LegalizeCommission Implementing Regulation (EU) 2024/221 of 12 January 2024 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase, produced by Trichoderma reesei ATCC 74444, as a feed additive for all poultry species for fattening, all poultry species for laying and weaned piglets (holder of authorisation: DSM Nutritional Products) and amending Implementing Regulation (EU) No 403/2013
Article 1
Renewal of authorisation
The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is renewed subject to the conditions laid down in that Annex.
Article 2
Amendment to Implementing Regulation (EU) No 403/2013
Implementing Regulation (EU) No 403/2013 is amended as follows:
(1) Article 1 is deleted;
(2) the Annex is deleted.
Article 3
Transitional measures
Article 4
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 | |||||||||
| 4a1602i | Novozymes A/S | Endo-1,4-beta-xylanase (EC 3.2.1.8) Endo–1,3(4)-beta-glucanase (EC 3.2.1.6) Endo-1,4-beta-glucanase (EC 3.2.1.4) | Additive composition Preparation of endo-1,4-beta-xylanase, endo-1,3(4)-beta-glucanase and endo-1,4-beta-glucanase, produced by Trichoderma reesei ATCC 74444, having a minimum activity of: — Endo-1,4-beta-xylanase 2 700 U (1)/ml or g additive — Endo-1,3(4)-beta-glucanase 700 U (2)/ml or g additive — Endo-1,4-beta-glucanase 800 U (3)/ml or g additive Liquid or solid form. Characterisation of the active substance Endo-1,4-beta-xylanase (EC 3.2.1.8), endo-1,4-beta-glucanase (EC 3.2.1.6) and endo-1,3(4)-beta-glucanase (EC 3.2.1.4), produced by Trichoderma reesei ATCC 74444 Analytical method (4) — For the determination of endo-1,4-beta-xylanase in the feed additive: colorimetric (DNS) method based on the enzymatic hydrolysis of the wheat arabinoxylan substrate. — For the determination of endo-1,3(4)-beta-glucanase in the feed additive: colorimetric (DNS) method based on the enzymatic hydrolysis of the barley betaglucan substrate. — For the determination of endo-1,4-beta-glucanase in the feed additive: colorimetric (DNS) method based on the enzymatic hydrolysis of the carboxy-methyl-cellulose substrate. — For the determination of endo-1,4-beta-xylanase in premixtures and compound feed: colorimetric method based on the enzymatic reaction on the azo-xylan (birchwood) substrate. — For the determination of endo-1,3(4)-beta-glucanase in premixtures and compound feed: colorimetric method based on the enzymatic reaction on the azo-barley-glucan substrate. — For the determination of endo-1,4-beta-glucanase in premixtures and compound feed: colorimetric method based on the enzymatic reaction on the azo-carboxy-methyl-cellulose substrate. | All poultry species for fattening other than turkeys for fattening | — | Endo-1,4-beta-xylanase: 135 U Endo-1,3(4)-beta-glucanase: 35 U Endo-1,4-beta-glucanase: 40 U | — | 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. | 4 February 2034 |
| All poultry species for laying | Endo-1,4-beta-xylanase: 216 U Endo-1,3(4)-beta-glucanase: 56 U Endo-1,4-beta-glucanase: 64 U | ||||||||
| Turkeys for fattening Piglets (weaned) | Endo-1,4-beta-xylanase: 270 U Endo-1,3(4)-beta-glucanase: 70 U Endo-1,4-beta-glucanase: 80 U | ||||||||
| (1) One endo-1,4-beta-xylanase unit (U) is the amount of enzyme which releases 1 micromole of reducing sugar (xylose equivalent) per minute from wheat arabinoxylan at 40 °C and pH 5,0. (2) One endo-1,3(4)-beta-glucanase unit (U) is the amount of enzyme which releases 1 micromole of reducing sugar (glucose equivalent) per minute from barley beta-glucan at 40 °C and pH 5,0. (3) One endo-1,4-beta-glucanase unit (U) is the amount of enzyme which releases 1 micromole of reducing sugar (glucose equivalent) per minute from carboxy-methyl-cellulose at 40 °C and pH 5,0. (4) 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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