Abstract
Abstract
On 16 December 2025, the European Commission published proposal COM(2025) 1030 within the Food and Feed Safety Simplification Omnibus, aiming to amend Regulation (EC) No 1107/2009 on plant protection products and Regulation (EU) No 528/2012 on biocidal products. The proposal converts the current time-limited approvals of pesticide and biocide active substances (typically 10 to 15 years, followed by mandatory renewal) into time-unlimited approvals by default, replacing periodic reassessment with a reactive, case-triggered review mechanism initiated at the Commission’s discretion. This paper sets out the proposed amendments, surveys the positions taken by the principal stakeholder groups (EU institutions, industry associations, farming organisations, civil society, and the scientific community), and finally presents our own analysis. The Commission justifies the suggested changes largely with the removal of administrative inefficiency. Industry and farming organisations broadly endorse this perspective, whereas civil society organisations oppose the proposal as a weakening of public safety and a disregard of environmental concerns. We find the Commission’s justifications insufficient. The proposal was adopted without a full impact assessment and without a public consultation, and the Commission’s claim that “no viable alternatives” exist disregards the obvious options of extending renewal periods, leveraging the One Substance, One Assessment framework, or reforming the Biocide Review Programme. Substantively, unlimited approval freezes the evidence base at the date of each substance’s most recent evaluation, which for many active substances predates the 2018 endocrine disruption criteria, the 2023 EFSA bee guidance, and ongoing revisions of aquatic and terrestrial ecotoxicology guidance. It also removes the self-selection mechanism through which industry currently withdraws substances expected to fail renewal. Because incumbent substances would no longer be displaced at renewal, market access for innovative alternatives may in turn be hampered. Finally, the proposal introduces legal uncertainty through the deemed mutual recognition between Member States. The replacement of periodic review by Commission-triggered reassessment makes regulatory action dependent on political will and on the monitoring capacity of under-resourced agencies, neither of which past practice gives reason to consider sufficient. A further structural consequence, not assessed by the Commission, is the displacement of scientific disputes from administrative procedure to judicial review. The underlying capacity problems are real, but without a structured and quantitative impact assessment, including an assessment of economic consequences and the outcomes for public health and the environment, the proportionality of the Commission’s proposal cannot be fully evaluated. A necessary next step is therefore the transparent comparison of less intrusive alternatives, before the principle of periodic, science-based reassessment is abandoned.