Commission Regulation (EU) 2026/1546

Contents

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^note, and in particular Article 14(1), point (a), Article 18(1), point (b), and Article 49(2) thereof,Whereas:

(1)For the active substances carbendazim and thiophanate-methyl, maximum residue levels (‘MRLs’) were set in Annex II and in Part B of Annex III to Regulation (EC) No 396/2005.

(2)The approval of the active substance carbendazim expired on 30 November 2014 and no application for its renewal was submitted.

(3)The approval of the active substance thiophanate-methyl was not renewed by Commission Implementing Regulation (EU) 2020/1498^note. An application for the renewal of its approval had been submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012^note within the set time period and assessed in accordance with the procedure described by Regulation (EC) No 1107/2009 of the European Parliament and of the Council^note. However, the applicant decided to withdraw the application. Nevertheless, based on the assessment of that application, the European Food Safety Authority (‘the Authority’) published its conclusion on the peer review of the pesticide risk assessment of the active substance thiophanate-methyl^note, which identified a number of critical areas of concern and data gaps. In particular, the Authority concluded that, given the clastogenic potential of thiophanate-methyl, toxicological reference values for consumers and operator risk assessment could not be derived. Based on the dossier available on thiophanate-methyl, the Authority indicated that carbendazim might also have a clastogenic potential.

(4)In its earlier reasoned opinion on the review of all existing MRLs for carbendazim and thiophanate-methyl in accordance with Article 12 of Regulation (EC) No 396/2005^note, the Authority noted that the two substances share a common mode of action and have similar metabolic patterns. In view of the concerns about the potential clastogenicity of carbendazim and thiophanate-methyl raised in the conclusions of the peer review, the Commission requested the Authority to provide a reasoned opinion under Article 43 of Regulation (EC) No 396/2005, assessing the toxicological properties of carbendazim and thiophanate-methyl. In its reasoned opinion^note, the Authority concluded that there is evidence indicating that carbendazim and thiophanate-methyl are aneugenic and proposed toxicological reference values for both substances. The toxicological reference values were confirmed by the Authority in two subsequent reasoned opinions^note^note and took into account the toxicological properties of the substances.

(5)Carbendazim is classified in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council^note as mutagenic, category 1B and toxic for reproduction, category 1B^note, and the Authority concluded that thiophanate-methyl meets the endocrine-disrupting criteria for the thyroid (T)-modality^note.

(6)In 2021^note, the Union submitted public health concerns with regards to the active substances carbendazim and thiophanate-methyl to the Codex Committee on Pesticide Residues. Consequently, carbendazim was scheduled for periodic review by the Joint FAO/WHO meeting on pesticides residues (JMPR) in 2023. On 14 November 2025^note, the Codex Alimentarius Commission revoked all Codex maximum residue limits (‘CXLs’) for the sum of carbendazim, benomyl and thiophanate-methyl (expressed as carbendazim), as insufficient data had been submitted to allow a re-evaluation of the toxicological properties of carbendazim, including the toxicological reference values established in 1995 and 2005. Thus, CXLs no longer exist for carbendazim or for benomyl. For thiophanate-methyl separately, there is only one CXL, for almonds, but the Union expressed a reservation based on the incompatibility of the residue definition of thiophanate-methyl in almonds in the Union with the residue definition set by JMPR, and that CXL was never implemented in the Union^note.

(7)Carbendazim and thiophanate-methyl are no longer approved for use in the Union and all authorisations for plant protection products containing carbendazim or thiophanate-methyl have been revoked. MRLs based on import tolerances are currently in place for those two substances in citrus fruits, in mangoes, papayas, and in okra/lady’s fingers. Those import tolerances had been assessed by the Authority in the framework of the review of all MRLs for carbendazim and thiophanate-methyl in accordance with Article 12 of Regulation (EC) No 396/2005^note.

(8)However, the Good Agricultural Practices (‘GAPs’) supporting those import tolerances for carbendazim and thiophanate-methyl on citrus fruits are no longer authorised^note. Under Article 14(2), point (e), of Regulation (EC) No 396/2005, a MRL may be set based on a GAP implemented in a third country for the legal use of an active substance in that country. Since the GAPs previously submitted for setting those MRLs based on import tolerances are no longer authorised, there is no basis to maintain the MRLs based on import tolerances in citrus fruits. The MRLs for carbendazim and thiophanate-methyl in citrus fruits should therefore be lowered to the limit of determination (‘LOD’).

