Commission Directive 2005/46/EC of 8 July 2005 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for amitraz   (Text with EEA relevance)
Date: 2005-07-08
Institutions: European Commission
Subjects: animal product, cereals, consumer protection, foodstuff, fruit, pesticide residue, plant health legislation, vegetable

9.7.2005

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Official Journal of the European Union

L 177/35

COMMISSION DIRECTIVE 2005/46/EC

of 8 July 2005

amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards
maximum residue levels for amitraz

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for
pesticide residues in and on cereals (1) and in particular Article 10 thereof,

Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for
pesticide residues in and on foodstuffs of animal origin (2) and in particular Article 10 thereof,

Having regard to Council Directive 90/642/EEC of 27 November 1990 on fixing of maximum levels for
pesticide residues in and on certain products of plant origin including fruit and vegetables (3) and in
particular Article 7 thereof,

Whereas:

(1)

(2)

(3)

(4)

For the existing active substance amitraz a decision was taken not to include it in Annex I to Council
Directive 91/414/EEC (4) by Commission Decision 2004/141/EC (5). This Decision provides that plant
protection products containing this active substance shall no longer be authorised for use in the
Community except for a limited number of uses, where at the moment no alternatives are available
(essential uses).

Decision 2004/141/EC allowed a phasing out period, and it is appropriate that maximum residue
levels (MRLs) premised on the notion that use of the substance concerned is not authorised in the
Community, should not apply until the end of the phasing out period applying to that substance.

For amitraz MRLs for residues resulting from veterinary medicinal uses have been set on animal
products in the framework of Council Regulation (EC) No 2377/90 (6). It is appropriate to take these
into account in this Directive.

Community MRLs and the levels recommended by the Codex Alimentarius (7) are fixed and evaluated
following similar procedures. There are a limited number of Codex MRLs for amitraz. These have
been considered in the setting of the MRLs fixed in this Directive. Codex MRLs that will be recom-
mended for withdrawal in the near future were not taken into account. The MRLs based on Codex
MRLs having been evaluated in the light of the risks for the consumers, no risk was established.

(1) OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2005/37/EC (OJ L 141, 4.6.2005,

p. 10).

(2) OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2004/61/EC (OJ L 127, 29.4.2004,

p. 81).

(3) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2005/37/EC.
(4) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation (EC) No 396/2005 of the European Parliament

and of the Council (OJ L 70, 16.3.2005, p. 1).

(5) OJ L 46, 17.2.2004, p. 35.
(6) OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 869/2005 (OJ L 145,

9.6.2005, p. 19).

(7) http://apps.fao.org/CodexSystem/pestdes/pest_q-e.htm

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Official Journal of the European Union

9.7.2005

(5)

(6)

(7)

(8)

In order to ensure that the consumer is adequately protected from exposure to residues resulting
from unauthorised uses of plant protection products, MRLs should be set for the relevant product/-
pesticide combinations at the lower limit of analytical determination.

It is therefore necessary to amend several of the pesticide residues arising from use of amitraz in the
Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC to allow for proper surveillance and
control of the prohibition of their uses and to protect the consumer.

The relevant annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be
amended accordingly.

The measures provided for in this Directive are in accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:

In part A of Annex II to Directive 86/362/EEC the following row is replaced:

Article 1

Pesticide residue

Maximum level in mg/kg

‘Amitraz including the metabolites containing the 2,4-
dimethylaniline moiety expressed as amitraz

0,05 (*) cereals

(*) Indicates lower limit of analytical determination.’

In part B of Annex II to Directive 86/363/EEC the following rows are replaced:

Article 2

Pesticide residue

Maximum level (mg/kg)

Of meat, including fat,
preparations of meat, offals
and animal fats as listed in
Annex I within CN code Nos
0201, 0202, 0203, 0204,
0205 00 00, 0206, 0207,
ex 0208, 0209 00, 0210,
1601 00 and 1602

0,05 (*), Poultry

For milk and milk products
listed in Annex 1 within CN
code Nos 0401, 0402,
0405 00 and 0406

Of shelled fresh eggs, for bird’s
eggs and egg yolks listed in
Annex 1 within CN code Nos
0407 00 and 0408

0,01 (*)

including

‘Amitraz
the
metabolites containing the
2,4-dimethylaniline moiety
expressed as amitraz

(*) Indicates lower limit of analytical determination.’

The maximum pesticide residue levels for amitraz in Annex II to Directive 90/642/EEC are replaced by
those in the Annex to this Directive.

Article 3

1. Member States shall adopt and publish, by 9 January 2006 at the latest, the laws, regulations and
administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the
Commission the text of those provisions and a correlation table between those provisions and this Directive.

Article 4

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They shall apply these provisions from 10 January 2007.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accom-
panied by such a reference on the occasion of their official publication. Member States shall determine how
such reference is to be made.

