The renewal process is taking longer than expected
Following the regulation on maximum residue limits (MRLs) for copper products and the clarification by Italian authorities regarding human and environmental risk assessment methodologies for these essential tools, it is only fitting that we turn our focus to the oldest crop protection input still fundamental to European agriculture: Sulfur.
As a crop protection tool, Sulfur is currently undergoing the European approval renewal process. Like all inorganic compounds, it is a poor fit for guidelines originally designed for synthetic organic molecules.
Following France’s publication of the Renewal Assessment Report (RAR) — which proposed renewing sulfur as a low-risk active substance — the detailed analysis of the submitted documentation and the ensuing debate among Member States are, as often happens, outlining a longer approval pathway than initially anticipated.
The EFSA Conclusion: A Profile Between Human Safety and Environmental Concerns
The peer review conducted by EFSA, which supersedes previous evaluations, confirmed the efficacy of sulfur as a fungicide and acaricide (miticide) on grapevines and cereals. From a human health perspective, sulfur is generally considered safe. Since it is an essential element for living organisms and given the high level of natural dietary exposure, it was deemed unnecessary to establish toxicological reference values such as ADI (Acceptable Daily Intake) or AOEL (Acceptable Operator Exposure Level). Regarding endocrine disrupting properties, the Authority also concluded that the substance is unlikely to meet the exclusion criteria. However, as is almost always the case, the evaluation highlighted several “critical areas of concern” regarding environmental impact. EFSA reported a high risk to bees (both adults and larvae), non-target arthropods in the field, and soil macro-organisms. Furthermore, for powder/dustable formulations, risks of the sulfate metabolite leaching into groundwater emerged under certain scenarios.
The SCoPAFF Debate of March 2026
During the SCoPAFF (Legislation section) meeting held on March 10–11, 2026, the European Commission discussed the status of the dossier with Member States, bringing to light diverging positions on how to manage these ecotoxicological issues.
A major point of discussion involved soil macro-organisms. One Member State formally requested a new mandate for EFSA to evaluate the final study reports on risks to these organisms, which were submitted late by producers and have not yet been thoroughly examined. However, the Commission pointed out that the EFSA conclusion had already taken interim reports into account and that the final data do not seem to add substantially different information. The debate over non-target arthropods is even more intense. The issue raised concerns the sensitivity of the genus Trichogramma, a beneficial insect crucial for biological and integrated pest management (IPM), but which does not belong to the priority species stipulated by current guidelines (Aphidius and Typhlodromus). Some experts pointed out that the effects observed on this organism are 20 to 300 times higher than those seen on standard laboratory-tested species. Despite not being a “standard” species according to classic models, its ecological importance makes these test results highly relevant for the overall risk assessment.
Toward a Refinement of the Risk Assessment
Given the complexity of the issue, the Commission proposed a strategy to break the impasse, initially focusing on 80% water-dispersible granule (WG) formulations for use on cereals. The plan is to grant a new mandate to EFSA to recalculate soil exposure levels and refine the recovery times for arthropod populations, potentially restricting the crop phenological stages during which treatment is permitted. For this reason, the EFSA assessment document for sulfur has been marked as “under review.” In conclusion, while safety for consumers and operators appears robust, further investigations are still underway regarding the risk assessment for non-target arthropods and soil organisms. The goal is to find solutions that mitigate risks while ensuring the availability of an indispensable tool for European agriculture.
References
- European Food Safety Authority (EFSA), Fernando Alvarez, Maria Arena, et al. “Peer Review of the Pesticide Risk Assessment of the Active Substance Sulfur.” EFSA Journal 21, no. 3 (2023): e07805. https://doi.org/10.2903/j.efsa.2023.7805 (under review).
- Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) Summary Reports.