At the CRAC 2025 Conference hosted by ChemLinked, Dr. Martin Weiszenstein from the National Institute of Public Health of the Czech Republic, a renowned authority in the field of EU pesticide registration, provided in-depth insights into the policy details and practical challenges of Technical Equivalence (TE) evaluation. His interpretations offer crucial guidance for enterprises seeking to enter the EU market.​

I. Access to Reference Source Information: The Boundary Between Public and Confidential Data​

The core of a TE application lies in demonstrating consistency with the Reference Source. However, there are clear limitations on the information enterprises can obtain. Dr. Weiszenstein pointed out that the EU only publicly discloses the active ingredient content and relevant impurity limits of the Reference Source. In contrast, specific data on non-relevant impurities is confidential and accessible only to the first registrant or members of the Task Force (joint registration body).​

This rule poses practical challenges for enterprises: due to the opacity of non-relevant impurity information, enterprises cannot fully predict the comparison results before submitting their applications. If new impurities are detected or impurity levels exceed the limits during the comparison, the application will automatically enter the Tier II evaluation phase, and the final conclusion awaits the EU official review. In response, enterprises need to strengthen impurity control in the production process and establish an internal control system based on publicly available limit standards.​

II. Reuse of Re-evaluation Data: Key Logic to Avoid Duplicate Work​

A common question is whether TE applicants need to resubmit new data supplemented during the active substance re-evaluation. The answer is negative. Dr. Weiszenstein clearly stated that toxicological data, impurity studies, and other materials supplemented by the first registrant do not need to be re-submitted by subsequent applicants, and there is no requirement for data compensation.​

The core logic of TE evaluation is confirmation of chemical and toxicological consistency: only when new impurities (not covered by the Reference Source) are identified or impurity levels exceed the approved range, the applicant is required to provide targeted toxicological data. For environmental risk assessment data (such as studies on birds, groundwater, and aquatic organisms), since these have already been included in the re-evaluation framework by the first registrant, TE applicants do not need to provide additional supplementary materials. This rule significantly reduces the registration costs for subsequent enterprises, particularly benefiting small and medium-sized manufacturers.​

III. TE Applications After Re-evaluation: Re-application Required if Standards Change​

After the successful re-evaluation of an active substance, do enterprises with existing TE approvals need to reapply? The answer depends on adjustments to the specifications of the Reference Source. Dr. Weiszenstein emphasized that even if an enterprise’s product still meets the updated standards, if the approval conditions of the Reference Source change, the original equivalence conclusion will no longer be valid, and a new TE application must be submitted.​

This requirement is directly aligned with the core principles of EU pesticide registration. According to Regulation (EC) No. 1107/2009, the approval of active substances is based on scientific assessment, with a typical validity period of 10 years. Re-evaluation may lead to standard upgrades. For example, although the impurity specifications of flumioxazin remained unchanged after re-evaluation, its approval period was extended to 15 years. In such cases, relevant TE applicants still need to confirm consistency with the new approval conditions.​

IV. Safeners and Synergists: Clarifying the Responsible Entity for Registration​

Enterprises often face confusion regarding their registration obligations when applying for formulations containing safeners or synergists. Dr. Weiszenstein clarified that the manufacturer of the substance (safener/synergist), rather than the formulation enterprise, bears the primary registration responsibility. Formulation enterprises should initiate their registration applications only after the relevant substances have completed their own registration, relying on data provided by the manufacturers.​

Currently, the EU is establishing a unified database for safeners and synergists, but implementation differences still exist among member states. Enterprises need to closely monitor the implementation guidelines in their target markets. For instance, there may be procedural differences between the Northern Region (including Denmark, Sweden, etc.) and the Central Region (including the Czech Republic, Germany, etc.). It is essential to establish a data docking mechanism with substance manufacturers in advance.​

V. The PFAS Ban Controversy: Unilateral National Policies Do Not Affect EU Approval​

Denmark’s recent ban on per- and polyfluoroalkyl substances (PFAS) has raised concerns in the industry: will products containing such substances be affected during TE applications? Dr. Weiszenstein provided a clear answer: No.​

This conclusion stems from the division of powers between the EU and its member states: member states may implement unilateral policies based on national conditions, but they have no authority to interfere with scientific reviews at the EU level. A similar case can be seen in the regulation of glyphosate: while France and Germany have imposed restrictive measures, this has not hindered the approval process at the EU level. For the re-evaluation of fluorine-containing active substances, the EU still takes the scientific assessment of the European Food Safety Authority (EFSA) as the core, and the final decision is made through voting by member states. Denmark’s political stance is insufficient to unilaterally influence the overall decision-making.​

Recommendations for Enterprises: Focus on Three Core Principles​

Prioritize Consistency Control: Centered on the publicly available Reference Source standards, strengthen impurity monitoring during production to reduce the risk of Tier II evaluation.​

Dynamically Track Policy Updates: Establish an early warning mechanism for re-evaluation information, with particular attention to adjustments in Reference Source specifications, and promptly initiate preparations for TE re-application.​

Distinguish Between EU and National Responsibilities: In response to unilateral bans by member states, mitigate risks through market diversification—for example, advancing registration in EU countries that have not implemented such bans.​

Dr. Weiszenstein’s interpretations confirm the core logic of EU pesticide registration: scientific assessment as the cornerstone, with clear division of powers and responsibilities. Enterprises should move beyond concerns about individual policies and focus on building a compliant system to navigate the complex regulatory environment.