Part 3Application, saving and transitional provisions

Part 1—Preliminary

1 Name

This instrument is the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020.

3 Authority

This instrument is made under section 7AA of the Therapeutic Goods Act 1989.

4 Definitions

Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:

advertise;

(b) batch;
(c) British Pharmacopoeia;
(d) default standard;
(e) European Pharmacopoeia;
(f) label;
(g) supply; and
(h) United States Pharmacopoeia-National Formulary.

In this instrument:

acceptable microbiological quality, in relation to water, means a microbial count that is less than 100 colony forming units per mL.

Act means the Therapeutic Goods Act 1989.

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.

Note: The Food Chemicals Codex is available online at: www.foodchemicalscodex.org.

other purification process, in relation to water, means a process, such as reverse osmosis, that meets the following requirements:

(a) the process is validated to produce and distribute water that is of acceptable chemical quality and acceptable microbiological quality; and
(b) regular microbiological testing of the water is undertaken, including sampling at the point of use, using one of the following methods:
(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
(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.

pharmacopoeial grade means compliance with an applicable default standard.

Note: The default standards are the British Pharmacopoeia, European Pharmacopoeia and the United States Pharmacopoeia-National Formulary.

Part 2—Excluded goods

5 Excluded goods

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.

Part 3—Application, saving and transitional provisions

6 Transitional provision

(1) In this section:

Amendment Determination means the Therapeutic Goods Amendment (Excluded Goods—Hand Sanitisers) Determination (No. 2) 2020.

commencement date means the day on which the Amendment Determination commences.

Former Determination means the Therapeutic Goods (Excluded Goods—Hand Sanitiser) Determination 2020, as in force immediately before the commencement date.

transition period means the period beginning on the commencement date and ending on 30 June 2020.

(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.

Schedule 1—Specified goods used, advertised, or presented for supply in a particular way

Note: See section 5.

