Commission Directive 2002/97/EC of 16 December 2002 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for pesticide residues (2,4-D, triasulfuron and thifensulfuron methyl) in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables (Text with EEA relevance)
Date: 2002-12-16
Institutions: European Commission
Subjects: animal product, cereals, consumer protection, foodstuff, fruit, pesticide residue, vegetable

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Official Journal of the European Communities

L 343/23

COMMISSION DIRECTIVE 2002/97/EC

of 16 December 2002

amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards
the fixing of maximum levels for pesticide residues (2,4-D, triasulfuron and thifensulfuron methyl)
in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit
and vegetables

(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 2002/79/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 2002/79/EC, 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 (4), as last
amended by Directive 2002/79/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 (5), as last amended by Commission Directive 2002/81/EC (6), and in particular
Article 4(1)(f) thereof,

WHEREAS:

(1)

(2)

The existing active substances 2,4-D, triasulfuron and thifensulfuron methyl, (the active substances
concerned), were included in Annex I to Directive 91/414/EEC by Commission Directives 2001/
103/EC (7), 2000/66/EC (8) and 2001/99/EC (9), respectively, for use as herbicides, but without
specifying particular conditions having an impact on crops which may be treated with plant
protection products containing this active substance.

The inclusion in Annex I to Directive 91/414/EEC of these active substances was based on the
assessment of the information submitted concerning the proposed use. Information relating to this
use has been submitted by certain Member States in accordance with Article 4(1)(f) of Directive
to allow certain
91/414/EEC. The information available has been reviewed and is sufficient
maximum residue levels (MRLs) to be fixed.

(3) Where no Community MRL or provisional MRL exists, Member States are to establish a national
provisional MRL in accordance with Article 4(1)(f) of Directive 91/414/EEC before plant protection
products containing this active substance may be authorised.

(1) OJ L 221, 7.8.1986, p. 37.
(2) OJ L 291, 28.10.2002, p. 1.
(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 276, 12.10.2002, p. 28.
(7) OJ L 313, 30.11.2001, p. 37.
(8) OJ L 276, 28.10.2000, p. 35.
(9) OJ L 304, 21.11.2001, p. 14.

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(4) With respect to the inclusion in Annex I to Directive 91/414/EEC of the active substance concerned,
the related technical and scientific evaluations were finalised in the form of the Commission review
report. The report was finalised on 2 October 2001 for 2,4-D, on 13 July 2000 for triasulfuron and
on 29 June 2001 for thifensulfuron methyl. The reports fixed the Acceptable Daily Intake (ADI) for
2,4-D at 0,05 mg/kg bw/day, for triasulfuron at 0,01 mg/kg bw/day and for thifensulfuron methyl
at 0,01 mg/kg bw/day. The lifetime exposure of consumers of food products treated with the active
substances concerned has been assessed and evaluated in accordance with Community procedures.
Account has also been taken of guidelines published by the World Health Organisation (1) and the
opinion of the Scientific Committee for Plants (2) on the methodology employed. It is concluded
that MRLs proposed will not lead to those ADIs being exceeded. No acute toxic effects requiring the
setting of an Acute Reference Dose were noted during the evaluations and discussions preceding the
inclusion of the active substances concerned in Annex I to Directive 91/414/EEC.

(5)

(6)

(7)

(8)

(9)

In order 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 MRLs at the
lower limit of analytical determination for all such products covered by Directives 86/362/EEC,
86/363/EEC and 90/642/EEC.

The setting at Community level of such provisional MRLs does not prevent the Member States from
establishing provisional maximum residue levels in accordance with Article 4(1)(f) of Directive
91/414/EEC and Annex VI thereto. It is considered that a period of four years is sufficient to permit
the development of further uses of the active substance concerned. The provisional MRLs should
then become definitive.

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

The Commission notified this Directive in draft form to the World Trade Organisation and the
comments received have been considered in finalising the Directive. The possibility of fixing import
tolerance MRLs for specific pesticide/crop combinations will be examined by the Commission on the
basis of acceptable data submitted.

