Commission Regulation (EU) 2024/376 of 24 January 2024 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for indoxacarb in or on certain products
Date: 2024-01-24
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal product, consumer protection, crop production, food inspection, food safety, foodstuff, fruit, pesticide, pesticide residue, vegetable




L_202400376EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2024/376


25.1.2024







            COMMISSION REGULATION (EU) 2024/376
of 24 January 2024
         
amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for indoxacarb 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), and Article 18(1), point (b) thereof,

Whereas:







(1)


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












(2)


In the context of the procedure for the renewal of the approval of indoxacarb in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (2), the European Food Safety Authority (‘the Authority’) published a conclusion on the peer review of the risk assessment of that active substance (3), establishing a lower acceptable daily intake (‘ADI’) and a lower acute reference dose (‘ARfD’).












(3)


The approval of the active substance indoxacarb expired on 19 December 2021 and was non-renewed (4). All authorisations for plant protection products containing that active substance have been revoked.












(4)


In accordance with Article 43 of Regulation (EC) No 396/2005, the Commission requested the Authority to provide a reasoned opinion on the risks that the current MRLs for indoxacarb based on import tolerances and Codex maximum residue limits (‘CXLs’) may pose to consumers in light of the lower ADI and ARfD. In its reasoned opinion (5), the Authority identified unacceptable risks concerning the current MRLs based on CXLs for apples, pears, apricots, cherries, peaches, plums, table and wine grapes, tomatoes, peppers, aubergines, cucumbers, gherkins, courgettes, melons, pumpkins, watermelons, broccoli, cauliflower and lettuce. Therefore, MRLs for these products should be lowered to the relevant limit of determination (LOD) in Annex II to Regulation (EC) No 396/2005.












(5)


Furthermore, in its conclusion (6) on the peer review published in the context of the procedure for the renewal of the approval of indoxacarb, the Authority explained that, due to insufficient data on the toxicity and genotoxicity of various metabolites and degradation products formed during processing at high temperature, risks for human health could not be excluded. Therefore, further decision by risk managers was needed. For products that are usually processed at high temperature, the MRLs based on CXLs cannot be confirmed as being safe for consumers. This concerns the MRLs for basil, potatoes, sweet corn, beans (dry), peas (dry), peanuts, soya beans, cotton seeds, as well as for fat, liver, kidney and edible offal of swine, bovine, sheep, goat and equine, for poultry tissues, milks and eggs. Therefore, MRLs for these products should be lowered to the relevant LOD in Annex II to Regulation (EC) No 396/2005 in accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1), point (a), thereof. For products that are usually not processed at high temperature, and thus for which those metabolites and degradation products would not be formed, existing MRLs based on CXLs can be maintained. This concerns the MRLs for cranberries and teas. Therefore, the MRLs for cranberries and teas should be maintained in Annex II to Regulation (EC) No 396/2005. Additionally, as the MRLs on apples, broccoli, cauliflowers, rucola, baby leaf crops, poultry tissues and eggs are set at the product specific LODs, there is no longer a need for confirmatory data. Therefore, all footnotes containing requests for confirmatory data should be deleted.












(6)


As regards products for which no import tolerances or CXLs exist, MRLs should be set at the product specific LOD or the default MRL should apply, as provided for in Article 18(1), point (b), of Regulation (EC) No 396/2005.












(7)


The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs. For all the active substances covered by this Regulation, those laboratories proposed product specific LODs that are analytically achievable.












(8)


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












(9)


Annexes II and V to Regulation (EC) No 396/2005 should therefore be amended accordingly.












(10)


A reasonable period should be allowed to elapse before the new MRLs 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.












(11)


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.
It shall apply from 14 August 2024.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 January 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309 24.11.2009, p. 1).

(3)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance indoxacarb. EFSA Journal 2018;16(1):5140.

(4)  Commission Implementing Regulation (EU) 2021/2081 of 26 November 2021 concerning the non-renewal of approval of the active substance indoxacarb, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (OJ L 426, 29.11.2021, p. 28).

(5)  European Food Safety Authority; Targeted review of maximum residues levels (MRLs) for indoxacarb. EFSA Journal 2022;20(8):7527.

(6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance indoxacarb. EFSA Journal 2018;16(1):5140.




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




Indoxacarb (sum of indoxacarb and its R enantiomer)(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




0,01
 (*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


1




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




0,01
 (*1)





0211000 








(a)



potatoes







 




0212000 








(b)



tropical root and tuber vegetables







 




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


 




0213020 


Carrots


 




0213030 


Celeriacs/turnip rooted celeries


 




0213040 


Horseradishes


 




0213050 


Jerusalem artichokes


 




0213060 


Parsnips


 




0213070 


Parsley roots/Hamburg roots parsley


 




0213080 


Radishes


 




0213090 


Salsifies


 




0213100 


Swedes/rutabagas


 




0213110 


Turnips


 




0213990 


Others (2)


 




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




0,01
 (*1)





0231000 








(a)



Solanaceae and Malvaceae







 




0231010 


Tomatoes


 




0231020 


Sweet peppers/bell peppers


 




0231030 


Aubergines/eggplants


 




0231040 


Okra/lady's fingers


 




0231990 


Others (2)


 




0232000 








(b)



cucurbits with edible peel







 




0232010 


Cucumbers


 




0232020 


Gherkins


 




0232030 


Courgettes


 




0232990 








 


Others (2)






 




0233000 








(c)



cucurbits with inedible peel







 




0233010 


Melons


 




0233020 


Pumpkins


 




0233030 


Watermelons


 




0233990 


Others (2)


 




0234000 








(d)



sweet corn







 




0239000 








(e)



other fruiting vegetables







 




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








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




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




0,01
 (*1)





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)


 




0402000 



Oil fruits



 




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



5




0620000 



Coffee beans



0,05 (*1)





0630000 



Herbal infusions from



0,05 (*1)





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



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


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




0,01
 (*1)





0900010 


Sugar beet roots


 




0900020 


Sugar canes


 




0900030 


Chicory roots


 




0900990 


Others (2)


 




1000000 



PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS



 




1010000 



Commodities from




0,01
 (*1)





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




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 (*1)





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)



 





Indoxacarb (sum of indoxacarb and its R enantiomer) (F)







(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



ELI: http://data.europa.eu/eli/reg/2024/376/oj
ISSN 1977-0677 (electronic edition)