Commission Regulation (EU) 2023/198 of 30 January 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for abamectin in or on certain productsText with EEA relevance.

Commission Regulation (EU) 2023/198 of 30 January 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for abamectin 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) For abamectin, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. (2) During the review of those MRLs in accordance with Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (the Authority), identified in its reasoned opinion European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels (MRLs) for abamectin according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2014;12(9):3823. some information as unavailable for certain products. The available information was sufficient for the Authority to propose MRLs that are safe for consumers and the data gaps were indicated in Annex II of that Regulation specifying the date by which the missing information was to be submitted to the Authority in support of the proposed MRLs. (3) The applicant submitted the missing data together with a request based on Article 6 of Regulation (EC) No 396/2005 to modify the existing MRLs for abamectin in certain products. (4) In accordance with Article 8 of Regulation (EC) No 396/2005, the application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. (5) The Authority assessed the application and the evaluation report, examining in particular risks to consumers and, where relevant, to animals. (6) On 23 January 2020, the Authority published a reasoned opinion on the evaluation of the confirmatory data submitted following the MRL review under Article 12 of Regulation (EC) No 396/2005 and on the request to modify the existing maximum residue levels for abamectin in various commodities European Food Safety Authority; Reasoned opinion on evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for abamectin in various commodities. EFSA Journal 2020;18(1):5989. . (7) For almonds, hazelnuts/cobnuts, walnuts, currants (black, red and white), gooseberries (green, red and yellow), papayas and witloofs/Belgian endives information concerning residue trials was not submitted by the applicant. The Authority concluded that the data gap was thus not sufficiently addressed and that risk managers may consider setting or keeping those MRLs at the limit of determination (LOD). Therefore, for these products, it is appropriate to set the MRLs in Annex II to Regulation (EC) No 396/2005 at the LOD. It is therefore appropriate to amend the Annex II and to delete the reference concerning additional information from that Annex.

(8) For quinces, medlars, loquats/Japanese medlars, the applicant proposed to derive an MRL based on an alternative Good Agricultural Practices (GAP). This use and the residue trials were already assessed in a previous reasoned opinion European Food Safety Authority; Reasoned opinion on the modification of the existing MRLs forabamectin in various crops. EFSA Journal 2015;13(7):4189. . The Authority concluded that the residue data were sufficient to support lower MRL proposals for those products. Therefore, for those products, MRLs in Annex II to Regulation (EC) No 396/2005 should be set at the level identified by the Authority. (9) For celery leaves, beans with pods and peas with pods, Authority concluded that residue data were sufficient to support the MRL for those products. Therefore, for these products, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the level requested by the applicant. (10) In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 applications for import tolerances were submitted for abamectin used in the United States on certain products. (11) The applicant states that the authorised uses of abamectin on such crops in that country lead to residues exceeding the MRLs contained in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of those crops. (12) In accordance with Article 8 of Regulation (EC) No 396/2005, those applications were evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. (13) The Authority assessed the applications and the evaluation report, examining in particular risks to consumers and, where relevant, to animals. (14) On 10 July 2020, the Authority published a reasoned opinion on setting of import tolerances for abamectin in various crops European Food Safety Authority; Reasoned opinion on setting of import tolerances for abamectin in various crops. EFSA Journal 2020;18(7):6173. . (15) As regards modifications to MRLs requested by the applicant for avocados, cresses and other sprouts and shoot, land cresses, Roman rocket/rucola, baby leaf crops (including brassica species), other lettuces and salad plants, purslanes, Florence fennels and cotton seeds, the Authority concluded, that all requirements with respect to completeness of data submission 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 the substance via consumption of all food products that may contain them, 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. Therefore, for these products, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the level requested by the applicant.

