Scientific Opinion on the safety and efficacy of Hostazym C (endo-1,4-beta-glucanase) as feed additive for chickens for fattening, all other birds for fattening and piglets (weaned)
Hostazym C is an enzyme preparation of endo-1,4-beta-glucanase produced by a non-genetically modified strain of Trichoderma citrinoviride. The results of an in vitro chromosomal aberration test and of an in vivo comet assay indicate the presence of genotoxic activity in the product. The tolerance studies provided in target species did not indicate any adverse effect of the additive. However, due to the genotoxic hazard from the product, the FEEDAP Panel cannot conclude on the safety of the additive for the target species. The results obtained in a repeated-dose oral toxicity study did not indicate any concern for consumer safety. However, the identity and fate of the substance causing the genotoxic effect is unknown; therefore, the source of the risk to the consumer cannot be established. Thus, the FEEDAP Panel cannot conclude on the safety of the additive for the consumer. The product should be considered a potential skin and eye irritant, and a potential skin and respiratory sensitiser. Due to the presence of genotoxic activity in the product, any level of exposure to the additive by any route is considered hazardous. No risks to the environment are expected to result from the use of the additive in feed, and, therefore, no further environmental risk assessment is required. Based on the results obtained in the efficacy studies, the FEEDAP Panel concludes that the additive has the potential to be efficacious in chickens for fattening at a dose of 500 CU/kg feed and in weaned piglets at 350 CU/kg. Conclusions on the efficacy can be extrapolated to minor poultry species for fattening.