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Document 32022R1264

Commission Regulation (EU) 2022/1264 of 20 July 2022 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fludioxonil in or on certain products (Text with EEA relevance)

C/2022/5061

OJ L 192, 21.7.2022, p. 1–13 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

In force

ELI: http://data.europa.eu/eli/reg/2022/1264/oj

21.7.2022   

EN

Official Journal of the European Union

L 192/1


COMMISSION REGULATION (EU) 2022/1264

of 20 July 2022

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

Whereas:

(1)

For fludioxonil maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005.

(2)

An application for import tolerances pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005 for fludioxonil used in the United States on sugar beet roots, and in Guatemala, Honduras and Colombia on bananas was submitted. The applicant states that the authorised uses of that substance on such crops in those countries lead to residues exceeding the MRLs provided for in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of those crops.

(3)

In accordance with Article 8 of Regulation (EC) No 396/2005, the application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission.

(4)

The European Food Safety Authority (‘the Authority’) assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals, and gave a reasoned opinion on the proposed MRLs (2). It forwarded that opinion to the applicant, the Commission and the Member States and made it available to the public.

(5)

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 applicant 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 information on the toxicological properties of the substance. The lifetime exposure to the substance via consumption of all food products that may contain it showed that there is no risk that the acceptable daily intake is exceeded. Moreover, the Authority concluded that the establishment of an acute reference dose is not necessary on the basis of the low acute toxicity profile of the active substance.

(6)

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

(7)

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

(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

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, 20 July 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 70, 16.3.2005, p. 1.

(2)  Reasoned opinion on the setting of import tolerances for fludioxonil in sugar beet roots and bananas. EFSA Journal 2021;19(11):6919. EFSA scientific reports available online: http://www.efsa.europa.eu.


ANNEX

In Annex II to Regulation (EC) No 396/2005, the column for fludioxonil 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)

Fludioxonil (R) (F)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

 

0110000

Citrus fruits

10

0110010

Grapefruits

 

0110020

Oranges

 

0110030

Lemons

 

0110040

Limes

 

0110050

Mandarins

 

0110990

Others (2)

 

0120000

Tree nuts

 

0120010

Almonds

0,01  (*1)

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

0,2

0120110

Walnuts

0,01  (*1)

0120990

Others (2)

0,01  (*1)

0130000

Pome fruits

5

0130010

Apples

 

0130020

Pears

 

0130030

Quinces

 

0130040

Medlars

 

0130050

Loquats/Japanese medlars

 

0130990

Others (2)

 

0140000

Stone fruits

 

0140010

Apricots

5

0140020

Cherries (sweet)

5

0140030

Peaches

10

0140040

Plums

5

0140990

Others (2)

0,01  (*1)

0150000

Berries and small fruits

 

0151000

(a)

grapes

 

0151010

Table grapes

5

0151020

Wine grapes

4

0152000

(b)

strawberries

4

0153000

(c)

cane fruits

5

0153010

Blackberries

 

0153020

Dewberries

 

0153030

Raspberries (red and yellow)

 

0153990

Others (2)

 

0154000

(d)

other small fruits and berries

 

0154010

Blueberries

4

0154020

Cranberries

4

0154030

Currants (black, red and white)

4

0154040

Gooseberries (green, red and yellow)

4

0154050

Rose hips

0,01  (*1)

0154060

Mulberries (black and white)

0,01  (*1)

0154070

Azaroles/Mediterranean medlars

0,01  (*1)

0154080

Elderberries

4

0154990

Others (2)

0,01  (*1)

0160000

Miscellaneous fruitswith

 

0161000

(a)

edible peel

0,01  (*1)

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)

15

0162020

Litchis/lychees

0,01  (*1)

0162030

Passionfruits/maracujas

0,01  (*1)

0162040

Prickly pears/cactus fruits

0,01  (*1)

0162050

Star apples/cainitos

0,01  (*1)

0162060

American persimmons/Virginia kaki

0,01  (*1)

0162990

Others (2)

0,01  (*1)

0163000

(c)

inedible peel, large

 

0163010

Avocados

1,5

0163020

Bananas

2

0163030

Mangoes

2

0163040

Papayas

0,01  (*1)

0163050

Granate apples/pomegranates

3

0163060

Cherimoyas

0,01  (*1)

0163070

Guavas

0,5

0163080

Pineapples

7

0163090

Breadfruits

0,01  (*1)

0163100

Durians

0,01  (*1)

0163110

Soursops/guanabanas

0,01  (*1)

0163990

Others (2)

0,01  (*1)

0200000

VEGETABLES, FRESH or FROZEN

 

0210000

Root and tuber vegetables

 

0211000

(a)

potatoes

5

0212000

(b)

tropical root and tuber vegetables

 

0212010

Cassava roots/manioc

0,01  (*1)

0212020

Sweet potatoes

10

0212030

Yams

10

0212040

Arrowroots

0,01  (*1)