(16) In the context of the procedure for the renewal of the approval of the active substance abamectin 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 published a conclusion on the peer review of the risk assessment European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance abamectin. EFSA Journal 2020;18(8):6227. of that active substance. The Authority proposed, based on the developmental neurotoxicity studies, that a lower acceptable daily intake (ADI) and acute reference dose (ARfD) should be established. (17) On 3 February 2021 and in accordance with Article 43 of Regulation (EC) No 396/2005, the Commission requested the Authority to provide a reasoned opinion assessing the risks on certain existing MRLs for abamectin that may pose to consumers in light of the lower ADI and ARfD. (18) On 6 October 2021, the Authority published a reasoned opinion on the focussed assessment of certain existing maximum residues levels of concern for abamectin European Food Safety Authority; Focused assessment of certain existing MRLs of concern for abamectin. EFSA Journal 2021;19(10):6842. . (19) For apples, pears and escaroles/broad-leaved endives, the Authority identified unacceptable risks concerning the current MRLs. Member States were consulted and requested to report potential fall-back GAPs which would lead to safe MRLs for consumers. For apples and pears, a fall-back GAP could not proposed by the Member States. Supporting data was not available for the GAP reported for escaroles/broad-leaved endives. Therefore, no MRL could be derived for apples, pears and escaroles/broad-leaved endives. Therefore, for these products, it is appropriate to set the MRLs in Annex II to Regulation (EC) No 396/2005 at the LOD. (20) For strawberries, tomatoes, cucumbers, courgettes, lamb’s lettuces/corn salads, lettuces, chervil and parsley, the Authority identified unacceptable risks concerning the current MRLs. Member States were consulted and requested to report potential fall-back GAPs which would lead to safe MRLs for consumers. Member States identified such GAPs for strawberries, tomatoes, cucumbers, courgettes, lamb’s lettuces/corn salads, lettuces, chervil and parsley. The Authority therefore recommended lowering the MRLs for those products. Therefore, for these products, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. (21) For sweet peppers/bell peppers, the Authority identified unacceptable risks for consumers with the current MRLs. Member States were consulted and requested to report potential fall-back GAPs which would lead to safe MRLs for consumers. The Authority concluded that although Member States identified a fall-back GAP for sweet peppers/bell peppers, some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for sweet peppers/bell peppers 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.

(22) The Commission consulted the European Union reference laboratories for residues of pesticides on the need to adapt certain LODs. For abamectin, those laboratories proposed product specific LODs that are analytically feasible. (23) 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. (24) Regulation (EC) No 396/2005 should therefore be amended accordingly. (25) In order to allow for the normal marketing, processing and consumption of products, this Regulation should not apply to products which have been produced in the Union or imported into the Union before the modified MRLs start applying and for which information shows that a high level of consumer protection is maintained. This is the case for all products except for apples, pears, strawberries, tomatoes, sweet peppers/bell peppers, cucumbers, courgettes, lamb’s lettuces/corn salads, lettuces, escaroles/broad-leaved endives, chervil and parsley. (26) 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 adapt themselves to meet the new requirements which will result from the modification of the MRLs. (27) 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

As regards active substance abamectin in and on all products except apples, pears, strawberries, tomatoes, sweet peppers/bell peppers, cucumbers, courgettes, lamb’s lettuces/corn salads, lettuces, escaroles/broad-leaved endives, chervil and parsley, 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 20 August 2023.

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 20 August 2023. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 30 January 2023. For the Commission The President Ursula von der Leyen

Annex

ANNEX In Annex II to Regulation (EC) No 396/2005, the column for abamectin is replaced by the following: Pesticide residues and maximum residue levels (mg/kg) Indicates lower limit of analytical determination For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I Abamectin (sum of avermectin B1a, avermectin B1b and delta-8,9 isomer of avermectin B1a, expressed as avermectin B1a) (R) (F) (R) The residue definition differs for the following combinations pesticide-code number: Abamectin — code 1000000 except 1040000: avermectin B1a

(F) Fat soluble 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 31 January 2025, or, if that information is not submitted by that date, the lack of it. 0231020 Sweet peppers/bell peppers Code numberGroups and examples of individual products to which the MRLs applyAbamectin (sum of avermectin B1a, avermectin B1b and delta-8,9 isomer of avermectin B1a, expressed as avermectin B1a) (R) (F)(1)(2)(3)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0,040110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,010120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0130010Apples0,0060130020Pears0,0060130030Quinces0,02 0130040Medlars0,020130050Loquats/Japanese medlars0,020130990Others (2)0,010140000Stone fruits0140010Apricots0,020140020Cherries (sweet)0,010140030Peaches0,020140040Plums0,010140990Others (2)0,010150000Berries and small fruits0151000 (a) grapes 0,010151010Table grapes0151020Wine grapes0152000 (b) strawberries 0,080153000 (c) cane fruits 0153010Blackberries0,080153020Dewberries0,010153030Raspberries (red and yellow)0,080153990Others (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 fruitswith0161000 (a) edible peel 0,010161010Dates0161020Figs0161030Table olives0161040Kumquats0161050Carambolas 0161060Kaki/Japanese persimmons0161070Jambuls/jambolans0161990Others (2)0162000 (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 0163010Avocados0,020163020Bananas0,020163030Mangoes0,010163040Papayas0,010163050Granate apples/pomegranates0,010163060Cherimoyas0,010163070Guavas0,010163080Pineapples0,010163090Breadfruits0,010163100Durians0,010163110Soursops/guanabanas0,010163990Others (2)0,010200000VEGETABLES, 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 celeries0213040Horseradishes 0213050Jerusalem artichokes0213060Parsnips0213070Parsley roots/Hamburg roots parsley0213080Radishes0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2)0220000Bulb vegetables0,010220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0231000

