
Article 1 
This Decision establishes a common format for the reporting and making available of information on ingredients and emissions of tobacco products and on sales volumes.
Article 2 

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 
Member States shall be entitled to use data storage services offered by the Commission to comply with their obligations under Article 5(7) of Directive 2014/40/EU provided they have signed a service level agreement with the Commission.
Article 4 
Before submitting information to Member States in accordance with this Decision for the first time, the manufacturer or importer shall apply for an identification number (Submitter ID) generated by the operator of the common entry gate. The manufacturer or importer shall, upon request, submit a document providing company identification and authentication of activities in accordance with the national legislation where the company is established. The Submitter ID shall be used for all subsequent submissions and in all subsequent correspondence.
Article 5 

1. Based on the Submitter ID referred to in Article 4, the manufacturer or importer shall assign a Tobacco Products ID (TP-ID) for each product to be reported.
2. When submitting information on products with the same composition and design, manufacturers and importers shall, to the extent possible, use the same TP-ID, in particular where 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 TP-ID is used for products with the same composition and design, it shall at least provide, in so far as possible, the different TP-ID that were assigned to such products.
Article 6 

1. In their submission, manufacturers and importers shall mark all information which they consider to be a trade secret or otherwise confidential and shall, upon request, duly justify their claims.
2. When using the information transmitted for the purposes of applying Directive 2014/40/EU and Regulation (EC) No 1049/2001 of the European Parliament and of the Council, the 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 than 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 quantities above 0,5 % of the total tobacco product unit weight;
(e) studies and data submitted according to Article 5(3) of Directive 2014/40/EU, in particular on toxicity and addictiveness. Where those studies are linked to specific brands, the explicit and implicit references to the brand shall be removed and the redacted version shall be accessible.
Article 7 
This Decision is addressed to the Member States.
Done at Brussels, 25 November 2015.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
ANNEX
1. 
All fields marked (M) in the common format are mandatory.

Filter-dependent mandatory fields (F) become mandatory if a specific response is selected from a previous variable.

System-generated fields (AUTO) are automatically generated by the software system.

For fields in which the response is to be selected from a list, corresponding reference tables will be provided, maintained and published on a Commission website.

2. 
The submitter is either the manufacturer or importer responsible for the submitted data.


Field # Field Description Reporting Submitter considers information confidential
 Submitter_ID Submitter ID is the identification number attributed pursuant to Article 4 M 
 Submitter_Name Official name of the submitter at Member State level, as linked to the VAT number M 
 Submitter_SME Indication whether the submitter, or its parent company if any, is an SME as defined in Commission Recommendation 2003/361/EC M 
 Submitter_VAT VAT number of the submitter M 
 Submitter_Type Indication whether the submitter is a manufacturer or importer M 
 Submitter_Address Address of the submitter M 
 Submitter_Country Country in which the submitter has its seat/domicile M 
 Submitter_Phone Business phone of the submitter M 
 Submitter_Email Functional business email address of the submitter M 
 Submitter_Has_Parent_Company Tick the box if the submitter has a parent company M 
 Submitter_Has_Affiliate_Company Tick the box if the submitter has an affiliate company M 
 Submitter_Appoints Enterer Tick the box if the submitter has appointed a third party to submit its data on its behalf (‘enterer’) M 

 2.1. 
For the parent company, the following information must be provided: Submitter ID number if any, official name, address, country, business phone and functional business email address.
 2.2. 
For each affiliate, the following information must be provided: Submitter ID number if any, official name, address, country, business phone and functional business email address.
 2.3. 
For the enterer, the following information must be provided: Submitter ID number if any, official name, address, country, business phone and functional business email address.

3. 

Field # Field Description Reporting Submitter considers information confidential
 Submission_Type Type of submission for the product M 
 Submission_Start_Date Submission date will be filled in automatically when the user submits the information about the product AUTO 
 Product_ID_(TP-ID) TP-ID is the identification number of the product used in the system in the format ‘submitter ID-year-product number’ (NNNNN-NN-NNNNN), where
 ‘submitter ID’ is the ID number of the submitter (see above),
 ‘year’ is the year within which data on the product were submitted for the first time (2 digits)
 ‘product number’ is the number attributed by the submitter to the product when submitting data for the first time M 
 Product_ID_Other_Exist Indication whether the submitter is aware of another product(s) with the same design and composition that is marketed in the EU using a different TP-ID M 
 Product_ID_Other List TP-ID of the product(s) with same design and composition. If TP-ID of the product(s) is not known to the submitter, full brand and subtype name(s) as well as Member State(s) where product(s) is placed on the market shall at least be provided F 
 Product_Same_Composition_Exist Indication whether the submitter is aware of another product(s) with the same proportion of ingredients in the tobacco blend composition M 
 Product_Same_Composition_Other List TP-ID of the product(s) with the same proportion of ingredients in the tobacco blend composition. If TP-ID of the product(s) is not known to the submitter, brand and subtype name(s) as well as Member State(s) where product(s) is placed on the market shall at least be provided F 
 Product_Type Type of tobacco product concerned M 
 Product_Length Average length of the product unit in mm F 
 Product_Diameter Average diameter (measured at the point with maximal diameter) of the product unit in mm F 
 Product_Weight Weight of one product unit, including the moisture, in mg M 
 Product_Tobacco_Weight Total weight of the tobacco in one product unit in mg M 
 Product_Manufacturer_Identification If the submitter is not the manufacturer, the official company name(s) of the manufacturer(s) of the product including its contact details F 
 Product_Filter Existence of a filter in the product F 
 Product_Filter_Length Length of the product filter in mm F 
 Product_Production_Site_Address For each manufacturer, address(es) of the site(s) where production is completed M 
 Product_Technical_File Technical document setting out a general description of the additives used and their properties F
 Product_Market_Research_File Internal and external studies on market research and preferences of various consumer groups, including young people and current smokers, relating to ingredients and emissions, available to submitter as well as executive summaries of any market surveys carried out when launching new products. To be updated in case new data become available. M 



