Glossary: supplement, food and cosmetic regulatory terms

Every definition below is drawn from our guides, which are checked against the regulator pages listed under Sources. Where a term has a long form or another name the regulators use, it is given under the heading. This is general information, not advice on a particular product.

ACCC

Australian Competition and Consumer Commission

The main regulator of cosmetic products in Australia, covering their safety, ingredient labelling and claims. It is responsible for the Consumer Goods (Cosmetics) Information Standard 2020, the mandatory standard a cosmetic's ingredient list follows.

More in our AICIS registration guide.

AICIS

Australian Industrial Chemicals Introduction Scheme

The regulator of the import and manufacture of industrial chemicals in Australia, which include cosmetic ingredients. It registers the businesses that introduce them, not products or ingredients, and it replaced NICNAS on 1 July 2020.

More in our AICIS registration guide.

ARTG

Australian Register of Therapeutic Goods

The TGA's public database of the therapeutic goods that can be legally supplied in Australia. A medicine on it carries an AUST R, AUST L or AUST L(A) number on its label. An entry means a product can be supplied, not always that the TGA has evaluated it.

More in our ARTG guide.

Assessed listed medicine

A medicine like a listed one, drawing its ingredients from the same pre-approved list, but whose indications the TGA assesses for efficacy before sale. Its label carries AUST L(A), it can make intermediate indications that may name a condition such as tinnitus, and it can say "TGA assessed".

More in our TGA listing guide.

AUST L

The number on the label of a listed medicine, the lowest-risk tier of medicine on the ARTG. It shows the medicine uses ingredients from the TGA's pre-approved list and low-level indications, and that its sponsor has certified it meets the rules; the TGA doesn't evaluate a listed medicine before sale.

More in our TGA listing guide.

AUST L(A)

The number on the label of an assessed listed medicine, whose indications the TGA has assessed for efficacy before sale.

More in our TGA listing guide.

AUST R

The number on the label of a registered medicine, which the TGA fully evaluates before sale, including the indications on its label. Registered medicines are the higher-risk ones: all prescription medicines, most over-the-counter medicines such as pain relief and antihistamines, and higher dose iron supplements.

More in our ARTG guide.

Compliance review

A TGA check of a listed medicine after it is listed, which can come at any time. It can ask for information on the label, quality, safety or efficacy. A medicine that doesn't comply can have its label changed, its listing suspended or cancelled, or be recalled.

More in our TGA listing guide.

Cosmetic

A product used on an external part of the body, or in the mouth, to change its odour or appearance, cleanse it, keep it in good condition or protect it. A cream, serum or lotion stays a cosmetic while its claims stay there; a claim to treat a condition, an ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard, or the way it is used can make it a therapeutic good.

More on skincare and cosmetics.

Declared goods

Declared therapeutic goods

Products the Therapeutic Goods (Declared Goods) Order 2019 declares to be therapeutic goods, so the medicines rules apply whatever else does. Some are declared by form alone, such as fibre in tablets, capsules or pills; others by how they are presented, such as beauty supplements, and sports supplements presented for a therapeutic use that contain certain substances or come as a tablet, capsule or pill. Once declared, a product cannot be a food, even if a food standard covers it.

More on how the line is drawn.

Electronic Listing Facility

The part of TGA Business Services that validates a listing application. The sponsor then submits it, certifies that the medicine meets every condition of listing and pays the fee. Passing validation doesn't mean the TGA has confirmed the medicine meets all regulatory requirements.

More in our TGA listing guide.

Excluded goods

Products the Therapeutic Goods (Excluded Goods) Determination 2018 takes out of the medicines rules, as long as they meet every condition it sets. Examples are an SPF 4 to 15 moisturiser that meets its conditions, and an acne product presented as controlling acne only by cleansing, moisturising, exfoliating or drying the skin, with no Schedule 2, 3, 4 or 8 poisons.

More on how the line is drawn.

Food Standards Code

Australia New Zealand Food Standards Code

The rules a food sold in Australia must meet. FSANZ writes it, and the states, territories and local councils enforce it. It sets what a food can contain, what it can claim and what its label says, in standards such as 1.2.7 for health claims and 2.9.4 for sports foods.

More on the food pathway.

Food-medicine interface

The line between a food and a medicine for a product that is swallowed. The TGA says that "generally a product that is swallowed will be either one form of therapeutic good (a medicine) or a food"; the Therapeutic Goods Act's definition of a therapeutic good, the declared and excluded goods lists and the food standards decide which, and the TGA's Food-Medicine Interface Guidance Tool walks through the questions.

