Commission Directive 2007/50/EC of 2 August 2007 amending Council Directive 91/414/EEC to include beflubutamid and Spodoptera exigua nuclear polyhedrosis virus as active substances (Text with EEA relevance)
Date: 2007-08-02
Institutions: European Commission
Subjects: exchange of information, marketing standard, pharmaceutical product, plant health control, plant health legislation, plant health product, testing

3.8.2007

EN

Official Journal of the European Union

L 202/15

DIRECTIVES

COMMISSION DIRECTIVE 2007/50/EC

of 2 August 2007

amending Council Directive 91/414/EEC to include beflubutamid and Spodoptera exigua nuclear
polyhedrosis virus as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Commission on 13 August 2002 (beflubutamid) and 1
November 1999 (Spodoptera exigua NPV) respectively.

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,

Whereas:

(4)

(5)

In accordance with Article 6(2) of Directive 91/414/EEC
Germany received on 27 June 2000 an application from
a Task Force consisting of UBE Europe GmbH and
Stähler Agrochemie GmbH & Co. KG (UBE Europe
the Task Force)
GmbH having later
the
substance beflubutamid in
inclusion of
91/414/EEC. Commission
Annex
Decision 2000/784/EC (2) confirmed that
the dossier
was ‘complete’ in the sense that it could be considered
the data and information
as satisfying,
in principle,
requirements of Annexes
to Directive
II
91/414/EEC.

left
active
to Directive

and III

the

for

I

by

the Member

For those substances the draft assessment reports have
been reviewed
the
Commission within the Standing Committee on the
review was
Food Chain and Animal Health. The
finalised on 15 May 2007 in the format of
the
for beflubutamid and
Commission review reports
Spodoptera exigua NPV.

States

and

the

products

protection

containing

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

appropriate

It

In accordance with Article 6(2) of Directive 91/414/EEC
the Netherlands received on 12 July 1996 an application
from Biosys (now: Certis USA) for the inclusion of the
active substance Spodoptera exigua nuclear polyhedrosis
virus (hereinafter Spodoptera exigua NPV)
in Annex I
to Directive
Commission Decision
97/865/EC (3) confirmed that the dossier was ‘complete’
in the sense that it could be considered as satisfying, in
the data and information requirements of
principle,
Annexes II and III to Directive 91/414/EEC.

91/414/EEC.

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
reports concerning the substances to the
assessment

products

containing

six months after

in Annex I, Member States

(6) 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
or
beflubutamid
Spodoptera exigua NPV to ensure that the requirements
laid down by Directive 91/414/EEC, in particular in its
Article 13 and the relevant conditions set out in Annex I,
are satisfied. Member States should transform existing
provisional
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 complete
Annex III dossier of each plant protection product for
each intended use in accordance with the uniform prin-
ciples laid down in Directive 91/414/EEC.

the submission and assessment of

authorisations

into

full

(1) OJ L 230, 19.8.1991, p. 1. Directive as

last amended by

Commission Directive 2007/31/EC (OJ L 140, 1.6.2007, p. 44).

(2) OJ L 311, 12.12.2000, p. 47.
(3) OJ L 351, 23.12.1997, p. 67.

(7)

is

It
therefore
91/414/EEC accordingly.

appropriate

to

amend Directive

(1)

(2)

(3)

L 202/16

EN

Official Journal of the European Union

3.8.2007

(8)

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.

Article 2

1. Member States shall adopt and publish by 31 May 2008
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 2008.

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 beflu-
butamid or Spodoptera exigua NPV as active substance by 31
May 2008. By that date, they shall
in particular verify that
the conditions in Annex I to that Directive relating to beflu-
butamid or Spodoptera exigua NPV, respectively, are met, with
the exception of
the entry
concerning the active substance, 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(2) of that Directive.

those identified in part B of

By way of derogation from paragraph 1,

for each
2.
authorised plant protection product containing beflubutamid
or Spodoptera exigua NPV 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 30 November 2007 at
the latest, Member States shall
in
accordance 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 beflubutamid or Spodoptera exigua NPV. 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

re-evaluate the product

that evaluation,

Following that determination Member States shall:

(a)

in the case of a product containing beflubutamid or
Spodoptera exigua NPV as the only active substance, where
necessary, amend or withdraw the authorisation by 31 May
2009 at the latest; or

(b) in the case of a product containing beflubutamid or
Spodoptera exigua NPV as one of several active substances,
where necessary, amend or withdraw the authorisation by
31 May 2009 or by the date fixed for such an 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.

This Directive shall enter into force on 1 December 2007.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 2 August 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

3.8.2007

EN

Official Journal of the European Union

L 202/17

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