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The Commission Regulation (EU) 2024/2609 amends Annex II to Regulation (EC) No 396/2005 by adjusting the maximum residue levels (MRLs) for the active substances napropamide, pyridaben, and tebufenpyrad in or on certain products.
Amendments to Maximum Residue Levels (MRLs)
1. Napropamide
The MRLs for napropamide have been revised as follows:
- Citrus Fruits, Strawberries, and Cane Fruits: The existing MRLs are maintained. Footnotes requiring the submission of additional information have been deleted.
- Blueberries, Cranberries, Currants, Gooseberries, Rose Hips, and Elderberries: MRLs have been lowered to the product-specific limit of determination (LOD) due to insufficient data on crop metabolism. Footnotes have been removed.
- Herbs and Edible Flowers: MRLs are set at the product-specific LOD because the required residue trials data were not submitted. Footnotes are deleted.
- Herbal Infusions and Fruit Spices: MRLs are maintained at the LOD. Footnotes requiring additional information are deleted.
2. Pyridaben
The MRLs for pyridaben have been updated as follows:
- Pome Fruits (Apples, Pears, Quinces, Medlars, Loquats/Japanese Medlars, and Other Pome Fruits): New residue data allowed for a lower, safe MRL for the whole group. Existing MRLs are adjusted, and footnotes are deleted.
- Apricots, Peaches, and Beans (with pods): MRLs are set at the product-specific LOD due to lack of required residue trials data. Footnotes are deleted.
- Bovine, Sheep, Goat, Equine (Muscle, Fat, Liver, Kidney), and Milk (Cattle, Sheep, Goat, Horse): For milk, MRLs remain at the LOD. For the mentioned animal products, the LOD is lowered from 0.05 mg/kg to 0.01 mg/kg, achievable with the provided analytical method. Footnotes are deleted.
3. Tebufenpyrad
The MRLs for tebufenpyrad have been changed as follows:
- Apricots and Peaches: Existing MRLs are lowered based on new residue trials. Footnotes are deleted.
- Blackberries and Dewberries: Existing MRLs are maintained. Footnotes are deleted.
- Beans (with pods) and Hops: MRLs are set at the product-specific LOD due to lack of required data. Footnotes are deleted.
- Products of Animal Origin (Except Honey and Other Apiculture Products): Existing MRLs are maintained. Footnotes are deleted.
- Honey and Other Apiculture Products: MRLs remain at the LOD. Footnotes are deleted.
- Table Grapes: MRL is lowered based on safer Good Agricultural Practices, as the current MRL could potentially exceed the acute reference dose.
Specific Changes to MRLs
The Annex to Regulation (EC) No 396/2005 is amended by replacing the columns for napropamide, pyridaben, and tebufenpyrad with updated MRLs for various products. Key changes include:
Napropamide
- Fruits: MRLs for citrus fruits are maintained at 0.6 mg/kg.
- Berries and Small Fruits: MRLs for strawberries are maintained at 0.9 mg/kg, and for cane fruits, MRLs are set to 0.01 mg/kg (LOD).
- Other Small Fruits and Berries: MRLs for blueberries, cranberries, currants, gooseberries, rose hips, and elderberries are set to 0.01 mg/kg (LOD).
- Herbs and Spices: MRLs for herbs and edible flowers are set at 0.02 mg/kg (LOD).
Pyridaben
- Pome Fruits: MRLs are lowered to 0.15 mg/kg for apples, pears, and other pome fruits.
- Stone Fruits: MRLs for apricots and peaches are set to 0.01 mg/kg (LOD).
- Beans (with pods): MRLs are set to 0.01 mg/kg (LOD).
- Animal Products: MRLs for bovine, sheep, goat, and equine tissues (muscle, fat, liver, kidney) are lowered to 0.01 mg/kg (LOD). MRLs for milk remain at 0.01 mg/kg (LOD).
Tebufenpyrad
- Apricots and Peaches: MRLs are lowered to 0.3 mg/kg.
- Table Grapes: MRL is lowered to 0.4 mg/kg.
- Blackberries and Dewberries: MRLs are maintained at 0.05 mg/kg.
- Beans (with pods) and Hops: MRLs are set to 0.01 mg/kg (LOD).
- Animal Products: MRLs for products of animal origin are maintained or set at the LOD. MRL for honey remains at 0.05 mg/kg (LOD).
Limit of Determination (LOD)
Where MRLs are set at the limit of analytical determination, they are indicated with an asterisk (*1) in the Annex (e.g., 0.01 mg/kg (*1)). This denotes the lowest concentration that can be reliably measured using current analytical methods.
Transitional Measures and Application Dates
- Entry into Force: The Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
- Application Date: The new MRLs apply from 28 April 2025.
- Transitional Provisions: Products placed on the market before 28 April 2025 may comply with the previous MRLs, except for tebufenpyrad in or on table grapes, which must comply with the new MRLs without transition.
Footnotes and Designations
In the updated Annex II:
- Footnote (*1): Indicates that the MRL corresponds to the lower limit of analytical determination.
- Fat Soluble Substances: Pyridaben and tebufenpyrad are designated as fat-soluble, noted with “(F)” in the Annex.
Conclusion
The amendments ensure that the MRLs for napropamide, pyridaben, and tebufenpyrad are updated based on recent data and assessments, aligning with current safety standards and analytical capabilities.
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