Scientific Opinion on the safety and efficacy of Biogalactosidase BL (alpha-galactosidase and beta-glucanase) as feed additive for chickens for fattening

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); EFSA Panel on Genetically Modified Organisms (GMO)

The additive Biogalactosidase BL is a preparation of an alpha-galactosidase produced by a genetically modified strain of Saccharomyces cerevisiae and an endo-1,4-beta-glucanase produced by a strain of Aspergillus niger. It is intended to be used as zootechnical feed additive for chickens for fattening. The final enzyme preparation contains no cultivable production organisms or recombinant DNA, given the limits of detection. Based on the results of a tolerance study made with a tenfold overdose, the product is considered safe for chickens for fattening at the proposed maximum dose of use. Both enzymes were tested separately for genotoxicity (two in vitro, one in vivo tests) and a 90-day oral repeated dose toxicity study in rats. From the outcome of these studies it can be concluded that Biogalactosidase BL when fed to food-producing animals is safe for the consumer. The additive is an irritant to skin and eyes and a dermal sensitiser, and should also be considered as a respiratory sensitiser. The active substances of Biogalactosidase BL are proteins 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. The use of Biogalactosidase BL in diets for chickens for fattening has the potential to improve the final body weight when used at the minimum dose proposed, as concluded from a meta analysis of four 42-day studies with chickens for fattening.

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(FEEDAP), EFSA / EFSA Panel on Genetically Modified Organisms (GMO): Scientific Opinion on the safety and efficacy of Biogalactosidase BL (alpha-galactosidase and beta-glucanase) as feed additive for chickens for fattening. 2011.

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