Lactiplantibacillus plantarum NCIMB 41028 (1k20713) and NCIMB 30148 (1k20714) for silage until 19 August 2035: CEN/TS 17697 and MRS agar to EN 15787, minimum 7 × 10¹⁰ CFU/g; OECD TG 492 test failed its acceptance criteria — no EFSA conclusion on eye irritation, the act still requires eye protection
Commission Implementing Regulation (EU) 2025/1527, published on 30 July 2025, authorises until 19 August 2035 two preparations of Lactiplantibacillus plantarum — NCIMB 41028 and NCIMB 30148, both isolated from perennial ryegrass — as silage additives for all animal species. In two opinions of 26 November 2024 EFSA found them safe and able to improve the production of silage at a minimum of 1 × 10⁹ CFU/kg fresh material; the additives are not skin irritants and are potential sensitisers, while no conclusion could be drawn on eye irritation.
- Methods in the annex (for both strains): identification — DNA sequencing or PFGE (CEN/TS 17697), enumeration — spread plate or pour plate on MRS agar (EN 15787). Each additive: at least 7 × 10¹⁰ CFU/g, minimum dose without other micro-organisms 1 × 10⁹ CFU/kg fresh plant material (applied as an aqueous suspension). Cryoprotectants in the annex: NCIMB 41028 — glycine and sodium erythorbate ≤ 14 %, NCIMB 30148 — ≤ 21 %; skin, eye and respiratory protection.
- NCIMB 41028 (opinion e9142): 45.4 % cells, 13.0 % medium, 41.6 % cryoprotectants; five batches 3.7 × 10¹¹ CFU/g on average (3.5–3.9 × 10¹¹); cadmium 0.16 mg/kg (0.15–0.17), mercury 0.02 mg/kg; ANI 99.04 % with the type strain ATCC 14917T. Stauber-Heubach dusting potential 6.08 g/m³ on average (5.50–6.63), particles < 10 µm 15.4 %; premixture stable for 23 months at −18 °C and 4 °C and 18 months at 20 °C.
- NCIMB 30148 (opinion e9143): 27.6 % cells, 10.7 % medium, 61.7 % cryoprotectants; five batches 6.1 × 10¹¹ CFU/g on average (5.3–7.1 × 10¹¹); cadmium 0.16 mg/kg (0.14–0.19), mercury 0.009 mg/kg, in one batch lead 0.07 and arsenic 0.3 mg/kg, in the premixture arsenic 0.4 mg/kg; ANI 99.8 %. Dusting potential 8.92 g/m³ on average (6.74–11.04), particles < 10 µm 14.7 %. In both additives all MICs were at or below the cut-off values, and resistance genes were checked in NCBI, CARD and AMRFinderPlus — no hits above the thresholds.
- Irritation: OECD TG 439 — neither additive is a skin irritant (UN-GHS “No Category”); in OECD TG 492 the replicates varied widely because the test item persisted on the tissues, so the acceptance criteria were not met and EFSA did not conclude on eye irritation. Both additives had already been authorised in the EU — the applicant reported no adverse effects in 2012–2022; efficacy was based on studies assessed by EFSA in 2012.