Enterococcus lactis DSM 7134 (formerly E. faecium; 4b1841) for sows renewed until 5 February 2036: counts on bile esculin azide or Slanetz-Bartley agar (EN 15788), PFGE or sequencing — no irritation data for the granulated form
Commission Implementing Regulation (EU) 2026/103, published on 16 January 2026, renews until 5 February 2036 the authorisation of a preparation of Enterococcus lactis DSM 7134 (Bonvital, isolated from grass; holder: Lactosan GmbH&Co.KG) as a gut flora stabiliser for sows and repeals Regulation (EU) No 1083/2014. The strain, authorised in 2014 as E. faecium, was reassigned to E. lactis on the basis of its genome sequence in a 2023 EFSA opinion; the opinion of 19 March 2025 confirmed that it remains safe and that the criteria for assessing E. faecium also apply to E. lactis.
- Methods in the annex (the EURL considered the previous conclusions still valid): count — spread or pour plate on bile esculin azide agar or Slanetz and Bartley agar according to EN 15788; identification — PFGE (CEN/TS 17697) or DNA sequencing. Two forms: powder (with sweet whey powder, lactose, sodium citrate, glutamate, ascorbate and lactate, and mannitol) and microencapsulated granules (with sucrose, maltodextrin and starch) — both min. 1 × 10¹⁰ CFU/g.
- Five batches of each form: powder 1.5 × 10¹⁰ CFU/g (1.3–1.8 × 10¹⁰), granules 1.5 × 10¹⁰ (1.3–1.6 × 10¹⁰). Enterobacteriaceae and yeasts and moulds < 1000 CFU/g, Salmonella absent in 25 g; arsenic, lead, cadmium, mercury, aflatoxins, deoxynivalenol and zearalenone below the LOQ. Composition and manufacturing process unchanged, so data on physical properties, shelf-life and homogeneity from the 2014 and 2023 assessments remain valid.
- Strain: a genome search against ResFinder and NCBI gave two hits above the EFSA thresholds, but further analysis revealed no acquired resistance genes; susceptibility to all relevant antibiotics and the absence of virulence determinants had been shown earlier. According to EFSA the additive is authorised for sows “in feed and water”, although the conditions of authorisation and the new annex give only a dose in feed (5 × 10⁸ CFU/kg complete feed). Bonvital is also authorised for weaned piglets, pigs for fattening, chickens, laying hens and minor poultry.
- User safety: the powder is not irritant to skin or eyes (data from earlier assessments); for the granules there are no data, so no conclusion is possible; both forms are considered skin and respiratory sensitisers. Where risks cannot be eliminated by procedures, the new annex requires eye, respiratory and skin protection (previously breathing protection and gloves were recommended) and an indication of storage conditions and stability to heat treatment. The act provides no transitional period.