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CropLife Europe Legal opinion ECJ judgements C-308/22, C-309/22 and C-310/22



➢ The ECJ confirmed that the system of division of work and mutual trust between Member States is retained. A concerned Member State (‘cMS’) cannot perform a re-assessment of the same factual circumstances and data that were already taken into account by the zonal Rapporteur Member State (‘zRMS’). There are only very limited situations where a cMS may depart from the assessment of a zRMS. The cMS needs to show which specific environmental or agricultural circumstances prevail in its territory that allow it to depart from the zRMS’ assessment and on the basis of which new reliable scientific and technical data.

➢ To enhance certainty, Member States should demonstrate in the preparation of their assessment that they have taken into account all available most reliable scientific and technical data. This would allow cMS to depart in the specific circumstances from the zRMS’ conclusions only on the basis of reliable scientific and technical data which becomes available after the assessment of the zRMS.

C-309/22 & C-310/22

➢ Th ECJ found that, in case a Member States has to decide on an authorisation application for a product containing an active substance that has Endocrine Disrupting (‘ED’) properties, the Member State is required to take their potential adverse effects into account on the basis of the relevant and reliable scientific and technical knowledge. The ECJ did not, however, rule that such Member State has to conduct a de novo ED assessment for the active substance at national level.

➢ The obligation to take an active substance properties’ potential adverse effects into account is limited to substances where it has been established that it has ED properties. A Member State may e.g. fulfil such obligation by taking note of the knowledge available at the time of its assessment (i.e. at the RMS / EFSA peer review level for the active substance) and, if necessary, consult with the RMS / EFSA.

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