Message 001
Communication from the Commission - TRIS/(2025) 1801
Directive (EU) 2015/1535
Notification: 2025/0362/BG
Notification of a draft text from a Member State
Notification – Notification – Notifzierung – Нотификация – Oznámení – Notifikation – Γνωστοποίηση – Notificación – Teavitamine – Ilmoitus – Obavijest – Bejelentés – Notifica – Pranešimas – Paziņojums – Notifika – Kennisgeving – Zawiadomienie – Notificação – Notificare – Oznámenie – Obvestilo – Anmälan – Fógra a thabhairt
Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20251801.EN
1. MSG 001 IND 2025 0362 BG EN 09-07-2025 BG NOTIF
2. Bulgaria
3A. Министерство на икономиката и индустрията
дирекция "Европейски въпроси и законодателство на ЕС за стоки и услуги"
ул. "Славянска" № 8, 1052 София
Tel.: +359 2 940 7336; +359 2 940 7522
E-mail: infopointBG@mi.government.bg
3B. 51-во Народно събрание на Република България
София 1169, пл. „Княз Александър I“ №1
тел. +359 2 939 39
4. 2025/0362/BG - X60M - Tobacco
5. Act amending and supplementing the Tobacco, Tobacco and Related Products Act
6. Tobacco products and products related to tobacco products
7.
8. The growing popularity of products other than tobacco products, smokeless tobacco products, novel tobacco products and heated tobacco products poses a serious risk to public health. The ban will limit the ever-increasing marketing of single-use e-cigarettes, with or without nicotine, whose liquids contain flavourings / additives that impart a taste and smell resembling fruit, confectionery, such as desserts and pastries, or other sweet foods, or any drinks are particularly attractive and seductive to children and adolescents.
9. The legislative initiative relates to the need to ensure a high level of public health protection for citizens, especially children, by introducing a total ban on the placing on the market of e-cigarettes containing or not containing nicotine - "vapes" and similar devices.
The ever-increasing marketing of e-cigarettes whose liquids contain flavourings / flavouring additives that impart a taste and smell resembling fruit, confectionery such as desserts and pastries, or other sweet foods, or any drinks are particularly attractive and seductive for children and adolescents. This trend is particularly dangerous given the health risks associated with the use of these products due to the potential for exposure to high levels of nicotine and other substances of unclear origin, including narcotic drugs and their analogues. The most recent data on induced acute intoxications after children’s use of these products, including those with fatal outcomes, are extremely alarming.
The World Health Organisation (WHO) and STOP published on 22 May 2024. The report ‘Addiction of the Next Generation’ shows that, despite significant progress in the overall reduction of smoking in the world, the use of e-cigarettes is increasing, especially among young people - almost threefold.
Disposable and refillable e-cigarettes, whether or not containing nicotine, resemble tobacco products and thus generate habits and perceptions in young people that smoking is a harmless and pleasant habit. Any product resembling a smoking product other than a tobacco product, regardless of its composition and mode of consumption, shall embed in children and adolescents a positive attitude towards these products, including tobacco products. The harms of such products are both direct and indirect. In addition to formation of harmful habits, the composition of new products that are introduced on a daily basis and that are widely used by both adults and children is also questionable. The apparent ‘lack of harmful substances’ or ‘reduced harm’ incentivises people to use these products in unmeasured quantities and for a prolonged period of time without interruption, and thus also increases their harm to health. The legislative change is in fulfillment of the constitutional duty of the state to protect the health of citizens, in particular that of children.
In addition, the proposed amendments to the Act on Child Protection introduce a ban on the use, marketing and sale to children of all nicotine-containing products, including pouches, snuses, chewing gums, etc., and of energy drinks.
According to the opinion of the European Food Safety Authority, when consuming two or more energy drinks a day, due to increased intake through them of caffeine in combination with other ingredients with a stimulating effect, adverse effects on the body are possible: increased nervousness, anxiety, tremor, insomnia, headache, palpitations, respiratory disorders, erosive changes of the mucous membrane of the gastrointestinal tract, dehydration due to loss of water and salts from the body. Children and adolescents are a riskier group due to the occurrence of the adverse effects of caffeine in much lower doses in them compared with their occurrence in adults.
Taurine and d-glucoronolactone are biologically active substances, often included in the composition of energy drinks, which are natural ingredients of food and are normal metabolites of metabolism in the body. With high intake, taurine may have adverse effects mainly on brain activity, and d-glucoronolactone on kidney activity. Their energizing effect is not associated with high energy value, but with a stimulating effect on the functions of the body of the biologically active substances, vitamins and plant extracts included in their composition. These beverages are developed as functional to support mental and physical activity, to reduce the signs of tiredness.
10. References of the Basic Texts: 2021/0650/BG.
Basic texts have been forwarded within the framework of previous notifications:
2021/0650/BG.
11. Yes
12. An increase in e-cigarette use from 10.8 % (2015) to 23.3 % (2023) among 13–15-year-olds (GYTS) has been recorded.
The most recent data on induced acute intoxications after children’s use of these products, including those with fatal outcomes, are extremely alarming. The use of tobacco and nicotine containing products can lead to serious and chronic diseases. Smoking is an avoidable health risk and is the most important cause of premature death in the EU. The concept of addiction to smoking is much broader as a result of the increasing range of new nicotine-containing and non-nicotine-containing products, after which demand has been growing rapidly in recent years. The total number of flavourings used in the production of e-liquids reached more than 7000 in 2014 (half of them fruity and of sweets liked by children, such as ‘vanilla’ and ‘cinnamon’). They are not safe and carry a risk of increased toxicity, and the ‘oil’ leads to ‘obliterating bronchiolitis’. There is strong evidence that flavourings contribute to the attractiveness of electronic cigarettes and an increase in their consumption.
Age between the ages of 13-18 is critical for brain development, which lasts until the mid-20s. In view of the risks to human health, in particular the health of adolescents and children, measures have been taken to temporarily suspend the availability of the products.
13. No
14. No
15. Yes
16.
TBT aspects: No
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu