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Commission Regulation (EU) 2023/1049 of 30 May 2023 amending Annexes II and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fish oil, pendimethalin, sheep fat and spirotetramat in or on certain products (Text with EEA relevance)

Commission Regulation (EU) 2023/1049 of 30 May 2023 amending Annexes II and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fish oil, pendimethalin, sheep fat and spirotetramat 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 5(1) and Article 14(1), point (a), thereof,

Whereas:

  1. For pendimethalin and spirotetramat, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. Fish oil and sheep fat are included in Annex IV to that Regulation.

  2. As regards the active substance pendimethalin, an application pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRLs was submitted for peas (with pods), beans (with pods) and leeks. As regards the active substance spirotetramat, such an application was submitted for herbs and edible flowers.

  3. In accordance with Article 8 of Regulation (EC) No 396/2005, those applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission.

  4. The European Food Safety Authority (‘the Authority’) assessed the applications and the evaluation reports, examining in particular the risks to consumers and, where relevant, to animals, and gave reasoned opinions on the proposed MRLs(2). It forwarded those opinions to the applicants, the Commission and the Member States and made them available to the public.

  5. As regards spirotetramat, in herbs and edible flowers, others, the Authority did not recommend a specific MRL value. Nevertheless, the Authority noted that risk managers may consider to implement the MRL of 10 mg/kg to the whole group of herbs and edible flowers, and that this would be safe for consumers. Therefore, it is appropriate to propose setting the MRL for spirotetramat in herbs and edible flowers, others, at 10 mg/kg in accordance with the relevant Commission Technical Guidelines(3).

  6. For pendimethalin and spirotetramat, 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 applicants 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 substances. Neither the long-term exposure to these substances via consumption of all food products that may contain them, 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.

  7. Based on the reasoned opinions of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, it is appropriate to conclude that the proposed modifications to the MRLs fulfil the requirements of that article.

  8. Fish oil and sheep fat were temporarily included in Annex IV to Regulation (EC) No 396/2005 pending the finalisation of their evaluation either under Council Directive 91/414/EEC(4) or under Regulation (EC) No 1107/2009 of the European Parliament and of the Council(5), and pending the review of MRLs on those active substances in accordance with Article 12 of Regulation (EC) No 396/2005. In the context of applications for renewal of the approval of those active substances under Regulation (EC) No 1107/2009, the Authority issued conclusions on the peer review of the pesticide risk assessment of fish oil and sheep fat(6). Based on those conclusions, no MRLs are required for fish oil and sheep fat. Therefore, it is appropriate for those substances to remain in Annex IV to Regulation (EC) No 396/2005.

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

  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 IV 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.

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

Done at Brussels, 30 May 2023.

For the Commission

The President

Ursula von der Leyen

ANNEX

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

  1. in Annex II, the columns for pendimethalin and spirotetramat are 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(2)

    Pendimethalin (F)

    Spirotetramat and spirotetramat-enol (sum of), expressed as spirotetramat (R)

    (1)

    (2)

    (3)

    (4)

    0100000

    FRUITS, FRESH or FROZEN; TREE NUTS

    0,05 (*)

    0110000

    Citrus fruits

    0,5

    0110010

    Grapefruits

    0110020

    Oranges

    0110030

    Lemons

    0110040

    Limes

    0110050

    Mandarins

    0110990

    Others (2)

    0120000

    Tree nuts

    0,5

    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

    0,7

    0130010

    Apples

    0130020

    Pears

    0130030

    Quinces

    0130040

    Medlars

    0130050

    Loquats/Japanese medlars

    0130990

    Others (2)

    0140000

    Stone fruits

    3

    0140010

    Apricots

    0140020

    Cherries (sweet)

    0140030

    Peaches

    0140040

    Plums

    0140990

    Others (2)

    0150000

    Berries and small fruits

    0151000

    1. grapes

    2

    0151010

    Table grapes

    0151020

    Wine grapes

    0152000

    1. strawberries

    0,3

    0153000

    1. cane fruits

    0,02 (*)

