Commission Directive 2001/48/EC of 28 June 2001 amending the Annexes to Council Directives 86/362/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance)
Date: 2001-06-28
Institutions: European Commission
Subjects: cereals, crop production, food inspection, fruit, pesticide residue, vegetable

L 180/26

EN

Official Journal of the European Communities

3.7.2001

COMMISSION DIRECTIVE 2001/48/EC

of 28 June 2001

amending the Annexes to Council Directives 86/362/EEC and 90/642/EEC on the fixing of
maximum levels for pesticide residues in and on cereals 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 2001/39/EC (2), and in
particular Article 10 thereof,

Having regard to Council Directive 90/642/EEC of 27 November1990 on the fixing of maximum levels for
pesticide residues in and on certain products of plant origin including fruit and vegetables (3), as last
amended by Directive 2001/39/EC, and in particular Article 7 thereof,

Having regard to Council Directive 91/414/EEC of 15 July 1991 on the placing of plant protection
products on the market (4), as last amended by Commission Directive 2001/47/EC (5), and in particular
Article 4(1)(f) thereof,

Whereas:

(1)

(2)

(3)

The new active substances, azoxystrobin and kresoxim methyl, were included in Annex I to Directive
91/414/EEC by Commission Directives 98/47/EC (6) and 1999/1/EC (7), respectively, for use as
fungicides only, without specifying particular conditions having an impact on crops which may be
treated with plant protection products containing these active ingredients.

Maximum residue levels in and on all commodities covered by Directives 86/362/EEC and 90/
642/EEC were fixed by Commission Directives 1999/71/EC (8) and 2000/48/EC (9) for azoxystrobin
residues, and by Commission Directive 2000/58/EC (10) for kresoxim methyl residues.

In fixing the said maximum residue levels, it was recognised that these levels should be kept under
review and should be changed to take account of new information and data. Directives 1999/71/EC,
2000/48/EC and 2000/58/EC acknowledged that national provisional maximum residue levels for
other cereals and fruit and vegetables should be fixed by Member States as a part of
their
authorisation of plant protection products containing azoxystrobin or kresoxim methyl and should
be notified to the Commission under the requirements of Article 4(1)(f) to Directive 91/414/EEC. To
facilitate this eventuality, some of the levels set in Directives 1999/71/EC and 2000/48/EC and all of
the levels set in Directive 2000/58/EC were fixed on a provisional basis, enabling Member States to
grant further authorisations for new uses and to notify the Commission under the procedure
described by the said Article. This Article provides that where a provisional Community maximum
residue level exists and where the new authorised use would lead to higher levels, the authorising
in accordance with
Member State shall establish a national provisional maximum residue level
Article 4(1)(f) of Directive 91/414/EEC before the authorisation may be granted.

(1) OJ L 221, 7.8.1986, p. 37.
(2) OJ L 148, 1.6.2001, p. 70.
(3) OJ L 350, 14.12.1990, p. 71.
(4) OJ L 230, 19.8.1991, p. 1.
(5) OJ L 175, 28.6.2001, p. 21.
(6) OJ L 191, 7.7.1998, p. 50.
(7) OJ L 21, 28.1.1999, p. 21.
(8) OJ L 194, 27.7.1999, p. 36.
(9) OJ L 197, 3.8.2000, p. 26.
(10) OJ L 244, 29.9.2000, p. 78.

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L 180/27

(4)

(5)

(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,
in adopting Directives
1999/71/EC, 2000/48/EC and 2000/58/EC, to set provisional maximum residue levels at the lower
level of analytical determination for such products. The setting at Community level of such
provisional maximum residue levels is without prejudice to the granting of provisional authorisations
by the Member States for uses of azoxystrobin and/or kresoxim methyl on such products in
accordance with Article 4(1)(f) of Directive 91/414/EEC.

