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Summary of Commission Regulation (EU) 2024/2619 of 8 October 2024
This regulation amends Annexes II and III to Regulation (EC) No 396/2005, specifically updating the maximum residue levels (MRLs) for fosetyl, potassium phosphonates, and disodium phosphonate in or on certain products.
Key Provisions:
- Residue Definition Update: The residue definition for enforcement is changed from “Fosetyl-Al (sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl)” to “phosphonic acid and its salts, expressed as phosphonic acid”. This change acknowledges that these substances degrade to phosphonic acid.
- New MRLs Established: Based on the new residue definition, new MRLs are set for various products as identified by the European Food Safety Authority (EFSA).
- Consideration of Other Sources: Since potassium phosphonates are also used in products like fertilizers and plant strengtheners, the regulation considers residues from sources other than plant protection products when setting MRLs.
- Findings of Fosetyl: Residues of the parent substance fosetyl may be found in some crops. The regulation stipulates that findings of fosetyl should not be considered, and the default MRL of 0.01 mg/kg does not apply. Instead, the MRL for phosphonic acid applies.
- Limits of Determination (LOD): The European Union Reference Laboratories have established achievable LODs:
- 0.1 mg/kg in high water and acidic plant origin matrices
- 0.2 mg/kg in high fat and dry/high starch content plant origin matrices
- 0.05 mg/kg in milk
- 0.2 mg/kg in fat
- 0.5 mg/kg in liver, kidney, and muscle
- Lowest MRLs Maintained: Due to residue persistence and multiple sources, the lowest MRL is maintained at 1.5 mg/kg (adjusted from 2 mg/kg). For teas, coffee, herbal infusions, cocoa, and carobs, a lowest MRL of 20 mg/kg is set.
- MRLs for Specific Products: MRLs are established for specific products even when some data is lacking, provided no consumer risk is identified. These MRLs will be reviewed in the future:
- Within Two Years: Oranges, grapefruits, apples, pears, pineapples, cucurbits with inedible peel, dry peas, and potatoes (processing studies).
- Within Five Years: Dates, figs, kumquats, litchis/lychees, certain vegetables, herbs, spices, sugar beet roots, and sugar canes.
- MRLs Set for Product Groups: For categories where specific MRLs were not recommended, MRLs are set to the lowest applicable within that group. For “Solanaceae and Malvaceae, others” and “lettuces and salad plants, others,” MRLs are set based on existing national authorizations.
- Animal Products: MRLs for edible offals (other than liver and kidney) are set to the highest within the group to ensure realistic levels. MRLs for “other farmed terrestrial animals” are aligned with those for bovine animals.
- Applications for MRL Modifications: The regulation incorporates modifications to existing MRLs based on applications for citrus fruits, cherries, plums, chards/beet leaves, herbal infusions, honey, leeks, and spring onions. EFSA assessed these applications, and MRLs were updated where data requirements were met and no consumer risk was identified.
- Transitional Arrangements: Products placed on the market before 29 April 2025 may continue to comply with previous MRLs. The new MRLs apply from 29 April 2025.
Amendments to Annexes II and III:
- Annex II: New columns for fosetyl and phosphonic acid are added, specifying MRLs for a wide range of products. Examples include:
- Tree Nuts: Almonds, hazelnuts, walnuts, pistachios with MRLs up to 1,000 mg/kg.
- Berries: Raspberries, blackberries with MRLs up to 200 mg/kg.
- Fruiting Vegetables: Tomatoes, sweet peppers, aubergines with an MRL of 70 mg/kg.
- Leaf Vegetables: Spinaches with an MRL of 200 mg/kg; lettuces up to 200 mg/kg.
- Cereals: Wheat with an MRL of 80 mg/kg; rice with an MRL of 3 mg/kg.
- Animal Products: Specific MRLs for muscle, fat, liver, kidney, and milk are established.
- Annex III: The column for fosetyl-Al in Part A is deleted, reflecting the updated residue definitions.
Important Notes:
- Non-Consideration of Fosetyl Findings: Fosetyl findings are not considered, and the MRL for phosphonic acid applies instead of the default 0.01 mg/kg.
- Footnotes and Deadlines: The regulation includes footnotes specifying deadlines for submitting additional data (e.g., by 9 October 2026 or 9 October 2029) for certain products where data is currently lacking.
Implementation Dates:
- Entry into Force: The regulation enters into force on the twentieth day after its publication in the Official Journal of the European Union.
- Applicability: The new MRLs apply from 29 April 2025.
- Transitional Measures: Products placed on the market before 29 April 2025 may continue to comply with the MRLs as they stood before this regulation.
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