Commission Directive 2003/5/EC of 10 January 2003 amending Council Directive 91/414/EEC to include deltamethrin as active substance (Text with EEA relevance)
Date: 2003-01-10
Institutions: European Commission
Subjects: exchange of information, insecticide, marketing, marketing standard, plant health product

14.1.2003

EN

Official Journal of the European Communities

L 8/7

COMMISSION DIRECTIVE 2003/5/EC

of 10 January 2003

amending Council Directive 91/414/EEC to include deltamethrin as active substance

(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 2002/
81/EC (2), and in particular Article 6(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

Commission Regulation (EEC) No 3600/92 of 11
December 1992 laying down the detailed rules for the
implementation of the first stage of the programme of
work referred to in Article 8(2) of Council Directive 91/
414/EEC concerning the placing of plant protection
products on the market (3), as last amended by Regula-
tion (EC) No 2266/2000 (4), establishes a list of active
substances of plant protection products to be assessed,
with a view to their possible inclusion in Annex I to
Directive 91/414/EEC. That list is contained in Commis-
sion Regulation (EC) No 933/94 of 27 April 1994 laying
down the active substances of plant protection products
and designating the rapporteur Member State for the
implementation of Regulation (EEC) No 3600/92 (5), as
last amended by Regulation (EC) No 2230/95 (6), and
includes deltamethrin.

For deltamethrin 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 notifiers. By Regula-
tion (EC) No 933/94 Sweden was designated as rappor-
teur Member State. Sweden submitted the relevant
assessment
to the
Commission on 6 October 1998 in accordance with
Article 7(1)(c) of Regulation (EEC) No 3600/92.

recommendations

reports

and

This assessment
report has been reviewed by the
Member States and the Commission within the Standing
Committee on the Food Chain and Animal Health. The
review was finalised on 18 October 2002 in the format
of the Commission review report for deltamethrin.

The review did not
reveal any open questions or
concerns, which would have required a consultation of
the Scientific Committee on Plants.

It has appeared from the various examinations made that
plant protection products containing deltamethrin may
be expected to satisfy, in general, the requirements laid

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 276, 12.10.2002, 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)

down in Article 5(1)(a) and (b) and Article 5(3) of Direc-
tive 91/414/EEC, in particular with regard to the uses
which were examined and detailed in the Commission
review report. It is therefore appropriate to include delta-
methrin in Annex I,
in all
Member States the authorisations of plant protection
products containing this active substance can be granted
in accordance with the provisions of that Directive.

in order to ensure that

The Commission review report is required for the proper
several
implementation by the Member States, of
sections of the uniform principles laid down in Directive
91/414/EEC. It is, therefore, appropriate to provide that
the finalised review report, except for confidential infor-
mation, should be kept available or made available by
the Member States for consultation by any interested
parties.

A reasonable period should be allowed to elapse before
an active substance is included in Annex I in order to
permit Member States and the interested parties to
prepare themselves to meet the new requirements which
will result from the inclusion.

After inclusion, Member States should be allowed a
reasonable period within which to implement the provi-
sions of Directive 91/414/EEC as regards plant protec-
tion products containing deltamethrin, and in particular,
to review existing authorisations to ensure that
the
conditions regarding deltamethrin set out in Annex I to
Directive 91/414/EEC are satisfied. A longer period
should be provided for the submission and assessment
of the complete dossier of each plant protection product
in accordance with the uniform principles laid down in
Directive 91/414/EEC.

(9)

It is therefore appropriate to amend Directive 91/414/
EEC accordingly.

(10)

The measures provided for in this Directive are in accor-
dance with the opinion of the Standing Committee on
the Food Chain and Animal Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 91/414/EEC is amended as set out in the
Annex to this Directive.

L 8/8

EN

Official Journal of the European Communities

14.1.2003

Article 2

except

Member States shall keep available the review report for delta-
methrin,
information within the
meaning of Article 14 of Directive 91/414/EEC, for consulta-
tion by any interested parties or shall make it available to them
on specific request.

confidential

for

Article 3

Member States shall adopt and publish by 30 April 2004 at the
latest the laws, regulations and administrative provisions neces-
sary to comply with this Directive. They shall forthwith inform
the Commission thereof.

They shall apply those provisions from 1 May 2004.

When Member States adopt this provision, they shall contain a
reference to this Directive or shall be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

Article 4

1. Member States shall review the authorisation for each
plant protection product containing deltamethrin to ensure that
the conditions relating to deltamethrin set out in Annex I to
Directive 91/414/EEC are complied with. Where necessary and
by 30 April 2004 at the latest, they shall amend or withdraw
the authorisation.

2. Member States shall, for each authorised plant protection
product containing deltamethrin as either
the only active
substance or as one of several active substances all of which
were listed in Annex I to Directive 91/414/EEC by 31 October
2003 at the latest, re-evaluate the product in accordance with
the uniform principles provided for in Annex VI to Directive
91/414/EEC, on the basis of a dossier satisfying the require-
ments of Annex III to that Directive. On the basis of that
evaluation, they shall determine whether the product satisfies
the conditions set out in Article 4(1)(b), (c), (d) and (e) of Direc-
tive 91/414/EEC. Where necessary and by 31 October 2007 at
the latest, they shall amend or withdraw the authorisation.

This Directive shall enter into force on 1 November 2003.

Article 5

This Directive is addressed to the Member States.

Article 6

Done at Brussels, 10 January 2003.

For the Commission

David BYRNE

Member of the Commission

The following entries shall be added at the end of the table in Annex I to Directive 91/414/EC:

ANNEX

No

Common name,
identification numbers

‘40

Deltamethrin

CAS No 52918-63-5

CIPAC No 333

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

(S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromo-
vinyl)-2,2-dimethylcyclopropane carboxylate

980 g/kg

1 November 2003

31 October 2013

Only uses as insecticide may be authorised

For the implementation of the uniform princi-
ples of Annex VI, the conclusions of the review
report on deltamethrin,
and in particular
Appendices I and II thereof, as finalised in the
Standing Committee on Plant Health on 18
October 2002 shall be taken into account. In
this overall assessment Member States:

— must pay particular attention to the oper-
ator safety and must ensure that the condi-
tions of authorisation include appropriate
protective measures,

— should observe the acute dietary exposure
situation of consumers in view of future
revisions of maximum residue levels,

— must pay particular attention to the protec-
tion of aquatic organisms, bees and non-
target arthropods and must ensure that the
conditions of authorisation include risk
mitigation measures, where appropriate.

(1) Further details on identity and specification of active substance are provided in the review report.’

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