Advice for Retailers and Producers
Advice for Retailers and Producers
Documents
Details
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:
- ECID
- Submitter Name
- Brand Name
- Brand Sub Type
- Product Type
A link below the search boxes on this page will provide access to:
- UK Products published up to 31 December 2020
- Products published for Northern Ireland from 1 January 2021
- Withdrawn Products
Products may not legally be supplied until the notification has been published on the relevant list for Great Britain and/or Northern Ireland.
Advice for retailers
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.
How to know if you are 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 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.
Cross border sales
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.
Advice for producers
Putting a new product onto the UK market (Great Britain and Northern Ireland).
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.
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.
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.
Other requirements for e-cigarettes
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 at ## Regulations: restriction of hazardous substances (RoHS). The regulation is enforced by the Office for Product Safety and Standards, part of the Department for Business, Energy and Industrial Strategy.
Waste Electrical and Electronic Equipment (WEEE) Regulations
Vapes, or e-cigarettes, are electrical and electronic equipment (EEE). The WEEE Regulations 2013 require producers of EEE to undertake a range of responsibilities to play their part in protecting natural resources and managing EEE appropriately when it becomes waste. This includes registering as an EEE producer and financing the collection and treatment of WEEE. Vape producers therefore need to ensure they are registered to comply with the WEEE Regulations.
The definition of an EEE producer.
You must register as an EEE producer annually. If you place more than 5 tonnes of EEE on the UK market in a year, you must join a producer compliance scheme (PCS). The PCS takes on your obligations to finance the collection, treatment, recovery, and environmentally sound disposal of household WEEE collected in the UK. If you place less than 5 tonnes of EEE on the UK market in a year, you can register directly with your environmental regulator as a small producer. For England, this is the Environment Agency (EA); for Scotland, this is the Scottish Environmental Protection Agency (SEPA); for Wales, this is Natural Resources Wales (NRW); and for Northern Ireland, this is Northern Ireland Environment Agency (NIEA).
Find out more information about your potential WEEE producer responsibility obligations and how you can register.
Batteries Regulations
Vapes contain portable batteries. The Waste Batteries and Accumulators Regulations 2009 require producers of batteries to take on responsibilities to minimise harmful effects of waste batteries on the environment. This includes registering as a portable battery producer and financing collection and treatment of waste portable batteries. Vape producers therefore need to ensure they are registered to comply with the Batteries Regulations.
The definition of a battery producer.
You must register as a battery producer annually. If you place more than 1 tonne of portable batteries on the UK market in a year, you must join a battery compliance scheme (BCS). The BCS takes on your duties to finance the collection and treatment of waste portable batteries. If you place less than 1 tonne of portable batteries on the UK market in a year, you must register directly with your environmental regulator.
Find more information about your potential battery producer responsibility obligations and how you can register.
Packaging Regulations
Vapes are transported and sold in packaging. The Producer Responsibility Obligations (Packaging Waste) Regulations 2007 require obligated producers of packaging to take on responsibilities to reduce the amount of packaging produced and increase the amount that is recycled. This includes registering as a packaging producer and financing collection and treatment of waste packaging. Vape producers may need to ensure they are registered to comply with the Packaging Regulations.
The definition of an obligated packaging producer.
If you are an obligated producer, you must either join a compliance scheme or register directly with your environmental regulator. A compliance scheme will take on your duties to finance the collection and treatment of waste packaging.
Find more information about your potential packaging producer responsibility obligations and how you can register.
Be aware that the way UK organisations responsible for packaging, carry out their recycling responsibilities, is changing. Find out if you are affected.
Compliance and Enforcement
The environmental regulators are responsible for monitoring compliance and carrying out enforcement under the WEEE, Batteries and Packaging Regulations. If you meet the definition of a producer under any of the regulations and do not register, then you are committing an offence and may face enforcement action.
If you would like to speak with the EA, you can contact the National Customer Contact Centre via telephone – 03708506506 – or email – enquiries@environment-agency.gov.uk.
If you would like to speak with SEPA, you can contact the Customer Service General Enquiries via telephone – 03000996699 – or via the contact form.
If you would like to speak with NRW, you can contact the General Enquiries via telephone – 03000653000 – or email – enquiries@naturalresourceswales.gov.uk.
If you would like to speak with NIEA, you can contact via telephone – 03002007856 – or email – nieainfo@daera-ni.gov.uk.
Further information
Key terms
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.
- Evidence that the product is available in compliant format or packaging for in Great Britain and Northern Ireland supply
- Evidence of corrective action taken to remove or bring the presentation of the product into compliance for the UK market
‘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.
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.
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.
Reporting safety concerns
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 various related E-cigarette legislation and the MHRA works with them to ensure acceptable standards of safety.
Contact
For more information on the regulatory framework, or to register for ongoing updates about the scheme, TPDnotifications@mhra.gov.uk.