Guidance

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 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 J (MS Excel Spreadsheet, 1.29MB)

List of submitted products, companies K to Z (MS Excel Spreadsheet, 748KB)

We process submissions for products which have been sent to MHRA via the EU-CEG in date order and update the list each week.

The list 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. Where there are more than 20 brand variants shown, click on the cell to see details of any additional brands.

We expect to be able to publish fuller information from the EU-CEG portal about each product in the future.

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.

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 manufacturer’s notification, then you do not need to submit a duplicate notification.

Products already in the UK market

Producers of all e-cigarettes and refill containers that are covered by the TPD and were on the market before 20 May 2016 had until 20 November 2016 to submit a notification to MHRA.

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 Products Regulations 2016 sets out the requirements for labelling of e-cigarette and refill container products. For additional advice on labelling or e-liquid products read the Labelling guidance (PDF, 85.2KB, 2 pages)

Our interpretation of Article 20(4) of the Tobacco Products Directive (TPD) is that all ingredients in the product should be listed on the label where they are used in quantities of 0.1% or more of the final formulation of the e-liquid. Where a flavour ingredient contains several component chemicals, we consider that it is acceptable to describe the ingredient on the label by the name of the flavour, for example ‘strawberry flavour’. For confidentiality reasons companies may choose to describe individual ingredients used in quantities below 0.1% of the final formulation by category, for example ‘other flavourings’.

This advice only applies to product labels, and a full list of ingredients in the flavouring must be included in notifications through the EU-CEG.

The TPD also requires that packs include an information leaflet about safe use of the product. We encourage you to ensure your leaflets include appropriate advice on product storage, particularly on how to ensure the battery does not malfunction.

Where all the required leaflet information can fit on the unit pack and other labelling within the pack without loss of legibility to the consumer, our interpretation of the TPD is that the packaging can be considered to include the leaflet, and a separate leaflet insert is not required.

Additional statutory labelling requirements may also apply, such as the European Regulation (EC) No 1272/2008 on classification, labelling and packaging of chemical substances (CLP).

If your e-cigarette product does not contain nicotine when sold, but can be used to contain nicotine, the warning statement ‘this product contains nicotine which is a highly addictive substance’ must still be applied. To provide clarity for consumers, we recommend adjacent wording (not part of the boxed warning) to the effect that the warning applies when the product is used as designed and charged / filled with nicotine-containing liquid. The warning statement should be included on all notified e-cigarette products.

Advice for retailers

When sourcing new supplies of any e-cigarette or e-liquid product, check that details of the notification for the product have been published in the list of Submitted Products.

If you cannot find the product on MHRA’s website, ask your supplier to confirm that the product complies with the TPD and has been notified to MHRA. If a producer has not notified the product or it does not comply with the TPD, they may not supply it to you.

See our advice for retailers setting out the key requirements (PDF, 118KB, 2 pages)

The TPD requirements on nicotine concentration (20mg/ml maximum) and size of presentation (10ml maximum for refill container and 2ml maximum for e-cigarettes) apply to products sold to end consumers (irrespective of whether the end consumer intends to modify the product).

Advice on the restrictions on advertising e-cigarettes and refill containers is available from the Department of Health here and from the Advertising Standards Authority here.

Are you also a producer?

As a retailer, you do not need to notify any products you sell unless you are also a ‘producer’ of the product.

A producer is anyone who manufactures or imports e-cigarette or refill container products and anyone who re-brands them as their own. If you qualify as a producer, please see the transition period guidance for producers above.

If you import or re-brand products, check with your supplier whether they have already made a UK notification for the specific product you sell. If they have done so, you do not need to submit a duplicate notification.

Cross Border Sales

You need to register your business if you supply e-cigarette products via cross-border distance sales, for example online sales. This applies to:

  • businesses established in the UK selling e-cigarettes and / or refill containers to consumers in another EEA state (European Economic Area – the 28 EU Member States plus Iceland, Liechtenstein and Norway)

  • businesses established in the EEA or third country selling to UK consumers. Business to business sales, that is sales not direct to consumers, do not need to be registered.

Registration is a legal requirement under the TPD. Without confirmation of registration businesses must not supply a relevant product to a consumer via a cross-border distance sale. The UK notification requirement applies to products supplied to UK consumers via a cross-border sale.

Public Health England have uploaded a list of EEA Member States that have either confirmed they are permitting cross-border distance sales of e-cigarettes and/or tobacco products or are yet to confirm domestic rules in this area, and a list of registered retailers. All other Member States have banned cross-border distance sales, and it would contravene the law to trade in those countries. Businesses who intend to trade in countries where the sales confirmation, registration website or contact details are yet to be confirmed (TBC) are advised to contact the national authorities before commencing supply.

You can find more information, along with a link to the online registration form to be completed here.

Submitting a notification

Applying for a Submitter ID and ECAS account

Notifications have to be submitted to MHRA through a European Common Entry Gate (EU-CEG) notification portal made available by the European Commission.

