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Document 32020R0192

Commission Regulation (EU) 2020/192 of 12 February 2020 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for prochloraz in or on certain products (Text with EEA relevance)

C/2020/700

OJ L 40, 13.2.2020, p. 4–17 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

In force

ELI: http://data.europa.eu/eli/reg/2020/192/oj

13.2.2020   

EN

Official Journal of the European Union

L 40/4


COMMISSION REGULATION (EU) 2020/192

of 12 February 2020

amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for prochloraz 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) and Article 49(2) thereof,

Whereas:

(1)

For prochloraz, maximum residue limits (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005.

(2)

For that active substance, the European Food Safety Authority (‘the Authority’) submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (2). The Authority proposed to change the residue definition to the sum of prochloraz, BTS 44595 (M201-04) and BTS 44596 (M201-03), expressed as prochloraz. The Authority identified a risk for consumers concerning the MRLs for citrus fruits, kiwi, bananas, mangoes, pineapples and bovine liver. It is therefore appropriate to lower these MRLs to the Limit of Determination (LOD) or the level identified by the Authority. The Authority recommended lowering the MRLs for garlic, shallots, lettuces and salad plants, purslanes, herbs and edible flowers, peas, linseeds, sunflower seeds, rapeseeds/canola seeds, barley, oat, rice, rye, wheat, coffee beans, herbal infusions from flowers, leaves and herbs and roots, spices, sugar beet roots, bovine (fat, kidney), equine fat and poultry liver. 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. The Authority concluded that concerning the Codex maximum residue levels (CXLs) for kumquats, litchis/lychees, passionfruits/maracujas, prickly pears/cactus fruits, star apples/cainitos, American persimmons/Virginia kaki, avocados, papayas, Granate apples/pomegranates, cherimoyas, guavas, breadfruits, durians and soursops/guanabanas, some information was not available in relation to the new residue definition 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 of the existing CXLs. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.

(3)

As regards products on which the use of the plant protection products concerned is not authorised, and for which no import tolerances or CXLs exist, MRLs should be set at the specific limit of determination or the default MRL should apply, as provided for in Article 18(1)(b) of 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 limits of determination. As regards several substances, those laboratories concluded that for certain commodities technical development requires the setting of specific limits of determination.

(5)

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.

(6)

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.

(7)

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

(8)

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.

(9)

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.

(10)

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

As regards the active substance prochloraz in and on all products except citrus fruits, kiwi, bananas, mangoes, pineapples and bovine liver, 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 4 September 2020.

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 4 September 2020.

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

Done at Brussels, 12 February 2020.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 70, 16.3.2005, p. 1.

(2)  European Food Safety Authority; Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2018; 16(8):5401.


ANNEX

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

(1)

in Annex II the column for prochloraz is replaced by the following:

Code number

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

Prochloraz (sum of prochloraz, BTS 44595 (M201-04) and BTS 44596 (M201-03), expressed as prochloraz) (F)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

 

0110000

Citrus fruits

0.03*

0110010

Grapefruits

 

0110020

Oranges

 

0110030

Lemons

 

0110040

Limes

 

0110050

Mandarins

 

0110990

Others (2)

 

0120000

Tree nuts

0.03*

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

0.03*

0130010

Apples

 

0130020

Pears

 

0130030

Quinces

 

0130040

Medlars

 

0130050

Loquats/Japanese medlars

 

0130990

Others (2)

 

0140000

Stone fruits

0.03*

0140010

Apricots

 

0140020

Cherries (sweet)

 

0140030

Peaches

 

0140040

Plums

 

0140990

Others (2)

 

0150000

Berries and small fruits

0.03*

0151000

(a)

grapes

 

0151010

Table grapes

 

0151020

Wine grapes

 

0152000

(b)

strawberries

 

0153000

(c)

cane fruits

 

0153010

Blackberries

 

0153020

Dewberries

 

0153030

Raspberries (red and yellow)

 

0153990

Others (2)

 

0154000

(d)

other small fruits and berries

 

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 fruits with

 

0161000

(a)

edible peel

 

0161010

Dates

0.03*

0161020

Figs

0.03*

0161030

Table olives

0.03*

0161040

Kumquats

10 (+)

0161050

Carambolas

0.03*

0161060

Kaki/Japanese persimmons

0.03*

0161070

Jambuls/jambolans

0.03*

0161990

Others (2)

0.03*

0162000

(b)

inedible peel, small

 

0162010

Kiwi fruits (green, red, yellow)

0.03*

0162020

Litchis/lychees

7 (+)

0162030

Passionfruits/maracujas

7 (+)

0162040

Prickly pears/cactus fruits

7 (+)

0162050

Star apples/cainitos

7 (+)

0162060

American persimmons/Virginia kaki

7 (+)

