Decree No. 141 / 2023 Coll.
Decree on nicotine tobacco-free bags
Valid
Order
Effective from 01.07.2023
Text versions:
01.07.2023
31.05.2023
141
DECLARATION
of 16 May 2023
on nicotine tobacco-free bags
According to Article 19 (4) (c) of Act No. 110 / 1997 Coll., on Food and Tobacco Products, and amending and supplementing certain related laws, as amended by Act No. 174 / 2021 Coll., hereinafter referred to as "the Act ':
Subject matter
This decree regulates
(a) the composition, appearance, quality and characteristics of nicotine tobacco-free sachets (hereinafter referred to as nicotine sachet),
(b) the labelling of nicotine bags, including prohibited elements and features; and
(c) the manner, time-limits and scope of reporting obligations of producers and importers of nicotine bags.
Quality and composition requirements for nicotine bags
(1) Nicotine sachets may contain only nicotine or nicotine salt and substances which do not present a risk to human health at the concentration used when used according to instructions for use.
(2) Only additives listed in Part B of Annex II to Regulation (EC) No 1333 / 2008 of the European Parliament and of the Council of 16 December 2008 on food additives, as amended, may be used as additives in nicotine bags. Components other than those listed in § 5 (2) may be contained in a nicotine bag in trace quantities only if it is technically impossible to avoid the presence of that trace quantity during the production of nicotine bags.
(3) Nicotine bags must not be added as separate substances
(a) vitamins (1), minerals (1), or other ingredients which give the impression that they are beneficial or pose a reduced health risk;
(b) addictions2) excluding nicotine and nicotine salts;
(c) caffeine, taurine or other stimulating ingredients associated with energy and vitality;
(d) ingredients having the characteristics of carcinogenic, mutagenic or toxic to reproduction, with the exception of nicotine and nicotine salts; and
(e) substances listed in Annex 1 thereto.
(4) The contents of the unit pack shall not exceed 240 mg nicotine and shall contain at least 20 doses of nicotine sachet. The total content of nicotine in the product is listed in milligram according to Section 12k (2) (c) of the Act.
(5) One dose of nicotine sachet may contain a maximum of 12 mg nicotine.
(6) The dose of nicotine sachet within the meaning of § 12k (2) (d) of the Act consists of:
(a) a individually packaged nicotine bag contained in a unit pack which does not pose a serious risk3) for human health; and
(b) edible or inedible packaging safe for human health in accordance with the requirements of Article 3 (1) of Regulation (EC) No 1935 / 2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80 / 590 / EEC and 89 / 109 / EEC, the requirements of Article 4 (a) and (e) in the part concerning the requirements for the composition of Commission Regulation (EU) No 10 / 2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food and the requirements of Article 3 (1) of Decree No 38 / 2001 Coll., the health requirements for products intended to come into contact with food and foodstuffs, as amended by the legislation, and
(c) a contained chemical mixture containing nicotine or nicotine salt according to the relevant provisions of the European Union4).
The appearance and properties of nicotine bags
(1) The unit packaging itself and any outer packaging of nicotine sachet must not resemble food, cosmetic product or toy by its shape, size, colour, drawing on it, glue or description. The outer packaging of a nicotine bag is the packaging in which the nicotine bags are placed on the market and which contains a unit pack or package of unit packs; transparent packaging shall not be considered as outer packaging.
(2) The unit packaging of a nicotine bag, which means the smallest individual packaging placed on the market, shall be secured against any undesirable handling which would in particular undermine the integrity of the product and be contrary to the purpose for which the nicotine bags are intended, in particular by tampering with the unit packaging by children.
Labelling of unit packaging and external packaging
(1) Information pursuant to § 12k (2) of the Act
(a) are printed unremovable;
(b) are visible; and
(c) shall not be covered when placed on the market.
(2) The packaging of unit and outer packaging must bear the name of the mark as well as the name of the subtype (5) if it exists for the product. The name of the mark shall be filled in only one line. The name of the sub-type shall be filled in only one row and shall be indicated directly under the name of the mark. The written text shall be given in parallel with the health warning text. The name of the sub-type of nicotine bag is the name used to distinguish between different nicotine bags of the same brand name.
(3) The information "Nicotine tobacco-free bag 'and the number of unit packs contained in the outer pack shall be given once on the outer packaging containing more than one unit pack.
(4) The packaging of the unit pack and the outer packaging of the nicotine sachet must contain:
(a) the product identification number under which the product is notified through the common electronic gateway (6);
(b) nicotine content in mg per dose of nicotine bag,
(c) the number of doses of nicotine bag per unit pack,
(d) the date of minimum durability,
(e) the graphic mark together with the text "The product is not intended for persons under the age of 18." and the phrase "The product is not intended for pregnant women." "The product is not intended for breastfeeding women." and "Save out of reach of children." the form of the graphic mark "The product is not intended for persons under the age of 18." is given in Annex 2 to this decree, and
(f) the entry referred to in Article 9 (1) (c) of Regulation (EU) No 1169 / 2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924 / 2006 and (EC) No 1925 / 2006 of the European Parliament and of the Council and repealing Commission Directive 87 / 250 / EEC, Council Directive 90 / 496 / EEC, Commission Directive 1999 / 10 / EC, Directive 2000 / 13 / EC of the European Parliament and of the Council, Commission Directives 2002 / 67 / EC and 2008 / 5 / EC and Commission Regulation (EC) No 608 / 2004.
