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

Abstract

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 antinutritional 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. SUMMARYFollowing a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the product PepSoyGen-C as a feed additive for all animal species. The additive is said to be composed of a mixture of pure cultures of Aspergillus oryzae and of Bacillus subtilis. PepSoyGen-C is intended to treat feed materials such as soybean meal for use in all animal species in order to reduce antinutritional factors. For this purpose the applicant is seeking an authorisation for PepSoyGen-C as a technological additive under a newly proposed, currently non-existent functional group, "substances for the reduction of antinutritional factors". The FEEDAP Panel 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. They are said to be combined only at the point of application to the target feed. The applicant indicates that the inclusion level is likely to be 2 % by weight of the total substrate (20 g/kg feed material). Th...

Safety and efficacy of Bacillus subtilis KCCM 10673P and Aspergillus oryzae KCTC 10258BP when used as a technological feed additive for all animal species

“…An opinion on the assessment of the two organisms as a technological additive in a proposed new functional group of 'substances for the reduction of anti-nutritional factors' for all animal species was published in 2015 (EFSA FEEDAP Panel, 2015). An opinion on the assessment of the two organisms as a technological additive in a proposed new functional group of 'substances for the reduction of anti-nutritional factors' for all animal species was published in 2015 (EFSA FEEDAP Panel, 2015).…”

“…In the previous opinion (EFSA FEEDAP Panel, 2015), it was concluded that the strain of B. subtilis met the criteria required for the Qualified Presumption of Safety (QPS) approach to safety assessment (EFSA BIOHAZ Panel, 2017) to be applied. On this basis, the strain was presumed safe for target species, the consumers of products derived from animals exposed to the bacterium and for the environment.…”