Commission Directive 98/82/EC of 27 October 1998 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: 1998-10-27
Institutions: European Commission
Subjects: animal product, cereals, food inspection, fruit, pesticide residue, vegetable

29. 10. 98

EN

Official Journal of the European Communities

L 290/25

COMMISSION DIRECTIVE 98/82/EC

of 27 October 1998

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,

October 1998 the appropriate lower limit of analytical
determination will apply;

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
last amended by
residues
Commission Directive 97/71/EC (2), and in particular
Article 10 thereof,

in and on cereals (1), as

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 97/71/EC, and in particular Article
10 thereof,

Having regard to Council Directive 90/642/EEC of 27
November 1990 on the fixing of maximum levels of
pesticide residues in and on products of plant origin,
including fruit and vegetables (4), as last amended by
Directive 97/71/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 Commis-
sion Directive 98/47/EC (6),

and 93/
Whereas Council Directives 93/57/EEC (7)
58/EEC (8) amended the Annexes II to Directives 86/
362/EEC and 86/363/EEC and 90/642/EEC to establish
maximum residue levels for a first list of pesticides for
cereals and products of animal origin and for products of
plant origin, including fruit and vegetables, respectively;
whereas, however, certain positions were left open where
available data were insufficient
to establish maximum
levels and interested parties were given the opportunity to
generate the missing data within a specified timetable;
if maximum levels are not adopted by 31
whereas,

(1) OJ L 221, 7. 8. 1986, p. 37.
(2) OJ L 347, 18. 12. 1997, p. 42.
(3) OJ L 221, 7. 8. 1986, p. 43.
(4) OJ L 350, 14. 12. 1990, p. 71.
(5) OJ L 230, 10. 8. 1991, p. 1.
(6) OJ L 191, 7. 7. 1998, p. 50.
(7) OJ L 211, 23. 8. 1993, p. 1.
(8) OJ L 211, 23. 8. 1993, p. 6.

Whereas, in accordance with the provisions of Directive
91/414/EEC, authorisations of plant protection products
for use on specific crops are the responsibility of the
Member States; whereas such authorisations are required
to be based on the evaluation of effects on human and
animal health and influence on the environment; whereas
elements to be taken into account in such evaluations
include operator and 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;

Whereas,
for cereals and products of plant origin,
including fruit and vegetables, maximum residue levels
reflect 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 practic-
able and is toxicologically acceptable, in particular in view
of the protection of the environment and in terms of
estimated dietary intake; whereas, for foodstuffs of animal
origin, maximum residue levels reflect the consumption
of cereals and products of plant origin treated with pesti-
cides resulting in residues in animals and animal prod-
the direct
ucts,
consequences of the use of veterinary medicines where
appropriate;

into account

as well

taking

as

Whereas maximum residue levels are fixed at the lower
limit of analytical determination where authorised uses of
plant protection do not result in detectable levels of pesti-
cide residue in or on the food product, or where there are
no authorised uses, or where uses which have been
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;

Whereas the lifetime exposure of consumers of
food
products treated with the pesticides covered by this
Directive have been assessed and evaluated in accordance

L 290/26

EN

Official Journal of the European Communities

29. 10. 98

with the procedures and practices used within the Euro-
pean Community, taking account of guidelines published
by the World Health Organisation (1);

Whereas the scientific approach and procedures for calcu-
lating acute reference doses (ARfDs) and estimating short-
term acute dietary exposure have not yet been agreed at
the Scientific
European Community level; whereas
Committee on Plants, considering that
the scientific
approach and procedures developed in the 1997
FAO/WHO consultation (2) is appropriate pending agree-
ment at Community level, has calculated the maximum
toxicologically acceptable residue levels for pome fruit,
peaches, apricots and peppers (3) with regard to methami-
dophos; whereas on the basis of information on GAP and
supervised field trials MRLs for methamidophos can be
fixed at the levels indicated to be toxicologically accept-
able for peaches and apricots; whereas in the absence of
such information for pome fruit, in order to accomodate
the residues of methamidophos arising from the use of
acephate, the MRL for methamidophos should also be
the toxicologically acceptable level; whereas
fixed at
Member States have to review, in particular for the above-
mentioned agricultural products, existing good agricul-
tural practices to ensure that the established MRLs for
acephate and methamidophos are satisfied;

