LegalizeCommission Implementing Regulation (EU) 2023/1333 of 29 June 2023 concerning the authorisation of a preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus fijiensis CBS 589.94 as a feed additive for chickens for fattening and weaned piglets (holder of authorisation: DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.), amending Regulation (EC) No 1811/2005 and repealing Regulation (EC) No 1259/2004 (Text with EEA relevance)
Article 1
Authorisation
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
Amendment of Regulation (EC) No 1811/2005
Article 1 and Annex I to Regulation (EC) No 1811/2005 are deleted.
Article 3
Repeal of Regulation (EC) No 1259/2004
Regulation (EC) No 1259/2004 is repealed.
Article 4
Transitional measures
Article 5
Entry into force
This Regulation shall enter into force on the twentieth day following that of 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
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Units of activity/kg of complete feedingstuff with a moisture content of 12 % | |||||||||
| Category of zootechnical additives. Functional group: digestibility enhancers | |||||||||
| 4a1603 | Novozymes A/S | Endo-1,3(4)-beta-glucanase (EC 3.2.1.6) | Additive composition Preparation of endo-1,3(4)-beta-glucanase (EC 3.2.1.6) produced by Aspergillus fijiensis CBS 589.94 with a minimum activity of: Coated form: 50 FBG (1)/g. Liquid form: 120 FBG/mL Characterisation of the active substance Endo-1,3(4)-beta-glucanase produced by Aspergillus fijiensis CBS 589.94 Analytical method (2) For the quantification of 1,3(4)-beta-glucanase activity in the feed additive: colorimetric method measuring coloured compound produced by the dinitro salicylic acid (DNSA) based on the enzymatic hydrolysis of beta-glucan at pH 5,0 and 50 °C. For the quantification of 1,3(4)-beta-glucanase activity in premixtures and compound feed: colorimetric method measuring water soluble dyed fragments based on the enzymatic hydrolysis of cross-linked azo-barley-glucan at pH 4,5 and 50 °C. | Chickens for fattening Weaned piglets | - | 10 FBG | - | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. 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, eye and skin protective equipment. | 20 July 2033 |
| (1) One glucanase unit (FBG) corresponds to the amount of enzyme which under standard conditions (pH 5,0 and 30 °C) liberates glucose or other reducing carbohydrates at a rate corresponding to 1 μmol glucose per minute. (2) 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 |
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