weight of the total substrate. The ratio of the two cultures is described as 50/50 on a weight basis. A dose expressed in colony-forming units per kilogram of feed is not proposed. No evidence of toxigenic potential or resistance to antibiotics of human and veterinary importance was found, according to the current guidance documents. Therefore, the B. subtilis additive is presumed safe for target animals, consumers of products fed the additive and the environment. The B. subtilis additive should be considered as having the potential to be a skin and eye irritant and a skin sensitiser and be treated accordingly. In the absence of data on production of toxic secondary metabolites in A. oryzae, the FEEDAP Panel cannot draw conclusions on its safety for the target species and consumers of products fed the additive. The A. oryzae additive should be considered as having the potential to be a skin and eye irritant and a skin and respiratory sensitiser and be treated accordingly. The use of the additive as a technological feed additive is not expected to pose a risk to the environment. The FEEDAP Panel cannot draw conclusions on the efficacy of the additives in reducing antinutritional factors in soybean and other feed materials.