Electronic cigarettes were added to the Tobacco Products Directive in 2014. They were given their own article within the document, Article 20, which classifies e-cigarettes and related items as tobacco products. Now, The TPD is written into the UK law and is outlined within the Tobacco and Related Products Regulations 2016 (TRPR). This new law has huge implications on the vaping industry but are you familiar with the requirements?
All requirements in the article must be met in order to manufacture and retail electronic cigarettes, refills and related products. We can help you understand how this effects your business and how your products become TPD compliant.
Why choose us?
TPD Primary Requirements
Manufacturers and importers must submit a dossier to the relevant authorities for each product. This is the MHRA in the UK.
Pre-filled refill tank and cartridges are limited to 2ml and refill bottles are limited to 10ml.
Colourings, caffeine, taurine and other additives are restricted.
E-liquids containing nicotine are restricted to a maximum strength of 20mg/ml.
All nicotine-containing products must have child-resistant, tamper evident packaging.
Advertising is heavily restricted.
There are restrictions on oversea sales.
Manufacturers and retailers are required to share market data trends with the related authority.
Before being taken to market, the TPD require a Technical Dossier for every eliquid flavour to be submitted to and approved by the Medical Health Regulatory Authority (MHRA). A full Toxicological Risk Assessment (TRA) for each eliquid flavour is required for the technical dossier.
The Dossier must also include full chemical compositions and toxicological data for each chemical component. It must also contain administrative information such as business addresses, descriptions and declarations. We are able to produce a TPD compliant Technical Dossier for your business and you can read more about our services below.
Our TPD Compliance services include:
Toxicology Risk Assessments
Final Technical Dossier Submission
All eliquids will undergo a full Toxicological Risk Assessment as follows:
Step One - Toxicological Determination
Working with fully registered, specialist Toxicologists, we’re able to identify hundreds of chemical components and their toxicological profiles. Every chemical is then individually assessed for potential side effects – any concerns will be examined and evaluated to ensure compliance to TPD.
Step Two: Compositional Determination
Chemical compositions of eliquids are established by information from the supplier and a range of analytical processes. With our start of the art equipment, we are able to undertake a wide range of different scientific methods including GC-MS, ICP-MS, UPLC and Thermal Desorption to name a few.
Step Three: Thermal Degradation Profiling
At high temperatures, there is a large chance that chemicals could degrade. Whilst there is no direct combustion when using an e-cigarette, atomiser coils may reach above 300 degrees celsius. It is important that potential degradation is investigation, we undertake this work using bespoke emissions equipment in our in-house laboratories.
Step Four: Toxicological Risk Assessment
Using the data captured through the previous stages, our Chemists will perform a Toxicological Risk Assessment (TRA) that is TPD compliant, for each eliquid flavour included in your Technical Dossier. Comparing each individual ingredient, we are able to compare the concentration against Health Criteria Values (HCVs). HCVs are established threshold limits at which ingredients can be present before they cause hazardous effects.
Step Five: Compilation & Submission
At Eliquid Solutions, we are dedicated to ensuring that each Technical Dossier is accurately compiled and compliant to TPD submission guidelines. Once our team of specialist Chemists are 100% happy that the Technical Dossiers ticks all of the requirements, your submission is ready to send! We can send this on your behalf directly to the MHRA.
Ready to start your journey to success?
Now that you have a clearer understanding of how our services can help you develop and launch an exceptional product range, it’s time to start the process! Simply complete the form below and let us know what you’re looking for and a member of the team will be in contact with you as soon as possible.