Commission Regulation (EU) 2023/1049 of 30 May 2023 amending Annexes II and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fish oil, pendimethalin, sheep fat and spirotetramat in or on certain productsText with EEA relevance.

Commission Regulation (EU) 2023/1049 of 30 May 2023 amending Annexes II and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fish oil, pendimethalin, sheep fat and spirotetramat 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 5(1) and Article 14(1), point (a), thereof, Whereas: (1) For pendimethalin and spirotetramat, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. Fish oil and sheep fat are included in Annex IV to that Regulation. (2) As regards the active substance pendimethalin, an application pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRLs was submitted for peas (with pods), beans (with pods) and leeks. As regards the active substance spirotetramat, such an application was submitted for herbs and edible flowers. (3) 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. (4) The European Food Safety Authority (the Authority) assessed the applications and the evaluation reports, examining in particular the risks to consumers and, where relevant, to animals, and gave reasoned opinions on the proposed MRLs Reasoned Opinion on the modification of the existing maximum residue levels for pendimethalin in peas (with pods), beans (with pods) and leeks. EFSA Journal 2023;21(3):7663. Reasoned Opinion on the modification of the existing maximum residue levels for spirotetramat in herbs and edible flowers. EFSA Journal 2022;20(12):7668. . It forwarded those opinions to the applicants, the Commission and the Member States and made them available to the public. (5) As regards spirotetramat, in herbs and edible flowers, others, the Authority did not recommend a specific MRL value. Nevertheless, the Authority noted that risk managers may consider to implement the MRL of 10 mg/kg to the whole group of herbs and edible flowers, and that this would be safe for consumers. Therefore, it is appropriate to propose setting the MRL for spirotetramat in herbs and edible flowers, others, at 10 mg/kg in accordance with the relevant Commission Technical Guidelines Commission Technical Guidelines on data requirements for setting MRLs, comparability of residue trials and extrapolation of residue data on products from plant and animal origin (SANTE/2019/12752) . (6) For pendimethalin and spirotetramat, 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 applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. In so concluding, the Authority took into account the most recent data on the toxicological properties of the substances. Neither the long-term exposure to these substances via consumption of all food products that may contain them, nor the short-term exposure due to high consumption of the relevant products showed a risk that the acceptable daily intake or the acute reference dose is exceeded.

(7) Based on the reasoned opinions of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, it is appropriate to conclude that the proposed modifications to the MRLs fulfil the requirements of that article. (8) Fish oil and sheep fat were temporarily included in Annex IV to Regulation (EC) No 396/2005 pending the finalisation of their evaluation either under Council Directive 91/414/EEC Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1). or under 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). , and pending the review of MRLs on those active substances in accordance with Article 12 of Regulation (EC) No 396/2005. In the context of applications for renewal of the approval of those active substances under Regulation (EC) No 1107/2009, the Authority issued conclusions on the peer review of the pesticide risk assessment of fish oil and sheep fat Conclusion on the peer review of the pesticide risk assessment of the active substance fish oil. EFSA Journal 2022;20(1):7079. Conclusion on the peer review of the pesticide risk assessment of the active substance sheep fat. EFSA Journal 2022;20(1):7073. . Based on those conclusions, no MRLs are required for fish oil and sheep fat. Therefore, it is appropriate for those substances to remain in Annex IV to Regulation (EC) No 396/2005. (9) Regulation (EC) No 396/2005 should therefore be amended accordingly. (10) 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 IV to Regulation (EC) No 396/2005 are 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. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 30 May 2023. For the Commission The President Ursula von der Leyen

Annex

ANNEX Annexes II and IV to Regulation (EC) No 396/2005 are amended as follows: (1) in Annex II, the columns for pendimethalin and spirotetramat are 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 Pendimethalin (F) (F) Fat soluble Spirotetramat and spirotetramat-enol (sum of), expressed as spirotetramat (R) (R) The residue definition differs for the following combinations pesticide-code number: Spirotetramat - Code 1000000 except 1040000: spirotetramat-enol expressed as spirotetramat

