Commission Regulation (EC) No 416/2008 of 8 May 2008 amending Regulation (EEC) No 3600/92 as regards the assessment of the active substance metalaxyl in the framework of Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market Text with EEA relevance
Date: 2008-05-08
Institutions: European Commission
Subjects: market approval, marketing, marketing standard, pesticide, pharmaceutical product, plant health product, toxic substance

9.5.2008

EN

Official Journal of the European Union

L 125/25

COMMISSION REGULATION (EC) No 416/2008

of 8 May 2008

amending Regulation (EEC) No 3600/92 as regards the assessment of the active substance metalaxyl
in the framework of Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant
protection products on the market

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection on the market (1),
and in particular the third subparagraph of Article 8(2) thereof,

Whereas:

(1)

(2)

(3)

Metalaxyl is one of the active substances listed in Annex I
to Commission Regulation (EEC) No 3600/92 of
11 December 1992 laying down the detailed rules for
the implementation of the first stage of the programme
of work referred to in Article 8(2) of Council Directive
91/414/EEC concerning the placing of plant protection
products on the market (2).

the

concerning

non-inclusion

As a consequence of the judgment of the Court of Justice
of the European Communities of 18 July 2007 in Case
C-326/05 P (3), which annulled Commission Decision
2003/308/EC (4)
of
metalaxyl in Annex I to Council Directive 91/414/EEC,
the Commission adopted Regulation (EC) No 1313/2007
of 8 November 2007 amending Regulations (EC) No
2076/2002 as regards the extension of the time period
referred to in Article 8(2) of Council Directive
to metalaxyl and (EC) No
91/414/EEC with respect
2024/2006 as regards the deletion of
the derogation
concerning metalaxyl (5).

Article 233 of the Treaty requires the institution whose
act has been declared void to take the necessary measures
to comply with the judgment of the Court of Justice.
Further measures are thus necessary as regards Regulation
(EEC) No 3600/92 in particular with regard to the time
limits for the submission of results of additional trials
and additional information.

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

last amended by

Commission Directive 2008/45/EC (OJ L 94, 5.4.2008, p. 21).
(2) OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regu-

lation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27).

(3) European Court Reports 2007, I-6557.
(4) OJ L 113, 7.5.2003, p. 8.
(5) OJ L 291, 9.11.2007, p. 11.

(5)

(6)

(7)

the

factual

judgment

situation of

Those further measures should be viewed against the
unique
in case
C-326/05 P. IQV had never lodged a complete dossier
and wished instead to invoke studies lodged by another
notifier. IQV claimed that it should only be required to
add any further material not found in the latter’s dossier,
which incidentally also contained gaps. IQV was however
refused access to the dossier by the other notifier, who
had withdrawn in the meantime. Throughout
the
IQV bore
the Commission insisted that
proceedings,
the burden of proof of demonstrating that metalaxyl
met the criteria for inclusion in Annex I to Directive
91/414/EEC. This position was not contested by the
Court. Since IQV did not have access to the other
notifier’s dossier, the Commission took the view that
the peer review could not be carried out successfully,
since the peer review would raise questions about the
studies contained in the other dossier.
IQV, having
been refused access to the dossier, would not be able
to answer such questions. The rapporteur Member State
submitted the Draft Assessment Report for the substance
on 26 January 2001 on the basis of all
the studies
available at that time. However, during the evaluation,
the data gaps that had been identified were of such
nature that an inclusion of the substance in Annex I of
Directive 91/414/EEC could not be envisaged.

During contacts with IQV on 17 September and
14 November 2007, the Commission informed IQV of
its intention to complete the evaluation of the substance.

that

submitted

information on metalaxyl

to the
The
to date is incomplete and does not
Commission till
allow an inclusion of metalaxyl in Annex I to Directive
91/414/EEC. The Commission is not in a position to
guarantee
that will be
provided by IQV for the evaluation under Regulation
(EEC) No 3600/92 will be sufficient to fill the gaps ident-
that
ified and,
sufficient
metalaxyl may be expected to satisfy,
the
requirements laid down in Article 5(1)(a) and (b) of
Directive 91/414/EEC.

to demonstrate

in general,

and data

thus, be

studies

the

take

The Commission and Member States will
a
pragmatic approach to rely as much as legally possible
on the already existing data. It is common that during
the peer review questions are brought forward. These
questions could be raised on all elements of
the
is IQV’s sole responsibility to address
dossier, and it
them should this situation occur.

L 125/26

EN

Official Journal of the European Union

9.5.2008

(8)

(9)

(10)

(11)

To complete the assessment of metalaxyl by the date laid
down in Regulation (EC) No 2076/2002, it is essential
that strict deadlines are applied in the different steps of
the procedure. Therefore, it can not be assumed that any
gaps identified later in the dossier can be remedied by
providing further
this would delay the
assessment.

studies

as

To allow metalaxyl to be examined, certain time periods
provided for in Regulation (EEC) No 3600/92 should be
adapted.

Regulation (EEC) No 3600/92 should therefore be
amended accordingly.

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

as regards metalaxyl the time limit will be at the latest
31 October 2008, unless an earlier time limit is estab-
lished by the Commission for a particular
active
substance except for the results of
long-term studies,
identified as being necessary by the rapporteur Member
State and the Commission during the examination of the
dossier and which are not expected to be fully completed
by the deadline established, provided that
the infor-
mation submitted contains evidence that such studies
have been commissioned and that their results will be
submitted at the latest on 25 May 2003. In exceptional
cases, where it has not been possible for the rapporteur
Member State and the Commission to identify such
studies by 25 May 2001, an alternative date may be
studies,
established
provided the notifier supplies the rapporteur Member
State with evidence that such studies have been com-
to
missioned within three months of
and
undertake
progress report of the study by 25 May 2002.

and with a protocol

completion of

the request

studies,

such

the

the

for

HAS ADOPTED THIS REGULATION:

Article 1

In the first subparagraph of Article 7(4) of Regulation (EEC) No
3600/92 the first and the second indents are replaced by the
following:

‘— the time limit within which the results or information
concerned must be submitted to the rapporteur Member
State and the experts designated according to paragraph
2 above, this time limit will be 25 May 2002, however,

— the time limit within which the notifiers concerned must
communicate to the rapporteur Member State and to the
Commission their undertaking to submit the required
results or information within the time limit laid down
in the first indent. However, as regards metalaxyl that
time limit shall be one month after the entering into
force of this Regulation.’

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 8 May 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission