{"id":"F2020L00340","name":"Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020","slug":"therapeutic-goods-excluded-goods-hand-sanitisers-determination-2020","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":100895,"registerId":"commonwealth-F2020L00340-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n This instrument is the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020.\n\n#### 3 Authority\n\n This instrument is made under section 7AA of the Therapeutic Goods Act 1989.\n\n#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:\n\n advertise;\n\n (b) batch;\n (c) British Pharmacopoeia;\n (d) default standard;\n (e) European Pharmacopoeia;\n (f) label;\n (g) supply; and\n (h) United States Pharmacopoeia-National Formulary.\n In this instrument:\n\n> acceptable microbiological quality, in relation to water, means a microbial count that is less than 100 colony forming units per mL.\n\n> Act means the Therapeutic Goods Act 1989.\n\n> food standard grade means compliance with an applicable standard in the Food Chemicals Codex, as in force or existing at the commencement of this instrument.\n\n> Note: The Food Chemicals Codex is available online at: www.foodchemicalscodex.org.\n\n> other purification process, in relation to water, means a process, such as reverse osmosis, that meets the following requirements:\n\n (a) the process is validated to produce and distribute water that is of acceptable chemical quality and acceptable microbiological quality; and\n (b) regular microbiological testing of the water is undertaken, including sampling at the point of use, using one of the following methods:\n (i) filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating on a single plate at 30-35°C for not less than 5 days; or\n (ii) filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating on separate plates at 35-37°C and 20-22°C for not less than 5 days.\n\n> pharmacopoeial grade means compliance with an applicable default standard.\n\n> Note: The default standards are the British Pharmacopoeia, European Pharmacopoeia and the United States Pharmacopoeia-National Formulary.\n\n## Part 2—Excluded goods\n\n#### 5 Excluded goods\n\n For subsection 7AA(2) of the Act, the goods specified in column 2 of an item of the table in Schedule 1, when used, advertised, or presented for supply in a way specified in column 3 of that item, are excluded goods for the purposes of the Act.\n\n## Part 3—Application, saving and transitional provisions\n\n#### 6 Transitional provision\n\n (1) In this section:\n\n> Amendment Determination means the Therapeutic Goods Amendment (Excluded Goods—Hand Sanitisers) Determination (No. 2) 2020.\n\n> commencement date means the day on which the Amendment Determination commences.\n\n> Former Determination means the Therapeutic Goods (Excluded Goods—Hand Sanitiser) Determination 2020, as in force immediately before the commencement date.\n\n> transition period means the period beginning on the commencement date and ending on 30 June 2020.\n\n (2) Despite the amendments made by the Amendment Determination, the Former Determination continues to apply for the duration of the transition period in relation to the manufacture and supply of goods specified in items 1 and 2 of the table in Schedule 1 to the Former Determination.\n\nSchedule 1—Specified goods used, advertised, or presented for supply in a particular way\n\n> Note: See section 5.\n\n```html\n

Specified goods that are excluded goods when used, advertised, or presented for supply in a particular way

Column 1

Column 2

Column 3

Item

Specified goods

Use, advertising or presentation

1

hand sanitiser in relation to which all of the following paragraphs apply:

(a) the final formulation of the hand sanitiser contains only the following ingredients:

(i) ethanol 80% v/v (pharmacopoeial grade or food standard grade) in an aqueous solution that may contain a denaturant such as denatonium benzoate (NLT 5ppm), sucrose octaacetate (0.12%w/v) or tertiary butyl alcohol (0.25%v/v);

(ii) purified water derived from potable water that has been rendered sterile or otherwise purified by boiling, distillation or other purification process;

(iii) glycerol 1.45% v/v (pharmacopoeial grade or food standard grade);

(iv) hydrogen peroxide 0.125% v/v (pharmacopoeial grade);

and does not contain any other active or inactive ingredients, including colours, fragrances or emollients;

(b) the concentration of ethanol specified in subparagraph (a)(i) is verified by the manufacturer testing samples of each batch of the final formulation of the hand sanitiser using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy;

(ba) the purified water specified in subparagraph (a)(ii) is used as soon as practicable following purification to maintain the acceptable chemical quality, and the acceptable microbiological quality, of the water;

(c) the hand sanitiser is manufactured under sanitary conditions using equipment that is well maintained and fit for purpose;

(d) records relating to the manufacture of the hand sanitiser are kept by the manufacturer in relation to each of the matters specified in paragraphs (a), (b), (ba) and (c)

when:

(a) presented for supply with the front and back labels set out in Part 1 of Schedule 2 attached to the goods, and not presented for supply in any other way, with the following exceptions:

(i) the labels may include a business name or logo of the manufacturer or supplier, and a trade name for the goods, neither of which may suggest or imply that the goods have been recommended or approved by or on behalf of a government or government authority;

(ii) the labels may include a batch number;

(iii) the labels may include an expiry date, which must not be more than 36 months after the completion of the manufacture of the goods;

(iv) the labels may state that the formulation of the goods is based on the handrub formulation of the World Health Organization;

(v) the labels may include any caution, warning or other marking that relates to the safe use, transportation or storage of the goods;

(vi) the labels may be printed in colour;

(vii) the front and back labels may be combined into a single label or may otherwise be co-located on the goods; and

(b) not presented for supply in a way that is likely to result in the goods being mistaken for or confused with food or beverages; and

(c) advertised in a manner that is consistent with the matters specified in paragraph (a) and not advertised in any other way with the following exceptions:

(i) an advertisement in relation to the goods may include information as to where the goods may be purchased;

(ii) an advertisement in relation to the goods may include price information

2

hand sanitiser in relation to which all of the following paragraphs apply:

(a) the final formulation of the hand sanitiser contains only the following ingredients:

(i) isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;

(ii) purified water derived from potable water that has been rendered sterile or otherwise purified by boiling, distillation or other purification process;

(iii) glycerol 1.45% v/v (pharmacopoeial grade or food standard grade);

(iv) hydrogen peroxide 0.125% v/v (pharmacopoeial grade);

and does not contain any other active or inactive ingredients, including colours, fragrances or emollients;

(b) the concentration of isopropyl alcohol specified in subparagraph (a)(i) is verified by the manufacturer testing samples of each batch of the final formulation of the hand sanitiser using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy;

(ba) the purified water specified in subparagraph (a)(ii) is used as soon as practicable following purification to maintain the acceptable chemical quality, and the acceptable microbiological quality, of the water;

(c) the hand sanitiser is manufactured under sanitary conditions using equipment that is well maintained and fit for purpose;

(d) records relating to the manufacture of the hand sanitiser are kept by the manufacturer in relation to each of the matters specified in paragraphs (a), (b), (ba) and (c)

when:

(a) presented for supply with the front and back labels set out in Part 2 of Schedule 2 attached to the goods, and not presented for supply in any other way, with the following exceptions:

(i) the labels may include a business name or logo of the manufacturer or supplier, and a trade name for the goods, neither of which may suggest or imply that the goods have been recommended or approved by or on behalf of a government or government authority;

(ii) the labels may include a batch number;

(iii) the labels may include an expiry date, which must not be more than 36 months after the completion of the manufacture of the goods;

(iv) the labels may state that the formulation of the goods is based on the handrub formulation of the World Health Organization;

(v) the labels may include any caution, warning or other marking that relates to the safe use, transportation or storage of the goods;

(vi) the labels may be printed in colour;

(vii) the front and back labels may be combined into a single label or may otherwise be co-located on the goods; and

(b) not presented for supply in a way that is likely to result in the goods being mistaken for or confused with food or beverages; and

(c) advertised in a manner that is consistent with the matters specified in paragraph (a) and not advertised in any other way with the following exceptions:

(i) an advertisement in relation to the goods may include information as to where the goods may be purchased;

(ii) an advertisement in relation to the goods may include price information

\n```\n\n \n\nSchedule 2—Labels\n\n## Part 1—Ethanol hand sanitiser\n\n> Note: See item 1 of Schedule 1.\n\n> Note: 1 Front label\n\n| Ethanol hand sanitiser 80%Hand rub [optional text: suitable for use in medical and health services]DO NOT DRINK[Insert volume of the product in mLs][Insert name of the manufacturer or supplier][Insert contact details of the manufacturer or supplier] |\n| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n\n> Note: 2 Back label\n\n| Contains:Ethanol 80% v/v, water, glycerol and hydrogen peroxide.[Insert name of denaturant used, if applicable]Use:Antiseptic hand rub when soap and water are not available.Directions for use:Apply sufficient amount of product on hands to cover all surfaces.Rub hands together until dry.Warnings:For external use only. Flammable. Keep away from heat or flame.Keep out of eyes, ears and mouth.Discontinue use if skin irritation or rash occurs.Keep out of reach of children.Poisons Information Centre 13 11 26.Store below 30 °C.Date of manufacture: [Insert dd mm yyyy] |\n| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n\n## Part 2—Isopropyl alcohol hand sanitiser\n\n> Note: See item 2 of Schedule 1.\n\n> Note: 1 Front label\n\n| Isopropyl alcohol hand sanitiser 75%Hand rub [optional text: suitable for use in medical and health services]DO NOT DRINK[Insert volume of the product in mLs][Insert name of the manufacturer or supplier][Insert contact details of the manufacturer or supplier] |\n| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n\n> Note: 2 Back label\n\n| Contains:Isopropyl alcohol 75% v/v, water, glycerol and hydrogen peroxide.Use:Antiseptic hand rub when soap and water are not available.Directions for use:Apply sufficient amount of product on hands to cover all surfaces.Rub hands together until dry.Warnings:For external use only. Flammable. Keep away from heat or flame.Keep out of eyes, ears and mouth.Discontinue use if skin irritation or rash occurs.Keep out of reach of children.Poisons Information Centre 13 11 26.Store below 30 °C.Date of manufacture: [Insert dd mm yyyy] |\n| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under section 7AA of the Therapeutic Goods Act 1989.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:\n\n advertise;\n\n (b) batch;\n (c) British Pharmacopoeia;\n (d) default standard;\n (e) European Pharmacopoeia;\n (f) label;\n (g) supply; and\n (h) United States Pharmacopoeia-National Formulary.\n In this instrument:\n\n> acceptable microbiological quality, in relation to water, means a microbial count that is less than 100 colony forming units per mL.\n\n> Act means the Therapeutic Goods Act 1989.\n\n> food standard grade means compliance with an applicable standard in the Food Chemicals Codex, as in force or existing at the commencement of this instrument.\n\n> Note: The Food Chemicals Codex is available online at: www.foodchemicalscodex.org.\n\n> other purification process, in relation to water, means a process, such as reverse osmosis, that meets the following requirements:\n\n (a) the process is validated to produce and distribute water that is of acceptable chemical quality and acceptable microbiological quality; and\n (b) regular microbiological testing of the water is undertaken, including sampling at the point of use, using one of the following methods:\n (i) filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating on a single plate at 30-35°C for not less than 5 days; or\n (ii) filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating on separate plates at 35-37°C and 20-22°C for not less than 5 days.\n\n> pharmacopoeial grade means compliance with an applicable default standard.\n\n> Note: The default standards are the British Pharmacopoeia, European Pharmacopoeia and the United States Pharmacopoeia-National Formulary.","sortOrder":3},{"sectionNumber":"Part 2","sectionType":"part","heading":"Excluded goods","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n This instrument is the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020.\n\n#### 3 Authority\n\n This instrument is made under section 7AA of the Therapeutic Goods Act 1989.\n\n#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:\n\n advertise;\n\n (b) batch;\n (c) British Pharmacopoeia;\n (d) default standard;\n (e) European Pharmacopoeia;\n (f) label;\n (g) supply; and\n (h) United States Pharmacopoeia-National Formulary.\n In this instrument:\n\n> acceptable microbiological quality, in relation to water, means a microbial count that is less than 100 colony forming units per mL.\n\n> Act means the Therapeutic Goods Act 1989.\n\n> food standard grade means compliance with an applicable standard in the Food Chemicals Codex, as in force or existing at the commencement of this instrument.\n\n> Note: The Food Chemicals Codex is available online at: www.foodchemicalscodex.org.\n\n> other purification process, in relation to water, means a process, such as reverse osmosis, that meets the following requirements:\n\n (a) the process is validated to produce and distribute water that is of acceptable chemical quality and acceptable microbiological quality; and\n (b) regular microbiological testing of the water is undertaken, including sampling at the point of use, using one of the following methods:\n (i) filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating on a single plate at 30-35°C for not less than 5 days; or\n (ii) filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating on separate plates at 35-37°C and 20-22°C for not less than 5 days.\n\n> pharmacopoeial grade means compliance with an applicable default standard.\n\n> Note: The default standards are the British Pharmacopoeia, European Pharmacopoeia and the United States Pharmacopoeia-National Formulary.\n\n## Part 2—Excluded goods\n\n#### 5 Excluded goods\n\n For subsection 7AA(2) of the Act, the goods specified in column 2 of an item of the table in Schedule 1, when used, advertised, or presented for supply in a way specified in column 3 of that item, are excluded goods for the purposes of the Act.\n\n## Part 3—Application, saving and transitional provisions\n\n#### 6 Transitional provision\n\n (1) In this section:\n\n> Amendment Determination means the Therapeutic Goods Amendment (Excluded Goods—Hand Sanitisers) Determination (No. 2) 2020.\n\n> commencement date means the day on which the Amendment Determination commences.\n\n> Former Determination means the Therapeutic Goods (Excluded Goods—Hand Sanitiser) Determination 2020, as in force immediately before the commencement date.\n\n> transition period means the period beginning on the commencement date and ending on 30 June 2020.\n\n (2) Despite the amendments made by the Amendment Determination, the Former Determination continues to apply for the duration of the transition period in relation to the manufacture and supply of goods specified in items 1 and 2 of the table in Schedule 1 to the Former Determination.\n\nSchedule 1—Specified goods used, advertised, or presented for supply in a particular way\n\n> Note: See section 5.\n\n```html\n

