Lactiplantibacillus plantarum NCIMB 30094 for silage (1k20723) authorised until 18 August 2035: CEN/TS 17697 and MRS agar to EN 15787, dose 1 × 10⁹ CFU/kg; OECD TG 492 test — eye irritant, 10 % of particles below 10 µm
Commission Implementing Regulation (EU) 2025/1523, published on 29 July 2025, authorises until 18 August 2035 a preparation of Lactiplantibacillus plantarum NCIMB 30094 as a silage additive for all animal species. The application was submitted under Article 7 of Regulation (EC) No 1831/2003; EFSA in its opinion of 26 November 2024 notes that the additive had previously been authorised in the EU and that no adverse effects were reported in 2012–2022. According to EFSA the additive is not a skin irritant, but is an eye irritant and a potential skin and respiratory sensitiser; efficacy was based on studies assessed in 2012.
- Methods in the annex: identification — DNA sequencing or PFGE (CEN/TS 17697), enumeration — spread plate or pour plate on MRS agar (EN 15787). Additive: at least 5 × 10¹⁰ CFU/g; minimum dose without other micro-organisms — 1 × 10⁹ CFU/kg fresh plant material (any forage, directly or as an aqueous suspension). Cryoprotectants in the annex: glycine ≤ 18 % and sodium erythorbate ≤ 18 %; skin, eye and respiratory protection.
- Composition according to EFSA: 38.9 % cells, 9.3 % fermentation medium, 51.8 % cryoprotectants (sucrose, glycine, sodium erythorbate approx. 1:1:1) and up to 2 % sodium aluminosilicate. Five batches — 6.3 × 10¹¹ CFU/g on average (5.7–7.4 × 10¹¹), i.e. more than ten times the minimum. Cadmium 0.03–0.09 mg/kg, lead < LOQ–0.15 mg/kg, mercury < LOQ–0.005 mg/kg, arsenic < LOQ–0.3 mg/kg, aflatoxins < LOQ; Salmonella and E. coli not detected (25 g and 10 g, three batches).
- Strain isolated from grass silage; ANI 99.1 % with the type strain L. plantarum ATCC 14917T, all MICs equal to or below the cut-off values, no resistance genes above the EFSA thresholds (NCBI, CARD). Bulk density 564 kg/m³, Stauber-Heubach dusting potential 20.78 g/m³ on average (18.20–26.31), particles < 100 µm 51.2 %, < 50 µm 35.6 %, < 10 µm 10 % — EFSA considered exposure by inhalation likely.
- Irritation tests: OECD TG 439 — the additive is not a skin irritant (UN-GHS “No Category”), OECD TG 492 — eye irritant. Stability: additive at −18 °C and 4 °C for 24 months, premixture also 12 months at 20 °C, suspension of 3 g/l at 20 °C for 48 h — losses < 0.5 log. Sodium erythorbate (about 17 % of the additive) gives about 0.27 mg/kg silage — of no concern according to EFSA. A literature search covering 2010–2021 (seven databases, 10 hits) contributed no data to the assessment.