2003/308/EC: Commission Decision of 2 May 2003 concerning the non-inclusion of metalaxyl in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant-protection products containing this active substance (Text with EEA relevance) (notified under document number C(2003) 1421)
Date: 2003-05-02
Institutions: European Commission
Subjects: dangerous substance, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

L 113/8

EN

Official Journal of the European Union

7.5.2003

COMMISSION DECISION

of 2 May 2003

concerning the non-inclusion of metalaxyl in Annex I to Council Directive 91/414/EEC and the
withdrawal of authorisations for plant-protection products containing this active substance

(notified under document number C(2003) 1421)

(Text with EEA relevance)

(2003/308/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant-protection products on
the market (1), as last amended by Commission Directive 2003/
23/EC (2), and in particular the fourth subparagraph of Article
8(2) thereof,

Having regard 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 (3), as last amended by Regulation (EC) No 2266/
2000 (4), and in particular Article 7(3A)(b) thereof,

Whereas:

(1)

(2)

Article 8(2) of Directive 91/414/EEC provided for the
Commission to carry out a programme of work for the
examination of
the active substances used in plant-
protection products which were already on the market
on 25 July 1993. Detailed rules for the carrying out of
this programme were established in Regulation (EEC) No
3600/92.

Commission Regulation (EC) No 933/94 of 27 April
1994 laying down the active substances of plant-protec-
tion products and designating the rapporteur Member
States for the implementation of Regulation (EEC) No
3600/92 (5), as last amended by Regulation (EC) No
2230/95 (6), designated the active substances which
should be assessed in the framework of Regulation (EEC)
No 3600/92, designated a Member State to act as
rapporteur
each
substance and identified the producers of each active
substance who submitted a notification in due time.

in respect of

assessment of

the

(3)

Metalaxyl is one of the 89 active substances designated
in Regulation (EC) No 933/94.

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 81, 28.3.2003, p. 39.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 259, 13.10.2000, p. 27.
(5) OJ L 107, 28.4.1994, p. 8.
(6) OJ L 225, 22.9.1995, p. 1.

(4)

(5)

(6)

(7)

(8)

(9)

The main notifier (Novartis, now Syngenta) informed the
Commission and the rapporteur Member State that it no
longer wished to participate in the programme of work
for
therefore, would not
submit further information.

this active substance and,

Nonetheless, in accordance with Article 7(1)(c) of Regu-
lation 3600/92, Portugal, being the designated rappor-
teur Member State, submitted on 26 January 2001 to
the Commission the report of its assessment of the infor-
mation submitted by the notifiers in accordance with
Article 6(1) of that Regulation.

On receipt of the report of the rapporteur Member State,
the Commission undertook consultations with the
Member States
the Standing
in the framework of
Committee on the Food Chain and Animal Health as
well as with the remaining notifier (Industrias Químicas
del Vallés sa (IQV)) as provided for in Article 7(3) of
Regulation (EEC) No 3600/92.

The remaining notifier did not submit a full dossier in
relation to metalaxyl within the time limit referred to in
Article 6(1) of Regulation 3600/92. Thus continued
evaluation of metalaxyl could only proceed on the basis
of the dossier submitted by Syngenta. However, since
IQV did not have access to that dossier, it was neither in
a position to submit information in relation to matters
arising from evaluation of it nor to complete its own
dossier within a reasonable period. Therefore it is not
possible to organise an efficient peer review of meta-
laxyl. For that reason it is not possible to conclude on
the basis of the data submitted for metalaxyl, that it may
be expected that, under the proposed conditions of use,
plant-protection products containing metalaxyl satisfy in
general the requirements laid down in Article 5(1)(a) and
(b) of Directive 91/414/EEC.

Metalaxyl should therefore not be included in Annex I to
Directive 91/414/EEC.

The review was finalised on 18 October 2002 in the
format of the Commission review report for metalaxyl,
in accordance with Article 7(6) of Regulation (EEC) No
3600/92.

7.5.2003

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Official Journal of the European Union

L 113/9

(10) Measures should be taken to ensure that existing author-
isations for plant-protection products containing meta-
laxyl are withdrawn within a prescribed period and will
not be renewed and that no new authorisations for such
products are granted.

(11) Any period of grace for disposal, storage, placing on the
market and use of existing stocks of plant-protection
products containing metalaxyl allowed by Member State,
in accordance with Article 4(6) of Directive 91/414/EEC
should be limited to a period no longer than 12 months
to allow existing stocks to be used in no more than one
further growing season.

(12)

This Decision does not prejudice
any action the
Commission may undertake at a later stage for this
active substance within the framework of Council Direc-
tive 79/117/EEC of 21 December 1978 prohibiting the
placing on the market and use of plant-protection
products containing certain active substances (1), as last
amended by the Act of Accession of Austria, Finland
and Sweden.

(13)

The measures provided for in this Decision are in accor-
dance with the opinion of the Standing Committee on
the Food Chain and Animal Health,

Article 2

Member States shall ensure that:

(a) authorisations

for plant-protection products containing
metalaxyl are withdrawn within a period of six months
from the date of adoption of the present Decision;

(b) from the date of adoption of the present Decision, no
authorisations
for plant-protection products containing
metalaxyl are granted or renewed under the derogation
provided for in Article 8(2) of Directive 91/414/EEC.

Article 3

Any period of grace granted by Member States in accordance
with the provisions of Article 4(6) of Directive 91/414/EEC,
shall be as short as possible and not longer than 18 months
from the date of adoption of the present Decision.

Article 4

This Decision is addressed to the Member States.

HAS ADOPTED THIS DECISION:

Done at Brussels, 2 May 2003.

Article 1

Metalaxyl
Directive 91/414/EEC.

is not included as active substance in Annex I to

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 33, 8.2.1979, p. 36.