Commission Regulation (EU) 2020/749 of 4 June 2020 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorate in or on certain products (Text with EEA relevance)
Date: 2020-06-04
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: consumer protection, crop production, food inspection, food safety, foodstuff, pesticide, pesticide residue








L_2020178EN.01000701.xml










8.6.2020   


EN


Official Journal of the European Union


L 178/7








            COMMISSION REGULATION (EU) 2020/749
of 4 June 2020
         
amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorate 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 16(1)(a) thereof,

Whereas:







(1)


According to Commission Decision 2008/865/EC (2) all authorisations for plant protection products containing chlorate have been revoked following the non-inclusion of chlorate in Annex I to Council Directive 91/414/EEC (3).












(2)


No specific maximum residue levels (MRLs) have been set for chlorate and, as this substance has not been included in Annex IV to Regulation (EC) No 396/2005, currently the default MRL of 0,01 mg/kg applies to all food and feed commodities included in Annex I to Regulation (EC) No 396/2005.












(3)


Apart from its former use in plant protection products, chlorate is also a substance that is formed as by-product resulting from the use of chlorine disinfectants in food and drinking water processing. These uses lead to the current situation of detectable residues of chlorate in food.












(4)


The European Food Safety Authority (‘the Authority’) collected between 2014 and 2018 monitoring data to investigate the presence of residues of chlorate in food and drinking water. Those data indicated that chlorate residues are present at levels that frequently exceed the default MRL of 0,01 mg/kg and that the levels vary depending on the source and the product. It follows from those findings that even if good practices are used, it is currently not possible to achieve levels of chlorate residues compliant with the current MRL of 0,01 mg/kg.












(5)


The Authority adopted a scientific opinion concerning the risks for public health related to the presence of chlorate in food (4). In that opinion the Authority established a tolerable daily intake (TDI) of 3 μg/kg body weight per day and an acute reference dose (ARfD) of 36 μg/kg body weight. The Authority concluded that based on the data collected in 2014 the acute dietary exposure to chlorate did not exceed the ARfD. The mean dietary exposures to chlorate in European countries exceeded the TDI in certain subgroups of the population such as infants and young children with mild to moderate iodine deficiency.












(6)


In order to bring chlorate levels down and reduce exposure through coordinated action in several relevant and related sectors, a multi-disciplinary action plan was agreed by the Member States in 2017 comprising a set of actions to be taken in parallel, including actions on drinking water, hygiene, and the setting of temporary maximum residue levels for food and feed.












(7)


This Regulation addresses the setting of temporary maximum levels in food. For this purpose a large number of occurrence data was collected between 2014 and 2018, both by Member States and by food business operators. The data shows a general trend towards decreasing levels, suggesting that manufacturing practices have already improved to a certain extent. In the specific case of chlorate, for which residues do not stem from pesticide use but result from use of chlorine-based solutions in food processing and drinking water treatment, maximum levels should be set at levels which are ‘as low as reasonably achievable’ (ALARA principle) by following good manufacturing practices while ensuring at the same time that good hygiene practices remain possible. This approach ensures that food business operators apply measures to prevent and reduce the chlorate levels in food as far as possible in order to protect public health, but also take into account the need for microbiological safety of food.












(8)


Temporary MRLs for chlorate according to the ALARA principle are based on the 95th percentile of the occurrence data, taking into account the use of legitimately treated drinking water in food processing.The temporary MRLs should be reviewed at the latest within five years of publication of this Regulation in the light of possible developments in the area of hygiene, of drinking water, further progress made by food business operators to bring chlorate levels down,or whenever new information and data become available that would warrant an earlier review.












(9)


The Commission consulted the European Union reference laboratories on appropriate limits of determination (LODs) for chlorate residues in certain specific commodties.












(10)


Based on the scientific opinion of the Authority and taking into account the factors relevant to the matter under consideration, the proposed 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 III to Regulation (EC) No 396/2005 is amended in accordance with the Annex to this Regulation.


Article 2
The temporary MRLs for chlorate shall be reviewed not later than 8 June 2025.


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.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 June 2020.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  Commission Decision 2008/865/EC of 10 November 2008 concerning the non-inclusion of chlorate in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (OJ L 307, 18.11.2008, p. 7).

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

(4)  EFSA (European Food Safety Authority), 2015. Scientific opinion on the risks for public health related to the presence of chlorate in food. EFSA Journal 2015;13(6):4135, 103 pp.




