10.8.2016   

EN

Official Journal of the European Union

L 215/4


COMMISSION REGULATION (EU) 2016/1355

of 9 August 2016

amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards thiacloprid

(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) thereof,

Whereas:

(1)

For thiacloprid, 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 thiacloprid on rapeseed, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRL in honey and other apiculture products.

(3)

In accordance with Article 8 of Regulation (EC) No 396/2005, that application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission.

(4)

The European Food Safety Authority, hereinafter ‘the Authority’, assessed the application and the evaluation report, examining in particular the risks to the consumer and, where relevant, to animals and gave a reasoned opinion on the proposed MRL (2). It forwarded that opinion to 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 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 product showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded.

(6)

The Authority proposed several MRLs for honey, to be considered by the risk managers, which were based on, respectively, the field trials submitted by the applicant and Union wide monitoring data. As there is no risk to consumers, the MRL for thiacloprid in honey should be set at the level of 0,2 mg/kg on the basis of the available residue trials. The monitoring data are in a similar range and confirm such level.

(7)

Based on the reasoned opinion of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modification to the MRL fulfils the requirements of Article 14(2) of Regulation (EC) No 396/2005.

(8)

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

(9)

In order to minimise the potential market disruptions that may arise from the temporary application of the MRL for honey, set at the limit of determination by Commission Regulation (EU) 2015/1200 (3), this Regulation should enter into force as soon as possible.

(10)

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 day following that of its publication in the Official Journal of the European Union.

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

Done at Brussels, 9 August 2016.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 70, 16.3.2005, p. 1.

(2)  EFSA scientific reports available online: http://www.efsa.europa.eu:

Reasoned opinion on the modification of the existing maximum residue level for thiacloprid in honey. EFSA Journal 2016;14(3):4418 [21 pp.].

(3)  Commission Regulation (EU) 2015/1200 of 22 July 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 amidosulfuron, fenhexamid, kresoxim-methyl, thiacloprid and trifloxystrobin in or on certain products (OJ L 195, 23.7.2015, p. 1).


ANNEX

In Annex II to Regulation (EC) No 396/2005, the column for thiacloprid 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 apply (1)

Thiacloprid

(1)

(2)

(3)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

 

0110000

Citrus fruits

0,01 (*)

0110010

Grapefruits

 

0110020

Oranges

 

0110030

Lemons

 

0110040

Limes

 

0110050

Mandarins

 

0110990

Others

 

0120000

Tree nuts

0,02 (*)

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

 

0130000

Pome fruits

 

0130010

Apples

0,3

0130020

Pears

0,3

0130030

Quinces

0,7

0130040

Medlars

0,7

0130050

Loquats/Japanese medlars

0,7

0130990

Others

0,01 (*)

0140000

Stone fruits

0,5

0140010

Apricots

 

0140020

Cherries (sweet)

 

0140030

Peaches

 

0140040

Plums

 

0140990

Others

 

0150000

Berries and small fruits

 

0151000

(a)

grapes

0,01 (*)

0151010

Table grapes

 

0151020

Wine grapes

 

0152000

(b)

strawberries

1

0153000

(c)

cane fruits

 

0153010

Blackberries

1

0153020

Dewberries

1

0153030

Raspberries (red and yellow)

6

0153990

Others

0,01 (*)

0154000

(d)

other small fruits and berries

1

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

 

0160000

Miscellaneous fruits with

 

0161000

(a)

edible peel

 

0161010

Dates

0,01 (*)

0161020

Figs

0,5

0161030

Table olives

4

0161040

Kumquats

0,01 (*)

0161050

Carambolas

0,01 (*)

0161060

Kaki/Japanese persimmons

0,01 (*)

0161070

Jambuls/jambolans

0,01 (*)

0161990

Others

0,01 (*)

0162000

(b)

inedible peel, small

 

0162010

Kiwi fruits (green, red, yellow)

0,2

0162020

Litchis/lychees

0,01 (*)

0162030

Passionfruits/maracujas

0,01 (*)

