Commission Regulation (EU) 2024/1314 of 15 May 2024 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for dithianon 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, pip fruit




L_202401314EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/1314


16.5.2024







            COMMISSION REGULATION (EU) 2024/1314
of 15 May 2024
         
amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for dithianon 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)


The maximum residue levels (‘MRLs’) for dithianon are set out in Part A of Annex III to Regulation (EC) No 396/2005.












(2)


The Authority has submitted a reasoned opinion on the review of the existing MRLs for dithianon in accordance with Article 12(1) of Regulation (EC) No 396/2005 (2). The Authority noted that the mutagenicity potential of the metabolite 1,4-naphthoquinone remains uncertain, pending the submission of additional studies fulfilling the previously identified data gap (3). Therefore, the values of the acceptable daily intake (ADI) and acute reference dose (ARfD) of 1,4-naphthoquinone are considered provisional and all MRLs for dithianon above the limits of determination (LODs) require further consideration by risk managers. As the missing data is to be submitted as part of the ongoing procedure for the renewal of the approval of dithianon, the MRLs should be reconsidered and revised by risk managers following the finalisation of that procedure.












(3)


Additionally, the Authority identified an exceedance of the ARfD of dithianon for apples and pears. The Authority consulted the Member States and requested them to report potential fall-back Good Agricultural Practices (GAPs) for apples and pears, authorised in Member States or third countries and already evaluated at Member State level, which would not lead to an unacceptable risk for consumers. Fall-back GAPs for apples and pears were identified that do not lead to exceedances of the ARfD of dithianon. It is therefore appropriate to lower the MRLs for dithianon on apples and pears to the values identified by the Authority in Part A of Annex III to Regulation (EC) No 396/2005.












(4)


The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs for dithianon. Those laboratories proposed product-specific LODs that are analytically achievable.












(5)


Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs for dithianon and their comments have been taken into account.












(6)


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












(7)


A reasonable period should be allowed to elapse before the new MRLs for dithianon become applicable, in order to permit Member States, third countries and food business operators to adapt themselves to the requirements which result from the modification of the MRLs.












(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
Part A of Annex III 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.
It shall apply from 5 December 2024.




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.

(2)  European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for dithianon according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2023;21(1):7731.

(3)  European Food Safety Authority; Conclusion on the updated peer review of the pesticide risk assessment for the active substance dithianon in light of confirmatory data submitted. EFSA Journal 2020;18(9):6189.




ANNEX
In Part A of Annex III to Regulation (EC) No 396/2005, the column for dithianon 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)




Dithianon





(1)


(2)


(3)




0100000 



FRUITS, FRESH or FROZEN; TREE NUTS



 




0110000 



Citrus fruits



 




0110010 


Grapefruits


1  ((+))





0110020 


Oranges


1  ((+))





0110030 


Lemons


1  ((+))





0110040 


Limes


1  ((+))





0110050 


Mandarins


3  ((+))





0110990 


Others (2)


1  ((+))





0120000 



Tree nuts



 




0120010 


Almonds


0,05  ((+))





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


0,01  (*1)





0120110 


Walnuts


0,05  ((+))





0120990 


Others (2)


0,01  (*1)





0130000 



Pome fruits



 




0130010 


Apples



1,5 
 ((+))





0130020 


Pears



1,5 
 ((+))





0130030 


Quinces


3  ((+))





0130040 


Medlars


3  ((+))





0130050 


Loquats/Japanese medlars


3  ((+))





0130990 


Others (2)


3  ((+))





0140000 



Stone fruits



 




0140010 


Apricots


0,5  ((+))





0140020 


Cherries (sweet)


2  ((+))





0140030 


Peaches


0,5  ((+))





0140040 


Plums


0,5  ((+))





0140990 


Others (2)


2  ((+))





0150000 



Berries and small fruits



 




0151000 








(a)



grapes







3  ((+))





0151010 


Table grapes



 ((+))





0151020 


Wine grapes



 ((+))





0152000 








(b)



strawberries







0,01  (*1)





0153000 








(c)



cane fruits







 




0153010 


Blackberries


0,5  ((+))





0153020 


Dewberries


0,5  ((+))





0153030 


Raspberries (red and yellow)


3  ((+))





0153990 


Others (2)


0,01  (*1)





0154000 








(d)



other small fruits and berries







 




0154010 


Blueberries


0,01  (*1)





0154020 


Cranberries


3  ((+))





0154030 


Currants (black, red and white)


