Commission Regulation (EU) 2024/891 of 22 March 2024 amending Annexes II and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for bifenazate in or on certain products

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), and Article 18(1), point (b), thereof,

Whereas:

For bifenazate, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005.
The approval of the active substance bifenazate was renewed by Commission Implementing Regulation (EU) 2022/698⁽²⁾. The consumer risk assessment for edible crops could not be finalised, as relevant information needed to ensure consumer safety was not provided and the toxicity of a relevant metabolite could not be determined. This was due to data gaps⁽³⁾ that could have an impact on the assessment of residue levels in the different crops and due to missing toxicological reference values for metabolite D3598 (bifenazate-diazene) included in the residue definition. Therefore, Regulation (EU) 2022/698 restricted the use of the active substance bifenazate to non-edible crops kept in permanent greenhouses.
According to Article 46 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council⁽⁴⁾, Member States can decide on the duration of the grace periods for sale and distribution, the disposal, storage, and use of existing stocks of the plant protection product concerned. Maximum grace periods granted by Member States for bifenazate will expire on or before 1 January 2024.
As bifenazate based plant protection products are only approved to be used in non-edible crops, it is appropriate to lower the MRLs set out for this substance in Annex II to Regulation (EC) No 396/2005 and list them in Annex V to that Regulation by establishing them at the limit of determination (‘LOD’) once the grace periods will have expired. Additionally, for the avoidance of doubt, the footnotes indicating lack of information on hydrolysis should be deleted.
The Commission consulted the European Union Reference laboratories for residues of pesticides as regards the appropriate LODs. Those laboratories proposed product specific LODs that are analytically achievable for those products for which MRLs are established at the LOD.
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.
Regulation (EC) No 396/2005 should therefore be amended accordingly.
A reasonable period should be allowed to elapse before the new MRLs become applicable in order to permit Member States, third countries and food business operators to adapt themselves to the requirements which result from the amendments.
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 V to Regulation (EC) No 396/2005 are 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 14 October 2024.

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

Done at Brussels, 22 March 2024.

For the Commission

The President

Ursula von der Leyen

ANNEX

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

in Annex II, the column for bifenazate is deleted;

in Annex V, the following column for bifenazate is added:

ANNEX V

PESTICIDE RESIDUES AND MAXIMUM RESIDUE LEVELS (MG/KG)

