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 productsText with EEA relevance.

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 OJ L 70, 16.3.2005, p. 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 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) In accordance with Article 5(3) of Regulation (EC) No 178/2002 of the European Parliament and of the Council 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). , 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 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. . The Union did not present reservations 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

, 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 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 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. . 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 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. , that some information on residue trials was unavailable. Therefore, Commission Regulation (EU) No 777/2013 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). 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

Annex

ANNEX In Annex II to Regulation (EC) No 396/2005, the columns for azoxystrobin, prosulfocarb, sedaxane and valifenalate are replaced by the following: Pesticide residues and maximum residue levels (mg/kg) Indicates lower limit of analytical determination For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I

Azoxystrobin The European Food Safety Authority identified some information on toxicity of metabolites as unavailable. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 5 August 2024, or, if that information is not submitted by that date, the lack of it. 1011000 (a) swine 1011010 Muscle 1011020 Fat 1011030 Liver 1011040 Kidney 1011050 Edible offals (other than liver and kidney) 1011990 Others (2) 1012000 (b) bovine 1012010 Muscle 1012020 Fat 1012030 Liver 1012040 Kidney 1012050 Edible offals (other than liver and kidney) 1012990 Others (2) 1013000 (c) sheep 1013010 Muscle 1013020 Fat 1013030 Liver 1013040 Kidney 1013050 Edible offals (other than liver and kidney) 1013990 Others (2) 1014000 d) goat 1014010 Muscle 1014020 Fat 1014030 Liver 1014040 Kidney 1014050 Edible offals (other than liver and kidney) 1014990 Others (2) 1016000 (f) poultry 1016010 Muscle 1016020 Fat 1016030 Liver 1016040 Kidney 1016050 Edible offals (other than liver and kidney) 1016990 Others (2) 1020000 Milk 1020010 Cattle 1020020 Sheep 1020030 Goat 1020040 Horse 1020990 Others (2) 1030000 Birds eggs 1030010 Chicken 1030020 Duck 1030030 Geese 1030040 Quail 1030990 Others (2) Prosulfocarb The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 17 August 2015, or, if that information is not submitted by that date, the lack of it. 0810000 Seed spices 0810010 Anise/aniseed 0810020 Black caraway/black cumin 0810030 Celery 0810040 Coriander 0810050 Cumin 0810060 Dill 0810070 Fennel 0810080 Fenugreek 0810090 Nutmeg 0810990 Others (2) 0820000 Fruit spices 0820010 Allspice/pimento 0820020 Sichuan pepper 0820030 Caraway 0820040 Cardamom 0820050 Juniper berry 0820060 Peppercorn (black green and white) 0820070 Vanilla 0820080 Tamarind 0820990 Others (2) The European Food Safety Authority identified some information on crop metabolism as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 17 August 2015, or, if that information is not submitted by that date, the lack of it. 0213020 Carrots 0213030 Celeriacs/turnip rooted celeries 0213040 Horseradishes 0213060 Parsnips 0213070 Parsley roots/Hamburg roots parsley 0213090 Salsifies 0270030 Celeries The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 17 August 2015, or, if that information is not submitted by that date, the lack of it. 0152000 (b) strawberries Valifenalate (R) (A) (R) The residue definition differs for the following combinations pesticide-code number: Valifenalate - code 1000000 except 1040000: Valifenalate and valifenalate acid (IR5839)

