# L_2015280EN.01000201.xml

| 24.10.2015 | EN | Official Journal of the European Union | L 280/2 |
| --- | --- | --- | --- |

24.10.2015

EN

Official Journal of the European Union

L 280/2

---

COMMISSION REGULATION (EU) 2015/1910

of 21 October 2015

amending Annexes III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for guazatine 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 Articles 14(1)(a) and 18(1)(b) and Article 49(2) thereof,

Whereas:

| (1) | For guazatine, maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005. |
| --- | --- |

(1)

For guazatine, maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005.

| (2) | The European Food Safety Authority, hereinafter ‘the Authority’, submitted a reasoned opinion on the existing MRLs for guazatine in accordance with Article 12(1) of Regulation (EC) No 396/2005 (2). All existing authorisations for plant protection products containing the active substance guazatine have been revoked. Neither were import tolerances reported at Union level nor were Codex MRLs available. In the absence of information on specific good agricultural practices that could be used in a consumer risk assessment, the Authority concluded that a value of 0,05 mg/kg provides a satisfactory level of protection for the European consumers. It is therefore appropriate to set the MRLs at the specific limit of determination. It is also appropriate to change the residue definition. |
| --- | --- |

(2)

The European Food Safety Authority, hereinafter ‘the Authority’, submitted a reasoned opinion on the existing MRLs for guazatine in accordance with Article 12(1) of Regulation (EC) No 396/2005 (2). All existing authorisations for plant protection products containing the active substance guazatine have been revoked. Neither were import tolerances reported at Union level nor were Codex MRLs available. In the absence of information on specific good agricultural practices that could be used in a consumer risk assessment, the Authority concluded that a value of 0,05 mg/kg provides a satisfactory level of protection for the European consumers. It is therefore appropriate to set the MRLs at the specific limit of determination. It is also appropriate to change the residue definition.

| (3) | Moreover, Belgium indicated that the existing MRLs for guazatine in grapefruit and oranges may raise concerns of consumer protection. In particular, an acute consumer risk could not be excluded even by a refined risk assessment, taking into account a processing factor for citrus fruit. The European Commission and the Member States represented in the Standing Committee on Plants, Animals, Food and Feed considered it an appropriate risk management decision to lower the MRLs to a level that has been demonstrated to be safe for European consumers. |
| --- | --- |

(3)

Moreover, Belgium indicated that the existing MRLs for guazatine in grapefruit and oranges may raise concerns of consumer protection. In particular, an acute consumer risk could not be excluded even by a refined risk assessment, taking into account a processing factor for citrus fruit. The European Commission and the Member States represented in the Standing Committee on Plants, Animals, Food and Feed considered it an appropriate risk management decision to lower the MRLs to a level that has been demonstrated to be safe for European consumers.

| (4) | In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was submitted for guazatine used on citrus fruits. In accordance with Article 8 of Regulation (EC) No 396/2005 this application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. 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 MRLs (3). It forwarded this opinion to the Commission and the Member States and made it available to the public. It concluded in the opinion that it does not recommend setting the proposed MRLs since the available data were not sufficient to exclude a risk for European consumers. |
| --- | --- |

(4)

In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was submitted for guazatine used on citrus fruits. In accordance with Article 8 of Regulation (EC) No 396/2005 this application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. 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 MRLs (3). It forwarded this opinion to the Commission and the Member States and made it available to the public. It concluded in the opinion that it does not recommend setting the proposed MRLs since the available data were not sufficient to exclude a risk for European consumers.

| (5) | The applicant requested an administrative review of the Authority's reasoned opinion according to Article 13 of Regulation (EC) No 396/2005. This review led to the conclusion that no substantial flaws and errors of assessment on the part of the Authority were identified. |
| --- | --- |

(5)

The applicant requested an administrative review of the Authority's reasoned opinion according to Article 13 of Regulation (EC) No 396/2005. This review led to the conclusion that no substantial flaws and errors of assessment on the part of the Authority were identified.

| (6) | Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005. |
| --- | --- |

(6)

Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.

| (7) | Regulation (EC) No 396/2005 should therefore be amended accordingly. |
| --- | --- |

