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,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Directive 2001/37/EC of the European 
Parliament and the Council of 5 June 2001 on the approxi ­
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,  
Whereas:  
(1) Article 5(2)(b) of Directive 2001/37/EC provides that 
each unit packet of tobacco products, except for 
tobacco for oral use and other smokeless tobacco 
products, and any outside packaging, with the 
exception of additional transparent wrappers, must 
carry an additional warning from the list set out in 
Annex I to that Directive.  
(2) Those additional warnings have been mandatory on all 
packages of smoking tobacco since September 2003 and 
on packages of other tobacco products since September 
2004.  
(3) Evidence suggests that the impact of current additional 
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.  
(4) In addition, new scientific evidence on the health effects 
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 
cancer, visual impairments as well as dental and gum 
disease. There is also evidence that parental smoking is 
a major risk factor for smoking initiation.  
(5) Article 9(2) of Directive 2001/37/EC provides that the 
Commission shall adapt to scientific and technical 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 
Conference of the Parties to the WHO Framework 
Convention on Tobacco Control in November 2008 
recommend that legal measures for packaging and 
labelling of tobacco products should be reviewed period ­
ically and updated as new evidence emerges and as 
specific health warnings and messages wear out.  
(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 
into account the new scientific developments.  
(7) This revision should be based on the results of the review 
of existing knowledge on tobacco labelling and the 
health effects of tobacco use and of testing of the 
warnings made in all Member States.  
(8) The measures provided for in this Directive are in 
accordance with the opinion of the Regulatory 
Committee established under Article 10(1) of Directive 
2001/37/EC and neither the European Parliament nor the 
Council has opposed them,  
HAS ADOPTED THIS DIRECTIVE:  
Article 1  
Annex I to Directive 2001/37/EC is replaced by the text in the 
Annex to this Directive.  
Article 2  
1. Member States shall bring into force the laws, regulations 
and administrative provisions necessary to comply with this 
Directive by 28 March 2014 at the latest. They shall 
forthwith communicate to the Commission the text of those 
provisions.EN 8.3.2012 Official Journal of the European Union L 69/15  
( 1 ) OJ L 194, 18.7.2001, p. 26.  ( 2 ) FCTC/COP3(10) Guidelines for implementation of Article 11 of the 
WHO Framework Convention on Tobacco Control (Packaging and 
labelling of tobacco products).When Member States adopt those provisions, they shall contain 
a reference to this Directive or be accompanied by such a 
reference on the occasion of their official publication. Member 
States shall determine how such reference is to be made.  
2. Member States shall communicate to the Commission the 
text of the main provisions of national law which they adopt in 
the field covered by this Directive.  
Article 3  
Member States may decide to allow the continuation of 
marketing of products not complying with the provisions of 
this Directive until 28 March 2016.  Article 4  
This Directive shall enter into force on the 20th day following 
its publication in the  Official Journal of the European Union . 
Article 5  
This Directive is addressed to the Member States.  
Done at Brussels, 7 March 2012.  
For the Commission  
The President  
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.’EN L 69/16 Official Journal of the European Union 8.3.2012