ANNEX
In Part A of Annex III to Regulation (EC) No 396/2005 the following column for chlorate is added:


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








Code number


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


Chlorate (A)




(1)


(2)


(3)




0100000








 



FRUITS, FRESH or FROZEN; TREE NUTS







 




0110000








 



Citrus fruits








0,05





0110010








 


Grapefruits






 




0110020








 


Oranges






 




0110030








 


Lemons






 




0110040








 


Limes






 




0110050








 


Mandarins






 




0110990








 


Others (2)






 




0120000








 



Tree nuts








0,1





0120010








 


Almonds






 




0120020








 


Brazil nuts






 




0120030








 


Cashew nuts






 




0120040








 


Chestnuts






 




0120050








 


Coconuts






 




0120060








 


Hazelnuts/cobnuts






 




0120070








 


Macadamias






 




0120080








 


Pecans






 




0120090








 


Pine nut kernels






 




0120100








 


Pistachios






 




0120110








 


Walnuts






 




0120990








 


Others (2)






 




0130000








 



Pome fruits








0,05





0130010








 


Apples






 




0130020








 


Pears






 




0130030








 


Quinces






 




0130040








 


Medlars






 




0130050








 


Loquats/Japanese medlars






 




0130990








 


Others (2)






 




0140000








 



Stone fruits








0,05





0140010








 


Apricots






 




0140020








 


Cherries (sweet)






 




0140030








 


Peaches






 




0140040








 


Plums






 




0140990








 


Others (2)






 




0150000








 



Berries and small fruits








0,05





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 fruitswith







 




0161000








(a)



edible peel







 




0161010








 


Dates







0,3





0161020








 


Figs







0,3





0161030








 


Table olives







0,7





0161040








 


Kumquats







0,3





0161050








 


Carambolas







0,3





0161060








 


Kaki/Japanese persimmons







0,3





0161070








 


Jambuls/jambolans







0,3





0161990








 


Others (2)







0,3





0162000








(b)



inedible peel, small








0,3





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








0,3





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







 




0211000








(a)



potatoes








0,05





0212000








(b)



tropical root and tuber vegetables








0,05





0212010








 


Cassava roots/manioc






 




0212020








 


Sweet potatoes






 




0212030








 


Yams






 




0212040








 


Arrowroots






 




0212990








 


Others (2)






 




0213000








(c)



other root and tuber vegetables except sugar beets








0,15





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







0,7





0220020








 


Onions







0,5





0220030








 


Shallots







0,5





0220040








 


Spring onions/green onions and Welsh onions







0,5





0220990








 


Others (2)







0,05





0230000








 



Fruiting vegetables







 




0231000








(a)



Solanaceae and Malvaceae







 




0231010








 


Tomatoes







0,1





0231020








 


Sweet peppers/bell peppers







0,3





0231030








 


Aubergines/eggplants







0,4





0231040








 


Okra/lady's fingers







0,1





0231990








 


Others (2)







0,1





0232000








(b)



cucurbits with edible peel








0,2





0232010








 


Cucumbers






 




0232020








 


Gherkins






 




0232030








 


Courgettes






 




0232990








 


Others (2)






 




0233000








(c)



cucurbits with inedible peel








0,08





0233010








 


Melons






 




0233020








 


Pumpkins






 




0233030








 


Watermelons






 




0233990








 


Others (2)






 




0234000








(d)



sweet corn








0,1





0239000








(e)



other fruiting vegetables








0,1





0240000








 



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







 




0241000








(a)



flowering brassica







 




0241010








 


Broccoli







0,4





0241020








 


Cauliflowers







0,06





0241990








 


Others (2)







0,06





0242000








(b)



head brassica








0,07





0242010








 


Brussels sprouts






 




0242020








 


Head cabbages






 




0242990








 


Others (2)






 




0243000








(c)



leafy brassica







 




0243010








 


Chinese cabbages/pe-tsai







0,06





0243020








 


Kales







0,2





0243990








 


Others (2)







0,06





0244000








(d)



kohlrabies








0,06





0250000








 



Leaf vegetables, herbs and edible flowers








0,7





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








0,35





0260010








 


Beans (with pods)






 




0260020








 


Beans (without pods)






 




0260030








 


Peas (with pods)






 




0260040








 


Peas (without pods)






 




0260050








 


Lentils






 




0260990








 


Others (2)






 




0270000








 



Stem vegetables








0,25





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







0,7





0280020








 


Wild fungi







0,7





0280990








 


Mosses and lichens







0,05





0290000








 



Algae and prokaryotes organisms








0,05





0300000








 



PULSES








0,35





0300010








 


Beans






 




0300020








 


Lentils






 




0300030








 


Peas






 




0300040








 


Lupins/lupini beans






 




0300990








 


Others (2)






 




0400000








 



OILSEEDS AND OIL FRUITS







 




0401000








 



Oilseeds








0,05





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








0,7





0402010








 


Olives for oil production






 




0402020








 


Oil palms kernels






 




0402030








 


Oil palms fruits






 




0402040








 


Kapok






 




