(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
[unless you have a Medical authorisation (will cost several million £ and take several years to obtain) you must follow these rules
Ties high strength e-cigs exclusively to Big T Big P and anyone else with very deep pockets]
[..] 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.
[the devil on this is in the detail, if all that's required is a letter to Govt. dept. x then not a big issue, if you have to wait for a reply first, good luck with that]
(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 means that the HIGHEST legally available e-liquid is going to be 18mg/ml as noone wants to produce liquid at 20.0000001mg/ml by accident and then get put out of business. The same way that you can only get Nic base right now at 72mg/ml where the legal limit is 75mg/ml.
This will establish a black market for nicbase and drive DIYers underground which has to be orders of magnitude worse for public health than things as they stand now]
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.
[utter bollocks. There is scientific evidence showing that you need 54mg/ml to do this in the peer reviewed literature, and why do you think bigT are using 54mg liquid? because they like wasting money?]
In order to limit the risks associated with
nicotine, maximum sizes for refill containers, tanks and cartridges should be set.
[this increases the risk as there will be more bottles of liquid around and increases waste]
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.
[maybe if you were describing a medicine that might be true. Nicotine is a recreational drug though and users self titrate. It's nearly impossible to overdose on nicotine from vaping. If you use e-liquid as eyedrops, or drink the stuff then you can easily OD but those are not 'normal conditions of use']
(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.
[what is a child proof label exactly? - and this is already covered in CLP regulations]
(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.
[this is unpossible. what kind of unobtanium are manufacturers supposed to make e-cigs out of so that they cannot break? this also vastly overrates the toxicity of nicotine from an ld50 based on centuries old 'science'
this could either be back door to banning items arbitrarily or something everyone just ignores as it makes zero sense as written]
Electronic cigarettes can develop into a gateway to nicotine addiction and
ultimately traditional tobacco consumption, as they mimic and normalize the
action of smoking.
[if I was only able to strike down one sentence in this whole sorry document it would be this one. e-cigs are NOT a gateway into smoking tobacco, anyone who has done both will be able to tell you why. They are a gateway OUT of smoking, a fact documented already in several studies and a document meant to outline the provisions of regulation has absolutely NO business using ANTZ buzz phrases anywhere inside it]
For this reason, it is appropriate to adopt a restrictive approach
to advertising electronic cigarettes and refill containers.
[You don't give us justifications for much of the rest of this document, why get all flowery about this one? In fact as e-cigarettes should not be sold to under 18's then all the restrictions on advertising need to be are such that they prevent advertising to children. (see alcohol)]
(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.
[I've read this many times and I still don't understand what it says. i) define comprehensive ii) what exactly is a manufacturers or importers "preferred consumer group" and how specific do we need to be? Does "adults" count? - why exactly do I need to tell joe public how many of item X I sold and how and who is going to stop me from making stuff up?]
(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.
[this reads like medicines regs again, see earlier comment]
(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 …∗∗∗
[this is at best unworkable, and probably unlawful.]
Member States are free to regulate such matters within the
remit of their own jurisdiction.
[the above sentence should be the entire directive]