bibra on ongoing safety obligations for e-liquids and e-cigarette hardware

Ahead of their presentation at ENDS this June in London, we spoke with Richard Young, Principal Toxicologist and Pete Watts, Director of Toxicology, at bibra toxicology advice and consulting about the ongoing safety obligations for ENDS, why this topic is important, the future of the industry and much more.

Your presentation will look at e-liquids and e-cigarette hardware and ongoing safety assessment obligations, can you provide a bit more information into what this will cover?

e-liquid topics: Resource/budgetary constraints, together with ambiguous drafting of the regulatory text (e.g. Article 20 of TPD2) and associated guidance, meant that many companies only carried out limited toxicity assessments of their e-liquid ingredients and mixtures prior to submitting their initial TPD notification. Some carried out no toxicity assessment at all, rather just conducting a literature search. Companies bear full responsibility for the safety and quality of their products, as placed on the EU market, and therefore need to reconsider the assessments that they have done to ensure that they are scientifically robust, well documented, include the most reliable and up-to-date toxicity/addictiveness data, and employ the most appropriate risk assessment methodologies. A first step in this will be to conduct literature searches for more recent data (or better data on read-across analogues). A robust safety assessment can then be conducted. Of course, it’s not just the underlying toxicity data that might change. We know that there is much interest in this sector coming from the authorities. For example, the European Chemicals Agency (ECHA) is currently reconsidering the harmonised classification of nicotine, and other key e-liquid ingredients (e.g. propylene glycol) are under scrutiny. Critical changes to the toxicity and/or classification of any ingredient could have a significant impact on the safety assessment and labelling of the associated product.

e-cigarette hardware: The safety assessment requires a careful health assessment of any compounds leaching from the e-liquid containers or e-cigarette devices into the liquid or vapour, and being inhaled by the consumer (potentially for many years), particularly in the light of the solvation properties of e-liquids.

Why is this topic pertinent to the ENDS community and what can they hope to learn?

e-liquid topics: If critical new toxicity/addictiveness data are identified following the updated literature searches, it should be assessed and the impact on the safety of the e-liquid mixture reconsidered. This re-evaluation might trigger the need for reformulation, for example to reduce or remove a concerning ingredient. Changes in classification (e.g. the harmonised classification of nicotine as proposed by ECHA) may trigger changes in the appropriate classification of companies’ e-liquid mixtures, and consequently their products' labels and packaging. It’s critical for companies to keep abreast of such possible classification changes, enabling them to react quickly to labelling and packaging changes ensuring uninterrupted manufacture and supply.

e-cigarette hardware: Regular monitoring of the leachables profiles of storage bottles and devices is key. First, these can ensure ongoing quality control and help account for normal analytical variability. Second, changes in materials, components or suppliers might well result in different leachables profiles. The possible health impact of any of these changes in manufacturing needs to be assessed and understood.

The ENDS community as a whole should be concerned, as poor quality products are more likely to be the cause of human health issues amongst consumers. Unfortunately, it is likely that any issues will tarnish the industry as a whole rather than be company/product specific. Further, information in the TPD notifications will be made publicly available in time. All notifications will be viewable, and those relating to toxicologically-concerning ingredients and emission profiles will be of most interest to the media and public; all should therefore be of the highest quality. The risk is that poor quality notifications could bolster the current view held by some, that all e-cigarettes are a high-risk alternative to combustible tobacco products when, in reality, any health risk will be product-specific.

In the last 5 years, have you noticed an increase in this industry and where do you foresee ENDS testing and best practices headed in the future?

It is not exaggerating to say that we have seen an explosion of interest in our toxicology consulting services in this sector over the past 5 years. The main areas have been the early identification of ingredients of high concern in companies’ e-liquid portfolios, the preparation of toxicity/addictiveness monographs on each e-liquid ingredient, advice on the appropriate classification and labelling of certain key ingredients (e.g. nicotine) and companies’ e-liquid mixtures (to EU CLP criteria), and provision of human health risk assessments of the analytically-determined emission profiles (e.g. are the levels of the low molecular weight aldehydes and diketones tolerable), as well as the assessment of the possible health impact of inhaling leachables from the e-cig hardware (e.g. from the e-liquid chamber, atomiser, coil etc) and refill containers.

What are you most looking forward to at the inaugural ENDS 2017 conference?

The conference provides an ideal opportunity for industry, service providers and the regulators to converse. This is a chance for all players in the ENDS sector to network and get up to speed on current issues, allowing transit to a common understanding and an arena for healthy comment and debate.


Richard and Pete will be presenting as part of the 'Product design, testing materials, labelling and manufacturing protocols' session this June. Other speakers include representatives from Committee of Advertising Practice (CAP), Hall Analytical, Eliquid Solutions, Leadscope and Elucid8. View the full programme here.

Book your ticket to join them and the MHRA, Eos Scientific, JT International, British American Tobacco, Battelle, Altria, British Standards Institute and many more now.

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bibra's website – https://www.bibra-information.co.uk/

bibra's electronic cigarette dedicated page – https://www.bibra-information.co.uk/e-cigarettes/

bibra's E&L electronic cigarette dedicated page – https://www.bibra-information.co.uk/ends-extractables-leachables/