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E-cigarettes: an evidence update <br /> <br />22 <br /> no promotional element or feature or such that suggests the product is harm <br />reducing (or other features described in Article 13 of the Directive) <br /> health warnings: <br /> One of the following must be shown: <br /> ‘This product contains nicotine which is a highly addictive substance. It is <br />not recommended for use by non-smokers’ or <br /> ‘This product contains nicotine which is a highly addictive substance ’ <br /> Member States shall determine which health warning to use <br /> health warnings must comply with regulations concerning specific provisions on <br />position and size <br /> cross-border advertising and promotion, sponsorship etc of products will be <br />prohibited (unless trade information) <br /> cross-border sales of products may be prohibited or subject to a registration <br />scheme <br /> manufacturers/importers of products to submit an annual submission on their <br />products to competent authorities in MS which should include: <br /> comprehensive data on sales volumes, by brand name and product type <br /> information on preferences of various consumer groups, including young <br />people, non-smokers and the main types of current users <br /> mode of sale of the products <br /> executive summaries of any market surveys carried out in respect of the above, <br />including an English translation thereof products <br /> MS shall monitor the market developments concerning products, including any <br />evidence that their use is a gateway to nicotine addiction and ultimately traditional <br />tobacco consumption among young people and non -smokers. This information to be <br />made publicly available on a website although the need to protect trade secrets <br />should be taken into account <br /> MS should on request, make all information relevant to this Article available to the <br />Commission and other Member States who will respect confidential information <br /> MS shall require manufacturers, importers and distributors of products to establish <br />and maintain a system for collecting information about all of the suspected adverse <br />effects on human health <br /> corrective action should be taken immediately if economic operators consider or <br />have reason to believe that products are not safe or of good quality or not <br />conforming to the Directive, ensuring conformity or withdrawal or recall from the <br />market. In such cases, operators are required to inform immediately market <br />surveillance authorities of the MS giving details of risk to human health and safety, <br />corrective action taken and results of such corrective action. MS may request <br />additional information from the economic operators on safety and quality aspects or <br />any adverse effect of products <br /> the Commission will submit a report to the European Parliament and the Council on <br />potential risks to public health by 20 May 2016 and as appropriate thereafter