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LEGAL ACTS OF THE REPUBLIC OF LATVIA
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Republic of Latvia

Cabinet
Regulation No. 440

Adopted 5 July 2016

Procedures for Providing and Processing Information Regarding Tobacco Products, Herbal Products for Smoking, Electronic Cigarettes, and Their Refill Containers

Issued pursuant to
Section 5, Paragraph two
of the Law on the Handling of Tobacco Products,
Herbal Products for Smoking,
Electronic Smoking Devices and Their Liquids

I. General Provisions

1. This Regulation prescribes:

1.1. the amount of information to be provided regarding tobacco products, electronic cigarettes, refill containers, and herbal products for smoking placed on the market;

1.2. the amount of information to be provided regarding tobacco products, herbal products for smoking, electronic cigarettes, refill containers, and novel tobacco products which are planned to be placed on the market or for which the composition is being altered;

1.3. the procedures by which manufacturers and importers of tobacco products, herbal products for smoking, electronic cigarettes and refill containers, and novel tobacco products shall provide information to the Health Inspectorate;

1.4. the procedures by which the Health Inspectorate shall store, process, analyse and publish the information received from manufacturers and importers of tobacco products, herbal products for smoking, electronic cigarettes and their refill containers, and novel tobacco products.

2. The manufacturer of the relevant product shall be responsible for timely and accurate provision of the information referred to in this Regulation, if he or she conducts commercial activity in the European Union and the European Economic Area. If the manufacturer of the relevant product conducts commercial activity outside the European Union and the European Economic Area and the importer of the relevant product conducts commercial activity in the European Union and the European Economic Area, the importer of the product concerned shall be responsible for provision of the required information. If the manufacturer and importer of the product concerned conducts commercial activity outside the European Union and the European Economic Area, the manufacturer and importer shall be responsible for provision of the information referred to in this Regulation.

II. Information to be Provided Regarding Tobacco Products

3. Manufacturers and importers of tobacco products shall submit the following information to the Health Inspectorate regarding each brand name and type of a tobacco product:

3.1. a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco product, in descending order of the weight of each ingredient included in the tobacco product. In addition the following information shall be provided regarding ingredients indicated in the list:

3.1.1. a statement setting out the reasons for the inclusion of such ingredients in the tobacco product concerned;

3.1.2. the status of the ingredients, including whether they have been registered under 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, as well as their classification under 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;

3.1.3. toxicological data regarding the ingredients in burnt or unburnt form, referring in particular to their effects on the health of consumers and taking into account any addictive effects;

3.2. for cigarettes and roll-your-own tobacco - a technical document setting out a general description of the additives used and their properties;

3.3. emission levels for tar, nicotine and carbon monoxide;

3.4. information regarding such emissions which are not tar, nicotine and carbon monoxide emissions, and their levels if such information is available, as well as the methods of measurement of such emissions used.

4. In addition to the information referred to in Paragraph 3 of this Regulation, manufacturers and importers of tobacco products shall provide the following to the Health Inspectorate:

4.1. the studies available to them on market research and preferences of various consumer groups, including young people and current smokers, relating to ingredients and emissions;

4.2. executive summaries of any market surveys carried out when launching new product.

5. Manufacturers and importers of tobacco products shall each year report to the Health Inspectorate regarding the sales volumes in the previous year per brand and type of the tobacco product (in sticks or kilograms).

6. Manufacturers and importers of the tobacco product shall inform the Health Inspectorate whenever the composition of the tobacco product is modified in a way that can affect the information referred to in Paragraphs 3 and 4 of this Regulation.

7. The information referred to in Paragraphs 3 and 4 of this Regulation shall be submitted prior to placing on the market of a novel tobacco product, as well as prior to placing on the market of such tobacco product the composition of which has been modified.

8. Upon providing the information referred to in Paragraphs 3 and 4 of this Regulation, manufacturers and importers shall indicate which information is considered commercial secret or otherwise confidential information by them, and shall appropriately justify their statements upon request of the Health Inspectorate.

