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Document 32024R0398

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

C/2024/446

OJ L, 2024/398, 30.01.2024, ELI: http://data.europa.eu/eli/reg/2024/398/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

In force

ELI: http://data.europa.eu/eli/reg/2024/398/oj

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Official Journal
of the European Union

EN

Series L


2024/398

30.1.2024

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 (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 (2). 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 (3) since the Authority concluded that the proposed MRL was safe for consumers (4).

(7)

In 2020, according to Commission Implementing Regulation (EU) 2020/1643 (5), 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 (6).

(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 (7).

(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


(1)   OJ L 70, 16.3.2005, p. 1.

(2)  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.

(3)  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).

(4)  European Food Safety Authority reasoned opinion on the setting of import tolerance for haloxyfop-P in soya beans. EFSA Journal 2016;14(7):4551.

(5)  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).

(6)  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).

(7)  European Food Safety Authority reasoned opinion on the targeted review of maximum residues levels (MRLs) for haloxyfop-P. EFSA Journal 2022;20(11):7658.


ANNEX

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

‘ANNEX II

Pesticide residues and maximum residue levels (mg/kg)

Code number

Groups and examples of individual products to which the MRLs apply  (1)

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

0,01  (*1)

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

0,01  (*1)

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

0,01  (*1)

0220020

Onions

0,2

0220030

Shallots

0,01  (*1)

0220040

Spring onions/green onions and Welsh onions

0,01  (*1)

0220990

Others (2)

0,01  (*1)

0230000

Fruiting vegetables

0,01  (*1)

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)

0,01  (*1)

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

0,01  (*1)

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

0,01  (*1)

0252010

Spinaches

 

0252020

Purslanes

 

0252030

Chards/beet leaves

 

0252990

Others (2)

 

0253000

(c)

grape leaves and similar species

0,01  (*1)

0254000

(d)

watercresses

0,01  (*1)

0255000

(e)

witloofs/Belgian endives

0,01  (*1)

0256000

(f)

herbs and edible flowers

0,02  (*1)

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

0,01  (*1)

0260010

Beans (with pods)

 

0260020

Beans (without pods)

 

0260030

Peas (with pods)

 

0260040

Peas (without pods)

 

0260050

Lentils

 

0260990

Others (2)

 

0270000

Stem vegetables

0,01  (*1)

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

0,01  (*1)

0280010

Cultivated fungi

 

0280020

Wild fungi

 

0280990

Mosses and lichens

 

0290000

Algae and prokaryotes organisms

0,01  (*1)

0300000

PULSES

0,01  (*1)

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

0,01  (*1)

0401030

Poppy seeds

0,01  (*1)

0401040

Sesame seeds

0,01  (*1)

0401050

Sunflower seeds

0,3 (+)

0401060

Rapeseeds/canola seeds

0,05

0401070

Soyabeans

0,5 (+)

0401080

Mustard seeds

0,01  (*1)

0401090

Cotton seeds

0,01  (*1)

0401100

Pumpkin seeds

0,01  (*1)

0401110

Safflower seeds

0,01  (*1)

0401120

Borage seeds

0,01  (*1)

0401130

Gold of pleasure seeds

0,01  (*1)

0401140

Hemp seeds

0,01  (*1)

0401150

Castor beans

0,01  (*1)

0401990

Others (2)

0,01  (*1)

0402000

Oil fruits

0,01  (*1)

0402010

Olives for oil production

 

0402020

Oil palms kernels

 

0402030

Oil palms fruits

 

0402040

Kapok

 

0402990

Others (2)

 

0500000

CEREALS

0,01  (*1)

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

0,05  (*1)

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

0,05  (*1)

0800000

SPICES

 

0810000

Seed spices

0,05  (*1)

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

0,05  (*1)

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

0,05  (*1)

0830010

Cinnamon

 

0830990

Others (2)

 

0840000

Root and rhizome spices

 

0840010

Liquorice

0,05  (*1)

0840020

Ginger (10)

 

0840030

Turmeric/curcuma

0,05  (*1)

0840040

Horseradish (11)

 

0840990

Others (2)

0,05  (*1)

0850000

Bud spices

0,05  (*1)

0850010

Cloves

 

0850020

Capers

 

0850990

Others (2)

 

0860000

Flower pistil spices

0,05  (*1)

0860010

Saffron

 

0860990

Others (2)

 

0870000

Aril spices

0,05  (*1)

0870010

Mace

 

0870990

Others (2)

 

0900000

SUGAR PLANTS

0,01  (*1)

0900010

Sugar beet roots

 

0900020

Sugar canes

 

0900030

Chicory roots

 

0900990

Others (2)

 

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

 

1010000

Commodities from

0,01  (*1)

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

0,002  (*1)

1020010

Cattle

 

1020020

Sheep

 

1020030

Goat

 

1020040

Horse

 

1020990

Others (2)

 

1030000

Birds eggs

0,01  (*1)

1030010

Chicken

 

1030020

Duck

 

1030030

Geese

 

1030040

Quail

 

1030990

Others (2)

 

1040000

Honey and other apiculture products (7)

0,05  (*1)

1050000

Amphibians and Reptiles

0,01  (*1)

1060000

Terrestrial invertebrate animals

0,01  (*1)

1070000

Wild terrestrial vertebrate animals

0,01  (*1)

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)

 

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


(*1)  Indicates lower limit of analytical determination

(1)  For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I


ELI: http://data.europa.eu/eli/reg/2024/398/oj

ISSN 1977-0677 (electronic edition)


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