Commission Regulation (EU) 2021/616 of 13 April 2021 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benalaxyl, benalaxyl-M, dichlobenil, fluopicolide, proquinazid and pyridalyl in or on certain products (Text with EEA relevance)
Commission Regulation (EU) 2021/616 of 13 April 2021 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benalaxyl, benalaxyl-M, dichlobenil, fluopicolide, proquinazid and pyridalyl in or on certain products (Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC(1), and in particular Article 14(1)(a), Article 18(1)(b) and Article 49(2) thereof,
Whereas:
For benalaxyl and benalaxyl-M maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For fluopicolide, proquinazid and pyridalyl MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. For dichlobenil MRLs were set in Annex V to Regulation (EC) No 396/2005.
For benalaxyl and benalaxyl-M the European Food Safety Authority (‘the Authority’), submitted a reasoned opinion on the review of the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005(2). It took into account a previous review for benalaxyl(3). For some products the Authority recommended raising or keeping the existing MRLs. The MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. The Authority concluded that concerning the MRLs for table grapes, potatoes, garlic, onions, shallots, lettuces and leeks some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.
For dichlobenil the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005.(4) As Dichlobenil is no longer approved in the EU and all authorisations for this substance have been revoked, the MRLs should remain in Annex V at the limit of determination (LOD).
For fluopicolide the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005(5). It recommended lowering the MRL for lettuces. For certain other products, it recommended raising or keeping the existing MRLs. The MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. The Authority concluded that concerning the MRLs for escaroles/broad-leaved endives, hops, swine (muscle, fat, liver, kidney), bovine (muscle, fat, liver, kidney), sheep (muscle, fat, liver, kidney), goat (muscle, fat, liver, kidney), equine (muscle, fat, liver, kidney), poultry (muscle, fat, liver, kidney), other farmed terrestrial animals (muscle, fat, liver, kidney), milk (cattle, sheep, goat, horse) and birds’ eggs some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.
For proquinazid the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005(6). It proposed to change the residue definition for commodities of animal origin and recommended raising or keeping the existing MRLs for certain products. The MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. It concluded that concerning the MRLs for barley, oats, bovine (muscle, fat, liver, kidney), sheep (muscle, fat, liver, kidney), goat (muscle, fat, liver, kidney), equine (muscle, fat, liver, kidney) and milk (cattle, sheep, goat, horse) some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.
For pyridalyl the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005(7). It recommended lowering the MRL for sweet peppers/bell peppers. For other products, the Authority recommended raising or keeping the existing MRLs. The MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority.
As regards products on which the use of the plant protection product concerned is not authorised, and for which no import tolerances or Codex maximum residue limits (CXLs) exist, MRLs should be set at the specific LOD or the default MRL should apply, as provided for in Article 18(1)(b) of Regulation (EC) No 396/2005.
The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain limits of determination. As regards several substances, those laboratories concluded that for certain commodities technical development requires the setting of specific limits of determination.
Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.
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.
Regulation (EC) No 396/2005 should therefore be amended accordingly.
In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained.
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.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Annexes II, III and V to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were produced in the Union or imported into the Union before 6 November 2021.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 6 November 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 April 2021.
For the Commission
The President
Ursula von der Leyen