Commission Regulation (EU) 2018/1515 of 10 October 2018 amending Annexes III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for diphenylamine and oxadixyl in or on certain products (Text with EEA relevance.)
Date: 2018-10-10
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: consumer protection, crop production, food inspection, food safety, foodstuff, pesticide, pesticide residue




L_2018256EN.01003301.xml










12.10.2018   


EN


Official Journal of the European Union


L 256/33








            COMMISSION REGULATION (EU) 2018/1515
of 10 October 2018
         
amending Annexes III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for diphenylamine and oxadixyl 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), Article 18(1)(b) and Article 49(2) thereof,

Whereas:







(1)


For diphenylamine and oxadixyl, maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005.












(2)


The active substance diphenylamine was not approved by Commission Implementing Regulation (EU) No 578/2012 (2). The active substance oxadixyl was not included in Annex I to Directive 91/414/EEC by Commission Regulation (EC) No 2076/2002 (3). All existing authorisations for plant protection products containing these active substances have been revoked. It is therefore appropriate to delete the existing MRLs set out for these substances in Annex III in accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1)(a) thereof.












(3)


For diphenylamine temporary MRLs were set by Regulation (EU) No 772/2013 (4) for apples and pears until 2 September 2015, to address an unavoidable cross-contamination that affected untreated apples and pears and which was due to the presence of residues of diphenylamine in storage facilities. Commission Regulation (EU) 2016/67 (5) extended the validity of those MRLs until 22 January 2018 to provide the necessary time for business operators to completely remove the residues of diphenylamine in storage facilities. The European Food Safety Authority (‘the Authority’) and food business operators submitted recent monitoring data showing that residues of diphenylamine no longer occur at levels above the relevant limit of determination (LOD).












(4)


For oxadixyl temporary MRLs were set by Regulation (EU) No 592/2012 (6) for parsley, celeries and the group of lettuces and salad plants until 31 December 2014, to address an unavoidable cross-contamination that affected untreated crops and which was due to the presence of residues of oxadixyl in soil. Commission Regulation (EU) 2016/46 (7) extended the validity of those MRLs until 19 January 2018 in view of the persistence of that active substance in soil. The Authority and food business operators submitted recent monitoring data showing that residues of oxadixyl no longer occur at levels above the relevant LOD.












(5)


In view of the non-approval of the active substance diphenylamine and the non-inclusion of the active substance oxadixyl in Annex I to Directive 91/414/EEC, the MRLs for these substances should be set at the LOD in accordance with Article 18 of Regulation (EC) No 396/2005. For the active substances for which all MRLs should be reduced to the relevant LOD, default values should be listed in Annex V in accordance with Article 18(1)(b) 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 III and V 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 1 May 2019.


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 1 May 2019.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 October 2018.


For the Commission


The President

Jean-Claude JUNCKER
            





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

(2)  Commission Implementing Regulation (EU) No 578/2012 of 29 June 2012 concerning the non approval of the active substance diphenylamine, 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 (OJ L 171, 30.6.2012, p. 2).

(3)  Commission Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article 8(2) of Council Directive 91/414/EEC and concerning the non-inclusion of certain active substances in Annex I to that Directive and the withdrawal of authorisations for plant protection products containing these substances (OJ L 319, 23.11.2002, p. 3).

(4)  Commission Regulation (EU) No 772/2013 of 8 August 2013 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for diphenylamine in or on certain products (OJ L 217, 13.8.2013, p. 1).

(5)  Commission Regulation (EU) 2016/67 of 19 January 2016 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for ametoctradin, chlorothalonil, diphenylamine, flonicamid, fluazinam, fluoxastrobin, halauxifen-methyl, propamocarb, prothioconazole, thiacloprid and trifloxystrobin in or on certain products (OJ L 15, 22.1.2016, p. 2).

(6)  Commission Regulation (EU) No 592/2012 of 4 July 2012 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 bifenazate, captan, cyprodinil, fluopicolide, hexythiazox, isoprothiolane, metaldehyde, oxadixyl and phosmet in or on certain products (OJ L 176, 6.7.2012, p. 1).

(7)  Commission Regulation (EU) 2016/46 of 18 January 2016 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for oxadixyl and spinetoram in or on certain products (OJ L 12, 19.1.2016, p. 28).




