Commission Regulation (EU) 2020/192 of 12 February 2020 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 prochloraz in or on certain products (Text with EEA relevance)
Date: 2020-02-12
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal product, consumer protection, crop production, food inspection, food safety, foodstuff, pesticide, pesticide residue








L_2020040EN.01000401.xml










13.2.2020   


EN


Official Journal of the European Union


L 40/4








            COMMISSION REGULATION (EU) 2020/192
of 12 February 2020
         
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 prochloraz 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)(a) and Article 49(2) thereof,

Whereas:







(1)


For prochloraz, maximum residue limits (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005.












(2)


For that active substance, the European Food Safety Authority (‘the Authority’) submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (2). The Authority proposed to change the residue definition to the sum of prochloraz, BTS 44595 (M201-04) and BTS 44596 (M201-03), expressed as prochloraz. The Authority identified a risk for consumers concerning the MRLs for citrus fruits, kiwi, bananas, mangoes, pineapples and bovine liver. It is therefore appropriate to lower these MRLs to the Limit of Determination (LOD) or the level identified by the Authority. The Authority recommended lowering the MRLs for garlic, shallots, lettuces and salad plants, purslanes, herbs and edible flowers, peas, linseeds, sunflower seeds, rapeseeds/canola seeds, barley, oat, rice, rye, wheat, coffee beans, herbal infusions from flowers, leaves and herbs and roots, spices, sugar beet roots, bovine (fat, kidney), equine fat and poultry liver. As there is no risk for consumers, the MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. The Authority concluded that concerning the Codex maximum residue levels (CXLs) for kumquats, litchis/lychees, passionfruits/maracujas, prickly pears/cactus fruits, star apples/cainitos, American persimmons/Virginia kaki, avocados, papayas, Granate apples/pomegranates, cherimoyas, guavas, breadfruits, durians and soursops/guanabanas, some information was not available in relation to the new residue definition and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the level of the existing CXLs. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.












(3)


As regards products on which the use of the plant protection products concerned is not authorised, and for which no import tolerances or CXLs exist, MRLs should be set at the specific limit of determination or the default MRL should apply, as provided for in Article 18(1)(b) of 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 limits of determination. As regards several substances, those laboratories concluded that for certain commodities technical development requires the setting of specific limits of determination.












(5)


Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.












(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)


In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained.












(9)


A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will 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
As regards the active substance prochloraz in and on all products except citrus fruits, kiwi, bananas, mangoes, pineapples and bovine liver, 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 4 September 2020.


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 4 September 2020.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 February 2020.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  European Food Safety Authority; Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2018; 16(8):5401.




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






(1)


in Annex II the column for prochloraz is replaced by the following:







Code number


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


Prochloraz (sum of prochloraz, BTS 44595 (M201-04) and BTS 44596 (M201-03), expressed as prochloraz) (F)




0100000



FRUITS, FRESH or FROZEN; TREE NUTS



 




0110000



Citrus fruits




0.03*





0110010


Grapefruits


 




0110020


Oranges


 




0110030


Lemons


 




0110040


Limes


 




0110050


Mandarins


 




0110990


Others (2)


 




0120000



Tree nuts




0.03*





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




0.03*





0130010


Apples


 




0130020


Pears


 




0130030


Quinces


 




0130040


Medlars


 




0130050


Loquats/Japanese medlars


 




0130990


Others (2)


 




0140000



Stone fruits




0.03*





0140010


Apricots


 




0140020


Cherries (sweet)


 




0140030


Peaches


 




0140040


Plums


 




0140990


Others (2)


 




0150000



Berries and small fruits




0.03*





0151000









(a)




grapes







 




0151010


Table grapes


 




0151020


Wine grapes


 




0152000









(b)




strawberries







 




0153000









(c)




cane fruits







 




0153010


Blackberries


 




0153020


Dewberries


 




0153030


Raspberries (red and yellow)


 




0153990


Others (2)


 




0154000









(d)




other small fruits and berries







 




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 fruits with



 




0161000









(a)




edible peel







 




0161010


Dates



0.03*





0161020


Figs



0.03*





0161030


Table olives



0.03*





0161040


Kumquats



10 (+)





0161050


Carambolas



0.03*





0161060


Kaki/Japanese persimmons



0.03*





0161070


Jambuls/jambolans



0.03*





0161990


Others (2)



0.03*





0162000









(b)




inedible peel, small







 




0162010


Kiwi fruits (green, red, yellow)



0.03*





0162020


Litchis/lychees



7 (+)





0162030


Passionfruits/maracujas



7 (+)





0162040


Prickly pears/cactus fruits



7 (+)





0162050


Star apples/cainitos



7 (+)





0162060


American persimmons/Virginia kaki



7 (+)