dietary

exposure

concerns

Whereas maximum residue levels for pesticides should be
kept under review; whereas the levels may be changed to
take account of new information and data and, in partic-
ular, should be urgently reconsidered with a view to
reduction if
of
about
consumers, based on new or reviewed information, are
brought to the attention of the Commission, in particular
in implementation of Article 9 of Directive 86/362/EEC,
Article 9 of Directive 86/363/EEC or Article 8 of
Directive 90/642/EEC; whereas, in particular, the MRLs
fixed for acephate, metamidophos and vinclozolin in this
Directive should be urgently reviewed together with the
MRLs for these pesticides fixed by Directives 93/57/EEC
and 93/58/EEC based on the evaluation work on these
active substances under the provisions of Article 8(2) of
Directive 91/414/EEC;

Whereas Community maximum residue levels and levels
recommended by the Codex Alimentarius are fixed and
evaluated following similar procedures; whereas however
the information in the relevant evaluations of
the
FAO/WHO Joint Meeting on Pesticide Residues (JMPR)

(1) Guidelines for predicting dietary intake of pesticide residues
(revised), prepared by the GEMS/Food Programme in collab-
oration with the Codex Committee on Pesticide Residues,
published by the World Health Organisation 1997.

(2) Consultation on food consumption and intake assessment of
chemicals, Geneva, Switzerland, 10 to 14 February 1997: Food
Safety Unit, Programme of Food Safety and Food Aid, World
Health Organisation 1997; WHO/FSF/FOS.97.5.

(3) Opinion of

the Scientific Committee on Plants

regarding
questions relating to amending the Annexes to Council Dir-
ectives 86/362/EEC, 86/363/EEC and 90/642/EEC: SCP/RESI/
024 Final: 4 August 1998.

concerning the pesticides covered by this Directive have
been presented in a way which over-summarises author-
ised uses/good agricultural practices
and supervised
residue trials and does not indicate a clear basis for the
recommended maximum level; whereas authorisations of
plant protection products in third countries may require
the use of greater quantities of pesticides or shorter pre-
harvest intervals than are authorised in the Community
and consequently may require higher
residue levels;
whereas the Community’s trading partners have been
consulted about
in this Directive
the levels set out
through the World Trade Organisation and their
comments on these levels have been considered and
discussed by the Standing Committee on Plant Health;
tolerance
whereas
specific pesticide/crop
maximum residue
combinations will be
the European
Community on the basis of the submission of acceptable
data;

the possibility of

fixing import

examined by

levels

for

Whereas the maximum residue levels established in this
Directive will have to be reviewed in the framework of the
re-evaluation of active substances provided for in the
programme of work established in Article 8(2) of Dir-
ective 91/414/EEC;

Whereas the opinion of the Scientific Committee on
concerning the protection of
Plants,
consumers of food products treated with pesticides, has
been taken into account;

in particular

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

In Annex II of Directive 86/362/EEC in the lists of
maximum residue levels for chlorothalonil, chlorpyriphos,
chlorpyriphos-methyl,
deltamethrin,
fenvalerate, glyphosate,
iprodione, permethrin,
imazalil,
‘the benomyl group' (benomyl, carbendazim, thiophanate-
‘the maneb group' (maneb, mancozeb, metiram,
methyl),
propineb, zineb) and procymidon are replaced by the lists
set out in Annex A to this Directive.

cypermethrin,

Article 2

In Annex II of Directive 86/363/EEC the lists of
maximum residue levels for chlorothalonil, chlorpyriphos,
chlorpyriphos-methyl,
deltamethrin,
iprodione, permethrin,
fenvalerate, glyphosate,

cypermethrin,

imazalil,

29. 10. 98

EN

Official Journal of the European Communities

L 290/27

‘the benomyl group' (benomyl, carbendazim, thiophanate-
methyl),
‘the maneb group' (maneb, mancozeb, metiram,
propineb, zineb) and procymidon are replaced by the lists
set out in Annex B to this Directive.

