Decree No. 261 / 2016 Coll.
Decree on tobacco products
Valid
Order
Effective from 07.09.2016
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261
DECLARATION
of 28 July 2016
on tobacco products
The Ministry of Agriculture provides pursuant to § 18 (1) (a), (b), (k) and (o) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related acts, as amended by Act No. 180 / 2016 Coll.:
Subject matter
This decree implements the relevant provisions of the European Union1) and provides for
(a) the method of providing information on tobacco products;
(b) the requirements for the appearance, characteristics, content, composition and marketing of tobacco products;
(c) the maximum level of cigarette emissions;
(d) the location and characteristics of the unique identifier and the extent of the data contained therein;
(e) the location and characteristics of the safety component;
(f) prohibited elements and features of tobacco products and their unit and special packaging;
(g) information on smoking cessation and a group of combined health warnings;
(h) the scope, time limits, information and handling of information on the marketing of tobacco products;
(i) the priority list of ingredients, the scope, the elements, the processing method, the focus and the presentation method of the study for the ingredients listed in the priority list and the scope, the deadline and the presentation method of the report on the outcome of the study for the ingredients listed in the priority list;
(j) the extent of the data required for registration prior to the start of marketing of tobacco products in the form of cross-border distance sales and the manner in which such registration is made;
(k) a list of prohibited substances which may not contain tobacco products placed on the market;
(l) the extent, time and method of information on the new tobacco product;
(m) the types of tobacco products and their breakdown into groups and sub-groups.
Definition of terms
For the purposes of this decree:
(a) tar-free, crude smoke condensate, not containing nicotine;
(b) the emission of a substance which is released when using a tobacco product for the intended purpose, such as substances found in smoke, or substances released when using non-tobacco products;
(c) a bag of unit packs of tobacco intended for the hand-wrapping of cigarettes, either in the form of a rectangular bag or in the form of a standing bag;
(d) a rectangular pouch with a rectangular pouch closed by a fold,
(e) the verification element element of the safety element,
(f) the apparent verification element of the verification element directly susceptible by one or more human senses without the use of external devices; the apparent verification element is considered to mean the category of apparent verification solutions specified in ISO 22383: 2020,
(g) a semi-hidden verification element of the verification element directly insensitive to human senses, but detectable by these senses using external UV lighting devices, a special pen or a marker that does not require expertise or training; a semi-hidden verification element is considered to mean a category of hidden verification solutions for which the tools normally available for verification are used, as specified in ISO 22383: 2020,
(h) a hidden verification element of a verification element directly insensitive to human senses and detectable only by the use of tools specially manufactured or professional laboratory equipment; the underlying verification element is considered to be a category of hidden verification solutions that require tools for this purpose specially manufactured and forensic analysis as specified in ISO 22383: 2020.
List of prohibited substances
The prohibited substances in tobacco products placed on the market are:
(a) vitamins or other ingredients which give the impression that the tobacco product is beneficial or presents a reduced health risk;
(b) caffeine, taurine or other additives and stimulating ingredients associated with energy and vitality;
(c) additives the properties of which cause the colouring of emissions;
(d) for tobacco products for smoking, ingredients which facilitate the inhalation or intake of nicotine; and
(e) additives having the characteristics of carcinogenic, mutagenic or toxic to reproduction in non-burnt form.
Prohibited elements and features
(1) The prohibited element or feature of a unit pack, any outer packaging of a tobacco product as well as the tobacco product itself is an element or feature which
(a) promote or promote the consumption of tobacco by creating a false impression of its characteristics, health, risk and emissions;
(b) contains information on the content of nicotine, tar or carbon monoxide in the tobacco product;
(c) suggests that the tobacco product is less harmful than other tobacco products or that its aim is to reduce the effects of certain harmful smoke constituents or that it has vitalizing, encouraging, healing, rejuvenating or natural properties of organic farming products or other health or lifestyle benefits;
(d) refers to the taste, smell, aroma or other ingredients or to their absence;
(e) resembles a food or cosmetic product; or
(f) suggests that the tobacco product has increased biodegradability or other environmental benefits.
