Listed Substances PDF

Substances that may be used in Listed medicines in Australia
December 2007
Therapeutic Goods Administration
About the Therapeutic Goods Administration (TGA)
The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. The TGA investigates reports received by it to determine any necessary regulatory action. To report a problem with a medicine or medical device, please see the information on the TGA website.
The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.
The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.
The TGA is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.
Copyright Commonwealth of Australia 2011
This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Attorney Generals Department, National Circuit, Barton ACT 2600 or posted at http://www.ag.gov.au/cca
Substances that may be used in Listed medicines in Australia December 2007
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Substances that may be used in Listed medicines in Australia
The following substances are eligible for use in medicines Listed on the Australian Register of Therapeutic Goods for supply in Australia. The list includes the approved role of the substance (ie. active, excipient, and/or component), and any restrictions and conditions that apply to the substance when used in Listed medicines.
Please note substances marked as components (C) are not approved as substances for use in their own right and can only be used in conjunction with an approved source. For example, iodine is not approved as a substance in its own right but is permitted when expressed as a component of Fucus vesiculosus (Kelp), which is known to naturally contain iodine.
A glossary of abbreviations is provided at the end of the document. For further information on Coded Warnings, refer to the following web page: https://www.ebs.tga.gov.au.
Please note this list does not include substances that may be used as homoeopathic preparations. The Office of Complementary Medicines is currently conducting a review of homoeopathic substance permitted in Listed medicines, and this document will be updated upon completion of the review.
Some substances are permitted as food excipients only. These substances (e.g. apple, pear) refer only to edible substances fit for human consumption as a food. Only certain preparations are permitted for most food excipients: fresh dry or powdered plant material and fresh, dried or concentrated juices. Juice preparations may only be named where the fresh plant part has a high water content. For further details, refer to the Introduction to the Herbal Substances AAN list in the TGA Approved Terminology for Medicines: http://www.tga.gov.au/industry/medicines-approved-terminology.htm.
For further information on conditions related to provisional ingredients (PRVs), refer to the Australian Regulatory Guidelines for OTC Medicines: http://www.tga.gov.au/industry/otc-argom.htm.
This list was updated on 12 December 2007 and is subject to change from time to time as new substances are approved for use in Listed medicines. Importantly, as a result of a safety concern, substances may be subject to new restrictions or may be removed from the list.
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Ingredient
1-Dodecanol
Use E E C E E E E E C C
Restrictions
1-Methylheptyl isostearate 1,1,1-Trichloroethane 1,2-Hexanediol 1,3-Butylene glycol 2-Ethoxyethanol
10-Hydroxy-2-decenoic acid
Approved for topical use only.
PRV may only be used as an excipient in topical preparations.
Product must contain 25% or less of designated solvents as defined in Part 1 of the SUSMP. Approved for topical use only. Concentration must not exceed 1%. Approved for topical use only.
2-Amino-2-methyl-1-propanol
(2S,3R,4S)-4-Hydroxyisoleucine (of Trigonella foenum-graecum) 4-Hydroxyisoleucine (of Trigonella foenum-graecum) 4-Methylbenzylidene camphor Abelmoschus moschatus Abies balsamea Abies nigra Abies pectinata
Concentration must not exceed 0.016%. Residual solvent limit is 1.6 mg per MDD.
A, E A, E A, E A, E
Sunscreen active permitted only in topical products. Concentration must not exceed 4%. Native species if exporting this product please contact the DSEWPC.
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Ingredient
Abies sibirica
Use A, E A A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E C
Restrictions If the plant part is seed, the MRDD must contain 1 mg or less of the equivalent dry seed. If any other plant part, it is listable without restriction. May be a native species if exporting this product please contact the DSEWPC.
Abrus cantoniensis Absidia ramosa Acacia Abutilon avicennae Acacia arabica
Acacia baileyana Acacia catechu Acacia dealbata Acacia senegal
Acacia longifolia Acalypha indica
Native species if exporting this product (excluding oil) please contact the DSEWPC. Native species if exporting this product please contact the DSEWPC.
Acanthopanax gracilistylus Acanthus mollis
Acemannan (of Aloe barbadensis)
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Ingredient
Acer campestre Acer negundo
Use A, E A, E A, E A, E E E E E E E E E E A, E
Restrictions
Acer saccharinum Acer saccharum Acerola
Acesulfame potassium Acetanisole Acetic acid
Only Malpighia punicifolia fruit flesh is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Approved for topical use only.
Acetic acid glacial Acetone
Concentration must not exceed 0.5%. Concentration of acetic acid from all ingredients must not exceed 80%. Residual solvent limit is 50 mg per MDD. Concentration must not exceed 0.5%. Concentration of acetic acid from all ingredients must not exceed 80%. Residual solvent limit is 50 mg per MDD. Concentration should not exceed 0.5%. Residual solvent limit is 50 mg per MDD. Product must contain 25% or less of designated solvents as defined in Part 1 of the SUSMP. Approved for topical use only. Concentration must not exceed 0.01%. Approved for topical use only. Concentration must not exceed 0.5%. PRV may only be used as an excipient in topical preparations. When used as an active in oral or sublingual products, the label must include the statement VIT.
Acetomenaphthone Acetyl dipeptide-1 cetyl ester Acetyl glucosamine Acetyl hexapeptide-3
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Ingredient
Acetyl trifluoromethylphenyl valylglycine Acetylated lanolin Acetylated lanolin alcohol Acetylcysteine
Use E E E E E
Restrictions
Approved for topical use only. Concentration must not exceed 0.5%. Approved for topical use only. Approved for topical use only.
Acetylated monoglycerides
Acetyllevocarnitine hydrochloride Achillea millefolium Achillea moschata Achillea ptarmica
A, E A, E A, E A, E A, E A, E A, E E E
Approved for topical use only. Concentration must not exceed 0.001%.
Achyranthes aspera Achyranthes fauriei Acid green 25 Acid red 33
Achyranthes bidentata
May be a native species if exporting this product please contact the DSEWPC.
Aconitum carmichaelii
Colour permitted only in topical preparations.
Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%.
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Ingredient
Aconitum ferox
Use A A A C
Restrictions
Aconitum kusnezoffi Aconitum napellus Acrylamide
Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%.
Acrothecium arenarium Acrylamides copolymer Acrylates copolymer
A, E E E E E E E E E
Acrylamide/sodium acryloyldimethyltaurate copolymer Acrylates/acrylamide copolymer Acrylates/c10-30 alkyl acrylate crosspolymer Acrylates/dimethicone acrylate/ethylhexyl acrylate copolymer
Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Acrylates/C12-22 alkyl methacrylate copolymer Acrylates/dimethicone copolymer
Approved for topical use only. Concentration must not exceed 5%. PRV may only be used as an excipient in topical preparations.
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Ingredient
Acrylates/octylacrylamide copolymer Acrylates/steareth-20 methacrylate copolymer Actaea pachypoda Actaea spicata
Use E E
Restrictions
Actinidia chinensis
A, E A, E A, E A A A A A A A A A
Ademetionine disulfate ditosylate dihydrate Ademetionine disulfate tosylate
(S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry).
Ademetionine disulfate tritosylate dihydrate
Ademetionine hexasulfate dihydrate
Ademetionine hexatosylate dihydrate Ademetionine pentasulfate dihydrate Ademetionine tetrasulfate dihydrate
Ademetionine pentatosylate dihydrate Ademetionine tetratosylate dihydrate
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Ingredient
Ademetionine trisulfate ditosylate dihydrate Adenophora stricta Adenophora tetraphylla Adenophora verticillata Adenosine phosphate
Use A
Restrictions
A, E A, E A, E E E E
(S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry).
Adenosine triphosphate Adhatoda vasica Adipic acid
Adenosine triphosphate disodium Adiantum capillus veneris
Approved for topical use only. Concentration must not exceed 0.1%. Approved as an excipient for topical use only. Approved for topical use only.
A, E A, E E E E
Adipic acid/diethylene glycol/glycerin crosspolymer Adonis vernalis Adzuki bean
Native species if exporting this product please contact the DSEWPC. Approved for topical use only. Concentration must not exceed 5%.
A A, E
Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Only Phaseolus angularis seed (bean) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Aegopodium podagraria
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Ingredient
Aesculus chinensis Aesculus glabra
Use A, E A, E A, E A, E A, E A, E A, E A, E C A, E A, E A, E A, E A, E A, E A, E
Restrictions
Aesculus hippocastanum Aesculus x carnea Agar Aethusa cynapium Agastache rugosa Agave americana Agnuside
Agrimonia eupatoria Agrimonia repens Agrostis tenuis Agropyron repens
Ailanthus altissima Ajuga chamaepitys Ajuga reptans
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Ingredient Alanine
Ajuga turkestanica whole plant extract Alantolactone
Use E C A, E A, E A, E A, E E A, E A, E A, E C C
Restrictions
Alaria esculenta Albizia lebbek Albumen
Albizia julibrissin
Iodine is a mandatory component of this ingredient (see separate entry).
Alchemilla alpina
Alchemilla arvensis Alchemilla vulgaris
Requires pre-clearance from TGAL.
Aldehydes calculated as cinnamaldehyde Aletris farinosa Aletris spicata Alginic acid
Aldehydes calculated as citral
A, E A, E E
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Ingredient
Alisma orientale
Use A, E A, E E C C C C C C C
Restrictions
Alisma plantago aquatica Alizarin cyanine green F
Alkaloids calculated as berberine Alkaloids calculated as emetine
Alkaloids calculated as hydrastine Alkaloids calculated as protopine Alkaloids calculated as quinine Alkanna officinalis Allantoin Allicin Alliin
Alkaloids calculated as hyoscyamine
Concentration must not exceed 300 micrograms/Kg or 300 micrograms/L or 0.00003%.
Alkylamides (of Echinacea angustifolia and E. purpurea) Alliaria petiolata
A, E E C C Approved for topical use only.
A, E
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Ingredient
Allium ascalonicum Allium cepa Allium fistulosum Allium odorum Allium porrum
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E E E C E
Restrictions
Allium macrostemon
Allium sativum
Allium schoenoprasum Allium ursinum Allura red AC
Allura red AC aluminium lake Allyl isothiocyanate Almond Almond oil
Quantity in the MRDD must not exceed 20 mg.
A, E
Only Prunus dulcis var. dulcis seed (kernel) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries).
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Ingredient
Alnus glutinosa Alnus rugosa Aloe ferox
Use A, E A, E A, E A, E A, E C C C
Restrictions
Aloe barbadensis
Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of this ingredient in oral preparations. Species listed on CITES if exporting or importing this product please contact the DSEWPC. Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of this ingredient in oral preparations. Species listed on CITES if exporting or importing this product please contact the DSEWPC. Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of this ingredient in oral preparations. Species listed on CITES if exporting or importing this product please contact the DSEWPC.
Aloe peryi
Aloeresin A Aloeresin B Aloeresin C Aloes cape
Aloes barbados
A A C
Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of this ingredient in oral preparations. Species listed on CITES if exporting or importing this product please contact the DSEWPC. Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of this ingredient in oral preparations. Species listed on CITES if exporting or importing this product please contact the DSEWPC.
Aloinoside A
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Ingredient
Aloinoside B
Use C C C E E
Restrictions
Alpha acids (humulone, cohumulone, adhumulone) of Humulus lupus Alpha-carotene Alpha-Ionone
Alpha-Phellandrene Alpha tocopherol Alpinia galanga
Alpha tocopherol acetate Alpinia katsumadai Alpinia oxyphylla Alstonia boonei
A, E, C A, E A, E A, E A, E A, E A, E A, E A, E A, E
Approved for topical use only. Approved for topical use only.
When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an active in oral or sublingual products, the label must include the statement VIT.
Alpinia officinarum
Alsidium helminthochorton Alstonia constricta
Iodine is a mandatory component of this ingredient (see separate entry). Native species if exporting this product please contact the DSEWPC.
Alternanthera philoxeroides
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Ingredient
Alternaria alternata Althaea officinalis Althaea rosea Alum
Use A, E A, E A, E A, E E E E E E E E E E E E
Restrictions
Aluminium chlorohydrate Aluminium citrate Aluminium distearate
Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Aluminium hydroxide
Approved only in topical preparations for localised effect.
Aluminium hydroxide - dried Aluminium monostearate Aluminium oxide
Aluminium magnesium silicate
Aluminium oxide anhydrous Aluminium silicate Aluminium sodium silicate
Approved for topical use only as an excipient. Approved for topical use only as an excipient.
When used in oral or sublingual and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
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Ingredient
Aluminium starch octenylsuccinate Aluminium stearate Amaranth
Use E E E E
Restrictions
Concentration must not exceed 7%. Approved for topical use only.
Amaranth aluminium lake Amaranthus hybridus Amarogentin Amaranthus retroflexus Ambrosia artemisiifolia Ambrosia psilostachya Aminobenzoic acid Aminobutyric acid Ammi visnaga Ammonia
A, E A, E C A, E A, E A E E
Aminopropyl ascorbyl phosphate
Sunscreen active permitted only in topical products. Concentration must not exceed 15%. PRV may only be used as an excipient in topical preparations. Approved for topical use only. Concentration must not exceed 0.1%.
A E
Ammonio methacrylate copolymer
E, C
Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Approved for topical use only as an excipient. Concentration from all ingredients must not exceed 0.5%. Approved for oral use only.
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Ingredient
Ammonium acrylates copolymer Ammonium acryloyldimethyltaurate/VP copolymer Ammonium bicarbonate Ammonium carbonate Ammonium chloride
Use E E E E E E E E E E E
Restrictions
Ammonium acrylates/acrylonitrogens copolymer
Approved for topical use only. Approved for topical use only. Approved for topical use only. Concentration must not exceed 5%.
Ammonium glycyrrhizinate Ammonium hydroxide Ammonium lactate
A, E
This ingredient is only listable as an uncompounded BP substance.
When used as an active, this ingredient is only listable as an uncompounded BP substance. Approved for topical use only as an excipient.
Ammonium laureth sulfate Ammonium lauryl sulfate Ammonium polyacrylate
If for internal use, the concentration must not exceed 0.25%. Ammonia is a mandatory component of this ingredient (see separate entry). Approved for topical use only. Concentration must not exceed 0.1%. Approved for topical use only. Approved for topical use only.
Ammonium phosphate - monobasic
Approved for topical and dental use only as an excipient.
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Ingredient
Ammonium polyacryloyldimethyl taurate Amodimethicone Amomum aromaticum Amomum villosum Amomum xanthioides Ampelopsis japonica Amygdalin Amylase Amyl acetate
Use E E
Restrictions
A, E A, E A, E A, E A, E C E
Amorphophallus rivieri
Amyris balsamifera
Amyris oil west indian Anacyclus pyrethrum
A, C
Listed medicines must not contain any amygdalin. Approved for topical use only.
Anacardium occidentale
A, E A, E A, E A, E E
Permitted only when derived from Aspergillus oryzae.
Anacystis nidulans ferment
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Ingredient
Anagallis arvensis Ananas sativus
Use A, E A, E A, E A, E A, E A, E C A, E A, E A, E A, E A, E A, E A, E A, E
Restrictions Sponsors must confirm the absence of aristolochic acids or herbal species known to contain these acids. Picrotoxin is a mandatory component of this ingredient (see separate entry).
Anamirta cocculus Anantherum muricatum Anaphalis sinica
Andrographis paniculata
Andrographolide (of Andrographis paniculata) Anemarrhena asphodeloides Anemone altaica Anemone chinensis Anemone hepatica Anethole
Anemone raddeana
Anethum graveolens Angelica acutiloba
When used as an active, permitted only in Medicated Space Sprays or Medicated Throat Lozenges.
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Ingredient
Angelica anomala
Use A, E A, E A, E A, E A, E A, E A, E A, E E A, E A, E A, E A, E E
Restrictions
Angelica archangelica Angelica dahurica Angelica polymorpha Angelica pubescens Angelica root dry Angelica root oil Angelica stem Anise oil Angelica seed oil
Aniba rosaeodora Aniseed dry Annatto
Only Angelica archangelica stem young or leaf stalk (petiole) permitted. May only be used as a food excipient refer to introduction for permitted preparations. Permitted without restriction in preparations containing 50% or less. When the concentration is more than 50%, the nominal capacity of the container must be less than 50 mL, a RFI must be fitted on the container and the product label must include the statement CHILD.
Aniseed powder
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Ingredient
Anogeissus latifolia Antennaria dioica Anthemis nobilis Anthocyanins
Use A, E A, E A, E E, C C C C C A, E A, E A, E C C C
Restrictions
Anthocyanins calculated as cyanidin chloride (of Sambucus nigra) Anthocyanosides (of Vitis vinifera) Anthocyanosides (of Vaccinium myrtillus) Anthoxanthum odoratum Anthriscus cerefolium Anthyllis vulneraria Apigenin Apiin Anthraquinones calculated as glucofrangulin A
Apigenin-7-glycoside
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Ingredient
Apium graveolens Apple
Use A, E A E E E E E A, E A, E A, E A, E E E E
Restrictions Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Only Malus X domestica, M. pumila, M. sylvestris and hybrids fruit permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Malus X domestica, M. pumila, M. sylvestris and hybrids fruit juice cider vinegar permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Malus X domestica, M. pumila, M. sylvestris and hybrids fruit fibre permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Prunus armeniaca fruit flesh permitted. May only be used as a food excipient refer to introduction for permitted preparations. Approved for topical use only. Species listed on CITES if exporting or importing this product please contact the DSEWPC. Species listed on CITES if exporting or importing this product please contact the DSEWPC.
Apocynum cannabinum Apple cider vinegar Apple fibre Apricot
Apricot kernel oil peg-6 esters Aquilaria agallocha Aquilaria sinensis
Aquilegia pubescens Aquilegia vulgaris Arachidonic acid Arachidyl alcohol
Arachidyl glucoside
Approved for topical use only. Concentration must not exceed 1.0%. Approved for topical use only. Concentration must not exceed 0.5%.
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Ingredient
Arachidyl propionate Arachis hypogaea Arachis oil Aralia cordata Aralia hispida
Use E A, E A, E A, E A, E A, E A, E C A, E A, E A, E A, E A, E A C A, E
Restrictions
Requires the label statement PEANUT. Requires the label statement PEANUT.
Aralia nudicaulis Aralia racemosa Arbutin
Archangelica atropurpurea Arctium lappa Arctium minus
Arctostaphylos uva-ursi Ardisia japonica Areca catechu Arecoline
Arecastrum romanzoffianum
Arecoline is a mandatory component of this ingredient (see separate entry).
Concentration from all ingredients must not exceed 10 mg/Kg or 10 mg/L or 0.001%.
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Ingredient Arginine Arginine ferulate
Use A, E E A A A
Restrictions
Arisaema atrorubens Arisaema japonicum Armoracia rusticana Arnebia euchroma Arnica flower dry Arnica mollis
Approved for topical use only. Requires the label statement ARGIN1.
Arisaema consanguineum
Approved for topical use only. Concentration must not exceed 0.0125%. MRDD must contain 1 mg or less of the equivalent dry herbal material. MRDD must contain 1 mg or less of the equivalent dry herbal material. MRDD must contain 1 mg or less of the equivalent dry herbal material.
A, E A, E A A A
Volatile oil components (of Armoracia rusticana) is a mandatory component of this ingredient (see separate entry). If the preparation is for use other than topically on unbroken skin, it is listable only if the MRDD contains 1 mg or less of the equivalent dry herbal material. For topical use on unbroken skin, it is listable without restriction. If the preparation is for use other than topically on unbroken skin, it is listable only if the MRDD contains 1 mg or less of the equivalent dry herbal material. For topical use on unbroken skin, it is listable without restriction. If the preparation is for use other than topically on unbroken skin, it is listable only if the MRDD contains 1 mg or less of the equivalent dry herbal material. For topical use on unbroken skin, it is listable without restriction.
Arnica montana Arrowroot
Arrhenatherum elatius
A, E A, E
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Ingredient
Artemia salina extract Artemisia abrotanum Artemisia annua Artemisia argyi Artemisia absinthium
Use E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A A
Restrictions
Oil derived from this species is a Customs Prohibited Import requires an import permit/licence. Oil derived from this species is a Customs Prohibited Import requires an import permit/licence. Oil derived from this species is a Customs Prohibited Import requires an import permit/licence. Oil derived from this species is a Customs Prohibited Import requires an import permit/licence. Oil derived from this species is a Customs Prohibited Import requires an import permit/licence. Oil derived from this species is a Customs Prohibited Import requires an import permit/licence. Oil derived from this species is a Customs Prohibited Import requires an import permit/licence. Oil derived from this species is a Customs Prohibited Import requires an import permit/licence. Oil derived from this species is a Customs Prohibited Import requires an import permit/licence. Oil derived from this species is a Customs Prohibited Import requires an import permit/licence. Oil derived from this species is a Customs Prohibited Import requires an import permit/licence.
Artemisia arborescens
Oil derived from this species is a Customs Prohibited Import requires an import permit/licence.
