Scientific Opinion on the safety and efficacy of Feedlyve AXC (endo-1,4- beta-xylanase) as a feed additive for turkeys

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

Feedlyve AXC is an enzyme preparation containing an endo-1,4-beta-xylanase produced by a non-genetically modified strain of Trichoderma koningii. The additive is intended for use in turkeys and is presented in several forms. A tolerance study performed with a 100-fold of the maximum recommended dose (100 AXC/kg feed) showed no adverse effects in turkeys for fattening. Therefore, it is concluded that Feedlyve AXC is safe for turkeys for fattening at the maximum recommended dose. This conclusion is extended to turkeys reared for breeding. The results of two genotoxicity in vitro studies and a sub-chronic oral toxicity study did not indicate any concern for consumer safety arising from the use of the additive in feed for turkeys. Feedlyve AXC 6000P was negative in dermal and eye irritation tests in the rabbit. No data on the skin/eye irritation potential of the BRUTE formulation is available. Therefore, the FEEDAP Panel considers it prudent to treat this formulation as a potential skin/eye irritant. No skin sensitization and no acute respiratory toxicity were observed in appropriate tests using the BRUTE formulation. Due to the proteinaceous nature of the compound the additive is to be considered as a potential respiratory sensitiser. The active substance of Feedlyve AXC is a protein and as such will be degraded/inactivated during the passage through the digestive tract of animals. Therefore, no risks for the environment are expected and no further environmental risk assessment is required. A total of three efficacy studies in turkeys for fattening were provided. Results showed that the additive has the potential to be efficacious when added to diets for turkeys for fattening at a minimum dose of 75 AXC/kg complete feed. This conclusion can be extended to turkeys reared for breeding.

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(FEEDAP), EFSA: Scientific Opinion on the safety and efficacy of Feedlyve AXC (endo-1,4- beta-xylanase) as a feed additive for turkeys. 2012.

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