9. The Health Inspectorate has the right to request that manufacturers or importers carry out studies in order to assess the effects of the ingredients contained in tobacco products on health, taking into account their addictiveness and toxicity.

III. Enhanced Reporting Obligation on Cigarettes and Roll-your-own Tobacco

10. Manufacturers and importers of cigarettes and roll-your-own tobacco shall carry out comprehensive studies regarding each additive in relation to cigarettes and roll-your-own tobacco the composition of which includes the additives referred to in Annex 1 to this Regulation. The following shall be examined in these studies:

10.1. whether the additive contributes to the toxicity or addictiveness of the products concerned, and whether this has the effect of increasing the toxicity or addictiveness of the products concerned to a significant or measurable degree;

10.2. whether the additive results in a characterising flavour;

10.3. whether the additive facilitates inhalation or nicotine uptake;

10.4. whether the additive leads to the formation of substances that have carcinogenic, mutagenic or toxic for reproduction properties, and whether, upon reaching a specific quantity, this has the effect of increasing the carcinogenic, mutagenic or toxic for reproduction properties to a significant or measurable degree.

11. The studies referred to in Paragraph 10 of this Regulation shall take into account the intended use of the products concerned and examine the emissions resulting from the combustion process involving the additive concerned, as well as examine the interaction of that additive with other ingredients contained in the products concerned.

12. Manufacturers or importers using the same additive referred to in Annex 1 to this Regulation in their cigarettes and roll-your-own tobacco may carry out a joint study when using that additive in a comparable product composition.

13. Manufacturers or importers shall establish a report on the results of the comprehensive studies carried out. The report 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.

14. Manufacturers or importers shall submit the report referred to in Paragraph 13 of this Regulation to the European Commission and a copy thereof to the Health Inspectorate at the latest 18 months after the additive concerned has been included in the list included in Annex 1 to this Regulation. The Health Inspectorate may also request supplementary information from manufacturers or importers regarding the additive concerned to be included in the report.

15. The Health Inspectorate may require the report referred to in Paragraph 13 of this Regulation to be peer reviewed by an independent scientific body, in particular as regards its comprehensiveness, methodology and conclusions. Manufacturers and importers shall pay a fee for the peer review to the relevant scientific body.

16. Upon submitting the report referred to in Paragraph 13 of this Regulation to the Health Inspectorate, manufacturers and importers shall indicate which information included in the report is considered commercial secret.

17. Small and medium-sized enterprises shall be exempted from the obligation specified in this Regulation to carry out comprehensive studies and to prepare a report on the results of such studies, if another manufacturer or importer has already prepared a report on the relevant additive.

IV. Information to be Provided Regarding Electronic Cigarettes and Refill Containers

18. Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the Health Inspectorate on electronic cigarettes and refill containers planned to be placed on the market. The notification shall be submitted six months prior to the intended placing on the market of an electronic cigarette or refill container, as well as any time when the composition of the electronic cigarette or refill container is significantly modified. Depending on whether the product is an electronic cigarette or refill container, the following information shall be included in the notification:

18.1. the manufacturer, a responsible legal or natural person within the European Union, and the importer into the European Union, as well as contact details;

18.2. a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand and type, including quantities thereof;

18.3. toxicological data regarding the product's ingredients and emissions (including when heated), including effects of ingredients and emissions on the health of consumers when inhaled and taking into account their addictive effect;

18.4. information on the nicotine doses and uptake when consumed under normal or foreseeable conditions;

18.5. a description of the components of the product; including the opening and refill mechanism of the electronic cigarette or refill container;

18.6. a description of the production process, including information on series production, and a declaration that the production process of the relevant product ensures conformity with the requirements of laws and regulations;

18.7. a 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.

19. If the Health Inspectorate detects that the information provided in accordance with Paragraph 18 of this Regulation is incomplete, it has the right to request that the manufacturer or importer of the relevant product supplements the information provided.