3. 
Where products are presented for sale in different formats or where the same product is presented for sale in different Member States, the following variables must be completed for each format and each Member State.


Field # Field Description Reporting Submitter considers information confidential
 Product_Brand_Name Brand name under which the product is marketed in the Member State to which information is being submitted. M 
 Product_Brand_Subtype_Name Product ‘subtype name’ (if any) as marketed in the Member State to which the product information is being submitted M 
 Product_Launch_Date Date on which the submitter plans to launch/launched the product on the market M 
 Product_Withdrawal_Indication Indication that the submitter plans to withdraw/withdrew the product from the market M 
 Product_Withdrawal_Date Date on which the submitter plans to withdraw/withdrew the product from the market F 
 Product_Submitter_Number ID number used internally by the submitter MAt least one of those numbers must be used consistently for all submissions made by a single submitter. 
 Product_UPC_Number UPC-12 (Universal Product Code) of the product 
 Product_EAN_Number EAN-13 or EAN-8, (European Article Number) of the product 
 Product_GTIN_Number GTIN (Global Trade Identification Number) of the product 
 Product_SKU_Number SKU (Stock Keeping Unit) number(s) of the product 
 Product_National_Market Member State to which the product information below is being provided M 
 Product_Package_Type Type of product package M 
 Product_Package_Units Number of individual product units in the unit packet M 
 Product_Package_Net_Weight Net weight of one unit packet in g F 
 Product_Sales_Volume Information on annual sales volume of the product per Member State to be reported annually in product units or in kg loose tobacco M 
 Product_Other_Market_Data Supplementary market data available to the submitter. To be updated in case new data become available. F 

4. 
For each of the tobacco ingredients used in the product, the following variables must be completed for each combination of leaf cure method, leaf type and part type.


Field # Field Description Reporting Submitter considers information confidential
 Tobacco_Part_Type Type of tobacco part M 
 Tobacco_Part_Type_Other Name of the tobacco part type if ‘other’ F 
 Tobacco_Part_Description_File General description of the manufactured part type in the recipe. The description must provide detailed information on the quantitative and qualitative composition of the manufactured tobacco F 
 Tobacco_Part_Manufactured_Supplier For each supplier, the official company name(s) including its contact details F 
 Tobacco_Leaf_Type Type of tobacco leaf used M 
 Tobacco_Leaf_Type_Other Name or description of the tobacco leaf type if ‘other’ or ‘unspecified’ F 
 Tobacco_Leaf_Cure_Method Method used to cure the tobacco leaf M 
 Tobacco_Leaf_Cure_Method_Other Name or description of the cure method used if ‘other’. F 
 Tobacco_Quantity Weight per product unit in mg M 



5. 

