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Japan Opens Consultation on Risk Assessment for Carbendazim and Related Fungicides

General
23
May 2025
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Dr Steven Brennan
Japan launches public consultation on carbendazim health risk assessment—crucial for stakeholders tracking pesticide regulations and compliance deadlines.
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Japan's FSC is reassessing the safety of carbendazim, thiophanate-methyl, and benomyl. The resulting exposure limits could influence compliance requirements across the chemicals and agri-food sectors. Stakeholders are urged to review and comment before the 19 June deadline.

What is the main concern with carbendazim and related fungicides?

The key concern is their shared ability to cause liver and reproductive toxicity. Thiophanate-methyl and benomyl also break down into carbendazim, compounding the exposure risk. Japan is proposing unified ADI and ARfD thresholds for all three.

How does this consultation affect non-agricultural sectors?

While aimed at food safety, changes to pesticide residue rules can impact consumer goods, retailers, and importers, especially those sourcing globally. It may also influence future R&D and formulation decisions within the chemicals industry.

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Japan’s Food Safety Commission (FSC) has launched a public consultation on the health risk assessment of the fungicides carbendazim, thiophanate-methyl, and benomyl, running from 21 May to 19 June 2025. This move holds wide-reaching implications for the chemicals sector, food producers, and the broader manufacturing supply chain, particularly those involved in agricultural inputs and consumer goods.

Evaluation Targets Benzimidazole-Based Fungicides

These three substances, all benzimidazole-class fungicides, are under scrutiny due to their shared metabolic pathways and toxicological concerns. Carbendazim, in particular, has shown stronger toxic effects, prompting its selection as the reference compound for group safety thresholds.

According to the FSC’s draft report, key toxicological effects include liver and testicular damage in animal studies. Acceptable Daily Intake (ADI) and Acute Reference Dose (ARfD) values have been proposed using chronic dog studies and rat reproductive toxicity data, with group limits applying to all three chemicals:

  • ADI: 0.025 mg/kg body weight/day
  • ARfD (general population): 0.14 mg/kg body weight
  • ARfD (pregnant women): 0.1 mg/kg body weight

This approach ensures harmonised exposure limits, especially as thiophanate-methyl and benomyl are known to degrade into carbendazim in plants.

Regulatory Implications for Supply Chain Actors

For stakeholders across agriculture, chemicals, food and beverage, and wholesale and retail, this assessment signals potential adjustments in residue standards and import controls. Companies marketing food products or agrochemicals in Japan must prepare for possible changes to Maximum Residue Limits (MRLs) and registration requirements.

The consultation originates from requests by Japan’s Ministry of Agriculture, Forestry and Fisheries and the Ministry of Health, Labour and Welfare in late 2023, following expanded pesticide applications in crops such as lettuce, grapes, peppers, and leafy greens.

Deadline and Participation Details

Stakeholders have until 19 June 2025 to submit scientific feedback through the e-Gov platform. Only written submissions via the official form, fax, or post are accepted. Contact information and guidelines are available via the FSC website.

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