The Commission puts the saving to pesticide makers from ending routine renewals at €49.6 million a year, on cost data its own annex records as unverified stakeholder input. What would go is the point at which the EU re-examines approved substances against current science, the process that removed chlorpyrifos, mancozeb and chlorothalonil. The Council has since capped most approvals at 15 and 25 years, and Parliament has yet to settle its position.
The Commission’s estimate of what pesticide applicants would save once systematic renewals end is €49.6 million a year. A peer-reviewed analysis in Environmental Sciences Europe traces the figure to an extrapolation from 31 active substances whose approvals expire between 2033 and 2035, for which the Commission puts avoided dossier costs and fees at €168.4 million, and notes that the average renewal dossier cost of €8.75 million behind it is recorded in the staff working document as stakeholder data, not independently verified. With a €71.5 million annual saving for biocides, the renewal changes make up about a quarter of the €428 million in yearly business savings the Commission projects from the whole food and feed omnibus once plant protection measures are fully operational from 2029. The other side of the ledger is unpriced. No impact assessment was carried out, and the 2018 REFIT study the Commission relies on states that the health benefits of the approval criteria cannot be quantified.
Omnibus X, published on December 16, 2025, replaces the current limits of 10 years for a first approval and up to 15 for a renewal with unlimited approval for most active substances, and converts existing approvals. Time limits would remain only for candidates for substitution (at most seven years), substances approved by derogation (at most five), and those with identified data gaps. Product authorisations stay capped at 15 years, but member states would have to rely on the last EU assessment of the active substance unless they judge an update necessary. Review shifts from a fixed schedule to a Commission trigger, through the existing Article 21 power and a new mechanism for full or targeted reassessments. The Commission says approval criteria are untouched and that review stays possible whenever warranted. The objection concerns who has to notice a problem first. In a renewal, applicants must update dossiers to current guidelines, whereas under the new model, the analysts argue, regulators can request new data only once a concern has already surfaced. The proposal leaves the precautionary principle clause in Article 1(4) of Regulation 1107/2009 untouched while, in the same reading, withdrawing the consequence the Court of Justice drew from it in 2024 for national product authorisations.
The analysts’ point about timing is concrete. An approval frozen at its last evaluation can predate the 2018 endocrine disruptor criteria or EFSA’s 2023 bee guidance. Chlorpyrifos (non-renewed in 2020), mancozeb (2020) and chlorothalonil (2019) were all withdrawn after renewal assessments. Mancozeb is the sharpest case. Its harmonised classification stood at reproductive toxicity category 2, which triggers neither the exclusion nor the substitution exception, and the evaluating member state proposed in 2017 to delete even that entry, before ECHA’s risk committee reached the opposite conclusion in March 2019 and the substance was non-renewed as a category 1B reproductive toxicant with endocrine-disrupting properties. On that reading, the exceptions in Omnibus X presuppose the periodic review they would replace. The ad hoc route has a thin record too: a legal opinion cited in the analysis notes that member state requests for Article 21 reviews, including on TFA formation, were still unaddressed in October 2025.
The case for change is not invented. The Commission says time-driven renewals have caused delays that force extensions, and the practice has already drawn judicial censure. In three judgments of November 19, 2025 (T-412/22 on dimoxystrobin, T-94/23 on boscalid and T-565/23 on glyphosate), the General Court held that extensions under Article 17 must be exceptional and temporary, tied to the actual progress of the assessment. Boscalid, approved in 2008 for ten years, had been extended six times by May 2023, and the Commission extended it again in February 2026. The omnibus followed the rulings by 27 days. The peer-reviewed analysis accepts that the capacity problem is real but notes that less intrusive options, such as longer renewal periods, were not examined. Corporate Europe Observatory attributes to EFSA the view that about 50 more experts and the rejection of incomplete industry dossiers would sharply cut reassessment delays, a statement the report cites but that was not independently confirmed here.
Corporate Europe Observatory’s report, published on October 7 and built on freedom of information documents, traces specific asks to the text. Bayer asked for authorisations of 20 years or unlimited approval with periodic literature reviews or safety updates, and Copa-Cogeca asked for reassessment only when new evidence of risk emerges. The Commission’s first call for information, sent on July 2, 2025, went only to CropLife Europe, Copa-Cogeca, the biocontrol producers’ association IBMA and the organic group IFOAM, while other organisations could respond from September 16. A Commission meeting with Copa-Cogeca, CropLife, PROFEL and IBMA on October 8 preceded the November leak of the draft. Copa-Cogeca’s own roadmap asked for unlimited approval after the first renewal, and the Commission went further by dropping the first renewal as well. Overlap between asks and text shows access and alignment, not causation by itself, and the Commission was working to its own simplification mandate. Some industry positions did not prevail: the proposal left the hazard-based cut-off criteria for carcinogens and endocrine disruptors in place, and the Commission’s plan to lower residue limits on imports of banned substances, opposed by BASF and CropLife, was backed by the Council on September 30, which agreed to technical zero limits for those substances.
The Council’s September 30 mandate otherwise retreats from the Commission text. Unlimited approval would apply only to low-risk substances, while other active substances would get 15 years for a first approval and 25 for renewals, with a periodic EFSA review of scientific literature and a more cautious approach to category 2 carcinogens, mutagens and reproductive toxicants, according to Agence Europe. Against today’s 10 and 15 years, those caps are 50% and 67% longer. In Parliament, the rapporteurs’ June 19 draft goes further than the Commission, extending unlimited approval to nationally authorised products and raising approvals for candidates for substitution from seven to 15 years, according to POLITICO, and the report counts about 1,500 amendments. The joint committee vote planned for October 5 has been postponed, and the Council aims for a provisional agreement by the end of 2026 once Parliament adopts its position.
The part of the story about innovators facing bureaucracy rests on real delays. A 2018 peer-reviewed comparison found that EU approval of microbial biocontrol active substances averaged 1,678 days, about 1.6 years longer than in the United States, while industry and trade coverage cite 7 to 10 years to market against about three in North America or Brazil. The Commission’s package includes an EU-wide biocontrol definition, provisional national authorisations, a single EU zone for biocontrol and low-risk products and tacit mutual recognition after 120 days. Whether unlimited approval for conventional substances speeds any of this is doubtful. The analysis calls the claim that freed capacity will accelerate biocontrol assessment plausible but unsubstantiated, since nothing ring-fences the savings for EFSA or ECHA, and it warns that removing renewal could entrench incumbents by ending the moment at which older substances drop out. The politics also cut across camps: IBMA welcomed the package, including unlimited approval, while Corporate Europe Observatory documents BASF opposing a fast lane for biocontrol, the German chemical lobby VCI warning that prioritisation must not come at the expense of synthetic chemistry, and six member states led by Estonia telling the Council in February that biologicals are not substitutes for chemical products.
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