On 25/04/2024, the European Court of Justice (ECJ) delivered two judgements in case C-308/22 and joined cases C-309/22 and C-310/22, which focus on the authorisation of plant protection products across the European Union. CropLife Europe presents its detailed interpretation of these judgements, highlighting the importance of the harmonized product assessment system based on the division of work and mutual trust between Member States.
This case was referred to the ECJ by the Dutch Administrative High Court for Trade and Industry, following the challenge, brought by Pesticide Action Network Europe, against the decision of the Dutch regulatory authority to extend the authorisation for the placing on the Dutch market of a specific plant protection product.
The ECJ upheld the principle of mutual trust and division of work between Member States. A concerned Member State (cMS) cannot reassess the same data already evaluated by the zonal Rapporteur Member State (zRMS) unless there are specific environmental or agricultural circumstances in its territory justifying a different conclusion. The cMS may then rely on new, reliable scientific and technical data to substantiate its deviation from the zRMS’s assessment.
To ensure regulatory certainty, Member States should demonstrate thorough consideration of all available reliable scientific and technical data during the the preparation of their assessment.
The case, referred to the ECJ by the same aforementioned national Dutch court, concerned a complaint by Pesticide Action Network Europe against the granting of an authorisation for the placing on the Dutch market of two specific plant protection products.
In these cases, the ECJ ruled that, when a Member State evaluates a product containing an active substance with Endocrine Disrupting (ED) properties, it must take into account their potential adverse effects based on the relevant and reliable scientific and technical knowledge.
This means that a Member State is not required to conduct a de novo active substance ED assessment at the national level. This would be a duplication of the work done by the European Union. Instead, in case ED properties have been established, Member States shall take note of any such relevant knowledge available at the time of their assessment and, if necessary, consult with the appropriate bodies such as the assigned Rapporteur Member State for the active substance assessment or EFSA.
Conclusion
The ECJ judgements play a role in reinforcing the collaborative framework within the EU for assessing pesticides and biopesticides. To a large extent, the questions referred to the ECJ result from regulatory assessments taking more time than foreseen, whilst scientific and technical knowledge may further develop. In the limited circumstances outlined by the ECJ, such new knowledge can be taken into account by a Member State. Against this background, and duly taking into account the specifics of the cases referred to the ECJ, these judgments must be interpreted as contributing to the importance of the system of division of work and mutual trust between Member States.
For further details, please see CropLife Eruope’s legal opinion here