Specified goods that are excluded goods when used, advertised, or presented for supply in a particular way

Column 1

Column 2

Column 3

Item

Specified goods

Use, advertising or presentation

1

hand sanitiser in relation to which all of the following paragraphs apply:

(a) the final formulation of the hand sanitiser contains only the following ingredients:

(i) ethanol 80% v/v (pharmacopoeial grade or food standard grade) in an aqueous solution that may contain a denaturant such as denatonium benzoate (NLT 5ppm), sucrose octaacetate (0.12%w/v) or tertiary butyl alcohol (0.25%v/v);

(ii) purified water derived from potable water that has been rendered sterile or otherwise purified by boiling, distillation or other purification process;

(iii) glycerol 1.45% v/v (pharmacopoeial grade or food standard grade);

(iv) hydrogen peroxide 0.125% v/v (pharmacopoeial grade);

and does not contain any other active or inactive ingredients, including colours, fragrances or emollients;

(b) the concentration of ethanol specified in subparagraph (a)(i) is verified by the manufacturer testing samples of each batch of the final formulation of the hand sanitiser using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy;

(ba) the purified water specified in subparagraph (a)(ii) is used as soon as practicable following purification to maintain the acceptable chemical quality, and the acceptable microbiological quality, of the water;

(c) the hand sanitiser is manufactured under sanitary conditions using equipment that is well maintained and fit for purpose;

(d) records relating to the manufacture of the hand sanitiser are kept by the manufacturer in relation to each of the matters specified in paragraphs (a), (b), (ba) and (c)

when:

(a) presented for supply with the front and back labels set out in Part 1 of Schedule 2 attached to the goods, and not presented for supply in any other way, with the following exceptions:

(i) the labels may include a business name or logo of the manufacturer or supplier, and a trade name for the goods, neither of which may suggest or imply that the goods have been recommended or approved by or on behalf of a government or government authority;

(ii) the labels may include a batch number;

(iii) the labels may include an expiry date, which must not be more than 36 months after the completion of the manufacture of the goods;

(iv) the labels may state that the formulation of the goods is based on the handrub formulation of the World Health Organization;

(v) the labels may include any caution, warning or other marking that relates to the safe use, transportation or storage of the goods;

(vi) the labels may be printed in colour;

(vii) the front and back labels may be combined into a single label or may otherwise be co-located on the goods; and

(b) not presented for supply in a way that is likely to result in the goods being mistaken for or confused with food or beverages; and

(c) advertised in a manner that is consistent with the matters specified in paragraph (a) and not advertised in any other way with the following exceptions:

(i) an advertisement in relation to the goods may include information as to where the goods may be purchased;

(ii) an advertisement in relation to the goods may include price information

2

hand sanitiser in relation to which all of the following paragraphs apply:

(a) the final formulation of the hand sanitiser contains only the following ingredients:

(i) isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;

(ii) purified water derived from potable water that has been rendered sterile or otherwise purified by boiling, distillation or other purification process;

(iii) glycerol 1.45% v/v (pharmacopoeial grade or food standard grade);

(iv) hydrogen peroxide 0.125% v/v (pharmacopoeial grade);

and does not contain any other active or inactive ingredients, including colours, fragrances or emollients;

(b) the concentration of isopropyl alcohol specified in subparagraph (a)(i) is verified by the manufacturer testing samples of each batch of the final formulation of the hand sanitiser using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy;

(ba) the purified water specified in subparagraph (a)(ii) is used as soon as practicable following purification to maintain the acceptable chemical quality, and the acceptable microbiological quality, of the water;