Artemisia dracunculus Artemisia frigida Artemisia herba-alba Artemisia maritima Artemisia pallens
Artemisia tridentata Artemisia vulgaris Arthrospira maxima
Arthrospira platensis
Iodine is a mandatory component of this ingredient (see separate entry). May be a native species if exporting this product please contact the DSEWPC. Iodine is a mandatory component of this ingredient (see separate entry). May be a native species if exporting this product please contact the DSEWPC.
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Ingredient
Arum maculatum
Use A C A, E A, E A, E A, E A, E A, E A, E E E
Restrictions
Arundo mauritianica Asafoetida gum
Aryltetralin lignins calculated as podophyllotoxin Asarum europaeum Asarum sieboldii
MRDD must contain 1 mg or less of the equivalent dry herbal material.
Asarum heterotropoides Asclepias tuberosa Ascorbic acid
Sponsors must confirm the absence of aristolochic acids or herbal species known to contain these acids. Sponsors must confirm the absence of aristolochic acids or herbal species known to contain these acids. Sponsors must confirm the absence of aristolochic acids or herbal species known to contain these acids. Iodine is a mandatory component of this ingredient (see separate entry). Approved for topical use only. Concentration must not exceed 2%. Approved for topical use only.
Ascophyllum nodosum Ascorbyl glucoside
Ascorbyl methylsilanol pectinate Ascorbyl palmitate
A, E, C
When used as an active in oral or sublingual products, the label must include the statement VIT.
A, E
When used as an active in oral products, the MRDD must not exceed 100 mg. When used as an active in oral or sublingual products, the label must include the statement VIT.
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Ingredient
Ascorbyl tocopheryl maleate Aspalathus linearis Asparagine Asparagus
Use E C
Restrictions
Asiaticoside (of Centella asiatica)
A, E A, E E A, E A, E A E
Asparagus lucidus
Asparagus officinalis Aspartame
Only Asparagus officinalis shoot permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Asparagus racemosus Aspartic acid
Approved only when the plant part is dried, peeled root, and water extracts or ethanol/water extracts (containing up to 45% ethanol) of the dried, peeled root. Requires the label statement ASPAR. Products for oral ingestion must also include the label statement PKU.
Aspergillus clavatus Aspergillus oryzae Asperula odorata Aster novi-belgii
A, E A, E A, E A, E A, E
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Ingredient
Aster tataricus
Use A, E A, E A, E A, E A, E A, E A, E A, E E A, E A, E A, E A C
Restrictions
Astragalus adsurgens Astragalus excarpus
Astragalus complanatus Astragalus gummifer
Astragalus lentiginosus
Astragalus membranaceus Astragalus penduliflorus Atractylodes japonica Atractylodes lancea Atropa belladonna Atropine
Astrocaryum murumuru seed butter
Atractylodes macrocephala
Atropine and Alkaloids calculated as hyoscyamine are mandatory components of this ingredient (see separate entries). When used as an active, this ingredient is only listable as an uncompounded BP substance.
Attapulgite activated
A, E
Concentration from all ingredients must not exceed 100 micrograms/kg or 100 micrograms/L or 0.00001%.
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Ingredient
Aucubin (of Vitex agnus-castus) Aureobasidium pullulans Avena fatua Avocado Avena sativa Avocado oil
Use C A, E A, E A, E E E E E E A
Restrictions
Gluten is a mandatory component of this ingredient when the plant part is seed and when route of administration is other than topical or mucosal (see separate entry). Only Persea gratissima fruit flesh permitted. May only be used as a food excipient refer to introduction for permitted preparations. Approved for topical use only.
Gluten is a mandatory component of this ingredient when the plant part is seed and when route of administration is other than topical or mucosal (see separate entry). Only Persea gratissima fruit flesh oil fixed permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Avocado oil unsaponifiables Azadirachta indica Azovan blue Azulene
Approved only when it is the oil derived from the seed and is for topical use only. When the concentration of cold pressed Azadirachta indica seed oil exceeds 1% a CRC is required. Requires the label statements PREGNT2, NTAKEN, and CHILD. Colour permitted only in topical preparations. Approved for topical use only.
Backhousia citriodora Bacopa monnieri
A, E A, E
Approved only when it is the oil derived from the leaf and is for topical use only. Concentration must not exceed 10 g/kg or 10 g/L or 1%. Requires the label statements IRRIT, CHILD3, and PREGNT. May be a native species if exporting this product please contact the DSEWPC.
Page 31 of 305
Ingredient
Bacosides calculated as bacoside A (of Bacopa monnieri) Ballota nigra Balm of gilead bud dry Bambusa breviflora Bambusa textilis Banana
Use C
Restrictions
Balm of gilead bud powder
A, E A A
A, E A, E E A, E A, E A, E A, E E E
Baphicacanthus cusia Baptisia confusa Baptisia tinctoria Barium sulfate Barley
Only Musa sterile hybrid cultivars fruit flesh permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Barbarea vulgaris
Only Hordeum distichon and H. vulgare seed (grain) permitted. May only be used as a food excipient refer to introduction for permitted preparations. Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry).
Page 32 of 305
Ingredient
Barley bran Barley germ Barley leaf
Use E E E E A, E E E E
Restrictions
Only Hordeum distichon and H. vulgare seed (grain) husk or seed coat (bran) permitted. May only be used as a food excipient refer to introduction for permitted preparations. Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry). Only Hordeum distichon and H. vulgare seed (grain) embryo (germ) permitted. May only be used as a food excipient refer to introduction for permitted preparations. Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry). Only Hordeum distichon and H. vulgare herb or leaf permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Barley sprout Barosma betulina Basic fuchsin
Basic butylated methacrylate copolymer Basic violet 2
Only Hordeum distichon and H. vulgare seed (grain) sprout permitted. May only be used as a food excipient refer to introduction for permitted preparations. Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry). Pulegone is a mandatory component of this ingredient (see separate entry). Colour permitted only in topical preparations.
Basil oil comoros
A, E
Permitted without restriction in preparations containing 5% or less of methyl chavicol. When the concentration is greater than 5% of methyl chavicol, the nominal capacity of the container must be 25 mL or less, a RFI must be fitted on the container and the product label must include the statement CHILD.
Page 33 of 305
Ingredient
Basil oil european Batyl alcohol Bay leaf Bay oil
Use A, E E E A, E
Restrictions
Permitted without restriction in preparations containing 5% or less of methyl chavicol. When the concentration is greater than 5% of methyl chavicol, the nominal capacity of the container must be 25 mL or less, a RFI must be fitted on the container and the product label must include the statement CHILD. Approved for topical use only. Only Laurus nobilis leaf permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Beeswax - synthetic Beeswax - white Beet red Beeswax - yellow Beetroot
E E E E E E A, E
Permitted without restriction in preparations containing 25% or less. When the concentration is greater than 25% and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. When the concentration is greater than 25% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. Approved for topical use only.
Begonia fimbristipula Beheneth-10
Only Beta vulgaris leaf blade or leaf permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Approved for topical use only. Concentration must not exceed 1.5%. Residual levels of ethylene oxide are to be kept below the levels of detection.
Page 34 of 305
Ingredient
Beheneth-20 Behenic acid Behenoxy dimethicone Behenoyl stearic acid Behenyl alcohol
Use E, C E E E
Restrictions
PRV may only be used as an excipient in topical preparations. Approved for topical use only.
Approved for topical use only as an excipient. MRDD must contain 383.5 mg or less in products for oral ingestion. Approved for topical use only. Concentration must not exceed 2.4%. Approved only in topical preparations for localised effect.
Belamcanda chinensis Belladonna herb dry Belladonna herb powder Bellis perennis Bemotrizinol Bentonite
A, E A A A A E E A, E A, E
Atropine and Alkaloids calculated as hyoscyamine are mandatory components of this ingredient (see separate entries). Atropine and Alkaloids calculated as hyoscyamine are mandatory components of this ingredient (see separate entries). Atropine and Alkaloids calculated as hyoscyamine are mandatory components of this ingredient (see separate entries). Sunscreen active permitted only in topical products. Concentration must not exceed 10%. May be a native species if exporting this product please contact the DSEWPC.
Belladonna herb prepared
Benincasia cerifera Benzaldehyde
Page 35 of 305
Ingredient
Benzalkonium chloride
Use E E E
Restrictions
Benzethonium chloride Benzoic acid
Benzylidene camphor sulfonic acid Benzoin siam
Approved only in products for topical or nasal administration. Concentration must not exceed 5%. Approved only in topical preparations for localised effect. Requires the label statement BNZTHC. Sunscreen active permitted only in topical products. Requires the label statement TBNZO8.
Benzoin sumatra Benzyl alcohol Benzyl benzoate Berberine
A, E A, E E E E C
Benzyl cinnamate
Topical products require the label statement BNZALC. Approved for topical use only.
Berberis aquifolium Berberis vulgaris
Bergamot oil coldpressed Bertholletia excelsa
A, E A, E A, E A, E
Permitted when: a) steam distilled or rectified; b) in preparations for internal use; c) in preparations containing 0.4% or less of bergamot oil; d) in soaps or bath and shower gels that are washed off the skin; or e) packed in containers labelled with the statement SENS. Oxedrine is a mandatory component of this ingredient when used for internal use (see separate entry).
Page 36 of 305
Ingredient
Beta-1, 2-D-oligofructofuranosides (of Echinacea purpurea) Beta-tocopherol Beta rapa Beta vulgaris Betadex Betaine
Use C
Restrictions
Beta-hydroxy-beta-methylbutyric acid
E, C
Betacarotene Betaglucan
A, E A, E E E E
A, E, C
Betaine hydrochloride Betonica officinalis Betula lenta Betula nigra
E, C
Approved for topical use only. Concentration must not exceed 0.01%. Approved for topical use only.
Betula papyrifera Betula pendula
Methyl salicylate is a mandatory component of this ingredient (see separate entry).
Page 37 of 305
Ingredient
Betula pubescens
Use A, E A A A A A A A A E E C C A, E
Restrictions
Bifidobacterium adolescentis Bifidobacterium animalis
Bifidobacterium animalis ssp animalis Bifidobacterium animalis ssp lactis Bifidobacterium bifidum Bifidobacterium breve Bifidobacterium lactis Bifidobacterium infantis
Bifidobacterium longum Bilberry
Bifidobacterium longum lysate Bilobalide
Biochanin A
Only Vaccinium myrtillus fruit permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Biosaccharide gum-1
Approved for topical use only. Concentration must not exceed 5%.
Page 38 of 305
Ingredient Biotin
Biota orientalis Birch leaf dry
Use A, E A, E A, E A, E E E E E
Restrictions When used as an active in oral or sublingual products, the label must include the statement VIT. Requires pre-clearance from TGAL.
Birch tar oil rectified
Bis-diglyceryl polyacyladipate-2 Bisabolol
Bis-peg-12 dimethicone beeswax
Bishydroxyethyl biscetyl malonamide Bitter gourd Bixa orellana
E, C
Approved for topical use only. Concentration must not exceed 0.2%. PRV may only be used as an excipient in topical preparations.
Black cohosh dry Black currant
Black cohosh powder Black currant fresh
A, E A A E
Only Momordica charantia fruit flesh permitted. May only be used as a food excipient refer to introduction for permitted preparations. Requires the label statement BLKCOH. Requires the label statement BLKCOH.
A, E
Only Ribes nigrum fruit permitted. May only be used as a food excipient refer to introduction for permitted preparations.
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Ingredient Blackberry
Black pepper oil Bladderwrack dry
Use A, E E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E
Restrictions Only Rubus fruticosus fruit permitted. May only be used as a food excipient refer to introduction for permitted preparations. Iodine is a mandatory component of this ingredient (see separate entry). Iodine is a mandatory component of this ingredient (see separate entry).
Bladderwrack powder Bletia hyacinthina Blue flag rhizome dry Blumea lacera
Blue flag rhizome powder Boehmeria nivea
Species listed on CITES if exporting or importing this product please contact the DSEWPC.
Boerhavia diffusa Bogbean leaf dry Bois de rose oil
May be a native species if exporting this product please contact the DSEWPC. May be a native species if exporting this product please contact the DSEWPC.
Boerhavia repens
Bogbean leaf powder
Bombax malabaricum
Page 40 of 305
Ingredient Borax
Borago officinalis
Use A, E A, E A, E A C
Restrictions
Borax pentahydrate Boric acid Boron
Permitted only if the preparation is fixed oil derived from the seed.
Boron is a mandatory component of this ingredient (see separate entry).
Boron is a mandatory component of this ingredient (see separate entry). Boron is a mandatory component of this ingredient (see separate entry).
Boron nitride
Boswellia carterii Boswellia serrata Boswellic acid
Boswellia thurifera Botrytis cinerea Brandy
A, E A, E A, E C A, E A, E E
When the dosage form is not dusting powder and the product is for paediatric dermal use, the concentration from all ingredients must not exceed 3500 mg/kg or 3500 mg/L or 0.35%. When the dosage form is dusting powder and the product is for paediatric dermal use, the concentration from all ingredients must not exceed 10 mg/kg or 10 mg/L or 0.001%. If the product is for internal use the concentration must not exceed 3 mg per RDD. If the product is for vaginal use the concentration must not exceed 10 mg/kg or 10 mg/L or 0.001%. Approved for topical use only. Concentration must not exceed 0.5%.
Bovista gigantea
Page 41 of 305
Ingredient
Brassica chinensis Brassica juncea Brassica napus Brassica nigra
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E
Restrictions
Allyl isothiocyanate is a mandatory component of this ingredient when the plant part is seed (see separate entry). Allyl isothiocyanate is a mandatory component of this ingredient when the plant part is seed (see separate entry). Allyl isothiocyanate is a mandatory component of this ingredient when the plant part is seed (see separate entry). Allyl isothiocyanate is a mandatory component of this ingredient when the plant part is seed (see separate entry). Allyl isothiocyanate is a mandatory component of this ingredient when the plant part is seed (see separate entry). Allyl isothiocyanate is a mandatory component of this ingredient when the plant part is seed (see separate entry).
Allyl isothiocyanate is a mandatory component of this ingredient when the plant part is seed (see separate entry). Allyl isothiocyanate is a mandatory component of this ingredient when the plant part is seed (see separate entry). Allyl isothiocyanate is a mandatory component of this ingredient when the plant part is seed (see separate entry).
Brassica oleracea var. botrytis
Brassica oleracea var. capitata Brassica oleracea var. Italica Brassica pekinensis Brassica rapa
Brassica oleracea var. gemmifera Brassica oleracea var. viridis
Allyl isothiocyanate is a mandatory component of this ingredient when the plant part is seed (see separate entry). Allyl isothiocyanate is a mandatory component of this ingredient when the plant part is seed (see separate entry).
Page 42 of 305
Ingredient Brazil nut
Use E E E E E E E E E A
Restrictions
Brilliant black BN Brilliant blue FCF
Only Bertholletia excelsa seed permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Brilliant blue FCF aluminium lake Brilliant blue FCF barium lake Brilliant scarlet 4R Briza media Broad bean pod Broccoli
A, E
Broad bean seed Bromelains
Only Vicia faba fruit (bean pod) cooked permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Vicia faba seed (bean) cooked permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Brassica oleracea convar. Botrytis var. symosa immature flower head dark green permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Bromus asper
Bromus catharticus
A, E A, E
May be derived from either the stem or fruit of the pineapple (Ananas comosus). Sponsors should hold information to identify whether the bromelain in their product is derived from the fruit or stem.
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Ingredient Bronopol
Bromus inermis
Use A, E E E A, E A, E A E
Restrictions Approved only in topical preparations for localised effect. Requires the label statement BRONOP. Colour permitted only in topical preparations.
Broussonetia papyrifera Brown FK Brucea amarissima Brunfelsia uniflora Brussel sprout Bryonia alba Bryonia dioica Buchu leaf dry Buckwheat
May be a native species if exporting this product please contact the DSEWPC. MRDD must contain 1 mg or less of the equivalent dry herbal material.
A, E A, E A, E A, E E A, E A, E
Only Brassica oleracea convar. Botrytis var. gemmifera axillary bud (swollen tight clusters of young leaves) permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Buchu leaf powder Buddleia officinalis Bulnesia sarmienti
Only Fagopyrum esculentum seed permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 44 of 305
Ingredient
Bunias orientalis Burdock leaf dry
Use A, E A, E A, E A, E A, E A, E E E E E E E E E A
Restrictions
Bupleurum falcatum
Burdock leaf powder Burdock root dry Butan-1-ol Butane Butter
Burdock root powder
Residual solvent limit is 50 mg per MDD. Concentration must not exceed 0.5%.
Buttermilk - dried Butyl acetate
Butyl ester of pvm/ma copolymer Butyl hydroxybenzoate Butyl stearate Butyl methoxydibenzoylmethane
Residual solvent limit is 50 mg per MDD. Concentration must not exceed 0.5%. Topical products require the label statement TOTBNZ. Approved for topical use only.
Approved only in topical preparations for localised effect. Concentration must not exceed 15%. Requires the label statements EYE and EYE2. Sunscreen active permitted only in topical products. Concentration must not exceed 5%.
Page 45 of 305
Ingredient
Butylated hydroxyanisole
Use E E E E E E E E E E E A, E
Restrictions
Butylated hydroxytoluene
Butylene glycol dicaprylate/dicaprate
Topical products require the label statement BHANIS.
Butylene/ethylene/styrene copolymer - hydrogenated Butyloctyl salicylate Butyrospermum parkii
Approved for topical use only. Concentration must not exceed 10%. Must not be derived from animals. Approved only in topical preparations for localised effect. The combined concentration of butylene/ethylene/stryene copolymer - hydrogenated and ethylene/propylene/styrene copolymer - hydrogenated must not exceed 9%. Approved for topical use only. Concentration must not exceed 5%. PRV may only be used as an excipient in topical preparations.
C1-8 alkyl tetrahydroxycyclohexanoate C12-13 Pareth-23 C12-13 Pareth-3
C10-30 cholesterol/lanosterol esters
Approved only in topical preparations for localised effect. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL.
Approved for topical use only. Concentration must not exceed 0.125%. Residual levels of 1, 4dioxane and ethylene oxide (and related substances) are to be kept below the levels of detection. Approved for topical use only. Concentration must not exceed 0.125%. Residual levels of 1, 4dioxane and ethylene oxide (and related substances) are to be kept below the levels of detection. Approved for topical use only. Concentration must not exceed 20%. Approved for topical use only. Concentration must not exceed 1.2%.
C12-15 alkyl benzoate C12-15 alkyl lactate
Page 46 of 305
Ingredient
C12-15 alkyl octanoate C12-16 alcohols
Use E E E E E E E E E E E E E E E
Restrictions
C12-20 acid PEG-8 ester C13-14 isoparaffin C15-19 alkane
PRV may only be used as an excipient in topical preparations. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Approved for topical use only. Concentration must not exceed 0.2%. Approved for topical use only. Concentration must not exceed 7%.
C18-36 acid glycol ester C20-40 alcohols
C18-36 acid triglyceride C20-40 alkyl stearate C20-40 pareth-3 C20-40 pareth-24
Approved for topical use only. Concentration must not exceed 2%. Approved for topical use only. Concentration must not exceed 2%. PRV may only be used as an excipient in topical preparations. Approved for topical use only.
C30-45 alkyl methicone C9-11 isoparaffin C9-11 pareth-3
C6-14 olefin polymers - hydrogenated
Approved for topical use only. Concentration must not exceed 0.25%. Residual levels of ethylene oxide are to be kept below the levels of detection. Approved for topical use only. Concentration must not exceed 7%. Approved only in topical preparations for localised effect.
Page 47 of 305
Ingredient Cabbage Cade oil
C9-15 alkyl phosphate
Use E E
Restrictions
Caesalpinia sappan Caffeine
Caesalpinia sepiaria Caffeoylquinic acids calculated as cynarin of cynara scolymus Cajuput oil
A, E A, E A, E E, C C
Only Brassica chinensis, B. oleracea and B. pekinensis leaf green permitted. May only be used as a food excipient refer to introduction for permitted preparations.
May only be used as an excipient in topical products. When present as a component of Paullinia cupana in products for oral ingestion, the product requires the label statement CAFF. Permitted without restriction in preparations containing 25% or less. When the concentration is greater than 25% and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. When the concentration is greater than 25% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. Cineole is a mandatory component of Cajuput oil (see separate entry).
A, E, C
Calamba root dry Calamine
Calamba root powder
A A
A, E
When used as an active, this ingredient is only listable as an uncompounded BP substance for topical use only.
Page 48 of 305
Ingredient Calcium
Calamintha officinalis
Use A, E C E
Restrictions
Calcium aluminium borosilicate Calcium amino acid chelate Calcium ascorbate Calcium behenate
A, E A, E A, E E A A E E
Calcium ascorbate dihydrate Calcium beta-hydroxy-betamethylbutyrate Calcium carbonate Calcium caseinate Calcium chloride Calcium citrate
If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. The declared quantity of calcium must not exceed 25% of the calcium amino acid chelate in the formulation. When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an active in oral or sublingual products, the label must include the statement VIT. Behenic acid is a mandatory component of this ingredient (see separate entry).
Calcium beta-hydroxy-betamethylbutyrate monohydrate
A, E
If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label.
A, E
If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label.