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






(1)


in Part A of Annex III, the columns for diphenylamine and oxadixyl are deleted;










(2)


in Annex V, the columns for diphenylamine and oxadixyl are added:
‘Pesticide residues and maximum residue levels (mg/kg)









Code number


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



Diphenylamine


Oxadixyl




(1)


(2)


(3)


(4)






0100000 



FRUITS, FRESH or FROZEN; TREE NUTS




0,05
 (*1)



0,01 (*1)







0110000 



Citrus fruits



 


 




0110010 


Grapefruits


 


 




0110020 


Oranges


 


 




0110030 


Lemons


 


 




0110040 


Limes


 


 




0110050 


Mandarins


 


 




0110990 


Others (2)


 


 






0120000 



Tree nuts



 


 




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


 


 




0130020 


Pears


 


 




0130030 


Quinces


 


 




0130040 


Medlars


 


 




0130050 


Loquats/Japanese medlars


 


 




0130990 


Others (2)


 


 






0140000 



Stone fruits



 


 




0140010 


Apricots


 


 




0140020 


Cherries (sweet)


 


 




0140030 


Peaches


 


 




0140040 


Plums


 


 




0140990 


Others (2)


 


 






0150000 



Berries and small fruits



 


 






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


 


 




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



0,05 (*1)




0,01
 (*1)







0210000 



Root and tuber vegetables



 


 




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



 


 




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


 


 




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)



 


 






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






 


 




0251010 


Lamb's lettuces/corn salads


 


 




0251020 


Lettuces


 


 




0251030 


Escaroles/broad-leaved endives


 


 




0251040 


Cresses and other sprouts and shoots


 


 




0251050 


Land cresses


 


 




0251060 


Roman rocket/rucola


 


 




0251070 


Red mustards


 


 




0251080 


Baby leaf crops (including brassica species)


 


 




0251990 


Others (2)


 


 






0252000 








(b)


spinaches and similar leaves






 


 




0252010 


Spinaches


 


 




0252020 


Purslanes


 


 




0252030 


Chards/beet leaves


 


 




0252990 


Others (2)


 


 




0253000 








(c)


grape leaves and similar species






 


 




0254000 








(d)


watercresses






 


 




0255000 








(e)


witloofs/Belgian endives






 


 






0256000 








(f)


herbs and edible flowers






 


 




0256010 


Chervil


 


 




0256020 


Chives


 


 




0256030 


Celery leaves


 


 




0256040 


Parsley


 


 




0256050 


Sage


 


 




0256060 


Rosemary


 


 




0256070 


Thyme


 


 




0256080 


Basil and edible flowers


 


 




0256090 


Laurel/bay leaves


 


 




0256100 


Tarragon


 


 




0256990 


Others (2)


 


 






0260000 



Legume vegetables



 


 




0260010 


Beans (with pods)


 


 




0260020 


Beans (without pods)


 


 




0260030 


Peas (with pods)


 


 




0260040 


Peas (without pods)


 


 




0260050 


Lentils


 


 




0260990 


Others (2)


 


 






0270000 



Stem vegetables



 


 




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


 


 




0280020 


Wild fungi


 


 




0280990 


Mosses and lichens


 


 




0290000 



Algae and prokaryotes organisms



 


 






0300000 



PULSES



0,05 (*1)



0,01 (*1)





0300010 


Beans


 


 




0300020 


Lentils


 


 




0300030 


Peas


 


 




0300040 


Lupins/lupini beans


 


 




0300990 


Others (2)


 


 






0400000 



OILSEEDS AND OIL FRUITS



0,05 (*1)



0,02 (*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



0,05 (*1)



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



0,05 (*1)



0,02 (*1)





0610000 



Teas



 


 




0620000 



Coffee beans



 


 






0630000 



Herbal infusions from



 


 






0631000 








(a)


flowers






 


 




0631010 


Chamomile


 


 




0631020 


Hibiscus/roselle


 


 




0631030 


Rose


 


 




0631040 


Jasmine


 


 




0631050 


Lime/linden


 


 




0631990 


Others (2)


 


 






0632000 








(b)


leaves and herbs






 


 




0632010 


Strawberry


 


 




0632020 


Rooibos


 


 




0632030 


Mate/maté


 


 




0632990 


Others (2)


 


 






0633000 








(c)


roots






 


 




0633010 


Valerian


 


 




0633020 


Ginseng


 


 




0633990 


Others (2)


 


 




