EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
  
COMMISSION IMPLEMENTING DECISION  
of XXX  
establishing a format for the submission and making available of information on 
ingredients and emissions of tobacco products and on sales volumes    
EN 2   EN COMMISSION IMPLEMENTING DECISION  
of XXX  
establishing  a format for the submission and making available of information on 
ingredients and emissions of tobacco products and on sales volumes  
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, regulations 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 5(5) thereof, 
Whereas:  
(1) Directive 2014/40/EU provides that manufacturers and importers of tobacco products 
are to submit to the  competent  authorities of the Member States concerned information 
on the ingredients and emissions of tobacco products, and on their sales volumes.  The 
information should be submitted prior to the placing on the market of new or modified 
products . The format for the submission of that information  and its making available 
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 new format.  
(3) A common electronic  reporting format for submission of information on ingredients 
and emissions of tobacco products should allow Member States and the Commission 
to compare, analyse and draw conclusions from the information received. The data 
will also help identifying the additives to be included in the priority list referred to in  
Article 6 of Directive 2014/40/EU, provide the basis for deciding whether  maximum 
content levels should be set pursuant to Article 7 (5) and (11) of th at Directive and 
facilitate a coherent enforce ment of the ban on products with characterising flavour as 
provided for in Article 7 (1) of that Directive.  
(4) A common electronic entry gate for submission of data is essential to ensure uniform 
application of the reporting obligations s et out in Directive 20 14/40/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 entry gate should foresee tools for submission of information which are 
adequate bot h 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 sized companies.  
(6) Member States should be free to make the tools  for submission of information on 
ingredients and emissions laid down  in this Decision available  for notification of novel 
tobacco products prior to their placing on the market in accordance with Article 19 of 
                                                 
1 OJ L 127, 29.04.2014 , p. 1.   
EN 3   EN Directive 2014/40/EU.  The tools  could also facilitate submission of information on 
herbal products for smoking pursuant to  Article 2 2 of Directive 2014/40/EU and 
submission of other relevant information on tobacco products.  
(7) When resubmitting data, including correcting errors in an earlier submission, the 
information sh ould 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 marked as obsolete where appropriate.  
(8) 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 
Commissio n facilities. The service offered by the Commission should provide 
Member States with technical tools to facilitate compliance  with their obligations  
under Article 5 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.  
(9) Member States should encourage manufacturers and import ers to provide up-to-date 
information on sales volume  and toxicology data if new data become available. In 
order to ensure comparability within the U nion of reported data on sales volumes, 
Member States should also encourage manufacturer s and importers to submit updates 
of th ose data during the first half of the subsequent calendar year. Finally, Member 
States should encourage manufacturer s and importers to submit information on actual 
quantities of ingredients in tobacco products annually and to update th at information.  
(10) When submitting information on p roducts with the same composition and design , 
manufacturers and importers should to the extent possible, use  the same identification 
number , regardless of brand and subtype or whether they are placed on the ma rket in 
one or more Member States.  
(11) It is appropriate to lay down rules concerning the treatment of confidential data by the 
Commission  in order to ensure t he 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 intend to consume should be weighed 
against manufacturers’ intere sts of protecting recipes of their products. Having regard 
to those competing interests, in particular data that could reveal flavours  used in small 
quantities in specific product s should be kept confidential.  
(12) 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,  
 
HAS ADOPTED THIS DECISION:  
Article 1  
Subject matter  
This Decision establishes a common format for the reporting and making available of 
information on in gredients and emissions of tobacco products  and on sales volumes .  
  
EN 4   EN Article 2  
Format for data submission  
1. Member States shall ensure that manufacturers and importers of tobacco products 
submit information on ingredients , emissions and sales volumes referred to in Article 
5 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 tobacco products 
submit  the information referred to in paragraph 1 by means of  a common electronic 
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 un der Article 5 (7) of Directive 2014/40/EU provided they have 
signed a service level agreement with the Commission.  
 
Article 4 
Identification number of the data submitter  
Before submitt ing information  to Member States in accordance with  this Decision for th e first 
time, 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 our commercial activ ities in the area of tobacco  
products , 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.    
 
Article 5  
Identification number of the product  
1.  Based on the identification number referred to in Article 4, the manufacturer or 
impor ter shall generate a product identification number for each product placed on 
the market.  
2.  When submitting information on p roducts w ith the same composition and design , 
manufacturers and importers  shall , to the extent possible , use the same identificat ion 
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 assign ed 
to such products .   
EN 5   EN  
Article 6 
Confidential data and disc losure of data  
1.  In their submission, manufacturers and importers shall mark all information which 
they consider to be a trade secret or otherwise confidential and shall duly justify their 
claims.  
2.  When using the information transmitted for the purpo ses of applying Directive 
2014/40/EU and Regulation (EC) N o 1049/2001, t he Commission shall , in principle,  
not consider the following information to be confidential or a trade secret:  
(a) for all tobacco products, inclusion and quantity of additives other tha n 
flavourings;  
(b) for all tobacco products, inclusion and quantity of ingredients  other than 
additives used in quantities above 0.5%  of the total tobacco product unit 
weight ;  
(c) for cigarettes and roll -your-own tobacco , inclusion and quantity of individual 
flavourings used in quantities above 0.1% of the total tobacco product unit 
weight;   
(d) for pipe tobacco, cigars, cigarillos, smokeless tobacco products and all other 
tobacco products  inclusion and quantity of  individual flavourings used in 
quanti ties above 0.5% of the total tobacco product unit weight ; 
(e) studies on toxicity, addictiveness or attractiveness not linked to specific brands ; 
where those studies are linked to specific brands, the explicit and implicit 
references to the brand shall be remo ved 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