We have compiled a list of the questions that we get asked most frequently by our clients regarding the upcoming Tobacco Products Directive (TPD) and the other services and products that we provide.
If your questions are not covered in our FAQ, please get in touch and we can discuss your queries with you.
What does the Tobacco Products Directive (TPD) involve?
In order for your eLiquids to be TPD compliant, you must submit a Technical Dossier containing a Toxicological Risk Assessment (TRA) for each of them to the MHRA. To produce the TRA, the flavour composition of the eLiquid needs to be detailed by either the supplier information or its analysis using our inhouse GC/MS; ideally, both. This information then needs to be combined with a robust set of toxicological data so that a registered Toxicologist can perform the TRA for that flavour.
Once the TRA has been compiled, it needs to be entered into the TPD common submission format along with some more administrative information, and then submitted to the MHRA.
EL-Science can assist you to be fully TPD compliant, and can even compile your Technical Dossiers for you.
What are your plans for the TPD?
While the TPD is will come into effect in May 2016, our team at EL-Science has been busy preparing for implementation over the past year. The comprehensive steps we have taken ensure that we are in the best position to assist you with the TPD requirements as they develop now and in the future.
To this end, we have recruited a dedicated team of qualified professionals, consisting of 9 chemists, 4 who hold Ph.D.s, and 3 senior managers. To support our in house specialist TPD team, we have partnered with 2 toxicology companies who are in the process of working through a list of more than 300 chemical compounds to provide us with the most up-to-date toxicological profiling in the industry.
To facilitate implementation, we have also invested heavily into our in house Analytical Laboratory, which has various high tech equipment, including two GC/MS instruments, spectrophotometers and a whole host of smaller analytical equipment which enable us to perform analysis- not just on eLiquids and eLiquid vapour, but on ecigarette hardware too.
To ensure that we remain at the forefront of this new legislation and that we are in the best position to advise you, we also regularly consult with the UK government and the MHRA, in addition to sitting on several committees.
Does your analysis cover the TPD?
For compliance with the TPD, a much more in-depth set of analysis is required. Our standard analysis is designed for batch testing of finished products prior to bottling and distribution, and isn’t suited to TPD requirements as it stands.
This standard set of analysis will be used after TPD implementation to ensure that batches of manufactured eLiquid remain compliant, and will evolve over the course of the TPD implementation to include more compounds of concern.
If my eLiquids pass analysis, does this mean that they are safe?
Our standard analysis is not intended as a safety check*, and is more of a batch confirmation check for production batches. This analysis looks for concerning diketones, such as diacetyl and acetonyl propionyl, as well as other compounds of potential interest, like acetoin. There are many other compounds which may be of concern which we do not look for in standard analysis, and many others which will be assessed during the upcoming TPD work.
*Initial overview from toxicology indicates that the generic flavour compounds, when used as intended at the low levels found within most ecigarettes, pose a very low risk– one that is many times lower than the risk posed by tobacco cigarettes.
How many samples to I need to send from my range for analysis?
e.g. If I have a strawberry flavour in 3 different strengths, do I need to send each one?
The answer to this question depends on what exactly you are trying to achieve. Sending a single strength from each flavour for analysis is a good starting point if you are at the first step and looking to increase your quality levels. The data generated will be helpful to you as you make recipe decisions, and will be sufficient for you to gain confidence in your recipes. However, this will not give you confidence in each individual batch.
Once you are satisfied with your recipe, the next step you should take is to begin batch testing, testing each strength. This ensures that every batch of eLiquid has been manufactured correctly, and your suppliers have not changed their ingredients for some batches. Batch testing is especially vital if you hold Products Liability insurance; without full batch testing, this insurance is very difficult to uphold in the case of a claim- effectively, it would be invalid.
What does it mean if my eLiquids fail analysis?
There are 2 ways that an eLiquid can ‘fail’ our analysis.
- i) The nicotine content is outside of our threshold value e.g., if what should be an 18mg nicotine eLiquid comes back at 15mg, then this would fail the nicotine.
- ii) One or more of the flavour compounds fail our internal threshold. This simply means that the eLiquid does not meet our internal threshold standards, and so this is not technically a fail, unless our thresholds are the ones you are attempting to meet.
Depending on what you require, we can issue analysis reports either against our threshold or as standard analytical reports (without our thresholds) for you to assess against whichever threshold you have decided upon yourself.
Do you offer discounts on bulk analysis?
Yes, we do have several ways to offer bulk discounts for multiple analyses. The main involves a 25% discount on your first order, with further discounts for ongoing batch analysis.
A great option for companies looking to achieve our level of quality and compliance, by performing full batch analysis on every produced batch of eLiquid, is to take our membership package, designed to assist companies transition into full batch testing, which offers a larger initial discount in addition to ongoing discounted analysis costs.
Can I split manufacture batches into different flavours and strengths?
e.g. Could I split a 1 L batch into 500 mL Apple 3 mg and 500 mL Cherry 3 mg?
No, a batch of eLiquid is always a single flavour in a single strength. Each batch is individually analysed following production to ensure quality, and this analytical cost is factored into the pricing. This is one of the primary reasons that larger batches rapidly reduce the price per litre, and is also a dictating factor that limits our minimum batch size to 1 litre.
We do offer a stock holding facility that is designed to allow you to take advantage of the cheaper pricing associated with the manufacture of a large batch. This facility allows you to pay for bottles as they are removed from the batch, as opposed to having to pay for the bulk quantity upfront. We designed this facility with significant input from some of our smaller customers, and have found that it can help a lot with cash flow.
Can I use bottles other than your standard ones?
Yes. We have more than 30 different eLiquid bottles available that range from 10m LDPE through to 30ml glass and above, bottles with or without droppers, and many other coloured eLiquid bottles to suit any design requirements you may have. If you prefer, we can also source new bottles, or use bottles that you supply yourself.