2007/379/EC: Commission Decision of 25 May 2007 concerning the non-inclusion of fenitrothion in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (notified under document number C(2007) 2164) (Text with EEA relevance)
Date: 2007-05-25
Institutions: European Commission
Subjects: dangerous substance, marketing restriction, pesticide, pharmaceutical product, plant health legislation, plant health product, withdrawal from the market

L 141/76

EN

Official Journal of the European Union

2.6.2007

COMMISSION

COMMISSION DECISION

of 25 May 2007

concerning the non-inclusion of fenitrothion in Annex I to Council Directive 91/414/EEC and the
withdrawal of authorisations for plant protection products containing that substance

(notified under document number C(2007) 2164)

(Text with EEA relevance)

(2007/379/EC)

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
fourth subparagraph of
Article 8(2) thereof,

the

Whereas:

(1)

(2)

Article 8(2) of Directive 91/414/EEC provides that a
Member State may, during a period of 12 years
that Directive, authorise
following the notification of
the placing on the market of plant protection products
containing active substances not listed in Annex I of that
Directive that are already on the market two years after
the date of notification, while those substances are
gradually being examined within the framework of a
programme of work.

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 feni-
trothion.

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

last amended by

Commission Directive 2007/25/EC (OJ L 106, 24.4.2007, p. 34).
(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.

For fenitrothion 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
the
rapporteur Member States which have to submit
relevant assessment
reports and recommendations to
the European Food Safety Authority (EFSA) in accordance
with Article 8(1) of Regulation (EC) No 451/2000. For
fenitrothion the rapporteur Member State was United
information was submitted
Kingdom and all relevant
on 4 November 2003.

(4)

(5)

The assessment report has been peer reviewed by the
Member States and the EFSA within its Working Group
Evaluation and presented to the Commission on 13
January 2006 in the format of
the EFSA conclusion
regarding the peer review of the pesticide risk assessment
of the active substance fenitrothion (4). This report has
been reviewed
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
report for fenitrothion.

the Member

States

and

by

and workers

During the evaluation of this active substance, a number
of concerns were identified. Based on the available infor-
mation it has not been demonstrated that the estimated
exposure of operators
acceptable.
Moreover, the estimated acute exposure of consumers
cannot be regarded acceptable due to the insufficient
certain degradation
information on the
effects of
products that may be present
in raw or processed
commodities, and so it was not possible to conclude
on the basis of the information available that fentrothion
met the criteria for inclusion in Annex I to Directive
91/414/EEC.

is

(4) EFSA Scientific Report
review of fenitrothion.

(2006)59, 1-80, Conclusion on the peer

2.6.2007

EN

Official Journal of the European Union

L 141/77

(6)

(7)

(8)

(9)

(10)

to submit

submitted its

its
The Commission invited the notifier
comments on the results of the peer review and on its
intention or not to further support the substance. The
notifier
comments which have been
carefully examined. However, despite the arguments put
forward by the notifier, the concerns identified could not
be eliminated, and assessments made on the basis of the
information submitted and evaluated during the EFSA
expert meetings have not demonstrated that it may be
expected that, under the proposed conditions of use,
plant protection products containing fenitrothion satisfy
in general the requirements laid down in Article 5(1)(a)
and (b) of Directive 91/414/EEC.

Fenitrothion should therefore not be included in Annex I
to Directive 91/414/EEC.

Measures should be taken to ensure that authorisations
granted for plant protection products containing feni-
trothion are withdrawn within a fixed period of time
and are not renewed and that no new authorisations
for such products are granted.

Any period of grace granted by a Member State for the
disposal, storage, placing on the market and use of
existing stocks of plant protection products containing
fenitrothion, should be limited to twelve months in order
to allow existing stocks to be used in one further
growing season.

(12)

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

Article 1

Fenitrothion shall not be included as an active substance in
Annex I to Directive 91/414/EEC.

Article 2

Member States shall ensure that:

(a) authorisations for plant protection products containing feni-

trothion are withdrawn by 25 November 2007;

(b) no authorisations for plant protection products containing
fenitrothion are granted or renewed from the date of publi-
cation of this Decision.

Article 3

Any period of grace granted by Member States in accordance
with the provisions of Article 4(6) of Directive 91/414/EEC,
expire on 25
shall be
November 2008 at the latest.

as possible

and shall

short

as

any

substance within the

This decision does not prejudice
action the
Commission may undertake at a later stage for this
active
framework of Council
Directive 79/117/EEC of 21 December 1978 prohibiting
the placing on the market and use of plant protection
products containing certain active substances (1).

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 25 May 2007.

(11)

This decision does not prejudice the submission of an
application for fenitrothion according to the provisions
of Article 6(2) of Directive 91/414/EEC in view of a
possible inclusion in its Annex I.

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) OJ L 33, 8.2.1979, p. 36. Directive as last amended by Regulation
(EC) No 850/2004 of the European Parliament and of the Council
(OJ L 158, 30.4.2004, p. 7); as corrected by OJ L 229, 29.6.2004,
p. 5.