0162040

Prickly pears/cactus fruits

0,01 (*)

0162050

Star apples/cainitos

0,01 (*)

0162060

American persimmons/Virginia kaki

0,01 (*)

0162990

Others

0,01 (*)

0163000

(c)

inedible peel, large

 

0163010

Avocados

0,01 (*)

0163020

Bananas

0,01 (*)

0163030

Mangoes

0,01 (*)

0163040

Papayas

0,5

0163050

Granate apples/pomegranates

0,01 (*)

0163060

Cherimoyas

0,01 (*)

0163070

Guavas

0,01 (*)

0163080

Pineapples

0,01 (*)

0163090

Breadfruits

0,01 (*)

0163100

Durians

0,01 (*)

0163110

Soursops/guanabanas

0,01 (*)

0163990

Others

0,01 (*)

0200000

VEGETABLES, FRESH or FROZEN

 

0210000

Root and tuber vegetables

 

0211000

(a)

potatoes

0,02

0212000

(b)

tropical root and tuber vegetables

0,01 (*)

0212010

Cassava roots/manioc

 

0212020

Sweet potatoes

 

0212030

Yams

 

0212040

Arrowroots

 

0212990

Others

 

0213000

(c)

other root and tuber vegetables except sugar beets

 

0213010

Beetroots

0,05

0213020

Carrots

0,05

0213030

Celeriacs/turnip rooted celeries

0,05

0213040

Horseradishes

0,05

0213050

Jerusalem artichokes

0,05

0213060

Parsnips

0,05

0213070

Parsley roots/Hamburg roots parsley

0,05

0213080

Radishes

0,05

0213090

Salsifies

0,05

0213100

Swedes/rutabagas

0,01 (*)

0213110

Turnips

0,01 (*)

0213990

Others

0,01 (*)

0220000

Bulb vegetables

 

0220010

Garlic

0,01 (*)

0220020

Onions

0,01 (*)

0220030

Shallots

0,01 (*)

0220040

Spring onions/green onions and Welsh onions

0,15

0220990

Others

0,01 (*)

0230000

Fruiting vegetables

 

0231000

(a)

solanacea

 

0231010

Tomatoes

0,5

0231020

Sweet peppers/bell peppers

1

0231030

Aubergines/eggplants

0,7

0231040

Okra/lady's fingers

0,01 (*)

0231990

Others

0,01 (*)

0232000

(b)

cucurbits with edible peel

0,5

0232010

Cucumbers

 

0232020

Gherkins

 

0232030

Courgettes

(+)

0232990

Others

 

0233000

(c)

cucurbits with inedible peel

 

0233010

Melons

0,2

0233020

Pumpkins

0,01 (*)

0233030

Watermelons

0,2

0233990

Others

0,01 (*)

0234000

(d)

sweet corn

0,01 (*)

0239000

(e)

other fruiting vegetables

0,01 (*)

0240000

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

 

0241000

(a)

flowering brassica

0,3 (+)

0241010

Broccoli

 

0241020

Cauliflowers

 

0241990

Others

 

0242000

(b)

head brassica

0,3

0242010

Brussels sprouts

 

0242020

Head cabbages

 

0242990

Others

 

0243000

(c)

leafy brassica

 

0243010

Chinese cabbages/pe-tsai

1

0243020

Kales

0,4

0243990

Others

0,01 (*)

0244000

(d)

kohlrabies

0,04

0250000

Leaf vegetables, herbs and edible flowers

 

0251000

(a)

lettuces and salad plants

 

0251010

Lamb's lettuces/corn salads

8

0251020

Lettuces

1

0251030

Escaroles/broad-leaved endives

0,15 (+)

0251040

Cresses and other sprouts and shoots

0,01 (*)

0251050

Land cresses

0,7 (+)

0251060

Roman rocket/rucola

2 (+)

0251070

Red mustards

0,01 (*)

0251080

Baby leaf crops (including brassica species)

2 (+)

0251990

Others

0,01 (*)

