Commission Regulation (EU) 2024/1318 of 15 May 2024 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels prothioconazole in or on certain products
Date: 2024-05-15
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: consumer protection, crop production, food inspection, food safety, foodstuff, pesticide, pesticide residue




L_202401318EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/1318


16.5.2024







            COMMISSION REGULATION (EU) 2024/1318
of 15 May 2024
         
amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels prothioconazole 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), point (a), thereof,

Whereas:







(1)


For the active substance prothioconazole, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005.












(2)


An application requesting a modification of the existing MRLs for prothioconazole in sugar beet roots and chicory roots was submitted to the Member State concerned pursuant to Article 6(1) of Regulation (EC) No 396/2005.












(3)


In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, the application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. The Commission forwarded the application, the evaluation report, and the supporting dossier to the European Food Safety Authority (the ‘Authority’).












(4)


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












(5)


As regards the modifications to the MRLs for prothioconazole in sugar beet roots and chicory roots requested by the applicant, the Authority concluded that all the data requirements had been 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 data on the toxicological properties of prothioconazole. Neither the long-term exposure to that substance via consumption of all food products that may contain it nor the short-term exposure due to high consumption of relevant products show a risk that the acceptable daily intake or the acute reference dose is exceeded.












(6)


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












(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, 15 May 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 70, 16.3.2005, p. 1, ELI: http://data.europa.eu/eli/reg/2005/396/oj.

(2)  EFSA 2023. Reasoned Opinion on the modification of the existing maximum residue levels for prothioconazole in sugar beet and chicory roots. EFSA Journal, 21(8), 1–49. https://doi.org/10.2903/j.efsa.2023.8198.




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



Prothioconazole: prothioconazole-desthio (sum of isomers) (F)




(1)


(2)


(3)




0100000 



FRUITS, FRESH or FROZEN; TREE NUTS



 




0110000 



Citrus fruits



0,01  (*1)





0110010 


Grapefruits


 




0110020 


Oranges


 




0110030 


Lemons


 




0110040 


Limes


 




0110050 


Mandarins


 




0110990 


Others (2)


 




0120000 



Tree nuts



0,02  (*1)





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



0,01  (*1)





0130010 


Apples


 




0130020 


Pears


 




0130030 


Quinces


 




0130040 


Medlars


 




0130050 


Loquats/Japanese medlars


 




0130990 


Others (2)


 




0140000 



Stone fruits



0,01  (*1)





0140010 


Apricots


 




0140020 


Cherries (sweet)


 




0140030 


Peaches


 




0140040 


Plums


 




0140990 


Others (2)


 




0150000 



Berries and small fruits



 




0151000 








(a)



grapes







0,01  (*1)





0151010 


Table grapes


 




0151020 


Wine grapes


 




0152000 








(b)



strawberries







0,01  (*1)





0153000 








(c)



cane fruits







0,01  (*1)





0153010 


Blackberries


 




0153020 


Dewberries


 




0153030 


Raspberries (red and yellow)


 




0153990 


Others (2)


 




0154000 








(d)



other small fruits and berries







 




0154010 


Blueberries


0,01  (*1)





0154020 


Cranberries


0,15 




0154030 


Currants (black, red and white)


0,01  (*1)





0154040 


Gooseberries (green, red and yellow)


0,01  (*1)





0154050 


Rose hips


0,01  (*1)





0154060 


Mulberries (black and white)


0,01  (*1)





0154070 


Azaroles/Mediterranean medlars


0,01  (*1)





0154080 


Elderberries


0,01  (*1)





0154990 


Others (2)


0,01  (*1)





0160000 



Miscellaneous fruitswith



0,01  (*1)





0161000 








(a)



edible peel







 




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)


 




0162020 


Litchis/lychees


 




0162030 


Passionfruits/maracujas


 




0162040 


Prickly pears/cactus fruits


 




0162050 


Star apples/cainitos


 




0162060 


American persimmons/Virginia kaki


 




0162990 


Others (2)


 




0163000 








(c)



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



 




0211000 








(a)



potatoes







0,02  (*1)





0212000 








(b)



tropical root and tuber vegetables







0,01  (*1)





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


0,1 (+)




0213020 


Carrots


0,1 (+)




0213030 


Celeriacs/turnip rooted celeries


0,01  (*1)





0213040 


Horseradishes


0,1 (+)




0213050 


Jerusalem artichokes


0,01  (*1)





0213060 


Parsnips


0,1 (+)




0213070 


Parsley roots/Hamburg roots parsley


0,1 (+)




0213080 


Radishes


0,01  (*1)





0213090 


Salsifies


0,1 (+)




0213100 


Swedes/rutabagas


0,1 (+)




0213110 


Turnips


0,1 (+)




0213990 


Others (2)


0,01  (*1)





0220000 



Bulb vegetables



 




0220010 


Garlic


0,01  (*1)





0220020 


Onions


0,05 (+)




0220030 


Shallots


0,05 (+)