0212990

Others (2)

0,01  (*1)

0213000

(c)

other root and tuber vegetables except sugar beets

 

0213010

Beetroots

1

0213020

Carrots

1

0213030

Celeriacs/turnip rooted celeries

0,2

0213040

Horseradishes

1

0213050

Jerusalem artichokes

0,01  (*1)

0213060

Parsnips

1

0213070

Parsley roots/Hamburg roots parsley

1

0213080

Radishes

0,3

0213090

Salsifies

1

0213100

Swedes/rutabagas

0,01  (*1)

0213110

Turnips

0,01  (*1)

0213990

Others (2)

0,01  (*1)

0220000

Bulb vegetables

 

0220010

Garlic

0,5

0220020

Onions

0,5

0220030

Shallots

0,5

0220040

Spring onions/green onions and Welsh onions

5

0220990

Others (2)

0,5

0230000

Fruiting vegetables

 

0231000

(a)

Solanaceae and Malvaceae

 

0231010

Tomatoes

3

0231020

Sweet peppers/bell peppers

1

0231030

Aubergines/eggplants

0,4

0231040

Okra/lady's fingers

0,01  (*1)

0231990

Others (2)

0,01  (*1)

0232000

(b)

cucurbits with edible peel

0,4

0232010

Cucumbers

 

0232020

Gherkins

 

0232030

Courgettes

 

0232990

Others (2)

 

0233000

(c)

cucurbits with inedible peel

0,3

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)

 

0241000

(a)

flowering brassica

 

0241010

Broccoli

0,7

0241020

Cauliflowers

0,01  (*1)

0241990

Others (2)

0,01  (*1)

0242000

(b)

head brassica

 

0242010

Brussels sprouts

0,01  (*1)

0242020

Head cabbages

2

0242990

Others (2)

0,01  (*1)

0243000

(c)

leafy brassica

 

0243010

Chinese cabbages/pe-tsai

10

0243020

Kales

0,01  (*1)

0243990

Others (2)

0,01  (*1)

0244000

(d)

kohlrabies

0,01  (*1)

0250000

Leaf vegetables, herbs and edible flowers

 

0251000

(a)

lettuces and salad plants

 

0251010

Lamb's lettuces/corn salads

20

0251020

Lettuces

40

0251030

Escaroles/broad-leaved endives

20

0251040

Cresses and other sprouts and shoots

20

0251050

Land cresses

20

0251060

Roman rocket/rucola

20

0251070

Red mustards

20

0251080

Baby leaf crops (including brassica species)

20

0251990

Others (2)

20

0252000

(b)

spinaches and similar leaves

 

0252010

Spinaches

30

0252020

Purslanes

20

0252030

Chards/beet leaves

20

0252990

Others (2)

20

0253000

(c)

grape leaves and similar species

0,01  (*1)

0254000

(d)

watercresses

10

0255000

(e)

witloofs/Belgian endives

0,02

0256000

(f)

herbs and edible flowers

20

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)

1

0260020

Beans (without pods)

0,4

0260030

Peas (with pods)

1

0260040

Peas (without pods)

0,3

0260050

Lentils

0,05

0260990

Others (2)

0,01  (*1)

0270000

Stem vegetables

 

0270010

Asparagus

0,01  (*1)

0270020

Cardoons

0,01  (*1)

0270030

Celeries

1,5

0270040

Florence fennels

1,5

0270050

Globe artichokes

0,01  (*1)

0270060

Leeks

0,01  (*1)

0270070

Rhubarbs

0,7

0270080

Bamboo shoots

0,01  (*1)

0270090

Palm hearts

0,01  (*1)

0270990

Others (2)

0,01  (*1)

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

 

0300010

Beans

0,5

0300020

Lentils

0,4

0300030

Peas

0,4

0300040

Lupins/lupini beans

0,4

0300990

Others (2)

0,4

0400000

OILSEEDS AND OIL FRUITS

 

0401000

Oilseeds

 

0401010

Linseeds

0,3

0401020

Peanuts/groundnuts

0,01  (*1)

0401030

Poppy seeds

0,01  (*1)

0401040

Sesame seeds

0,3

0401050

Sunflower seeds

0,01  (*1)

0401060

Rapeseeds/canola seeds

0,3

0401070

Soyabeans

0,2

0401080

Mustard seeds

0,3

0401090

Cotton seeds

0,01  (*1)

0401100

Pumpkin seeds

0,01  (*1)

0401110

Safflower seeds

0,01  (*1)

0401120

Borage seeds

0,3

0401130

Gold of pleasure seeds

0,3

0401140

Hemp seeds

0,3

0401150

Castor beans

0,01  (*1)

0401990

Others (2)

0,01  (*1)

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

0,01  (*1)

0500010

Barley

 

0500020

Buckwheat and other pseudocereals

 

0500030

Maize/corn

 

