Directive 2014/40/EU of the European Parliament and of the CouncilShow full title

Article 19 Notification of novel tobacco products

1. Member Stes shall require manufacturers and importers of novel tobacco products to submit a notification to the competent authorities of Member States of any such product they intend to place on the national market concerned. The notification shall be submitted in electronic form six months before the intended placing on the market. It shall be accompanied by a detailed description of the novel tobacco product concerned as well as instructions for its use and information on ingredients and emissions in accordance with Article 5. The manufacturers and importers submitting a notification of a novel tobacco product shall also provide the competent authorities with:

(a) available scientific studies on toxicity, addictiveness and attractiveness of the novel tobacco product, in particular as regards its ingredients and emissions;

(b) available studies, executive summaries thereof and market research on the preferences of various consumer groups, including young people and current smokers;

(c) other available and relevant information, including a risk/benefit analysis of the product, its expected effects on cessation of tobacco consumption, its expected effects on initiation of tobacco consumption and predicted consumer perception.

2. Member States shall require manufacturers and importers of novel tobacco products to transmit to their competent authorities any new or updated information on the studies, research and other information referred to in points (a) to (c) of paragraph 1. Member States may require manufacturers or importers of novel tobacco products to carry out additional tests or submit additional information. Member States shall make all information received pursuant to this Article available to the Commission.

3. Member States may introduce a system for the authorisation of novel tobacco products. Member States may charge manufacturers and importers proportionate fees for that authorisation.

4. Novel tobacco products placed on the market shall respect the requirements of this Directive. Which of the provisions of this Directive apply to novel tobacco products depends on whether those products fall under the definition of a smokeless tobacco product or of a tobacco product for smoking.