Commission Regulation (EU) 2022/78

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 396/2005^note 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, and in particular Article 14(1)(a) and Article 49(2) thereof,Whereas:

(1)For dazomet, hexythiazox and metam, maximum residue levels (‘MRLs’) were set in Part A of Annex III to Regulation (EC) No 396/2005.

(2)For dazomet and metam, the European Food Safety Authority (‘the Authority’) submitted reasoned opinions on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005^note. It proposed a revised common residue definition based on methylisothiocyanate, the main metabolite for dazomet and metam. The residue definition should therefore be changed accordingly. The Authority recommended lowering the MRLs for grapefruits, oranges, lemons, limes, mandarins, apples, pears, quinces, medlars, loquats/Japanese medlars, apricots, cherries (sweet), peaches, plums, table and wine grapes, blackberries, dewberries, raspberries (red and yellow), blueberries, cranberries, currants (black, red and white), gooseberries (green, red and yellow), rose hips, mulberries (black and white), azaroles/Mediterranean medlars, elderberries, figs, table olives, kumquats, kaki/Japanese persimmons, kiwi fruits (green, red, yellow), prickly pears/cactus fruits, avocados, mangoes and granate apples/pomegranates. For other products, it recommended raising or keeping the existing MRLs. The MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. The Authority concluded that concerning the MRLs for strawberries, beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, turnips, tomatoes, sweet peppers/bell peppers, aubergines/eggplants, okra/lady’s fingers, cucumbers, gherkins, courgettes, melons, pumpkins, watermelons, Chinese cabbages/pe-tsai, kales, lamb’s lettuces/corn salads, lettuces, escaroles/broad-leaved endives, cresses and other sprouts and shoots, land cresses, Roman rocket/rucola, red mustards, baby leaf crops (including brassica species), spinaches, purslanes, chards/beet leaves, herbal infusions from roots and hops, some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for those products should also be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within 2 years from the publication of this Regulation.

(3)For hexythiazox, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005^note. It proposed to change the residue definition. The residue definition should therefore be changed accordingly. The Authority recommended lowering the MRLs for grapefruits, oranges, lemons, limes, mandarins, almonds, brazil nuts, cashew nuts, chestnuts, coconuts, hazelnuts/cobnuts, macadamias, pecans, pine nut kernels, pistachios, walnuts, apples, pears, quinces, medlars, loquats/Japanese medlars, peaches, blackberries, dewberries, raspberries (red and yellow), blueberries, cranberries, currants (black, red and white), gooseberries (green, red and yellow), rose hips, mulberries (black and white), azaroles/Mediterranean medlars, elderberries, tomatoes, sweet peppers/bell peppers, aubergines/eggplants, cucumbers, gherkins, courgettes, melons, pumpkins, watermelons, maize/corn and hops. For other products, it recommended raising or keeping the existing MRLs. The MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. The Authority also concluded that concerning the MRLs for apricots, cherries (sweet), plums, soybeans and products of animal origin, some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within 2 years from the publication of this Regulation.

(4)Existing Codex maximum residue limits (CXLs) were taken into account in the reasoned opinions of the Authority. CXLs, which are safe for consumers in the Union were considered for MRL setting.

(5)As regards products on which the use of the plant protection product concerned is not authorised, and for which no import tolerances or CXLs exist, MRLs should be set at the specific limit of determination (‘LOD’) or the default MRL should apply, as provided for in Article 18(1)(b) of Regulation (EC) No 396/2005.

(6)The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs. As regards several substances, those laboratories concluded that, for certain commodities, technical development requires the setting of specific LODs.

(7)Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.

(8)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.

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

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

(11)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.

(12)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 #

Annexes II and III to Regulation (EC) No 396/2005 are 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 9 August 2022.

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 9 August 2022.

