This presentation will provide an overview of the assessment strategy employed by Imperial Brands plc for novel e-liquids from a European perspective only. All manufacturers have a duty to understand how products interact and behave in terms of consumer health and any potential risks that may arise.

The initial desk-based assessment reviews all the ingredients used in e-liquid specification. Initial checks include screening for CMRS (Carcinogens, Mutagens, Reproductive Toxins and Respiratory Sensitizers) using a combination of QSAR techniques and published literature. All ingredients used are checked to be of a suitable quality and purity, ensuring that the ingredients used are below internal limits based on toxicology and anticipated exposure. Following the successful completion of this desk-based evaluation, candidate e-liquids and their aerosols are assessed using the CORESTA Biological battery (Ames, IVM, NRU) and compared to a reference cigarette. Whole aerosol exposures are employed to assess the biological impact of the aerosol mixture. Any atypical results are investigated further with mechanistic in vitro studies (e.g., high content screening & mechanistic reporter assays) and dosimetry. Based on all this information, a decision for the e-liquid suitability is made by the Product Stewardship Toxicologists, and, if deemed acceptable, the e-liquid can proceed through the broader assessment process.

The described process is in keeping with assessment processes published by other manufacturers of e-liquids and the UK Committee of Toxicology’s proposed assessment process, ensuring that high quality, suitable e-liquids are developed in a timely manner.