Commission Directive 98/47/EC of 25 June 1998 including an active substance (azoxystrobin) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)
Date: 1998-06-25
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health product

L 191/50

EN

Official Journal of the European Communities

7. 7. 98

COMMISSION DIRECTIVE 98/47/EC

of 25 June 1998

including an active substance (azoxystrobin) in Annex I to 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,

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 Commis-
sion Directive 97/73/EC (2), hereafter referred to as ‘the
Directive', and in particular Article 6(3) thereof,

Whereas in accordance with Article 6(2) of Directive 91/
414/EEC, Germany received on 15 September 1995 an
application from Zeneca Agrochemicals, hereafter
referred to as ‘the applicant', for the inclusion of the
active substance azoxystrobin in Annex I to the Directive;

Whereas in accordance with the provisions of Article 6(3)
the Directive the Commission confirmed in its
of
Decision 96/523/EC (3)
the dossier submitted for
azoxystrobin could be considered as satisfying, in prin-
ciple, the data and information requirements of Annex II
and for a plant protection product containing this active
substance, of Annex III to the Directive;

that

Whereas, in accordance with Article 5(1) of the Directive,
an active substance should be included for a period not
exceeding 10 years in Annex I when it may be expected
that there will not be any harmful effects on human or
animal health or on groundwater or any unacceptable
influence on the environment;

Whereas for azoxystrobin, the effects on human health
and the environment have been assessed, in accordance
with the provisions of Article 6(2) and (4) of the Directive,
for the uses proposed by the applicant; whereas Germany
acting as nominated rapporteur Member State, has
submitted to the Commission on 5 February 1997 the
assessment report concerned;

Whereas the submitted report has been reviewed by the
Member States and the Commission within the Standing
Committee on Plant Health; whereas this review has been
finalised on 22 April 1998 in the format of the Commis-
sion review report for azoxystrobin; whereas it may be
necessary to update this report to take account of tech-
nical and scientific developments; whereas in such case

the conditions for the inclusion of azoxystrobin in Annex
I to Directive 91/414/EEC will also need to be amended
pursuant to Article 6(1) of that Directive;

Whereas the dossier and the information from the review
have also been submitted to the Scientific Committee for
Plants for consultation;

Whereas it has appeared from the assessments made that
plant protection products containing the active substance
concerned may be expected to satisfy in general
the
requirements laid down in Article 5(1)(a), (b) and (3) of the
Directive, in particular with regard to the uses which were
examined; whereas therefore it is necessary to include the
active substance concerned in Annex I, in order to ensure
that
in all Member States the authorisations of plant
protection products containing the active substance
concerned can be granted in accordance with the provi-
sions of the Directive;

Whereas after inclusion a reasonable period is necessary
to permit Member States to implement the provisions of
Directive 91/414/EEC on plant protection products
containing azoxystrobin and in particular
to review,
within this period, existing provisional authorisations or
to grant, by the end of this period at the latest, new
authorisations in accordance with the provisions of the
Directive; whereas a longer period may also be required
for plant protection products containing azoxystrobin and
other active substances included in Annex I;

Whereas it is appropriate to provide that the finalised
review report (except for confidential information in the
meaning of Article 14 of the Directive) is kept available or
made available by the Member States for consultation by
any interested parties;

Whereas the review report is required for the proper
implementation by the Member States, of several sections
of the uniform principles laid down in Annex VI to the
Directive, where these principles refer to the evaluation of
the Annex II data which were submitted for the purpose
of the inclusion of the active substance in Annex I to the
Directive;

(1) OJ L 230, 19. 8. 1991, p. 1.
(2) OJ L 353, 24. 12. 1997, p. 26.
(3) OJ L 220, 30. 8. 1996, p. 25.

Whereas the measures provided for in this Directive are
in accordance with the opinion of
the Standing
Committee on Plant Health,

7. 7. 98

EN

Official Journal of the European Communities

L 191/51

HAS ADOPTED THIS DIRECTIVE:

Article 1

Azoxystrobin is hereby designated as an active substance
in Annex I to Directive 91/414/EEC, as set out in the
Annex hereto.

Article 2

1. Member States shall bring into force the laws, regula-
tions and administrative provisions necessary to comply
with this Directive, at the latest by 1 January 1999.

2. However for plant protection products containing
azoxystrobin together with another active substance
included in Annex I to Directive 91/414/EEC, the period
referred to in paragraph 1 is extended to the extent that a
longer implementation period is provided for by the
provisions laid down in the Directive concerning the
inclusion of this other active substance in Annex I to
Directive 91/414/EEC.

3. Member States shall keep available the review report
(except for confidential information in the meaning of
Article 14 of the Directive) for consultation by any inter-

ested parties or shall make it available to them on specific
request.

4. When Member States adopt the measures, these shall
contain a reference to this Directive or shall be accom-
panied by such reference at the time of their official
publication. The procedure for such reference shall be
laid down by the Member States.

Article 3

This Directive shall enter into force on 1 July 1998.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 25 June 1998.

For the Commission

Franz FISCHLER

Member of the Commission

L 191/52

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Official Journal of the European Communities

7. 7. 98

ANNEX

AZOXYSTROBIN

1.

Identity

(IUPAC) Methyl (E)-2-{2[6-(2-cyanophenoxy) pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate

2.

Particular conditions to be fulfilled:

2.1. The active substance shall have a minimum purity of 930 g/kg (Z isomer maximim 25 g/kg)

2.2. Only uses as fungicide may be authorised.

Particular attention should be given to the impact on aquatic organisms. Authorisation conditions
should include appropriate risk mitigation measures.

2.3. For the implementation of the uniform principles of Annex VI, the conclusions of the review
report on azoxystrobin, and in particular Appendixes I and II thereof, as finalised in the Standing
Committee on Plant Health on 22 April 1998 shall be taken into account.

3.

Expiry date of the inclusion: 1 July 2008.