(c) the hand sanitiser is manufactured under sanitary conditions using equipment that is well maintained and fit for purpose;

(d) records relating to the manufacture of the hand sanitiser are kept by the manufacturer in relation to each of the matters specified in paragraphs (a), (b), (ba) and (c)

when:

(a) presented for supply with the front and back labels set out in Part 2 of Schedule 2 attached to the goods, and not presented for supply in any other way, with the following exceptions:

(i) the labels may include a business name or logo of the manufacturer or supplier, and a trade name for the goods, neither of which may suggest or imply that the goods have been recommended or approved by or on behalf of a government or government authority;

(ii) the labels may include a batch number;

(iii) the labels may include an expiry date, which must not be more than 36 months after the completion of the manufacture of the goods;

(iv) the labels may state that the formulation of the goods is based on the handrub formulation of the World Health Organization;

(v) the labels may include any caution, warning or other marking that relates to the safe use, transportation or storage of the goods;

(vi) the labels may be printed in colour;

(vii) the front and back labels may be combined into a single label or may otherwise be co-located on the goods; and

(b) not presented for supply in a way that is likely to result in the goods being mistaken for or confused with food or beverages; and

(c) advertised in a manner that is consistent with the matters specified in paragraph (a) and not advertised in any other way with the following exceptions:

(i) an advertisement in relation to the goods may include information as to where the goods may be purchased;

(ii) an advertisement in relation to the goods may include price information

\n```\n\n \n\nSchedule 2—Labels\n\n## Part 1—Ethanol hand sanitiser\n\n> Note: See item 1 of Schedule 1.\n\n> Note: 1 Front label\n\n| Ethanol hand sanitiser 80%Hand rub [optional text: suitable for use in medical and health services]DO NOT DRINK[Insert volume of the product in mLs][Insert name of the manufacturer or supplier][Insert contact details of the manufacturer or supplier] |\n| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n\n> Note: 2 Back label\n\n| Contains:Ethanol 80% v/v, water, glycerol and hydrogen peroxide.[Insert name of denaturant used, if applicable]Use:Antiseptic hand rub when soap and water are not available.Directions for use:Apply sufficient amount of product on hands to cover all surfaces.Rub hands together until dry.Warnings:For external use only. Flammable. Keep away from heat or flame.Keep out of eyes, ears and mouth.Discontinue use if skin irritation or rash occurs.Keep out of reach of children.Poisons Information Centre 13 11 26.Store below 30 °C.Date of manufacture: [Insert dd mm yyyy] |\n| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n\n## Part 2—Isopropyl alcohol hand sanitiser\n\n> Note: See item 2 of Schedule 1.\n\n> Note: 1 Front label\n\n| Isopropyl alcohol hand sanitiser 75%Hand rub [optional text: suitable for use in medical and health services]DO NOT DRINK[Insert volume of the product in mLs][Insert name of the manufacturer or supplier][Insert contact details of the manufacturer or supplier] |\n| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n\n> Note: 2 Back label\n\n| Contains:Isopropyl alcohol 75% v/v, water, glycerol and hydrogen peroxide.Use:Antiseptic hand rub when soap and water are not available.Directions for use:Apply sufficient amount of product on hands to cover all surfaces.Rub hands together until dry.Warnings:For external use only. Flammable. Keep away from heat or flame.Keep out of eyes, ears and mouth.Discontinue use if skin irritation or rash occurs.Keep out of reach of children.Poisons Information Centre 13 11 26.Store below 30 °C.Date of manufacture: [Insert dd mm yyyy] |\n| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |","sortOrder":4},{"sectionNumber":"5","sectionType":"section","heading":"Excluded goods","content":"#### 5 Excluded goods\n\n For subsection 7AA(2) of the Act, the goods specified in column 2 of an item of the table in Schedule 1, when used, advertised, or presented for supply in a way specified in column 3 of that item, are excluded goods for the purposes of the Act.","sortOrder":5},{"sectionNumber":"Part 3","sectionType":"part","heading":"Application, saving and transitional provisions","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n This instrument is the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020.\n\n#### 3 Authority\n\n This instrument is made under section 7AA of the Therapeutic Goods Act 1989.\n\n#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:\n\n advertise;\n\n (b) batch;\n (c) British Pharmacopoeia;\n (d) default standard;\n (e) European Pharmacopoeia;\n (f) label;\n (g) supply; and\n (h) United States Pharmacopoeia-National Formulary.\n In this instrument:\n\n> acceptable microbiological quality, in relation to water, means a microbial count that is less than 100 colony forming units per mL.\n\n> Act means the Therapeutic Goods Act 1989.\n\n> food standard grade means compliance with an applicable standard in the Food Chemicals Codex, as in force or existing at the commencement of this instrument.\n\n> Note: The Food Chemicals Codex is available online at: www.foodchemicalscodex.org.\n\n> other purification process, in relation to water, means a process, such as reverse osmosis, that meets the following requirements:\n\n (a) the process is validated to produce and distribute water that is of acceptable chemical quality and acceptable microbiological quality; and\n (b) regular microbiological testing of the water is undertaken, including sampling at the point of use, using one of the following methods:\n (i) filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating on a single plate at 30-35°C for not less than 5 days; or\n (ii) filtration of a suitable sample size through a membrane of nominal pore size not greater than 0.45 µm, using R2A agar and incubating on separate plates at 35-37°C and 20-22°C for not less than 5 days.\n\n> pharmacopoeial grade means compliance with an applicable default standard.\n\n> Note: The default standards are the British Pharmacopoeia, European Pharmacopoeia and the United States Pharmacopoeia-National Formulary.\n\n## Part 2—Excluded goods\n\n#### 5 Excluded goods\n\n For subsection 7AA(2) of the Act, the goods specified in column 2 of an item of the table in Schedule 1, when used, advertised, or presented for supply in a way specified in column 3 of that item, are excluded goods for the purposes of the Act.\n\n## Part 3—Application, saving and transitional provisions\n\n#### 6 Transitional provision\n\n (1) In this section:\n\n> Amendment Determination means the Therapeutic Goods Amendment (Excluded Goods—Hand Sanitisers) Determination (No. 2) 2020.\n\n> commencement date means the day on which the Amendment Determination commences.\n\n> Former Determination means the Therapeutic Goods (Excluded Goods—Hand Sanitiser) Determination 2020, as in force immediately before the commencement date.\n\n> transition period means the period beginning on the commencement date and ending on 30 June 2020.\n\n (2) Despite the amendments made by the Amendment Determination, the Former Determination continues to apply for the duration of the transition period in relation to the manufacture and supply of goods specified in items 1 and 2 of the table in Schedule 1 to the Former Determination.\n\nSchedule 1—Specified goods used, advertised, or presented for supply in a particular way\n\n> Note: See section 5.\n\n```html\n

