12Application, savings and transitional provisions

12 Application, savings and transitional provisions

Section 11, as in force immediately before the amendments made by the Therapeutic Goods (Therapeutic Goods Order No. 91– Standard for labels of prescription and related medicines) Amendment Order 2024, continues to apply to medicines manufactured or imported before 1 December 2026.

<table cellspacing="0" cellpadding="0" style="width:508.95pt; margin-right:auto; margin-left:auto; border-collapse:collapse"><thead><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="text-align:center; line-height:normal; font-size:10pt"><span style="font-weight:bold">Column 1</span></p><p style="text-align:center; line-height:normal; font-size:10pt"><span style="font-weight:bold">Substance name or Group of substances name</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="text-align:center; line-height:normal; font-size:10pt"><span style="font-weight:bold">Column 2</span></p><p style="text-align:center; line-height:normal; font-size:10pt"><span style="font-weight:bold">Circumstances (if any) and additional requirements (if any)</span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="text-align:center; line-height:normal; font-size:10pt"><span style="font-weight:bold">Column 3</span></p><p style="text-align:center; line-height:normal; font-size:10pt"><span style="font-weight:bold">Route of administration</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="text-align:center; line-height:normal; font-size:10pt"><span style="font-weight:bold">Column 4</span></p><p style="text-align:center; line-height:normal; font-size:10pt"><span style="font-weight:bold">Name to be included on the label</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">aspartame</span></p><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold"></span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>Oral</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>aspartame</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">antibiotics</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>When the antibiotic is not an active ingredient and is present only as a residual impurity</span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>Contains residual ‘antibiotic name’</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">benzoates</span><span>, including:</span></p><p style="margin-left:18.65pt; line-height:normal; font-size:10pt"><span>benzoic acid</span></p><p style="margin-left:18.65pt; line-height:normal; font-size:10pt"><span>sodium benzoate</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>benzoates</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">crustacea and crustacean products </span><span>(see Note 1), including:</span></p><p style="margin-left:21.05pt; line-height:normal; font-size:10pt"><span>crab</span></p><p style="margin-left:21.05pt; line-height:normal; font-size:10pt"><span>lobster</span></p><p style="margin-left:21.05pt; line-height:normal; font-size:10pt"><span>white shrimp</span><span style="width:11.5pt; display:inline-block"></span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold"></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>crustacea; or</span></p><p style="line-height:normal; font-size:10pt"><span>crustacean products</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">egg, egg products</span><span>, and products manufactured in eggs including:</span></p><p style="margin-left:21.05pt; line-height:normal; font-size:10pt"><span>dried egg yolk</span></p><p style="margin-left:21.05pt; line-height:normal; font-size:10pt"><span>egg lecithin</span></p><p style="margin-left:21.05pt; line-height:normal; font-size:10pt"><span>influenza vaccine</span></p><p style="margin-left:21.05pt; line-height:normal; font-size:10pt"><span></span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold"></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>egg; or</span></p><p style="line-height:normal; font-size:10pt"><span>egg products or manufactured in eggs</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">ethanol</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">Circumstance:</span><span> Where present in a concentration of 3% v/v or more.</span></p><p style="margin-top:6pt; line-height:normal; font-size:10pt"><span style="font-weight:bold">Requirement:</span><span> To declare on the label the quantity of ethanol as %</span><span> </span><span>v/v.</span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>alcohol</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">fish and fish products</span><span> (see Note 2), including:</span></p><p style="margin-left:21.05pt; line-height:normal; font-size:10pt"><span>cod</span></p><p style="margin-left:21.05pt; line-height:normal; font-size:10pt"><span>cod – liver oil</span></p><p style="margin-left:21.05pt; line-height:normal; font-size:10pt"><span>halibut</span></p><p style="margin-left:21.05pt; line-height:normal; font-size:10pt"><span>tuna</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold"></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>fish; or</span></p><p style="line-height:normal; font-size:10pt"><span>fish products</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">galactose</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold"></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>Oral</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>galactose</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">gluten </span><span>or ingredient</span><span style="font-weight:bold"> </span><span>derived from gluten-containing grain (see Note 3)</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">Circumstance:</span><span> Where gluten is present in a concentration of 20 parts per million or more.