What are the regulations on flavors for vaping products?

A study[1] from the Dutch National Institute for Public Health and the Environment (RIVM), published in the British Medical Journal, proposes a restrictive list of permitted flavouring ingredients that will only allow the production of e-liquids with tobacco flavours.

In order to discourage the use of e-cigarettes among young people and achieve a tobacco-free generation by 2040, the Dutch government announced in 2020 that it would only allow tobacco flavours in e-liquids.

The restrictive list of flavour-determining additives in e-cigarettes will be established on the basis of data notified by manufacturers via the European Common Entry Portal (EU-CEG). This is a database in which manufacturers and importers are legally required to provide information on the composition and other properties of tobacco and related products they market in each European country, in particular vaping products.

A predominance of non-tobacco e-liquids on the Dutch market

On 20 June 2020, just before the decision to ban flavours for e-cigarettes was announced, 28,556 e-liquids were registered on the Dutch market. All liquids were classified into 16 flavour categories by the authors and of all e-liquids, only 3,366 (11.8 %) were reported as having a primary tobacco flavour. 855 e-liquids (3%) had a tobacco flavour with a secondary flavour. Among the other flavour categories, the most important were fruity flavours (32.8%), sweet/dessert flavours (15%), flavours that are reminiscent of beverages (tea, coffee, alcohol for 8.8%) and menthol (7%). Only 1.6% of all e-liquids had no flavouring. For the remaining e-liquids, there was insufficient information to classify them into a category and they were classified as “unclassifiable”. However, these e-liquids were included in other calculations of the study covering all e-liquids.

A limited list of 16 authorized ingredients

All e-liquids, regardless of flavor, contained 1981 different ingredients. Tobacco-flavored e-liquids (without secondary flavors) contained 630 different ingredients. Of these, 503 were flavors with a valid Chemical Abstracts Service registry number.[2].

In order to ensure that only flavouring ingredients that taste like tobacco or are present in tobacco and do not pose any health hazard remain in use, the RIVM has established criteria:

• The flavor must be present in at least 0.5 % of liquids for sale that have a tobacco flavor. Flavors rarely used in tobacco flavored e-liquids are not considered essential to the creation of a tobacco flavor, even if they are necessary to create the specific tobacco flavor in which they are used.
• The flavor should be present more frequently in liquids with tobacco flavor than in other liquids. Such compounds are probably specific to tobacco flavor and not to other flavors.
• The aroma cannot be an extract of plant raw materials. The composition of these extracts is not constant and is therefore difficult to determine. This makes it difficult to monitor manufacturers' compliance with the regulations relating to the use of these ingredients.
• The flavour of the substance must resemble tobacco or the substance must be present in tobacco. In this step, sweet flavours, other than those of tobacco, were excluded, in order to minimise appeal to young people. The authors used flavour descriptions as contained in the Leffingwell database, data from the EU Independent Advisory Group (IAG) on Tobacco Consumption, as well as data from the European Commission on the characterisation of flavours in tobacco products and a comprehensive analysis of tobacco industry documents to assess flavour descriptions and ingredient sources.

Based on these criteria, the researchers established a list of 16 flavours that are authorised for the manufacture of tobacco-flavoured e-liquids. They nevertheless specify that the health effects of these 16 substances are unknown, as no data was available to assess them. These substances could be banned under the precautionary principle. After examining the different options, the Dutch government decided to authorise the use of these substances in e-liquids in order to keep this product available to smokers to help them quit smoking.

Similar Restrictive List Proposed in Canada

In June 2021, Health Canada[3] also released a proposal to limit e-cigarette flavours through a restrictive list. Canada would still allow tobacco and mint/menthol flavours. The Canadian proposal would amend Annex 2 of the Tobacco and Vaping Products Act that prohibits certain ingredients from being used in vaping product liquids (coloring agents, vitamins, caffeine, etc.), which would result in a ban on the use of most flavoring ingredients and all sugars and sweeteners in the manufacture of vaping products, unless those products are intended for export or authorized by the FDA.

To determine which flavouring ingredients to exclude, Health Canada first conducted a chemical analysis of e-liquid samples to identify the flavouring chemicals present. Next, the flavouring chemicals were examined for their ability to impart a tobacco or mint/menthol flavour. Based on the literature, the presence of these flavouring chemicals was also investigated.

The proposal also establishes a standard requiring that a vaping product – manufactured using specified ingredients that would be listed in Annex 2 – or its emissions not possess sensory attributes that result in a perception other than that which is typical of tobacco or mint/menthol. In this case, sensory perceptions refer to perception derived from stimuli from the olfactory or taste systems.

The Dutch list is generally stricter in that it only allows tobacco-flavoured e-liquids, while the Canadian list also allows mint/menthol-flavoured e-liquids and thus includes 40 flavours. Furthermore, Health Canada based its list on analytical chemical measurements in 825 e-liquids obtained on the Canadian market, while the Dutch researchers based their list on data provided by manufacturers via the European Union system, EU-CEG, for all e-liquids notified for the Dutch market, which are much more numerous. Furthermore, the two institutes did not use exactly the same inclusion and exclusion criteria; for example, the Dutch researchers also excluded substances that pose health risks. Finally, e-liquids containing tobacco flavours may have a different composition in Canada and the Netherlands.

Flavor bans expanding across EU and worldwide

Characterising flavours have been banned for traditional cigarettes and rolling tobacco in the European Union since May 2016, and for menthol products since May 2020. At the beginning of November 2022, the European Commission published the directive 2022/2100, extending the ban on characterising flavours to heated tobacco products. Member states are free to go beyond the EU directive and regulate flavours in e-liquids by banning them. Hungary, for example, bans all flavouring agents in vaping products. Finland and Estonia ban vaping products with flavours other than tobacco, and Denmark bans those with a flavour other than tobacco or menthol.

Similar provisions are also being adopted in other countries/states around the world, including the United States where several states have banned flavors for all nicotine products. Countries in South America and Asia have decided to ban vaping products entirely.

The WHO calls for vigilance around these new products and recommends strengthening existing regulations on these products in order to limit their use by young people as much as possible.

Keywords: Netherlands, aromas, flavors, ban, vaping, e-cigarettes, Europe, Canada, restrictive list

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[1] Pennings JLA, Havermans A, Krusemann EJZ, et al Reducing attractiveness of e-liquids: proposal for a restrictive list of tobacco-related flavors Tobacco Control Published Online First: 20 January 2023. doi: 10.1136/tc-2022-057764

[2] Division of the American Chemical Society. The Chemical Abstracts Service (CAS) has a registry system for all fully identified compounds or chemical substances.

[3] Canada Gazette, Part I, Volume 155, Number 25: Order Amending Schedules 2 and 3 to the Tobacco and Vaping Products Act (Flavors), Department of Health, published June 19, 2021