With the global vaping industry continuing to grow every year, it’s a good time to be in the vaping business. Even restrictive legislation such as the Tobacco Products Directive (TPD) can’t keep the e-cigarette market from expanding.
However, that doesn’t mean you can just sell any kind of product in your vape shop. Until the UK officially leaves the European Union (if it does) and/or creates its own vaping laws, all e-cig companies in the country have to follow the TPD.
An Overview of the Tobacco Products Directive
The Tobacco Products Directive 2014/40/EU or TPD is the legislation set by the European Union to regulate the production, presentation, and sale of tobacco and related products across the countries that are members of the EU. The TPD covers electronic cigarettes with nicotine and refill containers.
If you are up for reading all the details of this piece of legislation regarding e-cigs, you can find all the relevant information in Title III, Article 20 of the 38-page pdf.
The TPD was enacted with three goals in mind:
- Set minimum standards of safety and quality of e-cigs and e-liquids
- Provide information to customers so they can make informed decisions
- Prevent children from starting to use such products
The most important regulations from the directive are as follows:
- A single refill container of e-liquids can only have a maximum volume of 10ml
- A single e-cigarette tank can only have a maximum volume of 2ml
- Nicotine-containing e-liquids can only have a maximum nicotine strength of 20mg per ml
- E-cigarette products and their containers must be child- and tamper-proof
- E-cigarette products cannot have caffeine, taurine, and colourings
- E-cigarette products must have warning leaflets
- E-cigarette products must deliver nicotine doses at consistent levels
- Launching a new e-cigarette product requires sending a notification to the Medicines and Healthcare products Regulatory Agency (MHRA) six months prior
- Advertising nicotine-containing e-cigarette products is prohibited
The TPD was put into action on 20th May 2016. Vaping companies were allowed to manufacture non-compliant products until 20th November 2016. They were then given until 20th May 2017 to clear their shelves of all non-compliant stock. Retailers and producers that failed to comply faced legal action from the government.
Every e-cigarette product that can be legally produced and sold from 20th May 2017 onward has to meet the TPD requirements and go through the MHRA notification process.
TPD Concerns for Vape Retailers
If you’re a retailer of e-cigarette products, you need to make sure that what you are selling is included in the list of Submitted Products notified to MHRA via the European Common Entry Gate (EU-CEG).
Gov.uk has provided downloadable MS Excel sheets of the Submitted Products. Here is the list for companies A to I, and here’s the list for companies J to Z. They have also made available the list of withdrawn UK notifications.
The list is updated each week, so be sure to check it regularly if you are ever unsure about the legal status of the product you are thinking of putting up for sale.
You do not have to submit a notification of your products to MHRA, as long as you are strictly selling the products. However, if you are also the producer of the products you are selling, you need to follow the notification process to legally sell your e-cigarette merchandise.
A “producer” is defined by the TPD as one who manufactures or imports e-cigarette products or rebrands them as their own.
TPD Concerns for Vape Producers
If you are a producer of e-cigarette products, you have to submit a notification to MHRA six months before you intend to launch a new product for sale in the UK. Only until your notification has been published in the list of Submitted Products can you begin the sale of said product.
You can launch the product as soon as its notification is published, so you don’t have to wait for the full six months.
1. Modified Products
An existing product that has been substantially modified must undergo the notification process once more to be approved for sale. Gov.uk defines a substantially modified product in their submission type guide as such:
“A substantial modification is a change to the product that may have an effect on the human body. Such changes include one or more of the following:
- any change to the qualitative or quantitative composition of the nicotine-containing liquid
- any change to the volume of a refill container, tank or cartridge
- any change to the composition, design or power output of a device which would be likely to affect emissions”
2. Importing Products
If you are only importing an e-cigarette product, you do not have to submit a notification if the manufacturer has already done so.
If you are rebranding a product that you did not manufacture, you do not have to submit a notification for the product if the manufacturer has already done so and lists your brand name in the notification.
3. Reporting on Safety
If you think the product you have submitted a notification for turns out to be unsafe, of poor quality, or is non-compliant with the TPD, you need to inform MHRA as soon as possible. Provide details regarding what health and safety risks the product poses and any corrective action that can be taken.
4. Labelling Issues
Ingredients “used in quantities of 0.1% or more of the final formulation of the e-liquid” have to be listed on the label. Flavours composed of various chemical components can be listed as their name, such as “orange flavour”. You may choose how to describe ingredients used in quantities less than 0.1% of the final formulation by category.
However, a full breakdown of all the ingredients must be submitted for the notification process.
Gov.uk suggests that the packaging for your products can be “considered to include the leaflet”, so you can simply put the warning and instructions on the packaging without having to include a separate leaflet insert.
“This product contains nicotine which is a highly addictive substance” must be on all notified e-cigarette products. This also includes products that are not sold containing nicotine but can be used for that purpose.
The sale of e-cigarette products across borders also falls under the purview of the TPD. If you are an online vape business in the UK or you are based in another country and plan on selling to UK consumers, your business needs to be registered with the UK. If you have yet to do so, Gov.uk provides an online registration form.
Products manufactured from outside the country must also undergo the notification process before they can be sold to UK consumers.
Businesses selling to other businesses are not required to register.
Advertising of Vape Products
While the TPD does state that advertisements for nicotine-containing e-cigarette products is banned, e-cigarette products without any nicotine can technically be advertised. This can be done as long as it doesn’t indirectly advertise nicotine-containing products.
Health claims can be made, but only with robust evidence provided, and such claims can only be made per product, not for e-cigarettes in general.
Notification Submission Process
Submitting a notification to MHRA has to be done through the EU-CEG notification portal. You first need to get a submitter ID, which you have to register for with a European Commission Authentication System (ECAS) account. Registration for a submitter ID can take several days.
Once you have the ID, you can start the notification submission process by logging on to EU-CEG website. The EU has provided a simple step-by-step guide to navigate the EU-CEG portal and submit the requirements.
The whole notification process also comes with its own set of required fees:
Do note that the notification and annual fees must be paid for each product. The annual fee and substantial modification fee are payable starting April 2020.
To a Safer, Better, and Freer Vaping Future
While it is understandable that strict laws are put in place to ensure the safety and quality of vaping products, there has been considerable movement within government bodies looking to support vaping and relax regulations since the TPD was enacted, notably through the updated research from Public Health England in 2018. Here’s hoping a nice middle ground of security and freedom can be obtained for the continued growth of the industry.