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Document 32024R1314

    Commission Regulation (EU) 2024/1314 of 15 May 2024 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for dithianon in or on certain products

    C/2024/3150

    OJ L, 2024/1314, 16.5.2024, ELI: http://data.europa.eu/eli/reg/2024/1314/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    Legal status of the document In force

    ELI: http://data.europa.eu/eli/reg/2024/1314/oj

    European flag

    Official Journal
    of the European Union

    EN

    L series


    2024/1314

    16.5.2024

    COMMISSION REGULATION (EU) 2024/1314

    of 15 May 2024

    amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for dithianon 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), point (a), thereof,

    Whereas:

    (1)

    The maximum residue levels (‘MRLs’) for dithianon are set out in Part A of Annex III to Regulation (EC) No 396/2005.

    (2)

    The Authority has submitted a reasoned opinion on the review of the existing MRLs for dithianon in accordance with Article 12(1) of Regulation (EC) No 396/2005 (2). The Authority noted that the mutagenicity potential of the metabolite 1,4-naphthoquinone remains uncertain, pending the submission of additional studies fulfilling the previously identified data gap (3). Therefore, the values of the acceptable daily intake (ADI) and acute reference dose (ARfD) of 1,4-naphthoquinone are considered provisional and all MRLs for dithianon above the limits of determination (LODs) require further consideration by risk managers. As the missing data is to be submitted as part of the ongoing procedure for the renewal of the approval of dithianon, the MRLs should be reconsidered and revised by risk managers following the finalisation of that procedure.

    (3)

    Additionally, the Authority identified an exceedance of the ARfD of dithianon for apples and pears. The Authority consulted the Member States and requested them to report potential fall-back Good Agricultural Practices (GAPs) for apples and pears, authorised in Member States or third countries and already evaluated at Member State level, which would not lead to an unacceptable risk for consumers. Fall-back GAPs for apples and pears were identified that do not lead to exceedances of the ARfD of dithianon. It is therefore appropriate to lower the MRLs for dithianon on apples and pears to the values identified by the Authority in Part A of Annex III to Regulation (EC) No 396/2005.

    (4)

    The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs for dithianon. Those laboratories proposed product-specific LODs that are analytically achievable.

    (5)

    Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs for dithianon and their comments have been taken into account.

    (6)

    Annex III to Regulation (EC) No 396/2005 should therefore be amended accordingly.

    (7)

    A reasonable period should be allowed to elapse before the new MRLs for dithianon become applicable, in order to permit Member States, third countries and food business operators to adapt themselves to the requirements which result from the modification of the MRLs.

    (8)

    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

    Part A of Annex III 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 5 December 2024.

    This Regulation shall be binding in its entirety and directly applicable in all Member States.

    Done at Brussels, 15 May 2024.

    For the Commission

    The President

    Ursula VON DER LEYEN


    (1)   OJ L 70, 16.3.2005, p. 1.

    (2)  European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for dithianon according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2023;21(1):7731.

    (3)  European Food Safety Authority; Conclusion on the updated peer review of the pesticide risk assessment for the active substance dithianon in light of confirmatory data submitted. EFSA Journal 2020;18(9):6189.


    ANNEX

    In Part A of Annex III to Regulation (EC) No 396/2005, the column for dithianon is replaced by the following:

    Pesticide residues and maximum residue levels (mg/kg)

    Code number

    Groups and examples of individual products to which the MRLs apply  (1)

    Dithianon

    (1)

    (2)

    (3)

    0100000

    FRUITS, FRESH or FROZEN; TREE NUTS

     

    0110000

    Citrus fruits

     

    0110010

    Grapefruits

    1  ((+))

    0110020

    Oranges

    1  ((+))

    0110030

    Lemons

    1  ((+))

    0110040

    Limes

    1  ((+))

    0110050

    Mandarins

    3  ((+))

    0110990

    Others (2)

    1  ((+))

    0120000

    Tree nuts

     

    0120010

    Almonds

    0,05  ((+))

    0120020

    Brazil nuts

    0,01  (*1)

    0120030

    Cashew nuts

    0,01  (*1)

    0120040

    Chestnuts

    0,01  (*1)

    0120050

    Coconuts

    0,01  (*1)

