Updated info post: TPD – provisions relating to e-cigarettes

Sounds impressive!

Updated 7 May 2014. The articles and paragraphs have been renumbered to take account of inserted articles and paragraphs. Article 20 relates to E-cigarettes.  This is the full Tobacco Products Directive 2014/40/EU  as published in the Official Journal of the EU).  It will enter into force on 19 May 2014, with several compliance dates of 20 May in 2016 and 2017. The text below is designed to help you work out more easily what will apply to e-cigarettes, liquids and vaping devices.

Article 20 is divided into 13 paragraphs and cross references several other articles.  It is also supported by a set of recitals. The following are the broad themes and structure of the article – click on these to navigate to the relevant text:

1. Relation to medicines regulation

2. Notification regime – ingredients, toxicology, pharmacology, production process

3. Technical design restrictions and requirements

4. Leaflet, packaging and warning

5. Advertising, promotion, sponsorship

6. Cross border sales

7. Disclosure commercial data and market surveillance

8. Public disclosure of commercial data

9. Surveillance for adverse effects

10. Commission report on refillable devices

11. Basic for controlling products that present a serious risk to health

12. Process for adapting the wording of health warnings

13. Delegated responsibility to design notification regime and refill mechanism

Recitals

Other relevant articles or articles referred to from Article 20 include: 1. Subject matter,  2. Definitions,  7.6 Regulation of ingredients,  9.4 General warnings ,  12.2 Labelling,   13. Product presentation  18. Cross border sales,  25. Committee procedure,  26. Competent authority,  27.Delegation,  28. Report,  29. Transposition,  30. Transitional provisions.

TITLE III – ELECTRONIC CIGARETTES AND HERBAL PRODUCTS FOR SMOKING

Article 20

Electronic cigarettes

1.The Member States shall ensure that electronic cigarettes and refill containers are only placed on the market if they comply with 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 submit a notification to the competent authorities of the Member States 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 [2 years after entry into force] the notification shall be submitted within six 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. 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;

b. a 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 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;

d. information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions;

e. a description of the components of the product; including, where applicable, the opening and refill mechanism of the electronic cigarette or refill containers;

f. 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 Article;

g. 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.  

Where Member States consider that the information submitted is incomplete, they shall be entitled to request the completion of the information concerned. Member States may charge manufacturers and importers proportionate fees 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 nicotine-containing liquid does not contain nicotine in excess of 20 mg/ml;

c) the nicotine-containing liquid does not contain additives listed in Article 7(6);

d) only ingredients of high purity are used in the manufacture of the nicotine-containing liquid. Substances other than the ingredients referred to in paragraph 2(b) of this Article are only present in the nicotine-containing liquid in trace levels, if such traces are technically unavoidable during manufacture;

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

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. Member States shall ensure that:

(a) unit packets of electronic cigarettes and refill containers include a leaflet with information 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;

(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 point (i) of this point, do not include elements or features referred to in  Article 13, with the exception of Article 13(1)(a) and (c) concerning information on the nicotine content and on flavourings; and

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’.

or

‘This product contains nicotine which is a highly addictive substance.’

Member States shall determine which of these health warnings is to be used.

(c) health warnings comply with the requirements specified in  Article 12(2).  

 

5. Member States shall ensure that:

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 applies, are prohibited for electronic cigarettes and refill containers.

 

6. Article 18 of this Directive shall apply to cross-border distance sales of electronic cigarettes and refill containers.  

 

7. Member States shall require manufacturers and importers of electronic cigarettes and refill containers to submit, annually, to the competent authorities:

i.        comprehensive data on sales volumes, by brand name and type of the product;

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

iii.      the mode of sale of the products; and

iv.      executive summaries of any market surveys carried out in respect of the above, including an English translation thereof.

Member States 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. Member States shall ensure that the information received pursuant to paragraph 2 of this Article is made publicly available on a website. The Member States shall take the need to protect trade secrets duly into account when making that information publicly available. Member States shall, upon request, make all information received pursuant to this Article available to the Commission and other Member States. The Member States and the Commission shall ensure that trade secrets and other confidential information are treated in a confidential manner.

 

9. Member States shall require manufacturers, importers and distributers of electronic cigarettes and refill containers to 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 this Directive, that economic operator shall immediately take the corrective action necessary to bring the product concerned into conformity with this Directive, to withdraw or to recall it, as appropriate. In such cases the economic operator shall also be required to immediately inform the market surveillance authorities of the Member States in which the product is made available or is intended to be made available, 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. Member States 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. The Commission shall submit a report to the European Parliament and the Council on the potential risks to public health associated with the use of refillable electronic cigarettes by [two years after the entry into force] and where appropriate thereafter.

 

11.  In the case of electronic cigarettes and refill containers that comply with the requirements of this Article, where a competent authority 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, it may take appropriate provisional measures. It shall immediately inform the Commission and the competent authorities of other Member States of the measures taken and shall communicate any supporting data. The Commission shall determine, as soon as possible after having received that information, whether the provisional measure is justified. The Commission shall inform the Member State concerned of its conclusions to enable the Member State to take appropriate follow-up measures. Where, in application of the first subparagraph of this paragraph, the placing on the market of specific electronic cigarettes or refill containers, or a type of electronic cigarette or refill container has been prohibited on duly justified grounds in at least three Member States, the Commission shall be empowered to adopt delegated acts in accordance with Article 27 to extend such a prohibition to all Member States, if such an extension is justified and proportionate.

 

12. The Commission shall be empowered to adopt delegated acts in accordance with Article 27 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.  

 

13. The Commission shall, by means of an implementing act, lay down a common format for the notification provided for in paragraph 2 and technical standards for the refill mechanism provided for in paragraph 3(g). These implementing acts shall be adopted in accordance with the examination procedure referred to in Article 25.

Article 1

The objective of this Directive is to approximate the laws, regulations and administrative provisions of the Member States concerning:

(a)          the ingredients and emissions of tobacco products and related reporting obligations, including the maximum emission levels for tar, nicotine and carbon monoxide for cigarettes;

(b)          certain aspects of the labelling and packaging of tobacco products including the health warnings to appear on unit packets of tobacco products and any outside packaging as well as traceability and security features that are applied to tobacco products to ensure their compliance with this Directive;

(c)          the prohibition on the placing on the market of tobacco for oral use;

(d)          cross-border distance sales of tobacco products;

(e)          the obligation to submit a notification of novel tobacco products;

(f)          the placing on the market and the labelling of certain products, which are related to tobacco products, namely electronic cigarettes and refill containers, and herbal products for smoking; in order to facilitate the smooth functioning of the internal market for tobacco and related products, taking as a base a high level of protection of human health, especially for young people, and to meet the obligations of the Union under the WHO Framework Convention for Tobacco Control (“FCTC”).

Article 2

(16) ‘electronic cigarette’ means a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. Electronic cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges;

(17) ‘refill container’ means a receptacle that contains a nicotine-containing liquid, which can be used to refill an electronic cigarette;

Article 7 paragraph 6

6. Member States shall prohibit the placing on the market of tobacco products containing the following additives:

(a) vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks,

(b) caffeine or taurine or other additives and stimulant compounds that are associated with energy and vitality,

(c) additives having colouring properties for emissions,

(d) for tobacco products for smoking, additives that facilitate inhalation or nicotine uptake, and

(e) additives that have CMR properties in unburnt form.