(A) The EU reference laboratories identified the reference standard for valifenalate acid (IR5839) as commercially not available. When reviewing the MRLs, the Commission will take into account the commercial availability of the reference standard referred to it in the first sentence by 2 August 2023, or, if that reference standard is not commercially available by that date, the unavailability of it. Code numberGroups and examples of individual products to which the MRLs applyAzoxystrobinProsulfocarbSedaxane (sum of isomers)Valifenalate (R) (A)(1)(2)(3)(4)(5)(6)0100000FRUITS, FRESH or FROZEN; TREE NUTS0,010110000Citrus fruits150,010,010110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,020,010120010Almonds0,010120020Brazil nuts0,010120030Cashew nuts0,010120040Chestnuts0,010120050Coconuts0,010120060Hazelnuts/cobnuts0,010120070Macadamias0,010120080Pecans0,01 0120090Pine nut kernels0,010120100Pistachios10120110Walnuts0,010120990Others (2)0,010130000Pome fruits0,010,010,010130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits20,010,010140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2)0150000Berries and small fruits0151000 (a) grapes 30,0110151010Table grapes0151020Wine grapes0152000 (b) strawberries 100,05(+)0,010153000 (c) cane fruits 50,010,010153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2) 0154000 (d) other small fruits and berries 0,010,010154010Blueberries50154020Cranberries0,50154030Currants (black, red and white)50154040Gooseberries (green, red and yellow)50154050Rose hips50154060Mulberries (black and white)50154070Azaroles/Mediterranean medlars50154080Elderberries50154990Others (2)50160000Miscellaneous fruitswith0,010,010161000 (a) edible peel 0161010Dates0,010161020Figs0,010161030Table olives0,010161040Kumquats0,010161050Carambolas0,10161060Kaki/Japanese persimmons0,010161070Jambuls/jambolans0,010161990Others (2)0,010162000 (b) inedible peel, small 0162010Kiwi fruits (green, red, yellow)0,010162020Litchis/lychees0,010162030Passionfruits/maracujas40162040Prickly pears/cactus fruits0,30162050Star apples/cainitos0,010162060American persimmons/Virginia kaki0,010162990Others (2)0,01 0163000 (c) inedible peel, large 0163010Avocados0,010163020Bananas20163030Mangoes40163040Papayas0,30163050Granate apples/pomegranates0,010163060Cherimoyas0,010163070Guavas0,20163080Pineapples0,010163090Breadfruits0,010163100Durians0,010163110Soursops/guanabanas0,010163990Others (2)0,010200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0,010211000 (a) potatoes 70,010,150212000 (b) tropical root and tuber vegetables 10,010,010212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)0213000 (c) other root and tuber vegetables except sugar beets 0,010213010Beetroots10,010213020Carrots11(+)0213030Celeriacs/turnip rooted celeries10,08(+)0213040Horseradishes10,08(+)

0213050Jerusalem artichokes10,010213060Parsnips10,08(+)0213070Parsley roots/Hamburg roots parsley10,08(+)0213080Radishes1,50,010213090Salsifies10,08(+)0213100Swedes/rutabagas10,010213110Turnips10,010213990Others (2)10,010220000Bulb vegetables100,010220010Garlic0,010,010220020Onions0,030,50220030Shallots0,030,50220040Spring onions/green onions and Welsh onions0,020,010220990Others (2)0,010,010230000Fruiting vegetables0,010,010231000 (a) Solanaceae and Malvaceae 30231010Tomatoes0,40231020Sweet peppers/bell peppers0,010231030Aubergines/eggplants0,40231040Okra/lady's fingers0,010231990Others (2)0,010232000 (b) cucurbits with edible peel 10,010232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2) 0233000 (c) cucurbits with inedible peel 10,010233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)0234000 (d) sweet corn 0,010,010239000 (e) other fruiting vegetables 0,010,010240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,010,010,010241000 (a) flowering brassica 50241010Broccoli0241020Cauliflowers0241990Others (2)0242000 (b) head brassica 50242010Brussels sprouts0242020Head cabbages0242990Others (2)0243000 (c) leafy brassica 60243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)0244000 (d) kohlrabies 50250000Leaf vegetables, herbs and edible flowers0251000 (a) lettuces and salad plants 100,010,010,010251010Lamb's lettuces/corn salads0251020Lettuces 0251030Escaroles/broad-leaved endives0251040Cresses and other sprouts and shoots0251050Land cresses0251060Roman rocket/rucola0251070Red mustards0251080Baby leaf crops (including brassica species)0251990Others (2)0252000 (b) spinaches and similar leaves 150,010,010,010252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)0253000 (c) grape leaves and similar species 0,010,010,010,010254000 (d) watercresses 0,010,010,010,010255000 (e) witloofs/Belgian endives 0,30,010,010,010256000 (f) herbs and edible flowers 70200,020,020256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2) 0260000Legume vegetables30,010,010,010260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0,010,010270010Asparagus0,010,010270020Cardoons150,010270030Celeries151,5(+)0270040Florence fennels100,010270050Globe artichokes50,010270060Leeks100,010270070Rhubarbs0,60,010270080Bamboo shoots0,010,010270090Palm hearts0,010,010270990Others (2)0,010,010280000Fungi, mosses and lichens0,010,010,010,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010,010,010,010300000PULSES0,150,010,010,010300010Beans0300020Lentils0300030Peas 0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,020,010,010401000Oilseeds0401010Linseeds0,40401020Peanuts/groundnuts0,20401030Poppy seeds0,50401040Sesame seeds0,010401050Sunflower seeds0,50401060Rapeseeds/canola seeds0,70401070Soyabeans0,50401080Mustard seeds0,50401090Cotton seeds0,70401100Pumpkin seeds0,010401110Safflower seeds0,40401120Borage seeds0,40401130Gold of pleasure seeds0,50401140Hemp seeds0,010401150Castor beans0,010401990Others (2)0,010402000Oil fruits0402010Olives for oil production0,010402020Oil palms kernels0,010402030Oil palms fruits0,030402040Kapok0,010402990Others (2)0,01