    0120060

    Hazelnuts/cobnuts

    0,01  (*1)

    0120070

    Macadamias

    0,01  (*1)

    0120080

    Pecans

    0,01  (*1)

    0120090

    Pine nut kernels

    0,01  (*1)

    0120100

    Pistachios

    0,01  (*1)

    0120110

    Walnuts

    0,05  ((+))

    0120990

    Others (2)

    0,01  (*1)

    0130000

    Pome fruits

     

    0130010

    Apples

    1,5  ((+))

    0130020

    Pears

    1,5  ((+))

    0130030

    Quinces

    3  ((+))

    0130040

    Medlars

    3  ((+))

    0130050

    Loquats/Japanese medlars

    3  ((+))

    0130990

    Others (2)

    3  ((+))

    0140000

    Stone fruits

     

    0140010

    Apricots

    0,5  ((+))

    0140020

    Cherries (sweet)

    2  ((+))

    0140030

    Peaches

    0,5  ((+))

    0140040

    Plums

    0,5  ((+))

    0140990

    Others (2)

    2  ((+))

    0150000

    Berries and small fruits

     

    0151000

    (a)

    grapes

    3  ((+))

    0151010

    Table grapes

     ((+))

    0151020

    Wine grapes

     ((+))

    0152000

    (b)

    strawberries

    0,01  (*1)

    0153000

    (c)

    cane fruits

     

    0153010

    Blackberries

    0,5  ((+))

    0153020

    Dewberries

    0,5  ((+))

    0153030

    Raspberries (red and yellow)

    3  ((+))

    0153990

    Others (2)

    0,01  (*1)

    0154000

    (d)

    other small fruits and berries

     

    0154010

    Blueberries

    0,01  (*1)

    0154020

    Cranberries

    3  ((+))

    0154030

    Currants (black, red and white)

    3  ((+))

    0154040

    Gooseberries (green, red and yellow)

    3  ((+))

    0154050

    Rose hips

    0,01  (*1)

    0154060

    Mulberries (black and white)

    0,01  (*1)

    0154070

    Azaroles/Mediterranean medlars

    0,01  (*1)

    0154080

    Elderberries

    0,01  (*1)

    0154990

    Others (2)

    0,01  (*1)

    0160000

    Miscellaneous fruitswith

    0,01  (*1)

    0161000

    (a)

    edible peel

     

    0161010

    Dates

     

    0161020

    Figs

     

    0161030

    Table olives

     

    0161040

    Kumquats

     

    0161050

    Carambolas

     

    0161060

    Kaki/Japanese persimmons

     

    0161070

    Jambuls/jambolans

     

    0161990

    Others (2)

     

    0162000

    (b)

    inedible peel, small

     

    0162010

    Kiwi fruits (green, red, yellow)

     

    0162020

    Litchis/lychees

     

    0162030

    Passionfruits/maracujas

     

    0162040

    Prickly pears/cactus fruits

     

    0162050

    Star apples/cainitos

     

    0162060

    American persimmons/Virginia kaki

     

    0162990

    Others (2)

     

    0163000

    (c)

    inedible peel, large

     

    0163010

    Avocados

     

    0163020

    Bananas

     

    0163030

    Mangoes

     

    0163040

    Papayas

     

    0163050

    Granate apples/pomegranates

     

    0163060

    Cherimoyas

     

    0163070

    Guavas

     

    0163080

    Pineapples

     

    0163090

    Breadfruits

     

    0163100

    Durians

     

    0163110

    Soursops/guanabanas

     

    0163990

    Others (2)

     

    0200000

    VEGETABLES, FRESH or FROZEN

     

    0210000

    Root and tuber vegetables

     

    0211000

    (a)

    potatoes

    0,1  ((+))

    0212000

    (b)

    tropical root and tuber vegetables

    0,01  (*1)

    0212010

    Cassava roots/manioc

     

    0212020

    Sweet potatoes

     

    0212030

    Yams

     

    0212040

    Arrowroots

     

    0212990

    Others (2)

     

    0213000

    (c)

    other root and tuber vegetables except sugar beets

     

    0213010

    Beetroots

    0,01  (*1)

    0213020

    Carrots

    0,05  ((+))

    0213030

    Celeriacs/turnip rooted celeries

    0,01  (*1)

