Guidance on-cigarettes: regulations for consumer products
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The Medicines and Healthcare products Regulatory Agency has
published guidance on how to get an e-cigarette on the market in
Great Britain and Northern Ireland, including the notification
scheme and reporting problems with e-cigarettes. Contents Overview
Advice for consumers Notified products for Great Britain and
Northern Ireland Advice for retailers Advice for producers Guidance
on the submission and...Request free
trial
The Medicines and Healthcare products Regulatory Agency has published guidance on how to get an e-cigarette on the market in Great Britain and Northern Ireland, including the notification scheme and reporting problems with e-cigarettes. Contents
Overview The MHRA is the competent authority for a notification scheme for e-cigarettes and refill containers in Great Britain and Northern Ireland and is responsible for implementing the majority of provisions under Part 6 of the Tobacco and related Products Regulations (TRPR) and the Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020. The TRPR introduced rules which ensure:
The requirements:
The Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020 is available here: An Explanatory Memorandum explains the changes from a policy perspective: The 2020 regulations amend the Tobacco Products and Nicotine Inhaling Products (Amendment etc) (EU Exit) Regulations 2019 to implement the obligations of the Withdrawal Agreement and the Northern Ireland Protocol in law. This amends the way in which the Tobacco and Related Products Regulations 2016 apply in Great Britain and Northern Ireland The 2020 Regulations sets out the requirements for new products to be notified from 1 January 2021. This will mean that:
A producer is anyone who manufactures or imports these products or who re-brands any product as their own. Retailers do not need to submit information for any products they sell unless they also qualify as a producer. The Tobacco and Related Products Regulations 2016 do not cover nicotine-containing products that are authorised as medicines. Further information about licensing these products as medicines can be found here. Advice for consumersReporting an adverse reaction via Yellow Card If you feel unwell after using an e-cigarettes product you can report side effects and safety concerns with e-cigarettes or refill containers to the MHRA through the Yellow Card scheme. If you would like to provide information about the sale of defective, non-compliant or illegal e-cigarette products you can contact the MHRA at TPDsafety@mhra.gov.uk, alternatively you can contact Trading Standards. Yellow Card reports submitted to the MHRA are added to our vigilance database where reports are looked at by our specialist team of assessors. Reports are assessed for potential patterns of concern by our team of scientists, doctors and pharmacists. Should any potential safety concerns be identified the MHRA are able to take regulatory action to safeguard the public. Data from Yellow Card reports received relating to suspected side effects to nicotine-containing e-cigarettes can be viewed on the e-cigarette Analysis Print. It is important to note that inclusion of a report of the Analysis Print does not necessarily mean that the effect was caused by the e-cigarette just that there was a suspicion it might have been. Please see accompanying guidance document explaining how this data should be interpreted. The e-cigarette Analysis Profile contains data for all spontaneous suspected adverse reactions, or side effects, which have been reported to the MHRA, via the Yellow Card scheme from healthcare professionals and members of the public involving a nicotine-containing e-cigarette. Only adverse reaction reports to nicotine-containing e-cigarettes appear on the Analysis Profile, reports of other product safety or quality concerns associated with e-cigarettes are shared with local Trading Standards officers and Public Health England as appropriate. Notified products for Great Britain and Northern Ireland 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. List of UK products submissions published before 31.12.20 (A-I) (MS Excel Spreadsheet, 1.49MB) List of UK products submissions published before 31.12.20 (J-Z) (MS Excel Spreadsheet, 1.84MB) List of submitted Great Britain products (MS Excel Spreadsheet, 95.3KB) All products listed above remain notified for supply in Great Britain and Northern Ireland. Great Britain A list of products which have been notified to the MHRA for supply in Great Britain via the MHRA submission portal is available here: List of submitted Northern Ireland products (MS Excel Spreadsheet, 100KB) We process submissions for products which have been submitted to the MHRA via the MHRA submission portal in date order and aim to publish new products within 45 to 60 days of notification. Northern Ireland A list of products which have been notified to the MHRA for supply in Northern Ireland is available: List of withdrawn products (MS Excel Spreadsheet, 212KB) We process submissions for products which have been sent to the 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 the 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 TRPR, it is the responsibility of the producer to ensure that their products comply with the TRPR requirements. We check notifications submitted for completeness and verify TRPR compliance with producers. Where this review has been completed, the 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. Electronic Cigarette Drug Analytics Print up to 31.1.21 (PDF, 36.8KB, 23 pages) 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 Notified Products. If you cannot find the product on the MHRA’s website, ask your supplier to confirm that the product complies with the TRPR and has been notified to the MHRA. If a producer has not notified the product or it does not comply with the TRPR, they may not supply it to you. See our advice for retailers setting out the key requirements (PDF, 118KB, 2 pages) 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 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 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 new [Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020((https://www.legislation.gov.uk/uksi/2020/1316/contents/made). Updated guidance on the registration requirements for CBDS of 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 name and website addresse(s) will be published. New registrations requests that are not compliant with the new regulations will be rejected and not published. The current list of published retailers undertaking CBDS to the Great Britain and Northern Ireland will be reviewed and updated for compliancy 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 PHE at CBS.Tobacco@phe.gov.uk if you have any queries on the above. Advice for producersPutting a new product into 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. Other requirements for e-cigarettes 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. 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. Guidance on the submission and content of notifications for Great BritainBefore getting started Registering to make submissions to the MHRA provides guidance on how to use MHRA Submissions, including for e-cigarette information. Ensure that you have watched the videos and have referred to the user reference guides prior to clicking on the link in the Getting Started section. Three short video demos are provided below which cover all aspects of the user access management process - these steps will enable your organisation to gain access and manage user permissions for using MHRA Submissions. You can access all three videos on Sharefile.