(7)

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

| (8) | In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been lawfully produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained. |
| --- | --- |

(8)

In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been lawfully produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained.

| (9) | The transitional arrangement provided for by this Regulation should take the concerns of consumer protection with the existing MRLs for guazatine in grapefruit and oranges into account. |
| --- | --- |

(9)

The transitional arrangement provided for by this Regulation should take the concerns of consumer protection with the existing MRLs for guazatine in grapefruit and oranges into account.

| (10) | 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. |
| --- | --- |

(10)

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.

| (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. |
| --- | --- |

(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) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(12)

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

Annexes III and V to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

Article 2

As regards guazatine, Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to all products which were lawfully produced before 13 May 2016, except grapefruit and oranges.

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.

However, it shall apply from 13 May 2016.

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

Done at Brussels, 21 October 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 70, 16.3.2005, p. 1.

1

(2)  European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels (MRLs) for guazatine according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2013;11(5):3239. [20 pp.].

2

(3)  European Food Safety Authority; Reasoned opinion on the modification of the existing MRL for guazatine in citrus fruits. EFSA Journal 2014;12(8):3818. [29 pp.].

3

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ANNEX

Annexes III and V to Regulation (EC) No 396/2005 are amended as follows:

| (1) | in Annex III, the column for guazatine is deleted; |
| --- | --- |

(1)

in Annex III, the column for guazatine is deleted;

| (2) | in Annex V, the following column for guazatine is added:

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








  Code number | Groups and examples of individual products to which the MRLs apply (1) | Guazatine (guazatine acetate, sum of components) |
| --- | --- | --- | --- |
| (1) | (2) | (3) |
| 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | 0,05
   (*1) |
| 0110000 | Citrus fruits | |
| 0110010 | Grapefruits | |
| 0110020 | Oranges | |
| 0110030 | Lemons | |
| 0110040 | Limes | |
| 0110050 | Mandarins | |
| 0110990 | Others | |
| 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 | |
| 0130000 | Pome fruits | |
| 0130010 | Apples | |
| 0130020 | Pears | |
| 0130030 | Quinces | |
| 0130040 | Medlars | |
| 0130050 | Loquats/Japanese medlars | |
| 0130990 | Others | |
| 0140000 | Stone fruits | |
| 0140010 | Apricots | |
| 0140020 | Cherries (sweet) | |
| 0140030 | Peaches | |
| 0140040 | Plums | |
| 0140990 | Others | |
| 0150000 | Berries and small fruits | |
| 0151000 | (a) | grapes |

(2)

in Annex V, the following column for guazatine is added:

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

Code number

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

Guazatine (guazatine acetate, sum of components)

(1)

(2)

(3)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0,05
   (*1)

0110000

Citrus fruits

0110010

Grapefruits

0110020

Oranges

0110030

Lemons

0110040

Limes

0110050

Mandarins

0110990

Others

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

0130000

Pome fruits

0130010

Apples

0130020

Pears

0130030

Quinces

0130040

Medlars

0130050

Loquats/Japanese medlars

0130990

Others

0140000

Stone fruits

0140010

Apricots

0140020

Cherries (sweet)

0140030

Peaches

0140040

Plums

0140990

Others

0150000

Berries and small fruits

0151000

(a)

0151010

Table grapes

0151020

Wine grapes

0152000

| (b) | strawberries |
| --- | --- |

(b)

0153000

| (c) | cane fruits |
| --- | --- |

(c)

0153010

Blackberries

0153020

Dewberries

0153030

Raspberries (red and yellow)

0153990

Others

0154000

| (d) | other small fruits and berries |
| --- | --- |

(d)

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 |
| --- | --- |

(a)

0161010

Dates

0161020

Figs

0161030

Table olives

0161040

Kumquats

0161050

Carambolas

0161060

Kaki/Japanese persimmons

0161070

Jambuls/jambolans

0161990

Others

0162000

| (b) | inedible peel, small |
| --- | --- |

(b)

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

0163000

| (c) | inedible peel, large |
| --- | --- |

(c)

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

0200000

VEGETABLES, FRESH or FROZEN

0,05
   (*1)