Page 49 of 305
Ingredient
Calcium citrate hydrate Calcium diglutamate Calcium folinate Calcium gluconate
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E A, C A, E A, E
Restrictions
If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. MDD must not provide more than 500 micrograms of folinic acid. When used as an active in oral or sublingual products, the label must include the statement VIT.
Calcium glycerophosphate
If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. When used as an active, this ingredient is only listable as an uncompounded BP substance. If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label.
Calcium hydrogen phosphate Calcium hydrogen phosphate anhydrous Calcium hydrogen phosphate monohydrate Calcium hydroxide Calcium hydroxycitrate
Calcium lactate anhydrous Calcium lactate gluconate
If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label.
Page 50 of 305
Ingredient
Calcium lactate pentahydrate Calcium lactate trihydrate Calcium orotate Calcium oxide
Use A, E A, E A, E E A, E A, E A, E E E
Restrictions
If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. Approved for topical use only. When used as an active in oral or sublingual products, the label must include the statement VIT.
Calcium pantothenate Calcium phosphate Calcium phosphate - monobasic Calcium saccharate Calcium silicate
If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label.
Calcium sodium caseinate Calcium sodium lactate Calcium stearate
A, E E
Requires the label statement COWMK.
If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. When used as an excipient, the route of administration is either oral or sublingual, and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
Page 51 of 305
Ingredient
Calcium succinate Calcium sulfate Calcium sulfate - dried Calendula flower dry Calendula officinalis Callistemon citrinus
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E
Restrictions
If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label. If used as an active AND intended as a mineral supplementation, the equivalent quantity of calcium is required on the product label.
Calcium sulfate anhydrous Calendula flower powder Callicarpa pedunculata Callistephus chinensis Callitris rhomboidea Calluna vulgaris Caltha palustris Calochortus tolmiei
Native species if exporting this product please contact the DSEWPC.
Page 52 of 305
Ingredient
Calycanthus floridus Camellia japonica Camellia oleifera Camphor Camellia sinensis
Use A, E A, E A, E A, E A, E E, C
Restrictions
Calycanthus praecox
Camellia oleifera (seed oil) when used as a solvent is restricted to topical/suncreen preparations only. In solid and semi solid preparations, the concentration must not exceed 12.5%. In liquid preparations other than essential oils, the concentration must not exceed 2.5%. In essential oil preparations, when the concentration is greater than 2.5% but less than or equal to 10% and the nominal capacity of the container is 25 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. In essential oil preparations, when the concentration is greater than 10% and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. In essential oil preparations, when the concentration is greater than 10% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. Camphor, Cineole and Safrole are mandatory components of this ingredient (see separate entries). Camphor and Safrole are mandatory components of this ingredient (see separate entries).
Camphor oil brown Camphor oil white Canada balsam
Campsis grandiflora Cananga odorata
A, E A, E A, E A, E
Page 53 of 305
Ingredient
Cananga oil
Use A, E A A, E A, E A, E A, E E E E E E E E
Restrictions
Canarium indicum L. var. indicum Canarium luzonicum Candelilla wax Candida utilis Canola oil
Permitted only when the plant part is seed and the plant preparation is an oil. Requires the label statement DERIVED. Species listed on CITES if exporting or importing this product please contact the DSEWPC. Allyl isothiocyanate is a mandatory component of this ingredient (see separate entry).
Canthaxanthin
Cape gooseberry
Capparis masaikai
Caprylic/capric triglyceride
Caprylic/capric/isostearic/adipic triglyceride Caprylic/capric/myristic/stearic triglyceride Capryloyl glycine Caprylic/capric/stearic triglyceride
A, E
Only Physalis pubescens fruit permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Approved for topical use only. Concentration must not exceed 3%. Approved for topical use only. Approved for topical use only. Concentration must not exceed 2%.
Page 54 of 305
Ingredient
Capryloyl salicylic acid Caprylyl glycol Capsaicin Caprylyl methicone
Use E E E C
Restrictions
Capsella bursa-pastoris Capsicum Capsicum annuum Capsicum dry
A, E E A, E A, E A, E A, E A, E E A, E A, E A, E
Only Capsicum annuum and C. frutescens fruit non-spicy permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Capsicum fruit oleoresin Capsicum frutescens Capsicum powder Caramel Caraway dry Caraway oil
As per USP-NF monograph.
Caraway powder
Page 55 of 305
Ingredient
Carbomer - sodium Carbomer 1342 Carbomer 2001 Carbomer 910 Carbomer 934 Carbomer 940 Carbomer 941 Carbomer 954 Carbomer 956 Carbomer 980 Carbomer 981 Carbon
Restrictions
Approved for topical use only. Concentration must not exceed 1.0% in formulations at pH 7 (approximately neutral) and 0.1% in formulations at a different pH. Approved only in topical preparations for localised effect. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Carbomer 934p
Carbomer U-10 Carbon black
Page 56 of 305
Ingredient
Carbon dioxide
Use E C
Restrictions
Carbonyl compounds calculated as citral Cardamom fruit dry Cardamom oil Cardamom fruit powder
A, E A, E A, E C A, E A, E A, E E E E E E
Cardenolic glycosides calculated as digitoxin Cardiospermum halicacabum Carica papaya Carmellose Carlina acaulis
Carmellose calcium Carmellose sodium Carmoisine
Carmosine Aluminium lake
When used in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
Page 57 of 305
Ingredient Carob gum Carob pod Carotenes
Carnauba wax
Use A, E E E E C A, E A, E A, E E E
Restrictions Only Ceratonia siliqua seed endosperm (starch) powder or extract dry without diluent permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Ceratonia siliqua fruit pericarp (pod without seeds) permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Carotenoids calculated as betacarotene (of Dunaliella salina) Carpesium abrotanoides Carpinus betulus Carrageenan Carrot Carpinus cordata
Carrot seed oil Carum carvi
Carthamus tinctorius Carya illinoinensis
A, E A, E A, E A, E
Only Daucus carota ssp. sativus root permitted. May only be used as a food excipient refer to introduction for permitted preparations.
When Carthamus tinctorius is used as a solvent the resulting preparation is for topical use only.
Page 58 of 305
Ingredient
Carya ovata Cascara dry Cascara powder Cascarilla oil Cascaroside A Cascaroside B Casein
Use A, E A A C C C
Restrictions Hydroxyanthracene derivatives calculated as cascaroside A is a mandatory component of this ingredient in oral products (see separate entry). MRDD must contain 1 mg or less of the equivalent dry herbal material.
A, E
Hydroxyanthracene derivatives calculated as cascaroside A is a mandatory component of this ingredient in oral products (see separate entry).
Cascarosides calculated as cascaroside A Cashew nut
E E A
If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Only Anacardium occidentale seed (kernel) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of this ingredient in oral products (see separate entry).
Cassia angustifolia
Cassia cinnamon bark dry
Cassia cinnamon bark powder
A, E A, E
Page 59 of 305
Ingredient
Cassia fistula Cassia oil
Use A
Restrictions
Cassia occidentalis Cassia senna Cassia tora Castanea mollissima Castanea sativa Castor oil
A, E A, E A A
Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of this ingredient in oral products (see separate entry).
Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of this ingredient in oral products (see separate entry). Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of this ingredient in oral products (see separate entry). Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of this ingredient in oral products (see separate entry).
When the preparation is for dermal use as a rubefacient the concentration must not exceed 5%. In other products the concentration must not exceed 2%.
Casticin (of Vitex agnus-castus)
A, E A, E C A, E E E A, E A, E
Castor oil - ethoxylated hydrogenated Castor oil - hydrogenated Castor oil - sulfated Casuarina equisitifolia
When used as an active, this ingredient is only listable as an uncompounded BP substance. Approved for topical use only. May be a native species if exporting this product please contact the DSEWPC.
Page 60 of 305
Ingredient
Catalpa bignonioides Catalpa ovata
Use A, E A, E C C
Restrictions
Catechin (of Uncaria gambir) Catechu
Catechins (of Camellia sinensis) Catharanthus roseus Cauliflower
A, E A E
Vinblastine, Vincamine, Vincristine, Vindesine, Vinorelbine and Yohimbine are mandatory components of this ingredient (see separate entries).
Caulophyllum thalictroides Ceanothus americanus Cedar leaf oil Cedrela sinensis Cedrus atlantica Cedrus deodara Cedrus libani
A, E A, E A, E A, E A, E A, E A, E
Only Brassica oleracea convar. Botrytis var. botrytis immature flower head white is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 61 of 305
Ingredient Celeriac
Use E E
Restrictions
Celery leaf
Only Apium graveolens var. dulce root is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Apium graveolens var. dulce leaf stalk (petiole) or leaf is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Celery seed dry Celery seed oil Cellacephate Cellulase
Celery seed powder
A, E A, E A, E E E E E A, C
Cellulose - dispersible Cellulose - powdered Celosia argentia Celosia cristata
Cellulose - microcrystalline
Permitted only when derived from Trichoderma longibrachiatum,
Centaurea cyanus Centella asiatica
Centaurium erythraea
Page 62 of 305
Ingredient
Centipeda cunninghamii Centipeda minima Cephaelis acuminata
Use A, E A, E A A E E E E E
Restrictions
May be a native species if exporting this product please contact the DSEWPC. May be a native species if exporting this product please contact the DSEWPC. Emetine is a mandatory component of this ingredient (see separate entry). Emetine is a mandatory component of this ingredient (see separate entry). PRV may only be used as an excipient in topical preparations. Approved only in topical preparations for localised effect.
Cephaelis ipecacuanha Cephalins
Cephalanopsis segetum Ceramide 1 Ceramide 2 Ceramide 3
A, E
Ceramide 6 II
Approved for topical use only. Concentration must not exceed 0.05%. Approved only in topical preparations for localised effect. PRV may only be used as an excipient in topical preparations.
Ceratonia siliqua Ceresin
Ceratostigma willmottianum Cereus grandiflorus Ceteareth-12 Ceteareth-15
A, E A, E E E E A, E
Species listed on CITES if exporting or importing this product please contact the DSEWPC. PRV may only be used as an excipient in topical preparations.
Page 63 of 305
Ingredient
Ceteareth-2
Use E E E E E E E E E E E E E E
Restrictions
Ceteareth-20 Ceteareth-25 Ceteareth-30 Ceteareth-33 Cetearyl glucoside
Approved for topical use only. Approved for topical use only. Approved for topical use only.
Cetearyl isononanoate Cetearyl octanoate Ceteth-10 Ceteth-2 Ceteth-5 Ceteth-24
Approved for topical use only. Concentration must not exceed 0.2%. Residual levels of 1,4-dioxane and ethylene oxide (and related substances) are to be kept below the level of detection. Approved only in topical preparations for localised effect. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Cetomacrogol 1000 Cetostearyl alcohol Cetraria islandica
A, E
Page 64 of 305
Ingredient
Cetrimonium bromide Cetrimonium chloride Cetyl acetate Cetyl alcohol
Restrictions
Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Cetyl dimethicone Cetyl esters wax Cetyl lactate Cetyl myristate Cetyl palmitate
Cetyl dimethicone copolyol
Cetyl octanoate
Cetyl phosphate
Cetyl ricinoleate
Cetylpyridinium chloride Chaenomeles lagenaria Chaenomeles sinensis
A, E A, E
Approved only in topical preparations for localised effect. Requires the label statement CPYCHL.
Page 65 of 305
Ingredient
Chaenomeles speciosa Chaetomium indicum Chalk
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E C A, E A, E A, E
Restrictions
Chaetomium globosum
Chamaecyparis lawsoniana Chamaelirium luteum Chamomile flower dry Chamomile oil english
When used as an active, this ingredient is only listable as an uncompounded BP substance.
Chamomile oil german Charcoal - activated Cheiranthus cheiri Chelidonine
Changium smyrnioides
Requires the label statement ACCOAL.
Chelidonium majus Chelone glabra
Chenopodium album
Oral products require the label statement CELAND.
Page 66 of 305
Ingredient
Chenopodium ambrosioides Chenopodium vulvaria Cherry Chestnut sweet Chicken Chilli Chicken powder - black boned Chimaphila umbellata Chitin
Use A, E A, E E E E E A A, E A, E E E E A
Restrictions
Volatile oil components (of Chenopodium ambrosioides) is a mandatory component of this ingredient (see separate entry).
Only Prunus avium, P. cerasus and hybrids fruit flesh permitted. May only be used as a food excipient refer to introduction for permitted preparations. Requires pre-clearance from TGAL. Requires pre-clearance from TGAL.
Only Castanea sativa seed (nut kernel) permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Chionanthus virginica Chitosan
Only Capsicum annuum and C. frutescens fruit spicy-hot is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Chlamydomonas reinhardti cytoplasm extract ICID 2004 Chlorbutol
PRV may only be used as an excipient in topical preparations. Requires the label statements CHITO and SFOOD. PRV may only be used as an excipient in topical preparations.
Approved for topical use only. Concentration must not exceed 0.5%. Requires the label statement CHLORB.
Page 67 of 305
Ingredient Chlorella
Use E
Restrictions
Chlorella vulgaris (Chlorella pyrenoidosa is invalid) Chlorhexidine acetate Chloride Chlorine Chlorhexidine gluconate
A, E E E C C
Only Chlorella vulgaris (Chlorella pyrenoidosa is invalid) cells permitted. May be used as a food excipient refer to introduction for permitted preparations. Iodine is a mandatory component of this ingredient (see separate entry). Native species - if exporting this product please contact the DSEWPC. Iodine is a mandatory component of this ingredient (see separate entry). Native species - if exporting this product please contact the DSEWPC. Approved for topical use only. Approved for topical use only.
Chloroacetamide Chlorocresol Chloroform Chlorophyll
E E E E E E A, E
Concentration from all ingredients must not exceed 4%. Approved for topical use only.
Approved for topical use only. Concentration must not exceed 3%. Topical products require the label statement CHLCRS. Concentration must not exceed 0.006%. Residual solvent limit is 0.6 mg per MDD.
Chlorophyll-copper complexes Chlorophyllin-copper complex Chloroxylenol

Page 68 of 305
Ingredient
Chlorphenesin
Use E E E E E E E E C
Restrictions
Chocolate brown HT Cholecalciferol Cholesterol
A, E, C
Cholesteryl hydroxystearate Cholesteryl macadamiate Cholesteryl/behenyl/octyldodecyl lauroyl glutamate Cholesteryl/octyldodecyl lauroyl glutamate Choleth-24 Choline
If the product is for internal use it is listable only if the MRDD contains 25 micrograms or less of vitamin D. When used as an active in oral or sublingual products, the label must include the statement VIT. Approved for topical use only as an excipient. Requires pre-clearance from TGAL. Approved for topical use only. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL.
Approved only in topical preparations for localised effect. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL.
Approved for topical use only. Concentration must not exceed 0.5%. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL Approved for topical use only.
PRV may only be used as an excipient in topical preparations. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL
Choline bitartrate
Chondrodendron tomentosum
A, E A
Page 69 of 305
Ingredient
Chondroitin sulfate
Use C
Restrictions
Chondroitin sulfate - bovine
Chondroitin sulfate - bovine calcium Chondroitin sulfate - bovine sodium Chondroitin sulfate - shark Chondroitin sulfate - shark calcium Chondroitin sulfate - shark sodium Chondrus crispus Chondrus dry Chondrus extract Chromic chloride
A, C A A A A A A A
Can only be used as a component and it is not listable in its own right. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL.
Chondroitin sulfate - bovine potassium
Chondroitin sulfate - shark potassium
A, E A, E A, E A, E
Iodine is a mandatory component of this ingredient (see separate entry). Iodine is a mandatory component of this ingredient (see separate entry).
If used as an active AND intended as a mineral supplementation, the equivalent quantity of chromium is required on the product label.
Page 70 of 305
Ingredient Chromium
Use C
Restrictions
Chromium nicotinate Chromium picolinate
Chromium oxide greens
A, E E A, E A, E A, E A, E A, E A, E C A, E A, E C A, E A
MRDD may only provide 50 micrograms or less of chromium from organic sources (ie chromium picolinate and chromium nicotinate). Chromium sourced from inorganic materials is listable without restrictions. Chromium is a mandatory component of this ingredient (see separate entry). PRV may only be used as an excipient in topical preparations.
Chrysanthemum balsamita Chrysanthemum indicum
Chromium is a mandatory component of this ingredient (see separate entry).
Chrysanthemum leucanthemum Chrysanthemum marshallii Chrysanthemum sinense Chrysophanol
Chrysosporium pruinosum Cibotium barometz Cichoric acid Cichorium intybus Cicuta virosa
Page 71 of 305
Ingredient
Cimicifuga foetida
Use A, E A, E A, E A, E A A A A
Restrictions
Cimicifuga heracleifolia Cimicifuga racemosa Cimicifuga simplex Cinchona bark dry
Requires the label statement BLKCOH.
Cinchona bark powder Cinchona officinalis Cineole Cinchona pubescens
Quinidine and Quinine are mandatory components of this ingredient (see separate entries). Quinidine and Quinine are mandatory components of this ingredient (see separate entries). Quinidine and Quinine are mandatory components of this ingredient (see separate entries). Quinidine and Quinine are mandatory components of this ingredient (see separate entries).
A, E, C
Cinnamomum camphora Cinnamomum cassia
A, E A, E
When used as an active, permitted only in Medicated Space Sprays or Medicated Throat Lozenges. When the concentration is greater than 25% and the nominal capacity of the container is 15 mL or less, a a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. When the concentration is greater than 25% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. If the plant preparation is an oil, the concentration of this oil must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Cassia oil is a mandatory component of this ingredient (see separate entry).
Camphor, Cineole and Safrole are mandatory components of this ingredient (see separate entries).
Page 72 of 305
Ingredient
Cinnamomum zeylanicum
Use A, E
Restrictions
Cinnamon bark oil Cinnamon dry Cinnamon leaf oil
A, E A, E A, E
If the plant part is bark and the plant preparation is an oil, the concentration of this oil must not exceed 2%. When the plant part is leaf, the plant preparation is an oil, the concentration of this oil is greater than 25%, and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. When the plant part is leaf, the plant preparation is an oil the concentration of this oil is greater than 25%, and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. Concentration must not exceed 2%.
Cinnamon powder Cinoxate Cis-betacarotenes Cistanche salsa
A, E A C
Permitted without restriction in preparations containing 25% or less. When the concentration is greater than 25% and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. When the concentration is greater than 25% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. Sunscreen active permitted only in topical products. Concentration must not exceed 6%.
Cistanche deserticola Cistus ladaniferus
A, E A, E A, E
Page 73 of 305
Ingredient Citral Citrate
Use E C
Restrictions
Citric acid - anhydrous Citric acid-dihydrate Citron Citric acid monohydrate Citronella oil Citronellol
A, E, C A, E A, E E E A, E A, E A, E A, E A, E A, E
Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose. Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose. Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose. Topical products require the label statement CITRON. Approved for topical use only.
Only Citrus medica fruit flesh or fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Citrullus colocynthis Citrullus vulgaris Citrus aurantium Citrus aurantifolia
Citrus bioflavonoids extract
Oxedrine is a mandatory component of this ingredient when used for internal use (see separate entry).
Page 74 of 305
Ingredient Citrus fibre
Citrus chachiensis Citrus junos seed extract 1:10 in 90% E:W ICID 2006 Citrus limetta Citrus limon
Use A, E E E
Restrictions Only Citrus (species) fruit fibre is permitted. May only be used as a food excipient refer to introduction for permitted preparations. PRV may only be used as an excipient in topical preparations.
A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E
Citrus maxima Citrus medica
Citrus reticulata Citrus sinensis Citrus unshiu
Oxedrine is a mandatory component of this ingredient when used for internal use (see separate entry) Oxedrine is a mandatory component of this ingredient when used for internal use (see separate entry). Oxedrine is a mandatory component of this ingredient when used for internal use (see separate entry).
Citrus x paradisi Citrus x wilsonii Clary oil
Page 75 of 305
Ingredient
Claviceps purpurea Clematis armandii Clematis recta Clematis sinensis Clematis vitalba Clerodendron trichotomum Clinopodion polycephalum Cliver herb dry Clove bud oil Cliver herb powder
Use A A, E A, E A, E A, E A, E A, E A, E A, E A, E
Restrictions
Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Sponsors must confirm the absence of aristolochic acids or herbal species known to contain these acids. Sponsors must confirm the absence of aristolochic acids or herbal species known to contain these acids. Sponsors must confirm the absence of aristolochic acids or herbal species known to contain these acids. Sponsors must confirm the absence of aristolochic acids or herbal species known to contain these acids.
Clove dry
A, E
Permitted without restriction in preparations containing 25% or less. When the concentration is greater than 25% and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. When the concentration is greater than 25% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN.
Page 76 of 305
Ingredient
Clove leaf oil
Use A, E
Restrictions
Clove powder
Clove stem oil
A, E A, E
Permitted without restriction in preparations containing 25% or less. When the concentration is greater than 25% and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. When the concentration is greater than 25% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. Permitted without restriction in preparations containing 25% or less. When the concentration is greater than 25% and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. When the concentration is greater than 25% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN.