0402990








 


Others (2)






 




0500000








 



CEREALS








0,05





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








0,05





0800000








 



SPICES







 




0810000








 



Seed spices








0,07





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








0,07





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








0,07





0830010








 


Cinnamon






 




0830990








 


Others (2)






 




0840000








 



Root and rhizome spices







 




0840010








 


Liquorice







0,07





0840020








 


Ginger (10)






 




0840030








 


Turmeric/curcuma







0,07





0840040








 


Horseradish (11)






 




0840990








 


Others (2)







0,07





0850000








 



Bud spices








0,07





0850010








 


Cloves






 




0850020








 


Capers






 




0850990








 


Others (2)






 




0860000








 



Flower pistil spices








0,07





0860010








 


Saffron






 




0860990








 


Others (2)






 




0870000








 



Aril spices








0,07





0870010








 


Mace






 




0870990








 


Others (2)






 




0900000








 



SUGAR PLANTS








0,05





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







0,05





1011020








 


Fat







0,1(*)





1011030








 


Liver







0,05





1011040








 


Kidney







0,05





1011050








 


Edible offals (other than liver and kidney)







0,05





1011990








 


Others (2)







0,05





1012000








(b)



bovine







 




1012010








 


Muscle







0,05





1012020








 


Fat







0,1(*)





1012030








 


Liver







0,05





1012040








 


Kidney







0,05





1012050








 


Edible offals (other than liver and kidney)







0,05





1012990








 


Others (2)







0,05





1013000








(c)



sheep







 




1013010








 


Muscle







0,05





1013020








 


Fat







0,1(*)





1013030








 


Liver







0,05





1013040








 


Kidney







0,05





1013050








 


Edible offals (other than liver and kidney)







0,05





1013990








 


Others (2)







0,05





1014000








d)



goat







 




1014010








 


Muscle







0,05





1014020








 


Fat







0,1(*)





1014030








 


Liver







0,05





1014040








 


Kidney







0,05





1014050








 


Edible offals (other than liver and kidney)







0,05





1014990








 


Others (2)







0,05





1015000








(e)



equine







 




1015010








 


Muscle







0,05





1015020








 


Fat







0,1(*)





1015030








 


Liver







0,05





1015040








 


Kidney







0,05





1015050








 


Edible offals (other than liver and kidney)







0,05





1015990








 


Others (2)







0,05





1016000








(f)



poultry







 




1016010








 


Muscle







0,05





1016020








 


Fat







0,1(*)





1016030








 


Liver







0,05





1016040








 


Kidney







0,05





1016050








 


Edible offals (other than liver and kidney)







0,05





1016990








 


Others (2)







0,05





1017000








(g)



other farmed terrestrial animals







 




1017010








 


Muscle







0,05





1017020








 


Fat







0,1(*)





1017030








 


Liver







0,05





1017040








 


Kidney







0,05





1017050








 


Edible offals (other than liver and kidney)







0,05





1017990








 


Others (2)







0,05





1020000








 



Milk








0,1





1020010








 


Cattle







(+)





1020020








 


Sheep







(+)





1020030








 


Goat







(+)





1020040








 


Horse







(+)





1020990








 


Others (2)






 




1030000








 



Birds eggs








0,05





1030010








 


Chicken






 




1030020








 


Duck






 




1030030








 


Geese






 




1030040








 


Quail






 




1030990








 


Others (2)






 




1040000








 



Honey and other apiculture products (7)








0,05(*)





1050000








 



Amphibians and Reptiles








0,05





1060000








 



Terrestrial invertebrate animals








0,05





1070000








 



Wild terrestrial vertebrate animals








0,05





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.





Chlorate (A)







(A)


To take into account the specific situation of chlorate residues, in processed food (including for the purpose of this Regulation foodstuffs that have been derived using processes listed in Article 2(1)(n) of Regulation (EC) No 852/2004), that has come in contact with products containing chlorate residues, or that contains ingredients with such residues, such as processing aids or drinking water, used in compliance with the respective legal requirements, these additional contributions of chlorate residues should be taken into account when determining the permitted content of chlorate residues in or on the processed food products in accordance with Article 20 (1) of this Regulation. The burden of proof regarding the level of those additional contributions lies with the food and feed business operator.










(+)


Includes raw milk, heat-treated milk and milk for the manufacture of milk-based products as defined in Regulation (EU) No 1308/2013. The MRL applies to milk ready for use (marketed as such or reconstituted as instructed by the manufacturer)

1020010 Cattle











(+)


Includes raw milk, heat-treated milk and milk for the manufacture of milk-based products. The MRL applies to milk ready for use (marketed as such or reconstituted as instructed by the manufacturer)

1020020 Sheep


1020030 Goat


1020040 Horse’