
Revised EU Data Rules Set to Reshape Active Substance Approvals for Plant Protection Products
The EU is updating data requirements for active substances in plant protection products, raising safety standards and regulatory expectations.


In a significant legal decision dated 25 April 2024, the European Court of Justice (ECJ) has set a new precedent in the approval process for pesticides across the European Union. This ruling demands that national regulatory bodies assess the endocrine-disrupting potential of active substances in pesticides, which may pose health risks to humans.
The court's decision came in response to concerns about two specific pesticides, Dagonis and Pitcher, which contain substances previously deemed safe under existing EU approvals. Recent scientific research suggested these substances might have endocrine-disrupting effects that could harm human health.
The ECJ ruled that such emerging scientific data must be considered in the pesticide approval process, regardless of the timing of its publication relative to the approval timeline. This directive aligns with Regulation (EC) No 1107/2009, which emphasizes a high level of protection for human and animal health and the environment.
The court underscored that health and environmental safeguards should override the benefits to plant production. This stance reflects the precautionary principle, a foundational element of the EU’s approach to risk management in environmental and health matters.
This ruling clarifies that during the pesticide authorization process, if current and dependable scientific knowledge indicates potential harm from an active substance, it must be rigorously assessed. This includes adherence to the scientific criteria specified in the updated Annex II to Regulation (EC) No 1107/2009, which outlines the standards for identifying endocrine-disrupting properties.
The decision is poised to affect how pesticides are approved and regulated within the EU, leading to stricter evaluations and possibly resulting in the reformulation or withdrawal of certain products from the market. It reinforces the EU's commitment to maintaining stringent safety standards and adhering to the precautionary principle, prioritizing health and environmental considerations over agricultural interests.
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