Commission Directive 2000/81/EC of 18 December 2000 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 (Text with EEA relevance)
Date: 2000-12-18
Institutions: European Commission
Subjects: cereals, consumer protection, foodstuff, pesticide residue, plant health legislation

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COMMISSION DIRECTIVE 2000/81/EC

of 18 December 2000

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

(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 2000/58/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 2000/58/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 2000/58/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 2000/68/EC (6), and in particular
Article 4(1)(f) thereof,

Whereas:

(1)

(2)

The new active substance, spiroxamine, was included in Annex I to Directive 91/414/EEC by
Commission Directive 1999/73/EC (7) for use as fungicide only, without specifying particular condi-
tions having an impact on crops which may be treated with plant protection products containing
spiroxamine.

The said inclusion in Annex I was based on assessment of the information submitted concerning
proposed use as fungicide on cereals and vines. Information relating to uses on cereals and vines has
been submitted by certain Member States in accordance with the requirements of Article 4(1)(f) of
Directive 91/414/EEC. The information available has been reviewed and is sufficient to fix certain
maximum residue levels.

(3) Where no Community maximum residue level or provisional MRL exists Member States 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.

(4)

At the inclusion in Annex I to Directive 91/414/EEC the technical and scientific evaluation of
spiroxamine has been finalised on 12 May 1999 in the format of the Commission review report for
spiroxamine. In this review report the acceptable daily intake (ADI) for spiroxamine was set at
0,025 mg/kg bw/day. The lifetime exposure of consumers of food products treated with spiroxa-
mine 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 Organ-
isation (8) and it has been calculated that the maximum residue levels fixed in this Directive do not
give rise to an exceedence of this ADI.

(1) OJ L 221, 7.8.1986, p. 37.
(2) OJ L 244, 29.9.2000, p. 78.
(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, 28.10.2000, p. 41.
(7) OJ L 206, 5.8.1999, p. 16.
(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/FOS97.7).

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(5)

(6)

(7)

(8)

(9)

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

For certain agricultural products the use conditions for spiroxamine were already defined in a
manner which permits the establishing of definitive maximum residue levels.

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 Council 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 spiroxamine in accordance with Article 4(1)(f) of Directive 91/414/EEC,
and in accordance with Annex VI to Directive 91/414/EEC, in particular part B, section 2.4.2.3 of
this Annex; four years is considered a sufficient period of time during which to establish most
further uses of spiroxamine. After that period these provisional maximum residue levels should
become definitive.

The Community notified the draft Commission Directive to the World Trade Organisation and the
comments received have been considered in finalising the Directive. 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 acceptable data.

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

(10)

This Directive is in accordance with the opinion of the Standing Committee on Plant Health,

HAS ADOPTED THIS DIRECTIVE:

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

Article 1

Pesticide residue

Maximum level in mg/kg

‘Spiroxamine

0,3 (p)

0,05 (p) (*)

Barley and oats

Other cereals

(*)
(p)

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

The following shall be added to part B of Annex II to Directive 86/363/EEC:

Article 2

Pesticide residue

Maximum level (mg/kg)

‘Of meat,
including fat,
preparations of meat, offal
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,

ex 0206 Kidney,
0,05 (p) (*) Other

0,2 (p)
liver
products

For milk and milk prod-
ucts
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

0,02 (p)

0,05 (p) (*)

Spiroxamine carboxylic acid
expressed as spiroxamine

(*)
(p)

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

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The contents of the Annex to this Directive shall be added to Annex II to Directive 90/642/EEC.

Article 3

Article 4

1.
For those agricultural products listed in Annex II to Directives 86/362/EEC, 86/363/EEC and 90/
642/EEC where the maximum residue levels for spiroxamine are indicated as ‘(p)’, this shall mean that they
are provisional (p) in accordance with the provisions of Article 4(1)(f) of Directive 91/414/EEC.

2.
Four years after the entry into force of this Directive, provisional maximum residue levels for
spiroxamine in the Annexes shall cease to be provisional and shall become definitive in the sense of Article
4(1) of Directives 86/362/EEC and 86/363/EEC or Article 3 of Directive 90/642/EEC respectively.

Article 5

This Directive shall enter into force on the 20th day following that of its publication in the Official

1.
Journal of the European Communities.

2. Member States shall bring into force the laws, regulations and administrative provisions necessary to
comply with this Directive by 1 July 2001 at the latest. They shall forthwith inform the Commission
thereof.

3. When Member Sates 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 6

Done at Brussels, 18 December 2000.

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

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

Pesticide residues and maximum
residue levels
(mg/kg)

Spiroxamine

0,05 (p) (*)

(ii) TREE NUTS (SHELLED OR UNSHELLED)

0,05 (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) (*)

1 (p)

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)

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

(e) Wild berries and wild fruit

(vi) MISCELLANEOUS

Spiroxamine

0,05 (p) (*)

0,05 (p) (*)

0,05 (p) (*)

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

2. Vegetables, fresh or uncooked, frozen or dry

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

(ii) BULB VEGETABLES

Garlic
Onions
Shallots
Spring onions
Others

(iii) FRUITING VEGETABLES

(a) Solanacea
Tomatoes
Peppers
Aubergines
Others

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Groups and examples of individual products to which the MRLs apply

Pesticide residues and maximum
residue levels
(mg/kg)

Spiroxamine

(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

(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)

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

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Groups and examples of individual products to which the MRLs apply

Pesticide residues and maximum
residue levels
(mg/kg)

Spiroxamine

(vii) STEM VEGETABLES (fresh)

Asparagus
Cardoons
Celery
Fennel
Globe artichokes
Leeks
Rhubarb
Others

(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) (*)

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.