A legislative window for electronic cigarettes

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