Article 9 paragraph 4

4. The general warning and information message referred to in paragraphs 1 and 2 shall be:

(a) printed in black Helvetica bold type on a white background. In order to accommodate language requirements, Member States may determine the font size, provided that the font size specified in national law ensures that the relevant text occupies the greatest possible proportion of the surface reserved for these health warnings; and

(b) at the centre of the surface reserved for them, and on cuboid packets and any outside packaging they shall be parallel to the lateral edge of the unit packet or of the outside packaging;

Article 12 paragraph 2

2. The health warning laid down in paragraph 1 shall comply with the requirements specified in Article 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:

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

b) cover 30 % of the surfaces of the unit packet and any outside packaging. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with more than two official languages.

Article 13

1. The labelling of unit packets and any outside packaging and the tobacco product itself shall not include any element or feature that:

(a) promotes a tobacco product or encourages its consumption by creating an erroneous impression about its characteristics, health effects, risks or emissions; labels shall not include any information about the nicotine, tar or carbon monoxide content of the tobacco product;

(b) suggests that a particular tobacco product is less harmful than others or aims to reduce the effect of some harmful components of smoke or has vitalising, energetic, healing, rejuvenating, natural, organic properties or has other health or lifestyle benefits;

(c) refers to taste, smell, any flavourings or other additives or the absence thereof;

(d) resembles a food or a cosmetic product.

(e) suggests that a certain tobacco product has improved biodegradability or other environmental advantages.

2. The unit packets and any outside packaging shall not suggest economic advantages by including printed vouchers, offering discounts, free distribution, two-for-one or other similar offers.

3. The elements and features that are prohibited pursuant to paragraphs 1 and 1a may include but are not limited to texts, symbols, names, trade marks, figurative or other signs.

Article 18

Cross-border distance sales of tobacco products

1. Member States may prohibit cross-border distance sales of tobacco products to consumers. Member States shall cooperate to prevent such sales. Retail outlets engaging in cross-border distance sales of tobacco products may not supply such products to consumers in Member States where such sales have been prohibited. Member States which do not prohibit such sales shall require retail outlets intending to engage in cross-border distance sales to consumers located in the Union to register with the competent authorities in the Member State, where the retail outlet is established, and in the Member State, where the actual or potential consumers are located. Retail outlets established outside the Union shall be required to register with the competent authorities in the Member State where the actual or potential consumers are located. All retail outlets intending to engage in cross-border distance sales shall submit at least the following information to the competent authorities when registering:

(a) name or corporate name and permanent address of the place of activity from where the tobacco products will be supplied;

(b) the starting date of the activity of offering tobacco products for cross-border distance sales to consumers by means of information society services, as defined in Article 1(2) of Directive 98/34/EC; (c) the address of the website or websites used for that purpose and all relevant information necessary to identify the website.

2. The competent authorities of the Member States shall ensure that consumers have access to the list of all retail outlets registered with them. When making that list available, Member States shall ensure that the rules and safeguards laid down in Directive 95/46/EC are complied with. Retail outlets may only start placing tobacco products on the market via cross-border distance sales when they have received confirmation of their registration with the relevant competent authority.

3. The Member States of destination of tobacco products sold via cross-border distance sales may require that the supplying retail outlet nominates a natural person to be responsible for verifying – before the tobacco products reach the consumer – that they comply with the national provisions adopted pursuant to this Directive in the Member State of destination, if such verification is necessary in order to ensure compliance and facilitate enforcement.

4. Retail outlets engaged in cross-border distance sales shall operate an age verification system, which verifies, at the time of sale, that the purchasing consumer complies with minimum age requirements provided for under the national law of the Member State of destination. The retail outlet or natural person nominated pursuant to paragraph 3 shall provide to the competent authorities of that Member State a description of the details and functioning of the age verification system.

5. Retail outlets shall only process personal data of the consumer in accordance with Directive 95/46/EC  and those data shall not be disclosed to the manufacturer of tobacco products or companies forming part of the same group of companies or to other third parties. Personal data shall not be used or transferred for purposes other than the actual purchase. This also applies if the retail outlet forms part of a manufacturer of tobacco products.

Article 25

Committee procedure

1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

3. Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result when, within the time-limit for delivery of the opinion, the chair of the committee so decides or a simple majority of committee members so requests.

4. Where the Committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

Article 26

Competent authorities

Member States shall designate the competent authorities that shall be responsible for the implementation and enforcement of the obligations provided for in this Directive within three months from [two years after entry into force]. Member States shall inform the Commission about the identity of the designated authorities without delay. The Commission shall publish that information in the Official Journal of the European Union.

Article 27

Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Articles 3(2) and (3a), 4(3) and (4a), 6(3), (9) and (10), 8(5), 9(3), 10(5), 11(3), 14(12), 18a(10) and (11) shall be conferred on the Commission for a period of five years from [date of entry into force]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3. The delegation of powers referred to in Articles 3(2) and(3a), 4(3) and (4a), 6(3), (9) and (10), 8(5), 9(3), 10(5), 11(3), 14(12), 18a(10) and (11) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

Article 28

Report

No later than five years from [two years after entry into force], and whenever necessary thereafter, the Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the application of this Directive. When drafting the report, the Commission shall be assisted by scientific and technical experts in order to have all the necessary information at its disposal.

2. In the report, the Commission shall indicate, in particular, the elements of the Directive which should be reviewed or adapted in the light of scientific and technical developments, including the development of internationally agreed rules and standards on tobacco and related products. The Commission shall pay special attention to:

(a) the experience gained with respect to the design of package surfaces not governed by this Directive taking into account national, international, legal, economic and scientific developments;

(b) market developments concerning novel tobacco products considering, inter alia, notifications received under Article 19;

(c) market developments which constitute a substantial change of circumstances;

(d) the feasibility, benefits and possible impact of a European system for the regulation of the ingredients used in tobacco products, including the establishment, at Union level, of a list of ingredients that may be used or present in, or added to tobacco products, taking into account, inter alia, the information collected in accordance with Articles 5 and 6;

(e) market developments concerning cigarettes with a diameter of less than 7,5mm, and consumer perception of their harmfulness as well as the misleading character of such cigarettes.

(f) the feasibility, benefits and possible impact of a Union database containing information on ingredients and emissions from tobacco products collected in accordance with Articles 5 and 6;

(g) market developments concerning electronic cigarettes and refill containers considering, amongst others, information collected in accordance with Article 20, including on the initiation of consumption such products by young people and non-smokers and the impact of such products on cessation efforts as well as measures taken by Member States regarding flavours.

(h) market developments and consumer preferences as regards waterpipe tobacco, with a particular focus on its flavours.

The Member States shall assist the Commission and provide all available information for carrying out the assessment and preparing the report.

Article 29 paragraph 1

Transposition

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [two years after the entry into force ] at the latest. They shall forthwith communicate to the Commission the text of those provisions. The Member States shall apply those measures from [two years after entry into force] without prejudice to Articles 6(12), 9(1)(e), 14(13) and 14a(3).

