Commission Regulation (EU) 2025/195of 3 February 2025amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fenbuconazole and penconazole in or on certain products(Text with EEA relevance)

Commission Regulation (EU) 2025/195 of 3 February 2025 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for fenbuconazole and penconazole 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) and Article 49(2) thereof, Whereas: (1) For the active substances fenbuconazole and penconazole maximum residue levels (MRLs) were set in Annexes II and III to Regulation (EC) No 396/2005. (2) In 2017 and 2018, respectively, the European Food Safety Authority (the Authority) submitted reasoned opinions EFSA 2017. Reasoned opinion on the review of the existing maximum residue levels for penconazole according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(6):4853, 56 pp. https://doi.org/10.2903/j.efsa.2017.4853. EFSA 2018. Reasoned Opinion on the review of the existing maximum residue levels for fenbuconazole according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2018;16(8):5399, 51 pp. https://doi.org/10.2903/j.efsa.2018.5399. on the review of the MRLs for penconazole and fenbuconazole in accordance with Article 12 of Regulation (EC) No 396/2005. The Authority had identified some information as unavailable for certain products. The available information was sufficient for the Authority to propose MRLs that are safe for consumers. (3) In 2019, the Commission set new MRLs for fenbuconazole and penconazole in Annex II to Regulation (EC) No 396/2005, either maintaining them at the existing level or setting them at the level identified by the Authority. 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. (4) As fenbuconazole is no longer approved in the Union, the applicant submitted additional trial information addressing a data gap on Triazole Derivative Metabolites (TDMs) identified by the Authority EFSA 2023. Evaluation of confirmatory data following the Article 12 MRL review for fenbuconazole. EFSA Journal, 21(8), 1–44. https://doi.org/10.2903/j.efsa.2023.8205. that had also been assessed by the Joint WHO/FAO Expert Meeting on pesticides residues supporting the existing Codex maximum residue limits (CXLs) FAO (Food and Agriculture Organization of the United Nations), 2016. Submission and evaluation of pesticide residues data for the estimation of Maximum Residue Levels in food and feed. Pesticide Residues. 3rd Edition. FAO Plant Production and Protection Paper 225, 298 pp.

. The data gap was not addressed for trials originally submitted for the establishment of the existing tentative MRLs, higher than the CXL, for some crops. The data gap on TDMs regarding trials was addressed for grapefruits, oranges, lemons, limes, pome fruits, cherries, peaches, blueberries by the trials submitted in support of the CXLs. The data gap on TDMs for mandarins were addressed by extrapolation from residue data of lemons. (5) Therefore, the existing MRLs should be lowered to the level of CXLs for grapefruits, oranges and peaches and maintained at the current MRLs (already at the CXLs level) for lemons, limes, mandarins, pome fruits, cherries and blueberries. (6) The data gap on occurrence of TDMs was not addressed for fenbuconazole in the case of tree nuts, table and wine grapes, cranberries, bananas, sweet/bell peppers, sunflower seeds, peanuts/groundnuts, rapeseeds/canola seeds, barley, rye and wheat. Therefore, the MRLs laid down in Annex II to Regulation (EC) No 396/2005 for these products should be lowered to the limit of determination (LOD), except for tree nuts, which are already at the LOD. (7) Data regarding both trials and occurrence of TDMs in the case of fenbuconazole were not submitted for apricots, plums and cucurbits with edible and inedible peel. Therefore, the MRLs laid down in Annex II to Regulation (EC) No 396/2005 for these products should be lowered to the LOD. (8) For fenbuconazole, in the case of animal products, the calculated livestock dietary burden showed that the threshold was not exceeded considering TDM residues via apple pomace and citrus-dried pulp. The Authority assessed the new information provided and identified no consumer intake concerns. Therefore, MRLs for liver, kidney and edible offals of swine, bovine, sheep, goat, equine and other farmed terrestrial animals should be maintained. For milk, based on the assessment of the European Union reference laboratory, the LOD of 0,05 mg/kg laid down in Annex II to Regulation (EC) No 396/2005 should be lowered to 0,01 mg/kg. (9) For penconazole, the missing information on a representative study on primary crop metabolism, additional residue trials, and storage stability of the relevant metabolites were submitted for blackberries and raspberries. Those data gaps were addressed and the new residue trials point to the need for a higher MRL. The Authority confirmed EFSA 2023. Reasoned opinion on the evaluation of confirmatory data following the Article 12 MRL review for penconazole. EFSA Journal 2023;21(3):7889, 52 pp., https://doi.org/10.2903/j.efsa.2023.7889. that the higher MRL is safe for consumers, and therefore the existing MRL should be raised. (10) Data gaps for penconazole were also addressed for pumpkins and watermelons, confirming the existing MRL which should be maintained. (11) Trial data for penconazole had been submitted for pome fruits and plums from which higher MRLs could in principle be derived. Although the missing data on residue trials analysing simultaneously for the residue definitions for monitoring and risk assessment were not provided, the Authority was able to use a conversion factor to take into account the difference in residue definitions. As the Authority did not indicate a risk for consumers, based on the new data the MRLs should be raised.