3  ((+))





0154040 


Gooseberries (green, red and yellow)


3  ((+))





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







0,1  ((+))





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


0,01  (*1)





0213020 


Carrots


0,05  ((+))





0213030 


Celeriacs/turnip rooted celeries


0,01  (*1)





0213040 


Horseradishes


0,01  (*1)





0213050 


Jerusalem artichokes


0,01  (*1)





0213060 


Parsnips


0,01  (*1)





0213070 


Parsley roots/Hamburg roots parsley


0,01  (*1)





0213080 


Radishes


0,01  (*1)





0213090 


Salsifies


0,01  (*1)





0213100 


Swedes/rutabagas


0,01  (*1)





0213110 


Turnips


0,01  (*1)





0213990 


Others (2)


0,01  (*1)





0220000 



Bulb vegetables



0,01  (*1)





0220010 


Garlic


 




0220020 


Onions


 




0220030 


Shallots


 




0220040 


Spring onions/green onions and Welsh onions


 




0220990 


Others (2)


 




0230000 



Fruiting vegetables



 




0231000 








(a)



Solanaceae and Malvaceae







 




0231010 


Tomatoes


0,6  ((+))





0231020 


Sweet peppers/bell peppers


0,6  ((+))





0231030 


Aubergines/eggplants


0,01  (*1)





0231040 


Okra/lady's fingers


0,01  (*1)





0231990 


Others (2)


0,01  (*1)





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







0,01  (*1)





0239000 








(e)



other fruiting vegetables







0,01  (*1)





0240000 



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



0,01  (*1)





0241000 








(a)



flowering brassica







 




0241010 


Broccoli


 




0241020 


Cauliflowers


 




0241990 


Others (2)


 




0242000 








(b)



head brassica







 




0242010 


Brussels sprouts


 




0242020 


Head cabbages


 




0242990 


Others (2)


 




0243000 








(c)



leafy brassica







 




0243010 


Chinese cabbages/pe-tsai


 




0243020 


Kales


 




0243990 


Others (2)


 




0244000 








(d)



kohlrabies







 




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







 




0252010 


Spinaches


0,6  ((+))





0252020 


Purslanes


0,01  (*1)





0252030 


Chards/beet leaves


0,01  (*1)





0252990 


Others (2)


0,01  (*1)





0253000 








(c)



grape leaves and similar species







0,1  ((+))





0254000 








(d)



watercresses







0,01  (*1)





0255000 








(e)



witloofs/Belgian endives







0,01  (*1)





0256000 








(f)



herbs and edible flowers







0,01  (*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



 




0260010 


Beans (with pods)


0,01  (*1)





0260020 


Beans (without pods)


0,01  (*1)





0260030 


Peas (with pods)


0,01  (*1)





0260040 


Peas (without pods)


0,6  ((+))





0260050 


Lentils


0,01  (*1)





0260990 


Others (2)


0,01  (*1)





0270000 



Stem vegetables



0,01  (*1)





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  (*1)





0280010 


Cultivated fungi


 




0280020 


Wild fungi


 




0280990 


Mosses and lichens


 




0290000 



Algae and prokaryotes organisms



0,01  (*1)





0300000 



PULSES



0,01  (*1)





0300010 


Beans


 




0300020 


Lentils


 




0300030 


Peas


 




0300040 


Lupins/lupini beans


 




0300990 


Others (2)


 




0400000 



OILSEEDS AND OIL FRUITS



 




0401000 



Oilseeds



0,02  ((+))





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



0,01  (*1)





0402010 


Olives for oil production


 




0402020 


Oil palms kernels


 




0402030 


Oil palms fruits


 




0402040 


Kapok


 




0402990 


Others (2)


 




0500000 



CEREALS



 




0500010 


Barley


0,01  (*1)





0500020 


Buckwheat and other pseudocereals


0,01  (*1)





0500030 


Maize/corn


0,01  (*1)





0500040 


Common millet/proso millet


0,01  (*1)





0500050 


Oat


0,01  (*1)





0500060 


Rice


0,05  ((+))





0500070 


Rye


0,01  (*1)





0500080 


Sorghum


0,01  (*1)





0500090 


Wheat


0,05  ((+))





0500990 


Others (2)


0,01  (*1)





0600000 



TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS



0,01  (*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



100  ((+))





0800000 



SPICES



 




0810000 



Seed spices



0,01  (*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



0,01  (*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



0,01  (*1)





