Commission Implementing Regulation (EU) 2024/1058 of 10 April 2024 concerning the renewal of the authorisation of a preparation of endo–1,4-beta-xylanase produced by Aspergillus oryzae DSM 33700 as a feed additive for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, the change of the terms of the authorisation and authorisation of new uses of that preparation as a feed additive for all poultry species and all Suidae (holder of authorisation: DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.) and repealing Implementing Regulations (EU) No 1206/2012, (EU) No 2020/995 and (EU) 2020/1034

• CELEX: Implementing Regulation (EU) 2024/1058
• Articles: 6

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 for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, subject to the conditions laid down in that Annex.

Article 2 Authorisation

The 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 for all poultry species other than poultry for fattening and laying hens, and all Suidae other than weaned piglets, pigs for fattening and lactating sows, subject to the conditions laid down in that Annex.

Article 3 Repeals

Implementing Regulations (EU) No 1206/2012, (EU) No 2020/995 and (EU) 2020/1034 are repealed.

Article 4 Transitional measures

1.   The preparation specified in the Annex and premixtures containing that preparation, which are intended for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, and which are produced and labelled 1 November 2024 in accordance with the rules applicable before 1 May 2024 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 intended for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens, and which are produced and labelled before 1 May 2025 in accordance with the rules applicable before 1 May 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

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.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the feed 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: zootechnical additives. Functional group: digestibility enhancers.

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DSM Nutritional Products Ltd, represented by DSM Nutritional Products Sp. z o.o.

Endo–1,4-beta-xylanase (EC 3.2.1.8)

Additive composition

Preparation of endo–1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae DSM 33700 having a minimum activity of: Solid form: 1 000 FXU  ( 1 ) /g

Liquid form: 650 FXU/ml

Characterisation of the active substance

Endo–1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae DSM 33700.

Analytical method

( 2 )

For the quantification of endo–1,4-beta-xylanase in the feed additive:

—

colorimetric method measuring coloured compound produced by the dinitro salicylic acid (DNSA) and the xylosylic moieties released by the action of xylanase on arabinoxylan.

For the quantification of endo–1,4 -beta-xylanase in premixtures and compound feed:

—

colorimetric method measuring water soluble dye released by action of xylanase from dye-labelled oat spelt azo-xylan.

All poultry species

—

100 FXU

—

1.

In the directions for use of the additive and premixtures, 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 its use.

Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, eye protection and skin protection.

1 May 2034

All Suidae

200 FXU

( 1 )   One xylanase unit (FXU) is the amount of enzyme which liberates 7,8 micromoles of reducing sugars (xylose equivalents) from azo-wheat arabinoxylan per minute at pH 6,0 and 50 °C.

( 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