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/EECnote, 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 MRLnote. 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) 2017/171note since the Authority concluded that the proposed MRL was safe for consumersnote.
(7)In 2020, according to Commission Implementing Regulation (EU) 2020/1643note, 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 396/2005note.
(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 requirednote.
(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.
Annex II
Pesticide residues and maximum residue levels (mg/kg)
| Code number | Groups and examples of individual products to which the MRLs applynote | Haloxyfop (Sum of haloxyfop, its esters, salts and conjugates expressed as haloxyfop (sum of the R- and S- isomers at any ratio)) (R) (F) |
|---|---|---|
| 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | 0,01note |
| 0110000 | Citrus fruits | |
| 0110010 | Grapefruits | |
| 0110020 | Oranges | |
| 0110030 | Lemons | |
| 0110040 | Limes | |
| 0110050 | Mandarins | |
| 0110990 | Others (2) | |
| 0120000 | Tree nuts | |
| 0120010 | Almonds | |
| 0120020 | Brazil nuts | |
| 0120030 | Cashew nuts | |
| 0120040 | Chestnuts | |
| 0120050 | Coconuts | |
| 0120060 | Hazelnuts/cobnuts | |
| 0120070 | Macadamias | |
| 0120080 | Pecans | |
| 0120090 | Pine nut kernels | |
| 0120100 | Pistachios | |
| 0120110 | Walnuts | |
| 0120990 | Others (2) | |
| 0130000 | Pome fruits | |
| 0130010 | Apples | |
| 0130020 | Pears | |
| 0130030 | Quinces | |
| 0130040 | Medlars | |
| 0130050 | Loquats/Japanese medlars | |
| 0130990 | Others (2) | |
| 0140000 | Stone fruits | |
| 0140010 | Apricots | |
| 0140020 | Cherries (sweet) | |
| 0140030 | Peaches | |
| 0140040 | Plums | |
| 0140990 | Others (2) | |
| 0150000 | Berries and small fruits | |
| 0151000 | (a) grapes | |
| 0151010 | Table grapes | |
| 0151020 | Wine grapes | |
| 0152000 | (b) strawberries | |
| 0153000 | (c) cane fruits | |
| 0153010 | Blackberries | |
| 0153020 | Dewberries | |
| 0153030 | Raspberries (red and yellow) | |
| 0153990 | Others (2) | |
| 0154000 | (d) other small fruits and berries | |
| 0154010 | Blueberries | |
| 0154020 | Cranberries | |
| 0154030 | Currants (black, red and white) | |
| 0154040 | Gooseberries (green, red and yellow) | |
| 0154050 | Rose hips | |
| 0154060 | Mulberries (black and white) | |
| 0154070 | Azaroles/Mediterranean medlars | |
| 0154080 | Elderberries | |
| 0154990 | Others (2) | |
| 0160000 | Miscellaneous fruitswith | |
| 0161000 | (a) edible peel | |
| 0161010 | Dates | |
| 0161020 | Figs | |
| 0161030 | Table olives | |
| 0161040 | Kumquats | |
| 0161050 | Carambolas | |
| 0161060 | Kaki/Japanese persimmons | |
| 0161070 | Jambuls/jambolans | |
| 0161990 | Others (2) | |
| 0162000 | (b) inedible peel, small | |
| 0162010 | Kiwi fruits (green, red, yellow) | |
| 0162020 | Litchis/lychees | |
| 0162030 | Passionfruits/maracujas | |
| 0162040 | Prickly pears/cactus fruits | |
| 0162050 | Star apples/cainitos | |
| 0162060 | American persimmons/Virginia kaki | |
| 0162990 | Others (2) | |
| 0163000 | (c) inedible peel, large | |
| 0163010 | Avocados | |
| 0163020 | Bananas | |
| 0163030 | Mangoes | |
| 0163040 | Papayas | |
| 0163050 | Granate apples/pomegranates | |
| 0163060 | Cherimoyas | |
| 0163070 | Guavas | |
