European Union Renews Approval of Metconazole as Candidate for Substitution

Background and Regulatory Framework

Metconazole, an active substance initially included in Annex I to Council Directive 91/414/EEC, is primarily used as a fungicide and plant growth regulator. The substance has been approved under Regulation (EC) No 1107/2009 and is listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011. The approval was set to expire on 15 March 2025.

An application for the renewal of metconazole's approval was submitted to Belgium and the United Kingdom, acting as the rapporteur and co-rapporteur Member States, respectively. This application followed the procedures outlined in Commission Implementing Regulation (EU) No 844/2012.

Comprehensive Evaluation and Public Consultation

The rapporteur Member State, in consultation with the co-rapporteur Member State, prepared a draft renewal assessment report, which was submitted to the European Food Safety Authority (EFSA) and the European Commission on 26 February 2018. The draft report proposed the renewal of metconazole’s approval.

EFSA made the supplementary summary dossier available to the public and circulated the draft renewal assessment report for comments. A public consultation was launched, and comments received were forwarded to the Commission.

In 2019, EFSA requested additional information on the endocrine-disrupting properties of metconazole. The rapporteur Member State's updated draft renewal assessment report in 2022 confirmed the renewal of approval based on this new information.

Key Findings and Conditions for Renewal

EFSA's conclusion, communicated to the Commission on 11 July 2023, indicated that metconazole meets the approval criteria set out in Regulation (EC) No 1107/2009. The Commission presented a renewal report to the Standing Committee on Plants, Animals, Food and Feed in December 2023 and January 2024.

Despite the renewal, metconazole is considered a candidate for substitution due to its persistence and toxicity. The substance is classified as toxic for reproduction and has a long-term no-observed effect concentration for freshwater organisms of less than 0.01 mg/L. These properties make it essential to impose specific conditions and restrictions on its use.

Specific Provisions and Risk Mitigation Measures

The renewal approval specifies that metconazole's use is limited to professional users only. Member States must ensure that the consumer exposure assessment, protection of operators, bystanders/residents, and aquatic organisms are adequately addressed.

Additionally, confirmatory information on the assessment of water treatment processes and the general toxicity profile of certain metabolites must be submitted by 15 July 2026. This information will further refine the risk assessment and ensure ongoing protection of human health and the environment.

Implementation and Amendments

The renewed approval of metconazole will come into effect on 1 September 2024 and will be valid until 31 August 2031. The Commission Implementing Regulation (EU) No 540/2011 and Commission Implementing Regulation (EU) 2015/408 have been amended to reflect these changes.