Cnicus benedictus Cnicus japonicus Cnicus marianus
A, E A, E A, E A, E A, E E E
Cnidium monnieri Cocamide dea
Cnidium officinale Cocamide mea
Page 77 of 305
Ingredient
Cocamidopropyl betaine Coccolobia uvifera Cochineal
Use E
Restrictions
Cocculus sarmentosus Cochlearia officinalis Cocillana dry
A, E A, E E A, E A, E A A E E E E
Approved for topical use only. Concentration must not exceed 0.8% (buccal mucosa), 1% (dermal application) and 6% (wash-on/wash off products). Levels of impurities 3dimethylaminopropylamine (DMAPA) and amidoamine (dimethylaminopropyl cocoamide; AA) should be controlled to below the level of detection.
Sponsors must confirm the absence of aristolochic acids or herbal species known to contain these acids.
Cochliobolus heterostrophus Cocillana powder Coco-betaine
Coco-caprylate/caprate Cocoa powder Coconut Cocoglycerides
A, E
Only Cocos nucifera seed (nut) endosperm (flesh) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 78 of 305
Ingredient Coconut oil
Coconut acid
Use E E E A, E
Restrictions
Coconut oil - fractionated Cocos nucifera Cod-liver oil
Coconut oil - hydrogenated
Codonopsis lanceolata Codonopsis pilosula Coffea arabica Coffee Codonopsis tangshen Coffea canephora Cognac oil green Cola acuminata
A, E A, E A, E A, E A, E A, E A, E E A, E A, E A, E
If vitamin A is claimed as a component then it must conform to the BP monograph for cod-liver oil.
Coix lachryma-jobi
Only Coffea arabica and C. canephora seed (bean) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 79 of 305
Ingredient
Cola cotyledon dry Cola nitida Colchicine
Use A, E A, E A, E C A
Restrictions
Cola cotyledon powder
Colchicum autumnale Colecalciferol Collagen Coleus forskohlii Collagen - hydrolysed Colocasia esculenta Colophony
A, E A, E E E
Concentration must not exceed 10 mg/kg or 10 mg/L or 0.001%.
Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%. If the product is for internal use it is listable only if the MRDD contains 25 micrograms or less of vitamin D. When used as an active in oral or sublingual products, the label must include the statement VIT.
If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL.
Collinsonia canadensis
A, E A, E A, E A A, E
Colostrum powder - bovine Commiphora abyssinica
Requires pre-clearance from TGAL. Requires the label statement BOVCOL.

Page 80 of 305
Ingredient
Commiphora erythraea Commiphora molmol Commiphora myrrha Condurangin
Use A, E A, E A, E A C A A
Restrictions
Concentrated omega-3 triglyceridesfish Conifer green needle complex Conioselium univittatum Convallaria majalis Copaiba oil Convolvulus arvensis
Approved for oral use only. Permitted in oral and topical products only.
A, E A, E A, E A, E A, E C E
Copaifera langsdorffii Copernicia cerifera Copper
Copper acetyl tyrosinate methylsilanol

Page 81 of 305
Ingredient
Copper gluconate Coptis chinensis Coptis japonica
Use A, E E A, E A, E E A, E A, E A, E A, E A, E E A, E A, E A, E A, E
Restrictions
Copper tripeptide-1
Concentration of copper compounds in topical products must not exceed 5%. Products for internal use must not contain a MDD more than 5 mg of copper. If used as an active AND intended as a mineral supplementation, the equivalent quantity of copper is required on the product label. Approved for topical use only. Concentration must not exceed 3%.
Corallina officinalis Cordyceps sinensis Coriander dry Coriander oil
Must not contain any material of animal origin such as insect larvae.
Coriander powder Corn glycerides Corn silk dry
Coriandrum sativum
Corn silk powder Cornus florida
Cornus officinalis
Page 82 of 305
Ingredient
Corydalis ambigua Corydalis cava
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E E A, E A, E
Restrictions
Corydalis bungeana Corydalis fabacea
Corydalis formosa
Corydalis turtschaninovii Corylus americana Corylus avellana Costus root oil Cotton
Cosmos bipinnatus Costus spicatus Cottonseed oil
Cottonseed oil - hydrogenated Couch grass rhizome dry Couch grass rhizome powder
Page 83 of 305
Ingredient Coumarin
Use C
Restrictions
Cowberry
Cranberry
E E A, E A, E A, E A, E A, E A, E A, E A, E E E, C
Permitted only as a component and if its concentration is less than 0.001%. If it is in a proprietary ingredient as a fragrance or similar reason (ie non-therapeutic) then the restriction does not apply. Only Vaccinium vitis-idaea fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Vaccinium oxycoccus fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Crataegus cuneata
Crataegus laevigata
Crataegus monogyna Crateva nurvala Creatine
Crataegus pinnatifida
Creatine monohydrate Creatine phosphate Creatinine Cresol
Requires the label statement PROFES. Requires the label statement PROFES. Requires the label statement PROFES.
Approved only in topical preparations for localised effect. Requires the label statement CRESOL. Concentration of phenols including cresols and xylenols and any other homologue of phenol boiling below 220 degrees centigrade must not exceed 3%.
Page 84 of 305
Ingredient
Crithmum maritimum leaf ext 1:1 in 50% 1,3-butyleneglycol : W ICID2002 Crithmum maritimum whole plant extract 1:9 in 50% propylene glycol : W ICID2004 Crocus sativus Crospovidone Croscarmellose sodium Croton cascarilla Croton eluteria Cubeb oil
Use E E E E
Restrictions
PRV may only be used as an excipient in topical preparations. Concentration must not exceed 1%. Approved for topical use only. Concentration must not exceed 0.00341%.
A, E
Cryptomeria japonica Cucumber
A A
When used in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. MRDD must contain 1 mg or less of the equivalent dry herbal material.
A, E A, E E A, E A, E A, E
Cucumis melo
Cucumis sativus
Only Cucumis sativus fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Cucurbita maxima
Page 85 of 305
Ingredient
Cucurbita moschata Cucurbita pepo Cucurbitacin B Cucurbitacin E Cumin oil
Use A, E A, E C C
Restrictions
Cuminum cyminum Cunila pulegioides
A, E A, E A, E A, E A, E A, E A, E A, E A, E
Cupressus arizonica Cupressus funebris
Cupressus macrocarpa Cupric citrate
Cupressus sempervirens Cupric citrate hemipentahydrate
Permitted only if the MRDD provides 750 micrograms or less of copper from cupric citrate OR if the MRDD provides 1.86 milligrams or less of cupric citrate. If used as an active AND intended as a mineral supplementation, the equivalent quantity of copper is required on the product label.
Permitted only if the MRDD provides 750 micrograms or less of copper from Cupric citrate hemipentahydrate OR if the MRDD provides 2.13 milligrams or less of cupric citrate hemipentahydrate. If used as an active AND intended as a mineral supplementation, the equivalent quantity of copper is required on the product label.
Page 86 of 305
Ingredient
Cupric nitrate trihydrate Cupric oxide Cupric sulfate anhydrous
Use E A, E
Restrictions
Approved for topical use only. Concentration must not exceed 0.00008%
Cupric sulfate monohydrate Cupric sulfate pentahydrate Curculigo orchioides Curcuma aromatica Curcuma longa
A, E, C A, E A, E A, E A, E A, E A, E A, E C
In products for internal use it is listable without restriction. In other types of products the concentration from all ingredients must not exceed 5%. If used as an active AND intended as a mineral supplementation, the equivalent quantity of copper is required on the product label. In products for internal use it is listable without restriction. In other types of products the concentration from all ingredients must not exceed 5%. If used as an active AND intended as a mineral supplementation, the equivalent quantity of copper is required on the product label. When used topically, Cupric sulfate anhydrous is a mandatory component of this ingredient (see separate entry). If used as an active AND intended as a mineral supplementation, the equivalent quantity of copper is required in the application and also on the product label. When used topically, Cupric sulfate anhydrous is a mandatory component of this ingredient (see separate entry). If used as an active AND intended as a mineral supplementation, the equivalent quantity of copper is required in the application and also on the product label.
Curcuma xanthorrhiza Curcuma zedoaria Curcumin
Curcuminoids (of Curcuma longa)
A, E, C
Page 87 of 305
Ingredient
Cuscuta epithymum Cuscuta europaea
Use A, E A, E A, E A, E A, E A, E C A, E A, E E E C A, E
Restrictions
Cuscuta hygrophilae Cuscuta racemosa Cusparia febrifuga Cyanidin
Cyamopsis tetragonolobus Cyanocobalamin
Cyathula officinalis
Cyclamen aldehyde Cyclomethicone
When used as an active in oral or sublingual products, the label must include the statement VIT. Approved for topical use only. Approved for topical use only.
Cyclamen europaeum
Cyclopentane sesquiterpenes (of Valeriana officinalis) Cydonia oblonga Cymbopogon flexuosus
A, E A, E
Page 88 of 305
Ingredient
Cymbopogon martini Cymbopogon nardus Cynanchum atratum Cynara scolymus
Use A, E A, E A, E A, E A, E A, E C A, E A, E A, E A, E A, E A, E A, E A
Restrictions
Cymbopogon schoenanthus Cynanchum stauntonii
Cynarine (of Cyanara scolymus) Cynodon dactylon Cyperus longus Cynomorium songariorum Cyperus rotundus Cysteine Cystine
Cypripedium pubescens Cysteine hydrochloride Cytisus laburnum
A, E, C
Sparteine is a mandatory component of this ingredient (see separate entry).
Page 89 of 305
Ingredient
D-Alpha-tocopherol
Use
D-Alpha-tocopheryl acetate D-Pulegone
D-Alpha-tocopheryl acid succinate Dactylis glomerata Dahlia pinnata Daidzein Daidzin
A, E, C A, E, C A, E, C C A, E A, E A, E C C
Restrictions
When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an active in oral or sublingual products, the label must include the statement VIT.
Daemonorops draco
Permitted without restriction in preparations containing 4% or less. When the concentration is greater than 4%, the nominal capacity of the container must be 15 mL or less, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN.
Dalbergia odorifera Dandelion leaf dry
Damiana leaf powder
A, E A A, E A, E A, E A, E
Page 90 of 305
Dandelion leaf powder Dandelion root dry
Dandelion root powder
Ingredient
Daphne genkwa Date
Use A, E A E C A A, E E E E E E E E C
Restrictions MRDD must contain 1 mg or less of the equivalent dry herbal material.
Daphne mezereum Datura stramonium Daucosterol Daucus carota
Only Phoenix dactylifera fruit flesh (pitted) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Approved only for use in oral preparations. Alkaloids calculated as hyoscyamine is a mandatory component of this ingredient (see separate entry).
Dea-cetyl phosphate
DEA-Oleth-3 phosphate Decyl glucoside Decyl oleate
Decarboxy carnoisine dihydrochloride
Approved only in topical preparations for localised effect. Concentration must not exceed 1.0%. Requires the label statements EYE and EYE2. PRV may only be used as an excipient in topical preparations. Approved for topical use only. Approved for topical use only.
Dehydroacetic acid Delphinidin
Dehydroxanthan gum
Approved only in topical preparations for localised effect. Requires the label statement DACACD. Approved for topical use only. Concentration must not exceed 0.2%.
Page 91 of 305
Ingredient
Delphinium staphisagria Delta-tocopherol
Use A A E E, C
Restrictions
Demineralised fish proteoglycan extract Denatonium benzoate Dendrobium nobile
Concentration of equivalent dry herbal material must not exceed 0.2%.
Desmodium styracifolium Desmodium triquetum Devil's claw tuber dry Dexpanthenol Dextrates Dextrin
A, E A, E A, E A A E E E E E
Devil's claw tuber powder
A, E
Dextrin palmitate
Di-C12-13 alkyl malate
Di-C12-15 alkyl fumarate
Approved for topical use only. Concentration must not exceed 5%. Approved for topical use only. Concentration must not exceed 5%.
Page 92 of 305
Ingredient
Di-N propyl isocinchomeronate Diallyl disulfide
Use E E C E E C C
Restrictions
Di-PPG-3 myristyl ether adipate
Diammonium lauryl sulfosuccinate Dianthus superbus Diazolidinylurea
Approved for topical use only. Concentration must not exceed 15%. Approved for topical use only.
Dibenzocyclooctadiene lignans calculated as g-schisandrins (of Schizandra chinensis fruit) Dibutyl adipate
A, E
Approved for topical use only. Topical products require the label statement DUREA.
Dibenzocyclooctadiene lignans (of Schizandra chinensis seed) Dibutyl phthalate Dibutyl sebacate Dicaprylyl ether
E E E E E E
Approved only in topical preparations for localised effect. Approved for topical use only.
Dicaprylyl carbonate Dicaprylyl maleate
Approved for topical use only. Concentration must not exceed 34%. Approved for topical use only. Approved for topical use only. Concentration must not exceed 10%.
Page 93 of 305
Ingredient
Dichlorobenzyl alcohol Dichloromethane Dictamnus albus Diethanolamine Dichroa febrifuga
Use E E
Restrictions Concentration must not exceed 0.06%. Residual solvent limit is 6 mg per MDD.
Dictamnus desycarpus Diethyl phthalate
A, E A, E A, E E E E E E E E A A A
Diethyl toluamide
Diethylaminomethylcoumarin Diethylhexyl-2,6-naphthalate Diethylhexyl sebacate Digitalis leaf dry Digitalis leaf powder Digitalis purpurea
Diethylene glycol monoethyl ether
Approved only in topical preparations for localised effect. Concentration must not exceed 20%. Requires the label statement DEET. PRV may only be used as an excipient in topical preparations. Approved for topical use only.
Approved only in topical preparations for localised effect. Concentration must not exceed 10%. Requires the label statement EYE2. Approved for topical use only. Concentration must not exceed 5%. Concentration must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Concentration must not exceed 10 mg/Kg or 10 mg/L or 0.001%.
Page 94 of 305
Ingredient
Diglycol/chdm/isophthalates/sip copolymer Dihydrocholeth-30 Dihydroxyacetone
Use E E E E E E E E E
Restrictions
Dihydrogenated tallow phthalic acid amide Diisopropyl adipate
PRV may only be used as an excipient in topical preparations. Approved for topical use only.
Approved for topical use only. Concentration must not exceed 5%. Approved for topical use only. Concentration must not exceed 15%. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Concentration must not exceed 10%.
Diisopropyl dimer dilinoleate Diisopropyl sebacate
Diisostearyl dimer dilinoleate Dilauryl thiodipropionate Dill herb oil Dill seed oil
Dimer distearyltricarbonate Dimethicone 10 Dimethicone 100
A, E A, E E E E E
Dimethicone 1000
Page 95 of 305
Ingredient
Dimethicone 10000 Dimethicone 12500 Dimethicone 20 Dimethicone 30 Dimethicone 200 Dimethicone 350 Dimethicone 360 Dimethicone 450 Dimethicone 5 Dimethicone 50 Dimethicone 4000
Use E E E E
Restrictions
PRV may only be used as an excipient in topical preparations. Approved only in topical preparations for localised effect. Approved for topical use only.
A, E A, E E E E E E E E E E
When used as an active, this ingredient is only listable as an uncompounded BP substance. Approved for topical use only as an excipient. Concentration must not exceed 4%. When used as an active, this ingredient is only listable as an uncompounded BP substance. Approved for topical use only as an excipient. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. PRV may only be used as an excipient in topical preparations.
Dimethicone 500
Dimethicone copolyol
Dimethicone copolyol phosphate Dimethicone crosspolymer
Page 96 of 305
Ingredient
Dimethicone/methicone copolymer Dimethicone/vinyl dimethicone crosspolymer Dimethiconol Dimethiconol stearate Dioctyl adipate Dioctyl maleate
Use E E E E E E E
Restrictions
Approved for topical use only. Concentration must not exceed 4%. PRV may only be used as an excipient in topical preparations. Approved for topical use only. Approved for topical use only.
Approved for topical use only. Concentration must not exceed 2%. Approved for topical use only. Approved for topical use only.
Dioctyl succinate
Dioscorea batatas
Dioscorea collettii
Dioscorea hypoglauca Dioscorea japonica Dioscorea opposita Dioscorea villosa
A, E A, E A, E A, E A, E A, E A, E C
Dioscorea septemloba
Diosgenin and dioscin calc as diosgenin (of Dioscorea villosa)
Page 97 of 305
Ingredient
Diosgenin (of Dioscorea villosa) Diospyros kaki Dioxane Dioxybenzone
Use C C A, E A E E E E E E E
Restrictions
Concentration must not exceed 10 mg/kg or 10 mg/L or 0.001%. PRV may only be used as an excipient in topical preparations.
Dipentaerythrityl hexacaprylate/hexacaprate Dipentaerythrityl tetrahydroxystearate/tetraisostearate Diphenyl dimethicone Dipropylene glycol
Sunscreen active permitted only in topical products. Concentration must not exceed 3%.
Dipotassium glycyrrhizate
Dipropylene glycol dibenzoate Dipropylene glycol salicylate Dipsacus asper Dipsacus japonicus Dipteryx odorata
Approved for topical use only. Concentration must not exceed 0.1%. Approved for topical use only. Concentration must not exceed 1.3%. Approved for topical use only.
A, E A, E A, E
Page 98 of 305
Ingredient
Disodium ascorbyl sulfate
Use E E E E E E E E E E E E E
Restrictions
Disodium cocoamphodiacetate Disodium edetate Disodium NADH
Disodium dimethicone copolyol sulfosuccinate Disodium lauriminodipropionate tocopheryl phosphates Disodium oleamido PEG-2 sulfosuccinate
Approved for topical use only. Concentration must not exceed 14%. Requires the label statement EYE. When used in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved for topical use only. Concentration must not exceed 3%. PRV may only be used as an excipient in topical preparations. Approved for topical use only. Concentration must not exceed 1%. PRV may only be used as an excipient in topical preparations.
Disodium ricinoleamido MEAsulfosuccinate Disodium stearoyl glutamate Distarch phosphate Disteardimonium hectorite
Approved for topical use only. Concentration must not exceed 3%. Approved for topical use only. Concentration must not exceed 4%. Approved for topical use only. Concentration must not exceed 2%. Approved for topical use only.
Disteareth-6 dimonium chloride Distearyldimonium chloride
Page 99 of 305
Ingredient
Divinyldimethicone/dimethicone copolymer DL-Alpha-tocopherol DL-Alpha-tocopheryl acetate DL-Borneol
Use E
Restrictions
DL-Alpha-tocopheryl acid succinate DL-Limonene
A, E, C A, E, C E E E E
A, E, C
When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an active in oral or sublingual products, the label must include the statement VIT. Approved for topical use only. Approved for topical use only.
DL-Threonine
DMDM Hydantoin Docusate sodium Dolichos lablab Dolomite
Docosahexaenoic acid
A, E E, C
Dracaena draco Drimia indica
Drechslera sorokiniana
Page 100 of 305
Ingredient
Drimia maritima
Use A, E A A, E A, E A, E A, E A, E A, E A, E A, E A, E A A, E A, E E
Restrictions Sunscreen active permitted only in topical products. Concentration must not exceed 15%. May be a native species if exporting this product please contact the DSEWPC.
Drometrizole trisiloxane Drosera burmanni Drosera longifolia Drosera intermedia
Drosera ramentacia
Drosera rotundifolia Drynaria fortunei
Drosera rotundifolia mis Dryobalanops aromatica Dryopteris filix-mas Dunaliella salina
Dryopteris crassirhizoma
Dulacia inopiflora (synonym Liriosma ovata)
Durvillaea antartica extract ICID 2000
Page 101 of 305
Ingredient Ecamsule Echinacea angustifolia Echinacea pallida Echinacoside Echinacea purpurea Echinops spinosus Eclipta prostrata Ectoin Edetate sodium Edetic acid Eggplant
Use A A, E A, E A, E C A, E A, E E E E E A, E E, C A, E A, E
Restrictions
Native species if exporting this product please contact the DSEWPC. PRV may only be used as an excipient in topical preparations. Concentration must not exceed 0.25%.
Approved for topical and nasal use only. Concentration must not excced 0.2%
Eichhornia crassipes
Eicosapentaenoic acid Elaeis guineensis
Only Solanum melongena fruit flesh or fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Steroidal alkaloids calculated as solanine is a mandatory component of this ingredient (see separate entry).
Elaeagnus angustifolia
Page 102 of 305
Ingredient Elastin
Use E E
Restrictions
Elastin - hydrolysed
Approved for topical use only. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL.
Elder flower black dry
Elder flower black powder Elecampane rhizome dry Eleocharis tuberosa
A, E A, E A, E A, E A, E A, E A A A C
Approved for topical use only. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL.
Elecampane rhizome powder Elettaria cardamomum
Eleutherococcus root dry
Eleutherococcus root powder Eleutherococcus senticosus Elscholtzia splendens Emerald Emetine
Ellagic acid (of Punica granatum)
A, E E C
PRV may only be used as an excipient in topical preparations. Concentration from all ingredients must not exceed 0.2%.
Page 103 of 305
Ingredient Emu oil Eosine
Use A, E E A A C A, E A, E C A, E A, E A, E A, E A, E A, E A, E
Restrictions
Ephedra distachya Ephedra sinica Ephedrine
Native species if exporting this product please contact the DSEWPC. Colour permitted only in topical preparations.
