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

Press release
Indslev, Nørre Aaby, Denmark – 1. july 2025

Agrolab is pleased to announce the appointment of Louise Lading as the new CEO of Agrolab Holding and the subsidiary Agrolab Field, effective August 4, 2025.

Louise Lading brings 20 years of experience in the life sciences and plant protection industry from her time at Bayer, including 12 years in leadership roles. Her work has spanned both Nordic and international teams, giving her a strong understanding of the market and stakeholder landscape.

“I am truly excited to start this new chapter and to work closely with Agrolab’s customers, colleagues and management team. Together, we will ensure that Agrolab remains the preferred partner through unique services and a strong customer focus,” says Louise Lading.

With a background in agronomy and a professional focus on regulatory science, product development, and strategic innovation, Louise Lading is well-positioned to lead Agrolab into its next phase. She brings strong expertise at the interface between technical development, regulation, strategic planning and business, combined with a passionate people leadership style and a collaborative, strategic mindset.

She shares Agrolab’s mission to ensure a safe and sustainable food supply, both for people and the environment, and sees great opportunity in driving innovation and collaboration forward.

Louise takes over the role from Martin Gejl, who will now fully dedicate his time to leading innovation and digital transformation efforts as Innovation Manager at Agrolab's R&D department. An effort to meet the company vision of expanding and developing our services in line with the evolving needs of our clients.

“We’re entering an exciting new chapter, and Louise brings the leadership, customer insight, and innovation mindset to support us in taking the next step. I am very excited and proud to announce that Agrolab will now have a CEO fully dedicated to this role, as it is what the organisation deserves,” says Martin Gejl.

Earlier this year, Agrolab restructured into two subsidiaries, Agrolab Field and Agrolab Consulting, to better reflect its increasingly specialised services and expanding client base. Sandra Schmidt Jørgensen will continue in her role as CEO of Agrolab Consulting, leading the company’s regulatory consulting services. The appointment of a dedicated CEO for Agrolab Holding and Agrolab Field supports this growth and reinforces Agrolab’s position as a trusted partner for scientific field trials, regulatory expertise, and future-forward agricultural solutions.

For media inquiries, please contact:
Sarah Aagaard Hubert
Marketing manager
+45 93 40 66 90
shu@agrolab.dk

About Agrolab

Agrolab is an independent contract research organisation (CRO) made up of two specialised subsidiaries: Agrolab Field, focused on field trials, and Agrolab Consulting, providing regulatory consulting services.
With over 40 years of experience and five stations across Denmark, Latvia, Lithuania and Sweden. Agrolab supports clients both within and outside of the EU North Zone. Known for scientific precision, regulatory insight, and strong collaboration with authorities, Agrolab helps companies of all sizes bring safe, effective agricultural solutions to market.

From April 1, 2025, new data requirements for plant protection product (PPP) dispensation applications in Denmark will take effect. These regulatory updates mean that companies may need to generate additional data to meet compliance standards.

What’s Changing in PPP Dispensation Applications?

Previously, the Danish Environmental Protection Agency (EPA) assessed dispensation applications based on:

• Data provided by the applicant
• EFSA conclusions & EU regulatory evaluations
• Previous Danish or zonal assessments

Moving forward, all aspects of human health and environmental risk assessments must fully comply with the latest data requirements. If existing data does not meet these requirements, additional studies may be required.

Who Is Affected by These Changes?

These updates impact:

• Companies applying for a PPP dispensation in Denmark after March 31, 2025
• Applications that lack sufficient supporting data, which may result in delays or rejections
• Companies working with active substances that require updated risk assessment data

Important: The specific data requirements depend on the active substance and can change over time.

How to Prepare for the New PPP Dispensation Requirements

To avoid delays, the Danish EPA strongly advises applicants to engage with them early in the process to determine whether additional data is needed.

How Agrolab Consulting Can Assist You

Navigating regulatory changes can be complex, but Agrolab Consulting is here to help. Our regulatory experts can:

• Evaluate whether your PPP dispensation application meets the new data standards
• Identify potential data gaps and additional study requirements
• Guide you through the application process to prevent delays or rejections

Get Expert Support Today
Contact us to discuss your case and ensure your PPP dispensation applications remain compliant.

Read the Official EPA Announcement (in Danish) here.

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