0210000

Root and tuber vegetables

0211000

| (a) | potatoes |
| --- | --- |

(a)

0212000

| (b) | tropical root and tuber vegetables |
| --- | --- |

(b)

0212010

Cassava roots/manioc

0212020

Sweet potatoes

0212030

Yams

0212040

Arrowroots

0212990

Others

0213000

| (c) | other root and tuber vegetables except sugar beets |
| --- | --- |

(c)

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

0220000

Bulb vegetables

0220010

Garlic

0220020

Onions

0220030

Shallots

0220040

Spring onions/green onions and Welsh onions

0220990

Others

0230000

Fruiting vegetables

0231000

| (a) | solanacea |
| --- | --- |

(a)

0231010

Tomatoes

0231020

Sweet peppers/bell peppers

0231030

Aubergines/eggplants

0231040

Okra/lady's fingers

0231990

Others

0232000

| (b) | cucurbits with edible peel |
| --- | --- |

(b)

0232010

Cucumbers

0232020

Gherkins

0232030

Courgettes

0232990

Others

0233000

| (c) | cucurbits with inedible peel |
| --- | --- |

(c)

0233010

Melons

0233020

Pumpkins

0233030

Watermelons

0233990

Others

0234000

| (d) | sweet corn |
| --- | --- |

(d)

0239000

| (e) | other fruiting vegetables |
| --- | --- |

(e)

0240000

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

0241000

| (a) | flowering brassica |
| --- | --- |

(a)

0241010

Broccoli

0241020

Cauliflowers

0241990

Others

0242000

| (b) | head brassica |
| --- | --- |

(b)

0242010

Brussels sprouts

0242020

Head cabbages

0242990

Others

0243000

| (c) | leafy brassica |
| --- | --- |

(c)

0243010

Chinese cabbages/pe-tsai

0243020

Kales

0243990

Others

0244000

| (d) | kohlrabies |
| --- | --- |

(d)

0250000

Leaf vegetables, herbs and edible flowers

0251000

| (a) | lettuces and salad plants |
| --- | --- |

(a)

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

0252000

| (b) | spinaches and similar leaves |
| --- | --- |

(b)

0252010

Spinaches

0252020

Purslanes

0252030

Chards/beet leaves

0252990

Others

0253000

| (c) | grape leaves and similar species |
| --- | --- |

(c)

0254000

| (d) | watercresses |
| --- | --- |

(d)

0255000

| (e) | witloofs/Belgian endives |
| --- | --- |

(e)

0256000

| (f) | herbs and edible flowers |
| --- | --- |

(f)

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)

0260020

Beans (without pods)

0260030

Peas (with pods)

0260040

Peas (without pods)

0260050

Lentils

0260990

Others

0270000

Stem vegetables

0270010

Asparagus

0270020

Cardoons

0270030

Celeries

0270040

Florence fennels

0270050

Globe artichokes

0270060

Leeks

0270070

Rhubarbs

0270080

Bamboo shoots

0270090

Palm hearts

0270990

Others

0280000

Fungi, mosses and lichens

0280010

Cultivated fungi

0280020

Wild fungi

0280990

Mosses and lichens

0290000

Algae and prokaryotes organisms

0300000

PULSES

0,05
   (*1)

0300010

Beans

0300020

Lentils

0300030

Peas

0300040

Lupins/lupini beans

0300990

Others

0400000

OILSEEDS AND OIL FRUITS

0,05
   (*1)

0401000

Oilseeds

0401010

Linseeds

0401020

Peanuts/groundnuts

0401030

Poppy seeds

0401040

Sesame seeds

0401050

Sunflower seeds

0401060

Rapeseeds/canola seeds

0401070

Soyabeans

0401080

Mustard seeds

0401090

Cotton seeds

0401100

Pumpkin seeds

0401110

Safflower seeds

0401120

Borage seeds

0401130

Gold of pleasure seeds

0401140

Hemp seeds

0401150

Castor beans

0401990

Others

0402000

Oil fruits

0402010

Olives for oil production

0402020

Oil palms kernels

0402030

Oil palms fruits

0402040

Kapok

0402990

Others

0500000

CEREALS

0,05
   (*1)

