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

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 OJ L 127, 29.4.2014, p. 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 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). and of Regulation (EC) No 45/2001 of the European Parliament and the Council 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).

. (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

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). , 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

Annex

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. 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 #FieldDescriptionReportingSubmitter considers information confidentialSubmitter_IDSubmitter ID is the identification number attributed pursuant to Article 4MSubmitter_NameOfficial name of the submitter at Member State level, as linked to the VAT numberMSubmitter_SMEIndication whether the submitter, or its parent company if any, is an SME as defined in Commission Recommendation 2003/361/ECMSubmitter_VATVAT number of the submitterMSubmitter_TypeIndication whether the submitter is a manufacturer or importerMSubmitter_AddressAddress of the submitterMSubmitter_CountryCountry in which the submitter has its seat/domicileMSubmitter_PhoneBusiness phone of the submitterMSubmitter_EmailFunctional business email address of the submitterMSubmitter_Has_Parent_CompanyTick the box if the submitter has a parent companyMSubmitter_Has_Affiliate_CompanyTick the box if the submitter has an affiliate companyMSubmitter_Appoints EntererTick 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 One unit for loose tobacco is 1 g. For each manufacturer, the following information must be provided: ID number if any, official name, address, country, business phone and functional business email. Field #FieldDescriptionReportingSubmitter considers information confidentialSubmission_TypeType of submission for the productMSubmission_Start_DateSubmission date will be filled in automatically when the user submits the information about the productAUTOProduct_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 MProduct_ID_Other_ExistIndication 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-IDMProduct_ID_OtherList 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 providedFProduct_Same_Composition_ExistIndication whether the submitter is aware of another product(s) with the same proportion of ingredients in the tobacco blend compositionM Product_Same_Composition_OtherList 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 providedFProduct_TypeType of tobacco product concernedMProduct_LengthAverage length of the product unit in mmFProduct_DiameterAverage diameter (measured at the point with maximal diameter) of the product unit in mmFProduct_WeightWeight of one product unit, including the moisture, in mgMProduct_Tobacco_WeightTotal weight of the tobacco in one product unit in mgMProduct_Manufacturer_IdentificationIf the submitter is not the manufacturer, the official company name(s) of the manufacturer(s) of the product including its contact detailsFProduct_FilterExistence of a filter in the productFProduct_Filter_LengthLength of the product filter in mmFProduct_Production_Site_AddressFor each manufacturer, address(es) of the site(s) where production is completedMProduct_Technical_FileTechnical document setting out a general description of the additives used and their propertiesFProduct_Market_Research_FileInternal 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

1. 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 #FieldDescriptionReportingSubmitter considers information confidentialProduct_Brand_NameBrand name under which the product is marketed in the Member State to which information is being submitted.MProduct_Brand_Subtype_NameProduct subtype name (if any) as marketed in the Member State to which the product information is being submittedMProduct_Launch_DateDate on which the submitter plans to launch/launched the product on the marketMProduct_Withdrawal_IndicationIndication that the submitter plans to withdraw/withdrew the product from the marketMProduct_Withdrawal_DateDate on which the submitter plans to withdraw/withdrew the product from the marketFProduct_Submitter_NumberID 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_NumberUPC-12 (Universal Product Code) of the productProduct_EAN_NumberEAN-13 or EAN-8, (European Article Number) of the productProduct_GTIN_NumberGTIN (Global Trade Identification Number) of the productProduct_SKU_NumberSKU (Stock Keeping Unit) number(s) of the productProduct_National_MarketMember State to which the product information below is being providedMProduct_Package_TypeType of product packageMProduct_Package_UnitsNumber of individual product units in the unit packetMProduct_Package_Net_WeightNet weight of one unit packet in gFProduct_Sales_VolumeInformation on annual sales volume of the product per Member State to be reported annually in product units or in kg loose tobaccoMProduct_Other_Market_DataSupplementary market data available to the submitter. To be updated in case new data become available.F
2. 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. See definition of tobacco under Article 2(1) of Directive 2014/40/EU. 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 #FieldDescriptionReportingSubmitter considers information confidentialTobacco_Part_TypeType of tobacco partMTobacco_Part_Type_OtherName of the tobacco part type if otherFTobacco_Part_Description_FileGeneral description of the manufactured part type in the recipe. The description must provide detailed information on the quantitative and qualitative composition of the manufactured tobaccoFTobacco_Part_Manufactured_SupplierFor each supplier, the official company name(s) including its contact detailsFTobacco_Leaf_TypeType of tobacco leaf usedMTobacco_Leaf_Type_OtherName or description of the tobacco leaf type if other or unspecifiedFTobacco_Leaf_Cure_MethodMethod used to cure the tobacco leafMTobacco_Leaf_Cure_Method_OtherName or description of the cure method used if other.FTobacco_QuantityWeight per product unit in mgM

