EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
ANNEX 1  
  
ANNEX    
EN 2   EN ANNEX  
1. FIELD DESCRIPTIONS  
All fields provided for in the common format are mandatory (M).  
Filter 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, c orresponding reference tables will be provided, 
maintained and published on a Commission website.  
2. SUBMITTER CHARACTERIS TICS 
The submitter is either the manufacturer or importer responsible for the submitted data.  
Item #  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 R ecommendation 
2003/361 /EC1  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_Comp
any Tick the box if the submitter has a parent company  M   
 Submitter_Has_Affiliate_com
pany  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 Manufacturer/Importer Parent company characteristics  
For the parent company , the following information must  be provided:  Submitter ID number if any, official 
name, address, country, business phone and functional business e -mail address.   
                                                 
1 Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium -sized 
enterprises (OJ L 124, 20.5.2003, p. 36).   
EN 3   EN 2.2 Manufacturer/Importer affiliate company characteristics  
For each affiliate , the following information must  be provided:   Submitter ID number if any, official name, 
address, country, business phone and functional business e -mail address.   
2.3 Enterer reporting on behalf of the submitter  
For the enterer , the following information must be provided: Submitter ID number if any, official name, 
address, country, business phone and functional business e -mail address.   
3. PRODUCT INFORMATION SUBMISSION AND DESCRIPTION – PART A. 
Item #  Field  Comments  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   
 Tobacco_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  
 Tobacco_Product_ID_Other_Exist  Indication whether the submitter is aware of another 
product with the same  design and composition that is 
marketed in the EU using a different TP -ID  M  
 Tobacco_Product_ID_Other  TP_ID of the product(s) with  same design and composition 
known to the submitter  F  
 Tobacco_Product_ID_Other2  If TP_ID of the product(s) with same design and 
composition is not known to the submitter, indicate brand 
name and Member State (s) where product is placed on the 
market  F  
 Tobacco_Product_ Same_Compositio
n_Exist  Indication whether the submitter is aware of another 
product with the same proportion of ingredients in the 
tobacco blend composition  M  
 Tobacco_Product_Same_Compositio
n_Other  TP_ID of the product(s) with  the same proportion of 
ingredients in the tobacco blend composition known to 
the submitter  F  
 Tobacco_Product_Same_Compositio
n_Other2  If TP_ID of the product(s) with the same proportion of 
ingredients in the tobacco blend composition is not known 
to the submitter, indicate brand name and Member 
State (s) where product is placed on the market  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 unit2, including the specified 
moisture, in mg  M  
 Product_Tobacco_Weight  Total weight of the tobacco in one product unit in mg  
 M  
 Product_Manufacturer_Identificatio
n If the submitter is not the manufacturer, the official 
company name of the manufacturer of the product F   
                                                 
2 One unit for loose tobacco  is 1 g.   
EN 4   EN including its contact details (multiple entries possible if the 
product is manufactured by multiple companies)3 
 Product_Production_Multiple_Sites  Indication if the product is produced in multiple sites,  M  
 Product_Production_Site_Address  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 
3. PRODUCT INFORMATION SUBMISSION AND DESCRIPTION – PART B.  
Where product s are presented for sale in different formats,  the following variables must be completed for 
each format . 
Item #  Field  Comments  Reporting  Submitter 
considers 
information 
confidential  
 Product_Brand_Name  Brand name under which the product is  marketed in the 
Member State(s) to  which information is being submitted.  M  
 Product_Brand_Subtype_Name  Product “subtype name” (if any) as marketed in the Member 
State(s) to which the product information is being submitted  M  
 Product_Unit_ Packet_ Picture_File  Picture of the unit pack et (multiple entries possible). The 
picture must be clear enough to view details and to assist  in 
the identification of  unique product s  M  
 Tobacco Product_launch_date  Date on which the submitter plans to launch/launched the 
product on the market  M  
     
