UK Regulations
UK Vape Regulations Explained
Jan
UK Vape Regulations Explained
The vaping industry as a whole has been a rapidly changing landscape, owing largely to the incredible pace at which it has risen to public prominence. During the industry’s formative years, vaping businesses enjoyed a “wild west” period with little to no regulation in place, and no authority stepping forward to propose and enforce them.
The nature of the ingredients in a typical e-liquid, which can include a broad variety of flavour-oriented chemical compounds as well as nicotine itself, pose a variety of risks if utilised without proper regulation. Ensuring consumers can enjoy vaping products safely and responsibly is the driving force behind the regulations we have seen introduced in response.
While these are of course a necessity to ensure public safety, they are regularly reviewed, updated and brought in-line with contemporary market requirements. This can make navigating them a compliance minefield for vaping manufacturers and retailers who wish to operate properly.
At Future Regulatory Services one of the primary fields in which we specialise is regulatory and compliance for the vaping industry. We would like to help guide you through what is required so you can operate with confidence within the category; read on as we explain the basics.
TPD and TRPR Explained
The Tobacco Products Directive (TPD) is a piece of European (EU) legislature which was amalgamated into UK law as a part of the Tobacco and Related Products Regulations (TRPR).
TPD came into effect across the EU in May 2016, introducing a range of rules to ensure minimum standards for the safety and quality of all e-cigarettes and refill containers (e-liquids).
Who Enforces TPD/TRPR?
Within the UK, the Medicines and Healthcare Regulatory Agency (MHRA) is the competent authority for the notification process for all vaping products within Great Britain and Northern Ireland.
The MHRA are responsible for implementing the provisions detailed under Part 6 of the TRPR and, following Brexit, the Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020.
What is Required to Comply with TPD/TRPR?
The basic requirements described within the regulations are:
- E-cigarette tanks to be no larger than 2ml
- Refill Containers to contain no more than 10ml per unit
- Nicotine Strength to be capped at 20mg/ml
- Products to be sold to consumers within child-resistant and tamper evident packaging
- Certain ingredients are banned including colourings, caffeine, and taurine
- Stringent labelling requirements and warnings
- Notifications of all e-cigarettes and e-liquids to the MHRA prior to being sold
All manufacturers must ensure their products comply with the above, or they will not be approved for legal sale within the UK. Equally, retailers must also ensure they do not knowingly sell vaping products which do not comply, or else they may face repercussions of varying degrees of severity depending on the scale of the compliance breach.
What is the Cost of Registration for Vaping Products under TPD/TRPR?
The MHRA’s current (2021/22) cost for notifications are as follows:
Notification Fee: £150 (per ECID)
Annual & Substantial Modification: Due to be reviewed based on the number of notifications received annually.
Manufacturers should also take note of the potential cost of MHRA enforced emissions testing and analysis, which are required to prove that the safety parameters of a given product are not breached. Many independent laboratories offer these services at varying cost, but these results must be provided before a product may be approved for sale.
Has Brexit Impacted Vaping Regulations in the UK?
Following Brexit, after the 1st of January 2021, the Nicotine Inhaling Products (Amendment) (EU Exit) 2020 came into force. This means that all manufacturers/producers introducing products to the UK market now need to use the new domestic system, rather than the EU-CEG system that had been previously used for all EU-wide notifications.
Can UK Retailers Still Sell Vaping Products Internationally?
Retailers in Great Britain that wish to sell vaping products into additional countries via their websites or other commerce platforms will also need to register for cross-border distance sales (CBDS).
How Does the New UK MHRA Vaping Product Registration Portal Work?
The new MHRA registration portal allows manufacturers/producers to submit all required information in relation to their products including product design details, product presentations, ingredients (including toxicology information) and emissions reports.
Once submitted, the applicable submission fee can now be paid online – doing so immediately will help to speed up the review stage of the registration process. Once the MHRA notifications team have reviewed the notification, the product will be published on the MHRA website. Only when the product appears on the notified list can it be sold. You can see the notified list here.
For further information on what is required for UK TPD submissions explore our blog, UK TPD Submissions – What is Required?
How can Future Regulatory Services help you?
If you are reading this as a business owner, manufacturer or producer in the vaping industry and are daunted by the scope of what is required – you don’t have to tackle it alone.
You can benefit from years of industry specific experience, allowing us to efficiently guide you through the process and ensure you can operate with total confidence in the compliance of your products, a confidence which will resonate with your customers.
Our TPD/TRPR Services Include:
- Pre-screening of formulations to ensure compliance with relevant regulations
- Toxicological reports for ingredients
- Packaging review to ensure compliance with Classification, Labelling and Packaging Regulations
- Product Notifications to MHRA Portal
- Product Notifications to EUCEG (EU) Portal
- Worldwide Notifications – PMTA & UAE
- Annual Sales Notifications
- Technical File Dossier Compilations
- Adverse Effects & Reporting
- Laboratory Services – Nicotine Dose Consistency, Carbonyls/Aldehydes in aerosol, Metals analysis in e-liquids and aerosol
Contact us today for more information:
By Email – [email protected]
By Phone – (+44) 0161 917 6393
