Commission Directive 2004/95/EC of 24 September 2004 amending Council Directive 90/642/EEC as regards the maximum residues levels of bifenthrin and famoxadone fixed therein(Text with EEA relevance)
Date: 2004-09-24
Institutions: European Commission
Subjects: consumer protection, food safety, foodstuffs legislation, marketing standard, pesticide residue

L 301/42

EN

Official Journal of the European Union

28.9.2004

COMMISSION DIRECTIVE 2004/95/EC

of 24 September 2004

amending Council Directive 90/642/EEC as regards the maximum residues levels of bifenthrin and
famoxadone fixed therein

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 90/642/EEC of 27
November 1990 on the
for
pesticide residues in and on certain products of plant origin
including fruit and vegetables (1), and in particular Article 7
thereof,

fixing of maximum levels

Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the
market (2), and in particular Article 4(1)(f) thereof,

Whereas:

(1)

(2)

(3)

(4)

In accordance with Directive 91/414/EEC, authorisations
of plant protection products for use on specific crops are
the responsibility of the Member States. Such authori-
sations are required to be based on the evaluation of
effects on human and animal health and influence on
the environment. Elements to be taken into account in
such
bystander
exposure and impact on the terrestrial, aquatic and
aerial environments, as well as impact on humans and
animals through consumption of residues on treated
crops.

evaluations

operator

include

and

reflect

(MRLs)

Maximum residue levels
the use of
minimum quantities of pesticides to achieve effective
protection of plants, applied in such a manner that the
amount of residue is the smallest practicable and is toxi-
cologically acceptable, in particular in terms of estimated
dietary intake.

MRLs for pesticides should be kept under review. They
may be changed to take account of new uses, new infor-
mation and data.

MRLs are fixed at the lower limit of analytical determi-
nation 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

(1) OJ L 350, 14.12.1990, p. 71. Directive as last amended by
Commission Directive 2004/61/EC (OJ L 127, 29.4.2004, p. 81).
last amended by
Commission Directive 2004/71/EC (OJ L 127, 29.4.2004, p. 104).

(2) OJ L 230, 19.8.1991, p. 1. Directive as

authorised 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 with such necessary data.

Information on new or changed uses of certain pesticides
covered by Directive 90/642/EEC has been notified to the
Commission. This concerns bifenthrin, for which MRLs
were set by Commission Directive 2002/79/EC (3) and
famoxadone for which MRLs were set by Commission
Directive 2003/60/EC (4).

The lifetime exposure of consumers to these pesticides
via food products that may contain residues of these
pesticides has been assessed and evaluated in accordance
with the procedures and practices used within the
Community, taking account of guidelines published by
the World Health Organisation (5). It has been calculated
that the MRLs concerned will ensure that the acceptable
daily intakes are not exceeded.

In the case of famoxadone, for which an acute reference
(ARfD) dose exists, the acute exposure of consumers via
each of the food products that may contain residues of
these pesticides has been assessed and evaluated in
accordance with the procedures and practices currently
used within the European Community, taking account of
guidelines published by the World Health Organisation.
The opinions of the Scientific Committee for Plants, in
particular advice and recommendations concerning the
protection of consumers from food products treated
with pesticides, have been taken into account. The
intake assessment of famoxadone shows, that by setting
the MRLs concerned, the ARfD will not be exceeded. In
the case of bifenthrin, an assessment of the available
information has shown that no ARfD is required and
that therefore a short-term assessment is not needed.

Therefore it is appropriate to fix new maximum levels for
residues of those pesticides.

Directive 90/642/EEC should therefore be amended
accordingly.

(5)

(6)

(7)

(8)

(9)

(3) OJ L 291, 28.10.2002, p. 1.
(4) OJ L 155, 24.06.2003, p. 15.
(5) 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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Official Journal of the European Union

L 301/43

(10)

(11)

The setting or modification at Community level of provi-
sional MRLs does not prevent the Member States from
establishing provisional MRLs
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 further uses of the active
substance concerned. The provisional MRL should then
become definitive.

famoxadone

for

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DIRECTIVE:

Article 1

They shall apply these provisions from 26 March 2005.

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.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

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

The maximum pesticide residue levels
for bifenthrin and
famoxadone in Annex II to Directive 90/642/EEC are replaced
by those in the Annex to this Directive.

Article 4

This Directive is addressed to the Member States.

Article 2

the latest,

1. Member States shall adopt and publish, by 25 March
2005 at
the laws, regulations and administrative
provisions necessary to comply with this Directive. They shall
forthwith communicate to the Commission the text of those
provisions and a correlation table between those provisions and
this Directive.

Done at Brussels, 24 September 2004.

