Lysate of Willaertia magna approved as a low-risk substance until 7 July 2040 — for the whole species, not only strain C2c Maky; the manufacturer must observe microbial contaminant limits under OECD document No 65, and the EFSA specification is based on qPCR of the strain’s genomic DNA
Commission Implementing Regulation (EU) 2025/1177, published on 17 June 2025, approves lysate of Willaertia magna as a low-risk active substance in plant protection products for the period from 7 July 2025 to 7 July 2040 (Part D of the Annex to Regulation (EU) No 540/2011, entry 53). The application was submitted by AMOEBA SA in Austria on 18 June 2020; the EFSA conclusions were delivered on 13 December 2024.
- Scope of the approval (recital 7): EFSA confirmed that the conclusions for the lysate of strain C2c Maky also apply to Willaertia magna as a species, so — to reduce administrative burden and the risk of resistance — the approval is not restricted to the strain. Annex I: IUPAC name and purity “not applicable”, no relevant impurities.
- Conditions: Member States pay particular attention to the manufacturer strictly maintaining environmental conditions and quality control analysis during production to ensure compliance with the microbial contamination limits of OECD document No 65 (Microbial Contaminant Limits for Microbial Pest Control Products), and to the ability of the products to form a suspension, which may require continuous agitation during loading and application. Recital 11: the components of the substance occur naturally and it is readily biodegradable.
- Data from the EFSA conclusions (e9194): the reference specification is the number of specific genomic DNA copies — 1.49 × 10⁵–2.42 × 10⁶ copies/mg dry weight of technical material — quantified by quantitative PCR with primers and probe specific to strain C2c Maky; proteins, carbohydrates, mineral salts and water were analysed in pilot-scale batches but not included in the specification as other amoebas would give comparable quantities. The absence of viable cells in the technical material was demonstrated by a specifically developed method; no relevant microbial contaminants under SANCO/12116/2012-rev.0 were found. The analytical profile of batches must be provided again once industrial production has stabilised.
- Assessment (e9194): representative use — fungicide against downy mildew (Plasmopara viticola) on grapevines and table grapes; no critical issues in toxicology and residues, criterion III for inclusion in Annex IV of Regulation (EC) No 396/2005 (toxicological reference values unnecessary) met. Gaps: chronic risk to adult honey bees in the “treated crop” and “flowering weeds” scenarios (unclear mode of action, higher doses should have been tested in the chronic study), no data for bumble bees and solitary bees and no assessment of sublethal effects.