Commission Directive 1999/73/EC of 19 July 1999 including an active substance (spiroxamine) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)
Date: 1999-07-19
Institutions: European Commission
Subjects: dangerous substance, marketing, pharmaceutical legislation, pharmaceutical product, plant health legislation, plant health product

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EN

Official Journal of the European Communities

5. 8. 1999

COMMISSION DIRECTIVE 1999/73/EC

of 19 July 1999

including an active substance (spiroxamine)

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),
amended by Council Directive
99/1/EC (2), hereafter referred to as the Directive, and in partic-
ular Article 6(1);

last

as

(1) Whereas in accordance with Article 6(2) of Directive
91/414/EEC Germany received on 13 October 1995 an
application from Bayer AG, hereafter referred to as the
applicant, for the inclusion of the active substance spir-
oxamine in Annex I to the Directive;

(2) Whereas in accordance with the provisions of Article
6(3) of
the Directive the Commission confirmed in
Decision 96/522/EC of 29 July 1996 recognising in
principle the completeness of the dossier submitted for
detailed examination in view of the possible inclusion of
spiroxamine
to Council Directive
I
91/414/EEC concerning the placing of plant protection
products on the market (3) that the dossier submitted for
spiroxamine 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;

in Annex

(3) 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;

(4) Whereas for spiroxamine, 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,
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;

for

(5) 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

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 21, 28.1.1999, p. 21.
(3) OJ L 220, 30.8.1996, p. 23.

been finalised on 12 May 1999 in the format of the
Commission review report for spiroxamine; whereas it
may be necessary to update this report to take account
of
technical and scientific developments; whereas in
such case the conditions for the inclusion of spiroxa-
mine in Annex I to Directive 91/414/EEC will also need
to be amended pursuant to Article 6(1) of that Directive;

sediment

to algae,

for opinion; whereas

(6) Whereas the dossier and the information from the
review have also been submitted to the Scientific
Committee on Plants
this
Committee has given its opinion on 18 December
1998 (4); whereas this Committee identified potential
risks
- dwelling organisms and
possibly plants; whereas therefore, where appropriate,
risk mitigation measures must be taken; whereas for
operator exposure, this Committee concluded that with
the use of personal protective equipment (PPE), the esti-
mated operator exposure was acceptable; whereas there-
fore appropriate protective measures will need to be
taken in order to ensure operator safety; whereas these
conclusions are also consistent with the issues high-
lighted in the review carried out within the framework
of the Standing Committee on Plant Health;

(7) Whereas it has appeared from the various examinations
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 neces-
sary to include the active substance concerned in Annex
in order to ensure that in all Member States the
I,
authorisations of plant protection products containing
the active substance concerned can be granted in accord-
ance with the provisions of the said Directive;

(8) 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 spiroxamine 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 spiroxamine
and other active substances included in Annex I;

(4) SCP/Spirox/004-final dated l8 January 1999.

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(9) 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;

(10) 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 of the Directive;

(11) Whereas the measures provided for in this Directive are
the Standing
in accordance with the opinion of
Committee on Plant Health delivered on the 12 May
1999;

HAS ADOPTED THIS DIRECTIVE:

Article 1

Spiroxamine 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, regulations
and administrative provisions necessary to comply with this
Directive, at the latest by 1 January 2000.

However, for plant protection products containing spir-
2.
oxamine together with another active substance which is in
Annex I to Directive 91/414/EEC, the period referred to in
paragraph 1 is extended to the extent that a longer imple-
mentation period is provided for by the provisions laid down
in the Directive concerning the inclusion of the 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 interested 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 accompanied by
such reference at the time of their official publication. The
procedure for such reference shall be laid down by the Member
States.

This Directive shall enter into force on 1 September 1999.

Article 3

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 19 July 1999.

For the Commission

Franz FISCHLER

Member of the Commission

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Official Journal of the European Communities

5. 8. 1999

SPIROXAMINE

1.

Identity

ANNEX

(IUPAC) (8-tert-Butyl-1,4-dioxa-spiro [4.5] decan-2-ylmethyl)-ethyl-propyl-amine

2.

Conditions to be fulfilled:

2.1. The active substance shall have a minimum purity of 940 g/kg technical product (diastereomers A and B

combined).

2.2. Only uses as a fungicide may be authorised.

2.3. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on
spiroxamine, and in particular the Appendices I and II thereof, as finalised in the Standing Committee on Plant
Health on 12 May 1999 shall be taken into account. Furthermore, in this overall assessment Member States:

— must pay particular attention to operator safety and must ensure that the conditions of authorisation

include appropriate protective measures,

and,

— must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of

authorisation include, where appropriate, risk mitigation measures.

3.

Expiry date of the inclusion: 1 September 1999.