Commission Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active substances (Text with EEA relevance)
Date: 2008-12-19
Institutions: European Commission
Subjects: EU Member State, animal health, environmental impact, human nutrition, marketing standard, pharmaceutical product, plant health product

20.12.2008

EN

Official Journal of the European Union

L 344/89

COMMISSION DIRECTIVE 2008/127/EC

of 18 December 2008

amending Council Directive 91/414/EEC to include several 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:

(1)

(2)

(3)

(4)

Commission Regulations (EC) No 1112/2002 (2) and (EC)
No 2229/2004 (3) lay down the detailed rules for the
implementation of the fourth 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 the
active substances listed in the Annex to this Directive.

By Regulation (EC) No 1095/2007 (4) a new Article 24b
was inserted into Regulation (EC) No 2229/2004 to
allow active substances for which there are clear indi­
cations that it may be expected that they do not have
any harmful effects on human or animal health or on
groundwater or any unacceptable influence on the envi­
ronment,
to Directive
91/414/EEC without detailed scientific advice from the
European Food Safety Authority (EFSA) having been
sought.

to be included in Annex I

For the active substances listed in the Annex to this
Directive the Commission examined in accordance with
Article 24a of Regulation (EC) No 2229/2004 the effects
on human, animal health, groundwater and the environ­
ment for a range of uses proposed by the notifiers, with
the conclusion that those active substances satisfy the
requirements of Article 24b of Regulation (EC) No
2229/2004.

In accordance with Article 25(1) of Regulation (EC) No
2229/2004 the Commission has submitted draft review
reports for the active substances listed in the Annex to
this Directive to the Standing Committee on the Food
Chain and Animal Health, for examination. Those reports
have been reviewed by the Member States and the

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 168, 27.6.2002, p. 14.
(3) OJ L 379, 24.12.2004, p. 13.
(4) OJ L 246, 21.9.2007, p. 19.

Commission within the Standing Committee on the
Food Chain and Animal Health and finalised on
28 October 2008 in the format of
the Commission
review reports. In accordance with Article 25a of Regu­
lation (EC) No 2229/2004 the Commission is to request
the EFSA to deliver its view on the draft review reports
by 31 December 2010 at the latest.

(b)

the

and

products

protection

containing

It has appeared from the various examinations made that
plant
active
substances listed in the Annex to this Directive may be
the requirements laid
in general,
expected to satisfy,
of Directive
5(1)(a)
in Article
down
91/414/EEC,
in particular with regard to the uses
which have been examined and detailed in the
Commission review report.
is therefore appropriate
to that Directive the active
to include in Annex I
substances listed in the Annex to this Directive,
in
order to ensure that in all Member States the authori­
sations of plant protection products containing this
active substance can be granted in accordance with the
provisions of that Directive.

It

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
the new requirements
prepare
which will result from the inclusion.

themselves

to meet

(5)

(6)

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 the active substances listed in the
Annex to ensure that the requirements laid down by
in particular in its Article 13
Directive 91/414/EEC,
in Annex I, are
and the relevant conditions set out
replace or
satisfied. Member
in
withdraw, as appropriate, existing authorisations,
accordance
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.

provisions

should

States

vary,

with

the

of

L 344/90

EN

Official Journal of the European Union

20.12.2008

(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 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
that have
been adopted until now amending Annex I.

this clarification does not

requirements of Annex

access

the

II

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

in the Annex are met, with the exception of those identified in
part B of the entry concerning that active substance, and that
the authorisations have, or have access to,
the holders of
dossiers
to that
satisfying the requirements of Annex II
Directive in accordance with the conditions of Article 13 of
that Directive.

for each
2.
By way of derogation from paragraph 1,
the
authorised plant protection product containing one of
active substances listed in the Annex 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 31 August
2009 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 the active substances listed in the Annex.
On the basis of that evaluation, they shall determine whether
the product satisfies the conditions set out in Article 4(1)(b), (c),
(d) and (e) of Directive 91/414/EEC.

HAS ADOPTED THIS DIRECTIVE:

Following that determination Member States shall:

Article 1

(a)

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

the active
in the case of a product containing one of
active
substances
substance, where necessary, amend or withdraw the autho­
risation by 31 August 2015 at the latest; or

listed in the Annex as

the only

Article 2

Member States shall adopt and publish by 28 February 2010 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 March 2010.

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.

(b) in the case of a product containing one of

the active
substances listed in the Annex as one of several active
substances, where necessary, amend or withdraw the au­
thorisation by 31 August 2015 or by the date fixed for
such an amendment or withdrawal
in the respective
Directive or Directives which added the relevant substance
or
to Directive 91/414/EEC,
whichever is the latest.

to Annex I

substances

Article 4

This Directive shall enter into force on 1 September 2009.

Article 5

Article 3

This Directive is addressed to the Member States.

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing the
active substances listed in the Annex as active substances by
28 February 2010.

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to the active substances listed

Done at Brussels, 18 December 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

20.12.2008

EN

Official Journal of the European Union

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EN

Official Journal of the European Union

20.12.2008

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20.12.2008

EN

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L 344/93

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EN

Official Journal of the European Union

20.12.2008

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EN

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20.12.2008

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EN

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L 344/101

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EN

Official Journal of the European Union

20.12.2008

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EN

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L 344/103

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EN

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Official Journal of the European Union

20.12.2008

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