LegalizeCommission Implementing Regulation (EU) 2025/284 of 12 February 2025 concerning the renewal of the authorisation of a preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 as a feed additive for weaned piglets and the authorisation of that preparation as a feed additive for suckling piglets (holder of authorisation: AVEVE BV) and repealing Implementing Regulation (EU) No 527/2011
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| Image omitted; see official source | Official Journal of the European Union | EN L series |
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| 2025/284 | 13.2.2025 |
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition 1, and in particular Article 9(2) thereof,
Whereas:
- (1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and renewing such an authorisation.
- (2) A preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis (originally identified as Aspergillus aculeatus) CBS 589.94 was authorised for a period of 10 years as a feed additive for weaned piglets by Commission Implementing Regulation (EU) No 527/2011 2.
- (3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 as a feed additive for weaned piglets, requesting that additive to be classified in the additive category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’. In accordance with Article 7 of Regulation (EC) No 1831/2003, that application also concerned the authorisation of a new use of the same preparation as a feed additive for suckling piglets. That application was accompanied by the particulars and documents required under Article 14(2) and Article 7(3) of Regulation (EC) No 1831/2003.
- (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 June 2024 3 that the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 remains safe for weaned piglets, consumers and the environment under the authorised conditions of use, and that this conclusion also applies to the extension of its use to suckling piglets. The Authority further concluded that the preparation in both formulations (powder and liquid) is not irritant to the skin or eyes but due to its proteinaceous nature should be considered a dermal and respiratory sensitiser. The Authority considered that there is no need to assess the efficacy of the additive in the context of the renewal of the authorisation as the application does not include a proposal for amending or supplementing the conditions of use for weaned piglets for which there is an authorisation. It also considered that the conclusions reached for weaned piglets can be extended and extrapolated to other species and therefore concluded that the additive has the potential to be efficacious in suckling piglets. The Authority did not consider that there is a need for specific requirements of post-market monitoring.
- (5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 as a feed additive in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), points (a) and (c), of Commission Regulation (EC) No 378/2005 4, an evaluation report of the Reference Laboratory is therefore not required.
- (6) In view of the above, the Commission considers that the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed for weaned piglets, and the use of that preparation should be authorised for suckling piglets. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.
- (7) As a consequence of the renewal of the authorisation of the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 as a feed additive for weaned piglets, Implementing Regulation (EU) No 527/2011 should be repealed.
- (8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 for weaned piglets, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.
- (9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
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 weaned piglets, 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 suckling piglets, subject to the conditions laid down in that Annex.
Article 3
Repeal
Implementing Regulation (EU) No 527/2011 is repealed.
Article 4
Transitional measures
The feed additive endo-1,4-β-xylanase produced by Trichoderma reesei (MUCL 49755), endo-1,3(4)-β-glucanase produced by Trichoderma reesei (MUCL 49754) and polygalacturonase produced by Aspergillus aculeatus (CBS 589.94), as authorised by Implementing Regulation (EU) No 527/2011, and premixtures containing that additive, which are intended for weaned piglets and which are produced and labelled before 5 September 2025 in accordance with the rules applicable before 5 March 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.
Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for weaned piglets and which are produced and labelled before 5 March 2026 in accordance with the rules applicable before 5 March 2025 may continue to be placed on the market and used until the stocks concerned 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 February 2025.
For the Commission
The President
Ursula VON DER LEYEN
Commission Implementing Regulation (EU) No 527/2011 of 30 May 2011 concerning the authorisation of a preparation of endo-1,4-β-xylanase produced by Trichoderma reesei (MUCL 49755), endo-1,3(4)-β-glucanase produced by Trichoderma reesei (MUCL 49754) and polygalacturonase produced by Aspergillus aculeatus (CBS 589.94) as feed additive for weaned piglets (holder of the authorisation Aveve NV) (OJ L 143, 31.5.2011, p. 6, ELI: http://data.europa.eu/eli/reg_impl/2011/527/oj.