(1)in Annex II, the following columns for dazomet, hexythiazox, metam and methylisothiocyanate are added:“Pesticide residues and maximum residue levels (mg/kg)^note^noteMethylisothiocyanate (resulting from the use of dazomet or metam)(+)The European Food Safety Authority identified some information on residue trials on metam 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 20 January 2024, or, if that information is not submitted by that date, the lack of it.0152000 (b) strawberries(+)The European Food Safety Authority identified some information on residue trials on dazomet including analysis of parent and metabolites convertible to N, N'-dimethylthiourea (DMTU) and toxicological data on DMTU 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 20 January 2024, or, if that information is not submitted by that date, the lack of it.0213000 (c) other root and tuber vegetables except sugar beets0213010 Beetroots0213020 Carrots0213030 Celeriacs/turnip rooted celeries0213040 Horseradishes0213050 Jerusalem artichokes0213060 Parsnips0213070 Parsley roots/Hamburg roots parsley0213080 Radishes0213090 Salsifies0213100 Swedes/rutabagas0213110 Turnips0213990 Others (2)The European Food Safety Authority identified some information on residue trials on metam and on the nature of residues in processed commodities 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 20 January 2024, or, if that information is not submitted by that date, the lack of it.0231010 Tomatoes(+)The European Food Safety Authority identified some information on residue trials on dazomet including analysis of parent and metabolites convertible to N, N'-dimethylthiourea (DMTU) and toxicological data on DMTU 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 20 January 2024, or, if that information is not submitted by that date, the lack of it.0231020 Sweet peppers/bell peppers(+)The European Food Safety Authority identified some information on residue trials on metam and on the nature of residues in processed commodities 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 20 January 2024, or, if that information is not submitted by that date, the lack of it.0231030 Aubergines/eggplants(+)The European Food Safety Authority identified some information on residue trials on dazomet including analysis of parent and metabolites convertible to N, N'-dimethylthiourea (DMTU) and toxicological data on DMTU 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 20 January 2024, or, if that information is not submitted by that date, the lack of it.0231040 Okra/lady's fingers(+)The European Food Safety Authority identified some information on residue trials on metam and on the nature of residues in processed commodities 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 20 January 2024, or, if that information is not submitted by that date, the lack of it.0232000 (b) cucurbits with edible peel0232010 Cucumbers0232020 Gherkins0232030 Courgettes0232990 Others (2)(+)The European Food Safety Authority identified some information on residue trials on dazomet including analysis of parent and metabolites convertible to N, N'-dimethylthiourea (DMTU) and toxicological data on DMTU 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 20 January 2024, or, if that information is not submitted by that date, the lack of it.0233000 (c) cucurbits with inedible peel0233010 Melons0233020 Pumpkins0233030 Watermelons0233990 Others (2)0243000 (c) leafy brassica0243010 Chinese cabbages/pe-tsai0243020 Kales0243990 Others (2)0251000 (a) lettuces and salad plants0251010 Lamb's lettuces/corn salads0251020 Lettuces0251030 Escaroles/broad-leaved endives0251040 Cresses and other sprouts and shoots0251050 Land cresses0251060 Roman rocket/rucola0251070 Red mustards0251080 Baby leaf crops (including brassica species)0251990 Others (2)0252000 (b) spinaches and similar leaves0252010 Spinaches0252020 Purslanes0252030 Chards/beet leaves0252990 Others (2)(+)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 20 January 2024, or, if that information is not submitted by that date, the lack of it.0633000 (c) roots0633010 Valerian0633020 Ginseng0633990 Others (2)0700000 HOPSHexythiazox (any ratio of constituent isomers) (F)(F)Fat soluble(+)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 20 January 2024, or, if that information is not submitted by that date, the lack of it.0140010 Apricots0140020 Cherries (sweet)0140040 Plums0401070 Soyabeans(+)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 20 January 2024, or, if that information is not submitted by that date, the lack of it.1010000 Commodities from1011000 (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)1015000 (e) equine1015010 Muscle1015020 Fat1015030 Liver1015040 Kidney1015050 Edible offals (other than liver and kidney)1015990 Others (2)1016000 (f) poultry1016010 Muscle1016020 Fat1016030 Liver1016040 Kidney1016050 Edible offals (other than liver and kidney)1016990 Others (2)1017000 (g) other farmed terrestrial animals1017010 Muscle1017020 Fat1017030 Liver1017040 Kidney1017050 Edible offals (other than liver and kidney)1017990 Others (2)1020000 Milk1020010 Cattle1020020 Sheep1020030 Goat1020040 Horse1020990 Others (2) ”Code numberGroups and examples of individual products to which the MRLs apply^noteMethylisothiocyanate(resulting from the use of dazomet or metam)Hexythiazox (any ratio of constituent isomers) (F)Dazomet (see methylisothiocyanate)Metam (see methylisothiocyanate)(1)(2)(3)(4)(5)(6)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0,01^note0,50110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,01^note0,050120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,01^note0,40130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0,01^note0140010Apricots0,7 (+)0140020Cherries (sweet)1,5 (+)0140030Peaches0,70140040Plums0,7 (+)0140990Others (2)0,01^note0150000Berries 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