20. Each year manufacturers and importers of electronic cigarettes and refill containers shall submit the following to the Health Inspectorate regarding the previous year:

20.1. information on sales volumes, by brand and type of the electronic cigarette or refill container;

20.2. information on the preferences of various consumer groups, including young people, non-smokers, in relation to the electronic cigarettes and refill containers and indicating also the main types of product users;

20.3. information on the mode of sale of the electronic cigarettes and refill containers;

20.4. executive summaries of any market surveys carried out in respect of the information referred to in Sub-paragraphs 20.1, 20.2, and 20.3 of this Regulation, including an English translation thereof.

21. Upon submitting the information requested in this Regulation, manufacturers and importers of electronic cigarettes and refill containers shall indicate which information is considered commercial secret or otherwise confidential information by them, and shall appropriately justify their statements upon request.

V. Information to be Provided Regarding Herbal Products for Smoking

22. Prior to placing on the market of a new herbal product for smoking, manufacturers and importers shall submit a list of any ingredients to the Health Inspectorate which are used in manufacture of the relevant herbal product for smoking, indicating their quantity by brand and type of the herbal product for smoking.

23. If the composition of the herbal product for smoking is modified in a way that affects the information referred to in Paragraph 22 of this Regulation, manufacturers and importers of the herbal product for smoking shall inform the Health Inspectorate thereof. Information shall be provided before the herbal product for smoking the composition of which has been modified, is placed on the market.

24. Upon submitting the information referred to in Paragraphs 22 and 23 of this Regulation to the Health Inspectorate, manufacturers and importers of herbal products for smoking shall indicate which information is considered commercial secret.

VI. Information to be Provided Regarding Novel Tobacco Products

25. Manufacturers and importers shall submit a relevant notification to the Health Inspectorate six months prior to the intended placing on the market of a novel tobacco product. The notification shall include:

25.1. a detailed description of the novel tobacco product;

25.2. instructions for use of the novel tobacco product;

25.3. information on ingredients and emissions of the novel tobacco product in accordance with Paragraph 3 of this Regulation;

25.4. available scientific studies on toxicity, addictiveness and attractiveness of the novel tobacco product, in particular as regards its ingredients and emissions;

25.5. available studies, executive summaries thereof and market research on the preferences of various consumer groups, including young people and current smokers;

25.6. other available and relevant information, including a risk/benefit analysis of the product, its expected effects on cessation and initiation of tobacco consumption and predicted consumer perception.

26. Manufacturers and importers of novel tobacco products shall submit any new or updated information on the studies, research and other information referred to in Sub-paragraphs 25.4, 25.5, and 25.6 of this Regulation to the Health Inspectorate.

27. The Health Inspectorate has the right to require that manufacturers or importers of novel tobacco products carry out additional tests or submit additional information regarding the novel tobacco product regarding which a notification is submitted.

VII. Procedures by which Manufacturers and Importers of Tobacco Products (Including Novel Tobacco Products), Herbal Products for Smoking, Electronic Cigarettes and Refill Containers shall Provide Information

28. The information referred to in this Regulation regarding tobacco products, herbal products for smoking, as well as novel tobacco products shall be provided to the Health Inspectorate by manufacturers and importers in the form specified in Annex 2 to this Regulation, using the joint electronic input portal provided for provision of data (hereinafter - the portal).

29. The information referred to in this Regulation regarding electronic cigarettes and refill containers, including regarding changes and removal from the market, shall be provided to the Health Inspectorate by manufacturers and importers of electronic cigarettes and refill containers in the form specified in Annex 3 to this Regulation, using the portal.

30. Prior to primary submission of information to the portal a manufacturer or importer shall request an identification number of the submitter generated by the operator of the portal. The manufacturer or importer shall, upon request, upload a document to the portal containing the identification data of the merchant and a certification regarding the field of operation in accordance with the legal acts of such state in which commercial activity is conducted. The same identification number of the submitter shall be used for further provision of information and in further correspondence.

