Commission Implementing Regulation (EU) 2025/1468 of 22 July 2025 concerning the authorisation of a preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as a feed additive for all animal species

• CELEX: Implementing Regulation (EU) 2025/1468
• Articles: 3

Article 1 Authorisation

The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage 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.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the feed additive

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

CFU/kg of fresh material

Category: technological additives. Functional group: silage additives

1k1802

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 × 10 11 CFU/g additive with a ratio 1:4 (7,2 × 10 10 CFU Bacillus subtilis DSM 33862/g and 2,88 × 10 11 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

( 1 )

Identification of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856:

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DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697)

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Enumeration of Bacillus subtilis DSM 33862 in the feed additive: Spread plate method on tryptone soya agar (EN 15784)

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Enumeration of Lentilactobacillus buchneri DSM 12856 in the feed additive: Spread plate (or pour plate) method on MRS agar (EN 15787)

All animal species

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1.

In the directions for use of the additive and premixtures, the storage conditions shall be indicated.

2.

Minimum dose of the additive when it is not used in combination with other micro-organisms as silage additives: 1 × 10 8 CFU/kg fresh plant material.

3.

The additive shall only be used with easy and moderately difficult to ensile fresh plant material  ( 2 ) .

4.

On the label of the additive and premixtures the following shall be indicated: ‘It is recommended to use the additive 1k1802 only with fresh plant material with a dry matter range 32-65 %.’

5.

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 skin and breathing protective equipment.

12.8.2035

( 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 .

( 2 )   Easy to ensile forage: > 3 % soluble carbohydrates in fresh material; moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrates in the fresh material in accordance with Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives ( OJ L 133, 22.5.2008, p. 1 , http://data.europa.eu/eli/reg/2008/429/oj ).