EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
  
COMMISSION IMPLEMENTING DECISION  
of XXX  
establishing a common format for the notification of electronic cigarettes and refill 
containers  
   
EN 2   EN COMMISSION IMPLEMENTING DECISION  
of XXX  
establishing  a common format for the notification of electronic cigarettes and refill 
containers  
 
THE EUROPEAN COMMISSION,  
Having regard to Directive 2014/40/EU of the European Parliament and of the Council of 3 
April 2014 on the approximation of the laws, regulation s and administrative provisions of the 
Member States concerning the manufacture, presentation and sale of tobacco and related 
products and repealing Directive 2001/37/EC1, and in particular Article 20 (13) thereof,  
 
Whereas:  
(1) Directive 2014/40/EU provides that manufacturers and importers of electronic 
cigarettes and refill containers are to submit to the  competent authorities of the 
Member States concerned a notification of any such products which they intend to 
place on the market  or which are already placed on the market on 20 May 2016 . The 
information should be submitted six months before the intended placing on the market 
of new or substantially modified products. The format for that notification should be 
laid down.   
(2) The experience gained and the knowledge acquired with existing formats for the 
reporting of tobacco ingredients, where relevant, should be taken into account when 
developing the format.  
(3) A common electronic notification format for submission of information on electronic 
cigarettes and refill containers should allow Member States and the Commission to 
compare, analyse and draw conclusions from the information received. The data will 
also provide a basis for assessing health impacts  associated with these products . 
(4) A common electronic entry gate for submission of data is essential to ensure uniform 
application of the notification  obligations set out in Directive 2014/40/EU. In 
particular, a common entry gate facilitate s and harmonise s the submission of data from 
the manufacturer or importer to the Member States. Streamlining the submission 
process also reduces administrative burden for manufacturers, importers and national 
regulators and facilitates comparison of data.  
(5) The common entr y gate should foresee tools for submission of information which are 
adequate both for companies which have comprehensive IT solutions in place (system 
to system submissions ) and for companies which have no such solutions , in particular 
small and medium siz ed companies .   
(6) Member States should be free to make the tools  for submission of information laid 
down  in this Decision available for submission of information required under Article 
                                                 
1 OJ L 127, 29.04.2014 , p. 1.   
EN 3   EN 20(7) of Directive 2014/40/EU and should encourage updates to be submitte d during 
the first half of the subsequent calendar year in order to ensure comparability within 
the U nion. The tools could also facilitate submission of other information on 
electronic cigarettes and refill containers  pursuant  to Article 20 . 
(7) When resubmitting data, including correcting errors in an earlier submission, the 
information should be provided through the common entry gate indicating which 
previous data set should be replaced or deleted.  The previously submitted information 
should  remain available, but should  be mark ed as obsolete where appropriate.  
(8) In order to ensure the quality and comparability of data submitted, Member States 
should, where applicable, encourage manufacturer s and importers to use agreed 
standards or testing methods . In the absence of agreed U nion or international standards 
or testing methods, manufacturers and importers should clearly describe in their 
notifications the measurement methods used and should ensure that the y are   
reproducible.  
(9) In order to limit the ad ministrative burden and ensure comparability between reported 
data, Member States should encourage m anufacturers and importers to select 
compatible items when  testing components of electronic cigarettes  and refill 
containers  placed on the market as separat e items . 
(10) Whilst the full responsibility for gathering, verifying, analysing, storing and 
disseminating the data collected in accordance with this Decision lies with the 
Member States, they should have  the possibility to store the data submitted to them at 
Commission facilities. The service offered by the Commission should provide 
Member States with technical tools to facilitate compliance  with their obligations  
under Article 20 of Directive 2014/40/EU . The Commission will develop a standard 
service level agreement for this purpose.  With the agreement of Member States, t he 
Commission should keep an off -line copy of the data submitted through the common 
entry gate for the purpose of applying Directive 2014/40/EU.  
(11) Member Stat es should encourage manufacturers and importers to provide up -to-date 
toxicology data if new data become available.  
(12) When submitting information on products with the same composition and design , 
manufacturers and importers should to the extent possible, us e the same identification 
number , regardless of brand and subtype or whether they are placed on the market in 
one or more Member States.  
(13) It is appropriate to lay down rules concerning  the treatment of confidential data by the 
Commission in order to ensure  the greatest possible transparency of product 
information for the general public, whilst ensuring that due account is taken of trade 
secrets. The legitimate expectation of consumers to have access to adequate 
information on the content of products they in tend to consume should be weighed 
against manufacturers’ interests of protecting recipes of their products. Having regard 
to those competing interests , data that could reveal ingredients used in small quantities 
in specific product s should , in principle , be kept confidential.  
(14) The measures provided for in this Decision are in accordance with the opinion of the 
Committee referred to in Article 25 of Directive 2014/40/EU , 
  