0220040 


Spring onions/green onions and Welsh onions


0,01  (*1)





0220990 


Others (2)


0,01  (*1)





0230000 



Fruiting vegetables



 




0231000 








(a)



Solanaceae and Malvaceae







0,01  (*1)





0231010 


Tomatoes


 




0231020 


Sweet peppers/bell peppers


 




0231030 


Aubergines/eggplants


 




0231040 


Okra/lady's fingers


 




0231990 


Others (2)


 




0232000 








(b)



cucurbits with edible peel







0,01  (*1)





0232010 


Cucumbers


 




0232020 


Gherkins


 




0232030 


Courgettes


 




0232990 


Others (2)


 




0233000 








(c)



cucurbits with inedible peel







0,01  (*1)





0233010 


Melons


 




0233020 


Pumpkins


 




0233030 


Watermelons


 




0233990 


Others (2)


 




0234000 








(d)



sweet corn







0,02 




0239000 








(e)



other fruiting vegetables







0,01  (*1)





0240000 



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



 




0241000 








(a)



flowering brassica







0,05 (+)




0241010 


Broccoli


(+)




0241020 


Cauliflowers


(+)




0241990 


Others (2)


(+)




0242000 








(b)



head brassica







 




0242010 


Brussels sprouts


0,1 (+)




0242020 


Head cabbages


0,09 (+)




0242990 


Others (2)


0,01  (*1)





0243000 








(c)



leafy brassica







0,01  (*1)





0243010 


Chinese cabbages/pe-tsai


 




0243020 


Kales


 




0243990 


Others (2)


 




0244000 








(d)



kohlrabies







0,01  (*1)





0250000 



Leaf vegetables, herbs and edible flowers



 




0251000 








(a)



lettuces and salad plants







0,01  (*1)





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







0,01  (*1)





0252010 


Spinaches


 




0252020 


Purslanes


 




0252030 


Chards/beet leaves


 




0252990 


Others (2)


 




0253000 








(c)



grape leaves and similar species







0,01  (*1)





0254000 








(d)



watercresses







0,01  (*1)





0255000 








(e)



witloofs/Belgian endives







0,01  (*1)





0256000 








(f)



herbs and edible flowers







0,02  (*1)





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  (*1)





0260010 


Beans (with pods)


 




0260020 


Beans (without pods)


 




0260030 


Peas (with pods)


 




0260040 


Peas (without pods)


 




0260050 


Lentils


 




0260990 


Others (2)


 




0270000 



Stem vegetables



 




0270010 


Asparagus


0,01  (*1)





0270020 


Cardoons


0,01  (*1)





0270030 


Celeries


0,01  (*1)





0270040 


Florence fennels


0,01  (*1)





0270050 


Globe artichokes


0,01  (*1)





0270060 


Leeks


0,06 (+)




0270070 


Rhubarbs


0,01  (*1)





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


0,05 (+)




0300020 


Lentils


1 (+)




0300030 


Peas


1 (+)




0300040 


Lupins/lupini beans


1 (+)




0300990 


Others (2)


0,01  (*1)





0400000 



OILSEEDS AND OIL FRUITS



 




0401000 



Oilseeds



 




0401010 


Linseeds


0,09 (+)




0401020 


Peanuts/groundnuts


0,02  (*1)(+)




0401030 


Poppy seeds


0,09 (+)




0401040 


Sesame seeds


0,02  (*1)





0401050 


Sunflower seeds


0,2 




0401060 


Rapeseeds/canola seeds


0,15 (+)




0401070 


Soyabeans


0,2 




0401080 


Mustard seeds


0,09 (+)




0401090 


Cotton seeds


0,3 




0401100 


Pumpkin seeds


0,02  (*1)





0401110 


Safflower seeds


0,02  (*1)





0401120 


Borage seeds


0,02  (*1)





0401130 


Gold of pleasure seeds


0,04 (+)




0401140 


Hemp seeds


0,02  (*1)





0401150 


Castor beans


0,02  (*1)





0401990 


Others (2)


0,02  (*1)





0402000 



Oil fruits



0,02  (*1)





0402010 


Olives for oil production


 




0402020 


Oil palms kernels


 




0402030 


Oil palms fruits


 




0402040 


Kapok


 




0402990 


Others (2)


 




0500000 



CEREALS



 




0500010 


Barley


0,2 (+)




0500020 


Buckwheat and other pseudocereals


0,01  (*1)





0500030 


Maize/corn


0,1 




0500040 


Common millet/proso millet


0,01  (*1)





0500050 


Oat


0,05 (+)




0500060 


Rice


0,01  (*1)





0500070 


Rye


0,05 (+)




0500080 


Sorghum


0,01  (*1)





0500090 


Wheat


0,1 (+)




0500990 


Others (2)


0,01  (*1)





0600000 



TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS



0,05  (*1)





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



0,05  (*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


0,05  (*1)





0840020 


Ginger (10)


 




0840030 


Turmeric/curcuma


0,05  (*1)





0840040 


Horseradish (11)


