For those of you who have not the time to scroll through it all here are the main bits that pertain to us . Sorry for the wall of text for those able to visit and peruse the above PDF .
(32a) 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 Council1 or to Council
Directive 93/42/EEC2
. 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.
(32b) 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.
(32c) 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.
(32d) 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.
(32e) 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.
(32f) 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.
(32g) 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.
(32h) 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.
(32i) 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.
(32j) 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.
(32k) 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 …∗∗∗
.
(32l) 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.
(32m) 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