<table cellspacing="0" cellpadding="0" style="width:100%; margin-right:9pt; margin-left:9pt; border-collapse:collapse; float:left"><thead><tr style="height:2.85pt"><td colspan="3" style="border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Specified goods that are excluded goods when used, advertised, or presented for supply in a particular way</span></p></td></tr><tr style="height:2.85pt"><td style="width:13.02%; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:45.56%; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td><td style="width:41.42%; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p></td></tr><tr style="height:2.85pt"><td style="width:13.02%; border-top:1pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:45.56%; border-top:1pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Specified goods</span></p></td><td style="width:41.42%; border-top:1pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Use, advertising or presentation</span></p></td></tr></thead><tbody><tr style="height:14.15pt"><td style="width:13.02%; 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="Tabletext"><span>1</span></p></td><td style="width:45.56%; 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="Tabletext"><span>hand sanitiser in relation to which all of the following paragraphs apply:</span></p><p class="Tabletext" style="margin-left:25.55pt; text-indent:-25.55pt"><span>(a)</span><span style="width:14.45pt; text-indent:0pt; display:inline-block"> </span><span>the final formulation of the hand sanitiser contains only the following ingredients:</span></p><p class="Tabletext" style="margin-left:46.85pt; text-indent:-21.3pt"><span>(i)</span><span style="width:11.86pt; text-indent:0pt; display:inline-block"> </span><span>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);</span></p><p class="Tabletext" style="margin-left:46.85pt; text-indent:-21.3pt"><span>(ii)</span><span style="width:9.08pt; text-indent:0pt; display:inline-block"> </span><span>purified water derived from potable water that has been rendered sterile or otherwise purified by boiling, distillation or other purification process;</span></p><p class="Tabletext" style="margin-left:46.85pt; text-indent:-21.3pt"><span>(iii)</span><span style="width:6.3pt; text-indent:0pt; display:inline-block"> </span><span>glycerol 1.45% v/v (pharmacopoeial grade or food standard grade);</span></p><p class="Tabletext" style="margin-left:46.85pt; text-indent:-21.3pt"><span>(iv)</span><span style="width:6.86pt; text-indent:0pt; display:inline-block"> </span><span>hydrogen peroxide 0.125% v/v (pharmacopoeial grade);</span></p><p class="Tabletext" style="margin-left:25.65pt; text-indent:-0.1pt"><span>and does not contain any other active or inactive ingredients, including colours, fragrances or emollients;</span></p><p class="Tabletext" style="margin-left:25.55pt; text-indent:-25.55pt"><span>(b)</span><span style="width:13.89pt; text-indent:0pt; display:inline-block"> </span><span>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;</span></p><p class="Tabletext" style="margin-left:25.55pt; text-indent:-25.55pt"><span>(ba)</span><span style="width:9.45pt; text-indent:0pt; display:inline-block"> </span><span>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;</span></p><p class="Tabletext" style="margin-left:25.55pt; text-indent:-25.55pt"><span>(c)</span><span style="width:14.45pt; text-indent:0pt; display:inline-block"> </span><span>the hand sanitiser is manufactured under sanitary conditions using equipment that is well maintained and fit for purpose;</span></p><p class="Tabletext" style="margin-left:25.5pt; margin-bottom:12pt; text-indent:-25.5pt"><span>(d)</span><span style="width:13.84pt; text-indent:0pt; display:inline-block"> </span><span>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)</span></p></td><td style="width:41.42%; 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="Tabletext" style="margin-left:6.15pt"><span>when:</span></p><p class="Tabletext" style="margin-left:27.45pt; text-indent:-20.35pt"><span>(a)</span><span style="width:9.25pt; text-indent:0pt; display:inline-block"> </span><span>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:</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(i)</span><span style="width:11.81pt; text-indent:0pt; display:inline-block"> </span><span>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;</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(ii)</span><span style="width:9.03pt; text-indent:0pt; display:inline-block"> </span><span>the labels may include a batch number;</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(iii)</span><span style="width:6.25pt; text-indent:0pt; display:inline-block"> </span><span>the labels may include an expiry date, which must not be more than 36 months after the completion of the manufacture of the goods;</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(iv)</span><span style="width:6.81pt; text-indent:0pt; display:inline-block"> </span><span>the labels may state that the formulation of the goods is based on the handrub formulation of the World Health Organization;</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(v)</span><span style="width:9.59pt; text-indent:0pt; display:inline-block"> </span><span>the labels may include any caution, warning or other marking that relates to the safe use, transportation or storage of the goods;</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(vi)</span><span style="width:6.81pt; text-indent:0pt; display:inline-block"> </span><span>the labels may be printed in colour;</span></p><p class="Tabletext" style="margin-left:48.75pt; text-indent:-21.25pt; widows:0; orphans:0"><span>(vii)</span><span style="width:4.03pt; text-indent:0pt; display:inline-block"> </span><span>the front and back labels may be combined into a single label or may otherwise be co-located on the goods; and</span></p><p class="Tabletext" style="margin-left:27.45pt; text-indent:-20.35pt"><span>(b)</span><span style="width:8.69pt; text-indent:0pt; display:inline-block"> </span><span>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</span></p><p class="Tabletext" style="margin-left:27.45pt; text-indent:-20.35pt"><span>(c)</span><span style="width:9.25pt; text-indent:0pt; display:inline-block"> </span><span>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:</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(i)</span><span