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 
it exists, is an SME as defined in Commission  
Recommendation 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_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. 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.   
2.2. Manufacturer/Importer affiliate company characteristics  
For each affiliate , the following information must  be provided:  Su bmitter 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, offic ial 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 3. PRODUCT INFORMATION SUBMISSION AND DESCRIPTION – PART A 
Item #  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 by the system 
when the user submits the information about the product  AUTO   
 E-Cigarette_ID (EC -ID) EC-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  
 E-cigarette_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 EC -ID  M   
 E-cigarette_Product_ID_Other  EC_ID of the product(s) with same design and composition 
known to the submitter  F  
 E-cigarette_Product_ID_Other2  If EC_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  
 E-
cigarette_Product_Same_Compositi
on_Exist  Indication whether the submitter is aware of another product 
with the same c omposition  of e-liquid , but different design   M  
 E-
cigarette_Product_Same_Compositi
on_Other  EC_ID of the product(s) with the same composition of e-liquid 
but different design known to the submitter  F  
 E-
cigarette_Product_Same_Compositi
on_Other2  If EC_ID of the product(s) with the same composition of e -
liquid but different design 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 e -cigarette or refill liquid concerned  M  
 Product_Weight_E -liquid  Total weight of e -liquid in one product unit in mg.  F  
 Product_Volume_E -liquid  Total volume of e -liquid in one product unit in ml.    
 Product_Manufacturer_Identificatio
n If the submitter is not the manufacturer, the official company 
name of the manufacturer of the product including its contact 
details  (multiple entries possible if the product is 
manufactured by multiple companies)2  F   
 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_CLP_Classification  Overall product classification (including labelling elements) as a 
mixture of substances based on Regulation (EC) No 1272/2008  
of the European Parliament and of the Council3  and as F   
                                                 
2 For each manufacturer, the following information is to be provided: ID number if any,  official name, address, country, 
business phone and functional business e -mail.   
3 Regulation (EC) No 1272/2008 of the European Parliament and of th e 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 Regulation (EC) No 1907/2006  (OJ L 353, 31.12.2008, p. 1 ).  
EN 4   EN described in the “Guidance on the Application of the CLP 
Criteria” (http://echa.europa.eu/documents/10162/13562/clp_
en.pdf ])  
3. PRODUCT INFORMATION SUBMISSION AND DESCRIPTION – PART B. 
Where the product s are presented for sale in different formats ,  the  following variables  must be completed 
for each format . 
Item #  Field  Description   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 identif ication  of unique product s  M  
 E-cigarette_launch_date  The date on which the submitter plans to launch/launched 
the product on the market  M  
 E-cigarette_withdrawal_indication   Indication that the submitter plans to withdraw/withdrew 
the product from the market   M  
 E-cigarette_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 
consistent
ly for all 
submissio
ns 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 of the product   
 Product_National_Market  Member State (s) to which the product information below is 
being provided  M  
 Product_Package_Units  Number of individual units in the unit pack et  M  
4. DESCRIPTION OF INGRED IENTS CONTAINED IN T HE PRODUCT  
For each ingredient used in the product, variables in the following section shall be completed.4  
 
Item #  Field  Description  Reporting  Submitter 
considers 
information 
confidential  
 Ingredient_Name  Chemical name of the ingredient  M  
 Ingredient_CAS  CAS (Chemical Abstracts Service)  number   M  
                                                 
4 M and F in this sect ion applies only for product types where applicable.   
EN 5   EN  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 does not 
exist, at least one 
of those four 
number s must be 
indicated.  If more 
than one number 
is indicated, those 
numbers must  be 
indicated   in the 
following order of 
importance 
FEMA>Additive>F
L>EC   
 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 Council  5  
 Ingredient_FL_Number  FL number ( European Flavouring number as set out 
in Annex I to Regulation (EC) No 1334/2008 of the 
European Parliament and of the Council6)  
 Ingredient_EC_Number  European Community (EC) number, if any   
 Ingredient_Function  Function(s) of the ingredient  M  
 Ingredient_Function_Other  Function of the ingredient if “other”  F  
 Ingredient_Recipe_Quantity  Weight of the ingredient included in one product 
unit in mg according to recipe.  M  
 Ingredient_  non-vaporised _Status  Indication whether the ingredient in non-vapori sed 
status is characteri sed by a 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 
Council7 , if any.  M   
 Ingredient_CLP_Classification  Indication whether the ingredient has a harmonised 
classification and labelling  under Regulation (EC) No 
1272/2008 and is included in the C lassification  and 
labelling  Inventory  (Article 42 Regulation (EC) No 
1272/2008)   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_Dermal  Ingredient classification with regard to acute dermal 
toxicity based on Regulation (EC) No 1272/2008   
 Ingredient_CLP_Acute_Tox_Inhalatio
n Ingredient classification with regard to acute 
inhalation toxicity based on Regulation (EC) No 
1272/2008   
                                                 