0,01^note10151010Table grapes0151020Wine grapes01520000,03 (+)601530000,01^note0,01^note0153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)01540000,01^note0,01^note0154010Blueberries0154020Cranberries0154030Currants (black, red and white)0154040Gooseberries (green, red and yellow)0154050Rose hips0154060Mulberries (black and white)0154070Azaroles/Mediterranean medlars0154080Elderberries0154990Others (2)0160000Miscellaneous fruitswith0,01^note01610000161010Dates20161020Figs0,01^note0161030Table olives0,01^note0161040Kumquats0,01^note0161050Carambolas0,01^note0161060Kaki/Japanese persimmons0,01^note0161070Jambuls/jambolans0,01^note0161990Others (2)0,01^note01620000,01^note0162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees0162030Passionfruits/maracujas0162040Prickly pears/cactus fruits0162050Star apples/cainitos0162060American persimmons/Virginia kaki0162990Others (2)01630000,01^note0163010Avocados0163020Bananas0163030Mangoes0163040Papayas0163050Granate apples/pomegranates0163060Cherimoyas0163070Guavas0163080Pineapples0163090Breadfruits0163100Durians0163110Soursops/guanabanas0163990Others (2)0200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0,01^note02110000,01^note02120000,01^note0212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)0213000(+)0213010Beetroots0,020213020Carrots0,020213030Celeriacs/turnip rooted celeries0,020213040Horseradishes0,020213050Jerusalem artichokes0,020213060Parsnips0,020213070Parsley roots/Hamburg roots parsley0,020213080Radishes0,050213090Salsifies0,020213100Swedes/rutabagas0,020213110Turnips0,020213990Others (2)0,01^note0220000Bulb vegetables0,01^note0220010Garlic0,01^note0220020Onions0,150220030Shallots0,01^note0220040Spring onions/green onions and Welsh onions0,01^note0220990Others (2)0,01^note0230000Fruiting vegetables02310000231010Tomatoes0,4 (+)0,10231020Sweet peppers/bell peppers0,1 (+)0,090231030Aubergines/eggplants0,4 (+)0,10231040Okra/lady's fingers0,1 (+)0,01^note0231990Others (2)0,01^note0,01^note02320000,6 (+)0,050232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)02330000,1 (+)0,070233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)02340000,01^note0,01^note02390000,01^note0,01^note0240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,01^note02410000,01^note0241010Broccoli0241020Cauliflowers0241990Others (2)02420000,01^note0242010Brussels sprouts0242020Head cabbages0242990Others (2)02430000,03 (+)0243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)02440000,01^note0250000Leaf vegetables, herbs and edible flowers02510000,03 (+)0,01^note0251010Lamb's lettuces/corn salads0251020Lettuces0251030Escaroles/broad-leaved endives0251040Cresses and other sprouts and shoots0251050Land cresses0251060Roman rocket/rucola0251070Red mustards0251080Baby leaf crops (including brassica species)0251990Others (2)02520000,15 (+)0,01^note0252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)02530000,01^note0,01^note02540000,01^note0,01^note02550000,01^note0,01^note02560000,02^note0,02^note0256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,01^note0,01^note0260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0,01^note0,01^note0270010Asparagus0270020Cardoons0270030Celeries0270040Florence fennels0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0,01^note0,01^note0280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,01^note0,01^note0300000PULSES0,01^note0,01^note0300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,01^note0401000Oilseeds0401010Linseeds0,01^note0401020Peanuts/groundnuts0,01^note0401030Poppy