Reglamento (UE) 2024/398 de la Comisión, de 29 de enero de 2024

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Reglamento (UE) 2024/398 de la Comisión, de 29 de enero de 2024,  que modifica el anexo II del Reglamento (CE) nº 396/2005 del Parlamento Europeo y del Consejo por lo que respecta a los límites máximos de residuos de haloxifop en determinados productos.

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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Detectado: 31/01/2024
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