Commission Implementing Regulation (EU) 2026/2074 of 17 September 2026 concerning the authorisation of a preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as a feed additive for all animal species
| Image omitted; see official source | Official Journal of the European Union | EN L series |
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| 2026/2074 | 18.9.2026 |
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_202602074EN.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 subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856. 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 a preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 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 ‘acidity regulators’.
- (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 December 2025 [^ntr2-L_202602074EN.000101-E0002] that the preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 is safe for all animal species, as well as for the consumers and the environment. The Authority also concluded that the preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 is considered as a skin and respiratory sensitiser. Exposure of users via dermal and respiratory routes is considered a risk. This conclusion applies, in principle, to any preparations containing the active agents. The Authority further concluded that the preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 has the potential to reduce the pH of feed materials of plant origin at the minimum recommended level of 1,0 × 108 CFU/kg feed material. The Authority also verified the report on the method 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 subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for all animal species. 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 ‘technological additives’ and to the functional group ‘acidity regulators’, 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, 17 September 2026.
For the Commission
The President
Ursula VON DER LEYEN
[^ntr1-L_202602074EN.000101-E0001]: OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
[^ntr2-L_202602074EN.000101-E0002]: EFSA Journal 2026;24:e9876, https://doi.org/10.2903/j.efsa.2026.9876.
ANNEX
| Identification number of the additive | Name of the 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 additive | Name of the additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | CFU/kg of feed material | CFU/kg of feed material | Other provisions | End of period of authorisation |
| Category: technological additives. Functional group: acidity regulators. | Category: technological additives. Functional group: acidity regulators. | Category: technological additives. Functional group: acidity regulators. | Category: technological additives. Functional group: acidity regulators. | Category: technological additives. Functional group: acidity regulators. | Category: technological additives. Functional group: acidity regulators. | Category: technological additives. Functional group: acidity regulators. | Category: technological additives. Functional group: acidity regulators. | Category: technological additives. Functional group: acidity regulators. |
| 1k1802i | Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 | Additive composition Preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 containing a minimum of 3,6 × 1011 CFU/g additive with a ratio 1:4 (7,2 × 1010 CFU Bacillus subtilis DSM 33862/g and 2,88 × 1011 CFU Lentilactobacillus buchneri DSM 12856/g Solid form Characterisation of the active substance Viable cells of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 Analytical method [^ntr1-L_202602074EN.000301-E0001] — Identification of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856: DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE) (CEN/TS 17697) — Enumeration of Bacillus subtilis DSM 33862: Spread plate method on tryptone soya agar (EN 15784) — Enumeration of Lentilactobacillus buchneri DSM 12856: Spread plate (or pour plate) method on MRS agar (EN 15787) | All animal species | — | 1 × 108 | — | 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated. 2. In the directions for use of the additive and premixtures, the following should be indicated: ‘Shall be used exclusively in: — crushed feed materials of plant origin with high moisture content (64-87 %).’ 3. 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. | 8 October 2036 |
[^ntr1-L_202602074EN.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/2026/2074/oj
ISSN 1977-0677 (electronic edition)
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