Artikel 18 der geplanten Tabakprodukterichtlinie in der derzeit gültigen Fassung (10. Jan 2014, eng)
Hinweis vom 09.05.2014: Aktuelle Informationen zur veröffentlichten neuen Tabakrichtlinie und den Artikel 20 (E-Zigaretten) finden Sie hier: KLICK
Dies ist der Text der geplanten Tabakprodukterichtlinie in der derzeit gültigen Fassung:
Text of Article 18a
TITLE III – ELECTRONIC CIGARETTES
1. The Member States shall ensure that electronic cigarettes and refill containers are only placed on the market if they comply with the relevant provisions of 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/EC or to the requirements set out in Directive 93/42/EEC.
2. Manufacturers and importers of electronic cigarettes and refill containers shall notify the product with the competent authorities of the Member States in which the product is intended to be placed on the market. The notification shall be submitted in electronic form 6 months before the intended placing on the market. For products already placed on the market on the date referred to in paragraph 1 of Article 25, the notification shall be submitted within 6 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. name and contact details of the manufacturer, a responsible legal or natural person within the European Union, and, if applicable, the importer into the European Union;
b. 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 these ingredients and their emissions, including when heated, referring in particular to their effects on health of consumers when inhaled and taking into account, inter alia, any addictive effect;
d. information on nicotine dosing and uptake when used under normal or reasonably foreseeable conditions;
e. description of the components of the product; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers;
f. description of the production process including series production and declaration that the production process ensures conformity with the requirements in this article;
g. 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 data are incomplete, they are entitled to request the completion of such data.
Proportionate fees may be charged by Member States 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 liquid does not contain nicotine in excess of 20 mg/ml;
c) the liquid does not contain additives listed in paragraph 4 of Article 6;
d) only ingredients of high purity are used in the manufacture of the liquid; substances other than the ingredients referred to in paragraph 2(b) are only present in trace levels, if they are technically unavoidable during manufacture;
e) only ingredients are used in the liquid that are not hazardous to human health in heated or unheated form, with the exception of nicotine;
f) electronic cigarettes deliver the nicotine doses consistently;
g) electronic cigarettes and refill containers are child- and tamperproof; electronic cigarettes and the refill containers are protected against breakage and leakage and have a mechanism ensuring leakage free refilling.
4. Member States shall require manufacturers and importers to ensure that:
(a) unit packets of electronic cigarettes and refill containers include a leaflet with information instructions for use and storage, including a reference that the product is not recommended for use by young people and non-smokers, contra-indications, warnings for specific risk groups, information on possible adverse effects, on addictiveness and toxicity, and contact details of the manufacturer or importer and a legal or natural contact person within the European 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, and an indication of nicotine content and delivery per dose, the batch number and a recommendation to keep out of reach of children;
ii. do not include elements or features referred to in Article 12, with the exception of paragraph 1(a) of Article 12 concerning the nicotine content;
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‘.
‚This product contains nicotine which is a highly addictive substance.‘
Member States shall determine which of these health warnings are used.
(c) the health warnings shall comply with the provisions in paragraph 2 of Article 11.
5. Member States shall ensure that:
a) commercial communications with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers are prohibited in information society services as defined in Article 1(2) of Directive 98/48/EC, in the press and other printed publications, with the exception of publications that are intended exclusively for professionals in the trade of the products and for publications which are printed and published in third countries, where those publications are not principally intended for the European Union market;
b) commercial communications with the aim or direct or indirect effect of promoting electronic cigarettes and refill containers are prohibited in the radio;
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 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 falling under Directive 2010/13/EU are prohibited for electronic cigarettes and refill containers;
f) cross-border distance sales of electronic cigarettes and refill containers are regulated in accordance with Article 16.
6. Member States shall require manufacturers and importers of electronic cigarettes and refill containers to submit to competent authorities on an annual basis comprehensive data on sales volumes, by brand name and type, as well as information on preferences of various consumer groups, including young people, non-smokers and main types of current users, as well as the mode of sale of the products. They shall also submit executive summaries of any market surveys carried out in respect of the above, including an English translation thereof.
Member States shall monitor the development of the electronic cigarette market as well as the market for refill containers, including any evidence of gateway use among young people and non-smokers.
7. Member States shall ensure the dissemination of information received pursuant to paragraph 2 on a website with due regard to the protection of trade secrets.
Member States shall make available, upon request, all information received pursuant to this Article to the Commission and other Member States. Member States and the Commission shall ensure that trade secrets and other confidential information are treated in a confidential manner.
8. Member States shall require that manufacturers, importers or distributers establish and maintain a system to collect information about all suspected adverse effects. If any of these operators considers or has reason to believe that electronic cigarettes or refill containers, which are in its possession and are intended to be placed on the market, are not of good safety or quality or is otherwise not in conformity with this Directive, the operator shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, as appropriate. In such a case the operator shall also be required to immediately inform the market surveillance authorities of the Member States in which the product is made available, giving details, in particular, of the risk to health and safety and of any corrective action taken, and of the results of such corrective action. Member States may also request additional information from the operator, for example on safety and quality aspects or any adverse effects.
9. The Commission shall report on the potential risks to public health associated with the use of refillable electronic cigarettes at the latest on the date referred to in Article 25(1) and whenever needed thereafter.
10. In the case of products meeting the requirements of this Article, where a competent authority ascertains or has reasonable grounds for concerns that a given electronic cigarette or a refill container, or a type of electronic cigarettes or refill containers, could present a serious risk to human health, it may take appropriate provisional measures and shall immediately communicate to the Commission and the competent authorities of other Member States the measures taken and any supporting data. The Commission shall determine, as soon as possible, whether the provisional measure is justified. The Commission shall inform the Member State concerned of its assessment, in order for the Member State to ensure appropriate follow-up.
Where, in the application of the first subparagraph of this paragraph, a given type of electronic cigarette or refill container, or a type of electronic cigarettes or refill containers has been banned on justified ground by at least three Member States, the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to extend such a ban to all Member States, if that measure is justified and proportionate.
11. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the wording of the health warning in paragraph 4(b). When adapting that health warning, the Commission shall ensure that it is factual.
12. The Commission shall adopt by means of implementing acts a common notification format pursuant to paragraph 2 and the technical standards of the refill mechanism.
These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21.
Quelle: Europaabgeordneter Chris Davies