Commission Directive 1999/80/EC of 28 July 1999 including an active substance (azimsulfuron) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)
Date: 1999-07-28
Institutions: European Commission
Subjects: dangerous substance, marketing, pharmaceutical product, plant health product

10. 8. 1999

EN

Official Journal of the European Communities

L 210/13

COMMISSION DIRECTIVE 1999/80/EC

of 28 July 1999

including an active substance (azimsulfuron)

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,

furon in Annex I to Directive 91/414/EEC will also need
to be amended pursuant to Article 6(1) of that Directive;

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 1999/
1/EC (2), hereafter referred to as the Directive, and in particular
Article 6(1),

(1) Whereas in accordance with Article 6(2) of Directive
91/414/EEC Italy received on 4 March 1996 an applica-
tion from Du Pont de Nemours Italiana SpA, hereafter
referred to as the applicant, for the inclusion of the
active substance azimsulfuron in Annex I
to the
Directive;

(2) Whereas in accordance with the provisions of Article
6(3) of the Directive the Commission confirmed in its
Decision 97/164/EC (3) of 17 February 1997 that the
dossier submitted for azimsulfuron could be considered
as satisfying,
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 principle,

(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 azimsulfuron, 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 Italy acting as nominated rapporteur Member
State, has submitted to the Commission on 22 May
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
been finalised on 2 July 1999 in the format of the
Commission review report for azimsulfuron; whereas it
may be necessary to update this report to take account
technical and scientific developments; whereas in
of
such case the conditions for the inclusion of azimsul-

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 21, 28.1.1999, p. 21.
(3) OJ L 64, 5.3.1997, p. 17.

(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 4 February 1999;
whereas this Committee identified potential risks to
aquatic organisms and terrestrial non-target plants,
whereas therefore appropriate risk mitigation measures
must be taken (4);

for opinion; whereas

(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
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 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 azimsulfuron 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 azimsulfuron
and other active substances included in Annex I;

(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
several
implementation by the Member States, of
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;

(4) Opinion of the Scientific Committee on Plants regarding the inclu-
sion of azimsulfuron in Annex I to Directive 91/414/EEC concer-
ning the placing of plant protection products on the market (SCP/
AZIM/002-Final 24/02/1999)

L 210/14

EN

Official Journal of the European Communities

10. 8. 1999

(11) Whereas the measures provided for in this Directive are
in accordance with the opinion of
the Standing
Committee on Plant Health delivered on 2 July 1999,

mentation 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.

HAS ADOPTED THIS DIRECTIVE:

Article 1

Azimsulfuron 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 April 2000.

2.
However, with regard to evaluation and decision-making
pursuant to the uniform principles provided for in Annex VI to
Council Directive 91/414/EEC, on the basis of a dossier satis-
fying the requirements of Annex III thereto, the period laid
down in the first paragraph is extended for existing provisional
authorisations of plant protection products containing azimsul-
furon to 1 April 2001.

3.
However for plant protection products containing azim-
sulfuron 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-

4. 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.

5. 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 October 1999.

Article 3

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 28 July 1999.

For the Commission

Franz FISCHLER

Member of the Commission

10. 8. 1999

EN

Official Journal of the European Communities

L 210/15

ANNEX

AZIMSULFURON

1.

Identity

(IUPAC)

1-(4,6-dimethoxypyrimidin-2-yl)-3-[1-methyl-4-(2-methyl-2H-tetrazol-5-yl)-pyrazol-5-ylsulfonyl]-urea

2.

Particular conditions to be fulfilled:

2.1. The active substance shall have a minimum purity of 980 g/kg technical product.

2.2. Only uses as herbicide may be authorised.

2.3. Aerial applications may not be authorised.

2.4. Member States must pay particular attention to the impact on aquatic organisms and terrestrial non-target plants and
must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures (for example,
in rice cultivation minimum holding periods for water prior to discharge).

2.5. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on azimsul-
furon, and in particular the Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 2
July 1999 shall be taken into account.

3.

Expiry date of the inclusion: 1 October 2009.