Contents
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/EECnote, and in particular Article 14(1), point (a), thereof,Whereas:
(1)For azoxystrobin, famoxadone, flutriafol, mandipropamid, and mefentrifluconazole, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005.
(2)On 2 December 2023, the Codex Alimentarius Commission adopted new Codex maximum residue limits (CXLs) for the active substances azoxystrobin, famoxadone, flutriafol, mandipropamid, and mefentrifluconazolenote.
(3)In accordance with Article 5(3) of Regulation (EC) No 178/2002 of the European Parliament and of the Councilnote, 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 thereof would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives of the Union 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 Union 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 risks that those CXLs pose to consumers and published a scientific reportnote. The Union presented reservationsnote,note,note to the Codex Committee on Pesticides Residues on the CXLs proposed for the following pesticide/product combinations, for which the Authority had identified a potential consumer health risk in its scientific report: famoxadone in ‘bulb onions, subgroup of’, ‘cane berries, subgroup of’, ‘fruiting vegetables, cucurbits-cucumbers and summer squashes, subgroup of’, ‘peppers chili’ and ‘peppers sweet-including pimento or pimiento’; mandipropamid in ‘bulb onions, subgroup of’, ‘eggplants, subgroup of’, and ‘ginseng, dried, including red ginseng’; for mefentrifluconazole in ‘mammalian edible offal’, ‘eggs’, ‘mammalian fats except milk fats’, ‘meat from mammals other than marine mammals’, ‘milks’, ‘pome fruits, group of’, ‘edible offal of poultry’, ‘poultry fats’, and ‘poultry meat’.
(5)The CXLs for which the Authority did not identify risks to consumers in the Union, and for which the Union therefore did not present a reservation to the Codex Committee on Pesticides Residues or the Codex Alimentarius Commission, can be considered safe. This is the case for certain CXLs for azoxystrobin, famoxadone, flutriafol, mandipropamid and mefentrifluconazole. Those CXLs should therefore be included in Regulation (EC) No 396/2005, except where they relate to products which are not listed in Annex I to that Regulation or where they are at a lower level than the current MRLs for the pesticide/product combinations concerned.
(6)As regards mandipropamid in courgettes, during the review of all MRLs for that active substance in accordance with Article 12 of Regulation (EC) No 396/2005, the Authority identified some information on residue trials for courgettes as unavailable(4). The available information was sufficient for the Authority to propose an MRL of 0,2 mg/kg that is safe for consumers and the data gap was 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. As the new CXL of 0,2 mg/kg for mandipropamid in ‘fruiting vegetables, cucurbits – cucumbers and summer squashes (subgroup)’ with edible peel, which applies to cucumbers, gherkins, courgettes, and ‘cucurbits with edible peel, others’, was fully supported by data, and the Union did not present a reservation to the Codex Committee on Pesticides Residues on it, the data gap concerning residue trials for mandipropamid in courgettes can be considered sufficiently addressed.
(7)In addition, as regards mandipropamid in radish leaves, an application requesting a modification of the existing MRL was submitted to the Member State concerned pursuant to Article 6(1) of Regulation (EC) No 396/2005.
(8)In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, that application was evaluated by the Member States concerned and the evaluation report was forwarded to the Commission. The Commission forwarded the application, the evaluation report, and the supporting dossier to the Authority.
(9)The Authority assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals, and gave reasoned opinion on the proposed MRLnote. It forwarded its reasoned opinion to the applicant, the Commission and the Member States and made it available to the public.
(10)As regards mandipropamid in radish leaves, the Authority concluded that further consideration by risk managers was required on how to implement the proposed MRL. While radish leaves are included in Part B of Annex I to Regulation (EC) No 396/2005 and classified under the subgroup of kales, residues of mandipropamid in radish leaves derive from the use of that substance on radishes and not on kales. As a different MRL is set for mandipropamid in kales, based on uses of that substance on that crop, it is not appropriate to establish the new MRL of 50 mg/kg proposed by the Authority for mandipropamid in radish leaves to the whole subgroup of kales. Therefore, that MRL should apply to mandipropamid in radish leaves only.
