Commission Implementing Regulation (EU) 2023/1711 of 7 September 2023 concerning 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)

Renewal of the authorisation

Article 1

The authorisation of the preparation of the fermentation product of Aspergillus oryzae NRRL 458, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’ is renewed subject to the conditions laid down in the Annex.

Repeal of Regulation (EC) No 537/2007

Article 2

Regulation (EC) No 537/2007 is repealed.

Transitional measures

Article 3

1.   The preparation specified in the Annex and premixtures containing that preparation, which are produced and labelled before 28 March 2024 in accordance with the rules applicable before 28 September 2023 may continue to be placed on the market and used until the existing stocks are exhausted. 2.   Compound feed and feed materials containing the preparation specified in the Annex, which are produced and labelled before 28 September 2024 in accordance with the rules applicable before 28 September 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

Entry into force

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEXSupplementary provisions

ANNEX Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg of additive/kg of complete feedingstuff with a moisture content of 12 % Category of zootechnical additives. Functional group: digestibility enhancers 4a2i Biozyme Incorporated Fermentation product of Aspergillus oriyzae NRRL 458 Additive composition Preparation of:   Fermentation product of Aspergillus oryzae NRRL 458: 4 to 5 %   Wheat bran: 94 to 95 %   Solid form. Characterisation of the active substance Endo-1,4-beta-glucanase (EC 3.2.1.4) and alpha-amylase (EC 3.2.1.1) having respectively a minimum activity of 14,5 mU  ( 1 ) /g and 20 mIU  ( 2 ) /g. Analytical method  ( 3 ) For the quantification of endo-1,4-beta-glucanase in the feed additive: colorimetric method based on the enzymatic reaction by endo-1,4-beta-glucanase on a CellG5 substrate. For the quantification of alpha-amylase in the feed additive: colorimetric (DNS) method based on the enzymatic reaction by alpha-amylase on a potato starch substrate. Dairy cows — 85 300 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. Recommended dose: the quantity of the additive in daily ration should be 3 to 5 g/cow/day. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing protective equipment. 28 September 2033 ( 1 )   One CellG5 Unit (U) is the amount of enzyme in the presence of excess thermostable beta-glucosidase, required to release one micromole of 4-nitrophenol from CellG5 in one minute under the defined assay conditions. ( 2 )   One unit of alpha-amylase activity (IU) refers to the amylase that liberates 1 micromole of glucose per minute from potato starch at pH 6,9 and at 38 °C. ( 3 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en.