UK – E-cigarettes: regulations for consumer products

Guidance on how to get an e-cigarette on the market in the UK, including the notification scheme and reporting problems with e-cigarettes.

Overview

The Tobacco Products Directive 2014/14/EU (TPD) introduced new rules for nicotine-containing electronic cigarettes and refill containers (Article 20) from May 2016. MHRA is the competent authority for the notification scheme for e-cigarettes and refill containers in the UK and is responsible for implementing the majority of provisions under Article 20.

The TPD introduced new rules which ensure:

  • minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids)
  • that information is provided to consumers so that they can make informed choices
  • an environment that protects children from starting to use these products.

From 20 May 2017, the new requirements:

  • restrict e-cigarette tanks to a capacity of no more than 2ml
  • restrict the maximum volume of nicotine-containing e-liquid for sale in one refill container to 10ml
  • restrict e-liquids to a nicotine strength of no more than 20mg/ml
  • require nicotine-containing products or their packaging to be child-resistant and tamper evident
  • ban certain ingredients including colourings, caffeine and taurine
  • include new labelling requirements and warnings
  • require all e-cigarettes and e-liquids be notified to MHRA before they can be sold

Consumers and healthcare professionals can report side effects and safety concerns with e-cigarettes or refill containers to MHRA through the Yellow Card reporting system. You can also report products suspected to be defective or non-compliant to your local Trading Standards or to TPDsafety@mhra.gov.uk.

The UK Tobacco and Related Products Regulations 2016 implement the TPDin the UK, and came into force on 20 May 2016. Part 6 of the regulations sets out the requirements for e-cigarettes and refill containers.

The regulations introduce requirements for producers of e-cigarettes and refill containers. A producer is anyone who manufactures or imports these products or who re-brands any product as their own. Producers must submit information about their products to MHRA through a European Common Entry Gate (EU-CEG) notification portal.

Retailers do not need to submit information for any products they sell unless they also qualify as a producer. Retailers had until 20 May 2017 to sell through stock of products that do not comply with the labelling and product composition requirements of the TPD