    0153010

    Blackberries

    0153020

    Dewberries

    0153030

    Raspberries (red and yellow)

    0153990

    Others (2)

    0154000

    1. other small fruits and berries

    1,5

    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

    1. edible peel

    0161010

    Dates

    0,02 (*)

    0161020

    Figs

    0,02 (*)

    0161030

    Table olives

    1,5

    0161040

    Kumquats

    0,02 (*)

    0161050

    Carambolas

    0,02 (*)

    0161060

    Kaki/Japanese persimmons

    0,4

    0161070

    Jambuls/jambolans

    0,02 (*)

    0161990

    Others (2)

    0,02 (*)

    0162000

    1. inedible peel, small

    0162010

    Kiwi fruits (green, red, yellow)

    3

    0162020

    Litchis/lychees

    15

    0162030

    Passionfruits/maracujas

    0,02 (*)

    0162040

    Prickly pears/cactus fruits

    0,02 (*)

    0162050

    Star apples/cainitos

    0,02 (*)

    0162060

    American persimmons/Virginia kaki

    0,02 (*)

    0162990

    Others (2)

    0,02 (*)

    0163000

    1. inedible peel, large

    0163010

    Avocados

    0,4

    0163020

    Bananas

    0,4

    0163030

    Mangoes

    0,3

    0163040

    Papayas

    0,4

    0163050

    Granate apples/pomegranates

    0,4

    0163060

    Cherimoyas

    0,02 (*)

    0163070

    Guavas

    2

    0163080

    Pineapples

    0,15

    0163090

    Breadfruits

    0,02 (*)

    0163100

    Durians

    0,02 (*)

    0163110

    Soursops/guanabanas

    0,02 (*)

    0163990

    Others (2)

    0,02 (*)

    0200000

    VEGETABLES, FRESH or FROZEN

    0210000

    Root and tuber vegetables

    0211000

    1. potatoes

    0,05 (*)

    0,8

    0212000

    1. tropical root and tuber vegetables

    0,05 (*)

    0,02 (*)

    0212010

    Cassava roots/manioc

    0212020

    Sweet potatoes

    0212030

    Yams

    0212040

    Arrowroots

    0212990

    Others (2)

    0213000

    1. other root and tuber vegetables except sugar beets

    0,07

    0213010

    Beetroots

    0,05 (*)

    0213020

    Carrots

    0,7

    0213030

    Celeriacs/turnip rooted celeries

    0,2

    0213040

    Horseradishes

    0,7

    0213050

    Jerusalem artichokes

    0,05 (*)

    0213060

    Parsnips

    0,7

    0213070

    Parsley roots/Hamburg roots parsley

    0,7

    0213080

    Radishes

    0,05 (*)

    0213090

    Salsifies

    0,7

    0213100

    Swedes/rutabagas

    0,4

    0213110

    Turnips

    0,4

    0213990

    Others (2)

    0,05 (*)

    0220000

    Bulb vegetables

    0,05 (*)

    0220010

    Garlic

    0,3

    0220020

    Onions

    0,4

    0220030

    Shallots

    0,3

    0220040

    Spring onions/green onions and Welsh onions

    0,9

    0220990

    Others (2)

    0,02 (*)

    0230000

    Fruiting vegetables

    0,05 (*)

    0231000

    1. Solanaceae and Malvaceae

    1

    0231010

    Tomatoes

    0231020

    Sweet peppers/bell peppers

    0231030

    Aubergines/eggplants

    0231040

    Okra/lady's fingers

    0231990

    Others (2)

    0232000

    1. cucurbits with edible peel

    0,2

    0232010

    Cucumbers

    0232020

    Gherkins

    0232030

    Courgettes

    0232990

    Others (2)

    0233000

    1. cucurbits with inedible peel

    0,2

    0233010

    Melons

    0233020

    Pumpkins

    0233030

    Watermelons

    0233990

    Others (2)

