Commission Directive 2008/17/EC of 19 February 2008 amending certain Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for acephate, acetamiprid, acibenzolar-S-methyl, aldrin, benalaxyl, benomyl, carbendazim, chlormequat, chlorothalonil, chlorpyrifos, clofentezine, cyfluthrin, cypermethrin, cyromazine, dieldrin, dimethoate, dithiocarbamates, esfenvalerate, famoxadone, fenhexamid, fenitrothion, fenvalerate, glyphosate, indoxacarb, lambda-cyhalothrin, mepanipyrim, metalaxyl-M, methidathion, methoxyfenozide, pymetrozine, pyraclostrobin pyrimethanil, spiroxamine, thiacloprid, thiophanate-methyl and trifloxystrobin (Text with EEA relevance)
Date: 2008-02-19
Institutions: European Commission
Subjects: cereals, consumer protection, fruit, marketing standard, pesticide residue, plant health legislation, plant health product, vegetable

23.2.2008

EN

Official Journal of the European Union

L 50/17

DIRECTIVES

COMMISSION DIRECTIVE 2008/17/EC

of 19 February 2008

amending certain Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as
regards maximum residue levels for acephate, acetamiprid, acibenzolar-S-methyl, aldrin, benalaxyl,
benomyl,
cyfluthrin,
chlorothalonil,
cypermethrin, cyromazine, dieldrin, dimethoate, dithiocarbamates, esfenvalerate,
famoxadone,
lambda-cyhalothrin, mepanipyrim,
fenhexamid, fenitrothion, fenvalerate, glyphosate,
pyrimethanil,
metalaxyl-M, methidathion, methoxyfenozide,

indoxacarb,
pymetrozine,

pyraclostrobin

carbendazim,

chlormequat,

chlorpyrifos,

clofentezine,

spiroxamine, thiacloprid, thiophanate-methyl and trifloxystrobin

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Whereas:

Having regard to the Treaty
Community,

establishing the European

(1)

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), 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 (2), and in particular Article 10
thereof,

to

regard

Council Directive

Having
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), and in particular Article 7
thereof,

90/642/EEC

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

(1) OJ L 221, 7.8.1986, p. 37. Directive as

(2) OJ L 221, 7.8.1986, p. 43. Directive as

last amended by
Commission Directive 2007/73/EC (OJ L 329, 14.12.2007, p. 40).
last amended by
Commission Directive 2007/57/EC (OJ L 243, 18.9.2007, p. 61).
(3) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Directive

2007/73/EC.

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

last amended by
Commission Directive 2007/76/EC (OJ L 337, 21.12.2007, p. 100).

(2)

(3)

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 have to be based on the evaluation of effects
on human and animal health and influence on the envi-
ronment. Elements to be taken into account in such
evaluations
include operator and bystander exposure
and impact on the terrestrial, aquatic and aerial envi-
ronments, as well as impact on humans and animals
through consumption of residues on treated crops.

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.

residue

in the

acetamiprid,

MRLs for pesticides covered by Directive 90/642/EEC,
86/363/EEC and 86/362/EEC are to be kept under
review and may be modified to take account of new or
changed uses. Information about new or changed uses
has been communicated to the Commission which
should lead to changes
levels of
aldrin,
acephate,
benalaxyl, benomyl, carbendazim, chlormequat, chlo-
rothalonil, chlorpyrifos, clofentezine, cyfluthrin, cyper-
methrin, cyromazine, dieldrin, dimethoate, dithiocar-
feni-
bamates, esfenvalerate,
trothion,
lambda-
cyhalothrin, mepanipyrim, metalaxyl-M, methidation,
methoxyfenozide, pymetrozine, pyraclostrobin, pyri-
methanil, spiroxamine,
thiophanate-methyl
and trifloxystrobin.

fenvalerate, glyphosate,

acibenzolar-S-methyl,

famoxadone,

fenhexamid,

indoxacarb,

thiacloprid,

L 50/18

EN

Official Journal of the European Union

23.2.2008

(4)

(5)

The lifetime exposure of consumers to the pesticides
referred to in this Directive via food products that may
contain residues of those pesticides has been assessed and
evaluated in accordance with the procedures
and
taking account
practices used within the Community,
of guidelines published by the World Health Organi-
sation (1). Based on those assessments and evaluations,
the MRLs for those pesticides should be set so as to
ensure that the acceptable daily intake is not exceeded.

and

thiacloprid,

indoxacarb,

An acute reference dose (ARfD) has been set
for
acephate, acetamiprid, carbendazim, chlormequat, chlo-
rothalonil, chlorpyrifos, cyfluthrin, cypermethrin, cyro-
mazine, dieldrin, dimethoate, esfenvalerate, famoxadone,
fenitrothion,
lambda-cyhalothrin, mepa-
nipyrim, metalaxyl-M, methidation, methoxyfenozide,
pymetrozine, pyraclostrobin,
thio-
phanate-methyl. 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 Community, taking account of guidelines
published by the World Health Organisation. The
opinions of the Scientific Committee on Plants (SCP),
in particular advice and recommendations concerning
the protection of consumers of food products treated
with pesticides (2), have been taken into account. Based
on the dietary intake assessment, the MRLs for those
pesticides should be fixed so as to ensure that
the
In the case of the other
ARfD will not be exceeded.
substances, an assessment of the available information
has shown that no ARfD is required and that therefore
a short term assessment is not needed.

