Commission Directive 2007/28/EC of 25 May 2007 amending certain Annexes to Council Directives 86/363/EEC and 90/642/EEC as regards maximum residue levels for azoxystrobin, chlorfenapyr, folpet, iprodione, lambda-cyhalothrin, maleic hydrazide, metalaxyl-M and trifloxystrobin (Text with EEA relevance)
Date: 2007-05-25
Institutions: European Commission
Subjects: animal product, consumer protection, crop production, food inspection, foodstuffs legislation, fruit, pesticide residue, plant health legislation, vegetable

L 135/6

EN

Official Journal of the European Union

26.5.2007

DIRECTIVES

COMMISSION DIRECTIVE 2007/28/EC

of 25 May 2007

amending certain Annexes to Council Directives 86/363/EEC and 90/642/EEC as regards maximum
lambda-cyhalothrin, maleic
residue levels

for azoxystrobin, chlorfenapyr,

iprodione,

folpet,

hydrazide, metalaxyl-M and trifloxystrobin

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(2)

Having regard to the Treaty
Community,

establishing the European

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 (1), and in particular Article 10
thereof,

Having regard to Council Directive 90/642/EEC of 27
for
November 1990 on the
pesticide residues in and on certain products of plant origin,
including fruit and vegetables (2), 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 (3), and in particular Article 4(1)(f) thereof,

Whereas:

(1)

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 author-
isations have to be based on the evaluation of effects
on human and animal health and influence on the en-
vironment. Elements to be taken into account in such
evaluations include operator and bystander exposure and
impact on the
en-
vironments, as well as impact on humans and animals
through consumption of residues on treated crops.

and aerial

terrestrial,

aquatic

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

last amended by

Commission Directive 2007/27/EC (OJ L 128, 16.5.2007, p. 31).
(2) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Directive

2007/27/EC.

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

last amended by

Commission Directive 2007/25/EC (OJ L 106, 24.4.2007, p. 34).

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 covered by Directives 86/363/EEC
and 90/642/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 in the residue levels of azoxystrobin, chlor-
fenapyr,
lambda-cyhalothrin, maleic
iprodione,
hydrazide, metalaxyl-M and trifloxystrobin.

folpet,

The lifetime exposure of consumers to those pesticides
via food products that may contain residues of those
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 (4). Based on those
those
assessments
pesticides
the
should be set
acceptable daily intake is not exceeded.

and evaluations,

to ensure that

the MRLs

so as

for

folpet

case of

chlorfenapyr,

that may contain residues of

and lambda-
In the
cyhalothrin for which an acute reference dose (ARfD)
exists, the acute exposure of consumers via each of the
food products
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
protection
and

recommendations

concerning

the

(3)

(4)

(5)

(4) 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).

26.5.2007

EN

Official Journal of the European Union

L 135/7

of consumers of food products treated with pesticides (1),
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 ARfD will not be exceeded. In
the case of the other substances, an assessment of the
available information has
shown that no ARfD is
required and that therefore a short-term assessment is
not needed.

(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.

(7)

(8)

The setting or modification at Community level of pro-
visional MRLs does not prevent the Member States from
establishing provisional MRLs for maleic hydrazide and
trifloxystrobin in accordance with Article 4(1)(f) of
Directive 91/414/EEC and Annex VI to that Directive.
It is considered that a period of four years is sufficient
these substances. The pro-
to permit
visional Community MRLs should then become defi-
nitive.

further uses of

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

Article 2

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

Article 3

the latest,

1. Member States shall adopt and publish, by 26 November
2007 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.

They shall apply those provisions from 27 November 2007.

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 4

This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

Article 5

This Directive is addressed to the Member States.

(9)

Directives 86/363/EEC and 90/642/EEC should therefore
be amended accordingly.

Done at Brussels, 25 May 2007.

(10)

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

in this Directive are in
Standing
the

opinion

the

of

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) 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
in fruit
(Opinion expressed by the SCP on 14 July 1998);
http://europa.eu.int/comm/food/fs/sc/scp/outcome_ppp_en.html

residues

L 135/8

EN

Official Journal of the European Union

26.5.2007

In Part B of Annex II to Directive 86/363/EEC, the following line is added:

ANNEX I

Maximum levels in mg/kg

Pesticide residues

‘Maleic hydrazide (a)

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

meat (except poultry) 0,05 (p)
liver (except poultry) 0,05 (p)
kidney (except poultry) 0,5 (p)
others 0,02 (*) (p)

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

of shelled fresh eggs, for
birds’ eggs and egg yolks
listed in Annex I under
heading Nos 0407 and
0408

0,2 (p) (t)

0,1 (p)

Indicates lower limit of analytical determination.

(*)
(a) Residue definition for milk and milk products is: maleic hydrazide and its conjugates expressed as maleic hydrazide.
(p) Indicates that the maximum residue level has been established provisionally in accordance with Article 4(1)(f) of Directive 91/414/EEC.
Indicates that the maximum residue level has been established temporarily until 30 June 2008 pending data to be submitted by the
(t)
applicant. If no data has been received by that date, the MRL will be withdrawn by a Directive or a Regulation.’

26.5.2007

EN

Official Journal of the European Union

L 135/9

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Official Journal of the European Union

26.5.2007

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