Commission Directive 2006/85/EC of 23 October 2006 amending Council Directive 91/414/EEC to include fenamiphos and ethephon as active substances   (Text with EEA relevance)
Date: 2006-10-23
Institutions: European Commission
Subjects: exchange of information, marketing standard, plant health legislation, plant health product, testing

24.10.2006

EN

Official Journal of the European Union

L 293/3

COMMISSION DIRECTIVE 2006/85/EC

of 23 October 2006

amending Council Directive 91/414/EEC to include fenamiphos and ethephon as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

on 24 April 2006 for ethephon in the format of the
EFSA Scientific Reports (4). These reports have been
reviewed by the Member States and the Commission
within the Standing Committee on the Food Chain and
Animal Health and finalised on 14 July 2006 in the
format of the Commission review reports for fenamiphos
and ethephon.

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,

(4)

Whereas:

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 fena-
miphos and ethephon.

(5)

(1)

(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
designate the rapporteur Member States which have to
submit the relevant assessment reports and recommend-
ations to the European Food Safety Authority (EFSA) in
accordance with Article 8(1) of Regulation (EC) No
451/2000. For
rapporteur Member
State was the Netherlands and all relevant information
was submitted on 27 November 2003. For ethephon the
rapporteur Member State was the Netherlands and all
relevant information was submitted on 21 April 2004.

fenamiphos

the

(3)

The assessment reports have been peer reviewed by the
Member States and the EFSA and presented to the
Commission on 13 January 2006 for fenamiphos and

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

last amended by

Commission Directive 2006/75/EC (OJ L 248, 12.9.2006, p. 3).
(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.

in general,

It has appeared from the various examinations made that
plant protection products containing fenamiphos and
ethephon may be expected to satisfy,
the
requirements laid down in Article 5(1)(a) and (b) of
Directive 91/414/EEC,
in particular with regard to the
examined and detailed in the
uses which were
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
active
plant protection products
substances can be granted in accordance with the
provisions of that Directive.

containing

these

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

containing

fenamiphos

six months after

in Annex I, Member States

(6) 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
and ethephon to
products
the requirements laid down by Directive
ensure that
in its Article 13 and the
in particular
91/414/EEC,
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.

(4) EFSA Scientific Report (2006) 62, 1-81, Conclusion regarding the
peer review of the pesticide risk assessment of the active substance
fenamiphos (finalised: 13 January 2006).
EFSA Scientific Report (2006) 67, 1-61, Conclusion regarding the
peer review of the pesticide risk assessment of the active substance
ethephon (finalised: 24 April 2006).

L 293/4

EN

Official Journal of the European Union

24.10.2006

(7)

(8)

(9)

inclusions

in
The experience gained from previous
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 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

By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to fenamiphos and ethephon
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.

By way of derogation from paragraph 1,

2.
for each
authorised plant protection product containing fenamiphos
and ethephon 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 July 2007 at the latest, Member
in accordance with the
States shall re-evaluate the product
to Directive
uniform principles provided for
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 fenamiphos and ethephon respectively. On the
basis of
the
product satisfies the conditions set out in Article 4(1)(b), (c),
(d) and (e) of Directive 91/414/EEC.

they shall determine whether

in Annex VI
a dossier

that evaluation,

satisfying

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.

Article 2

Member States shall adopt and publish by 31 January 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.

(a)

in the case of a product containing fenamiphos and
ethephon as the only active substance, where necessary,
amend or withdraw the authorisation by 31 July 2011 at
the latest; or

several active

(b) in the case of a product containing fenamiphos and
substances, where
ethephon as one of
necessary, amend or withdraw the authorisation by 31
July 2011 or by the date fixed for such an amendment or
withdrawal
in the respective Directive or Directives which
added the relevant substance or substances to Annex I to
Directive 91/414/EEC, whichever is the latest.

Article 4

They shall apply those provisions from 1 February 2008.

This Directive shall enter into force on 1 August 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 5

This Directive is addressed to the Member States.

Article 3

Done at Brussels, 23 October 2006.

shall

States

1. Member
in accordance with Directive
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing fena-
miphos and ethephon as active substances by 31 January 2008.

For the Commission

Markos KYPRIANOU
Member of the Commission

24.10.2006

EN

Official Journal of the European Union

L 293/5

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