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Official Journal EN
of the European Union L series
2025/151 30.1.2025
COMMISSION IMPLEMENTING REGULATION (EU) 2025/151
of 29 January 2025
concerning the renewal of the authorisation of a preparation of Levilactobacillus brevis DSM 21982 as
a feed additive for all animal species and repealing Implementing Regulation (EU) No 838/2012
(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 authorisation.
(2) The preparation of Levilactobacillus brevis DSM 21982 (previously identified as Lactobacillus brevis DSMZ 21982) was
authorised for a period of 10 years as a feed additive for all animal species by Commission Implementing Regulation
(EU) No 838/2012(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 Levilactobacillus brevis DSM 21982 as a feed additive for all animal species,
requesting the additive to be classified in the additive category ‘technological additives’ and in the functional group
‘silage additives’. That application was accompanied by the particulars and documents required under Article 14(2)
of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 12 March 2024(3) that the
preparation of Levilactobacillus brevis DSM 21982 remains safe for all target animal species, the consumers and the
environment under the conditions of use currently authorised. The Authority also concluded that the additive
should be considered as a potential skin and respiratory sensitizer and any exposure through skin and respiratory
tract is considered a risk and stated that it cannot conclude on the eye irritation potential of the additive. The
Authority also indicated that there is no need for assessing the efficacy of the additive as the application for renewal
of its authorisation does not include a proposal for amending or supplementing the conditions of the original
authorisation which would have an impact on the efficacy of the additive.
(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 the preparation of
Levilactobacillus brevis DSM 21982 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), point (c), of Commission Regulation (EC)
No 378/2005(4), 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) Commission Implementing Regulation (EU) No 838/2012 of 18 September 2012 concerning the authorisation of Lactobacillus brevis
(DSMZ 21982) as a feed additive for all animal species (OJ L 252, 19.9.2012, p. 9, ELI: http://data.europa.eu/eli/reg_impl/2012/
838/oj).
(3) EFSA Journal, 22(4), e8725.
(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).
ELI: http://data.europa.eu/eli/reg_impl/2025/151/oj 1/3EN
OJ L, 30.1.2025
(6) In view of the above, the Commission considers that the preparation of Levilactobacillus brevis DSM 21982 satisfies
the conditions, as provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of
that additive should be renewed. 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 Levilactobacillus brevis DSM 21982 as a
feed additive, Implementing Regulation (EU) No 838/2012 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 Levilactobacillus brevis DSM 21982, 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 the authorisation
The authorisation of the preparation specified in the Annex, belonging to the additive category ‘technological additives’ and
to the functional group ‘silage additives’, is renewed subject to the conditions laid down in that Annex.
Article 2
Repeal of Implementing Regulation (EU) No 838/2012
Implementing Regulation (EU) No 838/2012 is repealed.
Article 3
Transitional measures
The preparation specified in the Annex and feed containing it, which are produced and labelled before 19 February 2026in
accordance with the rules applicable before 19 February 2025may continue to be placed on the market and used until the
existing stocks are exhausted.
Article 4
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/2025/151/ojANNEX
Minimum Maximum
Identification Species or
Composition, chemical formula, Maximum content content End of period of
number of the Additive category Other provisions
description, analytical method age authorisation
feed additive of animal
CFU/kg of fresh material
Category: technological additives. Functional group: silage additives
1k20715 Levilactobacillus Additive composition All — — — 1. In the directions for use of the 19 February
brevis DSM Preparation of Levilactobacillus brevis animal additive and premixtures, the 2035
21982 DSM 21982 containing a minimum of species storage conditions shall be
8 × 1010 CFU/g additive indicated.
Solid form 2. Minimum dose of the additive
when it is not used in
————————————
combination with other micro-
organisms as silage additives: 1 ×
Characterisation of the active substance
108 CFU/kg fresh material.
Viable cells of Levilactobacillus brevis
DSM 21982
3. For users of the additive and
premixtures, feed business
————————————
operators shall establish
Analytical method(1) operational procedures and
Enumeration in the feed additive of organisational measures to
Levilactobacillus brevis DSM 21982: address potential risks resulting
from their use. Where those risks
— Spread plate method on MRS agar
cannot be eliminated by such
(EN 15787) procedures and measures, the
additive and premixtures shall be
Identification of Levilactobacillus brevis
used with personal skin, eye and
DSM 21982:
breathing protective equipment.
— Pulsed Field Gel Electrophoresis
(PFGE) – CEN/TS 17697 or DNA
sequencing methods
(1) 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/2025/151/oj
3/3
OJ
L,
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