(2) Furthermore, the prohibited element or feature of unit packaging and any external packaging of tobacco products is an element or feature indicating economic benefits, including benefits through printed vouchers, discounts, free distribution, two-for-one offers and other similar offers.
(3) The text, symbol, name, trade mark, figurative or other character may be an element or feature prohibited under paragraph 1 or 2.
Appearance, characteristics and contents of unit packaging
(1) The unit pack of cigarettes must have a block shape. The unit packaging of tobacco intended for the manual packaging of cigarettes shall be in block or cylindrical shape or in the form of a bag.
(2) The unit packaging of tobacco intended for the manual packaging of cigarettes shall contain at least 30 g of such tobacco.
(3) The unit pack of cigarettes shall be made of cardboard or soft material and shall not have any other conclusion, except for the flip-off lid and the folding cap box, which, when opened for the first time, would allow its resealing or sealing. In the case of a package with a flip-off cap and a flip-down cap, the lid shall only be tilted in its rear refraction.
(4) A unit pack of cigarettes shall contain at least 20 cigarettes.
Maximum levels of cigarette emissions
(1) The maximum level of emissions of cigarette tar produced or marketed is 10 mg per cigarette.
(2) The maximum level of emissions of nicotine of cigarettes produced or marketed is 1 mg per cigarette.
(3) The maximum level of emissions of carbon monoxide from cigarettes produced or marketed is 10 mg per cigarette.
Method of labelling tobacco products with a unique identifier
(1) The unique identifier shall be printed or fixed unremovable, indelible and shall not be in any way hidden or disturbed, either by the use of a tobacco sticker or price tag or by opening the package.
(2) The unique identifier allows the identification of:
(a) the date and place of manufacture;
(b) a production facility;
(c) a machine used in the manufacture of tobacco products,
(d) the production shift or production period;
(e) a description of the product, by its trade name, type of group and sub-group and packaging method;
(f) the intended retail market;
(g) the intended route of transport;
(h) the name and, where applicable, the names and registered office and, where applicable, the name or business name and registered office of the importer in the case of importation into the European Union;
(i) the actual route of transport from the factory to the first retailer, including identification details of all warehouses used, transit countries as well as date of transport, address of destination, address of dispatch and address of consignee;
(j) the name and, where applicable, the names and registered office, the name or business name and registered office of all customers from the manufacturing plant to the first retailer; and
(k) invoice, order number and payment details of all customers from the factory to the first retailer.
(3) The data referred to in paragraph 2 (a) to (h) are part of a unique identifier.
(4) The data referred to in points (i), (j) and (k) of paragraph 2 must be made available in electronic form through interconnection with a unique identifier.
Method of labelling tobacco products with a safety element
(1) Safety element
(a) comprise at least 5 types of verification elements listed in Annex 7 to this Decree, at least one of which is apparent, at least one is semi-hidden and at least one is hidden;
(b) they must be printed, unremovably fixed or unremoved by a combination of fixing and printing in a manner which prevents unauthorised loading, indelible and in no way concealed or disturbed;
(c) it shall be used in such a way as to enable the identification and verification of the authenticity of each package of tobacco products as long as the tobacco product is placed on the market and which protects them from being replaced, reused or amended in any way.
