Commission Regulation (EU) 2022/1264 of 20 July 2022 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fludioxonil in or on certain products (Text with EEA relevance)
Date: 2022-07-20
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: chemical product, consumer protection, food inspection, food safety, pesticide, pesticide residue, sugar beet, third country, tropical fruit




L_2022192EN.01000101.xml










21.7.2022   


EN


Official Journal of the European Union


L 192/1








            COMMISSION REGULATION (EU) 2022/1264
of 20 July 2022
         
amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fludioxonil 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) thereof,

Whereas:







(1)


For fludioxonil maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005.












(2)


An application for import tolerances pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005 for fludioxonil used in the United States on sugar beet roots, and in Guatemala, Honduras and Colombia on bananas was submitted. The applicant states that the authorised uses of that substance on such crops in those countries lead to residues exceeding the MRLs provided for in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of those crops.












(3)


In accordance with Article 8 of Regulation (EC) No 396/2005, the application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission.












(4)


The European Food Safety Authority (‘the Authority’) assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals, and gave a reasoned opinion on the proposed MRLs (2). It forwarded that opinion to the applicant, the Commission and the Member States and made it available to the public.












(5)


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 applicant 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 information on the toxicological properties of the substance. The lifetime exposure to the substance via consumption of all food products that may contain it showed that there is no risk that the acceptable daily intake is exceeded. Moreover, the Authority concluded that the establishment of an acute reference dose is not necessary on the basis of the low acute toxicity profile of the active substance.












(6)


Based on the reasoned opinion of the Authority and taking into account the factors relevant to the matter under consideration, the proposed modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.












(7)


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












(8)


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
Annex II to Regulation (EC) No 396/2005 is 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, 20 July 2022.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 70, 16.3.2005, p. 1.

(2)  Reasoned opinion on the setting of import tolerances for fludioxonil in sugar beet roots and bananas. EFSA Journal 2021;19(11):6919. EFSA scientific reports available online: http://www.efsa.europa.eu.




ANNEX
In Annex II to Regulation (EC) No 396/2005, the column for fludioxonil is 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 (1)



Fludioxonil (R) (F)




0100000 



FRUITS, FRESH or FROZEN; TREE NUTS



 




0110000 



Citrus fruits



10 




0110010 


Grapefruits


 




0110020 


Oranges


 




0110030 


Lemons


 




0110040 


Limes


 




0110050 


Mandarins


 




0110990 


Others (2)


 




0120000 



Tree nuts



 




0120010 


Almonds


0,01  (*1)





0120020 


Brazil nuts


0,01  (*1)





0120030 


Cashew nuts


0,01  (*1)





0120040 


Chestnuts


0,01  (*1)





0120050 


Coconuts


0,01  (*1)





0120060 


Hazelnuts/cobnuts


0,01  (*1)





0120070 


Macadamias


0,01  (*1)





0120080 


Pecans


0,01  (*1)





0120090 


Pine nut kernels


0,01  (*1)





0120100 


Pistachios


0,2 




0120110 


Walnuts


0,01  (*1)





0120990 


Others (2)


0,01  (*1)





0130000 



Pome fruits



5 




0130010 


Apples


 




0130020 


Pears


 




0130030 


Quinces


 




0130040 


Medlars


 




0130050 


Loquats/Japanese medlars


 




0130990 


Others (2)


 




0140000 



Stone fruits



 




0140010 


Apricots


5 




0140020 


Cherries (sweet)


5 




0140030 


Peaches


10 




0140040 


Plums


5 




0140990 


Others (2)


0,01  (*1)





0150000 



Berries and small fruits



 




0151000 








(a)



grapes







 




0151010 


Table grapes


5 




0151020 


Wine grapes


4 




0152000 








(b)



strawberries







4 




0153000 








(c)



cane fruits







5 




0153010 


Blackberries


 




0153020 


Dewberries


 




0153030 


Raspberries (red and yellow)


 




0153990 


Others (2)


 




0154000 








(d)



other small fruits and berries







 




0154010 


Blueberries


4 




0154020 


Cranberries


4 




0154030 


Currants (black, red and white)


4 




0154040 


Gooseberries (green, red and yellow)


4 




0154050 


Rose hips


0,01  (*1)





0154060 


Mulberries (black and white)


