Commission Regulation (EU) 2022/1321 of 25 July 2022 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fluoride ion, oxyfluorfen, pyroxsulam, quinmerac and sulfuryl fluoride 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) and Article 49(2) thereof,

Whereas:

(1) For fluoride ion, oxyfluorfen, pyroxsulam, quinmerac and sulfuryl fluoride, maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005.

(2) For oxyfluorfen, the European Food Safety Authority ("the Authority") submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (2). It recommended lowering the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, grapes, table olives, kaki/Japanese persimmons, granate apples/pomegranates, onions, head brassicas and sunflower seeds. For other products, the Authority recommended keeping the existing MRLs. 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.

(3) For pyroxsulam, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (3). It recommended keeping the existing MRLs at the specific limit of determination (LOD) or the default MRL. For some commodities, specific LODs require adaptations to higher values in the light of analytical feasibility. These LODs should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority.

(4) For quinmerac, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (4). It proposed to change the residue definition for plant products and honey to sum of quinmerac and its metabolites BH 518-2 and BH 518-4 expressed as quinmerac. It recommended lowering the MRLs for sugar beet roots, muscle (swine, bovine, sheep, goat, equine, poultry), fat (swine, bovine, sheep, goat, equine, poultry), liver (swine, poultry), swine kidney, milk (cattle, sheep, goat, horse) and birds’ eggs. For other products, it recommended raising or keeping the existing MRLs. As there is no risk for consumers, those MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. The Authority concluded that concerning the MRLs for liver and kidney from ruminants and equine some information was not available and that further consideration by risk managers was required. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.

(5) For sulfuryl fluoride the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (5). It proposed to maintain the existing two residue definitions (sulfuryl fluoride and fluoride ion) as tentative given that further data are required to confirm them. It also concluded that concerning the MRLs for sulfuryl fluoride and fluoride ion for all the commodities listed in Annex I to Regulation (EC) No 396/2005 some information was not available and that further consideration by risk managers was required. Taking into account additional monitoring data provided by food business operators, as there is no risk for consumers fluoride ion MRLs for herbal infusions, rose hips, elderberries and “basil and edible flowers” should be set in Annex II to Regulation (EC) No 396/2005 at the existing level. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.

(6) 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.

(7) The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs. As regards several substances, those laboratories concluded that for certain commodities technical development requires the setting of specific LODs.

(8) 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 Article 14(2) of Regulation (EC) No 396/2005.

(9) 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.

(10) Regulation (EC) No 396/2005 should therefore be amended accordingly.

(11) 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.

(12) 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.

(13) 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 and III 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 21 February 2023.

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 21 February 2023.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 25 July 2022.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 70, 16.3.2005, p. 1.

(2) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for oxyfluorfen according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020;18(10):6269.

(3) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for pyroxsulam according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020;18(10):6260.

(4) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for quinmerac according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020;18(10):6257.

(5) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for sulfuryl fluoride according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2021;19(1):6390.