Latest pesticide non-renewals, withdrawals, restrictions, and non-approvals (2024)

Commission Implementing Regulation (EU) 2024/1207 of 29 April 2024 concerning the non-renewal of the approval of the active substance dimethomorph

Draft Commission Implementing Regulation withdrawing the approval of the active substance acibenzolar-S-methyl in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, amending Commission Implementing Regulation (EU) No 540/2011 and repealing Commission Implementing Regulation (EU) No 2016/389

Commission Implementing Regulation (EU) 2024/425 concerning the non-approval of the active substance asulam-sodium

Commission Implementing Regulation (EU) 2024/20 concerning non-renewal of the approval of the active substance S-metolachlor

Update

This report summarises recent EU decisions not to renew, or to withdraw, existing approvals for certain pesticide active substances. While these decisions primarily affect EU producers, they will probably be followed by legislation to reduce the maximum residue levels (MRLs) to 0.01 mg/kg or the limit of determination (LOD – the lowest level that can be detected using the most modern and reliable analytical methods). These decisions therefore provide an early indication of upcoming MRL changes, and the likely need to look for alternative solutions on crops for export to the EU.

This report also includes EU non-approval decisions. These are relevant to producers in exporting countries where these substances may be used locally. In such cases a default MRL of 0.01 mg/kg will be maintained.

What is changing?

The EU systematically reviews the status of all pesticide active substances that are approved for use within the European Union. Recent non-renewals and withdrawals of approvals are summarised in Table 1. To check the expiry or review dates of other pesticide active substances, see the EU Pesticides Database.

In addition, the EU has decided not to approve the active substance asulam-sodium.

Why?

EFSA (2021a) identified endocrine-disrupting properties as the main hazard associated with the use of asulam-sodium. EFSA’s approval criteria were not satisfied and the applicant ultimately withdrew its application for the approval of this substance. This decision does not prevent the submission of a further application for approval of asulam-sodium.

Timeline

Expiry dates for the substances affected are listed in Table 1. After these dates, the pesticides can no longer be used in the EU.

The European Commission is expected to follow up with proposals to reduce or remove the MRLs for these substances, which will affect their use on crops for export to the EU. Any changes to MRLs are notified to the World Trade Organization Sanitary and Phytosanitary (WTO SPS) Committee, and details will be provided on the AGRINFO website.

What are the major implications for exporting countries?

Decisions not to renew or to withdraw EU approvals for the use of certain pesticide active substances mainly affect their use within the EU. However, following a non-renewal or withdrawal of approval, in most cases the EU starts the process of lowering or removing the associated MRLs. These are typically set at 0.01 mg/kg or the LOD. In many circumstances this means that they can no longer be used on crops for export to the EU, and action is needed.

Recommended Actions

Export sectors affected should start looking for alternative crop protection solutions to S-metalochlor, or assess possible adaptations of GAP. Exporting countries could also consider requesting EU import tolerances (for guidelines see European Commission 2021). See Pesticide residue import tolerance MRLs explained.

Background

For decisions taken in 2023, see Pesticide non-renewals, withdrawals, and restrictions (2023).

Pesticide active substances are approved for up to a maximum period of 15 years. Manufacturers may apply for reapproval of a substance for a period not more than 15 years. The EU systematically reviews all active substances.

Substances can be:

• not reapproved: if there is insufficient data to permit reapproval, or because the manufacturer does not seek reapproval
• withdrawn: where specific consumer health or environmental issues are identified, sometimes before the normal expiry date
• restricted: where data supports renewal, but only under new specific conditions of use.

Where an authorisation for an active substance is withdrawn or expires due to withdrawal of approval or non-renewal, the European 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 set either to a default value of 0.01 mg/kg, or to the lowest limit technically possible using current analytical methods. MRLs based on the Codex MRLs (CXLs) are not deleted where there is no risk to EU consumers, or no global environmental concern. Changes to MRLs that impact trade are always notified to the WTO SPS Committee.

The precise timing of changes to MRLs resulting from the withdrawal or non-renewal 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 Overview table 2009–2020), but 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 establishing MRLs and import tolerances (European Commission 2021).

Resources

Sources

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Regulation

Regulation (EU) 2024/1207 concerning the non-renewal of the approval of the active substance dimethomorph

Regulation 2024/425 concerning the non-approval of the active substance asulam-sodium

Regulation (EU) 2024/20 concerning non-renewal of the approval of the active substance S-metolachlor

Draft Regulation withdrawing the approval of the active substance acibenzolar-S-methyl

What is changing and why?

The EU systematically reviews the status of all pesticide active substances that are approved for use within the European Union. Recent withdrawals of approvals are summarised in Table 1.

In addition, the EU has decided not to approve the active substance asulam-sodium because the approval criteria of the European Food Safety Authority (EFSA) could not be satisfied, and the applicant ultimately withdrew its application. This decision does not prevent the submission of a further application for approval of asulam-sodium.

Actions

Export sectors affected should start looking for alternative crop protection solutions to S-metalochlor, or assess possible adaptations of good agricultural practices (GAP). Exporting countries can also request EU import tolerances (for guidelines see European Commission 2021). See Pesticide residue import tolerance MRLs explained.

Timeline

The pesticides listed in Table 1 can no longer be used in the EU after the expiry dates shown.

For each substance, the European Commission is expected to follow up with proposals to reduce or remove the MRLs. Suppliers in non-EU countries may need to adjust agricultural practices to meet reduced MRLs. Any changes to MRLs are notified to the World Trade Organization Sanitary and Phytosanitary (WTO SPS) Committee. Details will be provided on the AGRINFO website.

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