Commission Regulation (EC) No 537/2007 of 15 May 2007 concerning the authorisation of the fermentation product of Aspergillus oryzae (NRRL 458) (Amaferm) as a feed additive (Text with EEA relevance)
Modified by
  • Commission Regulation (EC) No 905/2009of 28 September 2009amending Regulation (EC) No 537/2007 as regards the name of the holder of the authorisation of the fermentation product of Aspergillus oryzae (NRRL 458) (Amaferm)(Text with EEA relevance), 32009R0905, September 29, 2009
  • Commission Implementing Regulation (EU) 2023/1711of 7 September 2023concerning the renewal of the authorisation of a preparation of the fermentation product of Aspergillus oryzae NRRL 458 as a feed additive for dairy cows and repealing Regulation (EC) No 537/2007 (holder of authorisation: Biozyme Incorporated)(Text with EEA relevance), 32023R1711, September 8, 2023
Commission Regulation (EC) No 537/2007of 15 May 2007concerning the authorisation of the fermentation product of Aspergillus oryzae (NRRL 458) (Amaferm) as a feed additive(Text with EEA relevance)
Article 1The preparation specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "digestibility enhancers", is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX
1 IU refers to the cellulase that liberates 1 micromole of glucose per minute from carboxymethylcellulose at pH 6,5 and at 39 °C.1 IU refers to the amylase that liberates 1 micromole of glucose per minute from potato starch at pH 6,5 and at 39 °C.Category of zootechnical additives. Functional group: digestibility enhancers
Identification number of the additiveName of the holder of authorisationAdditive(Trade name)Composition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg of additive/kg of complete feedingstuff with a moisture content of 12 %
4a2Biozyme IncorporatedFermentation product of Aspergillus oryzaeNRRL 458(Amaferm)Additive composition:Fermentation product of Aspergillus oryzae NRRL 458: 4 to 5 %Wheat bran: 94 to 95 %Stainless grit containing 5 % cobalt carbonate 1 %Characterisation of the active substance:Fermentation product of Aspergillus oryzae (NRRL 458) containing:Endo-1,4-beta-glucanase EC 3.2.1.4: 3 IU/g;Alpha-amylase EC 3.2.1.1: 40 IU/g.Analytical method:Alpha amylase AOAC 17th Ed. 2002.01Endo-1,4-beta-glucanase (based on supernatant protein and cellulase activities of the anaerobic fungus (Neocallimastix frontalis EB 188) (Barichievich, EB, Calza RE (1990)).Dairy cows853001.Recommended dose: the quantity of the additive in daily ration should be 3 to 5 g/cow/day.2.For user safety: shall be used breathing protection during handling and safety glasses shall be worn.5 June 2017

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