Article 30

Transitional provision Member States may allow the following products, which are not in compliance with this Directive, to be placed on the market until [three years after entry into force]

(a) tobacco products manufactured or released for free circulation and labelled in accordance with Directive 2001/37/EC before [two years after entry into force]

(b) electronic cigarettes or refill containers manufactured or released for free circulation before [30 months after entry into force]

Recitals

(36) Electronic cigarettes and refill containers should be regulated by this Directive, unless they are – due to their presentation or function – subject to Directive 2001/83/EC of the European Parliament and of the Council or to Council Directive 93/42/EEC . Diverging legislation and practices as regards these products, including on safety requirements, exist between Member States, hence, action at Union level is required to improve the smooth functioning of the internal market. A high level of public health protection should be taken into account when regulating these products. In order to enable Member States to carry out their surveillance and control tasks, manufacturers and importers of electronic cigarettes and refill containers should be required to submit a notification of the relevant products before they are placed on the market.

(37) Member States should ensure that electronic cigarettes and refill containers comply with the requirements of this Directive. Where the manufacturer of the relevant product is not established in the Union, the importer of that product should bear the responsibilities relating to the compliance of those products with this Directive.

(38) Nicotine containing liquid should only be allowed to be placed on the market under this Directive, where the nicotine concentration does not exceed 20 mg/ml. This concentration allows for a delivery of nicotine that is comparable to the permitted dose of nicotine derived from a standard cigarette during the time needed to smoke such a cigarette . In order to limit the risks associated with nicotine, maximum sizes for refill containers, tanks and cartridges should be set.

(39) Only electronic cigarettes that deliver nicotine doses at consistent levels should be allowed to be placed on the market under this Directive. Delivery of nicotine doses at consistent levels under normal conditions of use is necessary for health protection, safety and quality purposes, including to avoid the risk of accidental consumption of high doses.

(40) Electronic cigarettes and refill containers could create a health risk when in the hands of children. Therefore, it is necessary to ensure that such products are child- and tamperproof, including by means of child-proof labelling, fastenings and opening mechanisms.

(41) In view of the fact that nicotine is a toxic substance and considering the potential health and safety risks, including to persons for whom the product is not intended, nicotine-containing liquid should only be placed on the market in electronic cigarettes or in refill containers that meet certain safety and quality requirements. It is important to ensure that electronic cigarettes do not break or leak during use and refill.

(42) The labelling and packaging of these products should display sufficient and appropriate information on their safe use, in order to protect human health and safety, should carry appropriate health warnings and should not include any misleading elements or features.

(43) Disparities between national laws and practices on advertising and sponsorship concerning electronic cigarettes present an obstacle to the free movement of goods and the freedom to provide services and create an appreciable risk of distortion of competition. Without further action at Union level, those disparities are likely to increase over the coming years, also taking into account the growing market for electronic cigarettes and refill containers. Therefore, it is necessary to approximate the national provisions on advertising and sponsorship of those products having cross-border effects, taking as a base a high level of protection of human health. 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 electronic cigarettes and refill containers.

(44) In order to perform their regulatory tasks, the Commission and Member States need comprehensive information on market developments as regards electronic cigarettes and refill containers. To this end manufacturers and importers of these products should be subject to reporting obligations on sales volumes, preference of various consumer groups and mode of sales. It should be ensured that this information is made available to the general public, taking the need to protect trade secrets duly into account.

(45) In order to ensure appropriate market surveillance by Member States, it is necessary that manufacturers, importers and distributors operate an appropriate system for monitoring and recording suspected adverse effects and inform the competent authorities about such effects so that appropriate action can be taken. It is warranted to provide for a safeguard clause that would allow Member States to take action to address serious risks to public health.

(46) In the context of an emerging market for electronic cigarettes, it is possible that, although complying with this Directive, specific electronic cigarettes or refill containers, or a type of electronic cigarette or refill container, placed on the market could pose an unforeseen risk to human health. It is therefore advisable to provide for a procedure to address this risk, which should include the possibility for a Member State to adopt provisional appropriate measures. Such provisional appropriate measures could involve the prohibition of the placing on the market of specific electronic cigarettes or refill containers, or of a type of electronic cigarette or refill container. In this context, the Commission should be empowered to adopt delegated acts in order to prohibit the placing on the market of specific electronic cigarettes or refill containers, or of a type of electronic cigarette or refill container. The Commission should be empowered to do so, when at least three Member States have prohibited the products concerned on duly justified grounds and it is necessary to extend this prohibition to all Member States in order to ensure the smooth functioning of the internal market for products complying with this Directive but not presenting the same health risks. The Commission should report on the potential risks associated with refillable electronic cigarettes by [two years after entry into force]

(47) This Directive does not harmonise all aspects of electronic cigarettes or refill containers. For example, the responsibility for adopting rules on flavours remains with the Member States. It could be useful for Member States to consider allowing the placing on the market of flavoured products . In doing so, they should be mindful of the potential attractiveness of such products for young people and non smokers. Any prohibition of such flavoured products would need to be justified and notification thereof submitted in accordance with Directive 98/34/EC.

(48) Moreover, this Directive does not harmonise the rules on smoke-free environments, or on domestic sales arrangements or domestic advertising, or brand stretching, nor does it introduce an age limit for electronic cigarettes or refill containers. In any case , the presentation and advertising of those products should not lead to the promotion of tobacco consumption or give rise to confusion with tobacco products. Member States are free to regulate such matters within the remit of their own jurisdiction and are encouraged to do so.

92 comments to Updated info post: TPD – provisions relating to e-cigarettes

  • Liam Bryan

    Thank you Clive for your tireless work with us and for us – without which I am sure ecigs would not still be a viable (albeit less so perhaps) alternative to lit tobacco today.

    Do you have any thoughts on what:

    3f and Recital d (the “consistent dose”) actually mean with respect to the devices available today?

  • Jonathan Bagley

    This will cause chaos. Do we want thousands of people keeping multiple bottles of 72 mg nicotine liquid in their fridges for when the ban comes in? That’s far more dangerous than the current situation.

  • I’m struggling to see how this will not result in widespread compliance failure (notification of ingredients and emissions, dose etc)…

  • Rob Crewe

    This legislation effectively prohibits all but the medical type, disposable units that will be marketed by Big Tobacco.

    The unnecessary nicotine limits will create a black market for high concentration nicotine that is freely available from the far east. Unless governments can increase customs and border control resources by several orders of magnitude, this will result in fatalities through leakage and accidental contact with high concentration nicotine.

    The removal of the right to free speech is way beyond reason.

  • silverbear

    Thanks from me too Clive. This is an absolute quagmire. Every time I read something that says ‘final position’, I get the feeling that the goal posts have moved again – well probably not the goal posts, but what has been ‘agreed’. Will sit down & read properly when I’m feeling calmer.

  • Mike

    Horrible legislation drafted by people who have no understanding of even the most basic aspects of electronic cigarettes.

    If passed as it stands, this legislation will destroy the industry as we know it and only allow products from big pharma/big tobacco.

    Just what they wanted.

  • Roger Hall

    I just wonder how many of the so called children safety concerns actually apply to medically regulated products. e.g. how exactly are a NRT gum & patches child proof? Watched a TV program yesterday (Masters of Sex) and it was interesting that in the late 50′s/early 60′s homosexuality was considered a medical condition and to be cured by Electric Shock Treatment and even chemical castration – seems that smoking (the taking of the legal recreational drug nicotine)is now considered to be along the same lines. Considering that the gay community represent just c.3% of the population I wonder if the smoking/vaping community will continue to allow themselves to be treated as pariahs of the community? Imagine any EU legislation that enshrined in law that the mention of gays, lesbians, homosexuality could not be publicly aired or communicated in any public forum or media. If that isn’t blatant discrimination then I’d like to see a worse case. All vapers/vendors/harm reduction advocates need to fight this legislation and not take the view that it’s OK I can get by, as our fundamental rights are being abused based on evidence that has no credibility scientifically. Forget about politicians now I say and let the courts of law now fight our case. At least the law base any decision on hard evidence and not ideology or appeasement of vested interests.

