Silage: authorisation of Pediococcus pentosaceus DSM 14021 (1k1009) renewed until 2035 — enumeration on MRS agar according to EN 15786, identification by PFGE according to CEN/TS 17697 or sequencing, batches 5.6–9.4 × 10¹¹ CFU/g, aflatoxin B1 tested with a method with an LOQ of 46 μg/kg
Commission Implementing Regulation (EU) 2025/159, published on 30 January 2025, renews until 19 February 2035 the authorisation of a preparation of Pediococcus pentosaceus DSM 14021 as a technological silage additive for all animal species and repeals Implementing Regulation (EU) No 84/2014, which also covered strains DSM 23688 and DSM 23689. It is based on the EFSA opinion of 12 March 2024 (applicant: Chr. Hansen A/S); the EU reference laboratory considered its earlier evaluation of the methods still valid.
- Conditions: at least 1 × 10¹¹ CFU/g additive (solid form), minimum dose without other silage microorganisms 1 × 10⁸ CFU/kg fresh material, only in easy (> 3 % soluble carbohydrates) and moderately difficult to ensile material (1.5–3.0 %). Official methods: enumeration by spread plate method on MRS agar (EN 15786), identification by pulsed-field gel electrophoresis (PFGE) according to CEN/TS 17697 or DNA sequencing methods. The reference laboratory did not need to draw up a new report (Article 5(4)(c) of Regulation (EC) No 378/2005).
- EFSA data: five batches averaged 7.6 × 10¹¹ CFU/g (5.6–9.4 × 10¹¹); the product is a powder with freeze-dried cell concentrate (17–42 %), an anti-caking agent (8 %) and a carrier (50–75 %). In three batches cadmium 0.038–0.061 mg/kg, lead 0.054–0.072 mg/kg, mercury 0.011–0.016 mg/kg, arsenic 0.026–0.044 mg/kg; aflatoxin B1 below the LOQ of the method, which is 46 μg/kg. Enterobacteriaceae and E. coli < 10 CFU/g, coliforms, yeasts and fungi < 1000 CFU/g, Salmonella not detected in 5 g.
- The strain was isolated from meat fermentation; whole-genome ANI against the P. pentosaceus type strain ATCC 33316ᵀ was 97.9 %. Gel electrophoresis showed plasmids (number and size not determined). In a broth microdilution test the MIC of tetracycline was 16 mg/L against a cut-off of 8 mg/L — one dilution step, which EFSA regards as within normal variation; no resistance genes above the EFSA thresholds were found in the ResFinder and NCBI databases.
- Safety: a literature search of four databases (95 hits since 2014) revealed no concerns; the strain remains safe for animals, consumers and the environment (QPS approach). The additive should be considered a potential skin and respiratory sensitiser; EFSA did not conclude on eye irritation for lack of data. Efficacy was not reassessed because the conditions of use are unchanged; the act requires skin, eye and respiratory protection where procedures cannot eliminate the risks.