Commission Regulation (EU) 2024/2609of 7 October 2024amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for napropamide, pyridaben and tebufenpyrad in or on certain products(Text with EEA relevance)

Commission Regulation (EU) 2024/2609 of 7 October 2024 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for napropamide, pyridaben and tebufenpyrad 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, ELI: http://data.europa.eu/eli/reg/2005/396/oj. , and in particular Article 14(1), point (a) and Article 49(2) thereof, Whereas: (1) For napropamide Commission Regulation (EU) 2020/770 of 8 June 2020 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 myclobutanil, napropamide and sintofen in or on certain products (OJ L 184, 12.6.2020, p. 1, ELI: http://data.europa.eu/eli/reg/2020/770/oj). , pyridaben Commission Regulation (EU) 2019/90 of 18 January 2019 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for bromuconazole, carboxin, fenbutatin oxide, fenpyrazamine and pyridaben in or on certain products (OJ L 22, 24.1.2019, p. 52, ELI: http://data.europa.eu/eli/reg/2019/90/oj). and tebufenpyrad Commission Regulation (EU) 2017/693 of 7 April 2017 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for bitertanol, chlormequat and tebufenpyrad in or on certain products (OJ L 101, 13.4.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/693/oj). , maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. (2) During the review of those MRLs pursuant to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (the Authority) identified some information as unavailable for certain products. The available information was sufficient for the Authority to propose MRLs that are safe for consumers. Data gaps were indicated in Annex II to that Regulation specifying the date by which the missing information was to be submitted to the Authority by the applicant in support of the proposed MRLs. (3) For napropamide in or on citrus fruits, strawberries and cane fruits, the applicant submitted the missing information concerning its storage stability. The Authority concluded that the data gap indicated in Annex II to Regulation (EC) No 396/2005 was sufficiently addressed European Food Safety Authority, Evaluation of confirmatory data following the Article 12 MRL review for napropamide (EFSA Journal, 2023;21(7):8125). . Therefore, for those products, it is appropriate to maintain the existing MRLs and delete the respective footnotes requiring the submission of additional information from Annex II to Regulation (EC) No 396/2005.

(4) For napropamide in or on blueberries, cranberries, currants (black, red and white), gooseberries (green, red and yellow), rose hips and elderberries, the applicant submitted the missing information concerning storage stability. The applicant, however, has not submitted the missing information on crop metabolism for those products. The Authority concluded that the data gap previously identified on crop metabolism has not been addressed and recommended that risk managers consider lowering the MRLs in or on those products to the limit of determination (LOD). Therefore, for those products, it is appropriate to set the MRLs for napropamide at the product-specific LOD and delete the respective footnotes requiring the submission of additional information from Annex II to Regulation (EC) No 396/2005. (5) For napropamide in or on herbs and edible flowers, the applicant did not submit the missing information concerning residue trials. The Authority concluded that the data gap previously identified has not been addressed and recommended that risk managers consider lowering the MRLs in or on those products to the LOD. Therefore, for these products, it is appropriate to set the MRLs for napropamide at the product-specific LOD and delete the respective footnotes requiring the submission of additional information from Annex II to Regulation (EC) No 396/2005. (6) For napropramide in or on herbal infusions from flowers, leaves and herbs, roots, herbal infusions from any other part of the plant, and fruit spices, the applicant did not submit the missing information concerning analytical method for matrices difficult to analyse. The Authority concluded that although that data gap was not addressed, the MRLs for those products should be maintained as they are already at the LOD. Therefore, for those products, it is appropriate to maintain the MRLs for napropamide at the LOD and delete the respective footnotes requiring the submission of additional information from Annex II to Regulation (EC) No 396/2005. (7) For pyridaben in or on apples, pears, quinces, medlars, loquats/Japanese medlars, and other pome fruits, the applicant did not submit the missing information concerning residue trials. However, the new residue data on pears and apples were submitted in support of alternative Good Agricultural Practices for a group of pome fruits. The Authority concluded that the provided residue trials are sufficient European Food Safety Authority, Evaluation of confirmatory data following Article 12 MRL review and modification of the existing MRLs in pome fruits for pyridaben (EFSA Journal, 2023;21(4):7970). to derive a lower MRL for the whole group of pome fruits. Therefore, for pome fruits, it is appropriate to set the MRLs at the level proposed by the Authority and delete the respective footnotes requiring the submission of additional information from Annex II to Regulation (EC) No 396/2005. (8) For pyridaben in or on apricots, peaches and beans (with pods), the applicant did not submit the missing information concerning residue trials. The Authority concluded that the data gap previously identified was not addressed and recommended that risk managers consider lowering the MRLs for those products to the LOD. Therefore, for those products, it is appropriate to set the MRLs for pyridaben at the product-specific LOD and delete respective footnotes requiring the submission of additional information from Annex II to Regulation (EC) No 396/2005.

