Vaping and e-liquids
“Vaping”, that is the vapour inhalation of liquids containing nicotine and flavours from an electronic cigarette (“e-cigarette”), as an alternative to smoking tobacco, has grown into a large industry since it was introduced in its modern format into Europe in 2006.
The liquids consumed in an “e-cigarette” are often referred to as “e-liquids”, by vapers and the vaping industry, although this term is not officially recognised by the chemical industry or chemical regulators.
E-liquids are always mixtures, usually comprising:
- glycerine (of vegetable origin);
- propylene glycol;
- flavourings; and
- nicotine (where required, as some e-liquids are nicotine-free, presumably as part of the process of weaning consumers off nicotine completely).
This sounds fairly straightforward, but many of the flavourings contain a great many component substances which need to be considered for classification purposes.
E-cigarettes work by heating the e-liquid to a point where vapours are released, which are then inhaled. Unlike normal cigarettes, there is no combustion, so in theory the vaper should only inhale the e-liquid contents, and new substances should not be created (as happens during smoking). However, some e-liquids do appear to produce particulates, giving the effect of “smoke”.
Regulation of e-liquids
At first, there was very little regulation of the vaping industry anywhere in the world, and there were concerns over the safety of e-liquids, even though they have been designed to help smokers reduce and eventually stop tobacco smoking and ultimately cease all nicotine ingestion.
Various countries introduced legislation from 2008 onwards, including some banning these products altogether, for an overview see http://casaa.org/historical-timeline-of-electronic-cigarettes/ .
The EU introduced the Tobacco Products Directive, 2014/14/EU to standardise labelling in the EU and protect consumers from potential hazards in the e-liquids. A list of relevant EU regulations is available from https://ec.europa.eu/health/tobacco/products/revision_en , and the directive itself can be downloaded from https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf (38 pages).
The UK Tobacco and Related Products Regulations 2016 (36 pages) implement this directive, and a thorough overview of how they work is given at https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products .
This guidance states: from 20 May 2017, the new requirements:
- restrict e-cigarette tanks to a capacity of no more than 2ml
- restrict the maximum volume of nicotine-containing e-liquid for sale in one refill container to 10ml
- restrict e-liquids to a nicotine strength of no more than 20mg/ml
- require nicotine-containing products or their packaging to be child-resistant and tamper evident
- ban certain ingredients including colourings, caffeine and taurine
- include new labelling requirements and warnings
- require all e-cigarettes and e-liquids be notified to MHRA before they can be sold
The specific part of the Tobacco and Related Products Regulations 2016 relating to e-liquids is Section 6, see http://www.legislation.gov.uk/uksi/2016/507/part/6/made .
In the UK, e-liquids are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency .
Labelling of e-liquids
There are specific labelling requirements for e-liquids given in the Tobacco and Related Products Regulations, Regulation 37. It is noted that the CLP regulations may also apply, so there is the potential to have two sets of labelling information.
The e-liquid labelling requirements include a health warning on the effects of vaping, who should use the product etc. There is also a requirement that all the ingredients should be listed on the label (or product information leaflet), which may be different to the disclosure requirements in CLP.
The UK’s interpretation of the listing requirement is “that all ingredients in the product should be listed on the label where they are used in quantities of 0.1% or more of the final formulation of the e-liquid. Where a flavour ingredient contains several component chemicals, we consider that it is acceptable to describe the ingredient on the label by the name of the flavour, for example ‘strawberry flavour’. For confidentiality reasons companies may choose to describe individual ingredients used in quantities below 0.1% of the final formulation by category, for example ‘other flavourings’”.
If there is a difference between the disclosure limits for the Tobacco Products regulation or CLP, it is recommended that you use the lowest disclosure limit.
As well as the regulation, the MHRA have also produced a guidance document to clarify some of the issues around e-liquid labelling, https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/520559/Labeling_Guidance.pdf .
Which e-liquids require CLP labelling
Any e-liquid which is classified as hazardous under CLP will need to be labelled for CLP. The maximum concentration of nicotine present in an e-liquid has been limited to 20 mg/ml (or 2% w/w), which does not give rise to a hazardous classification under CLP. However, some of the flavours and fragrances, or even the solvents used, may also give rise to a hazardous classification under CLP, or contain allergens which require a CLP label.
A Safety Data Sheet (SDS) may also be required for supply to other companies, e.g. for transport companies or third party warehousers, or for consumers who are buying the e-liquids over the internet, where full safety information must be made available prior to purchase. Many companies also provide SDSs to consumers on request, or even publish them on their websites.
Tactile warnings and child-resistant packaging for e-liquids
As e-liquids are consumer products, any higher-level health hazards may also require the use of tactile labelling and/or child resistant packaging, but it is considered that the child resistant packaging is already covered by the Tobacco Products Regulation.
Also, the new regulations state that “Nicotine-containing liquid in an electronic cigarette or refill container …must not include ingredients (except for nicotine) which pose a risk to human health in heated or unheated form.“, so unless the nicotine is at levels where it is classifiable for CLP, tactile warnings may not be required.
Should you use data from vapours or aerosols when classifying e-liquids for CLP
For some flavouring component substances, particularly those registered for REACH, health hazard information may be available for vapours and for aerosols/dusts/mists. The different test results may give rise to different hazard classifications for the same substance.
This can be confusing when classifying e-liquids, as in theory they should all be in the vapour phase, but in practice there may be aerosols formed during vaping, or particulates formed (perhaps deliberately as a “smoke substitute”).
There are two approaches possible:
- either to use the vapour phase information only, as it is likely to be the main route of inhalation
- or to classify using both pieces of information, and use the most severe classification which arises (which in turn may mean that you need to reduce the level of an ingredient to reduce the hazard classification)
In both instances, you should keep notes of your reasoning and justification for why you classified a product in a particular way, in the same way as you do for all your CLP classification decisions.
Note that the allergens under CLP are different from the 14 food allergens which may (or may not) also require listing on the label, which are: cereals containing gluten; crustaceans; molluscs; eggs; fish; peanuts; nuts; soybeans; milk; celery; mustard; sesame; lupin; and sulphur dioxide at levels above 10mg/kg, or 10 mg/litre, expressed as SO2. For more information on food allergens, see https://www.food.gov.uk/science/allergy-intolerance/label/ . You should investigate whether this applies to your products or not.