Blog | Agrolab https://agrolab.dk/category/blog/ Regulatory Consulting and Field trials Fri, 06 Mar 2026 09:29:37 +0000 en-GB hourly 1 https://wordpress.org/?v=6.5.10 https://agrolab.dk/wp-content/uploads/2024/06/cropped-Agrolab-website-icon-512-x-512-px-2-32x32.png Blog | Agrolab https://agrolab.dk/category/blog/ 32 32 https://agrolab.dk/northern-zone-efficacy-guidance-2025/ Wed, 10 Sep 2025 07:43:27 +0000 https://agrolab.dk/?p=8451 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 […]

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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:

Access Efficacy Guidance

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.

 

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]]> The EU North zone: the role it plays in regulatory approval https://agrolab.dk/eu-north-zone/ Mon, 10 Feb 2025 14:19:37 +0000 https://agrolab.dk/?p=7449 The EU North Zone consists of Denmark, Sweden, Latvia, Lithuania and Norway. While Norway is not an EU member the country still aligns with many EU regulations.For companies developing plant protection products (PPPs), the EU North Zone plays a key role in the regulatory approval process. To streamline product registrations and ensure testing reflects relevant […]

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Drone capturing canopy height measurements in a field trial.

The EU North Zone consists of Denmark, Sweden, Latvia, Lithuania and Norway. While Norway is not an EU member the country still aligns with many EU regulations.

For companies developing plant protection products (PPPs), the EU North Zone plays a key role in the regulatory approval process. To streamline product registrations and ensure testing reflects relevant agricultural and climatic conditions, the EU has divided its member states into North, Central, and South zones.

What Is the EU North Zone?

The EU has divided its member states into three regulatory zones—North, Central, and South—to harmonize the approval process for PPPs.

By grouping countries with similar climatic conditions, the North Zone system allows companies to conduct field trials and submit a single regulatory dossier that can be assessed for multiple countries. This approach reduces the need for duplicate studies, making the approval process more efficient.

Regulatory Approvals and Data Requirements

To register a PPP in the North Zone, applicants typically need:

  • Zonal dossiers that include efficacy, environmental, and human health risk assessments
  • GEP efficacy trials to demonstrate product performance under real-world conditions
  • GLP studies when required for environmental risk assessment
  • National addenda, as some countries impose additional requirements beyond zonal evaluations

While regulatory authorities in the North Zone cooperate on dossier evaluations, each country makes its own final decision on product approval. This means additional national data may sometimes be required.

For further details on North Zone regulatory cooperation, visit the Danish Environmental Protection Agency’s guide.

Conducting Field Trials in the North Zone

The North Zone’s cooler climate, long daylight hours, and unique agricultural practices influence how PPPs perform in the field. To ensure regulatory acceptance, field trials must:

  • Be conducted under Good Experimental Practice (GEP) to generate high-quality efficacy data
  • Reflect local agronomic conditions
  • Follow EU and national guidelines for data collection and reporting

For companies unfamiliar with the region, working with experienced partners can help ensure trials meet both EU and national requirements efficiently.

At Agrolab Field and Agrolab Consulting, we specialize in helping clients generate high-quality data and navigate regulatory approvals efficiently within the EU North Zone. Our close collaboration with authorities, deep regulatory expertise, and extensive field trial experience makes us a trusted partner.

 

Learn More

Ready to explore how drone technology can elevate your field trials? Contact us today or learn more about our GEP field trial services.

Stay at the forefront of innovation with Agrolab—the leading private research organization in the EU North zone.

Martin Gejl

Innovation Manager

Phone: +4520736575

Email: mg@agrolab.dk

EU North zone
Frequently asked questions

 

The EU North Zone is one of three regulatory zones in Europe for plant protection product (PPP) registration. It includes Denmark, Estonia, Finland, Ireland, Latvia, Lithuania, Sweden, and Norway. This grouping ensures that products are tested and evaluated under similar climatic conditions.

The zonal system was introduced to simplify the registration process by allowing companies to submit a single dossier for multiple countries within the same climatic zone. While the evaluation is shared among North Zone authorities, each country still makes its own final approval decision.

For efficacy data, GEP field trials are required to demonstrate how a product performs under real-world conditions. Additional GLP studies may be needed for environmental risk assessments. National authorities may also request supplementary data depending on local agricultural practices and regulations.

The EU North Zone has a cooler climate, long daylight hours in summer, and distinct seasonal variations that influence crop growth and pest pressures. Trials must reflect these conditions to ensure data is relevant for registration.

While the zonal approach streamlines PPP registration, national differences in additional data requirements, risk assessments, and product usage restrictions can add complexity. Close collaboration with local regulatory authorities and experienced partners can help navigate these challenges efficiently.

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