Commission Regulation (EU) 2020/192Show full title

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

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:

(*) 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
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)

(2)

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

(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.