
COMMISSION REGULATION (EU) 2019/1582 of 25 September 2019 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for imazalil 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, and in particular Article 14(1)(a) and Article 49(2) thereof,
Whereas:

(1) Maximum residue levels (MRLs) for imazalil were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005.

(2) The European Food Safety Authority (‘the Authority’) submitted a reasoned opinion on the existing MRLs for imazalil in accordance with Article 12(1) of Regulation (EC) No 396/2005. It recommended lowering the MRLs for potatoes, tomatoes, barley grains, oat grains, rye grains and wheat grains. For certain other products it recommended raising the existing MRLs.

(3) The Authority concluded that concerning certain MRLs, some information was not available and that further consideration by risk managers was required. From a risk management perspective, it is appropriate to set MRLs in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority for citrus fruits, strawberries, blackberries, raspberries, courgettes, melons, and muscle, fat tissue, liver and kidney of swine, bovine and equine, as well as cattle milk and horse milk, as for those products limited information was available and the Authority derived MRLs that do not raise concerns of consumer protection. Those MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. From a risk management perspective, it is appropriate to set MRLs in Annex II to Regulation (EC) No 396/2005 at the specific limit of determination or at the default MRL as set out in Article 18(1)(b) of Regulation (EC) No 396/2005 for pome fruits, persimmon, bananas and sweet peppers/bell peppers, as for those products no information was available from which the Authority could derive MRLs that do not raise concerns of consumer protection.

(4) The Authority indicated that the derived MRLs for imazalil in grapefruits, oranges, apples, pears, bananas, potatoes and bovine liver, as well as the Codex maximum residue limit (CXL) underlying the EU-MRL for medlar, may raise concerns of consumer protection. Taking into account additional information available for grapefruits, oranges and potatoes, it derived alternative MRLs for grapefruits, oranges, potatoes and bovine liver that do not raise such concerns. As regards the MRLs for apples, pears, medlar and bananas, the Authority indicated that risk managers may consider setting them at the specific limit of determination or at the default MRL as set out in Article 18(1)(b) of Regulation (EC) No 396/2005.

(5) The Authority proposed revised residue definitions. It is appropriate to change the residue definitions accordingly.

(6) Independently from the MRL review performed in accordance with Article 12(1) of Regulation (EC) No 396/2005, an application was submitted in accordance with Article 6 of that Regulation to modify the existing MRLs for imazalil in citrus fruits, apples, pears, bananas and potatoes and in products of animal origin.

(7) In accordance with Article 8 of Regulation (EC) No 396/2005, this application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission.

(8) In accordance with Article 10 of Regulation (EC) No 396/2005, the Authority assessed the application and the evaluation report, examining in particular the risks to the consumer and, where relevant, to animals and gave its reasoned opinion on the proposed MRLs. It forwarded that opinion to the applicants, the Commission and the Member States and made it available to the public.

(9) The Authority concluded in its reasoned opinion in accordance with Article 10 of Regulation (EC) No 396/2005 that the MRLs for the intended uses could not be amended until the risk assessment for the plant metabolites R014821, FK-772 and FK-284 was completed with regard to genotoxicity and general toxicity. It further concluded that certain information identified as not available in the MRL review performed in accordance with Article 12(1) of that Regulation was submitted with the application in accordance with Article 6 of that Regulation.

(10) Due to the adoption of the reasoned opinion under Article 10 of Regulation (EC) No 396/2005 after the adoption of the reasoned opinion under Article 12(1) of that Regulation and the horizontal nature of the toxicity concerns identified for the imazalil metabolites R014821, FK-772 and FK-284, the Commission requested the Authority to update its reasoned opinion on the existing MRLs for imazalil in accordance with Article 43 of Regulation (EC) No 396/2005.

(11) The Authority submitted a reasoned opinion updating the review of the existing MRLs for imazalil based on the new toxicological information.

(12) In that reasoned opinion, the Authority derived the same MRLs as in its reasoned opinion in accordance with Article 12 of Regulation (EC) No 396/2005, except for citrus fruits, melons and commodities of animal origin. For these commodities, it did not propose MRLs, because it could not finalise the assessment of the toxicological properties of metabolite R014821.

