This is the full Tobacco Products Directive 2014/40/EU (PDF) or HTML as published in the Official Journal of the EU). Disclosure commercial data and market surveillance 8. Delegated responsibility to design notification regime and refill mechanism Recitals Other relevant articles or articles referred to from Article 20 include: 1. Definitions, 7.6 Regulation of ingredients, 9.4 General warnings , 12.2 Labelling, 13. 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. Member States shall ensure that:(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; (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 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. or ‘This product contains nicotine which is a highly addictive substance.’ Member States shall determine which of these health warnings is to be used; 5.It entered into force on , with several compliance dates of 20 May in 2016 , 20 November 2016 and . 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 6. 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.
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