Commission Regulation (EU) 2020/749Show full title

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to Commission Decision 2008/865/EC(2) all authorisations for plant protection products containing chlorate have been revoked following the non-inclusion of chlorate in Annex I to Council Directive 91/414/EEC(3).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

Annex III to Regulation (EC) No 396/2005 is amended in accordance with the Annex to this Regulation.

Article 2 U.K.

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

Article 3 U.K.

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

ANNEX U.K.

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) U.K.

(*) 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’
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)

(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.