</span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All, other than skin and mucous membrane applications</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>gluten</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">hydroxybenzoic acid esters</span><span>, including:</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>ethyl hydroxybenzoate</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>methyl hydroxybenzoate</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>propyl hydroxybenzoate</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>sodium ethyl hydroxybenzoate</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>sodium methyl hydroxybenzoate</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>sodium propyl hydroxybenzoate</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>hydroxybenzoates</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">lactose </span><span>(see Note 4)</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>Oral</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>lactose</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal"><span style="font-weight:bold">milk and milk products</span><span>, including (see Note 4):</span></p><p style="margin-left:14.2pt; line-height:normal"><span>casein</span></p><p style="margin-left:14.2pt; line-height:normal"><span>hydrolysed milk protein</span></p><p style="margin-left:14.2pt; line-height:normal"><span>nonfat dry milk</span></p><p style="margin-left:13.95pt; line-height:normal"><span>whey powder</span></p><p style="margin-left:13.95pt; line-height:normal"><span>whole dry milk</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal"><span>milk; or</span></p><p style="line-height:normal"><span>milk products</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">peanuts and peanut products,</span><span> including:</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span style="font-style:italic">Arachis hypogaea</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>arachis (peanut) oil</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>peanuts; or</span></p><p style="line-height:normal; font-size:10pt"><span>peanut products</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">phenylalanine (see Note 5)</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All, other than skin and mucous membrane applications</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>phenylalanine</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">pollen</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>Oral</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>pollen</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">potassium salts</span><span>, including:</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>potassium bicarbonate</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>potassium chloride</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="Tabletext"><span style="font-weight:bold; background-color:#ffffff">Circumstance:</span><span class="apple-converted-space" style="background-color:#ffffff"> </span><span style="background-color:#ffffff">Where the total potassium content of the maximum recommended daily dose is greater than 39</span><span style="background-color:#ffffff"> </span><span style="background-color:#ffffff">mg (1mmol) elemental potassium.</span></p><p class="Tabletext"><span style="font-weight:bold">Requirement:</span><span> To declare on the label (in mg) the quantity of elemental potassium per dosage unit or in a stated weight or volume of the medicine.</span></p><p style="margin-top:6pt; line-height:normal; font-size:10pt"><span style="font-weight:bold"></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>Oral</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>potassium</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">propolis</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold"></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>Oral</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>propolis</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">royal jelly</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold"></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>Oral</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>royal jelly</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">saccharin</span><span>, including:</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>saccharin calcium</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>saccharin sodium</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>Oral</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>saccharin</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">sesame seeds and sesame seed products</span><span>, including:</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>sesame seed</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>sesame oil</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span style="font-style:italic">Sesamum indicum</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold"></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>sesame seeds; or</span></p><p style="line-height:normal; font-size:10pt"><span>sesame seed products</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">sodium salts</span><span>, including:</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>sodium bicarbonate</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>sodium chloride</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p class="Tabletext"><span style="font-weight:bold; background-color:#ffffff">Circumstance:</span><span class="apple-converted-space" style="font-weight:bold; background-color:#ffffff"> </span><span style="background-color:#ffffff">Where the total sodium content of the maximum recommended daily dose is greater than 120 mg of elemental sodium.