  1. Create an ECAS account

  2. Apply for a submitter ID number

  3. Guidance on the EU-CEG and how to complete these steps has been made available by the European Commission

Submitting a notification

Once you have an ECAS account and Submitter ID number, you can continue with the application process. The European Commission have published some guidance to help you with this. You can find this guidance by following the steps below:

  1. Ensure you have a ECAS account

  2. Go to the EU-CEG website

  3. In the tabs at the top select ‘Downloads’

  4. Click the link that says ‘e-cigarettes and refills’. You will need an ECAS account to access this page. If you cannot see the information below, you will need to create an ECAS account, log in, and start again from step 2

  5. You have now accessed the CIRCABC (Communication and Information Resource Centre for Administrations, Businesses and Citizens). Click ‘latest version of technical documents’

  6. Unless you have an AS4 Access point, you will need to click ‘XML Submission through web interface’ (if you do not know whether you have an AS4 Access point, or are not sure what one is, we recommend you use the web-interface option)

  7. On this page you will find:

  • The ETRUSTEX tutorial.pdf, which contains all the necessary information regarding how to:
    • submit your XML through the web interface;
    • read the encrypted messages sent by EU-CEG; and
    • manage user accounts in the XML upload system (E-trustex)
  • A keystore (EUCEG_GUI_USER) to decrypt the messages received by the EUCEG system. (The ETRUSTEX tutorial gives you the information about how to use this keystore)
    • How to install the XML creator tool procedure (procedure to install the TDP XML creator tool.pdf)
    • The XML creator system (tpd-xml-creator-tool-1.1.3.zip)
  1. Unless you wish to use a bespoke XML file creator, the Commission have provided one that is free for you to use. To access it, download the tpd-xml-creator-tool-1.1.3.zip and run the file named the tpd-xml-creator-tool-1.1.3.jar

  2. Once you have created your XML files using the tool, you can upload them to the portal by following the instructions in ETRUSTEX tutorial.pdf.

Please note MHRA does not run the notification portal or XML creator, and the steps above are for guidance only. If you have any difficulties, please contact the portal’s technical team directly via the email addresses below:

EU-CEG Contacts

Guidance on the content of notifications

The format and content of notifications are set out in the Commission Implementing Decision (EU) 2015/2183 on e-cigarettes.

Details of the information notifications are required to contain are set out by the Commission in the Data Dictionary (PDF, 888KB, 37 pages) .

Technical requirements for refill mechanisms, and information that must be included in the instructions for use of the product are set out in the Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes.

We have published below guidance to aid producers of e-cigarettes and refill containers to prepare notifications for their products. This guidance has been developed by the UK and other member states and discussed at the European Commission Working Group on notification of e-cigarettes and refill containers.

Product type guidance (PDF, 168KB, 3 pages)

Submission type guidance (PDF, 412KB, 3 pages)

Emissions testing guidance (PDF, 93.9KB, 3 pages)

Nicotine dose guidance (PDF, 74.2KB, 2 pages)

UK ingredient guidance (PDF, 265KB, 3 pages)

Labelling guidance (PDF, 85.2KB, 2 pages)

UK product presentation guidance (PDF, 41.2KB, 4 pages)

E-cigarette and CLP Regulation guidance (PDF, 317KB, 3 pages)

Annual reporting guidance (PDF, 35.9KB, 3 pages)

If you make your product available in the UK under several brand names, you will be able to include all the brand names for the identical products in a single notification, for no additional fee. Each brand should be listed on the notification as a separate presentation.

The TPD does not include any requirements as to where testing of e-cigarettes and refill container has to take place. The notifier will need to be satisfied as to the standards of any testing carried out as they have to submit a declaration that they bear full responsibility for the quality and safety of the product when placed on the market and used under normal or reasonably foreseeable conditions.

Fees

The fees for submitting a notification are a set out in The Electronic Cigarettes etc. (Fees) Regulations 2016. MHRA consulted on the level of these fees in January 2016 and the Government Response to the consultation can be found here.

The current costs of notifications are as follows:

Notification fee: £150

Annual Fee: £60 (payable from April 2018)

Substantial Modification Fee £80 (payable from April 2018)

MHRA has given a commitment to review the level of fees in the light of the number of notifications received in the first year.

Invoices

MHRA will send an invoice to each company for the notification fees due in relation to all products for which information has been submitted via the EU-CEG. Payment of this invoice is due immediately upon receipt.

In order to help you to prepare for payment, details of the MHRA bank account can be found below:

MHRA
Sort Code 60-70-80
Account No 10004386
Swift Code NWBKGB2L
IBAN GB68NWBK60708010004386

Further information

Key terms

The definitions of products that are subject to the new regulations are set out below.

‘Electronic cigarette’ means a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. E-cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges.

Products that require a notification are limited to the e-cigarette product and component elements sold separately that specifically contain, or could contain, nicotine in the form of e-liquid. Therefore e-cigarette products such as disposable units and tanks will require a notification; however e-cigarette equipment such as mouthpieces, batteries and other elements that would qualify as an individual component will not.

Replacement e-cigarette parts that could contain nicotine only require notification if they have not already been notified as part of a device or e-cigarette kit. Identical replacement parts that have already been notified as part of another notified e-cigarette product do not need to be separately re-notified if it is clear on the labelling what notified product the part is for. Any non-identical replacement part, particularly one that alters the consumer safety profile of a product (for example by changing its refill capacity), would require a separate notification.

