Tupakkadirektiivin sähkötupakoita säätelevä 18 artikla saatiin valmiiksi varhain tänä aamuna kolmikantaneuvotteluissa, joissa olivat mukana parlamentti, kommisio ja EU:n puheenjohtajamaa Liettua. Kaikilla oli omat neuvottelukunnat. Kolmikantaneuvotteluiden tuloksena syntynyt tupakkadirektiiviehdotus hyväksyttiin tänään myös EU:n jäsenvaltioiden ministereiden puolelta.
Koko direktiivi menee vielä parlamentin täysistuntoon, jossa sen kohtalosta päätetään lopullisesti. Parlamentti ei voi enään vaikuttaa direktiiviin, vaan päätös on hyväksy tai hylkää.
Tässä alkuperäinen artikla. Julkaisemme myöhemmin tarkemman analyysin mitä tämä käytännössä tulee tarkoittamaan ja mihin artikla johtaa.
(Text as submitted to Coreper on 13 December 2013 in doc. 17506/13 ADD2 with latest modifications indicated by
strikethrough for deletions and bold underlined for additions)
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 products 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 products 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 productsalready 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 delivery to blood stream and uptake when used under normal orreasonably foreseeable conditions;
e. description of the components of the electronic cigarette; 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, disposable electronic cigarettes or in single use cartridges. The cartridges or tanks shall not exceed a volume of 2 ml;
to be used in rechargeable electronic cigarettes or in disposable electronic cigarettes
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 and free from contaminants 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 toxic 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;
h) 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 useand 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.
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, itshall may take all appropriate 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 [following whenever possible appropriate consultations]. The Commission shall inform the Member State concerned, which will 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.
10. 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(j). When adapting that health warning, the Commission shall ensure that it is factual.
11. 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.
Recitals related to e-cigarettes
(a) Electronic cigarettes and refill containers should be regulated within this Directive, unless they are due to their presentation or function subject to Directive 2001/83/EC or to Directive 93/42/EEC. Diverging legislation and practices including on safety require Diverging legislation and practices including on safety requirements exist in Member States as regards these products requiring action at Union level to improve the functioning of the internal market. A high level of public health protection should be taken into account when regulating these products. In order to allow Member States to exercise their functions of surveillance and control, manufacturers and importers of electronic cigarettes and refill containers should be required to notify their products before the intended placing of the market
(b) Responsibility for ensuring that the products comply with the essential requirements should rest with manufacturers. If manufacturers are not established in the European Union, the natural or legal person who imports electronic cigarettes into the European Union should bear the responsibility.
(c) Nicotine containing liquid should only be allowed under this Directive where the nicotine concentration does not exceed 20 mg/ml. This level of concentration is similar to the dose of nicotine derived from a standard cigarette during the same duration of smoking.
time considered satisfactory for an average smoker that wants to reduce tobacco consumption with the assistance of an electronic cigarette. In order to limit risks associated with nicotine, maximum sizes for containers, cartridges and tanks are set.
(d) Only electronic cigarettes that deliver the nicotine doses consistently should be allowed under this Directive. Consistent delivery of the nicotine doses under normal use is necessary for health, safety and quality purposes including to avoid the risk of accidental consumption of high doses.
(e) Electronic cigarettes and refill containers may create a risk when they are in the hands of children. Therefore, it is necessary to ensure that these products are childproof including child-proof labelling, design, fastenings and opening mechanism.
(f) Given that nicotine is a toxic substance and considering the potential risks also to those for whom the product is not intended, nicotine-containing liquid should be placed on the market in electronic cigarettes or in refill containers that meets certain safety and quality requirements.
(g) The labelling and packaging of these products should display sufficient and appropriate information on safe use, in order to protect human health and safety, should carry appropriate health warnings and should not include any misleading elements or features.
(h) Disparities existing between national legislations and practices on advertising and sponsorship impede the free movement of goods and the freedom to provide services and create an appreciable risk of distortions to competition. Without further action at Union level, the existing disparities are likely to increase in the coming years, considering also the growing market for electronic cigarettes and refill containers. Therefore, it is necessary to approximate the national rules on advertising and sponsoring, taking as a base a high level of health protection. Electronic cigarettes can develop into a gateway to nicotine addiction and ultimately traditional tobacco consumption, as they mimic and normalize the action of smoking. For this reason, it is appropriate to adopt a restrictive approach to advertising of electronic cigarettes and refill containers.
(i) In order to exercise their regulatory function, Member States and the Commission require comprehensive information on market developments in electronic cigarettes and refill containers. To this end reporting obligations on sales volumes, preference of various consumers groups and mode of sales should be put on manufacturers and importers of these products. The transparency of this information should be ensured for the general public with due regard for trade secrets.
(j) In order to ensure appropriate market surveillance by Member States, it is necessary that manufacturers, importers and distributors have an appropriate system for monitoring, recording and informing the competent authorities about suspected adverse effects, so that appropriate action can be taken. A safeguard clause is warranted allowing Member States to act against serious risks to public health.
(k) This Directive does not harmonise all aspects of electronic cigarettes or refill containers, and leaves for example the regulation of flavours to the Member States. It may be useful for Member States to consider allowing flavours in the products. However, they should be mindful of the potential attractiveness for young people and non smokers. Such prohibitions of flavours would need to be justified and notified according to Directive 98/34/EC.
(l) Moreover, this Directive does not harmonise rules on smoke-free environments, or on domestic sales arrangements or advertising, brand stretching, nor does it introduce an age limit for electronic cigarettes or refill containers. In any case, the presentation and advertising of the products should not be used to promote tobacco consumption or give rise to confusion with tobacco products. Member States are free to regulate such matters in their own domain and are encouraged to do so.
(m) In the context of an emerging market on electronic cigarettes, it is possible that, although conforming to the provisions of this Directive, a given electronic cigarette or refill container, or a type of electronic cigarettes or refill containers, placed on the market could pose an unforeseen risk to human health. It is therefore advisable to provide for a procedure intended to address this risk, which should include the possibility for a Member State to adopt provisional appropriate measures. Such provisional measures could involve the prohibition on the placing on the market of a given electronic cigarette or refill container, or of a type of electronic cigarettes or refill containers. In this context, the Commission should be empowered to adopt delegated acts in order to prohibit a given electronic cigarette or refill container, or a type of electronic cigarettes or refill containers, when at least three Member States have prohibited these products on justified grounds and it is necessary to extend this prohibition to all the Member States in order to ensure the smooth functioning of the internal market for compliant products not presenting the same safety concerns.