(1) The packaging of the unit pack and the outer packaging of the nicotine sachet may once indicate the black bar code on the white background. The bar code shall not represent an image, a pattern or a symbol similar to anything other than the bar code.
(2) The ingredients contained in nicotine bags must be listed in descending order of weight. If one of the components is nicotine salt, the amount of nicotine salt contained in the dose shall be indicated in mg.
(3) Health warnings means warnings concerning the adverse effects of nicotine bags on human health. The health warning on each unit pack and on any outer pack of nicotine bag is: "This product contains nicotine and is highly addictive." No additional text may be provided on the packaging as described in the second sentence that would comment, paraphrase or refer to this health warning in any way.
(4) The health warning referred to in paragraph 3 must:
(a) be placed parallel to the main text on the area reserved for this warning;
(b) be printed in black in bold Helvetica with 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;
(c) be placed at the centre of the surface reserved for them;
(d) be parallel to the side edge of the unit pack or outer packaging in the case of block packaging and similar shape;
(e) cover 30% of the surface area of the unit pack and any outer packaging on which the health warning is printed;
(f) be indicated on the surface together with the name of the mark and the name of the subtype; and
(g) in the usual way of opening the unit pack, remain undisturbed.
(5) The labelling of the unit pack itself and any outer packaging of the nicotine bag must not contain any element or feature which:
(a) promote the nicotine bag or promote its consumption by creating a false impression of the product's characteristics, its effects on health, risks and emissions;
(b) suggests that the nicotine bag is less harmful than other products, has vitalisation, energizing, healing or rejuvenating effects, or the characteristics of the organic farming product, is of natural origin, has other health or lifestyle benefits;
(c) resembles a foodstuff, cosmetic product or toy; or
(d) indicates that the nicotine sachet has increased biodegradability or other environmental benefits.
(6) Unit pack and any outer packaging of nicotine sachet must not:
(a) indicate economic advantages, including through printed vouchers, discount offers, free distribution, two-for-one offers, or other similar offers,
(b) contain any elements related to illegal or dangerous substances, or promoting socially undesirable behaviour, or suggesting an increased possibility of achieving social or social success;
(c) contain any elements directly or indirectly targeting minors based on the culture of minors;
(d) contain any elements related to flavourings and flavourings which evoke confectionery or pastry products which may be particularly attractive to minors.
(7) An element or feature prohibited under paragraph 5 or 6 may be a text, symbol, name, brand name, figurative or other character. Product Flavouring Elements may only appear on the product in text form.
Method and scope of notification for placing nicotine bags on the market
(1) The notification provided for in Article 12k (4) (a) of the Act is made through the EU Common Entry Gate (EU- CEG) pursuant to the Implementing Decision establishing the format for the submission and disclosure of information on tobacco products. The notification is similar to that for oral tobacco products (6), according to the brand and type of oral tobacco. This notification shall include at least:
(a) a list of all ingredients contained in nicotine bags by brand name and type, including their quantities;
(b) toxicological data on the ingredients referred to in (a), in particular with regard to their oral, dermal, inhalation effects on consumer health, and any addictive effect in the Czech language;
(c) a safety data sheet processed in accordance with the directly applicable regulation of the European Union on chemicals (7);
(d) information on doses of nicotine and its intake when used under normal or foreseeable conditions; and
(e) the name and contact details of the manufacturer, the legal or natural person responsible in the European Union and, where appropriate, the importer to the European Union.
(2) Prior to the first notification pursuant to Article 12k (4) (a) of the Act, the manufacturer or importer shall request the operator of EU- CEG to assign the petitioner's identification number. The manufacturer or importer shall, upon request, submit information containing his identification data and verification of activities in accordance with the national legislation of the Member State in which he is established. The petitioner's identification number shall be used for all subsequent notifications made via EU- CEG and for any further correspondence with the Ministry of Health.
(3) On the basis of the petitioner's identification number, the manufacturer or importer shall assign the nicotine bag identification number to each product to be notified. When submitting notifications of products having the same composition and appearance, the manufacturer and importer shall use the same nicotine bag identification number, unless otherwise provided for in this Decree.
(4) The procedure referred to in paragraph 3 shall apply irrespective of the mark and subtype of the product and the number of markets on which the products are placed. If it is not possible to ensure that the same nicotine bag identification number is used for products of the same composition and appearance, the different nicotine bag identification numbers allocated to those products must be provided.
(5) The notification provided for in Article 12k (4) (a) and (5) of the Act is submitted before the nicotine bag is placed on the market.