Ephedrine is a mandatory component of this ingredient (see separate entry). Ephedrine is a mandatory component of this ingredient (see separate entry).
Epicoccum nigrum Epigaea repens
Concentration from all ingredients must not exceed 10 mg/kg or 10 mg/L or 0.001%. Customs Prohibited Import requires an import permit/licence.
Epigallocatechin-3-0-gallate Epilobium palustre Epilobium parviflorum
Epimedium brevicornu Epimedium sagittatum Equisetum arvense Equisetum hiemale
Epimedium grandiflorum
Page 104 of 305
Ingredient
Ergocalciferol
Use A, E E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E E E E
Restrictions
Ergothioneine
Erigeron breviscapus Erigeron canadensis Eriobotrya japonica
If the product is for internal use it is listable only if the MRDD contains 25 micrograms or less of vitamin D. When used as an active in oral or sublingual products, the label must include the statement VIT. PRV may only be used as an excipient in topical preparations.
Eriocaulon buergerianum Eriodictyon crassifolium Eriodictyon glutinosum Erodium cicutarium Eruca sativa Erythritol Erythrina variegata Erythrosine
Eriodendron anfractuosum
May be a native species if exporting this product please contact the DSEWPC. Approved for topical use only. Concentration must not exceed 0.1%.
Erythrosine aluminium lake
Page 105 of 305
Ingredient
Erythrulose Escin
Use E C C
Restrictions
Eschscholtzia californica
Esters calculated as menthyl acetate Ethanol Ethanol - absolute Ethanolamine Ethohexadiol Ethyl acetate Ether - solvent
A, E
Approved only in topical preparations for localised effect. Concentration must not exceed 2%. Requires the label statement EYE.
A, E, C A, E E E E E E E E
When used as an active, this ingredient is only listable as an uncompounded BP substance. If the concentration from all ingredients is more than 3%, the product label must include the statement ETHAN. When used as an active, this ingredient is only listable as an uncompounded BP substance. If the concentration from all ingredients is more than 3%, the product label must include the statement ETHAN. Approved for topical use only. Concentration must not exceed 5%. Concentration of must not exceed 10%.
Ethyl acrylate
Approved only in topical preparations for localised effect. Requires the label statement EHEXAD. Concentration must not exceed 0.5%. Residual solvent limit is 50 mg per MDD.
Ethyl butylacetylaminopropionate Ethyl hydroxybenzoate
Approved only in topical preparations for localised effect. Concentration must not exceed 7.5%. Requires the label statement EYE2. Topical products require the label statement TOTBNZ.
Page 106 of 305
Ingredient
Ethyl linoleate Ethyl maltol
Use E E E E E E E E E E C E E E E
Restrictions
Ethyl linolenate
Ethyl methacrylate Ethyl vanillin
Ethylbisiminomethyl guaiacol manganese chloride Ethylcellulose Ethylene brassylate Ethylene glycol Ethylene oxide
Ethylene glycol monostearate Ethylenediamine
Concentration should not exceed 0.062%. Residual solvent limit is 6.2 mg per MDD. Concentration must not exceed 1 mg/kg or 1 mg/L or 0.0001%. Approved for topical use only.
Ethylene/acrylic acid copolymer Ethylene/propylene/styrene copolymer - hydrogenated Ethylhexyl ethylhexanoate
The combined concentration of butylene/ethylene/stryene copolymer - hydrogenated and ethylene/propylene/styrene copolymer - hydrogenated must not exceed 9%.
Page 107 of 305
Ingredient
Ethylhexylglycerin Etidronic acid Eucalyptus citriodora
Use E E
Restrictions
A, E
Approved for topical use only. Concentration in topical preparations must not exceed 1%. Other than topical the concentration must not exceed 10 mg/kg or 10 mg/L or 0.001%.
Eucalyptus dives
Eucalyptus ficifolia
Eucalyptus fruticetorum Eucalyptus globulus Eucalyptus oil
A, E A, E A, E A, E A, E A, E A, E A, E A, E
Permitted without restriction in preparations containing 25% or less of eucalyptus oil. When the concentration of eucalyptus oil is greater than 25% and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. When the concentration of eucalyptus oil is greater than 25% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. Cineole is a mandatory component of this ingredient (see separate entry). Native species if exporting this product please contact the DSEWPC. As per Eucalyptus citriodora (see above). As per Eucalyptus citriodora (see above). As per Eucalyptus citriodora (see above). As per Eucalyptus citriodora (see above). As per Eucalyptus citriodora (see above). As per Eucalyptus citriodora (see above). As per Eucalyptus citriodora (see above). As per Eucalyptus citriodora (see above). As per Eucalyptus citriodora (see above).
Page 108 of 305
Eucalyptus macrorhyncha Eucalyptus radiata
Eucalyptus rostrata
Eucalyptus tereticortis
Ingredient
Eucommia ulmoides Eugenia cumini Eugenol
Use A, E A, E E
Restrictions
Euonymus atropurpureus Euonymus europaeus Eupatorium fortunei
A A
Approved for topical use only, Permitted without restriction in preparations containing 25% or less. When the concentration is greater than 25% and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. When the concentration is greater than 25% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. MRDD must contain 1 mg or less of the equivalent dry herbal material.
Eupatorium japonicum
Eupatorium perfoliatum Eupatorium purpureum Euphorbia cyparissias Euphorbia dry
A, E A, E A, E A, E A, E A, E A, E A, E
Euphorbia antisyphilitica
Species listed on CITES if exporting or importing this product please contact the DSEWPC. Species may be listed on CITES if exporting or importing this product please contact the DSEWPC.
Euphorbia heterodoxa
Page 109 of 305
Ingredient
Euphorbia hirta
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E
Restrictions
Euphorbia lathyris Euphorbia peplus
Euphorbia pekinensis Euphorbia powder
Euphorbia resinifera Euphrasia officinalis Euryale ferox Evodia lepta
Euphorbia sieboldiana
Species may be listed on CITES if exporting or importing this product please contact the DSEWPC.
Evening primrose oil Evodia rutaecarpa Fabiana imbricata Fagus grandifolia
Fagopyrum esculentum
Page 110 of 305
Ingredient Farnesol
Fagus sylvatica Fast green FCF Fatty acids
Use A, E E E E C A, E E A, E A, E A, E A, E
Restrictions PRV may only be used as an excipient in topical preparations. PRV may only be used as an excipient in topical preparations.
Fats and glyceridic oils, Limnanthes alba seed Fennel bitter seed dry Fennel leaf Fennel oil
Fennel sweet seed dry
Only Foeniculum vulgare ssp. vulgare var. dulce leaf stalk (petiole) base is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Ferric ammonium citrate Ferric chloride anhydrous
Iron is a mandatory component of this ingredient (see separate entry). Iron-containing Listed medicines require the label statement IRONDEF. Iron containing multivitamin/mineral products indicated for general nutritional support, and which do not make specific iron-deficiency related claims are exempt from this requirement. Iron is a mandatory component of this ingredient (see separate entry). Iron-containing Listed medicines require the label statement IRONDEF. Iron containing multivitamin/mineral products indicated for general nutritional support, and which do not make specific iron-deficiency related claims are exempt from this requirement.
Page 111 of 305
Ingredient
Ferric chloride hexahydrate Ferric glycerophosphate Ferric oxide
Use A, E A, E E, C
Restrictions
Ferric pyrophosphate Ferrous carbonate Ferrous chloride Ferrous fumarate
A, E A A, E A, E
Iron is a mandatory component of this ingredient (see separate entry). Iron-containing Listed medicines require the label statement IRONDEF. Iron containing multivitamin/mineral products indicated for general nutritional support, and which do not make specific iron-deficiency related claims are exempt from this requirement. Iron is a mandatory component of this ingredient (see separate entry). Iron-containing Listed medicines require the label statement IRONDEF. Iron containing multivitamin/mineral products indicated for general nutritional support, and which do not make specific iron-deficiency related claims are exempt from this requirement. Iron is a mandatory component of this ingredient (see separate entry). Iron-containing Listed medicines require the label statement IRONDEF. Iron containing multivitamin/mineral products indicated for general nutritional support, and which do not make specific iron-deficiency related claims are exempt from this requirement. Iron is a mandatory component of this ingredient (see separate entry). Iron-containing Listed medicines require the label statement IRONDEF. Iron containing multivitamin/mineral products indicated for general nutritional support, and which do not make specific iron-deficiency related claims are exempt from this requirement.
Page 112 of 305
Ingredient
Ferrous gluconate Ferrous gluconate dihydrate Ferrous lactate Ferrous phosphate Ferrous succinate Ferrous sulfate
Use A, E A, E A, E A, E A, E A, E
Restrictions
Iron is a mandatory component of this ingredient (see separate entry). Iron-containing Listed medicines require the label statement IRONDEF. Iron containing multivitamin/mineral products indicated for general nutritional support, and which do not make specific iron-deficiency related claims are exempt from this requirement.
Iron is a mandatory component of this ingredient (see separate entry). Iron-containing Listed medicines require the label statement IRONDEF. Iron containing multivitamin/mineral products indicated for general nutritional support, and which do not make specific iron-deficiency related claims are exempt from this requirement. Iron is a mandatory component of this ingredient (see separate entry). Iron-containing Listed medicines require the label statement IRONDEF. Iron containing multivitamin/mineral products indicated for general nutritional support, and which do not make specific iron-deficiency related claims are exempt from this requirement. Iron is a mandatory component of this ingredient (see separate entry). Iron-containing Listed medicines require the label statement IRONDEF. Iron containing multivitamin/mineral products indicated for general nutritional support, and which do not make specific iron-deficiency related claims are exempt from this requirement.
Page 113 of 305
Ingredient
Ferrous sulfate - dried Ferula assa-foetida Ferula foetida Ferula galbaniflua Ferula rubricaulis Ferula sumbul Ferulic acid
Use A, E A, E A, E A, E A, E A, E E, C C
Restrictions
Iron is a mandatory component of this ingredient (see separate entry). Iron-containing Listed medicines require the label statement IRONDEF. Iron containing multivitamin/mineral products indicated for general nutritional support, and which do not make specific iron-deficiency related claims are exempt from this requirement.
Ferulic and isoferulic acids Festuca elatior Feverfew herb dry Ficus carica Fig
Feverfew herb powder Ficus pumila
A, E A A
A, E A, E E
Only Ficus carica fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 114 of 305
Ingredient Fig dry Filipendula ulmaria
Use A, E A, E A, E A, E A, E A, E C C C C E
Restrictions
Fir needle oil canadian Fir needle oil siberian Fish oil - natural
Fish oil, rich in in Omega-3 acids
If therapeutic indications are made against Vitamin A or Cholecalciferol (Vitamin D) then these are mandatory components of this ingredient (see separate entries). May be a native species if exporting this product please contact the DSEWPC. If therapeutic indications are made against Vitamin A or Cholecalciferol (Vitamin D) then these are mandatory components of this ingredient (see separate entries). May be a native species if exporting this product please contact the DSEWPC.
Flavanolignins calculated as silybin
Flavonoid glycosides (of Hypericum perforatum) Fluorescein sodium Fluoride
Flavonoids calculated as baicalin (of Scutellaria baicalensis)
Foeniculum vulgare
A, E
In dental products, the concentration from all ingredients must not exceed 15 mg/kg or 15 mg/L or 0.0015%. In other products, the concentration from all ingredients must not exceed 1000 mg/kg or 1000 mg/L or 0.1%.
Page 115 of 305
Ingredient Folic acid
Use A, E E E E E C C
Restrictions
Food orange 6 Food orange 7 Food red 13
MRDD must not provide more than 500 micrograms. When used as an active in oral or sublingual products, the label must include the statement VIT. Additional conditions related to dissolution testing and permitted indications apply.
Formaldehyde/melamine/tosylamide copolymer Formononetin Forskolin (of Coleus forskohlii) Forsythia suspensa Fragaria chiloensis Fragaria vesca
Fragaria virginiana Frangula bark dry
A, E A, E A, E A, E A
Fragaria x ananassa
Glucofrangulins calculated as glucofrangulin A is a mandatory component of this ingredient (see separate entry).
Page 116 of 305
Ingredient
Frangula bark powder Fraxinus americana Fraxinus excelsior Fraxinus nigra Fraxinus ornus
Use A
Restrictions
A, E A, E A, E A, E A, E C A, E A, E A, E A, E A, E A, E E A
Glucofrangulins calculated as glucofrangulin A is a mandatory component of this ingredient (see separate entry).
Fraxinus rhynchophylla Fritillaria cirrhosa
Free alcohols calculated as menthol Fritillaria thundbergii Fritillaria verticillata Fructose Fucus vesiculosus Fumaric acid
Fumaria officinalis Fumitory herb dry
Page 117 of 305
Ingredient
Fumitory herb powder Fusarium oxysporum Galega officinalis Galium aparine Galium verum
Use A C
Restrictions
Furostanol saponins calc as protodioscin (of Tribulus terrestris) Fusarium vasinfectum Galeopsis ochroleuca Galium palustre
A, E A, E A, E A, E A, E A, E A, E A, E E E
Galphimia glauca
Gamma-decalactone
Gamma-linoleic acid Gamma-tocopherol
Gamma-linolenic acid Ganoderma lucidum
E, C E, C
A, E
Page 118 of 305
Ingredient
Garcinia quaesita Garden bean Gardenia florida Garlic bulb dry
Use A, E E A, E A, E A, E A, E A, E A, E C A, E A, E A, E E A, E
Restrictions Only Phaseolus coccineus and P. vulgaris fruit (bean pod) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Garlic bulb fresh
Garlic bulb powder Garlic oil
Garlic clove powder
Gallic acid (of Punica granatum) Gastrodia elata Gelatin Gaultheria procumbens Gelatin - hydrolysed Gelidium amansii
Species listed on CITES if exporting or importing this product please contact the DSEWPC. Methyl salicylate is a mandatory component of this ingredient (see separate entry).
If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Iodine is a mandatory component of this ingredient (see separate entry).
Page 119 of 305
Ingredient Gellan gum Gelsemium dry
Use E A A A C C
Restrictions Concentration must not exceed 1 mg/Kg or 1 mg/L or 0.0001%. Concentration must not exceed 1 mg/Kg or 1 mg/L or 0.0001%.
Gelsemium powder Genista tinctoria Genistein Genistin
Gelsemium sempervirens
A, E
Gentian dry
Gentian powder Gentiana lutea
A, E A, E A, E A, E A, E A, E A, E C C
Gentiana macrophylla Gentiana rhodantha Gentiana scabra Gentianose
Gentianella amarella Gentiopicroside
Page 120 of 305
Ingredient Geraniol Geranium maculatum Geranium oil
Use E A, E A, E A, E A, E E A, E A, E A, E A, E A, E A, E A, E C C
Restrictions
Geranium robertianum Geranium sibiricum Geranyl acetate Geum rivale Ghatti gum Ginger dry Ginger oil
Geum urbanum
Gigartina mamillosa
Iodine is a mandatory component of this ingredient (see separate entry). May be a native species if exporting this product please contact the DSEWPC.
ginger powder Gingerol-[6]
Gingerols calculated as gingerol-[6]
Page 121 of 305
Ingredient
Ginkgo biloba Ginkgolides
Use A, E C C C C C C C A, E A, E A, E A, E A, E A
Restrictions
Ginkgo flavonglycosides
Ginkgolides and bilobalide Ginsenoside Rg1
Ginsenosides calculated as ginsenoside Rg1 Ginsenosides calculated as Rg1 and Rb1 Ginsenosides Rg1, Re, Rf, Rg2, Rb1, Rb2, Rc, Rd (Panax ginseng) Glechoma hederacea Glechoma longituba Gleditsia australis Glehnia littoralis Gleditsia officinalis Gloriosa superba
Colchicine is a mandatory component of this ingredient (see separate entry).

Page 122 of 305
Ingredient
Glucofrangulin A
Use C C
Restrictions If the MRDD contains 10 mg or less of hydroxyanthracene derivatives and the product is NOT promoted or marketed as laxative, it is listable without restrictions. In products intended for oral use, if the MRDD contains 10 mg or less of hydroxyanthracene derivatives and the product is promoted or marketed as laxative, the product label must include the statements: CHILD3, LAX1, LAX2, and S. In products intended for oral use, if the MRDD contains more than 10 mg of hydroxyanthracene derivatives and the product is promoted or marketed as a laxative, the product label must include the statements CHILD3, LAX1, LAX2, LAX3, and S. In products intended for oral use, if the MRDD contains more than 10 mg of hydroxyanthracene derivatives and the product is NOT promoted or marketed as a laxative, the product label must include the statements: CHILD3, LAX2, LAX3, LAX4, LAX5, and S. Not listable if the dosage form of the preparation is a tablet. Customs Prohibited Import when in tablet form requires an import permit/licence.
Glucofrangulins calculated as glucofrangulin A
Glucomannan Glucosamine
Gluconolactone
E E C
Glucosamine hydrochloride Glucosamine sulfate
Glucosamine sulfate-potassium chloride complex
A, E A A
A, E, C
If sourced from seafood, the product label must include the statement SFOOD. If sourced from seafood, the product label must include the statement SFOOD. If sourced from seafood, the product label must include the statement SFOOD. If sourced from seafood, the product label must include the statement SFOOD.
Glucosamine sulfate-sodium chloride complex
Page 123 of 305
Ingredient Glucose
Use
Glucose - anhydrous Glucose - liquid
A, E, C A, E E E E A, E A, E A, E E C E E
Restrictions
When used as an excipient in oral products and the total amount of all sugars (glucose, invert sugar, lactose, maltose, and sucrose) exceeds 100 mg in the MDD of the product, the label requires the statement SUGARS. If one of the sugars is lactose the label also requires the statement LACT.
When used as an excipient in oral products and the total amount of all sugars (glucose, invert sugar, lactose, maltose, and sucrose) exceeds 100 mg in the MDD of the product, the label requires the statement SUGARS. If one of the sugars is lactose the label also requires the statement LACT. When used as an excipient in oral products and the total amount of all sugars (glucose, invert sugar, lactose, maltose, and sucrose) exceeds 100 mg in the MDD of the product, the label requires the statement SUGARS. If one of the sugars is lactose the label also requires the statement LACT. Approved for topical use only. Glucose is a mandatory component of this ingredient (see separate entry). Approved for topical use only. Concentration must not exceed 0.1%. Approved for topical use only.
Glucose glutamate Glucosylrutin Glutamic acid Glutamine Gluten
Glutamic acid hydrochloride Glutathione
Glycereth-26
Glycerin/oxybutylene copolymer stearyl ether
Medicines containing more than 0.3% gluten require the label statement GLUTEN. Approved for topical use only. Concentration must not exceed 7%. PRV may only be used as an excipient in topical preparations.
Page 124 of 305
Ingredient Glycerol
Use A, E E E E E E E E E E E E E E E
Restrictions
Glycerol triacetate Glyceryl behenate Glyceryl dilaurate Glyceryl dioleate
If used as a BP Uncompounded preparation no restrictions, if used as an active as part of a formulation, restricted to topical only. If used as an excipent there are no restrictions. Behenic acid is a mandatory component of this ingredient (see separate entry). Approved only in topical preparations for localised effect. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Glyceryl diisostearate
Glyceryl distearate Glyceryl laurate
Glyceryl isostearate Glyceryl linoleate
Glyceryl linolenate
Glyceryl mono-oleate
Glyceryl monostearate Glyceryl myristate
Glyceryl monostearate - selfemulsifying
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Ingredient
Glyceryl oleate citrate Glyceryl polyacrylate Glyceryl ricinoleate Glyceryl rosinate
Use E E E E E E E E E E
Restrictions
Glyceryl palmito-stearate
Glyceryl polymethacrylate
Approved for topical use only. Concentration must not exceed 0.15%. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Glyceryl sorbitan oleostearate Glyceryl stearate citrate
Glyceryl triacetyl hydroxystearate Glyceryl triacetyl ricinoleate Glycine Glycine max Glycitein Glycitin
A, E A, E C C
Glycogen
Glycol distearate
E E
Page 126 of 305
Ingredient
Glycol stearate Glycollic acid
Use E E
Restrictions
Glycoproteins
Glycosaminoglycans - hydrolysed Glycyrrhetinic acid Glycyrrhiza glabra
E E
E, C
Approved only in topical preparations for localised effect. Concentration must not exceed 20%. When present as an excipient in sunscreens, the concentration must not exceed 5%. If the concentration of glycollic acid is greater than 5% but less than 20% and it is a sunscreen it is listable only if pH is 3.5 or greater. Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose. PRV may only be used as an excipient in topical preparations. Approved for topical use only. Approved for topical use only.
Glycyrrhiza uralensis Glycyrrhizinic acid
A, E A, E E, C A, E A, E A, E E A, E
Gnaphalium multiceps
Gnaphalium polycephalum Gnaphalium uliginosum Gold Golden rod herb dry
Page 127 of 305
Ingredient
Golden seal root dry Golden syrup Gooseberry Grape
Use A A E E E E E E E A, E A, E
Restrictions
Golden seal root powder Gomphrena globosa Gossypium herbaceum Grape seed oil
Sucrose is a mandatory component of this ingredient in oral or sublingual preparations (see separate entry). Only Ribes grossularia fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Only Vitis vinifera fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Vitis vinifera seed oil fixed is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Vitis vinifera fruit juice fermented red is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Ethanol is a mandatory component of this ingredient (see separate entry).
