In recent years, the vape industry has grown to thrive around the world, but how does the regulation of these products vary between countries?
You may be questioning what markets are best for your vape product. In this article, we’ll cover a variety of areas across the world, and give you details of the regulations which apply, as well as the submission costs, allowing you to make an informed decision on where you should market your vape product.
EU - Tobacco Products Directive (TPD)
Vape products in the EU are governed by the Tobacco Products Directive (EUTPD) (2014/40/EU), although each individual EU member state has its own variation of the Directive.
This means that even though your product may technically be ‘TPD compliant’, it may not be classed as such in certain member states, so it is important to check your compliance for every country.
To market your vape product in the EU, you must submit a Notification to the European Commission through the EU-CEG Portal 6 months prior to placing your product on the market. The Notification should include testing and regulatory data for the product, including:
- Data on the delivery of nicotine from the product
- Emissions data following use of the product
- Disclosure of Ingredients
- Toxicological Reports on the Ingredients
- Manufacturing overview
- Manufacturer's declaration
- Packaging
Notifications to the European Commission are submitted using the Commission's submitter tool, which then sends the notification to each concerned country through a centralised system. Each country is responsible for the review (if appropriate) of the notification and a fee is charged by most countries in advance of allowing product sales.
Though TPD is the primary Directive regulating vape products in the EU, other Regulations such as Classification, Labelling & Packaging (CLP) are also effective, and manufacturers must also submit a Poisons Centre Notification (PCN) and label their products with a Unique Formulation Identifier (UFI) for products to be compliant for sale in Europe and Northern Ireland (this does not apply to products sold in England, Wales and Scotland).
For TPD submissions, you can expect to pay between €0-€1000 per notification.
UK – Tobacco & Related Products Regulation (TRPR)
Since the UK left the EU in 2020, TPD no longer applies to England, Scotland, and Wales where the UK Tobacco and Related Products Regulations (TRPR) is now effective. TRPR is often referred to as an adaptation of the TPD (EU), as it is widely the same apart from a few variances.
Note: TPD still applies to products sold in Northern Ireland.
Your TRPR Notification for the UK should contain the same regulatory and testing data as the EU, which includes:
- Data on the delivery of nicotine from the product
- Emissions data following use of the product
- Disclosure of Ingredients
- Toxicological Reports on the Ingredients
- Manufacturing overview
- Manufacturer's declaration
- Packaging
Unlike TPD, your TRPR Notification should be submitted through the MHRA Portal.
There are also several variances between the two regulations/directives, such as;
- Product conformity markings – Under EU safety, health and environmental requirements, the CE mark should be used to state conformity with EU directives however, in the UK, the UKCA mark should be used to state conformity with UK regulations. Products can carry both the CE and UKCA markings, so long as they are fully compliant with both EU and UK directives/regulations.
- Information leaflet – TPD and TRPR require products to be accompanied with a leaflet, regardless of the information displayed on outer packaging. The leaflet should include:
– Product name
– Contents of pack
– Instructions for use (including refill if applicable)
– Contra-indications
– Warnings and precautions
– Possible side effects
– Addictiveness and toxicity statements
– Instructions for use and disposal
– Storage instructions
– Contact detailers of manufacturer/importer/responsible person
- Application fees – The cost of applications varies between not only TPD/TRPR, but also specific countries within the EU. For TPD submissions, you can expect to pay between €0-€1000 per notification. For TRPR, a flat rate of £150 per notification applies with an annual fee of £80.
- Flavour bans – There are enforced or planned flavour bans in a number of EU countries including the Netherlands, Denmark, Hungary, Lithuania and Estonia. There are currently no banned vape flavours for GB under the TRPR.
For TRPR, a flat rate of £150 per notification applies with an annual fee of £80.
USA – Premarket Tobacco Application
The structure of vape regulation in the USA is different to other areas, in that through your application you must demonstrate the appropriateness of your product for the protection of public health (APPH).
In order for a PMTA submission to be successful, it must demonstrate that the product is in the interest of protecting public health by detailing the risks and benefits of the product, whether it will help smokers to choose an alternative product and the manufacturing, packaging and design process of the product.
The PMTA should include:
- Full reports of all information published which shows the health risks of the product and whether the product presents less risk than other tobacco products.
- A full statement of the components, ingredients, additives and properties of the product.
- A full description of the methods used in the manufacturing, processing, packing and installation.
- Evidence that the product meets the tobacco product standard, any information regarding deviation from a standard, samples of the product and its proposed labelling.
The purpose of the PMTA is to make sure that your product is safe to be on the US market and does not pose a health risk to the public. This means that the FDA will be looking for evidence that you are a responsible manufacturer in your application.
Make sure that you consider things such as how you intend to market your products in a way that protects youth and vulnerable people, that the ingredients and packaging are safe and how your products will impact the environment.
The application process can be costly (around $200,000 per SKU), and so if you’re thinking of entering the market this should be considered.
UAE – UAES 50:30
In order to be legally sold in the UAE, nicotine containing products must be approved by MoIAT (Ministry of Industry and Advanced Technology), and receive an ECAS mark of conformity.
As of January 2023, the registration fee for vape products in the UAE has been significantly reduced, meaning the vape industry can likely expect to see significant growth within the country over the coming years.
As with the other areas we’ve looked at across the globe, your UAE submission must include testing and regulatory and data.
There are several factors you should consider when preparing to be UAES 50:30 compliant, these include:
- Testing data – For UAE applications to market, all testing must be performed by an ISO 17025 laboratory. The testing required is:
– Nicotine, Carbonyls, Heavy Metals
– Caffeine, Taurine
– Ethylene Glycol, Diethylene Glycol
- Packaging requirements – Vape product packaging must include specific warnings in Arabic and English, and a user manual (also in Arabic and English).
- Nicotine strength, flavour and brand must also be included on packaging.
- Factory of manufacture – The factory from which the vape product is manufactured must be ISO 9001 Certified.
- UAE Trade License – In order to market your vape product in the UAE, you must either be based in the UAE yourself, or have a distributer based there. This person must also hold a UAE Trade License to legally trade.
- RoHS Full Report – You must provide a Restriction of Hazardous Substances (RoHS) Report in your application. This can be gained from the manufacturer of the vape product.
- Additionally, you must also provide evidence for Electromagnetic Compatibility (EMC) & battery test report.
For vape devices in the UAE, there are some limitations, including:
- 10ml tank (Disposable, Pod, Device tank)
- 50ml refill bottle
- 20mg/ml strength
You can expect a UAES 50:30 submission to cost between £1000 – £2000.
Worldwide Vape Compliance with Inter Scientific
We’re different to other compliance partners – with our laboratory and regulatory teams working together, we offer an integrated solution to help you comply with regulations and directives around the globe.
Contact our experts today to begin your journey to compliance.
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