Everything You Need to Know About Importing Tobacco Products and Electronic Cigarettes / Vaping Devices in Romania
Updated: 4 days ago
Are you a producer, importer, or do you market tobacco products or electronic cigarettes? We know you are dealing with somewhat unclear and interpretable legislation. The marketing and import of tobacco products and electronic cigarettes/vaping devices in Romania follow rules for market authorization, tax registration for excise duty payments, and various customs procedures. This article answers essential questions about current legislation, its implications for the local market, and the requirements that producers/importers of vaping products or traditional cigarettes must meet to operate within legal boundaries.
1. Are there regulations in Romania regarding import of vaping devices and tobacco?
In Romania, the regime for import of vaping devices and tobacco products, both combustible and non-combustible, is strictly regulated by Law No. 201/2016 for the prevention and combating of tobacco product consumption. This law was adopted in response to the need to align national legislation with European Union directives and aims to protect public health by reducing the rate of tobacco consumption, especially among young people.
Other mandatory regulations that outline the marketing regime for tobacco products or products like electronic cigarettes/vaping devices in Romania are:
Law No. 349 of 6 June 2002, for preventing and combating the effects of tobacco product consumption
The Fiscal Code
Orders of the Ministry of Health or other competent authorities.
2. What authorities are involved in implementing regulations on tobacco products, non-combustible cigarettes, electronic cigarettes, and vaping products?
The Ministry of Health is the main public authority responsible for authorizing tobacco products and electronic cigarettes/vaping products marketed within the country. The National Agency for Fiscal Administration (ANAF) and customs authorities have competencies regarding the application of excise duties and import/export customs regimes, and the National Consumer Protection Agency can intervene in disputes between professionals and consumers.
You can read more about commercial guarantees on products on our blog.
3. What are the main regulations in Law No. 201/2016 concerning tobacco products, heated tobacco, and vaping?
The main provisions of Law No. 201/2016 include:
Regulations on authorization
Producers and importers of tobacco products are required to prepare a product file for each brand name and type, which is submitted to the Ministry of Health for authorization and must provide additional information at the authority's request.
Regulations on ingredients
Law 201/2016 includes strict regulations on the ingredients that can be used in tobacco products and electronic cigarettes/vaping devices, including refill bottles alongside the maximum allowed levels for these.
Restrictions on advertising, promotion, and sponsorship of electronic cigarettes/vaping devices
Law No. 201/2016 imposes severe restrictions on the advertising, promotion, and sponsorship of tobacco products and electronic cigarettes. These restrictions are intended to reduce the attractiveness of tobacco products, especially to young people, and to limit the influence of marketing on consumer behavior.
Health warnings and labeling of electronic cigarettes/vaping devices
Packages of cigarettes and other tobacco products must carry graphic and textual health warnings that cover a significant proportion of the package area. The warnings are intended to inform consumers about the risks associated with smoking, including the risk of cancer and cardiovascular diseases.
Sanctions
Non-compliance with the law's provisions results in severe sanctions, including substantial fines for individuals and legal entities, and the possibility of suspension or withdrawal of the operating license for businesses that violate the law.
Read on our blog about how you can file a complaint yourself and what you need to do to manage a court process.
4. Are vaping products regulated in Romania?
Yes, vaping products are regulated in Romania. Electronic cigarettes and their liquids (refill bottles) have a legal regime established by Law 201/2016 concerning the authorization, marketing, labeling, and marketing.
An electronic cigarette is a product that can be used for consuming vapors that may or may not contain nicotine through a mouthpiece or any component of this product, including a cartridge, a tank, and the device without a cartridge or tank.
The refill bottle is a container with a liquid that may or may not contain nicotine and can be used to refill an electronic cigarette.
5. Is there a regulatory difference between disposable and reusable vaping products?
According to the law, vape products/electronic cigarettes can be disposable or can be refilled through a refill bottle or tank or can be recharged with disposable cartridges. All vaping products are subject to the same regulations, but where refill bottles exist, there may be additional obligations regarding the maximum allowed quantity, packaging, or marketing thereof.
