See Full Document Text
Official Journal EN
of the European Union L series
2025/284 13.2.2025
COMMISSION 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
(Text with EEA relevance)
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 2003on
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.
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) 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.
(3) EFSA Journal. 2024;22:e8854.
ELI: http://data.europa.eu/eli/reg_impl/2025/284/oj 1/5EN
OJ L, 13.2.2025
(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.
(4) 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.
2/5 ELI: http://data.europa.eu/eli/reg_impl/2025/284/ojEN
OJ L, 13.2.2025
Article 3
Repeal
Implementing Regulation (EU) No 527/2011 is repealed.
Article 4
Transitional measures
1. 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 2025in accordance with the rules applicable
before 5 March 2025may 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
weaned piglets and which are produced and labelled before 5 March 2026in accordance with the rules applicable before
5 March 2025may 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
ELI: http://data.europa.eu/eli/reg_impl/2025/284/oj 3/5ANNEX
Minimum Maximum
Identifica-
Name of the content content End of
tion Species or
holder of Composition, chemical formula, description, Maxi- period of
number of Additive category of Other provisions
authorisa- analytical method mum age Units of activity/kg of authorisa-
the feed animal
tion complete feedingstuff with a tion
additive
moisture content of 12 %
Category: zootechnical additives. Functional group: digestibility enhancers.
4a14 AVEVE BV Endo-1,4- Additive composition Piglets - Endo-1,4-be- - 1. In the directions 5 March
beta-xylanase Preparation of endo-1,4-beta-xylanase produced (weaned ta-xylanase: for use of the 2035
(EC 3.2.1.8) with Trichoderma reesei MUCL 49755, and 2 140XU additive and
Endo-1,3(4)- endo-1,3(4)-beta-glucanase produced with suckling) premixtures, the
beta- Trichoderma reesei MUCL 49754 and storage conditions
Endo-1,3(4)-
glucanase polygalacturonase produced and stability to
beta-
(EC 3.2.1.6) with Aspergillus fijiensis CBS 589.94 having a heat treatment
glucanase:
Polygalacturo- minimum activity of: shall be indicated.
1 230BGU
nase solid form: 2. For users of the
(EC 3.2.1.15) Endo-1,4-beta-xylanase: 21 400XU(1)/g additive and
Polygalactur-
Endo-1,3(4)-beta-glucanase: 12 300 BGU(2)/g premixtures, feed
onase:
Polygalacturonase: 460 PGLU(3)/g. business operators
46 PGLU
liquid form: shall establish
Endo-1,4-beta-xylanase: 10 700XU/g operational
Endo-1,3(4)-beta-glucanase: 6 150BGU/g procedures and
Polygalacturonase: 230 PGLU/g. organisational
measures to
Characterisation of the active substance address the
endo-1,4-beta-xylanase (EC 3.2.1.8) produced potential risks
with Trichoderma reesei MUCL 49755, resulting from
endo-1,3(4)-beta-glucanase (EC 3.2.1.6) their use. Where
produced with Trichoderma reesei MUCL 49754 those risks cannot
and polygalacturonase (EC 3.2.1.15) produced be eliminated by
with Aspergillus fijiensis CBS 589.94 such procedures
and measures, the
Analytical method(4) additive and
For the determination of endo-1,4-beta-xylanase premixtures shall
in the feed additive and premixtures: be used with
— colorimetric (DNS) method based on the personal breathing
enzymatic hydrolysis of the oat spelt xylan and skin protective
substrate equipment.
4/5
ELI:
http://data.europa.eu/eli/reg_impl/2025/284/oj
EN
OJ
L,
13.2.2025Minimum Maximum
Identifica-
Name of the content content End of tion Species or
holder of Composition, chemical formula, description, Maxi- period of
number of Additive category of Other provisions
authorisa- analytical method mum age Units of activity/kg of authorisa-
the feed animal
tion complete feedingstuff with a tion
additive
moisture content of 12 %
Category: zootechnical additives. Functional group: digestibility enhancers.
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
(1) 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.
(2) 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.
(3) 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.
(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.
ELI:
http://data.europa.eu/eli/reg_impl/2025/284/oj
5/5
OJ
L,
13.2.2025
EN