As anybody involved in the ENDS industry will know, taking your product from the drawing board onto the market is a long and complicated process, especially with the new regulations such as TPD2 in the EU now in force. It’s easy to imagine the disappointment if your product is ultimately not considered safe to place on the market and/or not approved by the regulators (e.g. the MHRA in the UK or the US FDA in the US) after many months of product design, research and development, often requiring significant resource and financial investment.

One of the reasons a product might not make it to market is that it contains ingredients that are hazardous to human health. For example, according to the EU TPD2, e-liquids are not permitted to contain additives that have Carcinogenic, Mutagenic or Reprotoxic properties (i.e. CMR substances). This seems a very sensible approach to help ensure that the most toxicologically concerning compounds are not added to e-liquid formulations going forwards.

So how could this potential disappointment be avoided?

After a new e-liquid has been formulated, a recipe of the flavouring ingredients and excipients is generated. From this, it is possible for bibra toxicologists to efficiently scan the recipe, briefly assessing and summarising the critical toxicity, addictiveness, and classification data on each constituent, identifying those of potential high health concern. Additives that have, for example, CMR properties, or are associated with respiratory sensitisation, can be quickly identified by our team of toxicologists with the help of our in-house database, TRACE. This will allow product reformulation at an early stage in the development process, notably prior to laboratory analyses of the product emissions (which can be quite expensive), where no toxicologically concerning ingredients are identified in the formulation. The data gathered as part of the pre-screening exercise, in addition to an understanding of the key datagaps, will aid in the evaluation of the hazards and potential risks to human health posed by the ENDS product, and ultimately in any regulatory submission (e.g. notification of the product under the TPD2).

Catching these CMRs, respiratory sensitizers, and other high-risk chemicals early on in the product development process is clearly highly advantageous. Not only will it save considerable resources such as time and money for e-cigarette companies, it will also help to provide reassurance of the safety of such products placed on the market, for which the e-liquid producer is fully responsible.

Get in touch if you think a pre-screen of your e-liquids would benefit you.




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