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 20 April 2023, or, if that information is not submitted by that date, the lack of it. 0242010 Brussels sprouts 0244000 (d) kohlrabies Code numberGroups and examples of individual products to which the MRLs applyPendimethalin (F)Spirotetramat and spirotetramat-enol (sum of), expressed as spirotetramat (R)(1)(2)(3)(4)0100000FRUITS, FRESH or FROZEN; TREE NUTS0,050110000Citrus fruits0,50110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0,50120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,70130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2) 0140000Stone fruits30140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2)0150000Berries and small fruits0151000 (a) grapes 20151010Table grapes0151020Wine grapes0152000 (b) strawberries 0,30153000 (c) cane fruits 0,020153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)0154000 (d) other small fruits and berries 1,50154010Blueberries0154020Cranberries0154030Currants (black, red and white)0154040Gooseberries (green, red and yellow)0154050Rose hips0154060Mulberries (black and white)0154070Azaroles/Mediterranean medlars0154080Elderberries0154990Others (2)0160000Miscellaneous fruitswith0161000 (a) edible peel 0161010Dates0,020161020Figs0,020161030Table olives1,50161040Kumquats0,020161050Carambolas0,02 0161060Kaki/Japanese persimmons0,40161070Jambuls/jambolans0,020161990Others (2)0,020162000 (b) inedible peel, small 0162010Kiwi fruits (green, red, yellow)30162020Litchis/lychees150162030Passionfruits/maracujas0,020162040Prickly pears/cactus fruits0,020162050Star apples/cainitos0,020162060American persimmons/Virginia kaki0,020162990Others (2)0,020163000 (c) inedible peel, large 0163010Avocados0,40163020Bananas0,40163030Mangoes0,30163040Papayas0,40163050Granate apples/pomegranates0,40163060Cherimoyas0,020163070Guavas20163080Pineapples0,150163090Breadfruits0,020163100Durians0,020163110Soursops/guanabanas0,020163990Others (2)0,020200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0211000 (a) potatoes 0,050,80212000 (b) tropical root and tuber vegetables 0,050,020212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2) 0213000 (c) other root and tuber vegetables except sugar beets 0,070213010Beetroots0,050213020Carrots0,70213030Celeriacs/turnip rooted celeries0,20213040Horseradishes0,70213050Jerusalem artichokes0,050213060Parsnips0,70213070Parsley roots/Hamburg roots parsley0,70213080Radishes0,050213090Salsifies0,70213100Swedes/rutabagas0,40213110Turnips0,40213990Others (2)0,050220000Bulb vegetables0,050220010Garlic0,30220020Onions0,40220030Shallots0,30220040Spring onions/green onions and Welsh onions0,90220990Others (2)0,020230000Fruiting vegetables0,050231000

(a) Solanaceae and Malvaceae 10231010Tomatoes0231020Sweet peppers/bell peppers0231030Aubergines/eggplants0231040Okra/lady's fingers0231990Others (2)0232000 (b) cucurbits with edible peel 0,20232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)0233000 (c) cucurbits with inedible peel 0,20233010Melons 0233020Pumpkins0233030Watermelons0233990Others (2)0234000 (d) sweet corn 1,50239000 (e) other fruiting vegetables 0,020240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0241000 (a) flowering brassica 0,0510241010Broccoli0241020Cauliflowers0241990Others (2)0242000 (b) head brassica 0,050242010Brussels sprouts0,3(+)0242020Head cabbages20242990Others (2)0,020243000 (c) leafy brassica 0,570243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)0244000 (d) kohlrabies 0,31,5(+)0250000Leaf vegetables, herbs and edible flowers0251000 (a) lettuces and salad plants 70251010Lamb's lettuces/corn salads0,60251020Lettuces40251030Escaroles/broad-leaved endives0,050251040Cresses and other sprouts and shoots0,60251050Land cresses0,050251060Roman rocket/rucola0,60251070Red mustards0,050251080Baby leaf crops (including brassica species)0,60251990Others (2)0,050252000 (b) spinaches and similar leaves 0,0570252010Spinaches0252020Purslanes 0252030Chards/beet leaves0252990Others (2)0253000 (c) grape leaves and similar species 0,050,020254000 (d) watercresses 0,0570255000 (e) witloofs/Belgian endives 0,050,030256000 (f) herbs and edible flowers 0256010Chervil0,670256020Chives0,670256030Celery leaves0,670256040Parsley270256050Sage2100256060Rosemary0,6100256070Thyme0,6100256080Basil and edible flowers0,670256090Laurel/bay leaves0,6100256100Tarragon0,670256990Others (2)0,6100260000Legume vegetables0260010Beans (with pods)0,0620260020Beans (without pods)0,051,50260030Peas (with pods)0,0920260040Peas (without pods)0,051,50260050Lentils0,051,50260990Others (2)0,050,020270000Stem vegetables0270010Asparagus0,10,020270020Cardoons0,050,020270030Celeries0,140270040Florence fennels0,140270050Globe artichokes0,0510270060Leeks0,30,90270070Rhubarbs0,0540270080Bamboo shoots0,050,020270090Palm hearts0,050,02 0270990Others (2)0,050,020280000Fungi, mosses and lichens0,050,020280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,050,020300000PULSES0,1520300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,050401000Oilseeds0401010Linseeds0,020401020Peanuts/groundnuts0,020401030Poppy seeds0,020401040Sesame seeds0,020401050Sunflower seeds0,020401060Rapeseeds/canola seeds0,020401070Soyabeans40401080Mustard seeds0,020401090Cotton seeds0,40401100Pumpkin seeds0,020401110Safflower seeds0,020401120Borage seeds0,020401130Gold of pleasure seeds0,020401140Hemp seeds0,020401150Castor beans0,020401990Others (2)0,020402000Oil fruits0402010Olives for oil production1,50402020Oil palms kernels0,020402030Oil palms fruits0,02 0402040Kapok0,020402990Others (2)0,020500000CEREALS0,050,020500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2)0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0610000Teas0,050,10620000Coffee beans0,050,10630000Herbal infusions from0631000

