Commission Regulation (EU) 2023/1753 of 11 September 2023 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for pyriproxyfen in or on certain products (Text with EEA relevance)
Date: 2023-09-11
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: consumer protection, crop production, food inspection, food safety, foodstuff, fruit, pesticide, pesticide residue, vegetable




L_2023224EN.01000101.xml










12.9.2023   


EN


Official Journal of the European Union


L 224/1








            COMMISSION REGULATION (EU) 2023/1753
of 11 September 2023
         
amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for pyriproxyfen 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 49(2) thereof,

Whereas:







(1)


Maximum residue levels (‘MRLs’) for pyriproxyfen were set in Part A of Annex III to Regulation (EC) No 396/2005.












(2)


The European Food Safety Authority (‘the Authority’) submitted a reasoned opinion on the review of the existing MRLs for pyriproxyfen (2) in accordance with Article 12(1) of Regulation (EC) No 396/2005. The Authority recommended to lower the existing MRLs for pyriproxyfen on swine/bovine/goat/horse muscle, fat, liver and kidney, as well as in cattle/horse milk to the limit of determination (‘LOD’) in line with the principle of setting MRLs at levels as low as reasonably achievable and based on sufficient supporting data for the current good agricultural practices (‘GAPs’). As there is no risk for consumers, it is appropriate to set the MRL for pyriproxyfen on these products in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority.












(3)


The Authority further concluded that the MRLs for pyriproxyfen on almonds, chestnuts, hazelnuts, pecans, pistachios, walnuts, pine nuts kernels, pome fruits, grapes, table olives, kaki/Japanese persimmons, pineapples, tomatoes, sweet peppers, aubergines, cucurbits with edible peel, and watermelons should be lowered in line with the principle of setting MRLs at levels as low as reasonably achievable and based on the current GAPs and Codex maximum residue limits (‘CXLs’), which are confirmed as being safe for consumers (3). It also concluded that the MRLs for pyriproxyfen on apricots, peaches, plums, strawberries, mangoes, papayas, melons, cotton seeds and tea should be maintained based on the current GAPs and CXLs, which are confirmed as being safe for consumers (4). In addition, the Authority concluded that the MRLs for pyriproxyfen on citrus fruits, cherries and kumquats should be raised based on the current GAPs and CXLs, which are confirmed as being safe for consumers. As the Authority confirmed in an earlier reasoned opinion (5) that the MRL for pyriproxyfen on banana is safe for consumers, that MRL can be maintained. However, as some information was not available, further consideration by risk managers was required. Therefore, while the MRLs for almonds, chestnuts, hazelnuts, pecans, pistachios, walnuts, pine nuts kernels, pome fruits, grapes, table olives, kaki/Japanese persimmons, pineapples, tomatoes, sweet peppers, aubergines, cucurbits with edible peel, watermelons, apricots, peaches, plums, strawberries, mangoes, papayas, melons, cotton seeds, tea, citrus fruits, cherries, kumquats and bananas are considered safe, they will be reviewed. The review will take into account the information available within two years from the publication of this Regulation. As there is no risk for consumers, it is appropriate to set the MRLs for pyriproxyfen on those products in Annex II to Regulation (EC) No 396/2005 at the levels identified by the Authority.












(4)


As the Authority identified that no residue trials were available to derive MRL values for pyriproxyfen on macadamias, avocados, granate apples/pomegranates, cherimoyas, potatoes, sweet potatoes and yams, other root and tuber vegetables except sugar beets, bulb vegetables, okra/lady’s fingers, pumpkins, brassica vegetables (excluding brassica roots and brassica baby leaf crops), lettuces and salad plants, spinaches and similar leaves, watercresses, witloofs/Belgian endives, herbs and edible flowers, legume vegetables, stem vegetables, beans (dry), and soyabeans, further consideration by risk managers was required. In the absence of such trials, which are necessary to derive an MRL value, the Commission considers that it is appropriate to set the MRLs for those products at the product specific LODs set out in Annex II to Regulation (EC) No 396/2005.












(5)


The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs. For pyriproxyfen, those laboratories proposed product specific LODs that are analytically achievable.












(6)


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.












(7)


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












(8)


To allow for the normal marketing, processing and consumption of products, this Regulation should not apply to products which have been produced in the Union or imported into the Union before the new MRLs become applicable and for which a high level of consumer protection is maintained. This is the case for all products.












(9)


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.












(10)


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
Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.


Article 2
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were produced in the Union or imported into the Union before 2 April 2024.


Article 3
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 2 April 2024.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 11 September 2023.


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 pyriproxyfen according to Article 12 of Regulation (EC) No 396/2005; EFSA Journal 2022;20(11):7617.

(3)  European Food Safety Authority; Scientific support for preparing an EU position in the 51st Session of the Codex Committee on Pesticide Residues (CCPR); EFSA Journal 2019;17(7):5797.

(4)  European Food Safety Authority; Scientific support for preparing an EU position for the 52nd Session of the Codex Committee on Pesticide Residues (CCPR); EFSA Journal 2021;19(8):6766.

(5)  European Food Safety Authority; Reasoned Opinion on the modification of the existing maximum residue level for pyriproxyfen in bananas; EFSA Journal 2016;14(2):4387.




