Metiram: approval not renewed by EU
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EU does not intend to renew approval of metiram – WTO TBT consultation
Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance Metiram, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011
The European Commission has informed the World Trade Organization Technical Barriers to Trade (WTO TBT) Committee (G/TBT/N/EU/996) that it does not intend to renew approval of the active substance metiram. This is due to concerns about potential adverse effects on human health, and high risks for aquatic organisms. EU Member States will have to withdraw authorisations for products containing metiram. A review of maximum residue levels (MRLs) for dithiocarbamates, which include metiram, will begin in autumn 2023.
What is changing?
The Commission proposes not to renew approval for the active substance metiram. European farmers will therefore no longer be able to use pesticides containing metiram.
For an overview of all other recent withdrawals, see Latest pesticide non-renewals, withdrawals & restrictions.
Approval for use of the active substance metiram in the EU was set to expire on 31 January 2024. An application to renew the approval was submitted and evaluated.
EFSA (2023) identified several concerns, particularly human health risks (endocrine-disrupting properties) to consumers, operators and bystanders; and environmental risks to non-target arthropods and aquatic organisms.
The Commission therefore proposes not to renew approval of this substance.
Proposed date of adoption: fourth quarter of 2023.
EU producers will be permitted to use stocks of products containing metiram until approximately the fourth quarter of 2024.
A revision of dithiocarbamates MRLs, including metiram, is expected in 2024.
What are the major implications for exporting countries?
Where active substances are not reapproved, or are withdrawn or restricted, the European Commission usually also lowers or removes MRLs. Metiram is included in combined MRLs for dithiocarbamates. A review of MRLs for dithiocarbamates will begin in autumn 2023.
Pesticide active substances are approved for up to a maximum of 15 years. Manufacturers may apply for reapproval for a period not exceeding 15 years. Work programmes have been developed by EU Member State authorities and EFSA for the systematic review of active substances. In some cases, active substances are not reapproved or manufacturers do not seek reapproval, so the substance is no longer authorised after the expiry date.
The approval of active substances is sometimes withdrawn before the approval expiry date, if specific consumer health or environmental issues are identified. In some cases, active substances are not withdrawn but their use may be restricted.
Where an authorisation for an active substance is withdrawn or expires due to non-approval or non-renewal, the Commission will prepare a draft measure to delete the relevant existing maximum residue levels (MRLs). In practice, the Commission starts this procedure once all existing authorisations for that active substance have been revoked. MRLs are either set to a default value of 0.01 mg/kg, or to the appropriate limit of quantification (based on specific data on analytical feasibility). MRLs based on the Codex MRLs (CXLs) are not deleted if there is no risk to EU consumers. Changes to MRLs are always notified to the WTO Sanitary and Phytosanitary (SPS) Committee.
The timing of changes to MRLs as a result of the withdrawal or non-approval of active substances is difficult to predict. In its review of pesticide policy, the Commission committed to “enhance communication efforts on the impacts of the PPP Regulation on MRLs as well as the timing of the various procedures to make the EU system more predictable for non-EU countries, including for the cut-off criteria” (European Commission 2020).
Import tolerances can be requested in anticipation of potential changes to MRLs (see the Commission’s Overview of import tolerances). Applicants must demonstrate the existence of relevant good agricultural practices (GAP) in the country of origin, and the safety of the proposed MRLs. Guidelines are available on the requirements and process for the establishment of MRLs, including import tolerances (European Commission 2021).
EFSA (2023) Peer review of the pesticide risk assessment of the active substance metiram. EFSA Journal, 21(4): 7937.
European Commission (2020) Evaluation of Regulation (EC) No 1107/2009 on the placing of plant protection products on the market and of Regulation (EC) No 396/2005 on maximum residue levels of pesticides.
Draft Commission Implementing Regulation concerning non-renewal of approval of the active substance metiram
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