Commission Directive 2007/25/EC of 23 April 2007 amending Council Directive 91/414/EEC to include dimethoate, dimethomorph, glufosinate, metribuzin, phosmet and propamocarb as active substances (Text with EEA relevance)
Date: 2007-04-23
Institutions: European Commission
Subjects: exchange of information, marketing standard, plant health control, plant health legislation, plant health product, testing

L 106/34

EN

Official Journal of the European Union

24.4.2007

DIRECTIVES

COMMISSION DIRECTIVE 2007/25/EC

of 23 April 2007

amending Council Directive 91/414/EEC to include dimethoate, dimethomorph, glufosinate,
metribuzin, phosmet and propamocarb as active substances

(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:

(3)

(1)

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
includes
dimethoate,
glufosinate, metribuzin,
phosmet and propamocarb.

to Directive 91/414/EEC. That

dimethomorph,

list

the

submitted on 4 August 2004.

designate the rapporteur Member States which have to
submit the relevant assessment reports and recommen-
dations to the European Food Safety Authority (EFSA) in
accordance with Article 8(1) of Regulation (EC) No
451/2000. For dimethoate,
rapporteur Member
State was the United Kingdom and all relevant infor-
mation was
For
dimethomorph and metribuzin, the rapporteur Member
State was Germany and all relevant
information was
submitted on 11 June 2004 and 23 august 2004 respec-
tively. For glufosinate, the rapporteur Member State was
Sweden and all relevant information was submitted on 3
January 2003. For phosmet, the rapporteur Member State
was Spain and all relevant information was submitted on
the rapporteur
23 August 2004. For propamocarb,
Member State was Ireland and all relevant information
was submitted on 5 October 2004.

The assessment reports have been peer reviewed by the
Member States and the EFSA and presented to the
Commission on 14 March 2005 for glufosinate, on 12
May 2006 for phosmet and propamocarb, on 23 June
2006 for dimethoate and dimethomorph, and on 28 July
2006 for metribuzin, in the format of the EFSA Scientific
Reports (4). These reports have been reviewed by the
Member
the Commission within the
Standing Committee on the Food Chain and Animal
Health and finalised on 24 November 2006 in the
format of the Commission review reports for dimethoate,
dimethomorph, glufosinate, metribuzin, phosmet and
propamocarb.

States

and

(2)

For those active substances 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 notifier. Moreover, those Regulations

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

last amended by

Commission Directive 2007/21/EC (OJ L 97, 12.4.2007, p. 42).
(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) 27, 1-81, Conclusion regarding the
Peer review of the pesticide risk assessment of the active substance
glufosinate (finalised: 14 March 2005).
EFSA Scientific Report (2006) 75, 1-72, Conclusion regarding the
Peer review of the pesticide risk assessment of the active substance
phosmet (finalised: 12 May 2006).
EFSA Scientific Report (2006) 78, 1-72, Conclusion regarding the
Peer review of the pesticide risk assessment of the active substance
propamocarb (finalised: 12 May 2006).
EFSA Scientific Report (2006) 84, 1-102, Conclusions on the peer
review of
the active substance
dimethoate (finalised: 23 June 2006).
EFSA Scientific Report (2006) 82, 1-69, Conclusions on the peer
review of
the active substance
dimethomorph (finalised: 23 June 2006).
EFSA Scientific Report (2006) 88, 1-74, Conclusions on the peer
review of
the active substance
metribuzin (finalised: 28 July 2006).

the pesticide risk assessment of

the pesticide risk assessment of

the pesticide risk assessment of

24.4.2007

EN

Official Journal of the European Union

L 106/35

(4)

products

protection

containing

It has appeared from the various examinations made that
plant
dimethoate,
dimethomorph, glufosinate, metribuzin, phosmet and
propamocarb may be expected to satisfy,
in general,
the requirements laid down in Article 5(1)(a) and (b) of
Directive 91/414/EEC,
in particular with regard to the
uses which were
examined and detailed in the
Commission review reports. It is therefore appropriate
to include these active substances in Annex I, in order
to ensure that in all Member States the authorisations of
plant protection products
active
substances can be granted in accordance with the
provisions of that Directive.

containing

these

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.

(5) Without prejudice to that conclusion, it is appropriate to
information on certain specific points
obtain further
concerning dimethoate,
glufosinate, metribuzin and
phosmet. 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
dimethoate, glufosinate, metribuzin and phosmet should
be subjected to further testing for confirmation of the
risk assessment for some issues and that such studies
should be presented by the notifiers.

(9)

(10)

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

(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
review existing
authorisations of plant protection
products containing dimethoate, dimethomorph, glufo-
sinate, metribuzin, phosmet
and propamocarb to
the requirements laid down by Directive
ensure that
in its Article 13 and the
91/414/EEC,
in particular
in Annex I, are satisfied.
relevant conditions set out
Member States should vary, replace or withdraw, as
appropriate, existing authorisations,
in accordance with
the provisions of Directive 91/414/EEC. By way of dero-
gation 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.

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 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 April 2008.

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.

(8)

The experience gained from previous inclusions in Annex
I to Directive 91/414/EEC of active substances assessed

(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).

L 106/36

EN

Official Journal of the European Union

24.4.2007

Article 3

Following that determination Member States shall:

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations
containing
dimethoate, dimethomorph, glufosinate, metribuzin, phosmet
and propamocarb as active substances by 31 March 2008.

protection

products

plant

for

(a)

a

the

product

in
case
dimethoate,
dimethomorph,
and
substance, where
propamocarb
necessary, amend or withdraw the authorisation by 30
September 2011 at the latest; or

of
glufosinate, metribuzin, phosmet
active

containing

only

the

as

I

to

relating

that Directive

By that date they shall in particular verify that the conditions in
Annex
dimethoate,
dimethomorph, glufosinate, metribuzin, phosmet and propa-
mocarb are met, with the exception of those identified in part
B 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.

to

(b) in

a

the

product

containing

of
glufosinate, metribuzin, phosmet

dimethoate,
case
dimethomorph,
and
propamocarb as one of several active substances, where
necessary, amend or withdraw the authorisation by 30
September 2011 or by the date fixed for
such an
in the respective directive or
amendment or withdrawal
directives which added the relevant substance or substances
to Annex I to Directive 91/414/EEC, whichever is the latest.

By way of derogation from paragraph 1,

for each
2.
authorised plant protection product containing dimethoate,
dimethomorph, glufosinate, metribuzin, phosmet and propa-
mocarb 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 2007 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
the
requirements of Annex III to that Directive and taking into
account part B of
to that Directive
the entry in Annex I
concerning dimethoate, dimethomorph, glufosinate, metribuzin,
phosmet and propamocarb respectively. On the basis of that
evaluation, they shall determine whether the product satisfies
(d) and (e) of
the conditions set out in Article 4(1)(b),
Directive 91/414/EEC.

a dossier

satisfying

(c),

Article 4

This Directive shall enter into force on 1 October 2007.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 23 April 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

24.4.2007

EN

Official Journal of the European Union

L 106/37

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EN

Official Journal of the European Union

24.4.2007

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