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Entitled ‘Electronic cigarettes’, Article 20 of Directive 2014/40 reads as follows: ‘1. The Member States shall ensure that electronic cigarettes and refill containers are only placed on the market if they comply with this Directive and with all other relevant Union legislation. This Directive does not apply to electronic cigarettes and refill containers that are subject to an authorisation requirement under Directive [2001/83] or to the requirements set out in Directive [93/42]. 2. Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. The notification shall be submitted in electronic form six months before the intended placing on the market. For electronic cigarettes and refill containers already placed on the market on 20 May 2016, the notification shall be submitted within six months of that date. A new notification shall be submitted for each substantial modification of the product. The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the following information: (a) the name and contact details of the manufacturer, a responsible legal or natural person within the Union, and, if applicable, the importer into the Union; (b) a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof; (c) toxicological data regarding the product’s ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account, inter alia, any addictive effect; (d) information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions; (e) a description of the components of the product; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers; (f) a description of the production process, including whether it involves series production, and a declaration that the production process ensures conformity with the requirements of this Article; (g) a declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions. Where Member States consider that the information submitted is incomplete, they shall be entitled to request the completion of the information concerned. Member States may charge manufacturers and importers proportionate fees for receiving, storing, handling and analysing the information submitted to them. 3. 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 Article 7(6); (d) only ingredients of high purity are used in the manufacture of the nicotine-containing liquid. Substances other than the ingredients referred to in point (b) of the second subparagraph of paragraph 2 of this Article are only present in the nicotine-containing liquid in trace levels, if such traces are technically unavoidable during manufacture; (e) except for nicotine, only ingredients are used in the nicotine-containing liquid that do not pose a risk to human health in heated or unheated form; (f) electronic cigarettes deliver the nicotine doses at consistent levels under normal conditions of use; (g) electronic cigarettes and refill containers are child- and tamper-proof, are protected against breakage and leakage and have a mechanism that ensures refilling without leakage. 4. Member States shall ensure that: (a) unit packets of electronic cigarettes and refill containers include a leaflet with information on: (i) instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers; (ii) contra-indications; (iii) warnings for specific risk groups; (iv) possible adverse effects; (v) addictiveness and toxicity; and (vi) contact details of the manufacturer or importer and a legal or natural contact person within the Union; (b) unit packets and any outside packaging of electronic cigarettes and refill containers: (i) include a list of all ingredients contained in the product in descending order of the weight, and an indication of the nicotine content of the product and the delivery per dose, the batch number and a recommendation to keep the product out of reach of children; (ii) without prejudice to point (i) of this point, do not include elements or features referred to in Article 13, with the exception of Article 13(1)(a) and (c) concerning information on the nicotine content and on flavourings; and (iii) carry one of the following health warnings: “This product contains nicotine which is a highly addictive substance. It is not recommended for use by non-smokers.” or “This product contains nicotine which is a highly addictive substance.” Member States shall determine which of these health warnings is to be used; (c) health warnings comply with the requirements specified in Article 12(2). 5. Member States shall ensure that: (a) commercial communications in Information Society services, in the press and other printed publications, with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers are prohibited, except for publications that are intended exclusively for professionals in the trade of electronic cigarettes or refill containers and for publications which are printed and published in third countries, where those publications are not principally intended for the Union market; (b) commercial communications on the radio, with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers, are prohibited; (c) any form of public or private contribution to radio programmes with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers is prohibited; (d) any form of public or private contribution to any event, activity or individual person with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers and involving or taking place in several Member States or otherwise having cross-border effects is prohibited; (e) audiovisual commercial communications to which [Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ 2010 L 95, p. 1)] applies, are prohibited for electronic cigarettes and refill containers. 6. Article 18 of this Directive shall apply to cross-border distance sales of electronic cigarettes and refill containers. 7. 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. Member States shall monitor the market developments concerning electronic cigarettes and refill containers, including any evidence that their use is a gateway to nicotine addiction and ultimately conventional tobacco consumption among young people and non-smokers. … 13. The Commission shall, by means of an implementing act, lay down a common format for the notification provided for in paragraph 2 and technical standards for the refill mechanism provided for in paragraph 3(g). …’