More on how the line is drawn.

FSANZ

Food Standards Australia New Zealand

The body that develops and administers the Food Standards Code. It has no enforcement powers: in Australia, state and territory agencies and local councils enforce the Code, and the Department of Agriculture, Fisheries and Forestry enforces it at the border.

More on the food pathway.

GMP

Good manufacturing practice

The standard a listed medicine must be made under. In Australia, every manufacturing step needs a TGA manufacturing licence unless it is exempt, including testing, packaging, labelling and release for supply; an overseas site needs a TGA GMP clearance or certification. The standard the TGA holds manufacturers to is the PIC/S Guide to GMP.

More on TGA licences and GMP.

GMP clearance

TGA GMP clearance

What an overseas manufacturing site needs before it makes a listed medicine for Australia, since only Australian sites can hold a TGA manufacturing licence. The Australian sponsor, or an agent for it, applies, should hold evidence of GMP compliance for every overseas site, and applies to renew a clearance at least six months before it expires.

More on TGA licences and GMP.

Health claim

A claim a food can make only as Standard 1.2.7 of the Food Standards Code permits, at two levels. High level claims refer to a serious disease or a biomarker of one and must rest on a pre-approved relationship; general level claims, such as "calcium for healthy bones and teeth", can rest on a pre-approved relationship or on one notified to FSANZ first. No claim on a food may refer to preventing, diagnosing, curing or alleviating a disease, disorder or condition.

More on what a food can claim.

Listed medicine

The TGA's lowest-risk tier of non-prescription medicine, with an AUST L number on the pack; most complementary medicines sold in Australia, from vitamins to herbal medicines, are listed medicines. It can only use ingredients from the TGA's pre-approved list and make low-level claims from its permitted indications, with evidence held for every claim. The TGA doesn't evaluate it before sale: the Australian sponsor certifies that it meets the rules, and the TGA can review it at any time after.

More on the listed-medicines pathway.

Novel food

A non-traditional food that needs a safety assessment before it is sold. Under Standard 1.5.1 of the Food Standards Code, a novel food can't be sold at retail unless it is listed in Schedule 25 and used within its conditions, and listing follows a safety assessment by FSANZ.

More on the food pathway.

Permissible Indications Determination

Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025

The legal list of the indications a listed medicine can make, in force since 3 April 2025. For each indication it gives the wording, the type of evidence the sponsor must hold, scientific or traditional, and any requirements for using it, such as a label statement.

More in our claims and indications guide.

Permissible Ingredients Determination

Therapeutic Goods (Permissible Ingredients) Determination

The TGA's pre-approved list of the ingredients a listed medicine can use, with the purposes and limits each one is used within. The list changes: there have been three determinations in 2026 alone. An ingredient that isn't on it needs its own application and evaluation before any product using it can be listed.

More in our TGA listing guide.

Permitted indications

The therapeutic claims a listed medicine is allowed to make, set out in the Permissible Indications Determination. In the TGA's words, indications "are statements that describe the specific therapeutic use for a medicine", such as "relieves coughs". A listed medicine can make low-level claims only: "relieves throat irritation", not "reduces high blood pressure".

More in our claims and indications guide.

Primary sunscreen

A product presented mainly to protect the skin from UV. It is a therapeutic good and must be on the ARTG before it is sold, generally as a listed medicine with an AUST L number on the label.

More on sunscreens.

Prohibited representation

A claim that advertising for a medicine can't make and that can't be applied for, listed in the Therapeutic Goods Regulations 1990, such as a claim about treating or preventing cancer or mental illness. The TGA can permit one in a specific ad if it is necessary for public health or the appropriate use of the goods.

More in our claims and indications guide.

Registered medicine

The TGA's higher-risk tier of medicine, marked AUST R on the label. The TGA fully evaluates it for safety, quality and efficacy before it goes on sale, including the indications on its label. All prescription medicines are registered, and so are most over-the-counter medicines, such as pain relief and antihistamines, and higher dose iron supplements.

More in our TGA listing guide.

Restricted representation

A claim in advertising for a medicine that refers to a serious form of a disease, condition, ailment or defect, one that requires "a health professional to diagnose, follow-up or treat". It needs the TGA's prior approval or permission, unless it is part of a required health warning.

More in our claims and indications guide.