(11)Based on the scientific report and on the reasoned opinion of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, it is concluded that the proposed modifications to the MRLs are acceptable.
(12)Regulation (EC) No 396/2005 should therefore be amended accordingly.
(13)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.
In Annex II to Regulation (EC) No 396/2005, the columns for azoxystrobin, famoxadone, flutriafol, mandipropamid and mefentrifluconazole are replaced by the following:
‘Pesticide residues and maximum residue levels (mg/kg)notenote(+)Pesticide-product combination for which a footnote exists. The list of footnotes is provided below.AzoxystrobinThe 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) swine1011010 Muscle1011020 Fat1011030 Liver1011040 Kidney1011050 Edible offals (other than liver and kidney)1011990 Others (2)1012000 (b) bovine1012010 Muscle1012020 Fat1012030 Liver1012040 Kidney1012050 Edible offals (other than liver and kidney)1012990 Others (2)1013000 (c) sheep1013010 Muscle1013020 Fat1013030 Liver1013040 Kidney1013050 Edible offals (other than liver and kidney)1013990 Others (2)1014000 d) goat1014010 Muscle1014020 Fat1014030 Liver1014040 Kidney1014050 Edible offals (other than liver and kidney)1014990 Others (2)1016000 (f) poultry1016010 Muscle1016020 Fat1016030 Liver1016040 Kidney1016050 Edible offals (other than liver and kidney)1016990 Others (2)1020000 Milk1020010 Cattle1020020 Sheep1020030 Goat1020040 Horse1020990 Others (2)1030000 Birds eggs1030010 Chicken1030020 Duck1030030 Geese1030040 Quail1030990 Others (2)Famoxadone (F)(F) Fat solubleMandipropamid (any ratio of constituent isomers)The European Food Safety Authority identified some information on toxicity of metabolites 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 23 January 2026, or, if that information is not submitted by that date, the lack of it.0211000 (a) potatoes0213010 Beetroots0213080 RadishesThe European Food Safety Authority identified some information on toxicity of metabolites 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 11 July 2021, or, if that information is not submitted by that date, the lack of it.0220020 Onions0220040 Spring onions/green onions and Welsh onionsThe 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 11 July 2021, or, if that information is not submitted by that date, the lack of it.0231010 Tomatoes0232030 CourgettesFor radish leaves the MRL of 50 mg/kg applies0243020 Kales’Code numberGroups and examples of individual products to which the MRLs applynoteAzoxystrobinFamoxadone (F)FlutriafolMandipropamid (any ratio of constituent isomers)Mefentrifluconazole(1)(2)(3)(4)(5)(6)(7)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits150,01note0,01note0110010Grapefruits0,20,50110020Oranges0,410110030Lemons0,51,50110040Limes0,51,50110050Mandarins0,51,50110990Others (2)0,50,50120000Tree nuts0,01note0,01note0,060120010Almonds0,010,80120020Brazil nuts0,010,02note0120030Cashew nuts0,010,02note0120040Chestnuts0,010,02note0120050Coconuts0,010,02note0120060Hazelnuts/cobnuts0,010,02note0120070Macadamias0,010,02note0120080Pecans0,010,02note0120090Pine nut kernels0,010,02note0120100Pistachios10,02note0120110Walnuts0,010,02note0120990Others (2)0,010,02note0130000Pome fruits0,01note0,01note0,40,01note0,40130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits20,01note0,01note0140010Apricots0,01note20140020Cherries (sweet)150140030Peaches0,620140040Plums0,41,50140990Others (2)0,01note0,01note0150000Berries and small fruits0151000
(a)grapes
(a)edible peel
(a)potatoes
(a)Solanaceae and Malvaceae
(a)flowering brassica
(a)lettuces and salad plants
(a)flowers
(a)swine
(b)strawberries
(b)inedible peel, small