Specified goods that are excluded goods when used, advertised, or presented for supply in a particular way

Column 1

Column 2

Column 3

Item

Specified goods

Use, advertising or presentation

1

hand sanitiser in relation to which all of the following paragraphs apply:

(a) the final formulation of the hand sanitiser contains only the following ingredients:

(i) ethanol 80% v/v (pharmacopoeial grade or food standard grade) in an aqueous solution that may contain a denaturant such as denatonium benzoate (NLT 5ppm), sucrose octaacetate (0.12%w/v) or tertiary butyl alcohol (0.25%v/v);

(ii) purified water derived from potable water that has been rendered sterile or otherwise purified by boiling, distillation or other purification process;

(iii) glycerol 1.45% v/v (pharmacopoeial grade or food standard grade);

(iv) hydrogen peroxide 0.125% v/v (pharmacopoeial grade);

and does not contain any other active or inactive ingredients, including colours, fragrances or emollients;

(b) the concentration of ethanol specified in subparagraph (a)(i) is verified by the manufacturer testing samples of each batch of the final formulation of the hand sanitiser using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy;

(ba) the purified water specified in subparagraph (a)(ii) is used as soon as practicable following purification to maintain the acceptable chemical quality, and the acceptable microbiological quality, of the water;

(c) the hand sanitiser is manufactured under sanitary conditions using equipment that is well maintained and fit for purpose;

(d) records relating to the manufacture of the hand sanitiser are kept by the manufacturer in relation to each of the matters specified in paragraphs (a), (b), (ba) and (c)

when:

(a) presented for supply with the front and back labels set out in Part 1 of Schedule 2 attached to the goods, and not presented for supply in any other way, with the following exceptions:

(i) the labels may include a business name or logo of the manufacturer or supplier, and a trade name for the goods, neither of which may suggest or imply that the goods have been recommended or approved by or on behalf of a government or government authority;

(ii) the labels may include a batch number;

(iii) the labels may include an expiry date, which must not be more than 36 months after the completion of the manufacture of the goods;

(iv) the labels may state that the formulation of the goods is based on the handrub formulation of the World Health Organization;

(v) the labels may include any caution, warning or other marking that relates to the safe use, transportation or storage of the goods;

(vi) the labels may be printed in colour;

(vii) the front and back labels may be combined into a single label or may otherwise be co-located on the goods; and

(b) not presented for supply in a way that is likely to result in the goods being mistaken for or confused with food or beverages; and

(c) advertised in a manner that is consistent with the matters specified in paragraph (a) and not advertised in any other way with the following exceptions:

(i) an advertisement in relation to the goods may include information as to where the goods may be purchased;

(ii) an advertisement in relation to the goods may include price information

2

hand sanitiser in relation to which all of the following paragraphs apply:

(a) the final formulation of the hand sanitiser contains only the following ingredients:

(i) isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;

(ii) purified water derived from potable water that has been rendered sterile or otherwise purified by boiling, distillation or other purification process;

(iii) glycerol 1.45% v/v (pharmacopoeial grade or food standard grade);

(iv) hydrogen peroxide 0.125% v/v (pharmacopoeial grade);

and does not contain any other active or inactive ingredients, including colours, fragrances or emollients;

(b) the concentration of isopropyl alcohol specified in subparagraph (a)(i) is verified by the manufacturer testing samples of each batch of the final formulation of the hand sanitiser using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy;

(ba) the purified water specified in subparagraph (a)(ii) is used as soon as practicable following purification to maintain the acceptable chemical quality, and the acceptable microbiological quality, of the water;

(c) the hand sanitiser is manufactured under sanitary conditions using equipment that is well maintained and fit for purpose;

(d) records relating to the manufacture of the hand sanitiser are kept by the manufacturer in relation to each of the matters specified in paragraphs (a), (b), (ba) and (c)

when:

(a) presented for supply with the front and back labels set out in Part 2 of Schedule 2 attached to the goods, and not presented for supply in any other way, with the following exceptions:

(i) the labels may include a business name or logo of the manufacturer or supplier, and a trade name for the goods, neither of which may suggest or imply that the goods have been recommended or approved by or on behalf of a government or government authority;

(ii) the labels may include a batch number;

(iii) the labels may include an expiry date, which must not be more than 36 months after the completion of the manufacture of the goods;

(iv) the labels may state that the formulation of the goods is based on the handrub formulation of the World Health Organization;

(v) the labels may include any caution, warning or other marking that relates to the safe use, transportation or storage of the goods;

(vi) the labels may be printed in colour;

(vii) the front and back labels may be combined into a single label or may otherwise be co-located on the goods; and

(b) not presented for supply in a way that is likely to result in the goods being mistaken for or confused with food or beverages; and

(c) advertised in a manner that is consistent with the matters specified in paragraph (a) and not advertised in any other way with the following exceptions:

(i) an advertisement in relation to the goods may include information as to where the goods may be purchased;

