Safety and efficacy of alpha-amylase from Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251, Aspergillus oryzae CBS 585.94 and Aspergillus oryzae ATTC SD-5374, endo-1,4-beta-glucanase from Trichoderma reesei ATCC PTA-10001, Trichoderma reesei ATCC SD-6331 and Aspergillus niger CBS 120604, endo-1,4-beta-xylanase from Trichoderma koningii MUCL 39203 and Trichoderma citrinoviride CBS 614.94 and endo-1,3(4)beta-glucanase from Aspergillus tubingensis MUCL 39199 as silage additives for all animal species

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

A total of 11 enzymes were assessed including alpha-amylase, endo-1,4-beta-glucanase, endo-1,4-betaxylanase and endo-1,3(4)-beta-glucanase as silage additives for all animal species. These enzymes are obtained by fermentation of bacterial or fungi non-genetically modified production strains. Throughout information regarding the production strains of each product were provided, including the origin and history of modifications and allowing their identification. The identification was conclusive for 8 of 10 production strains. For three of the strains, more information/data would still be required in order to conclude. Three of the amylases are produced by bacterial strains that belong to a species that is considered by EFSA to be suitable for the Qualified Presumption of Safety approach to safety assessment. The identity of the strains has been established and the qualifications were met, and consequently, those products were regarded as safe. For the products derived from fungal strains, the strains or resulting products were tested for the presence of secondary metabolites which could be of toxicological concern. These were found to be below the limits of detection or the strain not capable of producing them. Considering all the information provided by the applicant, the Panel concluded that these products can be regarded as safe for the target species, consumer and the environment. In the absence of data, the Panel could not conclude on the skin and eye irritancy or skin sensitisation potential of the products under evaluation. These products should be considered to have the potential to be a respiratory sensitiser. For some of the products under evaluation, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that they have a potential to improve the characteristic of the silage material; for some other products, the Panel could not conclude on their efficacy.

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(FEEDAP), EFSA: Safety and efficacy of alpha-amylase from Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251, Aspergillus oryzae CBS 585.94 and Aspergillus oryzae ATTC SD-5374, endo-1,4-beta-glucanase from Trichoderma reesei ATCC PTA-10001, Trichoderma reesei ATCC SD-6331 and Aspergillus niger CBS 120604, endo-1,4-beta-xylanase from Trichoderma koningii MUCL 39203 and Trichoderma citrinoviride CBS 614.94 and endo-1,3(4)beta-glucanase from Aspergillus tubingensis MUCL 39199 as silage additives for all animal species. 2018.

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