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Fieldfisher Brussels Regulatory team has successfully overturned the EU General Court’s judgment on the non-renewal of mancozeb under Regulation 1107/2009 for our clients, UPL Europe Ltd and Indofil Industries (Netherlands) BV.
In a landmark judgment delivered on 4 October 2024, the ECJ ruled that the European Commission had wrongly relied on non-legally binding and outdated scientific evidence to decide against renewing the approval of mancozeb, a widely used fungicide. The court found that the Commission's reliance on a non-legally binding opinion from the European Chemicals Agency’s (ECHA) Risk Assessment Committee (RAC) was unjustified.
Mancozeb, commonly used to protect crops like potatoes and tomatoes from fungal diseases, has faced scrutiny over potential toxicity concerns. In 2020, the European Commission issued a regulation (EU 2020/2087) refusing to renew the substance’s approval, largely based on concerns about its classification as toxic to reproduction. The Commission’s decision was primarily supported by a 2018 opinion from the RAC, which classified mancozeb as a toxic substance for reproduction in category 1B, whereas at the time the legally applicable classification of mancozeb was Cat 2. Moreover, the Commission did not give the applicants the possibility to challenge the RAC opinion effectively, thereby denying their right of defence.
The RAC opinion mainly relied on an outdated, non-GLP study from 1980 on a metabolite of mancozeb (ETU), raising questions about its scientific reliability and relevance. The ECJ found that the Commission, and in turn the General Court, failed to take these important elements into account.
This outstanding achievement was achieved by a team led by Partner, Claudio Mereu, alongside Senior Associate Iacopo Zonca, Counsel Simon Englebert and Associate Maria Beatrice Grassi.
Claudio Mereu commented: "This is a landmark decision setting an important precedent whereby reference cannot be made to a non-legally binding RAC opinion when there is an existing CLP classification. It also questions the validity of scientific opinions classifying one substance based on old studies conducted on another substance (in this case a metabolite of mancozeb)."