Commission Regulation (EU) 2019/88

of 18 January 2019

amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid in 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/EEC1, and in particular Article 14(1)(a) thereof,

Whereas:

(1)

For acetamiprid, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005.

(2)

In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance acetamiprid on table olives and olives for oil production, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.

(3)

Such an application was also submitted for the use of acetamiprid on barley and oats.

(4)

In accordance with Article 8 of Regulation (EC) No 396/2005, those applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission.

(5)
The European Food Safety Authority (‘the Authority’) assessed the applications and the evaluation reports, examining in particular the risks to the consumer and, where relevant, to animals and gave a reasoned opinion on the proposed MRLs2. The Authority forwarded that opinion to the applicant, the Commission and the Member States and made it available to the public.
(6)

The Authority concluded in its reasoned opinion that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicant were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. The Authority took into account the most recent information on the toxicological properties of the substance. Neither the lifetime exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded.

(7)
In the context of the procedure for the renewal of the approval of the active substance acetamiprid in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council3, the Authority submitted a conclusion on the peer review of the pesticide risk assessment concerning that active substance4, where new toxicological endpoints were proposed. These endpoints were agreed by the Standing Committee on Plants, Animals, Food and Feed on 13 December 20175.
(8)

In accordance with Article 43 of Regulation (EC) No 396/2005, the Commission requested the Authority to assess the risks the current MRLs for acetamiprid may pose to consumers in the light of the resulting lower acute reference dose (ARfD).

(9)
The Authority identified in its reasoned opinion6 consumer intake concerns for apples, pears, peaches, head cabbages, Chinese cabbages, kales, lettuces, escaroles, spinaches, purslanes, chards and celeries. Member States were consulted to report potential fall-back Good Agricultural Practices (GAPs) that would not lead to an unacceptable risk for consumers. Member States identified fall-back GAPs for all concerned products except for Chinese cabbages, kales and celeries, for which the MRLs should be set at the relevant limit of determination.
(10)

As regards escaroles, the Authority concluded that some information was not available and that further consideration by risk managers was required. As there is no risk for consumers in relation to the fall-back GAP, the MRL for that product should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. This MRL will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.

(11)

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.

(12)

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

(13)

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.

(14)

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

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 13 August 2019.

However, for acetamiprid in olives for oil production, table olives, barley and oats, it shall apply from 13 February 2019.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 18 January 2019.

For the Commission

The President

Jean-Claude Juncker

ANNEX

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

‘Pesticide residues and maximum residue levels (mg/kg)

Code number

Groups and examples of individual products to which the MRLs apply8

Acetamiprid (R)

(1)

(2)

(3)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0110000

Citrus fruits

0,9

0110010

Grapefruits

0110020

Oranges

0110030

Lemons

0110040

Limes

0110050

Mandarins

0110990

Others (2)

0120000

Tree nuts

0,07

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

0,4

0130020

Pears

0,4

0130030

Quinces

0,8

0130040

Medlars

0,8

0130050

Loquats/Japanese medlars

0,8

0130990

Others (2)

0,8

0140000

Stone fruits

0140010

Apricots

0,8

0140020

Cherries (sweet)

1.5

0140030

Peaches

0,2

0140040

Plums

0,03

0140990

Others (2)

0,017

0150000

Berries and small fruits

0151000

(a)

grapes

0,5

0151010

Table grapes

0151020

Wine grapes

0152000

(b)

strawberries

0,5

0153000

(c)

cane fruits

2

0153010

Blackberries

0153020

Dewberries

0153030

Raspberries (red and yellow)

0153990

Others (2)

0154000

(d)

other small fruits and berries

0154010

Blueberries

2

0154020

Cranberries

2

0154030

Currants (black, red and white)

2

0154040

Gooseberries (green, red and yellow)

2

0154050

Rose hips

2

0154060

Mulberries (black and white)

2

0154070

Azaroles/Mediterranean medlars

0,017

0154080

Elderberries

2

0154990

Others (2)

0,017

0160000

Miscellaneous fruits with

0161000

(a)

edible peel

0161010

Dates

0,017

0161020

Figs

0,03

0161030

Table olives

3

0161040

Kumquats

0,017

0161050

Carambolas

0,017

0161060

Kaki/Japanese persimmons

0,017

0161070

Jambuls/jambolans

0,017

0161990

Others (2)

