S.L. 315.10 Art. 18Electronic cigarettes.

(1) Electronic cigarettes and refill containers shall only be placed on the market if they comply with these regulations and with all other relevant national and Union legislation.

This does not apply to electronic cigarettes and refill containers that are subject to an authorisation requirement under Directive 2001/83/EC or to the requirements set out in Directive 93/42/EEC.

(2) (a) Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the Superintendent 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.

(b) The notification shall, depending on whether the product is an electronic cigarette or a refill container, contain the following information:

(i) 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;

(ii) a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof;

(iii) 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;

(iv) information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions;

(v) a description of the components of the product; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers;

(vi) 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 regulation;

(vii) 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;

(c) Where the Superintendent considers that the information submitted is incomplete, he shall be entitled to request the completion of the information concerned.

(d) The Superintendent may charge manufacturers and importers of tobacco products proportionate fees which the Minister may by regulations prescribe, for receiving, storing, handling and analysing the information submitted to him.

(3) Electronic cigarettes and refill containers shall only be placed on the market if they comply with the following requirements:

(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 regulation 7(3);

(d) only ingredients of high purity are used in the manufacture of the nicotine-containing liquid. Substances other than the ingredients referred to in sub-regulation (2)(b)(ii) are only present in the nicotine-containing liquid in trace levels, if such trac

(e) except for nicotine, only ingredients that do not pose a risk to human health in heated or unheated form are used in the nicotine-containing liquid;

(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) Electronic cigarettes and refill containers shall only be placed on the market if they comply to these further requirements:

(a) unit packets of electronic cigarettes and refill containers shall include a leaflet with information in the Maltese or in the English language 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: Provided that the leaflet containing the information stipulated in this paragraph may be substituted by a label affixed to the packaging or a leaflet contained within the packaging, which includes a Quick Response (QR) code containing an electronic link with information stipulated in this paragraph in either the Maltese or the English language.

(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 sub-paragraph (i), do not include elements or features referred to in regulation 12, with the exception of regulation 12(1)(a) and (c) concerning information on the nicotine content and on flavourings; and

(iii) carry the following health warning: ‘This product contains nicotine which is a highly addictive substance’ and ‘Dan il-prodott fih in-nikotina li hija sustanza li tista’ faċilment twassal għad-dipendenza’.

(c) the health warning shall comply with the requirements specified in regulation 9(4). The text of the health warnings shall be parallel to the main text on the surface reserved for these warnings. In addition, it shall:

(i) appear on the two largest surfaces of the unit packet and any outside packaging;

(ii) cover 32% of the surfaces of the unit packet and any outside packaging.

(5) The following shall also apply to electronic cigarettes:

(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 applies, are prohibited for electronic cigarettes and refill containers.

(6) Regulation 16 shall apply to cross-border distance sales of electronic cigarettes and refill containers.For the purpose of this sub-regulation, the terms "electronic cigarettes" and "refill containers" shall refer to both nicotine and non-nicotine containing electronic cigarettes and refill containers.

(7) Manufacturers and importers of electronic cigarettes and refill containers shall annually submit to the Superintendent:

(a) comprehensive data on sales volumes, by brand name and type of the product;

(b) information on the preferences of various consumer groups, including young people, non-smokers and the main types of current users;

(c) the mode of sale of the products; and

(d) executive summaries of any market surveys carried out in respect of the above, including an English translation thereof: Provided that the Superintendent 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 traditional tobacco consumption among young people and non-smokers.

(8) The information received pursuant to sub-regulation (2) shall be made publicly available on a website, duly taking into account the need to protect trade secrets. All information received pursuant to this regulation shall be made available, upon request, to the Commission and other Member States, duly ensuring that trade secrets and other confidential information are treated in a confidential manner.

(9) Manufacturers, importers and distributors of electronic cigarettes and refill containers shall establish and maintain a system for collecting information about all of the suspected adverse effects on human health of these products.

Should any of these economic operators consider or have reason to believe that electronic cigarettes or refill containers, which are in their possession and are intended to be placed on the market or are placed on the market, are not safe or are not of good quality or are otherwise not in conformity with these regulations, that economic operator shall immediately take the corrective action necessary to bring the product concerned into conformity with these regulations, to withdraw or to recall it, as appropriate. In such cases, the economic operator shall also be required to immediately inform the Superintendent, giving details, in particular, of the risk to human health and safety and of any corrective action taken, and of the results of such corrective action. The Superintendent may also request additional information from the economic operators, for example on the safety and quality aspects or any adverse effects of electronic cigarettes or refill containers.

(10) In the case of electronic cigarettes and refill containers that comply with the requirements of this regulation, where the Superintendent ascertains or has reasonable grounds to believe that specific electronic cigarettes or refill containers, or a type of electronic cigarette or refill container, could present a serious risk to human health, he may take appropriate provisional measures. The Superintendent shall immediately inform the Commission and the competent authorities of other Member States of the measures taken and shall communicate any supporting data.

(11) The notification provided for in sub-regulation (2) shall be in compliance with Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 establishing a common format for the notification of electronic cigarettes and refill containers (notified under document C(2015) 8087).

Technical standards for the refill mechanism shall be laid down and subsequently updated in accordance with Commission Implementing Acts.