    0213040

    Horseradishes

    0,01  (*1)

    0213050

    Jerusalem artichokes

    0,01  (*1)

    0213060

    Parsnips

    0,01  (*1)

    0213070

    Parsley roots/Hamburg roots parsley

    0,01  (*1)

    0213080

    Radishes

    0,01  (*1)

    0213090

    Salsifies

    0,01  (*1)

    0213100

    Swedes/rutabagas

    0,01  (*1)

    0213110

    Turnips

    0,01  (*1)

    0213990

    Others (2)

    0,01  (*1)

    0220000

    Bulb vegetables

    0,01  (*1)

    0220010

    Garlic

     

    0220020

    Onions

     

    0220030

    Shallots

     

    0220040

    Spring onions/green onions and Welsh onions

     

    0220990

    Others (2)

     

    0230000

    Fruiting vegetables

     

    0231000

    (a)

    Solanaceae and Malvaceae

     

    0231010

    Tomatoes

    0,6  ((+))

    0231020

    Sweet peppers/bell peppers

    0,6  ((+))

    0231030

    Aubergines/eggplants

    0,01  (*1)

    0231040

    Okra/lady's fingers

    0,01  (*1)

    0231990

    Others (2)

    0,01  (*1)

    0232000

    (b)

    cucurbits with edible peel

    0,01  (*1)

    0232010

    Cucumbers

     

    0232020

    Gherkins

     

    0232030

    Courgettes

     

    0232990

    Others (2)

     

    0233000

    (c)

    cucurbits with inedible peel

    0,01  (*1)

    0233010

    Melons

     

    0233020

    Pumpkins

     

    0233030

    Watermelons

     

    0233990

    Others (2)

     

    0234000

    (d)

    sweet corn

    0,01  (*1)

    0239000

    (e)

    other fruiting vegetables

    0,01  (*1)

    0240000

    Brassica vegetables(excluding brassica roots and brassica baby leaf crops)

    0,01  (*1)

    0241000

    (a)

    flowering brassica

     

    0241010

    Broccoli

     

    0241020

    Cauliflowers

     

    0241990

    Others (2)

     

    0242000

    (b)

    head brassica

     

    0242010

    Brussels sprouts

     

    0242020

    Head cabbages

     

    0242990

    Others (2)

     

    0243000

    (c)

    leafy brassica

     

    0243010

    Chinese cabbages/pe-tsai

     

    0243020

    Kales

     

    0243990

    Others (2)

     

    0244000

    (d)

    kohlrabies

     

    0250000

    Leaf vegetables, herbs and edible flowers

     

    0251000

    (a)

    lettuces and salad plants

    0,01  (*1)

    0251010

    Lamb's lettuces/corn salads

     

    0251020

    Lettuces

     

    0251030

    Escaroles/broad-leaved endives

     

    0251040

    Cresses and other sprouts and shoots

     

    0251050

    Land cresses

     

    0251060

    Roman rocket/rucola

     

    0251070

    Red mustards

     

    0251080

    Baby leaf crops (including brassica species)

     

    0251990

    Others (2)

     

    0252000

    (b)

    spinaches and similar leaves

     

    0252010

    Spinaches

    0,6  ((+))

    0252020

    Purslanes

    0,01  (*1)

    0252030

    Chards/beet leaves

    0,01  (*1)

    0252990

    Others (2)

    0,01  (*1)

    0253000

    (c)

    grape leaves and similar species

    0,1  ((+))

    0254000

    (d)

    watercresses

    0,01  (*1)

    0255000

    (e)

    witloofs/Belgian endives

    0,01  (*1)

    0256000

    (f)

    herbs and edible flowers

    0,01  (*1)

    0256010

    Chervil

     

    0256020

    Chives

     

    0256030

    Celery leaves

     

    0256040

    Parsley

     

    0256050

    Sage

     

    0256060

    Rosemary

     

    0256070

    Thyme

     

    0256080

    Basil and edible flowers

     

    0256090

    Laurel/bay leaves

     

    0256100

    Tarragon

     

    0256990

    Others (2)

     

    0260000

    Legume vegetables

     

    0260010

    Beans (with pods)

    0,01  (*1)

    0260020

    Beans (without pods)

    0,01  (*1)

    0260030

    Peas (with pods)

