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Official Journal EN
of the European Union L series
2025/161 30.1.2025
COMMISSION IMPLEMENTING REGULATION (EU) 2025/161
of 29 January 2025
concerning the authorisation of a preparation of muramidase produced with Trichoderma reesei DSM
32338 as a feed additive for laying hens (holder of authorisation: DSM Nutritional Products Ltd,
represented by DSM Nutritional Products Sp. z o.o.)
(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 such an authorisation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation
of a preparation of muramidase produced with Trichoderma reesei DSM 32338 as a feed additive. That application
was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) The application concerns the authorisation of the preparation of muramidase produced with Trichoderma reesei DSM
32338 as a feed additive for laying hens, requesting that additive to be classified in the category ‘zootechnical
additives’ and in the functional group ‘other zootechnical additives’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 April 2024(2)that, under the
proposed conditions of use, the preparation of muramidase produced with Trichoderma reesei DSM 32338 is safe for
the target species, consumers and the environment. It also concluded that the liquid formulation of the preparation
is considered not irritant to the skin or eyes, that its solid formulation is considered not irritant to the skin, and that
due to the proteinaceous nature of the preparation both formulations should be considered respiratory sensitisers.
However, the Authority could not conclude on the potential of the preparation (both formulations) to be a dermal
sensitiser or the potential of its solid formulation to be irritant to the eyes. The Authority further concluded that the
preparation has the potential to be efficacious as a zootechnical additive for laying hens at 30 000LSU(F)/kg feed. It
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 previous assessment regarding the methods used for the control of muramidase in
animal feed are valid and applicable for the current application. In accordance with Article 5(4), point (a), of
Commission Regulation (EC) No 378/2005(3), an evaluation report of the Reference Laboratory is therefore not
required.
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) EFSA Journal. 2024;22:e8788.
(3) 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).
ELI: http://data.europa.eu/eli/reg_impl/2025/161/oj 1/3EN
OJ L, 30.1.2025
(6) In view of the above, the Commission considers that the preparation of muramidase produced with Trichoderma reesei
DSM 32338 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use
of that preparation should be authorised. 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.
(7) 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
Authorisation
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional
group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in
that Annex.
Article 2
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, 29 January 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/3 ELI: http://data.europa.eu/eli/reg_impl/2025/161/ojANNEX
Minimum Maximum
Identifica- content content
Composition, chemical Species or End of period
tion number Name of the holder of
Additive formula, description, category of Maximum age Other provisions of
of the feed authorisation Unit of activity/kg of complete
analytical method animal authorisation
additive feedingstuff with a moisture
content of 12 %
Category: zootechnical additives. Functional group: other zootechnical additives (improvement of laying performance)
4d16 DSM Nutritional Muramidase Additive composition Laying hens — 30 000 60 000 1. In the directions for use 19 February
Products Ltd, (EC Preparation of LSU(F) LSU(F) of the additive and 2035
represented by 3.2.1.17) muramidase (EC premixtures, the storage
DSM Nutritional 3.2.1.17) produced conditions and stability
Products Sp. z o.o. with Trichoderma reesei to heat treatment shall
DSM 32338 having a be indicated.
minimum activity of 2. For users of the additive
60 000 LSU(F)(1)/g. and premixtures, feed
Solid and liquid forms. business operators shall
establish operational
Characterisation of the
procedures and
active substance
organisational measures
Muramidase (EC
to address potential risks
3.2.1.17, also known as
resulting from their use.
‘lysozyme’) produced
Where those risks
with Trichoderma reesei
cannot be eliminated by
DSM 32338
such procedures and
Analytical method(2) measures, the additive
For the quantification and premixtures shall be
of muramidase: used with personal skin
fluorescence-based and breathing protective
enzyme assay method equipment, as well as
that determines the personal eye protective
enzyme-catalyzed equipment for the solid
depolymerisation of a form of the additive.
fluorescein-labelled
peptidoglycan
preparation at pH 6,0
and 30 °C.
(1) One LSU(F) is defined as the amount of enzyme that increases the fluorescence of 12,5 μg/ml fluorescein-labelled peptidoglycan per minute at pH 6,0 and 30 °C by a value that corresponds to the fluorescence
of approximately 0,06 nmol fluorescein isothiocyanate isomer.
(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
ELI:
http://data.europa.eu/eli/reg_impl/2025/161/oj
3/3
OJ
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