Electronic cigarette pre-screening
An electronic cigarette and e-liquid manufacturer.
Each particular e-liquid flavour consists of many ingredients (usually in addition to PG and/or VG and nicotine). According to the Tobacco Products Directive (TPD2; 2014/40/EU), any ingredient that poses a risk to human health (apart from nicotine), in particular those that are carcinogenic, mutagenic or reprotoxic (CMR), are not permitted as ingredients in e-liquids.
Bibra was asked to perform a high-throughput screening of the supplied list of flavouring ingredients in which the critical toxicity was noted and any substances of high concern were identified.
Preliminary searches on each ingredient were carried out using bibra’s in-house database, TRACE, to identify critical toxicology data (as well as any relevant other properties e.g. addictiveness). In addition, any EU harmonised (or REACH-registrant/industry notified) classifications were recorded.
Bibra supplied the client with a list flagging ingredients as ‘not of high hazard concern’, ‘possible hazard concern’ and ‘high hazard concern’, with brief justifications and classifications, as well as identifying if any significant data gaps exist in the chemical’s human health database.
Substances of high hazard concern (such as CMRs) as well as corrosive chemicals and respiratory tract irritants and sensitisers) were identified and the client informed. This allowed them to consider mitigating action (e.g. reformulation, prior to analytical emissions testing and subsequent TPD2 notification).
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