Commission Regulation (EU) 2024/398of 29 January 2024amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for haloxyfop in or on certain products(Text with EEA relevance)

Commission Regulation (EU) 2024/398 of 29 January 2024 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for haloxyfop 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 the active substance haloxyfop, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. (2) In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005, an application for import tolerance was submitted for haloxyfop used in Australia on linseeds and rapeseeds/canola seeds. The applicant claims that the authorised uses of that substance on such crop in Australia leads to residues exceeding the MRL contained in Regulation (EC) No 396/2005 for linseeds, and that a higher MRL is necessary to avoid trade barriers for the importation of linseeds and rapeseeds. (3) In accordance with Article 8 of Regulation (EC) No 396/2005, the application was evaluated by the Member State concerned and in accordance with Article 9 of that Regulation, the evaluation report was forwarded to the Commission. (4) The European Food Safety Authority (the Authority) assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals and gave a reasoned opinion on the proposed MRL European Food Safety Authority reasoned opinion on the setting of import tolerances for haloxyfop-P in linseed and rapeseed. EFSA Journal 2018;16(11):5470. . It forwarded that opinion to the applicant, the Commission and the Member States, and made it available to the public. (5) The Authority concluded that all requirements with respect to data were met and that the modification to the MRL requested by the applicant was acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the consumption data and the information on the toxicological properties of the substance valid at that time. The Authority concluded that neither the lifetime exposure to the substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of those products showed that there is any risk that the acceptable daily intake or the acute reference dose is exceeded. (6) A MRL for soya beans based on an application for an import tolerance was previously implemented in Commission Regulation (EU) 2017/171 Commission Regulation (EU) 2017/171 of 30 January 2017 amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for aminopyralid, azoxystrobin, cyantraniliprole, cyflufenamid, cyproconazole, diethofencarb, dithiocarbamates, fluazifop-P, fluopyram, haloxyfop, isofetamid, metalaxyl, prohexadione, propaquizafop, pyrimethanil, Trichoderma atroviride strain SC1 and zoxamide in or on certain products (OJ L 30, 3.2.2017, p. 45).

since the Authority concluded that the proposed MRL was safe for consumers European Food Safety Authority reasoned opinion on the setting of import tolerance for haloxyfop-P in soya beans. EFSA Journal 2016;14(7):4551. . (7) In 2020, according to Commission Implementing Regulation (EU) 2020/1643 Commission Implementing Regulation (EU) 2020/1643 of 5 November 2020 amending Implementing Regulation (EU) No 540/2011 as regards the approval periods of the active substances calcium phosphide, denathonium benzoate, haloxyfop-P, imidacloprid, pencycuron and zeta-cypermethrin (OJ L 370, 6.11.2020, p. 18). , the approval of the active substance haloxyfop was not renewed due to the decision, of the applicant for renewal, to no longer support that application for renewal of approval. (8) All authorisations for plant protection products containing haloxyfop have been revoked. It is therefore appropriate to delete the existing MRLs set for that active substance in Annex II of Regulation (EC) No 396/2005 in accordance with Article 17 of that Regulation in conjunction with Article 14(1)(a) thereof. (9) In accordance with Article 43 of Regulation (EC) No 396/2005, the Commission requested the Authority to provide a reasoned opinion, assessing the risks that the current MRLs based on import tolerances and CXLs for haloxyfop may pose to consumers considering the most recent consumption data available and the presence or absence of submission of the required confirmatory information to address the data gaps identified during the MRL review in accordance to the Article 12 of Regulation (EC) No 396/2005 Commission Regulation (EU) 2015/2075 of 18 November 2015 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 abamectin, desmedipham, dichlorprop-P, haloxyfop-P, oryzalin and phenmedipham in or on certain products (OJ L 302, 19.11.2015, p. 15). . (10) The Authority concluded that the existing MRLs for haloxyfop in soya beans, as well as the proposed import tolerances for that active substance in linseed and rapeseed/canola seeds and the existing CXLs for onions and sunflowers seeds are not expected to pose a risk to consumers. However, considering the most recent consumption data and data requirements, for soya beans and sunflower seeds some information was not available and further consideration by risk managers was therefore required European Food Safety Authority reasoned opinion on the targeted review of maximum residues levels (MRLs) for haloxyfop-P. EFSA Journal 2022;20(11):7658. . (11) Since the MRL for haloxyfop in soya beans and the CXL for sunflower seeds are considered safe for consumers and the missing information was identified during the risk assessment performed by the Authority only in 2022, it is appropriate to provide the applicant time to submit the requested data. Those MRLs will therefore be reviewed taking into account the information available within two years from the publication of this Regulation. As there is no risk for consumers, it is appropriate to set the MRLs for onions, soya beans, linseed, rapeseed/canola seeds and sunflower seeds in Annex II to Regulation (EC) No 396/2005 at the levels identified by the Authority.