0500000CEREALS0,010,010,010500010Barley1,50500020Buckwheat and other pseudocereals0,010500030Maize/corn0,020500040Common millet/proso millet0,010500050Oat1,50500060Rice50500070Rye0,50500080Sorghum100500090Wheat0,50500990Others (2)0,010600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,050,050610000Teas0,050,050620000Coffee beans0,030,050630000Herbal infusions from0631000 (a) flowers 6020631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)0632000 (b) leaves and herbs 6020632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2) 0633000 (c) roots 0,30,050633010Valerian0633020Ginseng0633990Others (2)0639000 (d) any other parts of the plant 0,050,050640000Cocoa beans0,050,050650000Carobs/Saint John's breads0,050,050700000HOPS300,050,050,050800000SPICES0810000Seed spices0,30,3(+)0,050,050810010Anise/aniseed(+)0810020Black caraway/black cumin(+)0810030Celery(+)0810040Coriander(+)0810050Cumin(+)0810060Dill(+)0810070Fennel(+)0810080Fenugreek(+)0810090Nutmeg(+)0810990Others (2)(+)0820000Fruit spices0,30,3(+)0,050,050820010Allspice/pimento(+)0820020Sichuan pepper(+)0820030Caraway(+)0820040Cardamom(+)0820050Juniper berry(+)0820060Peppercorn (black, green and white)(+) 0820070Vanilla(+)0820080Tamarind(+)0820990Others (2)(+)0830000Bark spices0,050,050,050,050830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,050,050,050,050840020Ginger (10)0840030Turmeric/curcuma0,050,050,050,050840040Horseradish (11)0840990Others (2)0,050,050,050,050850000Bud spices0,050,050,050,050850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,050,050,050,050860010Saffron0860990Others (2)0870000Aril spices0,050,050,050,050870010Mace0870990Others (2)0900000SUGAR PLANTS0,010,010,010900010Sugar beet roots50900020Sugar canes0,050900030Chicory roots0,090900990Others (2)0,01 1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from0,010,010,031011000 (a) swine 1011010Muscle0,01(+)1011020Fat0,05(+)1011030Liver0,07(+)1011040Kidney0,07(+)1011050Edible offals (other than liver and kidney)0,07(+)1011990Others (2)0,01(+)1012000 (b) bovine 1012010Muscle0,01(+)1012020Fat0,05(+)1012030Liver0,07(+)1012040Kidney0,07(+)1012050Edible offals (other than liver and kidney)0,07(+)1012990Others (2)0,01(+)1013000 (c) sheep 1013010Muscle0,01(+)1013020Fat0,05(+)1013030Liver0,07(+)1013040Kidney0,07(+)1013050Edible offals (other than liver and kidney)0,07(+)1013990Others (2)0,01(+) 1014000 d) goat 1014010Muscle0,01(+)1014020Fat0,05(+)1014030Liver0,07(+)1014040Kidney0,07(+)1014050Edible offals (other than liver and kidney)0,07(+)1014990Others (2)0,01(+)1015000 (e) equine 1015010Muscle0,011015020Fat0,051015030Liver0,071015040Kidney0,071015050Edible offals (other than liver and kidney)0,071015990Others (2)0,011016000 (f) poultry 0,01(+)1016010Muscle(+)1016020Fat(+)1016030Liver(+)1016040Kidney(+)1016050Edible offals (other than liver and kidney)(+)1016990Others (2)(+)1017000 (g) other farmed terrestrial animals

1017010Muscle0,011017020Fat0,051017030Liver0,07 1017040Kidney0,071017050Edible offals (other than liver and kidney)0,071017990Others (2)0,011020000Milk0,01(+)0,010,010,031020010Cattle(+)1020020Sheep(+)1020030Goat(+)1020040Horse(+)1020990Others (2)(+)1030000Birds eggs0,01(+)0,010,010,031030010Chicken(+)1030020Duck(+)1030030Geese(+)1030040Quail(+)1030990Others (2)(+)1040000Honey and other apiculture products (7)0,050,050,050,051050000Amphibians and Reptiles0,010,010,010,031060000Terrestrial invertebrate animals0,010,010,010,031070000Wild terrestrial vertebrate animals0,010,010,010,031100000PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)1200000PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)1300000PROCESSED FOOD PRODUCTS (9)