# L_2022109EN.01003501.xml

| 8.4.2022 | EN | Official Journal of the European Union | L 109/35 |
| --- | --- | --- | --- |

8.4.2022

EN

Official Journal of the European Union

L 109/35

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COMMISSION REGULATION (EU) 2022/566

of 7 April 2022

amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for flutianil 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 flutianil, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. |
| --- | --- |

(1)

For flutianil, 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 was submitted for flutianil used in the United States on apples, cherries (sweet), strawberries, cucumbers, courgettes and melons. The applicant provided data showing that the authorised uses of that substance on these crops in the United States lead to residues exceeding the MRLs contained in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation into the EU of those crops. |
| --- | --- |

(2)

An application for import tolerances pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005 was submitted for flutianil used in the United States on apples, cherries (sweet), strawberries, cucumbers, courgettes and melons. The applicant provided data showing that the authorised uses of that substance on these crops in the United States lead to residues exceeding the MRLs contained in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation into the EU of those crops.

| (3) | In accordance with Article 8 of Regulation (EC) No 396/2005, the application was evaluated by the Member State to which it had been submitted, and the evaluation report by that Member State was forwarded to the Commission. |
| --- | --- |

(3)

In accordance with Article 8 of Regulation (EC) No 396/2005, the application was evaluated by the Member State to which it had been submitted, and the evaluation report by that Member State 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. |
| --- | --- |

(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) | As regards flutianil in melons, the Authority concluded that the submitted data was insufficient to set a new MRL. As regards all other modifications to MRLs requested by the applicant, the Authority concluded that the data submitted was sufficient for it to perform a risk assessment. It further concluded 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 data on the toxicological properties of the substance. Neither the lifetime exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed a risk that the acceptable daily intake or the acute reference dose is exceeded. |
| --- | --- |

(5)

As regards flutianil in melons, the Authority concluded that the submitted data was insufficient to set a new MRL. As regards all other modifications to MRLs requested by the applicant, the Authority concluded that the data submitted was sufficient for it to perform a risk assessment. It further concluded 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 data on the toxicological properties of the substance. Neither the lifetime exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed a risk that the acceptable daily intake or the acute reference dose is exceeded.

| (6) | Based on the reasoned opinion of the Authority and taking into account the factors relevant to the matter under consideration, the modifications to the MRLs proposed by this Regulation fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005. |
| --- | --- |

(6)

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

| (7) | Regulation (EC) No 396/2005 should therefore be amended accordingly. |
| --- | --- |

(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, |
| --- | --- |

(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, 7 April 2022.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 70, 16.3.2005, p. 1.

1

(2)  EFSA scientific reports are available online: http://www.efsa.europa.eu

2

Reasoned opinion on the setting of import tolerance for flutianil in various crops. EFSA Journal 2021;19(9):6840.

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ANNEX

In Annex II to Regulation (EC) No 396/2005, the column for flutianil 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) | Flutianil |
| --- | --- | --- |
| 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | |
| 0110000 | Citrus fruits | 0,01  (*1) |
| 0110010 | Grapefruits | |
| 0110020 | Oranges | |
| 0110030 | Lemons | |
| 0110040 | Limes | |
| 0110050 | Mandarins | |
| 0110990 | Others (2) | |
| 0120000 | Tree nuts | 0,01  (*1) |
| 0120010 | Almonds | |
| 0120020 | Brazil nuts | |
| 0120030 | Cashew nuts | |
| 0120040 | Chestnuts | |
| 0120050 | Coconuts | |
| 0120060 | Hazelnuts/cobnuts | |
| 0120070 | Macadamias | |
| 0120080 | Pecans | |
| 0120090 | Pine nut kernels | |
| 0120100 | Pistachios | |
| 0120110 | Walnuts | |
| 0120990 | Others (2) | |
| 0130000 | Pome fruits | |
| 0130010 | Apples | 0,15 |
| 0130020 | Pears | 0,01  (*1) |
| 0130030 | Quinces | 0,01  (*1) |
| 0130040 | Medlars | 0,01  (*1) |
| 0130050 | Loquats/Japanese medlars | 0,01  (*1) |
| 0130990 | Others (2) | 0,01  (*1) |
| 0140000 | Stone fruits | |
| 0140010 | Apricots | 0,01  (*1) |
| 0140020 | Cherries (sweet) | 0,4 |
| 0140030 | Peaches | 0,01  (*1) |
| 0140040 | Plums | 0,01  (*1) |
| 0140990 | Others (2) | 0,01  (*1) |
| 0150000 | Berries and small fruits | |
| 0151000 | (a) | grapes |

