Electronic cigarettes, e-cigarettes, or e-cigarettes may also be referred to as personal vaporizers (PVs) or electronic nicotine delivery systems (ENDS), although these latter terms are less commonly used. E-cigarettes are smokeless, battery-powered devices that typically contain nicotine. The mechanism uses a lithium battery to heat a liquid, which is then converted into vapor. It is this vapor that is inhaled.
E-cigarettes consist of three main components: a lithium battery, an atomizer, and a cartridge containing a nicotine solution.
E-cigarette refill cartridge with a scale
Typical sales packaging of an e-cigarette with two refill cartridges
Regulations
E-cigarettes are not exempt from the supply or transport legislation. They still need to meet the requirements of the Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (CHIP), the European Classification, Labelling and Packaging of Substances and Mixtures Regulations (CLP), the Evaluation, Authorisation and Restriction of Supply Regulation (REACH) as set out in the Registration Regulation, as well as transport regulations and relevant modes of transport, such as road ADR and air IATA. Tobacco Products Directive and Medicines Directive
E-cigarettes do not fall under the scope of the Tobacco Products Directive, but there are proposals to reclassify e-cigarettes with a content exceeding 4 mg/ml (0.4%) as medical products, thus making them subject to Medicines Directive 2001/83/EC.
The Electronic Cigarette Industry Trade Association (ECITA), which represents the e-cigarette industry, recommends that "e-cigarettes be either removed from the Tobacco Products Directive (TPD) and placed under the General Product Safety Directive (GPSD), as they currently are, or that the proposed level be raised from 0.4% (as drafted) to 5% (weight by volume), with some clarity around that level to ensure ease of implementation."
CHIP/CLP
E-cigarette cartridges containing nicotine are subject to CHIP review. CHIP is being replaced by CLP and will be withdrawn on June 1, 2015. Both regulations set out packaging and labelling requirements for dangerous substances and preparations. Nicotine is classified as a toxicant under both CHIP and CLP, with a partially harmonized classification listed in Annex VI of CLP. It is also included in the Toxic Substances List, but is exempt from the Toxic Substances List requirement if its concentration in a mixture does not exceed 7.5%.
According to the Electronic Cigarette Industry Trade Association (ECITA), nicotine concentrations in European e-cigarettes vary but typically range from 0 mg/ml to 36 mg/ml (0–3.6%).
The requirement to provide a Safety Data Sheet (SDS) falls under Article 31 of the REACH SDS requirements, which states that "A supplier of a substance or preparation shall provide to the recipient of the substance or preparation: (a) that the substance or preparation complies with the hazard classification criteria set out in Directive 67/548/EEC or 1999/45/EC in accordance with Annex II.
So, for example, when liquids are sent to a company, workers may fill cartridges and an SDS would be required.
When kits are sent for retail supply, no SDS is required as this falls under Article 31 (4) of REACH: "A safety data sheet need not be provided for dangerous substances or preparations made available or sold to the public if sufficient information is provided to enable users to take the necessary measures to protect human health, safety and the environment, unless requested by a downstream user or distributor." However, sufficient information must be included, which can be achieved by providing an "Instructions for Use" leaflet. If a downstream user or distributor requests an SDS, it must be provided. While the provision of these products is not legally required, some supermarkets do.
Transport Regulations
Nicotine meets the requirements for the transport of dangerous goods for all modes of transport. Nicotine itself has UN number 1654 and nicotine packaging group II. However, the liquid in the cartridge is a preparation, so when the nicotine concentration exceeds approximately 1%, it is UN number 3144, Nicotine Preparation Liquids NOS, Packing Groups I, II, and III, which is relevant to e-cigarette nicotine preparations. Both UN numbers are classified as Class 6.1, which means toxic.
It is worth noting that while requirements for liquids have been considered, requirements for the transport of lithium batteries have also been proposed.
There is a proposal to amend the wording in the ADR regarding the prohibition on using e-cigarettes when handling dangerous goods. The regulation currently states that smoking is prohibited when handling dangerous goods, but the wording would be changed to read: "This prohibition also applies to the use of e-cigarettes." "
Chargers
Power adapters supplied for charging e-cigarettes must be safe and comply with the Electrical (Safety) Equipment Regulations 1994 and the Electromagnetic Compatibility Regulations 2006. They must also be marked with the following:
CE marking
Name or trademark of the manufacturer or responsible supplier
Unique identifier, such as model, type, batch/serial number
Rated voltage, power/current, and frequency.