Overview
The Tobacco Products Directive 2014/14/EU (TPD) introduces new rules for nicotine-containing e-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, which were laid before Parliament on 22 April 2016, implement the TPD in the UK, and come into force on 20 May 2016. Part 6 of the regulations sets out the requirements for e-cigarettes and refill containers.
From May 2016, 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.
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.
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.
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.
The TPD does not cover nicotine-containing products that are authorised as medicines.
Putting a new product into the UK market
From 20 May 2016 onwards, producers of new e-cigarette and refill container products will need to submit a notification to MHRA 6 months before they intend to put their product on the UK market.
There are transitional arrangements for the period between 20 May to 19 November 2016. During this period, applications for new products which companies intend to put on the market must be made at least one day before they are sold for the first time.
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.
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 will have until 20 November 2016 to submit a notification to MHRA. After that date producers may only sell batches of a product that does not comply with the TPD requirements if the batch was produced before 20 November 2016.
Advice for retailers
If you sell e-cigarettes and / or e-liquids 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
No change.
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 e-liquid product, 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 e-liquid 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.
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 e-liquids 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.
You can find more information, along with a link to the online registration form to be completed, at https://www.gov.uk/government/publications/tobacco-products-and-e-cigarette-cross-border-sales-registration
Submitting a notification
Notifications have to be submitted to MHRA through a European Common Entry Gate (EU-CEG) notification portal made available by the European Commission.
Steps you can take now
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Create an ECAS account at https://webgate.ec.europa.eu/cas.
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Apply for a submitter ID number, see http://ec.europa.eu/health/euceg/index_en.htm#fragment0
Guidance on the EU-CEG and how to complete these steps has been made available by the European Commission here
We will provide further details of later stages here as soon as further functionality of the EU-CEG portal is made available by the European Commission.
Guidance on the content of notifications
The format and content of notifications are set out in Commission Implementing Decision (EU) 2015/2183 on e-cigarettes.
Technical requirements for refill mechanisms, and information that must be included in the instructions for use of the product are set out in Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes.
We are publishing below initial draft guidance to aid producers of e-cigarettes and e-liquids 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 -
Submission type guidance -
Emissions testing guidance -
Nicotine dose guidance -
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. The costs of notifications are as follows:
Notification fee: £150
Annual Fee: £60
Substantial Modification Fee £80
MHRA consulted on the level of these fees in January 2016 and the Government Response to the consultation can be found here.
MHRA has given a commitment to review the level of fees in the light of the number of notifications received in the first year.
Labeling your product
Regulation 37 of the Tobacco and Related Products Regulations 2016 sets out the requirements for labelling of e-cigarette and e-liquid products. Additional advice on labelling or e-liquid products is available here -
Reporting problems with e-cigarette products
Problems with e-cigarettes or refill containers should be reported to the producer. Consumers can also contact Citizens Advice to report any problems.
From 20 May 2016, producers should 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.
Further details on how to report problems with e-cigarettes to MHRA will be published here when the TPD comes into force.
Key terms
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.
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
This page will be updated as more details become available.
Contact
For more information on the regulatory framework, or to register for ongoing updates about the scheme, email info@mhra.gsi.gov.uk
We will be updating this page with the latest information, register for updates