(a) Solanaceae and Malvaceae 0231010Tomatoes0,0150231020Sweet peppers/bell peppers0,03(+)0231030Aubergines/eggplants0,090231040Okra/lady's fingers0,010231990Others (2)0,010232000 (b) cucurbits with edible peel 0232010Cucumbers0,020232020Gherkins0,040232030Courgettes0,020232990Others (2)0,040233000 (c) cucurbits with inedible peel 0,010233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)0234000 (d) sweet corn 0,010239000 (e) other fruiting vegetables 0,010240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0241000 (a) flowering brassica 0,010241010Broccoli0241020Cauliflowers0241990Others (2) 0242000 (b) head brassica 0,010242010Brussels sprouts0242020Head cabbages0242990Others (2)0243000 (c) leafy brassica 0243010Chinese cabbages/pe-tsai0,050243020Kales0,010243990Others (2)0,010244000 (d) kohlrabies 0,010250000Leaf vegetables, herbs and edible flowers0251000 (a) lettuces and salad plants 0251010Lamb's lettuces/corn salads0,080251020Lettuces0,030251030Escaroles/broad-leaved endives0,010251040Cresses and other sprouts and shoots0,080251050Land cresses0,080251060Roman rocket/rucola0,080251070Red mustards0,010251080Baby leaf crops (including brassica species)30251990Others (2)0,080252000 (b) spinaches and similar leaves 0252010Spinaches0,010252020Purslanes0,10252030Chards/beet leaves0,010252990Others (2)0,10253000 (c) grape leaves and similar species 0,010254000 (d) watercresses 0,010255000 (e) witloofs/Belgian endives 0,010256000 (f) herbs and edible flowers 0256010Chervil0,030256020Chives20256030Celery leaves0,030256040Parsley0,030256050Sage20256060Rosemary20256070Thyme2 0256080Basil and edible flowers20256090Laurel/bay leaves20256100Tarragon20256990Others (2)0,020260000Legume vegetables0260010Beans (with pods)0,080260020Beans (without pods)0,010260030Peas (with pods)0,080260040Peas (without pods)0,010260050Lentils0,010260990Others (2)0,010270000Stem vegetables0270010Asparagus0,010270020Cardoons0,010270030Celeries0,050270040Florence fennels0,030270050Globe artichokes0,010270060Leeks0,010270070Rhubarbs0,010270080Bamboo shoots0,010270090Palm hearts0,010270990Others (2)0,010280000Fungi, mosses and lichens0,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010300000PULSES0,010300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0401000Oilseeds0401010Linseeds0,010401020Peanuts/groundnuts0,01 0401030Poppy seeds0,010401040Sesame seeds0,010401050Sunflower seeds0,010401060Rapeseeds/canola seeds0,010401070Soyabeans0,010401080Mustard seeds0,010401090Cotton seeds0,020401100Pumpkin seeds0,010401110Safflower seeds0,010401120Borage seeds0,010401130Gold of pleasure seeds0,010401140Hemp seeds0,010401150Castor beans0,010401990Others (2)0,010402000Oil fruits0,010402010Olives 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 breads0700000HOPS0,10800000SPICES0810000Seed 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)0840030Turmeric/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 0,011011010Muscle1011020Fat1011030Liver1011040Kidney1011050Edible offals (other than liver and kidney)1011990Others (2) 1012000 (b) bovine 1012010Muscle0,011012020Fat0,011012030Liver0,021012040Kidney0,011012050Edible offals (other than liver and kidney)0,021012990Others (2)0,011013000 (c) sheep 1013010Muscle0,021013020Fat0,051013030Liver0,0251013040Kidney0,021013050Edible offals (other than liver and kidney)0,051013990Others (2)0,011014000 d) goat 1014010Muscle0,011014020Fat0,011014030Liver0,021014040Kidney0,011014050Edible offals (other than liver and kidney)0,021014990Others (2)0,011015000 (e) equine 1015010Muscle0,011015020Fat0,011015030Liver0,021015040Kidney0,011015050Edible offals (other than liver and kidney)0,021015990Others (2)0,011016000 (f) poultry 0,011016010Muscle1016020Fat1016030Liver1016040Kidney1016050Edible offals (other than liver and kidney)1016990Others (2)1017000 (g) other farmed terrestrial animals 1017010Muscle0,011017020Fat0,01 1017030Liver0,021017040Kidney0,011017050Edible offals (other than liver and kidney)0,021017990Others (2)0,011020000Milk0,011020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds 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)