Commission Regulation (EU) 2019/88 of 18 January 2019 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid in certain productsText with EEA relevance.

Commission Regulation (EU) 2019/88 of 18 January 2019 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid in 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) thereof, Whereas: (1) For acetamiprid, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. (2) In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance acetamiprid on table olives and olives for oil production, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs. (3) Such an application was also submitted for the use of acetamiprid on barley and oats. (4) In accordance with Article 8 of Regulation (EC) No 396/2005, those applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission. (5) The European Food Safety Authority (the Authority) assessed the applications and the evaluation reports, examining in particular the risks to the consumer and, where relevant, to animals and gave a reasoned opinion on the proposed MRLs EFSA scientific reports available online: http://www.efsa.europa.eu: Reasoned opinion on the focussed assessment of certain existing MRLs of concern for acetamiprid and modification of the existing MRLs for table olives, olives for oil production, barley and oats. EFSA Journal 2018;16(5):5262. . The Authority forwarded that opinion to the applicant, the Commission and the Member States and made it available to the public. (6) The Authority concluded in its reasoned opinion that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicant were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. The Authority took into account the most recent information on the toxicological properties of the substance. Neither the lifetime exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded. (7) In the context of the procedure for the renewal of the approval of the active substance acetamiprid in accordance with 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).

, the Authority submitted a conclusion on the peer review of the pesticide risk assessment concerning that active substance Conclusion on the peer review of the pesticide risk assessment of the active substance acetamiprid. EFSA Journal 2016;14(11):4610. , where new toxicological endpoints were proposed. These endpoints were agreed by the Standing Committee on Plants, Animals, Food and Feed on 13 December 2017 Review report for the active substance acetamiprid (SANTE/10502/2017 Rev. 4). . (8) In accordance with Article 43 of Regulation (EC) No 396/2005, the Commission requested the Authority to assess the risks the current MRLs for acetamiprid may pose to consumers in the light of the resulting lower acute reference dose (ARfD). (9) The Authority identified in its reasoned opinion Reasoned opinion on the focussed assessment of certain existing MRLs of concern for acetamiprid and modification of the existing MRLs for table olives, olives for oil production, barley and oats. EFSA Journal 2018;16(5):5262. consumer intake concerns for apples, pears, peaches, head cabbages, Chinese cabbages, kales, lettuces, escaroles, spinaches, purslanes, chards and celeries. Member States were consulted to report potential fall-back Good Agricultural Practices (GAPs) that would not lead to an unacceptable risk for consumers. Member States identified fall-back GAPs for all concerned products except for Chinese cabbages, kales and celeries, for which the MRLs should be set at the relevant limit of determination. (10) As regards escaroles, the Authority concluded that some information was not available and that further consideration by risk managers was required. As there is no risk for consumers in relation to the fall-back GAP, the MRL for that product should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. This MRL will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. (11) 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. (12) Regulation (EC) No 396/2005 should therefore be amended accordingly. (13) 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. (14) 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 II to Regulation (EC) No 396/2005 is amended in accordance with the Annex to this Regulation.

Article 2

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 13 August 2019. However, for acetamiprid in olives for oil production, table olives, barley and oats, it shall apply from 13 February 2019.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 18 January 2019. For the Commission The President Jean-Claude Juncker

Annex

ANNEX In Annex II to Regulation (EC) No 396/2005, the column for acetamiprid is replaced by the following: Pesticide residues and maximum residue levels (mg/kg) Limit of analytical determination For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I. Acetamiprid (R) (R) The residue definition differs for the following combinations pesticide-code number: Acetamiprid - code 1000000 except 1040000: Sum of acetamiprid and N-desmethyl-acetamiprid (IM-2-1), expressed as acetamiprid (+) 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 24 January 2021, or, if that information is not submitted by that date, the lack of it. 0251030Escaroles/broad-leaved endives Code numberGroups and examples of individual products to which the MRLs applyAcetamiprid (R)(1)(2)(3)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0,90110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,070120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0130010Apples0,40130020Pears0,40130030Quinces0,80130040Medlars0,80130050Loquats/Japanese medlars0,80130990Others (2)0,80140000Stone fruits0140010Apricots0,80140020Cherries (sweet)1.50140030Peaches0,20140040Plums0,030140990Others (2)0,010150000Berries and small fruits0151000 (a) grapes 0,50151010Table grapes0151020Wine grapes 0152000 (b) strawberries 0,50153000 (c) cane fruits 20153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)0154000 (d) other small fruits and berries 0154010Blueberries20154020Cranberries20154030Currants (black, red and white)20154040Gooseberries (green, red and yellow)20154050Rose hips20154060Mulberries (black and white)20154070Azaroles/Mediterranean medlars0,010154080Elderberries20154990Others (2)0,010160000Miscellaneous fruits with0161000 (a) edible peel 0161010Dates0,010161020Figs0,030161030Table olives30161040Kumquats0,010161050Carambolas0,010161060Kaki/Japanese persimmons0,010161070Jambuls/jambolans0,010161990Others (2)0,010162000 (b) inedible peel, small 0,010162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees0162030Passionfruits/maracujas0162040Prickly pears/cactus fruits0162050Star apples/cainitos0162060American persimmons/Virginia kaki0162990Others (2)0163000 (c) inedible peel, large 0163010Avocados0,010163020Bananas0,40163030Mangoes0,010163040Papayas0,010163050Granate apples/pomegranates0,010163060Cherimoyas0,010163070Guavas0,010163080Pineapples0,010163090Breadfruits0,010163100Durians0,010163110Soursops/guanabanas0,010163990Others (2)0,01

