Product Standards

Foreword

Note: This information applies only to the EU regulations are very different or non existent in other parts of the world!

About

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, 1.48MB)

• List of submitted products, companies J to Z (MS Excel Spreadsheet, 1.76MB)

• List of withdrawn UK notifications (MS Excel Spreadsheet, 199KB)

The Government aims to 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 manufacturer’s 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 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). Information on CLP requirements is available from the ECHA website and the HSE website. Additional advice is available from the UK CLP Helpdesk at UKREACHCA@hse.gov.uk.

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 and Social Care 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 guidance above for putting a new product onto the UK market.

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.

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:

1. Ensure you have a ECAS account
3. Go to the EU-CEG website
5. In the tabs at the top select ‘Downloads’
7. 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
9. You have now accessed the CIRCABC (Communication and Information Resource Centre for Administrations, Businesses and Citizens). Click ‘latest version of technical documents’
10. 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)
12. 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)
• 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 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

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)

Should you encounter difficulties in obtaining a submitter ID, please contact SANTE-SUBID-EUCEG@ec.europa.eu.

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 (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)

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

General advice on vigilance (PDF, 44.5KB, 2 pages)

General advice on due diligence (PDF, 42.5KB, 2 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 2021)

Substantial Modification Fee £80 (payable from April 2021)

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