Code number

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

Flutianil

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0110000

Citrus fruits

0,01  (*1)

0110010

Grapefruits

0110020

Oranges

0110030

Lemons

0110040

Limes

0110050

Mandarins

0110990

Others (2)

0120000

Tree nuts

0,01  (*1)

0120010

Almonds

0120020

Brazil nuts

0120030

Cashew nuts

0120040

Chestnuts

0120050

Coconuts

0120060

Hazelnuts/cobnuts

0120070

Macadamias

0120080

Pecans

0120090

Pine nut kernels

0120100

Pistachios

0120110

Walnuts

0120990

Others (2)

0130000

Pome fruits

0130010

Apples

0,15

0130020

Pears

0,01  (*1)

0130030

Quinces

0,01  (*1)

0130040

Medlars

0,01  (*1)

0130050

Loquats/Japanese medlars

0,01  (*1)

0130990

Others (2)

0,01  (*1)

0140000

Stone fruits

0140010

Apricots

0,01  (*1)

0140020

Cherries (sweet)

0,4

0140030

Peaches

0,01  (*1)

0140040

Plums

0,01  (*1)

0140990

Others (2)

0,01  (*1)

0150000

Berries and small fruits

0151000

(a)

grapes

0,15

0151010

Table grapes

0151020

Wine grapes

0152000

| (b) | strawberries |
| --- | --- |

(b)

strawberries

0,3

0153000

| (c) | cane fruits |
| --- | --- |

(c)

cane fruits

0,01  (*1)

0153010

Blackberries

0153020

Dewberries

0153030

Raspberries (red and yellow)

0153990

Others (2)

0154000

| (d) | other small fruits and berries |
| --- | --- |

(d)

other small fruits and berries

0,01  (*1)

0154010

Blueberries

0154020

Cranberries

0154030

Currants (black, red and white)

0154040

Gooseberries (green, red and yellow)

0154050

Rose hips

0154060

Mulberries (black and white)

0154070

Azaroles/Mediterranean medlars

0154080

Elderberries

0154990

Others (2)

0160000

Miscellaneous fruitswith

0,01  (*1)

0161000

| (a) | edible peel |
| --- | --- |

(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 |
| --- | --- |

(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 |
| --- | --- |

(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

0,01  (*1)

0211000

| (a) | potatoes |
| --- | --- |

(a)

potatoes

0212000

| (b) | tropical root and tuber vegetables |
| --- | --- |

(b)

tropical root and tuber vegetables

0212010

Cassava roots/manioc

0212020

Sweet potatoes

0212030

Yams

0212040

Arrowroots

0212990

Others (2)

0213000

| (c) | other root and tuber vegetables except sugar beets |
| --- | --- |

(c)

other root and tuber vegetables except sugar beets

0213010

Beetroots

0213020

Carrots

0213030

Celeriacs/turnip rooted celeries

0213040

Horseradishes

0213050

Jerusalem artichokes

0213060

Parsnips

0213070

Parsley roots/Hamburg roots parsley

0213080

Radishes

0213090

Salsifies

0213100

Swedes/rutabagas

0213110

Turnips

0213990

Others (2)

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 |
| --- | --- |

(a)

Solanaceae and Malvaceae

0,01  (*1)

0231010

Tomatoes

0231020

Sweet peppers/bell peppers

0231030

Aubergines/eggplants

0231040

Okra/lady's fingers

0231990

Others (2)

0232000

| (b) | cucurbits with edible peel |
| --- | --- |

(b)

cucurbits with edible peel

0232010

Cucumbers

0,03

0232020

Gherkins

0,01  (*1)

0232030

Courgettes

0,03

0232990

Others (2)

0,01  (*1)

0233000

| (c) | cucurbits with inedible peel |
| --- | --- |

(c)

cucurbits with inedible peel

0,01  (*1)

0233010

Melons

0233020

Pumpkins

0233030

Watermelons

0233990

Others (2)

0234000

| (d) | sweet corn |
| --- | --- |

(d)

sweet corn

0,01  (*1)

