COMMISSION REGULATION (EU) 2022/1363

of 3 August 2022

amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 2,4-D, azoxystrobin, cyhalofop-butyl, cymoxanil, fenhexamid, flazasulfuron, florasulam, fluroxypyr, iprovalicarb and silthiofam 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 2,4-D, azoxystrobin, cyhalofop-butyl, cymoxanil, fenhexamid, flazasulfuron, florasulam, fluroxypyr, iprovalicarb and silthiofam maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005.

(2) During the review of those MRLs in accordance with Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (‘the Authority’) identified some information as unavailable for certain products. The available information was sufficient for the Authority to propose MRLs that are safe for consumers and the data gaps were indicated in Annex II of that Regulation specifying the date by which the missing information was to be submitted to the Authority in support of the proposed MRLs.

(3) For 2,4-D, such information concerning analytical methods for almonds, brazil nuts, cashew nuts, coconuts, hazelnuts/cobnuts, macadamias, pecans, pine nut kernels, pistachios, walnuts and other tree nuts was submitted by the applicant and the Authority concluded that this data gap was sufficiently addressed (2). Therefore, for these products, the existing MRLs in Annex II to Regulation (EC) No 396/2005 should be kept and the requirement to submit additional information should be deleted from that Annex. However, for buckwheat and other pseudo-cereals such information concerning residue trials was not submitted and the Authority concluded that the data gap was thus not sufficiently addressed and that risk managers may consider replacing those MRLs with the Limit of Determination (LOD) (3). Therefore, for these products, it is appropriate to keep the MRL in Annex II to Regulation (EC) No 396/2005 at the LOD and to delete the requirement to submit additional information from that Annex.

(4) For azoxystrobin, such information concerning residue trials for lamb's lettuces/corn salads, escaroles/broad-leaved endives, cresses and other sprouts and shoots, roman rocket/rucola, red mustards and baby leaf crops (including brassica species) was submitted by the applicant. The Authority concluded that this data gap was sufficiently addressed (4) and proposed lowering the MRLs for those products based on the new information. Therefore, MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority and the requirement to submit additional information should be deleted from that Annex. Together with the confirmatory data, pursuant to Article 6 of Regulation (EC) No 396/2005, the applicant also submitted an application to modify the existing MRLs for azoxystrobin in lettuces and the Authority recommended4 lowering the MRL for that product. Therefore, the MRL for lettuces should be set at the level identified by the Authority. During the Article 12 review, the Authority had identified a data gap concerning the toxicological profile of the metabolites L1, L4 and L9 for swine (muscle, fat, liver, kidney, edible offals), bovine (muscle, fat, liver, kidney, edible offals), sheep (muscle, fat, liver, kidney, edible offals), goat (muscle, fat, liver, kidney, edible offals), poultry (muscle, fat, liver, kidney, edible offals), milk (cattle, sheep, goat, horse) and birds’ eggs. Such information was not submitted by the applicant4. The Authority concluded4 that these metabolites do not occur on muscle, but that a full characterisation of their toxicological profile has not been provided by the applicant and that further consideration by risk managers was necessary, taking into account that the existing MRLs for these products reflect Codex maximum residue limits (CXLs). Therefore, for these products, the existing MRLs in Annex II to Regulation (EC) No 396/2005 should be kept and the requirement to submit additional information should be maintained in that Annex.

(5) For cyhalofop-butyl, such information concerning analytical methods for rice was submitted by the applicant and the Authority concluded that this data gap was sufficiently addressed (5). Therefore, for this product, the existing MRL in Annex II to Regulation (EC) No 396/2005 should be kept and the requirement to submit additional information should be deleted from that Annex.

(6) For cymoxanil, such information on residue trials for table grapes, wine grapes, lettuces and spinaches was submitted by the applicant. The Authority concluded that this data gap was sufficiently addressed (6) and proposed keeping or lowering MRLs for those products. Therefore, for those products, MRLs in Annex II to Regulation (EC) No 396/2005 should be set at the level identified by the Authority and the requirement to submit additional information should be deleted from that Annex. The Authority concluded6 that the data gaps concerning analytical methods for herbal infusions and hops and storage stability for pulses, herbal infusions and hops have not been addressed and that MRLs for those products should be kept at the LOD. Therefore, MRLs for those products in Annex II to Regulation (EC) No 396/2005 should be set at the level identified by the Authority and the requirement to submit additional information should be deleted from that Annex.

(7) For fenhexamid, such information concerning residue trials and Good Agricultural Practice (GAP) parameters for kiwi fruits (green, red, yellow) was not submitted. However, the Authority concluded that the requested information is no longer required (7) as the evaluation was performed with older data requirements thus further residue trials and information on GAPs are no longer required. Therefore, for this product, the existing MRL in Annex II to Regulation (EC) No 396/2005 should be kept and the requirement to submit additional information should be deleted from that Annex.

(8) For flazasulfuron, such information concerning storage stability for table olives and olives for oil production was submitted by the applicant and the Authority concluded that this data gap was sufficiently addressed (8). Therefore, for these products, the existing MRLs in Annex II to Regulation (EC) No 396/2005 should be kept and the requirement to submit additional information should be deleted from that Annex.