style="width:11.81pt; text-indent:0pt; display:inline-block"> </span><span>an advertisement in relation to the goods may include information as to where the goods may be purchased;</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(ii)</span><span style="width:9.03pt; text-indent:0pt; display:inline-block"> </span><span>an advertisement in relation to the goods may include price information</span></p></td></tr><tr style="height:85.05pt"><td style="width:13.02%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:45.56%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>hand sanitiser in relation to which all of the following paragraphs apply:</span></p><p class="Tabletext" style="margin-left:25.55pt; text-indent:-25.55pt"><span>(a)</span><span style="width:14.45pt; text-indent:0pt; display:inline-block"> </span><span>the final formulation of the hand sanitiser contains only the following ingredients:</span></p><p class="Tabletext" style="margin-left:46.85pt; text-indent:-21.3pt"><span>(i)</span><span style="width:11.86pt; text-indent:0pt; display:inline-block"> </span><span>isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;</span></p><p class="Tabletext" style="margin-left:46.85pt; text-indent:-21.3pt"><span>(ii)</span><span style="width:9.08pt; text-indent:0pt; display:inline-block"> </span><span>purified water derived from potable water that has been rendered sterile or otherwise purified by boiling, distillation or other purification process;</span></p><p class="Tabletext" style="margin-left:46.85pt; text-indent:-21.3pt"><span>(iii)</span><span style="width:6.3pt; text-indent:0pt; display:inline-block"> </span><span>glycerol 1.45% v/v (pharmacopoeial grade or food standard grade);</span></p><p class="Tabletext" style="margin-left:46.85pt; text-indent:-21.3pt"><span>(iv)</span><span style="width:6.86pt; text-indent:0pt; display:inline-block"> </span><span>hydrogen peroxide 0.125% v/v (pharmacopoeial grade);</span></p><p class="Tabletext" style="margin-left:25.65pt; text-indent:-0.1pt"><span>and does not contain any other active or inactive ingredients, including colours, fragrances or emollients;</span></p><p class="Tabletext" style="margin-left:25.55pt; text-indent:-25.55pt"><span>(b)</span><span style="width:13.89pt; text-indent:0pt; display:inline-block"> </span><span>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;</span></p><p class="Tabletext" style="margin-left:25.55pt; text-indent:-25.55pt"><span>(ba)</span><span style="width:9.45pt; text-indent:0pt; display:inline-block"> </span><span>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;</span></p><p class="Tabletext" style="margin-left:25.55pt; text-indent:-25.55pt"><span>(c)</span><span style="width:14.45pt; text-indent:0pt; display:inline-block"> </span><span>the hand sanitiser is manufactured under sanitary conditions using equipment that is well maintained and fit for purpose;</span></p><p class="Tabletext" style="margin-left:25.55pt; text-indent:-25.55pt"><span>(d)</span><span style="width:13.89pt; text-indent:0pt; display:inline-block"> </span><span>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)</span></p></td><td style="width:41.42%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>when:</span></p><p class="Tabletext" style="margin-left:27.45pt; text-indent:-20.35pt"><span>(a)</span><span style="width:9.25pt; text-indent:0pt; display:inline-block"> </span><span>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:</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(i)</span><span style="width:11.81pt; text-indent:0pt; display:inline-block"> </span><span>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;</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(ii)</span><span style="width:9.03pt; text-indent:0pt; display:inline-block"> </span><span>the labels may include a batch number;</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(iii)</span><span style="width:6.25pt; text-indent:0pt; display:inline-block"> </span><span>the labels may include an expiry date, which must not be more than 36 months after the completion of the manufacture of the goods;</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(iv)</span><span style="width:6.81pt; text-indent:0pt; display:inline-block"> </span><span>the labels may state that the formulation of the goods is based on the handrub formulation of the World Health Organization;</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(v)</span><span style="width:9.59pt; text-indent:0pt; display:inline-block"> </span><span>the labels may include any caution, warning or other marking that relates to the safe use, transportation or storage of the goods;</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(vi)</span><span style="width:6.81pt; text-indent:0pt; display:inline-block"> </span><span>the labels may be printed in colour;</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(vii)</span><span style="width:4.03pt; text-indent:0pt; display:inline-block"> </span><span>the front and back labels may be combined into a single label or may otherwise be co-located on the goods; and</span></p><p class="Tabletext" style="margin-left:27.45pt; text-indent:-20.35pt"><span>(b)</span><span style="width:8.69pt; text-indent:0pt; display:inline-block"> </span><span>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</span></p><p class="Tabletext" style="margin-left:27.45pt; text-indent:-20.35pt"><span>(c)</span><span style="width:9.25pt; text-indent:0pt; display:inline-block"> </span><span>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:</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(i)</span><span style="width:11.81pt; text-indent:0pt; display:inline-block"> </span><span>an advertisement in relation to the goods may include information as to where the goods may be purchased;</span></p><p class="Tabletext" style="margin-left:48.7pt; text-indent:-21.25pt"><span>(ii)</span><span style="width:9.03pt; text-indent:0pt; display:inline-block"> </span><span>an advertisement in relation to the goods may include price information</span></p></td></tr></tbody></table>

Schedule 2—Labels

Part 1—Ethanol hand sanitiser

Note: See item 1 of Schedule 1.

Note: 1 Front label

Note: 2 Back label

Part 2—Isopropyl alcohol hand sanitiser

Note: See item 2 of Schedule 1.

Note: 1 Front label

Note: 2 Back label