(9) For pyridaben in or on bovine (muscle, fat, liver, kidney), sheep (muscle, fat, liver, kidney), goat (muscle, fat, liver, kidney), equine (muscle, fat, liver, kidney), and milk (cattle, sheep, goat, horse), the applicant submitted the missing information concerning storage stability, feeding studies and analytical methods. The Authority concluded that the data gap indicated in Annex II to Regulation (EC) No 396/2005 was sufficiently addressed. Therefore, for milk (cattle, sheep, goat, horse) it is appropriate to maintain the MRLs which are already at the LOD and since a lower LOD of 0,01 mg/kg for bovine (muscle, fat, liver, kidney), sheep (muscle, fat, liver, kidney), goat (muscle, fat, liver, kidney), equine (muscle, fat, liver, kidney) is now achievable using the analytical method provided by the applicant, it is appropriate to lower the current LOD of 0,05 mg/kg for those products to the LOD of 0,01 mg/kg, set that LOD and delete the respective footnotes requiring the submission of additional information from Annex II to Regulation (EC) No 396/2005. (10) For tebufenpyrad in or on apricots, peaches, blackberries and dewberries, the applicant submitted the missing information concerning residue trials and the Authority concluded that the data gap indicated in Annex II to Regulation (EC) No 396/2005 was sufficiently addressed European Food Safety Authority, Evaluation of confirmatory data following the Article 12 MRL review for tebufenpyrad (EFSA Journal 2023;21(2):7774). . Based on the residue trials provided, the Authority proposed lowering the existing MRLs for apricots and peaches and maintaining MRLs for blackberries and dewberries. Therefore, for apricots and peaches it is appropriate to set the MRLs at the level proposed by the Authority and maintain the MRLs for blackberries and dewberries and delete the respective footnotes requiring the submission of additional information from Annex II to Regulation (EC) No 396/2005. (11) For tebufenpyrad in or on beans (with pods) and hops, the applicant did not submit the missing information on residue trials for beans (with pods) and on analytical methods for hops. The Authority concluded that the data gap previously identified was not addressed and recommended that risk managers consider lowering the MRLs for those products to the LOD. Therefore, for those products, it is appropriate to set the MRLs for tebufenpyrad at the product-specific LOD and delete respective footnotes requiring the submission of additional information from Annex II to Regulation (EC) No 396/2005. (12) For tebufenpyrad in or on products of animal origin, except honey and other apiculture products, the applicant submitted the missing information. The Authority concluded that the data gap indicated in Annex II to Regulation (EC) No 396/2005 was sufficiently addressed. Therefore, for those products, it is appropriate to maintain the existing MRLs for tebufenpyrad and delete the respective footnotes requiring the submission of additional information in Annex II to Regulation (EC) No 396/2005.