(9)Additionally, in its 2024 risk assessment^note, the Authority conducted a combined risk assessment for residues of carbendazim and thiophanate-methyl considering that these substances have similar metabolic patterns, share the same mode of action and may be used on the same crop. In this combined risk assessment, the Authority identified unacceptable risks concerning the current MRLs for carbendazim in grapefruits, oranges, mangoes and papayas, and for thiophanate-methyl in grapefruits, oranges, mandarins, mangoes and papayas. Since it cannot be excluded that both substances may be used on the same crop, the MRLs based on import tolerances for carbendazim in grapefruits, oranges, mangoes and papayas, and for thiophanate-methyl in grapefruits, oranges, mandarins, mangoes and papayas should therefore be lowered to the LOD.

(10)With regards to okra/lady’s fingers, the Authority could not conduct a combined exposure assessment as only a GAP for thiophanate-methyl had been submitted to the Union^note. In this regard, uncertainty remains as to whether both substances may be applied on the same crop in practice, or whether they may be present together in a plant protection product used in a third country. GAPs for both plant protection products containing carbendazim and plant protection products containing thiophanate-methyl on okra/lady’s fingers, as well as GAPs for plant protection products containing a mixture of both, are registered in some third countries^note. It is not possible to know how these plant protection products are applied in practice in third countries. Therefore, to ensure a high level of consumer protection, the Commission considers it appropriate to also lower the MRLs for both substances on okra/lady's fingers to the LOD.

(11)In view of the above, all MRLs for carbendazim and thiophanate-methyl should be lowered to the relevant product-specific LODs and listed in Annex V to Regulation (EC) No 396/2005.

(12)In addition, in its reasoned opinions, the Authority proposed to modify the residue definitions for carbendazim, which currently includes benomyl, and to set separate MRLs for both substances. It also proposed to change the residue definitions for enforcement purposes for carbendazim in all products of animal origin from ‘carbendazim and thiophanate-methyl, expressed as carbendazim’ to ‘sum of carbendazim and 5-hydroxy-carbendazim, expressed as carbendazim’ and for thiophanate-methyl in all products of animal origin from ‘carbendazim and thiophanate-methyl, expressed as carbendazim’ to ‘thiophanate-methyl’. The Commission, therefore, considers it appropriate to establish these new residue definitions.

(13)Benomyl is not approved as an active substance in plant protection products under Regulation (EC) No 1107/2009 and was never assessed in the Union. It is classified as mutagenic and reprotoxic, category B, under Regulation (EC) No 1272/2008^note.

(14)For benomyl, no EU toxicological reference values are available and the safety of MRLs for this substance could not be assessed. As uses for benomyl are not authorised in the Union, and as no import tolerances or CXLs exist for this substance, default MRL values should be listed in Annex V to Regulation (EC) No 396/2005, as provided for in Article 18(1), point (b), of that Regulation.

(15)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.

(16)Regulation (EC) No 396/2005 should therefore be amended accordingly.

(17)For all active substances covered by this Regulation, in order to allow for normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been placed on the market in the Union before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained. Based on the opinion of the Authority^note, this applies to all products except for carbendazim in grapefruits, oranges, papayas and mangoes, and for thiophanate-methyl in grapefruits, oranges, mandarins, papayas and mangoes.

(18)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 to meet the new requirements resulting from the amendments.

(19)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, III and V to Regulation (EC) No 396/2005 are 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 products which were placed on the market in the Union before 29 January 2027, except for carbendazim in grapefruits, oranges, papayas and mangoes, and for thiophanate-methyl in grapefruits, oranges, mandarins, papayas and mangoes.

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 29 January 2027.

