ANNEX
1.FIELD DESCRIPTIONS
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.SUBMITTER CHARACTERISTICS
The submitter is either the manufacturer or importer responsible for the submitted data.
| a 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). | ||||
| 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/ECa | 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 email address.
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 email 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 email address.
3.PRODUCT INFORMATION SUBMISSION AND DESCRIPTION — PART A
| a One unit for loose tobacco is 1 g. | ||||
| b For each manufacturer, the following information must be provided: ID number if any, official name, address, country, business phone and functional business email. | ||||
| 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
| 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 unita, 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 detailsb | 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.PRODUCT INFORMATION SUBMISSION AND DESCRIPTION — PART B
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 | 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 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.DESCRIPTION OF INGREDIENTS: TOBACCO
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.
| a See definition of tobacco under Article 2(1) of Directive 2014/40/EU. | ||||
| b For each supplier, the following information must be provided: Submitter ID if any, official name, address, country, business phone and functional business email address. | ||||
| Field # | Field | Description | Reporting | Submitter considers information confidential |
|---|---|---|---|---|
| Tobacco_Part_Type | Type of tobacco parta | 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 detailsb | 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 INGREDIENTS: ADDITIVES AND OTHER SUBSTANCES/ELEMENTS
| a 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). | ||||
| b 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/EC (OJ L 354, 31.12.2008, p. 34). | ||||
| c As created by the European Community Commission Decision 81/437/EEC of 11 May 1981 laying down the criteria in accordance with which information relating to the inventory of chemical substances is supplied by the Member States to the Commission (OJ L 167, 24.6.1981, p. 31). | ||||
| d 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). | ||||
| e 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 Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). | ||||
| 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 | F If 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 Councila | |||
| 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 Councilb) | |||
| Ingredient_EC_Number | European Community (EC) numberc 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 Councild, 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 Councile 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.TNCO AND OTHER EMISSIONS
| a For each ‘other emission’ measured, all ‘Emission_Other’ fields in this section must be completed. | ||||
| 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 measureda | 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.CIGARETTE SPECIFIC(1)
| 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.SMOKELESS (ORAL-NASAL-CHEWING) SPECIFIC(2)
| 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.ROLL-YOUR-OWN AND PIPE TOBACCO SPECIFIC(3)
| 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 |
M and F in this section apply only to cigarettes.
M and F in this section apply only to smokeless products.
M and F in this section apply only to roll-your own and pipe tobacco.