(2) At least one of the verification elements referred to in paragraph 1 is supplied from a provider which is an independent third party fulfilling the following conditions of independence:
(a) independence from the tobacco industry in terms of legal form, organisation and decision-making; In particular, it shall be assessed whether the undertaking or group of undertakings are not directly or indirectly controlled by the tobacco industry, including minority interests;
(b) financial independence from the tobacco industry; This criterion is considered to be met if, in the last two calendar years, an undertaking or group of undertakings generated less than 10% of its annual worldwide turnover, excluding VAT and any other indirect taxes, on goods and services supplied to the tobacco industry, as can be determined on the basis of the latest approved accounts and, for each calendar year thereafter, the annual worldwide turnover, excluding VAT and all other indirect taxes, does not exceed 20%,
(c) the absence of a conflict of interest with the tobacco industry in the case of persons responsible for the management of an undertaking or group of undertakings, including members of the Management Board or any other form of management body; in particular:
1. does not participate in the structures of tobacco companies in the last 5 years;
2. act independently of any financial or non-financial interest related to the tobacco industry, including ownership of shares, participation in private pension schemes or a share held by their partners, spouses, ancestors or descendants in a direct line.
(3) The tobacco sticker used on the unit packaging of the tobacco product shall act as a safety element provided that it fulfils the conditions set out in paragraph 1.
Breakdown of tobacco products
(1) The types of tobacco products and their breakdown into groups and sub-groups are listed in Annex 1 to this Decree.
(2) The tobacco product is identified by the name of the species and group.
(3) Tobacco shall be identified by the name of the species, group and subgroup.
Method of putting general warnings and information messages on tobacco products intended for smoking
(1) The general warning on tobacco products intended for smoking is "Smoking kills - stop now." This figure shall cover 50% of the area on which it is printed.
(2) The information message on tobacco products intended for smoking is "Tobacco smoke contains over 70 substances that can be proven to cause cancer." This figure shall cover 50% of the area on which it is printed.
(3) As regards unit packs of cigarettes and tobacco intended for hand-wrapping cigarettes in block-shaped packaging, the general warning shall be placed at the bottom of one side of the unit pack and the information message shall be placed at the bottom of the other side. Each of these particulars shall be at least 20 mm wide. The width is measured in the direction of the text location.
(4) In the case of unit packs of cigarettes and tobacco intended for the hand-wrapping of cigarettes in the form of a folding lid box, where the sides are divided into two parts when opened, the whole general warning and information message shall always be placed on the larger part of the distributed surface of the side side. The general warning shall also be placed on the inside of the upper surface of the tilting lid, which is visible when the package is opened. The side side of this type of package shall be at least 16 mm high.
(5) In the case of tobacco intended for the manual packaging of cigarettes sold in a bag, the general warning and information message shall be placed on areas where full visibility is ensured. In the case of tobacco intended for the hand-wrapping of cigarettes in cylindrical shape, the general warning shall be placed on the outside of the lid and the information communication on the inside of the lid.
(6) The general warnings and information messages on tobacco products intended for smoking must be:
(a) printed in black in bold Helvetica, maintaining the default character interpolation setting, which is 100% scale and spaces normal, on white background; point font size must be such that the text concerned occupies as much of the surface reserved for it as possible;
(b) placed at the centre of the surface reserved for them; and
(c) packaging of quad shape and any external packaging of tobacco product intended for smoking, parallel to the side edge of the unit pack or outer packaging.
(1) In the case of tobacco intended for the manual packaging of cigarettes in the form of a rectangular bag, the general warning and information messages must be printed on both surfaces which will be visible when the individual package is fully opened, as set out in points 1 and 2 of Annex 2 to this Decree. The general warning and information message shall be located on the upper edge of the rectangular bags and shall cover 50% of the areas on which they are printed, as specified in points 1 and 2 of Annex 2 to this Decree. The general warning shall be printed on the upper surface of the rectangular bags.
(2) In the case of tobacco intended for the manual packaging of cigarettes in standing bags, the general warning and information message must be placed on the surfaces on the lower part of the standing bag (hereinafter referred to as "the base of the bag") which will be visible when the bag is placed on the back as referred to in point 4 of Annex 2 to this Regulation.