(a) flowers 0,050,10631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)0632000 (b) leaves and herbs 0,05500632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)0633000 (c) roots 0,50,10633010Valerian0633020Ginseng0633990Others (2) 0639000 (d) any other parts of the plant 0,050,10640000Cocoa beans0,050,10650000Carobs/Saint John's breads0,050,10700000HOPS0,05150800000SPICES0810000Seed spices0,050,10810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,050,10820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,050,10830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,050,10840020Ginger (10)0840030Turmeric/curcuma0,050,1 0840040Horseradish (11)0840990Others (2)0,050,10850000Bud spices0,050,10850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,050,10860010Saffron0860990Others (2)0870000Aril spices0,050,10870010Mace0870990Others (2)0900000SUGAR PLANTS0900010Sugar beet roots0,050,060900020Sugar canes0,050,020900030Chicory roots0,20,070900990Others (2)0,050,021000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from1011000 (a) swine 1011010Muscle0,010,051011020Fat0,20,021011030Liver0,050,71011040Kidney0,050,71011050Edible offals (other than liver and kidney)0,050,71011990Others (2)0,010,021012000 (b) bovine 1012010Muscle0,010,051012020Fat0,20,021012030Liver0,050,71012040Kidney0,050,71012050Edible offals (other than liver and kidney)0,050,71012990Others (2)0,010,02 1013000 (c) sheep 1013010Muscle0,010,051013020Fat0,20,021013030Liver0,050,71013040Kidney0,050,71013050Edible offals (other than liver and kidney)0,050,71013990Others (2)0,010,021014000 (d) goat 1014010Muscle0,010,051014020Fat0,20,021014030Liver0,050,71014040Kidney0,050,71014050Edible offals (other than liver and kidney)0,050,71014990Others (2)0,010,021015000 (e) equine 1015010Muscle0,010,051015020Fat0,20,021015030Liver0,050,71015040Kidney0,050,71015050Edible offals (other than liver and kidney)0,050,71015990Others (2)0,010,021016000 (f) poultry 0,010,021016010Muscle1016020Fat1016030Liver1016040Kidney1016050Edible offals (other than liver and kidney)1016990Others (2)1017000 (g) other farmed terrestrial animals 1017010Muscle0,010,051017020Fat0,20,021017030Liver0,050,71017040Kidney0,050,71017050Edible offals (other than liver and kidney)0,050,71017990Others (2)0,010,02 1020000Milk0,020,011020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,010,011030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,050,51050000Amphibians and Reptiles0,010,021060000Terrestrial invertebrate animals0,010,021070000Wild terrestrial vertebrate animals0,010,021100000PRODUCTS 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)