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 productsText with EEA relevance.

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 OJ L 70, 16.3.2005, p. 1. , 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 European Food Safety Authority; Review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(9):4977. . 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 European Food Safety Authority; Modification of the existing maximum residue levels for imazalil in various commodities. EFSA Journal 2018;16(6):5329. 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 European Food Safety Authority; Reasoned Opinion on the updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information. EFSA Journal 2018;16(10):5453. 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 Commission Implementing Regulation (EU) No 705/2011 of 20 July 2011 approving the active substance imazalil, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 190, 21.7.2011, p. 43).

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 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). . While in the risk assessment preceding the adoption of that Regulation the Authority had identified uncertainties regarding the toxicological properties of metabolite R014821 European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance imazalil. EFSA Journal 2010, 8(3):1526. , 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

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) Limit of analytical determination () Pesticide-code combination for which the MRL as set in Annex III Part B applies. For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I. 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 Code numberGroups and examples of individual products to which the MRLs applyImazalil (any ratio of constituent isomers) (R)(1)(2)(3)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0110010Grapefruits4 (+)0110020Oranges4 (+)0110030Lemons5 (+)0110040Limes5 (+)0110050Mandarins5 (+)0110990Others (2)0,010120000Tree nuts0,010120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,010130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0,010140010Apricots0140020Cherries (sweet)0140030Peaches 0140040Plums0140990Others (2)0150000Berries and small fruits0151000 (a) grapes 0,010151010Table grapes0151020Wine grapes0152000 (b) strawberries 20153000 (c) cane fruits 0153010Blackberries20153020Dewberries0,010153030Raspberries (red and yellow)20153990Others (2)0,010154000 (d) other small fruits and berries 0,010154010Blueberries0154020Cranberries0154030Currants (black, red and white)0154040Gooseberries (green, red and yellow)0154050Rose hips0154060Mulberries (black and white)0154070Azaroles/Mediterranean medlars0154080Elderberries0154990Others (2)0160000Miscellaneous fruits with0,010161000 (a) edible peel 0161010Dates0161020Figs0161030Table olives0161040Kumquats0161050Carambolas0161060Kaki/Japanese persimmons0161070Jambuls/jambolans0161990Others (2)0162000 (b) inedible peel, small 0162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees0162030Passionfruits/maracujas0162040Prickly pears/cactus fruits0162050Star apples/cainitos0162060American persimmons/Virginia kaki0162990Others (2)0163000 (c) inedible peel, large 0163010Avocados0163020Bananas 0163030Mangoes0163040Papayas0163050Granate apples/pomegranates0163060Cherimoyas0163070Guavas0163080Pineapples0163090Breadfruits0163100Durians0163110Soursops/guanabanas0163990Others (2)0200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0,010211000 (a) potatoes 0212000 (b) tropical root and tuber vegetables 0212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)0213000 (c) other root and tuber vegetables except sugar beets 0213010Beetroots0213020Carrots0213030Celeriacs/turnip rooted celeries0213040Horseradishes0213050Jerusalem artichokes0213060Parsnips0213070Parsley roots/Hamburg roots parsley0213080Radishes0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2)0220000Bulb vegetables0,010220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0231000