    0234000

    1. sweet corn

    1,5

    0239000

    1. other fruiting vegetables

    0,02 (*)

    0240000

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

    0241000

    1. flowering brassica

    0,05 (*)

    1

    0241010

    Broccoli

    0241020

    Cauliflowers

    0241990

    Others (2)

    0242000

    1. head brassica

    0,05 (*)

    0242010

    Brussels sprouts

    0,3(+)

    0242020

    Head cabbages

    2

    0242990

    Others (2)

    0,02 (*)

    0243000

    1. leafy brassica

    0,5

    7

    0243010

    Chinese cabbages/pe-tsai

    0243020

    Kales

    0243990

    Others (2)

    0244000

    1. kohlrabies

    0,3

    1,5(+)

    0250000

    Leaf vegetables, herbs and edible flowers

    0251000

    1. lettuces and salad plants

    7

    0251010

    Lamb's lettuces/corn salads

    0,6

    0251020

    Lettuces

    4

    0251030

    Escaroles/broad-leaved endives

    0,05 (*)

    0251040

    Cresses and other sprouts and shoots

    0,6

    0251050

    Land cresses

    0,05 (*)

    0251060

    Roman rocket/rucola

    0,6

    0251070

    Red mustards

    0,05 (*)

    0251080

    Baby leaf crops (including brassica species)

    0,6

    0251990

    Others (2)

    0,05 (*)

    0252000

    1. spinaches and similar leaves

    0,05 (*)

    7

    0252010

    Spinaches

    0252020

    Purslanes

    0252030

    Chards/beet leaves

    0252990

    Others (2)

    0253000

    1. grape leaves and similar species

    0,05 (*)

    0,02 (*)

    0254000

    1. watercresses

    0,05 (*)

    7

    0255000

    1. witloofs/Belgian endives

    0,05 (*)

    0,03

    0256000

    1. herbs and edible flowers

    0256010

    Chervil

    0,6

    7

    0256020

    Chives

    0,6

    7

    0256030

    Celery leaves

    0,6

    7

    0256040

    Parsley

    2

    7

    0256050

    Sage

    2

    10

    0256060

    Rosemary

    0,6

    10

    0256070

    Thyme

    0,6

    10

    0256080

    Basil and edible flowers

    0,6

    7

    0256090

    Laurel/bay leaves

    0,6

    10

    0256100

    Tarragon

    0,6

    7

    0256990

    Others (2)

    0,6

    10

    0260000

    Legume vegetables

    0260010

    Beans (with pods)

    0,06

    2

    0260020

    Beans (without pods)

    0,05 (*)

    1,5

    0260030

    Peas (with pods)

    0,09

    2

    0260040

    Peas (without pods)

    0,05 (*)

    1,5

    0260050

    Lentils

    0,05 (*)

    1,5

    0260990

    Others (2)

    0,05 (*)

    0,02 (*)

    0270000

    Stem vegetables

    0270010

    Asparagus

    0,1

    0,02 (*)

    0270020

    Cardoons

    0,05 (*)

    0,02 (*)

    0270030

    Celeries

    0,1

    4

    0270040

    Florence fennels

    0,1

    4

    0270050

    Globe artichokes

    0,05 (*)

    1

    0270060

    Leeks

    0,3

    0,9

    0270070

    Rhubarbs

    0,05 (*)

    4

    0270080

    Bamboo shoots

    0,05 (*)

    0,02 (*)

    0270090

    Palm hearts

    0,05 (*)

    0,02 (*)

    0270990

    Others (2)

    0,05 (*)

    0,02 (*)

    0280000

    Fungi, mosses and lichens

    0,05 (*)

    0,02 (*)

    0280010

    Cultivated fungi

    0280020

    Wild fungi

    0280990

    Mosses and lichens

    0290000

    Algae and prokaryotes organisms

    0,05 (*)

    0,02 (*)