(3) For tobacco intended for the manual packaging of cigarettes in standing bags, the general warning must be printed on the surface above the bend at the base of the bag and the information message on the surface below the fold. General warnings and information messages shall cover 50% of the areas of the standing bags on which they are printed. These areas shall be calculated on the basis of their dimensions when the edges are sealed.
Method of putting combined health warnings on tobacco products intended for smoking
(1) The combined health warning given on a tobacco product intended for smoking must:
(a) be indicated on each unit pack and any external packaging of tobacco product intended for smoking;
(b) contain one of the text warnings listed in Annex 3 to this Order and the corresponding colour photograph specified in the list of visual warnings set out in Annex 4 to this Order;
(c) include information relating to smoking cessation, which reads "How to quit smoking: www.koureni-znaji.cz" and "National line for cessation: 800 35 00 00";
(d) cover 65% of the outer surface of both the front and the rear sides of the unit pack and any outer packaging; two combined health warnings shall be placed on roll-shaped packs at a uniform distance and each combined health warning shall cover 65% of its half of the rounded surface;
(e) display the same text warning and the corresponding colour photograph on both sides of the unit pack and any external packaging;
(f) be placed on the upper edge of the unit pack and any outer packaging and be placed in the same direction as any other information appearing on the packaging surface;
(g) be reproduced in accordance with the format, presentation, design and proportions set out in Annexes 4 and 5 to this Decree; and
(h) for unit packs of cigarettes, comply with a height of not less than 44 mm and a width of not less than 52 mm.
(2) If the height of the combined health warning exceeds 70% of its width, the combined health warning shall be used in a vertical format as specified in point 1 of Annex 5 to this Regulation. If the height of the combined health warning is more than 20% but less than 65% of its width, the combined health warning shall be used in a horizontal format as specified in point 2 of Annex 5 to this Regulation. If the height of the combined health warning is 65% or more of its width, but not more than 70% of its width, the use of a vertical or horizontal format may be chosen, provided that all elements of the combined health warning remain fully visible and undistorted.
(3) If a vertical format is used, the photograph shall be placed at the top of the combined health warning and text warning and the information relating to smoking cessation shall be printed at the bottom as set out in point 1 of Annex 5 to this Regulation. Photographs shall cover 50%, 38% text warning and 12% area of combined health warning within the outer black frame. If a horizontal format is used, the photograph shall be placed in the left half of the combined health warning, the text warning at the top right and the information relating to smoking cessation at the bottom right as set out in point 2 of Annex 5 to this Decree. Photographs shall cover 50%, 40% text warning and 10% area of combined health warning inside the outer black frame.
(4) Where, due to the shape of the unit pack or outer packaging, the height of the combined health warning is less than 20% of its width or equal to 20% of its width, the combined health warning shall be in a horizontal, particularly wide format as specified in point 3 of Annex 5 to this Regulation. Photographs shall occupy 35%, text warning 50% and information on smoking cessation 15% of the combined health warning area inside the outer black frame.
(5) The division of combined health warnings into three groups is set out in Annex 4 to this Decree.
(1) The combined health warning must be printed in the CMYK four-colour printing. All elements in black shall be C0, M0, Y0 and K100 and the elements in warm yellow shall be C0, M10, Y100 and K0. The combined health warning shall be reproduced in a minimum resolution of 300 dpi when printed in real size.
(2) The text warning must be printed in white on a black background.
(3) Where a horizontal, vertical, inverted or horizontal particularly wide format is used, the black edge shall be printed within the smoking cessation information area 1 mm wide between smoking cessation information and photographs.
(4) Photos
(a) it must be reproduced without the use of special effects, colour modifications, retouching or background extensions;
(b) it must not be cut too close or too far from the focus of the photograph; and
(c) it must not be disproportionately broad or narrow.