0252000

(b)

spinaches and similar leaves

 

0252010

Spinaches

0,15 (+)

0252020

Purslanes

0,01 (*)

0252030

Chards/beet leaves

0,15 (+)

0252990

Others

0,01 (*)

0253000

(c)

grape leaves and similar species

0,01 (*)

0254000

(d)

watercresses

0,01 (*)

0255000

(e)

witloofs/Belgian endives

0,01 (*)

0256000

(f)

herbs and edible flowers

5

0256010

Chervil

 

0256020

Chives

 

0256030

Celery leaves

 

0256040

Parsley

 

0256050

Sage

 

0256060

Rosemary

 

0256070

Thyme

 

0256080

Basil and edible flowers

 

0256090

Laurel/bay leave

 

0256100

Tarragon

 

0256990

Others

 

0260000

Legume vegetables

 

0260010

Beans (with pods)

0,4 (+)

0260020

Beans (without pods)

0,01 (*)

0260030

Peas (with pods)

0,2

0260040

Peas (without pods)

0,2

0260050

Lentils

0,01 (*)

0260990

Others

0,01 (*)

0270000

Stem vegetables

 

0270010

Asparagus

0,01 (*)

0270020

Cardoons

0,01 (*)

0270030

Celeries

0,7

0270040

Florence fennels

0,7

0270050

Globe artichokes

0,01 (*)

0270060

Leeks

0,1

0270070

Rhubarbs

0,02

0270080

Bamboo shoots

0,01 (*)

0270090

Palm hearts

0,01 (*)

0270990

Others

0,01 (*)

0280000

Fungi, mosses and lichens

0,01 (*)

0280010

Cultivated fungi

 

0280020

Wild fungi

 

0280990

Mosses and lichens

 

0290000

Algae and prokaryotes organisms

0,01 (*)

0300000

PULSES

 

0300010

Beans

0,08 (+)

0300020

Lentils

0,01 (*)

0300030

Peas

0,08 (+)

0300040

Lupins/lupini beans

0,01 (*)

0300990

Others

0,01 (*)

0400000

OILSEEDS AND OIL FRUITS

 

0401000

Oilseeds

 

0401010

Linseeds

0,02 (*)

0401020

Peanuts/groundnuts

0,02 (*)

0401030

Poppy seeds

0,3

0401040

Sesame seeds

0,02 (*)

0401050

Sunflower seeds

0,02 (*)

0401060

Rapeseeds/canola seeds

0,6 (+)

0401070

Soyabeans

0,02 (*)

0401080

Mustard seeds

0,6 (+)

0401090

Cotton seeds

0,15

0401100

Pumpkin seeds

0,02 (*)

0401110

Safflower seeds

0,02 (*)

0401120

Borage seeds

0,02 (*)

0401130

Gold of pleasure seeds

0,02 (*)

0401140

Hemp seeds

0,02 (*)

0401150

Castor beans

0,02 (*)

0401990

Others

0,02 (*)

0402000

Oil fruits

 

0402010

Olives for oil production

4

0402020

Oil palms kernels

0,02 (*)

0402030

Oil palms fruits

0,02 (*)

0402040

Kapok

0,02 (*)

0402990

Others

0,02 (*)

0500000

CEREALS

 

0500010

Barley

0,9

0500020

Buckwheat and other pseudo-cereals

0,01 (*)

0500030

Maize/corn

0,01* (+)

0500040

Common millet/proso millet

0,01 (*)

0500050

Oat

0,9

0500060

Rice

0,02

0500070

Rye

0,06

0500080

Sorghum

0,01 (*)

0500090

Wheat

0,1

0500990

Others

0,01 (*)

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

 

0610000

Teas

10 (+)

0620000

Coffee beans

0,05 (*)

0630000

Herbal infusions from

 

0631000

(a)

flowers

0,05 (*)

0631010

Chamomile

 

0631020

Hibiscus/roselle

 

0631030

Rose

 

0631040

Jasmine

 

0631050

Lime/linden

 

0631990

Others

 

