On 16 December 2021, the Ukrainian parliament adopted the Law On Amendments to Certain Laws of Ukraine related to the Public Health Protection from the Harmful Effects of Tobacco No. 1978-IX, which amends the regulation on the manufacturing, sale, labelling, promotion and advertising of tobacco products, including heated tobacco products (HTPs), electronic cigarettes or e-cigarettes and products related to e-cigarettes.

The amendments put a wide range of measures in place to mitigate the adverse effects of tobacco consumption, significantly tightens rules of play for the industry, and aligns local antismoking legislation with EU Directive No. 2014/40, as required under the EU-Ukraine Association Agreement.

The main changes include the following restrictions for tobacco market players:

  • Extended prohibition on certain tobacco products on the Ukrainian market, including:
    • tobacco products that fall outside the requirements for cigarettes to smoke (tar less than 10mg/stick; nicotine less than 1.0mg/stick or 20 mg/1 ml for e-cigarettes; and CO less than 10mg/stick).
    • liquids used in e-cigarettes must only be marketed in special charging containers of a volume no greater than 10 ml (and for single-use e-cigarettes, no greater than 2 ml).
    • tobacco products labelled with any statements, including promotional or misleading information, regarding product characteristics (e.g. health risks, content, eco-friendliness, statements regarding flavour or taste).
    • cigarettes and tobacco for hand-rolled cigarettes, e-cigarettes, refill containers, and liquids used in e-cigarettes with a specific flavour and/or taste.
    • tobacco products or liquids used in e-cigarettes with additives (e.g. vitamins or substances that give the impression that there are health advantages for smoking or consuming caffeine, taurine or other additives and stimulants associated with energy and vitality, etc.).
    • cigarettes and tobacco for hand-rolled cigarettes that include flavoured and taste additives in filters, paper, packaging and capsules that attempt to change the taste and flavour of tobacco.
    • cigarettes and tobacco for hand-rolled cigarettes (i.e. filter, paper or capsules that contain tobacco or nicotine).
    • liquids used in e-cigarettes manufactured using ingredients of insufficient quality or ingredients (except nicotine) that are associated with health risks when heated.
    • e-cigarettes that do not ensure the equal consumption of nicotine doses under usual consumption conditions.
    • e-cigarettes, refill containers, and liquids used in e-cigarettes that are not safe due to the possibility of non-authorised access (including access to children), leakage and defects.
  • Notification obligation for producers or importers of e-cigarettes, refill containers, liquids used in e-cigarettes, or any new tobacco products before putting such products on the Ukrainian market;
  • Improving reporting on the ingredients and emissions required for tobacco-product producers and importers. The emission concentration of nicotine, tar, and CO is to be determined under:
    • Nicotine – ISO 10315;
    • Tar – ISO 4387;
    • CO – ISO 8454.

The nicotine, tar, and CO concentration accuracy must be measured by ISO 8243 standard.

  • An obligation for tobacco-product producers and importers to report volumes of annual sales of tobacco products by brands and types.
  • Ensuring that medical warnings on single packs and outer packaging of smoking-related tobacco products (including e-cigarettes) cover 65% of the outer front and rear surfaces of a single pack or outer package, and that the warnings contain the same text warning and the corresponding colour photograph on both sides of the package.
  • Advertising, promotion, and sponsorship of e-cigarettes, refill containers and liquids used in e-cigarettes and HTPs are prohibited, including on the Internet and social media.
  • Ban on smoking in certain places is extended to e-cigarettes and smoking by means of HTPs.

The failure of a market player to comply with new rules can result in fines of between UAH 1,000 and UAH 30,000 (EUR 35 and EUR 975) per breach, depending on the violation.

The Law will enter into force on 11 July 2023, except for some definitions and provisions concerning warning labels and the extension of the list of public places where smocking is prohibited.

For more information on this law, contact your CMS client partner or local CMS experts: Maria Orlyk, Borys Danevych.

Source (in Ukrainian): http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?pf3511=70397