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396/2005

Maximum residue levels for thiophanate-methyl

  • Food safety
  • Pesticide MRLs
  • Pesticides

Summary

The European Commission has presented a draft proposal to reduce the maximum residue levels (MRLs) for thiophanate-methyl MRLs to the limit of determination (LOD) on oranges, grapefruits, mandarins, mangoes, and papayas. (The LOD is the lowest level that can be detected using the most modern and reliable analytical methods.)

This proposal follows the rejection by the European Parliament in September 2024 of a previous Commission proposal to maintain MRLs on limes and okra. The Parliament requested the Commission to reduce the MRLs for thiophanate-methyl MRL on all products to the LOD. See Maximum residue levels for benomyl, carbendazim, thiophanate-methyl, cyproconazole, and spirodiclofen.

The new proposal is limited to those products for which acute health risks have been identified. Discussion of other MRLs that do not have implications for consumer health will be held at a later stage (European Commission 2025a).

European Commission proposes to reduce thiophanate-methyl MRL to 0.01 mg/kg on oranges, grapefruit, mandarins, mangoes, and papayas

Draft Commission Regulation amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for carbendazim and thiophanate-methyl in or on certain products

Update

The European Commission has presented a draft proposal to reduce the maximum residue levels (MRLs) for thiophanate-methyl MRLs to the limit of determination (LOD) on oranges, grapefruits, mandarins, mangoes, and papayas. (The LOD is the lowest level that can be detected using the most modern and reliable analytical methods.)

This proposal follows the rejection by the European Parliament in September 2024 of a previous Commission proposal to maintain MRLs on limes and okra. The Parliament requested the Commission to reduce the MRLs for thiophanate-methyl MRL on all products to the LOD. See Maximum residue levels for benomyl, carbendazim, thiophanate-methyl, cyproconazole, and spirodiclofen.

The new proposal is limited to those products for which acute health risks have been identified. Discussion of other MRLs that do not have implications for consumer health will be held at a later stage (European Commission 2025a).

Impacted Products

Oranges, grapefruit, mandarins, mangoes, papayas

What is changing?

In February 2025, the European Commission presented a draft proposal to lower the MRLs for thiophanate-methyl to 0.01 mg/kg on oranges, grapefruit, mandarins, mangoes, and papayas due to acute health risks (see Table 1).

Why?

Thiophanate-methyl is no longer authorised in the EU because the manufacturer withdrew its new application for approval.

EFSA (2021) suggested reducing the MRLs to the LOD, except on certain products that are considered safe. It proposed increasing the MRLs for thiophanate-methyl on limes, aligning with good agricultural practices (GAP) observed in certain non-EU countries, and a lower MRL deemed safe for thiophanate-methyl on okra/ lady’s fingers, also derived from the GAP in non-EU countries.

The Commission proposal is limited to those products for which acute health risks have been identified. Discussion of other MRLs identified by EFSA that do not have implications for consumer health will be held at a later stage

Timeline

The proposal will be discussed by EU Member States in June 2025 (European Commission 2025b). Due to the acute health risk, the Commission proposes that the new MRLs should apply 3 months after the new Regulation is published, rather than the usual 6 months (European Commission 2025a). Publication is likely to be in the fourth quarter of 2025.

Recommended Actions

Suppliers to the EU market of oranges, grapefruit, mandarins, mangoes, and papayas should prepare for the thiophanate-methyl MRLs to be reduced to 0.01 mg/kg, taking into account the potentially short period for transition (see Timeline).

Background

In September 2024, the European Parliament rejected a Commission Regulation that proposed to reduce the MRLs for thiophanate-methyl to the LOD on all products except limes and okra (see Maximum residue levels for benomyl, carbendazim, thiophanate-methyl, cyproconazole, and spirodiclofen). The Parliament requested the Commission to withdraw its draft Regulation and present a new one, setting the MRLs for thiophanate-methyl MRL on all products to the LOD.

MRLs are set in accordance with the rules set out in Regulation 396/2005. For information on current MRLs for other substances, please consult the EU Pesticide Residues database.

Resources

Sources

Draft Commission Regulation as regards maximum residue levels for carbendazim and thiophanate-methyl in or on certain products

Tables & Figures

AG00340_Table1_REV1_04-06-25

Source: based on Draft Commission Regulation

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European Commission proposes to reduce thiophanate-methyl MRL to 0.01 mg/kg on oranges, grapefruit, mandarins, mangoes, and papayas

Draft Commission Regulation as regards maximum residue levels for carbendazim and thiophanate-methyl in or on certain products

What is changing and why?

The European Commission has presented a draft proposal to lower the maximum residue levels (MRLs) for thiophanate-methyl to 0.01 mg/kg on oranges, grapefruit, mandarins, mangoes, and papayas (see Table 1).

Actions

Suppliers to the EU market of oranges, grapefruit, mandarins, mangoes, and papayas should prepare for the thiophanate-methyl MRLs to be reduced to 0.01 mg/kg, taking into account the potentially short period for transition.

Timeline

The proposal will be discussed by EU Member States in June 2025. Due to the acute health risk, the Commission proposes that the new MRLs should apply 3 months after the new Regulation is published, rather than the usual 6 months. Publication is likely to be in the fourth quarter of 2025.

Tables & Figures

AG00340_Table1_REV1_04-06-25

Source: based on Draft Commission Regulation

Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.