Hello from the e-cigarettes team
In this email we
cover information for producers on the notification process, ingredient labels,
information leaflets, safety information and cross border sales.
Thank you to everyone who has submitted a notification
so far, we have already received hundreds of applications from a range of large
and small companies. Our IT team are developing a system to streamline the
process of downloading notifications from the EU-CEG, and we are planning to
publish them on our website in November.
We encourage all companies to begin the process of
submitting notifications as soon as possible. So as not to provide an incentive
to delay making notifications, we are not planning to send out invoices for
submissions received until October.
As a reminder, before 20 November, our transition
periods mean that you can start to sell a new product the day after you
have submitted your notification, and do not have to wait for us to publish it
first. You must notify products already on the market before 20 November 2016, if
you wish to continue manufacturing and selling them after that date.
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.
Information on how to notify is available on our website
and from the European Commission.
labelling new information
Since our previous statement (update email #6) on
ingredients labelling, we have looked at how ingredients are described on the
label in a way that is meaningful to the consumer. 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
If you can fit all the required leaflet
information on your products labelling, you may not need to include a
separate leaflet in the pack.
Where all the required information can be
fitted onto 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. Be aware however that additional statutory labelling
requirements may also apply, such as the European Regulation (EC) No
1272/2008 on classification, labelling and packaging of chemical substances
The TPD requires information on the use and
storage of e-cigarettes to be included in the package leaflet given to
consumers. We encourage you to ensure your leaflets include appropriate advice
on product storage, particularly on how to ensure the battery does not
have reason to believe that one of your products is unsafe or not of good
quality you must tell MHRA and provide us with details of the risk to human
health and safety and any corrective action taken. Reports should be sent by
email to TPDsafety@mhra.gsi.gov.uk.
Department of Health 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
other Member States have banned cross-border distance sales, and it would
contravene the law to trade in those countries.
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.
Any other queries
If you have any technical enquires about the e-cigarette notification
scheme under the Tobacco Products Directive, or the work of the MHRA, please
send them to our official enquiries inbox: firstname.lastname@example.org.
Thank you for your time in reading and sharing this email with your
contacts. We look forward to hearing from you.
Healthcare products Regulatory Agency
151 Buckingham Palace Road, London SW1W 9SZ, UK
Telephone: 020 3080 6069