  • This is leaving no question: The new §18 is custom-tailored for pharma and tobacco! What a mess!

    Single-Use and Refillable Cartridges and Tanks with a maximum size of 2ml?
    Up to 20mg per ml?

    This is designed for the “cig-a-likes” from BigPharma and BigTobacco!

    Memberstates are able to ban? Delegated acts for the commission?

    This is harmonisation?

    ROFL!

  • Kenneth

    I heard that the commission will take a new look at the situation about this in 2016. Does anyone have an idea about when this law will take effect?

  • cnc

    f) cross-border distance sales of electronic cigarettes and refill containers are regulated in accordance with Article 16.

    What this means?

    Where to find Article 16 ?

    • Not sure if this is any good:
      http://europa.eu/rapid/press-release_MEMO-13-1177_en.htm Section 5
      I think it’s more to do with age verification and warnings etc.

    • lvd

      Article 16

      Distance sales of tobacco products

      1. Member States shall prohibit retail
      outlets established on their territory from
      engaging in cross border distance sales.

    • lvd

      PS: The age verification, etc in 16.1a and further apply for national distance sales, not for cross border distance sales, that are strickly prohibited.

    • Clive Bates

      Start of Article 16 reads….

      Member States may prohibit cross-border distance sales of tobacco products to consumers. Member States shall cooperate to prevent such sales. Retail outlets engaging in cross-border distance sales of tobacco products may not supply consumers in Member States where such sales have been prohibited. Member States which do not prohibit these sales shall oblige retail outlets intending to engage in cross-border distance sales to consumers located in the Union to register with the competent authorities in the Member State where the retail outlet is established and in the Member State where the actual or potential consumer is located.

      In other words it allows rather than requires member states to ban cross border internet trade.

      • Anonymous

        Have the amendements by the EP been overruled in the trilogue?

      • Rita Cheliotis

        Sorry, I have tried hard….but I cannot figure out what are exactly
        the rules for online sales/purchases inside and outside of the EU?
        For the HW, liquid and flavors, as well as for the rest of e-cig equipment.
        Can somebody help me out here?-Thankyou.

  • Steve HAAS

    I wish the commission and the memberstates good luck in implementing and enforcing this piece of legislative junk that is in complete denial of the pratical and economic factors of ecigarettes.

    Destroying a perfectly well functionning market by a completely randomized and senseless overregulation. Those that brought this abominable piece of crap to life can be very proud of themselves. The parliament must reject this and take ecigs out of TPD otherwise there is gonna be a mess of apocalyptic dimension the day that this directive will be in effect in the different memberstates.

  • EU legislation should have provided *protections* for e-cigs as a safer alternative to cigarettes – this ruling does nothing except lower the level of nicotine e-cig users can purchase/consume in cartos or refill bottles.

    All the other things we e-cig users feared – bans, classification as medical devices – are left to individual member states to decide as they wish. Instead of having a unified approach to regulation EU-wide it’s now a free-for-all.

    Terrible. Yet the politicians think we’ve ‘won’ *mind boggles*

  • Alan Depauw

    No-one noticed this?

    “e)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;”

    One presumes that some member states have not yet discovered the meaning of “freedom of speech”; or that older members have decided that it has become too troublesome.

    • vapingpoint

      It’s exactly this removal of freedom of speech that is the most scary aspect of all. Many vapers are set for Armageddon with physical equipment. We will buy black market nicotine but where does one find black market freedom of speech? Will my videos be banned in the UK, but allowed in the USA? Will Vapoutrails TV be banned? Will the words “vaping” “tanks” “e liquid” be blocked by our ISP’s as the UK attempts to manipulate the Internet with its new anti pedophile Internet protection legislation? Will we be sending our message out on the dark web? That paragraph hit me in the face! THAT is evil. That alone is illegal surely?

      • Anonymous

        Some of that article 18 of the TPD referring to advertising etc. is in direct contravention to article 11 of the freedom of speech directive. So it can be ignored by vendors…legally and without worry, Vapouttrails can easily continue for example because nobody in Brussels would dare try to stop it by arguing that Dave should be silenced yet the UK national front should be allowed to continue unhindered. I’ll be ignoring it and waiting for them to try stop me.

        They won’t try to stop me obviously because no EU commissioner, MEP or bureaucrat wants to find themselves in a courtroom arguing against freedom of speech, not unless they are politically suicidal.

        The whole thing will fail miserably anyway, by the time it takes effect there will be 4 times more vapers. Plus boxes of rubber vials that refill ecigs through a slot will easily overcome both the 20ml nonsense and the 10ml bottle nonsense.

        And …nobody…absolutely nobody would dare tell the media what they can and cannot report.

      • Mick Wright

        Some of that article 18 of the TPD referring to advertising etc. is in direct contravention to article 11 of the freedom of speech directive. So it can be ignored by vendors…legally and without worry, Vapouttrails can easily continue for example because nobody in Brussels would dare try to stop it by arguing that Dave should be silenced yet the UK national front should be allowed to continue unhindered. I’ll be ignoring it and waiting for them to try stop me.

        They won’t try to stop me obviously because no EU commissioner, MEP or bureaucrat wants to find themselves in a courtroom arguing against freedom of speech, not unless they are politically suicidal.

        The whole thing will fail miserably anyway, by the time it takes effect there will be 4 times more vapers. Plus boxes of rubber vials that refill ecigs through a slot will easily overcome both the 20ml nonsense and the 10ml bottle nonsense.

        And …nobody…absolutely nobody would dare tell the media what they can and cannot report.

    • Clive Bates

      This word ‘contribution’ refers to payment – so it is a bureaucrat’s way of defining paid advertising, sponsorship and promotion – and exactly the same as the language used in the directive banning cross border tobacco advertising 2003/33/EC

  • By ‘contribution’ they mean sponsorship – still, it means that e-cigs won’t be able to be advertised in places that alcohol still is such as football stadiums.

    For something with so many potential benefits to public health this prohibitionist stance is disgraceful.

    • vapingpoint

      Vapourtrails TV is sponsored by vendors.

      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;”

      Should stifle quite a few reviewers too?

      Cross borders must mean the Internet?

  • evaporate

    This is a mixture of med regs and industrial standards
    section 2 is requirements for a product dossier required for pre market approval and change control.
    competant authority is the MHRA
    Responsible legal person is authorised representative in med regs
    Sections 2c and d are clinical data
    Section 8 is pharmavovigilance
    section 9 gives power to ban
    section 5 bans free speech
    I do not think the MEP s will realise they are med regs in disguise

  • Jonathan Bagley

    I reckon the volume of my cartridge is at least 5ml. However, its eliquid capacity is at most 1.5ml, as the liquid is soaked up and retained in some sort of plastic foam. A total volume limit of 2ml would render this kind of cartridge useless.

    • Clive Bates

      Another mess created by legislator ignorance… But I think this refers to single use cartridge – is that what you mean?

