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TGO110 testing in Australia
The Australian Therapeutic Goods Administration (TGA) announced that starting from October 1, 2021, all commercially available nicotine vaping products would be regulated as prescription drugs as specified in Schedule 4 of the 1989 Drug Act Toxic Standards. Australian importers need to ensure that nicotine containing vaping products produced overseas meet the necessary standards for importation and supply, specifically by maintaining records that prove that the product meets the requirements of the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110). Therefore, the official may require foreign manufacturers to provide a declaration of compliance and related evidence for products that comply with TGO 110.
Technical requirements
-The nicotine content in the E-liquid shall not exceed 100 mg/mL;
-The following 8 substances are prohibited as E-liquid ingredients:
- Refillable vaping product shall comply with the requirements of Section 9 (excluding Article 9 (6)) of the Australian TGO 95, that is, pass ISO 8317 Child-resistant packaging test.
No. | Substance Name | CAS No. | Common Uses |
1 | 2,3-Butanedione | 431-03-8 | Edible flavour |
2 | 2,3-Pentanedione | 600-14-6 | Edible flavour |
3 | Acetoin | 513-86-0 | Edible flavour |
4 | Cinnamaldehyde | 104-55-2 | Edible flavour |
5 | Benzaldehyde | 100-52-7 | Solvent |
6 | Ethylene glycol | 107-21-1 | Solvent |
7 | Diethylene glycol | 111-46-6 | Solvent |
8 | DL-α-tocopheryl acetate | 7695-91-2 / 52225-20-4 | Vitamin |
What is TGO 110?
Full name: Therapeutic Goods Order No. 110 — Standard for Nicotine Vaping Products.
Nature: It is not a single "test" but a legally mandatory standard document issued by the Therapeutic Goods Administration (TGA) of Australia.
Core Objective: To establish minimum requirements for quality, safety, and composition of nicotine e-cigarette products (nicotine liquid, nicotine-containing pods/capsules) legally supplied in Australia (whether through importers, manufacturers, or pharmacists).
Legal Basis: Established under the Therapeutic Goods Act 1989 and legally binding. Products that do not comply with TGO 110 are non-compliant and cannot be legally sold or supplied in the Australian market.
Why is TGO 110 so important? (Especially under the current policy)
From October 1, 2021, Australia has stipulated:
Consumers must have a doctor's prescription to legally obtain nicotine-containing e-cigarette products.
These prescription products (whether purchased from local pharmacies or imported through personal channels) must comply with the TGO 110 standard.
This means that any importer, manufacturer, or pharmacy wishing to introduce their nicotine e-cigarette products into the Australian supply chain must ensure their products pass all tests stipulated by TGO 110 and maintain ongoing compliance.
What tests and requirements does TGO 110 primarily stipulate?
The standard content is highly detailed and primarily covers the following key areas:
a. Nicotine content and purity
Testing requirements: The actual nicotine content in the product must be highly consistent with the labeled content (with slight deviations allowed).
Purity requirements: Nicotine raw materials must achieve high chemical purity, with strict limits on the upper limit of impurities (such as β - nicotine, nornicotine, other tobacco specific nitrosamines, etc.).
b. Ingredient restrictions and prohibited substances
Permitted Ingredients: A list of ingredients that can be used in electronic cigarette liquids is specified, mainly including:
Propylene glycol, plant glycerin.
Pharmaceutical grade essence (only those permitted by TGA).
Benzoic acid, benzoate salts (in certain specific cases).
Strictly prohibited ingredients:
Vitamin E acetate (associated with EVALI lung injury).
Caffeine and taurine.
Pigments (coloring agents).
Anesthetics, stimulants, psychoactive substances (such as THC).
Substances that can produce additional effects (such as energy enhancement, therapeutic claims).
Certain specific toxic chemicals (such as diethylene glycol, ethylene glycol).
c. Child safety and tamper proof packaging
All nicotine e-liquid containers must be equipped with child safety covers that comply with international standards such as ISO 8317 or similar.
The packaging must be tamper proof.
d. Labels and Information
The label must contain mandatory warning statements (such as "Nicotine is an addictive substance" and "Please keep this product out of reach of children").
Nicotine concentration (mg/mL), ingredient list, expiration date, batch number, manufacturer/importer information, etc. must be clearly labeled.
Prohibit any design that may be attractive to minors (such as cartoon characters, candy names).
e. Stability and shelf life
Manufacturers must provide stability research data to demonstrate that the product maintains stable quality throughout its entire shelf life (usually 2-3 years), and that there will be no significant changes in nicotine content and composition or the production of harmful degradation products.
f. Limits on pollutants and heavy metals
Strict upper limits have been set for potential pollutants in electronic cigarette liquids and aerosols, including:
Heavy metals: such as lead, cadmium, mercury, arsenic, etc.
Other chemical pollutants.
Who will conduct the TGO 110 test?
Responsible party: The product supplier (importer or manufacturer) bears primary responsibility and must commission an accredited laboratory to conduct testing to demonstrate that their product complies with all the terms of TGO 110.
Testing institutions: usually third-party analytical chemistry laboratories with relevant qualifications, which use high-precision instruments (such as gas chromatography-mass spectrometry, liquid chromatography, atomic absorption spectrometer, etc.) for testing.
Regulatory Authority: TGA will conduct market supervision and randomly inspect products to ensure compliance. Products that do not meet the standards will be taken down, and suppliers may face legal penalties.
What does it mean for consumers and the industry?
For consumers: Products obtained through prescription channels should theoretically have higher quality assurance and safety, as they are strictly regulated medical products. Consumers should not use unverified products from informal channels.
For the industry: extremely high barriers to entry have been established. Only companies that can afford strict testing, documentation, and compliance costs can enter the pharmaceutical nicotine e-cigarette market in Australia. This completely changes the previously relatively free market pattern.
summary
The Australian TGO 110 testing is essentially a mandatory compliance testing system established for nicotine electronic cigarette products to be marketed as therapeutic products. It sets strict standards in all aspects from ingredients, purity, impurities, packaging, labeling to stability, aiming to maximize the safety, quality, and consistency of these products obtained through medical channels.
If you need to view the complete legal text, you can visit the official website of the Therapeutic Goods Australia (TGA) and search for "TGO 110".
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