Commission Directive 2005/58/EC of 21 September 2005 amending Council Directive 91/414/EEC to include bifenazate and milbemectin as active substances   (Text with EEA relevance)
Date: 2005-09-21
Institutions: European Commission
Subjects: market approval, marketing standard, plant health product

22.9.2005

EN

Official Journal of the European Union

L 246/17

COMMISSION DIRECTIVE 2005/58/EC

of 21 September 2005

amending Council Directive 91/414/EEC to include bifenazate and milbemectin as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the
market (1), and in particular Article 6(1) thereof,

(6)

Whereas:

In accordance with Article 6(2) of Directive 91/414/EEC,
the Netherlands received on 3 July 2001 an application
for the inclusion of the
from Crompton Europe Ltd.
active substance bifenazate in Annex I
to Directive
91/414/EEC. Commission Decision 2002/268/EC (2)
confirmed that the dossier was ‘complete’
in the sense
that it could be considered as satisfying, in principle, the
data and information requirements of Annexes II and III
to Directive 91/414/EEC.

The Netherlands received an application under Article
6(2) of Directive 91/414/EEC on 6 March 2000 from
for the inclusion of the active
Sankyo Company Ltd.
to Directive
I
substance milbemectin
91/414/EEC. Commission Decision 2000/540/EC (3)
confirmed that the dossier was ‘complete’
in the sense
that it could be considered as satisfying, in principle, the
data and information requirements of Annexes II and III
to Directive 91/414/EEC.

in Annex

For those active substances, the effects on human health
and the environment have been assessed, in accordance
with the provisions of Article 6(2) and (4) of Directive
91/414/EEC, for the uses proposed by the applicants. The
designated rapporteur Member States submitted draft
assessment
reports concerning the substances to the
Commission on 3 April 2003 (bifenazate) and 16 June
2001 (milbemectin).

(1)

(2)

(3)

(4)

The review of bifenazate and milbemectin did not reveal
any open questions or concerns, which would have
required a consultation of the Scientific Committee on
Plants or of the European Food Safety Authority which
has taken over the role of that Committee.

the

products

protection

containing

It has appeared from the various examinations made that
active
plant
in
substances concerned may be expected to satisfy,
general, the requirements laid down in Article 5(1)(a)
and (b) and Article 5(3) of Directive 91/414/EEC,
in
particular with regard to the uses which were examined
and detailed in the Commission review report.
is
therefore appropriate to include bifenazate and milbe-
mectin in Annex I,
in all
in order
Member States the authorisations of plant protection
products containing these active substances may be
granted in accordance with the provisions of
that
Directive.

to ensure that

It

in particular

six months after

in Annex I, Member States

(7) Without prejudice to the obligations defined by Directive
including an active
91/414/EEC as a consequence of
should be
substance
inclusion to
allowed a period of
authorisations of plant
review existing provisional
protection products containing bifenazate or milbemectin
to ensure that the requirements laid down by Directive
in its Article 13 and the
91/414/EEC,
relevant conditions set out
in Annex I, are satisfied.
Member States should transform existing provisional
authorisations into full authorisations, amend them or
withdraw them in accordance with the provisions of
Directive 91/414/EEC. By derogation from the above
deadline, a longer period should be provided for the
submission and assessment of the complete Annex III
dossier of each plant protection product
for each
intended use in accordance with the uniform principles
laid down in Directive 91/414/EEC.

The draft assessment reports have 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 3 June 2005 in the format of the
Commission review reports for bifenazate and milbe-
mectin.

(8)

(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Regulation
(EC) No 396/2005 of the European Parliament and of the Council
(OJ L 70, 16.3.2005, p. 1).

(2) OJ L 92, 9.4.2002, p. 34.
(3) OJ L 230, 12.9.2000, p. 14.

The inclusion of bifenazate in Annex I is based on a
dossier covering the use of this active substance on orna-
mental plants in greenhouses. Other uses are currently
not adequately supported by data from the notifier and
not all of the risks from such uses have shown to be
adequately addressed under
the criteria required by
Annex VI. If Member States are to grant authorisations
for other uses, they should therefore require the data and
information necessary to prove
are
compatible with the criteria in Directive 91/414/EEC, in
particular concerning the effect on human consumers
and the environment.

the uses

that

L 246/18

EN

Official Journal of the European Union

22.9.2005

(9)

(10)

is

therefore
It
91/414/EEC accordingly.

appropriate

to

amend Directive

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

By way of derogation from paragraph 1,

for each
2.
authorised plant protection product containing bifenazate or
milbemectin as either the only active substance or as one of
several active substances all of which were listed in Annex I to
the latest,
Directive 91/414/EEC by 30 November 2005 at
in accordance
Member States shall re-evaluate the product
with 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 to that Directive and taking into
to that Directive
the entry in Annex I
account part B of
concerning bifenazate and milbemectin, respectively. On the
basis of
the
product satisfies the conditions set out in Article 4(1)(b), (c),
(d) and (e) of Directive 91/414/EEC.

they shall determine whether

that evaluation,

Article 2

Following that determination Member States shall:

1. Member States shall adopt and publish by 31 May 2006
at the latest the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive.

They shall apply those provisions from 1 June 2006.

When Member States adopt those provisions, 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.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 3

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing bife-
nazate or milbemectin as active substances by 31 May 2006.
By that date, they shall in particular verify that the conditions in
Annex I to that Directive relating to bifenazate and milbe-
mectin, respectively, are met, with the exception of those iden-
tified in part B of the entry concerning those active substances,
and that the holder of the authorisation has, or has access to, a
dossier satisfying the requirements of Annex II to that Directive
in accordance with the conditions of Article 13.

(a)

in the case of a product containing bifenazate or milbe-
mectin as
the only active substance, where necessary,
amend or withdraw the authorisation by 31 May 2007 at
the latest; or

(b) in the case of a product containing bifenazate or milbe-
substances, where
several
mectin as one of
authorisation by
amend or withdraw the
necessary,
such an
fixed for
31 May 2007 or by the date
amendment or withdrawal
in the respective Directive or
Directives which added the relevant substance or substances
to Annex I to Directive 91/414/EEC, whichever is the latest.

active

Article 4

This Directive shall enter into force on 1 December 2005.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 21 September 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

22.9.2005

EN

Official Journal of the European Union

L 246/19

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