EU Technical Equivalence Assessment for Pesticides

In recent years, an increasing number of pesticide companies have focused on the EU market for product registration and expansion. Compared to the full active substance approval and formulation registration process, the EU Active Substance Technical Equivalence (TE) assessment offers a more efficient pathway to market entry.

Governed by the Plant Protection Products (PPP) Regulation No 1107/2009, this assessment applies to the EU-level approval of active substances (technical materials). For the authorization of product formulations, aside from using the reference source of active substances already approved, companies can incorporate a new source from a different manufacturer, provided it meets the technical equivalence requirements.

Who Can Apply for the EU TE Assessment?

The EU TE assessment has no specific requirements regarding the identity or location of the applicant. Generally, manufacturers or trading entities can apply directly for TE assessments without the necessity of establishing a subsidiary within the European Union. However, it should be noted that certain EU member states may require the applicant to provide a local contact or address as part of the administrative process.

Strategic Selection of the Reference Member State (RMS)

Although the TE assessment is valid across the entire EU, the evaluation is conducted by a specific RMS, and other Member States recognize the result. The choice of RMS is critical and should be based on several factors:

• Evaluation Capacity: The technical resources available to the authority.
• Staff Configuration and Workload: The availability of experts to handle the specific dossier.
• Review Style: Some member states may have more cautious review styles and request data beyond standard criteria.
• Financial Factors: Variation in evaluation fees and established timelines across different authorities.

Two Stages of EU TE Assessment

The evaluation process is divided into two distinct tiers to compare the new source with the approved reference source:

Tier I (First Stage)

This stage focuses primarily on the evaluation of the chemical composition, the production process, five-batch analysis, and technical specifications. If this stage confirms the sources are technically equivalent, the assessment is approved.

Tier II (Second Stage)

If Tier I fails to establish equivalence—typically due to new impurities or increased levels of existing impurities—the process enters the second, more complex stage. This tier evaluates the toxicological and ecotoxicological properties and hazards of the substance to determine if the risk is manageable.

Selecting the Right Product for Assessment

When choosing an active substance for a TE assessment, companies should consider the following strategic factors:

• Approval Status

The substance must be an active substance already approved at the EU level.

• Patent Status

For substances nearing the end of their patent protection, companies should act quickly to secure market opportunity.

• Risk of Restriction

Consideration should be given to whether the substance faces a risk of being banned or restricted (e.g., endocrine disruptors).

• Economic Benefit

The potential market return in the EU should justify the initial registration costs.

Proregulations' EU Technical Equivalence Services

• EU TE Feasibility Study and Data Gap Analysis
  Determining the feasibility of data reduction or authorization and identifying necessary testing to avoid unnecessary repeat assessments.
• EU TE RMS Selection and Liaison
  Assisting in the selection of the most appropriate RMS and maintaining professional communication with authorities to counter unreasonable data demands.
• EU TE Tier I and Tier II Dossier Preparation
  Compiling the comprehensive technical materials required for both chemical specification reviews and complex toxicological hazard evaluations.
• EU TE Five-Batch Analysis and Laboratory Coordination
  Managing the production and review of five-batch reports, ensuring production dates and analytical method validations meet strict EU standards.
• EU TE Post-Approval Maintenance and LOA Support
  Providing support once the approval letter is issued, including assistance in providing the Letter of Access (LOA) to downstream formulation manufacturers.

If you need to ensure your pesticide active substances meet EU Technical Equivalence requirements or require assistance with RMS selection and Tier I/II assessments, please contact us.