(12) Additionally, the Authority identified that the product specific LOD for milk of 0,01 mg/kg is the major contributor to chronic exposure, so that the LOD for this product should be set at 0,002 mg/kg. For all other products, it is appropriate to lower the respective MRLs set out for haloxyfop in Annex II to Regulation (EC) No 396/2005 to the product specific LOD in accordance with Article 14(1)(a) of Regulation (EC) No 396/2005, in conjunction with Article 17 of that Regulation. (13) The Commission consulted the European Union reference laboratories for residues of haloxyfop as regards the need to adapt certain LODs. Those laboratories proposed product specific LODs that are analytically achievable for all products. (14) 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. (15) Annex II to Regulation (EC) No 396/2005 should therefore be amended accordingly. (16) 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 new MRLs become applicable and for which a high level of consumer protection is maintained. (17) 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 themselves to meet the new requirements which will result from the modification of the MRLs. (18) 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 products which were produced in the Union or imported into the Union before 19 August 2024.

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 19 August 2024. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 29 January 2024. For the Commission The President Ursula von der Leyen

Annex

ANNEX In Annex II to Regulation (EC) No 396/2005 the column for haloxyfop is replaced by the following:

Annex

ANNEX II 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 Haloxyfop (Sum of haloxyfop, its esters, salts and conjugates expressed as haloxyfop (sum of the R- and S- isomers at any ratio)) (R) (F) (R) The residue definition differs for the following combinations pesticide-code number: Haloxyfop — code 1000000 except 1040000: Sum of haloxyfop, its salts and conjugates expressed as haloxyfop (sum of the R- and S- isomers at any ratio)

(F) Fat soluble The European Food Safety Authority identified some information on hydrolysis studies 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 19 February 2026, or, if that information is not submitted by that date, the lack of it. 0401050 Sunflower seeds 0401070 Soyabeans Code numberGroups and examples of individual products to which the MRLs applyHaloxyfop (Sum of haloxyfop, its esters, salts and conjugates expressed as haloxyfop (sum of the R- and S- isomers at any ratio)) (R) (F)0100000FRUITS, FRESH or FROZEN; TREE NUTS0,010110000Citrus fruits0110010Grapefruits0110020Oranges0110030Lemons0110040Limes0110050Mandarins0110990Others (2)0120000Tree nuts0120010Almonds0120020Brazil nuts0120030Cashew nuts 0120040Chestnuts0120050Coconuts0120060Hazelnuts/cobnuts0120070Macadamias0120080Pecans0120090Pine nut kernels0120100Pistachios0120110Walnuts0120990Others (2)0130000Pome fruits0130010Apples0130020Pears0130030Quinces0130040Medlars0130050Loquats/Japanese medlars0130990Others (2)0140000Stone fruits0140010Apricots0140020Cherries (sweet)0140030Peaches0140040Plums0140990Others (2)0150000Berries and small fruits0151000 (a) grapes 0151010Table grapes0151020Wine grapes0152000 (b) strawberries 0153000 (c) cane fruits 0153010Blackberries 0153020Dewberries0153030Raspberries (red and yellow)0153990Others (2)0154000 (d) other small fruits and berries 0154010Blueberries0154020Cranberries0154030Currants (black, red and white)0154040Gooseberries (green, red and yellow)0154050Rose hips0154060Mulberries (black and white)0154070Azaroles/Mediterranean medlars0154080Elderberries0154990Others (2)0160000Miscellaneous fruitswith0161000 (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/cainitos 0162060American persimmons/Virginia kaki0162990Others (2)0163000 (c) inedible peel, large 0163010Avocados0163020Bananas0163030Mangoes0163040Papayas0163050Granate apples/pomegranates0163060Cherimoyas0163070Guavas0163080Pineapples0163090Breadfruits0163100Durians0163110Soursops/guanabanas0163990Others (2)0200000VEGETABLES, 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 vegetables0220010Garlic0,010220020Onions0,20220030Shallots0,010220040Spring onions/green onions and Welsh onions0,010220990Others (2)0,010230000Fruiting vegetables0,010231000

