Electronic cigarettes and refills have been regulated by Czech Act No. 110/1997 Coll., on food and tobacco products since 2016. They are included in the text of the act either independently or within the tobacco product-related product group (together with herbal products intended for smoking).

The act enshrines the obligation to report information about the product and its market (volume, consumer groups, etc.) as well as to collect information on any adverse effects of such products on human health. The Act also regulates conditions for transboundary sale (i.e. sale via e-shops). Each manufacturer, importer, retailer and distributor must take measures to ensure that the products they handle meet the requirements of Czech Regulation No. 37/2017 Coll., on electronic cigarettes, replacement refills and herbal products intended for smoking. In addition to the requirements for the structure and details of the reports and registrations, the regulation also defines the labelling requirements, which are more detailed than the labelling requirements for tobacco products. In addition to the common elements such as the manufacturer, importer or distributor, product group name, weight and health warnings, the information must also include items such as the list of all ingredients present in the refill, nicotine content in the product/dose, warning that the product should be kept out of the reach of persons younger than 18 years, etc. In addition, the product must be accompanied by a leaflet containing additional information on the use and storage, contraindications, addictive nature and toxicity, etc.

What, however, is frequently forgotten is the fact that additional legislative documents exist, from which refills are not specifically exempt, specifically Regulation (EC) No. 1272/2008 (CLP Regulation) and Regulation (EC) No. 1907/2006 (REACH Regulation). In the meaning of those documents, the electronic cigarette refill liquid is a chemical mixture and hence, a safety data sheet must be compiled for it (for additional requirements see Article 31, and Annex II, of the REACH Regulation) and the product must be classified, labelled and packed in accordance with CLP Regulation Titles II, III and IV. This means that the label must include the warning symbol, the appropriate H-phrases and P-phrases, the signal word and additional information as may be appropriate (EUH phrases), as well as a list of the components due to which the mixture is categorised as hazardous (with certain exceptions). The refill volume must not exceed 10 ml, owing to which some exceptions from the CLP Regulation requirements apply. The H-phrases and P-phrases for certain hazard classes may be omitted, however, this does not apply to the “acutely toxic” classification, which is quite frequent for these products due to the nicotine content. Also, it is admissible to print the CLP label elements on the outer packaging only (e.g. on the box), but not on the bottle (immediate packaging).

So, the labelling of electronic cigarettes and refills is not governed by one, but by three legislative documents. If the products are included in your portfolio and you are not sure as to the labelling and wish to save time, contact us and we will gladly prepare the draft labels for you or review your labels or translate the labels so all the applicable legislative requirements are met. We cover the complete service portfolio for this product type and we can, of course, also be your reliable partner in other chemical legislation areas.

Author: PhDr. Lucie Šerá

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: https://eur-lex.europa.eu/legal-content/CS/TXT/HTML/?uri=CELEX:52021DC0249&from=EN.