EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
KB1 […](2014) XXX  draft 
  
COMMISSION D ELEGATED DIRECTIVE ../…/EU 
of XXX  
amending Annex II to Directive 2014/40/EU of  the European Parliament and of the 
Council by establishing the li brary of picture warnings to be used on tobacco products 
(Text with EEA relevance) 
  
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT 
Directive 2014/40/EU of the Eu ropean Parliament and of th e Council of 3 April 2014 on the 
approximation of the laws, regulations and admi nistrative provisions of  the Member States 
concerning the manufacture, presentation and sale of tobacco and related products1 provides 
for, in Article 10(1), the mandatory use of comb ined health warnings on tobacco products for 
smoking. However, Member States may exempt  tobacco products for smoking other than 
cigarettes, roll your own tobacco and waterpip e tobacco from the obligation to carry the 
combined health warnings in line with Article 11(1). The co mbined health warnings should 
contain, inter alia,  one of the text warnings listed in Annex I and a corresponding colour 
photograph specified in the picture library in  Annex II. In line with Article 10(2) the 
combined health warnings should be grouped into  three sets as set ou t in Annex II and each 
set should be used in a given year and rotated on an annual basis. In line  with Article 10(3)(b) 
the picture library should be es tablished by a delegated act. S ubsequently, the picture library 
should be inserted as Annex II into Directive 2014/40/EU.  
In order to use the combined health warnings on tobacco products for smoking, it needs to be 
ensured that they comply with  Article 10 of Directive 2014/40/EU . That article provides for, 
inter alia,  the display of smoking cessation informa tion by the Member States. Furthermore, 
Directive 2014/40/EU empowers the Commission to  adopt implementing acts to define the 
technical specifications for the layout, design and shape of the combined health warnings, 
taking into account the different packet shapes . Those implementing acts are to be adopted in 
due course. 
 2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT 
The Commission has consulted experts thr ough the Commission Expert Group on Tobacco 
Policy before adoption of this act.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT 
According to Article 10(3)(b) of Directive 2014/40/EU, the Commissi on is empowered to 
adopt delegated acts in accordance with Article 27 of that Directive to establish and adapt the 
picture library referred to in  Article 10(1)(a) taking into account scientific and market 
developments.  
 
                                                 
1 OJ L 127, 29.04.2014, p. 1.  
EN 3   EN COMMISSION DELEGATED DIRECTIVE ../…/EU 
of XXX  
amending Annex II to Directive 2014/40/EU of the European Parliament and of the 
Council by establishing the library of picture warnings to be used on 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 2014/40/EU of the Eu ropean Parliament and of the Council of 3 
April 2014 on the approximation of the laws, regul ations and administrative provisions of the 
Member States concerning the manufacture, pres entation and sale of tobacco and related 
products and repeali ng Directive 2001/37/EC
2, and in particular Article 10(3)(b) thereof, 
 Whereas: (1) Article 10 of Directive 2014/40/EU provides that each unit packet and any outside 
packaging of tobacco products for smoking is to carry combined health warnings unless exempted in accordance with Article 11. The combined  health warnings are to 
contain, inter alia , one of the text warnings list ed in Annex I and a corresponding 
colour photograph specified in  the picture library  in Annex II to that Directive.  
(2) Directive 2014/40/EU also empowers the Commission to adopt delegated acts to 
establish and adapt the pictur e library in Annex II taking into account scientific and 
market developments. 
(3) Therefore, Annex II to Directive 2014/ 40/EU should be amended accordingly,  
 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex II to Directive 2014/40/EU is  replaced in accordance with the Annex to this Directive.  
 
Article 2  
1. Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comp ly with this Directive by 20 May 2016 at the latest. 
They shall forthwith communicate to the Co mmission the text of those provisions. 
They shall apply those provisions from 20 May 2016. 
                                                
 
2 OJ L 127, 29.04.2014, p. 1.   
EN 4   EN 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 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union .  
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, 
For the Commission 
The President […]