0239000

| (e) | other fruiting vegetables |
| --- | --- |

(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 |
| --- | --- |

(a)

flowering brassica

0241010

Broccoli

0241020

Cauliflowers

0241990

Others (2)

0242000

| (b) | head brassica |
| --- | --- |

(b)

head brassica

0242010

Brussels sprouts

0242020

Head cabbages

0242990

Others (2)

0243000

| (c) | leafy brassica |
| --- | --- |

(c)

leafy brassica

0243010

Chinese cabbages/pe-tsai

0243020

Kales

0243990

Others (2)

0244000

| (d) | kohlrabies |
| --- | --- |

(d)

kohlrabies

0250000

Leaf vegetables, herbs and edible flowers

0251000

| (a) | lettuces and salad plants |
| --- | --- |

(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 |
| --- | --- |

(b)

spinaches and similar leaves

0,01  (*1)

0252010

Spinaches

0252020

Purslanes

0252030

Chards/beet leaves

0252990

Others (2)

0253000

| (c) | grape leaves and similar species |
| --- | --- |

(c)

grape leaves and similar species

0,01  (*1)

0254000

| (d) | watercresses |
| --- | --- |

(d)

watercresses

0,01  (*1)

0255000

| (e) | witloofs/Belgian endives |
| --- | --- |

(e)

witloofs/Belgian endives

0,01  (*1)

0256000

| (f) | herbs and edible flowers |
| --- | --- |

(f)

herbs and edible flowers

0,02  (*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

0,01  (*1)

0260010

Beans (with pods)

0260020

Beans (without pods)

0260030

Peas (with pods)

0260040

Peas (without pods)

0260050

Lentils

0260990

Others (2)

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

0,01  (*1)

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)

0402000

Oil fruits

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

0,05  (*1)

0610000

Teas

0620000

Coffee beans

0630000

Herbal infusions from

0631000

| (a) | flowers |
| --- | --- |

(a)

flowers

0631010

Chamomile

0631020

Hibiscus/roselle

0631030

Rose

0631040

Jasmine

0631050

Lime/linden

0631990

Others (2)

0632000

| (b) | leaves and herbs |
| --- | --- |

(b)

leaves and herbs

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others (2)

0633000

| (c) | roots |
| --- | --- |

(c)

roots

0633010

Valerian

0633020

Ginseng

0633990

Others (2)

0639000

| (d) | any other parts of the plant |
| --- | --- |

(d)

any other parts of the plant

0640000

Cocoa beans

0650000

Carobs/Saint John's breads

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

0,05  (*1)

0840020

Ginger (10)

0,05  (*1)

0840030

Turmeric/curcuma

0,05  (*1)

0840040

Horseradish (11)

0840990

Others (2)

0,05  (*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

0,01  (*1)

0900010

Sugar beet roots

0900020

Sugar canes

0900030

Chicory roots

0900990

Others (2)

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

1010000

Commodities from

0,01  (*1)

1011000

| (a) | swine |
| --- | --- |

(a)

swine

1011010

Muscle

1011020

Fat

1011030

Liver

1011040

Kidney

1011050

Edible offals (other than liver and kidney)

1011990

Others (2)

1012000

| (b) | bovine |
| --- | --- |

(b)

bovine

1012010

Muscle

1012020

Fat

1012030

Liver

1012040

Kidney

1012050

Edible offals (other than liver and kidney)

1012990

Others (2)

1013000

| (c) | sheep |
| --- | --- |

(c)

sheep

1013010

Muscle

1013020

Fat

1013030

Liver

1013040

Kidney

1013050

Edible offals (other than liver and kidney)

1013990

Others (2)

1014000

| d) | goat |
| --- | --- |

d)

goat

1014010

Muscle

1014020

Fat

1014030

Liver

1014040

Kidney

1014050

Edible offals (other than liver and kidney)

1014990

Others (2)

1015000

| (e) | equine |
| --- | --- |

(e)

equine

1015010

Muscle

1015020

Fat

1015030

Liver

1015040

Kidney

1015050

Edible offals (other than liver and kidney)

1015990

Others (2)

1016000

| (f) | poultry |
| --- | --- |

(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 |
| --- | --- |

(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

0,01  (*1)

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others (2)

1030000

Birds eggs

0,01  (*1)

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

0,01  (*1)

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)

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(*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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