    0300000

    PULSES

    0,15

    2

    0300010

    Beans

    0300020

    Lentils

    0300030

    Peas

    0300040

    Lupins/lupini beans

    0300990

    Others (2)

    0400000

    OILSEEDS AND OIL FRUITS

    0,05 (*)

    0401000

    Oilseeds

    0401010

    Linseeds

    0,02 (*)

    0401020

    Peanuts/groundnuts

    0,02 (*)

    0401030

    Poppy seeds

    0,02 (*)

    0401040

    Sesame seeds

    0,02 (*)

    0401050

    Sunflower seeds

    0,02 (*)

    0401060

    Rapeseeds/canola seeds

    0,02 (*)

    0401070

    Soyabeans

    4

    0401080

    Mustard seeds

    0,02 (*)

    0401090

    Cotton seeds

    0,4

    0401100

    Pumpkin seeds

    0,02 (*)

    0401110

    Safflower seeds

    0,02 (*)

    0401120

    Borage seeds

    0,02 (*)

    0401130

    Gold of pleasure seeds

    0,02 (*)

    0401140

    Hemp seeds

    0,02 (*)

    0401150

    Castor beans

    0,02 (*)

    0401990

    Others (2)

    0,02 (*)

    0402000

    Oil fruits

    0402010

    Olives for oil production

    1,5

    0402020

    Oil palms kernels

    0,02 (*)

    0402030

    Oil palms fruits

    0,02 (*)

    0402040

    Kapok

    0,02 (*)

    0402990

    Others (2)

    0,02 (*)

    0500000

    CEREALS

    0,05 (*)

    0,02 (*)

    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 (*)

    0,1 (*)

    0620000

    Coffee beans

    0,05 (*)

    0,1 (*)

    0630000

    Herbal infusions from

    0631000

    1. flowers

    0,05 (*)

    0,1 (*)

    0631010

    Chamomile

    0631020

    Hibiscus/roselle

    0631030

    Rose

    0631040

    Jasmine

    0631050

    Lime/linden

    0631990

    Others (2)

    0632000

    1. leaves and herbs

    0,05 (*)

    50

    0632010

    Strawberry

    0632020

    Rooibos

    0632030

    Mate/maté

    0632990

    Others (2)

    0633000

    1. roots

    0,5

    0,1 (*)

    0633010

    Valerian

    0633020

    Ginseng

    0633990

    Others (2)

    0639000

    1. any other parts of the plant

    0,05 (*)

    0,1 (*)

    0640000

    Cocoa beans

    0,05 (*)

    0,1 (*)

    0650000

    Carobs/Saint John's breads

    0,05 (*)

    0,1 (*)

    0700000

    HOPS

    0,05 (*)

    15

    0800000

    SPICES

    0810000

    Seed spices

    0,05 (*)

    0,1 (*)

    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 (*)

    0,1 (*)

    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 (*)

    0,1 (*)

    0830010

    Cinnamon

    0830990

    Others (2)

    0840000

    Root and rhizome spices

    0840010

    Liquorice

    0,05 (*)

    0,1 (*)

    0840020

    Ginger (10)

    0840030

    Turmeric/curcuma

    0,05 (*)

    0,1 (*)

    0840040

    Horseradish (11)

    0840990

    Others (2)

    0,05 (*)

    0,1 (*)

    0850000

    Bud spices

    0,05 (*)

    0,1 (*)

    0850010

    Cloves

    0850020

    Capers

    0850990

    Others (2)

    0860000

    Flower pistil spices

    0,05 (*)

    0,1 (*)

    0860010

    Saffron

    0860990

    Others (2)

    0870000

    Aril spices

    0,05 (*)

    0,1 (*)

    0870010

    Mace

    0870990

    Others (2)

    0900000

    SUGAR PLANTS

    0900010

    Sugar beet roots

    0,05 (*)

    0,06

    0900020

    Sugar canes

    0,05 (*)

    0,02 (*)

    0900030

    Chicory roots

    0,2

    0,07

    0900990

    Others (2)

