Provision of 100’s of TPD2-compliant toxicity / addictiveness monographs for “e-liquid” ingredients

Background

There has been recent rapid expansion in the market for non-tobacco products that deliver inhaled nicotine, most notably, electronic cigarettes. These do not involve burning processes, rather converting an e‑liquid, containing nicotine and other excipients, into a vapour that is inhaled by the user. It is incumbent on manufacturers to ensure that, with the exception of nicotine, any compounds present in e-liquids do not pose a (significant) risk to human health in heated or unheated form; and are compliant with the revised Tobacco Products Directive (TPD2; 2014/40/EU).

Client

A number of e-liquid manufacturers.

Project goals

To provide high quality toxicity/addictiveness monographs on a range of e-liquid ingredients and to identify any critical toxicity/addictiveness data that may impact on consumer safety, particularly any substances of high concern to human health. To additionally provide, where required, periodic updates to monographs in order to communicate changes to the toxicity and/or classification of any ingredient that could have an impact on the safety assessment and labelling of the e-liquid; thus allowing companies to react quickly in terms of safety and compliance to ensure uninterrupted manufacture and supply.

Approach

Literature searches were performed by a bibra toxicologist in a range of data-sources to identify and assess potentially relevant addictiveness and toxicological data based on compound-specific CAS RNs and synonyms, with specific focus being placed on the inhalation route, CMR and cardiovascular properties. Primary data-sources included the bibra TRACE database (an unrivalled resource for the identification of expert group reports and other expert and/or comprehensive reviews), PubMed, and the TOXNET system. The monograph includes a summary of the critical aspects of key available studies including irritation, sensitisation, acute/repeated dose toxicity, genotoxicity, carcinogenicity, reproductive/developmental toxicity, cardiopulmonary effects, chemistry/toxicity of emissions and attractiveness/addictiveness. REACH status and EU CLP harmonised classifications were also included. All monographs are peer-reviewed by a senior bibra European Registered Toxicologist (ERT).

Project outcome

To date, bibra has prepared hundreds of e-liquid toxicity/addictiveness monographs for numerous companies. As well as assisting with TPD2 notifications and EU CLP compliance, these provide a good basis should further e-liquid ingredient safety assessment be required e.g. determination of tolerable thresholds.

Bibra project team

Richard Young

Anne Edwards

Charlie Johnson

Beth O’Connell

 

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