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Scientific Opinion on the safety and efficacy of Amylofeed® (endo-1,3(4)-beta-glucanase, endo-1,4-beta-xylanase and alpha-amylase) as a feed additive for piglets and young minor porcine species

The additive Amylofeed® is a solid enzyme preparation containing endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase from the fermentation product produced by Aspergillus niger and of alpha-amylase from the fermentation product produced by Aspergillus oryzae. The product is to be used in feed for piglets and young minor porcine species. The manufacturing process of the products present in the additive has not been fully characterised. The composition of the additive and the exact amount of each component remains unclear. Based on the tolerance study provided by the applicant, the FEEDAP Panel concludes that the additive is safe at the recommended dose for the target species, weaned piglets; given the margin of safety established in weaned piglets, the FEEDAP Panel considers that the conclusions reached can be extrapolated to minor porcine species for growing, provided that the same dose applies. Based on the toxicological studies provided and on the information on the manufacturing process, the FEEDAP Panel cannot conclude on the safety of Amylofeed® for the consumer. The product should be considered a potential skin and eye irritant and a potential skin and respiratory sensitiser. Considering that the components of Amylofeed® are likely to be degraded/inactivated during the passage through the digestive tract of animals, and that Aspergillus niger and Aspergillus oryzae are naturally occurring organisms in the environment, the Panel considers that no risks to the environment are expected and no further environmental risk assessment is required. The efficacy of Amylofeed® has not been sufficiently demonstrated in weaned piglets. Therefore, no conclusions can be drawn on the efficacy in young minor porcine species either.



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