Rebuildable devices come within the definition above and require notification. See the product type guidance for further advice.

‘Refill container’ means a receptacle that holds a nicotine-containing liquid, which can be used to refill an electronic cigarette. These are more commonly known as e-liquids.

Products that do not meet the definition (such as disposable e-cigarettes that do not contain nicotine and 0% nicotine e-liquids) are out of scope of the TPD and do not have to meet its requirements. These products will continue to be regulated under the General Product Safety Regulations.

The requirements do not apply to ‘trade sales’, for example where you are selling industrial quantities of nicotine-containing liquid (typically over 25 litres) to another business and the sale is not directed to a consumer. But for all sales (trade and to consumers) the tank capacity of a refillable e-cigarette must not exceed 2ml.

‘Producers’ refers to any manufacturer; importer and/or those who re-brand any of the products covered by the above definitions as their own.

Sources of further information

European Commission pages on tobacco policy – for the text of the Tobacco Products Directive and Implementing Acts, notes of Commission meetings, etc.

Department of Health Consultation on the sale and manufacture of tobacco products.

Contact

For more information on the regulatory framework, or to register for ongoing updates about the scheme, email info@mhra.gov.uk.

We will be updating this page with the latest information, register for updates.

Published 29 February 2016
Last updated 21 February 2018 + show all updates
  1. Updated ingredient list & submitted products
  2. updated submitted products
  3. Updated lists of submitted products.
  4. Updated lists of submitted products for TPD.
  5. Updated lists of submitted products.
  6. Updated list of submitted products.
  7. Update to published products
  8. list of submitted products updated.
  9. Updated list of submitted products and withdrawn products
  10. Updated list of submitted products and withdrawn products
  11. Updated list of submitted products.
  12. Updated lists of submitted products and added a new list of withdrawn products.
  13. Updated list of submitted products
  14. Updated list of submitted products
  15. Updated list of submitted products
  16. General information update
  17. Updated list of submitted products.
  18. Updated list of submitted products
  19. Updated lists of submitted products
  20. New list of published products added to the page.
  21. List of submitted products updated.
  22. Updated list of submitted products added to the page.
  23. New list of submitted products added to the page.
  24. Latest list of submitted products added to the page.
  25. List of submitted products updated
  26. Updated list of submitted products added to the page.
  27. Latest info on submitted products added to the page.
  28. Latest list of published e-cigarette products added to the page.
  29. Up-to-date list of submitted products added to the page.
  30. list of submitted products updated
  31. list of submitted products updated.
  32. Updated documents
  33. list of submitted products updated to 28 June.
  34. Update to the 'further information' section including info about replacement e-cigarette parts and rebuildable devices.
  35. New list of submitted products for June 21 added to the page.
  36. List of submitted products up to 20 June added to the page.
  37. New list of submitted products added to the page.
  38. Updated list of submitted products from 6 June added to the page.
  39. Updated list of submitted products.
  40. Updated list of notified products up to 23 May
  41. New list of submitted products added to the page.
  42. Information updated after 20 May - the deadline for retailers and manufacturers to comply to the TPD
  43. Updated list of submitted products
  44. list of submitted products updated
  45. Updated to advise we are currently checking notifications listed for completeness and verifying TPD compliance with producers.
  46. Updated list of submitted products
  47. Updated information to include guidance on annual reporting.
  48. Updated list of submitted products
  49. Listed of submitted products updted
  50. Submitted products for 03/03/2017 published
  51. Updated the list of submitted products.
  52. List of paid for notifications updated to 20 March 2017.
  53. List of notifications updated
  54. Updated the List of submitted products - 13 March 2017
  55. List of paid notification up to 2 March 2017.
  56. List of submitted products up to 24 February added to the page.
  57. List of submitted products up to February 15th added to the page.
  58. Updated list of submitted products added to the page.
  59. Latest list of submitted products added to the page.
  60. Latest list of submitted products until 01 February 2017 added to the page.
  61. Latest list of submitted products through to 27 January added to the page.
  62. List of submitted products up to 19 January 2017 added to the page.
  63. New list of submitted products up to and including 6 January 2017 added to the page.
  64. Updated links to list of registered retailers and member states that permit cross-border distance selling.
  65. Updated advice for producers including advice about the 6-month waiting period and new list of submitted products. New guidance on E-cigarette and CLP Regulation also added to the 'Guidance on the content of notifications' section.
  66. This update includes updated information on the deadline, non-compliant notifications and invoices.
  67. Important information on official transitional period deadline added under 'Submission deadline' heading.
  68. Updated instructions in 'submitting a notification' section.
  69. guidance has been updated to include information on flavourings
  70. Re-organised page layout and addition of UK product presentation guidance document.
  71. Additional information and guidance added to 'submitting a notification' section
  72. Several updates
  73. Updated to the latest guidance.
  74. Uploaded proposed e-cigarette transition periods flow chart.
  75. Updated to include a link to the initial information about the EU-CEG which has been published by the European Commission.
  76. First published.