COMMISSION IMPLEMENTING DECISION (EU) 2015/2183
of 24 November 2015
establishing a common format for the notification of electronic cigarettes and refill containers
(notified under document C(2015) 8087)
(Text with EEA relevance)
Article 1
Subject matter
Article 2
Format for notification
Article 3
Storage of data
Article 4
Identification number of the data submitter
Article 5
Identification number of the product
Article 6
Confidential data and disclosure of data
Article 7
Addressees
ANNEX
1. FIELD DESCRIPTIONS
2. SUBMITTER CHARACTERISTICS
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 it exists, is an SME as defined in Commission Recommendation 2003/361/EC(1) |
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
2.2.
Manufacturer/Importer affiliate company characteristics
2.3.
Enterer reporting on behalf of the submitter
3. PRODUCT INFORMATION SUBMISSION AND DESCRIPTION — PART A
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 by the system when the user submits the information about the product |
AUTO |
|
||||||
|
Product_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
|
M |
|
||||||
|
Product_ID_Other_Exist |
Indication whether the submitter is aware of other product(s) with the same design and composition that is marketed in the EU using a different EC-ID |
M |
|
||||||
|
Product_ID_Other |
List EC-ID of the product(s) with same design and composition. If EC-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 other product(s) with the same composition of e-liquid, but different design |
M |
|
||||||
|
Product_Same_Composition_Other |
List EC-ID of the product(s) with the same composition of e-liquid but different design. If EC-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 product 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. |
F |
|
||||||
|
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(2) |
F |
|
||||||
|
Product_Production_Site_Address |
For each manufacturer, 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 Council(3) and as described in the ‘Guidance on the Application of the CLP Criteria’(4) |
F |
|
3. PRODUCT INFORMATION SUBMISSION AND DESCRIPTION — PART B.
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 |
The 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 |
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 of the product |
|
|
|
Product_National_Market |
Member State to which the product information is being provided |
M |
|
|
Product_Package_Units |
Number of individual units in the unit packet |
M |
|
4. DESCRIPTION OF INGREDIENTS CONTAINED IN THE PRODUCT
Field # |
Field |
Description |
Reporting |
Submitter considers information confidential |
|
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 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(6) |
|
|
|
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 Council(7) |
|
|
|
Ingredient_EC_Number |
European Community (EC) number(8), 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-vaporised form is characterised 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 Council(9), 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(10) and is in the classification and labelling Inventory |
M |
|
|
Ingredient_CLP_Classification |
Ingredient classification with to regard 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 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
Field # |
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. If EC_ID of the additional product(s) is not known to the submitter, brand and subtype name(s) as well as Member State(s) where product is placed on the market shall at least be provided |
F |
|
|
Emission_Product_Combination |
If the product contains more than one item or more than one combination of an e-cigarette or refill container, specification of the item or combination used to measure the emission |
F |
|
|
Emission_Methods_File |
Description of the measurement methods used to assess the emissions, including reference to the relevant approved standard, when available |
M |
|
|
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 emissions 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 |
|
6. PRODUCT DESIGN
Field # |
Field |
Description |
Reporting for e-cigarettes |
Submitter considers information confidential |
Reporting for refill container |
Submitter considers information confidential |
|
E-Cigarette_Description |
Description of the product to facilitate unique product identification, including a description of all items and 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 |
Lowest voltage obtainable |
F |
|
N/A |
|
|
E-Cigarette_Voltage_Upper_Range |
Highest 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 |
Lowest wattage obtainable |
F |
|
N/A |
|
|
E-Cigarette_Wattage_Upper_Range |
Highest 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 consistent dosing and nicotine uptake, including reference to the relevant approved standard, when available. Description of the outcomes of the assessment |
M |
|
M |
|
|
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 |
|