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The text below is designed to help you work out more easily what will apply to e-cigarettes, liquids and vaping devices. Article 18 of this Directive shall apply to cross-border distance sales of electronic cigarettes and refill containers. Member States shall require manufacturers and importers of electronic cigarettes and refill containers to submit, annually, to the competent authorities: (i) comprehensive data on sales volumes, by brand name and type of the product; (ii) information on the preferences of various consumer groups, including young people, non-smokers and the main types of current users; (iii) the mode of sale of the products; and (iv) executive summaries of any market surveys carried out in respect of the above, including an English translation thereof.

Retail outlets engaging in cross-border distance sales of tobacco products may not supply such products to consumers in Member States where such sales have been prohibited.

Electronic cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges; (17)‘refill container’ means a receptacle that contains a nicotine-containing liquid, which can be used to refill an electronic cigarette; 6.

Member States shall prohibit the placing on the market of tobacco products containing the following additives: (a) vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks; (b) caffeine or taurine or other additives and stimulant compounds that are associated with energy and vitality; (c) additives having colouring properties for emissions; (d) for tobacco products for smoking, additives that facilitate inhalation or nicotine uptake; and (e) additives that have CMR properties in unburnt form. The general warning and information message referred to in paragraphs 1 and 2 shall be: (a) printed in black Helvetica bold type on a white background.

The text of the health warnings shall be parallel to the main text on the surface reserved for these warnings.

In addition, it shall: (a) appear on the two largest surfaces of the unit packet and any outside packaging; (b) cover 30 % of the surfaces of the unit packet and any outside packaging.

For electronic cigarettes and refill containers already placed on the market on , the notification shall be submitted within six months of that date.

The notification shall be submitted in electronic form six months before the intended placing on the market.

These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25 The objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States concerning: (a) the ingredients and emissions of tobacco products and related reporting obligations, including the maximum emission levels for tar, nicotine and carbon monoxide for cigarettes; (b) certain aspects of the labelling and packaging of tobacco products including the health warnings to appear on unit packets of tobacco products and any outside packaging as well as traceability and security features that are applied to tobacco products to ensure their compliance with this Directive; (c) the prohibition on the placing on the market of tobacco for oral use; (d) cross-border distance sales of tobacco products; (e) the obligation to submit a notification of novel tobacco products; (f) the placing on the market and the labelling of certain products, which are related to tobacco products, namely electronic cigarettes and refill containers, and herbal products for smoking; in order to facilitate the smooth functioning of the internal market for tobacco and related products, taking as a base a high level of protection of human health, especially for young people, and to meet the obligations of the Union under the WHO Framework Convention for Tobacco Control (‘FCTC’).

(16) ‘electronic cigarette’ means a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank.

Process for adapting the wording of health warnings 13. Member States may charge manufacturers and importers proportionate fees for receiving, storing, handling and analysing the information submitted to them. Member States shall ensure that: (a) nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml, in disposable electronic cigarettes or in single use cartridges and that the cartridges or tanks do not exceed a volume of 2 ml; (b) the nicotine-containing liquid does not contain nicotine in excess of 20 mg/ml; (c) the nicotine-containing liquid does not contain additives listed in (d) only ingredients of high purity are used in the manufacture of the nicotine-containing liquid.

Basis for controlling products that present a serious risk to health 12. Where Member States consider that the information submitted is incomplete, they shall be entitled to request the completion of the information concerned.

Where, in application of the first subparagraph of this paragraph, the placing on the market of specific electronic cigarettes or refill containers, or a type of electronic cigarette or refill container has been prohibited on duly justified grounds in at least three Member States, the Commission shall be empowered to adopt delegated acts in accordance with Article 27 to extend such a prohibition to all Member States, if such an extension is justified and proportionate. The Commission shall be empowered to adopt delegated acts in accordance with Article 27 to adapt the wording of the health warning in paragraph 4(b) of this Article.

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