Northern Zone Efficacy Guidance 2025 (Version 10) – Key Updates

Discover what’s new in Northern Zone efficacy guidance 2025 (Version 10). Learn updated PPP trial requirements to streamline EU registration.

Updated guidance on efficacy requirements in the northern zone

When applying for authorization of a plant protection product (PPP) in the EU Northern Zone, applicants must follow strict efficacy trial requirements. These are set out in the Guidance on Requirements for Efficacy Data for Zonal Evaluation of a Plant Protection Product in the Northern Zone.

A newly updated Version 10.0 (2025) has now been released. This guidance defines the minimum number, type, and conditions of field trials required to demonstrate product performance — making it central for companies seeking registration.

What’s new in northern zone efficacy guidance (2025, V10)

Here are the top 5 changes in the updated document:

• Trials must now be summarized both according to EPPO Climate Zones and the Regulatory Zone.

• For intended uses with multiple applications per crop, assessments must be made after each application.

• Lower efficacy levels may be accepted if the product provides benefits (e.g., low-risk substances).

• For herbicides and plant growth regulators, wheat selectivity trials no longer automatically cover spelt and durum.

• At least two trials per EPPO climate zone per weed species are now required if the species is listed on the product label.

If you’re preparing a submission, these changes may impact your Biological Assessment Dossier (BAD).

Why this update matters for Applicants

For startups and established companies alike, understanding these updates is critical:

• Delays in registration: Missing or misaligned efficacy data can postpone approval by months or even years.

• Costly repeat studies: Trials that don’t meet Version 10 criteria risk rejection.

• Conservative interpretations: Authorities in Northern Zone countries (Denmark, Sweden, Finland, Norway, Estonia, Latvia, Lithuania) may apply requirements strictly — making careful planning essential.

By aligning development strategies with, applicants can:

• Save time
• Reduce costs
• Increase the chance of first-time dossier approval

Access the full Northern Zone efficacy guidance document

Download Northern Zone Efficacy Guidance (2025, Version 10) via the button below:

You can also access the Version 10 guidance on the Northern Zone Guidance via the official site.

Need Help Navigating the Update?

Agrolab specializes in guiding companies through the full regulatory process — from field trials to dossier preparation.

Talk to our consulting experts about how Version 10 impacts your PPP strategy.

Related Reading

• New data requirements for applications for dispensation of plant protection products in Denmark

• Overview of Northern Zone Registration Process