0,01  (*1)





0154070 


Azaroles/Mediterranean medlars


0,01  (*1)





0154080 


Elderberries


4 




0154990 


Others (2)


0,01  (*1)





0160000 



Miscellaneous fruitswith



 




0161000 








(a)



edible peel







0,01  (*1)





0161010 


Dates


 




0161020 


Figs


 




0161030 


Table olives


 




0161040 


Kumquats


 




0161050 


Carambolas


 




0161060 


Kaki/Japanese persimmons


 




0161070 


Jambuls/jambolans


 




0161990 


Others (2)


 




0162000 








(b)



inedible peel, small







 




0162010 


Kiwi fruits (green, red, yellow)


15 




0162020 


Litchis/lychees


0,01  (*1)





0162030 


Passionfruits/maracujas


0,01  (*1)





0162040 


Prickly pears/cactus fruits


0,01  (*1)





0162050 


Star apples/cainitos


0,01  (*1)





0162060 


American persimmons/Virginia kaki


0,01  (*1)





0162990 


Others (2)


0,01  (*1)





0163000 








(c)



inedible peel, large







 




0163010 


Avocados


1,5 




0163020 


Bananas



2 





0163030 


Mangoes


2 




0163040 


Papayas


0,01  (*1)





0163050 


Granate apples/pomegranates


3 




0163060 


Cherimoyas


0,01  (*1)





0163070 


Guavas


0,5 




0163080 


Pineapples


7 




0163090 


Breadfruits


0,01  (*1)





0163100 


Durians


0,01  (*1)





0163110 


Soursops/guanabanas


0,01  (*1)





0163990 


Others (2)


0,01  (*1)





0200000 



VEGETABLES, FRESH or FROZEN



 




0210000 



Root and tuber vegetables



 




0211000 








(a)



potatoes







5 




0212000 








(b)



tropical root and tuber vegetables







 




0212010 


Cassava roots/manioc


0,01  (*1)





0212020 


Sweet potatoes


10 




0212030 


Yams


10 




0212040 


Arrowroots


0,01  (*1)





0212990 


Others (2)


0,01  (*1)





0213000 








(c)



other root and tuber vegetables except sugar beets







 




0213010 


Beetroots


1 




0213020 


Carrots


1 




0213030 


Celeriacs/turnip rooted celeries


0,2 




0213040 


Horseradishes


1 




0213050 


Jerusalem artichokes


0,01  (*1)





0213060 


Parsnips


1 




0213070 


Parsley roots/Hamburg roots parsley


1 




0213080 


Radishes


0,3 




0213090 


Salsifies


1 




0213100 


Swedes/rutabagas


0,01  (*1)





0213110 


Turnips


0,01  (*1)





0213990 


Others (2)


0,01  (*1)





0220000 



Bulb vegetables



 




0220010 


Garlic


0,5 




0220020 


Onions


0,5 




0220030 


Shallots


0,5 




0220040 


Spring onions/green onions and Welsh onions


5 




0220990 


Others (2)


0,5 




0230000 



Fruiting vegetables



 




0231000 








(a)



Solanaceae and Malvaceae







 




0231010 


Tomatoes


3 




0231020 


Sweet peppers/bell peppers


1 




0231030 


Aubergines/eggplants


0,4 




0231040 


Okra/lady's fingers


0,01  (*1)





0231990 


Others (2)


0,01  (*1)





0232000 








(b)



cucurbits with edible peel







0,4 




0232010 


Cucumbers


 




0232020 


Gherkins


 




0232030 


Courgettes


 




0232990 


Others (2)


 




0233000 








(c)



cucurbits with inedible peel







0,3 




0233010 


Melons


 




0233020 


Pumpkins


 




0233030 


Watermelons


 




0233990 


Others (2)


 




0234000 








(d)



sweet corn







0,01  (*1)





0239000 








(e)



other fruiting vegetables







0,01  (*1)





0240000 



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



 




0241000 








(a)



flowering brassica







 




0241010 


Broccoli


0,7 




0241020 


Cauliflowers


0,01  (*1)





0241990 


Others (2)


0,01  (*1)





0242000 








(b)



head brassica







 




0242010 


Brussels sprouts


0,01  (*1)





0242020 


Head cabbages


2 




0242990 


Others (2)


