The European Food Safety Authority (EFSA) has concluded its peer review of the pesticide risk assessment for the active substance Bacillus paralicheniformis strain FMCH001, identifying a data gap on the presence of bacitracin in edible crops that prevents finalisation of the consumer risk assessment. The conclusion, published on 10 July 2026, follows an application from FMC Agricultural Solutions A/S submitted on 30 November 2018 and deemed admissible on 4 September 2019, with the Netherlands acting as rapporteur Member State (RMS).
EFSA's assessment covers representative uses of the microbial active substance as a fungicide and nematicide for potato tuber treatment (field) and seed treatment (indoor) on maize, sunflower, sugar beet and winter oil seed rape, as well as drip irrigation and pre-transplant plant module treatment on solanaceous and cucurbit vegetables and lettuce in field and greenhouse settings. The peer review, initiated on 20 April 2023 after the RMS delivered its draft assessment report (DAR) on 13 February 2023, included an expert consultation in March 2024 and a final Member State consultation in April 2026.
No critical areas of concern were identified in identity, biological properties, physical-chemical properties, analytical methods, mammalian toxicology, or ecotoxicology. However, EFSA flagged a data gap for qualitative and quantitative occurrence of bacitracin — a toxin produced by some Bacillus strains — in edible commodities under the representative uses. Consequently, the consumer risk assessment cannot be finalised. In the area of environmental fate and behaviour, further information may be needed depending on outstanding data on bacitracin levels in the manufactured active substance.
The conclusion, approved on 29 May 2026, is based on the evaluation table dated 4 May 2026 and the peer review report. The RMS revised its DAR in 2025. The outcome will inform the European Commission's decision on whether the active substance meets the approval criteria under Regulation (EC) No 1107/2009. The identified data gap may require the applicant to submit additional studies, potentially delaying market approval for the product.