0500010

Barley

0500020

Buckwheat and other pseudo-cereals

0500030

Maize/corn

0500040

Common millet/proso millet

0500050

Oat

0500060

Rice

0500070

Rye

0500080

Sorghum

0500090

Wheat

0500990

Others

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

0,05
   (*1)

0610000

Teas

0620000

Coffee beans

0630000

Herbal infusions from

0631000

| (a) | flowers |
| --- | --- |

(a)

0631010

Chamomile

0631020

Hibiscus/roselle

0631030

Rose

0631040

Jasmine

0631050

Lime/linden

0631990

Others

0632000

| (b) | leaves and herbs |
| --- | --- |

(b)

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others

0633000

| (c) | roots |
| --- | --- |

(c)

0633010

Valerian

0633020

Ginseng

0633990

Others

0639000

| (d) | any other parts of the plant |
| --- | --- |

(d)

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

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

0830000

Bark spices

0,05
   (*1)

0830010

Cinnamon

0830990

Others

0840000

Root and rhizome spices

0840010

Liquorice

0,05
   (*1)

0840020

Ginger

0,05
   (*1)

0840030

Turmeric/curcuma

0,05
   (*1)

0840040

Horseradish

(+)

0840990

Others

0,05
   (*1)

0850000

Bud spices

0,05
   (*1)

0850010

Cloves

0850020

Capers

0850990

Others

0860000

Flower pistil spices

0,05
   (*1)

0860010

Saffron

0860990

Others

0870000

Aril spices

0,05
   (*1)

0870010

Mace

0870990

Others

0900000

SUGAR PLANTS

0,05
   (*1)

0900010

Sugar beet roots

0900020

Sugar canes

0900030

Chicory roots

0900990

Others

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

1010000

Tissues from

0,05
   (*1)

1011000

| (a) | swine |
| --- | --- |

(a)

1011010

Muscle

1011020

Fat tissue

1011030

Liver

1011040

Kidney

1011050

Edible offals (other than liver and kidney)

1011990

Others

1012000

| (b) | bovine |
| --- | --- |

(b)

1012010

Muscle

1012020

Fat tissue

1012030

Liver

1012040

Kidney

1012050

Edible offals (other than liver and kidney)

1012990

Others

1013000

| (c) | sheep |
| --- | --- |

(c)

1013010

Muscle

1013020

Fat tissue

1013030

Liver

1013040

Kidney

1013050

Edible offals (other than liver and kidney)

1013990

Others

1014000

| d) | goat |
| --- | --- |

d)

1014010

Muscle

1014020

Fat tissue

1014030

Liver

1014040

Kidney

1014050

Edible offals (other than liver and kidney)

1014990

Others

1015000

| (e) | equine |
| --- | --- |

(e)

1015010

Muscle

1015020

Fat tissue

1015030

Liver

1015040

Kidney

1015050

Edible offals (other than liver and kidney)

1015990

Others

1016000

| (f) | poultry |
| --- | --- |

(f)

1016010

Muscle

1016020

Fat tissue

1016030

Liver

1016040

Kidney

1016050

Edible offals (other than liver and kidney)

1016990

Others

1017000

| (g) | other farmed terrestrial animals |
| --- | --- |

(g)

1017010

Muscle

1017020

Fat tissue

1017030

Liver

1017040

Kidney

1017050

Edible offals (other than liver and kidney)

1017990

Others

1020000

Milk

0,02
   (*1)

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others

1030000

Birds eggs

0,05
   (*1)

1030010

Chicken

1030020

Duck

1030030

Geese

1030040

Quail

1030990

Others

1040000

Honey and other apiculture products

0,05
   (*1)

1050000

Amphibians and Reptiles

0,05
   (*1)

1060000

Terrestrial invertebrate animals

0,05
   (*1)

1070000

Wild terrestrial vertebrate animals

0,05
   (*1)

Guazatine (guazatine acetate, sum of components)

| (+) | 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’ |
| --- | --- | --- |

(+)

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’

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(*1)  Indicates lower limit of analytical determination

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

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