ANNEX
Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:






(1)


in Annex II, the following column for pyriproxyfen is added:


‘ANNEX II
Pesticide residues and maximum residue levels (mg/kg)







Code number


Groups and examples of individual products to which the MRLs apply (1)



Pyriproxyfen (F)




0100000



FRUITS, FRESH or FROZEN; TREE NUTS



 




0110000



Citrus fruits




0,7





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



 




0130010


Apples



0,05(+)





0130020


Pears



0,01
 (*1)
(+)





0130030


Quinces



0,01
 (*1)
(+)





0130040


Medlars



0,01
 (*1)
(+)





0130050


Loquats/Japanese medlars



0,01
 (*1)
(+)





0130990


Others (2)



0,01
 (*1)





0140000



Stone fruits



 




0140010


Apricots


0,4(+)





0140020


Cherries (sweet)



1,5(+)





0140030


Peaches


0,5(+)





0140040


Plums


0,3(+)





0140990


Others (2)



0,01
 (*1)





0150000



Berries and small fruits



 




0151000








(a)



grapes








0,01
 (*1)





0151010


Table grapes


(+)




0151020


Wine grapes


(+)




0152000








(b)



strawberries







0,05(+)





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








0,01
 (*1)





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
 (*1)





0161020


Figs



0,01
 (*1)





0161030


Table olives



0,01
 (*1)
(+)





0161040


Kumquats



0,5(+)





0161050


Carambolas



0,01
 (*1)





0161060


Kaki/Japanese persimmons



0,01
 (*1)
(+)





0161070


Jambuls/jambolans



0,01
 (*1)





0161990


Others (2)



0,01
 (*1)





0162000








(b)



inedible peel, small








0,01
 (*1)





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



0,01
 (*1)





0163020


Bananas


0,7(+)





0163030


Mangoes



0,02
 (*1)
(+)





0163040


Papayas


0,3(+)





0163050


Granate apples/pomegranates



0,01
 (*1)





0163060


Cherimoyas



0,01
 (*1)





0163070


Guavas



0,01
 (*1)





0163080


Pineapples



0,01
 (*1)
(+)





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




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



 




0231000








(a)



Solanaceae and Malvaceae







 




0231010


Tomatoes



0,7(+)





0231020


Sweet peppers/bell peppers



0,6(+)





0231030


Aubergines/eggplants



0,6(+)





0231040


Okra/lady's fingers



0,01
 (*1)





0231990


Others (2)



0,01
 (*1)





0232000








(b)



cucurbits with edible peel








0,04





0232010


Cucumbers


(+)




0232020


Gherkins


(+)




0232030


Courgettes


(+)




0232990


Others (2)


 




0233000








(c)



cucurbits with inedible peel







 




0233010


Melons


0,07(+)





0233020


Pumpkins



0,01
 (*1)





0233030


Watermelons



0,02(+)





0233990


Others (2)



0,01
 (*1)





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








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



 




0401000



Oilseeds



 




0401010


Linseeds



0,01
 (*1)





0401020


Peanuts/groundnuts



0,01
 (*1)





0401030


Poppy seeds



0,01
 (*1)





0401040


Sesame seeds



0,01
 (*1)





0401050


Sunflower seeds



0,01
 (*1)





0401060


Rapeseeds/canola seeds



0,01
 (*1)





0401070


Soyabeans



0,01
 (*1)





0401080


Mustard seeds



0,01
 (*1)





0401090


Cotton seeds


0,05(+)





0401100


Pumpkin seeds



0,01
 (*1)





0401110


Safflower seeds



0,01
 (*1)





0401120


Borage seeds



0,01
 (*1)





0401130


Gold of pleasure seeds



0,01
 (*1)





0401140


Hemp seeds



0,01
 (*1)





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



15(+)





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)



 






Pyriproxyfen (F)


(F) Fat soluble
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 12 September 2025, or, if that information is not submitted by that date, the lack of it.

0110010 Grapefruits


0110020 Oranges


0110030 Lemons


0110040 Limes


0110050 Mandarins


0120010 Almonds


0120020 Brazil nuts


0120030 Cashew nuts


0120040 Chestnuts


0120050 Coconuts


0120060 Hazelnuts/cobnuts


0120080 Pecans


0120090 Pine nut kernels


0120100 Pistachios


0120110 Walnuts


0130020 Pears


0130030 Quinces


0130040 Medlars


0130050 Loquats/Japanese medlars


0140010 Apricots


0140030 Peaches


0151010 Table grapes


0151020 Wine grapes


0152000 (b) strawberries


0161030 Table olives


0161040 Kumquats


0161060 Kaki/Japanese persimmons


0163030 Mangoes


0163040 Papayas


0163080 Pineapples


0231010 Tomatoes


0231020 Sweet peppers/bell peppers


0231030 Aubergines/eggplants


0232010 Cucumbers


0232020 Gherkins


0232030 Courgettes


0233010 Melons


0401090 Cotton seeds


0402010 Olives for oil production


0610000 Teas

The European Food Safety Authority identified some information on residue trials and 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 12 September 2025, or, if that information is not submitted by that date, the lack of it.

0130010 Apples


0140020 Cherries (sweet)


0140040 Plums


0163020 Bananas


0233030 Watermelons







                        ’
                     









(2)


in Part A of Annex III, the column for pyriproxyfen is deleted.






(*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