6. Is there any obligation regarding electronic cigarettes/vaping devices that do not contain nicotine?
As of March 28, 2024, the regulations of Law No. 201/2016 apply to electronic cigarettes and refill devices whether they contain nicotine or not. The amendment was introduced by Law No. 64 of March 27, 2024, amending and supplementing some normative acts in the field of tobacco products.
7. Are flavors allowed in liquids for vaping devices in Romania?
Yes, flavors are permitted in vaping liquids in Romania. However, there are discussions at the European Union level about potentially restricting certain flavors that could appeal to minors. It is important to follow legislative changes to ensure compliance with the law.
8. Are there market authorization obligations for tobacco products?
Yes, any new tobacco product that has not been authorized by law must be notified to the Ministry of Health at least six months before the anticipated market introduction date. This obligation also applies to manufacturers and importers of heated tobacco products.
Additionally, any changes to an existing product must be notified.
The notification obligations for the market introduction of tobacco products are accompanied by obligations to comply with customs regimes and tax duties related to excise payments. To fulfill these, the manufacturer/importer of tobacco products must obtain additional authorizations.
9. Must electronic cigarettes/vaping devices also be notified to the Ministry of Health?
Yes. Manufacturers and importers of electronic cigarettes and refill containers must notify the Ministry of Health about any such products they intend to introduce to the market.
10. What does the product file for authorization at the Ministry of Health contain?
Manufacturers and importers of tobacco products (i.e., any product that contains tobacco, even partially) are required to authorize tobacco products introduced into the country by submitting a file to the competent public authority – the Ministry of Health.
The notification file for tobacco products or vaping devices/electronic cigarettes includes:
Information on ingredients: a list of all ingredients, the corresponding quantities used in manufacturing the tobacco products, in descending order of the mass of each ingredient included in the tobacco products, the status of ingredients, classification according to EU standards; a general description of the additives used and their properties, in the case of cigarettes and rolling tobacco;
A statement describing the reasons why the ingredients were included in the respective tobacco products;
Relevant toxicological data regarding the ingredients, in burned or unburned form, particularly their effects on consumer health and dependency;
Information on emissions: information regarding emissions and their levels, methods used to measure emissions, other than those for tar, nicotine, and carbon monoxide (the methods of measuring emissions of tar, nicotine, and carbon monoxide are internationally agreed and adopted through delegated acts of the European Commission).
The annual sales volume in Romania per brand and type for the year preceding the reporting year, reported in the number of cigarettes or kilograms.
Internal and external studies available to manufacturers and importers of tobacco products concerning market research and preferences of various consumer groups, including young people and current smokers, related to ingredients and emissions;
Summaries of any market studies that manufacturers and importers of tobacco products conduct when launching new products.
11. Is the manufacturer/importer required to provide product samples to the authority for the authorization of non-combustible cigarettes?
The law does not expressly mandate this, but in practice, manufacturers/importers provide product samples to the Ministry of Health for the authorization of non-combustible cigarettes.
12. What is EU-CEG?
EU-CEG, or the Common Entry Gate of the European Union, is a centralized system within the EU designed for monitoring and reporting on tobacco products and related items, such as electronic cigarettes and their liquids. The primary purpose of EU-CEG is to facilitate the implementation of the Tobacco Products Directive (Directive 2014/40/EU), which includes strict rules on traceability, reporting, and monitoring of tobacco products and related items marketed within the European Union.
In Romania, as in other EU member states, manufacturers and importers of tobacco products and related items are required to transmit detailed information about their products to EU-CEG. This information includes, but is not limited to:
Identification of tobacco/electronic cigarette products: details about the product, including type, brand, and technical specifications.
Traceability: data on production, distribution chain, and retail sales, to ensure tracking of each product from manufacture to consumer.
Ingredients: information about the ingredients and chemicals used in the manufacture of tobacco products and related items.
Emissions: data on emissions of nicotine, tar, and carbon monoxide for smoking products, and other relevant emissions for vaping products.
Manufacturers and importers of tobacco/electronic cigarette products must register in the EU-CEG system to be able to report these data. National authorities in Romania, such as the Ministry of Health and the National Authority for Consumer Protection, are responsible for overseeing and controlling compliance with the regulations by economic operators. These authorities can access the information submitted to EU-CEG to verify product compliance and implement control measures.
13. Are there maximum allowed levels for electronic cigarettes/vaping products?
Electronic cigarettes/vaping products and refill containers marketed in Romania must comply with certain standards:
Liquids containing nicotine can only be introduced on the market in dedicated refill bottles, with a maximum volume of 10 ml, in disposable electronic cigarettes or in disposable cartridges, and the maximum volume of cartridges and tanks does not exceed 2 ml;
The nicotine level in nicotine-containing liquid does not exceed 20 mg/ml;
Nicotine-containing liquid must not contain additives that are banned by law.
14. What usage instructions are mandatory for vaping products/electronic cigarettes?
Each individual package of electronic cigarettes/vaping products and refill containers must include a leaflet with useful information for the correct use of the product. The information in the leaflet accompanying the vaping products includes, among others, usage instructions, contraindications, storage instructions, warnings, contact information of the manufacturer or importer.
15. Can flavored cigarettes be sold in Romania?
No, combustible or non-combustible cigarettes that contain flavors are prohibited. Flavors cannot be found in any of the components of tobacco products, such as filters, papers, packaging, capsules, or any technical feature that allows modifying the smell or taste of the respective tobacco products or modifying the intensity of combustion.
16. Are click-type flavored capsules allowed?
The law does not expressly prohibit the marketing of click-type capsules containing flavors, which can be introduced in cigarettes with or without combustion.
17. What products are subject to traceability obligations?
Traceability of tobacco products in Romania refers to the ability to track the origin, production, distribution, and sale of tobacco products from the manufacturer to the final consumer. This concept is used to combat the illegal trade in tobacco products and electronic cigarettes/vaping and to ensure compliance with national and European regulations.
To implement traceability requirements, each pack of cigarettes or other tobacco products must be marked with a unique identifier. This allows authorities and other interested parties to track the product's journey from production to the retail point.
The necessary information includes the place and date of production, the factory, the machinery used in production, the work shift, the product description, the target market, the anticipated transport route, information on all intermediate buyers.
National authorities, such as the National Authority for Consumer Protection, customs authorities, or the Ministry of Health, use this information to verify the compliance of tobacco products with current laws and to prevent the illegal marketing of tobacco products.
Effective implementation of traceability helps reduce the illegal trade in cigarettes and other tobacco products, a phenomenon that not only affects state revenue through tax evasion but also undermines public health efforts to reduce tobacco consumption. Thus, traceability is an essential tool in public health policy and tobacco control in Romania.
18. Are tobacco products subject to excise duties?
Yes, processed tobacco is one of the excisable products according to the Fiscal Code. Processed tobacco includes: cigarettes, cigars, cigarillos, and smoking tobacco.
19. Are there customs obligations for producers/importers arising from the excise regime?
Excise payers are required to register with the competent authority. Additionally, excise payers are responsible for correctly calculating and paying the excise duties to the state budget and for submitting excise declarations to the competent authority on time.
20. Are electronic cigarettes/vaping products and nicotine-free liquids subject to excise duties?
Starting in 2024, the regime of non-harmonized excise duties applies to liquids with or without nicotine, intended for non-combustion inhalation, including those contained in reserves delivered with electronic cigarettes and other electric vaping devices, as well as products intended for non-combustion inhalation that contain tobacco substitutes, with or without nicotine, including those contained in reserves delivered with electronic cigarettes and other personal vaporization devices.