5 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 ). 
6 Regulation (EC) No 1334/2008 of the European Parliament and of the Council 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/E C (OJ L 354, 31.12.2008, 
p.34). 
7 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 6   EN  Ingredient_CLP_Skin_Corrosive/Irrita
nt Ingredient classification as a skin corrosive/irritant 
based on Regulation (EC) No 1272/2008   
 Ingredient_CLP_Eye_Damage/Irritati
on  Ingredient classification as responsible for eye 
damage/irritation based on Regulation (EC) No 
1272/2008   
 Ingredient_CLP_Respiratory_Sensitis
ation  Ingredient classification with regard to respiratory 
sensitisation based on Regulation (EC) No 1272/2008   
 Ingredient_CLP_Skin_Sensitisation  Ingredient classification with regard to skin 
sensitisation based on Re gulation (EC) No 1272/2008   
 Ingredient_CLP_Mutagen/Genotox  Ingredient classification with regard to 
mutagenicity/genotoxicity based on Regulation (EC) 
No 1272/2008   
 Ingredient_CLP_Carcinogenity  Ingredient classification with regard to its 
carcinogenity 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_Description  Explanations with regard to specific organ(s) affected 
based on the above classification (in text format)    
 Ingredient_CLP_Aspiration_Tox  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 toxicological data 
relate to the substance in heated or unheated form.   M  
 Ingredient _Tox_ Emission  Existence of studies that inform about the chemistry 
and/or toxicity of emissions.  F/M   
 Ingredient_Tox_CMR  Existence of any studies  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   
5. EMISSIONS  
Where multiple emissions have been measured , variables in the following sections are requested for each 
individual emission.  
Item #  Field  Description  Reporting  Submitter 
considers 
information 
confidential  
 Emission_test_product_EC -ID If the product requires an additional product(s) for use, the EC -ID of 
the additional product(s) used to carry out the tests must be 
provided  F  
 Emission_Methods_File  Description of the measurement methods used to assess the 
emissions, including reference to the relevant approved standard, 
when available  M   
EN 7   EN  Emission_Name  Name of the emission produced during the testing of the product  M  
 Emission_CAS  CAS (Chemical Abstracts Service) number of emissions  F  
 Emission_IUPAC  IUPAC (International Union of Pure and Applied Chemistry) name of 
emissions, should a CAS number not exist  F   
 Emission_Quantity  Quantity of emission s produced during the process of using the 
product based on the measurement method used.  M  
 Emission_Units  Unit in which the emission is measured  F   
  
EN 8   EN 6. PRODUCT DESIGN  
Item #  Field  Description  Reporting for e -cigarettes  Submitter 
considers 
information 
confidential  Reporting for 
e-cigarette 
refill 
container  Submitter 
considers 
information 
confidential  
 E-Cigarette_Description  Description of the e -cigarette or refill container to 
facilitate unique product identification, including a 
description of the individual parts  (components/e -liquid)  M  M  
 E-Cigarette_Liquid_Volume/Capacity  Volume/capacity in ml (for devices, indicate tank size, for 
cartridges/cartomisers or for refill container actual volume 
when placed on the market)  M  M  
 E-cigarette_Nicotine_Concentration  Nicotine concentration in mg/ml  F  M  
 E-Cigarette_Battery_Type  Description of the battery type  F  N/A  
 E-Cigarette_Battery_Type_Capacity  Indication of the battery capacity in mAh  F  N/A  
 E-Cigarette_Volt/Watt_Adjustable  Indication whether the e -cigarette is voltage/wattage 
adjustable  M  N/A  
 E-Cigarette_Voltage  Nominal voltage of the e -cigarette if non -adjustable and 
recommended voltage if adjustable.  F  N/A  
 E-Cigarette_Voltage_Lower_Range  Lower voltage obtainable  F  N/A  
 E-Cigarette_Voltage_Upper_Range  Upper voltage obtainable.  F  N/A  
 E-Cigarette_Wattage  Nominal wattage output if non -adjustable and 
recommended wattage if adjustable.   F  N/A  
 E-Cigarette_Wattage_Lower_Range  Lower wattage obtainable  F  N/A  
 E-Cigarette_Wattage_Upper_Range  Upper wattage obtainable  F  N/A  
 E-Cigarette_Airflow_Adjustable  Indication whether the airflow of the e -cigarette is 
adjustable  M  N/A  
 E-Cigarette_Wick_Changeable  Indication whether the consumer may adjust/alter/replace 
the wick  M  N/A  
 E-Cigarette_Microprocessor  Indication whether the e -cigarette contains a 
microprocessor  
 
 M  N/A  
 E-Cigarette_Coil_Composition  Chemical composition of the wiring (coil) in the atomiser  M  N/A  
 E-
Cigarette_Nicotine_Dose/Uptake_File  Description of the measurement methods used to  assess 
consisting dosing and nicotine uptake, including reference 
to the relevant approved standard, when available. 
Description of the outcomes of the assessment  M  M   
EN 9   EN  E-Cigarette_Production _File  Description of the final production process, including 
series production  
 M  M  
 E-Cigarette_Production_Conformity  Declaration that the production process ensures 
conformity (including but not limited to information on 
series production).  
 M  M  
 E-Cigarette_Quality_Safety  Declaration that the manufacturer and importer bear full 
responsibility for the quality and safety of the product, 
when placed on the market and used under normal or 
reasonably foreseeable conditions.  M  M  
 E_Cigarette_Opening/Refill _File  Description of the opening and refill mechanism,  where 
applicable.  F  M