0162990

Others (2)

0.03*

0163000

(c)

inedible peel, large

 

0163010

Avocados

7 (+)

0163020

Bananas

0.03*

0163030

Mangoes

0.03*

0163040

Papayas

7 (+)

0163050

Granate apples/pomegranates

7 (+)

0163060

Cherimoyas

7 (+)

0163070

Guavas

7 (+)

0163080

Pineapples

0.03*

0163090

Breadfruits

7 (+)

0163100

Durians

7 (+)

0163110

Soursops/guanabanas

7 (+)

0163990

Others (2)

0.03*

0200000

VEGETABLES, FRESH or FROZEN

 

0210000

Root and tuber vegetables

0.03*

0211000

(a)

potatoes

 

0212000

(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

 

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

0.03*

0220010

Garlic

 

0220020

Onions

 

0220030

Shallots

 

0220040

Spring onions/green onions and Welsh onions

 

0220990

Others (2)

 

0230000

Fruiting vegetables

0.03*

0231000

(a)

Solanaceae and Malvaceae

 

0231010

Tomatoes

 

0231020

Sweet peppers/bell peppers

 

0231030

Aubergines/eggplants

 

0231040

Okra/lady's fingers

 

0231990

Others (2)

 

0232000

(b)

cucurbits with edible peel

 

0232010

Cucumbers

 

0232020

Gherkins

 

0232030

Courgettes

 

0232990

Others (2)

 

0233000

(c)

cucurbits with inedible peel

 

0233010

Melons

 

0233020

Pumpkins

 

0233030

Watermelons

 

0233990

Others (2)

 

0234000

(d)

sweet corn

 

0239000

(e)

other fruiting vegetables

 

0240000

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

0.03*

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

0.03*

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

0.03*

0252010

Spinaches

 

0252020

Purslanes

 

0252030

Chards/beet leaves

 

0252990

Others (2)

 

0253000

(c)

grape leaves and similar species

0.03*

0254000

(d)

watercresses

0.03*

0255000

(e)

witloofs/Belgian endives

0.03*

0256000

(f)

herbs and edible flowers

0.06*

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

0.03*

0260010

Beans (with pods)

 

0260020

Beans (without pods)

 

0260030

Peas (with pods)

 

0260040

Peas (without pods)

 

0260050

Lentils

 

0260990

Others (2)

 

0270000

Stem vegetables

0.03*

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

 

0280010

Cultivated fungi

3

0280020

Wild fungi

0.03*

0280990

Mosses and lichens

0.03*

0290000

Algae and prokaryotes organisms

0.03*

0300000

PULSES

0.03*

0300010

Beans

 

0300020

Lentils

 

0300030

Peas

 

0300040

Lupins/lupini beans

 

0300990

Others (2)

 

0400000

OILSEEDS AND OIL FRUITS

 

0401000

Oilseeds

 

0401010

Linseeds

0.3

0401020

Peanuts/groundnuts

0.03*

0401030

Poppy seeds

0.3

0401040

Sesame seeds

0.03*

0401050

Sunflower seeds

0.3

0401060

Rapeseeds/canola seeds

0.3

0401070

Soyabeans

0.03*

0401080

Mustard seeds

0.03*

0401090

Cotton seeds

0.03*

0401100

Pumpkin seeds

0.03*

0401110

Safflower seeds

0.03*

0401120

Borage seeds

0.03*

0401130

Gold of pleasure seeds

0.03*

0401140

Hemp seeds

0.03*

0401150

Castor beans

0.03*

0401990

Others (2)

0.03*

0402000

Oil fruits

0.03*

0402010

Olives for oil production

 

0402020

Oil palms kernels

 

0402030

Oil palms fruits

 

0402040

Kapok

 

0402990

Others (2)

 

0500000

CEREALS

 

0500010

Barley

0.03*

0500020

Buckwheat and other pseudocereals

0.03*

0500030

Maize/corn

0.03*

0500040

Common millet/proso millet

0.03*

0500050

Oat

0.03*

0500060

Rice

0.03*

0500070

Rye

0.2

0500080

Sorghum

0.03*

0500090

Wheat

0.2

0500990

Others (2)

0.03*

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

0.15*

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

0.15*

0800000

SPICES

 

0810000

Seed spices

0.15*

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

0.15*

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

0.15*

0830010

Cinnamon

 

0830990

Others (2)

 

0840000

Root and rhizome spices

 

0840010

Liquorice

0.15*

0840020

Ginger (10)

0.15*

0840030

Turmeric/curcuma

0.15*

0840040

Horseradish (11)

 

0840990

Others (2)

0.15*

0850000

Bud spices

0.15*

0850010

Cloves

 

0850020

Capers

 

0850990

Others (2)