31. The manufacturer or importer shall assign an identification number of the product to each product reported. On the basis of the identification number of the submitter referred to in Paragraph 30 of this Regulation, the identification number of the product for tobacco products shall be created using the letter combination "TP-ID", but for electronic cigarettes and refill containers - "EC-ID".

32. Upon submitting information regarding products with the same composition and design, manufacturers and importers shall, as much as possible, use the same identification number of the product, particularly in cases if data is submitted by different participants of a group of companies. This condition shall be applied regardless of the brand type and sub-type, as well as regardless of the number of states in which the products have been placed on the market. If the manufacturer or importer cannot ensure that the same identification numbers of products are used for products with the same composition and design, at least the different identification numbers of products assigned to the products shall be indicated as much as possible.

VIII. Procedures for Processing, Storing and Publishing Information

33. In accordance with this Regulation the Health Inspectorate shall store the information submitted by manufacturers and importers to the portal in the national data repository of the European Commission, ensuring that:

33.1. information is available to the European Commission and other Member States of the European Union and of the European Economic Area;

33.2. confidentiality is taken into account when processing a commercial secret and other confidential information.

34. The Health Inspectorate shall publish the information which has been submitted by manufacturers and importers in accordance with Sub-paragraphs 3.1, 3.3, 3.4 and Paragraphs 10, 18, and 22 of this Regulation on its website. The information which has been indicated as commercial secret by manufacturers and importers shall not be published.

35. Within the meaning of this Regulation the following information submitted regarding tobacco products is not considered confidential information or commercial secret:

35.1. the additives included in the composition of tobacco products which are not flavourings, and their quantity;

35.2. the ingredients included in the composition of tobacco products which are not additives and the quantity of which exceeds 0.5 % of the total weight of a tobacco product unit, and their quantity;

35.3. the flavourings included in the composition of cigarettes and roll-your-own tobacco the quantity of which exceeds 0.1 % of the total weight of a tobacco product unit, and their quantity;

35.4. the flavourings included in the composition of pipe tobacco, cigars, cigarillos, smokeless tobacco products and any other tobacco products the quantity of which exceeds 0.5 % of the total weight of a tobacco product unit, and their quantity;

35.5. studies and data submitted in accordance with Sub-paragraphs 3.1.3, 3.2, and 3.4, as well as Paragraph 9 of this Regulation, particularly regarding toxicity and addictiveness. If such studies are related to specific brands, direct and indirect references to the brand shall be removed and the edited version shall be submitted.

36. Within the meaning of this Regulation the following information submitted regarding electronic cigarettes and refill containers is not considered confidential information or commercial secret:

36.1. ingredients which are used in such quantities that exceed 0.1 % of the final composition of the liquid;

36.2. studies and data submitted in accordance with Paragraph 18 of this Regulation, particularly regarding toxicity and addictiveness. If such studies are related to specific brands, direct and indirect references to brands shall be removed and the edited version shall be submitted.

IX. Closing Provisions

37. The information referred to in Paragraphs 3 and 4 of this Regulation regarding the tobacco products which have been placed on the market until 20 May 2016 shall be submitted until 20 November 2016.

38. The information referred to in Paragraph 18 of this Regulation regarding electronic cigarettes and refill containers which have been placed on the market until 20 May 2016 shall be submitted until 20 November 2016.

39. The obligation referred to in Paragraphs 13 and 14 of this Regulation to prepare and submit a report on the additives referred to in Annex 1 to this Regulation shall be applicable from 1 January 2017.

40. Manufacturers and importers shall submit the information referred to in Paragraph 5 of this Regulation for the first time in 2016 regarding sales volumes in 2015.

Informative Reference to the European Union Directive

This Regulation contains legal norms arising from 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.

Prime Minister Māris Kučinskis

Minister for Health Anda Čakša

 

Annex 1
Cabinet Regulation No. 440
5 July 2016

Priority List of Additives Used in Cigarettes and Roll-your-own tobacco Subject to Enhanced Reporting Obligations

No.