(13) Commission Implementing Regulation (EU) No 705/2011 renewed the approval of imazalil in accordance with Article 13(2) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council. While in the risk assessment preceding the adoption of that Regulation the Authority had identified uncertainties regarding the toxicological properties of metabolite R014821, the approval conditions were not restricted in this regard at the risk management stage. Additional information on the toxicological properties of metabolite R014821 submitted with the application in accordance with Article 6 of Regulation (EC) No 396/2005 did not entirely address those uncertainties but did not lead to an increased level of concern, either. From a risk management perspective, it is consistent and appropriate to set MRLs for those products for which the Authority in its reasoned opinion in accordance with Article 12 of Regulation (EC) No 396/2005 derived MRLs that do not raise concerns of consumer protection in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority.

(14) Existing CXLs were taken into account in the reasoned opinions of the Authority. CXLs which are safe for consumers in the Union were considered for MRL setting.

(15) As regards products on which the use of the plant protection product concerned is not authorised, and for which no import tolerances or CXLs exist, MRLs should be set at the specific limit of determination or the default MRL should apply, as provided for in Article 18(1)(b) of Regulation (EC) No 396/2005.

(16) The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain limits of determination. Those laboratories concluded that for certain commodities technical development requires the setting of specific limits of determination.

(17) Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.

(18) Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account.

(19) Regulation (EC) No 396/2005 should therefore be amended accordingly.

(20) In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained.

(21) A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs.

(22) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:

Article 1 
Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2 
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were produced in the Union or imported into the Union before 16 April 2020, except for grapefruit, oranges, apples, pears, medlar, bananas, potatoes and bovine liver.
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 16 April 2020.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 25 September 2019.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

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

((1)) In Annex II, the column for imazalil is replaced by the following:
'

Pesticide residues and maximum residue levels (mg/kg)Code number Groups and examples of individual products to which the MRLs apply Imazalil (any ratio of constituent isomers) (R)
(1) (2) (3)
0100000 FRUITS, FRESH or FROZEN; TREE NUTS 
0110000 Citrus fruits 
0110010 Grapefruits 4 (+)
0110020 Oranges 4 (+)
0110030 Lemons 5 (+)
0110040 Limes 5 (+)
0110050 Mandarins 5 (+)
0110990 Others (2) 0,01
0120000 Tree nuts 0,01
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 0,01
0130010 Apples 
0130020 Pears 
0130030 Quinces 
0130040 Medlars 
0130050 Loquats/Japanese medlars 
0130990 Others (2) 
0140000 Stone fruits 0,01
0140010 Apricots 
0140020 Cherries (sweet) 
0140030 Peaches 
0140040 Plums 
0140990 Others (2) 
0150000 Berries and small fruits 
0151000 
(a) grapes
 0,01
0151010 Table grapes 
0151020 Wine grapes 
0152000 
(b) strawberries
 2
0153000 
(c) cane fruits
 
0153010 Blackberries 2
0153020 Dewberries 0,01
0153030 Raspberries (red and yellow) 2
0153990 Others (2) 0,01
0154000 
(d) other small fruits and berries
 0,01
0154010 Blueberries 
0154020 Cranberries 
0154030 Currants (black, red and white) 
0154040 Gooseberries (green, red and yellow) 
0154050 Rose hips 
0154060 Mulberries (black and white) 
0154070 Azaroles/Mediterranean medlars 
0154080 Elderberries 
0154990 Others (2) 
0160000 Miscellaneous fruits with 0,01
0161000 
(a) edible peel
 
0161010 Dates 
0161020 Figs 
0161030 Table olives 
0161040 Kumquats 
0161050 Carambolas 
0161060 Kaki/Japanese persimmons 
0161070 Jambuls/jambolans 
0161990 Others (2) 
0162000 
(b) inedible peel, small
 
0162010 Kiwi fruits (green, red, yellow) 
0162020 Litchis/lychees 
0162030 Passionfruits/maracujas 
0162040 Prickly pears/cactus fruits 
0162050 Star apples/cainitos 
0162060 American persimmons/Virginia kaki 
0162990 Others (2) 
0163000 
(c) inedible peel, large
 
0163010 Avocados 
0163020 Bananas 
0163030 Mangoes 
0163040 Papayas 
0163050 Granate apples/pomegranates 
0163060 Cherimoyas 
0163070 Guavas 
0163080 Pineapples 
0163090 Breadfruits 
0163100 Durians 
0163110 Soursops/guanabanas 
0163990 Others (2) 
0200000 VEGETABLES, FRESH or FROZEN 
0210000 Root and tuber vegetables 0,01
0211000 
(a) potatoes
 