There are two user reference guides which contain step by step guidance on the processes: User Reference Guide – Gaining Access to MHRA Submissions User Reference Guide – Managing users on MHRA Submissions Once you have an MHRA Submission Portal account, you can continue with the application process. The MHRA have published guidance to help you with this: E-cigarette user reference guide (PDF, 1.22MB, 23 pages) If the MHRA submission portal is providing an option to generate new submitter ID instead of pre-populating your EU submitter ID please report this to the MHRA via the ‘Help and Support’ tile on MHRA submission portal before completing any submissions. Once you have validated the submitter ID assigned by the MHRA submission portal and it is in line with your EU submitter ID you will have an option to raise a request to update your company display name. A request can be raised via the ‘Help and Support’ tile. NOTE- Company name displayed on the MHRA submission portal is also used in the extract published on our MHRA gov website. If your company ownership has changed and you require a new company ID on the MHRA submission portal then you can raise a ticket via the ‘Help and Support’ tile for a change of ownership. Please note that the MHRA does not provide an XML creator. Notifications to the MHRA can be provided via existing XML documents or manually using our bulk uploader or online form. To receive fee reduction for both Northern Ireland and Great Britain products must retain the same ECID in both regions. The regulations enable submitters to pay a single fee for Great Britain and Northern Ireland. Changes to the ECID between regions will result in two unique product identifiers which will be charged accordingly. If you have any difficulties, please contact the portal’s technical team directly via the email addresses below: Contacts
The format and content of notifications will remain in line with those 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). We have published below guidance to aid producers of e-cigarettes and refill containers to prepare notifications for their products. Product type guidance Great Britain (PDF, 168KB, 3 pages) Submission type guidance Great Britain (PDF, 412KB, 3 pages) Emissions testing guidance Great Britain (PDF, 93.9KB, 3 pages) Nicotine dose guidance Great Britain (PDF, 74.2KB, 2 pages) Ingredient guidance Great Britain (PDF, 265KB, 3 pages) Labelling guidance Great Britain (PDF, 85.2KB, 2 pages) Product presentation guidance Great Britain (PDF, 41.2KB, 4 pages) Annual reporting guidance Great Britain (PDF, 35.9KB, 3 pages) General advice on due diligence Great Britain If you make your product available in Great Britain 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. Guidance on the submission and content of notifications for Northern Ireland 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 regulators and other member states and discussed at the European Commission Working Group on notification of e-cigarettes and refill containers. Submitting a notification via EUCEG Product type guidance Northern Ireland (PDF, 168KB, 3 pages) Submission type guidance Northern Ireland (PDF, 412KB, 3 pages) Emissions testing guidance North Ireland (PDF, 93.9KB, 3 pages) Nicotine dose guidance Northern Ireland (PDF, 74.2KB, 2 pages) UK ingredient guidance Northern Ireland (PDF, 265KB, 3 pages) Labelling guidance Northern Ireland (PDF, 85.2KB, 2 pages) Product presentation guidance Northern Ireland (PDF, 41.2KB, 4 pages) General advice on due diligence Northern Ireland (PDF, 42.5KB, 2 pages) Fees The fees for submitting a notification are a set out in The Electronic Cigarettes etc. (Fees) Regulations 2016. The 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 (Per ECID notified in both Great Britain and Northern Ireland) Annual and Substantial Modification fees will be reviewed in 2021 The MHRA has given a commitment to review the level of fees in the light of the number of notifications received each year. Invoices The MHRA will send an invoice to each company for the notification fees due in relation to all products for which information has been submitted. Payment of this invoice is due immediately upon receipt. When making payments please reference the invoice number and your MHRA account information. In order to help you to prepare for payment, details of the MHRA bank account can be found below:
MHRA Further informationKey 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.
‘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) Vape Products in nicotine containing refill containers are likely to create the impression that the product has a health benefit, and therefore, 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 the legislation and the 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. 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. 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. |