Additive

Chemical formula (if available)

Number of the chemical substance in the register of chemical substances (CAS number(s)) applicable to the substance (not exhaustive)

1. Carob bean   9000-40-2,

84961-45-5

2. Cocoa   84649-99-0,

84649-99-3,

95009-22-6,

8002-31-1

3. Diacetyl C4H6O2 431-03-8
4. Fenugreek   68990-15-8,

977018-53-3,

84625-40-1

5. Fig   90028-74-3
6. Geraniol C10H18O 106-24-1,

8000-46-2

7. Glycerol C3H8O3 56-81-5
8. Guaiacol C6H4(OH)(OCH3) 90-05-1
9. Guar gum   9000-30-0
10. Liquorice root   68916-91-6
11. Maltol C6H6O3 118-71-8
12. Menthol C10H20O 2216-51-5,

15356-60-2,

89-78-1,

1490-04-6,

8006-90-4,

68606-97-3,

84696-51-5,

8008-79-5

13. Propylene glycol C3H8O2 57-55-6
14. Sorbitol C6H14O6 50-70-4
15. Titanium dioxide TiO2 13463-67-7,

1317-70-0

Minister for Health Anda Čakša

 

Annex 2
Cabinet Regulation No. 440
5 July 2016

Electronic Form for Submission of Information Regarding Tobacco Products

1. Field description

1.1. All fields marked "M" in the electronic form for submission of information regarding tobacco products (hereinafter - the common format) are mandatory.

1.2. Fields marked "F" in the common format become mandatory if a specific response is selected from a previous variable.

1.3. Fields "AUTO" are automatically generated by the software system.

1.4. For fields in which the response is to be selected from a list, corresponding reference tables will be provided in the common format, which will be maintained and published on a European Commission website.

2. Characteristics of the manufacturer or importer responsible for the submitted data (hereinafter - submitter)

Field #

Field

Description

Reporting

Submitter considers information confidential

  Submitter_ID Submitter identification number (hereinafter - submitter ID) is the identification number attributed pursuant to Paragraph 30 of this Regulation M  
  Submitter_Name Official name of the submitter at Member State level, as linked to the value added tax (hereinafter - VAT) number M  
  Submitter_SME Indication whether the submitter, or its parent company if any, is a small- or medium-sized enterprise 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. Parent company characteristics of the submitter

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. Affiliate company characteristics of the submitter

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 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) the identification number of the product (TP-ID) used in the system in the following format: 'submitter ID-year-product number' (NNNNN-NN-NNNNN), where:

'submitter ID' is the ID number of the submitter (see Paragraph 2);

'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  
  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, 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_Type Type of tobacco product concerned M  
  Product_Length Average length of the product unit in millimetres F  
  Product_Diameter Average diameter (measured at the point with maximal diameter) of the product unit in millimetres F  
  Product_Weight Weight of one product unit, including the moisture, in milligrams (one unit for loose tobacco is 1 gram) M  
  Product_Tobacco_Weight Total weight of the tobacco in one product unit in milligrams 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 details (for each manufacturer, the following information must be provided: ID number if any, official name, address, country, business phone and functional business email address) F  
  Product_Filter Existence of a filter in the product F  
  Product_Filter_Length Length of the product filter in millimetres 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 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  

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 Universal Product Code (UPC-12) of the product  
  Product_EAN_Number European Article Number (EAN-13 or EAN-8) of the product  
  Product_GTIN_Number Global Trade Identification Number (GTIN) of the product  
  Product_SKU_Number Stock Keeping Unit (SKU) 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 grams F  
  Product_Sales_Volume Information on annual sales volume of the product per Member State to be reported annually in product units or in kilograms 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 (see definition of tobacco under the Law on the Handling of Tobacco Products, Herbal Products for Smoking, Electronic Smoking Devices and Their Liquids) 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. For each supplier, the following information must be provided: Submitter ID (if any), official name, address, country, business phone and functional business email address 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 milligrams 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 Flavour and Extract Manufacturers Association (hereinafter - FEMA) 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 of 16 December 2008 on food additives  
  Ingredient_FL_Number European Flavouring (FL) number, if any, as set out in Annex I to 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  
  Ingredient_EC_Number European Community (EC) number, 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 milligrams according to recipe M  
  Ingredient_Recipe_Range_Min_Level Indication of the lowest weight (milligrams) 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 (milligrams) 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 list of additives included in Annex 1 to this Regulation 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 of the ingredient pursuant to 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, 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 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 and is in the classification and labelling inventory M  
  Ingredient_CLP_Classification Ingredient classification with regard to 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 and is in the classification and labelling inventory 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 (hereinafter - CMR) 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. Tar, nicotine and carbon monoxide emissions and other emissions