(ii) an advertisement in relation to the goods may include price information

\n```\n\n \n\nSchedule 2—Labels\n\n## Part 1—Ethanol hand sanitiser\n\n> Note: See item 1 of Schedule 1.\n\n> Note: 1 Front label\n\n| Ethanol hand sanitiser 80%Hand rub [optional text: suitable for use in medical and health services]DO NOT DRINK[Insert volume of the product in mLs][Insert name of the manufacturer or supplier][Insert contact details of the manufacturer or supplier] |\n| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n\n> Note: 2 Back label\n\n| Contains:Ethanol 80% v/v, water, glycerol and hydrogen peroxide.[Insert name of denaturant used, if applicable]Use:Antiseptic hand rub when soap and water are not available.Directions for use:Apply sufficient amount of product on hands to cover all surfaces.Rub hands together until dry.Warnings:For external use only. Flammable. Keep away from heat or flame.Keep out of eyes, ears and mouth.Discontinue use if skin irritation or rash occurs.Keep out of reach of children.Poisons Information Centre 13 11 26.Store below 30 °C.Date of manufacture: [Insert dd mm yyyy] |\n| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n\n## Part 2—Isopropyl alcohol hand sanitiser\n\n> Note: See item 2 of Schedule 1.\n\n> Note: 1 Front label\n\n| Isopropyl alcohol hand sanitiser 75%Hand rub [optional text: suitable for use in medical and health services]DO NOT DRINK[Insert volume of the product in mLs][Insert name of the manufacturer or supplier][Insert contact details of the manufacturer or supplier] |\n| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n\n> Note: 2 Back label\n\n| Contains:Isopropyl alcohol 75% v/v, water, glycerol and hydrogen peroxide.Use:Antiseptic hand rub when soap and water are not available.Directions for use:Apply sufficient amount of product on hands to cover all surfaces.Rub hands together until dry.Warnings:For external use only. Flammable. Keep away from heat or flame.Keep out of eyes, ears and mouth.Discontinue use if skin irritation or rash occurs.Keep out of reach of children.Poisons Information Centre 13 11 26.Store below 30 °C.Date of manufacture: [Insert dd mm yyyy] |\n| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |","sortOrder":6},{"sectionNumber":"6","sectionType":"section","heading":"Transitional provision","content":"#### 6 Transitional provision\n\n (1) In this section:\n\n> Amendment Determination means the Therapeutic Goods Amendment (Excluded Goods—Hand Sanitisers) Determination (No. 2) 2020.\n\n> commencement date means the day on which the Amendment Determination commences.\n\n> Former Determination means the Therapeutic Goods (Excluded Goods—Hand Sanitiser) Determination 2020, as in force immediately before the commencement date.\n\n> transition period means the period beginning on the commencement date and ending on 30 June 2020.\n\n (2) Despite the amendments made by the Amendment Determination, the Former Determination continues to apply for the duration of the transition period in relation to the manufacture and supply of goods specified in items 1 and 2 of the table in Schedule 1 to the Former Determination.\n\nSchedule 1—Specified goods used, advertised, or presented for supply in a particular way\n\n> Note: See section 5.\n\n```html\n

Specified goods that are excluded goods when used, advertised, or presented for supply in a particular way

Column 1

Column 2

Column 3

Item

Specified goods

Use, advertising or presentation

1

hand sanitiser in relation to which all of the following paragraphs apply:

(a) the final formulation of the hand sanitiser contains only the following ingredients:

(i) ethanol 80% v/v (pharmacopoeial grade or food standard grade) in an aqueous solution that may contain a denaturant such as denatonium benzoate (NLT 5ppm), sucrose octaacetate (0.12%w/v) or tertiary butyl alcohol (0.25%v/v);

(ii) purified water derived from potable water that has been rendered sterile or otherwise purified by boiling, distillation or other purification process;

(iii) glycerol 1.45% v/v (pharmacopoeial grade or food standard grade);

(iv) hydrogen peroxide 0.125% v/v (pharmacopoeial grade);

and does not contain any other active or inactive ingredients, including colours, fragrances or emollients;

(b) the concentration of ethanol specified in subparagraph (a)(i) is verified by the manufacturer testing samples of each batch of the final formulation of the hand sanitiser using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy;

(ba) the purified water specified in subparagraph (a)(ii) is used as soon as practicable following purification to maintain the acceptable chemical quality, and the acceptable microbiological quality, of the water;

(c) the hand sanitiser is manufactured under sanitary conditions using equipment that is well maintained and fit for purpose;

(d) records relating to the manufacture of the hand sanitiser are kept by the manufacturer in relation to each of the matters specified in paragraphs (a), (b), (ba) and (c)

when:

(a) presented for supply with the front and back labels set out in Part 1 of Schedule 2 attached to the goods, and not presented for supply in any other way, with the following exceptions:

(i) the labels may include a business name or logo of the manufacturer or supplier, and a trade name for the goods, neither of which may suggest or imply that the goods have been recommended or approved by or on behalf of a government or government authority;

(ii) the labels may include a batch number;

(iii) the labels may include an expiry date, which must not be more than 36 months after the completion of the manufacture of the goods;

(iv) the labels may state that the formulation of the goods is based on the handrub formulation of the World Health Organization;

(v) the labels may include any caution, warning or other marking that relates to the safe use, transportation or storage of the goods;

(vi) the labels may be printed in colour;

(vii) the front and back labels may be combined into a single label or may otherwise be co-located on the goods; and

(b) not presented for supply in a way that is likely to result in the goods being mistaken for or confused with food or beverages; and

(c) advertised in a manner that is consistent with the matters specified in paragraph (a) and not advertised in any other way with the following exceptions:

(i) an advertisement in relation to the goods may include information as to where the goods may be purchased;

(ii) an advertisement in relation to the goods may include price information

2

hand sanitiser in relation to which all of the following paragraphs apply:

(a) the final formulation of the hand sanitiser contains only the following ingredients:

(i) isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;

(ii) purified water derived from potable water that has been rendered sterile or otherwise purified by boiling, distillation or other purification process;

