
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.


The General Court of the European Union delivered a decisive judgement in the case of Ascenza Agro and Industrias Afrasa v Commission (Case T-77/20). This case centred on the controversial non-renewal of approval for the active substance chlorpyrifos-methyl, a key ingredient in many plant protection products.
Ascenza Agro, SA (Portugal) and Industrias Afrasa, SA (Spain), challenged the European Commission's decision to not renew chlorpyrifos-methyl's approval under Regulation (EC) No 1107/2009. This regulation governs the market placement of plant protection products. The applicants sought annulment of Commission Implementing Regulation (EU) 2020/17, which led to the removal of chlorpyrifos-methyl from the EU market.
The Court dismissed the action, upholding the Commission's decision. It ordered Ascenza Agro and Industrias Afrasa to bear their own costs and those incurred by the European Commission, including costs related to interim measures and costs incurred by the Health and Environment Alliance (HEAL). Additionally, the Kingdom of Denmark, the French Republic, and the European Crop Care Association (ECCA) were ordered to bear their own costs.
Chlorpyrifos-methyl is a widely used pesticide in the realm of plant protection for several key reasons:
However, it's important to note that the use of chlorpyrifos-methyl has raised significant environmental and health concerns. Studies have linked it to potential neurological effects in humans, especially children, and it has been found to be harmful to wildlife, particularly aquatic organisms and non-target insects like bees. These concerns have led to regulatory scrutiny and bans or restrictions in several countries, including the European Union.
This judgement underscores the EU's commitment to stringent chemical safety standards and the precautionary principle. The Court's decision highlights the importance of comprehensive risk assessments and the need for transparency in the approval process of active substances in plant protection products.




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