Commission Directive 2006/5/EC of  17 January 2006  amending Council Directive 91/414/EEC to include warfarin 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 12/17

COMMISSION DIRECTIVE 2006/5/EC

of 17 January 2006

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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:

The report on warfarin and further information were also
submitted to the Scientific Committee for Plants. The
Committee was asked to comment on the acceptability
of using clinical data generated following repeated
warfarin use as an anti-coagulant in human medicine
for establishing an acceptable daily intake (ADI) and an
In its
exposure
acceptable operator
opinion (4), the Scientific Committee concluded that it
is not necessary to allocate an ADI
for warfarin.
Furthermore, data available from the extensive clinical
use of warfarin as an anticoagulant may confidently be
expected to support the establishment of an ADI, should
this be considered necessary. An AOEL can likewise be
established based on human data, taking into account
that in rats about 15 % of the applied dose is absorbed
through the skin.

(AOEL).

level

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 (2) establishes 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 warfarin.

(5)

(1)

(2)

For warfarin the effects on human health and the envi-
ronment has 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
Commission Regulation (EC) No 933/94 of 27 April
substances of plant
1994 laying down the active
protection products and designating the
rapporteur
Member State for the implementation of Commission
Regulation (EEC) No 3600/92 (3), Ireland was designated
as Rapporteur Member State.
Ireland submitted the
relevant assessment report and recommendations to the
Commission on 8 May 1996 in accordance with Article
7(1)(c) of Regulation (EEC) No 3600/92.

(3)

and the Commission within the

The assessment report has been reviewed by the Member
States
Standing
Committee on the Food Chain and Animal Health. The
review was finalised on 23 September 2005 in the
format of the Commission review report for warfarin.

and

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

States
containing warfarin can be

in order to ensure that

authorisation

granted

plant

(b)

of

It

as

are

used

covered

rodenticides

(6) Warfarin is used as a rodenticide. All other active
substances
by
Commission Regulation (EC) No 1112/2002 of 20
June 2002 laying down the detailed rules for the imple-
mentation of the fourth stage of the programme of work
referred to in Article 8(2) of Council Directive
91/414/EEC (5). Furthermore, the substance is currently
subject
to evaluation in the framework of Directive
98/8/EC of the European Parliament and of the Council
of 16 February 1998 concerning the placing of biocidal
products on the market (6). As with all
substances
included in Annex I
the
status of warfarin could be reviewed under Article 5(5)
of that Directive in the light of any new data becoming
in particular from the assessment of similar
available,
substances or from the assessment of warfarin itself
under Directive 98/8/EC.

to Directive 91/414/EEC,

(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 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).

(3) OJ L 107, 28.4.1994, p. 8. Regulation as last amended by Regu-

lation (EC) No 2230/95 (OJ L 225, 22.9.1995, p. 1).

(4) Opinion of the Scientific Committee on Plants regarding the possible
inclusion of warfarin in Annex I to Council Directive 91/414/EEC
concerning the placing of plant protection products on the market;
SCP/WARFAR/002 final, adopted on 6 June 2000.

(5) OJ L 168, 27.6.2002, p. 14.
(6) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Regulation

(EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

L 12/18

EN

Official Journal of the European Union

18.1.2006

(7)

(8)

The experience gained from previous inclusions in Annex
I to Directive 91/414/EEC of active substances assessed
in the framework of Regulation (EEC) No 3600/92 has
shown that difficulties can arise in interpreting the duties
of holders of existing authorisations in relation to access
to data. In order to avoid further difficulties, it therefore
appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder of
to a dossier
an authorisation demonstrates
to that
satisfying
Directive. However,
impose
any new obligations on Member States or holders of
authorisations compared to the directives which have
been adopted until now amending Annex I.

this clarification does not

requirements of Annex

access

the

II

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

containing warfarin to ensure

(9) 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
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,

that

(10)

(11)

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

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.

They shall apply those provisions from 1 April 2007.

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 3

for

shall

plant

States

products

protection

they shall

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations
containing
warfarin as an active substance by 31 March 2007. By that
date,
the conditions in
in particular verify that
Annex I to that Directive, relating to warfarin, are met, with
the entry
the exception of
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.

those identified in part B of

By derogation from paragraph 1, for each authorised plant
2.
protection product containing warfarin 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 concerning warfarin. On the basis of that evaluation,
they shall determine whether the product satisfies the condi-
tions set out in Article 4(1)(b),
(d) and (e) of Directive
91/414/EEC.

(c),

HAS ADOPTED THIS DIRECTIVE:

Following that determination Member States shall:

Article 1

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

(a)

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

18.1.2006

EN

Official Journal of the European Union

L 12/19

active

substances, where necessary,

(b) in the case of a product containing warfarin 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 5

This Directive is addressed to the Member States.

Done at Brussels, 17 January 2006.

Article 4

This Directive shall enter into force on 1 October 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 12/20

EN

Official Journal of the European Union

18.1.2006

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