Commission Directive 2002/71/EC of 19 August 2002 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for pesticide residues (formothion, dimethoate and oxydemeton-methyl) in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables (Text with EEA relevance)
Date: 2002-08-19
Institutions: European Commission
Subjects: animal product, cereals, foodstuff, fruit, health control, pesticide residue, plant health control, vegetable

22.8.2002

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Official Journal of the European Communities

L 225/21

COMMISSION DIRECTIVE 2002/71/EC

of 19 August 2002

amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC
as regards the fixing of maximum levels for pesticide residues (formothion, dimethoate and
oxydemeton-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,

(2)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 76/895/EEC of 23
November 1976 relating to the fixing of maximum levels for
pesticide residues in and on fruit and vegetables (1), as last
amended by Commission Directive 2002/66/EC (2), and in
particular Article 5 thereof,

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 (3), as last amended by Directive 2002/66/EC,
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 (4), as last amended by
Directive 2002/66/EC, 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 products of plant origin, including fruit and
vegetables (5), as last amended by Directive 2002/66/EC, and in
particular Article 7 thereof,

Whereas:

(1)

In the case of cereals and products of plant origin
including fruit and vegetables, residue levels reflect the
use of minimum quantities of pesticides necessary to
achieve effective protection of plants, applied in such a
manner that the amount of residue is both as low as is
practicable and toxicologically acceptable, having regard,
in particular to the protection of the environment and
the estimated dietary intake of consumers. In the case of
foodstuffs of animal origin, residue levels reflect the
consumption by animals of cereals and products of
plant origin treated with pesticides, and where relevant,
the direct consequences of the use of veterinary medi-
cines. Community maximum residue levels
(MRLs)
represent the upper limit of the amount of such residues
that might be expected to be found in commodities
when good agricultural practices have been respected.

(3)

(4)

MRLs for pesticides should be kept under review and
may be changed to take account of new information and
data. MRLs are fixed at the lower limit of analytical
determination where authorised uses of plant protection
products do not result in detectable levels of pesticide
residue in or on the food product, or where there are no
authorised uses, or where uses which have been author-
ised by Member States have not been supported by the
necessary data, or where uses in third countries resulting
in residues in or on food products which may enter into
circulation in the Community market have not been
supported by the necessary data.

for

intake.

Proposals

In the case of dimethoate and oxydemeton-methyl some
Member States informed the Commission of their desire
to revise national MRLs in accordance with Article 8 of
in the light of concerns about
Directive 90/642/EEC,
review of
the
consumer
Community MRLs were submitted to the Commission.
The Commission concluded that it is prudent to modify
some of the MRLs in view of the possible risks to
consumers. It is important that additional risk manage-
ment measures should be taken by the Member States to
adequately protect the consumer. For dimethoate and
oxydemeton-methyl Member States shall have to review
existing authorisations in accordance with Article 4 of
Directive 91/414/EEC (6), as last amended by Commis-
sion Directive 2002/64/EC (7) in order that authorised
uses do not lead to MRLs being exceeded.

and practices,

The lifetime exposure of consumers to these pesticides
in this Directive via food products has been reassessed
and evaluated in accordance with Community proced-
taking account of guidelines
ures
published by the World Health Organisation (8).
It is
calculated that the MRLs fixed in this Directive will not
lead to the acceptable daily intakes being exceeded. The
ADI for oxydemeton-methyl is 0,0003 mg/kg bw (JMPR
1989), the ARfD is 0,005 mg/kg bw, the ADI for dime-
thoate is 0,002 mg/kg bw (JMPR 1996), the ARfD is
0,03 mg/kg bw.

(1) OJ L 340, 9.12.1976, p. 26.
(2) OJ L 192, 20.7.2002, p. 47.
(3) OJ L 221, 7.8.1986, p. 37.
(4) OJ L 221, 7.8.1986, p. 43.
(5) OJ L 350, 14.12.1990, p. 71.