0,017

0162000

(b)

inedible peel, small

0,017

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

0,017

0163020

Bananas

0,4

0163030

Mangoes

0,017

0163040

Papayas

0,017

0163050

Granate apples/pomegranates

0,017

0163060

Cherimoyas

0,017

0163070

Guavas

0,017

0163080

Pineapples

0,017

0163090

Breadfruits

0,017

0163100

Durians

0,017

0163110

Soursops/guanabanas

0,017

0163990

Others (2)

0,017

0200000

VEGETABLES, FRESH or FROZEN

0210000

Root and tuber vegetables

0,017

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

0,02

0220020

Onions

0,02

0220030

Shallots

0,017

0220040

Spring onions/green onions and Welsh onions

0,017

0220990

Others (2)

0,017

0230000

Fruiting vegetables

0231000

(a)

Solanaceae and Malvaceae

0231010

Tomatoes

0,5

0231020

Sweet peppers/bell peppers

0,3

0231030

Aubergines/eggplants

0,2

0231040

Okra/lady's fingers

0,2

0231990

Others (2)

0,2

0232000

(b)

cucurbits with edible peel

0232010

Cucumbers

0,3

0232020

Gherkins

0,6

0232030

Courgettes

0,3

0232990

Others (2)

0,3

0233000

(c)

cucurbits with inedible peel

0,2

0233010

Melons

0233020

Pumpkins

0233030

Watermelons

0233990

Others (2)

0234000

(d)

sweet corn

0,017

0239000

(e)

other fruiting vegetables

0,2

0240000

Brassica vegetables (excluding brassica roots and brassica baby leaf crops)

0241000

(a)

flowering brassica

0,4

0241010

Broccoli

0241020

Cauliflowers

0241990

Others (2)

0242000

(b)

head brassica

0242010

Brussels sprouts

0,05

0242020

Head cabbages

0,4

0242990

Others (2)

0,017

0243000

(c)

leafy brassica

0,017

0243010

Chinese cabbages/pe-tsai

0243020

Kales

0243990

Others (2)

0244000

(d)

kohlrabies

0,017

0250000

Leaf vegetables, herbs and edible flowers

0251000

(a)

lettuces and salad plants

0251010

Lamb's lettuces/corn salads

3

0251020

Lettuces

1,5

0251030

Escaroles/broad-leaved endives

0,4 (+)

0251040

Cresses and other sprouts and shoots

3

0251050

Land cresses

3

0251060

Roman rocket/rucola

3

0251070

Red mustards

3

0251080

Baby leaf crops (including brassica species)

3

0251990

Others (2)

0,017

0252000

(b)

spinaches and similar leaves

0,6

0252010

Spinaches

0252020

Purslanes

0252030

Chards/beet leaves

0252990

Others (2)

0253000

(c)

grape leaves and similar species

0,017

0254000

(d)

watercresses

0,017

0255000

(e)

witloofs/Belgian endives

0,017

0256000

(f)

herbs and edible flowers

3

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

0260010

Beans (with pods)

0,6

0260020

Beans (without pods)

0,3

0260030

Peas (with pods)

0,6

0260040

Peas (without pods)

0,3

0260050

Lentils

0,017

0260990

Others (2)

0,017

0270000

Stem vegetables

0270010

Asparagus

0,8

0270020

Cardoons

0,017

0270030

Celeries

0,017

0270040

Florence fennels

0,017

0270050

Globe artichokes

0,7

0270060

Leeks

0,017

0270070

Rhubarbs

0,017

0270080

Bamboo shoots

0,017

0270090

Palm hearts

0,017

0270990

Others (2)

0,017

0280000

Fungi, mosses and lichens

0,017

0280010

Cultivated fungi

0280020

Wild fungi

0280990

Mosses and lichens

0290000

Algae and prokaryotes organisms

0,017

0300000

PULSES

0,15

0300010

Beans

0300020

Lentils

0300030

Peas

0300040

Lupins/lupini beans

0300990

Others (2)

0400000

OILSEEDS AND OIL FRUITS

0401000

Oilseeds

0401010

Linseeds

0,017

0401020

Peanuts/groundnuts

0,017

0401030

Poppy seeds

0,017

0401040

Sesame seeds

0,017

0401050

Sunflower seeds

0,017

0401060

Rapeseeds/canola seeds

0,4

0401070

Soyabeans

0,017

0401080

Mustard seeds

0,017

0401090

Cotton seeds

0,7

0401100

Pumpkin seeds

0,017

0401110

Safflower seeds

0,017

0401120

Borage seeds

0,017

0401130

Gold of pleasure seeds

0,017

0401140

Hemp seeds

0,017

0401150

Castor beans

0,017

0401990

Others (2)