(b)tropical root and tuber vegetables
(b)cucurbits with edible peel
(b)head brassica
(b)spinaches and similar leaves
(b)leaves and herbs
(b)bovine
(c)cane fruits
(c)inedible peel, large
(c)other root and tuber vegetables except sugar beets
(c)cucurbits with inedible peel
(c)leafy brassica
(c)grape leaves and similar species
(c)roots
(c)sheep
(d)other small fruits and berries
(d)sweet corn
(d)kohlrabies
(d)watercresses
(d)any other parts of the plant
d)goat
(e)other fruiting vegetables
(e)witloofs/Belgian endives
(e)equine
(f)herbs and edible flowers
(f)poultry
(g)other farmed terrestrial animals
320151010Table grapes0,01note0,80,90151020Wine grapes21,520152000100,01note1,50,01note2015300050,01note0,01note0,01note30153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)01540000,01note0,01note0,01note0154010Blueberries550154020Cranberries0,520154030Currants (black, red and white)550154040Gooseberries (green, red and yellow)550154050Rose hips550154060Mulberries (black and white)520154070Azaroles/Mediterranean medlars520154080Elderberries550154990Others (2)520160000Miscellaneous fruitswith0,01note01610000,01note0161010Dates0,01note0,01note0,01note0161020Figs0,01note0,01note0,01note0161030Table olives0,01note0,01note20161040Kumquats0,01note0,51,50161050Carambolas0,10,01note0,01note0161060Kaki/Japanese persimmons0,01note0,01note0,20161070Jambuls/jambolans0,01note0,01note0,01note0161990Others (2)0,01note0,01note0,01note01620000,01note0,01note0,01note0162010Kiwi fruits (green, red, yellow)0,01note0162020Litchis/lychees0,01note0162030Passionfruits/maracujas40162040Prickly pears/cactus fruits0,30162050Star apples/cainitos0,01note0162060American persimmons/Virginia kaki0,01note0162990Others (2)0,01note01630000163010Avocados0,01note0,01note0,01note10163020Bananas20,30,01note1,50163030Mangoes40,01note0,01note0,60163040Papayas40,01note0,80,50163050Granate apples/pomegranates0,01note0,01note0,01note0,01note0163060Cherimoyas0,01note0,01note0,01note0,01note0163070Guavas0,20,01note0,01note0,01note0163080Pineapples0,01note0,01note0,01note0,01note0163090Breadfruits0,01note0,01note0,01note0,01note0163100Durians0,01note0,01note0,01note0,01note0163110Soursops/guanabanas0,01note0,01note0,01note0,01note0163990Others (2)0,01note0,01note0,01note0,01note0200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0,01note021100070,020,1(+)0,05021200010,01note0,01note0,050212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)02130000,01note0213010Beetroots10,1(+)0,50213020Carrots10,01note0,50213030Celeriacs/turnip rooted celeries10,01note0,50213040Horseradishes10,01note0,50213050Jerusalem artichokes10,01note0,10213060Parsnips10,01note0,50213070Parsley roots/Hamburg roots parsley10,01note0,50213080Radishes1,50,3(+)0,50213090Salsifies10,01note0,50213100Swedes/rutabagas10,01note0,50213110Turnips10,01note0,50213990Others (2)10,01note0,50220000Bulb vegetables100,01note0,01note0220010Garlic0,01note0,20220020Onions0,1(+)0,20220030Shallots0,01note0,20220040Spring onions/green onions and Welsh onions7(+)40220990Others (2)0,01note0,01note0230000Fruiting vegetables023100030231010Tomatoes20,83(+)0,70231020Sweet peppers/bell peppers0,01note111,50231030Aubergines/eggplants0,01note0,01note31,50231040Okra/lady's fingers0,01note0,01note0,01note1,50231990Others (2)0,01note0,01note0,01note0,01note023200010,150,20,30232010Cucumbers0,20232020Gherkins0,01note0232030Courgettes0,2(+)0232990Others (2)0,01note023300010,01note0,30,50233010Melons0,50233020Pumpkins0,40233030Watermelons0,40233990Others (2)0,302340000,01note0,01note0,01note0,01note0,0402390000,01note0,01note0,01note0,01note0,01note0240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,01note0,01note024100050,70241010Broccoli20241020Cauliflowers0,30241990Others (2)0,01note024200050242010Brussels sprouts0,20,40242020Head cabbages30,040242990Others (2)0,01note0,01note02430006250,01note0243010Chinese cabbages/pe-tsai0243020Kales(+)0243990Others (2)024400050,10,01note0250000Leaf vegetables, herbs and edible flowers0251000100,01note250251010Lamb's lettuces/corn salads0,01note0,01note0251020Lettuces1,50,01note0251030Escaroles/broad-leaved endives0,01note0,01note0251040Cresses and other sprouts and shoots0,01note0,01note0251050Land cresses0,01note0,01note0251060Roman rocket/rucola0,01note70251070Red mustards0,01note0,01note0251080Baby leaf crops (including brassica species)0,01note70251990Others (2)0,01note0,01note0252000150,01note0,01note250252010Spinaches70252020Purslanes0,01note0252030Chards/beet leaves0,01note0252990Others (2)0,01note02530000,01note0,01note0,01note250,01note02540000,01note0,01note0,01note250,01note02550000,30,01note0,01note0,150,01note0256000700,02note0,02note3070256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables30,01note0,01note0260010Beans (with pods)10,050260020Beans (without pods)0,01note0,040260030Peas (with pods)0,01note0,150260040Peas (without pods)0,30,080260050Lentils0,01note0,01note0260990Others (2)0,01note0,01note0270000Stem vegetables0,01note0,01note0270010Asparagus0,01note0,01note0,01note0270020Cardoons150,01note30270030Celeries152030270040Florence fennels100,01note30270050Globe artichokes50,30,70270060Leeks100,01note0,01note0270070Rhubarbs0,60,01note30270080Bamboo shoots0,01note0,01note0,01note0270090Palm hearts0,01note0,01note0,01note0270990Others (2)0,01note0,01note0,01note0280000Fungi, mosses and lichens0,01note0,01note0,01note0,01note0,01note0280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,01note0,01note0,01note0,01note0,01note0300000PULSES0,150,01note0,01note0,01note0300010Beans0,070300020Lentils1,50300030Peas0,20300040Lupins/lupini beans0,20300990Others (2)0,20400000OILSEEDS AND OIL FRUITS0,01note0,01note0401000Oilseeds0401010Linseeds0,40,02note10401020Peanuts/groundnuts0,20,150,01note0401030Poppy seeds0,50,02note10401040Sesame seeds0,01note0,02note10401050Sunflower seeds0,50,02note0,150401060Rapeseeds/canola seeds0,70,510401070Soyabeans0,50,40,40401080Mustard seeds0,50,02note10401090Cotton seeds0,70,50,20401100Pumpkin seeds0,01note0,02note0,01note0401110Safflower seeds0,40,02note0,150401120Borage seeds0,40,02note10401130Gold of pleasure seeds0,50,02note10401140Hemp seeds0,01note0,02note0,01note0401150Castor beans0,01note0,02note0,01note0401990Others (2)0,01note0,02note0,01note0402000Oil fruits0,02note0402010Olives for oil production0,01note30402020Oil palms kernels0,01note0,01note0402030Oil palms fruits0,030,01note0402040Kapok0,01note0,01note0402990Others (2)0,01note0,01note0500000CEREALS0,01note0500010Barley1,50,21,530500020Buckwheat and other pseudocereals0,01note0,01note0,01note0,01note0500030Maize/corn0,020,01note0,01note0,01note0500040Common millet/proso millet0,01note0,01note0,01note20500050Oat1,50,01note0,01note0,60500060Rice50,01note0,01note1,50500070Rye0,50,01note0,01note0,40500080Sorghum100,01note1,520500090Wheat0,50,10,150,40500990Others (2)0,01note0,01note0,01note0,01note0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,05note0610000Teas0,05note0,05note0,05note0,05note0620000Coffee beans0,030,150,05note0,40630000Herbal infusions from0,05note0,05note0631000600,05note0631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)0632000600,05note0632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)06330000,30633010Valerian0,05note0633020Ginseng0,50633990Others (2)0,05note06390000,05note0,05note0640000Cocoa beans0,05note0,05note0,060,05note0650000Carobs/Saint John's