Recently, the European Court of Justice ruled on the interpretation of Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. The case focused on the claim that the College voor de toelating van gewasbeschermingsmiddelen en biociden (Plant Protection Products and Biocides Approval Board, Netherlands) (‘CTGB’) failed to properly risk assess several plant protection products using the most up to date scientific knowledge.
This ruling was brought about after PAN Europe filed three complaints before a Dutch Court (which were subsequently passed on to the ECJ), against the reauthorisation of Closer (sulfoxaflor), Dagonis (difenoconazole) and Pitcher (fludioxonil). The argument focused on whether recent guidelines to evaluate endocrine disruption, or the toxicity to bees, should have been used in the assessment rather than deferring to previous assessments performed on the active ingredients performed some years earlier.
More specifically, the complainant stated that the CTGB was required to assess the Endocrine Disrupting properties of a plant protection product, as part of the examination of the application for authorisation, in the light of current scientific and technical knowledge at the time of the decision on that application. In response, CTGB argued that endocrine disrupting properties were not to be re-assessed as part of the authorisation process because assessment of the active ingredient had already taken place, albeit years earlier. In addition, CTGB took the view that the new scientific criteria for the determination of endocrine disrupting properties concern only the approval of the active substance at EU level. The ECJ sided with PAN Europe and clarified that Member States must ensure that the most up-to-date scientific and technical knowledge is considered during authorisation, including assessment for endocrine disruption.
Going forward we are likely to see more evidence of Member States performing their own assessments on active ingredients in plant protection products rather than deferring to EU level conclusions that may or may not be years old and possibly based on outdated science. Consequently, there is likely to be an increase in requests for data and information before authorisation is given for any particular plant protection product.
As regulatory obligations become increasingly complex, there is value in understanding your obligations when you are considering renewing or launching a new product into the market. CEA offers a comprehensive data gap analysis (DGA) service to clients which includes identification of missing data and studies required to complete the dossier submitted for authorisation. This service can be extended to include study monitoring to ensure that data generation is performed to the required standard. Finally, CEA can assist with dossier preparation before submission to the regulators.
To learn more about CEA services and capabilities click here.
To read the court rulings click here: C-308/22(link is external), C-309/22 and C310/22(link is external)
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