Commission Directive 2000/67/EC of 23 October 2000 including an active substance (esfenvalerate) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market
Date: 2000-10-23
Institutions: European Commission
Subjects: marketing, pharmaceutical product, plant health product

L 276/38

EN

Official Journal of the European Communities

28.10.2000

COMMISSION DIRECTIVE 2000/67/EC

of 23 October 2000

including an active substance (esfenvalerate)

in Annex I

to Council Directive 91/414/EEC

concerning the placing of plant protection products on the market

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 2000/
10/EC (2), and in particular Article 6(1) and the fourth subpara-
graph of Article 8(2) thereof,

Whereas:

(1)

(2)

(3)

(4)

Commission Regulation (EEC) No 3600/92 (3), as last
amended by Regulation (EC) No 2266/2000 (4),
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

In accordance with Article 5(1) of the Directive, an
active substance should be included in Annex I if it may
be expected that neither the use of, nor residues from,
plant protection products
active
substance will have any harmful effects on human or
animal health or on groundwatr or any unacceptable
influence on the environment.

containing

that

Such an active substance may be included in Annex I for
a period not exceeding 10 years.

For esfenvalerate 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 range of uses proposed by the notifier. Portugal
was designated as rapporteur Member State under Regu-
lation (EC) No 933/94 laying down the active substance
of plant protection products and designating the rappor-
teur Member State for the implementation of Regulation
(EEC) No 3600/92. It submitted the relevant assessment
report to the Commission on 11 October 1996,
in
accordance with Article 7(1)(c) of Regulation (EEC) No
3600/92.

(5)

The assessment report has been reviewed by the Member
States
and the Commission within the Standing
Committee on Plant Health. This review was finalised on

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 57, 2.3.2000, p. 28.
(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.

(6)

(7)

(8)

(9)

13 July 2000 in the format of the Commission review
report for esfenvalerate.

The dossier and the information from the review have
also been submitted to the Scientific Committee for
Plants for consultation. The Scientific Committee for
Plants in its opinion (7) noted that Member States must
apply appropriate risk mitigation measures to protect
the aquatic environment and non-target arthropods.

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. It is appropriate therefore 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 esfenvalerate can
be undertaken in accordance with the provisions of the
Directive.

Article 8(2) of the Directive provides that after inclusion
of an active substance in its Annex I, Member States
shall, within a prescribed period, grant, vary or with-
draw, 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 requirements laid down
in its Article 13.

Before inclusion, a reasonable deadline is necessary to
permit Member States and the interested parties to
prepare themselves to meet 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
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. For plant protection
products
the
complete evaluation on the basis of the uniform princi-
ples can only be carried out when all
the active
substances concerned have been included in Annex I to
the Directive.

containing several

substances,

active

(7) Scientific Committee on Plants SCP/ESFEN/002 final. 6 April 2000.

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Official Journal of the European Communities

L 276/39

(10)

(11)

(except

It is appropriate to provide that the finalised review
report
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.

for confidential

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

(12)

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

Esfenvalerate 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 31 January 2002 and shall imme-
diately inform the Commission thereof. In particular they shall,
in accordance with the provisions of Directive 91/414/EEC,
where necessary, amend or withdraw existing authorisations
for plant protection products containing esfenvalerate 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 esfenvalerate as
the only active substance, to four years from the entry into
force of this Directive,

— for plant protection products containing esfenvalerate
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.

3. Member States shall keep available the review report
(except for confidential
information within 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 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

This Directive shall enter into force on 1 August 2001.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 23 October 2000.

For the Commission

David BYRNE

Member of the Commission

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Official Journal of the European Communities

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ANNEX

Esfenvalerate

1.

Identity:

Common name:
IUPAC name:

esfenvalerate
(S)-α-Cyano-3-phenoxybenzyl-(S)-2-(4-chlorophenyl)-3-methylbutyrate

2.

Particular conditions to be fulfilled:

2.1. The active substance as manufactured shall have a minimum purity of 830 g/kg.

2.2. Only uses as insecticide may be authorised.

2.3. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on esfenvalerate,
and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 13 July
2000 shall be taken into account. In this overall assessment Member States:

must pay particular attention to the potential impact on aquatic organisms and non-target arthropods and must
ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

3.

Expiry date of the inclusion: 31 July 2011.