it was considered prudent,

In order to authorise a plant protection product, Member States must apply the uniform principles
provided for in Annex VI to Directive 91/414/EEC in evaluating, in particular, a dossier conforming
to the requirements of Annex III to Directive 91/414/EEC, submitted by the applicant for author-
isation. Annex III, Part A, section 8 of Directive 91/414/EEC requires applicants to submit certain
information including proposed maximum residue levels together with full justification and estima-
tions of the potential and actual exposure through diet and other means. Annex VI, part B, section
2.4.2 and Part C, section 2.5 of Directive 91/414/EEC requires Member States to evaluate the
information submitted concerning impact on human or animal health arising from residues and the
impact on the environment and to take decisions on authorisations which ensure that residues
occurring reflect the minimum quantities of the plant protection product necessary to achieve
adequate control corresponding to good agricultural practice, applied in such a manner that the
residues at harvest, slaughter or after storage, as appropriate, are reduced to a minimum.

New data has been provided for uses of azoxystrobin on aubergines, peppers, oats, hops, peas (fresh
and dry) and for uses of kresoxim methyl on asparagus, strawberries and other small fruits and
berries. This new data has been evaluated and it is considered appropriate to revise the provisional
maximum residue levels fixed for these products in Directives 1999/71/EC, 2000/48/EC and 2000/
58/EC.

At the inclusion in Annex I to Directive 91/414/EEC the technical and scientific evaluation of
azoxystrobin has been finalised on 22 April 1998 in the format of the Commission review report for
azoxystrobin. In this review report the acceptable daily intake (ADI) for azoxystrobin was set at
0,1 mg/kg bw/day. At the inclusion in Annex I to Directive 91/414/EEC the technical and scientific
evaluation of kresoxim methyl has been finalised on 16 October 1998 in the format of the
Commission review report for kresoxim methyl. In this review report the acceptable daily intake
(ADI) for kresoxim methyl was set at 0,4 mg/kg bw/day. The lifetime exposure of consumers of
food products treated with azoxystrobin or kresoxim methyl 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 (1) and it has been calculated that the
maximum residue levels fixed in this Directive do not give rise to an exceedence of these ADIs.

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

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.
The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combi-
nations will be examined by the Commission on the basis of the submission of acceptable data.

(10)

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

(11)

The measures provided for in this Directive are in accordance with the opinion of the Standing
Committee on Plant Health,

(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)

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HAS ADOPTED THIS DIRECTIVE:

Article 1

In part A of Annex II to Directive 86/362/EEC the following entry shall be added in respect of azoxy-
strobin:

Pesticide residue

Maximum level in mg/kg

‘Azoxystrobin

0,3 (p) Oats

(p) Indicates provisional maximum residue level established in accordance with Directive 91/414/EEC Article 4(1)(f); all provisional
maximum residue levels for these pesticide residues will be treated as defintive in accordance with Article 10 of the Directive with effect
from 1 August 2003.’

In Annex II to Directive 90/642/EEC the columns headed ‘azoxystrobin’, and ‘kresoxim methyl’ are replaced
by those set out in the Annex to this Directive.

Article 2

The provision in Article 3(2) of Directive 2000/42/EC where ‘The maximum level for residues of acephate
on peaches shall be fixed at 0,02(*) mg/kg’ shall be applied by the Member States as of 1 December 2001.

Article 3

Article 4

This Directive shall enter into force on the day following that of its publication in the Official Journal

1.
of the European Communities.

2. Member States shall adopt and publish the legislative, regulatory or administrative measures to
comply with this Directive by 28 February 2002 at the latest. They shall forthwith inform the Commission
thereof.

3.

They shall apply these measures as from 1 March 2002.

