Commission Regulation (EU) 2024/342of 22 January 2024amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for cyflumetofen, oxathiapiprolin and pyraclostrobin in or on certain products(Text with EEA relevance)

Commission Regulation (EU) 2024/342 of 22 January 2024 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for cyflumetofen, oxathiapiprolin and pyraclostrobin 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 the active substances cyflumetofen, oxathiapiprolin and pyraclostrobin, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. (2) As regards cyflumetofen, an application requesting a modification of the existing MRL for cyflumetofen in courgettes and gherkins was submitted pursuant to Article 6(1) of Regulation (EC) No 396/2005. (3) For that application, a Member State made a request to use the fast-track procedure, provided for in the Technical Guidelines on the MRL setting procedure Technical guidelines MRL setting procedure in accordance with Articles 6 to 11 of Regulation (EC) No 396/2005 and Article 8 of Regulation (EC) No 1107/2009 (SANTE/2015/10595 Rev. 6.1). , to set an MRL based on residue trials on cucumbers. (4) The European Food Safety Authority (the Authority) has assessed residue trials on cucumbers in the framework of the review of the existing MRLs for cyflumetofen and given a reasoned opinion on the proposed MRL European Food Safety Authority. Reasoned opinion on the review of the existing maximum residue levels for cyflumetofen according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2021;19(8):6812. . That opinion relies on the current scientific and technical knowledge on the subject. As it is appropriate to extrapolate from the residue trials on cucumbers to courgettes, gherkins and other cucurbits with edible peel, as confirmed by the Technical Guidelines on extrapolation of MRLs Technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and extrapolation of residue data on products from plant and animal origin (SANTE/2019/12752 – 10 May 2023). , it is unnecessary to request the Authority to provide a reasoned opinion on those crops specifically. (5) It is therefore appropriate to set the MRL for cyflumetofen in courgettes, gherkins and other cucurbits with edible peel at 0,4 mg/kg on the basis of the residue trials performed on cucumbers. (6) As regards oxathiapiprolin, an application requesting a modification of the existing MRL for radish leaves was submitted pursuant to Article 6(1) of Regulation (EC) No 396/2005. (7) As regards pyraclostrobin, an application for import tolerances for that substance used in Brazil on papayas was submitted pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005. The applicant provided data showing that the uses of pyraclostrobin on that crop that are authorised in Brazil lead to residues exceeding the MRL set in Regulation (EC) No 396/2005 and that a higher MRL would be needed to avoid trade barriers when importing this crop.

(8) In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, the applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission. (9) The Authority assessed the applications and the evaluation reports. It examined in particular the risks to consumers and, where relevant, to animals, and gave reasoned opinions on the proposed MRLs Reasoned Opinion on the modification of the existing maximum residue level for oxathiapiprolin in kales/radish leaves. EFSA Journal 2022;20(1):7049, Reasoned Opinion on the setting of import tolerance for pyraclostrobin in papayas. EFSA Journal 2023;21(6):8056. . It forwarded its reasoned opinions to the applicants, the Commission and the Member States and made them available to the public. (10) As regards oxathiapiprolin in radish leaves, the Authority concluded that further consideration by risk managers was required concerning how to implement the proposed MRL since radish leaves are included in Part B of Annex I to Regulation (EC) No 396/2005 and classified under the subgroup of kales, referred to in Part A of that Annex, but residues of oxathiapiprolin in radish leaves derive from the use of this substance on radishes. Since no use is currently reported in the Union for oxathiapiprolin in kales, in accordance with the decision taken by the Standing Committee on Plants, Animals, Food and Feed Report of the Standing Committee on Plants, Animals, Food and Feed, Section Phytopharmaceuticals – Residues, April 2022. https://food.ec.europa.eu/system/files/2022-05/sc_phyto_20220411_ppl_sum.pdf. , it is appropriate to establish the new MRL of 1,5 mg/kg proposed by the Authority for oxathiapiprolin in radish leaves only. (11) As regards pyraclostrobin in papayas, the Authority concluded that further consideration by risk managers was required concerning whether to establish the new MRL at the level of 0,6 mg/kg, as derived by the Authority based on the assessment of the residue trials on papayas submitted by Brazil, or at the MRL of 0,5 mg/kg, which is in force in the exporting country, Brazil. In accordance with the Technical Guidelines on the MRL setting procedure Technical guidelines MRL setting procedure in accordance with Articles 6 to 11 of Regulation (EC) No 396/2005 and Article 8 of Regulation (EC) No 1107/2009 (SANTE/2015/10595 Rev. 6.1). , an MRL established in the framework of an import tolerance application should not exceed the one approved in the exporting country. Therefore, it is appropriate to set the MRL at the level established in Brazil (0,5 mg/kg). (12) For all the above-mentioned modifications to MRLs for cyflumetofen, oxathiapiprolin and pyraclostrobin requested by the applicants, the Authority concluded that all the data requirements had been 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 relevant products show a risk that the acceptable daily intake or the acute reference dose is exceeded.

