Commission Regulation (EU) 2023/129 of 18 January 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin, prosulfocarb, sedaxane and valifenalate 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), point (a), thereof,

Whereas:

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

(2) On 14 December 2021, the Codex Alimentarius Commission adopted new Codex maximum residue limits (CXLs) for azoxystrobin in guavas and for valifenalate in onions, shallots, tomatoes, and eggplants (2).

(3) In accordance with Article 5(3) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (3), where international standards exist or their completion is imminent, they are to be taken into consideration in the development or adaptation of food law, except where such standards or relevant parts would be an ineffective or inappropriate means to fulfil the legitimate objectives of food law or where there is a scientific justification, or where they would result in a different level of protection from the one determined as appropriate in the Union. Moreover, in accordance with Article 13, point (e), of that Regulation, the Union is to promote consistency between international technical standards and food law while ensuring that the high level of protection adopted in the Union is not reduced.

(4) The European Food Safety Authority (‘the Authority’) assessed the CXLs proposed for azoxystrobin in guavas and for valifenalate in onions, shallots, tomatoes, and eggplants and concluded they are safe for consumers in the Union (4). The Union did not present reservations (5) , (6) to the Codex Committee on Pesticides Residues on these proposed CXLs.

(5) It is therefore appropriate to include these CXLs in Regulation (EC) No 396/2005 as MRLs. In the framework of the evaluation of the proposed CXL for valifenalate in tomatoes, a sufficient number of residue trials was submitted and the Authority concluded that these data were sufficient for the uses under consideration. Therefore, it is appropriate to delete the respective footnote in Regulation (EC) No 396/2005 highlighting the need for additional data.

(6) As regards azoxystrobin, an application pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRLs was submitted for rapeseeds/canola seeds and linseeds. As regards prosulfocarb, such an application was submitted for herbs and edible flowers. As regards sedaxane, such an application was submitted for potatoes.

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

(8) The Authority assessed the applications and the evaluation reports, examining in particular the risks to consumers and, where relevant, to animals, and gave reasoned opinions on the proposed MRLs (7). It forwarded those opinions to the applicants, the Commission and the Member States and made them available to the public.

(9) As regards azoxystrobin in linseeds, the Authority concluded that the submitted data was insufficient to modify the existing MRL. Therefore, it is not appropriate to modify that MRL.

(10) As regards all other modifications to MRLs requested by the applicants for azoxystrobin, prosulfocarb and sedaxane, the Authority concluded that all requirements with respect to completeness of data submission 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. In so concluding, the Authority took into account the most recent data on the toxicological properties of the substances. Neither the long-term exposure to these substances via consumption of all food products that may contain them, 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.

(11) As regards prosulfocarb in herbs and edible flowers, the Authority had previously identified, in the framework of the review of the existing MRLs for prosulfocarb according to Article 12 of Regulation (EC) No 396/2005 (8), that some information on residue trials was unavailable. Therefore, Commission Regulation (EU) No 777/2013 (9) required further residue data to confirm the tentative MRL of 0,05 mg/kg for that active substance in those products. In the framework of the new application requesting the modification of the MRLs for prosulfocarb in herbs and edible flowers, new uses and new residue trials were submitted and the Authority concluded that these data were sufficient for the uses under consideration and to support a new higher MRL. Therefore, it is appropriate to modify the MRL and to delete the respective footnote in Regulation (EC) No 396/2005 highlighting the need for additional data.

(12) Based on the on the scientific report and on the reasoned opinions of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, the proposed modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.

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

(14) 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.

It shall apply from 26 February 2023 as regards all proposed MRLs.

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

Done at Brussels, 18 January 2023.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 70, 16.3.2005, p. 1.

(2) Report of the 44th Session of the Codex Alimentarius Commission (REP21/CAC) https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-701-44%252FFINAL%252520REPORT%252FRep21_CACe.pdf

(3) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

(4) Scientific support for preparing an EU position for the 52nd Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2021;19(8):6766.

(5) European Union comments on Codex CX/PR 21/52/5(REV): https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-718-52%252FCRDs%252Fpr52_CRD22x.pdf

(6) Report of the 52nd session of the Codex Committee on Pesticide Residues REP21/PR: https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-718-52%252FREPORT%252FFINAL%2BREPORT%252FREP21_PR52e.pdf

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

Reasoned Opinion on the modification of the existing maximum residue levels for azoxystrobin in rapeseeds and linseeds. EFSA Journal 2022;20(1):7051.

Reasoned Opinion on the modification of the existing maximum residue levels for prosulfocarb in herbs and edible flowers. EFSA Journal 2022;20(5):7334.

Reasoned Opinion on the modification of the existing maximum residue level for sedaxane in potatoes. EFSA Journal 2022;20(6):7371.

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

Reasoned Opinion: Review of the existing maximum residue levels (MRLs) for prosulfocarb according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2011; 9(8):2346.

(9) Commission Regulation (EU) No 777/2013 of 12 August 2013 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 clodinafop, clomazone, diuron, ethalfluralin, ioxynil, iprovalicarb, maleic hydrazide, mepanipyrim, metconazole, prosulfocarb and tepraloxydim in or on certain products (OJ L 221, 17.8.2013, p. 1).