Scientific Opinion on the safety and efficacy of Safizym?X (endo‐1, 4‐beta‐xylanase) as a feed additive for chickens and turkeys for fattening and laying hens

摘要

Safizym~(?)X is an enzyme preparation of endo‐1, 4‐beta‐xylanase produced by a non‐genetically modified strain of Trichoderma reesei which is presented in solid and liquid forms. The solid and liquid formulations are considered to be equivalent in terms of safety and efficacy for the target species. In the tolerance studies provided, the animals tolerated well 100‐fold (chickens and laying hens) or 10‐fold (turkeys for fattening) the minimum recommended dosage. Therefore, the FEEDAP Panel concludes that the additive is safe for chickens and turkeys for fattening at 1 400 IFP/kg feed and in laying hens at 840 IFP/kg feed. The results obtained in the toxicological studies are insufficient to reach conclusions on the safety for the consumers. The identity of the test item used and its relationship with the fermentation product that is used to formulate the additive was not provided. Therefore, the FEEDAP Panel cannot conclude on the safety of the additive for the consumer. The solid final formulation is not considered a skin or eye irritant; however, the liquid formulation should be considered as a skin and eye irritant. In the absence of data on skin sensitisation, and taking account of its proteinaceous nature, the additive is to be considered a potential skin and respiratory sensitiser. The active substance of Safizym~(?)X is a protein, and as such will be degraded/inactivated during passage through the digestive tract of animals. Therefore, no risks to the environment are expected and no further environmental risk assessment is required. The FEEDAP Panel concludes that the additive has the potential to be efficacious at a dose of 1 400 IFP/kg feed in chickens and turkeys for fattening and at 840 IFP/kg feed in laying hens.