Revised EU Data Rules Set to Reshape Active Substance Approvals for Plant Protection Products

Strengthened Safety Standards for Active Substances

The draft regulation introduces significant changes to the types of information required for chemical and biological active substances seeking EU approval. These updates reflect enhanced methodologies for risk assessment and data evaluation, with a strong emphasis on protecting human health, vulnerable groups, animals, and the environment.

Applicants will now need to provide more comprehensive data, including:

• All available toxicological and ecotoxicological studies, including non-target species effects and long-term environmental impact.
• Information on relevant metabolites, breakdown products, and potential groundwater contamination.
• Summaries of peer-reviewed scientific literature.
• Comparative assessments for active substances also used in veterinary or biocidal products.
• Expanded testing protocols for endocrine-disrupting properties, neurotoxicity, and developmental toxicity.

Revised Approach for Biologicals and Micro-organisms

Reflecting a growing market interest in biopesticides, the regulation clearly differentiates data expectations between chemical and biological active substances. A separate dossier structure (Part B) applies for micro-organisms, including metabolites claimed to contribute to plant protection effects. This distinction supports tailored assessments based on substance type and function.

Transition Period and Compliance Strategy

To ease the burden of immediate compliance, the Commission is offering a transitional period of 24 months. During this time, applicants may submit data using either the existing or updated requirements, provided the decision is clearly stated at the time of application and remains fixed for the procedure.

Importantly, plant protection product authorisation applications may also use legacy data requirements if they relate to active substances approved or renewed under the previous rules. This flexibility acknowledges varying levels of readiness across the industry.

Implications Across the Agricultural Supply Chain

This regulatory update carries wide-reaching implications for chemical manufacturers, formulators, food producers, environmental scientists, and policymakers. Stakeholders will need to:

• Reassess existing dossiers and pipeline substances for compliance gaps.
• Prepare to invest in additional studies, particularly those addressing newer endpoints like endocrine disruption and environmental persistence.
• Anticipate extended review times due to expanded data packages.
• Monitor further updates from EFSA and ECHA guidance linked to the new rules.

<h2>New Testing Protocols and Environmental Focus</h2>

The regulation incorporates EFSA’s latest guidance on risk assessments for birds, mammals, and bees, as well as new protocols concerning water treatment and residues. This underscores a shift towards holistic ecosystem protection and drinking water safety.

Industry Response and Call for Feedback

Stakeholders have until 2 October 2025 to submit feedback on the proposed changes via the Commission’s “Have Your Say” portal. Contributions will inform the final version of the regulation, which is expected to be adopted shortly thereafter.