Preliminary guidance on how to get an e-cigarette on the market in the UK, including the notification scheme and reporting problems with e-cigarettes.
The Tobacco Products Directive 2014/14/EU (TPD) introduces new rules for nicotine-containing electronic cigarettes and refill containers (Article 20). MHRA is responsible for implementing the majority of provisions under Article 20 and has been designated as the competent authority for the notification scheme for e-cigarettes and refill containers in the UK.
The TPD introduces 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 will be provided to consumers so that they can make informed choices
- an environment that protects children from starting to use these products.
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.
Details of when producers need to submit a notification can be found in the document below. E-cigarette transition periods for producers (PDF, 317KB, 1 page)
When MHRA is satisfied that a product notification is complete and complies with the TPD, we will publish all non-confidential information. Producers will be able to specify information that they consider to be confidential when they submit a notification.
Retailers do not need to submit information for any products they sell unless they also qualify as a producer. Retailers have until 20 May 2017 to sell through stock of products that do not comply with the labelling and product composition requirements of the TPD.
Consumers and healthcare professionals can report side effects and safety concerns with e-cigarettes or refill containers to the MHRA through the Yellow Card reporting system.
The TPD does not cover nicotine-containing products that are authorised as medicines.
Published below is a list of the first products which have been submitted to MHRA via the EU-CEG:
List of submitted products – 10 January 2017 (PDF, 1.01MB, 225 pages)
This list is only a small proportion of the numbers of submissions we have received. We are currently processing these in date order and will be adding to the list each week.
We expect the list to 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.
The list has limited details at this stage and some products listed are also available under other brand names. We expect to be able to publish fuller information from the EU-CEG portal about each product in the future.
We have not yet been able to check each notification listed for completeness or to verify TPD compliance. We are publishing this list at an early stage to give retailers and other interested parties the opportunity to check that producers have notified the products they are offering for sale and to minimise the time before new products can be introduced onto the market.
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 are on the market before 20 May 2016 had until 20 November 2016 to submit a notification to MHRA.
If you were unable to make a submission due to a technical issue with the portal or for another reason, please send an email as soon as possible to TPDnotifications@mhra.gsi.gov.uk using your Submitter ID as the subject line. The email should provide:
- the submitter company name
- your submitter ID
- a list of product brand names
- the reason for delay
We encourage you to keep trying to submit your notifications, and expect that all submissions will be made as soon as possible after that date. Please confirm to us when you have completed your submissions.
From 20 November 2016, producers may only sell batches of a product that does not comply with the TPD requirements if a notification has been submitted and the batch was produced before 20 November 2016.
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 the MHRA by email to TPDsafety@mhra.gsi.gov.uk.
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 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. We are seeking further clarification on this from the European Commission.
Advice for retailers
If you sell e-cigarettes and/or refill containers by retail to the general public, you need to be aware of the transition periods for implementation of the new rules:
20 May 2016 – 19 November 2016
20 November 2016 – 19 May 2017
You may continue to sell products you already have in stock during this period.
When sourcing new supplies of any e-cigarette or refill container products, ask your supplier whether the product complies with the requirements of the TPD. If the answer is no, be aware that you may only sell the product until 19 May 2017.
On 20 May 2017
You will need to remove from sale any remaining stocks of products that do not comply with the TPD.
From 20 May 2017
When sourcing new supplies of any e-cigarette or e-liquid product, check that details of the notification for the product have been published on the MHRA website. A link will be made available here when the web page goes live.
If you cannot find the product on the MHRA 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.
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.
Nicotine Base Liquid
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).
The requirements do not apply to ‘trade sales’ i.e. where you are selling industrial quantities 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.
The application of all TPD requirements are subject to transitional provisions.
Cross Border Sales
From 20 May 2016, 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.
The Department of Health 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.
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.
- Create an ECAS account
- Apply for a submitter ID number
- 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:
- Ensure you have a ECAS account
- Go to the EU-CEG website
- In the tabs at the top select ‘Downloads’
- 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
- You have now accessed the CIRCABC (Communication and Information Resource Centre for Administrations, Businesses and Citizens). Click ‘latest version of technical documents’
- 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)
- 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)
- The ETRUSTEX tutorial.pdf, which contains all the necessary information regarding how to:
- 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
- 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 that 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:
- Should you encounter technical difficulties, please contact SANTE-EUCEG-ITSUPPORT@ec.europa.eu (including in your message a ‘print screen’ of the window where the problem appears)
- For other general matters related to the functioning of the EU-CEG, but not to your request, please contact SANTE-EU-CEG@ec.europa.eu.
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.
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, 268KB, 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, 346KB, 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.
Notifying Non-compliant Products
Producers who wish to continue selling non-compliant products (that were manufactured on or before 19 November 2016) to retailers after 19 November 2016 need to submit a notification for the non-compliant products, with the intention of modifying them to bring them into compliance with the TRPRs by 19 May 2017.
In order to simplify this process, we advised you to make a notification for the compliant product by 21 November. This allows you to meet the requirement to notify the modified product six months before marketing it. In the Product Presentation section of the notification you should include a statement in the National Comment field (item 33 in the Commission’s data dictionary) that:
‘Until [enter date] this product is currently being sold as [describe the non-compliant product highlighting the differences between this and the compliant product notified].’
This will save the need to further modify the notification and pay the associated fee. Once the non-compliant product is no longer marketed you should update the comment field to remove the reference to the non-compliant product. This update will not attract a fee. If you have already submitted a notification for the non-compliant product, you can amend the notification by submitting a correction notification for no additional fee.
The fees for submitting a notification are a set out in The Electronic Cigarettes etc. (Fees) Regulations 2016. The costs of notifications are as follows:
MHRA has given a commitment to review the level of fees in the light of the number of notifications received in the first year.
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:
Sort Code 60-70-80
Account No 10004386
Swift Code NWBKGB2L
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 products such as disposable units and tanks will require a notification; however equipment such as mouthpieces, batteries and other elements that would qualify as an individual component will not.
‘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.
‘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.
This page will be updated as more details become available.