(a) Solanaceae and Malvaceae 0231010Tomatoes0,30231020Sweet peppers/bell peppers0,010231030Aubergines/eggplants0,010231040Okra/lady's fingers0,010231990Others (2)0,01 0232000 (b) cucurbits with edible peel 0232010Cucumbers0,50232020Gherkins0,50232030Courgettes0,1 (+)0232990Others (2)0,010233000 (c) cucurbits with inedible peel 0233010Melons2 (+)0233020Pumpkins0,010233030Watermelons0,010233990Others (2)0,010234000 (d) sweet corn 0,010239000 (e) other fruiting vegetables 0,010240000Brassica vegetables (excluding brassica roots and brassica baby leaf crops)0,010241000 (a) flowering brassica 0241010Broccoli0241020Cauliflowers0241990Others (2)0242000 (b) head brassica 0242010Brussels sprouts0242020Head cabbages0242990Others (2)0243000 (c) leafy brassica 0243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)0244000 (d) kohlrabies 0250000Leaf vegetables, herbs and edible flowers0251000 (a) lettuces and salad plants 0,010251010Lamb's lettuces/corn salads0251020Lettuces0251030Escaroles/broad-leaved endives0251040Cresses and other sprouts and shoots0251050Land cresses0251060Roman rocket/rucola0251070Red mustards0251080Baby leaf crops (including brassica species)0251990Others (2)0252000 (b) spinaches and similar leaves 0,010252010Spinaches0252020Purslanes 0252030Chards/beet leaves0252990Others (2)0253000 (c) grape leaves and similar species 0,010254000 (d) watercresses 0,010255000 (e) witloofs/Belgian endives 0,010256000 (f) herbs and edible flowers 0,020256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,010260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0,010270010Asparagus0270020Cardoons0270030Celeries0270040Florence fennels0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010300000PULSES0,010300010Beans0300020Lentils 0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,010401000Oilseeds0401010Linseeds0401020Peanuts/groundnuts0401030Poppy seeds0401040Sesame seeds0401050Sunflower seeds0401060Rapeseeds/canola seeds0401070Soyabeans0401080Mustard seeds0401090Cotton seeds0401100Pumpkin seeds0401110Safflower seeds0401120Borage seeds0401130Gold of pleasure seeds0401140Hemp seeds0401150Castor beans0401990Others (2)0402000Oil fruits0402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)0500000CEREALS0,010500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2)0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,050610000Teas0620000Coffee beans0630000Herbal infusions from0631000

(a) flowers 0631010Chamomile0631020Hibiscus/roselle 0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)0632000 (b) leaves and herbs 0632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)0633000 (c) roots 0633010Valerian0633020Ginseng0633990Others (2)0639000 (d) any other parts of the plant 0640000Cocoa beans0650000Carobs/Saint John's breads0700000HOPS0,050800000SPICES0810000Seed spices0,050810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,050820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,050830010Cinnamon0830990Others (2) 0840000Root and rhizome spices0840010Liquorice0,050840020Ginger (10)0,050840030Turmeric/curcuma0,050840040Horseradish (11)0840990Others (2)0,050850000Bud spices0,050850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,050860010Saffron0860990Others (2)0870000Aril spices0,050870010Mace0870990Others (2)0900000SUGAR PLANTS0,010900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from1011000 (a) swine 0,021011010Muscle(+)1011020Fat(+)1011030Liver(+)1011040Kidney(+)1011050Edible offals (other than liver and kidney)1011990Others (2)1012000 (b) bovine 1012010Muscle0,02 (+)1012020Fat0,02 (+)1012030Liver0,03 (+)1012040Kidney0,02 (+)1012050Edible offals (other than liver and kidney)0,021012990Others (2)0,021013000 (c) sheep 0,011013010Muscle1013020Fat1013030Liver 1013040Kidney1013050Edible offals (other than liver and kidney)1013990Others (2)1014000 (d) goat 0,011014010Muscle1014020Fat1014030Liver1014040Kidney1014050Edible offals (other than liver and kidney)1014990Others (2)1015000 (e) equine 1015010Muscle0,02 (+)1015020Fat0,02 (+)1015030Liver0,03 (+)1015040Kidney0,02 (+)1015050Edible offals (other than liver and kidney)0,021015990Others (2)0,021016000 (f) poultry 0,011016010Muscle1016020Fat1016030Liver1016040Kidney1016050Edible offals (other than liver and kidney)1016990Others (2)1017000 (g) other farmed terrestrial animals 0,011017010Muscle1017020Fat1017030Liver1017040Kidney1017050Edible offals (other than liver and kidney)1017990Others (2)1020000Milk1020010Cattle0,02 (+)1020020Sheep0,011020030Goat0,011020040Horse0,02 (+)1020990Others (2)0,011030000Birds eggs0,011030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2) 1040000Honey and other apiculture products (7)0,051050000Amphibians and Reptiles0,011060000Terrestrial invertebrate animals0,011070000Wild terrestrial vertebrate animals0,011100000PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)1200000PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)1300000PROCESSED FOOD PRODUCTS (9) (2) In part B of Annex III, the column for imazalil is deleted.