(5) The text warning must:
(a) be aligned to the left and vertically centred;
b) be printed with the font Neue Frutiger Condensed Bold,
(c) be printed in single-size characters;
d) be as large as possible to ensure maximum visibility of the text,
(e) have a minimum font size of 6 b,
(f) have a distance between lines of 2 b greater than the font size of the text warning; and
(g) be reproduced in accordance with Annex 3 to this Decree, including as regards the use of capital letters, except numbering.
(6) By way of derogation from paragraph 5 (e) and (f), manufacturers or importers of tobacco products for smoking other than cigarettes, tobacco intended for the manual packaging of cigarettes and tobacco intended for water pipes may reduce the font size or distance between text warning lines and cessation information, provided that all elements of the combined health warning remain fully visible.
(1) Information relating to smoking cessation must:
(a) be aligned to the left and vertically centred,
b) be printed with the font Neue Frutiger Condensed Bold,
c) be as large as possible to ensure maximum visibility of the text,
d) have a minimum font size of 5 b,
(e) have a distance between lines of 1 to 2 b greater than the font size of the smoking cessation information; and
(f) be printed in black on a warm yellow background as set out in Annex 5 to this Decree.
(2) By way of derogation from paragraph 1 (e) and (d), manufacturers or importers of tobacco products for smoking other than cigarettes, tobacco intended for the manual packaging of cigarettes and tobacco intended for water pipes may reduce the font size or distance between text warning lines and cessation information, provided that all elements of the combined health warning remain fully visible.
(1) By way of derogation from the first and second sentences of Paragraph 12 (3), combined health warnings placed on the front of the unit packaging with a flip-off cap shall be provided in accordance with paragraphs 2 and 3.
(2) If the cap of the unit pack with the flip-off cap is smaller than the area specified in the photograph pursuant to § 12 (3) and compliance with § 12 (3) would result in the photo being divided into several parts after opening the lid, it must:
(a) the text warning shall be placed at the top of the combined health warning and the information relating to smoking cessation and the photograph at the bottom as referred to in point 4 of Annex 5 to this Regulation; and
(b) photographs cover at least 50% of the area of the combined health warning, a text warning of at least 30% and information concerning smoking cessation of at least 10% but not more than 12% of the area of the combined health warning within the outer black frame.
(3) If the lid is larger than the area specified in the photograph in accordance with § 12 (4) and compliance with § 12 (4) would result in a distribution of a text warning or smoking cessation information after opening the lid, it shall:
(a) the photograph is placed at the top of the combined health warning and text warning and information concerning smoking cessation at the bottom as referred to in point 1 of Annex 5 to this Regulation; and
(b) photographs cover at least 50% of the area of the combined health warning, a text warning of at least 30% and information concerning smoking cessation of at least 10% but not more than 12% of the area of the combined health warning within the outer black frame.
(4) None of the three elements of the combined health warning on the unit pack with the flip-off cap shall be divided into several parts after opening the unit pack.
Method of putting a general warning and a text warning on tobacco products intended for smoking other than cigarettes, tobacco intended for hand-packing cigarettes, tobacco intended for water pipe and heated tobacco products
(1) The general warning on tobacco products intended for smoking other than cigarettes, tobacco intended for hand-wrapping cigarettes, tobacco intended for water pipe and heated tobacco products is "Smoking kills - stop now."
(2) The information relating to smoking cessation attached to the general warning is "How to quit smoking: www.koureni-zabaji.cz" and "National line for cessation: 800 35 00 00."
(3) General warnings on tobacco products intended for smoking other than cigarettes, tobacco intended for hand-wrapping cigarettes, water pipe tobacco and heated tobacco products
(a) be placed on the most visible surface area of the unit packaging and any outer packaging; and
(b) shall cover 30% of the area of the surface area of the unit pack or any outer packaging.
(4) For the purposes of marking tobacco products intended for smoking other than cigarettes, tobacco intended for the manual packaging of cigarettes, tobacco intended for water pipe and heated tobacco products pursuant to Section 12e of Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended, hereinafter referred to as "the Act ', a text warning shall be deemed to be a health warning. The list of text warnings and their wording are set out in Annex 3 to this Decree.
