Safety and efficacy of an additive consisting of Bacillus subtilis DSM 32324 for all animal species (Chr. Hansen A/S)

Abstract

Following 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 additive consisting of Bacillus subtilis DSM 32324 when used as a technological additive (hygiene condition enhancer) in feed for all animal species. The product is intended for use in dry feeds at a minimum inclusion level of 1 × 108 colony forming unit (CFU)/kg complete feedingstuff. The bacterial species Bacillus subtilis DSM 32324 is considered by EFSA to be eligible for the qualified presumption of safety approach. As the identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance, the use of the strain in animal nutrition is considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritancy or skin sensitisation potential of the product. Exposure of users by inhalation is likely and the product should be considered a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of Bacillus subtilis DSM 32324 when used in animal nutrition as hygiene condition enhancer due to lack of data. Bacillus subtilis DSM 32324 is compatible with diclazuril, decoquinate and halofuginone. The data provided do not allow to conclude on the compatibility of the additive with monensin sodium, salinomycin sodium, narasin, robenidine hydrochloride and maduramicin ammonium.