for

famoxadone,

provisional MRLs

acetamiprid,
establishing
fenamiphos,
acibenzolar-S-methyl,
indoxacarb, mepanipyrim, methoxyfenozide,
glyphosate,
pymetrozine, pyraclostrobin,
thiacloprid and trifloxy-
strobin in accordance with Article 4(1)(f) of Directive
91/414/EEC and Annex VI
is
considered that a period of four years is sufficient to
permit further uses of these substances. The provisional
Community MRLs should then become definitive.

to that Directive.

It

(8)

(9)

It
in
is therefore necessary to modify the MRLs set
Directives 86/362/EEC, 86/363/EEC and 90/642/EEC,
to allow proper surveillance and control of the uses of
the plant protection products concerned and to protect
the consumer. Where MRLs have already been defined in
the Annexes to those Directives,
is appropriate to
amend them. Where MRLs have not yet been defined,
it is appropriate to set them for the first time.

it

Through the World Trade Organisation, the Community’s
trading partners have been consulted where necessary
and their comments on these levels have been taken
into account.

(10) Directives 86/362/EEC, 86/363/EEC and 90/642/EEC

should therefore be amended accordingly.

(11)

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

in this Directive are in
Standing
the

opinion

the

of

(6) Where authorised uses of plant protection products do
not result in detectable levels of pesticide residues 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, MRLs should
be fixed at the lower limit of analytical determination.

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 86/362/EEC is amended in accordance with Annex I
to this Directive.

(7)

The setting or modification at Community level of provi-
sional MRLs does not prevent the Member States from

Article 2

(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).

Directive 86/363/EEC is amended in accordance with Annex II
to this Directive.

(2) Opinion regarding questions relating to amending the Annexes to
Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC
(Opinion expressed by the SCP on 14 July 1998); Opinion
regarding variable pesticide
and vegetables
(Opinion expressed by the SCP on 14 July 1998) http://europa.
eu.int/comm/food/fs/sc/scp/outcome_ppp_en.html

in fruit

residues

Article 3

Directive 90/642/EEC is amended in accordance with Annex III
to this Directive.

23.2.2008

EN

Official Journal of the European Union

L 50/19

Article 4

Article 5

Member States shall adopt and publish, by 14 September 2008
at the latest, 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.

This Directive shall enter into force on the 20th day following
the European
that of
Union.

its publication in the Official

Journal of

Article 6

This Directive is addressed to the Member States.

They shall apply those provisions from 15 September 2008.

Done at Brussels, 19 February 2008.

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.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 50/20

EN

Official Journal of the European Union

23.2.2008

ANNEX I

In Part A of Annex II to Directive 86/362/EEC, the lines for fenitrothion are added and the lines for cypermethrin,
famoxadone, mepanipyrim, methidathion and thiacloprid are replaced by the following:

Pesticide residues

Maximum levels in mg/kg

including other mixtures of constituents,

‘Cypermethrin:
sum of isomers

Famoxadone

Fenitrothion

2 wheat, barley, oats, rye, triticale
0,01 (*) others

0,2 oats
0,02 (*) others

0,5 (t) wheat, barley, rye, triticale
0,05 (*) others

Mepanipyrim and its metabolite (2-anilino-4-(2-hydroxy-
propyl)-6-methylpyrimidine) expressed as mepanipyrim

0,01 (*) (p)
cereals

Methidathion

Thiacloprid

0,1 maize, 0,2 sorghum, 0,02 (*) others

0,1 wheat, 1 barley, oats, 0,05 (p) others

(t) Temporary MRL until 1 June 2009. Should this MRL not be replaced by a Directive or a Regulation before that date the appropriate

LOD will apply.’

In Part B of Annex II to Directive 86/363/EEC, the line for glyphosate is replaced by the following:

ANNEX II

Pesticide residues

‘Glyphosate

of meat, including fat, preparations
of meat, offal and animal fats listed
in Annex I under headings Nos
ex 0201, 0202, 0203, 0204,
0205 00 00, 0206, 0207, ex 0208,
0209 00, 0210, 1601 00 and 1602

2 (p) kidney of cattle
0,2 (p) liver of cattle
0,5 (p) kidney of pigs
0,1 (p) kidney of poultry
0,05 (*) (p) others

Maximum levels in mg/kg (ppm)

for milk and milk products listed in
Annex I under headings Nos 0401,
0402, 0405 00 and 0406

of shelled fresh eggs, for bird's eggs
and egg yolks listed in Annex I
under headings Nos 0407 00 and
0408

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.’

23.2.2008

EN

Official Journal of the European Union

L 50/21

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EN

Official Journal of the European Union

23.2.2008

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L 50/50

EN

Official Journal of the European Union

23.2.2008

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