EN    EN                             
 
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2015) XXX  draft 
  
COMMISSION IMPLEMENTING DECISION 
of XXX  
on technical standards for the refill  mechanism of electronic cigarettes 
 
(Text with EEA relevance) 
 EN 2   EN COMMISSION IMPLEMENTING DECISION 
of XXX  
on technical standards for the refill  mechanism of electronic cigarettes 
 
(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
1, and in particular Ar ticle 20(13) thereof, 
 
Whereas: 
(1) Article 20(3)(g) of Directiv e 2014/40/EU requires Member States to ensure that 
electronic cigarettes and their refill containers have a mechanism that ensures refilling 
without leakage.  
(2) Article 20(13) of Directive 2014/40/EU confers implementing powers on the 
Commission to lay down techni cal standards for the refill mechanism of electronic 
cigarettes. 
(3) Given the toxicity of the nicotine-containi ng liquids used in electronic cigarettes and 
refill containers, it is appropriate to ensure th at electronic cigarettes can be refilled in a 
manner that minimises the risk of dermal contact or accidental ingestion of such 
liquids. 
(4) On the basis of feedback received from stakeholders and work carried out by an 
external contractor, technical standards ha ve been identified which are intended to 
ensure that compliant refill mechanisms provide sufficient protection against leakage. 
(5) The technical standards identified also comp rise measures ensuring that consumers are 
properly informed of how to operate the ref ill mechanisms in order to ensure leakage 
free refilling.  
(6) These technical standards should therefor e constitute the basis for the technical 
standards to be adopted. 
(7) Stakeholders may wish to provide the Co mmission with information on alternative 
mechanisms they have developed for leakag e-free refilling, which may result in a 
revision of this decision.  
(8) The measures provided for in this Decision ar e in accordance with the opinion of the 
Committee referred to in Article  25 of Directive 2014/40/EU, 
                                                 
1 OJ L 127, 29.04.2014, p. 1.  EN 3   EN  
HAS ADOPTED THIS DECISION:  
Article 1 
Subject matter 
This Decision lays down the technical standa rds applicable to the refill mechanism of 
electronic cigarettes manufactured in or imported into the Union..  
 
Article 2 
Requirements for the refill mechanism   
1.  Member States shall ensure that refilla ble electronic cigarettes and refill containers 
are only placed on the market if the mech anism by which the electronic cigarettes are 
refilled  complies with one of the following conditions: 
(a) it entails the use of a refill containe r possessing a non-detachable nozzle at 
least 1cm long, which is narrower than a nd slots comfortably into the opening 
of the tank of the electroni c cigarette with which it is used and possessing a 
flow control mechanism that emits no more than 20 drops of refill liquid per minute when placed vertically; 
(b) it operates by means of a docking system  which only releases refill liquids 
when the electronic cigarette and refill container are connected.  
2.  Member States shall ensure that refilla ble electronic cigarettes and refill containers 
include appropriate instructions for refilling including graphic illustrations as part of  the instructions for use required by Artic le 20(4)(a)(i) of Directive 2014/40/EU. 
Refillable electronic cigarettes and refill c ontainers with a ref ill mechanism of the 
type referred to in paragraph 1(a) shall in dicate the width of the nozzle or width of 
the opening of the tank in the instructions for use in a manner that enables consumers 
to identify the compatibility of refill containers and electronic cigarettes.   
 
Article 3 
Addressees 
This Decision is addressed to the Member States. 
 Done at Brussels, 
 For the Commission 
 Vytenis ANDRIUKAITIS  
 Member of the Commission