Categorisation of chemicals in e-cigarettes and personal vaporisers

Have you checked if your chemical is on our Inventory? If your chemical is on our Inventory and your introduction meets any terms of the Inventory listing, your introduction is categorised as a ‘listed’ introduction. Read about listed introductions.

Who should read this?

Importers and manufacturers of industrial chemicals (and products that release industrial chemicals) who are working out if the importation/manufacture (introduction) of their chemical for use in e-cigarettes and personal vaporisers will be an exempted, reported or assessed introduction. This information should be read in conjunction with our categorisation guide.

What is a personal vaporiser?

A personal vaporiser  is a device intended to produce a vapour or aerosol delivered into a person’s body when they inhale through the device. E-cigarettes are an example of a personal vaporiser. Other examples include:

• e-cigars
• e-hookah pens
• e-pens
• e-pipes
• vape pens

We refer to introductions of an industrial chemical for an end use in a personal vaporiser as a ‘specified class of introduction’. We have an increased level of concern for specified classes of introductions, due to: 

• a greater potential for particular hazards or 
• high levels of human or environmental exposure. 

For this reason, there may be extra or different requirements when working out your category of introduction as well as extra record keeping obligations.

Our increased level of concern is because these devices heat a mixture of chemicals to produce an inhalable vapour a user breathes into their lungs. The inhaled chemicals can then cause damage to the lungs and can be absorbed into the body. We outline the extra or different requirements arising from these concerns below.

Note:   

• Nicotine is not an industrial chemical. Contact the TGA if you’re introducing nicotine for use in e-cigarettes and personal vaporisers.
• We do not consider chemicals designed to be used in room diffusers or humidifiers as having an end use in a personal vaporiser. This is because it is intended that users will not inhale the concentrated vapours or aerosols directly.

Is this introduction exempted, reported or assessed? 

You must work out if your introduction meets the criteria for the exempted or reported categories by going through steps 1-6 of the categorisation guide. If your introduction does not meet the criteria for the exempted or reported categories, it will be an assessed introduction. 

The extra or different requirements to be aware of when working out your category of introduction are at:

• Step 4.3: Work out your human health exposure band
• Step 4.4: Work out your human health hazard characteristics

What is the human health exposure band? 

Exposure arising from an end use in a personal vaporiser is a ‘designated kind of human exposure’. The human health exposure band for the introduction of a chemical for an end use in a personal vaporiser, is human health exposure band 4. 

Information you need to demonstrate that your chemical does not have human health hazard characteristics

You’ll need extra or different information to show your chemical doesn’t have the following human health hazard characteristics:

• acute toxicity (fatal or toxic) – Human health hazard band B
• specific target organ toxicity after repeated exposure – Human health hazard band B
• acute toxicity (harmful) – Human health hazard band A

Acute toxicity (fatal or toxic) – Human health hazard band B

If your introduction is to be categorised as reported or exempted, you need to show that your chemical doesn’t have this hazard characteristic. To do this, you’ll need a test result from a study on your chemical (or from suitable read-across information), conducted following an acceptable test guideline for acute inhalation toxicity. 

The test result (LC50) you’ll need depends on the state of your chemical: 

• for gases - greater than 2,500 ppmV/4h, or 
• for vapours - greater than 10 mg/L/4h, or 
• for dusts/mists/fumes - greater than 1 mg/L/4h, 

Specific target organ toxicity after repeated exposure – Human health hazard band B

For your introduction to be categorised as reported or exempted, you need to show that your chemical doesn’t have this hazard characteristic. To do this, you’ll need a test result from a study on your chemical (or from suitable read-across information), conducted following an acceptable test guideline for subacute inhalation toxicity or subchronic inhalation toxicity. In this test:

• there must be no significant toxic effects of relevance to human health, as discussed in chapter 3.9 of the GHS, or 
• the NOAEC (no observed adverse effect concentration – inhalation) must be as shown in this table, and depends on the state of your chemical. 

Acute toxicity (harmful) – Human health hazard band A

If your introduction is to be categorised as exempted, you need to show that your chemical doesn’t have this hazard characteristic. To do this, you’ll need a test result from a study on your chemical (or from suitable read-across information), conducted following an acceptable test guideline for acute inhalation toxicity. 

The test result (median lethal concentration – LC50) you’ll need depends on the state of your chemical: 

• for gases - greater than 20,000 ppmV/4h, or 
• for vapours - greater than 20 mg/L/4h, or 
• for dusts/mists/fumes - greater than 5 mg/L/4h, 

Are there any extra record keeping obligations?

There are no unique records that must be kept based on the introduction of a chemical with an end use in a personal vaporiser. We have prepared guidance for record keeping requirements that apply to all chemical introductions.

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