0162990


Others (2)



0.03*





0163000









(c)




inedible peel, large







 




0163010


Avocados



7 (+)





0163020


Bananas



0.03*





0163030


Mangoes



0.03*





0163040


Papayas



7 (+)





0163050


Granate apples/pomegranates



7 (+)





0163060


Cherimoyas



7 (+)





0163070


Guavas



7 (+)





0163080


Pineapples



0.03*





0163090


Breadfruits



7 (+)





0163100


Durians



7 (+)





0163110


Soursops/guanabanas



7 (+)





0163990


Others (2)



0.03*





0200000



VEGETABLES, FRESH or FROZEN



 




0210000



Root and tuber vegetables




0.03*





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




0.03*





0220010


Garlic


 




0220020


Onions


 




0220030


Shallots


 




0220040


Spring onions/green onions and Welsh onions


 




0220990


Others (2)


 




0230000



Fruiting vegetables




0.03*





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)




0.03*





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








0.03*





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








0.03*





0252010


Spinaches


 




0252020


Purslanes


 




0252030


Chards/beet leaves


 




0252990


Others (2)


 




0253000









(c)




grape leaves and similar species








0.03*





0254000









(d)




watercresses








0.03*





0255000









(e)




witloofs/Belgian endives








0.03*





0256000









(f)




herbs and edible flowers








0.06*





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




0.03*





0260010


Beans (with pods)


 




0260020


Beans (without pods)


 




0260030


Peas (with pods)


 




0260040


Peas (without pods)


 




0260050


Lentils


 




0260990


Others (2)


 




0270000



Stem vegetables




0.03*





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



 




0280010


Cultivated fungi


3




0280020


Wild fungi



0.03*





0280990


Mosses and lichens



0.03*





0290000



Algae and prokaryotes organisms




0.03*





0300000



PULSES




0.03*





0300010


Beans


 




0300020


Lentils


 




0300030


Peas


 




0300040


Lupins/lupini beans


 




0300990


Others (2)


 




0400000



OILSEEDS AND OIL FRUITS



 




0401000



Oilseeds



 




0401010


Linseeds



0.3





0401020


Peanuts/groundnuts



0.03*





0401030


Poppy seeds



0.3





0401040


Sesame seeds



0.03*





0401050


Sunflower seeds



0.3





0401060


Rapeseeds/canola seeds



0.3





0401070


Soyabeans



0.03*





0401080


Mustard seeds



0.03*





0401090


Cotton seeds



0.03*





0401100


Pumpkin seeds



0.03*





0401110


Safflower seeds



0.03*





0401120


Borage seeds



0.03*





0401130


Gold of pleasure seeds



0.03*





0401140


Hemp seeds



0.03*





0401150


Castor beans



0.03*





0401990


Others (2)



0.03*





0402000



Oil fruits




0.03*





0402010


Olives for oil production


 




0402020


Oil palms kernels


 




0402030


Oil palms fruits


 




0402040


Kapok


 




0402990


Others (2)


 




0500000



CEREALS



 




0500010


Barley



0.03*





0500020


Buckwheat and other pseudocereals



0.03*





0500030


Maize/corn



0.03*





0500040


Common millet/proso millet



0.03*





0500050


Oat



0.03*





0500060


Rice



0.03*





0500070


Rye



0.2





0500080


Sorghum



0.03*





0500090


Wheat



0.2





0500990


Others (2)



0.03*





0600000



TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS




0.15*





0610000



Teas



 




0620000



Coffee beans



 




0630000



Herbal infusions from



 




0631000









(a)




flowers







 




0631010


Chamomile


 




0631020


Hibiscus/roselle


 




0631030


Rose


 




0631040


Jasmine


 




0631050


Lime/linden


 




0631990


Others (2)


 




0632000









(b)




leaves and herbs







 




0632010


Strawberry


 




0632020


Rooibos


 




0632030


Mate/maté


 




0632990


Others (2)


 




0633000









(c)




roots







 




0633010


Valerian


 




0633020


Ginseng


 




0633990


Others (2)


 




0639000









(d)




any other parts of the plant







 




0640000



Cocoa beans



 




0650000



Carobs/Saint John's breads



 




0700000



HOPS




0.15*





0800000



SPICES



 




0810000



Seed spices




0.15*





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




0.15*





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




0.15*





0830010


Cinnamon


 




0830990


Others (2)


 




0840000



Root and rhizome spices



 




0840010


Liquorice



0.15*





0840020


Ginger (10)



0.15*





0840030


Turmeric/curcuma



0.15*





0840040


Horseradish (11)


 




0840990


Others (2)



0.15*





0850000



Bud spices




0.15*





0850010


Cloves


 




0850020


Capers


 




0850990


Others (2)


 




