TPD Compliance

The Tobacco Products Directive 2014/14/EU (TPD), effective from May 2016, introduced new regulations for nicotine-containing electronic cigarettes and refill containers (Article 20). The Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority in the UK responsible for implementing most provisions under Article 20 and managing the notification scheme for e-cigarettes and refill containers.

The TPD introduced several key measures to ensure the safety and quality of e-cigarettes and refill containers, including:

  • Minimum Standards: Establishing minimum safety and quality standards for all e-cigarettes and refill containers, commonly known as e-liquids.
  • Consumer Information: Providing consumers with essential information to enable informed choices.
  • Child Protection: Creating an environment that protects children from starting to use these products.

From May 2017, the new requirements included:

  • Limiting E-Cigarette Tanks: Restricting the maximum capacity of e-cigarette tanks to 2ml.
  • Nicotine-Containing E-Liquid Restrictions: Limiting the maximum volume of nicotine-containing e-liquid for sale in one refill container to 10ml.
  • Nicotine Strength Restrictions: Limiting the nicotine strength of e-liquids to no more than 20mg/ml.
  • Child-Resistant and Tamper-Evident Packaging: Requiring nicotine-containing products or their packaging to be child-resistant and tamper-evident.
  • Ingredient Restrictions: Banning certain ingredients, including colorings, caffeine, and taurine.
  • New Labelling Requirements and Warnings: Implementing new labelling requirements and warnings.
  • Notification to MHRA: Requiring all e-cigarettes and e-liquids to be notified to MHRA before they can be sold.

Consumers and healthcare professionals can report side effects and safety concerns related to e-cigarettes or refill containers to MHRA through the Yellow Card reporting system. Additionally, they can report suspected defective or non-compliant products to their local Trading Standards office or [email protected].

The UK Tobacco and Related Products Regulations 2016, which implement the TPD, came into force on May 20, 2016. Part 6 of these regulations outlines the specific requirements for e-cigarettes and refill containers.

The regulations introduce requirements for e-cigarette producers and refill containers. A producer is anyone who manufactures, imports, or rebrands these products. Producers must submit information about their products to MHRA through the European Common Entry Gate (EU-CEG) notification portal.

Retailers don’t need to submit information for any products they sell unless they also qualify as a producer. Retailers had until May 20, 2017, to sell products that don’t comply with the labelling and product composition requirements of the Tobacco Products Directive (TPD).

The TPD doesn’t cover nicotine-containing products that are authorised as medicines. For more information on licensing these products as medicines, please visit https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products.