2009/9/EC: Commission Decision of 8 December 2008 concerning the non-inclusion of nicotine 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) 7714) (Text with EEA relevance)
Date: 2008-12-08
Institutions: European Commission
Subjects: European Food Safety Authority, dangerous substance, marketing standard, pharmaceutical product, plant health product, smoking, tobacco, tobacco industry

9.1.2009

EN

Official Journal of the European Union

L 5/7

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

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 8 December 2008

concerning the non-inclusion of nicotine 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) 7714)

(Text with EEA relevance)

(2009/9/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Annex I
nicotine.

to Directive 91/414/EEC. That

list

includes

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
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

(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.

(3)

(4)

(5)

laid

down

Regulations

For nicotine the effects on human health and the envi­
ronment have been assessed in accordance with the
provisions
(EC) No
in
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
recommendations
Safety
Authority (EFSA) in accordance with Article 20 of Regu­
lation (EC) No 2229/2004. For nicotine the rapporteur
Member State was the United Kingdom and all relevant
information was submitted in January 2008.

the relevant assessment

European

Food

the

to

The Commission examined nicotine in accordance with
Article 24a of Regulation (EC) No 2229/2004. A draft
review report for that substance was reviewed by the
the Commission within the
Member
Standing Committee on the Food Chain and Animal
Health and finalised on 26 September 2008 in the
format of the Commission review report.

States

and

During the examination of this active substance by the
taking into account
it was
Committee,
concluded,
comments
the
received from Member States,
existing evidence is not sufficient to demonstrate a safe
use with respect to operators, workers, bystanders and
consumers. Moreover, other concerns which were iden­
tified by the rapporteur Member State in its assessment
report are
the
substance.

included in the

review report

that

for

L 5/8

EN

Official Journal of the European Union

9.1.2009

(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 have not demonstrated that
it
may be expected that, under the proposed conditions
of use, plant protection products containing nicotine
satisfy in general
laid down in
the
Article 5(1)(a) and (b) of Directive 91/414/EEC.

requirements

(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

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

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

Member States shall ensure that:

Article 2

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

for

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
nicotine 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 nicotine remain available to farmers for 18
months from the adoption of this Decision.

(a) authorisations

for plant protection products containing

nicotine are withdrawn by 8 June 2009;

(b) no authorisations for plant protection products containing
nicotine 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,
shall be as short as possible and shall expire on 8 June 2010
at the latest.

This Decision does not prejudice the submission of an
application for nicotine in accordance with Article 6(2)
of Directive 91/414/EEC and Commission Regulation
(EC) No 33/2008 of 17 January 2008 laying down
detailed rules for the application of Council Directive
91/414/EEC as regards a regular and an accelerated
procedure
substances
assessment of
which were part of the programme of work referred to
that Directive but have not been
in Article 8(2) of
included into its Annex I (1),
in view of a possible
inclusion in its Annex I.

active

the

for

This Decision is addressed to the Member States.

Article 4

Done at Brussels, 8 December 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

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