0860000



Flower pistil spices




0.15*





0860010


Saffron


 




0860990


Others (2)


 




0870000



Aril spices




0.15*





0870010


Mace


 




0870990


Others (2)


 




0900000



SUGAR PLANTS




0.03*





0900010


Sugar beet roots


 




0900020


Sugar canes


 




0900030


Chicory roots


 




0900990


Others (2)


 




1000000



PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS



 




1010000



Commodities from



 




1011000









(a)




swine







 




1011010


Muscle



0.03*





1011020


Fat



0.03*





1011030


Liver



0.3 (+)





1011040


Kidney



0.05 (+)





1011050


Edible offals (other than liver and kidney)



0.03*





1011990


Others (2)



0.03*





1012000









(b)




bovine







 




1012010


Muscle



0.03*





1012020


Fat



0.07 (+)





1012030


Liver



1 (+)





1012040


Kidney



0.2 (+)





1012050


Edible offals (other than liver and kidney)



0.03*





1012990


Others (2)



0.03*





1013000









(c)




sheep







 




1013010


Muscle



0.03*





1013020


Fat



0.15 (+)





1013030


Liver



3 (+)





1013040


Kidney



0.5 (+)





1013050


Edible offals (other than liver and kidney)



0.03*





1013990


Others (2)



0.03*





1014000









d)




goat







 




1014010


Muscle



0.03*





1014020


Fat



0.15 (+)





1014030


Liver



3 (+)





1014040


Kidney



0.5 (+)





1014050


Edible offals (other than liver and kidney)



0.03*





1014990


Others (2)



0.03*





1015000









(e)




equine







 




1015010


Muscle



0.03*





1015020


Fat



0.07 (+)





1015030


Liver



1 (+)





1015040


Kidney



0.2 (+)





1015050


Edible offals (other than liver and kidney)



0.03*





1015990


Others (2)



0.03*





1016000









(f)




poultry







 




1016010


Muscle



0.03* (+)





1016020


Fat



0.03* (+)





1016030


Liver



0.04 (+)





1016040


Kidney



0.03* (+)





1016050


Edible offals (other than liver and kidney)



0.03* (+)





1016990


Others (2)



0.03* (+)





1017000









(g)




other farmed terrestrial animals








0.03*





1017010


Muscle


 




1017020


Fat


 




1017030


Liver


 




1017040


Kidney


 




1017050


Edible offals (other than liver and kidney)


 




1017990


Others (2)


 




1020000



Milk




0.03*





1020010


Cattle


 




1020020


Sheep


 




1020030


Goat


 




1020040


Horse


 




1020990


Others (2)


 




1030000



Birds eggs




0.1





1030010


Chicken



(+)





1030020


Duck



(+)





1030030


Geese



(+)





1030040


Quail



(+)





1030990


Others (2)


 




1040000



Honey and other apiculture products (7)




0.15*





1050000



Amphibians and Reptiles




0.03*





1060000



Terrestrial invertebrate animals




0.03*





1070000



Wild terrestrial vertebrate animals




0.03*





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)



 










(*)


Limit of analytical determination










(a)


For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.










(F) =


Fat soluble





Prochloraz (sum of prochloraz, BTS 44595 (M201-04) and BTS 44596 (M201-03), expressed as prochloraz) (F)







(+)


The European Food Safety Authority identified some information on residue trials in relation with the new residue definition as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by [Office of Publication: please insert date 2 years after publication], or, if that information is not submitted by that date, the lack of it.





0161040 Kumquats


0162020 Litchis/lychees


0162030 Passionfruits/maracujas


0162040 Prickly pears/cactus fruits


0162050 Star apples/cainitos


0162060 American persimmons/Virginia kaki


0163010 Avocados


0163040 Papayas


0163050 Granate apples/pomegranates


0163060 Cherimoyas


0163070 Guavas


0163090 Breadfruits


0163100 Durians


0163110 Soursops/guanabanas







(+)


The European Food Safety Authority identified some information on feeding studies analysing both enforcement and risk assessment residue definitions 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 [Office of Publication: please insert date 2 years after publication], or, if that information is not submitted by that date, the lack of it.





1011030 Liver


1011040 Kidney


1012020 Fat


1012030 Liver


1012040 Kidney


1013020 Fat


1013030 Liver


1013040 Kidney


1014020 Fat


1014030 Liver


1014040 Kidney


1015020 Fat


1015030 Liver


1015040 Kidney


1016010 Muscle


1016020 Fat


1016030 Liver


1016040 Kidney


1016050 Edible offals (other than liver and kidney)


1016990 Others (2)


1030010 Chicken


1030020 Duck


1030030 Geese


1030040 Quail















(2)


in part B of Annex III the column for prochloraz is deleted.