(13) Based 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 that article. (14) Regulation (EC) No 396/2005 should therefore be amended accordingly. (15) 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, 22 January 2024. For the Commission The President Ursula von der Leyen

Annex

ANNEX In Annex II to Regulation (EC) No 396/2005, the columns for cyflumetofen, oxathiapiprolin and pyraclostrobin are replaced by the following:

Annex

ANNEX II 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 Pesticide-product combination for which a footnote exists. The list of footnotes is provided below. Cyflumetofen (sum of isomers) 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 27 January 2025, or, if that information is not submitted by that date, the lack of it. 1011010 Muscle 1011020 Fat 1011030 Liver 1011040 Kidney 1012010 Muscle 1012020 Fat 1012030 Liver 1012040 Kidney 1013010 Muscle 1013020 Fat 1013030 Liver 1013040 Kidney 1014010 Muscle 1014020 Fat 1014030 Liver 1014040 Kidney 1015010 Muscle 1015020 Fat 1015030 Liver 1015040 Kidney 1020010 Cattle 1020020 Sheep 1020030 Goat 1020040 Horse Oxathiapiprolin The following MRL applies to radish leaves: 1,5 mg/kg. 0243020 Kales Pyraclostrobin (F) (F) Fat soluble Code numberGroups and examples of individual products to which the MRLs applyCyflumetofen (sum of isomers)OxathiapiprolinPyraclostrobin (F)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0,50,0520110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,010,010120010Almonds0,020120020Brazil nuts0,020120030Cashew nuts0,020120040Chestnuts0,020120050Coconuts0,020120060Hazelnuts/cobnuts0,020120070Macadamias0,02 0120080Pecans0,020120090Pine nut kernels0,020120100Pistachios10120110Walnuts0,020120990Others (2)0,020130000Pome fruits0,40,010,50130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0,010140010Apricots0,310140020Cherries (sweet)0,0130140030Peaches0,30,30140040Plums0,010,80140990Others (2)0,010,020150000Berries and small fruits0151000