| 0163080 | Pineapples | |
| 0163090 | Breadfruits | |
| 0163100 | Durians | |
| 0163110 | Soursops/guanabanas | |
| 0163990 | Others (2) | |
| 0200000 | VEGETABLES, FRESH or FROZEN | |
| 0210000 | Root and tuber vegetables | 0,01note |
| 0211000 | (a) potatoes | |
| 0212000 | (b) tropical root and tuber vegetables | |
| 0212010 | Cassava roots/manioc | |
| 0212020 | Sweet potatoes | |
| 0212030 | Yams | |
| 0212040 | Arrowroots | |
| 0212990 | Others (2) | |
| 0213000 | (c) other root and tuber vegetables except sugar beets | |
| 0213010 | Beetroots | |
| 0213020 | Carrots | |
| 0213030 | Celeriacs/turnip rooted celeries | |
| 0213040 | Horseradishes | |
| 0213050 | Jerusalem artichokes | |
| 0213060 | Parsnips | |
| 0213070 | Parsley roots/Hamburg roots parsley | |
| 0213080 | Radishes | |
| 0213090 | Salsifies | |
| 0213100 | Swedes/rutabagas | |
| 0213110 | Turnips | |
| 0213990 | Others (2) | |
| 0220000 | Bulb vegetables | |
| 0220010 | Garlic | 0,01note |
| 0220020 | Onions | 0,2 |
| 0220030 | Shallots | 0,01note |
| 0220040 | Spring onions/green onions and Welsh onions | 0,01note |
| 0220990 | Others (2) | 0,01note |
| 0230000 | Fruiting vegetables | 0,01note |
| 0231000 | (a) Solanaceae and Malvaceae | |
| 0231010 | Tomatoes | |
| 0231020 | Sweet peppers/bell peppers | |
| 0231030 | Aubergines/eggplants | |
| 0231040 | Okra/lady's fingers | |
| 0231990 | Others (2) | |
| 0232000 | (b) cucurbits with edible peel | |
| 0232010 | Cucumbers | |
| 0232020 | Gherkins | |
| 0232030 | Courgettes | |
| 0232990 | Others (2) | |
| 0233000 | (c) cucurbits with inedible peel | |
| 0233010 | Melons | |
| 0233020 | Pumpkins | |
| 0233030 | Watermelons | |
| 0233990 | Others (2) | |
| 0234000 | (d) sweet corn | |
| 0239000 | (e) other fruiting vegetables | |
| 0240000 | Brassica vegetables(excluding brassica roots and brassica baby leaf crops) | 0,01note |
| 0241000 | (a) flowering brassica | |
| 0241010 | Broccoli | |
| 0241020 | Cauliflowers | |
| 0241990 | Others (2) | |
| 0242000 | (b) head brassica | |
| 0242010 | Brussels sprouts | |
| 0242020 | Head cabbages | |
| 0242990 | Others (2) | |
| 0243000 | (c) leafy brassica | |
| 0243010 | Chinese cabbages/pe-tsai | |
| 0243020 | Kales | |
| 0243990 | Others (2) | |
| 0244000 | (d) kohlrabies | |
| 0250000 | Leaf vegetables, herbs and edible flowers | |
| 0251000 | (a) lettuces and salad plants | 0,01note |
| 0251010 | Lamb's lettuces/corn salads | |
| 0251020 | Lettuces | |
| 0251030 | Escaroles/broad-leaved endives | |
| 0251040 | Cresses and other sprouts and shoots | |
| 0251050 | Land cresses | |
| 0251060 | Roman rocket/rucola | |
| 0251070 | Red mustards | |
| 0251080 | Baby leaf crops (including brassica species) | |
| 0251990 | Others (2) | |
| 0252000 | (b) spinaches and similar leaves | 0,01note |
| 0252010 | Spinaches | |
| 0252020 | Purslanes | |
| 0252030 | Chards/beet leaves | |
| 0252990 | Others (2) | |
| 0253000 | (c) grape leaves and similar species | 0,01note |
| 0254000 | (d) watercresses | 0,01note |
| 0255000 | (e) witloofs/Belgian endives | 0,01note |
| 0256000 | (f) herbs and edible flowers | 0,02note |
| 0256010 | Chervil | |
| 0256020 | Chives | |
| 0256030 | Celery leaves | |
| 0256040 | Parsley | |
| 0256050 | Sage | |
| 0256060 | Rosemary | |
| 0256070 | Thyme | |
| 0256080 | Basil and edible flowers | |
| 0256090 | Laurel/bay leaves | |