    0,01  (*1)

    0260040

    Peas (without pods)

    0,6  ((+))

    0260050

    Lentils

    0,01  (*1)

    0260990

    Others (2)

    0,01  (*1)

    0270000

    Stem vegetables

    0,01  (*1)

    0270010

    Asparagus

     

    0270020

    Cardoons

     

    0270030

    Celeries

     

    0270040

    Florence fennels

     

    0270050

    Globe artichokes

     

    0270060

    Leeks

     

    0270070

    Rhubarbs

     

    0270080

    Bamboo shoots

     

    0270090

    Palm hearts

     

    0270990

    Others (2)

     

    0280000

    Fungi, mosses and lichens

    0,01  (*1)

    0280010

    Cultivated fungi

     

    0280020

    Wild fungi

     

    0280990

    Mosses and lichens

     

    0290000

    Algae and prokaryotes organisms

    0,01  (*1)

    0300000

    PULSES

    0,01  (*1)

    0300010

    Beans

     

    0300020

    Lentils

     

    0300030

    Peas

     

    0300040

    Lupins/lupini beans

     

    0300990

    Others (2)

     

    0400000

    OILSEEDS AND OIL FRUITS

     

    0401000

    Oilseeds

    0,02  ((+))

    0401010

    Linseeds

     ((+))

    0401020

    Peanuts/groundnuts

     ((+))

    0401030

    Poppy seeds

     ((+))

    0401040

    Sesame seeds

     ((+))

    0401050

    Sunflower seeds

     ((+))

    0401060

    Rapeseeds/canola seeds

     ((+))

    0401070

    Soyabeans

     ((+))

    0401080

    Mustard seeds

     ((+))

    0401090

    Cotton seeds

     ((+))

    0401100

    Pumpkin seeds

     ((+))

    0401110

    Safflower seeds

     ((+))

    0401120

    Borage seeds

     ((+))

    0401130

    Gold of pleasure seeds

     ((+))

    0401140

    Hemp seeds

     ((+))

    0401150

    Castor beans

     ((+))

    0401990

    Others (2)

     ((+))

    0402000

    Oil fruits

    0,01  (*1)

    0402010

    Olives for oil production

     

    0402020

    Oil palms kernels

     

    0402030

    Oil palms fruits

     

    0402040

    Kapok

     

    0402990

    Others (2)

     

    0500000

    CEREALS

     

    0500010

    Barley

    0,01  (*1)

    0500020

    Buckwheat and other pseudocereals

    0,01  (*1)

    0500030

    Maize/corn

    0,01  (*1)

    0500040

    Common millet/proso millet

    0,01  (*1)

    0500050

    Oat

    0,01  (*1)

    0500060

    Rice

    0,05  ((+))

    0500070

    Rye

    0,01  (*1)

    0500080

    Sorghum

    0,01  (*1)

    0500090

    Wheat

    0,05  ((+))

    0500990

    Others (2)

    0,01  (*1)

    0600000

    TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

    0,01  (*1)

    0610000

    Teas

     

    0620000

    Coffee beans

     

    0630000

    Herbal infusions from

     

    0631000

    (a)

    flowers

     

    0631010

    Chamomile

     

    0631020

    Hibiscus/roselle

     

    0631030

    Rose

     

    0631040

    Jasmine

     

    0631050

    Lime/linden

     

    0631990

    Others (2)

     

    0632000

    (b)

    leaves and herbs

     

    0632010

    Strawberry

     

    0632020

    Rooibos

     

    0632030

    Mate/maté

     

    0632990

    Others (2)

     

    0633000

    (c)

    roots

     

    0633010

    Valerian

     

    0633020

    Ginseng

     

    0633990

    Others (2)

     

    0639000

    (d)

    any other parts of the plant

     

    0640000

    Cocoa beans

     

    0650000

    Carobs/Saint John's breads

     

    0700000

    HOPS

    100  ((+))

    0800000

    SPICES

     

    0810000

    Seed spices

    0,01  (*1)

    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

    0,01  (*1)

    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)

     

    0830000

    Bark spices

    0,01  (*1)

    0830010

    Cinnamon

     

    0830990

    Others (2)

     

    0840000

    Root and rhizome spices

     

    0840010

    Liquorice

    0,01  (*1)

