Tobacco-free nicotine pouches in the legislative context

A new nicotine product type has appeared in the Czech market: nicotine pouches, which are small casings containing a mixture of nicotine, flavouring ingredients and other substances, but no tobacco. The nicotine pouch is intended to be put in the mouth under the upper lip. Nicotine is released from the pouch and is absorbed buccally, that is, without the need to chew the material. Until recently, nicotine pouches “floated in a vacuum” in the context of Czech legislation. This fact, among other things, posed a problem in regards to placing this product on the market in accordance with legislation. Nicotine pouches were not covered by the definition of a tobacco product because of the absence of tobacco in them (according to the previous wording of Act No. 110/1997 Coll.), nor could they be classed as food or medicinal products. So, the only remaining way out was to categorise nicotine pouches generally as chemical mixtures, or combinations of a mixture (filling on a carrier) and an article, which are subject to the obligations set out in the European REACH1 and CLP2 regulations. The obligation to classify, label, pack, report in PCN format (to the poison centres) and develop safety data sheets, etc., according to the CLP2 and REACH1 regulations remains valid for the nicotine pouches, however, what is new is the inclusion of the nicotine pouches in Act No. 110/1997 Coll., on food and tobacco products3. This occurred  by amendment of the above act via Act No. 174/2021 Coll., of 13 April 2021. The parts of the act that concern nicotine pouches came into force on 12 May 2021. By this amendment, Section 2 of Act No. 110/1997 Coll., 3 was extended with a point marked “za”, which defines a tobacco-free nicotine pouch as a tobacco-free product containing nicotine for oral use. No similar definition is included in the directly applicable European legislative document (i.e. Regulation (EC) No. 178/2002, laying down the general principles and requirements of food law4). Certain obligations applying to nicotine pouches basically copy the obligations applying to electronic cigarette refills, which are also  regarded as chemical mixtures (or combinations of a mixture and an article) from the legislative aspect. For instance, nicotine pouches must display information about contraindications, their addictive nature, toxicity, warning(s) for the risk groups and other mandatory information. A notification must additionally be sent to the Ministry of Health before importing any pouches or putting them on the market. The amendment, however, refers to an implementing regulation as regards specific conditions and requirements, but no such implementing document had not been issued so far. This concerns, in particular, requirements for product quality and for the scope of the information to be submitted. The Czech amendment to the act got ahead of the European legislation as regards the nicotine pouch issue, because the European Union thus far does not regulate such products in any way . This situation, however, is likely to change soon: this change will probably consist in an amendment of Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products (Tobacco Product Directive, TPD). This directive attempted to anticipate the ingenuity of the market, which offers new and new tobacco/nicotine products, by introducing the term “new tobacco products” but, as the report on the application of Directive 2014/40/EU remarks, “[…] the provisions are not specific to the unique properties of certain new products. Moreover, the directive does not fully cover some new tobacco-free products such as nicotine pouches for oral use.”5   In conclusion, we can await additional changes in legislation regarding tobacco-free nicotine pouches,  not only in the Czech Republic, but certainly in the European Union as well. We are monitoring the developments closely, and as such, if you are not sure or just wish to get insight into the current situation in this area, please do not hesitate to contact us, people who are qualified to help.   Authors: PhDr. Lucie Šerá, Ing. Sabina Fraňková

  1. Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
  2. Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP)
  3. Czech Act No. 110/1997 Coll., on foods and tobacco products
  4. Regulation (EC) No. 178/2002 laying down the general principles and requirements of food law
  5. Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products. [online]. Brussels, European Commission, 2021. [cit. 2021-7-20]. Available from: