Guide to the New Tobacco and Vape Regulations in Romania
Romania has taken a significant step towards strengthening its tobacco control measures with the enactment of Law No. 64/2024 on March 28, 2024. This new legislation introduces a series of amendments and additions to the existing laws governing tobacco products, electronic cigarettes, heated tobacco products, and related products in Romania. The primary objective of Law 64 is to enhance public health protection, particularly for minors, by imposing stricter regulations on the marketing, sale, and packaging of these products.
First of all, Romania follows the European Union’s Tobacco Products Directive (TPD) regarding e-cigarettes. The TPD, which came into effect in May 2016, sets out specific rules for the manufacture, presentation, and sale of tobacco and related products across the EU, including e-cigarettes. These rules aim to ensure a high level of health protection for European citizens.
Read more: LEGE nr. 201 din 4 noiembrie 2016
Protecting Minors from Nicotine Products
One of the most crucial changes brought by Law 64 is the extension of the prohibition on sales to minors (under 18 years of age) to a broader range of products. These include electronic cigarettes, refill containers, electronic devices for heating tobacco, products for smokeless inhalation of tobacco substitutes, pouches with nicotine for oral use, and products for smokeless inhalation of tobacco substitutes, collectively referred to as “Vaping and Heating Products, Nicotine Pouches and Tobacco Substitutes.” Prior to Law 64, only the sale of traditional tobacco products to minors was prohibited.
To ensure compliance with this restriction, Law 64 requires operators selling these products to include a mandatory statement on their health operating permit, clearly stating the prohibition of sales to persons under 18 years of age. Violators face severe penalties, including fines of approximately EUR 2,000 and a 30-day suspension of business activities for the first offense. Repeated offenses can result in fines of approximately EUR 4,000 and the closure of the business.
Furthermore, Law 64 reinforces the protection of minors by banning smoking and the use of any tobacco products, Vaping and Heating Products, Nicotine Pouches, and Tobacco Substitutes in all educational institutions, irrespective of the students’ age. Educational institutions must implement internal regulations to enforce this prohibition, and the Romanian Education Ministry is required to establish sanctions for non-compliant students.
Restrictions on Distance Sales and Vending Machines
Law 64 introduces indirect restrictions on the cross-border distance sale of all traditional tobacco products, as well as Vaping and Heating Products, Nicotine Pouches, and Tobacco Substitutes, to consumers in Romania (incoming). The law also prohibits retailers in Romania from engaging in cross-border distance sales to consumers in other EU Member States where such sales have been prohibited. It specifically prohibits the sale of these products through easybox/locker devices, which are defined as secure boxes/spaces intended for storing parcels to be picked up by the addressee in exchange for a code/words provided by electronic means or at the time of payment.
Moreover, the sale of Vaping and Heating Products, Nicotine Pouches, and Tobacco Substitutes through vending machines is now prohibited. Previously, this prohibition only applied to traditional tobacco products. Infringements of these restrictions carry substantial fines and potential suspension or closure of business activities.
New Packaging and Labeling Requirements
Law 64 introduces a new requirement for all tobacco products, Vaping and Heating Products, Nicotine Pouches, and Tobacco Substitutes sold via courier services. The package must now include the following warning in Romanian:
«ATENTIE! ACEST PACHET CONTINE PRODUSE DIN TUTUN SI/SAU PRODUSE CARE CONTIN NICOTINĂ: ASE VERIFICA VARSTA CLIENTULUI».”
eng: “WARNING! THIS PACKAGE CONTAINS TOBACCO PRODUCTS AND/OR PRODUCTS CONTAINING NICOTINE. PLEASE CHECK CLIENT’S AGE.”
This amendment affects the packaging of all products sold via courier, while products sold in stores are exempt from this requirement. Non-compliance with this obligation can result in fines and the suspension or closure of business activities.
Introducing New Definitions and Product Categories
Law 64 introduces several new definitions into the Romanian Tobacco Law, including “pouch with nicotine for oral use,” “product for smokeless inhalation of tobacco substitutes,” “electronic device for heating tobacco and products for smokeless inhalation of tobacco substitutes,” “electronic cigarette,” and “refill container.” These definitions aim to fill gaps in the existing legislation and align with the EU Tobacco Products Directive (2014/40/EU).
However, the definition of “electronic cigarette” in Law 64 deviates from the EU directive by including products that can be used for the consumption of vapors that do not contain nicotine. This means that all provisions for electronic cigarettes in the Romanian Tobacco Law and related legislation should also apply to nicotine-free electronic cigarettes, which contrasts with the EU directive that does not regulate these products.
ECIGATOR
Ecigator is one of the well-known vape brands spun off from FM Technology Co., Ltd, it’s an ISO-certified disposable vape manufacturer for OEMs, ODMs, and OBM since 2010. The founder team comes from top firms with more than 10 years of experience in the vaping industry and has devoted thousands of hours to providing users with a better and better experience.
Regulating Nicotine Content in Pouches
Law 64 prohibits the placing on the market of pouches with nicotine for oral use exceeding 20 mg/pouch. Non-compliance with this prohibition is considered a misdemeanor and is sanctioned with a fine of between approximately EUR 15,000 and EUR 20,000, along with the complementary sanction of banning the non-compliant products from the market.
The Need for Further Clarification and Consistency
While some amendments introduced by Law 64 were necessary to reduce minors’ exposure to products that can affect their health, others require further clarification. The inclusion of definitions from the EU Tobacco Products Directive that were previously omitted in the Romanian transposition is a positive step. However, new amendments for consistency and a more complete regulation of the newly defined products, particularly electronic cigarettes that do not contain nicotine, would be welcome to ensure a clear and comprehensive regulatory framework.
As Romania continues to strengthen its tobacco control measures, it is essential for consumers, businesses, and stakeholders in the tobacco and e-cigarette industry to stay informed about these changes and their implications. By understanding and complying with the new regulations, all parties can contribute to the protection of public health, particularly the well-being of minors, while navigating the evolving landscape of tobacco and nicotine products in Romania.
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