    0840020

    Ginger (10)

     

    0840030

    Turmeric/curcuma

    0,01  (*1)

    0840040

    Horseradish (11)

     

    0840990

    Others (2)

    0,01  (*1)

    0850000

    Bud spices

    0,01  (*1)

    0850010

    Cloves

     

    0850020

    Capers

     

    0850990

    Others (2)

     

    0860000

    Flower pistil spices

    0,01  (*1)

    0860010

    Saffron

     

    0860990

    Others (2)

     

    0870000

    Aril spices

    0,01  (*1)

    0870010

    Mace

     

    0870990

    Others (2)

     

    0900000

    SUGAR PLANTS

    0,01  (*1)

    0900010

    Sugar beet roots

     

    0900020

    Sugar canes

     

    0900030

    Chicory roots

     

    0900990

    Others (2)

     

    1000000

    PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

    0,01  (*1)

    1010000

    Commodities from

     

    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)

     

    1015000

    (e)

    equine

     

    1015010

    Muscle

     

    1015020

    Fat

     

    1015030

    Liver

     

    1015040

    Kidney

     

    1015050

    Edible offals (other than liver and kidney)

     

    1015990

    Others (2)

     

    1016000

    (f)

    poultry

     

    1016010

    Muscle

     

    1016020

    Fat

     

    1016030

    Liver

     

    1016040

    Kidney

     

    1016050

    Edible offals (other than liver and kidney)

     

    1016990

    Others (2)

     

    1017000

    (g)

    other farmed terrestrial animals

     

    1017010

    Muscle

     

    1017020

    Fat

     

    1017030

    Liver

     

    1017040

    Kidney

     

    1017050

    Edible offals (other than liver and kidney)

     

    1017990

    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)

     

    1040000

    Honey and other apiculture products (7)

     

    1050000

    Amphibians and Reptiles

     

    1060000

    Terrestrial invertebrate animals

     

    1070000

    Wild terrestrial vertebrate animals

     

    1100000

    PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)

     

    1200000

    PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)

     

    1300000

    PROCESSED FOOD PRODUCTS (9)

     

    Dithianon

    The European Food Safety Authority identified some information on the metabolite 1,4-naphthoquinone 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 during the procedure for renewal of approval of the active substance dithianon, or, if that information is not submitted, the lack of it.

    0110010 Grapefruits

    0110020 Oranges

    0110030 Lemons

    0110040 Limes

    0110050 Mandarins

    0110990 Others (2)

    0120010 Almonds

    0120110 Walnuts

    0130010 Apples

    0130020 Pears

    0130030 Quinces

    0130040 Medlars

    0130050 Loquats/Japanese medlars

    0130990 Others (2)

    0140010 Apricots

    0140020 Cherries (sweet)

    0140030 Peaches

    0140040 Plums

    0140990 Others (2)

    0151000 (a) grapes

    0151010 Table grapes

    0151020 Wine grapes

    0153010 Blackberries

    0153020 Dewberries

    0153030 Raspberries (red and yellow)

    0154020 Cranberries

    0154030 Currants (black, red and white)

    0154040 Gooseberries (green, red and yellow)

    0211000 (a) potatoes

    0213020 Carrots

    0231010 Tomatoes

    0231020 Sweet peppers/bell peppers

    0252010 Spinaches

    0253000 (c) grape leaves and similar species

    0260040 Peas (without pods)

    0401000 Oilseeds

    0401010 Linseeds

    0401020 Peanuts/groundnuts

    0401030 Poppy seeds

    0401040 Sesame seeds

    0401050 Sunflower seeds

    0401060 Rapeseeds/canola seeds

    0401070 Soyabeans

    0401080 Mustard seeds

    0401090 Cotton seeds

    0401100 Pumpkin seeds

    0401110 Safflower seeds

    0401120 Borage seeds

    0401130 Gold of pleasure seeds

    0401140 Hemp seeds

    0401150 Castor beans

    0401990 Others (2)

    0500060 Rice

    0500090 Wheat

    0700000 HOPS


    (*1)  Indicates lower limit of analytical determination

    (1)  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.


    ELI: http://data.europa.eu/eli/reg/2024/1314/oj

    ISSN 1977-0677 (electronic edition)


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