(6) OJ L 230, 19.8.1991, p. 1.
(7) OJ L 189, 18.7.2002, p. 27.
(8) 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).

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(5) Where relevant, the acute exposure of consumers to
these pesticides via each of the food products that may
contain residues of these pesticides has been assessed
and evaluated in accordance with Community proced-
ures
taking account of guidelines
is
published by the World Health Organisation.
concluded that the presence of pesticide residues at or
below the MRLs proposed in this Directive will not
cause acute toxic effects.

and practices,

It

followed for the protection of consumers of agricultural
products treated with pesticides.

(9)

(10)

Annexes to Directives 76/895/EEC, 86/362/EEC, 86/
363/EEC and 90/642/EEC should therefore be amended.

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

(6)

(7)

For formothion no uses are reported worldwide. In the
absence of sufficient data on residues and toxicology it is
appropriate to set Maximum Residue Levels for formo-
thion for all products at the Lower Limit of Analytical
Determination.

HAS ADOPTED THIS DIRECTIVE:

Article 1

Through the World Trade Organisation, the Communi-
ty's trading partners were consulted about the levels for
formothion,
oxydemeton-methyl
proposed in this Directive and their comments on these
levels were taken into account.

dimethoate

and

In Annex II to Directive 76/895/EEC the entries relating to
‘dimethoate’,
‘oxydemeton-methyl’,
‘demeton-S-methyl’, and ‘demeton-S-methylsulfone’ are deleted.

‘formothion’,

‘omethoate’,

(8)

The opinions of the Scientific Committee for Plants have
been taken into account,
in particular its advice and
recommendations concerning the methodology to be

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

Article 2

Pesticide residue

‘Oxydemeton-methyl
demeton-S-methylsulfone
methyl)

(sum of oxydemeton-methyl and
oxydemeton-
as

expressed

Dimethoate (sum of dimethoate and omethoate expressed
as dimethoate)

Formothion

(*) Indicates lower limit of analytical determination.’

Maximum level in mg/kg

0,1 Barley and oats
0,02 (*) Other cereals

0,3 Wheat, rye and triticale,
0,02 (*) Other cereals

0,02 (*) Cereals

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

Article 3

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

For milk and milk
products listed in Annex 1
within CN codes 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

‘Oxydemetonmethyl (sum of oxyde-
metonmethyl
demeton-S-
and
methylsulfone expressed as oxyde-
metonmethyl)

(*) Indicates lower limit of analytical determination.’

0,02 (*)

0,02 (*)

0,02 (*)

The maximum residue levels listed in the Annex to this Directive are added or replace those listed in Annex
II to Directive 90/642/EEC for the pesticides in question.

Article 4

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Article 5

Member States shall bring into force the laws, regulations and administrative provisions necessary to
comply with this Directive by 31 December 2002 at the latest. They shall forthwith inform the Commis-
sion thereof.

They shall apply those provisions with effect from 1 January 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 seventh day following that of its publication in the Official
Journal of the European Communities.

Article 6

This Directive is addressed to the Member States.

Article 7

Done at Brussels, 19 August 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 would apply

Pesticide residue and maximum residue level (mg/kg)

Formothion

Oxydemeton-methyl
(sum of oxydemeton-me-
thyl and demeton-S-me-
thylsulfone expressed as
oxydemeton-methyl)

Dimethoate
(sum of dimethoate and
omethoate expressed
as dimethoate)

1. Fruit,

fresh, dried or uncooked, preserved by freezing, not

0,02 (*)

containing added sugar; nuts

(i)

CITRUS FRUIT

Grapefruit

Lemons

Limes

Mandarins (including clementines and other hybrids)

Oranges

Pomelos

Others

0,02 (*)

0,02 (*)

(ii)

TREE NUTS (shelled or unshelled)

0,05 (*)

0,05 (*)

Almonds

Brazil nuts

Cashew nuts

Chestnuts

Coconuts

Hazelnuts

Macadamia

Pecans

Pine nuts

Pistachios

Walnuts

Others

(iii)