      • No… this refers not only to single use cartridges!

        “dedicated refill containers not exceeding a volume of 10 ml”

        The meaning of “refill containers” is the usual bottle in which liquid is sold.

        “The cartridges or tanks shall not exceed a volume of 2 ml;”

        This is clear: This refers to single use cartridges AND (refillable) tanks.

    • Kurtis

      A total mess really.
      This needs to be pointed out to MEPs and members of national parliaments.
      I shall be going through the text and pointing out some of the stupidities in in. For example that the nicotine levels allowed will not make e-cigs attractive to or useful to people who are now heavy smokers (the tobacco companies’s most profitable customers) etc.

      In a recent article in Forbes it was pointed out that if the FDA had managed to classify e-cigs as medical devices (courts overturned their attempt) then something like an extra 750 million packets of tobacco cigarettes would have been sold between then and now. How many millions of packets of cigarettes will be sold because of this botched attempt at regulation that might not have been? This is the kind of point I will also be attempting to get across when I set pen to paper.

      The whole thing needs to be taken out of the TPD.

  • "Path to Paradise"

    George Orwell “1984″

    how sad

  • lvd

    Maybe a strategy is to compile a list of things that need to be clarified in an amendment from the EP to article 2 : Definitions regarding electronic cigarettes. If they realize the work that needs to be done, they could decide this is undoable in the framework set out by the trilogue.

    - Electronic cigarettes means ???
    - Pre filled electronic cigarettes means ???
    - Refillable electronic cigarettes means ???
    - Refill containers means ???
    - Tanks means ???
    - Products that are subject to an authorisation requirement under Directive 2001/83/EC or to the requirements set out in Directive 93/42/EEC means ???
    - Emissions means ??? and should be measured according ???
    - Nicotine uptake means ??? and should be measured according ???
    - Normal or reasonably foreseeable conditions means ???
    - Consistent dose means ???
    - The technical standards of the refill mechanism ensuring leakage free refilling of refill containers means ???.
    - Reasonable grounds for concerns to a serious risk to human health means ???.
    … (the list is endless)

  • Roger Hall

    Clive, are you aware of any suitably qualified legal scrutiny with regard to the proposal as there may appear to be a serious back door provision for delegated banning of devices. Far too many loose terms/wording for a legal document of this type that can be used in the future. For example “appropriate” should always be subject to the legal definition and understanding of what does “appropriate” mean.

  • Mike B

    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;

    Clive, whilst I bow to your experience and knowledge in this field I cannot wrap my brain around your stance, that this is only used in the meaning of the word paid. Even the section quoted on the save Ecigs site uses a different wording

    ”any form of public or private contribution to [media] with the aim or direct or indirect effect of promoting electronic cigarettes is prohibited“.

    Could you possibly clarify it a bit more? Would this not stop an EU wide Vapefest 2016 in its tracks?

    Would it not mean that vendors or for that matter consumers, would be prohibited from giving their opinion in a radio broadcast?
    EG: If they wanted to state openly that Refill containers were by and large favoured by Vapers because they work well and are able to be modified to the users requirements whereas Cartridges of the sort they seem to favour in the TPD, are ineffective, expensive and generally of poor vape quality.

    Would a vendor or a consumer be allowed to state on a TV chat show that Ecigs are less harmful than tobacco cigarettes so people who are struggling to quit should try them?

    Could not Paragraph D be interpreted in that way?

    Sorry to be obtuse but that is what it appears to be to me and we all know how eager some agencies would be to use it like that if at all possible.

  • Clive Bates

    The short answer is that Article 18 para 5 is there to ban certain types of advertising, sponsorship and promotion of e-cigs, not to stop people talking about them or to curtail free speech (except perhaps ‘commercial free speech’)

    The language of Article 18 para 5 aims to limit it to that purpose, but also to prevent loopholes. So ‘contribution’ could cover payment, payment in kind, underwriting etc. It doesn’t actually mean participation or ‘contribution’ in the sense of contributing to a discussion. It is exactly the same language used in the tobacco advertising directive 2003/33/EC. That directive does not stop people discussing smoking on the radio or anywhere else. Even paid lobbyists or trade associations can go on the radio or TV and talk about it – as long as they don’t pay the radio/TV station for access. I hope this distinction is clear.

    This 2003/33/EC directive is the outcome of a successful legal challenge to an earlier directive (98/41/EC), which was more sweeping. The court challenge found that the EU only had jurisdiction over cross-border advertising, sponsorship and promotion, and that member states had jurisdiction over domestic advertising (eg. billboards). That’s why the sponsorship ban stated in Article 18 para 5 is limited to events ‘involving or taking place in several member states or otherwise having cross border effects’.

    So…
    + You can arrange any sort of Vapefest anywhere that doesn’t have e-cig company sponsorship.
    + As far as this directive is concerned you can have a Vapefest with e-cig company sponsorship as long as it is a single country event. Note though that national rules might one day apply on top of the EU directive.
    + You can’t run a Vapefest that is EU-wide, cross border or involving several countries and takes e-cig sponsorship. But I suspect simultaneous national events would not have the authorities breaking in doors. The tobacco version of this was aimed firmly at tobacco companies’ sponsorship of Formula 1 and other major sporting events.

    The situation is more troubling for vaping social media thank flesh and blood meetings, for example forums, YouTube channels, blogs, if these are funded by advertising or sponsorship by e-cig companies. The proposed Article 18 text also refers to directive 98/48/EC – this is the directive that defines Information Society Services directive and has the effect of advertising, sponsorship and promotional bans to the internet. It also refers to 2010/13/EC, the Audiovisual Media Services Directive – so the scope is very broad. Given that e-cigs are a much bigger deal on the internet than tobacco ever was, then these restrictions could have all manner of unintended consequences.

    Where did this all come from? When the MEPs agreed their amendment 170 they said:

    “the limitations on advertising, sponsorship, audiovisual commercial communication and product placement for tobacco products as set out in Directive 2003/33/EC and Directive 2010/13/EC shall apply to nicotine-containing products;”

    .
    That text doesn’t work legally, as those directives don’t apply to e-cigs. So the Commission took the critical words from those directives and included them in the Article 18 proposal.

    I really dislike this measure and wrote the MEPs involved just before they agreed it to say so, but was ignored of course.

    My view is that this is a crude prohibition, disproportionate to any risk, simply borrowed from tobacco but without recognising vaping is 100x safer than smoking. It runs counter to the effective operation of the internal market and should be challenge in court. it is perfectly possible to control advertising through codes etc – this is already done for alcohol.

  • […] même jour, Clives Bates, fervent acteur en faveur des inhalateurs électroniques, dévoilent enfin l’article 18 qui aurait amené à un accord entre le parlement européen et le […]

  • Vita

    I lived in socialism, now I live in the EU. Where is the difference?

  • The main difficulty I have is understanding what motivates people to introduce e-cigarette legislation. Should I choose to eat to much butter and clog my arteries, nobody will stop me. Should I choose to drink too much alcohol and be a nuisance to society, nobody will stop me. Should I choose to smoke cigarettes, with all it entails as cost to society, nobody will stop me. Why are e-cigarettes any different? I suspect that there’s an irrational fear that those who vape will become cigarette smokers; anyone who’s vaped will see this as ridiculous. The root cause, to my mind, is that the holier-than-thou legislator just can’t stand the idea that a vaper is enjoying himself gratuitously; the fact that vaping bothers no-one just angers him further, because he no longer has the right to control others’ pleasure.

