Commission Directive 2002/42/EC of 17 May 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 (bentazone and pyridate) in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables (Text with EEA relevance)
Date: 2002-05-17
Institutions: European Commission
Subjects: animal product, cereals, foodstuff, fruit, health control, pesticide residue, plant health control, vegetable

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COMMISSION DIRECTIVE 2002/42/EC

of 17 May 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 (bentazone and pyridate) 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 2002/23/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 2002/23/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 2002/23/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 2002/37/EC (6), and in particular
Article 4(1)(f) thereof,

Whereas:

(1)

(2)

The existing active substances bentazone and pyridate were included in Annex I to Directive
91/414/EEC by Commission Directives 2000/68/EC (7) and 2001/21/EC (8), for use as a herbicide on
cereals, vegetables and forage.

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

(4) With respect to the inclusion in Annex I to Directive 91/414/EEC of the active substances concerned,
the related technical and scientific evaluations were finalised in the form of Commission review
reports. The reports were finalised on 13 July 2000, in the case of bentazone and on 12 December
for bentazone at
2000 in the case of pyridate. They fixed the acceptable daily intake (ADI)

(1) OJ L 221, 7.8.1986, p. 37.
(2) OJ L 64, 7.3.2002, p. 13.
(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 117, 4.5.2002, p. 10.
(7) OJ L 276, 28.10.2000, p. 41.
(8) OJ L 69, 10.3.2001, p. 17.

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0,1 mg/kg bw/day and for pyridate at 0,036 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 the MRLs proposed will not lead to those ADIs being
exceeded.

(5)

(6)

(7)

(8)

(9)

No acute toxic effects requiring the setting of an acute reference dose were noted during the
evaluations and discussions preceding the inclusion of pyridate in Annex I to Directive 91/414/EEC.
The acute reference dose for bentazone was established at 0,25 mg/kg bw/day. According to the
exposure assessment the MRLs proposed will not lead to an unacceptable acute exposure of
consumers.

In order to ensure that the consumer is adequately protected from exposure to residues in or on
products, for which no authorisation has 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 MRLs for bentazone and pyridate 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 most further uses of the active substances concerned. The provisional MRL 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 no
comments have been received. The possibility of fixing import tolerance MRLs for specific pesticide/
crop combinations will be examined by the Commission on the basis of the acceptable data
submitted.

(10)

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 levels are added to Part A of Annex II to Directive 86/362/EEC:

Pesticide residue

Maximum level in mg/kg

‘Bentazone (sum of bentazone and the conjugates of 6-OH- and 8-OH-ben-
tazone expressed as bentazone)

0,1 (p) (*)

Cereals

Pyridate (sum of pyridate, its hydrolysis product CL 9673 (6-chloro-4-hy-
droxy-3-phenylpyridazin) and hydrolysable conjugates of CL 9673 ex-
pressed as pyridate)

0,05 (p) (*)

Cereals

(p)

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 the Directive introducing this amendment.

(*) Indicates lower limit of analytical determination.’

(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/food/fs/sc/out21_en.html).

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Article 2

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

Maximum level (mg/kg)

Pesticide residue

Of meat, including fat, preparations
of meat, offals 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

For milk and milk
products listed in Annex I
within CN codes 0401,
0402,
0405 00 and 0406

Of shelled fresh eggs, for
birds' eggs and egg yolks
listed in Annex I within
CN codes 0407 00 and
0408

‘Bentazone

0,05 (p) (*)

Pyridate (sum of pyridate and its
hydrolysis product CL 9673 (6-
chloro-4-hydroxy-3-phenylpyri-
dazin) expressed as pyridate)

Kidney except poultry 0,4 (p)
Other products (p) (*)

0,02 (p) (*)

0,05 (p) (*)

0,05 (p) (*)

0,05 (p) (*)

(p)

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 the Directive introducing this amendment.

(*) Indicates lower limit of analytical determination.’

The maximum pesticide residue levels for bentazone and pyridate 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 31 December 2002 at the latest. They shall forthwith inform the Commis-
sion thereof.

They shall apply these 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 20th 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, 17 May 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 residues and maximum residue levels
(mg/kg)

Bentazone (sum of benta-
zone and the conjugates of
6-OH- and 8-OH-bentazo-
ne expressed as bentazone)

Pyridate (sum of pyridate,
its hydrolysis product CL
9673 (6-chloro-4-hydroxy-
3-phenylpridazin) and hy-
drolysable conjugates of
CL 9673 expressed as
pyridate)

1. Fruits, fresh, dried or uncooked, preserved by freezing, not

0,1 (p) (*)

0,05 (p) (*)

containing added sugar: nuts

(i)

(ii)

(iii)

(iv)

CITRUS FRUIT
Grapefruit
Lemons
Limes
Mandarins (including clementines and other hybrids)
Oranges
Pomelos
Others

