Bill. amending the Tobacco Control Act, No. 6/2002, with subsequent amendments. From the Minister of Health.

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146 th Legislative session, 2016 2017. Parliamentary document x x. matter. Government bill. Bill amending the Tobacco Control Act, No. 6/2002, with subsequent amendments. From the Minister of Health. Article 1 Article 1 of the Act shall read as follows. The objective of this Act is to reduce damage to health and fatalities caused by tobacco by means including measures to reduce tobacco consumption and protecting people from the effects of tobacco smoke. In particular, efforts are to be made to combat the use of tobacco and the consumption of nicotine in electronic cigarettes among young people. The right of every individual not to have to inhale air that is polluted by smoke or vapour resulting from the consumption of tobacco or the use of electronic cigarettes shall be respected. Those who are responsible for the care of children shall take steps to have their rights under the second paragraph observed, including as regards places where smoking and the use of electronic cigarettes are not prohibited under Section III of this Act. Article 2 Two new paragraphs, reading as follows, shall be added to Article 2 of the Act. Within the meaning of this Act, electronic cigarette refers to a product that can be used for the consumption of nicotine-containing vapour via a mouthpiece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. Electronic cigarettes may be disposable or refillable by means of a refill container and a tank, or rechargeable with single-use cartridges. Within the meaning of this Act, refill container refers to a receptacle that contains nicotine-containing liquid, which can be used to refill an electronic cigarette. Article 3 Article 3 of the Act shall read as follows. This Act does not apply to tobacco or nicotine-containing liquid that is used as a medication under the Pharmaceuticals Act, or to toxic substances under the Toxic and Hazardous Substances Act, or to electronic cigarettes that are classified as medical devices under the Medical Devices Act. Article 4 A new paragraph shall stand after the first paragraph of Article 6, reading as follows.

2 Electronic cigarettes and refill containers may only be made available for sale or distribution if warnings are inscribed on their packaging. The third paragraph of Article 6, which shall become the fourth paragraph of Article 6, shall read as follows: The Minister shall issue regulations laying down further provisions on labelling as provided for in the first, second and third paragraphs, including as regards warning texts and warning images, their size and type of lettering and other matters that may be of significance. A new paragraph shall stand after the fourth paragraph of Article 6, which shall become the sixth paragraph, reading as follows: It is prohibited to show any text or pictures on packages of tobacco, electronic cigarettes or refill containers that can appeal particularly to children and youths, e.g. with pictures or slogan, and by that encourage the use of tobacco or electronic cigarettes. The fifth paragraph of Article 6, which shall become the sixth paragraph of Article 6, shall read as follows: Tobacco manufacturers and the manufacturers of electronic cigarettes and refill containers shall meet the costs of labelling under this Article. Article 5 The following amendments shall be made to the first paragraph of Article 7. a. After the word tobacco, and instead of and smoking accessories in the first sentence of the first paragraph of Article 7, shall stand:, smoking accessories, electronic cigarettes and refill containers. b. After the words tobacco products in the second sentence of the first paragraph of Article 7 shall stand:, electronic cigarettes or refill containers. c. After the words tobacco products in the third sentence of the first paragraph of Article 7 shall stand:, electronic cigarettes or refill containers. d. After the words tobacco products in the fourth sentence of the first paragraph of Article 7 shall stand: and the Directorate of Health may do the same regarding harmful substances in refill containers. The second paragraph of Article 7 shall read as follows. It is prohibited to show consumption or any form of handling of tobacco, smoking accessories, electronic cigarettes or refill containers in advertisements or information on good or services of other kinds and in illustrations on goods. In addition it is prohibited to import, manufacture or sell toys or confectionery which are made to resemble tobacco, smoking accessories, electronic cigarettes or refill containers. After the word traditional and instead of the words tobacco trademarks in the second item of the third paragraph of Article 7 shall stand: tobacco, electronic cigarette or refill container trademarks. After the word tobacco in the fourth and fifth paragraphs of Article 7 shall stand:, electronic cigarettes or refill containers. The sixth paragraph of Article 7 shall read as follows.

