2008/902/EC: Commission Decision of 7 November 2008 concerning the non-inclusion of napropamide 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(2008) 6281) ((Text with EEA relevance))
Date: 2008-11-07
Institutions: European Commission
Subjects: animal health, health legislation, marketing restriction, pharmaceutical product, plant health product, withdrawal from the market

4.12.2008

EN

Official Journal of the European Union

L 326/35

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 7 November 2008

concerning the non-inclusion of napropamide 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(2008) 6281)

(Text with EEA relevance)

(2008/902/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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 napropamide.

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)

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.

(2)

Commission Regulations (EC) No 451/2000 (2) and (EC)
No 1490/2002 (3) lay down the detailed rules for the
implementation of the third stage of the programme of
work referred to in Article 8(2) of Directive 91/414/EEC

(3)

(4)

For napropamide 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 1490/2002 for a range of uses proposed by
the notifier. Moreover, those Regulations designate the
rapporteur Member States which have to submit
the
reports and recommendations to
relevant assessment
the European Food Safety Authority (EFSA) in accordance
with Article 10(1) of Regulation (EC) No 1490/2002. For
napropamide the rapporteur Member State was Denmark
and
on
relevant
6 September 2005.

information was

submitted

all

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
26 March 2008 in the format of the EFSA conclusion
regarding the peer review of the pesticide risk assessment
of the active substance napropamide (4). This report has
been reviewed
the
Commission within the Standing Committee on the
Food Chain and Animal Health and finalised on
11 July 2008 in the format of the Commission review
report for napropamide.

the Member

States

and

by

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 55, 29.2.2000, p. 25.
(3) OJ L 224, 21.8.2002, p. 23.

(4) EFSA Scientific Report (2008), 140, 1-72. Conclusion regarding the peer
review of the pesticide risk assessment of the active substance napropamide
finalised 26 March 2008.

L 326/36

EN

Official Journal of the European Union

4.12.2008

(5)

(6)

(7)

(8)

(9)

During the evaluation of this active substance, a number
of concerns have been identified. In particular it was not
possible to perform a reliable risk assessment for the
leaching of the metabolite NOPA to the groundwater
the
on the basis of
available data did not demonstrate that
the risks to
aquatic organisms and fish eating birds and mammals
are acceptable. Consequently,
it was not possible to
conclude on the basis of the information available that
napropamide met the criteria for inclusion in Annex I to
Directive 91/414/EEC.

the available data. Moreover,

to submit

submitted its

The Commission invited the notifier
its
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,
containing napropamide
plant protection products
satisfy in general
laid down in
the
Article 5(1)(a) and (b) of Directive 91/414/EEC.

requirements

plementation rules of which have been laid down in
Commission Regulation (EC) No 33/2008 (1),
in view
of a possible inclusion in its Annex I.

(11)

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

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

Member States shall ensure that:

Article 2

(a) authorisations

for plant protection products containing

napropamide are withdrawn by 7 May 2009;

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

(b) no authorisations for plant protection products containing
napropamide are granted or renewed from the date of
publication of this Decision.

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

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 7 May 2010
at the latest.

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
napropamide should be limited to twelve months in
order to allow existing stocks to be used in one further
growing season, which ensures that plant protection
products containing napropamide remain available to
farmers
this
Decision.

from the adoption of

for 18 months

This Decision is addressed to the Member States.

Article 4

Done at Brussels, 7 November 2008.

(10)

This Decision does not prejudice the submission of an
application for napropamide according to the provisions
of Article 6(2) of Directive 91/414/EEC, the detailed im­

For the Commission

Androulla VASSILIOU
Member of the Commission

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