On 4 October 2024, the European Court of Justice’s Ninth Chamber ruled that the European Commission wrongly relied on outdated scientific evidence when deciding not to renew the approval of mancozeb, a widely used fungicide. The court found that the Commission's reliance on an old opinion from the European Chemicals Agency’s (ECHA) Risk Assessment Committee (RAC) was unjustified, partially overturning the General Court’s previous judgment.
The Case Against Mancozeb
Mancozeb, a fungicide commonly used to protect crops such as potatoes and tomatoes from fungal diseases, has faced increasing scrutiny due to concerns over its potential toxicity. 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.
UPL Europe Ltd and Indofil Industries’ Appeal
UPL Europe Ltd and Indofil Industries (Netherlands) BV, companies that produce products containing mancozeb, appealed the Commission’s decision. They argued that the Commission relied on outdated and flawed data without fully considering new scientific evidence, particularly the updated draft renewal assessment report (RAR) submitted by the new rapporteur member state (RMS), Greece, in 2020.
Court’s Findings
The Ninth Chamber agreed with the appellants that the European Commission should not have based its decision solely on the RAC’s 2018 opinion, which was derived from older studies. The court stressed that regulatory decisions must be made using the latest scientific data, in line with EU regulations requiring pesticide assessments to ensure the protection of human health and the environment.
The court also criticised the General Court for denying the appellants the opportunity to challenge the RAC’s opinion, stating that applicants should have been allowed to present new scientific evidence.
Claudio Mereu, a Partner at Fieldfisher who represented the case in court, 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).
Commission’s Procedural Errors
One of the key issues identified was the Commission’s failure to take into account the more recent scientific evaluations provided by Greece, the new RMS following the UK’s departure from the EU. The Court highlighted that this procedural oversight led to a flawed risk assessment of mancozeb, which could have influenced the final decision on its renewal.
What Happens Next?
Although the European Court of Justice has set aside part of the General Court’s ruling, it did not issue a final judgement on the renewal of mancozeb. The case has been referred back to the General Court, which must now re-examine the evidence based on updated scientific data and decide whether the Commission’s decision to refuse renewal still stands.
Implications for Future Pesticide Regulations
This ruling emphasises the importance of making regulatory decisions on pesticides using the most current scientific evidence available. As the EU continues to refine its pesticide approval process, this case sets a significant precedent, ensuring that regulatory bodies thoroughly evaluate new data and respect applicants’ rights.
