Tobacco Products Directive 2014/40(EU) Article 20 a recap.

May 2, 2017

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:

  1. E-cigarettes may be sold as licensed medical products, in which case they are not subject to the limitations imposed by the TPD.
  2. E-cigarettes and e-liquid not sold as medical products are considered to be tobacco products, and may be sold subject to TPD regulation.
  3. 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.
  4. E-liquid may only be sold in pre-filled cartridges containing 2ml or less, or dedicated refill containers containing 10ml or less.
  5. E-liquid may not exceed nicotine content of 20mg/ml.
  6. Only high purity ingredients that do not pose a risk to human health may be used in e-liquid.
  7. Consistent nicotine doses must be delivered in consistent operating conditions.
  8. 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.
  9. Information leaflets must be included with all e-cigarette and e-liquid products.
  10. Ingredients should be listed in descending order of weight, with a notification of nicotine delivery per dose.
  11. Promotion and advertising of e-cigarettes by print, radio, televisual or public event media is prohibited.
  12. Submission of comprehensive sales and marketing data is required

Totally Wicked Ltd is taking legal action against the European Commission as we believe this Directive not to be a legal document on a number of grounds.

The majority of the requirements of the TPD fall into 4 categories as laid out below.

Absurd (2,7,11)

E-cigarettes are quite clearly neither a medical product, nor a tobacco product. Vapers are neither unwell, nor are they tobacco users. Consistent doses cannot be guaranteed, as the users are all different from one another, but “self-titrate” to achieve their desired nicotine dose. The idea of allowing a product to be placed on the market, but not to allow it to be marketed defines a new height of absurdity. Consumers need to be allowed to make positive choices for alternatives to combustible cigarettes.

Of no value (4,5)

There is no reason to limit container size or nicotine strength. The toxicity of nicotine containing fluids is well known to have been substantially overestimated, and the clauses relating to this have negative consequences whilst mitigating risks that do not exist.

Impossible (8)

Nothing is leak proof or unbreakable, nothing is tamper proof, nothing is childproof. Most of all, how can anything ensure leak free refilling? We can make filling without spills possible, but much like fuel pumps at a petrol station, there will always be the potential for people to pour fluid onto something other than their e-cigarette tank. Much like fuel pumps on a forecourt, they tend not to, and the consequences of spilt e-liquid are extremely minimal in comparison.