EU Regulation 2024/891: Revised Bifenazate MRLs Effective October 14, 2024

The European Union (EU) continually updates its regulations to ensure consumer safety and maintain high standards in food safety. One of the recent updates is the Commission Regulation (EU) 2024/891, which amends the maximum residue levels (MRLs) for bifenazate, a pesticide used predominantly in non-edible crops. This amendment, enforceable from October 14, 2024, lowers the MRLs for bifenazate in certain products, aligning with the latest scientific insights and international trade considerations.

Background on Bifenazate and Its Regulation

Bifenazate is an acaricide used to control mite populations in agricultural settings. Due to concerns regarding its safety, particularly the unresolved toxicity of its metabolite bifenazate-diazene, the EU has restricted its use to non-edible crops within permanent greenhouses. The renewal of bifenazate's approval in 2022, under Commission Implementing Regulation (EU) 2022/698, highlighted data gaps in the consumer risk assessment for edible crops. Consequently, the new regulation targets ensuring that any residues in or on products are minimized to protect consumer health.

Key Changes in Regulation 2024/891

Amendment of Annexes II and V:

• Annex II: The column for bifenazate is deleted, reflecting the cessation of permissible MRLs for edible crops.
• Annex V: New columns are added, setting MRLs at the limit of determination (LOD) for bifenazate in various non-edible crops. This means that detectable residues should be virtually non-existent, effectively banning any significant residues.

Impact on Different Product Categories

The regulation affects various product groups, setting the MRLs at 0.01 mg/kg or the analytical LOD. Key product categories include:

1. Fruits and Vegetables:

   • Includes citrus fruits, tree nuts, pome fruits, berries, brassica vegetables, and leafy greens.
   • MRLs are generally set at 0.01 mg/kg, indicating minimal residue levels.

2. Herbs and Edible Flowers:

   • Higher sensitivity products like chives, parsley, and basil are included, with LODs ensuring negligible residues.

3. Pulses and Oilseeds:

   • Beans, lentils, soybeans, and sunflower seeds are set to LODs, ensuring safety in these staple products.

4. Animal Products:

   • Residues in meat (swine, bovine, poultry) and products like milk and honey are also tightly controlled, with MRLs at 0.02 mg/kg for animal products and 0.05 mg/kg for honey.

Rationale and Consultations

The regulation is grounded in scientific evaluations and stakeholder consultations:

• Scientific Assessments: The European Food Safety Authority (EFSA) provided critical evaluations, noting gaps in toxicity data for bifenazate and its metabolites.
• International Consultations: The EU engaged with trading partners through the World Trade Organisation (WTO), ensuring that the regulation considers global trade dynamics and does not unfairly impact international partners.

Methodological Approaches to Measuring LODs: The determination of the limits of detection (LOD) involved the use of advanced analytical techniques and equipment, such as high-performance liquid chromatography (HPLC) coupled with mass spectrometry (MS), gas chromatography (GC), and sensitive detectors capable of accurately measuring low levels of residual substances in various product matrices. These methodologies ensure high precision and reproducibility of results, providing reliable and scientifically justified LODs for bifenazate.

Compliance and Adaptation Period

A grace period until January 1, 2024, allows for the sale, distribution, and use of existing stocks, ensuring a smooth transition. By October 14, 2024, full compliance is mandatory, giving ample time for member states, businesses, and trading partners to adapt to the new requirements.

Conclusion

EU Regulation 2024/891 represents a significant step in enhancing food safety standards within the EU by imposing stricter controls on pesticide residues. This proactive measure ensures that consumer health is protected while accommodating international trade standards. Stakeholders in the agricultural and food industries must closely follow these updates to ensure compliance and maintain market access within the EU.