(a) Solanaceae and Malvaceae 0231010Tomatoes0231020Sweet peppers/bell peppers0231030Aubergines/eggplants0231040Okra/lady's fingers0231990Others (2)0232000 (b) cucurbits with edible peel 0232010Cucumbers0232020Gherkins0232030Courgettes0232990Others (2)0233000 (c) cucurbits with inedible peel 0233010Melons0233020Pumpkins 0233030Watermelons0233990Others (2)0234000 (d) sweet corn 0239000 (e) other fruiting vegetables 0240000Brassica vegetables(excluding brassica roots and brassica baby leaf crops)0,010241000 (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 0,010251010Lamb'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 0,010252010Spinaches0252020Purslanes0252030Chards/beet leaves0252990Others (2)0253000 (c) grape leaves and similar species 0,010254000 (d) watercresses 0,010255000 (e) witloofs/Belgian endives 0,010256000 (f) herbs and edible flowers 0,020256010Chervil0256020Chives0256030Celery leaves0256040Parsley0256050Sage0256060Rosemary0256070Thyme0256080Basil and edible flowers0256090Laurel/bay leaves0256100Tarragon0256990Others (2)0260000Legume vegetables0,010260010Beans (with pods)0260020Beans (without pods)0260030Peas (with pods)0260040Peas (without pods)0260050Lentils0260990Others (2)0270000Stem vegetables0,010270010Asparagus 0270020Cardoons0270030Celeries0270040Florence fennels0270050Globe artichokes0270060Leeks0270070Rhubarbs0270080Bamboo shoots0270090Palm hearts0270990Others (2)0280000Fungi, mosses and lichens0,010280010Cultivated fungi0280020Wild fungi0280990Mosses and lichens0290000Algae and prokaryotes organisms0,010300000PULSES0,010300010Beans0300020Lentils0300030Peas0300040Lupins/lupini beans0300990Others (2)0400000OILSEEDS AND OIL FRUITS0401000Oilseeds0401010Linseeds0,050401020Peanuts/groundnuts0,010401030Poppy seeds0,010401040Sesame seeds0,010401050Sunflower seeds0,3(+)0401060Rapeseeds/canola seeds0,050401070Soyabeans0,5(+) 0401080Mustard seeds0,010401090Cotton seeds0,010401100Pumpkin 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 beans

0630000Herbal infusions from0631000 (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 beans0650000Carobs/Saint John's breads0700000HOPS0,050800000SPICES0810000Seed spices0,050810010Anise/aniseed0810020Black caraway/black cumin0810030Celery0810040Coriander0810050Cumin0810060Dill 0810070Fennel0810080Fenugreek0810090Nutmeg0810990Others (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 spices0,050860010Saffron 0860990Others (2)0870000Aril spices0,050870010Mace0870990Others (2)0900000SUGAR PLANTS0,010900010Sugar beet roots0900020Sugar canes0900030Chicory roots0900990Others (2)1000000PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS1010000Commodities from0,011011000 (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 1013010Muscle1013020Fat1013030Liver 1013040Kidney1013050Edible 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)1020000Milk0,0021020010Cattle1020020Sheep1020030Goat1020040Horse1020990Others (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)