Code number	Groups and examples of individual products to which the MRLs apply⁽²⁾	Bifenazate (sum of bifenazate plus bifenazate-diazene expressed as bifenazate) (F)
0100000	FRUITS, FRESH or FROZEN; TREE NUTS	0,01 ^(*)
0110000	Citrus fruits
0110010	Grapefruits
0110020	Oranges
0110030	Lemons
0110040	Limes
0110050	Mandarins
0110990	Others (2)
0120000	Tree nuts
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
0130020	Pears
0130030	Quinces
0130040	Medlars
0130050	Loquats/Japanese medlars
0130990	Others (2)
0140000	Stone fruits
0140010	Apricots
0140020	Cherries (sweet)
0140030	Peaches
0140040	Plums
0140990	Others (2)
0150000	Berries and small fruits
0151000	grapes
0151010	Table grapes
0151020	Wine grapes
0152000	strawberries
0153000	cane fruits
0153010	Blackberries
0153020	Dewberries
0153030	Raspberries (red and yellow)
0153990	Others (2)
0154000	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 fruitswith
0161000	edible peel
0161010	Dates
0161020	Figs
0161030	Table olives
0161040	Kumquats
0161050	Carambolas
0161060	Kaki/Japanese persimmons
0161070	Jambuls/jambolans
0161990	Others (2)
0162000	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	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 ^(*)
0211000	potatoes
0212000	tropical root and tuber vegetables
0212010	Cassava roots/manioc
0212020	Sweet potatoes
0212030	Yams
0212040	Arrowroots
0212990	Others (2)
0213000	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 ^(*)
0220010	Garlic
0220020	Onions
0220030	Shallots
0220040	Spring onions/green onions and Welsh onions
0220990	Others (2)
0230000	Fruiting vegetables	0,01 ^(*)
0231000	Solanaceae and Malvaceae
0231010	Tomatoes
0231020	Sweet peppers/bell peppers
0231030	Aubergines/eggplants
0231040	Okra/lady's fingers
0231990	Others (2)
0232000	cucurbits with edible peel
0232010	Cucumbers
0232020	Gherkins
0232030	Courgettes
0232990	Others (2)
0233000	cucurbits with inedible peel
0233010	Melons
0233020	Pumpkins
0233030	Watermelons
0233990	Others (2)
0234000	sweet corn
0239000	other fruiting vegetables
0240000	Brassica vegetables(excluding brassica roots and brassica baby leaf crops)	0,01 ^(*)
0241000	flowering brassica
0241010	Broccoli
0241020	Cauliflowers
0241990	Others (2)
0242000	head brassica
0242010	Brussels sprouts
0242020	Head cabbages
0242990	Others (2)
0243000	leafy brassica
0243010	Chinese cabbages/pe-tsai
0243020	Kales
0243990	Others (2)
0244000	kohlrabies
0250000	Leaf vegetables, herbs and edible flowers
0251000	lettuces and salad plants	0,01 ^(*)
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	spinaches and similar leaves	0,01 ^(*)
0252010	Spinaches
0252020	Purslanes
0252030	Chards/beet leaves
0252990	Others (2)
0253000	grape leaves and similar species	0,01 ^(*)
0254000	watercresses	0,01 ^(*)
0255000	witloofs/Belgian endives	0,01 ^(*)
0256000	herbs and edible flowers	0,02 ^(*)
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 ^(*)
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 ^(*)
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 ^(*)
0280010	Cultivated fungi
0280020	Wild fungi
0280990	Mosses and lichens
0290000	Algae and prokaryotes organisms	0,01 ^(*)
0300000	PULSES	0,01 ^(*)
0300010	Beans
0300020	Lentils
0300030	Peas
0300040	Lupins/lupini beans
0300990	Others (2)
0400000	OILSEEDS AND OIL FRUITS	0,01 ^(*)
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 ^(*)
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 ^(*)
0610000	Teas
0620000	Coffee beans
0630000	Herbal infusions from
0631000	flowers
0631010	Chamomile
0631020	Hibiscus/roselle
0631030	Rose
0631040	Jasmine
0631050	Lime/linden
0631990	Others (2)
0632000	leaves and herbs
0632010	Strawberry
0632020	Rooibos
0632030	Mate/maté
0632990	Others (2)
0633000	roots
0633010	Valerian
0633020	Ginseng
0633990	Others (2)
0639000	any other parts of the plant
0640000	Cocoa beans
0650000	Carobs/Saint John's breads
0700000	HOPS	0,05 ^(*)
0800000	SPICES
0810000	Seed spices	0,05 ^(*)
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 ^(*)
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 ^(*)
0830010	Cinnamon
0830990	Others (2)
0840000	Root and rhizome spices
0840010	Liquorice	0,05 ^(*)
0840020	Ginger (10)
0840030	Turmeric/curcuma	0,05 ^(*)
0840040	Horseradish (11)
0840990	Others (2)	0,05 ^(*)
0850000	Bud spices	0,05 ^(*)
0850010	Cloves
0850020	Capers
0850990	Others (2)
0860000	Flower pistil spices	0,05 ^(*)
0860010	Saffron
0860990	Others (2)
0870000	Aril spices	0,05 ^(*)
0870010	Mace
0870990	Others (2)
0900000	SUGAR PLANTS	0,01 ^(*)
0900010	Sugar beet roots
0900020	Sugar canes
0900030	Chicory roots
0900990	Others (2)
1000000	PRODUCTS OF ANIMAL ORIGIN – TERRESTRIAL ANIMALS
1010000	Commodities from	0,02 ^(*)
1011000	swine
1011010	Muscle
1011020	Fat
1011030	Liver
1011040	Kidney
1011050	Edible offals (other than liver and kidney)
1011990	Others (2)
1012000	bovine
1012010	Muscle
1012020	Fat
1012030	Liver
1012040	Kidney
1012050	Edible offals (other than liver and kidney)
1012990	Others (2)
1013000	sheep
1013010	Muscle
1013020	Fat
1013030	Liver
1013040	Kidney
1013050	Edible offals (other than liver and kidney)
1013990	Others (2)
1014000	goat
1014010	Muscle
1014020	Fat
1014030	Liver
1014040	Kidney
1014050	Edible offals (other than liver and kidney)
1014990	Others (2)
1015000	equine
1015010	Muscle
1015020	Fat
1015030	Liver
1015040	Kidney
1015050	Edible offals (other than liver and kidney)
1015990	Others (2)
1016000	poultry
1016010	Muscle
1016020	Fat
1016030	Liver
1016040	Kidney
1016050	Edible offals (other than liver and kidney)
1016990	Others (2)
1017000	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	0,02^(*)
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^(*)
1050000	Amphibians and Reptiles	0,02^(*)
1060000	Terrestrial invertebrate animals	0,02^(*)
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)