The Tobacco Products Directive (TPD, EU) and The Tobacco and Related Products Regulations (TRPR, UK), cover the requirements for the sale of e-cigarette products.
The protection of consumers is of supreme importance, therefore, both regulations require a safety assessment of the ingredients in the e-liquid to be carried out.
E-liquid Ingredients & Flavourings
E-liquids contain flavours, many of which are food-grade. Such food flavours are not usually evaluated for inhalation exposure, and so it would be incorrect to assume that these are safe to be inhaled, which is why further testing is required when these are being used in e-liquids.
Among their ingredients, e-liquids may also contain;
- herbal extracts
- essential oils
- non-chemically synthesised flavourings
- tobacco extracts
Toxicological Data
TPD/TRPR notifications for e-cigarettes and refill containers should include toxicological data on the ingredients and emissions. This data should refer to the product’s effects on the consumer’s health when inhaled, and its addictive effect, if any. The following information per ingredient should also be provided:
- Emissions toxicity: Data from studies assessing the emissions' toxicity and/or chemistry.
- Carcinogenic, mutagenic, or toxic for reproduction (CMR) toxicity: Data from studies assessing the ingredient's CMR potential.
- CardioPulmonary toxicity: Information in vitro and in vivo studies examining the ingredient's toxicity on the heart, blood vessels or respiratory tract.
- Addictive toxicity: Data from assessing the potential addictive properties of the ingredient.
- Other toxicity: Provision of any other toxicological data not assessed in the previous points.
Potential Challenges
The main challenge faced when generating a toxicological report is the lack of data available in areas such as emissions or inhalation data.
Sometimes, information may be available only on read-across material; while the data gives insights into the potential toxicity of the ingredient assessed, the information is not explicitly derived from the ingredient subject to the toxicology assessment in question. Also, the ingredients are part of a mixture that may differ between manufacturers, meaning typically there is no data available for the toxicity of the e-liquid as a whole. Thus, the evaluation of single compounds hampers other aspects that may influence the toxicity of the e-liquid when vaping, such as the interactions between ingredients.
Preparation is Key
Safety assessments are an important and mandatory part of the TPD notification. We recommend that applicants plan in advance the number of toxicological reports required and the time to complete them, as the notification should be made six months before marketing the product.
In summary, the toxicological evaluation of the ingredient contained in the e-liquids plays a crucial role in the e-cigarette/e-liquid notification. Submission of this data is essential for protecting the consumer’s health and the success of the TPD notification.
For more information on TPD/TRPR safety assessment, or if you are looking for help with your product testing and notifications, please contact us at: info@inter-scientific.com
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