Commission Regulation (EU) 2023/127 of 18 January 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acequinocyl in or on certain products (Text with EEA relevance)
Date: 2023-01-18
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: crop production, food inspection, food safety, fruit, fruit vegetable, pesticide, pesticide residue




L_2023017EN.01000801.xml










19.1.2023   


EN


Official Journal of the European Union


L 17/8








            COMMISSION REGULATION (EU) 2023/127
of 18 January 2023
         
amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acequinocyl 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 acequinocyl, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005.












(2)


In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance acequinocyl on sweet peppers/bell peppers, an application pursuant to Article 6(1) of Regulation (EC) No 396/2005, requesting a modification of the existing MRL, was submitted.












(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 MRL (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 modification to the MRL requested by the applicant was 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. Neither the lifetime exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded.












(6)


An application pursuant to Article 6(1) of Regulation (EC) No 396/2005, requesting a modification of the existing MRL for acequinocyl in kaki/Japanese persimmons, was submitted.












(7)


As regards this application, a Member State made a request to use the fast-track procedure, foreseen in the Technical Guidelines on the MRL setting procedure (3), to set an MRL based on residue trials on apples.












(8)


The Authority has recently assessed residue trials on apples in the framework of the review of the existing MRLs for acequinocyl, and gave a reasoned opinion on the proposed MRL (4). This opinion from the Authority relies on the current scientific and technical knowledge on the subject. As it is appropriate to extrapolate from the residue trials on apples to kaki/Japanese persimmons, as confirmed by the existing Union guidelines on extrapolation of MRLs (5), it is unnecessary to request the Authority to provide a reasoned opinion on kaki/Japanese persimmons.












(9)


It is therefore appropriate to set the MRL for kaki/Japanese persimmons at 0,05 mg/kg on the basis of the residue trials performed on apples.












(10)


Based on the reasoned opinions 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.












(11)


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












(12)


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 23 February 2023 as regards all proposed MRLs.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 January 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  Reasoned Opinion on the modification of the existing maximum residue level for acequinocyl in sweet peppers/bell peppers. EFSA Journal 2022;20(3):7175. EFSA scientific reports available online: http://www.efsa.europa.eu

(3)  Technical guidelines MRL setting procedure in accordance with Articles 6 to 11 of Regulation (EC) No 396/2005 and Article 8 of Regulation (EC) No 1107/2009 (SANTE/2015/10595 Rev. 6.1).

(4)  Reasoned Opinion on the review of the existing maximum residue levels for acequinocyl according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020;18(1):5983. EFSA scientific reports available online: http://www.efsa.europa.eu

(5)  Technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and extrapolation of residue data on products from plant and animal origin (SANTE/2019/12752 – 23 November 2020).




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




Acequinocyl (F)





(1)



(2)



(3)




0100000 



FRUITS, FRESH or FROZEN; TREE NUTS



 




0110000 



Citrus fruits



0,6 (+)




0110010 


Grapefruits


(+)




0110020 


Oranges


(+)




0110030 


Lemons


(+)




0110040 


Limes


(+)




0110050 


Mandarins


(+)




0110990 


Others (2)


 




0120000 



Tree nuts



0,01  (*)





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



0,4 (+)




0130010 


Apples


(+)




0130020 


Pears


(+)




0130030 


Quinces


(+)




0130040 


Medlars


(+)




0130050 


Loquats/Japanese medlars


(+)




0130990 


Others (2)


 




0140000 



Stone fruits



 




0140010 


Apricots


0,01  (*)





0140020 


Cherries (sweet)


0,1 




0140030 


Peaches


0,1 




0140040 


Plums


0,03 




0140990 


Others (2)


0,01  (*)





0150000 



Berries and small fruits



 




0151000 








(a)



grapes







0,8 




0151010 


Table grapes


(+)




0151020 


Wine grapes


(+)




0152000 








(b)



strawberries







0,01  (*)





0153000 








(c)



cane fruits







0,01  (*)





0153010 


Blackberries


 




0153020 


Dewberries


 




0153030 


Raspberries (red and yellow)


 




0153990 


Others (2)


 




0154000 








(d)



other small fruits and berries







0,01  (*)





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 








(a)



edible peel







 




0161010 


Dates


0,01  (*)





0161020 


Figs


0,01  (*)





0161030 


Table olives


0,01  (*)





0161040 


Kumquats


0,01  (*)





0161050 


Carambolas


0,01  (*)





0161060 


Kaki/Japanese persimmons



0,05 





0161070 


Jambuls/jambolans


0,01  (*)





0161990 


Others (2)


0,01  (*)





0162000 








(b)



inedible peel, small







0,01  (*)





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







0,01  (*)





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  (*)





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  (*)





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


0,3 (+)