(a) grapes 0,60,70151010Table grapes0,30151020Wine grapes20152000 (b) strawberries 0,60,011,50153000 (c) cane fruits 0,010153010Blackberries0,530153020Dewberries0,0120153030Raspberries (red and yellow)0,530153990Others (2)0,012 0154000 (d) other small fruits and berries 0154010Blueberries0,010,540154020Cranberries0,010,0130154030Currants (black, red and white)0,010,0130154040Gooseberries (green, red and yellow)0,010,0130154050Rose hips0,010,0130154060Mulberries (black and white)0,010,0130154070Azaroles/Mediterranean medlars0,40,0130154080Elderberries0,010,0130154990Others (2)0,010,0130160000Miscellaneous fruitswith0,010161000 (a) edible peel 0,020161010Dates0,010161020Figs0,010161030Table olives0,010161040Kumquats0,010161050Carambolas0,010161060Kaki/Japanese persimmons0,40161070Jambuls/jambolans0,010161990Others (2)0,010162000 (b) inedible peel, small 0,010162010Kiwi fruits (green, red, yellow)0,020162020Litchis/lychees0,020162030Passionfruits/maracujas0,20162040Prickly pears/cactus fruits0,020162050Star apples/cainitos0,020162060American persimmons/Virginia kaki0,02 0162990Others (2)0,020163000 (c) inedible peel, large 0,010163010Avocados0,20163020Bananas0,020163030Mangoes0,60163040Papayas0,50163050Granate apples/pomegranates0,020163060Cherimoyas0,020163070Guavas0,020163080Pineapples0,30163090Breadfruits0,020163100Durians0,020163110Soursops/guanabanas0,020163990Others (2)0,020200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0,010,010211000 (a) potatoes 0,020212000 (b) tropical root and tuber vegetables 0,020212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)0213000 (c) other root and tuber vegetables except sugar beets 0213010Beetroots0,50213020Carrots0,50213030Celeriacs/turnip rooted celeries0,50213040Horseradishes0,5 0213050Jerusalem artichokes0,060213060Parsnips0,50213070Parsley roots/Hamburg roots parsley0,50213080Radishes0,50213090Salsifies0,50213100Swedes/rutabagas0,50213110Turnips0,50213990Others (2)0,020220000Bulb vegetables0,010220010Garlic0,040,30220020Onions0,041,50220030Shallots0,040,30220040Spring onions/green onions and Welsh onions21,50220990Others (2)0,040,020230000Fruiting vegetables0231000 (a) Solanaceae and Malvaceae 0231010Tomatoes0,40,40,30231020Sweet peppers/bell peppers0,010,20,50231030Aubergines/eggplants0,40,40,30231040Okra/lady's fingers0,010,20,020231990Others (2)0,010,20,020232000 (b) cucurbits with edible peel 0,40,20,50232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2) 0233000 (c) cucurbits with inedible peel 0,010,20,50233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)0234000 (d) sweet corn 0,010,010,040239000 (e) other fruiting vegetables 0,010,010,020240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,010241000 (a) flowering brassica 1,50,50241010Broccoli0241020Cauliflowers0241990Others (2)0242000 (b) head brassica 0242010Brussels sprouts0,010,30242020Head cabbages0,70,40242990Others (2)0,010,020243000 (c) leafy brassica