 

0860000

Flower pistil spices

0.15*

0860010

Saffron

 

0860990

Others (2)

 

0870000

Aril spices

0.15*

0870010

Mace

 

0870990

Others (2)

 

0900000

SUGAR PLANTS

0.03*

0900010

Sugar beet roots

 

0900020

Sugar canes

 

0900030

Chicory roots

 

0900990

Others (2)

 

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

 

1010000

Commodities from

 

1011000

(a)

swine

 

1011010

Muscle

0.03*

1011020

Fat

0.03*

1011030

Liver

0.3 (+)

1011040

Kidney

0.05 (+)

1011050

Edible offals (other than liver and kidney)

0.03*

1011990

Others (2)

0.03*

1012000

(b)

bovine

 

1012010

Muscle

0.03*

1012020

Fat

0.07 (+)

1012030

Liver

1 (+)

1012040

Kidney

0.2 (+)

1012050

Edible offals (other than liver and kidney)

0.03*

1012990

Others (2)

0.03*

1013000

(c)

sheep

 

1013010

Muscle

0.03*

1013020

Fat

0.15 (+)

1013030

Liver

3 (+)

1013040

Kidney

0.5 (+)

1013050

Edible offals (other than liver and kidney)

0.03*

1013990

Others (2)

0.03*

1014000

d)

goat

 

1014010

Muscle

0.03*

1014020

Fat

0.15 (+)

1014030

Liver

3 (+)

1014040

Kidney

0.5 (+)

1014050

Edible offals (other than liver and kidney)

0.03*

1014990

Others (2)

0.03*

1015000

(e)

equine

 

1015010

Muscle

0.03*

1015020

Fat

0.07 (+)

1015030

Liver

1 (+)

1015040

Kidney

0.2 (+)

1015050

Edible offals (other than liver and kidney)

0.03*

1015990

Others (2)

0.03*

1016000

(f)

poultry

 

1016010

Muscle

0.03* (+)

1016020

Fat

0.03* (+)

1016030

Liver

0.04 (+)

1016040

Kidney

0.03* (+)

1016050

Edible offals (other than liver and kidney)

0.03* (+)

1016990

Others (2)

0.03* (+)

1017000

(g)

other farmed terrestrial animals

0.03*

1017010

Muscle

 

1017020

Fat

 

1017030

Liver

 

1017040

Kidney

 

1017050

Edible offals (other than liver and kidney)

 

1017990

Others (2)

 

1020000

Milk

0.03*

1020010

Cattle

 

1020020

Sheep

 

1020030

Goat

 

1020040

Horse

 

1020990

Others (2)

 

1030000

Birds eggs

0.1

1030010

Chicken

(+)

1030020

Duck

(+)

1030030

Geese

(+)

1030040

Quail

(+)

1030990

Others (2)

 

1040000

Honey and other apiculture products (7)

0.15*

1050000

Amphibians and Reptiles

0.03*

1060000

Terrestrial invertebrate animals

0.03*

1070000

Wild terrestrial vertebrate animals

0.03*

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)

 

(*)

Limit of analytical determination

(a)

For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.

(F) =

Fat soluble

Prochloraz (sum of prochloraz, BTS 44595 (M201-04) and BTS 44596 (M201-03), expressed as prochloraz) (F)

(+)

The European Food Safety Authority identified some information on residue trials in relation with the new residue definition 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 [Office of Publication: please insert date 2 years after publication], or, if that information is not submitted by that date, the lack of it.

0161040 Kumquats

0162020 Litchis/lychees

0162030 Passionfruits/maracujas

0162040 Prickly pears/cactus fruits

0162050 Star apples/cainitos

0162060 American persimmons/Virginia kaki

0163010 Avocados

0163040 Papayas

0163050 Granate apples/pomegranates

0163060 Cherimoyas

0163070 Guavas

0163090 Breadfruits

0163100 Durians

0163110 Soursops/guanabanas

(+)

The European Food Safety Authority identified some information on feeding studies analysing both enforcement and risk assessment residue definitions 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 [Office of Publication: please insert date 2 years after publication], or, if that information is not submitted by that date, the lack of it.

1011030 Liver

1011040 Kidney

1012020 Fat

1012030 Liver

1012040 Kidney

1013020 Fat

1013030 Liver

1013040 Kidney

1014020 Fat

1014030 Liver

1014040 Kidney

1015020 Fat

1015030 Liver

1015040 Kidney

1016010 Muscle

1016020 Fat

1016030 Liver

1016040 Kidney

1016050 Edible offals (other than liver and kidney)

1016990 Others (2)

1030010 Chicken

1030020 Duck

1030030 Geese

1030040 Quail

(2)

in part B of Annex III the column for prochloraz is deleted.


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