4. 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, 28 June 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)

Azoxystrobin

Kresoxim methyl

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

added sugar; nuts

(i)

CITRUS FRUIT

Grapefruit

Lemons

Limes

Mandarins (including clementines and other hybrids)

Oranges

Pomelos

Others

0,05 (p) (*)

0,05 (p) (*)

(ii)

TREE NUTS (shelled or unshelled)

0,1 (p) (*)

0,1 (p) (*)

Almonds

Brazil nuts

Cashew nuts

Chestnuts

Coconuts

Hazelnuts

Macadamia

Pecans

Pine nuts

Pistachios

Walnuts

Others

(iii)

POME FRUIT

0,05 (p) (*)

0,2 (p)

Apples

Pears

Quinces

Others

(iv)

STONE FRUIT

Apricots

Cherries

Peaches (including nectarines and similar hybrids)

Plums

Others

(v)

BERRIES AND SMALL FRUIT

0,05 (p) (*)

0,05 (p) (*)

(a) Table and wine grapes

2

1 (p)

Table grapes

Wine grapes

(b) Strawberries (other than wild)

0,05 (p) (*)

0,05 (p) (*)

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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)

Azoxystrobin

Kresoxim methyl

(c) Cane fruit (other than wild)

0,05 (p) (*)

0,05 (p) (*)

Blackberries

Dewberries

Loganberries

Raspberries

Others

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

0,05 (p) (*)

Bilberries

Cranberries

Currants (red, black and white)

Gooseberries

Others

1 (p)

1 (p)

0,05 (p) (*)

(e) Wild berries and wild fruit

0,05 (p) (*)

0,05 (p) (*)

(vi) MISCELLANEOUS

Avocados

Bananas

Dates

Figs

Kiwi

Kumquats

Litchis

Mangoes

Olives

Passion fruit

Pineapples

Pomegranates

Others

2

0,2 (p)

0,05 (p) (*)

0,05 (p) (*)

2. Vegetables, fresh or uncooked, frozen or dry

(i)

ROOT AND TUBER VEGETABLES

0,05 (p) (*)

0,05 (p) (*)

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)

Azoxystrobin

Kresoxim methyl

(ii)

BULB VEGETABLES

0,05 (p) (*)

0,05 (p) (*)

Garlic

Onions

Shallots

Spring onions

Others

(iii)

FRUITING VEGETABLES

(a) Solanacea

Tomatoes

Peppers

Aubergines

Others

(b) Cucurbits — edible peel

Cucumbers

Gherkins

Courgettes

Others

2 (p)

2 (p)

2 (p)

0,5 (p)

1 (p)

0,5 (p)

0,05 (p) (*)

0,05 (p) (*)

1 (p)

0,05 (p) (*)

(c) Cucurbits — inedible peel

0,5 (p)

0,2 (p)

0,05 (p) (*)

0,05 (p) (*)

0,05 (p) (*)

0,05 (p) (*)

Melons

Squashes

Watermelons

Others

(d) Sweetcorn

(iv)

BRASSICA VEGETABLES

(a) Flowering brassica

Broccoli

Cauliflowers

Others

(b) Head brassica

Brussels sprouts

Head cabbage

Others

(c) Leafy brassica

Chinese cabbage

Kale

Others

(d) Kohlrabi

(v)

LEAF VEGETABLES AND FRESH HERBS

0,05 (p) (*)

0,05 (p) (*)

(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)

Azoxystrobin

Kresoxim methyl

(b) Spinach and similar

Spinach
Beet leaves (chard)
Others

(c) Watercress

(d) Witloof

(e) Herbs

Chervil
Chives
Parley
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

0,05 (p) (*)

0,5 (p)
0,2 (p)
0,05 (p) (*)

0,05 (p) (*)

0,05 (p) (*)

(viii) FUNGI

0,05 (p) (*)

0,05 (p) (*)

(a) Cultivated mushrooms

(b) Wild mushrooms

0,05 (p) (*)

0,1 (p)
0,05 (p) (*)

0,05 (p) (*)

0,1 (p) (*)

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

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

5. Potatoes

Early potatoes
Ware potatoes

Pesticide residues and maximum residue levels
(mg/kg)

Azoxystrobin

Kresoxim methyl

0,05 (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

20 (p)

0,1 (p) (*)

(*)
(p)

Indicates lower limit of analytical determination.
Indicates provisional maximum residue level established in accordance with Directive 91/414/EC Article 4(i)(f); all provisional maximum
residue levels for these pesticides will be treated as definitive in accordance with Article 10 of the Directive with effect from 1 August
2003 for azoxystrobin and 19 October 2004 for kresoxim methyl.