In May of 2016, new EU legislation rocked the e-cigarette industry and forced many manufacturers to pay much closer attention to the contents of their products in the name of public safety. For some, the implementation of the TPD (Tobacco Products Directive) took them right back to the drawing board to ensure their e-liquids met the new criteria, and could continue to be sold to the public.
EL-Science led the charge into this new territory – taking many products back through the laboratory before the deadline to avoid interruption for the consumers. Not only did they refine and perfect the process of TPD compliance testing, their findings are helping to educate various parties the world over, adding real scientific data to the ongoing studies by advocates and sceptics alike.
James Henderson, the Assistant Scientific Officer at EL-Science, was one of those responsible for getting the process right. His continued efforts are helping many other retailers bring their product ranges into line with the standards achieved by his team.
We caught up with James to learn more about the compliance testing, to understand exactly why it’s so important, and why the work his team conducts is so highly sought after and respected.
Hi James! Thanks for giving us the opportunity to speak to you. Can we start with a quick introduction to yourself and what you do here at EL-Science?
Hello! I’m James Henderson, Assistant Scientific Officer for EL- Science. I work directly with Jaydene Halliday, the Chief Scientific Officer. My day to day duties mostly include management decisions and the general running of the company and its various divisions. Mostly we oversee the running of the analytical, flavour and production laboratories, operations and marketing, alongside juggling a bit of trouble shooting (which I thoroughly enjoy!), and providing technical support to our customers.
Sounds varied! Do you have an ‘average day’ you can take us through?
It really does differ – tasks I expect every day are new TPD compliance submissions or advising existing customers through the process. I handle all the product submissions to the MHRA for approval. Once something has gone through the lab, and is approved and ready for submission, it comes to me. I’m in constant contact with the regulatory bodies of various countries because our clients always have new questions, and it is imperative to this work to stay up to date with any regulatory changes.
Let’s say for example that I was a client – I’ve created a liquid for use by the public in e-cigarettes, and I come to you for testing. What is involved in the TPD compliance process?
Well, if we look at it from start to finish, the first step for a flavour or range of flavours is to be sent to our lab where it will undergo preliminary measurements to make sure it’s been manufactured properly. This is a lot like any other quality assurance process for any number of consumable goods. We usually look at density and pH levels first. Density measurements help accurately identify how much PG and VG (propylene glycol and vegetable glycerine) are in the liquid. This is important because the ratio may be noted as 80% VG upon submission to the lab, but when measured it’s perhaps closer to 50%. pH details acidity of the liquid, which is crucial as a high presence of acids will directly influence the way in which we test the juice.
Next, the sample is tested using ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) to determine if there are any metals present. It then undergoes full compositional analysis using GC-MS (Gas Chromatography-Mass Spectrometry) and UPLC (Ultra-Performance Liquid Chromatography) techniques. The diketones diacetyl and acetylpropionyl are specifically named within the TPD legislation as banned substances, which makes it crucial for us to identify them. We also look at the nicotine levels. If a liquid is stated to contain 12 mg/mL of nicotine but it comes back with a vastly different result, it may highlight a problem with the mixing of the e-liquid, or an error from their supplier. We also identify and quantify all other individual components of the e-liquid. We target approximately 500 common flavour components and investigate anything that we find out of the ordinary. This way we have a very accurate determination of the final product.
The very last analytical step is an emissions test – this is another lawful requirement to see if anything harmful can form once the liquid is heated. E-cigarette heating elements can reach high temperatures, and this can cause a lot of reaction chemistry to take place, such as the formation of harmful carbonyls from VG breakdown.
Our Flavour and Toxicology Chemists then assess the toxicological implications of not only each individual ingredient, but the product as a whole, taking the ingredient concentrations into consideration. If they determine that a particular ingredient or a number of ingredients are above their health criteria values (HCVs), then the Flavour Team will reformulate the sample with the aim of reducing or eliminating the ingredient(s) of toxicological concern, whilst maintaining the e-liquid’s flavour.
Finally, we compile all relevant information onto our database, including the ingredients and the toxicological implications of each of them, the name of the liquid, where it’s destined to be sold, how it’s going to be sold, etc. We need a production file from the customer that describes the way in which they produce their e-liquid product and we provide method statements that detail the way in which the testing was conducted. This information is then compiled into an XML file, and submitted to all relevant member state regulatory bodies for approval.
So, some issues you find could be from factors outside the control of the creator – this could be a problem carried across from individual components, regardless of how trusted the source is?
Especially if the liquid is made from concentrates, yes – there’s no guarantee of what these contain. We have seen cases where the importer believed their liquid contained 18 mg/mL of nicotine, but analysis revealed it contained closer to 2 mg/mL. This was traced back to the nicotine they’d purchased – it had not been produced under strict manufacturing conditions, which led to oxidation of the nicotine. This wasn’t the importer’s fault, but highlights the importance of not only testing for TPD compliance, but for manufacturing quality also.