# E-cigarettes: regulations for consumer products

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/415e156b-2eae-4d75-aa7e-df6790d8460a
Type: Detailed Guide
Published: February 29, 2016
Updated: August 16, 2024

> The Medicines and Healthcare products Regulatory Agency (MHRA) serves as the competent authority for the United Kingdom’s vaping product notification scheme, operating under the Tobacco and Related Products Regulations 2016 (TRPR). This regulatory framework, updated by the 2020 EU Exit Regulations, mandates strict safety and quality standards for nicotine-containing e-cigarettes and refill containers across Great Britain and Northern Ireland. Key requirements include limiting tank capacity to 2ml, refill volumes to 10ml, and nicotine concentration to 20mg/ml. Products must also feature child-resistant packaging, exclude banned ingredients such as caffeine or taurine, and adhere to specific labeling and warning standards.

Required actions apply to all producers—including manufacturers, importers, and re-branders—who must formally notify the MHRA before any product can be legally sold. Following the policy implementation on January 1, 2021, producers must utilize the EU Common Entry Gate (EU-CEG) for Northern Ireland markets and a domestic UK system for Great Britain. A single notification fee applies regardless of whether a product is registered for one or both territories. These regulations are designed to ensure product safety, facilitate informed consumer choices, and prevent nicotine use among children. Retailers are generally exempt from notification unless they also function as producers, while medicinal nicotine products are handled under separate licensing systems.

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## Content

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 the UKs notification scheme for nicotine containing Vaping products (E-cigarettes and refill containers) in Great Britain and Northern Ireland and is responsible, working with other regulatory bodies, for implementing a number 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 .

## Attachments

- [E-cigarette user reference guide](https://assets.publishing.service.gov.uk/media/62442005e90e075f0f865481/E-Cig_User_Guide_for_MHRA_Submissions_2022.pdf)
- [E-Cigarette Analysis Print Guidance Document](https://assets.publishing.service.gov.uk/media/602bb93e8fa8f503896d6c5b/E-Cigarette_Analysis_Print_Guidance_Document.pdf)
- [Data Dictionary](https://assets.publishing.service.gov.uk/media/623b02fa8fa8f540ef20d195/TPD_submission_data_dictionary_electronic_cigarettes_1.1.1__002_.pdf)
- [e-cigarette Analysis Print](https://assets.publishing.service.gov.uk/media/62cd9f268fa8f54e88ec4fd5/Electronic_Cigarette_Drug_Analysis_Print_up_to_30.06.2022.pdf)
- [E-Cigarette user guide - troubleshooting](https://assets.publishing.service.gov.uk/media/623c58488fa8f540eea34c29/E-Cigarette_User_Guide_-_Troubleshooting.pdf)
