COMMISSION IMPLEMENTING DECISION (EU) 2015/2186

of 25 November 2015

establishing a format for the submission and making available of information on tobacco products

(notified under document C(2015) 8162)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC(1), and in particular Article 5(5) thereof,

Whereas:

(1) Directive 2014/40/EU provides that manufacturers and importers of tobacco products are to submit to the competent authorities of the Member States concerned information on the ingredients and emissions of tobacco products, and on their sales volumes. The information should be submitted prior to the placing on the market of new or modified products. The format for the submission of that information and its making available should be laid down.

(2) The experience gained and the knowledge acquired with existing formats for the reporting of tobacco ingredients, where relevant, should be taken into account when developing the new format.

(3) A common electronic reporting format for submission of information on ingredients and emissions of tobacco products should allow Member States and the Commission to process, compare, analyse and draw conclusions from the information received. The data will also help to identify the additives to be included in the updates of the priority list referred to in Article 6 of Directive 2014/40/EU, provide the basis for deciding whether maximum content levels should be set pursuant to Article 7(5) and (11) of that Directive and facilitate a coherent enforcement of the ban on products with characterising flavour as provided for in Article 7(1) of that Directive.

(4) A common electronic entry gate for submission of data is essential to ensure uniform application of the reporting obligations set out in Directive 2014/40/EU. In particular, a common entry gate facilitates and harmonises the submission of data from the manufacturer or importer to the Member States. Streamlining the submission process also reduces administrative burden for manufacturers, importers and national regulators and facilitates comparison of data. To facilitate multiple uploads a repository might be established at the level of the common entry gate to allow for references to non-confidential documents.

The common entry gate should foresee tools for submission of information which are adequate both for companies which have comprehensive IT solutions in place (system-to-system submissions) and for companies which have no such solutions, in particular small and medium-sized companies. Companies will be provided with a submitter identification number which should be used for all submissions by this company.

(5) Member States should be free to make the tools for submission of information on ingredients and emissions laid down in this Decision available for notification of novel tobacco products prior to their placing on the market in accordance with Article 19 of Directive 2014/40/EU. The tools could also facilitate submission of information on herbal products for smoking pursuant to Article 22 of Directive 2014/40/EU and submission of other relevant information on tobacco products.

(6) When resubmitting data, including correcting errors in an earlier submission, the information should be provided through the common entry gate.

(7) Whilst the full responsibility for gathering, verifying, analysing as appropriate, storing and disseminating the data collected in accordance with this Decision lies with the Member States, they should have the possibility to store the data submitted to them at Commission facilities. The service offered by the Commission should provide Member States with technical tools to facilitate compliance with their obligations under Article 5 of Directive 2014/40/EU. The Commission will develop a standard service level agreement for this purpose. The Commission should keep an off-line copy of the data submitted through the common entry gate for the purpose of applying Directive 2014/40/EU.

(8) Manufacturers and importers should be encouraged to keep data provided to Member States up-to-date. To facilitate comparison within the Union, Member States should encourage manufacturers and importers to submit updates, such as annual sales data, during the first half of the subsequent calendar year. Member States should encourage manufacturers and importers, in the case of minor fluctuations across product batches, to submit information on actual quantities of ingredients in tobacco products annually and to update that information.

(9) When submitting information on products with the same composition and design, manufacturers and importers should, to the extent possible, use the same product identification number, regardless of brand and subtype or whether they are placed on the market in one or more Member States.

(10) It is appropriate to lay down rules concerning the treatment of confidential data by the Commission in order to ensure the greatest possible transparency of product information for the general public, whilst ensuring that due account is taken of trade secrets. The legitimate expectation of consumers to have access to adequate information on the content of products they intend to consume should be weighed against manufacturers' interests of protecting recipes of their products. Having regard to those competing interests, in particular data that could reveal flavours used in small quantities in specific products should be kept confidential.

(11) Personal data should be processed in accordance with the rules and safeguards laid down in Directive 95/46/EC of the European Parliament and the Council(2) and of Regulation (EC) No 45/2001 of the European Parliament and the Council(3).

(12) The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 25 of Directive 2014/40/EU,

HAS ADOPTED THIS DECISION:

Article 1

Subject matter

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

Format for data submission

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

Storage of data

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

Identification number of the data submitter

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

Identification number of the product

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

Confidential data and disclosure of data

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(4), 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

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 25 November 2015.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

(1)

OJ L 127, 29.4.2014, p. 1

(2) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (

OJ L 281, 23.11.1995, p. 31

(3) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (

OJ L 8, 12.1.2001, p. 1

(4) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (

OJ L 145, 31.5.2001, p. 43

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.

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(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

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

Field #

Field

Description

Reporting

Submitter considers information confidential

Submission_Type

Type of submission for the product

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

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

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

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

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

Product_Type

Type of tobacco product concerned

Product_Length

Average length of the product unit in mm

Product_Diameter

Average diameter (measured at the point with maximal diameter) of the product unit in mm

Product_Weight

Weight of one product unit(2), including the moisture, in mg

Product_Tobacco_Weight

Total weight of the tobacco in one product unit in mg

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(3)

Product_Filter

Existence of a filter in the product

Product_Filter_Length

Length of the product filter in mm

Product_Production_Site_Address

For each manufacturer, address(es) of the site(s) where production is completed

Product_Technical_File

Technical document setting out a general description of the additives used and their properties

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.

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.

Field #	Field	Description	Reporting	Submitter considers information confidential
	Tobacco_Part_Type	Type of tobacco part(4)	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(5)	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

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 Council(6)
	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(7))
	Ingredient_EC_Number	European Community (EC) number(8) 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(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 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

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(11)	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(12)

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(13)

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(14)

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

(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

(2) One unit for loose tobacco is 1 g.

(3) For each manufacturer, the following information must be provided: ID number if any, official name, address, country, business phone and functional business email.

(4) See definition of tobacco under Article 2(1) of Directive 2014/40/EU.

(5) For each supplier, the following information must be provided: Submitter ID if any, official name, address, country, business phone and functional business email address.

(6) 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

(7) 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

(8) 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

(9) 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

(10) 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

(11) For each ‘other emission’ measured, all ‘Emission_Other’ fields in this section must be completed.

(12) M and F in this section apply only to cigarettes.

(13) M and F in this section apply only to smokeless products.

(14) M and F in this section apply only to roll-your own and pipe tobacco.