Field # Field Description Reporting Submitter considers information confidential
 Ingredient_Category Category of product component (e.g. filters, papers etc.) M 
 Ingredient_Category_Other The category of product component if ‘other’ F 
 Ingredient_Name Chemical name of the ingredient M 
 Ingredient_CAS CAS (Chemical Abstracts Service) number M 
 Ingredient_CAS_Additional Additional CAS numbers if applicable. F 
 Ingredient_FEMA_Number FEMA (Flavour and Extract Manufacturers Association) number if any FIf a CAS number does not exist, at least one of those four numbers must be indicated. If more than one number is indicated, those numbers must be indicated in the following order of importance FEMA>Additive> FL>EC 
 Ingredient_Additive_Number If the ingredient is a food additive, its food additive ‘E number’ set out in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council 
 Ingredient_FL_Number FL number, if any (European Flavouring number as set out in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council) 
 Ingredient_EC_Number European Community (EC) number if any 
 Ingredient_Quantity_Fluctuate Indication whether the ingredient quantity fluctuates across production batches M 
 Ingredient_Recipe_Quantity Standard weight of the ingredient included in one product unit in mg according to recipe M 
 Ingredient_Recipe_Range_Min_Level Indication of the lowest weight (mg) of the ingredient in one product unit according to recipe, if the declared quantity fluctuates in order to adjust for the natural variations of the tobacco leaf F 
 Ingredient_Recipe_Range_Max_Level Indication of the highest weight (mg) of the ingredient in one product unit according to recipe, if the declared quantity fluctuates in order to adjust for the natural variations of the tobacco leaf F 
 Ingredient_Measured_Mean_Quantity Weight of the ingredient in mg that was actually added per product unit during the reporting period (calculated in the form of the statistical mean of the quantities of that ingredient added to each produced standardised batch) F 
 Ingredient_Measured_SD Statistically derived standard deviation of the mean quantity of ingredient added per product unit within each standardised batch F 
 Ingredient_Measured_Number Number of measurements considered F 
 Ingredient_Function Function(s) of the ingredient M 
 Ingredient_Function_Other Function of the ingredient if ‘other’ F 
 Ingredient_Priority_Additive Indication whether the ingredient is part of the priority list established pursuant to Article 6 of Directive 2014/40/EU M 
 Ingredient_Priority_Additive_Files Copies of the report(s) which shall include an executive summary, and a comprehensive overview compiling the available scientific literature on that additive and summarising internal data on the effects of the additive F 
 Ingredient_Unburnt_Status Indication whether the ingredient in unburnt form is characterised by any known type of toxicity or has carcinogenic, mutagenic or toxic for reproduction properties. M 
 Ingredient_REACH_Registration Registration number pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council, if any M 
 Ingredient_CLP_Whether_Classification Indication whether the ingredient has been classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council and is in the classification and labelling inventory M 
 Ingredient_CLP_Classification Ingredient classification with regard to Regulation (EC) No 1272/2008 F 
 Ingredient_Tox_Data Availability of toxicological data, concerning a substance, either in isolation or as part of a mixture. In each case, specify whether the toxicological data relate to the substance in burnt or unburnt form M 
 Ingredient_Tox_Emission Existence of studies that indicate the chemistry and/or toxicity of emissions F/M 
 Ingredient_Tox_CMR Existence of any study relating to the carcinogenicity, mutagenicity or toxicity for reproduction of the ingredient. F/M 
 Ingredient_Tox_CardioPulmonary Existence of in vitro and in vivo assays to evaluate the toxicological effects of the ingredient on the heart, blood vessels or respiratory tract. F/M 
 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient. F/M 
 Ingredient_Tox_Other Existence of any other toxicological data not stated above F/M 
 Ingredient_Tox/Addictive_File Upload available studies indicated in the previous six fields (Ingredient Tox Data, Emission, CMR, CardioPulmonary, Addictive, Other) F/M 






6. 

Field # Field Description Reporting Submitter considers information confidential
 Emission_Tar Tar yield according to the ISO standard 4387 with the accuracy of measurements determined in accordance with ISO standard 8243 F 
 Emission_Nicotine Nicotine yield according to the ISO standard 10315 with the accuracy of measurements determined in accordance with ISO standard 8243 F 
 Emission_CO Carbon monoxide yield according to the ISO standard 8454 with the accuracy of measurements determined in accordance with ISO standard 8243 F 
 Emission_TNCO_Lab Identification of the laboratory/laboratories used to measure emissions of tar, nicotine and carbon monoxide F 
 Emission_Other_Available Indication as to whether other emissions have been measured M 
 Emission_Other_Methods_File Description of the measurement methods used to assess the other emission. F 
 Emission_Other_Name Chemical name of the other emission produced during the testing of the product F 
 Emission_Other_CAS CAS (Chemical Abstracts Service) number of the other emission F 
 Emission_Other_IUPAC IUPAC (International Union of Pure and Applied Chemistry) name of the other emission, should a CAS number not exist F 
 Emission_Other_Quantity Quantity of the other emission produced during the process of using the product, based on the measurement method used F 
 Emission_Other_Units Unit in which the other emission is measured F 


7. 

Field # Field Description Reporting Submitter considers information confidential
 Cigarette_Characterising_Flavour Classification of the cigarette as having a characterising flavour as referred to in Article 7(14) of Directive 2014/40/EU M 
 Cigarette_Filter_Ventilation Total ventilation of the filter (0-100 %) M 
 Cigarette_Filter_Drop_Pressure_Closed Drop of pressure with closed vents (mmH2O) M 
 Cigarette_Filter_Drop_Pressure_Open Drop of pressure with open vents (mmH2O) M 

8. 

Field # Field Description Reporting Submitter considers information confidential
 Smokeless_pH pH of the product M 
 Smokeless_Nicotine_Content Total nicotine content of the product per product unit M 

9. 

Field # Field Description Reporting Submitter considers information confidential
 Roll-your-own/pipe_Total_Nicotine_Content Total nicotine content of the loose product per product unit M 
