Tobacco Products Directive 2014/40(EU) Article 20
Tobacco Products Directive 2014/40(EU) was adopted by the European Parliament on 3rd April 2014. Its implementation is underway, including that of Article 20, the section pertaining to electronic cigarettes. It has some specific consequences for the way in which electronic cigarettes and e-liquid may be manufactured and sold. Individual Member State transposition leading to enforcement is starting in many EU Member States already. In the UK the Department of Health (DH) is the body responsible for implementation, and although the path to implementation has not been clarified, the TPD is required by the European Parliament to come into force for e-cigarettes from 20th May 2016. DH have stated an intention to meet this target.
The main points of the TPD in relation to e-cigarettes are as follows:
- E-cigarettes may be sold as licensed medical products, in which case they are not subject to the limitations imposed by the TPD.
- E-cigarettes and e-liquid not sold as medical products are considered to be tobacco products, and may be sold subject to TPD regulation.
- All products must be notified to the competent authority (DH) 6 months prior to being placed on the market. Products already on the market on 20th May 2016 must be notified within 6 months of that date. The notification procedure is complex and requires substantial testing and technical work for every product.
- E-liquid may only be sold in pre-filled cartridges containing 2ml or less, or dedicated refill containers containing 10ml or less.
- E-liquid may not exceed nicotine content of 20mg/ml.
- Only high purity ingredients that do not pose a risk to human health may be used in e-liquid.
- Consistent nicotine doses must be delivered in consistent operating conditions.
- E-cigarettes and refill containers must be child and tamper proof, protected against breakage and leakage, and when refillable there must be a mechanism that ensures leak free refilling.
- Information leaflets must be included with all e-cigarette and e-liquid products.
- Ingredients should be listed in descending order of weight, with a notification of nicotine delivery per dose.
- Promotion and advertising of e-cigarettes by print, radio, televisual or public event media is prohibited.
- Submission of comprehensive sales and marketing data is required