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 vegetables0220010Garlic0,020220020Onions0,020220030Shallots0,010220040Spring onions/green onions and Welsh onions0,010220990Others (2)0,010230000Fruiting vegetables0231000 (a) Solanaceae and Malvaceae 0231010Tomatoes0,50231020Sweet peppers/bell peppers0,30231030Aubergines/eggplants0,20231040Okra/lady's fingers0,20231990Others (2)0,20232000 (b) cucurbits with edible peel 0232010Cucumbers0,30232020Gherkins0,60232030Courgettes0,30232990Others (2)0,30233000 (c) cucurbits with inedible peel 0,20233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)0234000 (d) sweet corn 0,010239000 (e) other fruiting vegetables 0,2 0240000Brassica vegetables (excluding brassica roots and brassica baby leaf crops)0241000 (a) flowering brassica 0,40241010Broccoli0241020Cauliflowers0241990Others (2)0242000 (b) head brassica 0242010Brussels sprouts0,050242020Head cabbages0,40242990Others (2)0,010243000 (c) leafy brassica 0,010243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)0244000 (d) kohlrabies 0,010250000Leaf vegetables, herbs and edible flowers0251000 (a) lettuces and salad plants 0251010Lamb's lettuces/corn salads30251020Lettuces1,50251030Escaroles/broad-leaved endives0,4 (+)0251040Cresses and other sprouts and shoots30251050Land cresses30251060Roman rocket/rucola30251070Red mustards30251080Baby leaf crops (including brassica species)30251990Others (2)0,010252000 (b) spinaches and similar leaves 0,60252010Spinaches0252020Purslanes0252030Chards/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 30256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0260010Beans (with pods)0,60260020Beans (without pods)0,3 0260030Peas (with pods)0,60260040Peas (without pods)0,30260050Lentils0,010260990Others (2)0,010270000Stem vegetables0270010Asparagus0,80270020Cardoons0,010270030Celeries0,010270040Florence fennels0,010270050Globe artichokes0,70270060Leeks0,010270070Rhubarbs0,010270080Bamboo shoots0,010270090Palm hearts0,010270990Others (2)0,010280000Fungi, mosses and lichens0,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010300000PULSES0,150300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0401000Oilseeds0401010Linseeds0,010401020Peanuts/groundnuts0,010401030Poppy seeds0,010401040Sesame seeds0,010401050Sunflower seeds0,010401060Rapeseeds/canola seeds0,40401070Soyabeans0,010401080Mustard seeds0,010401090Cotton seeds0,70401100Pumpkin seeds0,010401110Safflower seeds0,010401120Borage seeds0,010401130Gold of pleasure seeds0,010401140Hemp seeds0,010401150Castor beans0,010401990Others (2)0,010402000Oil fruits0402010Olives for oil production30402020Oil palms kernels0,010402030Oil palms fruits0,010402040Kapok0,010402990Others (2)0,01

0500000CEREALS0500010Barley0,050500020Buckwheat and other pseudocereals0,010500030Maize/corn0,010500040Common millet/proso millet0,010500050Oat0,050500060Rice0,010500070Rye0,010500080Sorghum0,010500090Wheat0,10500990Others (2)0,010600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,050610000Teas0620000Coffee beans0630000Herbal infusions from0631000 (a) flowers 0631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/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 spices0820010Allspice/pimento0,050820020Sichuan pepper0,050820030Caraway0,050820040Cardamom0,10820050Juniper berry0,050820060Peppercorn (black, green and white)0,10820070Vanilla0,050820080Tamarind0,050820990Others (2)0,050830000Bark 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 1011010Muscle0,51011020Fat0,31011030Liver11011040Kidney11011050Edible offals (other than liver and kidney)11011990Others (2)0,021012000 (b) bovine 1012010Muscle0,51012020Fat0,31012030Liver11012040Kidney1 1012050Edible offals (other than liver and kidney)11012990Others (2)0,021013000 (c) sheep 1013010Muscle0,51013020Fat0,31013030Liver11013040Kidney11013050Edible offals (other than liver and kidney)11013990Others (2)0,021014000 d) goat 1014010Muscle0,51014020Fat0,31014030Liver11014040Kidney11014050Edible offals (other than liver and kidney)11014990Others (2)0,021015000 (e) equine 1015010Muscle0,51015020Fat0,31015030Liver11015040Kidney11015050Edible offals (other than liver and kidney)11015990Others (2)0,021016000 (f) poultry 1016010Muscle0,021016020Fat0,021016030Liver0,11016040Kidney0,11016050Edible offals (other than liver and kidney)0,021016990Others (2)0,021017000 (g) other farmed terrestrial animals 1017010Muscle0,51017020Fat0,31017030Liver11017040Kidney11017050Edible offals (other than liver and kidney)11017990Others (2)0,021020000Milk0,21020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,021030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2) 1040000Honey and other apiculture products (7)0,051050000Amphibians and Reptiles0,021060000Terrestrial invertebrate animals0,021070000Wild terrestrial vertebrate animals0,021100000PRODUCTS 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)