This Directive is in accordance with the opinion of the Standing Committee on the Food Chain and
Animal Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The following maximum pesticide residue level are added to Part A of Annex II to Directive 86/362/EEC:

‘Pesticide residue

Maximum level in mg/kg

2,4-D (sum of 2,4-D and its esters expressed as 2,4-D)

0,05 (*) (p) cereals

Triasulfuron

Thifensulfuron methyl

0,05 (*) (p) cereals

0,05 (*) (p) cereals

(*)
(p)

indicates lower limit of analytical determination
indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless amended, this level
will become definitive with effect from 4 years from date of coming into force of this Directive.’

(1) Guidelines for predicting dietary intake of pesticide 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).

(2) 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 Committee on Plants,
14 July 1998) (http://europa.eu.int/comm/dg24/health/sc/scp/out21_en.html).

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The following maximum pesticide residue levels are added to Part B of Annex II to Directive 86/363/EEC:

Article 2

‘Pesticide residue

2,4-D

Of meat, including fat, prepara-
tions 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

Kidney (except poultry)
1(p)
Others 0,05 (*) (p)

Maximum level (mg/kg)

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 (*) (p)

0,01 (*) (p)

(*)
(p)

Indicates lower limit of analytical determination
indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless amended, this level
will become definitive with effect from 4 years from date of coming into force of this Directive’

The maximum pesticide residue levels for the active substances concerned as shown in the Annex to this
Directive are added to Annex II to Directive 90/642/EEC.

Article 3

Article 4

Member States shall bring into force the laws, regulations and administrative provisions necessary to
comply with this Directive by 30 June 2003 at the latest. They shall forthwith inform the Commission
thereof.

They shall apply these provisions with effect from 1 July 2003.

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 twentieth day following that of 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, 16 December 2002.

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 residue and maximum residue levels
(mg/kg)

Triasulfuron

Thifensulfuron methyl

2,4-D
(sum of 2,4-D and its
esters) expressed as
2,4-D)

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

0,05 (*) (p)

0,05 (*) (p)

0,05 (*) (p)

(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
hybrids)

Plums

Others

(including nectarines

and similar

(v)

BERRIES AND SMALL FRUIT

(a) Table and wine grapes

Table grapes

Wine grapes

(b) Strawberries (other than wild)

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Pesticide residue and maximum residue levels
(mg/kg)

Triasulfuron

Thifensulfuron methyl

2,4-D
(sum of 2,4-D and its
esters) expressed as
2,4-D)

Groups and examples of individual products to which the MRLs
apply

(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

0,05 (*) (p)

0,05 (*) (p)

0,05 (*) (p)

(i)

ROOT AND TUBER VEGETABLES

Beetroot

Carrots

Celeriac

Horseradish

Jerusalem artichokes

Parsnips

Parsley root

Radishes

Salsify

Sweet potatoes

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Groups and examples of individual products to which the MRLs
apply

Pesticide residue and maximum residue levels
(mg/kg)

Triasulfuron

Thifensulfuron methyl

2,4-D
(sum of 2,4-D and its
esters) expressed as
2,4-D)

Swedes

Turnips

Yam

Others

(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) 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

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Groups and examples of individual products to which the MRLs
apply

(v)

LEAF VEGETABLES AND FRESH HERBS

Pesticide residue and maximum residue levels
(mg/kg)

Triasulfuron

Thifensulfuron methyl

2,4-D
(sum of 2,4-D and its
esters) expressed as
2,4-D)

(a) Lettuce & similar

Cress

Lamb's lettuce

Lettuce

Scarole

Others

(b) Spinach & 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

(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

0,05 (*) (p)

0,05 (*) (p)

0,05 (*) (p)

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Groups and examples of individual products to which the MRLs
apply

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

Pesticide residue and maximum residue levels
(mg/kg)

Triasulfuron

Thifensulfuron methyl

2,4-D
(sum of 2,4-D and its
esters) expressed as
2,4-D)

0,05 (*) (p)

0,05 (*) (p)

0,1 (*) (p)

0,05 (*) (p)

0,05 (*) (p)

0,05 (*) (p)

6. Tea (leaves and stems, dried, fermented or other-
wise, from the leaves of Camellia sinensis)

0,1 (*) (p)

0,1 (*) (p)

0,1 (*) (p)

7. Hops (dried), including hop pellets and uncon-

0,1 (*) (p)

0,1 (*) (p)

0,1 (*) (p)

centrated powder

(*)
(p)

Indicates lower limit of analytical determination
indicates provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC: unless amended, this level will
become definitive with effect from 4 years from date of coming into force of this Directive.’