Tobacco and Related Products in the Light of Amendments of the Law on Tobacco – Is Regulation of Related Products Market Overdue?

The Law on Amendments to the Law on Tobacco (“the Law”)was published in the Official Gazette of the Republic of Serbia no. 92/2023 of October 27, 2023. The subject amendments entered into force on the eighth day upon the day of publishing i.e., on November 4, 2023, with several exceptions.

The main reasons for adoption of the Law are the establishment of improved conditions for operation in the market of tobacco and tobacco products, more efficient regulation of manufacturing and trade in tobacco products, as well as the establishment of legal framework that would enable regulated manufacturing and trade in new and alternative products related to tobacco products. Namely, since this market is continuously changing, particularly in the direction of development of stated new and/or alternative products related to tobacco products, which do not contain tobacco but rather nicotine or nicotine-free aromas, there is a need to precisely define such products and to regulate the operation of economic entities that perform the activities related to new and alternative products in the market of the Republic of Serbia.

Moreover, when it comes to products that do not contain tobacco but whose consummation type and certain properties are related to tobacco products, one can say that the legislator recognised the need to regulate their trade much later than their uncontrolled placement resulted in significant consumption among minors. It remains to be seen in the upcoming period how strictly the new legal restrictions would be applied and controlled, i.e., what their real effects would be.

In addition, the new solutions provide for the alignment with the EU acquis, notably Directive 2014/40/EU, in the part referring to packaging and labelling of tobacco products.

Below, we shall present the key novelties.

Extension of the subject of regulation

The Law now covers related products,which are defined as products with or without nicotine, which are not comprised of tobacco but correspond to tobacco products regarding other criteria, namely:

• Liquid for e-cigarettes,which denotes liquid with or without nicotine contained in the re-filling tank, in disposable liquid pods, in disposable e-cigarette and in parts of e-cigarettes;
• Herbal products for smoking/heating,which are products on basis of herbs, grass or fruits, used by combusting/heating;
• Nicotine pouches,which imply disposable products that contain nicotine or nicotine compounds and other components, packed in bags or transparent bags, exclusively intended for oral use; and
• Products for water pipe,i.e., hookah aromas, which are products intended for consumption through water pipe.

Given the extended subject of regulation, one can question whether the legislator failed to change the title of this law because its subject is no longer tobacco and tobacco-based products, hence the modification of the name would certainly be appropriate.

In addition, definitions of certain tobacco products are specified, for instance:

• Heated tobacco product/non-combustible tobacco,which is defined as tobacco product used for inhaling vapour (aerosol) through electronic device for heating tobacco/herbal product, made in such a manner that it heats during consumption and does not combust;
• Tobacco for oral consumption i.e., snus, which represents any tobacco product used for oral consumption except for those intended for inhaling or chewing, which is entirely or partly made of tobacco, in form of powder or particles or any combination of these forms, packed in bags or transparent bags; and
• Tobacco for water pipe/hookah, which implies tobacco product that can be consumed through water pipe, whereas, if the product can be used both through water pipe and as cut tobacco, it shall be considered cut tobacco.

Also, the Law introduces the definition of electronic device for heating tobacco and/or herbal product and e-cigarettes, for clear distinction between devices and products, hence:

• Electronic device for heating tobacco, i.e., herbal products entails any device used for consumption of heated tobacco products, i.e., heated herbal products and it is used for the delivery of aerosolised or vapoured nicotine or any other substance inhaled from the device, which does not include combustion process; while
• E-cigarette represents a device or any electronic system for inhaling vapour (aerosol) that is generated by heating liquid for filling the device and/or electronic system and used through mouthpiece.

Restrictions with regard to composition and nicotine content

The Law prescribes restrictions with regard to composition and nicotine content, by stipulating that:

• liquid for filling e-cigarettes may contain maximum 20 mg/ml of nicotine;
• individual package of nicotine pouches shall contain maximum 20 pouches; and
• nicotine pouch may contain maximum 17 mg of nicotine.

In addition, the Law stipulates that sale of liquid for filling e-cigarettes with nicotine shall be allowed to consumers:

• in appropriate tanks for re-filling, with volume up to 10 ml;
• in disposable e-cigarette tanks, with volume up to 2 ml;
• in disposable pods, with volume up to 2 ml.

