Commission Directive 2007/52/EC of 16 August 2007 amending Council Directive 91/414/EEC to include ethoprophos, pirimiphos-methyl and fipronil as active substances (Text with EEA relevance )
Date: 2007-08-16
Institutions: European Commission
Subjects: insecticide, marketing standard, pesticide, pharmaceutical product, plant health legislation, plant health product

17.8.2007

EN

Official Journal of the European Union

L 214/3

DIRECTIVES

COMMISSION DIRECTIVE 2007/52/EC

of 16 August 2007

amending Council Directive 91/414/EEC to include ethoprophos, pirimiphos-methyl and fipronil as
active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

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)

(1)

(2)

implementation of

(EC) No 451/2000 (2) and
Commission Regulations
(EC) No 703/2001 (3)
lay down the detailed rules for
the
the
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 ethoprophos, pirimiphos-methyl and fipronil.

second stage of

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
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 ethoprophos and pirimiphos-methyl the
rapporteur Member State was the United Kingdom and
all relevant information was submitted on 19 January
2004 and 4 November 2003 respectively. For fipronil,
the rapporteur Member State was France and all relevant
information was submitted on 10 February 2004.

(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 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.

fipronil,

in the format of

The assessment reports have been peer reviewed by the
Member States and the EFSA and presented to the
Commission on 3 March 2006 for ethoprophos, on 10
August 2005 for pirimiphos-methyl, on 3 March 2006
for
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 16 March 2007 in the format
the Commission review reports for ethoprophos,
of
pirimiphos-methyl and fipronil.

States

and

the

containing

in general,

requirements

It has appeared from the various examinations made that
plant protection products
ethoprophos,
pirimiphos-methyl and fipronil may be expected to
laid down in
satisfy,
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.
is
therefore appropriate to include these active substances
in Annex I, in order to ensure that in all Member States
the
products
containing these active substances can be granted in
accordance with the provisions of that Directive.

authorisations

protection

plant

of

It

ethoprophos,

pirimiphos-methyl

(5) Without prejudice to that conclusion, it is appropriate to
obtain further information on certain specific points
concerning
and
fipronil. Article 6(1) of Directive 91/414/EC provides
inclusion of a substance in Annex I may be
that
is appropriate to
subject
require
and
fipronil should be subjected to further testing for confir-
mation of the risk assessment for some issues and that
such studies should be presented by the notifiers.

to conditions. Therefore it
ethoprophos,
that

pirimiphos-methyl

(4) EFSA Scientific Report (2006) 66, 1-72, Conclusion regarding the
peer review of the pesticide risk assessment of the active substance
ethoprophos (finalised: 3 March 2006). EFSA Scientific Report
(2005) 44, 1-53, Conclusion regarding the peer review of
the
pesticide risk assessment of the active substance pirimiphos-methyl
(finalised: 10 August 2005). EFSA Scientific Report
(2006) 65,
1-110, Conclusion regarding the peer review of the pesticide risk
assessment of the active substance fipronil (finalised: 3 March 2006
version of 12 April 2006).

L 214/4

EN

Official Journal of the European Union

17.8.2007

(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

containing

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
products
ethoprophos, pirimiphos-methyl
and fipronil to ensure that the requirements laid down
by Directive 91/414/EEC, in particular in its Article 13
in Annex I, are
and the relevant conditions set out
replace or
satisfied. Member
withdraw, as appropriate, existing authorisations,
in
Directive
accordance
91/414/EEC. By way of derogation from the above
deadline, a longer period should be provided for the
submission and assessment of the complete Annex III
for each
dossier of each plant protection product
intended use in accordance with the uniform principles
laid down in Directive 91/414/EEC.

provisions

should

States

vary,

with

the

of

(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

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.

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 etho-
prophos, pirimiphos-methyl and fipronil as active substances
by 31 March 2008.

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to ethoprophos, pirimiphos-
methyl and fipronil are met, with the exception of those ident-
ified in part B of the entry concerning that active substance, and
that the holder of the authorisation has, or has access to, a
dossier
to that
Directive in accordance with the conditions of Article 13 of
that Directive.

requirements of Annex II

satisfying the

either

By way of derogation from paragraph 1,

2.
for each
authorised plant protection product containing ethoprophos,
pirimiphos-methyl and fipronil as
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 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
and
Directive
fipronil
they
shall determine whether the product satisfies the conditions
set out
(d) and (e) of Directive
(c),
91/414/EEC.

ethoprophos, pirimiphos-methyl
that evaluation,

respectively. On the basis of

in Article 4(1)(b),

concerning

HAS ADOPTED THIS DIRECTIVE:

Article 1

Following that determination Member States shall:

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

(a)

(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).

case of

a product

in the
ethoprophos,
pirimiphos-methyl or fipronil as the only active substance,
where necessary, amend or withdraw the authorisation by
30 September 2011 at the latest; or

containing

17.8.2007

EN

Official Journal of the European Union

L 214/5

(b) in the

case of

a product

containing
fipronil as one of

ethoprophos,
several active
pirimiphos-methyl or
substances, where necessary,
amend or withdraw the
authorisation by 30 September 2011 or by the date fixed
in the respective
for such an amendment or withdrawal
Directive or Directives which added the relevant substance
or
to Directive 91/414/EEC,
whichever is the latest.

to Annex I

substances

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 16 August 2007.

Article 4

This Directive shall enter into force on 1 October 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 214/6

EN

Official Journal of the European Union

17.8.2007

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