For the Commission

David BYRNE
Member of the Commission

L 301/44

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Official Journal of the European Union

28.9.2004

ANNEX

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

Pesticide residue and maximum residue level (mg/kg)

Bifenthrin

Famoxadone

1. Fruit,

fresh, dried or uncooked, preserved by freezing, not

containing added sugar; nuts

(i)

CITRUS FRUIT

0,1

0,02 (*) (p)

Grapefruit

Lemons

Limes

Mandarins (including clementines and other hybrids)

Oranges

Pomelos

Others

(ii) TREE NUTS (shelled or unshelled)

0,05 (*)

0,02 (*) (p)

Almonds

Brazil nuts

Cashew nuts

Chestnuts

Coconuts

Hazelnuts

Macadamia

Pecans

Pine nuts

Pistachios

Walnuts

Others

(iii) POME FRUIT

0,3

0,02 (*) (p)

Apples

Pears

Quinces

Others

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Official Journal of the European Union

L 301/45

Pesticide residue and maximum residue level (mg/kg)

Bifenthrin

Famoxadone

0,2

0,02 (*) (p)

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

(iv) STONE FRUIT

Apricots

Cherries

Peaches (including nectarines and similar hybrids)

Plums

Others

(v) BERRIES & SMALL FRUIT

(a) Table and wine grapes

0,2

2 (p)

Table grapes

Wine grapes

(b) Strawberries (other than wild)

(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

0,5

0,3

0,3

0,05 (*)

0,05 (*)

(e) Wild berries and wild fruit

0,05 (*)

(vi) MISCELLANEOUS

Avocados

Bananas

Dates

Figs

0,1

0,02 (*) (p)

0,02 (*) (p)

0,02 (*) (p)

0,02 (*) (p)

0,02 (*) (p)

L 301/46

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Official Journal of the European Union

28.9.2004

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

Pesticide residue and maximum residue level (mg/kg)

Bifenthrin

Famoxadone

Kiwifruit

Kumquats

Lychees

Mangoes

Olives

Passion fruit

Pineapples

Pomegranate

Others

0,05 (*)

2. Vegetables, fresh or uncooked, frozen or dry

(i)

ROOT AND TUBER VEGETABLES

0,05 (*)

0,02 (*) (p)

Beetroot

Carrots

Celeriac

Horseradish

Jerusalem artichokes

Parsnips

Parsley root

Radishes

Salsify

Sweet potatoes

Swedes

Turnips

Yam

Others

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Official Journal of the European Union

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Pesticide residue and maximum residue level (mg/kg)

Bifenthrin

0,05 (*)

Famoxadone

0,02 (*) (p)

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

(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

0,2

0,1

(c) Cucurbits-inedible peel

0,05 (*)

Melons

Squashes

Watermelons

Others

(d) Sweet corn

(iv) BRASSICA VEGETABLES

(a) Flowering brassica

Broccoli (including Calabrese)

0,05 (*)

0,2

1 (p)

0,2 (p)

0,02 (*) (p)

0,2 (p)

0,3 (p)

0,02 (*) (p)

0,02 (*) (p)

0,02 (*) (p)

L 301/48

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Official Journal of the European Union

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

Pesticide residue and maximum residue level (mg/kg)

Bifenthrin

Famoxadone

Cauliflower

Others

(b) Head brassica

Brussels sprouts

Head cabbage

Others

(c) Leafy brassica

Chinese cabbage

Kale

Others

(d) Kohlrabi

(v)

LEAF VEGETABLES & FRESH HERBS

(a) Lettuce and similar

Cress

Lamb's lettuce

Lettuce

Scarole (broad-leaf endive)

Others

1

0,05 (*)

0,05 (*)

2

0,02 (*) (p)

(b) Spinach and similar

0,05 (*)

Spinach

Beet leaves (chard)

Others

(c) Water cress

(d) Witloof

(e) Herbs

Chervil

0,05 (*)

0,05 (*)

0,05 (*)

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

Pesticide residue and maximum residue level (mg/kg)

Bifenthrin

Famoxadone

Chives

Parsley

Celery leaves

Others

(vi) LEGUME VEGETABLES (fresh)

0,02 (*) (p)

Beans (with pods)

Beans (without pods)

Peas (with pods)

Peas (without pods)

Others

(vii) 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

0,5

0,1

0,05 (*)

0,05 (*)

0,02 (*) (p)

0,05 (*)

0,02 (*) (p)

0,05 (*)

0,02 (*) (p)

L 301/50

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Official Journal of the European Union

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

Pesticide residue and maximum residue level (mg/kg)

Bifenthrin

Famoxadone

Others

4. Oilseeds

Linseed

Peanuts

Poppy seed

Sesame seed

Sunflower seed

Rape seed

Soya bean

Mustard seed

Cotton seed

Others

5. Potatoes

Early potatoes

Ware potatoes

0,1 (*)

0,05 (*) (p)

0,05 (*)

0,02 (*) (p)

6. Tea (dried leaves and stalks, fermented or other-wise, Camellia sinensis)

7. Hops (dried), including hop pellets and unconcentrated powder

5

10

0,05 (*) (p)

0,05 (*) (p)

(*) Indicates lower limit of analytical determination
(p) Indicates that the maximum residue level has been established provisionally in accordance with Article 4(1)(f) of Directive 91/414/EEC.’