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Amendments to the Law on Tobacco – A Big Step Towards Harmonization with the EU Legislation

Published on
01
December 2023
Contributors
Luka Radojević
Attorney at Law
Živko Kovačević
Attorney at Law

In late October 2023, the Serbian Parliament was quite busy with a significant number of legislative changes and novelties on its docket at the 26 October session. One of the items on the list was also the adoption of the long-awaited Law on Amendments to the Law on Tobacco ("Law"), which entered into force on 4 November 2023 ("Effective Date").

According to the legislator, the Law was adopted for the following key reasons:

  • Regulating new and alternative products similar to tobacco products which have been available on the Serbian market for a while, such as electronic cigarettes, nicotine pouches, etc.;
  • Protection of minors and public health; and
  • Harmonization with the EU legislation (i.e., the Tobacco Products Directive (2014/40/EU).

Businesses to which the Law applies are obliged to comply with its provisions within 60 days from the Effective Date (i.e., by 3 January 2024), with certain specific provisions’ application date being deferred a bit further.

  1. REGULATION OF TOBACCO FREE PRODUCTS

Unlike the previous legislation, the Law regulates tobacco free products with or without nicotine, which in terms of other criteria correspond to tobacco products (referred to in the Law as "Related Products" (in Serbian: srodni proizvodi)).

According to the Law, the following products are classified as Related Products:

  • Electronic cigarette liquid - a liquid with or without nicotine contained in refill containers, disposable refill cartridges, disposable electronic cigarettes or parts of electronic cigarettes ("e-Liquid").
  • Herbal products for smoking or heating - products based on herbs, grass or fruit, used by burning or heating;
  • Nicotine pouches - disposable products containing nicotine or nicotine compounds, packed in pouches or porous pouches and intended exclusively for oral use; and
  • Waterpipe products (hookah flavours) - products intended for consumption through a waterpipe.

Devices for heating tobacco or herbal products and electronic cigarette devices without e-Liquid are not considered Related Products.

As of 1 January 2025, Related Products placed on the Serbian market must, inter alia, comply with the following requirements:

  • Health warning - individual and group packaging of Related Products (including nicotine-free products) must have a printed health warning in a specified format;
  • Information on packaging - individual and group packaging of e-Liquids and nicotine pouches must include specific details, such as information on ingredients, nicotine level, production and expiration date;
  • Volume limits – e-Liquid with nicotine can be sold in refill containers up to 10ml, and in disposable electronic cigarettes and cartridges up to 2ml; and
  • Nicotine content – e-Liquid may contain up to 20mg/ml of nicotine, and individual packaging of nicotine pouches may contain up to 20 pouches, with one nicotine pouch containing up to 17mg of nicotine.
  1. PROHIBITION OF TOBACCO FOR ORAL USE

The Law explicitly prohibits the import and sale of tobacco for oral use (snus) on the Serbian market.

  1. FURTHER STATUTORY PROHIBITIONS

The Law also prohibits the following practices:

  • sale of Related Products, devices for heating tobacco or herbal products and electronic cigarette devices (without e-Liquid) to minors;
  • distance sales (e.g., via a website) and solicit sales of tobacco products and Related Products;
  • sale of electronic cigarettes and devices for heating tobacco or herbal products with a shape that is identical or resembles the shape of toys, food and drinks;
  • production and sale of tobacco products and Related Products that contain psychoactive controlled substances;
  • sale of tobacco products and Related Products in pharmacies and specialized stores for medical devices; and
  • sale of e-Liquid, herbal products for smoking or heating and nicotine pouches that, on their packaging, contain prints, illustrations or elements related to sweets, candies, desserts, or e.g., toys, cartoon characters, action figures, etc.
  1. NEW LABELING RULES FOR TOBACCO PRODUCTS (INCLUDING CIGARETTES)

As of 1 January 2027, individual and group packaging of tobacco products (e.g., cigarettes, cigars, fine cut tobacco, etc.) shall have, inter alia, a combined health warning which comprises a text warning, a photo in colour and smoking cessation information.

  1. NEW RULES FOR RETAIL LICENCES

The Law introduces a new retail license covering both tobacco products and Related Products. If a retailer holds a valid license for the retail sale of tobacco products, it is permitted to also sell Related Products based on such license. Once this license for the retail of tobacco products expires, the retailer must apply for the newly introduced combined license.

Retailers currently selling Related Products without a license for the retail of tobacco products (such as electronic cigarette shops which do have not sell tobacco products) are permitted to continue selling Related Products provided they submit a request for the newly introduced retail license by 4 December 2023.

The newly introduced combined retail license is valid for two years and the license fee amounts to RSD 25,000 per registered retail object.

  1. NEW REGISTERS

An important step towards regulating the market of Related Products is also the establishment of registers of manufacturers and importers of Related Products.

The registration fee amounts to RSD 5 million and can be paid in five equal annual instalments and the registration decision is issued for a five-year period.

Business entities that have already manufactured and/or imported Related Products prior to the Effective Date may continue performing such activities provided they submit a request for the registration in the relevant register by 4 December 2023.