Commission Regulation (EU) 2022/566 of 7 April 2022 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for flutianil 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) thereof,

Whereas:

(1) For flutianil, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005.

(2) An application for import tolerances pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005 was submitted for flutianil used in the United States on apples, cherries (sweet), strawberries, cucumbers, courgettes and melons. The applicant provided data showing that the authorised uses of that substance on these crops in the United States lead to residues exceeding the MRLs contained in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation into the EU of those crops.

(3) In accordance with Article 8 of Regulation (EC) No 396/2005, the application was evaluated by the Member State to which it had been submitted, and the evaluation report by that Member State was forwarded to the Commission.

(4) The European Food Safety Authority (‘the Authority’) assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals, and gave a reasoned opinion on the proposed MRLs (2). It forwarded that opinion to the applicant, the Commission and the Member States and made it available to the public.

(5) As regards flutianil in melons, the Authority concluded that the submitted data was insufficient to set a new MRL. As regards all other modifications to MRLs requested by the applicant, the Authority concluded that the data submitted was sufficient for it to perform a risk assessment. It further concluded that the modifications to the MRLs requested by the applicant were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. In so concluding, the Authority took into account the most recent data on the toxicological properties of the substance. Neither the lifetime exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed a risk that the acceptable daily intake or the acute reference dose is exceeded.

(6) Based on the reasoned opinion of the Authority and taking into account the factors relevant to the matter under consideration, the modifications to the MRLs proposed by this Regulation fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.

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

(8) 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

Annex II to Regulation (EC) No 396/2005 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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

Done at Brussels, 7 April 2022.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 70, 16.3.2005, p. 1.

(2) EFSA scientific reports are available online: http://www.efsa.europa.eu

Reasoned opinion on the setting of import tolerance for flutianil in various crops. EFSA Journal 2021;19(9):6840.