(12) For penconazole, sufficient trial data had been submitted for apricots, peaches, table and wine grapes from which lower MRLs can be derived, and for cherries, gooseberries, tomatoes and aubergines/eggplants to support the existing MRLs. Although the missing residue trials analysing simultaneously for the residue definitions for monitoring and risk assessment were not provided, the Authority was able to use a conversion factor to take into account the difference in residue definitions. As the Authority did not indicate a risk for consumers the MRLs should therefore be lowered to levels identified by the Authority for apricots, peaches and table and wine grapes, and the existing MRLs maintained for cherries, gooseberries, tomatoes and aubergines/eggplant. (13) All footnotes requiring the submission of additional information should be deleted from Annex II to Regulation (EC) No 396/2005 for fenbuconazole and penconazole. (14) In addition, on 6 February 2023 Joint FAO/WHO Food Standards Programme Codex Alimentarius Commission. Forty-fifth Session. FAO headquarters, Rome, Italy. 21-25 November 2022, 12-13 December 2022, and 19 December 2022-6 February 2023. fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-701-45%252FFinal%2BReport%2BCAC45%252FCompiled%2BREP22_CAC.pdf. , the Codex Alimentarius Commission adopted a new CXL for fenbuconazole in tea green, black (fermented and dried). (15) In accordance with Article 5(3) of Regulation (EC) No 178/2002 of the European Parliament and of the Council Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1, ELI: http://data.europa.eu/eli/reg/2002/178/oj). , where international standards exist or their completion is imminent, they are to be taken into consideration in the development or adaptation of Union food law, except where such standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives of food law or where there is a scientific justification, or where they would result in a different level of protection from the one determined as appropriate in the Union. Moreover, in accordance with Article 13, point (e), of that Regulation, the Union is to promote consistency between international technical standards and Union food law while ensuring that the high level of protection adopted in the Union is not reduced. (16) The Authority assessed the risks that that CXL poses to consumers and published a scientific report EFSA (European Food Safety Authority), 2022. Scientific support for preparing an EU position in the 53rd Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2022;20(9):7521, 310 pp. https://doi.org/10.2903/j.efsa.2022.7521.

. In cases where the Authority did not identify risks for consumers in the Union, and for which the Union therefore did not present a reservation https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-718-53%252FCRDs%252Fpr53_crd13revx.pdf. to the Codex Committee on Pesticides Residues, the CXLs can be considered safe. This is the case for the CXL for fenbuconazole in tea green, black (fermented and dried), therefore it should be included in Regulation (EC) No 396/2005. (17) 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. (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 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. (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 adapt themselves to the requirements which 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

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 the products which were placed on the market in the Union before 24 August 2025.

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 24 August 2025. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 3 February 2025. For the Commission The President Ursula von der Leyen

Annex

ANNEX In Annex II to Regulation (EC) No 396/2005, the columns for fenbuconazole and penconazole 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. Penconazole (sum of constituent isomers) (F) (F) Fat soluble Code numberGroups and examples of individual products to which the MRLs applyFenbuconazole (sum of constituent enantiomers)Penconazole (sum of constituent isomers) (F)(1)(2)(3)(4)0100000FRUITS, FRESH or FROZEN; TREE NUTS0110000Citrus fruits0,010110010Grapefruits0,50110020Oranges0,50110030Lemons10110040Limes10110050Mandarins0,50110990Others (2)0,50120000Tree nuts0,010,010120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0,50,30130010Apples0,30130020Pears0,30130030Quinces0,30130040Medlars0,30130050Loquats/Japanese medlars0,30130990Others (2)0,3

