The European Food Safety Authority (EFSA) has concluded its peer review of the pesticide risk assessment for the active substance Bacillus subtilis strain FMCH002, finding no critical areas of concern or unresolved issues across all assessed areas, including mammalian toxicology, residues, environmental fate, and ecotoxicology. The conclusion, published on 9 July 2026, supports the potential approval of the microbial active substance as a fungicide and nematicide for uses including potato tuber treatment, seed treatment on maize, sunflower, sugar beet and oilseed rape, and drip irrigation or pre-transplant treatment on solanaceous and cucurbit vegetables and lettuce in field and greenhouse settings.
The assessment follows an application submitted by FMC Agricultural Solutions A/S on 30 November 2018, with the dossier deemed admissible on 4 September 2019. The Netherlands, acting as rapporteur Member State (RMS), provided the initial draft assessment report (DAR) on 13 February 2023. EFSA initiated the peer review on 13 April 2023, consulting Member States and the applicant, and conducted a public consultation. A tele-conference on 15 March 2024 identified the need for additional information and an expert consultation on human health and non-target organisms. The final Member State consultation via written procedure took place in March–April 2026.
The peer review confirmed sufficient efficacy against target fungi and nematodes for the representative uses. No data gaps were identified in identity, biological properties, physical-chemical properties, analytical methods, mammalian toxicology, residues (consumer risk assessment finalised), environmental fate, or ecotoxicology. The formulated product evaluated was 'F4018-4', a suspension concentrate containing both B. subtilis strain FMCH002 and Bacillus paralicheniformis strain FMCH001. The conclusion report and supporting documents, including the peer review report and the DAR, are publicly available.
For FMC Agricultural Solutions and other producers of microbial pesticides, the positive conclusion removes a key regulatory hurdle, potentially accelerating market access for a biological alternative to chemical fungicides and nematicides. EU farmers gain a new tool for integrated pest management, particularly for crops like potatoes, maize, and vegetables, which may reduce reliance on synthetic pesticides. EU regulatory bodies and national authorities now have a clear scientific basis for the approval decision under Regulation (EC) No 1107/2009. Environmental and consumer groups may view the absence of critical concerns favourably, though the co-formulation with another Bacillus strain may warrant separate scrutiny. The conclusion does not impose new compliance costs beyond standard registration procedures.