Considerations on COM(2023)739 - Amendment of Annex II to Regulation 396/2005 as regards maximum residue levels for thiacloprid in or on certain products - Main contents
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| dossier | COM(2023)739 - Amendment of Annex II to Regulation 396/2005 as regards maximum residue levels for thiacloprid in or on certain products. |
|---|---|
| document | COM(2023)739  |
| date | November 24, 2023 |
(2)According to Commission Implementing Regulation (EU) 2020/23 5 , the approval of the active substance thiacloprid was not renewed, following the critical concerns identified by the European Food Safety Authority (the ‘Authority’) in relation to the contamination of groundwater with metabolites of thiacloprid 6 . Additionally, thiacloprid is classified in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council 7 as toxic for reproduction category 1B 8 .
(3)All authorisations for plant protection products containing the active substance thiacloprid have been revoked, due to the human health risk emanating from the use of thiacloprid and the contamination of groundwater. It is therefore appropriate to delete the existing MRLs based on the good agricultural practices related to those authorisations set for this substance in Annex II of Regulation (EC) No 396/2005 in accordance with Article 17 of that Regulation in conjunction with Article 14(1)(a) thereof.
(4)In accordance with Article 43 of Regulation (EC) No 396/2005, the Commission requested the Authority to provide a reasoned opinion, assessing the risks that the current MRLs based on import tolerances and Codex MRLs (CXLs) for thiacloprid may pose to consumers considering the most recent consumption data available and the presence or absence of the required confirmatory data to address the data gaps identified during the MRL review in accordance to the Article 12 of Regulation (EC) No 396/2005 9 .
(5)The Authority concluded that the MRLs set for thiacloprid residues in papayas and tea were derived from import tolerances, which had been supported by data and are considered safe for consumers 10 . These MRLs should therefore be maintained in accordance with Article 3 (2)(g) of Regulation (EC) No 396/2005.
(6)For thiacloprid residues in tree nuts, quinces, medlars, loquats/Japanese medlars, apricots, cherries (sweet), plums, strawberries, blackberries, dewberries, other small fruits and berries, kiwis, potatoes, tomatoes, aubergines/eggplants, melons, watermelons, rice, wheat, animal (swine, bovine, sheep, horse, poultry, and other farm animals) products from tissues (muscle, liver, kidney and edible offal), milk and eggs the existing MRLs correspond to the CXL values and the Authority concluded that are considered safe for consumers7; they should therefore also be maintained according to the principles of Article 14(2)(e) of Regulation (EC) No 396/2005.
(7)For raspberries, cucumbers, courgettes, rapeseeds/canola seeds, mustard seeds and cotton seeds, it is appropriate to lower the existing MRLs to the corresponding CXL values, which the Authority concluded are safe for consumers7; they should therefore also be lowered. The Authority evaluated the confirmatory data submitted to address the data gaps identified during the MRL review in accordance with Article 12 of Regulation (EC) No 396/2005 and concluded that the data requirements were fulfilled or not longer required7. Therefore, and for the avoidance of doubt, the respective footnotes indicating lack of information on residue trials, on crop metabolism with seed treatment and on analytical methods for different commodities should be deleted.
(8)The Authority identified a health risk for consumers concerning the MRLs for peaches and sweet peppers/bell peppers7. It is therefore appropriate to lower the MRLs for those products to the product specific LODs.
(9)For thiacloprid residues based on non-longer authorised good agricultural practices in the EU, it is appropriate to lower the respective MRLs set in Annex II to Regulation (EC) No 396/2005 to the product-specific limit of determination (‘LOD’) in accordance with Article 14(1)(a) of Regulation (EC) No 396/2005, in conjunction with Article 17 of that Regulation.
(10)The Commission consulted the European Union reference laboratories for residues of thiacloprid as regards the need to adapt certain LODs. Those laboratories proposed product specific LODs that are analytically achievable for all products.
(11)Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account. In particular the MRLs for fat from swine, bovine, sheep, goat, equine and other farmed terrestrial animal were aligned to that of muscle, for which the respective CXLs were implemented, to reflect the proportion of muscle and fat in “meat (from mammals other than marine mammals)” .
(12)Regulation (EC) No 396/2005 should therefore be amended accordingly.
(13)To allow for the normal marketing, processing and consumption of products, this Regulation should not apply to any products, which have been produced in the Union or imported into the Union before the new MRLs become applicable and for which a high level of consumer protection is maintained. This is the case for all products, except peaches and sweet peppers/bell peppers.
(14)A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs.
(15)The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. The measures provided for in this Regulation should therefore be adopted by the Council.