Commission Directive 2007/27/EC of 15 May 2007 amending certain Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for etoxazole, indoxacarb, mesosulfuron, 1-methylcyclopropene, MCPA and MCPB, tolylfluanid and triticonazole (Text with EEA relevance)
Date: 2007-05-15
Institutions: European Commission
Subjects: cereals, consumer protection, foodstuffs legislation, fruit, marketing standard, pesticide residue, plant health legislation, vegetable

16.5.2007

EN

Official Journal of the European Union

L 128/31

DIRECTIVES

COMMISSION DIRECTIVE 2007/27/EC

of 15 May 2007

amending certain Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as
regards maximum residue levels for etoxazole, indoxacarb, mesosulfuron, 1-methylcyclopropene,
MCPA and MCPB, tolylfluanid and triticonazole

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

and MCPB by Commission Directive 2005/57/EC (5),
tolylfluanid by Commission Directive 2006/6/EC (6), triti-
conazole by Commission Directive 2006/39/EC (7).

Having regard to the Treaty
Community,

establishing the European

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,

(2)

(3)

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 (3), 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 (4), and in particular Article 4(1)(f) thereof,

Whereas:

(1)

The following existing active substances have been
to Directive 91/414/EEC: MCPA
included in Annex I

The following new active substances have been included
in Annex I
to Directive 91/414/EEC: etoxazole by
Commission Directive 2005/34/EC (8), mesosulfuron by
Commission Directive 2003/119/EC (9),
indoxacarb by
Commission Directive 2006/10/EC (10) and 1-methyl-
cyclopropene by Commission Directive 2006/19/EC (11).

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
use. Information relating to that use has been submitted
by certain Member States in accordance with Article
4(1)(f) of that Directive. The information available has
to allow certain
been reviewed and is
maximum residue levels (MRLs) to be fixed.

sufficient

(4) 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.

(5)

Community MRLs and the levels recommended by the
Codex Alimentarius are fixed and evaluated following
similar procedures. There are a number of Codex MRLs
for tolylfluanid and they were taken into account. The
MRLs based on Codex MRLs have been evaluated in the
light of the risks for the consumers. No unacceptable risk
was identified when using the toxicological end points
based on the studies available to the Commission.

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

last amended by

Commission Directive 2007/11/EC (OJ L 63, 1.3.2007, p. 26).

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

last amended by

Commission Directive 2007/11/EC.

(3) OJ L 350, 14.12.1990, p. 71. Directive as last amended by
Commission Directive 2007/12/EC (OJ L 59, 27.2.2007, p. 75).

(4) 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).

(5) OJ L 246, 22.9.2005, p. 14.
(6) OJ L 12, 18.1.2006, p. 21.
(7) OJ L 104, 13.4.2006, p. 30.
(8) OJ L 125, 18.5.2005, p. 5.
(9) OJ L 325, 12.12.2003, p. 41.
(10) OJ L 25, 28.5.2006, p. 24.
(11) OJ L 44, 15.2.2006, p. 15.

L 128/32

EN

Official Journal of the European Union

16.5.2007

Article 2

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

Article 3

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

Article 4

the latest,

1. Member States shall adopt and publish, by 16 November
the laws, regulations and administrative
2007 at
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 17 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 5

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

Article 6

This Directive is addressed to the Member States.

Done at Brussels, 15 May 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

(6)

(7)

(8)

(9)

food products

The Commission review reports which were prepared for
the inclusion in Annex I to Directive 91/414/EEC of the
active substances concerned, fixed the Acceptable Daily
Intake (ADI) and, if necessary, the Acute Reference Dose
(ARfD) for those substances. The exposure of consumers
of
treated with the active substance
concerned has been assessed in accordance with
Community procedures. Account has also been taken
of guidelines published by the World Health Organi-
sation (1) and the opinion of the Scientific Committee
for Plants (2) on the methodology employed.
is
concluded that MRLs proposed will not lead to those
ADIs or ARfD being exceeded.

It

the consumer is adequately
In order to ensure that
protected from exposure to residues
resulting from
unauthorised uses of plant protection products, provi-
sional MRLs should be set for the relevant product/pest-
icide combinations at the lower limit of analytical deter-
mination.

for

The setting at Community level of such provisional MRLs
does not prevent the Member States from establishing
provisional MRLs
concerned 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 to permit further uses of
the active substance concerned. The provisional MRL
should then become definitive.

substances

the

It is therefore necessary to modify the MRLs set out in
the Annexes to Directives 86/362/EEC, 86/363/EEC and
90/642/EEC, to allow for proper surveillance and control
of
the
consumer.

their uses and to protect

the prohibition of

(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

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

(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/index_en.html).

16.5.2007

EN

Official Journal of the European Union

L 128/33

In Part A of Annex II to Directive 86/362/EEC, the following lines are added:

ANNEX I

‘Pesticide residues

Etoxazole

Indoxacarb as sum of the isomers S and R

MCPA, MCPB including their salts, esters and conjugates expressed as
MCPA

Tolylfluanid (Sum of tolylfluanid and dimethylaminosulfotoluidide
expressed as tolylfluanid)

Mesosulfuron-methyl expresssed as mesosulfuron

Triticonazole

1-methylcyclopropene

Maximum levels in mg/kg

0,02 (*) (p)
cereals

0,02 (*) (p)
cereals

0,05 (*) (p)
cereals

0,05 (*) (p)
cereals

0,01 (*) (p)
cereals

0,01 (*) (p)
cereals

0,01 (*) (p)
cereals

Indicates lower limit of analytical determination.

(*)
(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 5 June 2011.’

L 128/34

EN

Official Journal of the European Union

16.5.2007

In Part A of Annex II to Directive 86/363/EEC, the following lines are added:

ANNEX II

Pesticide residues

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

Maximum levels in mg/kg

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

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

‘Indoxacarb as sum of the
isomers S and R

meat and edible offals:
0,01 (*) (p); fat: 0,3 (p)

milk: 0,02 (p); cream of
milk 0,3 (p)

0,01 (*) (p)

MCPA, MCPB and MCPA
thioethyl expressed as MCPA

0,1 (*) (p); edible offals:
0,5 (*) (p)

0,05 (*) (p)

0,05 (*) (p)

Tolylfluanid (tolylfluanid
analysed as dimethylamino-
sulfotoluidide and expressed
as tolylfluanid)

0,1 (*) (p)

0,02 (*) (p)

0,1 (*) (p)

Indicates lower limit of analytical determination.

(*)
(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 5 June 2011.’

16.5.2007

EN

Official Journal of the European Union

L 128/35

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Official Journal of the European Union

16.5.2007

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