Metribuzin approval not renewed by EU
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EU proposes not to renew approval of metribuzin
Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance metribuzin, 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 and Commission Implementing Regulation (EU) 2015/408
Update
The European Commission has proposed not to renew approval of the active substance metribuzin due to concerns about its endocrine-disrupting properties. EU Member States will have to withdraw authorisations for products containing metribuzin.
Following this decision, the maximum residue levels (MRLs) for metribuzin are likely to be reduced to the limit of determination (LOD), probably in 2026. (The LOD is the lowest level that can be detected using the most modern and reliable analytical methods.) This would potentially have impacts on exports of cassava, land cresses, and olives for oil production.
Impacted Products
All products; olives for oil production; cassava roots/manioc
What is changing?
The Commission proposes not to renew its approval for the active substance metribuzin. European farmers will therefore no longer be able to use pesticides containing metribuzin. Metribuzin is a herbicide used to control weeds in cereals and a range of horticultural crops.
For an overview of all withdrawals, see Latest pesticide non-renewals, withdrawals & restrictions.
Why?
Approval for use of the active substance metribuzin in the EU was set to expire on 15 February 2025. An application to renew the approval was submitted and evaluated.
EFSA (2023) identified several concerns, particularly endocrine-disrupting properties that may cause adverse effects in humans, and that pose a high risk to bees.
The Commission therefore proposes not to renew approval for this substance.
Timeline
Expected date of entry into force: fourth quarter of 2024.
Existing EU Member State authorisations of products containing metribuzin will need to be withdrawn within 6 months of the Regulation’s entry into force. EU producers will be permitted to use stocks of products for up to 12 months after the Regulation enters into force (approximately end 2025). A revision of metribuzin MRLs is expected for 2026.
What are the major implications for exporting countries?
EU decisions not to renew or withdraw approvals for pesticide active substances primarily impact EU producers. However, following the non-renewal or withdrawal of approvals for pesticide active substances, the EU starts the process of lowering or removing the MRLs. In the case of metribuzin, MRLs are already set for most products at the LOD. However, MRLs are currently still in place for cassava, land cresses, and olives for oil production, and these are likely be lowered. In most circumstances this will mean that metribuzin can no longer be used on these crops for export to the EU. Exporting countries should start to look for alternative solutions to metribuzin or consider a request for EU import tolerances.
Recommended Actions
Authorities in countries that are members of the WTO can provide feedback on the EU’s proposal (G/TBT/N/EU/1076) by emailing the EU TBT Enquiry Point until 10 September 2024.
Suppliers of cassava, land cresses, and olives currently using metribuzin should review current agricultural practices and start to seek alternative solutions in anticipation of changes to EU MRLs.
Background
Pesticide active substances are approved for up to a maximum period 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 to allow for the systematic review of active substances. In some instances, active substances are not reapproved or manufacturers do not seek reapproval, and the substance ceases to be authorised after the expiry date.
The approval of active substances is sometimes withdrawn prior to the approval expiry date where 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 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 at the appropriate limit of quantification (based on specific data on analytical feasibility). MRLs based on Codex MRLs (CXLs) are not deleted where there is no risk to EU consumers. Changes to MRLs are always notified to the World Trade Organization Sanitary and Phytosanitary (WTO 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 European Commission, 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).
Resources
EFSA (2023) Peer review of the pesticide risk assessment of the active substance metribuzin. EFSA Journal, 21(8): 8140.
Sources
Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance metribuzin