CELEX: 
Language: en
Date: 2020-06-04 00:00:00
Title: COMMISSION REGULATION (EU) …/… 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

EUROPEAN
                            COMMISSION
                                                   Brussels, 4.6.2020
                                                   C(2020) 3541 final
                        COMMISSION REGULATION (EU) …/…
                                       of 4.6.2020
   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)
EN                                                                                       EN
 ---pagebreak---                                  COMMISSION REGULATION (EU) …/…
                                                       of 4.6.2020
   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/EEC1, and in particular
   Article 14(1)(a) and Article 16(1)(a) thereof,
   Whereas:
   (1)     According to Commission Decision 2008/865/EC2 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           protection products containing chlorate have been revoked following the non-inclusion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/EEC3.
   (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
   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, 19.08.1991, 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.
EN                                                           1                                                           EN
 ---pagebreak---         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.
EN                                              2                                                 EN
 ---pagebreak---    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 [Office of Publication:
   please insert date 5 years after publication].
                                               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, 4.6.2020
                                                 For the Commission
                                                 The President
                                                 Ursula VON DER LEYEN
EN                                                 3                                                EN
 ---documentbreak---                                                                         SANTE/10684/2015
                                                                               D059760/07
                                              EN
                                           ANNEX
In Part A of Annex III to Regulation (EC) No 396/2005 the following column for chlorate is
added:
              '[Office of Publication: please insert table Annex IIIA]'
 ---documentbreak--- NA ---documentbreak---           SANTE/10684/2015            D059760/07
          [AnnexIIIA]
          Pesticide residues and maximum residue levels (mg/kg)
 Code      Groups and examples of individual products to which the MRLs
number                              apply (a)
                                                                           Chlorate (A)
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
                                                                                          page 1/5
 ---pagebreak---           SANTE/10684/2015            D059760/07
          [AnnexIIIA]
          Pesticide residues and maximum residue levels (mg/kg)
 Code      Groups and examples of individual products to which the MRLs
number                              apply (a)
                                                                               Chlorate (A)
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
             Brassica vegetables(excluding brassica roots and brassica baby
0240000
          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)
                                                                                              page 2/5
 ---pagebreak---           SANTE/10684/2015            D059760/07
          [AnnexIIIA]
          Pesticide residues and maximum residue levels (mg/kg)
 Code      Groups and examples of individual products to which the MRLs
number                              apply (a)
                                                                           Chlorate (A)
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)
                                                                                          page 3/5
 ---pagebreak---           SANTE/10684/2015                   D059760/07
          [AnnexIIIA]
          Pesticide residues and maximum residue levels (mg/kg)
 Code       Groups and examples of individual products to which the MRLs
number                               apply (a)
                                                                                            Chlorate (A)
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
          PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY
1100000
          OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)
          PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR
1200000
          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.
                                                                                                           page 4/5
 ---pagebreak---                SANTE/10684/2015                  D059760/07
               [AnnexIIIA]
               Pesticide residues and maximum residue levels (mg/kg)
   Code          Groups and examples of individual products to which the MRLs
  number                                  apply (a)
                                                                                                    Chlorate (A)
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
                                                                                                                   page 5/5