(1)in Annex II, the columns for carbendazim and thiophanate-methyl are deleted;

(2)in Part B of Annex III, the columns for carbendazim and thiophanate-methyl are deleted;

(3)in Annex V, the following columns for benomyl, carbendazim and thiophanate-methyl are added:‘Pesticide residues and maximum residue levels (mg/kg)^note^note(+)Pesticide-product combination for which a footnote exists. The list of footnotes is provided below.Carbendazim (R)(R) The residue definition differs for the following combinations pesticide-code number: Carbendazim - code 1000000: Sum of carbendazim and 5-hydroxy-carbendazim, expressed as carbendazim’Code numberGroups and examples of individual products to which the MRLs apply^noteBenomylCarbendazim (R)Thiophanate-methyl0100000FRUITS, FRESH or FROZEN; TREE NUTS0,01^note0,01^note0,01^note0110000Citrus fruits0110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0120010Almonds0120020Brazil nuts0120030Cashew nuts0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2)0150000Berries and small fruits0151000

(a)grapes

(a)edible peel

(a)potatoes

(a)Solanaceae and Malvaceae

(a)flowering brassica

(a)lettuces and salad plants

(a)flowers

(a)swine

(b)strawberries

(b)inedible peel, small

(b)tropical root and tuber vegetables

(b)cucurbits with edible peel

(b)head brassica

(b)spinaches and similar leaves

(b)leaves and herbs

(b)bovine

(c)cane fruits

(c)inedible peel, large

(c)other root and tuber vegetables except sugar beets

(c)cucurbits with inedible peel

(c)leafy brassica

(c)grape leaves and similar species

(c)roots

(c)sheep

(d)other small fruits and berries

(d)sweet corn

(d)kohlrabies

(d)watercresses

(d)any other parts of the plant

d)goat

(e)other fruiting vegetables

(e)witloofs/Belgian endives

(e)equine

(f)herbs and edible flowers

(f)poultry

(g)other farmed terrestrial animals

0151010Table grapes0151020Wine grapes015200001530000153010Blackberries0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)01540000154010Blueberries0154020Cranberries0154030Currants (black, red and white)0154040Gooseberries (green, red and yellow)0154050Rose hips0154060Mulberries (black and white)0154070Azaroles/Mediterranean medlars0154080Elderberries0154990Others (2)0160000Miscellaneous fruitswith01610000161010Dates0161020Figs0161030Table olives0161040Kumquats0161050Carambolas0161060Kaki/Japanese persimmons0161070Jambuls/jambolans0161990Others (2)01620000162010Kiwi fruits (green, red, yellow)0162020Litchis/lychees0162030Passionfruits/maracujas0162040Prickly pears/cactus fruits0162050Star apples/cainitos0162060American persimmons/Virginia kaki0162990Others (2)01630000163010Avocados0163020Bananas0163030Mangoes0163040Papayas0163050Granate apples/pomegranates0163060Cherimoyas0163070Guavas0163080Pineapples0163090Breadfruits0163100Durians0163110Soursops/guanabanas0163990Others (2)0200000VEGETABLES, FRESH or FROZEN0,01^note0,01^note0,01^note0210000Root and tuber vegetables021100002120000212010Cassava roots/manioc0212020Sweet potatoes0212030Yams0212040Arrowroots0212990Others (2)02130000213010Beetroots0213020Carrots0213030Celeriacs/turnip rooted celeries0213040Horseradishes0213050Jerusalem artichokes0213060Parsnips0213070Parsley roots/Hamburg roots parsley0213080Radishes0213090Salsifies0213100Swedes/rutabagas0213110Turnips0213990Others (2)0220000Bulb vegetables0220010Garlic0220020Onions0220030Shallots0220040Spring onions/green onions and Welsh onions0220990Others (2)0230000Fruiting vegetables02310000231010Tomatoes0231020Sweet peppers/bell peppers0231030Aubergines/eggplants0231040Okra/lady's fingers0231990Others (2)02320000232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)02330000233010Melons0233020Pumpkins0233030Watermelons0233990Others (2)023400002390000240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)02410000241010Broccoli0241020Cauliflowers0241990Others (2)02420000242010Brussels sprouts0242020Head cabbages0242990Others (2)02430000243010Chinese cabbages/pe-tsai0243020Kales0243990Others (2)02440000250000Leaf vegetables, herbs