Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the enzyme preparation “Bio-Feed®Pro” (proteinase) for chickens for fattening, pigs for fattening and piglets for use as a feed additive

The European Food Safety Authority (EFSA) received a request from the Commission to assess the safety of the enzyme product Bio-Feed®Pro for the target animals, the consumer, the user, the environment, and its efficacy when used under the proposed conditions. Bio-Feed®Pro is an enzyme preparation based on proteinase, produced by fermentation of a strain of Bacillus licheniformis. The applicant is seeking provisional authorisation for Bio-Feed®Pro to be used as feed additive for piglets, pigs for fattening and chickens for fattening. The application covers a coated thermo tolerant granulate (CT) and an aqueous liquid (L) formulations of the enzyme preparation. There is insufficient evidence to demonstrate the efficacy at any dose of Bio-Feed®Pro in chickens for fattening, piglets and pigs for fattening. The applicant has provided evidence that Bio-Feed®Pro is tolerated by chickens for fattening and piglets at ten times the maximum recommended dose with no negative effects on performance or health. The data presented for piglets is considered by the FEEDAP Panel to provide enough evidence to support the safety for pigs for fattening. There is no evidence of any genotoxic effects of Bio-Feed®Pro. The results of sub-chronic toxicity studies indicate effects which appear to be due to the protease or other entities within the product that are, at least partly, inactivated by the procedure used to inactivate the protease. The available data does not make it possible to exclude the presence of potentially harmful residues. Therefore, no conclusion can be reached on the safety for the consumer. B. licheniformis DSM 9552 produced no evidence of toxicity in the cytotoxicity assay. However, no data on the presence of genes encoding for known Bacillus toxins was provided. The product Bio-Feed®Pro is a dermal sensitizer, severely irritant/corrosive to the eyes and harmful by inhalation. There are also serious systemic effects seen in the sub-chronic feeding study which may indicate potential consequences for the user. The range of potential effects indicates that the product should be handled with extreme caution, with appropriate protection and management procedures to minimise all exposures. The safety data sheet provided by the applicant does not adequately identify the above hazards. The active ingredient is an enzyme, which is a natural substance considered to be of no environmental concern. Thus, no further environmental assessment is required. In summary, the FEEDAP Panel is unable to conclude on the efficacy of the product or its safety for the consumer. Bio-Feed®Pro does pose risks to those handling the product.