0,017

0402000

Oil fruits

0402010

Olives for oil production

3

0402020

Oil palms kernels

0,017

0402030

Oil palms fruits

0,017

0402040

Kapok

0,017

0402990

Others (2)

0,017

0500000

CEREALS

0500010

Barley

0,05

0500020

Buckwheat and other pseudocereals

0,017

0500030

Maize/corn

0,017

0500040

Common millet/proso millet

0,017

0500050

Oat

0,05

0500060

Rice

0,017

0500070

Rye

0,017

0500080

Sorghum

0,017

0500090

Wheat

0,1

0500990

Others (2)

0,017

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

0,057

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

0,057

0800000

SPICES

0810000

Seed spices

0,057

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

0820010

Allspice/pimento

0,057

0820020

Sichuan pepper

0,057

0820030

Caraway

0,057

0820040

Cardamom

0,1

0820050

Juniper berry

0,057

0820060

Peppercorn (black, green and white)

0,1

0820070

Vanilla

0,057

0820080

Tamarind

0,057

0820990

Others (2)

0,057

0830000

Bark spices

0,057

0830010

Cinnamon

0830990

Others (2)

0840000

Root and rhizome spices

0840010

Liquorice

0,057

0840020

Ginger (10)

0,057

0840030

Turmeric/curcuma

0,057

0840040

Horseradish (11)

(+)

0840990

Others (2)

0,057

0850000

Bud spices

0,057

0850010

Cloves

0850020

Capers

0850990

Others (2)

0860000

Flower pistil spices

0,057

0860010

Saffron

0860990

Others (2)

0870000

Aril spices

0,057

0870010

Mace

0870990

Others (2)

0900000

SUGAR PLANTS

0,017

0900010

Sugar beet roots

0900020

Sugar canes

0900030

Chicory roots

0900990

Others (2)

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

1010000

Commodities from

1011000

(a)

swine

1011010

Muscle

0,5

1011020

Fat

0,3

1011030

Liver

1

1011040

Kidney

1

1011050

Edible offals (other than liver and kidney)

1

1011990

Others (2)

0,027

1012000

(b)

bovine

1012010

Muscle

0,5

1012020

Fat

0,3

1012030

Liver

1

1012040

Kidney

1

1012050

Edible offals (other than liver and kidney)

1

1012990

Others (2)

0,027

1013000

(c)

sheep

1013010

Muscle

0,5

1013020

Fat

0,3

1013030

Liver

1

1013040

Kidney

1

1013050

Edible offals (other than liver and kidney)

1

1013990

Others (2)

0,027

1014000

d)

goat

1014010

Muscle

0,5

1014020

Fat

0,3

1014030

Liver

1

1014040

Kidney

1

1014050

Edible offals (other than liver and kidney)

1

1014990

Others (2)

0,027

1015000

(e)

equine

1015010

Muscle

0,5

1015020

Fat

0,3

1015030

Liver

1

1015040

Kidney

1

1015050

Edible offals (other than liver and kidney)

1

1015990

Others (2)

0,027

1016000

(f)

poultry

1016010

Muscle

0,027

1016020

Fat

0,027

1016030

Liver

0,17

1016040

Kidney

0,17

1016050

Edible offals (other than liver and kidney)

0,027

1016990

Others (2)

0,027

1017000

(g)

other farmed terrestrial animals

1017010

Muscle

0,5

1017020

Fat

0,3

1017030

Liver

1

1017040

Kidney

1

1017050

Edible offals (other than liver and kidney)

1

1017990

Others (2)

0,027

1020000

Milk

0,2

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others (2)

1030000

Birds eggs

0,027

1030010

Chicken

1030020

Duck

1030030

Geese

1030040

Quail

1030990

Others (2)

1040000

Honey and other apiculture products (7)

0,057

1050000

Amphibians and Reptiles

0,027

1060000

Terrestrial invertebrate animals

0,027

1070000

Wild terrestrial vertebrate animals

0,027

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)

Acetamiprid (R)

  • (R)

    The residue definition differs for the following combinations pesticide-code number:

    Acetamiprid - code 1000000 except 1040000: Sum of acetamiprid and N-desmethyl-acetamiprid (IM-2-1), expressed as acetamiprid

(+) The European Food Safety Authority identified some information on residue trials 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 24 January 2021, or, if that information is not submitted by that date, the lack of it.

  • 0251030

    Escaroles/broad-leaved endives’

8

For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.

7

Limit of analytical determination