Article 3

cypermethrin,

In Annex II of Directive 90/642/EEC the lists of
maximum residue levels for chlorothalonil, chlorpyriphos,
deltamethrin,
chlorpyriphos-methyl,
fenvalerate, glyphosate,
iprodione, permethrin,
imazalil,
‘the benomyl group' (benomyl, carbendazim, thiophanate-
methyl),
‘the maneb group' (maneb, mancozeb, metiram,
propineb, zineb) and procymidon and the maximum
levels specifically fixed for tea are replaced by the lists set
out in Annex C to this Directive.

Article 5

This Directive will enter into force on 1 November

1.
1998.

2. Member States shall adopt and publish the legisla-
tive, regulatory or administrative measures to comply with
this Directive by 30 April 1999. They shall immediately
inform the Commission thereof.

They shall apply these measures as from 1 August 1999.

When Member States adopt these measures, they shall
contain a reference to this Directive or shall be accom-
panied by such reference at the time of their official
publication. The procedure for such reference shall be
adopted by Member States.

Article 4

Article 6

The maximum residue levels set out in Annex D to this
Directive are fixed on a temporary basis for acephate,
methamidophos and vinclozolin, in advance of the adop-
tion for all agricultural products of reviewed maximum
residue levels for these three pesticides on the basis of the
evaluation works on these active substances under the
provisions of Article 8(2) of Directive 91/414/EEC, and
before 30 April 2001 at
for acephate and
methamidophos and before 31 December 1999 at the
latest for vinclozolin.

the latest,

This Directive is addressed to the Member States.

Done at Brussels, 27 October 1998.

For the Commission

Franz FISCHLER

Member of the Commission

L 290/28

EN

Official Journal of the European Communities

29. 10. 98

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L 290/30

EN

Official Journal of the European Communities

29. 10. 98

ANNEX B

(part A)

Maximum levels in mg/kg (ppm)

Pesticide residues

Chlorpyrifos

Of fat contained in meat, pre-
parations of meat, offal and
animal fats listed in Annex I
within CN code Nos ex 0201,
0202, 0203, 0204, 0205 00 00,
0206, 0207, ex 0208, 0209 00,
0210, 1601 00 and 1602 (1) (4)

0,05 (*)
ex 0207 poultry meat

Chlorpyrifos-methyl

0,05 (*)

Cypermethrin, including other mixtures
of constituent isomers (sum of isomers)

Deltamethrin

Fenvalerate, including other mixtures of
constituents (sum of isomers)

0,05 (*)
ex 0207 poultry meat
0,2 other products

0,05 (*)
ex 0207 poultry meat

0,05 (*)
ex 0207 poultry meat
0,5 other products

Permethrin (sum of isomers)

0,5

(*) Indicates lower limit of analytical determination.

For cow’s milk and whole cream
cow’s milk listed in Annex I
within CN code No 0401;
for other foodstuffs within CN
code Nos 0401, 0402, 0405 00,
0406 in accordance with (2) (4)

Of shelled fresh eggs, for bird’s
eggs and egg yolks listed in
Annex I within CN code Nos
0407 00 and 0408 (3) (4)

0,01 (*)

0,01 (*)

0,02

0,05

0,05

0,01 (*)

0,01 (*)

0,05 (*)

0,05 (*)

0,05 (*)

0,05

(1) In case of foodstuffs with a fat content of 10 % or less by weight, the residue is related to the total weight of the boned foodstuff. In such cases, the

maximum level is one-tenth of the value related to the fat content, but must be no less than 0,01 mg/kg.

(2) In determining the residues in raw cow’s milk and whole cream cow’s milk, a fat content of 4 % by weight should be taken as basis.

For raw milk and whole cream milk of another animal origin the residues are expressed on the basis of the fat.
For other foodstuffs listed in Annex I within CN code Nos 0401, 0402, 0405 00, 0406:
— with a fat content of less than 2 % by weight, the maximum level is taken as half that set for raw milk and whole cream milk,
— with a fat content of 2 % or more by weight, the maximum level is expressed in mg/kg of fat. In such cases, the maximum level is 25 times that set for

raw milk and whole cream milk.