0632000

(b)

leaves and herbs

50 (+)

0632010

Strawberry

 

0632020

Rooibos

 

0632030

Mate/maté

 

0632990

Others

 

0633000

(c)

roots

0,02 (+)

0633010

Valerian

 

0633020

Ginseng

 

0633990

Others

 

0639000

(d)

any other parts of the plant

0,05 (*)

0640000

Cocoa beans

0,05 (*)

0650000

Carobs/Saint John's breads

0,05 (*)

0700000

HOPS

0,05 (*)

0800000

SPICES

 

0810000

Seed spices

0,08 (+)

0810010

Anise/aniseed

 

0810020

Black caraway/black cumin

 

0810030

Celery

 

0810040

Coriander

 

0810050

Cumin

 

0810060

Dill

 

0810070

Fennel

 

0810080

Fenugreek

 

0810090

Nutmeg

 

0810990

Others

 

0820000

Fruit spices

0,05 (*)

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

 

0830000

Bark spices

0,05 (*)

0830010

Cinnamon

 

0830990

Others

 

0840000

Root and rhizome spices

 

0840010

Liquorice

0,05 (*)

0840020

Ginger

0,05 (*)

0840030

Turmeric/curcuma

0,05 (*)

0840040

Horseradish

(+)

0840990

Others

0,05 (*)

0850000

Bud spices

0,05 (*)

0850010

Cloves

 

0850020

Capers

 

0850990

Others

 

0860000

Flower pistil spices

0,05 (*)

0860010

Saffron

 

0860990

Others

 

0870000

Aril spices

0,05 (*)

0870010

Mace

 

0870990

Others

 

0900000

SUGAR PLANTS

 

0900010

Sugar beet roots

0,02

0900020

Sugar canes

0,01 (*)

0900030

Chicory roots

0,05

0900990

Others

0,01 (*)

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

 

1010000

Tissues from

 

1011000

(a)

swine

 

1011010

Muscle

0,1

1011020

Fat tissue

0,01 (*)

1011030

Liver

0,5

1011040

Kidney

0,5

1011050

Edible offals (other than liver and kidney)

0,5

1011990

Others

0,01 (*)

1012000

(b)

bovine

 

1012010

Muscle

0,1

1012020

Fat tissue

0,04

1012030

Liver

0,5

1012040

Kidney

0,5

1012050

Edible offals (other than liver and kidney)

0,5

1012990

Others

0,01 (*)

1013000

(c)

sheep

 

1013010

Muscle

0,1

1013020

Fat tissue

0,04

1013030

Liver

0,5

1013040

Kidney

0,5

1013050

Edible offals (other than liver and kidney)

0,5

1013990

Others

0,01 (*)

1014000

(d)

goat

 

1014010

Muscle

0,1

1014020

Fat tissue

0,04

1014030

Liver

0,5

1014040

Kidney

0,5

1014050

Edible offals (other than liver and kidney)

0,5

1014990

Others

0,01 (*)

1015000

(e)

equine

 

1015010

Muscle

0,1

1015020

Fat tissue

0,04

1015030

Liver

0,5

1015040

Kidney

0,5

1015050

Edible offals (other than liver and kidney)

0,5

1015990

Others

0,01 (*)

1016000

(f)

poultry

 

1016010

Muscle

0,02

1016020

Fat tissue

0,01 (*)

1016030

Liver

0,02

1016040

Kidney

0,01 (*)

1016050

Edible offals (other than liver and kidney)

0,02

1016990

Others

0,01 (*)

1017000

(g)

other farmed terrestrial animals

 

1017010

Muscle

0,1

1017020

Fat tissue

0,04

1017030

Liver

0,5

1017040

Kidney

0,5

1017050

Edible offals (other than liver and kidney)

0,5

1017990

Others

0,01 (*)

1020000

Milk

0,05

1020010

Cattle

 

1020020

Sheep

 

1020030

Goat

 

1020040

Horse

 

1020990

Others

 

1030000

Birds eggs

0,02 (*)

1030010

Chicken

 

1030020

Duck

 

1030030

Geese

 

1030040

Quail

 

1030990

Others

 

1040000

Honey and other apiculture products

0,2

1050000

Amphibians and Reptiles

0,01 (*)

1060000

Terrestrial invertebrate animals

0,01 (*)

1070000

Wild terrestrial vertebrate animals

0,01 (*)


(*)  Indicates lower limit of analytical determination

(**)

Pesticide-code combination for which the MRL as set in Annex III Part B applies.