(9) For florasulam, such information concerning analytical methods for bovine (muscle, fat, liver, kidney, edible offals), sheep (muscle, fat, liver, kidney, edible offals), goat (muscle, fat, liver, kidney, edible offals) and milk (cattle, sheep, goat, horse) was submitted by the applicant and the Authority concluded that this data gap was sufficiently addressed (9). Therefore, for those products, the existing MRLs in Annex II to Regulation (EC) No 396/2005 should be kept and the requirement to submit additional information should be deleted from that Annex.

(10) For fluroxypyr, such information concerning analytical methods, storage stability, pre-harvest interval and residue trials for apples and onions was submitted by the applicant. Additional information on the analytical method used in the residue trials for thyme was also submitted by the applicant. The Authority concluded that these data gaps were sufficiently addressed (10) , (11). Therefore, for these products, the MRLs in Annex II to Regulation (EC) No 396/2005 should be set at the level identified by the Authority and the requirement to submit additional information should be deleted from that Annex. The Authority concluded that the data gap concerning the analytical method for garlics and shallots has been addressed, however for leeks, cereals, herbal infusions from flowers and sugar canes it has not been addressed and that further risk management consideration is needed. It also concluded that the data gaps concerning storage stability and metabolism for swine (muscle, fat, liver, kidney, edible offals), bovine (muscle, fat, liver, kidney, edible offals), sheep (muscle, fat, liver, kidney, edible offals), goat (muscle, fat, liver, kidney, edible offals) and milk (cattle, sheep, goat, horse) were only partially addressed and that further risk management consideration is needed. In the Final Review report (12) for this substance, it was concluded that the available data was sufficient to also address these data gaps. Therefore, for these products, MRLs in Annex II to Regulation (EC) No 396/2005 should be kept and the requirement to submit additional information should be deleted from that Annex.

(11) For iprovalicarb, such information concerning crop metabolism on lettuces, escaroles/broad-leaved endives and roman rocket/rucola was not submitted and the Authority concluded that the data gap previously identified was thus not addressed (13) and that risk managers may consider replacing those MRLs with the LOD. Therefore, for these products, it is appropriate to set the MRLs in Annex II to Regulation (EC) No 396/2005 at the specific LOD and to delete the requirement to submit additional information from that Annex.

(12) For silthiofam, such information concerning analytical methods for barley, rye and wheat was submitted by the applicant and the Authority concluded that this data gap was sufficiently addressed (14). Therefore, for these products, the existing MRLs in Annex II to Regulation (EC) No 396/2005 should be kept and the requirements to submit additional information should be deleted from that Annex.

(13) The Commission consulted the European Union reference laboratories as regards the need to adapt certain LODs. Those laboratories concluded that for certain products technical development permits the setting of lower LODs.

(14) 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.

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

(16) In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional measure 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.

(17) 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.

(18) 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 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 25 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 25 February 2023.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 3 August 2022. For the Commission The President Ursula VON DER LEYEN

(1) OJ L 70, 16.3.2005, p. 1.

(2) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance 2,4-D. EFSA Journal 2014;12(9):3812.

(3) European Food Safety Authority; Lack of confirmatory data following Article 12 MRL reviews for 2,4-D, fenhexamid and iprovalicarb. EFSA Journal 2021;19(10):6910.

(4) European Food Safety Authority; Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for azoxystrobin. EFSA Journal 2020;18(8):6231.

(5) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance cyhalofop (variant evaluated cyhalofop-butyl). EFSA Journal 2015; 13(1):3943.

(6) European Food Safety Authority; Evaluation of confirmatory data following the Article 12 review for cymoxanil. EFSA Journal 2019; 17(10):5823.

(7) European Food Safety Authority; Lack of confirmatory data following Article 12 MRL reviews for 2,4-D, fenhexamid and iprovalicarb. EFSA Journal 2021;19(10):6910.

(8) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance flazasulfuron. EFSA Journal 2016;14(8):4575.

(9) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance florasulam. EFSA Journal 2015;13(1):3984.

(10) European Food Safety Authority; Evaluation of confirmatory data following the Article 12 MRL review for fluroxypyr. EFSA Journal 2019;17(9):5816.

(11) European Food Safety Authority; Modification of the existing maximum residue levels for fluroxypyr in chives, celery leaves, parsley, thyme and basil and edible flowers. EFSA Journal 2020;18(10):6273.

(12) SANCO/11019/2011 rev.5, ‘Final Review report for the active substance fluroxypyr finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 17 June 2011 in view of the approval of fluroxypyr as active substance in accordance with Regulation (EC) No 1107/2009’, 23 March 2017, https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/active-substances/?event=as.details&as_id=734

(13) European Food Safety Authority; Lack of confirmatory data following Article 12 MRL reviews for 2,4-D, fenhexamid and iprovalicarb. EFSA Journal 2021;19(10):6910.

(14) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance silthiofam. EFSA Journal 2016;14(8):4574.