seeds0,01^note0401040Sesame seeds0,01^note0401050Sunflower seeds0,01^note0401060Rapeseeds/canola seeds0,01^note0401070Soyabeans0,5 (+)0401080Mustard seeds0,01^note0401090Cotton seeds0,01^note0401100Pumpkin seeds0,01^note0401110Safflower seeds0,01^note0401120Borage seeds0,01^note0401130Gold of pleasure seeds0,01^note0401140Hemp seeds0,01^note0401150Castor beans0,01^note0401990Others (2)0,01^note0402000Oil fruits0,01^note0402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0,01^note0500010Barley0,01^note0500020Buckwheat and other pseudocereals0,01^note0500030Maize/corn0,020500040Common millet/proso millet0,01^note0500050Oat0,01^note0500060Rice0,01^note0500070Rye0,01^note0500080Sorghum0,01^note0500090Wheat0,01^note0500990Others (2)0,01^note0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,05^note0610000Teas150620000Coffee beans0,05^note0630000Herbal infusions from0,05^note06310000631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)06320000632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)0633000(+)0633010Valerian0633020Ginseng0633990Others (2)06390000640000Cocoa beans0,05^note0650000Carobs/Saint John's breads0,05^note0700000HOPS0,05^note (+)30800000SPICES0810000Seed spices0,05^note0,05^note0810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,05^note0,05^note0820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,05^note0,05^note0830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,05^note0,05^note0840020Ginger (10)0840030Turmeric/curcuma0,05^note0,05^note0840040Horseradish (11)0840990Others (2)0,05^note0,05^note0850000Bud spices0,05^note0,05^note0850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,05^note0,05^note0860010Saffron0860990Others (2)0870000Aril spices0,05^note0,05^note0870010Mace0870990Others (2)0900000SUGAR PLANTS0,01^note0,05^note0900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from0,01^note0,05 (+)10110001011010Muscle1011020Fat1011030Liver1011040Kidney1011050Edible offals (other than liver and kidney)1011990Others (2)10120001012010Muscle1012020Fat1012030Liver1012040Kidney1012050Edible offals (other than liver and kidney)1012990Others (2)10130001013010Muscle1013020Fat1013030Liver1013040Kidney1013050Edible offals (other than liver and kidney)1013990Others (2)10140001014010Muscle1014020Fat1014030Liver1014040Kidney1014050Edible offals (other than liver and kidney)1014990Others (2)10150001015010Muscle1015020Fat1015030Liver1015040Kidney1015050Edible offals (other than liver and kidney)1015990Others (2)10160001016010Muscle1016020Fat1016030Liver1016040Kidney1016050Edible offals (other than liver and kidney)1016990Others (2)10170001017010Muscle1017020Fat1017030Liver1017040Kidney1017050Edible offals (other than liver and kidney)1017990Others (2)1020000Milk0,01^note0,05 (+)1020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,01^note0,01^note1030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,05^note0,05^note1050000Amphibians and Reptiles0,01^note0,01^note1060000Terrestrial invertebrate animals0,01^note0,02^note1070000Wild terrestrial vertebrate animals0,01^note0,01^note1100000PRODUCTS 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)

(2)in Part A of Annex III the columns for dazomet, hexythiazox and metam are deleted.

Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:

Commission Regulation (EU) 2022/78

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