0140000Stone fruits0140010Apricots0,010,070140020Cherries (sweet)10,150140030Peaches0,50,070140040Plums0,010,150140990Others (2)0,60,010150000Berries and small fruits0151000 (a) grapes 0,010,40151010Table grapes0151020Wine grapes0152000 (b) strawberries 0,010,50153000 (c) cane fruits 0,010153010Blackberries0,40153020Dewberries0,010153030Raspberries (red and yellow)0,40153990Others (2)0,010154000 (d) other small fruits and berries 0154010Blueberries0,50,010154020Cranberries0,010,010154030Currants (black, red and white)0,0120154040Gooseberries (green, red and yellow)0,010,10154050Rose hips0,010,010154060Mulberries (black and white)0,010,010154070Azaroles/Mediterranean medlars0,010,010154080Elderberries0,010,010154990Others (2)0,010,010160000Miscellaneous fruitswith0,010,010161000 (a) edible peel 0161010Dates0161020Figs0161030Table olives0161040Kumquats0161050Carambolas0161060Kaki/Japanese persimmons0161070Jambuls/jambolans0161990Others (2)0162000 (b) inedible peel, small 0162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees 0162030Passionfruits/maracujas0162040Prickly pears/cactus fruits0162050Star apples/cainitos0162060American persimmons/Virginia kaki0162990Others (2)0163000 (c) inedible peel, large 0163010Avocados0163020Bananas0163030Mangoes0163040Papayas0163050Granate apples/pomegranates0163060Cherimoyas0163070Guavas0163080Pineapples0163090Breadfruits0163100Durians0163110Soursops/guanabanas0163990Others (2)0200000VEGETABLES, FRESH or FROZEN0210000Root and tuber vegetables0,010,010211000 (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 artichokes0213060Parsnips0213070Parsley roots/Hamburg roots parsley0213080Radishes0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2) 0220000Bulb vegetables0,010,010220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables0,010231000 (a) Solanaceae and Malvaceae 0231010Tomatoes0,10231020Sweet peppers/bell peppers0,20231030Aubergines/eggplants0,10231040Okra/lady's fingers0,010231990Others (2)0,010232000 (b) cucurbits with edible peel 0,060232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)0233000 (c) cucurbits with inedible peel 0,150233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)0234000 (d) sweet corn 0,010239000 (e) other fruiting vegetables 0,010240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,010,010241000 (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 0,010,010251010Lamb'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 0,010,010252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)0253000 (c) grape leaves and similar species 0,010,010254000 (d) watercresses 0,010,010255000 (e) witloofs/Belgian endives 0,010,010256000 (f) herbs and edible flowers 0,020,020256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,010,010260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2) 0270000Stem vegetables0,010270010Asparagus0,010270020Cardoons0,010270030Celeries0,010270040Florence fennels0,010270050Globe artichokes0,060270060Leeks0,010270070Rhubarbs0,010270080Bamboo shoots0,010270090Palm hearts0,010270990Others (2)0,010280000Fungi, mosses and lichens0,010,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010300000PULSES0,010,010300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,010,010401000Oilseeds0401010Linseeds0401020Peanuts/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)0500000CEREALS0,010,010500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2)0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,050610000Teas300620000Coffee beans0,050630000Herbal infusions from0,050631000 (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 beans0,05 0650000Carobs/Saint John's breads0,050700000HOPS0,050,050800000SPICES0810000Seed spices0,050,050810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,050,050820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,050,050830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,050,050840020Ginger (10)0840030Turmeric/curcuma0,050,050840040Horseradish (11)0840990Others (2)0,050,050850000Bud spices0,050,050850010Cloves0850020Capers0850990Others (2)

0860000Flower pistil spices0,050,050860010Saffron0860990Others (2)0870000Aril spices0,050,050870010Mace0870990Others (2)0900000SUGAR PLANTS0,010,010900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from1011000 (a) swine 0,051011010Muscle0,051011020Fat0,051011030Liver0,11011040Kidney0,11011050Edible offals (other than liver and kidney)0,11011990Others (2)0,051012000 (b) bovine 0,051012010Muscle0,051012020Fat0,051012030Liver0,11012040Kidney0,11012050Edible offals (other than liver and kidney)0,11012990Others (2)0,051013000 (c) sheep 0,051013010Muscle0,051013020Fat0,051013030Liver0,11013040Kidney0,11013050Edible offals (other than liver and kidney)0,11013990Others (2)0,051014000 d) goat 0,051014010Muscle0,051014020Fat0,051014030Liver0,11014040Kidney0,1 1014050Edible offals (other than liver and kidney)0,11014990Others (2)0,051015000 (e) equine 0,051015010Muscle0,051015020Fat0,051015030Liver0,11015040Kidney0,11015050Edible offals (other than liver and kidney)0,11015990Others (2)0,051016000 (f) poultry 0,051016010Muscle0,051016020Fat0,011016030Liver0,051016040Kidney0,051016050Edible offals (other than liver and kidney)0,051016990Others (2)0,011017000 (g) other farmed terrestrial animals 0,051017010Muscle0,051017020Fat0,051017030Liver0,11017040Kidney0,11017050Edible offals (other than liver and kidney)0,11017990Others (2)0,051020000Milk0,010,011020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,050,051030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,050,051050000Amphibians and Reptiles0,050,011060000Terrestrial invertebrate animals0,050,011070000Wild terrestrial vertebrate animals0,050,05 1100000PRODUCTS 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)