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Tobacco and Related Products Regulations 2016

03.06.2016

Dear Minister of State,

Proposed menthol ban on vape products in Germany

We are writing in relation to the German Government’s intention to ban the use of menthol as an additive in vape products.

Although this is an issue that you may already be aware of, please see below for a brief summary of the key issues:

  • The German Government is seeking to prohibit the use of menthol and certain other additives in vape products by way of a negative list in an Amending Ordinance, which is designed to amend the Tobacco Products Ordinance. [1]
  • The German Government is purporting to justify the menthol ban on vape products pursuant to the Tobacco Products Directive 2014/40/EU (“TPD2”). However, whilst TPD2 prohibits the placing on the market of cigarettes and roll-your-own tobacco with menthol as a characterising flavour [2] from 20 May 2020, the prohibition does not comprise vape products. Accordingly, the proposed ban is unjustified, and does not fall within the scope of TPD2.
  • The proposed ban is unsupported by the German Government’s own evidence, is disproportionate, and represents a violation of domestic, EU and WTO legislation.
    The UK vape industry is at the forefront of innovation and has seen phenomenal growth over the past three to five years. We consider the banning of menthol in vape products to be a serious obstacle for the industry. The measure will hinder the free movement of TPD2-compliant goods and will likely impact the UK exports of vape products to Germany. The economic impact will have particularly devastating repercussions for UK manufacturers with cross-border operations. The measure will also undermine significant investments made by the UK vape industry, especially in the areas of research and development. We are also concerned than a ban in Germany could trigger similar unjustified bans in other countries, particularly within the EU.

A menthol ban in vape products would require the removal of numerous products from the market in Germany, as menthol is not only used in menthol flavoured e-liquids but also as an additive in small quantities in many other flavoured e-liquids. We estimate that it will affect 60% - 70% of the products currently available on the German market.

This ban is even more surprising given that leading public health authorities have suggested that vaping is at least 95% less harmful than combustibles [3] - without differentiating between vape products with or without menthol. Furthermore, over fifty international public health researchers requested that the World Health Organisation refrain from proposing bans and/or undue restrictions on vape products. [4]

The German Government notified the Amending Ordinance to the European Commission, which it is required to do pursuant to Article 24(3) TPD2 and under Directive 2015/1535, on 20 May 2016. There is now a minimum three months “standstill” period, during which Member States and the European Commission, are able to submit a “detailed opinion”.

We consider that the prohibition on the use of menthol in vape products would have a serious impact on vape product manufacturers, suppliers, and consumers, not only in Germany, but in the UK and elsewhere for the reasons outlined above.

We would welcome the opportunity to meet with you to elaborate further on our concerns and engage your support on behalf of the UK vape product industry in relation to the critical issues surrounding the proposed regulation in Germany.

Yours sincerely

[1] The Tobacco Products Ordinance is supplemental to the primary legislation that will transpose the Tobacco Products Directive. This entered into force on 20 May 2016.

[2] TPD2 definition: ‘characterising flavour’ means a clearly noticeable smell or taste other than one of tobacco, resulting from an additive or a combination of additives, including, but not limited to, fruit, spice, herbs, alcohol, candy, menthol or vanilla, which is noticeable before or during the consumption of the tobacco product.

[3] E-cigarettes: an evidence update. A report commissioned by Public Health England (August 2015)

[4] 26 May 2014 Letter to Dr. Margaret Chan, Director General of WHO on "Reducing the toll of death and disease from tobacco" - Statement from specialists in nicotine science and public health policy"; available at http://ecigarette-research.com/WHO.pdf.

27.05.2016

Labelling your product
Regulation 37 of the Tobacco and Related Products Regulations 2016 sets out the requirements for labelling of e-cigarette and refill container products. Additional advice on labelling or e-liquid products is available here - Labelling Guidance (PDF, 85.2KB, 2 pages)

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

Advertising

Guidance on the e-cigarette advertising provisions of The Tobacco and Related Products Regulations 2016 has now been published by the Department of Health. They expect that the Committee of Advertising Practice (CAP) will consult on further detailed guidance shortly and 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.

Nicotine Base Liquid

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.

