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.
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EU North zone
Frequently asked questions
What is the EU North Zone, and which countries are included?
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.
Why is the EU divided into regulatory zones for PPP registration?
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.
What types of field trials are required for North Zone registration?
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.
How does the climate of the North Zone impact field trials?
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.
What are the main regulatory challenges in the EU North Zone?
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.