Grape wine red
Grape wine sherry Grape wine white
Only Vitis vinifera fruit juice fermented sherry is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Ethanol is a mandatory component of this ingredient (see separate entry). Only Vitis vinifera fruit juice fermented white is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Ethanol is a mandatory component of this ingredient (see separate entry).
Page 128 of 305
Ingredient Grapefruit Grass pea
Use E E
Restrictions
Grapefruit oil coldpressed Gratiola linifolia
A, E A, E A, E A, E A, E A, E A A E
Only Citrus X paradisi fruit or fruit flesh is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Lathyrus sativus seed (grain) cooked is permitted. May only be used as a food excipient refer to introduction for permitted preparations. MRDD must contain 1 mg or less of the equivalent dry seed (grain) and must not contain any lathyrogenic amino acids.
Greater nettle herb dry Greater nettle root dry
Greater nettle herb powder Greater nettle root powder Green lipped mussel dried Green lipped mussel oil Green S Grindelia camporum Grindelia robusta Ground ivy herb dry
A, E A, E A, E
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Ingredient Guaiacol
Ground ivy herb powder Guaiacum officinale Guaiacum resin Guanine Guaiacum sanctum Guanosine Guar gum
Use A, E A A, E A, E A, E E E E E C
Restrictions
Species listed on CITES if exporting or importing this product please contact the DSEWPC. Species listed on CITES if exporting or importing this product please contact the DSEWPC. Species listed on CITES if exporting or importing this product please contact the DSEWPC. Approved for topical use only. Approved for topical use only. Concentration must not exceed 0.01%. Approved for topical use only.
Guar hydroxypropyltrimonium chloride Guarea rusbyi Guava
A, E A, E A, E A, E
Gymnema sylvestre
Gymnemic acids (of Gymnema sylvestre) Gymnocladus dioica
Only Psidium guajava fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 130 of 305
Ingredient
Gynura pinnatifida Halibut-liver oil
Use A, E A, E A, E A, E A, E A, E E E C
Restrictions
Hamamelis leaf dry
Hamamelis leaf powder Hamamelis virginiana Hamamelis water Hard fat Haricot bean Harpagoside Hazel nut
Harpagophytum procumbens Harungana madagascariensis Hazel nut oil
A, E A, E E E E
Only Phaseolus vulgaris seed (bean) haricot or navy is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Only Corylus avellana seed (nut kernel) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. PRV may only be used as an excipient in topical preparations.
HDI/Trimethylol hexyllactone crosspolymer
Only Corylus avellana seed (nut kernel) oil fixed is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 131 of 305
Ingredient Hectorite HEDTA Hedera helix
Use E E A
Restrictions
Hedyotis diffusa
Helianthemum nummularium Helianthus annuus Helianthus tuberosus
A, E A, E A, E A, E A, E A, E A A A A E
Emetine is a mandatory component of this ingredient (see separate entry).
Helichrysum angustifolium Helichrysum arenarium Helleborus niger Helleborus viridis
Helonias rhizome dry Hemidesmus indicus Heptane
MRDD must contain 1 mg or less of the equivalent dry herbal material. MRDD must contain 1 mg or less of the equivalent dry herbal material.
Helonias rhizome powder
Heracleum hemsleyanum
A, E A, E
Concentration must not exceed 0.5%. Residual solvent limit is 50 mg per MDD.
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Ingredient Hesperidin Hexane
Herniaria glabra
Use A, E A, E E E E E E E A, E, C
Restrictions
Hevea brasiliensis Hexyl laurate
Hexyl nicotinate Hexyldecanol
Concentration must not exceed 0.029%. Approved for topical use only.
Hexyldecyl stearate Hexylene glycol
Approved for topical use only. Concentration must not exceed 3%. PRV may only be used as an excipient in topical preparations. Approved for topical use only.
Hibiscus abelmoschus Hibiscus esculentus Hibiscus mutabilis Hibiscus sabdariffa
A, E A, E A, E A, E A, E E
Hieracium pilosella
Himanthalia elongata whole plant extract ICID 2000

Page 133 of 305
Ingredient
Hippomane mancinella Hirschfeldia incana Histidine
Use A A A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E E
Restrictions
Hippophae rhamnoides
Physostigmine is a mandatory component of this ingredient (see separate entry).
Histidine hydrochloride Holcus lanatus Holy thistle herb dry
Allyl isothiocyanate is a mandatory component of this ingredient when the plant part is seed (see separate entry).
Holy thistle herb powder Homalomena occulta Homosalate Honey
Sunscreen ingredient permitted only in topical products. Concentration must not exceed 15%.
Honey - purified Honey extract
Oral products must include the label statement BABY2. If the product is for oral ingestion and the total amount of all sugars (glucose, invert sugar, lactose, maltose, and sucrose) exceeds 100 mg in the MDD, then the label must include the statement SUGARS. Oral products must include the label statement BABY2. If the product is for oral ingestion and the total amount of all sugars (glucose, invert sugar, lactose, maltose, and sucrose) exceeds 100 mg in the MDD, then the label must include the statement SUGARS. Approved for topical use only. Concentration must not exceed 1%.
Page 134 of 305
Ingredient
Honokiol (of Magnolia officinalis) Hop strobile dry Hops oil Hop strobile powder Hordeum distichon Hordeum vulgare Horse radish
Use C A, E A, E A, E A, E A, E E
Restrictions
Gluten is a mandatory component of this ingredient when the plant part is seed and the route of administration is other than topical and mucosal (see separate entry). Gluten is a mandatory component of this ingredient when the plant part is seed and the route of administration is other than topical and mucosal (see separate entry). Only Armoracia rusticana root is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Volatile oil components (of Armoracia rusticana) is a mandatory component of this ingredient (see separate entry).
Hottonia palustris Hovenia dulcis Humulone
Houttuynia cordata
A, E A, E A, E C A, E E
Humulus lupulus Hyaluronic acid
Approved for topical use only. Requires pre-clearance from TGAL.

Page 135 of 305
Ingredient
Hydnocarpus anthelmintica Hydrangea arborescens Hydrangea paniculata Hydrastine Hydrastis canadensis Hydrochloric acid Hydrocyanic acid
Use A
Restrictions
A, E A, E C A, E E C A, E A, E E E E E
If the plant part is seed and it is for use other than topical, the MRDD must contain 1 mg or less of the equivalent dry seed. The seed used topically and plant parts other than seed are listable without restriction.
Hydrocotyle umbellata Hydrogen peroxide
Species listed on CITES if exporting or importing this product please contact the DSEWPC. Only the root included on CITES powders, pills, extracts, tonics etc are excluded. Review required when the quantity is greater than 0.5%.
Hydrogenated coco-glycerides Hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer Hydrogenated polydecene Hydrolysed algin
The concentration from all ingredients must not exceed 1 microgram/kg or 1 microgram/L or 0.0000001%. May only be used as an active in topical products. Concentration must not exceed 3%. Approved for topical use only. Concentration must not exceed 3%. Approved for topical use only. Concentration must not exceed 4%. Approved for topical use only.
Page 136 of 305
Ingredient
Hydrolysed extensin
Use E E E C C C
Restrictions
Hydrolysed soy flour Hydrolyzed oat flour Hydroquinone
PRV may only be used as an excipient in topical preparations. PRV may only be used as an excipient in topical preparations. PRV may only be used as an excipient in topical preparations.
Hydroquinone derivatives calculated as anhydrous arbutin Hydroxocobalamin Hydroxyanthracene derivatives
Concentration from all ingredients must be less than 10 mg/kg or 10 mg/L or 0.001%. When used as an active in oral or sublingual products, the label must include the statement VIT.
A, E
Hydroxyanthracene derivatives calculated as anhydrous barbaloin Hydroxyanthracene derivatives calculated as cascaroside A Hydroxyanthracene derivatives calculated as rhein
C C C
If the MRDD contains 10 mg or less of hydroxyanthracene derivatives and the product is NOT promoted or marketed as laxative, it is listable without restrictions. In products intended for oral use, if the MRDD contains 10 mg or less of hydroxyanthracene derivatives and the product is promoted or marketed as laxative, the product label must include the statements CHILD3, LAX1, LAX2, and S. In products intended for oral use, if the MRDD contains more than 10 mg of hydroxyanthracene derivatives and the product is promoted or marketed as a laxative, the product label must included the statements CHILD3, LAX1, LAX2, LAX3, and S. In products intended for oral use, if the MRDD contains more than 10 mg of hydroxyanthracene derivatives and the product is NOT promoted or marketed as a laxative, the product label must include the statements: CHILD3, LAX2, LAX3, LAX4, LAX5, and S. Restrictions as per Hydroxyanthracene derivatives (see separate entry) Restrictions as per Hydroxyanthracene derivatives (see separate entry) Restrictions as per Hydroxyanthracene derivatives (see separate entry)
Page 137 of 305
Ingredient
Hydroxyanthracene glycosides calculated as cascaroside A Hydroxyanthracene glycosides calculated as sennoside B Hydroxyapatite Hydroxycaprylic acid Hydroxycitric acid
Use C C
Restrictions
Restrictions as per Hydroxyanthracene derivatives (see separate entry)
A, E E A E E E E E E
Restrictions as per Hydroxyanthracene derivatives (see separate entry) PRV may only be used as an excipient in topical preparations.
Hydroxycitrate complex Hydroxyethyl cetearamidopropyldimonium chloride Hydroxyethyl urea Hydroxyethylcellulose
If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Approved only when it contains one or more of the three salts (calcium, sodium or potassium hydroxycitrate) of hydroxycitric acid. Approved for topical use only. Concentration must not exceed 0.1%. Approved for topical use only. Concentration must not exceed 1%.
A, C
Hydroxyethylmethylcellulose Hydroxylated milk glycerides Hydroxylysine Hydroxymethylcellulose
A, E
Page 138 of 305
Ingredient
Hydroxyoctacosanyl hydroxystearate Hydroxyproline Hydroxypropyl beta cyclodextrin Hydroxypropyl starch Hydroxystearic acid Hylocereus undatus Hyoscamus leaf dry Hyoscine
Use E E E E E E C A, E
Restrictions
Approved only in topical preparations for localised effect. Approved for topical use only
Hydroxypropyl distarch phosphate Hydroxypropylcellulose
Approved for topical use only. Concentration must not exceed 2%. Synonym: Hydroxypropyl starch phosphate
Hydroxytyrosol (of Olea europaea)
A, E A A C C
Hyoscamus leaf powder Hyoscyamine
Alkaloids calculated as hyoscyamine and Hyoscine are mandatory components of this ingredient (see separate entries). Alkaloids calculated as hyoscyamine and Hyoscine are mandatory components of this ingredient (see separate entries). Concentration from all ingredients must be less than 300 micrograms/kg or 300 micrograms/L or 0.00003%. Concentration from all ingredients must be less than 300 micrograms/kg or 300 micrograms/L or 0.00003%.
Page 139 of 305
Ingredient
Hyoscyamus niger Hypericin
Use A C C C A, E A, E A, E C E E
Restrictions
Hyperforin (of Hypericum perforatum)
Alkaloids calculated as hyoscyamine and Hyoscine are mandatory components of this ingredient (see separate entries).
Hypericin deriv calc as hypericin (of H. perforatum) Hypericum ascyron Hypericum japonicum
Hypericum perforatum Hyperoside (of Betula) Hypromellose
Preparations for oral ingestion containing this ingredient as a herbal ingredient or a mother tincture require the label statement STJOHN.
Hypromellose phthalate Hyptis suaveolens Iberis amara Hyssopus officinalis
A, E A, E A, E C
Page 140 of 305
Icariin (of Epimedium brevicornu)
Ingredient
Ilex aquifolium Ilex chinensis Ilex rotunda
Use A, E A, E A, E A, E A, E A, E E C A, E A, E A, E E E
Restrictions
Ilex paraguariensis Ilex verticillata Illicium verum Imidurea
Permitted without restriction in preparations containing 50% or less. When the plant preparation is an oil and the concentration of this oil is more than 50%, the nominal capacity of the container must be 50 mL or less, a RFI must be fitted on the container and the product is label must include the statement CHILD. Approved only in topical preparations for localised effect. Topical products require the label statement IMIDUR.
Immunoglobulin G - bovine Impatiens balsamina Imperata cylindrica Indigo carmine Impatiens glandulifera
Indigo carmine aluminium lake Indigofera tinctoria
A, E
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Ingredient Inositol Inula britannica Inula helenium Inulin Inula racemosa Invert syrup Iodine
Use A, E A, E A, E A, E A, E E C
Restrictions
Glucose is a mandatory component of this ingredient in oral and sublingual products (see separate entry). In preparations for external use, the concentration of available iodine (excluding salts, derivatives or iodophors) must not exceed 2.5%. In preparations for internal use the RDD must contain less than 300 micrograms of iodine. Approved only in topical preparations for localised effect. Concentration in aqueous preparations must not exceed 10%. Approved for topical use only. Emetine is a mandatory component of this ingredient (see separate entry). Emetine is a mandatory component of this ingredient (see separate entry). Emetine is a mandatory component of this ingredient (see separate entry). Emetine is a mandatory component of this ingredient (see separate entry).
Page 142 of 305
Iodopropynyl butylcarbamate Ionone Ipecacuanha dry
E E A A A A
Ipecacuanha powder
Ipecacuanha prepared Ipomoea batatas
Ipecacuanha root liquid extract
A, E
Ingredient
Ipomoea jalapa Ipomoea purga Iris florentina Iris pallida Iris tenax Iron
Use A, E A, E A, E A, E A, E A, E A, E A, E C
Restrictions
Iridophycus flaccidum Iris germanica
Iris versicolor
Iron amino acid chelate
A, E
MRDD must contain 24 mg or less of iron. Undivided preparations with a MRDD of 24 mg of iron or less must be supplied in a pack containing less than 750 mg or less of iron (excluding iron oxides when present as an excipient [up to 1% in undivided preparations]). Solid dosage forms containing more than 5 mg of elemental iron in each dosage unit and liquid preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a CRC. Divided preparations for internal use are listable without pack size restrictions when the quantity of iron from all ingredients in the product (excluding up to 10 mg of iron oxide when used as an excipient) is 5 mg or less per dosage unit and the MRDD contains less than 24 mg of iron. If the divided dosage form contains more than 5 mg of iron per dosage unit but the MRDD contains less than 24 mg of iron then the product is listable when supplied in a pack containing 750 mg or less of iron (excluding up to 10 mg of iron oxide when used as an excipient). When used internally, iron is a mandatory component of this ingredient (see separate entry). Ironcontaining Listed medicines are required to include the label statement IRONDEF. Iron containing multivitamin/mineral products indicated for general nutritional support, and which do not make specific iron-deficiency related claims are exempt from this label requirement.
Page 143 of 305
Ingredient
Iron oxide black Iron oxide red
Use E E E
Restrictions
In divided preparations for internal use the concentration must not exceed 10 mg per dosage unit. In undivided preparations for internal use, when the concentration exceeds 1%, it is considered part of the total iron content. In divided preparations for internal use the concentration must not exceed 10 mg per dosage unit. In undivided preparations for internal use, when the concentration exceeds 1%, it is considered part of the total iron content. In divided preparations for internal use the concentration must not exceed 10 mg per dosage unit. In undivided preparations for internal use, when the concentration exceeds 1%, it is considered part of the total iron content. When used internally, iron is a mandatory component of this ingredient (see separate entry). Ironcontaining Listed medicines are required to include the label statement IRONDEF. Iron containing multivitamin/mineral products indicated for general nutritional support, and which do not make specific iron-deficiency related claims are exempt from this label requirement. Approved for topical use only.
Iron oxide yellow Iron phosphate Irone
A, E E
Isatis tinctoria
Isoamyl methoxycinnamate Isoascorbic acid Isobutane Isobutyl alcohol
A, E A E E E E E
Sunscreen active permitted only in topical products. Concentration must not exceed 10%. Approved for topical use only.
Isobutyl hydroxybenzoate Isobutyl salicylate
Concentration must not exceed 0.5%. Residual solvent limit is 50 mg per MDD. Approved for topical use only.
Approved only in topical preparations for localised effect. Requires the label statement TOTBNZ.
Page 144 of 305
Ingredient
Isocetyl alcohol
Use E E E E E E E E E E C C C
Restrictions
Isocetyl linoleoyl stearate Isocetyl stearate Isodeceth-6
Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Isodecyl isononanoate Isodecyl oleate Isododecane Isoeicosane
Isodecyl neopentanoate
Isodon japonicus leaf and stem extract Isoferulic acid
Isoflavone glycosides calc as genistin and daidzin (of Glycine max) Isoflavones calc daidzin/ein, genistin/ein, glycitin/ein (Glycine max)
Page 145 of 305
Ingredient
Isoflavones calculated as daidzin, daidsein and puerarin (of Pueraria lobata) Isohexadecane Isoleucine Isomalt
Use C C
Restrictions
Isoflavones (of Trifolium pratense)
E E E E E E E E E E E
A, E
Isononyl isononanoate Isopropyl acetate Isopropyl adipate Isopropyl alcohol
When the quantity of sugar alcohols per RDD exceeds 2 g, the quantity of the sugar alcohols must be declared on the label in addition to the label statement SUGOLS. Approved for topical use only. Concentration must not exceed 15%. Approved for topical use only. Approved for topical use only.
Isopropyl hydroxybenzoate Isopropyl isostearate Isopropyl lanolate
Approved only in topical preparations for localised effect. Requires the label statement TOTBNZ. Approved for topical use only. Approved for topical use only.
Isopropyl lauroyl sacrosinate Isopropyl myristate
Page 146 of 305
Ingredient
Isopropyl palmitate Isopropyl stearate Isoquercitrin
Use E E E C E E E E E E C
Restrictions
Isopropyl titanium triisostearate Isostearic acid
Approved for topical use only. Concentration must not exceed 0.3%. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Isostearyl alcohol
Isostearyl isostearate Isostearyl palmitate Isovitexin
Isostearyl neopentanoate Isotridecyl isononanoate Ispaghula husk dry Iva axillaris
Ispaghula husk powder
A, E A, E A, E A A
If a dose for children is stated, it must be followed by the label statement PSYLL. If a dose for children is stated, it must be followed by the label statement PSYLL.
Jamaica dogwood bark dry
Jamaica dogwood bark powder
Page 147 of 305
Ingredient
Jasmine lactone
Use E A, E A, E A, E A, E E E
Restrictions
Jasminum officinale
Jateorrhiza columba Jateorrhiza palmata Jatropha curcas Jojoba esters
Jerusalem artichoke Juglans cinerea Juglans nigra Juglans regia
A, E A, E A, E A, E A, E A, E A, E A, E
Only Helianthus tuberosus tuber is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Approved for topical use only. Concentration must not exceed 25%.
Juncus effusus
Juniper berry oil
Juniperus californica Juniperus communis Juniperus oxycedrus
Page 148 of 305
Ingredient
Juniperus virginiana Kadsura coccinea Kaempferol Kaolin Kaempferia galanga Kalmia latifolia Kaolin - heavy Kaolin - light
Use A, E A, E A, E C A, E E E E C C
Restrictions
Kavalactones (of Piper methysticum) Kelp dry Keratin
Kawapyrones (of Piper methysticum) Kelp powder
A, E A, E E E E
If the dosage form is tablet or capsule then the quantity must not exceed 125 mg per tablet or capsule. MDD in oral products must not exceed 250 mg. Oral products containing more than 25 mg per dose require the label statement PIPER. Iodine is a mandatory component of this ingredient (see separate entry). Iodine is a mandatory component of this ingredient (see separate entry). Approved for topical use only. Concentration must not exceed 5%. Approved for topical use only. Concentration must not exceed 5%. PRV may only be used as an excipient in topical preparations.
Keratin - hydrolysed Keratin amino acids
Page 149 of 305
Ingredient Kerosene
Use E C E E A, E A A
Restrictions
Ketones calculated as menthone Kidney bean Kiwi fruit
In liquid preparations, the concentration must not exceed 25%. In solid and semi-solid preparations, it is listable without restrictions.
Only Phaseolus vulgaris seed (bean) kidney is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Actinidia chinensis fruit (berry) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Kochia scoparia
Korean ginseng root dry Krameria ixiena
Korean ginseng root powder Krameria triandra Kunzea ambigua Labdanum oil
Species listed on CITES if exporting or importing this product please contact the DSEWPC. Only if root and from the Russian Federation. Species listed on CITES if exporting or importing this product please contact the DSEWPC. Only if root and from the Russian Federation.
Kukui (Aleurites moluccana) nut oil
A, E A, E E A
A, E
Permitted only if it is an essential oil, supplied in a container with a RFI, for topical use only and labelled with the statements CHILD, EXTERN and UNDILU.