0830010 


Cinnamon


 




0830990 


Others (2)


 




0840000 



Root and rhizome spices



 




0840010 


Liquorice


0,01  (*1)





0840020 


Ginger (10)


 




0840030 


Turmeric/curcuma


0,01  (*1)





0840040 


Horseradish (11)


 




0840990 


Others (2)


0,01  (*1)





0850000 



Bud spices



0,01  (*1)





0850010 


Cloves


 




0850020 


Capers


 




0850990 


Others (2)


 




0860000 



Flower pistil spices



0,01  (*1)





0860010 


Saffron


 




0860990 


Others (2)


 




0870000 



Aril spices



0,01  (*1)





0870010 


Mace


 




0870990 


Others (2)


 




0900000 



SUGAR PLANTS



0,01  (*1)





0900010 


Sugar beet roots


 




0900020 


Sugar canes


 




0900030 


Chicory roots


 




0900990 


Others (2)


 




1000000 



PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS



0,01  (*1)





1010000 



Commodities from



 




1011000 








(a)



swine







 




1011010 


Muscle


 




1011020 


Fat


 




1011030 


Liver


 




1011040 


Kidney


 




1011050 


Edible offals (other than liver and kidney)


 




1011990 


Others (2)


 




1012000 








(b)



bovine







 




1012010 


Muscle


 




1012020 


Fat


 




1012030 


Liver


 




1012040 


Kidney


 




1012050 


Edible offals (other than liver and kidney)


 




1012990 


Others (2)


 




1013000 








(c)



sheep







 




1013010 


Muscle


 




1013020 


Fat


 




1013030 


Liver


 




1013040 


Kidney


 




1013050 


Edible offals (other than liver and kidney)


 




1013990 


Others (2)


 




1014000 








d)



goat







 




1014010 


Muscle


 




1014020 


Fat


 




1014030 


Liver


 




1014040 


Kidney


 




1014050 


Edible offals (other than liver and kidney)


 




1014990 


Others (2)


 




1015000 








(e)



equine







 




1015010 


Muscle


 




1015020 


Fat


 




1015030 


Liver


 




1015040 


Kidney


 




1015050 


Edible offals (other than liver and kidney)


 




1015990 


Others (2)


 




1016000 








(f)



poultry







 




1016010 


Muscle


 




1016020 


Fat


 




1016030 


Liver


 




1016040 


Kidney


 




1016050 


Edible offals (other than liver and kidney)


 




1016990 


Others (2)


 




1017000 








(g)



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



 




1020010 


Cattle


 




1020020 


Sheep


 




1020030 


Goat


 




1020040 


Horse


 




1020990 


Others (2)


 




1030000 



Birds eggs



 




1030010 


Chicken


 




1030020 


Duck


 




1030030 


Geese


 




1030040 


Quail


 




1030990 


Others (2)


 




1040000 



Honey and other apiculture products (7)



 




1050000 



Amphibians and Reptiles



 




1060000 



Terrestrial invertebrate animals



 




1070000 



Wild terrestrial vertebrate animals



 




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)



 





Dithianon

The European Food Safety Authority identified some information on the metabolite 1,4-naphthoquinone 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 during the procedure for renewal of approval of the active substance dithianon, or, if that information is not submitted, the lack of it.

0110010  Grapefruits


0110020  Oranges


0110030  Lemons


0110040  Limes


0110050  Mandarins


0110990  Others (2)


0120010  Almonds


0120110  Walnuts


0130010  Apples


0130020  Pears


0130030  Quinces


0130040  Medlars


0130050  Loquats/Japanese medlars


0130990  Others (2)


0140010  Apricots


0140020  Cherries (sweet)


0140030  Peaches


0140040  Plums


0140990  Others (2)


0151000  (a) grapes


0151010  Table grapes


0151020  Wine grapes


0153010  Blackberries


0153020  Dewberries


0153030  Raspberries (red and yellow)


0154020  Cranberries


0154030  Currants (black, red and white)


0154040  Gooseberries (green, red and yellow)


0211000  (a) potatoes


0213020  Carrots


0231010  Tomatoes


0231020  Sweet peppers/bell peppers


0252010  Spinaches


0253000  (c) grape leaves and similar species


0260040  Peas (without pods)


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)


0500060  Rice


0500090  Wheat


0700000  HOPS’







(*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

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



ELI: http://data.europa.eu/eli/reg/2024/1314/oj
ISSN 1977-0677 (electronic edition)