Commission Directive 2001/39/EC of 23 May 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
Date: 2001-05-23
Institutions: European Commission
Subjects: animal product, cereals, foodstuff, fruit, pesticide residue, vegetable

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COMMISSION DIRECTIVE 2001/39/EC

of 23 May 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

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
2000/82/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
Directive 2000/82/EC, and in particular Article 10 thereof,

accordance with Article 4 of the Directive, and estab-
lished provisional maximum residue levels as required
by Article 4(1)(f). As required by the Directive, those
levels, and the information on which they were based,
have been notified to the Commission. This information
together with data available from other sources has been
reviewed and is sufficient
to fix certain maximum
residue levels (MRLS). Where no Community maximum
residue level or provisional MRL exists, Member States
must establish a national provisional maximum residue
level in accordance with Article 4(1)(f) of the Directive
before the authorisation may be granted.
In view of
Article 5 of Directive 86/363/EEC, this also applies for
provisional MRLs for animal products where commodi-
ties containing residues of an active substance may be
expected to be used as animal feeds.

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 (4), as last amended by Directive 2000/
82/EC, and in particular Article 7 thereof,

(4)

Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
the market (5), as last amended by Commission Directive 2001/
21/EC (6), and in particular Article 4(1)(f) thereof,

Whereas:

(1)

(2)

(3)

The new active substances, azimsulfuron, and prohexa-
dione calcium were included in Annex I to Directive
91/414/EEC by Commission Directives 1999/80/EC (7)
and 2000/50/EC (8), respectively, for use as a pre-emer-
gence herbicide on rice, and as a plant growth regulator
respectively.

The substances were included in Annex I to Directive
91/414/EEC based on assessment of the information
submitted concerning the proposed uses.

Prior to the inclusion of the substances in Annex I to
Directive 91/414/EEC, their use had been provisionally
authorised in certain Member States in accordance with
Article 8(1) of the Directive. Following inclusion of the
substances in Annex I, those Member States authorised a
number of plant protection products containing them in

(1) OJ L 221, 7.8.1986, p. 37.
(2) OJ L 3, 6.1.2001, p. 18.
(3) OJ L 221, 7.8.1986, p. 43.
(4) OJ L 350, 14.12.1990, p. 71.
(5) OJ L 230, 19.8.1991, p. 1.
(6) OJ L 69, 10.3.2001, p. 17.
(7) OJ L 210, 10.8.1999, p. 13.
(8) OJ L 198, 4.8.2000, p. 39.

At their inclusion in Annex I to Directive 91/414/EEC,
the technical and scientific evaluations of azimsulfuron,
and prohexadione calcium were finalised on 2 July
1999, and 16 June 2000, respectively in the Commis-
sion review reports for azimsulfuron and prohexadione
In these review reports the acceptable daily
calcium.
intake (ADI)
for azimsulfuron was set at 0,1 mg/kg
bw/day, and for prohexadione calcium at 0,2 mg/kg
bw/day. The lifetime exposure of consumers of food
products treated with azimsulfuron, and prohexadione
calcium has been assessed and evaluated in accordance
with the procedures and practices used within the
Community, taking account of guidelines published by
the World Health Organisation (9) and the opinion of the
Scientific Committee for Plants (10) on this methodology.
It has been calculated that the maximum residue levels
provided for in this Directive do not result in these ADIs
being exceeded.

(5)

Acute toxic effects requiring the setting of an acute
reference dose were not noted during the evaluations
and discussions that preceded the inclusion of azimsul-
furon, and prohexadione calcium in Annex I to Directive
91/414/EEC.

(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

(10) Opinion of the Scientific Committee on Plants regarding questions
relating to amending the annexes
to Council Directives 86/
362/EEC, 86/363/EEC and 90/642/EEC (Opinion expressed by the
Scientific
1998)
on
(http://europa.eu.int/comm/dg24/health/sc/scp/out21_en.html).

