Commission Directive 2000/48/EC of 25 July 2000 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: 2000-07-25
Institutions: European Commission
Subjects: consumer protection, foodstuff, market approval, pesticide residue, pharmaceutical product, plant health product

L 197/26

EN

Official Journal of the European Communities

3.8.2000

COMMISSION DIRECTIVE 2000/48/EC

of 25 July 2000

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 Directive 2000/42/EC (2),
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 (3), as last amended by Directive 2000/
42/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 2000/
10/EC (5), and in particular Article 4(1)(f) thereof,

(4)

Whereas:

(1)

(2)

(3)

The new active substance, azoxystrobin, was included in
to Directive 91/414/EEC by Commission
Annex I
Directive 98/47/EC (6) for use as fungicide only, without
specifying particular conditions having an impact on
crops which may be treated with plant protection prod-
ucts containing azoxystrobin.

Maximum levels for azoxystrobin residues in and on all
commodities covered by Directives 86/362/EEC and 90/
642/EEC were fixed by Commission Directive 1999/
71/EC (7).

(5)

In fixing the said maximum levels for azoxystrobin resi-
dues, it was recognised that these levels should be kept
under review and should be changed to take account of
new information and data. Directive 1999/71/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 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

(1) OJ L 221, 7.8.1986, p. 37.
(2) OJ L 158, 30.6.2000, p. 51.
(3) OJ L 350, 14.12.1990, p. 71.
(4) OJ L 230, 19.8.1991, p. 1.
(5) OJ L 57, 2.3.2000, p. 28.
(6) OJ L 191, 7.7.1998, p. 50.
(7) OJ L 194, 27.7.1999, p. 36.

levels set in Directive 1999/71/EC were fixed on a provi-
sional basis, enabling Member States to grant further
authorisations for new uses and to notify the Commis-
sion under the procedure described by the said Article.
a provisional
This Article provides
Community maximum residue level exists and where the
new authorised use would lead to higher levels, the
authorising Member State shall establish a national
provisional maximum residue level in accordance with
Article 4(1)(f) of Directive 91/414/EEC before the
authorisation may be granted.

that where

To ensure that the consumer is adequately protected
from exposure to residues in or on products for which
no authorisations have been granted, it was considered
prudent, in adopting Directive 1999/71/EC, to set provi-
sional 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 the
use of azoxystrobin on such products in accordance
with Article 4(1)(f) of Directive 91/414/EEC.

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
in particular, a dossier conforming to the
evaluating,
requirements of Annex III
to Directive 91/414/EEC,
submitted by the applicant for authorisation. 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 estimations 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 provides for 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
the
which ensure
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.

residues occurring reflect

that

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Official Journal of the European Communities

L 197/27

(6)

(7)

(8)

(9)

(10)

(11)

New data has been provided for uses of azoxystrobin on
rice, bananas, tomatoes and cucurbits with edible and
inedible peel. This new data has been evaluated and it is
considered
the provisional
maximum residue levels fixed for these products in
Directive 1999/71/EC.

appropriate

to revise

for azoxystrobin.

At the inclusion in Annex I to Directive 91/414/EEC the
technical and scientific evaluation of azoxystrobin was
the
finalised on 22 April 1998 in the format of
Commission review report
In this
review report the acceptable daily intake (ADI) for azox-
ystrobin was set at 0,1 mg/kg bw/day. The lifetime
exposure of consumers of food products treated with
azoxystrobin has been assessed and evaluated in accord-
ance 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 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 azoxystrobin 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 combinations will be examined by the
Commission on the basis of the submission of accept-
able data.

the Scientific
The advice and recommendations of
Committee for Plants,
in particular 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:

Article 1

The following shall be added to part A of Annex II to Directive
86/362/EEC:

Pesticide residue

Maximum level in mg/kg

‘Azoxystrobin

5

Rice’

Article 2

The maximum residues levels in the Annex to this Directive
shall replace those listed for azoxystrobin in Annex II
to
Directive 90/642/EEC.

Article 3

1.
This Directive shall enter into force on the twentieth day
following its publication in the Official Journal of the European
Communities.

2. Member States shall adopt and publish the legislative,
regulatory or administrative measures to comply with this
Directive by 31 March 2001 at the latest. They shall forthwith
inform the Commission thereof.

3.

They shall apply these measures as from 1 April 2001.

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 4

Done at Brussels, 25 July 2000.

For the Commission

David BYRNE

Member of the Commission

(1) Guidelines

for predicting dietary intake of pesticide

(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).

residues

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Official Journal of the European Communities

3.8.2000

ANNEX

Groups and examples of individual products to which the MRLs apply

Pesticide residues and maximum
residue levels
(mg/kg)

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) (*)

(ii) TREE NUTS (SHELLED OR UNSHELLED)

0,1 (p) (*)

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)

(c) Cane fruit (other than wild)

Blackberries

Dewberries

Loganberries

Raspberries

Others

0,05 (p) (*)

0,05 (p) (*)

2

0,05 (p) (*)

0,05 (p) (*)

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Groups and examples of individual products to which the MRLs apply

Pesticide residues and maximum
residue levels
(mg/kg)

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

0,05 (p) (*)

Bilberries
Cranberries
Currants (red, black and white)
Gooseberries
Others

(e) Wild berries and wild fruit

(vi) MISCELLANEOUS

Avocados
Bananas
Dates
Figs
Kiwi
Kumquats
Lychees
Mangoes
Olives
Passion fruit
Pineapples
Pomegranates
Others

2. Vegetables, fresh or uncooked, frozen or dry

(i)

ROOT AND TUBER VEGETABLES

Beetroot
Carrots
Celeriac
Horseradish
Jerusalem artichokes
Parsnips
Parsley root
Radishes
Salsify
Sweet potatoes
Swedes
Turnips
Yam
Others

0,05 (p) (*)

2

0,05 (p) (*)

0,05 (p) (*)

(ii) BULB VEGETABLES

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)

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

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Pesticide residues and maximum
residue levels
(mg/kg)

0,5 (p)

0,05 (p) (*)

0,05 (p) (*)

Groups and examples of individual products to which the MRLs apply

(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

0,05 (p) (*)

Cress
Lamb's lettuce
Lettuce
Scarole
Others

(b) Spinach and similar

Spinach
Beet leaves (chard)
Others
(c) Watercress
(d) Witloof
(e) Herbs

Chervil
Chives
Parsley
Celery leaves
Others

(vi) LEGUME VEGETABLES (fresh)

0,05 (p) (*)

Beans (with pods)
Beans (without pods)
Peas (with pods)
Peas (without pods)
Others

(vii) STEM VEGETABLES (fresh)

0,05 (p) (*)

Asparagus
Cardoons
Celery
Fennel
Globe artichokes
Leeks
Rhubarb
Others

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Groups and examples of individual products to which the MRLs apply

Pesticide residues and maximum
residue levels
(mg/kg)

(viii) FUNGI

(a) Cultivated mushrooms
(b) Wild mushrooms

3. Pulses
Beans
Lentils
Peas
Others

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

0,05 (p) (*)

0,05 (p) (*)

0,05 (p) (*)

0,05 (p) (*)

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

0,1 (p) (*)

sinensis)

7. Hops (dried),

including hop pellets and unconcentrated powder

0,1 (p) (*)

(*)
(p)

Indicates lower limit of analytical determination.
Indicates provisional maximum residue level.