(13) For tebufenpyrad in or on honey and other apiculture products, the applicant did not submit the missing information on specific analytical methods for honey. The Authority concluded that the data gap previously identified was not addressed and recommended to maintain the current MRL, which is at the LOD. Therefore, for those products, it is appropriate to maintain the MRL for tebufenpyrad at the LOD and delete respective footnotes requiring the submission of additional information from Annex II to Regulation (EC) No 396/2005. (14) For tebufenpyrad in or on table grapes, the Authority found that it could not be excluded that the acute reference dose would be exceeded with the current MRL. Risk managers therefore proposed to set a lower MRL for table grapes, based on the less critical and safe fall-back Good Agricultural Practices European Food Safety Authority, Review of the existing maximum residue levels for tebufenpyrad according to Article 12 of Regulation (EC) No 396/2005 (EFSA Journal 2016;14(4):4469). . It is therefore appropriate to lower the existing MRL for tebufenpyrad in Annex II to Regulation (EC) No 396/2005. (15) The Commission consulted the European Union reference laboratories as regards the need to adapt certain LODs. Those laboratories concluded that for certain products technical developments permit the setting of lower LODs. (16) 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. (17) Regulation (EC) No 396/2005 should therefore be amended accordingly. (18) In order to allow for the normal marketing, processing and consumption of products, this Regulation should not apply to products which have been placed on the market in the Union before the new MRLs become applicable and for which a high level of consumer protection is maintained. This is the case for all products except for tebufenpyrad in or on table grapes. (19) 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 the requirements which result from the modification of the MRLs. (20) 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

Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to all products which have been placed on the market in the Union before 28 April 2025 except for tebufenpyrad in or on table grapes.

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 28 April 2025. This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 7 October 2024. For the Commission The President Ursula von der Leyen

Annex

ANNEX In Annex II to Regulation (EC) No 396/2005, the columns for napropamide, pyridaben and tebufenpyrad 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. (+) Pesticide-product combination for which a footnote exists. The list of footnotes is provided below. Pyridaben (F) (F) Fat soluble Tebufenpyrad (F) (F) Fat soluble Code numberGroups and examples of individual products to which the MRLs applyNapropamide (sum of isomers)Pyridaben (F)Tebufenpyrad (F)(1)(2)(3)(4)(5)0100000FRUITS, FRESH or FROZEN; TREE NUTS0,010110000Citrus fruits0,60110010Grapefruits0,50110020Oranges0,30110030Lemons0,30110040Limes0,30110050Mandarins0,30110990Others (2)0,30120000Tree nuts0,050,010120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,15 0130010Apples0,30130020Pears0,30130030Quinces0,80130040Medlars0,80130050Loquats/Japanese medlars0,80130990Others (2)0,010140000Stone fruits0,010140010Apricots0,30140020Cherries (sweet)0,010140030Peaches0,30140040Plums0,20140990Others (2)0,010150000Berries and small fruits0151000 (a) grapes 0,010151010Table grapes0,40151020Wine grapes0,60152000 (b) strawberries 0,910153000 (c) cane fruits 0,010153010Blackberries0,050153020Dewberries0,050153030Raspberries (red and yellow)0,150153990Others (2)0,010154000 (d) other small fruits and berries 0,011,50154010Blueberries0154020Cranberries0154030Currants (black, red and white) 0154040Gooseberries (green, red and yellow)0154050Rose hips0154060Mulberries (black and white)0154070Azaroles/Mediterranean medlars0154080Elderberries0154990Others (2)0160000Miscellaneous fruitswith0,010,010161000 (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 0163010Avocados 0163020Bananas0163030Mangoes0163040Papayas0163050Granate apples/pomegranates0163060Cherimoyas0163070Guavas0163080Pineapples0163090Breadfruits0163100Durians0163110Soursops/guanabanas0163990Others (2)0200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0,010,010,010211000 (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 artichokes