TREE NUTS (shelled or unshelled)
Almonds
Brazil nuts
Cashew nuts
Chestnuts
Coconuts
Hazelnuts
Macadamia
Pecans
Pine nuts
Pistachios
Walnuts
Others

POME FRUIT
Apples
Pears
Quinces
Others

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)

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Pesticide residues and maximum residue levels
(mg/kg)

Bentazone (sum of benta-
zone and the conjugates of
6-OH- and 8-OH-bentazo-
ne expressed as bentazone)

Pyridate (sum of pyridate,
its hydrolysis product CL
9673 (6-chloro-4-hydroxy-
3-phenylpridazin) and hy-
drolysable conjugates of
CL 9673 expressed as
pyridate)

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

Banans

Dates

Figs

Kiwi

Kumquats

Litchis

Mangoes

Olives

Passion fruit

Pineapples

Pomegranate

Others

2. Vegetables, fresh or uncooked, frozen or dry

(i)

ROOT AND TUBER VEGETABLES

0,1 (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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Pesticide residues and maximum residue levels
(mg/kg)

Bentazone (sum of benta-
zone and the conjugates of
6-OH- and 8-OH-bentazo-
ne expressed as bentazone)

Pyridate (sum of pyridate,
its hydrolysis product CL
9673 (6-chloro-4-hydroxy-
3-phenylpridazin) and hy-
drolysable conjugates of
CL 9673 expressed as
pyridate)

0,1 (p) (*)

0,05 (p) (*)

Groups and examples of individual products to which the MRLs apply

(ii)

BULB VEGETABLES
Garlic
Onions
Shallots
Spring onions
Others

(iii)

FRUITING VEGETABLES

0,1 (p) (*)

0,05 (p) (*)

(a) Solanacea

Tomatoes
Peppers
Aubergines
Others

(b) Cucurbits — edible peel

Cucumbers
Gherkins
Courgettes
Others

(c) Cucurbits — inedible peel

Melons
Squashes
Watermelons
Others

(d) Sweetcorn

(iv)

BRASSICA VEGETABLES

0,1 (p) (*)

(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

0,1 (p) (*)

Cress
Lamb's lettuce
Lettuce
Scarole
Others

0,05 (p) (*)

0,05 (p) (*)

0,2 (p)
0,05 (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)

Bentazone (sum of benta-
zone and the conjugates of
6-OH- and 8-OH-bentazo-
ne expressed as bentazone)

Pyridate (sum of pyridate,
its hydrolysis product CL
9673 (6-chloro-4-hydroxy-
3-phenylpridazin) and hy-
drolysable conjugates of
CL 9673 expressed as
pyridate)

(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

(a) Cultivated mushrooms

(b) Wild mushrooms

3. Pulses
Beans
Lentils
Peas
Others

4. Oils seeds
Linseed
Peanuts
Poppy seed
Sesame seed
Sunflower seed
Rapeseed
Soya bean
Mustard seed
Cotton seed
Others

0,1 (p) (*)

0,1 (p) (*)

0,1 (p) (*)

0,1 (p) (*)

0,5 (p)
0,2 (p)
0,1 (p) (*)

0,1 (p) (*)

0,1 (p) (*)

0,05 (p) (*)

1 (p)

0,05 (p) (*)

0,05 (p) (*)

0,1 (p) (*)

0,05 (p) (*)

0,05 (p) (*)

0,1 (p)

0,1 (p) (*)

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Groups and examples of individual products to which the MRLs apply

5. Potatoes

Early potatoes
Ware potatoes

Pesticide residues and maximum residue levels
(mg/kg)

Bentazone (sum of benta-
zone and the conjugates of
6-OH- and 8-OH-bentazo-
ne expressed as bentazone)

Pyridate (sum of pyridate,
its hydrolysis product CL
9673 (6-chloro-4-hydroxy-
3-phenylpridazin) and hy-
drolysable conjugates of
CL 9673 expressed as
pyridate)

0,1 (p) (*)

0,05 (p) (*)

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

0,1 (p)

0,1 (p) (*)

sinensis)

7. Hops

(dried), including hop pellets and unconcentrated powder

0,1 (p) (*)

0,1 (p) (*)

(p) Indicates provisional maximum residue level. For those agricultural products listed in Annex II to Directive 90/642/EEC where the
maximum residue levels for flupyrsulfuron-methyl, pymetrozine and azoxystrobin are indicated as provisional as ‘(p)’, this shall mean that
they are provisional
By 1 December 2005, provisional maximum residue levels for flupyrsulfuron-methyl and pyrmetrozine shall cease to be provisional and
shall become definitive in the sense of Article 3 of Directive 90/624/EEC. For azoxystrobin this shall be 1 August 2003.

in accordance with the provisions of Article 4(1)(f) of Directive 91/414/EEC.

(*) Indicates lower limit of analtical determination.