Page 150 of 305
Ingredient
Lablab bean
Use E E E
Restrictions
Lachnanthes tinctoria Lactalbumin Lactic acid Lactamide MEA Lactobacillus acidophilus Lactobacillus brevis Lactobacillus casei
A, E
Only Dolichos lablab seed (bean) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
A, E A A A A A A A A
If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. PRV may only be used as an excipient in topical preparations. When used as an active, this ingredient is only listable as an uncompounded BP substance. Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose.
Lactobacillus amylovorus
Lactobacillus crispatus
Lactobacillus delbrueckii ssp bulgaricus Lactobacillus fermentum
Lactobacillus delbrueckii ssp lactis
Page 151 of 305
Ingredient
Lactobacillus gallinarum Lactobacillus gasseri Lactobacillus kefir Lactobacillus johnsonii
Use A A A A A A A A E A A A A E A
Restrictions
Lactobacillus kefiranofaciens Lactobacillus kefirgranum Lactobacillus parakefir Lactobacillus plantarum Lactobacillus reuteri
Lactobacillus plantarum ferment lysate Lactobacillus rhamnosus
Lactobacillus salivarius ssp salicinius Lactobionic acid
Lactobacillus salivarius ssp salivarius Lactoferrin - bovine
Requires the label statement COWMK. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL.
Page 152 of 305
Ingredient Lactose
Use E, C E
Restrictions
Lactose anhydrous Lactuca sativa Lactulose Lactuca virosa
A, E A, E E A, E A, E A, E A, E A, E A, E E E
Lactulose solution
Lagenaria vulgaris Laminaria digitata Lamium album Laneth-20 Laneth-5
Laminaria cloustoni Laminaria japonica
When used as an active, this ingredient is only listable as an uncompounded BP substance. Iodine is a mandatory component of this ingredient (see separate entry). Iodine is a mandatory component of this ingredient (see separate entry). Approved for topical use only. Approved for topical use only.
Page 153 of 305
Ingredient
Lanolin - hydrogenated Lanolin - hydroxylated Lanolin alcohol Lanolin oil Lanolin wax Lanosterol Lantana camara Larix decidua
Use E E E E E E A
Restrictions
Approved for topical use only. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Approved for topical use only. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Approved for topical use only. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Approved for topical use only. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Approved for topical use only. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. PRV may only be used as an excipient in topical preparations. MRDD must contain 1 mg or less of the equivalent dry herbal material. Requires the label statement CHAP.
Larrea tridentata Lathyrus sativus Laurel leaf oil
Lashiosphera nipponica Lauramine oxide
A, E A, E A, E A, E E A, E
MRDD must contain 1 mg or less of the equivalent dry herbal material and must contain no lathyrogenic amino acids. Approved for topical use only.
Page 154 of 305
Ingredient Laureth-10 Laureth-12 Laureth-2 Laureth-3 Laureth-4 Laureth-7 Laureth-8 Laureth-9 Laureth-23
Restrictions Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Approved for topical use only. Concentration must not exceed 4.0%. Residual levels of ethylene oxide are to be kept below the levels of detection.
Lauric acid
Lauroyl lysine
Laurus nobilis
Lauryl betaine
Lauryl glucoside
A, E
Page 155 of 305
Ingredient
Lauryl lactate Lauryl PCA Lauryl PEG/PPG-18/18 Methicone Lauryl polyglucose Lauryl pyrrolidone
Use E E E E E E E E A, E A, E A, E A, E A, E
Restrictions
Approved for topical use only. Concentration must not exceed 3%. Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose. Approved for topical use only. Concentration must not exceed 1.0%. Approved for topical use only. Concentration must not exceed 2%. Approved for topical use only.
Lauryldimonium hydroxypropyl hydrolysed collagen Lauryldimonium hydroxypropyl hydrolysed soy protein Laurylmethicone copolyol Lavandin oil abrial Lavandula angustifolia Lavandula intermedia Lavandula spica Lavender oil
Approved for topical use only. Concentration must not exceed 1% in 'leave-on' products and 3% in 'wash-on/wash-off' products. Approved for topical use only. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Approved for topical use only. Concentration must not exceed 0.007%. Approved for topical use only.
Camphor is a mandatory component of this ingredient (see separate entry).
Camphor is a mandatory component of this ingredient (see separate entry). Camphor is a mandatory component of this ingredient (see separate entry).
Page 156 of 305
Ingredient Lead
Lawsonia inermis Lecithin
Use A, E C A, E A, E E A A
Restrictions Concentration must not exceed 0.001%. Requires pre-clearance from TGAL.
Lecithin - egg
Lecithin - hydrogenated
If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Approved for topical use only. Concentration must not exceed 5%.
Lecithin liquid - soy phosphatidylserine-enriched soy Lecithin powder - soy phosphatidylserine-enriched soy Ledebouriella divaricata Ledum groenlandicum Ledum palustre Lemna minor Lemon Ledebouriella seseloides
Soy phosphatidylserine is a mandatory component of this ingredient (see separate entry).
A, E A, E A, E A, E A, E E A, E
Soy phosphatidylserine is a mandatory component of this ingredient (see separate entry).
Lemon balm leaf dry
Only Citrus limon fruit flesh or fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 157 of 305
Ingredient Lemon oil
Lemon balm leaf powder Lemon oil distilled Lemon peel dried Lemongrass oil Lens culinaris Lentil
Use A, E A, E A, E A, E A, E A, E A, E E A, E A, E A, E A, E E A, E
Restrictions Permitted only when: a) steam distilled or rectified; b) in preparations for internal use; c) in preparations containing 0.05% or less of lemon oil; d) in soaps or bath and shower gels that are washed off the skin; or e) packed in containers labelled with the statement SENS.
Lemon oil terpeneless
Lentinula edodes
Leonurus cardiaca
Only Lens culinaris seed is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Leonurus sibiricus
Lepidium apetalum Lespedeza capitata
Leptospermum petersonii
Page 158 of 305
Ingredient Lettuce
Use E
Restrictions
Leucine
Leuzea uniflorum Levocarnitine
Levisticum officinale
A, E A, E A, E A, C A A A A C C
Only Lactuca sativa leaf or herb is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Levocarnitine fumarate
Levocarnitine hydrochloride Levocarnitine tartrate Levomenol Liatris odoratissima Ligusticum lucidum Ligusticum sinense
Levocarnitine magnesium citrate
Lignans calc secoisolariciresinol diglucoside (Linum usitatissimum seed)
A, E A, E A, E
Page 159 of 305
Ingredient Ligustilide
Ligusticum wallichii Ligustrum lucidum Ligustrum vulgare Lilium brownii Lilium candidum
Use A, E C A, E A, E A, E A, E A, E A, E A, E E E
Restrictions
Lilium lancifolium Lilium tigrinum Lime Lime fruit
Lilium longiflorum
Lime oil coldpressed Lime oil distilled Lime tree flower dry
A, E A, E A, E
Only Citrus aurantifolia fruit flesh or fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Permitted only when: a) in preparations for internal use; b) in preparations containing 0.5% or less of lime oil; c) in soaps or bath and shower gels that are washed off the skin; or d) packed in containers labelled with the statement SENS.
Page 160 of 305
Ingredient Limonene Linalool
Lime tree flower powder
Use A, E E E E E
Restrictions Maxium daily dose in oral preparations is 10 mg. Approved for topical use only. Approved for topical use only.
Linalyl acetate
Lindera strychnifolia Linoleic acid Linseed acid Linseed dry Linseed oil
Linoleamidopropyl PG-dimonium chloride phosphate Linolenic acid
A, E E, C E, C E
Linseed powder Lipase
A, E A, E A, E A, E A, C A, E
Linum usitatissimum Lippia citriodora
Lipase is only listable when derived from Rhizopus oryzae.

Page 161 of 305
Ingredient
Lippia dulcis
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E C A
Restrictions
Liquidambar formosana Liquidambar orientalis Liquidambar styraciflua Liquorice dry
Liquidambar taiwaniana Liquorice liquid extract Liquorice powder Litchi chinensis Lithium
Lithospermum officinale Litsea cubeba Lobelia dry Lobaria pulmonaria Lobelia inflata
A, E A, E A A
Concentration from all ingredients must not exceed 0.01%.
Concentration must not exceed 0.001% or 10 mg/kg or 10ml/L or 10 ppm unless the product is administered by smoking or burning. Concentration must not exceed 0.001% or 10 mg/kg or 10ml/L or 10 ppm unless the product is administered by smoking or burning.
Page 162 of 305
Ingredient
Lobelia powder Lobeline Lolium multiflorum Lolium perenne
Use A C
Restrictions
Lolium temulentum Lonicera japonica
A, E A, E A, E A, E A, E A, E A, E E A, E A, E A, E A, E A, E
Concentration must not exceed 0.001% or 10 mg/kg or 10ml/L or 10 ppm unless the product is administered by smoking or burning.
Lonicera caprifolium
Lonicera periclymenum Lophatherum gracile Loquat
Loranthus parasiticus Lotus corniculatus Lovage oil Lovage root dry
Loropetalum chinensis
Only Eriobotrya japonica fruit flesh or fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 163 of 305
Ingredient
Lovage root powder Ludwigia prostrata Luffa cylindrica Luffa purgans Lutein
Use A, E A, E A, E A, E A, C C C
Restrictions
Lutein esters calculated as lutein (of Targetes erecta) Luteolin-7-O-glucoside (of Cyanara scolymus) Lychee Lycium barbarum Lycium chinense Lycopene
A, E A, E A, C A, E A, E A, E
Only Litchi chinensis fruit flesh is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Lycopersicon esculentum Lycopodium annotinum Lycopodium clavatum
Steroidal alkaloids calculated as solanine is a mandatory component of this ingredient (see separate entry). May be a native species if exporting this product please contact the DSEWPC.
Page 164 of 305
Ingredient
Lycopodium complanatum Lycopus europaeus Lycopus lucidus Lycopus virginicus
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E E E
Restrictions
Lygodium japonicum Lysimachia vulgaris Lysine
Lysimachia christinae
Pulegone is a mandatory component of this ingredient (see separate entry).
Lysine hydrochloride Lythrum salicaria Macadamia nut
Lythrum hyssopifolium Lythrum verticillatum Macadamia nut oil
A, E, C
Only Macadamia ternifolia seed (nut kernel) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Macadamia ternifolia seed (nut kernel) oil fixed is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Macadamia ternifolia
A, E
Page 165 of 305
Ingredient Mace
Use E
Restrictions
Mace oil Macrocystis pyrifera Macrogol 1000 Macrogol 1450 Macrogol 1500 Macrogol 200 Macrogol 300
A, E A, E E E E E E E E E E
Only Myristica fragrans seed aril is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Safrole is a mandatory component of this ingredient (see separate entry).
Permitted without restriction in preparations containing 50% or less. When the concentration is greater than 50%, the nominal capacity of the container must be 25 mL or less, a RFI must be fitted on the container and the product label must include the statement CHILD. Safrole is a mandatory component of this ingredient (see separate entry). Iodine is a mandatory component of this ingredient (see separate entry). Approved for topical use only.
Macrogol 20000 Macrogol 3000 Macrogol 3350 Macrogol 40 Macrogol 400
A, E
When used as an active, this ingredient is only listable as an uncompounded BP substance. Approved for topical use only.
Page 166 of 305
Ingredient
Macrogol 4000 Macrogol 600
Use E E E E E E E E C
Restrictions Approved for topical use only.
Macrogol 45000 Macrogol 6000 Macrogol 800 Macrogol 900 Magnesium
Macrogol 600000 Macrogol 8000
Magnesium amino acid chelate Magnesium ascorbate Magnesium ascorbate monohydrate Magnesium ascorbyl phosphate Magnesium aspartate
A, E A, E A, E E A, E
Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label.
When used as an active in oral or sublingual products, the label must include the statement VIT. Approved for topical use only.
When used as an active in oral or sublingual products, the label must include the statement VIT. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label.
Page 167 of 305
Ingredient
Magnesium aspartate anhydrous Magnesium aspartate dihydrate Magnesium carbonate Magnesium carbonate - heavy Magnesium carbonate - light Magnesium chloride Magnesium citrate
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E E
Restrictions
Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label.
Magnesium diglutamate Magnesium gluconate Magnesium glycerophosphate Magnesium hydroxide Magnesium nitrate
Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. When used as an active, this ingredient is only listable as an uncompounded BP substance. Approved for topical use only.
Page 168 of 305
Ingredient
Magnesium orotate Magnesium oxide
Use A, E A, E A, E A, E A, E A, E A, E A, E E A, E A, E
Restrictions
Magnesium orotate dihydrate Magnesium oxide - heavy Magnesium oxide - light Magnesium phosphate
Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label.
Magnesium phosphate - dibasic trihydrate Magnesium stearate Magnesium sulfate
Magnesium phosphate - tribasic anhydrous
Magnesium sulfate - dried
Page 169 of 305
Ingredient
Magnesium sulfate dihydrate
Use A, E A, E A, E E A, E A, E A, E A, E A, E C E E
Restrictions
Magnesium sulfate monohydrate Magnesium sulfate trihydrate Magnesium trisilicate Magnolia glauca Magnolia liliflora
Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label. Magnesium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of magnesium is required on the label.
Magnolia obovata
Magnolia officinalis Magnolia salicifolia Maize
Magnolol (of Magnolia officinalis) Maize bran Maize oil
Only Zea mays seed (kernel) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
A, E
Only Zea mays seed (kernel) husk or seed coat (bran) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 170 of 305
Ingredient
Malachite green Male fern dry Malic acid Male fern powder Malpighia glabra Malt extract Maltitol
Use E A A E A, E A, E E E E E E E
Restrictions
MRDD must contain 1 mg or less of equivalent dry herbal material. May be a native species if exporting this product please contact the DSEWPC. MRDD must contain 1 mg or less of equivalent dry herbal material. May be a native species if exporting this product please contact the DSEWPC. Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose.
Malpighia punicifolia
Maltitol solution Maltodextrin Maltol Maltose
When the quantity of sugar alcohols per RDD exceeds 2 g, the quantity of the sugar alcohols must be declared on the label in addition to the label statement SUGOLS. When the quantity of sugar alcohols per RDD exceeds 2 g, the quantity of the sugar alcohols must be declared on the label in addition to the label statement SUGOLS.
Page 171 of 305
Ingredient
Malus pumila
Use A, E A, E A, E A, E A, E A, E C E
Restrictions
Malus sylvestris
Malus X domestica Malva moschata Malva sylvestris Malvidin
Malva verticillata Mandarin
Mandarin oil coldpressed Mandragora officinarum Manganese
A, E A C
Only Citrus reticulata and hybrids formed with C. sinensis and/or C. X paradisi fruit flesh or fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Concentration must not exceed 10 mg/kg or 10 mg/L or 0.001%. Atropine, Hyoscine and Hyoscyamine are mandatory components of this ingredient (see separate entries).
Manganese amino acid chelate Manganese aspartate
A, E A, E
If used as an active AND intended as a mineral supplementation, the equivalent quantity of manganese is required on the label.
Manganese is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of manganese is required on the label.
Page 172 of 305
Ingredient
Manganese chloride
Use A, E A, E A, E A, E A, E A, E A, E E E A, E A, E
Restrictions
Manganese gluconate Manganese oxide
Manganese is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of manganese is required on the label. Manganese is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of manganese is required on the label. Manganese is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of manganese is required on the label. Manganese is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of manganese is required on the label. Manganese is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of manganese is required on the label. Manganese is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of manganese is required on the label.
Manganese glycerophosphate Manganese sulfate Mangifera indica Mango
Manganese sulfate monohydrate
Manihot utilissima Mannitol Maranta arundinacea
Only Mangifera indica fruit flesh or fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations. When the quantity of sugar alcohols per RDD exceeds 2 g, the quantity of the sugar alcohols must be declared on the label in addition to the label statement SUGOLS.
Page 173 of 305
Ingredient
Marjoram oil spanish Marjoram oil sweet Marrubiin
Use A, E A, E C A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E
Restrictions
Permitted without restriction in preparations containing 50% or less. When the concentration is greater than 50%, the nominal capacity of the container must be 50mL or less, a RFI must be fitted on the container and the product label must include the statement CHILD. Permitted without restriction in preparations containing 50% or less. When the concentration is greater than 50%, the nominal capacity of the container must be 50mL or less, a RFI must be fitted on the container and the product label must include the statement CHILD.
Marrubium vulgare
Marsdenia reichenbaachi Marshmallow root dry Martynia parviflora Mastic
Marshmallow root powder
Matricaria flower dry Matricaria recutita
Meadowsweet herb dry
Meadowsweet herb powder
Page 174 of 305
Ingredient
Medicago sativa Medium chain triglycerides Melaleuca alternifolia
Use A, E E
Restrictions
A, E
When the ingredient is a fresh leaf extract and the extraction ratio is between 34:1 and 46:1 then the quantity of l-canavanine in the extract must not be more than that in the fresh leaf. When the ingredient is a herbal extract, the quantity of l-canavanine in the extract must not be more than that in the dry herbal material.
Melaleuca cajuputi
A, E
Permitted without restriction in preparations containing 25% or less of melaleuca oil. When the concentration of melaleuca oil is greater than 25% and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. When the concentration of melaleuca oil is greater than 25% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. Melaleuca oil, Cajuput oil and Cineole are mandatory components of this ingredient (see separate entries). Native species if exporting this product (excluding oil) please contact the DSEWPC.
Melaleuca dissitiflora
A, E
Permitted without restriction in preparations containing 25% or less of melaleuca oil. When the concentration of melaleuca oil is greater than 25% and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. When the concentration of melaleuca oil is greater than 25% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. Cajuput oil and Cineole are mandatory components of this ingredient (see separate entries). Native species if exporting this product (excluding oil) please contact the DSEWPC. Permitted without restriction in preparations containing 25% or less of melaleuca oil. When the concentration of melaleuca oil is greater than 25% and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. When the concentration of melaleuca oil is greater than 25% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. Cineole is a mandatory component of this ingredient (see separate entry). Native species if exporting this product (excluding oil) please contact the DSEWPC.
Page 175 of 305
Ingredient
Melaleuca ericifolia Melaleuca oil Melanin
Use A, E A, E A, E E A, E A, E E E
Restrictions
Melaleuca linariifolia
Melaleuca quinquenervia Melilotus officinalis Melissa officinalis Melon
A, E, C
As per Melaleuca dissitiflora (see above). As per Melaleuca dissitiflora (see above). As per Melaleuca dissitiflora (see above).
As per Melaleuca dissitiflora (see above).
PRV may only be used as an excipient in topical preparations. If derived from skin, hair, feathers or human urine this ingredient requires pre-clearance from TGAL. Coumarin is a mandatory component of this ingredient (see separate entry).
Menadione sodium bisulfite Menispermum canadense Mentha aquatica Mentha arvensis
Only Cucumis melo fruit flesh or fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. MRDD must contain 1 mg or less of the equivalent dry herbal material. Sponsors must confirm the absence of aristolochic acids or herbal species known to contain these acids.
Mentha haplocalyx
A, E A, E A, E
Page 176 of 305
Ingredient
Mentha pulegium Mentha spicata Mentha X cardiaca Mentha X piperita Menthol
Use A, E A, E A, E A, E A, E A, E C C C
Restrictions
D-Pulegone and Volatile oil components (of Mentha pulegium) are mandatory components of this ingredient (see separate entries).
Mentha X piperita nothosubsp. citrata Menthol (of Mentha arvensis) Menthol (of Peppermint oil) Menthoxypropanediol Menthyl anthranilate Menthyl lactate Menthyl PCA
Menthol (of Mentha X piperita)
When used as an active, permitted only in Medicated Space Sprays or Medicated Throat Lozenges.
E E E
Permitted only as an excipient in oral products. Concentration must not exceed 0.04%. Approved only in topical preparations for localised effect.
Sunscreen active permitted only in topical products. Concentration must not exceed 5%. PRV may only be used as an excipient in topical preparations.
Menyanthes trifoliata Meretrix meretrix
A, E A, E
Page 177 of 305
Ingredient
Mespilus germanica Meta-Cresol Methanol
Use A, E E E E E E E C E E E E E
Methacrylic acid copolymer Methicone
Methionine
E, C
Methyl acetate
Methyl acetyl ricinoleate Methyl benzoate Methyl chavicol Methyl ether
A, E
Concentration must not exceed 0.3%. Residual solvent limit is 30 mg per MDD. Approved for topical use only. Concentration must not exceed 1%.
Concentration must not exceed 0.5%. Residual solvent limit is 50 mg per MDD. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Methyl ethyl ketone Methyl gluceth-10 Methyl gluceth-20
Concentration must not exceed 0.5%. Residual solvent limit is 50 mg per MDD. Product must contain 25% or less of designated solvents as defined in Part 1 of the SUSMP. PRV may only be used as an excipient in topical preparations. Approved for topical use only. Approved for topical use only.
Methyl gluceth-20 sesquihydrate
Page 178 of 305
Ingredient
Methyl glucose dioleate
Use E E E E E E E E E E E E E, C
Restrictions
Methyl glucose sesquioleate
Methyl glucose sesquistearate Methyl hydrojasmonate Methyl isobutyl ketone Methyl methacrylate Methyl salicylate Methyl stearate
Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Methyl hydrogenated rosinate Methyl hydroxybenzoate
Topical products require the label statement TOTBNZ.