1,50243010Chinese cabbages/pe-tsai90243020Kales0,010243990Others (2)0,010244000 (d) kohlrabies 0,010,020250000Leaf vegetables, herbs and edible flowers0251000 (a) lettuces and salad plants 0,0150251010Lamb's lettuces/corn salads100251020Lettuces20251030Escaroles/broad-leaved endives0,4 0251040Cresses and other sprouts and shoots100251050Land cresses100251060Roman rocket/rucola100251070Red mustards100251080Baby leaf crops (including brassica species)100251990Others (2)100252000 (b) spinaches and similar leaves 0,01150252010Spinaches0,60252020Purslanes0,020252030Chards/beet leaves1,50252990Others (2)0,020253000 (c) grape leaves and similar species 0,01400,020254000 (d) watercresses 0,010,010,020255000 (e) witloofs/Belgian endives 0,010,010,090256000 (f) herbs and edible flowers 0,0220256010Chervil0,020256020Chives0,020256030Celery leaves0,020256040Parsley0,020256050Sage0,020256060Rosemary0,020256070Thyme0,020256080Basil and edible flowers100256090Laurel/bay leaves0,020256100Tarragon0,020256990Others (2)0,02 0260000Legume vegetables0,010260010Beans (with pods)0,010,60260020Beans (without pods)0,010,30260030Peas (with pods)10,60260040Peas (without pods)0,010,150260050Lentils0,010,020260990Others (2)0,010,020270000Stem vegetables0,010270010Asparagus20,020270020Cardoons0,010,020270030Celeries0,011,50270040Florence fennels0,011,50270050Globe artichokes0,0130270060Leeks20,80270070Rhubarbs0,010,020270080Bamboo shoots0,010,020270090Palm hearts0,010,020270990Others (2)0,010,020280000Fungi, mosses and lichens0,010,010,020280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010,010,020300000PULSES0,010,010300010Beans0,30300020Lentils0,50300030Peas0,3 0300040Lupins/lupini beans0,050300990Others (2)0,30400000OILSEEDS AND OIL FRUITS0,010,010401000Oilseeds0401010Linseeds0,20401020Peanuts/groundnuts0,040401030Poppy seeds0,20401040Sesame seeds0,20401050Sunflower seeds0,30401060Rapeseeds/canola seeds0,20401070Soyabeans0,20401080Mustard seeds0,20401090Cotton seeds0,30401100Pumpkin seeds0,020401110Safflower seeds0,20401120Borage seeds0,20401130Gold of pleasure seeds0,20401140Hemp seeds0,020401150Castor beans0,20401990Others (2)0,020402000Oil fruits0,020402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0,010,010500010Barley1 0500020Buckwheat and other pseudocereals0,020500030Maize/corn0,020500040Common millet/proso millet0,020500050Oat10500060Rice0,090500070Rye0,20500080Sorghum0,50500090Wheat0,20500990Others (2)0,020600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,050610000Teas0,050,10620000Coffee beans0,050,30630000Herbal infusions from0,10631000 (a) flowers 0,050631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)0632000 (b) leaves and herbs 0,050632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)0633000 (c) roots 0633010Valerian0,05 0633020Ginseng0,150633990Others (2)0,050639000 (d) any other parts of the plant

0,050640000Cocoa beans0,050,10650000Carobs/Saint John's breads0,050,10700000HOPS308150800000SPICES0810000Seed spices0,050,050,10810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,050,050,10820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2) 0830000Bark spices0,050,050,10830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,050,050,10840020Ginger (10)0840030Turmeric/curcuma0,050,050,10840040Horseradish (11)0840990Others (2)0,050,050,10850000Bud spices0,050,050,10850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,050,050,10860010Saffron0860990Others (2)0870000Aril spices0,050,050,10870010Mace0870990Others (2)0900000SUGAR PLANTS0,010,010900010Sugar beet roots0,20900020Sugar canes0,080900030Chicory roots0,50900990Others (2)0,021000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from0,010,051011000 (a) swine 1011010Muscle0,01 1011020Fat0,011011030Liver0,021011040Kidney0,021011050Edible offals (other than liver and kidney)0,021011990Others (2)0,011012000 (b) bovine 0,011012010Muscle1012020Fat1012030Liver1012040Kidney1012050Edible offals (other than liver and kidney)1012990Others (2)1013000 (c) sheep 1013010Muscle0,011013020Fat0,011013030Liver0,021013040Kidney0,021013050Edible offals (other than liver and kidney)0,021013990Others (2)0,011014000 d) goat 1014010Muscle0,011014020Fat0,011014030Liver0,021014040Kidney0,021014050Edible offals (other than liver and kidney)0,021014990Others (2)0,011015000 (e) equine 0,011015010Muscle 1015020Fat1015030Liver1015040Kidney1015050Edible offals (other than liver and kidney)1015990Others (2)1016000 (f) poultry 0,011016010Muscle1016020Fat1016030Liver1016040Kidney1016050Edible offals (other than liver and kidney)1016990Others (2)1017000 (g) other farmed terrestrial animals 1017010Muscle0,011017020Fat0,011017030Liver0,021017040Kidney0,021017050Edible offals (other than liver and kidney)0,021017990Others (2)0,011020000Milk0,010,010,011020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,010,010,051030010Chicken 1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,050,050,051050000Amphibians and Reptiles0,010,010,051060000Terrestrial invertebrate animals0,010,010,051070000Wild terrestrial vertebrate animals0,010,010,051100000PRODUCTS 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)