|
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)