2. Member States shall communicate to the Commission the text of the main provisions of national law
which they adopt in the field covered by this Directive.

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.

Article 5

This Directive is addressed to the Member States.

Article 6

Done at Brussels, 8 July 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX

Groups and examples of individual products to which the MRLs apply

Amitraz including the
metabolites containing the
2,4-dimethylaniline moiety
expressed as amitraz

‘1. Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar;

0,05 (*)

nuts

(i)

CITRUS FRUIT

Grapefruit

Lemons

Limes

Mandarins (including clementines and other hybrids)

Oranges

Pomelos

Others

(ii)

TREE NUTS (shelled or unshelled)

Almonds

Brazil nuts

Cashew nuts

Chestnuts

Coconuts

Hazelnuts

Macadamia

Pecans

Pine nuts

Pistachios

Walnuts

Others

(iii)

POME FRUIT

Apples

Pears

Quinces

Others

(iv)

STONE FRUIT

Apricots

Cherries

Peaches (including nectarines and similar hybrids)

Plums

Others

(v)

BERRIES AND SMALL FRUIT

(a) Table and wine grapes

Table grapes

Wine grapes

(b) Strawberries (other than wild)

(c) Cane fruit (other than wild)

Blackberries

Dewberries

Loganberries

Raspberries

Others

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Groups and examples of individual products to which the MRLs apply

(d) Other small fruit and berries (other than wild)

Amitraz including the
metabolites containing the
2,4-dimethylaniline moiety
expressed as amitraz

Bilberries

Cranberries

Currants (red, black and white)

Gooseberries

Others

(e) Wild berries and wild fruit

(vi) MISCELLANEOUS

Avocados

Bananas

Dates

Figs

Kiwi

Kumquats

Litchis

Mangoes

Olives

Passion fruit

Pineapples

Pomegranate

Others

2. Vegetables, fresh or uncooked, frozen or dry

(i)

ROOT AND TUBER VEGETABLES

0,05 (*)

Beetroot

Carrots

Celeriac

Horseradish

Jerusalem artichokes

Parsnips

Parsley root

Radishes

Salsify

Sweet potatoes

Swedes

Turnips

Yam

Others

(ii)

BULB VEGETABLES

Garlic

Onions

Shallots

Spring onions

Others

(iii)

FRUITING VEGETABLES

(a) Solanacea

Tomatoes

Peppers

Aubergines

Others

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Groups and examples of individual products to which the MRLs apply

Amitraz including the
metabolites containing the
2,4-dimethylaniline moiety
expressed as amitraz

(b) Cucurbits — edible peel

Cucumbers

Gherkins

Courgettes

Others

(c) Cucurbits — inedible peel

Melons

Squashes

Watermelons

Others

(d) Sweet corn

(iv) BRASSICA VEGETABLES

(a) Flowering brassica

Broccoli

Cauliflower

Others

(b) Head brassica

Brussels sprouts

Head cabbage

Others

(c) Leafy brassica

Chinese cabbage

Kale

Others

(d) Kohlrabi

(v)

LEAF VEGETABLES AND FRESH HERBS

(a) Lettuce and similar

Cress

Lamb's lettuce

Lettuce

Scarole

Others

(b) Spinach and similar

Spinach

Beet leaves (chard)

Others

(c) Water cress

(d) Witloof

(e) Herbs

Chervil

Chives

Parsley

Celery leaves

Others

(vi)

LEGUME VEGETABLES (fresh)

Beans (with pods)

Beans (without pods)

Peas (with pods)

Peas (without pods)

Others

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Groups and examples of individual products to which the MRLs apply

Amitraz including the
metabolites containing the
2,4-dimethylaniline moiety
expressed as amitraz

(vii) STEM VEGETABLES (fresh)

Asparagus

Cardoons

Celery

Fennel

Globe artichokes

Leek

Rhubarb

Others

(viii) FUNGI

(a) Cultivated mushrooms

(b) Wild mushrooms

3. Pulses

Beans

Lentils

Peas

Others

4. Oil seeds

Linseed

Peanuts

Poppy seeds

Sesame seeds

Sunflower seed

Rape seed

Soya bean

Mustard seed

Cotton seed

Others

5. Potatoes

Early potatoes

Ware potatoes

6. Tea (leaves and stems, dried, fermented or otherwise, from the leaves of Camellia

sinensis)

7. Hops (dried), including hop pellets and unconcentrated powder

0,05 (*)

1 (x)

0,05 (*)

0,05 (*)

0,1 (*)

0,1 (*)

(*) Indicates lower limit of analytical determination.
(x) Should this level not be confirmed or amended by a directive, with effect from 1 July 2007, the appropriate lower limit of analytical

determination shall apply.’