Field #

Field

Notes

Reporting

Submitter considers information confidential

  Emission_Tar Tar yield according to the standard LVS ISO 4387:2007 "Cigarettes. Determination of total and nicotine-free dry particulate matter using a routine analytical smoking machine" with the accuracy of measurements determined in accordance with the standard LVS ISO 8243:2013 "Cigarettes - Sampling" F  
  Emission_Nicotine Nicotine yield according to the standard LVS ISO 10315:2013 "Cigarettes - Determination of nicotine in smoke condensates - Gas-chromatographic method" with the accuracy of measurements determined in accordance with the standard LVS ISO 8243:2013 "Cigarettes - Sampling" F  
  Emission_CO Carbon monoxide yield according to the standard LVS ISO 8454+A1:2011 "Cigarettes - Determination of carbon monoxide in the vapour phase of cigarette smoke - NDIR method" with the accuracy of measurements determined in accordance with the standard LVS ISO 8243:2013 "Cigarettes - Sampling" 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 (for each 'other emission' measured, all 'Emission_Other' fields in this section must be completed) 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 number of the other emission F  
  Emission_Other_IUPAC International Union of Pure and Applied Chemistry (IUPAC) 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 (M and F in this section apply only to cigarettes)

Field #

Field

Description

Reporting

Submitter considers information confidential

  Cigarette_Characterising_Flavour Classification of the cigarette as having a characterising flavour as referred to in Paragraph 4 of the Transitional Provisions of the Law on the Handling of Tobacco Products, Herbal Products for Smoking, Electronic Smoking Devices and Their Liquids 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 (chewing tobacco, nasal tobacco, and tobacco for oral use) specific (M and F in this section apply only to smokeless products)

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

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  

Minister for Health Anda Čakša

 

Annex 3
Cabinet Regulation No. 440
5 July 2016

Electronic Form for Submission of Information Regarding Electronic Cigarettes and Refill Containers

1. Field description

1.1. All fields marked "M" in the electronic form for submission of information regarding electronic cigarettes and refill containers are mandatory.

1.2. Filter dependent mandatory fields "F" become mandatory if a specific response is selected from a previous variable.

1.3. Fields "AUTO" are automatically generated by the software system.

1.4. For fields in which the response is to be selected from a list, corresponding reference tables will be provided, maintained and published on a European Commission website.

2. Characteristics of the manufacturer or importer responsible for the submitted data (hereinafter - submitter)

Field #

Field

Description

Reporting

Submitter considers information confidential

  Submitter_ID Submitter identification number (hereinafter - submitter ID) is the identification number attributed pursuant to Paragraph 30 of this Regulation M  
  Submitter_Name Official name of the submitter at Member State level, as linked to the value added tax (hereinafter - VAT) number M  
  Submitter_SME Indication whether the submitter, or its parent company (if any) is a small- or medium-sized enterprise 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. Parent company characteristics of the submitter

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. Affiliate company characteristics of the submitter

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 provision and description

Part A

Field #

Field

Description

Reporting

Submitter considers information confidential

  Submission_Type Type of submission for the product M  
  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:

'submitter ID' is the ID number of the submitter (see Paragraph 2);

'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  
  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 liquid containing nicotine (hereinafter - 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 milligrams F  
  Product_Volume_E-liquid Total volume of e-liquid in one product unit in millilitres 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 (for each manufacturer, the following information is to be provided: ID number if any, official name, address, country, business phone and functional business email) 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 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 and as described in the 'Guidance on the Application of the Classification, Labelling and Packaging Criteria' F  

