Annexes II and IV to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
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:
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.
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.
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.
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.
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).
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.
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.
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.
Regulation (EC) No 396/2005 should therefore be amended accordingly.
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
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:
-
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
-
grapes
2
0151010
Table grapes
0151020
Wine grapes
0152000
-
strawberries
0,3
0153000
-
cane fruits
0,02 (*)
0153010
Blackberries
0153020
Dewberries
0153030
Raspberries (red and yellow)
0153990
Others (2)
0154000
-
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
-
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
-
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
-
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
-
potatoes
0,05 (*)
0,8
0212000
-
tropical root and tuber vegetables
0,05 (*)
0,02 (*)
0212010
Cassava roots/manioc
0212020
Sweet potatoes
0212030
Yams
0212040
Arrowroots
0212990
Others (2)
0213000
-
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
-
Solanaceae and Malvaceae
1
0231010
Tomatoes
0231020
Sweet peppers/bell peppers
0231030
Aubergines/eggplants
0231040
Okra/lady's fingers
0231990
Others (2)
0232000
-
cucurbits with edible peel
0,2
0232010
Cucumbers
0232020
Gherkins
0232030
Courgettes
0232990
Others (2)
0233000
-
cucurbits with inedible peel
0,2
0233010
Melons
0233020
Pumpkins
0233030
Watermelons
0233990
Others (2)
0234000
-
sweet corn
1,5
0239000
-
other fruiting vegetables
0,02 (*)
0240000
Brassica vegetables(excluding brassica roots and brassica baby leaf crops)
0241000
-
flowering brassica
0,05 (*)
1
0241010
Broccoli
0241020
Cauliflowers
0241990
Others (2)
0242000
-
head brassica
0,05 (*)
0242010
Brussels sprouts
0,3(+)
0242020
Head cabbages
2
0242990
Others (2)
0,02 (*)
0243000
-
leafy brassica
0,5
7
0243010
Chinese cabbages/pe-tsai
0243020
Kales
0243990
Others (2)
0244000
-
kohlrabies
0,3
1,5(+)
0250000
Leaf vegetables, herbs and edible flowers
0251000
-
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
-
spinaches and similar leaves
0,05 (*)
7
0252010
Spinaches
0252020
Purslanes
0252030
Chards/beet leaves
0252990
Others (2)
0253000
-
grape leaves and similar species
0,05 (*)
0,02 (*)
0254000
-
watercresses
0,05 (*)
7
0255000
-
witloofs/Belgian endives
0,05 (*)
0,03
0256000
-
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
-
flowers
0,05 (*)
0,1 (*)
0631010
Chamomile
0631020
Hibiscus/roselle
0631030
Rose
0631040
Jasmine
0631050
Lime/linden
0631990
Others (2)
0632000
-
leaves and herbs
0,05 (*)
50
0632010
Strawberry
0632020
Rooibos
0632030
Mate/maté
0632990
Others (2)
0633000
-
roots
0,5
0,1 (*)
0633010
Valerian
0633020
Ginseng
0633990
Others (2)
0639000
-
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
-
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
-
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
-
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
-
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
-
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
-
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
-
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)
-
-
Annex IV is amended as follows:
-
the entry for ‘Repellants: Fish oil(1)’ is replaced by the following:
-
‘Repellants: Fish oil’;
-
-
the entry for ‘Repellants: Sheep fat(1)’ is replaced by the following:
-
‘Repellants: Sheep fat’.
-
-