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MHRA TPD Update Email #6: Labelling, guidance, sales and more

   

Medicines and Healthcare Products Regulatory Agency

Hello from the MHRA e-cigarettes team.

As you will be aware, the Tobacco Products Directive and the UK Tobacco and Related Products Regulations 2016 come into effect today, bringing with them new requirements for producers of e-cigarettes and e-liquids.

Whilst the UK regulations are in force from today, there are still transition periods in place for producers and retailers.

This email brings you our latest information and guidance, based on your feedback to previous emails. Below you can find updated information on the European Union Common Entry Gate, ingredient guidance, sale of nicotine base liquid, warning statements, cross-border sales and advertising, and how to report problems with e-cigarettes and e-liquids.

European Union Common Entry Gate

Producers wishing to submit notifications for their products will be able to do so shortly via the European Union Common Entry Gate (EU-CEG), more information on which you can find here.

The Commission has today published temporary instructions for companies ready to submit notifications via the EU-CEG portal. These instructions are specifically addressed to companies who are ready to make a product submission on 20 May 2016 or immediately after this date.

Ingredient Guidance (attached*)

The TPD requires information about each ingredient in notifiable products to be included within the submission, and this document explains further what will be required. It also sets out a preliminary list of ingredients that should not be included as ingredients in e-liquids.

We have also had questions about listing ingredients on the label.  Our interpretation of the TPD requirement 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.  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’.  We are seeking further clarification on this from the European Commission.

*this document is attached at the bottom of this email 

Nicotine Base Liquid

We have had a number of questions as to whether the sale of nicotine base liquid to consumers is covered by the TPD. The following text will be placed on our website to clarify this issue:

The TPD 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). 

The requirements do not apply to ‘trade sales’ i.e. where you are not selling direct to a consumer. But for all sales (trade and to consumers) the tank capacity of a refillable e-cigarette must not exceed 2ml.    

The application of all TPD requirements are subject to transitional provisions.

Warning Statements

Several companies have asked about the requirement to include the warning statement ‘This product contains nicotine which is a highly addictive substance’ where the product as sold does not contain nicotine. 

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. We are also seeking further clarification on this from the European Commission.

Cross-Border Registration and Advertising

Cross-border registration and Advertising of e-cigarettes and e-liquids are managed by The Department of Health (DH). However, as we have received a number of enquires on these subjects, DH have asked us to share with you the information below. For further information, please visit the Department of Health website here.

Cross-Border Registration

From 20 May 2016, you need to register your business if you supply tobacco products and/or e-cigarettes via cross-border distance sales, for example online sales. 

This applies to:

  • businesses established in the UK selling tobacco products and/or e-cigarettes to consumers
  • in another EEA state (European Economic Areas – the 28 EU Member States plus Iceland, Liechtenstein and Norway) businesses established in the EEA or third country selling direct to UK consumers.

Businesses that only undertake business to business sales, that is sales not direct to consumers, do not need to be registered.

Registration is a legal requirement under the EU Tobacco Products Directive (2014/40/EU).  Without confirmation of registration businesses must not supply a relevant product to a consumer via 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.

Advertising

DH guidance on the e-cigarette advertising provisions of The Tobacco and Related Products Regulations 2016 has now been published on gov.uk.

The restrictions on certain forms of advertising come into force today and businesses are expected to work towards compliance. We expect that the Committee of Advertising Practice (CAP) will consult on further detailed guidance shortly and we will work with them to ensure the consistent application of the law which requires that businesses do not procure or place any advertising that promotes or indirectly promotes e-cigarettes, as defined in the legislation. CAP will make further announcements on its plans for consultation in due course. Those interested should sign up for CAP’s Update e-newsletter on www.cap.org.uk.

Reporting problems with e-cigarette products

E-cigarette producers must 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.  E-cigarette producers should notify the MHRA by email to TPDsafety@mhra.gsi.gov.uk.

From the 20 May 2016 consumers and healthcare professionals can report side effects and safety concerns with e-cigarettes or refill containers to the MHRA through the Yellow Card reporting system.     

Spread the word

We know our guidance will be of great interest to your colleagues in the e-cigarette industry. Please help us make sure they know about it by sharing the link to our guidance page on social media. Below are some suggested tweets and Facebook posts you may wish to use.

Twitter (You can follow us at @MHRAgovuk)

The Tobacco Products Directive is here! Are you prepared? Make sure you read & share @MHRAgovuk's latest guidance http://ow.ly/YVyxX

The Tobacco Products Directive starts today! Get prepared with the latest guidance from @MHRAgovuk http://ow.ly/YVyxX

Want to know how the TPD will affects the #ecigarettes industry? Take a look at the latest guidance from @MHRAgovuk http://ow.ly/YVyxX

The #TPD came into effect on the 20th May - are you prepared? please share @MHRAgovuk's guidance on #vape regulation http://ow.ly/YVyxX

Facebook/LinkedIn (You can like us on Facebook and follow us on LinkedIn)

Do you make or sell #ecigarettes? Make sure your business is ready for the Tobacco Products Directive which came into force on the 20th May! MHRA have put together guidance on how you can be prepared http://ow.ly/YVyxX

Have you heard about the Tobacco Products Directive, and wonder what it means for you? The MHRA have put together guidance for #vaping businesses on how you can be prepared http://ow.ly/YVyxX

Get in touch

If you have any technical enquires about the notification process, please send them to our official enquiries inbox:  info@mhra.gsi.gov.uk.

Thank you for your time in reading and sharing this email with your contacts. We look forward to hearing from you.

Kind regards

Mark Wilcox

Campaigns Specalist

Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London SW1W 9SZ, UK 
Telephone: 020 3080 6069

Email: mark.wilcox@mhra.gsi.gov.uk

 

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