Thiacloprid

(+)

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 23 July 2017, or, if that information is not submitted by that date, the lack of it.

0232030

Courgettes

0241000

(a)

flowering brassica

0241010

Broccoli

0241020

Cauliflowers

0241990

Others

0251030

Escaroles/broad-leaved endives

0251050

Land cresses

0251060

Roman rocket/rucola

0251080

Baby leaf crops (including brassica species)

0252010

Spinaches

0252030

Chards/beet leaves

0260010

Beans (with pods)

0300010

Beans

0300030

Peas

0401060

Rapeseeds/canola seeds

0401080

Mustard seeds

(+)

The European Food Safety Authority identified some information on crop metabolism with seed treatment 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 23 July 2017, or, if that information is not submitted by that date, the lack of it.

0500030

Maize/corn

(+)

The European Food Safety Authority identified some information on analytical methods 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 23 July 2017, or, if that information is not submitted by that date, the lack of it.

0610000

Teas

0632000

(b)

leaves and herbs

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others

0633000

(c)

roots

0633010

Valerian

0633020

Ginseng

0633990

Others

0810000

Seed spices

0810010

Anise/aniseed

0810020

Black caraway/black cumin

0810030

Celery

0810040

Coriander

0810050

Cumin

0810060

Dill

0810070

Fennel

0810080

Fenugreek

0810090

Nutmeg

0810990

Others

(+)

The applicable maximum residue level for horseradish (Armoracia rusticana) in the spice group (code 0840040) is the one set for horseradish (Armoracia rusticana) in the Vegetables category, root and tuber vegetables group (code 0213040) taking into account changes in the levels by processing (drying) according to Art. 20 (1) of Regulation (EC) No 396/2005.

0840040

Horseradish’

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

Thiacloprid

(+)

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 23 July 2017, or, if that information is not submitted by that date, the lack of it.

0232030

Courgettes

0241000

(a)

flowering brassica

0241010

Broccoli

0241020

Cauliflowers

0241990

Others

0251030

Escaroles/broad-leaved endives

0251050

Land cresses

0251060

Roman rocket/rucola

0251080

Baby leaf crops (including brassica species)

0252010

Spinaches

0252030

Chards/beet leaves

0260010

Beans (with pods)

0300010

Beans

0300030

Peas

0401060

Rapeseeds/canola seeds

0401080

Mustard seeds

(+)

The European Food Safety Authority identified some information on crop metabolism with seed treatment 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 23 July 2017, or, if that information is not submitted by that date, the lack of it.

0500030

Maize/corn

(+)

The European Food Safety Authority identified some information on analytical methods 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 23 July 2017, or, if that information is not submitted by that date, the lack of it.

0610000

Teas

0632000

(b)

leaves and herbs

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others

0633000

(c)

roots

0633010

Valerian

0633020

Ginseng

0633990

Others

0810000

Seed spices

0810010

Anise/aniseed

0810020

Black caraway/black cumin

0810030

Celery

0810040

Coriander

0810050

Cumin

0810060

Dill

0810070

Fennel

0810080

Fenugreek

0810090

Nutmeg

0810990

Others

(+)

The applicable maximum residue level for horseradish (Armoracia rusticana) in the spice group (code 0840040) is the one set for horseradish (Armoracia rusticana) in the Vegetables category, root and tuber vegetables group (code 0213040) taking into account changes in the levels by processing (drying) according to Art. 20 (1) of Regulation (EC) No 396/2005.

0840040

Horseradish’