Levilactobacillus brevis DSM 21982 (1k20715) for silage renewed until 19 February 2035: ≥ 8 × 10¹⁰ CFU/g, counting on MRS agar according to EN 15787, identification by PFGE (CEN/TS 17697) or DNA sequencing; EFSA: five batches averaging 6.6 × 10¹¹ CFU/g, MICs of ampicillin and tetracycline one dilution above the cut-off
Commission Implementing Regulation (EU) 2025/151, published on 30 January 2025, renews the authorisation of the preparation of Levilactobacillus brevis DSM 21982 (formerly Lactobacillus brevis DSMZ 21982) as a technological silage additive for all animal species and repeals Implementing Regulation (EU) No 838/2012. It is based on the EFSA opinion of 12 March 2024 (e8725).
- Specification and methods (annex): solid preparation with at least 8 × 10¹⁰ CFU/g of viable cells; enumeration in the additive — spread plate method on MRS agar (EN 15787); identification — pulsed-field gel electrophoresis PFGE (CEN/TS 17697) or DNA sequencing. Minimum dose when not combined with other microorganisms: 1 × 10⁸ CFU/kg of fresh material. The directions for use state the storage conditions; personal protective equipment for skin, eyes and the respiratory tract. Valid until 19 February 2035; the additive and feed labelled before 19 February 2026 may be used until stocks are exhausted.
- The EU reference laboratory considered that the evaluation of methods from the previous authorisation remains valid, so no new report was drawn up (recital 5). EFSA: the additive is safe for all species, consumers and the environment, should be considered a skin and respiratory sensitiser, and no conclusion can be drawn on eye irritancy; no efficacy assessment was needed for the renewal.
- Data from the EFSA opinion (e8725): in five batches on average 6.6 × 10¹¹ CFU/g (3.5 × 10¹¹–1.5 × 10¹²); coliforms 115 CFU/g, yeasts 20 CFU/g, Enterobacteriaceae 55 CFU/g (in three batches < 10), E. coli < 10 and filamentous fungi < 20 CFU/g, Salmonella not detected in 25 g; in three batches arsenic 0.26–0.32, lead 0.015–0.11, cadmium 0.11–0.15 and mercury 0.002–0.008 mg/kg; mycotoxins (aflatoxins, fumonisins B1–B3, ochratoxin A, deoxynivalenol, zearalenone, T-2 and HT-2) below the LOD or LOQ. The strain was isolated from grass and is not genetically modified.
- Identity and resistance (e8725): ANI from WGS 97.68 % against the type strain L. brevis DSM 20054ᵀ, confirmed by an analysis of 71 core genes; a plasmid was predicted in the genome. MICs (broth microdilution) were within the cut-offs except for ampicillin (4 vs 2 mg/L), tetracycline (16 vs 8 mg/L) and chloramphenicol (in one of three replicates 8 vs 4 mg/L) — the Panel considered exceeding by one dilution to be within normal variation; WGS found no resistance genes above EFSA thresholds. The previous authorisation recommended breathing protection and gloves; storage temperature and storage life were stated in the directions for use.