法律人 LawPlayer logo

資料由法律人 LawPlayer整理提供·EU law / curated by LawPlayer from EUR-Lex

Regulation

Commission Implementing Regulation (EU) 2026/1016 of 7 May 2026 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced with Talaromyces versatilis IMI 378536 and Talaromyces versatilis DSM 26702 as a feed additive for chickens for fattening and reared for laying, laying hens, turkeys for fattening and reared for breeding, and minor poultry species for fattening and reared for laying, the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced with Talaromyces versatilis IMI 378536 and Talaromyces versatilis DSM 26702 as a feed additive for chickens reared for breeding, chickens for breeding, turkeys for breeding, minor poultry species reared for breeding, and minor poultry species for laying and breeding (holder of authorisation: Adisseo France S.A.S.), and repealing Implementing Regulations (EU) 2015/661, (EU) 2015/2304 and (EU) 2017/210

CELEX
Implementing Regulation (EU) 2026/1016
Date of document
Articles
6
Source
EUR-Lex
Article 1Renewal of the 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 chickens for fattening and reared for laying, laying hens, turkeys for fattening and reared for breeding, and minor poultry species for fattening and reared for laying, subject to the conditions laid down in that Annex.

Article 2Authorisation

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 chickens reared for breeding, chickens for breeding, turkeys for breeding, minor poultry species reared for breeding, and minor poultry species for laying and breeding, subject to the conditions laid down in that Annex.

Article 3Repeal

Implementing Regulations (EU) 2015/661, (EU) 2015/2304 and (EU) 2017/210 are repealed.

Article 4Transitional measures

1.   The feed additive endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced with Talaromyces versatilis IMI 378536 and Talaromyces versatilis DSM 26702, as authorised by Implementing Regulations (EU) 2015/661, (EU) 2015/2304 and (EU) 2017/210, and premixtures containing that additive, which are intended for chickens for fattening and reared for laying, laying hens, turkeys for fattening and reared for breeding, and minor poultry species for fattening and reared for laying and which are produced and labelled before 28 November 2026 in accordance with the rules applicable before 28 May 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.

2.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for chickens for fattening and reared for laying, laying hens, turkeys for fattening and reared for breeding, and minor poultry species for fattening and reared for laying, and which are produced and labelled before 28 May 2027 in accordance with the rules applicable before 28 May 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.

Article 5Entry 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 additive

Name of the holder of authorisation

Name of the 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 feed with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a22

Adisseo France S.A.S.

Endo-1,4-beta-xylanase (EC 3.2.1.8)

and

Endo-1,3(4)-beta-glucanase (EC 3.2.1.6)

Additive composition

Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) and endo-1,3(4)-beta-glucanase (EC 3.2.1.6) produced with Talaromyces versatilis IMI 378536 and Talaromyces versatilis DSM 26702 having a minimum activity of:

solid form: endo-1,4-beta-xylanase 22 000 VU  ( 1 ) /g and endo-1,3(4)-beta-glucanase 15 200 VU/g;

liquid form: endo-1,4-beta-xylanase activity of 5 500 VU/ml and endo-1,3(4)-beta-glucanase 3 800 VU/ml.

Characterisation of the active substance

Endo-1,4-beta-xylanase (EC 3.2.1.8) and endo-1,3 (4)-beta-glucanase (EC 3.2.1.6) produced with Talaromyces versatilis IMI 378536 and Talaromyces versatilis DSM 26702.

Analytical method

( 2 )

For the determination of endo- 1,4-beta-xylanase activity:

viscosimetric method based on decrease in viscosity produced by action of endo-1,4- beta-xylanase on the xylan containing substrate (wheat arabinoxylan).

For the determination of endo- 1,3(4)-beta-glucanase activity:

viscosimetric method based on decrease in viscosity produced by action of endo-1,3 (4)-beta-glucanase on the glucan containing substrate (barley beta-glucan).

Poultry

-

Endo-1,4- beta-xylanase

1 100 VU

Endo-1,3(4)-beta-glucanase 760 VU

-

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 the potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing and skin protections.

28 May 2036

( 1 )   1 VU (viscosimetric unit) of the xylanase or glucanase activity is the amount of the enzyme which hydrolyses the substrate (wheat arabinoxylan or barley betaglucan, respectively), reducing the viscosity of the solution, to give a change in relative fluidity of 1 (dimensionless unit)/min at 30 °C and pH 5,5.

( 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

6 articles

Cite this act

Commission Implementing Regulation (EU) 2026/1016 of 7 May 2026 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced with Talaromyces versatilis IMI 378536 and Talaromyces versatilis DSM 26702 as a feed additive for chickens for fattening and reared for laying, laying hens, turkeys for fattening and reared for breeding, and minor poultry species for fattening and reared for laying, the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced with Talaromyces versatilis IMI 378536 and Talaromyces versatilis DSM 26702 as a feed additive for chickens reared for breeding, chickens for breeding, turkeys for breeding, minor poultry species reared for breeding, and minor poultry species for laying and breeding (holder of authorisation: Adisseo France S.A.S.), and repealing Implementing Regulations (EU) 2015/661 (EU) 2015/2304 and (EU) 2017/210 (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32026R1016

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

EU-EurLex-Reuse-2011-833

本頁資料來源:EUR-Lex·整理提供:法律人 LawPlayer· lawplayer.com