POME FRUIT

0,02 (*)

0,02 (*)

Apples

Pears

Quinces

Others

(iv)

STONE FRUIT

Apricots

Cherries

0,02 (*)

Peaches (including nectarines and similar hybrids)

Plums

Others

(v)

BERRIES AND SMALL FRUIT

0,02 (*)

(a) Table and wine grapes

Table grapes

Wine grapes

(b) Strawberries (other than wild)

1

0,02 (*)

0,02 (*)

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Official Journal of the European Communities

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Pesticide residue and maximum residue level (mg/kg)

Formothion

Oxydemeton-methyl
(sum of oxydemeton-me-
thyl and demeton-S-me-
thylsulfone expressed as
oxydemeton-methyl)

Dimethoate
(sum of dimethoate and
omethoate expressed
as dimethoate)

Groups and examples of individual products to which
the MRLs would 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

0,02 (*)

Avocados

Bananas

Dates

Figs

Kiwi

Kumquats

Litchis

Mangoes

Olives

Passion fruit

Pineapples

Pomegranate

Others

2

0,02 (*)

2. Vegetables, fresh or uncooked, frozen or dry

0,02 (*)

(i)

ROOT AND TUBER VEGETABLES

0,02 (*)

0,02 (*)

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 would apply

Pesticide residue and maximum residue level (mg/kg)

Formothion

Oxydemeton-methyl
(sum of oxydemeton-me-
thyl and demeton-S-me-
thylsulfone expressed as
oxydemeton-methyl)

Dimethoate
(sum of dimethoate and
omethoate expressed
as dimethoate)

(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 (including Calabrese)

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 (broad-leaf endive)

Others

0,02 (*)

0,02 (*)

0,02 (*)

0,05

0,05

0,02 (*)

0,02 (*)

0,05

0,05

2

0,02 (*)

0,02 (*)

0,2

0,02 (*)

0,3

1

0,02 (*)

0,02 (*)

0,02 (*)

0,5

0,02 (*)

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Pesticide residue and maximum residue level (mg/kg)

Formothion

Oxydemeton-methyl
(sum of oxydemeton-me-
thyl and demeton-S-me-
thylsulfone expressed as
oxydemeton-methyl)

Dimethoate
(sum of dimethoate and
omethoate expressed
as dimethoate)

0,02 (*)

0,02 (*)

0,02 (*)

0,02 (*)

0,02 (*)

0,02 (*)

0,02 (*)

0,02 (*)

0,02 (*)

0,02 (*)

1

0,02 (*)

0,02 (*)

0,02 (*)

0,02 (*)

0,02 (*)

0,02 (*)

0,02 (*)

0,05 (*)

0,05 (*)

0,05 (*)

Groups and examples of individual products to which
the MRLs would apply

(b) Spinach and similar

Spinach
Beet leaves (chard)
Others

(c) Water cress

(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

Cultivated mushrooms

Wild mushrooms

3. Pulses
Beans
Lentils
Peas
Others

4. Oilseeds
Linseed
Peanuts
Poppy seed
Sesame seed
Sunflower seed
Rape seed
Soya bean
Mustard seed
Cotton seed
Others

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Groups and examples of individual products to which
the MRLs would apply

5. Potatoes

Early potatoes
Ware potatoes

Pesticide residue and maximum residue level (mg/kg)

Formothion

Oxydemeton-methyl
(sum of oxydemeton-me-
thyl and demeton-S-me-
thylsulfone expressed as
oxydemeton-methyl)

Dimethoate
(sum of dimethoate and
omethoate expressed
as dimethoate)

0,02 (*)

0,02 (*)

0,02 (*)

6. Tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis)

7. Hops (dried),

including hop pellets and unconcentrated powder

0,05 (*)

0,05 (*)

0,05 (*)

0,05 (*)

0,05 (*)

0,05 (*)

(*) Indicates lower limit of analytical determination.