2009/65/EC: Commission Decision of 26 January 2009 concerning the non-inclusion of 2-Naphtyloxyacetic acid 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(2009) 204) (Text with EEA relevance)
Date: 2009-01-26
Institutions: European Commission
Subjects: dangerous substance, market approval, marketing restriction, pharmaceutical product, plant health legislation, plant health product

27.1.2009

EN

Official Journal of the European Union

L 23/33

COMMISSION DECISION

of 26 January 2009

concerning the non-inclusion of 2-Naphtyloxyacetic acid 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(2009) 204)

(Text with EEA relevance)

(2009/65/EC)

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
fourth subparagraph of
Article 8(2) thereof,

the

Whereas:

(1)

(2)

(3)

Article 8(2) of Directive 91/414/EEC provides that a
Member State may, during a period of 12 years
following the notification of
that Directive, authorise
the placing on the market of plant protection products
containing active substances not listed in Annex I to 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 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 2-
Naphtyloxyacetic acid.

For 2-Naphtyloxyacetic acid the effects on human health
and the environment have been assessed in accordance
with the provisions laid down in Regulations (EC) No
1112/2002 and (EC) No 2229/2004 for a range of
uses proposed by the notifier. Moreover, those Regu­
lations designate the rapporteur Member States which
reports and
have to submit

the relevant assessment

(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)

(5)

(6)

(7)

(8)

recommendations to the European Food Safety Authority
(EFSA) in accordance with Article 20 of Regulation (EC)
No 2229/2004.
the
rapporteur Member State was France and all relevant
information was submitted in October 2007.

For 2-Naphtyloxyacetic

acid

The Commission examined 2-Naphtyloxyacetic acid in
accordance with Article 24a of Regulation (EC) No
2229/2004. A draft review report
for that substance
was reviewed by the Member States and the 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 report.

it was

it may be expected that

During the examination of this active substance by the
Committee,
taking into account
concluded,
comments received from Member States, that there are
it has
clear indications that
harmful effects on human health and in particular the
crucial missing data does not allow to set an ADI and
such value is necessary to conduct the risk assessment.
Moreover, other concerns which were identified by the
rapporteur Member States in its assessment report are
included in the review report for the substance.

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
forwards by the notifier, the concerns identified could
not be eliminated, and assessments made on the basis
of the information submitted have not demonstrated that
it may be expected that, under the proposed conditions
of use, plant protection products containing 2-Naphty­
loxyacetic acid satisfy in general the requirements laid
down in Article 5(1)(a) and (b) of Directive 91/414/EEC.

2-Naphtyloxyacetic acid 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 2-Naph­
tyloxyacetic acid are withdrawn within a fixed period of
time and are not renewed and that no new authorisations
for such products are granted.

L 23/34

EN

Official Journal of the European Union

27.1.2009

(9)

(10)

(11)

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
2-Naphtyloxyacetic acid should be limited to 12 months
in order to allow existing stocks to be used in one
further growing season, which ensures
that plant
protection products containing 2-Naphtyloxyacetic acid
remain available to farmers for 18 months from the
adoption of this Decision.

(EC) No

6(2)
Regulation

This Decision does not prejudice the submission of an
application for 2-Naphtyloxyacetic acid in accordance
91/414/EEC and
with Article
of Directive
Commission
of
33/2008
17 January 2008 laying down detailed rules for the
application of Council Directive 91/414/EEC as regards
a regular and an accelerated procedure for the assessment
of active substances which were part of the programme
of work referred to in Article 8(2) of that Directive but
have not been included into its Annex I (1), in view of a
possible inclusion in its Annex I.

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

in this Decision are in
Standing
the

opinion

the

of

Article 2

Member States shall ensure that:

(a) authorisations for plant protection products containing 2-
Naphtyloxyacetic acid are withdrawn by 26 July 2009;

(b) no authorisations for plant protection products containing
2-Naphtyloxyacetic acid are granted or renewed from the
date of publication 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,
shall be as short as possible and shall expire on 26 July
2010 at the latest.

Article 4

This Decision is addressed to the Member States.

HAS ADOPTED THIS DECISION:

Article 1

2-Naphtyloxyacetic
substance in Annex I to Directive 91/414/EEC.

acid shall not be

included as

Done at Brussels, 26 January 2009.

active

For the Commission

Androulla VASSILIOU
Member of the Commission

(1) OJ L 15, 18.1.2008, p. 5.