  • Joan

    Una vez mas el Parlamento Europeo, que por cierto pagamos entre todos, defiende los intereses de las Tabaqueras y la industria farmacéutica, coartando la libertad de los europeos con prohibiciones y recortes a la libertad individual, sin apoyarse en argumenetos científicos serios.

  • godek

    I read several versions several times, but this has slipped by me until now:
    Article 12 1c makes sales if flavoured single use devices impossible. How would you tell them apart if nothing may be put outside referring to taste, smell ect.?
    Not sure if 12 1c also applies to refills.

    br
    godek

  • G.Slater

    I have not seen any reference to the impact of these requirements for manufacturers and importers of eliquid etc. From what I read above, the costs involved, albeit probably less than the med regs licenses, are still going to be massive. The only way for businesses to recoup such costs would be to increase costs of refills etc. And if I am right about what these kinds of requirements will cost (even simple lab work is v.costly, what to speak of pointless blood plasma level tests) the increase in cost is going to be substantial. Have these politicians referenced any kind of costing data, to check the impact on businesses? Or is that irelevant to them?

    • They are required to do such an assessment and have not done so…. its another reason this will end up in a courtroom… no impact assessment was completed. The impact assessment and inclusion of a consultation are not ‘mice to have’ they are part of the original treaty… not negotiable.

      This entire section 18 would as it stands be thrown out of the EU court of justice, and the EU court of human rights if it emerged neither of those processes were included in the initial preperation without any need for eveidence of anything else.

  • Linda

    Many people stop smoking due to the cost, so if eliquid goes up in price this will stop many changing to vaping. So I think its very relevant as they want to put ecig vendors out of business. Who wins?…… Tobacco, Pharma and Governments

  • @godek
    Yes, this seems to be the case – well spotted. They are clear that 12.1(a) does not apply, so 12.1(c) must be assumed to apply. I’d be surprised if deliberate, more like chaotic incoherence. This is the problem with cross referencing – no one can hold it in their head to see the full picture. This adds to the case to take it out and do it properly.

  • Dodderer

    This partly links to the first comment but it struck me as perverse that the ‘tobacco product’ regulatory option refers to ‘dose’ – presumably this is a medicinal term in this context.

    There is no equivalent restriction for the real tobacco products so this TPD effectively favours lit tobacco over ecigs – crazy.

  • Yes, but there this wording is the definition of “sponsorship”. In the regulation itself the word “sponsorship” is used.

    By omitting this word, this opens up a whole world of ways to interpret it. This may just be another example of the total screw up with art 18, but my growing paranoia suggests a deliberate attempt to disrupt and distract us by making us targets for zealots.

    If this gets through, I’m afraid a lot of rabid (well funded) ANTZ will pop up and sue the hell out of bloggers, forums, youtubers, vendors etc. Even if the courts are sensible, this harassment via law suits will have cost time, money and lots nerves.

  • And another big goof in this “clean” version:

    They changed Title III from “Non Tobacco Products” to “E-Cigs”.

    What about Article 19?
    That’s also part of this section. Are now herbal smokes to be called e-cig???

    Changing Article 18 form “Nicotine Containing Products” to “E-cigs” already raised a few questions for me.

    What about (at the moment rather hypothetical) non-medicinal gums, lozenges, and other nicotine containig products?
    Why leave them now totally unregulated like before the TPD?

    My paranoia suggests:

    The original proposal was taylored to prevent any competition on the free market to NRTs. The levels were so low that not only e-cigs would be useless.
    The result of ENVI was even “better”.
    But the MEP’s choice would also have granted legal security for this market.
    Now some friends of Pharma intervened to prevent the worst for them.

    Am I just paranoid?

  • Tlow

    Article 11 paragraph 2 – The health warning laid down in paragraph 1 shall comply with the requirements…

    b) cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion shall be increased to 32 % for Member States with more than two official languages and 35 % for Member States with three official languages.

    -Doesn’t the last sentence here contradict itself:- 32% for more than two languages, and 35% for 3 languages?

  • Great news for manufacturing and importer e cigarettes. I like this very much.We need quality service not quantity.

  • […] someone link me to the contents/effects of the legislation passed? Here's a comprehensive list: link There might be a summary somewhere on Clive Bate's web site if you have a look […]

  • Ash

    Good luck to the police and customs when this comes into effect… By then there will be 3 million vapers in this country and they won’t be able to bust us all.

    Just ignore the whole thing. Continue vaping. The authorities simply don’t have the budgets to enforce a ban. They won’t be able to stop the black market.

    Stupid noise, for the most part, this is.

  • […] Updated 26 February 2014. The European Parliament has just voted through an amended text as polished up by lawyers and linguists. The e-cigarette relevant text below has been brought into line wit…  […]

  • nisakiman

    Welcome back, vapers, to the lunacy of Tobacco Control.

  • Irish Lass

    Our MEPs and MPs just don’t seem to care about the health of tobacco smokers. We are living in an Orwellian nightmare world of doublethink, doublespeak and the rewriting of anything that the people in power don’t wish to have known or remembered.
    I feel sick at heart.

  • Rita Cheliotis

    THAT MAKES ME CRAZY!!! FOR THAT WAS THE WHO WAITING FOR!!!…TO JUMP ON THE TRAIN ! Sorry, cannot think straight after such a load of ….. comming from the MEP!!!….to give in in an entire pre-determined farce!

    Thirdly, there have been developments at international level over the past decade, to which EU Member States have responded with different regulatory approaches. The EU and all Member States are parties to the legally binding WHO Framework Convention on Tobacco Control (FCTC), which entered into force in February 2005.

  • It is not actually possible for eliquid manufactures to comply with these regulations. The requirement to state the nicotine delivery per dose is simply ridiculous, because it depends on the ecig used, the vapers inhale etc.

    I cant see this being enforcable, as they cant shut businesses down for not doing the impossible…can they?

  • jredheadgirl

    “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;”

    Doesn’t this seem to imply that private citizens and advocates(like ourselves) for e-cigarettes and vaporizers will thus be prohibited from exercising their/our right to free speech? What does “indirect” effect mean, that you can’t even talk about e-cigarettes or tobacco? Am I interpreting this incorrectly?

  • Dave Atherton

    EU votes through draconian new anti-smoking rules. Especially e-cigs and snus.

    A quote from Mr. C. Bates.

    http://www.breitbart.com/Breitbart-London/2014/02/26/EU-Votes-Through-Draconian-New-Anti-Smoking-Rules

  • anonymous

    Well at last that stage is out of the way, take a deep breath and let’s think about the future.
    It would appear that legal challenges can first be made when the directive is incorporated in national legislation, so there’s a while to go yet.

    In the mean time the European Free Vaping Initiative http://www.efvi.eu/ should be promoted tirelessly, as, if nothing else, a way to confront the EU politicians with the consequences of legislating things of which they have absolutely no knowledge. If that is a viable route to radically change article 18, remains to be seen, but it looks the best vehicle for Europe-wide action at this moment.

    If we are all going to be criminalised for using nicotine without burning dried leaves, we might as well do it properly. So prepare for Darknet http://answers.yahoo.com/question/index?qid=20110602162228AAd5dIH nicotine, device and atomizer suppliers.