3 Tobacco products, electronic cigarettes and refill containers, and their trademarks, shall be so placed at points of sale as not to be visible to the customer. Specialist shops dealing in tobacco, electronic cigarettes and refill containers, i.e. shops which mainly offer tobacco, smoking accessories, electronic cigarettes and refill containers for sale, may nevertheless place tobacco, smoking accessories, electronic cigarettes and refill containers, and tobacco trademarks in such a way as to be visible to customers after they enter the shop. Article 6 The following amendments shall be made to Article 8 of the Act. a. After the word tobacco in the first sentence of the first paragraph of Article 8 shall stand:, electronic cigarettes or refill containers. b. After the word tobacco in the second sentence of the first paragraph of Article 8, and instead of is for sale shall stand:, electronic cigarettes or refill containers are for sale. c. After the word tobacco in the third sentence of the first paragraph of Article 8 shall stand:, electronic cigarettes or refill containers. d. Three new paragraphs, the fifth, sixth and seventh, shall stand after the fourth paragraph of Article 8, reading as follows. Refill containers with liquid containing nicotine in excess of 20 mg/ml may not be sold. Refill containers with more than 10 ml of liquid may not be sold. Refill cartridges for electronic cigarettes containing more than 2 ml of liquid may not be sold. e. After the word tobacco in the sixth paragraph, which shall become the ninth paragraph, shall stand:, electronic cigarettes or refill containers. f. After the word tobacco in the seventh paragraph, which shall become the tenth paragraph, shall stand:, electronic cigarettes and refill containers. g. After the word tobacco in the eighth paragraph, which shall become the eleventh paragraph, shall stand:, electronic cigarettes and refill containers. h. The first sentence of the tenth paragraph of Article 8, which shall become the first sentence of the thirteenth paragraph of Article 8, shall read as follows: The Minister shall issue further provisions in a regulation, in accordance with the valid EU Directives, stating the maximum permissible levels of substances in tobacco, refill containers, tobacco smoke and vapour associated with the use of electronic cigarettes and how measurements and monitoring are to be carried out to ensure observance of these levels. Article 7 The title of Section III shall be: Restrictions on smoking and the use of electronic cigarettes.

4 Article 8 The following amendments shall be made to Article 9 of the Act. a. After the word Smoking in the first paragraph of Article 9 shall stand: and the use of electronic cigarettes. b. After the word smoking in the first sentence of the third paragraph of Article 9 shall stand: and the use of electronic cigarettes. c. After the word smoking in the second sentence of the third paragraph of Article 9 shall stand: and the use of electronic cigarettes. d. After the words smoking and smoke in the fourth paragraph of Article 9 shall stand: and the use of electronic cigarettes. e. After the word smoking in the sixth paragraph of Article 9 shall stand: and the use of electronic cigarettes. f. After the word Smoking in the seventh paragraph of Article 9 shall stand: and the use of electronic cigarettes. g. After the words tobacco consumption in the eighth paragraph of Article 9 shall: and the use of electronic cigarettes. Article 9 The following amendments shall be made to Article 10 of the Act. a. After the word Smoking in the first paragraph of Article 10 shall stand: and the use of electronic cigarettes. b. After the word smoking in item 5 of the first paragraph of Article 10, instead of by patients in certain circumstances shall stand: and the use of electronic cigarettes by patients in certain circumstances. c. After the word smoking in item 6 of the first paragraph of Article 10 shall stand: and the use of electronic cigarettes. d. After the word Non-smokers and instead of must be offered non-smoking cells in item 6 of the first paragraph of Article 10 shall stand: and those who do not use electronic cigarettes must be offered cells that are not polluted by tobacco smoke or vapours produced by the use of electronic cigarettes. e. After the words consumption of tobacco in the second paragraph of Article 10 shall stand: and the use of electronic cigarettes. f. After the words primary/lower secondary schools in the second paragraph of Article 10 shall stand: upper secondary schools, special schools. g. The third paragraph of Article 10 shall read as follows: Directors of all public institutions other than those mentioned in the first paragraph shall, in consultation with staff, draw up a plan regarding the prohibition of smoking and the use of electronic cigarettes within their institutions.