Protection of minors

For the purpose of protection of minors, the Law prescribes that retailers, i.e., persons issued retail permit shall be obliged to display special notice “Prohibited sale of tobacco and related products to minors” in visible place in a retail facility and/or on each humidor. Furthermore, the retailer performing tourist or catering activities (HORECA) shall be obliged to display such special notice on a visible place in the retail facility and/or on each humidor.

It is explicitly prohibited to sell tobacco and related products to minors, and it is also prohibited:

• to sell tobacco and related products in retail shops through customer self-service;
• to sell in retail tobacco and related products through vending machines;
• to manufacture and sell sweets, snacks, toys, cosmetic and other products in form of tobacco products;
• to offer and sell tobacco and related products by using one or more remote communication means, as well as by offering in person;
• to sell cigarettes and nicotine pouches by piece;
• to provide services of using water pipe (hookah) in catering facilities, unless tobacco for water pipe and products for water pipe are sold along with the service;
• to sell tobacco and related products in pharmacies and specialised shops for medical devices;
• to sell and import tobacco for oral consumption (snus);
• to manufacture and sell tobacco and related products that contain psychoactive substances;
• to sell electronic devices for heating tobacco and/or herbal products and e-cigarettes to minors;
• to sell liquid for filling e-cigarettes, herbal products for smoking and/or heating and nicotine pouches with writings, illustrations and elements on packaging that refer to sweets, candies, desserts or e.g. toys, cartoon characters, action figures etc.; and
• to sell e-cigarettes and electronic devices for heating tobacco and/or herbal product, whose form is identical with or resembling the form of toys, food and beverages.

As we can see, the prohibitions that were exclusively applied to tobacco products are now applied to related products as well.

Introduction of two new registers

The Law introduces two new registers that are kept by the Tobacco Administration, namely:

• Register of manufacturers of related products; and
• Register of importers of related products.

The Law stipulates that the activity of manufacturing related products may be performed by an economic entity registered with the authority in charge of registration and in the Register of manufacturers of related products, while import of related products may be performed by an economic entity registered with the authority in charge of registration and in the Register of importers of related products.

Therefore, a precondition for performing these activities is entry into the relevant register.

Registration is done upon request of the economic entity and followed by the prescribed evidence.

The decision on registration is issued for a period of five years, while the manufacturer, i.e., importer of related products may re-register by applying to the Administration no later than 15 days before the expiry of the valid decision on registration.

Obligation to display warning on harmful effects

The Law prescribes that each individual, i.e., group packaging of tobacco products that is traded in the Republic of Serbia shall be labelled with health warning referring to harmful effects for the life and health of humans or other harmful consequences of consumption. The health warnings are now regulated as textual warnings, combined health warnings, general warnings and informative notice, while the Law specifies in detail the appearance and content of the warning, dimensions and consistency, i.e., special rules are prescribed for each individual type of warning.

The Law also specifies special rules with regard to labelling of tobacco products, except for cigarettes, cut tobacco and tobacco for water pipe, as well as labelling of other tobacco products.

It is also prescribed that each individual, i.e., group packaging of related products traded in the Republic of Serbia shall have printed health warning,while the content of the warning depends on whether the related product contains nicotine or not, namely:

• Health warning for related products that contain nicotine reads: “This product contains nicotine that causes strong addiction.“; while
• Health warning for related products that do not contain nicotine reads: “This product may contain substances harmful for Your health.“

Other changes

The Law expands the subject of performance of retail in tobacco products, so as to cover related products.

Also, it is explicitly prescribed that destroying tobacco in a cadastral lot shall be performed with mandatory presence of phyto-sanitary inspector and that record shall be made thereof.

Application of the Law

Finally, as we have noted in the introduction of this text, the Law entered into force on November 4, 2023, with the exception of:

• provisions referring to labelling of related products, which will be applied from January 1, 2025; and
• provisions regulating labelling of tobacco products, namely cigars, cigarillos, cigarettes, cut tobacco, tobacco for pipe and water pipe, which will be applied January 1, 2027.