breads0,05note0,05note0,05note0,05note0700000HOPS40502090150800000SPICES0810000Seed spices0,30,05note0,05note0,05note0,05note0810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,30,05note0,05note0,05note0,05note0820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,05note0,05note0,05note0,05note0,05note0830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,05note0,05note0,05note0,05note0,05note0840020Ginger (10)0840030Turmeric/curcuma0,05note0,05note0,05note0,05note0,05note0840040Horseradish (11)0840990Others (2)0,05note0,05note0,05note0,05note0,05note0850000Bud spices0,05note0,05note0,05note0,05note0,05note0850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,05note0,05note0,05note0,05note0,05note0860010Saffron0860990Others (2)0870000Aril spices0,05note0,05note0,05note0,05note0,05note0870010Mace0870990Others (2)0900000SUGAR PLANTS0,01note0,01note0900010Sugar beet roots50,020,060900020Sugar canes0,050,01note1,50900030Chicory roots10,01note0,50900990Others (2)0,01note0,01note0,01note1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from1011000(+)1011010Muscle0,01note(+)0,050,01note0,01note0,01note1011020Fat0,05(+)0,50,020,020,01note1011030Liver0,07(+)0,510,01note0,021011040Kidney0,07(+)0,510,01note0,01note1011050Edible offals (other than liver and kidney)0,07(+)0,510,01note0,01note1011990Others (2)0,01note(+)0,01note0,01note0,01note0,021012000(+)1012010Muscle0,01note(+)0,050,01note0,01note0,041012020Fat0,05(+)0,50,020,020,21012030Liver0,07(+)0,510,01note0,41012040Kidney0,07(+)0,510,01note0,151012050Edible offals (other than liver and kidney)0,07(+)0,510,01note0,11012990Others (2)0,01note(+)0,01note0,01note0,01note0,41013000(+)1013010Muscle0,01note(+)0,050,01note0,01note0,061013020Fat0,05(+)0,50,020,020,41013030Liver0,07(+)0,510,01note0,71013040Kidney0,07(+)0,510,01note0,31013050Edible offals (other than liver and kidney)0,07(+)0,510,01note0,31013990Others (2)0,01note(+)0,01note0,01note0,01note0,71014000(+)1014010Muscle0,01note(+)0,050,01note0,01note0,061014020Fat0,05(+)0,50,020,020,41014030Liver0,07(+)0,510,01note0,71014040Kidney0,07(+)0,510,01note0,31014050Edible offals (other than liver and kidney)0,07(+)0,510,01note0,31014990Others (2)0,01note(+)0,01note0,01note0,01note0,710150001015010Muscle0,01note0,050,01note0,01note0,041015020Fat0,050,50,020,020,21015030Liver0,070,510,01note0,41015040Kidney0,070,510,01note0,11015050Edible offals (other than liver and kidney)0,070,510,01note0,11015990Others (2)0,01note0,01note0,01note0,01note0,410160000,01note(+)0,01note0,01note1016010Muscle(+)0,01note0,0151016020Fat(+)0,030,031016030Liver(+)0,030,031016040Kidney(+)0,030,031016050Edible offals (other than liver and kidney)(+)0,030,031016990Others (2)(+)0,01note0,0310170000,01note1017010Muscle0,01note0,050,01note0,01note1017020Fat0,050,50,020,021017030Liver0,070,510,01note1017040Kidney0,070,510,01note1017050Edible offals (other than liver and kidney)0,070,510,01note1017990Others (2)0,01note0,01note0,01note0,01note1020000Milk0,01note(+)0,030,01note0,01note1020010Cattle(+)0,031020020Sheep(+)0,041020030Goat(+)0,041020040Horse(+)0,021020990Others (2)(+)0,01note1030000Birds eggs0,01note(+)0,01note0,01note0,01note0,0151030010Chicken(+)1030020Duck(+)1030030Geese(+)1030040Quail(+)1030990Others (2)(+)1040000Honey and other apiculture products (7)0,05note0,05note0,05note0,05note0,05note1050000Amphibians and Reptiles0,01note0,01note0,01note0,01note0,01note1060000Terrestrial invertebrate animals0,01note0,01note0,01note0,01note0,01note1070000Wild terrestrial vertebrate animals0,01note0,01note0,01note0,01note0,01note1100000PRODUCTS 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)
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