Vapouround magazine Issue 05 | Page 28

NEWS Why Your E-liquid Needs To Be Tested, Approved and Awarded A Technical Dossier There are two main reasons why the e-liquids sold to customers as vaping products need to be tested: because your customers have the right to know that the product is not harmful and because the law says it must be tested. We dealt with the first part in the accompanying article about e-liquid testing laboratory EL Science which extensively quoted the views of its Technical Director Shaun Wedgwood. In a nutshell, customers have the right to be reassured that the vaping products sold to them are not going to be unsafe for them to use. That alone is a very good reason why the vaping industry as a whole should welcome, encourage and actively promote the testing of e-liquids. As far as the law is concerned, if anyone wants to sell e-liquid within Europe then they must comply with the Tobacco Products Directive (TPD) which came into force on May 20 this year. The primary requirement of the TPD as it applies to e-liquid testing is that manufacturers and importers must submit a ‘technical dossier’ to the relevant authorities for each product sold. In the UK the relevant authority is the Medical Health Regulatory Authority (MHRA) and a technical dossier for every e-liquid flavour sold must be provided to them by November at the latest. The technical dossier must: • Contain administrative information such as addresses, descriptions and declarations. • Detail the full chemical composition. • Provide a complete set of toxicological data for each chemical component. • Have an associated Toxicological Risk Assessment (TRA) prepared using the accumulated data for each end product. EL Science has been working closely with the MHRA and wants to be able to set the ‘gold standard’ for e-liquid testing to ensure that not only is the law complied 28 ISSUE 05 VAPOUROUND MAGAZINE with but that customers can feel confident that the products they will vape have been thoroughly and rigorously tested by highly competent experts. When EL Science carries out a full Toxicological Risk Assessment, the process can be split into five main stages. Stage One – Toxicological Determination EL Science works with specialist, fully registered toxicological companies to determine the toxicological profiles of over 300 individual chemical components, which form the base components of the vast majority of flavour concentrates. Each chemical is individually assessed for potential adverse effects, and components of concern will be further investigated to achieve effective threshold limits. Stage Two – Compositional Determination The chemical composition of an e-liquid must be determined through a combination of supplier information and analytical determination and confirmation. The EL Science laboratory contains the very latest high specification GCMS, Thermal Desorption, Atomic Absorption equipment and a whole range of smaller laboratory instrumentation which has been specifically chosen and commissioned to allow for chemical compositional analysis of e-liquid and e-liquid vapour. Stage Three – Thermal Degradation Profiling While no direct combustion occurs during the usage of e-cigarettes, the atomiser coil may elevate temperatures to above 300 degrees celsius. At such high temperat ures, certain chemicals can degrade so it is important to investigate these potential degradation pathways. This investigation work is then confirmed by GC/MS Thermal Desorption technology. Stage Four – Toxicological Risk Assessment Where appropriate, utilising the data generated in the previous stages, a full TPD compliant Toxicological Risk Assessment (TRA) is compiled for the specific e-liquid flavour under examination for inclusion in the Technical Dossier. Stage Five – Compilation and Submission The EL Science team of organic chemists ensure that each Technical Dossier is correctly compiled and compliant with submission requirements. Only when the team is fully satisfied that the Technical Dossier contains all the required data do they submit the notification directly to the MHRA. It can be seen that the vaping industry has come a long way since the early days when people would just mix flavours together in the hope of finding ones which tasted good. Now we have developed as an industry to the point where we can use the very best that science and chemical analysis can provide to provide great flavours which have also been shown to be free from harmful compounds. As EL Science’s Shaun Wedgwood put it: “We can no longer develop new flavours based solely on taste - flavour development has now become a merging of art and science. “In our new post-TPD world, flavour development is something which will take months, not weeks, and putting a new flavour onto the market is going to take a significant investment and become a significant business decision.” * To find out more on being TPD compliant, you can contact Shaun Wedgwood at [email protected] or call 01733 352553.