Committee

Plants,

July

14

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(6)

(7)

(8)

(9)

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 provisional maximum residue levels
at the lower limit of analytical determination for all those products covered by Directives 86/
362/EEC, 86/363/EEC and 90/642/EEC. The setting at Community level of such provisional
maximum residue levels does not prevent
the Member States from establishing provisional
maximum residue levels for azimsulfuron and prohexadione calcium in accordance with Article
4(1)(f) of Directive 91/414/EEC and Annex VI thereto. Four years is considered a sufficient period of
time during which to establish most further uses of azimsulfuron and prohexadione calcium. After
that period these provisional maximum residue levels should become definitive.

The measures provided for in this Directive were communicated to the World Trade Organisation
and the comments received were taken into consideration. The possibility of fixing import tolerance
maximum residue levels for specific pesticide/crop combinations will be examined by the Commis-
sion on the basis of the submission of acceptable data.

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

The measures provided for in this Directive are 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)

Azimsulfuron

0,02 (*) (p)

Cereals

Prohexadione (prohexadione and its salts expressed as prohexadione

0,2 (p)

Wheat and barley

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.

In part B of Annex II to Directive 86/363/EEC the following row is added:

Article 2

Maximum level
(mg/kg)

Pesticide residue

Of meat, including fat, prepa-
rations 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

Prohexadione (prohexadi-
one and its salts expressed
as prohexadione)

0,05 (p) (*)

0,01 (p) (*)

0,05 (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.

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Article 3

In Annex II to Directive 90/642/EEC the columns headed ‘Azimsulfuron’, and ‘Prohexadione (prohexadione
and its salts expressed as prohexadione)’ set out in the Annex to this Directive are added.

Article 4

Member States shall adopt and publish the provisions necessary to comply with this Directive by 31
December 2001 at the latest. They shall forthwith inform the Commission thereof.

They shall apply those provisions from 1 January 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 shall enter into force on the 20th day following its publication in the Official Journal of the
European Communities.

Article 5

This Directive is addressed to the Member States.

Article 6

Done at Brussels, 23 May 2001.

For the Commission

David BYRNE

Member of the Commission

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ANNEX

Groups and examples of individual products to which the MRLs apply

Pesticide residues and maximum residue levels
(mg/kg)

Azimsulfuron

Prohexadione
(prohexadione and its
salts expressed as
prohexadione)

1. Fruits,

fresh, dried or uncooked, preserved by freezing, not

0,02 (p) (*)

0,05 (p) (*)

containing 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 MRLs apply

Pesticide residues and maximum residue levels
(mg/kg)

Azimsulfuron

Prohexadione
(prohexadione and its
salts expressed as
prohexadione)

(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

Pomegranate

Others

2. Vegetables, fresh or uncooked, frozen or dry

0,02 (p) (*)

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 MRLs apply

Pesticide residues and maximum residue levels
(mg/kg)

Azimsulfuron

Prohexadione
(prohexadione and its
salts expressed as
prohexadione)

(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 MRLs apply

Pesticide residues and maximum residue levels
(mg/kg)

Azimsulfuron

Prohexadione
(prohexadione and its
salts expressed as
prohexadione)

(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. Oils seeds
Linseed
Peanuts
Poppy seeds
Sesame seeds
Sunflower seed
Rapeseed
Soya bean
Mustard seed
Cotton seed
Others

0,02 (p) (*)

0,05 (p) (*)

0,1 (p) (*)

0,1 (p) (*)

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Groups and examples of individual products to which the MRLs apply

5. Potatoes

Early potatoes
Ware potatoes

Pesticide residues and maximum residue levels
(mg/kg)

Azimsulfuron

Prohexadione
(prohexadione and its
salts expressed as
prohexadione)

0,02 (p) (*)

0,05 (p) (*)

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

0,1 (p) (*)

0,1 (p) (*)

Camellia sinensis)

7. Hops

(dried),

including hop pellets and unconcentrated powder

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.