Secondary sunscreen

A product with an SPF that isn't presented mainly to protect the skin from UV, such as an SPF moisturiser. Most secondary sunscreens are cosmetics, but an SPF moisturiser stays a cosmetic only if it meets every condition of the Excluded Goods Determination, among them SPF 4 to 15, a pack of 300 mL or 300 g or less and no claim of water resistance; above SPF 15 it is a therapeutic sunscreen. A cosmetic sunscreen must still meet the testing and labelling requirements of the Australian sunscreen standard.

More on sunscreens.

Shelf life

How long a product keeps meeting its specifications, stored as its label says: the period to the expiry date on the label. TGA guidance says a listed medicine's sponsor should hold stability evidence for it at or before listing; if full data aren't ready, older TGA guidance allows an interim shelf life supported by evidence, and testing only at expiry isn't acceptable.

More in our stability testing guide.

Sponsor

The person or company responsible for a therapeutic good in Australia: the one that imports, exports or manufactures it, or arranges for someone else to. A sponsor must be an Australian resident, or a company incorporated and doing business in Australia with a representative who lives here, so an overseas brand needs an Australian sponsor. At listing, the sponsor certifies that the medicine meets every condition of listing and holds the evidence for its claims, and it stays responsible for the medicine meeting every requirement.

More in our TGA listing guide.

Sports food

Formulated supplementary sports food

In the Food Standards Code, "a product that is specifically formulated to assist sports people in achieving specific nutritional or performance goals". Standard 2.9.4 covers it, allows substances restricted or not permitted in other foods and, since 9 June 2026, permits up to 200 mg of caffeine in a day's amount. A sports supplement presented for a therapeutic use can be a declared medicine instead, for example when it comes as a tablet, capsule or pill.

More on the food pathway.

Stability testing

Stability studies

The studies that prove a product's shelf life: that it meets its specifications, stored as its label says, until its expiry date. Real-time studies store the product at its label's storage conditions, to at least the end of its shelf life; accelerated studies store it above the label's maximum temperature, to predict a shelf life from short-term results. For a listed medicine the ongoing program is mandatory and runs in real time, with at least one batch from each product group going on it each year.

More in our stability testing guide.

TGA

Therapeutic Goods Administration

Australia's regulator of therapeutic goods, which runs the Therapeutic Goods Act 1989. It keeps the ARTG, sets the lists a listed medicine's ingredients and indications come from, licenses and clears manufacturers, and can review a listed medicine at any time after it is listed.

More in our TGA listing guide.

TGA Business Services

Where a sponsor enters a medicine for listing. The Electronic Listing Facility validates it there, the sponsor submits, certifies and pays the application fee within 14 days, and once the medicine is on the ARTG its listing usually shows there the next day. A new sponsor first gets a client number through the TGA's organisation details form.

More in our TGA listing guide.

TGO 92

The labelling standard for non-prescription medicines, including listed medicines, until TGO 116 replaced it on 30 September 2026. A medicine released for supply before 1 October 2031 can still follow TGO 92, or a set mix of TGO 116 and TGO 92 provisions.

More in our TGA listing guide.

TGO 101

Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019

The quality standard for tablets, capsules and pills, which TGA guidance says medicines must comply with "throughout their shelf-lives". Unless it follows a pharmacopoeial monograph, a listed tablet or capsule must assay at 90.0 to 120.0% of the amount on the label for most active ingredients; vitamins, minerals, enzymes and probiotics have their own limits.

More in our stability testing guide.

TGO 116

Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026

The labelling standard for non-prescription medicines, including listed medicines, since 30 September 2026, when it replaced TGO 92. The transition runs to 1 October 2031, QR codes are allowed but can't replace what the label must say, and the Therapeutic Goods Advertising Code now refers to it.

More in our TGA listing guide.

Therapeutic good

A product that is presented as, or likely to be taken to be, for therapeutic use: preventing, curing or alleviating a disease, or "influencing, inhibiting or modifying a physiological process". The TGA weighs the name, the claims, the form, dosage instructions, warnings, the advertising and even where it is sold. Declared goods are therapeutic goods whatever else applies; excluded goods are not.

More on how the line is drawn.

Therapeutic Goods Advertising Code

Advertising Code

The rules for advertising therapeutic goods, where advertising includes the label. Advertising must be accurate and balanced, substantiated before it is published and not inconsistent with the indications on the ARTG; most medicine ads must carry "ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE", and none can use an endorsement from a current or former health practitioner, health professional or medical researcher. The Code doesn't apply to advertising directed only at health professionals.

More in our claims and indications guide.