21. Is it legal to sell vaping products to minors in Romania?
No, it is illegal to sell vaping products to minors. The sale of tobacco products and similar items, including vaping devices, to persons under 18 years old is strictly prohibited and can attract administrative penalties.
22. Is smoking banned in public areas?
Law No. 349/2002 prohibits smoking in all enclosed public spaces, including bars, restaurants, workplaces, public transportation, and children's playgrounds. This measure aims to protect non-smokers from the harmful effects of passive smoking and to create a healthier environment for all citizens. Spaces of detention where individuals are deprived of liberty are exempt from this prohibition.
23. Does the smoking ban in public places apply to heated tobacco products or electronic cigarettes/vaping devices?
Although the term "smoking" is commonly used to refer also to the inhalation of non-combustion tobacco products or vaping products, the official definition is constructed in association with the combustion process. Specifically, "smoking" is legally defined as the voluntary inhalation of smoke resulting from the burning of tobacco contained in cigarettes, cigars, cigarillos, and pipes. Consequently, it can be argued that electronic cigarettes and non-combustion devices can still be used in enclosed spaces.
24. To whom can tobacco products, with or without combustion, and electronic cigarettes/vaping products be sold?
The sale of tobacco products is allowed only to individuals who have reached the legal age of 18. Additionally, cigarette vending machines and the sale of tobacco products in educational institutions and their vicinity are prohibited.
25. Are nicotine pouches regulated in Romania?
Starting at the end of March 2024, nicotine pouches for oral use are regulated by law. A nicotine pouch is a tobacco-free product that contains nicotine and is used for the oral consumption of nicotine in powder or particulate form or any combination thereof.
The nicotine level contained in each nicotine pouch for oral use cannot exceed 20 mg per pouch.
26. Is advertising for electronic cigarettes/vaping products and refill bottles prohibited?
Advertising for electronic cigarettes/vaping products and refill bottles is not completely prohibited but is significantly restricted. Places where advertising for electronic cigarettes/vaping products and refill bottles cannot occur include:
In information society services, in the press or other printed publications,
On radio channels;
On television and other audiovisual channels.
In theaters, cinemas, or other types of visual material projection halls intended for the public;
On billboards, canopies, or any other display structures, regardless of their location or the fees due.
27. Where is advertising for electronic cigarettes/vaping products and refill bottles allowed?
In professional magazines or other publications and materials intended exclusively for professionals in the trade of electronic cigarettes and refill bottles.
In publications and materials that are printed and published in third countries, provided that these publications or materials are not primarily intended for the European Union market.
28. Can electronic cigarettes/vaping devices be promoted on the internet?
Advertising for electronic cigarettes/vaping devices on the internet is also restricted in Romania. According to current legislation, forms of advertising that directly target consumers are not allowed. However, product information intended exclusively for professionals in the field may be exempt from these restrictions.
29. Is it legal to use the packaging of electronic cigarettes/vaping devices for advertising purposes?
Yes, product information can be displayed on the packaging of electronic cigarettes/vaping devices, but it must comply with certain rules, primarily regarding the inclusion of health warnings and other mandatory information according to EU directives and national law. The packaging must not contain marketing elements that might attract minors or encourage consumption.
30. Can I organize events or sponsor festivals to promote electronic cigarettes?
No, organizing events or sponsoring festivals for the purpose of promoting electronic cigarettes/vaping devices is prohibited in Romania. This is part of the general restrictions on promoting tobacco products and related items, intended to limit public exposure to these products.
31. Can I advertise electronic cigarettes/vaping devices at the point of sale?
Advertising for electronic cigarettes/vaping devices at points of sale is allowed, but it must be strictly limited to information about availability and pricing. Marketing materials that misinform about the benefits of using electronic cigarettes/vaping devices or that attract minors through design or promotional messages are not allowed.
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