(iii) glycerol 1.45% v/v (pharmacopoeial grade or food standard grade);

(iv) hydrogen peroxide 0.125% v/v (pharmacopoeial grade);

and does not contain any other active or inactive ingredients, including colours, fragrances or emollients;

(b) the concentration of isopropyl alcohol specified in subparagraph (a)(i) is verified by the manufacturer testing samples of each batch of the final formulation of the hand sanitiser using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy;

(ba) the purified water specified in subparagraph (a)(ii) is used as soon as practicable following purification to maintain the acceptable chemical quality, and the acceptable microbiological quality, of the water;

(c) the hand sanitiser is manufactured under sanitary conditions using equipment that is well maintained and fit for purpose;

(d) records relating to the manufacture of the hand sanitiser are kept by the manufacturer in relation to each of the matters specified in paragraphs (a), (b), (ba) and (c)

when:

(a) presented for supply with the front and back labels set out in Part 2 of Schedule 2 attached to the goods, and not presented for supply in any other way, with the following exceptions:

(i) the labels may include a business name or logo of the manufacturer or supplier, and a trade name for the goods, neither of which may suggest or imply that the goods have been recommended or approved by or on behalf of a government or government authority;

(ii) the labels may include a batch number;

(iii) the labels may include an expiry date, which must not be more than 36 months after the completion of the manufacture of the goods;

(iv) the labels may state that the formulation of the goods is based on the handrub formulation of the World Health Organization;

(v) the labels may include any caution, warning or other marking that relates to the safe use, transportation or storage of the goods;

(vi) the labels may be printed in colour;

(vii) the front and back labels may be combined into a single label or may otherwise be co-located on the goods; and

(b) not presented for supply in a way that is likely to result in the goods being mistaken for or confused with food or beverages; and

(c) advertised in a manner that is consistent with the matters specified in paragraph (a) and not advertised in any other way with the following exceptions:

(i) an advertisement in relation to the goods may include information as to where the goods may be purchased;