0,01  (*1)





0243000 








(c)



leafy brassica







 




0243010 


Chinese cabbages/pe-tsai


10 




0243020 


Kales


0,01  (*1)





0243990 


Others (2)


0,01  (*1)





0244000 








(d)



kohlrabies







0,01  (*1)





0250000 



Leaf vegetables, herbs and edible flowers



 




0251000 








(a)



lettuces and salad plants







 




0251010 


Lamb's lettuces/corn salads


20 




0251020 


Lettuces


40 




0251030 


Escaroles/broad-leaved endives


20 




0251040 


Cresses and other sprouts and shoots


20 




0251050 


Land cresses


20 




0251060 


Roman rocket/rucola


20 




0251070 


Red mustards


20 




0251080 


Baby leaf crops (including brassica species)


20 




0251990 


Others (2)


20 




0252000 








(b)



spinaches and similar leaves







 




0252010 


Spinaches


30 




0252020 


Purslanes


20 




0252030 


Chards/beet leaves


20 




0252990 


Others (2)


20 




0253000 








(c)



grape leaves and similar species







0,01  (*1)





0254000 








(d)



watercresses







10 




0255000 








(e)



witloofs/Belgian endives







0,02 




0256000 








(f)



herbs and edible flowers







20 




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



 




0260010 


Beans (with pods)


1 




0260020 


Beans (without pods)


0,4 




0260030 


Peas (with pods)


1 




0260040 


Peas (without pods)


0,3 




0260050 


Lentils


0,05 




0260990 


Others (2)


0,01  (*1)





0270000 



Stem vegetables



 




0270010 


Asparagus


0,01  (*1)





0270020 


Cardoons


0,01  (*1)





0270030 


Celeries


1,5 




0270040 


Florence fennels


1,5 




0270050 


Globe artichokes


0,01  (*1)





0270060 


Leeks


0,01  (*1)





0270070 


Rhubarbs


0,7 




0270080 


Bamboo shoots


0,01  (*1)





0270090 


Palm hearts


0,01  (*1)





0270990 


Others (2)


0,01  (*1)





0280000 



Fungi, mosses and lichens



0,01  (*1)





0280010 


Cultivated fungi


 




0280020 


Wild fungi


 




0280990 


Mosses and lichens


 




0290000 



Algae and prokaryotes organisms



0,01  (*1)





0300000 



PULSES



 




0300010 


Beans


0,5 




0300020 


Lentils


0,4 




0300030 


Peas


0,4 




0300040 


Lupins/lupini beans


0,4 




0300990 


Others (2)


0,4 




0400000 



OILSEEDS AND OIL FRUITS



 




0401000 



Oilseeds



 




0401010 


Linseeds


0,3 




0401020 


Peanuts/groundnuts


0,01  (*1)





0401030 


Poppy seeds


0,01  (*1)





0401040 


Sesame seeds


0,3 




0401050 


Sunflower seeds


0,01  (*1)





0401060 


Rapeseeds/canola seeds


0,3 




0401070 


Soyabeans


0,2 




0401080 


Mustard seeds


0,3 




0401090 


Cotton seeds


0,01  (*1)





0401100 


Pumpkin seeds


0,01  (*1)





0401110 


Safflower seeds


0,01  (*1)





0401120 


Borage seeds


0,3 




0401130 


Gold of pleasure seeds


0,3 




0401140 


Hemp seeds


0,3 




0401150 


Castor beans


0,01  (*1)





0401990 


Others (2)


0,01  (*1)





0402000 



Oil fruits



0,01  (*1)





0402010 


Olives for oil production


 




0402020 


Oil palms kernels


 




0402030 


Oil palms fruits


 




0402040 


Kapok


 




0402990 


Others (2)


 




0500000 



CEREALS



0,01  (*1)





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  (*1)





0620000 



Coffee beans



0,05  (*1)





0630000 



Herbal infusions from



 




0631000 








(a)



flowers







0,05  (*1)





0631010 


Chamomile


 




0631020 


Hibiscus/roselle


 




0631030 


Rose


 




0631040 


Jasmine


 




0631050 


Lime/linden


 




0631990 


Others (2)


 




0632000 








(b)



leaves and herbs







0,05  (*1)





0632010 


Strawberry


 




