Tritosulfuron: non-renewal of approval
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EU proposes not to renew its approval of tritosulfuron
Draft Commission Implementing Regulation concerning the non-renewal of approval of the active substance tritosulfuron, 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
Update
The European Commission has proposed not to renew its approval of the active substance tritosulfuron following the manufacturer’s withdrawal of their application for renewal of approval (G/TBT/N/EU/1078). EU Member States will have to withdraw authorisations for products containing tritosulfuron.
This decision should have no impact on exports to the EU.
What is changing?
The European Commission proposes not to renew its approval for the active substance tritosulfuron. European farmers will therefore no longer be able to use pesticides containing tritosulfuron.
Why?
The manufacturer has withdrawn its application for renewal of the approval of tritosulfuron. The Commission therefore proposes not to renew its approval of this active substance.
Timeline
Expected date of entry into force: fourth quarter of 2024.
Existing EU Member State authorisations of products containing tritosulfuron will have to be withdrawn within 6 months after the Regulation enters into force.
EU producers will be permitted to use stocks of products containing this substance for up to 12 months after the Regulation enters into force (approximately to the end of 2025).
What are the major implications for exporting countries?
EU decisions not to renew or withdraw approvals for pesticide active substances primarily affect EU producers.
EU maximum residue levels (MRLs) for tritosulfuron are already set at the limit of determination (LOD – the lowest level that can be detected using the most modern and reliable analytical methods). Suppliers exporting to the EU may only continue to use tritosulfuron provided residues do not exceed these existing MRLs (0.01–0.05 mg/kg).
Recommended Actions
Authorities in countries that are members of the World Trade Organization (WTO) can provide feedback on the EU’s proposal (G/TBT/N/EU/1078) by emailing the EU TBT Enquiry Point until 28 September 2024.
Background
Tritosulfuron is a herbicide used to control broad-leaved weeds in cereals and other crops.
For an overview of all withdrawals and non-renewals, see Latest pesticide non-renewals, withdrawals & restrictions.
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 the European Food Safety Authority (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).
Sources
Draft Commission Implementing Regulation concerning the non-renewal of approval of the active substance tritosulfuron