(ii) an advertisement in relation to the goods may include price information

\n```\n\n \n\nSchedule 2—Labels","sortOrder":7}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":true,"description":"This instrument narrows the regulatory reach of the Therapeutic Goods Act for a specific set of hand sanitiser products by excluding them from the Act when strict compositional, testing, manufacturing and labelling conditions are met (section 5; Schedule 1). In other words, goods that otherwise would be treated as 'therapeutic goods' become exempted if they conform to the two prescribed WHO‑style formulations and the labelling/testing regimes. That is a substantive scope change from default regulation because it creates a conditional regulatory carve‑out: it reduces pre‑market TGA oversight for those narrowly described products in exchange for specific, technical compliance obligations. The transitional provision (section 6) also adjusts temporal scope by preserving an earlier determination for a defined transition period, so the practical regulatory coverage differs from the Act’s baseline for a limited time and for the specified items."},"complexity_factors":["Multiple defined terms with technical meanings (acceptable microbiological quality, food standard grade, other purification process, pharmacopoeial grade).","Two parallel, detailed product specifications in Schedule 1 (ethanol and isopropyl formulations) with nested subparagraphs (composition, batch testing, water use, manufacturing conditions, recordkeeping).","Prescriptive microbiological testing protocols for water (membrane filtration, R2A agar, temperatures and incubation times) increasing technical specificity.","Mandatory batch‑level verification of alcohol concentration with a list of acceptable analytical methods (gas chromatography, alcoholmeter, hydrometer or equivalent).","Prescribed label templates in Schedule 2 with a number of permitted exceptions and constraints (expiry limits, permitted statements, prohibition on implying government approval).","Constraints on presentation and advertising with enumerated exceptions (risk of subtle interpretative questions about permitted vs prohibited advertising).","Transitional provision referencing an Amendment Determination and a former determination, creating cross‑instrument temporal application (section 6).","References to external standards (British Pharmacopoeia, European Pharmacopoeia, USP‑NF, Food Chemicals Codex) which require users to consult other documents.","Technical manufacturing requirements expressed at a behavioural level (\"sanitary conditions\", \"well maintained and fit for purpose\" equipment) that require discretionary judgments in compliance.","Repetition and overlap across parts and schedules that can make locating the operative obligations slightly cumbersome."],"plain_english_summary":"**What this instrument does (mechanically)\n\n- It declares that certain simple hand sanitiser products are \"excluded goods\" under the Therapeutic Goods Act 1989. That means those specific products are not treated as \"therapeutic goods\" for the purposes of that Act when they meet the conditions set out in this instrument (see section 5 and Schedule 1).\n\n- The instrument specifies two narrowly‑defined formulations: an ethanol‑based hand sanitiser (80% v/v ethanol) and an isopropyl‑based hand sanitiser (75% v/v isopropyl alcohol). Each formulation must contain only the other listed ingredients (purified water, glycerol 1.45% v/v, hydrogen peroxide 0.125% v/v) and no other actives or additives (colours, fragrances, emollients). (Schedule 1, items 1–2)\n\n- Manufacturers must verify the alcohol concentration for each batch using designated chemical tests (gas chromatography, alcoholmeter, hydrometer or equivalent), use purified water promptly after purification, make and keep manufacturing records, and produce the goods under sanitary, well‑maintained equipment. (Schedule 1, items 1–2)\n\n- The goods must be presented for supply with the front and back labels set out in Schedule 2 (with limited permitted variations such as adding a trade name, batch number or expiry date up to 36 months). They must not be presented in a way likely to cause confusion with food or drink. Advertising is limited to material consistent with the required labelling (with limited exceptions such as price or where to buy). (Schedule 1; Schedule 2)\n\n- The instrument sets out an explicit transitional saving so a former determination continues to apply for a defined transition period for the manufacture and supply of these goods. (section 6)\n\n\nWho this affects\n\n- Manufacturers and suppliers of hand sanitiser who want to produce and supply the two specified formulations without the product being regulated as a therapeutic good under the Therapeutic Goods Act. They must meet the composition, testing, manufacturing‑record and labelling rules in this instrument.\n\n- Small producers, distillers, compounding businesses and new entrants that might otherwise have needed to register or list products with the Therapeutic Goods Administration (TGA) to supply hand sanitisers of these basic formulas.\n\n- Consumers indirectly, because the instrument affects what products can be sold without going through TGA regulatory processes and therefore affects supply, competition and the amount of regulatory oversight on those products.\n\n\nWhy it matters (official claim and concrete trade‑offs)\n\n- The instrument operates to remove specified, simple hand rub formulations from the TGA’s regulatory regime provided they meet the technical and labelling requirements. The stated effect (from the instrument’s structure) is to allow these basic formulations to be supplied more quickly and with lower regulatory friction (see section 5 and Schedule 1).\n\n- Costs and incentives created by the instrument:\n - Who pays: manufacturers/suppliers pay the direct compliance costs — batch testing for alcohol concentration, validated water purification or testing, sanitary production, and recordkeeping (Schedule 1).\n - Who decides: manufacturers decide whether to produce under these conditions; suppliers decide labelling and how to present/advertise the goods (subject to the instrument’s constraints).\n - Behaviour changes: firms can choose a narrow WHO‑style formulation and follow the instrument’s labelling/testing requirements to avoid TGA listing. That lowers regulatory barriers for basic formulations, encouraging entry and potentially increasing supply and downward pressure on prices.\n\n- Trade‑offs and implementation risks:\n - Lower regulatory cost and faster market entry are traded against narrower regulatory oversight of product quality by the TGA. The instrument mitigates some quality risk by prescribing batch testing methods, water quality requirements (including specific microbiological test methods), and mandatory records (Schedule 1 and Definitions). Those requirements create a measurable compliance burden but do not substitute for full product registration or post‑market surveillance.\n - Enforcement and consumer protection remain relevant: excluded status under the Act removes TGA pre‑market controls for these products, but other laws (e.g. consumer protection, poisons scheduling, state/territory dangerous goods rules) may still apply.\n - Ambiguities or errors in testing, recordkeeping, or labelling by producers create implementation risk (poorly mixed concentrations, microbial contamination, or labelling that misleads consumers). The instrument limits some misleading presentation by forbidding presentation likely to cause confusion with food or beverages and by prescribing label text (Schedule 2).\n\n\nKey mechanical details to note (selective)\n\n- Alcohol concentrations and permitted grades: ethanol 80% v/v may be \"pharmacopoeial grade or food standard grade\"; isopropyl 75% v/v must be pharmacopoeial grade (Definitions; Schedule 1).\n- Water: must be purified from potable water by boiling, distillation or an \"other purification process\" that is validated and subject to regular microbiological testing using specified membrane filtration/R2A agar methods (Definitions; Schedule 1).\n- Labelling: front and back labels are prescribed in Schedule 2; some limited additions are allowed (trade name, batch number, expiry up to 36 months, WHO formulation claim, safety markings) but labels must not imply government approval (Schedule 1; Schedule 2).\n- Advertising: constrained to information consistent with labels, except price and place of sale may be advertised (Schedule 1).\n\n\nNet practical effect\n\n- The instrument creates an explicit, conditional shortcut around the TGA pre‑market regime for two narrowly defined, simple hand sanitiser formulations where producers comply with specified testing, manufacturing, and labelling rules. It reduces regulatory steps for those products while imposing specific technical and recordkeeping obligations.\n\n(See: section 5; Schedule 1 (items 1–2); Schedule 2; section 6.)"},"kimi_summary":{"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":false,"description":"The legislation remains tightly focused on its original purpose: creating a temporary, narrow exemption for specific WHO-recommended hand sanitiser formulations during the COVID-19 pandemic. The scope has not expanded beyond hand sanitisers, and the requirements remain strictly limited to the two specified formulations with their exact ingredient lists and manufacturing protocols."},"complexity_factors":["Nested conditional structure: The exemption only applies if multiple cumulative conditions are met (formulation + manufacturing + labelling + advertising)","Technical specifications: Precise chemical concentrations required (e.g., 'ethanol 80% v/v', 'hydrogen peroxide 0.125% v/v') with specific measurement methods","Cross-references to external standards: References to British Pharmacopoeia, European Pharmacopoeia, US Pharmacopoeia-National Formulary, and Food Chemicals Codex","Detailed microbiological testing protocols: Specific membrane filtration methods with exact pore sizes (0.45 µm), agar types (R2A), and incubation temperatures and durations","Exceptions to exceptions in labelling: Labels must follow templates BUT with seven specific permitted variations, plus advertising restrictions with two further exceptions","Transitional provisions: Complex saving provision preserving earlier version of the instrument for a limited transition period ending 30 June 2020","Multiple defined terms: 5 explicit definitions plus 8 incorporated from the parent Act","Tabular format with parallel but distinct requirements for ethanol vs isopropyl formulations"],"plain_english_summary":"This Determination temporarily exempts hand sanitisers made to two specific WHO recipes from Australia’s usual therapeutic-goods regulation, letting manufacturers (including non-traditional producers) supply sanitiser quickly without full licencing. It still enforces strict formulation, hygiene, testing, labelling and record-keeping rules to protect consumers and allow medical use, balancing rapid pandemic supply with minimum safety standards."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-excluded-goods-hand-sanitisers-determination-2020","history":"/api/acts/therapeutic-goods-excluded-goods-hand-sanitisers-determination-2020/history","analysis":"/api/acts/therapeutic-goods-excluded-goods-hand-sanitisers-determination-2020/analysis","conflicts":"/api/acts/therapeutic-goods-excluded-goods-hand-sanitisers-determination-2020/conflicts","importantCases":"/api/acts/therapeutic-goods-excluded-goods-hand-sanitisers-determination-2020/important-cases","documents":"/api/acts/therapeutic-goods-excluded-goods-hand-sanitisers-determination-2020/documents"}}