EFSA Journal. 2024;22:e8854.
Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/2005/378/oj.
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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 | Units of activity/kg of complete feedingstuff with a moisture content of 12 % | Units of activity/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation |
| Category: zootechnical additives. Functional group: digestibility enhancers. | Category: zootechnical additives. Functional group: digestibility enhancers. | Category: zootechnical additives. Functional group: digestibility enhancers. | Category: zootechnical additives. Functional group: digestibility enhancers. | Category: zootechnical additives. Functional group: digestibility enhancers. | Category: zootechnical additives. Functional group: digestibility enhancers. | Category: zootechnical additives. Functional group: digestibility enhancers. | Category: zootechnical additives. Functional group: digestibility enhancers. | Category: zootechnical additives. Functional group: digestibility enhancers. | Category: zootechnical additives. Functional group: digestibility enhancers. |
| 4a14 | AVEVE BV | Endo-1,4- beta-xylanase (EC 3.2.1.8) Endo-1,3(4)-beta- glucanase (EC 3.2.1.6) Polygalacturonase (EC 3.2.1.15) | Additive composition Preparation of endo-1,4-beta-xylanase produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase produced with Trichoderma reesei MUCL 49754 and polygalacturonase produced with Aspergillus fijiensis CBS 589.94 having a minimum activity of: solid form: Endo-1,4-beta-xylanase: 21 400 XU5/g Endo-1,3(4)-beta-glucanase: 12 300 BGU6/g Polygalacturonase: 460 PGLU7/g. liquid form: Endo-1,4-beta-xylanase: 10 700 XU/g Endo-1,3(4)-beta-glucanase: 6 150 BGU/g Polygalacturonase: 230 PGLU/g. Characterisation of the active substance endo-1,4-beta-xylanase (EC 3.2.1.8) produced with Trichoderma reesei MUCL 49755, endo-1,3(4)-beta-glucanase (EC 3.2.1.6) produced with Trichoderma reesei MUCL 49754 and polygalacturonase (EC 3.2.1.15) produced with Aspergillus fijiensis CBS 589.94 Analytical method 8 For the determination of endo-1,4-beta-xylanase in the feed additive and premixtures: — colorimetric (DNS) method based on the enzymatic hydrolysis of the oat spelt xylan substrate For the determination of endo-1,4-beta-xylanase in compound feed: — colorimetric method based the enzymatic reaction of endo-1,4-beta-xylanase on the azurine cross-linked wheat arabinoxylan substrate For the determination of endo-1,3(4)-beta-glucanase in the feed additive and premixtures: — colorimetric (DNS) method based on the enzymatic hydrolysis of the barley beta-glucan substrate For the determination of endo-1,3(4)-beta-glucanase in compound feed: — colorimetric method based the enzymatic reaction of endo-1,3(4)-beta-glucanase on the azo barley glucan substrate For the determination of polygalacturonase in the feed additive and premixtures: — colorimetric (DNS) method based on the enzymatic hydrolysis of the pectin substrate For the determination of polygalacturonase in compound feed: — viscosimetric method based on decrease in viscosity produced by action of polygalacturonase on the pectin substrate | Piglets (weaned and suckling) | - | Endo-1,4-beta-xylanase: 2 140 XU Endo-1,3(4)-beta-glucanase: 1 230 BGU Polygalacturonase: 46 PGLU | - | 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 by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment. | 5 March 2035 |
1 XU is the amount of enzyme which releases 1 μmol of reducing sugar per minute from xylan of oat spelt at pH 4,8 and 50 °C.
1 BGU is the amount of enzyme which releases 1 μmol of reducing sugar per minute from β-glucan of barley at pH 5,0 and 50 °C.
1 PGLU is the amount of enzyme which releases 1 μmol of reducing sugar per minute from polymethyl galacturonic acid (low methylation degree) at pH 4,8 and 35 °C.
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.
ELI: http://data.europa.eu/eli/reg_impl/2025/284/oj
ISSN 1977-0677 (electronic edition)
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