| 0256100 | Tarragon | |
| 0256990 | Others (2) | |
| 0260000 | Legume vegetables | 0,01note |
| 0260010 | Beans (with pods) | |
| 0260020 | Beans (without pods) | |
| 0260030 | Peas (with pods) | |
| 0260040 | Peas (without pods) | |
| 0260050 | Lentils | |
| 0260990 | Others (2) | |
| 0270000 | Stem vegetables | 0,01note |
| 0270010 | Asparagus | |
| 0270020 | Cardoons | |
| 0270030 | Celeries | |
| 0270040 | Florence fennels | |
| 0270050 | Globe artichokes | |
| 0270060 | Leeks | |
| 0270070 | Rhubarbs | |
| 0270080 | Bamboo shoots | |
| 0270090 | Palm hearts | |
| 0270990 | Others (2) | |
| 0280000 | Fungi, mosses and lichens | 0,01note |
| 0280010 | Cultivated fungi | |
| 0280020 | Wild fungi | |
| 0280990 | Mosses and lichens | |
| 0290000 | Algae and prokaryotes organisms | 0,01note |
| 0300000 | PULSES | 0,01note |
| 0300010 | Beans | |
| 0300020 | Lentils | |
| 0300030 | Peas | |
| 0300040 | Lupins/lupini beans | |
| 0300990 | Others (2) | |
| 0400000 | OILSEEDS AND OIL FRUITS | |
| 0401000 | Oilseeds | |
| 0401010 | Linseeds | 0,05 |
| 0401020 | Peanuts/groundnuts | 0,01note |
| 0401030 | Poppy seeds | 0,01note |
| 0401040 | Sesame seeds | 0,01note |
| 0401050 | Sunflower seeds | 0,3(+) |
| 0401060 | Rapeseeds/canola seeds | 0,05 |
| 0401070 | Soyabeans | 0,5(+) |
| 0401080 | Mustard seeds | 0,01note |
| 0401090 | Cotton seeds | 0,01note |
| 0401100 | Pumpkin seeds | 0,01note |
| 0401110 | Safflower seeds | 0,01note |
| 0401120 | Borage seeds | 0,01note |
| 0401130 | Gold of pleasure seeds | 0,01note |
| 0401140 | Hemp seeds | 0,01note |
| 0401150 | Castor beans | 0,01note |
| 0401990 | Others (2) | 0,01note |
| 0402000 | Oil fruits | 0,01note |
| 0402010 | Olives for oil production | |
| 0402020 | Oil palms kernels | |
| 0402030 | Oil palms fruits | |
| 0402040 | Kapok | |
| 0402990 | Others (2) | |
| 0500000 | CEREALS | 0,01note |
| 0500010 | Barley | |
| 0500020 | Buckwheat and other pseudocereals | |
| 0500030 | Maize/corn | |
| 0500040 | Common millet/proso millet | |
| 0500050 | Oat | |
| 0500060 | Rice | |
| 0500070 | Rye | |
| 0500080 | Sorghum | |
| 0500090 | Wheat | |
| 0500990 | Others (2) | |
| 0600000 | TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS | 0,05note |
| 0610000 | Teas | |
| 0620000 | Coffee beans | |
| 0630000 | Herbal infusions from | |
| 0631000 | (a) flowers | |
| 0631010 | Chamomile | |
| 0631020 | Hibiscus/roselle | |
| 0631030 | Rose | |
| 0631040 | Jasmine | |
| 0631050 | Lime/linden | |
| 0631990 | Others (2) | |
| 0632000 | (b) leaves and herbs | |
| 0632010 | Strawberry | |
| 0632020 | Rooibos | |
| 0632030 | Mate/maté | |
| 0632990 | Others (2) | |
| 0633000 | (c) roots | |
| 0633010 | Valerian | |
| 0633020 | Ginseng | |
| 0633990 | Others (2) | |
| 0639000 | (d) any other parts of the plant | |
| 0640000 | Cocoa beans | |
| 0650000 | Carobs/Saint John's breads | |
| 0700000 | HOPS | 0,05note |
| 0800000 | SPICES | |
| 0810000 | Seed spices | 0,05note |
| 0810010 | Anise/aniseed | |
| 0810020 | Black caraway/black cumin | |
| 0810030 | Celery | |
| 0810040 | Coriander | |
| 0810050 | Cumin | |
| 0810060 | Dill | |
| 0810070 | Fennel | |
| 0810080 | Fenugreek | |
| 0810090 | Nutmeg | |
| 0810990 | Others (2) | |
| 0820000 | Fruit spices | 0,05note |
| 0820010 | Allspice/pimento | |
| 0820020 | Sichuan pepper | |
| 0820030 | Caraway | |