(6) When a notification is submitted, any information which the manufacturer or importer considers to be business secrets or otherwise confidential shall be identified. The name of the petitioner, the country in which the petitioner has his registered office or residence, the type of petitioner referred to in the Annex to Commission Implementing Decision (EU) 2015 / 2186 of 25 November 2015 laying down the format for the submission and disclosure of information on tobacco products, the identification number of the nicotine bag, the name of the mark, the name of the sub-type, the product type, the first date of submission, the date of the last update of the submission, the date on which the petitioner introduced or intends to place the product on the market.
Notification of market information for nicotine bags
(1) The notification pursuant to § 12k (4) (b) of the Act contains:
(a) summary information on sales volume by brand name and product type,
(b) any information on the preferences of different consumer groups, including young people, non-smokers and the main types of current users.
(2) The information referred to in paragraph 1 (a) shall be provided by the manufacturer or importer through the relevant EU- CEG section in the form of a newly supplemented figure for each calendar year. The information referred to in paragraph 1 (a) shall be submitted by the manufacturer or importer by 31 May of the calendar year following the end of the calendar year in which the sale took place. The information referred to in paragraph 1 (b) shall be submitted by the manufacturer or importer by 31 December of the calendar year following the end of the calendar year in which the sale took place.
Transitional provision
Nicotine bags which do not comply with the requirements laid down in this Decree and which have been manufactured or placed on the market and labelled before the date of entry into force of this Order may be offered for sale and sold no more than 12 months after the date of entry into force of this Order.
Final provision
This Decree was notified in accordance with Directive (EU) 2015 / 1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical and information society services.
Efficacy
This Decree shall take effect on 1 July 2023.
Minister:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
Příloha č. 1
Annex No 1 to Decree No 141 / 2023 Coll.
List of prohibited substances which cannot be added as separate components to nicotine bags
| Název látky | Číslo (čísla) CAS |
|---|---|
| kyselina agaricinová | 666-99-9 |
| aloin | 1415-73-2 |
| kapsaicin | 404-86-4 |
| hypericin | 548-04-9 |
| beta-asaron | 5273-86-9 |
| estragol | 140-67-0 |
| kyanovodík | 3017-23-0 |
| menthofuran | 494-90-6 |
| methyleugenol | 93-15-2 |
| pulegon | 89-82-7; 15932-80-6 |
| quassin | 76-78-8 |
| safrol | 94-59-7 |
| teucrin A | 12798-51-5 |
| thujon (alfa a beta) | 546-80-5; 76231-76-0 |
| kumarin | 91-64-5 |
| kolchicin | 64-86-8 |
| bergamottin (furanokumarin) | 7380-40-7 |
| 6,7 – dihydroxibergamottin (furanokumarin) | 145414-76-2 |
Příloha č. 2
Annex No 2 to Decree No 141 / 2023 Coll.
Graphic Mark
The graphic mark "The product is not intended for persons under 18 years of age." The character of the custom graphic mark (Figure 1) has a circular shape with a diameter of at least 1 cm with a white background and a circle with a red reinforced edge, a red oblique stripe over black text 18 on a white background.
Figure 1
1) Regulation (EC) No 1925 / 2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foodstuffs, as amended.
2) Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended.
3) Act No. 102 / 2001 Coll., on general product safety and amending certain other laws (Act on general product safety), as amended.
(4) Regulation (EC) No 1907 / 2006 of the European Parliament and of the Council of 18 December 2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals, establishing a European Chemicals Agency, amending Directive 1999 / 45 / EC and repealing Council Regulation (EEC) No 793 / 93, Commission Regulation (EC) No 1488 / 94, Council Directive 76 / 769 / EEC and Commission Directives 91 / 155 / EEC, 93 / 67 / EEC, 93 / 105 / EC and 2000 / 21 / EC, as amended. 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, as amended.
(5) Point 3 of the Annex to Commission Implementing Decision (EU) 2015 / 2186 of 25 November 2015 establishing a format for the submission and making available of information on tobacco products.
6) Commission Implementing Decision (EU) 2015 / 2186.
7) Regulation (EC) No 1907 / 2006 of the European Parliament and of the Council of 18 December 2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals, establishing a European Chemicals Agency, amending Directive 1999 / 45 / EC and repealing Council Regulation (EEC) No 793 / 93, Commission Regulation (EC) No 1488 / 94, Council Directive 76 / 769 / EEC and Commission Directives 91 / 155 / EEC, 93 / 67 / EEC, 93 / 105 / EC and 2000 / 21 / EC, as amended.
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Decree No. 141 / 2023 Coll., on nicotine tobacco-free bags |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.05.2023 |
|---|---|
| Effective from | 01.07.2023 |
| Effective until | - |
| Status | Valid |
Public Contracts 2
Objednatel má s Dodavatelem uzavřenou „Rámcovou dohodu na zajištění služeb v oblasti
elektronického...
Ministerstvo zdravotnictví
Asseco Central Europe, a.s.
10.10.2025
Notifications
vytvoření systému
veřejné zprávy „Resortní informační systém KHS“
Ministerstvo zdravotnictví
Asseco Central Europe, a.s.
32 656 388 CZK
19.02.2025
Source:
Hlídač státu
(CC BY 3.0 CZ)
The regulation text is for informational purposes only.
Comments 0