Safety and efficacy of muramidase from DSM 32338 as a feed additive for chickens for fattening and minor poultry species.

The additive under assessment is a muramidase from DSM 32338 which is to be used as a zootehcnical additive in feed for chickens for fattening and minor poultry species. The production strain is a genetically modified microorganism. The introduced genetic sequences do not give rise to safety concerns and no viable cells and no DNA of the production strain were detected in the additive. The results of a tolerance trial in chickens for fattening showed that the birds tolerated well 10-fold the highest recommended level of 45,000 LSU(F)/kg feed. Therefore, the Panel concluded that the additive is safe for chickens for fattening and extrapolated the conclusion to minor poultry species for fattening. The enzyme filtrate used to formulate the additive was tested in genotoxicity studies and in a subchronic oral toxicity study. The results of these tests did not indicate any reason for concern for consumer safety arising from the use of the product as a feed additive. Therefore, the Panel concluded that the additive is safe for the consumers. The Panel could not conclude on the potential of the additive for skin/eye irritancy or for its skin sensitisation potential. Owing to the proteinaceous nature of the active substance, the additive is considered to have potential for respiratory sensitisation. The FEEDAP Panel concluded that the use of this product as a feed additive poses no risks to the environment. The additive is to be used as a zootechnical additive, functional group other additives. To support the efficacy, the applicant submitted three efficacy studies with comparable design. The results showed significant and positive improvements on the feed to gain ratio of the birds receiving the additive at the lowest recommended level (25,000 LSU(F)/kg feed). This conclusion was extrapolated to minor poultry species for fattening.