GovWire

• Advice for consumers
• Advice for retailers and producers
• Guidance on the submission and content of notifications for Great Britain
• Guidance on the submission and content of notifications for Northern Ireland
• Notification Fees for Great Britain and Northern Ireland

The MHRA is the competent authority for a notification scheme for e-cigarettes and refill containers in Great Britain and Northern Ireland and is responsible for implementing the majority of provisions under Part 6 of the Tobacco and Related Products Regulations 2016 (TRPR), as amended.

The TRPR introduced 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.

The 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 and published by the MHRA before they can be sold

View the The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020.

An Explanatory Memorandum explains the changes from a policy perspective.

The 2020 regulations amend the Tobacco Products and Nicotine Inhaling Products (Amendment etc) (EU Exit) Regulations 2019 to implement the obligations of the Withdrawal Agreement and the Northern Ireland Protocol in law. This amends the way in which the Tobacco and Related Products Regulations 2016 apply in Great Britain and Northern Ireland

The 2020 Regulations sets out the requirements for new products to be notified from 1 January 2021. This will mean that:

• Producers placing products on the Northern Ireland market will be required to notify using the EU Common Entry Gate (EU-CEG) system for the notification of tobacco and e-cigarette products.
• Producers placing products on the Great Britain market will be required to notify on the Great Britain domestic system.
• Notifiers will be required to pay one fee if they notify in relation to placing products on one of the Great Britain or Northern Ireland markets and the same one fee if they notify in relation to placing products on the two markets.

A producer is anyone who manufactures or imports these products or who re-brands any product as their own.Retailers do not need to submit information for any products they sell unless they also qualify as a producer.

The Tobacco and Related Products Regulations 2016 do not cover nicotine-containing products that are authorised as medicines. See more information about licensing these products as medicines.