| 0820040 | Cardamom | |
| 0820050 | Juniper berry | |
| 0820060 | Peppercorn (black, green and white) | |
| 0820070 | Vanilla | |
| 0820080 | Tamarind | |
| 0820990 | Others (2) | |
| 0830000 | Bark spices | 0,05note |
| 0830010 | Cinnamon | |
| 0830990 | Others (2) | |
| 0840000 | Root and rhizome spices | |
| 0840010 | Liquorice | 0,05note |
| 0840020 | Ginger (10) | |
| 0840030 | Turmeric/curcuma | 0,05note |
| 0840040 | Horseradish (11) | |
| 0840990 | Others (2) | 0,05note |
| 0850000 | Bud spices | 0,05note |
| 0850010 | Cloves | |
| 0850020 | Capers | |
| 0850990 | Others (2) | |
| 0860000 | Flower pistil spices | 0,05note |
| 0860010 | Saffron | |
| 0860990 | Others (2) | |
| 0870000 | Aril spices | 0,05note |
| 0870010 | Mace | |
| 0870990 | Others (2) | |
| 0900000 | SUGAR PLANTS | 0,01note |
| 0900010 | Sugar beet roots | |
| 0900020 | Sugar canes | |
| 0900030 | Chicory roots | |
| 0900990 | Others (2) | |
| 1000000 | PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS | |
| 1010000 | Commodities from | 0,01note |
| 1011000 | (a) swine | |
| 1011010 | Muscle | |
| 1011020 | Fat | |
| 1011030 | Liver | |
| 1011040 | Kidney | |
| 1011050 | Edible offals (other than liver and kidney) | |
| 1011990 | Others (2) | |
| 1012000 | (b) bovine | |
| 1012010 | Muscle | |
| 1012020 | Fat | |
| 1012030 | Liver | |
| 1012040 | Kidney | |
| 1012050 | Edible offals (other than liver and kidney) | |
| 1012990 | Others (2) | |
| 1013000 | (c) sheep | |
| 1013010 | Muscle | |
| 1013020 | Fat | |
| 1013030 | Liver | |
| 1013040 | Kidney | |
| 1013050 | Edible offals (other than liver and kidney) | |
| 1013990 | Others (2) | |
| 1014000 | (d) goat | |
| 1014010 | Muscle | |
| 1014020 | Fat | |
| 1014030 | Liver | |
| 1014040 | Kidney | |
| 1014050 | Edible offals (other than liver and kidney) | |
| 1014990 | Others (2) | |
| 1015000 | (e) equine | |
| 1015010 | Muscle | |
| 1015020 | Fat | |
| 1015030 | Liver | |
| 1015040 | Kidney | |
| 1015050 | Edible offals (other than liver and kidney) | |
| 1015990 | Others (2) | |
| 1016000 | (f) poultry | |
| 1016010 | Muscle | |
| 1016020 | Fat | |
| 1016030 | Liver | |
| 1016040 | Kidney | |
| 1016050 | Edible offals (other than liver and kidney) | |
| 1016990 | Others (2) | |
| 1017000 | (g) other farmed terrestrial animals | |
| 1017010 | Muscle | |
| 1017020 | Fat | |
| 1017030 | Liver | |
| 1017040 | Kidney | |
| 1017050 | Edible offals (other than liver and kidney) | |
| 1017990 | Others (2) | |
| 1020000 | Milk | 0,002note |
| 1020010 | Cattle | |
| 1020020 | Sheep | |
| 1020030 | Goat | |
| 1020040 | Horse | |
| 1020990 | Others (2) | |
| 1030000 | Birds eggs | 0,01note |
| 1030010 | Chicken | |
| 1030020 | Duck | |
| 1030030 | Geese | |
| 1030040 | Quail | |
| 1030990 | Others (2) | |
| 1040000 | Honey and other apiculture products (7) | 0,05note |
| 1050000 | Amphibians and Reptiles | 0,01note |
| 1060000 | Terrestrial invertebrate animals | 0,01note |
| 1070000 | Wild terrestrial vertebrate animals | 0,01note |
| 1100000 | PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8) | |
| 1200000 | PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8) | |
| 1300000 | PROCESSED FOOD PRODUCTS (9) |
In Annex II to Regulation (EC) No 396/2005 the column for haloxyfop is replaced by the following:
‘’
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