0212000 
(b) tropical root and tuber vegetables
 
0212010 Cassava roots/manioc 
0212020 Sweet potatoes 
0212030 Yams 
0212040 Arrowroots 
0212990 Others (2) 
0213000 
(c) other root and tuber vegetables except sugar beets
 
0213010 Beetroots 
0213020 Carrots 
0213030 Celeriacs/turnip rooted celeries 
0213040 Horseradishes 
0213050 Jerusalem artichokes 
0213060 Parsnips 
0213070 Parsley roots/Hamburg roots parsley 
0213080 Radishes 
0213090 Salsifies 
0213100 Swedes/rutabagas 
0213110 Turnips 
0213990 Others (2) 
0220000 Bulb vegetables 0,01
0220010 Garlic 
0220020 Onions 
0220030 Shallots 
0220040 Spring onions/green onions and Welsh onions 
0220990 Others (2) 
0230000 Fruiting vegetables 
0231000 
(a) Solanaceae and Malvaceae
 
0231010 Tomatoes 0,3
0231020 Sweet peppers/bell peppers 0,01
0231030 Aubergines/eggplants 0,01
0231040 Okra/lady's fingers 0,01
0231990 Others (2) 0,01
0232000 
(b) cucurbits with edible peel
 
0232010 Cucumbers 0,5
0232020 Gherkins 0,5
0232030 Courgettes 0,1 (+)
0232990 Others (2) 0,01
0233000 
(c) cucurbits with inedible peel
 
0233010 Melons 2 (+)
0233020 Pumpkins 0,01
0233030 Watermelons 0,01
0233990 Others (2) 0,01
0234000 
(d) sweet corn
 0,01
0239000 
(e) other fruiting vegetables
 0,01
0240000 Brassica vegetables (excluding brassica roots and brassica baby leaf crops) 0,01
0241000 
(a) flowering brassica
 
0241010 Broccoli 
0241020 Cauliflowers 
0241990 Others (2) 
0242000 
(b) head brassica
 
0242010 Brussels sprouts 
0242020 Head cabbages 
0242990 Others (2) 
0243000 
(c) leafy brassica
 
0243010 Chinese cabbages/pe-tsai 
0243020 Kales 
0243990 Others (2) 
0244000 
(d) kohlrabies
 
0250000 Leaf vegetables, herbs and edible flowers 
0251000 
(a) lettuces and salad plants
 0,01
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
 0,01
0252010 Spinaches 
0252020 Purslanes 
0252030 Chards/beet leaves 
0252990 Others (2) 
0253000 
(c) grape leaves and similar species
 0,01
0254000 
(d) watercresses
 0,01
0255000 
(e) witloofs/Belgian endives
 0,01
0256000 
(f) herbs and edible flowers
 0,02
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 0,01
0260010 Beans (with pods) 
0260020 Beans (without pods) 
0260030 Peas (with pods) 
0260040 Peas (without pods) 
0260050 Lentils 
0260990 Others (2) 
0270000 Stem vegetables 0,01
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 0,01
0280010 Cultivated fungi 
0280020 Wild fungi 
0280990 Mosses and lichens 
0290000 Algae and prokaryotes organisms 0,01
0300000 PULSES 0,01
0300010 Beans 
0300020 Lentils 
0300030 Peas 
0300040 Lupins/lupini beans 
0300990 Others (2) 
0400000 OILSEEDS AND OIL FRUITS 0,01
0401000 Oilseeds 
0401010 Linseeds 
0401020 Peanuts/groundnuts 
0401030 Poppy seeds 
0401040 Sesame seeds 
0401050 Sunflower seeds 
0401060 Rapeseeds/canola seeds 
0401070 Soyabeans 
0401080 Mustard seeds 
0401090 Cotton seeds 
0401100 Pumpkin seeds 
0401110 Safflower seeds 
0401120 Borage seeds 
0401130 Gold of pleasure seeds 
0401140 Hemp seeds 
0401150 Castor beans 
0401990 Others (2) 
0402000 Oil fruits 
0402010 Olives for oil production 
0402020 Oil palms kernels 
0402030 Oil palms fruits 
0402040 Kapok 
0402990 Others (2) 
0500000 CEREALS 0,01
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 0,05
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 0,05
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 0,05
0830010 Cinnamon 
0830990 Others (2) 
0840000 Root and rhizome spices 
0840010 Liquorice 0,05
0840020 Ginger (10) 0,05
0840030 Turmeric/curcuma 0,05
0840040 Horseradish (11) 
0840990 Others (2) 0,05
0850000 Bud spices 0,05
0850010 Cloves 
0850020 Capers 
0850990 Others (2) 
0860000 Flower pistil spices 0,05
0860010 Saffron 
0860990 Others (2) 
0870000 Aril spices 0,05
0870010 Mace 
0870990 Others (2) 
0900000 SUGAR PLANTS 0,01
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
 0,02
1011010 Muscle (+)
1011020 Fat (+)
1011030 Liver (+)
1011040 Kidney (+)
1011050 Edible offals (other than liver and kidney) 
1011990 Others (2) 
1012000 
(b) bovine
 