EN 4   EN HAS ADOPTED THIS DECISION:  
Article 1  
Subject matter  
This Decision establishes a common format for the notification of information on electronic 
cigarettes and refill containers . 
 
Article 2  
Format for notification   
1.  Member States shall ensure that manufacturers and importers of electronic cigarettes 
and refill containe rs submit information referred  to in Article 20(2) of Directive 
2014/40/EU , including modifications and withdrawal from the market,  in accordance 
with the format provided for in the Annex.   
2.  Member States shall ensure that manufacturers and importers of electronic cigarettes 
and refill containers submit  the information  referred to in paragraph 1 by means of  a 
common  entry gate for data submission .   
 
Article 3  
Storage of data  
Member States  shall be entitled to use data storage services offered by the Commission to 
comply with their obligations under Article 20 (2) of Directive 2014/40/EU provided they 
have signed a service level agreement with the Commission.  
 
Article 4 
Identification number o f the data submitter  
Before submitt ing information  to Member States for the first time  pursuant  to this Decision , 
the manufacturer or importer shall obtain an identification number  generated from the 
common entry gate . In its application for the identification number, the manufacturer or 
importer shall provide the Commission with a certifi cate by a competent national authority  
that the manufacturer or importer is carrying out commercial activ ities in the area of 
electronic cigarettes , including a  description  of its main activities and an English translation 
thereof where needed. The manufacturer or importer  shall use the identification number for all 
subsequent submissions and in all subsequent correspondence.    
 
Artic le 5  
Identification number of the product   
EN 5   EN 1.  Based on the identification number referred to in Article 4, the manufacturer or 
importer shall generate  a product identification number for each product placed on 
the market.  
2.  When submitting information on products w ith the same composition  and design , 
manufacturers and importers shall, to the extent possible, use the same identification 
number , in particular whe re data are submitted by various members of a group of 
companies. This shall apply regardless of brand, subtype and the number of markets 
on which they are placed.  
3.  Where  the manufacturer or importer is not able to ensure that the same identification 
number is used for products with the same composition and design , it shall at least 
provide, in so far as possible the different identification number s that were assigned 
to such products .  
  
Article 6 
Confidential data and disclosure of data  
1.  In their submission, manufacturers and importers shall mark all information w hich 
they consider to be a trade secret or otherwise confidential and shall duly justify their 
claims.  
2.  In using the data transmitted for applying Directive 2014/40/EU  and Regulation (EC) 
No 1049/2001 , the Commission shall, in principle, not consider t he following 
information to be confidential or amount to a trade secret:  
(a) ingredients used in quantities above 0.1% of the final formulation of the liquid ;  
(b) studies on toxicity, addictiveness or attractiveness not linked to specific brands ; 
where those stu dies are linked to specific brands, the explicit and implicit 
references  allowing to identify  the brand shall be removed and the redacted 
version shall be accessible.    
 
Article 7 
Addressees  
This Decision is addressed to the Member States.  
 
Done at Brussels,  
 For the Commission  
 […] 
 
  
 The President (