(5) For each brand of tobacco products intended for smoking other than cigarettes, tobacco intended for the manual packaging of cigarettes, tobacco intended for the water pipe and heated tobacco products, the individual text warnings shall be displayed in the same number and as far as possible. The text warning shall be located on the second most visible surface area of the unit packaging and any outer packaging. For unit packages with flip-down lid, the second most visible surface area shall be the area that becomes visible when the package is opened.
(1) The text warning must cover 40% of the relevant surface area of the unit pack or any external packaging of tobacco product intended for smoking other than cigarettes, tobacco intended for hand-wrapping cigarettes, tobacco intended for water pipe and heated tobacco products.
(2) General warnings and text warnings
(a) it shall be lined with a black edge of not less than 3 mm wide and not more than 4 mm wide; this edge shall be situated outside the surface reserved for such warnings;
(b) they shall cover an area of 45 cm2 if they are situated on the surface of a unit pack or any external packaging of tobacco products intended for smoking other than cigarettes, tobacco intended for the manual packaging of cigarettes, tobacco intended for a water pipe and heated tobacco products of more than 150 cm2; and
(c) they must comply with the requirements set out in Section 10 (6), with the text of the general warning and the text warning being parallel to the main text on the area reserved for this warning.
Method of indicating health warnings on non-tobacco products
(1) The health warning on non-tobacco products is "This tobacco product is harmful to your health and is addictive."
(2) Health warnings on non-tobacco products
(a) they must comply with the requirements set out in Paragraph 10 (6), with the health warning text parallel to the main text on the area reserved for that warning; and
(b) they must be situated on the two largest surfaces of the unit pack and any outer packaging, while covering 30% of the surface area of the unit pack and any external packaging.
Additional requirements for the presentation of general warnings, information messages, text warnings, health warnings and combined health warnings on tobacco products
(1) General warnings, information messages, text warnings, health warnings and combined health warnings on tobacco products
(a) must be in the Czech language;
(b) they shall cover the entire surface of the unit pack or outer packaging reserved for them and shall in no way comment, paraphrase or refer to them;
(c) must be printed unremovable, indelible and fully visible;
(d) when using a tobacco sticker, a price tag, security features, packaging, pocket, box or other device when placing tobacco products on the market, it must not be partially or completely covered or interrupted; the unit packaging of tobacco products other than cigarettes and tobacco intended for the manual packaging of cigarettes sold in a bag may be affixed by means of stickers which must be unremovable,
(e) must not be disturbed by opening unit packs other than those with flip-off caps; for packaging with flip-off lid, health warnings may be impaired by opening the package, but only in such a way as to ensure the graphical integrity and visibility of text, photographs and smoking cessation information,
(f) it must not in any way overlap or interfere with the tracking and tracing marks, tobacco stickers, price tags or security features on unit packs; and
(g) it shall be lined with a black margin of 1 mm wide inside the surface reserved for that indication, with the exception of the particulars referred to in Article 15.
(2) The dimensions of the data referred to in Articles 10 (1), (2) and (3), 12 (1) (d) and (h), 16 (3) (b), 17 (1), 17 (2) (b) and 18 (2) (b) shall be calculated in relation to the whole surface of the closed package.
Method of implementing the information obligation for the placing on the market of new tobacco products
(1) The notification of a new tobacco product pursuant to Article 12g (1) of the Act shall be made by means of a common electronic input gate for the submission of data in the format set out in the Annex to the Implementing Decision adjusting the format for the submission and disclosure of information on tobacco products2) and shall contain, by brand and type of new tobacco product:
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Regulation Information
| Citation | Decree No. 261 / 2016 Coll., on Tobacco Products |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 08.08.2016 |
|---|---|
| Effective from | 07.09.2016 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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