0632020 


Rooibos


 




0632030 


Mate/maté


 




0632990 


Others (2)


 




0633000 








(c)



roots







 




0633010 


Valerian


1 




0633020 


Ginseng


4 




0633990 


Others (2)


1 




0639000 








(d)



any other parts of the plant







0,05  (*1)





0640000 



Cocoa beans



0,05  (*1)





0650000 



Carobs/Saint John's breads



0,05  (*1)





0700000 



HOPS



0,05  (*1)





0800000 



SPICES



 




0810000 



Seed spices



0,05  (*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  (*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  (*1)





0830010 


Cinnamon


 




0830990 


Others (2)


 




0840000 



Root and rhizome spices



 




0840010 


Liquorice


1 




0840020 


Ginger (10)


 




0840030 


Turmeric/curcuma


1 




0840040 


Horseradish (11)


 




0840990 


Others (2)


1 




0850000 



Bud spices



0,05  (*1)





0850010 


Cloves


 




0850020 


Capers


 




0850990 


Others (2)


 




0860000 



Flower pistil spices



0,05  (*1)





0860010 


Saffron


 




0860990 


Others (2)


 




0870000 



Aril spices



0,05  (*1)





0870010 


Mace


 




0870990 


Others (2)


 




0900000 



SUGAR PLANTS



 




0900010 


Sugar beet roots



4 





0900020 


Sugar canes


0,01  (*1)





0900030 


Chicory roots


0,01  (*1)





0900990 


Others (2)


0,01  (*1)





1000000 



PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS



 




1010000 



Commodities from



 




1011000 








(a)



swine







 




1011010 


Muscle


0,02 




1011020 


Fat


0,02 




1011030 


Liver


0,1 




1011040 


Kidney


0,1 




1011050 


Edible offals (other than liver and kidney)


0,1 




1011990 


Others (2)


0,02 




1012000 








(b)



bovine







 




1012010 


Muscle


0,02 




1012020 


Fat


0,02 




1012030 


Liver


0,1 




1012040 


Kidney


0,1 




1012050 


Edible offals (other than liver and kidney)


0,1 




1012990 


Others (2)


0,02 




1013000 








(c)



sheep







 




1013010 


Muscle


0,02 




1013020 


Fat


0,02 




1013030 


Liver


0,1 




1013040 


Kidney


0,1 




1013050 


Edible offals (other than liver and kidney)


0,1 




1013990 


Others (2)


0,02 




1014000 








(d)



goat







 




1014010 


Muscle


0,02 




1014020 


Fat


0,02 




1014030 


Liver


0,1 




1014040 


Kidney


0,1 




1014050 


Edible offals (other than liver and kidney)


0,1 




1014990 


Others (2)


0,02 




1015000 








(e)



equine







 




1015010 


Muscle


0,02 




1015020 


Fat


0,02 




1015030 


Liver


0,1 




1015040 


Kidney


0,1 




1015050 


Edible offals (other than liver and kidney)


0,1 




1015990 


Others (2)


0,02 




1016000 








(f)



poultry







 




1016010 


Muscle


0,01  (*1)





1016020 


Fat


0,01  (*1)





1016030 


Liver


0,1 




1016040 


Kidney


0,1 




1016050 


Edible offals (other than liver and kidney)


0,1 




1016990 


Others (2)


0,01  (*1)





1017000 








(g)



other farmed terrestrial animals







 




1017010 


Muscle


0,02 




1017020 


Fat


0,02 




1017030 


Liver


0,1 




1017040 


Kidney


0,1 




1017050 


Edible offals (other than liver and kidney)


0,1 




1017990 


Others (2)


0,02 




1020000 



Milk



0,04 




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  (*1)





1050000 



Amphibians and Reptiles



0,01  (*1)





1060000 



Terrestrial invertebrate animals



0,01  (*1)





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)



 





Fludioxonil (R) (F)







(R)


The residue definition differs for the following combinations pesticide-code number: Fludioxonil - code 1000000  except 1040000  : sum of fludioxonil and its metabolites oxidized to metabolite 2,2-difluoro-benzo[1,3]dioxole-4 carboxylic acid, expressed as fludioxonil










(F)


Fat soluble’











(*1)  Indicates lower limit of analytical determination

(1)  For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I