Commission Directive 2001/57/EC of 25 July 2001 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance)
Date: 2001-07-25
Institutions: European Commission
Subjects: animal product, cereals, crop production, fruit, pesticide residue, vegetable

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Official Journal of the European Communities

1.8.2001

COMMISSION DIRECTIVE 2001/57/EC

of 25 July 2001

amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing
of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain
products of plant origin, including fruit and vegetables respectively

(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), as last amended by Commission Directive
2001/48/EC (2), 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 (3), as last amended by
Commission Directive 2001/39/EC (4), and in particular Article
10 thereof,

Having regard to Council Directive 90/642/EEC of 27
November 1990 on the fixing of maximum levels for pesticide
residues in and on certain products of plant origin including
fruit and vegetables (5), as last amended by Directive 2001/
48/EC, and in particular Article 7 thereof,

Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
the market (6), as last amended by Commission Directive 2001/
49/EC (7), and in particular Article 4(1)(f) thereof,

Whereas:

(1)

(2)

The existing active substance, fluroxypyr, was included
in Annex I to Directive 91/414/EEC by Commission
Directive 2000/10/EC (8). No harmonised maximum
residue levels for this active substance have yet been set
by the Commission. The harmonisation of maximum
residue levels is desirable both from the public health
and from the trade point of view.

Following inclusion of
the substance in Annex I,
Member States authorised a number of plant protection
products containing it in accordance with Article 4 of
Directive 91/414/EEC,
and established provisional
maximum residue levels as required by Article 4(1)(f)
thereof. These authorisations concern uses as a herbicide
in orchards or as a post emergence herbicide on apples,
olives, onions, cereals, meadows and pastures. As
required by that Directive, those levels, and the informa-
tion on which they were based, have been notified to the

(1) OJ L 221, 7.8.1986, p. 37.
(2) OJ L 180, 3.7.2001, p. 26.
(3) OJ L 221, 7.8.1986, p. 43.
(4) OJ L 148, 1.6.2001, p. 70.
(5) OJ L 350, 14.12.1990, p. 71.
(6) OJ L 230, 19.8.1991, p. 1.
(7) OJ L 176, 29.6.2001, p. 61.
(8) OJ L 57, 2.3.2000, p. 28.

(3)

(4)

(5)

(6)

Commission. This information together with data avail-
able from other sources has been reviewed and is suffi-
cient
to provisionally fix certain maximum residue
levels.

Article 5 of Directive 86/363/EEC requires that provi-
sional maximum residue levels for animal products
established pursuant to Article 4(1)(f) of Directive 91/
414/EEC be indicated in Annex II
to Directive 86/
363/EEC.

At the inclusion in Annex I to Directive 91/414/EEC the
technical and scientific evaluation of
fluroxypyr was
finalised on 30 November 1999 in the format of the
Commission review report for fluroxypyr. In this review
report the acceptable daily intake (ADI) for fluroxypyr
was set at 0,8 mg/kg bw/day. The lifetime exposure of
consumers of food products treated with fluroxypyr has
been assessed and evaluated in accordance with the
procedures and practices used within the European
Community, taking account of guidelines published by
the World Health Organisation (9) and it has been calcu-
lated that
the maximum residue levels fixed in this
Directive do not give rise to an exceeding of this ADI.

Acute toxic effects requiring the setting of an acute
reference dose were not noted during the evaluation and
discussion that preceded the inclusion of fluroxypyr in
Annex I to Directive 91/414/EEC.

To ensure that the consumer is adequately protected
from exposure to residues in or on products for which
no authorisations have been granted, it is prudent to set
maximum residue levels at the lower limit of analytical
determination for all such products covered by Direct-
ives 86/362/EEC, 86/363/EEC and 90/642/EEC. The
setting at Community level of provisional maximum
residue levels does not prevent Member States from
establishing provisional maximum residue levels for flur-
oxypyr in accordance with Article 4(1)(f) of Directive
91/414/EEC and Annex VI thereto.

(7)

Four years is considered a sufficient period of
time
during which to establish most further uses of flurox-
ypyr. After that period, provisional maximum residue
levels should become definitive.

(9) Guidelines

for predicting dietary

residues
(revised), prepared by the GEMS/Food Programme in collaboration
with the Codex Committee on Pesticide Residues, published by the
World Health Organisation 1997 (WHO/FSF/FOS/97.7).

intake of pesticide

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(8)

(9)

The Community's trading partners have been consulted about the levels set out in this Directive
through the World Trade Organisation and their comments on these levels have been considered. No
CODEX maximum residue levels are defined for fluroxypyr. The possibility of fixing maximum
residue levels for specific pesticide/crop combinations other than those listed herein will be examined
by the Commission on the basis of the submission of acceptable data.

The opinions of the Scientific Committee for Plants,
in particular advice and recommendations
concerning the protection of consumers of food products treated with pesticides, have been taken
into account.