1. DESCRIPTION OF INGREDIENTS: ADDITIVES AND OTHER SUBSTANCES/ELEMENTS 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). 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). 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). 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). 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 #FieldDescriptionReportingSubmitter considers information confidentialIngredient_CategoryCategory of product component (e.g. filters, papers etc.)MIngredient_Category_OtherThe category of product component if otherFIngredient_NameChemical name of the ingredientM Ingredient_CASCAS (Chemical Abstracts Service) numberMIngredient_CAS_AdditionalAdditional CAS numbers if applicable.FIngredient_FEMA_NumberFEMA (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_NumberIf 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 CouncilIngredient_FL_NumberFL 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)Ingredient_EC_NumberEuropean Community (EC) number if anyIngredient_Quantity_FluctuateIndication whether the ingredient quantity fluctuates across production batchesMIngredient_Recipe_QuantityStandard weight of the ingredient included in one product unit in mg according to recipeMIngredient_Recipe_Range_Min_LevelIndication 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 leafFIngredient_Recipe_Range_Max_LevelIndication 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 leafFIngredient_Measured_Mean_QuantityWeight 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)FIngredient_Measured_SDStatistically derived standard deviation of the mean quantity of ingredient added per product unit within each standardised batchF

Ingredient_Measured_NumberNumber of measurements consideredFIngredient_FunctionFunction(s) of the ingredientMIngredient_Function_OtherFunction of the ingredient if otherFIngredient_Priority_AdditiveIndication whether the ingredient is part of the priority list established pursuant to Article 6 of Directive 2014/40/EUMIngredient_Priority_Additive_FilesCopies 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 additiveFIngredient_Unburnt_StatusIndication whether the ingredient in unburnt form is characterised by any known type of toxicity or has carcinogenic, mutagenic or toxic for reproduction properties.MIngredient_REACH_RegistrationRegistration number pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council, if anyMIngredient_CLP_Whether_ClassificationIndication whether the ingredient has been classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council and is in the classification and labelling inventoryMIngredient_CLP_ClassificationIngredient classification with regard to Regulation (EC) No 1272/2008FIngredient_Tox_DataAvailability 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 formMIngredient_Tox_EmissionExistence of studies that indicate the chemistry and/or toxicity of emissionsF/MIngredient_Tox_CMRExistence of any study relating to the carcinogenicity, mutagenicity or toxicity for reproduction of the ingredient.F/MIngredient_Tox_CardioPulmonaryExistence 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_AddictiveExistence of an analysis of the possible addictive properties of the ingredient.F/MIngredient_Tox_OtherExistence of any other toxicological data not stated aboveF/MIngredient_Tox/Addictive_FileUpload available studies indicated in the previous six fields (Ingredient Tox Data, Emission, CMR, CardioPulmonary, Addictive, Other)F/M 6. TNCO AND OTHER EMISSIONS For each other emission measured, all Emission_Other fields in this section must be completed. Field #FieldDescriptionReportingSubmitter considers information confidentialEmission_TarTar yield according to the ISO standard 4387 with the accuracy of measurements determined in accordance with ISO standard 8243FEmission_NicotineNicotine yield according to the ISO standard 10315 with the accuracy of measurements determined in accordance with ISO standard 8243FEmission_COCarbon monoxide yield according to the ISO standard 8454 with the accuracy of measurements determined in accordance with ISO standard 8243FEmission_TNCO_LabIdentification of the laboratory/laboratories used to measure emissions of tar, nicotine and carbon monoxideFEmission_Other_AvailableIndication as to whether other emissions have been measuredMEmission_Other_Methods_FileDescription of the measurement methods used to assess the other emission.FEmission_Other_NameChemical name of the other emission produced during the testing of the productF

Emission_Other_CASCAS (Chemical Abstracts Service) number of the other emissionFEmission_Other_IUPACIUPAC (International Union of Pure and Applied Chemistry) name of the other emission, should a CAS number not existFEmission_Other_QuantityQuantity of the other emission produced during the process of using the product, based on the measurement method usedFEmission_Other_UnitsUnit in which the other emission is measuredF 7. CIGARETTE SPECIFIC M and F in this section apply only to cigarettes. Field #FieldDescriptionReportingSubmitter considers information confidentialCigarette_Characterising_FlavourClassification of the cigarette as having a characterising flavour as referred to in Article 7(14) of Directive 2014/40/EUMCigarette_Filter_VentilationTotal ventilation of the filter (0-100 %)MCigarette_Filter_Drop_Pressure_ClosedDrop of pressure with closed vents (mmH2O)MCigarette_Filter_Drop_Pressure_OpenDrop of pressure with open vents (mmH2O)M 8. SMOKELESS (ORAL-NASAL-CHEWING) SPECIFIC M and F in this section apply only to smokeless products. Field #FieldDescriptionReportingSubmitter considers information confidentialSmokeless_pHpH of the productMSmokeless_Nicotine_ContentTotal nicotine content of the product per product unitM 9. ROLL-YOUR-OWN AND PIPE TOBACCO SPECIFIC M and F in this section apply only to roll-your own and pipe tobacco. Field #FieldDescriptionReportingSubmitter considers information confidentialRoll-your-own/pipe_Total_Nicotine_ContentTotal nicotine content of the loose product per product unitM