and edible flowers02510000251010Lamb's lettuces/corn salads0251020Lettuces0251030Escaroles/broad-leaved endives0251040Cresses and other sprouts and shoots0251050Land cresses0251060Roman rocket/rucola0251070Red mustards0251080Baby leaf crops (including brassica species)0251990Others (2)02520000252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)02530000254000025500002560000256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0270010Asparagus0270020Cardoons0270030Celeries0270040Florence fennels0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0300000PULSES0,01^note0,01^note0,01^note0300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0,01^note0,01^note0,01^note0401000Oilseeds0401010Linseeds0401020Peanuts/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)0500000CEREALS0,01^note0,01^note0,01^note0500010Barley0500020Buckwheat and other pseudocereals0500030Maize/corn0500040Common millet/proso millet0500050Oat0500060Rice0500070Rye0500080Sorghum0500090Wheat0500990Others (2)0600000TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS0,05^note0,05^note0,05^note0610000Teas0620000Coffee beans0630000Herbal infusions from06310000631010Chamomile0631020Hibiscus/roselle0631030Rose0631040Jasmine0631050Lime/linden0631990Others (2)06320000632010Strawberry0632020Rooibos0632030Mate/maté0632990Others (2)06330000633010Valerian0633020Ginseng0633990Others (2)06390000640000Cocoa beans0650000Carobs/Saint John's breads0700000HOPS0,05^note0,05^note0,05^note0800000SPICES0810000Seed spices0,05^note0,05^note0,05^note0810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (2)0820000Fruit spices0,05^note0,05^note0,05^note0820010Allspice/pimento0820020Sichuan pepper0820030Caraway0820040Cardamom0820050Juniper berry0820060Peppercorn (black, green and white)0820070Vanilla0820080Tamarind0820990Others (2)0830000Bark spices0,05^note0,05^note0,05^note0830010Cinnamon0830990Others (2)0840000Root and rhizome spices0840010Liquorice0,05^note0,05^note0,05^note0840020Ginger (10)0840030Turmeric/curcuma0,05^note0,05^note0,05^note0840040Horseradish (11)0840990Others (2)0,05^note0,05^note0,05^note0850000Bud spices0,05^note0,05^note0,05^note0850010Cloves0850020Capers0850990Others (2)0860000Flower pistil spices0,05^note0,05^note0,05^note0860010Saffron0860990Others (2)0870000Aril spices0,05^note0,05^note0,05^note0870010Mace0870990Others (2)0900000SUGAR PLANTS0,01^note0,01^note0,01^note0900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from0,01^note0,01^note0,01^note10110001011010Muscle1011020Fat1011030Liver1011040Kidney1011050Edible offals (other than liver and kidney)1011990Others (2)10120001012010Muscle1012020Fat1012030Liver1012040Kidney1012050Edible offals (other than liver and kidney)1012990Others (2)10130001013010Muscle1013020Fat1013030Liver1013040Kidney1013050Edible offals (other than liver and kidney)1013990Others (2)10140001014010Muscle1014020Fat1014030Liver1014040Kidney1014050Edible offals (other than liver and kidney)1014990Others (2)10150001015010Muscle1015020Fat1015030Liver1015040Kidney1015050Edible offals (other than liver and kidney)1015990Others (2)10160001016010Muscle1016020Fat1016030Liver1016040Kidney1016050Edible offals (other than liver and kidney)1016990Others (2)10170001017010Muscle1017020Fat1017030Liver1017040Kidney1017050Edible offals (other than liver and kidney)1017990Others (2)1020000Milk0,01^note0,01^note0,01^note1020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (2)1030000Birds eggs0,01^note0,01^note0,01^note1030010Chicken1030020Duck1030030Geese1030040Quail1030990Others (2)1040000Honey and other apiculture products (7)0,05^note0,05^note0,05^note1050000Amphibians and Reptiles0,01^note0,01^note0,01^note1060000Terrestrial invertebrate animals0,01^note0,01^note0,01^note1070000Wild terrestrial vertebrate animals0,01^note0,01^note0,01^note1100000PRODUCTS 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)

Annexes II, III and V to Regulation (EC) No 396/2005 are amended as follows:

Article 1#

Article 2#

Article 3#

Article 1 #

Article 2 #

Article 3 #