Commission Directive 2006/6/EC of  17 January 2006  amending Council Directive 91/414/EEC to include tolylfluanid as active substance   (Text with EEA relevance)
Date: 2006-01-17
Institutions: European Commission
Subjects: chemical compound, market approval, marketing standard, pharmaceutical product, plant health product, testing

18.1.2006

EN

Official Journal of the European Union

L 12/21

COMMISSION DIRECTIVE 2006/6/EC

of 17 January 2006

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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:

(1)

(2)

(3)

Commission Regulations (EC) No 451/2000 (2) and (EC)
No 703/2001 (3)
lay down the detailed rules for the
implementation of the second stage of the programme
of work referred to in Article 8(2) of Directive
91/414/EEC and establish a list of active substances to
be assessed, with a view to their possible inclusion in
Annex I to Directive 91/414/EEC. That list includes tolyl-
fluanid.

For tolylfluanid the effects on human health and the
environment have been assessed in accordance with the
provisions laid down in Regulations (EC) No 451/2000
and (EC) No 703/2001 for a range of uses proposed by
the notifiers. Moreover, those regulations designate the
the
rapporteur Member States which have to submit
relevant assessment
reports and recommendations to
the European Food Safety Authority (EFSA) in accordance
with Article 8(1) of Regulation (EC) No 451/2000. For
tolylfluanid the rapporteur Member State was Finland
and all relevant information was submitted on 13 June
2003.

The assessment report has been peer reviewed by the
Member States and the EFSA within its Working Group
Evaluation and presented to the Commission on 14
March 2005 in the format of
the EFSA Scientific
tolylfluanid (4). This
been
Report
reviewed by the Member States and the Commission

report has

for

(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 55, 29.2.2000, p. 25. Regulation as last amended by Regu-

lation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

(3) OJ L 98, 7.4.2001, p. 6.
(4) EFSA Scientific Report (2005) 29, 1-76, Conclusions on the peer

review of tolylfluanid (finalised 14 March 2005).

within the Standing Committee on the Food Chain and
Animal Health and finalised on 23 September 2005 in
the format of the Commission review report for tolyl-
fluanid.

(4)

in general,

It has appeared from the various examinations made that
plant protection products containing tolylfluanid may
be expected to satisfy,
the requirements
laid down in Article 5(1) (a) and (b) of Directive
in particular with regard to the uses
91/414/EEC,
which were examined and detailed in the Commission
review report. It is therefore appropriate to include tolyl-
fluanid in Annex I, in order to ensure that 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.

(5) Without prejudice to that conclusion, it is appropriate to
obtain further information on certain specific points.
Article 6(1) of Directive 91/414/EEC provides
that
inclusion of a substance in Annex I may be subject to
conditions. Therefore it is appropriate to require that
tolylfluanid should be subjected to further testing for
confirmation of the long term risk assessment for herbi-
vorous mammals and that
should be
presented by the notifier.

such studies

(6)

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
the new requirements
which will result from the inclusion.

themselves

to meet

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 protection
review existing
the
products containing tolylfluanid to ensure that
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
vary,
existing
authorisations,
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.

replace or withdraw, as appropriate,

L 12/22

EN

Official Journal of the European Union

18.1.2006

(8)

(9)

(10)

The experience gained from previous inclusions in Annex
I to Directive 91/414/EEC of active substances assessed
in the framework of Commission Regulation (EEC) No
3600/92 (1) has shown that difficulties can arise in inter-
preting the duties of holders of existing authorisations in
relation to access to data. In order to avoid further diffi-
culties it therefore appears necessary to clarify the duties
of the Member States, especially the duty to verify that
the holder of an authorisation demonstrates access to a
dossier satisfying the requirements of Annex II to that
Directive. However, this clarification does not impose any
new obligations on Member States or holders of author-
isations compared to the directives which have been
adopted until now amending Annex I.

is

It
therefore
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.

Article 2

Member States shall adopt and publish by 31 March 2007 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.

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to tolylfluanid are met, with
the exception of
the entry
concerning that 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 of that Directive.

those identified in part B of

2.
By derogation from paragraph 1, for each authorised plant
protection product containing tolylfluanid 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
September 2006 at the latest, Member States shall 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 requirements of Annex III to that Directive
and taking into account part B of the entry in Annex I to that
Directive
that
evaluation, they shall determine whether the product satisfies
the conditions set out in Article 4(1)(b),
(d) and (e) of
Directive 91/414/EEC.

concerning tolylfluanid. On the basis of

(c),

Following that determination Member States shall:

(a)

in the case of a product containing tolylfluanid as the only
active substance, where necessary, amend or withdraw the
authorisation by 30 September 2010 at the latest; or

active

substances, where necessary,

(b) in the case of a product containing tolylfluanid as one of
several
amend or
withdraw the authorisation by 30 September 2010 or by
the date fixed for such an amendment or withdrawal in the
respective Directive or Directives which added the relevant
substance
to Directive
91/414/EEC, whichever is the latest.

to Annex

substances

or

I

Article 4

They shall apply those provisions from 1 April 2007.

This Directive shall enter into force on 1 October 2006.

When Member States adopt those provisions, they shall contain
a reference to this Directive or 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 5

This Directive is addressed to the Member States.

Article 3

Done at Brussels, 17 January 2006.

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing tolyl-
fluanid as an active substance by 31 March 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regu-

lation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27).

18.1.2006

EN

Official Journal of the European Union

L 12/23

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