0639000 








(d)


any other parts of the plant






 


 




0640000 



Cocoa beans



 


 




0650000 



Carobs/Saint John's breads



 


 




0700000 



HOPS



0,05 (*1)



0,02 (*1)







0800000 



SPICES



0,05 (*1)



 






0810000 



Seed spices



 


0,02 (*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



 


0,02 (*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



 


0,02 (*1)





0830010 


Cinnamon


 


 




0830990 


Others (2)


 


 






0840000 



Root and rhizome spices



 


 




0840010 


Liquorice


 


0,02 (*1)





0840020 


Ginger (10)


 


0,02 (*1)





0840030 


Turmeric/curcuma


 


0,02 (*1)





0840040 


Horseradish (11)


 


 




0840990 


Others (2)


 


0,02 (*1)







0850000 



Bud spices



 


0,02 (*1)





0850010 


Cloves


 


 




0850020 


Capers


 


 




0850990 


Others (2)


 


 






0860000 



Flower pistil spices



 


0,02 (*1)





0860010 


Saffron


 


 




0860990 


Others (2)


 


 






0870000 



Aril spices



 


0,02 (*1)





0870010 


Mace


 


 




0870990 


Others (2)


 


 






0900000 



SUGAR PLANTS



0,05 (*1)



0,01 (*1)





0900010 


Sugar beet roots


 


 




0900020 


Sugar canes


 


 




0900030 


Chicory roots


 


 




0900990 


Others (2)


 


 






1000000 



PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS



0,05 (*1)



0,01 (*1)







1010000 



Commodities from



 


 






1011000 








(a)


swine






 


 




1011010 


Muscle


 


 




1011020 


Fat


 


 




1011030 


Liver


 


 




1011040 


Kidney


 


 




1011050 


Edible offals (other than liver and kidney)


 


 




1011990 


Others (2)


 


 






1012000 








(b)


bovine






 


 




1012010 


Muscle


 


 




1012020 


Fat


 


 




1012030 


Liver


 


 




1012040 


Kidney


 


 




1012050 


Edible offals (other than liver and kidney)


 


 




1012990 


Others (2)


 


 






1013000 








(c)


sheep






 


 




1013010 


Muscle


 


 




1013020 


Fat


 


 




1013030 


Liver


 


 




1013040 


Kidney


 


 




1013050 


Edible offals (other than liver and kidney)


 


 




1013990 


Others (2)


 


 






1014000 








(d)


goat






 


 




1014010 


Muscle


 


 




1014020 


Fat


 


 




1014030 


Liver


 


 




1014040 


Kidney


 


 




1014050 


Edible offals (other than liver and kidney)


 


 




1014990 


Others (2)


 


 






1015000 








(e)


equine






 


 




1015010 


Muscle


 


 




1015020 


Fat


 


 




1015030 


Liver


 


 




1015040 


Kidney


 


 




1015050 


Edible offals (other than liver and kidney)


 


 




1015990 


Others (2)


 


 






1016000 








(f)


poultry






 


 




1016010 


Muscle


 


 




1016020 


Fat


 


 




1016030 


Liver


 


 




1016040 


Kidney


 


 




1016050 


Edible offals (other than liver and kidney)


 


 




1016990 


Others (2)


 


 






1017000 








(g)


other farmed terrestrial animals






 


 




1017010 


Muscle


 


 




1017020 


Fat


 


 




1017030 


Liver


 


 




1017040 


Kidney


 


 




1017050 


Edible offals (other than liver and kidney)


 


 




1017990 


Others (2)


 


 






1020000 



Milk



 


 




1020010 


Cattle


 


 




1020020 


Sheep


 


 




1020030 


Goat


 


 




1020040 


Horse


 


 




1020990 


Others (2)


 


 






1030000 



Birds eggs



 


 




1030010 


Chicken


 


 




1030020 


Duck


 


 




1030030 


Geese


 


 




1030040 


Quail


 


 




1030990 


Others (2)


 


 




1040000 



Honey and other apiculture products (7)



 


 




1050000 



Amphibians and Reptiles



 


 




1060000 



Terrestrial invertebrate animals



 


 




1070000 



Wild terrestrial vertebrate animals



 


 




1100000 



PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)



 


 




1200000 



PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)



 


 




1300000 



PROCESSED FOOD PRODUCTS (9)



 


 










(*1)  Limit of analytical determination

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