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This instrument is the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2026.
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Commonwealth legislation
This is the TGA’s approved “recipe book” of ingredients allowed in medicines sold in Australia, naming substances from common chemicals to botanicals and probiotics and indicating whether each may be used as an active, excipient or homeopathic ingredient.
It also sets safety rules — concentration, dose, age, route limits and required warnings — so manufacturers, practitioners and consumers know what’s permitted and how products must be labelled.
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Direct links to the current provisions in Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2026.
This instrument is the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2026.
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
<table cellspacing="0" cellpadding="0" style="width:418.2pt; margin-left:5.35pt; border-collapse:collapse"><thead><tr><td colspan="3" style="width:407.5pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Commencement information</span></p></td></tr><tr><td style="width:95.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:209pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td><td style="width:81.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p></td></tr><tr><td style="width:95.65pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Provisions</span></p></td><td style="width:209pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Commencement</span></p></td><td style="width:81.45pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Date/Details</span></p></td></tr></thead><tbody><tr><td style="width:95.65pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1.</span><span> </span><span>The whole of this instrument</span></p></td><td style="width:209pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1 March 2026</span></p></td><td style="width:81.45pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1 March 2026</span></p></td></tr></tbody></table>
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
This instrument is made under subsection 26BB(1) of the Therapeutic Goods Act 1989.
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) British Pharmacopoeia;
(b) European Pharmacopoeia;
(c) medicine;
(d) Register;
(e) United States Pharmacopeia-National Formulary.
(1) In this instrument:
Act means the Therapeutic Goods Act 1989.
active ingredient, or A, for a medicine, has the same meaning as in the Regulations.
code tables means the tables accessed via the Code Tables item in the Public TGA Information menu in TGA eBusiness Services.
excipient or E, for a medicine, means an ingredient that is not an active ingredient or a homoeopathic preparation ingredient.
Note: An excipient includes an ingredient that provides flavour, fragrance or colour to the medicine.
homoeopathic preparation has the same meaning as in the Regulations.
homoeopathic preparation ingredient or H, means an ingredient that is a constituent of a homoeopathic preparation.
Regulations means the Therapeutic Goods Regulations 1990.
TGA eBusiness Services means TGA eBusiness Services on the Therapeutic Goods Administration website, which may be accessed on the internet at www.ebs.tga.gov.au.
Therapeutic Goods Administration has the same meaning as in the Regulations.
(2) To avoid doubt, the terms set out in closed brackets in column 4 of the table in Schedule 1, which are associated with warning statements in relation to particular ingredients, are:
(a) terms from the code tables under the heading Product Warning; and
(b) not required to be reproduced in a warning statement on the label of a medicine.
Note: Examples of these terms include the following:
(a) (ARGIN1);
(b) (CHILD3);
(c) (GLUTEN);
(d) (PEANUT);
(e) (PREGNT).
The ingredients specified in column 2 of the table in Schedule 1 are specified for the purposes of paragraph 26BB(1)(a) of the Act.
For an ingredient mentioned in column 2 of an item in the table in Schedule 1, the following requirements are specified for the purposes of paragraph 26BB(1)(b) of the Act: (a) the ingredient must only be used in a medicine for a purpose specified in relation to the ingredient in column 3 of that item; and (b) subject to section 6A, the ingredient must comply with the requirements specified in relation to the ingredient in column 4 of that item; and (c) if the ingredient is derived from animal originthe safety of the ingredient must have been assessed against, and comply with, the principles and requirements in the European Pharmacopoeia general monograph 1483 Products with risk of transmitting agents of animal spongiform encephalopathies, including General Text 5.2.8: Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products.
Where more than one ingredient in a medicine (the relevant ingredients) must comply with a requirement, specified in column 4 of the table in Schedule 1 in relation to the ingredient, that a warning statement must be stated on the medicine label (the specified warning statement) in the form of either: (a) “In [rare/very rare] cases, [ingredient] may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching”; or (b) “In [rare/very rare] cases, [ingredient] may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine”; the warning statement may be stated only once on the label of the medicine (the combined warning statement), provided that: (c) the combined warning statement lists all the relevant ingredients; and (d) if the specified warning statement for at least one of the relevant ingredients includes the words ‘in rare cases’—the combined warning statement includes the words ‘in rare cases’ instead of the words ‘in very rare cases’; and (e) if the specified warning statement for at least one of the relevant ingredients is in the form mentioned in paragraph (a)—the combined warning statement must be in the form mentioned in paragraph (a).
The Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2025 is repealed.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
This instrument is the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2026.
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
<table cellspacing="0" cellpadding="0" style="width:418.2pt; margin-left:5.35pt; border-collapse:collapse"><thead><tr><td colspan="3" style="width:407.5pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Commencement information</span></p></td></tr><tr><td style="width:95.65pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:209pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td><td style="width:81.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p></td></tr><tr><td style="width:95.65pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Provisions</span></p></td><td style="width:209pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Commencement</span></p></td><td style="width:81.45pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Date/Details</span></p></td></tr></thead><tbody><tr><td style="width:95.65pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1.</span><span> </span><span>The whole of this instrument</span></p></td><td style="width:209pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1 March 2026</span></p></td><td style="width:81.45pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1 March 2026</span></p></td></tr></tbody></table>
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
This instrument is made under subsection 26BB(1) of the Therapeutic Goods Act 1989.
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) British Pharmacopoeia;
(b) European Pharmacopoeia;
(c) medicine;
(d) Register;
(e) United States Pharmacopeia-National Formulary.