26.05.2016

Report from the Commission to the European Parliament and the Council on the potential risks to public health associated with the use of refillable electronic cigarettes.

20.05.2016

Update on EU CG

The European Commission has updated its website setting out temporary instructions for businesses intending to submit notification via the EU CEG portal. Further details are available on the European Commission’s website:

https://ec.europa.eu/health/euceg/download_en

Please note that these instructions are specifically addressed to companies who are ready to make a product submission on 20 May 2016 or immediately after this date.

Further updates and information on the operation of the EU CEG will posted on the Commission’s website: https://ec.europa.eu/health/euceg/introduction_en

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 of E-Cigarettes
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.

Ingredient Guidance

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.

Link to draft guidance

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.

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.

***

22.4.2016

The Government today published the Tobacco and Related Products Regulations 2016 (SI No. 507) (TRPR) implementing the revised Tobacco Products Directive (Directive 2014/40/EU). The new rules will come into force on 20 May 2016. Part 6 sets out the requirements for e-cigarettes and e-liquids (refill containers).

A copy of the regulations can be viewed on: http://www.legislation.gov.uk.

Guidance on what this means for producers of e-cigarettes and e-liquids, and your obligations under the TPD and TRPR, can be found on our website.

Submitter IDs

The European Commission has released new information on how producers of e-cigarettes and e-liquids can apply for a Submitter ID on the European Common Entry Gateway (EU-CEG). This ID will be required in order notify your products.

You will need to create a European Commission Authentication Service (ECAS) account first, which you can do here.

You can now download a registration form for a Submitter ID, which you can complete and return to the European Commission. Once your form has been submitted, the Commission will start the process of assigning you an ID.

We will update you with further news on the next steps in this process as we receive them.

Refill mechanisms

After receiving feedback from the UK and other member states earlier in the year, the European Commission has released an Implementing Decision on the technical standards for the refill mechanism of electronic cigarettes, which you can read here.

The Commission have confirmed that refillable electronic cigarettes and refill containers can only be placed on the market if the mechanism by which they are refilled meets one of the following conditions:

It entails the use of a refill container possessing a securely attached nozzle at least 9 mm long, which is narrower than and slots comfortably into the opening of the tank of the electronic cigarette with which it is used and possessing a flow mechanism that emits no more than 20 drops of refill liquid per minute, when placed vertically and subjected to atmospheric pressure alone at 20°C ± 5 °C
It operates by means of a docking system which only releases refill liquids into the tank of the electronic cigarette when the electronic cigarette and refill
In this Decision, The Commission have updated the requirements to better align with industry needs. For example, the standards now specify that nozzles must be ‘securely attached’ as opposed to ‘non-detachable’, and the minimum length of the nozzle has been shortened from 10mm to 9mm.

Consultation

Thank you to all those who took part in the consultation process, as your responses have helped shape the final draft of the Implementing Decision. An update regarding our other consultation on regulatory fees for E-cigarettes will be released early next week.

Will businesses need to submit a full toxicology report on each flavour and strength?

The MHRA have confirmed that the toxicology of every ingredient that makes up a flavour will need to be reviewed. The notification portal has the intended function that once a toxicological review has been submitted for a given ingredient, repeat notifications of the same substance in other products are not required from that submitter.

MHRA Manufactures Survey

The MHRA has produced a short survey for manufacturers of vape products (devices and liquids) to help them gain a greater understanding of what manufacturers would like from the notification website.

Putting a new product into the UK market

From 20th May 2016 onwards, producers of new e-cigarettes and refill container products will need to submit a notification to MHRA 6 months before putting their product on the UK market.

There are transitional arrangements for the period from 20th May to 19th November 2016. For new products which companies intend to put on the market during this period, the application must be made at least one day before you sell it for the first time.

The MHRA are looking to implement the TPD in a pragmatic way so that importers do not need to submit a duplicate notification if the manufacturer or re-brander has already submitted a notification.

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 will be made publicly available in line with the European Commission’s timetable.

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 20th May 2016 will have until 20th November 2016 to submit a notification to MHRA.

Retailers have until 20th May 2017 to sell through stock of products that do not comply with the labelling and product composition requirements of the TPD. Batches of products which do not comply with these requirements may only be sold if they were produced before 20th November 2016.

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