0231020 


Sweet peppers/bell peppers



0,3 





0231030 


Aubergines/eggplants


0,3 (+)




0231040 


Okra/lady's fingers


0,01  (*)





0231990 


Others (2)


0,01  (*)





0232000 








(b)



cucurbits with edible peel







 




0232010 


Cucumbers


0,08 




0232020 


Gherkins


0,04 




0232030 


Courgettes


0,08 




0232990 


Others (2)


0,01  (*)





0233000 








(c)



cucurbits with inedible peel







0,01  (*)





0233010 


Melons


 




0233020 


Pumpkins


 




0233030 


Watermelons


 




0233990 


Others (2)


 




0234000 








(d)



sweet corn







0,01  (*)





0239000 








(e)



other fruiting vegetables







0,01  (*)





0240000 



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



0,01  (*)





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  (*)





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  (*)





0252010 


Spinaches


 




0252020 


Purslanes


 




0252030 


Chards/beet leaves


 




0252990 


Others (2)


 




0253000 








(c)



grape leaves and similar species







0,01  (*)





0254000 








(d)



watercresses







0,01  (*)





0255000 








(e)



witloofs/Belgian endives







0,01  (*)





0256000 








(f)



herbs and edible flowers







0,02  (*)





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  (*)





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  (*)





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  (*)





0280010 


Cultivated fungi


 




0280020 


Wild fungi


 




0280990 


Mosses and lichens


 




0290000 



Algae and prokaryotes organisms



0,01  (*)





0300000 



PULSES



0,01  (*)





0300010 


Beans


 




0300020 


Lentils


 




0300030 


Peas


 




0300040 


Lupins/lupini beans


 




0300990 


Others (2)


 




0400000 



OILSEEDS AND OIL FRUITS



0,01  (*)





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  (*)





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



0,05  (*)





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



20 (+)




0800000 



SPICES



 




0810000 



Seed spices



0,05  (*)





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  (*)





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  (*)





0830010 


Cinnamon


 




0830990 


Others (2)


 




0840000 



Root and rhizome spices



 




0840010 


Liquorice


0,05  (*)





0840020 


Ginger (10)


 




0840030 


Turmeric/curcuma


0,05  (*)





0840040 


Horseradish (11)


 




0840990 


Others (2)


0,05  (*)





0850000 



Bud spices



0,05  (*)





0850010 


Cloves


 




0850020 


Capers


 




0850990 


Others (2)


 




0860000 



Flower pistil spices



0,05  (*)





0860010 


Saffron


 




0860990 


Others (2)


 




0870000 



Aril spices



0,05  (*)





0870010 


Mace


 




0870990 


Others (2)


 




0900000 



SUGAR PLANTS



0,01  (*)





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  (*)





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  (*)





1020010 


Cattle


(+)




1020020 


Sheep


 




1020030 


Goat


 




1020040 


Horse


(+)




1020990 


Others (2)


 




1030000 



Birds eggs



0,01  (*)





1030010 


Chicken


 




1030020 


Duck


 




1030030 


Geese


 




1030040 


Quail


 




1030990 


Others (2)


 




1040000 



Honey and other apiculture products (7)



0,05  (*)





1050000 



Amphibians and Reptiles



0,01  (*)





1060000 



Terrestrial invertebrate animals



0,01  (*)





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)



 




Acequinocyl (F)

(F) Fat soluble

The European Food Safety Authority identified some information on analytical methods and storage stability 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 2 August 2024, or, if that information is not submitted by that date, the lack of it.

0120060 Hazelnuts/cobnuts

The European Food Safety Authority identified some information on analytical methods 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 2 August 2024, or, if that information is not submitted by that date, the lack of it.

1011010 Muscle


1011020 Fat


1011030 Liver


1011040 Kidney


1012010 Muscle


1012020 Fat


1012030 Liver


1012040 Kidney


1015010 Muscle


1015020 Fat


1015030 Liver


1015040 Kidney


1020010 Cattle


1020040 Horse

The European Food Safety Authority identified some information on hydrolysis studies simulating pasteurisation, boiling and sterilisation 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 2 August 2024, or, if that information is not submitted by that date, the lack of it.

0110000 Citrus fruits


0110010 Grapefruits


0110020 Oranges


0110030 Lemons


0110040 Limes


0110050 Mandarins


0130000 Pome fruits


0130010 Apples


0130020 Pears


0130030 Quinces


0130040 Medlars


0130050 Loquats/Japanese medlars


0151010 Table grapes


0151020 Wine grapes


0231010 Tomatoes


0231030 Aubergines/eggplants

The European Food Safety Authority identified some information on storage stability and hydrolysis studies simulating pasteurisation, boiling and sterilisation 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 2 August 2024, or, if that information is not submitted by that date, the lack of it.

0700000 HOPS”







(*)  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