0213060Parsnips0213070Parsley roots/Hamburg roots parsley0213080Radishes0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2)0220000Bulb vegetables0,010,010,010220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0,010231000 (a) Solanaceae and Malvaceae 0231010Tomatoes0,150,80231020Sweet peppers/bell peppers0,30,010231030Aubergines/eggplants0,150,80231040Okra/lady's fingers0,010,010231990Others (2)0,010,010232000 (b) cucurbits with edible peel 0,150232010Cucumbers0,30232020Gherkins0,50232030Courgettes0,30232990Others (2)0,010233000 (c) cucurbits with inedible peel 0,01 0233010Melons0,30233020Pumpkins0,010233030Watermelons0,30233990Others (2)0,010234000 (d) sweet corn 0,010,010239000 (e) other fruiting vegetables 0,010,010240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,010,010241000 (a) flowering brassica 0,010241010Broccoli0241020Cauliflowers0241990Others (2)0242000 (b) head brassica 0,010242010Brussels sprouts0242020Head cabbages0242990Others (2)0243000 (c) leafy brassica 0,050243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)0244000 (d) kohlrabies 0,050250000Leaf vegetables, herbs and edible flowers0251000 (a) lettuces and salad plants 0,010,010251010Lamb's lettuces/corn salads0,050251020Lettuces0,010251030Escaroles/broad-leaved endives0,010251040Cresses and other sprouts and shoots0,01 0251050Land cresses0,010251060Roman rocket/rucola0,050251070Red mustards0,050251080Baby leaf crops (including brassica species)0,050251990Others (2)0,010252000 (b) spinaches and similar leaves 0,010,010,010252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)0253000 (c) grape leaves and similar species 0,010,010,010254000 (d) watercresses 0,010,010,010255000 (e) witloofs/Belgian endives 0,010,010,010256000 (f) herbs and edible flowers 0,020,020,020256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,010,010,01 0260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0,010,010,010270010Asparagus0270020Cardoons0270030Celeries0270040Florence fennels0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0,010,010,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010,010,010300000PULSES0,010,010,010300010Beans0300020Lentils0300030Peas 0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,010401000Oilseeds0401010Linseeds0,020,010401020Peanuts/groundnuts0,010,010401030Poppy seeds0,020,010401040Sesame seeds0,020,010401050Sunflower seeds0,020,010401060Rapeseeds/canola seeds0,020,010401070Soyabeans0,020,010401080Mustard seeds0,020,010401090Cotton seeds0,020,050401100Pumpkin seeds0,020,010401110Safflower seeds0,020,010401120Borage seeds0,020,010401130Gold of pleasure seeds0,020,010401140Hemp seeds0,020,010401150Castor beans0,020,010401990Others (2)0,010,010402000Oil fruits0,010,010402010Olives for oil production0402020Oil palms kernels0402030Oil palms fruits0402040Kapok0402990Others (2)

0500000CEREALS0,010,010,010500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2)0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,050,050,050610000Teas0620000Coffee beans0630000Herbal infusions from0631000 (a) flowers 0631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)0632000 (b) leaves and herbs 0632010Strawberry0632020Rooibos0632030Mate/maté 0632990Others (2)0633000 (c) roots 0633010Valerian0633020Ginseng0633990Others (2)0639000 (d) any other parts of the plant 0640000Cocoa beans0650000Carobs/Saint John's breads0700000HOPS0,050,050,050800000SPICES0810000Seed spices0,050,050,050810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,050,050,050820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom 0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,050,050,050830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,050,050,050840020Ginger (10)0840030Turmeric/curcuma0,050,050,050840040Horseradish (11)0840990Others (2)0,050,050,050850000Bud spices0,050,050,050850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,050,050,050860010Saffron0860990Others (2)0870000Aril spices0,050,050,050870010Mace0870990Others (2)0900000SUGAR PLANTS0,010,010,010900010Sugar beet roots 0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from0,010,010,011011000 (a) swine 1011010Muscle1011020Fat1011030Liver1011040Kidney1011050Edible offals (other than liver and kidney)1011990Others (2)1012000 (b) bovine 1012010Muscle1012020Fat1012030Liver1012040Kidney1012050Edible offals (other than liver and kidney)1012990Others (2)1013000 (c) sheep 1013010Muscle1013020Fat1013030Liver1013040Kidney1013050Edible offals (other than liver and kidney)1013990Others (2) 1014000 (d) goat 1014010Muscle1014020Fat1014030Liver1014040Kidney1014050Edible offals (other than liver and kidney)1014990Others (2)1015000 (e) equine 1015010Muscle1015020Fat1015030Liver1015040Kidney1015050Edible offals (other than liver and kidney)1015990Others (2)1016000 (f) poultry 1016010Muscle1016020Fat1016030Liver1016040Kidney1016050Edible offals (other than liver and kidney)1016990Others (2)1017000 (g) other farmed terrestrial animals 1017010Muscle1017020Fat1017030Liver1017040Kidney 1017050Edible offals (other than liver and kidney)1017990Others (2)1020000Milk0,010,010,011020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,010,010,011030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,050,050,051050000Amphibians and Reptiles0,010,010,011060000Terrestrial invertebrate animals0,010,010,011070000Wild terrestrial vertebrate animals0,010,010,011100000PRODUCTS 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)