As things stand e‐cigarettes cannot be presented as a remedy to get rid of nicotine addiction – it is just another way of smoking – unless manufacturers decide to manufacture according to all the provisions of the Medical Device Directive 93/42/EEC.
Unless the e‐cigarette device is not used to deliver a medicinal intended to get rid of nicotine addiction it cannot be considered as a medical device. If a manufacturer decides to market e‐cigarette devices and e‐liquids as a way to get rid of nicotine addiction compliance to Directive 2001/83 and Medical Device Directive 93/42/EEC would be necessary – that would mean presenting data showing the doses of nicotine delivered to the blood etc.
As regards the e‐liquids – there is currently no clear definition of what constitutes a danger to the health and safety of consumers. The LD50 of nicotine is 50 mg/kg for rats and 3 mg/kg for mice. 30–60 mg (0.5–1.0 mg/kg) can be a lethal dosage for adult humans. A normal cigarette has 0.9 mg of nicotine.
The most feasible and reasonable action would be to advise consumers that they smoke – whatever they ‘smoke’ – at their own risk
Regarding labels on Liquids and Batteries please refer to the below:
In addition to this symbol, if the batteries, accumulators and button cells contain more than a given amount of these metals ‐ 0.0005 % mercury (Hg), 0.002 % cadmium (Cd) and 0.004 % lead (Pb) ‐ the crossed‐out wheeled bin should be accompanied by a chemical symbol (Hg, Cd, Pb). In other words, the chemical symbol always accompanies the crossed‐out wheeled bin, never as a stand‐alone label.
CE Mark and Declaration of Conformity (DoC) on the Electric / Electronic product parts. Besides the CE Mark displayed on the product part/s where applicable, a complete DoC containing the elements according to applicable Directives is demanded. Typical Directives that may be applicable are:
Low Voltage Directive
The manufacturer needs to be aware of the content stated on a Declaration of Conformity. With reference to MCCAA, giving information on how to fill and/ or complete a Declaration of Conformity is considered consultancy. Please note that the above is without prejudice to the other applicable legislation.
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