At the fifth Dublin Plant Protection Symposium, Kerona was pleased to welcome Peter Kugel, partner at VVGB Advocaten in Belgium, who specializes in the intersection of science and law. He offered valuable insights into the legal challenges currently affecting plant protection products (PPPs) in the EU.
Peter discussed several legal cases impacting the PPPs sector in the EU, brought by PAN Europe against authorizations granted by the Dutch authority (CTGB) for products by several companies. The main issue was whether the scientific data used by Member States (MS’) to grant authorizations was sufficient, especially in mutual recognition (MR) procedures. The cases raised questions about risk assessments and the interpretation of “current scientific and technical knowledge” (CSTK), balancing legal certainty and the precautionary principle. PAN Europe argued that outdated guidance led to improper authorizations, while the CTGB defended its decisions based on current legislation. The cases were referred to the European Court of Justice (ECJ), whose ruling will have significant implications for industry and regulatory authorities across Europe.
The recent legal challenges in the EU concerning PPPs highlight judicial cooperation between national courts and the ECJ. National courts refer complex questions to the ECJ to ensure uniform interpretation of EU law. Key issues include whether authorities must assess adverse effects, such as endocrine disruption, when authorizing products and how to incorporate the latest scientific knowledge. Additionally, the role of MR and whether MS’ can depart from the zonal rapporteur’s risk assessment are central concerns. The ECJ’s ruling will provide crucial guidance for regulatory procedures in the EU.
In conclusion, the full impact of the court rulings on PPPs remains uncertain. While the CTGB has adapted its processes, it’s still unclear whether these changes fully align with the court’s interpretations. As the National Court prepares to issue final judgments, questions remain about whether new scientific data should affect authorizations. The Court’s ruling doesn’t allow MS’ to simply reassess active substances, and they must provide clear evidence of unacceptable risks. Moving forward, the system’s efficiency and mutual trust between MS’ will be crucial in addressing these ongoing challenges.
If you missed the Dublin Plant Protection Symposium, please contact Kerona if you wish to purchase a copy of the presentations. For assistance with the Regulation of PPP in the EU and UK the Kerona Regulatory team can be contacted at info@kerona.ie