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Advice for Retailers and Producers
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Part 6 of the Tobacco and Related Products Regulations 2016 sets out the requirements for e-cigarettes and refill containers.
Producers must submit information about their products to the MHRA through the MHRA Submission Portal and European Common Entry Gate (EU-CEG) notification portal for UK wide supply.
From 23 August, products which have been successfully notified via MHRA Submissions will be published directly on the MHRA publication home page. Selecting the “ECIG” tile will provide direct access to the GB notified products list, published since 1 January 2021. You will be able to view this information using the following searches:
A link below the search boxes on this page will provide access to:
Products may not legally be supplied until the notification has been published on the relevant list for Great Britain and/or Northern Ireland.
When sourcing new supplies of any e-cigarette or e-liquid product, check that a notification has been published in one of the Notified Product lists above.
If you cannot find the product on the MHRA’s website, ask your supplier to confirm that it has been properly notified and to provide details to enable you to confirm the product’s status. If a product notification is not yet published, they may not supply it to you.
See Advice for retailers of e-cigarettes and nicotine-containing e-liquids.
The TRPR 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 and from the Advertising Standards Authority.
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 below 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.
The requirement for retailers to register for cross-border distance sales (CBDS) in Great Britain and Northern Ireland has changed following the end of the transition period.
The requirement to register for CBDS into and out of Northern Ireland will be the same. However, the requirement to register for CBDS into and out of Great Britain (England, Scotland and Wales) is removed. This is set out in the Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020.
Updated guidance on the registration requirements for CBDS for tobacco products and electronic cigarettes (including e-liquids, devices and components) to consumers in Great Britain, Northern Ireland, European Union member states or a third country, is available at Tobacco products and e-cigarette cross-border sales: registration.
The UK government will publish registrations that are compliant with the new regulations. Retailers’ trading names and website addresses will be published.
New registration requests that are not compliant with the new regulations will be rejected and not published. The current list of published retailers undertaking CBDS to Great Britain and Northern Ireland will be reviewed and updated for compliance to the new regulations. Where a registration is found to be non-compliant it will be removed from the published list and the retailer informed by email.
Contact the Office for Health Improvement and Disparities at CBS.Tobacco@phe.gov.uk if you have any queries on the above.
Producers of new e-cigarette and refill container products must submit a notification to the MHRA six months before they intend to put their product on the market in Great Britain and/or Northern Ireland. Once your notification has been published on our website you can launch the product in the notified region. 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 market in the notified region.
Note: Supplying a product to the UK market will require separate notifications for a product via EUCEG (Northern Ireland) and the MHRA submission portal (Great Britain).
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 both a Great Britain and Northern Ireland 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.
If you make your product available in Great Britain and Northern Ireland under several brand names, you will be able to include all the brand names for the identical products in a single notification in each region, for no additional fee. Each brand must be listed on the notification as a separate presentation and may not be supplied in Great Britain and Northern Ireland until published on the relevant list for that region.
The TRPR does not include any requirements as to where testing of e-cigarettes and refill containers 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.
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 (GB, NI) for further advice.
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.
The definitions of products that are subject to the 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.
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 TRPR 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.The capacity of refill containers must not exceed 10 ml with a maximum nicotine concentration of 20mg.
‘Producers’ refers to any manufacturer; importer and/or those who re-brand any of the products covered by the above definitions as their own.
Extender and replacement tanks cannot be supplied in the UK if they are above 2ml capacity, as they do not meet the requirements of the regulations. Non-compliant extender/replacement tanks may not be supplied as part of a notified product/kit for sale.
Products that feature non-essential components that alter maximum tank size, such as plastic plugs and bungs do not meet the requirement of the regulations and are considered non-compliant for UK supply.
Squonkers do not meet the requirements of the regulations if supplied with a squonk bottle/ reservoir or tank by any other name with a capacity above 2ml. Any containers supplied with a squonker must comply with the regulations and therefore cannot be supplied if the capacity exceeds 2ml. Any refill containers supplied with a squonker must comply with the regulations.
Notified compliant products cannot be packaged with non-compliant accessories for supply in the UK market.
Producers supplying any of the products listed above should take immediate corrective action and may be required to provide the following information.
‘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.
Cannabidiol (CBD) in nicotine containing refill containers is likely to create the impression that the product has a health benefit, and therefore CBD is an additive subject to prohibition under regulations 16(1)(a) of the Regulations. Regulation 16(1)(a) prohibits the use of “vitamins or other additives that create the impression that a tobacco product has a health benefit”. This opinion is consistent with the prohibitions on other additives under the Regulations and is not a statement of CBD’s safety for use in consumer products.
E-cigarette producers must inform the MHRA if they have reason to believe that a notifiable product is unsafe, not of good quality or not compliant with TRPR 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.gov.uk.
Trading Standards bodies have enforcement responsibilities under the legislation and the MHRA works with them to ensure acceptable standards of safety.
Regulation 37 of the Tobacco and Related Products Regulations 2016 sets out the requirements for labelling of e-cigarette and refill container products.
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 TRPR 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 producer.
Department of Health Consultation on the sale and manufacture of tobacco products.
For more information on the regulatory framework, or to register for ongoing updates about the scheme, TPDnotifications@mhra.gov.uk.
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