(3) For eggs and egg products with a fat content higher than 10 % the maximum level is expressed in mg/kg fat. In this case the maximum level is 10 times

higher than the maximum level for fresh eggs.

(4) Footnotes (1),

(2) and (3) do not apply in cases where lower limit of analytical determination is indicated.

29. 10. 98

EN

Official Journal of the European Communities

L 290/31

(part B)

Maximum levels in mg/kg (ppm)

Of meat, including fat, prepara-
tions of meat, offal and animal
fats listed in Annex I within CN
code Nos ex 0201, 0202, 0203,
0204, 0205 00 00, 0206, 0207, ex
0208, 0209 00, 0210, 1601 00 and
1602

0,1 (*)

0,01 (*)

0,5 ex 0206 pig kidney
2 ex 0206 cattle, goat and
sheep kidney
0,1 (*) other products

0,02 (*)

0,05 (*)

0,05 (*)

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

Of shelled fresh eggs, for bird’s
eggs and egg yolks listed in
Annex I within CN code Nos
0407 00 and 0408

0,1 (*)

0,01 (*)

0,1 (*)

0,02 (*)

0,05 (*)

0,05 (*)

0,1 (*)

0,01 (*)

0,1 (*)

0,02 (*)

0,05 (*)

0,05 (*)

Pesticide residues

Benomyl/carbendazim
tiophanate-methyl
(sum expressed as carbendazim)

Chlorothalonil

Glyphosate

Imazalil

Maneb, mancozeb, metiram, probineb,
zineb
(sum expressed as CS2)

Vinclozolin, iprodione, procymidone
(sum of compounds and all metabolites
containing the 3,5-dichloroaniline
moity expressed as 3,5-dichloroaniline)

(*) Indicates lower limit of analytical determination.

L 290/32

EN

Official Journal of the European Communities

29. 10. 98

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L 290/33

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Official Journal of the European Communities

29. 10. 98

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Official Journal of the European Communities

29. 10. 98

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Official Journal of the European Communities

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Official Journal of the European Communities

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Official Journal of the European Communities

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(

1
0

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)
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(

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5

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2

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(

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0

,

.

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n

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B
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H

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p
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g
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F

29. 10. 98

EN

Official Journal of the European Communities

L 290/53

ANNEX D

1. Acephate

Product

Pome fruit

Peaches

Plums

Peppers

Aubergines

Cucumbers

Fl. brassica

Leaf brassica

Beans (with pods)

Peas (with pods)

Beans (without pods)

Peas (without pods)

Globe artichokes

Leeks

Beans (pulses)

Peas (pulses)

Hops

2. Methamidophos

Product

Pome fruit

Apricots

Peaches

Plums

Other stone fruit

Peppers

Fl. brassica

Legume veg (with pods)

Legume veg (without pods)

Globe artichokes

Leeks

Beans, pulses

Peas, pulses

MRL

1

0,2 (x)

2

0,02 (*)

0,5

0,02 (*)

2

0,02 (*)

3

3

0,02 (*)

0,02 (*)

0,2

0,02 (*)

0,02 (*)

0,02 (*)

0,1 (*)

MRL

0,05

0,1

0,05

0,3

0,01 (*)

0,01 (*)

0,5

0,5

0,01 (*)

0,1

0,01 (*)

0,01 (*)

0,01 (*)

L 290/54

EN

Official Journal of the European Communities

29. 10. 98

3. Vinclozolin

Product

Plums

Currants

Carrots

Kiwi

Horseradish

Radishes

Swedes

Beans (without pods)

Peas (without pods)

Celery

Dry peas and beans

Other pulses

MRL

2

10

0,5

10

0,05 (*)

0,05 (*)

0,05 (*)

0,5

0,3

0,05 (*)

0,5

0,05 (*)

(*) Indicates lower limit of analytical determination.
(x) Should this level not be confirmed or amended by a Directive, with effect from 1 July 2000, the appropriate lower limit

of analytical determination shall apply.