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 productsText with EEA relevance.

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 OJ L 70, 16.3.2005, p. 1. , and in particular Article 14(1)(a) and Article 16(1)(a) thereof, Whereas: (1) According to Commission Decision 2008/865/EC 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). all authorisations for plant protection products containing chlorate have been revoked following the non-inclusion of chlorate in Annex I to Council Directive 91/414/EEC Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant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). . (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 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. . 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

Annex

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) () 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 numberGroups 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 0,050110010 Grapefruits 0110020 Oranges 0110030 Lemons 0110040 Limes 0110050 Mandarins 0110990 Others (2) 0120000 Tree nuts 0,10120010 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 0,050130010 Apples 0130020 Pears 0130030 Quinces 0130040 Medlars 0130050 Loquats/Japanese medlars 0130990 Others (2) 0140000 Stone fruits 0,050140010 Apricots 0140020 Cherries (sweet) 0140030 Peaches 0140040 Plums 0140990 Others (2) 0150000 Berries and small fruits 0,050151000 (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 0,30161020 Figs 0,30161030 Table olives 0,70161040 Kumquats 0,30161050 Carambolas 0,30161060 Kaki/Japanese persimmons 0,30161070 Jambuls/jambolans 0,30161990 Others (2) 0,3 0162000 (b) inedible peel, small 0,30162010 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 0,30163010 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 0,050212000 (b) tropical root and tuber vegetables 0,050212010 Cassava roots/manioc 0212020 Sweet potatoes 0212030 Yams 0212040 Arrowroots 0212990 Others (2) 0213000 (c) other root and tuber vegetables except sugar beets 0,150213010 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 0,70220020 Onions 0,50220030 Shallots 0,50220040 Spring onions/green onions and Welsh onions 0,50220990 Others (2) 0,050230000 Fruiting vegetables 0231000 (a) Solanaceae and Malvaceae 0231010 Tomatoes 0,10231020 Sweet peppers/bell peppers 0,30231030 Aubergines/eggplants 0,40231040 Okra/lady's fingers 0,10231990 Others (2) 0,10232000 (b) cucurbits with edible peel 0,20232010 Cucumbers 0232020 Gherkins 0232030 Courgettes 0232990 Others (2) 0233000 (c) cucurbits with inedible peel 0,080233010 Melons 0233020 Pumpkins 0233030 Watermelons 0233990 Others (2) 0234000 (d) sweet corn 0,10239000 (e) other fruiting vegetables 0,10240000 Brassica vegetables(excluding brassica roots and brassica baby leaf crops) 0241000 (a) flowering brassica 0241010 Broccoli 0,4 0241020 Cauliflowers 0,060241990 Others (2) 0,060242000 (b) head brassica 0,070242010 Brussels sprouts 0242020 Head cabbages 0242990 Others (2) 0243000 (c) leafy brassica 0243010 Chinese cabbages/pe-tsai 0,060243020 Kales 0,20243990 Others (2) 0,060244000 (d) kohlrabies 0,060250000 Leaf vegetables, herbs and edible flowers 0,70251000 (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 0,350260010 Beans (with pods) 0260020 Beans (without pods) 0260030 Peas (with pods) 0260040 Peas (without pods) 0260050 Lentils 0260990 Others (2) 0270000 Stem vegetables 0,250270010 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 0,70280020 Wild fungi 0,70280990 Mosses and lichens 0,050290000 Algae and prokaryotes organisms 0,050300000 PULSES 0,350300010 Beans 0300020 Lentils 0300030 Peas 0300040 Lupins/lupini beans 0300990 Others (2) 0400000 OILSEEDS AND OIL FRUITS 0401000 Oilseeds 0,050401010 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 0,70402010 Olives for oil production 0402020 Oil palms kernels 0402030 Oil palms fruits 0402040 Kapok 0402990 Others (2) 0500000 CEREALS 0,050500010 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 0,050610000 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 0,050800000 SPICES 0810000 Seed spices 0,070810010 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 0,070820010 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 0,070830010 Cinnamon 0830990 Others (2) 0840000 Root and rhizome spices 0840010 Liquorice 0,070840020 Ginger (10) 0840030 Turmeric/curcuma 0,070840040 Horseradish (11) 0840990 Others (2) 0,070850000 Bud spices 0,070850010 Cloves 0850020 Capers 0850990 Others (2)

0860000 Flower pistil spices 0,070860010 Saffron 0860990 Others (2) 0870000 Aril spices 0,070870010 Mace 0870990 Others (2) 0900000 SUGAR PLANTS 0,050900010 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 0,051011020 Fat 0,1()1011030 Liver 0,051011040 Kidney 0,051011050 Edible offals (other than liver and kidney) 0,051011990 Others (2) 0,051012000 (b) bovine 1012010 Muscle 0,051012020 Fat 0,1()1012030 Liver 0,051012040 Kidney 0,051012050 Edible offals (other than liver and kidney) 0,051012990 Others (2) 0,051013000 (c) sheep 1013010 Muscle 0,051013020 Fat 0,1()1013030 Liver 0,051013040 Kidney 0,051013050 Edible offals (other than liver and kidney) 0,051013990 Others (2) 0,051014000 d) goat 1014010 Muscle 0,051014020 Fat 0,1()1014030 Liver 0,051014040 Kidney 0,051014050 Edible offals (other than liver and kidney) 0,051014990 Others (2) 0,051015000 (e) equine 1015010 Muscle 0,051015020 Fat 0,1()1015030 Liver 0,051015040 Kidney 0,05 1015050 Edible offals (other than liver and kidney) 0,051015990 Others (2) 0,051016000 (f) poultry 1016010 Muscle 0,051016020 Fat 0,1()1016030 Liver 0,051016040 Kidney 0,051016050 Edible offals (other than liver and kidney) 0,051016990 Others (2) 0,051017000 (g) other farmed terrestrial animals 1017010 Muscle 0,051017020 Fat 0,1()1017030 Liver 0,051017040 Kidney 0,051017050 Edible offals (other than liver and kidney) 0,051017990 Others (2) 0,051020000 Milk 0,11020010 Cattle (+)1020020 Sheep (+)1020030 Goat (+)1020040 Horse (+)1020990 Others (2) 1030000 Birds eggs 0,051030010 Chicken 1030020 Duck 1030030 Geese 1030040 Quail 1030990 Others (2) 1040000 Honey and other apiculture products (7) 0,05()1050000 Amphibians and Reptiles 0,051060000 Terrestrial invertebrate animals 0,051070000 Wild terrestrial vertebrate animals 0,051100000 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)