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8.3.2012 Official
Journal
of
the
European
Union L
69/15
DIRECTIVES
COMMISSION DIRECTIVE 2012/9/EU
of 7 March 2012
amending Annex I to Directive 2001/37/EC of the European Parliament and of the Council on the
approximation of the laws, regulations and administrative provisions of the Member States
concerning the manufacture, presentation and sale of tobacco products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
progress the health warnings set out in Annex I of the
same Directive. Furthermore, guidelines on tobacco
packaging and labelling
( 2 ) adopted by the Third
Having regard to the Treaty on the Functioning of the European
Conference of the Parties to the WHO Framework
Union,
Convention on Tobacco Control in November 2008
recommend that legal measures for packaging and
labelling of tobacco products should be reviewed period
Having regard to Directive 2001/37/EC of the European
ically and updated as new evidence emerges and as
Parliament and the Council of 5 June 2001 on the approxi
specific health warnings and messages wear out.
mation of the laws, regulations and administrative provisions of
the Member States concerning the manufacture, presentation
and sale of tobacco products ( 1 ), and in particular Article 9(2)
thereof,
(6) A
revision
of
the
current
additional
warnings
set
out
in
Annex I to Directive 2001/37/EC is therefore needed in
order to maintain and increase their impact, and to take
Whereas:
into account the new scientific developments.
(1) Article
5(2)(b)
of
Directive
2001/37/EC
provides
that
each unit packet of tobacco products, except for
(7)
This revision should be based on the results of the review
tobacco for oral use and other smokeless tobacco
of existing knowledge on tobacco labelling and the
products, and any outside packaging, with the
health effects of tobacco use and of testing of the
exception of additional transparent wrappers, must
warnings made in all Member States.
carry an additional warning from the list set out in
Annex I to that Directive.
(8) The
measures
provided
for
in
this
Directive
are
in
accordance with the opinion of the Regulatory
(2) Those
additional
warnings
have
been
mandatory
on
all
Committee established under Article 10(1) of Directive
packages of smoking tobacco since September 2003 and
2001/37/EC and neither the European Parliament nor the
on packages of other tobacco products since September
Council has opposed them,
2004.
(3) Evidence
suggests
that
the
impact
of
current
additional HAS ADOPTED THIS DIRECTIVE:
warnings set out in Annex I to Directive 2001/37/EC has
decreased over time as the novelty effect of the warning
messages has worn off.
Article 1
Annex I to Directive 2001/37/EC is replaced by the text in the
(4) In
addition,
new
scientific
evidence
on
the
health
effects Annex to this Directive.
of tobacco use and the principles of effective tobacco
labelling has emerged since the adoption of Directive
2001/37/EC. In particular, there is evidence that
smoking plays a causal role in mouth and throat
Article 2
cancer, visual impairments as well as dental and gum
1. Member
States
shall
bring
into
force
the
laws,
regulations
disease. There is also evidence that parental smoking is
and administrative provisions necessary to comply with this
a major risk factor for smoking initiation.
Directive by 28 March 2014 at the latest. They shall
forthwith communicate to the Commission the text of those
provisions.
(5) Article
9(2)
of
Directive
2001/37/EC
provides
that
the
Commission shall adapt to scientific and technical
( 2 ) FCTC/COP3(10) Guidelines for implementation of Article 11 of the
WHO Framework Convention on Tobacco Control (Packaging and
( 1 ) OJ L 194, 18.7.2001, p. 26.
labelling of tobacco products).

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L 69/16
EN
Official Journal of the European Union
8.3.2012
When Member States adopt those provisions, they shall contain
Article 4
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
This Directive shall enter into force on the 20th day following
States shall determine how such reference is to be made.
its publication in the Official Journal of the European Union.
Article 5
2. Member
States
shall
communicate
to
the
Commission
the This Directive is addressed to the Member States.
text of the main provisions of national law which they adopt in
the field covered by this Directive.
Done at Brussels, 7 March 2012.
Article 3
For the Commission
Member States may decide to allow the continuation of
marketing of products not complying with the provisions of
The President
this Directive until 28 March 2016.
José Manuel BARROSO
ANNEX
‘ANNEX I
List of additional health warnings
(referred to in Article 5(2)(b))
(1) Smoking causes 9 out of 10 lung cancers
(2) Smoking causes mouth and throat cancer
(3) Smoking damages your lungs
(4) Smoking causes heart attacks
(5) Smoking causes strokes and disability
(6) Smoking clogs your arteries
(7) Smoking increases the risk of blindness
(8) Smoking damages your teeth and gums
(9) Smoking can kill your unborn child
(10) Your smoke harms your children, family and friends
(11) Smokers’ children are more likely to start smoking
(12) Quit smoking – stay alive for those close to you ( 1 )
(13) Smoking reduces fertility
(14) Smoking increases the risk of impotence
___________
( 1 ) To be completed by a reference to the telephone/Internet address of the quit lines/cessation services if existing in the
Member State concerned.’

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Document Outline

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