 




0840990 


Others (2)


0,05  (*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



0,03 





0900020 


Sugar canes


0,01  (*1)





0900030 


Chicory roots



0,03 





0900990 


Others (2)


0,01  (*1)





1000000 



PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS



 




1010000 



Commodities from



 




1011000 








(a)



swine







 




1011010 


Muscle


0,01 




1011020 


Fat


0,02 




1011030 


Liver


0,5 (+)




1011040 


Kidney


0,5 (+)




1011050 


Edible offals (other than liver and kidney)


0,5 (+)




1011990 


Others (2)


0,5 (+)




1012000 








(b)



bovine







 




1012010 


Muscle


0,01 




1012020 


Fat


0,02 




1012030 


Liver


0,5 (+)




1012040 


Kidney


0,5 (+)




1012050 


Edible offals (other than liver and kidney)


0,5 (+)




1012990 


Others (2)


0,5 (+)




1013000 








(c)



sheep







 




1013010 


Muscle


0,01 




1013020 


Fat


0,02 




1013030 


Liver


0,5 (+)




1013040 


Kidney


0,5 (+)




1013050 


Edible offals (other than liver and kidney)


0,5 (+)




1013990 


Others (2)


0,5 (+)




1014000 








d)



goat







 




1014010 


Muscle


0,01 




1014020 


Fat


0,02 




1014030 


Liver


0,5 (+)




1014040 


Kidney


0,5 (+)




1014050 


Edible offals (other than liver and kidney)


0,5 (+)




1014990 


Others (2)


0,5 (+)




1015000 








(e)



equine







 




1015010 


Muscle


0,01 




1015020 


Fat


0,02 




1015030 


Liver


0,5 (+)




1015040 


Kidney


0,5 (+)




1015050 


Edible offals (other than liver and kidney)


0,5 (+)




1015990 


Others (2)


0,5 (+)




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


0,01 




1017020 


Fat


0,02 




1017030 


Liver


0,5 (+)




1017040 


Kidney


0,5 (+)




1017050 


Edible offals (other than liver and kidney)


0,5 (+)




1017990 


Others (2)


0,5 (+)




1020000 



Milk



0,01  (*1)(+)




1020010 


Cattle


(+)




1020020 


Sheep


(+)




1020030 


Goat


(+)




1020040 


Horse


(+)




1020990 


Others (2)


(+)




1030000 



Birds eggs



0,01  (*1)





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



0,01 




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)



 










(+)


Pesticide-product combination for which a footnote exists. The list of footnotes is provided below.





Prothioconazole: prothioconazole-desthio (sum of isomers) (F)







(F)


Fat soluble




The European Food Safety Authority identified some information on residue trials and storage stability data complying with the proposed 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 27 January 2018, or, if that information is not submitted by that date, the lack of it.

0213010 Beetroots


0213020 Carrots


0213040 Horseradishes


0213060 Parsnips


0213070 Parsley roots/Hamburg roots parsley


0213090 Salsifies


0213100 Swedes/rutabagas


0213110 Turnips


0220020 Onions


0241000 (a) flowering brassica


0241010 Broccoli


0241020 Cauliflowers


0241990 Others (2)


0242010 Brussels sprouts


0242020 Head cabbages


0270060 Leeks


0300010 Beans


0300020 Lentils


0300030 Peas


0300040 Lupins/lupini beans


0401010 Linseeds


0401020 Peanuts/groundnuts


0401030 Poppy seeds


0401060 Rapeseeds/canola seeds


0401080 Mustard seeds


0401130 Gold of pleasure seeds


0500010 Barley


0500050 Oat


0500070 Rye


0500090 Wheat

The European Food Safety Authority identified some information on analytical methods and storage stability data complying with the proposed 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 27 January 2018, or, if that information is not submitted by that date, the lack of it.

0220030 Shallots

The European Food Safety Authority identified some information on residue trials on grass (major component of the livestock dietary burden), 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 27 January 2018, or, if that information is not submitted by that date, the lack of it.

1011030 Liver


1011040 Kidney


1011050 Edible offals (other than liver and kidney)


1011990 Others (2)


1012030 Liver


1012040 Kidney


1012050 Edible offals (other than liver and kidney)


1012990 Others (2)


1013030 Liver


1013040 Kidney


1013050 Edible offals (other than liver and kidney)


1013990 Others (2)


1014030 Liver


1014040 Kidney


1014050 Edible offals (other than liver and kidney)


1014990 Others (2)


1015030 Liver


1015040 Kidney


1015050 Edible offals (other than liver and kidney)


1015990 Others (2)


1017030 Liver


1017040 Kidney


1017050 Edible offals (other than liver and kidney)


1017990 Others (2)


1020000 Milk


1020010 Cattle


1020020 Sheep


1020030 Goat


1020040 Horse


1020990 Others (2)
                     ’
                  



(*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



ELI: http://data.europa.eu/eli/reg/2024/1318/oj
ISSN 1977-0677 (electronic edition)