You may have noticed that e-cigarettes have become one of the fastest-growing industries in the UK and North America. Walk down your local high street and you’re likely to be engulfed by a candy-floss flavoured plume of vape from a nearby e-cigarette enthusiast, as they make their way toward one of the many dedicated e-cigarette and e-liquid retailers, or trendy “vape lounges”, that are appearing.

The need for regulation

With increasing mainstream popularity for e-cigarettes, or electronic nicotine delivery systems (ENDS), comes the inevitable need for regulation.

On 20th May 2016, Article 20 of the Tobacco Products Directive (TPD) came into effect across Europe. This legislation has introduced various restrictions on, for example: e‑liquid bottle size, maximum nicotine content, maximum cartridge size and restricted advertising. Certain ingredients are now banned from e-liquids; particularly those concerning chemicals which have carcinogenic, mutagenic or reprotoxic (CMR) properties and/or are respiratory sensitisers.

All ENDS products (including e-liquids and e‑cig devices) now require a notification to be submitted to the relevant EU Competent Authority (the MHRA, for products in the UK) prior to placing on the market. As part of this notification, manufacturers or importers of ENDS must provide “toxicological data regarding the product’s ingredients and emissions”.

This may seem a relatively straight-forward  request, but it has generated a multitude of issues and queries in the industry due to its ambiguity. For example, how much data is required? Will a literature search for each ingredient/emission suffice? What endpoints should be covered? What level of detail is appropriate or necessary? Should the assessment be carried out by a professionally registered toxicologist?

It’s a minefield, but Bibra can help

Bibra has assisted a large number of e‑cigarette and e-liquid manufacturers, and has successfully been involved in the toxicological aspects of thousands of TPD notifications.

Expert bibra toxicologists screen the e-liquid ingredients early on in the process – identifying high concern substances (e.g. CMR and respiratory sensitisers) – so there’s time for product reformulation if necessary.

A fundamental service that the Bibra team has provided its e-cig clients over the last few years is the generation of e-liquid ingredient toxicity and addictiveness monographs. We’ve produced literally hundreds of these monographs, each one including summaries of the key data on the ingredient’s potential toxicity (e.g. CMR and Cardiopulmonary properties) as well as addictiveness. For more detail on Bibra’s e-liquid ingredient monographs, click here.

We have long argued that the results of a literature search are not adequate for assessing the safety of e-liquid ingredients, rather the key toxicological data for a wide-range of endpoints must be assessed for each. In support of our position, the MHRA are now requesting more details from those notifiers that have submitted only literature search results.

Bibra has conducted many health risk assessments for its ENDS clients. Certain concerning compounds are inherently present in the emissions of vaporised PG- or VG-based e‑liquids, most notably aldehydes and ketones such as formaldehyde and diacetyl.  After being provided with the analytical results of the e‑liquid emissions, our toxicologists were able to conclude on the potential health risks posed by inhalation exposure to such compounds through vaping.

Bibra scientists will soon be discussing their experiences of working in the ENDS industry, providing further plumes of toxicological wisdom for (mainly) e-liquids and e-cig emissions.

Please get in touch now if you are an e-cigarette importer/manufacturer. Our dedicated team of scientists will be happy to assist with your e-cig needs.

 

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