 Tobacco 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   M  
 
At 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(s) 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 pack et  M   
 Product_Package_Net_Weight  Net weight of one unit pack et 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 (multiple entries possible)  M  
 Product_Other_Market_Data  Supplementary market data available to the submitter . To 
be updated in case new data become available.    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 carrie d out when 
launching new products.  To be updated in case new data M  
                                                 
3 For each manufacturer, the following information must be  provided: ID number if any , official name, address, country, 
business phon e and functional business e -mail.    
EN 5   EN become available .   
4. DESCRIPTION OF INGREDIENTS : TOBACCO  
For each of the tobacco ingredients defined by leaf cure method, leaf type and part type  used in the product, 
the following variables must  be completed.  
Item #  Field  Comments  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_Fil
e 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 following information needs to be 
provided: Submitter ID if existant, official name, address, 
country, business phone and functional business e -mail address  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. DESCRIPTION OF INGRED IENTS : ADDITIVES AND OTHER S UBSTANCES /ELEMENTS  
Item #  Field  Comments  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  F 
If a CAS number 
does not exist, at 
least one of those  
four  numbers must  
be indicated . If  
 Ingredient_Additive_Number  If the ingredient is a food additive, its food additive “E 
number” set out in Annex es II and III to Regulation (EC) 
No 1333/2008 of the European Parliament and of the 
Council4  
                                                 
4 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives 
(OJ L 354, 31.12.2008, p.16).   
EN 6   EN  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 Council5) more than one 
number is 
indicated, t hose 
numbers  must  be 
indicated  in the 
following order of 
importance 
FEMA>Additive>FL>
EC  
 Ingredient_EC_Number  European Community (EC) number, if  any  
 Ingredient_Quantity_Fluctuat
e Indication whether the ingredient quantity fluctuates 
across production batches   M  
 Ingredient_Recipe_Quantity  Standard w eight of the ingredient included in one 
product unit in mg according to recipe  M  
 Ingredient_Recipe_Min_Level  Indication of the lowest range in 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_Max_Leve
l Indication of the highest range in weight (mg) of the 
additive 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  Mean  weigh t of the ingredient in mg that was actually 
added per product unit during the reporting period 
calculated as the average of the quantit ies 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 standardi sed 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 Art icle 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 status  is 
characterised by any known type of toxicity or has 
carcinogenic, mutagenic or toxic for reproduction  
properties.  M  
 Ingredient_REACH_Registrati
on Registration number  pursuant to Regulation (EC) No 
1907/2006 of the European Parliament and of the 
Council6, if any  M  
                                                 
