• 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.
• Without prejudice to other legislation, the placing on the market of e‐cigarettes falls under the Tobacco (Smoking) Control Act (Legal notice 22 of 2010) and the Product Safety Act.
• 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:

1. E‐liquids: According to the harmonized classification found in Annex VI of the CLP Regulation (EC) No 1272/2008, nicotine is a hazardous substance.  Thus, the E‐liquids containing nicotine should be labelled according to the Dangerous Preparations Directive 1999/45/EEC until 01‐06‐2015 or the CLP (EC) Regulation No. 1272/2008.  As per legislation the label shall include the following information: 

• The name, address and telephone number of the supplier   
• The nominal quantity of a substance or mixture in the packages made available to the general public (unless this quantity is specified elsewhere on the package)
• Product identifiers – chemical name and identification no. (e.g. CAS, EC)
• Where applicable, hazard pictograms, signal words, risk phrases (hazard statements), safety phrases (precautionary statements) and supplemental information required by other legislation.  

2. Batteries:  According to the Batteries and Accumulators Regulations, 2007 (Legal Notice 311 of 2007), accumulators and battery packs shall be appropriately marked with the symbol shown hereunder.  The symbol indicating “separate collection” for all batteries, accumulators and battery packs shall be the crossed‐out wheeled bin. 

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
• EMC Directive
• RoHS 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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Feel free to send us an email - rad@mccaa.org.mt or give us a call at +356 23952000.