Commission Regulation (EU) 2022/85 of 20 January 2022 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for flonicamid 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) Maximum residue levels (‘MRLs’) for flonicamid were set in Annex II to Regulation (EC) No 396/2005.

(2) In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance flonicamid on citrus fruits, cherries, plums, strawberries, blackberries, raspberries, ‘other small fruits and berries’, ‘other root and tuber vegetables’, tomatoes, aubergines, courgettes, cucurbits with inedible peel, ‘lettuces and salad plants’, pulses, rye, wheat and hops, applications were submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.

(3) In accordance with Article 8 of Regulation (EC) No 396/2005, those applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission.

(4) The European Food Safety Authority (‘the Authority’) assessed the applications and the evaluation reports, examining in particular the risks to the consumer and, where relevant, to animals and gave reasoned opinions on the proposed MRLs (2). It forwarded those opinions to the applicants, the Commission and the Member States and made them available to the public.

(5) As regards citrus fruits, cherries, plums, tomatoes, aubergines, courgettes, cucurbits with inedible peel, rye, wheat and hops, the applicants submitted information previously unavailable during the review conducted in accordance with Article 12 of Regulation (EC) No 396/2005. That information concerns analytical methods, residue trials, storage stability and hydrolysis studies.

(6) The Authority concluded that, for all the products listed in recital 2, all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of flonicamid. 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 that there is a risk that the acceptable daily intake or the acute reference dose is exceeded.

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

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

(9) 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, 20 January 2022.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 70, 16.3.2005, p. 1.

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

Reasoned opinion on the modification of the existing maximum residue levels for flonicamid in strawberries and other berries. EFSA Journal 2019;17(7):5745.

Reasoned opinion on the modification of the existing maximum residue levels for flonicamid in various crops. EFSA Journal 2018;16(9):5410.

Reasoned opinion on the modification of the existing maximum residue levels for flonicamid in various root crops. EFSA Journal 2018;16(9):5414.

Reasoned Opinion on the evaluation of confirmatory data following the Article 12 MRL review for flonicamid. EFSA Journal 2020;18(5):6117.