    We have only lost when we accept defeat.

  • […] Updated 26 February 2014. The European Parliament has just voted through an amended text as polished up by lawyers and linguists. The e-cigarette relevant text below has been brought into line with the official current text of the Tobacco Products Directive as voted by European Parliament today.Article 18 is divided into 12 paragraphs and cross references several other articles. It is also supported by a set of recitals. The following are the broad themes and structure of the article – click on these to navigate to the relevant text: 1. Relation to medicines regulation2. Notification regime – ingredients, toxicology, pharmacology, production process3. Technical design restrictions and requirements4. Leaflet, packaging and warning5. Advertising, promotion, sponsorship and cross border sales6. Disclosure commercial data and market surveillance7. Public disclosure of commercial data8. Surveillance for adverse effects9. Commission report on refillable devices10. Basic for controlling products that present a serious risk to health11. Process for adapting the wording of health warnings12. Delegated responsibility to design notification regime and refill mechanism  […]

  • strayan

    “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’.

    or

    ‘This product contains nicotine which is a highly addictive substance.’”

    Where is the evidence that nicotine in electronic cigarette vapor is highly addictive?

    These warnings demonstrate a complete lack of understanding of what is called ‘pharmacological synergism’.

    There are over 4000 chemicals in tobacco smoke. It is now known that chemicals such as carbon monoxide are pharmacologically active. One recent study concluded that:

    “CO exerts pharmacological effects, which may modulate craving processes associated with cigarette withdrawal, and exploration for the role of CO and other cigarette smoke constituents is warranted.” http://www.ingentaconnect.com/content/apl/gart/2012/00000020/00000002/art00008?crawler=true

    There is no CO in vapor. Nor are there anywhere near the number of chemicals in vapor that there are in tobacco smoke.

    The assumption that nicotine is as ‘highly addictive’ as cigarettes because cigarettes also contain nicotine is scientific nonsense!

    • Joao Pargana

      “The assumption that nicotine is as ‘highly addictive’ as cigarettes because cigarettes also contain nicotine is scientific nonsense!”

      I’m so tired of hearing the ‘addictive nicotine’ lie…

      “Kids are going to be addicted to nicotine, and then move to smoking”…!

      It’s not going to happen. The last paragraph makes it clear.

      “There is no evidence that nicotine is dependence-forming except in tobacco smoke along with a mix of 9,600 other compounds including multiple synergens and boosters. Describing one item from a list of 9,600 as responsible for the whole is a gross logic error. Ketchup could be made to create dependence with such an ingredient profile.

      “There is no evidence whatsoever that nicotine has any significant potential for dependence outside of tobacco smoking, and anyone who tells you that it can create dependence is offering an unsupported personal opinion, or is badly misinformed. In the case of a well-informed expert who would know that there is no evidence that nicotine (by itself) is dependence-creating and that in contrast there is a body of anecdotal evidence that it isn’t, then it may be hard to avoid the interpretation that the statement is a deliberate lie (…)”

      “There is not a single published clinical trial of nicotine administration to never-smokers for the purpose of determining its potential for dependence. Anyone claiming expertise in the area who tells you there is such a published trial is badly misinformed (or a liar)”

      “Ask for a reference to a clinical trial that examines the potential of nicotine to cause dependence in never-smokers (the only valid method); there is no such trial. All citations lead to trials of smoking dependence or where the subjects are smokers (or ex-smokers)”

      “However, there are around six clinical trials identified so far, of this type, where nicotine was administered to never-smokers, for other purposes. (Administration to ever-smokers is irrelevant.) These trials took place in order to evaluate nicotine’s beneficial effects on medical conditions such as cognitive dysfunction and auto-immune diseases. Despite high doses administered for several months, no subject experienced withdrawal effects, or symptoms of dependence, or continued to use nicotine afterward. In these trials, nicotine was demonstrated to have no potential for dependence. It must be stressed that this is pure nicotine, not tobacco with nicotine or tobacco smoke with nicotine (…)”

      http://www.ecigarette-politics.com/nicotine-propaganda.html

  • Dodderer

    “Member States shall designate the competent authorities that shall be responsible for the implementation and enforcement of the obligations provided for in this Directive within three months from May 2016″

    “For electronic cigarettes and refill containers already placed on the market in May 2016 the notification shall be submitted within six months of that date.”

    Cutting it fine?

  • Dodderer

    Could the Commission make an assessment of the estimated impact of the new Art 18?Perhaps some idea of the registration costs plus the cost of providing the requisite information – just ball-park,of course.I’m sure they haven’t legislated in ignorance of the effect.

  • […] Please take a look at the European Free Vaping Initiative: http://www.efvi.eu/ Up to you whether you sign it or not. I have. The EU voted through amendments to the Tobacco Product Directive yesterday. More info here: http://www.clivebates.com/?p=1747 […]

  • Well, that’s settled then. Pharma lobbyists should feel their money was well spent.

    Also, it’s nice to see the EU protecting their tax revenues from tobacco sales at the expense of citizens health.

    I’m really looking forwards to the time when I get arrested for vaping my non-compliant mod and non-compliant atomiser with non-compliant juice.

    Screw the EU. I think UKIP will see a massive rise in votes.

  • Jean

    They may pass any directive they want, they might face some problems implementing it.

    - The number of vapers is growing fast. By the time the national governments have to transpose the directive, it will probably not be an electoral winner.

    - Not only that, but the growing number of vapers is correlated with the diminishing number of smokers, as a study published in France two days ago confirmed. That means the transposition may raise some eyebrows. My best guess is that member states will try to empty the e-cig part in some ways.

    - To the extent the directive gets properly transposed into national legislations, vapers will probably have some options.

    - First, the directive is so badly written and thought out that loopholes should be relatively easy to find. For instance, if the nicotine concentration is limited, a more effective e-cig should be able to deal with it so that the nicotine effectively delivered remains the same. Manufacturers have time to adapt.

    - Of course, there is the black market. Will national governments seriously go after illegal imports of e-cigs, which will be known to be an effective smoking rate reducer? I doubt it.

    - And I suppose there is 3D printing. How about downloading your next e-cig?

    This directive doesn’t look much more realistic than the US alcohol prohibition amendment.

    It is still a pity, and you have to wonder how these people are supposed to represent us in European and national institutions.

  • Jean

    They may pass any directive they want, they might face some problems implementing it.

    - The number of vapers is growing fast. By the time the national governments have to transpose the directive, it will probably not be an electoral winner.

    - Not only that, but the growing number of vapers is correlated with the diminishing number of smokers, as a study published in France two days ago confirmed. That means the transposition may raise some eyebrows. My best guess is that member states will try to empty the e-cig part in some ways.

    - To the extent the directive gets properly transposed into national legislations, vapers will probably have some options.

    - First, the directive is so badly written and thought out that loopholes should be relatively easy to find. For instance, if the nicotine concentration is limited, a more effective e-cig should be able to deal with it so that the nicotine effectively delivered remains the same. Manufacturers have time to adapt.

    - Of course, there is the black market. Will national governments seriously go after illegal imports of e-cigs, which will be known to be an effective smoking rate reducer? I doubt it.

    - And I suppose there is 3D printing. How about downloading your next e-cig?

    This directive doesn’t look much more realistic than the US alcohol prohibition amendment.

