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Detailed guide: E-cigarettes: regulations for consumer products

Medicines Healthcare Products Regulatory Agency

September 4
14:57 2020

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 TPD in 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.

The TPD does not cover nicotine-containing products that are authorised as medicines. Further information about licensing these products as medicines can be found here

Submitted products

A list of products which have been notified to MHRA via the EU-CEG is available here:

List of submitted products, companies A to I (MS Excel Spreadsheet, 1.5MB)

List of submitted products, companies J to Z (MS Excel Spreadsheet, 1.73MB)

List of withdrawn UK notifications (MS Excel Spreadsheet, 201KB)

We process submissions for products which have been sent to MHRA via the EU-CEG in date order and aim to publish new products within 45 to 60 days of notification.

These lists may be useful for retailers, consumers and Trading Standards bodies to be able to verify the companies and brands of e-cigarettes and refill containers (e-liquids) that have been notified to MHRA or withdrawn from UK supply. Where there are more than 20 brand variants shown, click on the cell to see details of any additional brands.

Under the TPD, it is the responsibility of the producer to ensure that their products comply with the TPD requirements. We check notifications submitted for completeness and verify TPD compliance with producers. Where this review has been completed, the TPD compliance status of products is recorded as declared to indicate that the notification is complete and the product has been declared compliant by the producer. Products may be withdrawn from sale by the producer for a number of reasons including commercial changes, superseded products and compliance or safety issues.

Advice for producers

Putting a new product into the UK market

Producers of new e-cigarette and refill container products must submit a notification to MHRA six months before they intend to put their product on the UK market. Once your notification has been published in the list on our website below, you can launch your product in the UK. If your notification has been published, you do not need to wait for the remainder of the 6 month period to elapse before you place your product on the UK market.

A product which has been substantially modified will count as a new product and must also follow this process. Further information regarding what qualifies as a substantial modification can be found in the guidance on submission type below.

If the manufacturer has submitted a UK notification for the specific product you import, then you do not need to submit a duplicate notification. Similarly, if the manufacturer has notified details of a product that you have re-branded, and your brand name is listed in the manufacturers notification, then you do not need to submit a duplicate notification.

Manufacturers, Importers and Distributers of e-cigarettes also need to comply with the Restriction of Hazardous Substances in Electrical and Electronic Equipment Regulation 2012 (known as RoHS). These regulations limit the amount of certain hazardous substances in specific electrical equipment, of which e-cigarettes are included. They place obligations onto Manufacturers, Importers and Distributers of e-cigarette models. Details can be found here. The regulation is enforced by the Office for Product Safety and Standards, part of the Department for Business, Energy and Industrial Strategy.

Reporting safety concerns

E-cigarette producers must inform MHRA if they have reason to believe that a notifiable product is unsafe, not of good quality or not compliant with TPD regulations and provide details of the risk to human health and safety and any corrective action taken. E-cigarette producers should notify MHRA by email to TPDsafety@mhra.gov.uk.

Trading Standards bodies have enforcement responsibilities under the legislation and MHRA works with them to ensure acceptable standards of safety.

Labelling and leaflets

Regulation 37 of the Tobacco and Related Product

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