(1) In this instrument:
Act means the Therapeutic Goods Act 1989.
active ingredient, or A, for a medicine, has the same meaning as in the Regulations.
code tables means the tables accessed via the Code Tables item in the Public TGA Information menu in TGA eBusiness Services.
excipient or E, for a medicine, means an ingredient that is not an active ingredient or a homoeopathic preparation ingredient.
Note: An excipient includes an ingredient that provides flavour, fragrance or colour to the medicine.
homoeopathic preparation has the same meaning as in the Regulations.
homoeopathic preparation ingredient or H, means an ingredient that is a constituent of a homoeopathic preparation.
Regulations means the Therapeutic Goods Regulations 1990.
TGA eBusiness Services means TGA eBusiness Services on the Therapeutic Goods Administration website, which may be accessed on the internet at www.ebs.tga.gov.au.
Therapeutic Goods Administration has the same meaning as in the Regulations.
(2) To avoid doubt, the terms set out in closed brackets in column 4 of the table in Schedule 1, which are associated with warning statements in relation to particular ingredients, are:
(a) terms from the code tables under the heading Product Warning; and
(b) not required to be reproduced in a warning statement on the label of a medicine.
Note: Examples of these terms include the following:
(a) (ARGIN1);
(b) (CHILD3);
(c) (GLUTEN);
(d) (PEANUT);
(e) (PREGNT).
The ingredients specified in column 2 of the table in Schedule 1 are specified for the purposes of paragraph 26BB(1)(a) of the Act.
For an ingredient mentioned in column 2 of an item in the table in Schedule 1, the following requirements are specified for the purposes of paragraph 26BB(1)(b) of the Act: (a) the ingredient must only be used in a medicine for a purpose specified in relation to the ingredient in column 3 of that item; and (b) subject to section 6A, the ingredient must comply with the requirements specified in relation to the ingredient in column 4 of that item; and (c) if the ingredient is derived from animal originthe safety of the ingredient must have been assessed against, and comply with, the principles and requirements in the European Pharmacopoeia general monograph 1483 Products with risk of transmitting agents of animal spongiform encephalopathies, including General Text 5.2.8: Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products.
Where more than one ingredient in a medicine (the relevant ingredients) must comply with a requirement, specified in column 4 of the table in Schedule 1 in relation to the ingredient, that a warning statement must be stated on the medicine label (the specified warning statement) in the form of either: (a) “In [rare/very rare] cases, [ingredient] may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching”; or (b) “In [rare/very rare] cases, [ingredient] may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine”; the warning statement may be stated only once on the label of the medicine (the combined warning statement), provided that: (c) the combined warning statement lists all the relevant ingredients; and (d) if the specified warning statement for at least one of the relevant ingredients includes the words ‘in rare cases’—the combined warning statement includes the words ‘in rare cases’ instead of the words ‘in very rare cases’; and (e) if the specified warning statement for at least one of the relevant ingredients is in the form mentioned in paragraph (a)—the combined warning statement must be in the form mentioned in paragraph (a).
The Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2025 is repealed.
Note: See sections 5, 6 and 6A.
<table cellspacing="0" cellpadding="0" style="width:454pt; border-collapse:collapse"><tbody><tr><td colspan="4" style="width:443.2pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span>Permissible ingredients and requirements</span></p></td></tr><tr><td style="width:67.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span>Column 1</span></p></td><td style="width:152.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span>Column 2</span></p></td><td style="width:53pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span>Column 3</span></p></td><td style="width:138.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span>Column 4</span></p></td></tr><tr><td style="width:67.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span>Item</span></p></td><td style="width:152.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span>Ingredient Name</span></p></td><td style="width:53pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span>Purpose</span></p></td><td style="width:138.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span>Specific requirements</span></p></td></tr><tr><td style="width:67.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">1</span></p></td><td style="width:152.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">(+-)-NARINGENIN</span></p></td><td style="width:53pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">E</span></p></td><td style="width:138.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">Permitted for use only in combination with other permitted ingredients as a flavour.</span></p><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">If used in a flavour the total flavour concentration in a medicine must be no more than 5%.</span></p><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal"></span></p></td></tr><tr><td style="width:67.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">2</span></p></td><td style="width:152.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">(-)-MENTHYL METHYL ETHER</span></p></td><td style="width:53pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">E</span></p></td><td style="width:138.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">(-)-Menthyl methyl ether must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.</span></p><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">The total concentration of flavour proprietary excipient formulations containing (-)-menthyl methyl ether must not be more than 5% of the total medicine.</span></p><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">When the medicine is for internal use, the maximum recommended daily dose of the medicine must not provide more than 53 micrograms of (-)-menthyl methyl ether.</span></p><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal"></span></p></td></tr><tr><td style="width:67.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">3</span></p></td><td style="width:152.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">(1,7,7-TRIMETHYLBICYCLO(2.2.1)HEPT-2-YL)-CYCLOHEXANOL</span></p></td><td style="width:53pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">E</span></p></td><td style="width:138.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">Permitted for use only in combination with other permitted ingredients as a fragrance.</span></p><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.</span></p><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal"></span></p></td></tr><tr><td style="width:67.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">4</span></p></td><td style="width:152.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading" style="page-break-after:auto"><span style="font-weight:normal">(1R,2S,5R)-N-(4-METHOXYPHENYL)-5-METHYL-2-(1-METHYLETHYL) CYCLOHEXANECARBOXAMIDE</span></p></td><td style="width
This is an opening excerpt, not the complete document.