5 Regulation (EC) No 1334/2008 of the European Parliament and of the Counci l of 16  December 2008 on flavourings and 
certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) 
No 1601/91, Regulations (EC) No  2232/96 and  (EC) No  110/2008 and Directive 2000/13/EC  (OJ L 354, 31.12.2008, 
p.34).  
6 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the 
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals 
Agency, amending Directive 1999/45 /EC and repealing Council Regulation (EEC) No 793/93 and Commission 
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 
93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006 , p.1).  
EN 7   EN  Ingredient_CLP_Classification  Indication whether the ingredient has been classified 
under Regulation (EC) No 1272/2008 of the European 
Parliament and of the Council7 and is in the 
classification and labelling  inventory  M  
 Ingredient_CLP_Acute_Tox_
Oral  Ingredient classification with regard to acute oral 
toxicity based on Regulation (EC) No 1272/2008  F   
 Ingredient_CLP_Acute_Tox_D
ermal  Ingredient classification with regard to acute dermal 
toxicity based on Regulation (EC) No 1272/2008   
 Ingredient_CLP_Acute_Tox_I
nhalation  Ingredient classification with regard to acute 
inhalation toxicity based on Regulation (EC) No 
1272/2008   
 Ingredient_CLP_Skin_Corrosi
ve/Irritant  Ingredient classification as a skin corrosive/irritant 
based on Regulation (EC) No 1272/2008   
 Ingredient_CLP_Eye_Damage
/Irritation  Ingredient classification as responsible for eye 
damage/irritation based on Regulation (EC) No 
1272/2008   
 Ingredient_CLP_Respiratory_
Sensitisation  Ingredient classification with regard to respiratory 
sensitisation based on Regulation (EC) No 1272/2008   
 Ingredient_CLP_Skin_Sensitis
ation  Ingredient classification with regard to skin 
sensitisation based on Regulation (EC) No 1272/2008   
 Ingredient_CLP_Mutagen/Ge
notox  Ingredient classification with regard to 
mutagenicity/genotoxicity based on Regulation (EC) 
No 1272/2008   
 Ingredient_CLP_Carcinogenit
y Ingredient classification with regard to its 
carcinogeni city based on Regulation (EC) No 
1272/2008   
 Ingredient_CLP_Reproductive
_Tox  Ingredient classification with regard to its reproductive 
toxicity based on Regulation (EC)  No 1272/2008   
 Ingredient_CLP_STOT  Ingredient classification with regard to its specific 
target organ toxicity based on Regulation (EC) No 
1272/2008   
 Ingredient_CLP_STOT_Descri
ption  Explanations with regard to specific organ(s) affected 
based on the above classification (in text format)   
 Ingredient_CLP_Aspiration_T
ox Ingredient classification with regard to aspiration 
toxicity based on Regulation (EC) No 1272/2008   
 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 toxic ological data 
relate to the substa nce 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_CardioPulmo
nary  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_Fil
e Upload available studies indicated in  the previous six 
fields (Ingredient Tox Data , Emission , CMR , F/M   
                                                 
7 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, 
labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, 
and amending Regula tion (EC) No 1907/2006 (OJ L 353, 31.12.2008, p.1 ).  
EN 8   EN CardioPulmonary , Addictive , Other)  
6. TNCO  AND OTHER EMISSIONS  
Item #  Field  Comments  Reporting  Submitter 
considers 
information 
confidential  
 Emission_Tar  Tar yield according to the ISO standard 4387 with the 
accuracy measurements determined in accordance with ISO 
standard 8243  F   
 Emission_Nicotine  Nicotine yield according to the ISO standard 10315 with the 
accuracy measurements determined in accordance with ISO 
standard 8243  F   
 Emission_CO  Carbon monoxide yield according to the ISO standard 8454 
with the accuracy 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_Methods_File  Description of the measurement methods used to assess the 
other emissions.  F  
 Emission_Name  Chemical name of the other emission(s) produced during the 
testing of the  product  F  
 Emission_CAS  CAS (Chemical Abstracts Service) number of the other 
emissions  F  
 Emission_IUPAC  IUPAC ( International Union of Pure and Applied Chemistry)  
name of the other emissions, should a CAS number not exist  F   
 Emission_Quantity  Quantity of the other emission s produced during the process 
of using the product , based on the measurement method 
used  F  
 Emission_Units  Unit in which the  other  emission is measured  F   
7. CIGARETTE SPECIFIC8 
Item #  Field  Comments  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  Existence of a filter in the cigarette   M   
 Cigarette_Filter_Length  Length of the cigarette filter in mm  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 M and F in this section applies only to cigarettes.   
EN 9   EN 8. SMOKELESS (ORAL-NASAL -CHEWING ) SPECIFIC9 
Item#  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. ROLL-YOUR -OWN AND  PIPE TOBACCO SPECIFIC10 
Field  Field  Comments  Reporting  Submitter 
considers 
information 
confidential  
 Roll-your -own /pipe_Total_Nicotine_Content  Total nicotine content of the loose product per 
product unit  M  
 
                                                 
9 M and F in this section applies only to smokeless products.  
10 M and F in this section applies only to roll -your own and pipe tobacco specific.