Safety and efficacy of a feed additive consisting of alpha-galactosidase (produced by Aspergillus tubingensis ATCC SD6740) and endo-1,4-beta-xylanase (produced by Trichoderma longibrachiatum CBS 139997) (Capsozyme SB Plus) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying) (Industrial Tecnica Pecuaria S.A.)
EFSA J. 2021 Dec 13;19(12):e06981. doi: 10.2903/j.efsa.2021.6981. eCollection 2021 Dec.
Following a request from the European Commission, the EFSA 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 Capsozyme SB Plus as a zootechnical feed additive (digestibility enhancers) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying). The additive contains two enzyme ingredients (α-galactosidase, produced by a non-genetically modified strain of Aspergillus tubingensis; and endo-1,4-β-xylanase, produced by a non-genetically modified strain of Trichoderma longibrachiatum) and is presented in solid form. In 2020, the FEEDAP Panel issued an opinion on this product. In that assessment, the Panel considered the additive safe for the target species and the environment. The Panel concluded that the additive does not raise concern for genotoxicity but could not conclude on consumer safety due to the limitations identified in the 90-day toxicity study. Owing to the lack of data, the Panel could not conclude on the potential of the additive as a skin or eye irritant nor as a skin sensitiser. Moreover, the Panel could not conclude on the efficacy of the additive for chickens for fattening due to the limited evidence provided. The applicant provided supplementary data to support the safety for consumers and the efficacy of the product in chickens for fattening. The FEEDAP Panel concluded that the data provided support the absence of toxicological risk for the consumer. Likewise, according to the new data submitted, the FEEDAP Panel concluded that the additive has the potential to be efficacious in chickens for fattening at the level of 14 GALU (α-galactosidase)/18 AXC (endo-1,4-β-xylanase) per kg feed, and this conclusion was extended to chickens reared for laying and extrapolated to minor poultry species for fattening/reared for laying.