    It is still a pity, and you have to wonder how these people are supposed to represent us in European and national institutions.

  • […] Updated 27 February 2014. The articles and paragraphs have been renumbered to take account of inserted articles and paragraphs. Article 18 becomes Article 20. This is the full Tobacco Products Directive as it stands now (online source). It is due to be agreed word for word by the Council on 14 March 2014. It will enter into force shortly after publication in the Official Journal (likely May 2014). The text below is designed to help you work out more easily what will apply to e-cigarettes, liquids and vaping devices.  […]

  • Marco

    The Q&A section here: http://europa.eu/rapid/press-release_MEMO-14-134_en.htm
    states that: “(products that do not contain nicotine are not covered by the Directive)”. However such phrase does not appear in the Directive. Somebody have an explanation for this?

    • Clive Bates

      Yes – look at Article 2 – definitions. E-cigs and liquids are defined as products containing nicotine.

      • Marco

        Well, in reality it states: “‘electronic cigarette’ means a product that can be used for consumption of nicotine-containing vapour”

        Maybe it’s due to my poor understanding of the English language, but it says “can be used for”, does it have the same meaning of your statement?

        later on, there is: “or any component of that product [...] and the device without cartridge or tank”.

  • Tim

    Having reviewed all of the comments, it would seem that:

    1) The legislation sets out to destroy the existing vaping market

    2) The legislation is poorly constructed and potentially contravenes basic human rights

    3) Vaping is set to become more popular in the intervening years before the legislation has to be enacted

    So we continue to vape, lobby our respective governments and point out the stupidity of replacing one functioning (if, let’s face it, slightly flakey) market with a black market and all the misery this will bring with it.

    We obviously won’t stop vaping and we need to make the it clear that the destruction of the existing market will result in significant economic harm to the community (and possible arrests/change in careers to drug dealers etc!)

  • Pam

    I’ve read the directive over and over again, and every time I interpret it that e-cigs are classed as pharmaceuticals ONLY if they are presented (my assumption by the seller) as a stop-smoking aid, and that this applies to all member states.

    But I’ve read many comments saying member states are being given the freedom to classify them as pharmaceuticals if they want.

    English is not my first language so obviously I’m missing something, can somebody please tell me exactly where it says that member states are allowed to do this?

  • Pam

    Thanks for the fast answer! But I’m still confused :-( Does Article 18/20 say that member states may class e-cig as pharmaceutical as they choose? Or that they may not?

    • Sorry – that was supposed to answer a different question!

      The directive allows, but does not prevent and does not require, medicines regulation, it doesn’t somehow make it legal either – so it doesn’t protect member states from legal challenge if they decide to impose a ‘medicine by function’ definition. It doesn’t stop them doing that either. Another reason why it’s useless – it is supposed to harmonise things.

      It might be necessary to have this sort of exclusion for where the manufacturer voluntarily decides to seek a medicine license. For example BAT’s Nicoventures is doing this for a product that uses an inhaler approach. So para 1 of Art 20 makes sure it’s only meds and not both that apply.

      Cluve

  • […] You can read a summary of the Directive, with the provisions relating to e-cigarettes in full, here. Setting aside the fact that the Directive’s revisions were presented to members on a ‘take it […]

  • […] Updated 27 February 2014. The articles and paragraphs have been renumbered to take account of inserted articles and paragraphs. Article 18 becomes Article 20. This is the full Tobacco Products Dir…  […]

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  • Jonathan Bagley

    Recitals, number 38, states:

    (38) Nicotine containing liquid should only be allowed to be placed on the market under this Directive, where the nicotine concentration does not exceed 20 mg/ml. This concentration allows for a delivery of nicotine that is comparable to the permitted dose of nicotine derived from a standard cigarette during the time needed to smoke such a cigarette . In order to limit the risks associated with nicotine, maximum sizes for refill containers, tanks and cartridges should be set.
    ——————————–
    This limit is therefore based on a comparison with cigarettes. However, I suspect it is an incorrect comparison. It is generally stated that a cigarette DELIVERS around 1mg of nicotine. An ecig delivers around a third of the available nicotine. This empirical fact is supported by the results of informal polls of vapers, who compare their current ecig nicotine consumption with their previous cigarette consumption. For example, I smoked on average 24 cigarettes a day and I now consume around 72mg of eliquid nicotine a day (promise, I’m not making this up!).

    My question is, if this comparison were found to be based on the false premise that 1 cigarette is equivalent to 1mg of eliquid nicotine, can some kind of legal challenge against the strength limit be successful.

  • Chris Price

    All research that specifically addressed this issue shows:

    1. The ‘nicotine strength’ on the refill label is unrelated to the amount of nicotine actually delivered to the user. This is a complex issue, too involved to discuss here. The statement appears, on the surface, to be erroneous – but the more it is examined, the more accurate it can be found to be.

    2. Part of the problem is that, as we have known since 2009 (from the work by the professional chemists on ECF), only about half the nicotine in the refill liquid is delivered into the vapour (see ‘Goniewicz 1′ and ‘Goniewicz 2′). Since there is a range of delivery efficiencies varying from 10% to 80%, some hardware / refill / user combinations will deliver about zero nicotine (see ‘Eissenberg 1′, Bullen et al, both 2010).

    The labelled amount of nicotine may have little or no relation to the amount delivered. On average, 3ml of 20mg refill might deliver 30mg of nicotine in total; but it could be anywhere from close to zero upward. It will almost certainly never exceed 45mg and such a high delivery can be considered rare.

    • Jonathan Bagley

      Chris, my point is independent of the debate on the amount of nicotine delivered to the body by ecigs.

      People using a wide variety of devices have reported, on UKV for example, that an empirical formula proposed by Trogg, equating former cigarette consumption with current eliquid nicotine consumption, is fairly accurate. This formula says that 1 cigarette is equivalent to vaping eliquid, in whatever strength, containing 3.5 mg of nicotine (however much ends up in the body). For me the factor is nearer 3.0 than 3.5.

      As it is stated that a cigarette delivers 1 mg of nicotine to the body, the regulators may be using the ratio 1:1, rather than 1:3.5. Unfortunately they are able to quote the exaggerated claims of the cigalike manufacturers in their support. The cigalike manufacturers typically claim a refill is equivalent to 20 cigarettes when the true figure is around 6 or 7.

      • Chris Price

        OK Jonathan. I agree a formula might be useful for new vapers but it can only apply to a percentage of people. For example, I smoked 2 cigarettes a day but now use 36mg refill liquid. Presumably I’m way out at one end of the curve, and there will also be people at the other end (those who smoked a lot but vape 6mg and not much of it).

        It would be fun to see the minis taxed at a rate proportionate to the number of cigarettes their vendors say the product is equivalent to – their claims might fall rapidly to a more realistic 6 cigs :) Not sure who they have doing their maths for them, but calling the average 18 drops of refill liquid deliverable by a regular carto ‘equivalent to 20 cigarettes’ is a little hard to accept unless they use a different kind of maths from the usual sort – 1 cig is about 3 drops (as you say / infer).

  • Vapegg

    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 this Directive, that economic operator shall immediately take the corrective action necessary to bring the product concerned into conformity with this Directive, to withdraw or to recall it, as appropriate.

    I am very curious for what the meaning of “possession” is in this context. I hope that “economic operators” don’t get to withdraw products from the market.

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