(10)

This Directive is in accordance with the opinion of the Standing Committee on Plant Health,

HAS ADOPTED THIS DIRECTIVE:

In part A of Annex II to Directive 86/362/EEC, the following rows are added:

Article 1

Pesticide residue

Maximum level
(mg/kg)

‘Fluroxypyr including its esters expressed as fluroxypyr

0,1 (p) Barley, oats, rye, triticale and wheat

0,05 (*) (p) Other cereals

(*)
(p)

Indicates lower limit of analytical determination.
Indicates provisional maximum residue level established in accordance with Article 4(1)(f) of Directive 91/414/EEC: all provisional
maximum residue levels for these pesticide residues will be treated as definitive in accordance with Article 10 of the Directive with
effect from four years after the entry into force of this Directive.’

The following row shall be added to part B of Annex II to Directive 86/363/EEC:

Article 2

Maximum level
(mg/kg)

Pesticide residue

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

For milk and milk products listed
in Annex I within CN codes 0401,
0402, 0405 00 and 0406

Of shelled fresh eggs, for bird's
eggs and egg yolks listed in
Annex I within CN codes 0407 00
and 0408

‘Fluroxypyr

0,5 (p) ex 0206 Kidney

0,05 (*) (p)

0,05 (*) (p)

0,05 (*) (p) other products

(*)
(p)

Indicates lower limit of analytical determination.
Indicates provisional maximum residue level established in accordance with Article 4(1)(f) of Directive 91/414/EEC: all provisional
maximum residue levels for these pesticide residues will be treated as definitive in accordance with Article 10 of the Directive with
effect from four years after the entry into force of this Directive.’

In Annex II to Directive 90/642/EEC the column headed ‘Fluroxypyr including its esters expressed as
fluroxypyr’, set out in the Annex to this Directive,

is added.

Article 3

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Article 4

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

Member States shall bring into force the laws, regulations and administrative provisions necessary to
comply with this Directive by 28 February 2002 at the latest. They shall forthwith inform the Commission
thereof.

They shall apply these provisions as of 1 March 2002.

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

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 25 July 2001.

For the Commission

David BYRNE

Member of the Commission

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ANNEX

Groups and examples of individual products to which the maximum
residue levels apply

Pesticide residues
and maximum residue levels
(mg/kg)

Fluroxypyr including its esters
expressed as fluroxypyr

1. Fruit, fresh, dried or uncooked, preserved by freezing, not containing

0,05 (*) (p)

added sugar; 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)

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Groups and examples of individual products to which the maximum
residue levels apply

Pesticide residues
and maximum residue levels
(mg/kg)

Fluroxypyr including its esters
expressed as fluroxypyr

(c) Cane fruit (other than wild)

Blackberries

Dewberries

Loganberries

Raspberries

Others

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

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

Pomegranates

Others

2. Vegetables, fresh or uncooked, frozen or dry

0,05 (*) (p)

(i)

ROOT AND TUBER VEGETABLES

Beetroot

Carrots

Celeriac

Horseradish

Jerusalem artichokes

Parsnips

Parsley root

Radishes

Salsify

Sweet potatoes

Swedes

Turnips

Yam

Others

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Groups and examples of individual products to which the maximum
residue levels apply

Pesticide residues
and maximum residue levels
(mg/kg)

Fluroxypyr including its esters
expressed as fluroxypyr

(ii)

BULB VEGETABLES

Garlic

Onions

Shallots

Spring onions

Others

(iii)

FRUITING VEGETABLES

(a) Solanacea

Tomatoes

Peppers

Aubergines

Others

(b) Cucurbits — edible peel

Cucumbers

Gherkins

Courgettes

Others

(c) Cucurbits — inedible peel

Melons

Squashes

Watermelons

Others

(d) Sweetcorn

(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

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Groups and examples of individual products to which the maximum
residue levels apply

Pesticide residues
and maximum residue levels
(mg/kg)

Fluroxypyr including its esters
expressed as fluroxypyr

(b) Spinach and similar

Spinach
Beet leaves (chard)
Others

(c) Watercress

(d) Witloof

(e) Herbs

Chervil
Chives
Parsley
Celery leaves
Others

(vi)

(vii)

LEGUME VEGETABLES (fresh)
Beans (with pods)
Beans (without pods)
Peas (with pods)
Peas (without pods)
Others

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 seeds
Rape seed
Soya bean
Mustard seed
Cotton seed
Others

0,05 (*) (p)

0,05 (*) (p)

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Groups and examples of individual products to which the maximum
residue levels apply

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

Pesticide residues
and maximum residue levels
(mg/kg)

Fluroxypyr including its esters
expressed as fluroxypyr

0,05 (*) (p)

0,1 (*) (p)

0,1 (*) (p)

(*)
(p)

Indicates lower limit of analytical determination.
Indicates provisional maximum residue level established in accordance with Article 4(1)(f) of Directive 91/414/EEC: all provisional
maximum residue levels for these pesticide residues will be treated as definitive in accordance with Article 10 of the Directive with effect
from four years after the entry into force of this Directive.