5 Article 10 After the word smoking in Article 11 of the Act shall stand: and the use of electronic cigarettes. Article 11 After the word atmosphere in the first paragraph of Article 12 shall stand: and an atmosphere that is not polluted by vapour resulting from the use of electronic cigarettes,. After the word smoking in the second paragraph of Article 12 shall stand: and the use of electronic cigarettes.. Article 12 After the word smoking in the first paragraph of Article 13 shall stand: and the use of electronic cigarettes. After the word smoking in the second paragraph of Article 13 shall stand: and the use of electronic cigarettes. After the word non-smokers in the second paragraph of Article 13 shall stand: or persons who do not use electronic cigarettes. Article 13 After Section III of the Act shall stand a new section, Section IV : Electronic cigarettes, containing the following five Articles; the numbers of other Sections and Articles shall change accordingly. a. The importation, sale or manufacture of electronic cigarettes and refill containers that do not meet the requirements of this Act, or of regulations issued hereunder, shall be prohibited. b. Manufacturers and importers of electronic cigarettes and refill containers which they intend to market in Iceland shall send the Consumer Agency a notification to this effect 6 months prior to the intended marketing. A new notification shall be submitted for each substantial change to the product. The Minister may issue regulations containing further provisions on notification in accordance with the first paragraph, including as regards the information to accompany a notification, the receipt of notifications and the storing, handling and analysis of information accompanying notifications.

6 The Consumer Agency may charge a fee for the receipt of notifications, cf. the first paragraph in order to meet the costs connected with the receipt of notifications and the storage, handling and analysis of information it receives. The Minister may issue regulations containing further provisions on demands regarding the quality, safety, labelling and content descriptions of electronic cigarettes and refill containers. c. If manufacturers, importers or distributors of electronic cigarettes and refill containers have reason to consider that electronic cigarettes or refill containers that are in their keeping and are intended for marketing, or which are on the market, are not safe or of high quality, or are in some other respect not in conformity with this Act, the party in question shall immediately take the necessary remedial measures to bring the product in question into line with this Act, or recall it, as appropriate. Furthermore, the parties referred to in the first sentence shall inform the Consumer Agency immediately about the situation as it stands. The Minister may issue regulations containing further provisions on the monitoring of the consequences/side-effects of the use of electronic cigarettes. d. Each year, the manufacturers and importers of cigarettes and refill containers shall submit to the Directorate of Health information on sales of electronic cigarettes and refill containers, and on consumer habits, in accordance with a regulation issued by the Minister. e. Electronic cigarettes and refill containers containing the following additives may not be imported, manufactured or sold in Iceland. a) Vitamins or other additives that create the impression that the product has a health benefit or reduced health risks. b) Caffeine, taurine or other additives and stimulants associated with energy and vitality. c) Additives that colour the emissions. d) Substances that facilitate the inhalation or uptake of nicotine. e) Substances that have carcinogenic, mutagenic or reprotoxic properties ( CMR properties ) in unburnt form. Manufacturers and importers of electronic cigarettes or refill cartridges may be charged a fee, in accordance with a scale of charges set by the Minister, for assessing whether prohibited additives or flavourings are used in products or whether the products contain additives in quantities that increase, to a significant or measurable degree, their toxicity, addictiveness or CMR properties. Article 14

7 The words regarding the labelling, advertising and sale of tobacco in the first paragraph of Article 17 shall be deleted. Article 15 After the word smoke in the first paragraph of Article 20 shall stand: or to use electronic cigarettes. Article 16 The title of the Act shall be: Act on Tobacco Control and Restrictions on the Sale and Use of Electronic Cigarettes. Article 17 This Act shall take effect on 1 September 2017.