The instrument rests on a small set of recurring legal and technical concepts. Each concept has operational consequences for manufacturers, suppliers and distributors.
Excluded goods for the purposes of the Act , The central legal mechanism is exclusion under s 5. For subsection 7AA(2) of the Act, where a specified item in Schedule 1 is used, advertised, or presented as set out in column 3, it is excluded from the Therapeutic Goods Act regime. That is a categorical scope rule: if all prescribed conditions are met, the product is not treated as a therapeutic good under the Act (s 5). The instrument does not itself state what follows from exclusion in administrative or civil remedy terms; it simply implements the exclusion power granted by s 7AA of the Act (see s 3 Authority).
Formulation specificity , Schedule 1, Column 2 sets tightly constrained formulations. Item 1 requires the final formulation to contain only ethanol 80% v/v (pharmacopoeial grade or food standard grade), purified water derived from potable water rendered sterile or otherwise purified, glycerol 1.45% v/v (pharmacopoeial or food standard grade), and hydrogen peroxide 0.125% v/v (pharmacopoeial grade). Item 2 mirrors that structure with isopropyl alcohol 75% v/v (pharmacopoeial grade) instead of ethanol, and similar requirements for water, glycerol and hydrogen peroxide. Both items explicitly prohibit any other active or inactive ingredients, including colours, fragrances or emollients (Schedule 1 items 1(a)-(iv) and 2(a)-(iv)).
Testing and verification , Each batch’s alcohol concentration must be verified by the manufacturer using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy (Schedule 1 paragraphs (b) in both items). For water purified by an "other purification process", the process must be validated and regular microbiological testing undertaken with specified membrane filtration and incubation methods (s 4 Definitions).
Sanitary manufacturing and recordkeeping , The goods must be manufactured under sanitary conditions, using equipment that is well maintained and fit for purpose (Schedule 1 paragraph (c)). Manufacturers must keep records relating to composition, batch testing of alcohol concentration, water use, and sanitary manufacturing (Schedule 1 paragraph (d)).
Labelling, presentation and advertising constraints , Column 3 prescribes that the goods must be presented for supply only with the front and back labels set out in the relevant part of Schedule 2 attached to the goods, with limited label exceptions (business name/logo, batch number, expiry date no more than 36 months after manufacture, optional WHO formulation statement, cautions/warnings, and colour printing). The goods must not be presented in a way likely to cause confusion with food or beverages. Advertising must be consistent with the matters specified in the label provision; permitted exceptions for advertising are limited to indicating where the goods may be purchased and price information (Schedule 1 column 3).
Definitions and standards cross-referencing , The instrument borrows and defines technical standards. "Pharmacopoeial grade" is cross-referenced to default standards identified in the Act (British Pharmacopoeia, European Pharmacopoeia, United States Pharmacopeia-National Formulary) in s 4. "Food standard grade" requires compliance with the Food Chemicals Codex as in force at commencement. The instrument sets an explicit microbiological threshold for water quality (acceptable microbiological quality is <100 colony forming units per mL) and prescribes test media and incubation regimes for validation sampling (s 4 Definitions).
Transitional mechanics , Section 6 creates a time-limited transitional arrangement preserving application of the Former Determination for certain periods and goods, referencing an Amendment Determination (the Therapeutic Goods Amendment (Excluded Goods,Hand Sanitisers) Determination (No. 2) 2020). The transition rule is narrowly framed to apply only during the defined transition period to the manufacture and supply of goods specified in items 1 and 2 of the Former Determination (s 6(2)).
In short, the instrument operationalises a narrow safe-harbour regime: if manufacturers comply precisely with composition, testing, water and manufacturing standards, and with specified labelling/presentation/advertising requirements, their products are treated as excluded from the therapeutic-goods regulatory regime created by the Act.