Commission Implementing Regulation (EU) 2024/764 of 29 February 2024 concerning the authorisation of a preparation of Bacillus subtilis CNCM I-4606, CNCM I-5043 and CNCM I-4607 and Lactococcus lactis CNCM I-4609 as a feed additive for all animal species
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘hygiene condition enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEX Identification number of the 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/L of complete feedingstuff Category: technological additives. Functional group: hygiene condition enhancers (reduction of the contamination by Salmonella Typhimurium) 1n01 Bacillus subtilis CNCM I-4606, CNCM I-5043 and CNCM I-4607 and Lactococcus lactis CNCM I-4609 Additive composition Preparation of Bacillus subtilis CNCM I-4606, CNCM I-5043 and CNCM I-4607 and Lactococcus lactis CNCM I-4609 containing a minimum of: — 2 × 10 9 CFU/g in total for the three Bacillus subtilis strains (in ratio 1:1:1); — 2 × 10 9 CFU/g for the Lactococcus lactis. All animal species - 1 × 10 9 of Bacillus subtilis CNCM I- 4606, 4607, and 5043 (in ratio 1:1:1) 1 × 10 9 of Lactococcus lactis CNCM I-4609 - 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. The additive shall only be used in mash compound feed or in solid feed materials, intended for the preparation of feed with a moisture content of 60-90 %. 3. The additive shall not be used in premixtures containing trace elements or preservatives. 4. On the label of the additive and premixtures, the following shall be indicated: ‘The additive 1n01 is intended for the reduction of the contamination by Salmonella Typhimurium. It cannot be considered as a replacement for the standard hygiene farming conditions.’ 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 breathing protective equipment. 21 March 2034 Characterisation of the active substance Viable spores of Bacillus subtilis strains CNCM I-4606, CNCM I-5043 and CNCM I-4607 and live cells of Lactococcus lactis CNCM I-4609 Analytical method ( 1 ) Enumeration in the feed additive, premixtures and compound feeds of the total Bacillus subtilis CNCM I-4606, CNCM I-5043 and CNCM I-4607: — Spread plate method on tryptone soya agar (EN 15784); Enumeration in the feed additive, premixtures and compound feeds of the Lactococcus lactis CNCM I-4609: — Poured plate method on MRS agar (EN 15214). Identification of Bacillus subtilis CNCM I-4606, CNCM I-5043 and CNCM I-4607 and of the Lactococcus lactis CNCM I-4609: 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
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.