    0,05 (*)

    0,02 (*)

    1000000

    PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

    1010000

    Commodities from

    1011000

    1. swine

    1011010

    Muscle

    0,01 (*)

    0,05

    1011020

    Fat

    0,2

    0,02 (*)

    1011030

    Liver

    0,05

    0,7

    1011040

    Kidney

    0,05

    0,7

    1011050

    Edible offals (other than liver and kidney)

    0,05

    0,7

    1011990

    Others (2)

    0,01 (*)

    0,02 (*)

    1012000

    1. bovine

    1012010

    Muscle

    0,01 (*)

    0,05

    1012020

    Fat

    0,2

    0,02 (*)

    1012030

    Liver

    0,05

    0,7

    1012040

    Kidney

    0,05

    0,7

    1012050

    Edible offals (other than liver and kidney)

    0,05

    0,7

    1012990

    Others (2)

    0,01 (*)

    0,02 (*)

    1013000

    1. sheep

    1013010

    Muscle

    0,01 (*)

    0,05

    1013020

    Fat

    0,2

    0,02 (*)

    1013030

    Liver

    0,05

    0,7

    1013040

    Kidney

    0,05

    0,7

    1013050

    Edible offals (other than liver and kidney)

    0,05

    0,7

    1013990

    Others (2)

    0,01 (*)

    0,02 (*)

    1014000

    1. goat

    1014010

    Muscle

    0,01 (*)

    0,05

    1014020

    Fat

    0,2

    0,02 (*)

    1014030

    Liver

    0,05

    0,7

    1014040

    Kidney

    0,05

    0,7

    1014050

    Edible offals (other than liver and kidney)

    0,05 (*)

    0,7

    1014990

    Others (2)

    0,01 (*)

    0,02 (*)

    1015000

    1. equine

    1015010

    Muscle

    0,01 (*)

    0,05

    1015020

    Fat

    0,2

    0,02 (*)

    1015030

    Liver

    0,05

    0,7

    1015040

    Kidney

    0,05

    0,7

    1015050

    Edible offals (other than liver and kidney)

    0,05

    0,7

    1015990

    Others (2)

    0,01 (*)

    0,02 (*)

    1016000

    1. poultry

    0,01 (*)

    0,02 (*)

    1016010

    Muscle

    1016020

    Fat

    1016030

    Liver

    1016040

    Kidney

    1016050

    Edible offals (other than liver and kidney)

    1016990

    Others (2)

    1017000

    1. other farmed terrestrial animals

    1017010

    Muscle

    0,01 (*)

    0,05

    1017020

    Fat

    0,2

    0,02 (*)

    1017030

    Liver

    0,05

    0,7

    1017040

    Kidney

    0,05

    0,7

    1017050

    Edible offals (other than liver and kidney)

    0,05

    0,7

    1017990

    Others (2)

    0,01 (*)

    0,02 (*)

    1020000

    Milk

    0,02

    0,01 (*)

    1020010

    Cattle

    1020020

    Sheep

    1020030

    Goat

    1020040

    Horse

    1020990

    Others (2)

    1030000

    Birds eggs

    0,01 (*)

    0,01 (*)

    1030010

    Chicken

    1030020

    Duck

    1030030

    Geese

    1030040

    Quail

    1030990

    Others (2)

    1040000

    Honey and other apiculture products (7)

    0,05 (*)

    0,5

    1050000

    Amphibians and Reptiles

    0,01 (*)

    0,02 (*)

    1060000

    Terrestrial invertebrate animals

    0,01 (*)

    0,02 (*)

    1070000

    Wild terrestrial vertebrate animals

    0,01 (*)

    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)

  2. Annex IV is amended as follows:

    1. the entry for ‘Repellants: Fish oil(1)’ is replaced by the following:

      • ‘Repellants: Fish oil’;

    2. the entry for ‘Repellants: Sheep fat(1)’ is replaced by the following:

      • ‘Repellants: Sheep fat’.