General Information

Overview of Directive 2014/40/EU

By November 1, 2018 March 1st, 2019 No Comments

A directive is a text published by the European Commission that sets out a goal all EU Member States must achieve; however it is up to each Member State how to implement the laws at a national level. This is the case for the revised tobacco regulation, the Tobacco Products Directive (Directive 2014/40/EU or TPD2). TPD2 includes Article 20 on electronic cigarettes what means that these products will be regulated under the tobacco legislation from the day it is enforced, 20 May 2016.

Key requirements to comply with TPD2:

E-liquid/E-cigarette

  • Nicotine concentration ≤ 20mg/ml
  • Limit volume: 10ml (refill container) or 2ml (disposable e-cigs or single use cartridges and tanks).
  • Prohibited additives: vitamins, stimulants, emission colourings, with CMR properties in unburnt form
  • Ingredients of high purity
  • Consistent nicotine delivery (also hardware)
  • Child resistant
  • Tamper evident
  • No leakage
  • Not easily broken
  • Leakage free refill mechanism. The consultation process on the technical standards for the refill mechanism finished last January 21st. The options given were:
  1. A refill container possessing a non-detachable nozzle at least 1cm long, which is narrower than and slots comfortably into the opening of the tank of the electronic cigarette with which it is used and possessing a flow control mechanism that emits no more than 20 drops of refill liquid per minute when placed vertically; or
  2. A docking system which only releases refill liquids when the electronic cigarette and refill container are connected.
  • Member States can decide to have a sell through period of non-compliant products until 20 May 2017.

Packaging

  • Include a leaflet
  • Indicate: list of all ingredients (mg), nicotine content, delivery per dose, batch number, recommendation to keep out of reach of children
  • Health warning covering 30% of the surface. Members States can choose between 1) This product contains nicotine which is a highly addictive substance and 2) This product contains nicotine which is a highly addictive substance. It is not recommended for use by non-smokers.

Notification

  • Six months before placing the product on the market
  • In electronic form, through an online EU portal that submits the information to the national competent authorities.
  • Name and contact details of the manufacturer
  • All ingredients in the product
  • Emissions resulting from the use of the product by brand name and type, including quantities
  • Toxicological data for ingredients and emissions
  • Information on nicotine dose and uptake
  • Description of the components of the product, including opening and refill mechanism of the electronic cigarette or refill container
  • Description of the production process
  • Declaration that manufacturer and importer bear full responsibility for quality and safety

Annual submission

  • Mode of sale
  • Data on sales volumes
  • Preferences of consumer groups
  • Executive summaries of any market surveys

Ban on Advertising

  • Commercial communications in printed publications (except if directed to professionals in the trade)
  • Promoting on the radio
  • Audiovisual commercial communications
  • Public or private contributions to any event, activity or individual person

Cross-border distance sales

  • Member States may prohibit cross-border distance sales
  • Retail outlets shall register with the competent authority in the Member State (where retail outlet is established and where consumers are located).
  • Only after confirmation of the registration, cross-border distance sales are permitted

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