Part B

Where the products are presented for sale in different formats or where the same product is presented for sale in different Member States, the following information must be provided 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 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 Universal Product Code (UPC-12) of the product  
  Product_EAN_Number European Article Number (EAN-13 or EAN-8) of the product  
  Product_GTIN_Number Global Trade Identification Number (GTIN) of the product  
  Product_SKU_Number Stock Keeping Unit (SKU) number(s) 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

For each ingredient used in the product, variables in the following section shall be completed (M and F in this section applies only for product types where applicable). In the case of products containing more than one item with ingredients, the following variables must be completed for each of these items.

Field #

Field

Description

Reporting

Submitter considers information confidential

  Ingredient_Name Chemical name of the ingredient M  
  Ingredient_CAS CAS (Chemical Abstracts Service) number (hereinafter - CAS) M  
  Ingredient_CAS_Additional Additional CAS numbers if applicable F  
  Ingredient_FEMA_Number Flavour and Extract Manufacturers Association (hereinafter - FEMA) 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 of 16 December 2008 on food additives  
  Ingredient_FL_Number European Flavouring (FL) number (if any) as set out in Annex I to 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  
  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 milligrams 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 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, 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 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 and is in the classification and labelling inventory M  
  Ingredient_CLP_Classification Ingredient classification with regard to 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 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 study relating to the carcinogenicity, mutagenicity or toxicity for reproduction of the ingredient (hereinafter - CMR) 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. In the case of products containing more than one item or more than one combination of an e-cigarette or refill container, the following variables must be completed for each of these items or combinations.

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 number of emissions F  
  Emission_IUPAC International Union of Pure and Applied Chemistry (hereinafter - IUPAC) name of emissions shall be provided, 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 containers

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 millilitres (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 milligrams/millilitres F   M  
  E-Cigarette_Battery_Type Description of the battery type F   Not applicable  
  E-Cigarette_Battery_Type_Capacity Indication of the battery capacity in mAh F   Not applicable  
  E-Cigarette_Volt/Watt_Adjustable Indication whether the e-cigarette is voltage/wattage adjustable M   Not applicable  
  E-Cigarette_Voltage Nominal voltage of the e-cigarette if non-adjustable. Recommended voltage of the e-cigarette if adjustable F   Not applicable  
  E-Cigarette_Voltage_Lower_Range Lowest voltage obtainable F   Not applicable  
  E-Cigarette_Voltage_Upper_Range Highest voltage obtainable F   Not applicable  
  E-Cigarette_Wattage Nominal wattage output if non-adjustable. Recommended wattage output if adjustable F   Not applicable  
  E-Cigarette_Wattage_Lower_Range Lowest wattage obtainable F   Not applicable  
  E-Cigarette_Wattage_Upper_Range Highest wattage obtainable F   Not applicable  
  E-Cigarette_Airflow_Adjustable Indication whether the airflow of the e-cigarette is adjustable M   Not applicable  
  E-Cigarette_Wick_Changeable Indication whether the consumer may adjust/alter/replace the wick M   Not applicable  
  E-Cigarette_Microprocessor Indication whether the e-cigarette contains a microprocessor M   Not applicable  
  E-Cigarette_Coil_Composition Chemical composition of the wiring (coil) in the atomiser M   Not applicable  
  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  

Minister for Health Anda Čakša

 


Translation © 2017 Valsts valodas centrs (State Language Centre)

 
Document information
Title: Kārtība, kādā sniedz un apstrādā informāciju par tabakas izstrādājumiem, augu smēķēšanas .. Status:
In force
in force
Issuer: Cabinet of Ministers Type: regulation Document number: 440Adoption: 05.07.2016.Entry into force: 13.07.2016.Publication: Latvijas Vēstnesis, 132, 12.07.2016. OP number: 2016/132.1
Language:
LVEN
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