</span></p><p style="margin-top:6pt; line-height:normal; font-size:10pt"><span style="font-weight:bold">Requirement:</span><span> To declare on the label (in mg) the quantity of elemental sodium per dosage unit or in a stated weight or volume of the medicine.</span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>Oral</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>sodium</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">soya beans and soya bean products</span><span>, including:</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span style="font-style:italic">Glycine max</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>soya bean</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>soya oil</span></p><p style="line-height:normal; font-size:10pt"><span>excluding:</span></p><ul style="margin:0pt; padding-left:0pt"><li style="margin-left:17.95pt; text-indent:-17.95pt; line-height:normal; font-family:serif; font-size:10pt; list-style-position:inside"><span style="width:4.85pt; font:7pt 'Times New Roman'; display:inline-block"></span><span style="font-family:'Times New Roman', serif">soya oil that is fully refined;</span></li><li style="margin-left:9.6pt; line-height:normal; padding-left:4.6pt; font-family:serif; font-size:10pt"><span style="font-family:'Times New Roman', serif">d-alpha tocopherol, d-alpha tocopheryl acetate, d-alpha tocopheryl acid succinate, mixed (high-alpha type) tocopherols concentrate, or mixed (low-alpha type) tocopherols concentrate when derived from soybean sources;</span></li><li style="margin-left:9.6pt; line-height:normal; padding-left:4.6pt; font-family:serif; font-size:10pt"><span style="font-family:'Times New Roman', serif">vegetable oils derived phytosterols and phytosterol esters from soybean sources;</span></li><li style="margin-left:9.6pt; line-height:normal; padding-left:4.6pt; font-family:serif; font-size:10pt"><span style="font-family:'Times New Roman', serif">plant stanol ester produced from vegetable oil sterols from soybean sources.</span></li></ul></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>soya beans; or</span></p><p style="line-height:normal; font-size:10pt"><span>soya bean products</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">sorbic acid and sorbic acid salts</span><span>, including:</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>potassium sorbate</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>sorbates</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">sucralose</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>Oral</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>sucralose</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">sugar alcohols </span><span>(see Note 5A), including:</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>erythritol</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>isomalt</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>lactitol</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>maltitol</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>mannitol</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>polydextrose</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>sorbitol</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>xylitol</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">Circumstance</span><span>: Where the total sugar alcohol content of the formulation exceeds 2 g per maximum recommended daily dose.</span></p><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold"></span></p><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">Requirement:</span><span> To declare on the label the quantity of sugar alcohols present per recommended maximum daily dose; and a statement 'Products containing (name of sugar alcohol) may have a laxative effect or cause diarrhoea'.</span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>Oral</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>sugar alcohols; or name of sugar alcohol</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">sugars – monosaccharides and disaccharides</span><span> (see Note 6), including:</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>fructose</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>glucose</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>honey (as a mixture of sugars)</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>invert sugar</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>lactose</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>maltose</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>sucrose</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">Circumstance: </span><span>Where the presence of sugars may have a significant glycaemic effect and the total sugar content (including lactose which requires a separate declaration) exceeds 100</span><span> </span><span>mg per maximum recommended daily dose.