Commission Directive 2000/10/EC of 1 March 2000 including an active substance (fluroxypyr) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)
Date: 2000-03-01
Institutions: European Commission
Subjects: marketing, plant health product

L 57/28

EN

Official Journal of the European Communities

2. 3. 2000

COMMISSION DIRECTIVE 2000/10/EC

of 1 March 2000

including an active substance (fluroxypyr) 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 Commission Directive 1999/
80/EC (2), and in particular Article 6(1) and the fourth subpara-
graph of Article 8(2) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Commission Regulation (EEC) No 3600/92 (3), as last
amended by Regulation (EC) No 1972/1999 (4), has laid
down the detailed rules for the implementation of the
first stage of the programme of work referred to in
Article 8(2) of Directive 91/414/EEC (hereinafter referred
to as
to that Regulation,
Commission Regulation (EC) No 933/94 (5), as last
amended by Regulation (EC) No 2230/95 (6), laid down
the list of active substances of plant protection products
to be assessed, with a view to their possible inclusion in
Annex I to the Directive.

‘the Directive’). Pursuant

Those active substances should be included in that
Annex 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.

Such inclusion should be made for a period not
exceeding 10 years.

The Directive, at Article 8(2), provides that after inclu-
sion of an active substance in Annex I to the Directive,
Member States shall, within a prescribed period, grant,
vary or withdraw, as appropriate, the authorisations of
the plant protection products containing the active
substance. In particular, Articles 4(1) and 13(1) of the
Directive require that plant protection products are not
authorised unless account is taken of the conditions
associated with the inclusion of the active substance in
Annex I and the uniform principles laid down in Annex
VI on the basis of a dossier satisfying the data require-
ments laid down in Article 13.

For fluroxypyr the effects on human health and the
environment have been assessed in accordance with the
provisions laid down in Regulation (EEC) No 3600/92
for a number of uses proposed by the notifiers.
Germany, acting as designated rapporteur Member State

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 210, 10.8.1999, p. 13.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 244, 16.9.1999, p. 41.
(5) OJ L 107, 28.4.1994, p. 8.
(6) OJ L 225, 22.9.1995, p. 1.

(6)

(7)

(8)

(9)

under Regulation (EC) No 933/94, submitted to the
Commission on 27 September 1996 the relevant assess-
ment report.

The submitted report has been reviewed by the Member
States
and the Commission within the Standing
Committee on Plant Health. This review was finalised on
30 November 1999 in the format of the Commission
review report for fluroxypyr. It may be necessary to
update this report
technical and
scientific developments. In such case the conditions for
the inclusion of fluroxypyr in Annex I to Directive 91/
414/EEC will also need to be amended pursuant to
Article 6(1) of that Directive. The dossier and the infor-
maiton from the review have also been submitted to the
Scientific Committee for Plants for consultation.

to take account of

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) and (b) of the
in particular with regard to the uses which
Directive,
were examined. Therefore it is necessary to include the
active substance concerned in Annex I,
in order to
ensure that, in all Member States, the granting, varying
or withdrawing, as appropriate, of the authorisations of
plant protection products containing fluroxypyr can be
organised in accordance with the provisions of
the
Directive, and to ensure that this activity is not further
delayed.

The Scientific Committee for Plants in its opinion identi-
fied the need to confirm by additional data the environ-
mental safety of certain breakdown products of flurox-
ypyr occurring in soil and water.

Article 5(5) of Directive 91/414/EEC provides that the
inclusion of an active substance in Annex I can be
reviewed at any time if there are indications that the
criteria for inclusion are no longer satisfied. Therefore,
the Commission will reconsider the inclusion in Annex I
if the results of the requested additional trials as outlined
in point 7 of the review report were to indicate potential
adverse effects, or if the requested additional data results
and information were not submitted.

(10)

Before inclusion a reasonable deadline is necessary to
permit Member States and the interested parties to
prepare themselves for the new requirements which will
result from the inclusion. Moreover after inclusion a
reasonable period is necessary for the Member States to
implement the Directive and in particular to vary or

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Official Journal of the European Communities

L 57/29

withdraw, as appropriate, existing authorisations or
grant new authorisations in accordance with the provi-
sions of Directive 91/414/EEC. A longer period should
be provided for the submission and assessment of the
complete Annex III dossier of each plant protection
product in accordance with the uniform principles laid
down in Annex VI to the Directive. However, for plant
protection products containing several active substances,
the complete evaluation on the basis of the uniform
principles can only be carried out when all the active
substances concerned have been included in Annex I to
the Directive.

The periods laid down for
this
Directive do not prejudice the periods which will be
established for the inclusion of other active substances in
Annex I of the Directive.

implementation of

The review report is required for the proper imple-
mentation 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 active substance in
Annex I to the Directive.

the inclusion of

(11)

(12)

where necessary, amend or withdraw existing authorisations
for plant protection products containing fluroxypyr as an
active substance within such period.

2.
However, with regard to evaluation and decision-making
pursuant to the uniform principles provided for in Annex VI to
Directive 91/414/EEC, on the basis of a dossier satisfying the
requirements of Annex III thereto, the period laid down in the
first paragraph is extended:
— for plant protection products containing only fluroxypyr, to
four years from the entry into force of this Directive,

— for plant protection products

fluroxypyr
together with another active substance which is in Annex I
to Directive 91/414/EEC, to four years from the entry into
force of such Directive as shall include the last of those
substances in Annex I.

containing

3. When Member States adopt the provisions referred to in
paragraph 1, 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
adopted by Member States.

Article 3

(13)

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

Member States shall inform the Commission if the requested
additional trials and information as outlined in point 7 of the
review report are not submitted by 1 December 2000.

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

This Directive shall enter into force on 1 December 2000.

Article 4

This Directive is addressed to the Member States.

Article 5

Article 2

Done at Brussels, 1 March 2000.

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive, at the latest by 1 June 2001. In particular they shall,
in accordance with the provisions of Directive 91/414/EEC,

For the Commission

David BYRNE

Member of the Commission

L 57/30

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Official Journal of the European Communities

2. 3. 2000

ANNEX

FLUROXYPYR

1.

Identity:

Common name: fluroxypyr
IUPAC name: 4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid

2.

Particular conditions to be fulfilled:

2.1. Purity of the active substance as manufactured shall have a minimum purity of 950 g/kg.

2.2. Only uses as herbicide may be authorised.

2.3. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fluroxypyr,
and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 30
November 1999 shall be taken into account. In this overall assessment, Member States:

— shall take into account the additional

information requested in point 7 of the review report,

— must pay particular attention to the protection of groundwater,

— 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: 30 November 2010.