0500040

Common millet/proso millet

 

0500050

Oat

 

0500060

Rice

 

0500070

Rye

 

0500080

Sorghum

 

0500090

Wheat

 

0500990

Others (2)

 

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

 

0610000

Teas

0,05  (*1)

0620000

Coffee beans

0,05  (*1)

0630000

Herbal infusions from

 

0631000

(a)

flowers

0,05  (*1)

0631010

Chamomile

 

0631020

Hibiscus/roselle

 

0631030

Rose

 

0631040

Jasmine

 

0631050

Lime/linden

 

0631990

Others (2)

 

0632000

(b)

leaves and herbs

0,05  (*1)

0632010

Strawberry

 

0632020

Rooibos

 

0632030

Mate/maté

 

0632990

Others (2)

 

0633000

(c)

roots

 

0633010

Valerian

1

0633020

Ginseng

4

0633990

Others (2)

1

0639000

(d)

any other parts of the plant

0,05  (*1)

0640000

Cocoa beans

0,05  (*1)

0650000

Carobs/Saint John's breads

0,05  (*1)

0700000

HOPS

0,05  (*1)

0800000

SPICES

 

0810000

Seed spices

0,05  (*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

0,05  (*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

0,05  (*1)

0830010

Cinnamon

 

0830990

Others (2)

 

0840000

Root and rhizome spices

 

0840010

Liquorice

1

0840020

Ginger (10)

 

0840030

Turmeric/curcuma

1

0840040

Horseradish (11)

 

0840990

Others (2)

1

0850000

Bud spices

0,05  (*1)

0850010

Cloves

 

0850020

Capers

 

0850990

Others (2)

 

0860000

Flower pistil spices

0,05  (*1)

0860010

Saffron

 

0860990

Others (2)

 

0870000

Aril spices

0,05  (*1)

0870010

Mace

 

0870990

Others (2)

 

0900000

SUGAR PLANTS

 

0900010

Sugar beet roots

4

0900020

Sugar canes

0,01  (*1)

0900030

Chicory roots

0,01  (*1)

0900990

Others (2)

0,01  (*1)

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

 

1010000

Commodities from

 

1011000

(a)

swine

 

1011010

Muscle

0,02

1011020

Fat

0,02

1011030

Liver

0,1

1011040

Kidney

0,1

1011050

Edible offals (other than liver and kidney)

0,1

1011990

Others (2)

0,02

1012000

(b)

bovine

 

1012010

Muscle

0,02

1012020

Fat

0,02

1012030

Liver

0,1

1012040

Kidney

0,1

1012050

Edible offals (other than liver and kidney)

0,1

1012990

Others (2)

0,02

1013000

(c)

sheep

 

1013010

Muscle

0,02

1013020

Fat

0,02

1013030

Liver

0,1

1013040

Kidney

0,1

1013050

Edible offals (other than liver and kidney)

0,1

1013990

Others (2)

0,02

1014000

(d)

goat

 

1014010

Muscle

0,02

1014020

Fat

0,02

1014030

Liver

0,1

1014040

Kidney

0,1

1014050

Edible offals (other than liver and kidney)

0,1

1014990

Others (2)

0,02

1015000

(e)

equine

 

1015010

Muscle

0,02

1015020

Fat

0,02

1015030

Liver

0,1

1015040

Kidney

0,1

1015050

Edible offals (other than liver and kidney)

0,1

1015990

Others (2)

0,02

1016000

(f)

poultry

 

1016010

Muscle

0,01  (*1)

1016020

Fat

0,01  (*1)

1016030

Liver

0,1

1016040

Kidney

0,1

1016050

Edible offals (other than liver and kidney)

0,1

1016990

Others (2)

0,01  (*1)

1017000

(g)

other farmed terrestrial animals

 

1017010

Muscle

0,02

1017020

Fat

0,02

1017030

Liver

0,1

1017040

Kidney

0,1

1017050

Edible offals (other than liver and kidney)

0,1

1017990

Others (2)

0,02

1020000

Milk

0,04

1020010

Cattle

 

1020020

Sheep

 

1020030

Goat

 

1020040

Horse

 

1020990

Others (2)

 

1030000

Birds eggs

0,02

1030010

Chicken

 

1030020

Duck

 

1030030

Geese

 

1030040

Quail

 

1030990

Others (2)

 

1040000

Honey and other apiculture products (7)

0,05  (*1)

1050000

Amphibians and Reptiles

0,01  (*1)

1060000

Terrestrial invertebrate animals

0,01  (*1)

1070000

Wild terrestrial vertebrate animals

0,02

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)

 

Fludioxonil (R) (F)

(R)

The residue definition differs for the following combinations pesticide-code number: Fludioxonil - code 1000000 except 1040000 : sum of fludioxonil and its metabolites oxidized to metabolite 2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid, expressed as fludioxonil

(F)

Fat soluble’


(*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


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