LegalizeCommission Implementing Regulation (EU) 2025/2511 of 11 December 2025 concerning the authorisation of a preparation of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 as a feed additive for ruminants for milk production/reproduction (holder of authorisation: Chr. Hansen A/S)
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| Image omitted; see official source | Official Journal of the European Union | EN L series |
| --- | --- | --- |
| 2025/2511 | 12.12.2025 |
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 [^ntr1-L_202502511EN.000101-E0001], 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 Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903. 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 Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 as a feed additive for dairy cows and other dairy ruminants, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘gut flora stabilisers’.
- (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 9 April 2025 [^ntr2-L_202502511EN.000101-E0002] that, under the proposed conditions of use, the preparation of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 is safe for the target species, consumers and the environment. The Authority also concluded that the preparation of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 in its both forms is considered non-irritant to the skin and eyes, but skin and respiratory sensitiser, and any exposure through the skin and respiratory tract are considered a risk. The Authority further concluded that the preparation of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 has the potential to be efficacious as a zootechnical additive in dairy cows and other dairy ruminants when used in feed and water. It also concluded that the minimum use level of the preparation in feed can be established at 3,8 × 108 CFU/kg complete feed while the minimum use level in water can be established based on the daily dose per animal (9,6 × 109 CFU per animal) and the daily water intake. The Authority did not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
- (5) In view of the above, the Commission considers that the preparation of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for ruminants for milk production/reproduction. 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.
- (6) 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 ‘gut flora stabilisers’, 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, 11 December 2025.
For the Commission
The President
Ursula VON DER LEYEN
[^ntr1-L_202502511EN.000101-E0001]: OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
[^ntr2-L_202502511EN.000101-E0002]: EFSA Journal 2025; 23:e9426. https://doi.org/10.2903/j.efsa.2025.9426.
ANNEX
| Identification number of the feed 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 | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Identification number of the feed additive | Name of the holder of authorisation | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | CFU/kg of complete feed with a moisture content of 12 % | CFU/kg of complete feed with a moisture content of 12 % | CFU/l of water for drinking | CFU/l of water for drinking | Other provisions | End of period of authorisation |
| Category: zootechnical additives. Functional group: gut flora stabilisers. | Category: zootechnical additives. Functional group: gut flora stabilisers. | Category: zootechnical additives. Functional group: gut flora stabilisers. | Category: zootechnical additives. Functional group: gut flora stabilisers. | Category: zootechnical additives. Functional group: gut flora stabilisers. | Category: zootechnical additives. Functional group: gut flora stabilisers. | Category: zootechnical additives. Functional group: gut flora stabilisers. | Category: zootechnical additives. Functional group: gut flora stabilisers. | Category: zootechnical additives. Functional group: gut flora stabilisers. | Category: zootechnical additives. Functional group: gut flora stabilisers. | Category: zootechnical additives. Functional group: gut flora stabilisers. | Category: zootechnical additives. Functional group: gut flora stabilisers. |
| 4b1896 | Chr. Hansen A/S | Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 | Additive composition Preparation of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 containing a minimum total of Bacillus spp. 3,2 × 1010 CFU/g additive (1:1 ratio) Solid form Characterisation of the active substance Viable spores of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903. Analytical method [^ntr1-L_202502511EN.000301-E0001] For enumeration in the feed additive, compound feed and water for drinking: Spread-plate method on tryptone soya agar (EN 15784) For identification: DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE) (CEN/TS 17697) | Ruminants for milk production/ reproduction | - | 3,8 × 10 8 | - | 7,4 × 10 7 | - | 1. The additive may be used via water for drinking. 2. In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated. 3. When it is used via water for drinking, the additive shall be used ensuring a minimum dose of: 9,6 × 109 CFU/animal/day. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address 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. | 1 January 2036 |
[^ntr1-L_202502511EN.000301-E0001]: 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/2025/2511/oj
ISSN 1977-0677 (electronic edition)
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