1012010 Muscle 0,02 (+)
1012020 Fat 0,02 (+)
1012030 Liver 0,03 (+)
1012040 Kidney 0,02 (+)
1012050 Edible offals (other than liver and kidney) 0,02
1012990 Others (2) 0,02
1013000 
(c) sheep
 0,01
1013010 Muscle 
1013020 Fat 
1013030 Liver 
1013040 Kidney 
1013050 Edible offals (other than liver and kidney) 
1013990 Others (2) 
1014000 
(d) goat
 0,01
1014010 Muscle 
1014020 Fat 
1014030 Liver 
1014040 Kidney 
1014050 Edible offals (other than liver and kidney) 
1014990 Others (2) 
1015000 
(e) equine
 
1015010 Muscle 0,02 (+)
1015020 Fat 0,02 (+)
1015030 Liver 0,03 (+)
1015040 Kidney 0,02 (+)
1015050 Edible offals (other than liver and kidney) 0,02
1015990 Others (2) 0,02
1016000 
(f) poultry
 0,01
1016010 Muscle 
1016020 Fat 
1016030 Liver 
1016040 Kidney 
1016050 Edible offals (other than liver and kidney) 
1016990 Others (2) 
1017000 
(g) other farmed terrestrial animals
 0,01
1017010 Muscle 
1017020 Fat 
1017030 Liver 
1017040 Kidney 
1017050 Edible offals (other than liver and kidney) 
1017990 Others (2) 
1020000 Milk 
1020010 Cattle 0,02 (+)
1020020 Sheep 0,01
1020030 Goat 0,01
1020040 Horse 0,02 (+)
1020990 Others (2) 0,01
1030000 Birds eggs 0,01
1030010 Chicken 
1030020 Duck 
1030030 Geese 
1030040 Quail 
1030990 Others (2) 
1040000 Honey and other apiculture products (7) 0,05
1050000 Amphibians and Reptiles 0,01
1060000 Terrestrial invertebrate animals 0,01
1070000 Wild terrestrial vertebrate animals 0,01
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) 


(**) Pesticide-code combination for which the MRL as set in Annex III Part B applies.
Imazalil (any ratio of constituent isomers) (R)
(R)The residue definition differs for the following combinations pesticide-code number: imazalil - code 1000000 except 1040000: sum of imazalil and metabolite FK-772 (any ratio of constituent isomers), expressed as imazalil
(+) The European Food Safety Authority identified some information on the toxicity of metabolites as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 26 September 2021, or, if that information is not submitted by that date, the lack of it.0110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins
(+) The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 26 September 2021, or, if that information is not submitted by that date, the lack of it.0232030Courgettes
(+) The European Food Safety Authority identified some information on the toxicity of metabolites as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 26 September 2021, or, if that information is not submitted by that date, the lack of it.0233010Melons
(+) The European Food Safety Authority identified some information on the toxicity of metabolites and storage stability as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 26 September 2021, or, if that information is not submitted by that date, the lack of it.1011010Muscle1011020Fat1011030Liver1011040Kidney1012010Muscle1012020Fat1012030Liver1012040Kidney1015010Muscle1015020Fat1015030Liver1015040Kidney1020010Cattle1020040Horse'
((2)) In part B of Annex III, the column for imazalil is deleted.