</span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>Oral</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>sugars</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">sulfites</span><span>, including: (see Note 7)</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>potassium metabisulfite</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>sodium bisulfite</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>sodium metabisulfite</span></p><p style="margin-left:13.95pt; line-height:normal; font-size:10pt"><span>sodium sulfite</span></p><p style="margin-left:14.45pt; line-height:normal; font-size:10pt"><span>sulfur dioxide</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>sulfites</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">tartrazine</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>tartrazine</span></p></td></tr><tr><td style="width:132.8pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span style="font-weight:bold">tree nuts and tree nut products</span><span> (see Note 8), including:</span></p><p style="margin-left:14.2pt; line-height:normal; font-size:10pt"><span>almond oil</span></p><p style="margin-left:14.2pt; line-height:normal; font-size:10pt"><span style="font-style:italic">Juglans nigra</span></p><p style="margin-left:14.2pt; line-height:normal; font-size:10pt"><span>macadamia nut oil</span></p><p style="margin-left:14.45pt; line-height:normal; font-size:10pt"><span style="font-style:italic">Macadamia ternifolia</span><span style="width:11.46pt; display:inline-block"></span></p><p style="margin-left:14.45pt; line-height:normal; font-size:10pt"><span style="font-style:italic">Prunus dulcis</span></p><p style="margin-left:14.45pt; line-height:normal; font-size:10pt"><span>walnut</span></p></td><td style="width:166.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span></span></p></td><td style="width:81.35pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>All</span></p></td><td style="width:84.5pt; border:0.75pt solid #000000; padding-right:5.03pt; padding-left:5.03pt; vertical-align:top"><p style="line-height:normal; font-size:10pt"><span>tree nuts; or</span></p><p style="line-height:normal; font-size:10pt"><span>tree nut products</span></p></td></tr><tr><td colspan="4" style="width:497.4pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:12pt; margin-bottom:6pt; line-height:normal"><span style="font-weight:bold">Note 1</span><span>: </span><span style="font-weight:bold">Crustacea</span><span> include various species of aquatic animals which have an inedible chitinous outer shell.</span><span> </span><span>These include but are not limited to crab, crayfish, lobster, prawn and shrimp.</span></p><p style="margin-bottom:6pt; line-height:normal"><span style="font-weight:bold">Note 2</span><span>: </span><span style="font-weight:bold">Fish</span><span> includes freshwater fish, diadromous fish and marine fish, including shark.</span></p><p style="margin-bottom:6pt; line-height:normal"><span style="font-weight:bold">Note 3: Gluten –</span><span> some formulations of medicines may contain gluten that is present naturally as a constituent of an ingredient such as wheat starch.</span></p><p style="margin-bottom:6pt; line-height:normal"><span style="font-weight:bold">Note 4: Lactose, </span><span>where obtained from milk, does not require the ‘contains milk product’ statement.</span></p><p style="line-height:normal"><span style="font-weight:bold">Note 5: Phenylalanine - </span><span>In the context of complementary medicines that contain phenylalanine, the Schedule 1 requirements apply in the following instances:</span></p><p style="margin-left:36pt; text-indent:-18pt; line-height:normal"><span><span style="font-family:Symbol, serif"></span></span><span style="width:15.25pt; font:7pt 'Times New Roman'; display:inline-block"> </span><span>Where phenylalanine is an ingredient in a medicine formulation.</span></p><p style="margin-left:36pt; text-indent:-18pt; line-height:normal"><span><span style="font-family:Symbol, serif"></span></span><span style="width:15.25pt; font:7pt 'Times New Roman'; display:inline-block"> </span><span>For medicines containing ingredients such as </span><span style="font-style:italic">Spirulina</span><span>, legumes, nuts or soy products that are naturally high in phenylalanine.</span></p><p style="margin-left:36pt; text-indent:-18pt; line-height:normal"><span><span style="font-family:Symbol, serif"></span></span><span style="width:15.25pt; font:7pt 'Times New Roman'; display:inline-block"> </span><span>Where processing of an ingredient, prior to inclusion in a pharmaceutical dosage form, results in enrichment of the phenylalanine content.</span></p><p style="line-height:normal"><span style="font-weight:bold"></span></p><p style="line-height:normal"><span style="font-weight:bold">Note 5A: Sugar alcohols</span><span> – It is generally accepted that while glycerol is a sugar alcohol, it does not have a laxative effect. Therefore, glycerol is not required to be declared in relation to sugar alcohols and their associated laxative effect.</span></p><p style="line-height:normal"><span style="font-weight:bold"></span></p><p style="line-height:normal"><span style="font-weight:bold">Note 6: Sugars – monosaccharides and disaccharides – </span><span>some sugar derivatives may not have a significant impact on glycaemic control.</span><span> </span><span>Lactose forms part of total sugars for the purposes of determining if the sugars will have a significant glycaemic effect and for calculating the total daily dose. Where lactose is present in the medicine, the entries under ‘lactose', ‘sugars –monosaccharides and disaccharides' and ‘milk and milk products’ (if of dairy origin) each apply.</span></p><p style="margin-top:12pt; margin-bottom:6pt; line-height:normal"><span style="font-weight:bold">Note 7: Sulfur dioxide </span><span>– some formulations of medicines may contain sulfur dioxide as a residue, for example, gelatin, but must be identified.</span></p><p style="margin-bottom:6pt; line-height:normal"><span style="font-weight:bold">Note 8</span><span>: </span><span style="font-weight:bold">Tree nuts</span><span> are the seeds of a variety of trees and shrubs which are characterised by a hard inedible shell enclosing an oily seed.</span><span> </span><span>Tree nuts include almond, Brazil, cashew, chestnut, and walnut.</span><span> </span><span>Coconut is the fruit of the palm (</span><span style="font-style:italic">Cocos nucifera</span><span>) and is not considered to be a tree nut.</span></p></td></tr></thead></table>