Concentration must not exceed 0.5%. Residual solvent limit is 50 mg per MDD. Product must contain 25% or less of designated solvents as defined in Part 1 of the SUSMP.
Methylated spirit - industrial Methylcellulose Methylchloroisothiazolinone
Approved for topical use only. In liquid preparations, the concentration must be less than 25%.
Methyldibromo glutaronitrile Methylene bis-benzotriazolyl tetramethylbutylphenol
A, E
Page 179 of 305
Ingredient
Methylisothiazolinone Methylpropanediol
Use E E E E E E
Restrictions
Methylsilanol mannuronate Mica
Methylstyrene/vinyltoluene copolymer Micrococcus luteus lysate Microcos paniculata Milk - goat Microsporum gypseum Milk - nonfat dry Milk - whole dry
Approved for topical use only. Concentration in the product must not exceed 10%. PRV may only be used as an excipient in topical preparations. Approved for topical use only. Approved for topical use only.
A, E A E E E E A, E A, E
If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL.
Milk protein - hydrolysed Milk thistle fruit dry Milk thistle fruit powder
If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL.
Page 180 of 305
Ingredient Millet
Use E
Restrictions
Millettia dielsiana
Millettia reticulata Mimulus guttatus Mitchella repens
Mimosa ternuiflora bark 4:1 aqueous extract ICID 2004 Mint oil dementholised Moghania macrophylla Molasses - blackstrap Molybdenum
A, E A, E E A, E A, E A, E A, E E C
Only Panicum milliaceum seed (grain) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Molybdenum trioxide Momordica charantia
Momordica balsamina
Sucrose is a mandatory component of this ingredient in oral and sublingual products (see separate entry). Molybdenum is a mandatory component of this ingredient. MDD of molybdenum from molybdenum trioxide must not exceed 125 micrograms. Review required. May be a native species if exporting this product please contact the DSEWPC. May be a native species if exporting this product please contact the DSEWPC.
Momordica cochinchinensis
A, E A, E A, E
Page 181 of 305
Ingredient
Monarda didyma
Use A, E E A, E A, E E A, E A, E A, E E E
Restrictions
Mono- and di- glycerides
Monoammonium glutamate Monopotassium glutamate Monosodium glutamate Monotospora brevis Monstera deliciosa Montan wax Mordant red 11
Monosodium dihydrogen citrate
When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
If the plant part is leaf, the MRDD must contain 1 mg or less of the equivalent dry leaf. If any other plant part, it is listable without restriction. Colour permitted only in topical preparations. Concentration must not exceed 0.05%.
Morinda citrifolia
Morinda officinalis Morus alba
Moringa pterygosperma
A, E A, E A, E
Only the fruit juice or fruit powder are permitted. Fruit powder must be produced by freezedrying the whole fruit, excluding the seeds.
Page 182 of 305
Ingredient
Morus bombycis Morus nigra
Use A, E A, E A A E
Restrictions
Motherwort herb dry Mucopolysaccharide Mucor racemosus Mucuna pruriens Mulberry Mung bean
Motherwort herb powder
A, E A, E E E
Only Morus alba and M. nigra fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Vigna radiata seed (bean) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. May be a native species if exporting this product please contact the DSEWPC.
Murraya exotica
Murraya koenigii Musa sapientum Musk ketone Musk xylol
A, E A, E A, E E E
Mussel - green lipped
Page 183 of 305
Ingredient Mustard
Use E E E C
Restrictions
Mustard oil volatile Mustard seed oil Myreth-4 Myosotis arvensis Myrica cerifera Myricetin Myristic acid
A, E A, E A, E E
Only Brassica juncea, B. nigra and Sinapis alba seed is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Allyl isothiocyanate is a mandatory component of this ingredient (see separate entry). Allyl isothiocyanate is a mandatory component of this ingredient (see separate entry). Only Brassica juncea, B. nigra and Sinapis alba seed oil fixed is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Allyl isothiocyanate is a mandatory component of this ingredient (see separate entry). PRV may only be used as an excipient in topical preparations.
Myristica fragrans Myristyl alcohol Myristyl lactate
A, E E E E
Permitted without restriction in preparations containing 50% or less. When the concentration is greater than 50%, the nominal capacity of the container must be 25 mL or less, a RFI must be fitted on the container and the product label must include the statement CHILD. Safrole is a mandatory component of this ingredient (see separate entry). Approved for topical use only. Approved for topical use only. Approved for topical use only.
Page 184 of 305
Myristyl myristate
Ingredient
Myroxylon balsamum Myroxylon pereirae Myrrh Myrrh oil
Use A, E A, E A, E A, E A, E A, E A, E C A, E A, E A, E A, E E E E
Restrictions
Myrrhis odorata
Myrsine africana
Myrtus communis
Naphthaquinones calc as lapachol (of Tabebuia avellanedae heartwood) Nardostachys chinensis Nasturtium officinale Nauclea officinalis
Nelumbium speciosum Neopentyl glycol dicaprylate/dicaprate Neopentyl glycol diheptanoate Neopentyl glycol diisostearate
May be a native species if exporting this product please contact the DSEWPC. Approved for topical use only. PRV may only be used as an excipient in topical preparations.
Page 185 of 305
Ingredient
Neopentyl glycol dioctanoate Nepeta cataria Nephelium longana Nerium oleander Nicotinamide Neurospora crassa
Use E A, E A A
Restrictions
Pulegone is a mandatory component of this ingredient (see separate entry).
Nicotinamide ascorbate Nicotinic acid Nigella sativa Nigella damascena
A, E A, E A, E A, E A, E A, E E E E
A, E, C A, E, C
Concentration of equivalent dry herbal material must not exceed 1 mg/Kg or 1 mg/L or 0.0001%. When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an active in oral or sublingual products, the label must include the statement VIT.
Product must contain 100 mg or less of nicotinic acid per dosage unit. When used as an active in oral or sublingual products, the label must include the statement VIT.
Nigritella angustifolia Nigrospora sphaerica Nitric acid Nonoxinol 10 Nonoxinol 9
Species listed on CITES if exporting or importing this product please contact the DSEWPC. Approved for topical use only as an excipient. Concentration must not exceed 0.5%. Approved for topical use only.
Approved only in topical preparations for localised effect. Concentration must not exceed 25%.
Page 186 of 305
Ingredient
Nordihydroguaiaretic acid Notopterygium forbesii Nuphar japonicum Nuphar luteum Nutmeg dry Nutmeg oil Notopterygium incisium
Use E A, E A, E A, E A, E A, E A, E A, E A A
Restrictions
Safrole is a mandatory component of this ingredient (see separate entry)
Nutmeg powder Nux vomica dry
Permitted without restriction in preparations containing 50% or less. When the concentration is greater than 50%, the nominal capacity of the container must be 25 mL or less, a RFI must be fitted on the container and the product label must include the statement CHILD. Safrole is a mandatory component of this ingredient (see separate entry). Safrole is a mandatory component of this ingredient (see separate entry) Concentration must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Concentration must not exceed 10 mg/Kg or 10 mg/L or 0.001%.
Nux vomica powder Nycteria capensis Nylon Nylon-12
Nyctanthes arbor-tristis
A, E A, E E E

Page 187 of 305
Ingredient
Nymphaea alba Oat
Use A, E A, E E E A, E A, E A, E A, E A, E A, E E, C E E
Restrictions
Nymphaea odorata Oat bran Oatmeal colloidal
Only Avena sativa seed (grain) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry). Only Avena sativa seed (grain) husk or seed coat (bran) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry).
Ocimum basilicum
Ocimum kilimandscharicum Ocimum minimum Ocotea pretiosa Octacosanol Octhilinone Ocimum tenuiflorum
Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry). Camphor is a mandatory component of this ingredient (see separate entry).
Octadecene/MA copolymer
Safrole is a mandatory component of this ingredient (see separate entry). Approved for topical use only. Approved for topical use only.
Page 188 of 305
Ingredient
Octocrylene
Use A E E E E E E E E E E E
Restrictions
Octoxinol 10
Octyl hydroxystearate Octyl isononanoate Octyl palmitate Octyl salicylate Octyl stearate Octyl triazone
Sunscreen active permitted only in topical products. Concentration must not exceed 10%. Approved for topical use only. Approved for topical use only.
Octyl methoxycinnamate
A A A
Approved only in topical preparations for localised effect. Approved for topical use only. Approved for topical use only.
Sunscreen active permitted only in topical products. Concentration must not exceed 10%. Sunscreen active permitted only in topical products. Concentration must not exceed 5%.
Octylbicycloheptenedicarboximide Octyldodecanol Octyldodeceth-25
Sunscreen active permitted only in topical products. Concentration must not exceed 5%. Approved for topical use only.
Approved only in topical preparations for localised effect. Requires the label statement OBCARB.
Octyldodecyl myristate Octyldodecyl stearate
Octyldodecyl neopentanoate
Approved for topical use only. Concentration must not exceed 5%. Residual levels of 1, 4-dioxane and ethylene oxide (and related substances) are to be kept below the levels of detection. PRV may only be used as an excipient in topical preparations. Approved for topical use only.
Page 189 of 305
Ingredient
Oenanthe crocata
Use A A
Restrictions
Oenanthe phellandrium Oenothera biennis Oenothera stricta
Oil (of Syzygium aromaticum) Oil (of Tanacetum vulgare) Okoubaka aubrevillei Olea europaea Oleanolic acid Oleic acid Oleth-10 Oleth-2 Oleth-3 Oleth-20
A, E A, E C C
A, E A, E C E, C E E E E E
May only be used as a component and it is not listable in its own right. Concentration from all ingredients must not exceed 0.8%.
Approved for topical use only. Dioxane and Ethylene oxide are mandatory components of this ingredient (see separate entries).
Oleth-3 phosphate
Page 190 of 305
Ingredient Oleth-5 Oleuropein
Use E C E
Restrictions
Oleyl alcohol Olibanum oil Olive
Oligofructose Olive oil
A, E A, E E C A, E A, E E A, E A, E A, E A, E A, E
Omega-3 marine triglycerides Omphalia lapidescens Onion Onion oil
Only Olea europaea fruit flesh (pitted) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Ononis spinosa
Only the Allium cepa bulb is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Onopordon acanthium Ophiopogon japonicus
Onosmodium virginianum
Page 191 of 305
Ingredient
Opopanax chironium Opuntia ficus-indica Orange Orange flower oil Orange oil
Use A, E A, E E A, E A, E A, E A, E A, E A, E E E
Restrictions Species listed on CITES if exporting or importing this product please contact the DSEWPC.
Only Citrus sinensis fruit flesh or fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Orange oil bitter coldpressed Orange oil distilled Orange oil terpeneless Orange roughy oil Orchis latifolia
Permitted only when: a) in preparations for internal use; b) in preparations containing 1.4% or less of orange oil bitter; c) in soaps or bath and shower gels that are washed off the skin; or d) packed in containers labelled with the statement SENS.
Orange peel dried bitter Orbignya speciosa
Oreodaphne californica Origanum majorana
A, E A, E A, E
Page 192 of 305
Ingredient
Origanum oil spanish Origanum vulgare Ornithine
Use A, E A, E A, E A, E A, E A, E A, E A, E E E
Restrictions
Ornithine aspartate
Ornithine monohydrochloride Ornithogalum umbellatum Orostachys fimbriatus Oroxylon indicum Orris root oil
A, E, C
Ortho-Cymen-5-ol
Ortho-Phenylphenol Oryza sativa Oryzanol
Orthosiphon stamineus
A, E A, E E, C A, E A, E
Osbeckia chinensis Ottelia alismoides
Page 193 of 305
Ingredient
Oxacyclohexadecan-2-one Oxalis acetosella Oxedrine
Use E C C A, E
Restrictions
Oxindole alkaloids calc as mitraphylline (of Uncaria tomentosa bark) Oxybenzone Oyster Oyster shell Padimate O
Concentration in RDD must not exceed 30 mg. Sunscreen active permitted only in topical products. Concentration must not exceed 10%.
A E E
p-Anisic acid
A, E A
Paecilomyces variotii Paeonia lactiflora Paeonia obovata Paeonia veitchii
A, E A, E A, E A, E A, E A, E
Paeonia suffruticosa
Paliurus spina-christi
Page 194 of 305
Ingredient
Palm fruit oil
Use A, E E A, E A, E E E E E E E E
Restrictions Approved for topical use only. Concentration must not exceed 1%.
Palm glycerides - hydrogenated Palm kernel oil Palm kernel oil - fractionated Palm oil - hydrogenated Palmarosa oil Palmitic acid
Palm kernel oil - hydrogenated
When used as an active, this ingredient is only listable as an uncompounded BP substance. Approved for topical use only. Concentration must not exceed 1.2%.
Palmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymer Palmitoyl oligopeptide Palmitoyl pentapeptide-3 Palmitoyl tetrapeptide-3 Panax ginseng Panax japonicus
A, E
Approved for topical use only. Concentration must not exceed 2%. Concentration of polycyclic aromatic hydrocarbons should be kept below the level of detection.
Approved for topical use only. Concentration must not exceed 0.002%. Approved for topical use only. Concentration must not exceed 0.001%.
A, E A
Species listed on CITES if exporting or importing this product please contact the DSEWPC. Only if root and from the Russian Federation.
Page 195 of 305
Ingredient
Panax notoginseng
Use A A A E E E E C C A, E A, E
Restrictions Species listed on CITES if exporting or importing the root of this plant please contact the DSEWPC. Species listed on CITES if exporting or importing the root of this plant please contact the DSEWPC. Approved for topical use only. Approved for topical use only.
Panax pseudoginseng Panax quinquefolium Panicum milliaceum Pantethine Panthenol
Panthenyl ethyl ether Pantolactone Pantothenic acid
Pantothenic acid polypeptide Papain Paper
Pantothenic acid (of Saccharomyces cerevisiae) Papain (of Carica papaya)
A, E, C
When used as an active in oral or sublingual products, the label must include the statement VIT. Approved for topical use only. Concentration must not exceed 0.1%.
A, E E

Page 196 of 305
Ingredient
Para-Hydroxybenzoic acid Paraffin - hard Paraffin - light liquid Paraffin - liquid Paraffin - soft white
Use E E
Restrictions
A, E A, E A, E A, E A, E A, E A, E A, E E A, E A, E A, E A, E
When used as an active, this ingredient is only listable as an uncompounded BP substance. When used as an active, this ingredient is only listable as an uncompounded BP substance. When used as an active, this ingredient is only listable as an uncompounded BP substance. Approved for topical use only. When used as an active, this ingredient is only listable as an uncompounded BP substance.
Paraffin - soft yellow Parameria laevigata Parietaria diffusa Paris polyphylla Parsley Paris quadrifolia Parsley herb dry Parsley herb oil Parsley seed oil
Only Petroselinum crispum leaf and herb is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Parsley herb powder
Page 197 of 305
Ingredient
Parthenocissus tricuspidata Parthenolide Paspalum notatum
Use A, E C A, E A, E A E E A, E
Restrictions
Passiflora caerulea
Passiflora herb dry Patent blue V
Passiflora incarnata
Patent blue V aluminium lake Patrinia scabiosaefolia Patrinia villosa Paullinia cupana Pawpaw Pea
A, E A, E A, E A, E E E
Paullinia pinnata
Caffeine is a mandatory component of this ingredient when intended for oral ingestion (see separate entry).
Only Carica papaya fruit flesh or fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Pisum sativum seed (pea) green or other colours permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 198 of 305
Ingredient Peach Pear
Use E E E E E E E E E E E E E A, E
Restrictions
Peanut Pecan
Only Prunus persica fruit flesh is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Arachis hypogaea seed is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Requires the label statement PEANUT. Only Pyrus communis fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Pectin
PEG-10 dimethicone PEG-10 soya sterol PEG-100 stearate PEG-12 dilaurate
Only Carya illinoinensis seed (nut kernel) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. PRV may only be used as an excipient in topical preparations. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only.
PEG-120 methyl glucose dioleate PEG-120 stearate PEG-15 cocamine PEG-150 stearate
PEG-150 distearate
Page 199 of 305
Ingredient
PEG-2 oleate
Use E E E E E E
Restrictions
PEG-20 almond glycerides
PEG-20 methyl glucose distearate PEG-20 sorbitan isostearate PEG-20 stearate PEG-25 PABA
PEG-20 methyl glucose sesquistearate
Approved for topical use only. Concentration must not exceed 0.5%. Approved only in topical preparations for localised effect. Approved only in topical preparations for localised effect. Approved for topical use only. Sunscreen active permitted only in topical products. Approved for topical use only. Approved for topical use only. Approved for topical use only.
PEG-30 dipolyhydroxystearate PEG-30 stearate PEG-4 dilaurate PEG-4 laurate PEG-4 stearate PEG-35 castor oil
A E E E E E E E
E,
PEG-40 castor oil
Approved only in topical preparations for localised effect. Dioxane and Ethylene oxide are mandatory components of this ingredient (see separate entries).
PEG-40 hydrogenated castor oil
Page 200 of 305
Ingredient
PEG-40 sorbitan diisostearate PEG-40 stearate PEG-5 castor oil PEG-45/dodecyl glycol copolymer PEG-5 glyceryl stearate PEG-5 rapeseed sterol PEG-50 stearate
Restrictions
Approved only in topical preparations for localised effect. Dioxane and Ethylene oxide are mandatory components of this ingredient (see separate entries). Approved for topical use only. Approved for topical use only. Approved for topical use only.
PEG-55 propylene glycol oleate PEG-6 lauramide PEG-6 Methyl ether
Approved for topical use only. Concentration in the product must not exceed 0.6%. Approved only in topical preparations for localised effect. PRV may only be used as an excipient in topical preparations.
PEG-60 almond glycerides
PEG-60 glyceryl isostearate PEG-7 cocamide
PEG-60 hydrogenated castor oil
Approved only in topical preparations for localised effect. Concentration for products applied directly to the skin must not exceed 10%. Concentration when used in bath oil products is not to exceed 30% prior to addition to the bath. Approved for topical use only. Concentration must not exceed 2%. Approved for topical use only. Approved for topical use only.
Page 201 of 305
Ingredient
PEG-7 glyceryl cocoate PEG-75 lanolin
Use E E E E E E E E E E E
Restrictions
PEG-7 hydrogenated castor oil PEG-75 stearate
PEG-8 cetyl dimethicone PEG-8 distearate PEG-8 stearate
Approved for topical use only. Concentration must not exceed 1.5%. Approved for topical use only. Approved for topical use only.
PEG-8 propylene glycol cocoate PEG/PPG-14/7 dimethyl ether PEG/PPG-18/18 dimethicone PEG/PPG-20/15 dimethicone Pelargonium graveolens Peltigera canina
PRV may only be used as an excipient in topical preparations
Penicillium chrysogenum Penicillium digitatum Penicillium expansum
Page 202 of 305
Ingredient
Penicillium glaucum Pennyroyal oil
Use A, E A, E A, E C
Restrictions
Penicillium notatum Pentacyclic oxindole alkaloids (of Uncaria tomentosa) Pentadoxynol-200 Pentaerythrityl tetra-di-t-butyl hydrocinnamate Pentaerythrityl tetralaurate
When used topically, the MRDD must only provide 150 mg or less. For any other route of administration, the MRDD must provide 50 mg or less. D-Pulegone is a mandatory component of this ingredient (see separate entry). PRV may only be used as an excipient in topical preparations. PRV may only be used as an excipient in topical preparations. Approved for topical use only. Approved for topical use only. Concentration must not exceed 61%. Approved for topical use only.
E E E E E E E C E
Pentaerythrityl tetraisostearate Pentaerythrityl tetraoctanoate Pentasodium ethylenediamine tetramethylene phosphonate Pentylene glycol Peonidin Pepper black
Only Piper nigrum fruit unripe (whole peppercorn) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 203 of 305
Ingredient
Pepper white
Use E
Restrictions
Peppermint leaf dry Peppermint oil
Peppermint leaf powder
A, E A, E A, E E A, E A, E E A, E A, E E A, E A, E A, E
Only Piper nigrum fruit endocarp and seed ripe (peppercorn without soft outer layer) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Perfluoropolymethylisopropyl ether Perilla frutescens Periploca sepium Permethrin Persic oil
Persea gratissima Persimmon
Approved for topical use only as an excipient. Concentration must not exceed 2%.
Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries).
Peru balsam
Peru balsam oil
Only Diospyros kaki fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Petitgrain oil paraguay
Page 204 of 305
Ingredient Petunidin
Petroselinum crispum
Use A, E C A, E A, E A A, E A, E A, E A, E A, E A, E A, E A, E E E
Restrictions
Peucedanum decursivum Peumus boldus
Peucedanum praeruptorum Phalaris arundinacea Phalaris canariensis Phaseolus angularis
Volatile oil components (of Peumus boldus) is a mandatory component of this ingredient (see separate entry).
Phaseolus calcaratus Phaseolus coccineus Phaseolus vulgaris Phellinus robiniae Phenacetin
Phellodendron amurense Phenethyl alcohol
Approved for topical use only. Products for topical use require the label statement PHEALC.
Page 205 of 305
Ingredient
Phenethyl benzoate Phenol
Use E E E E E E E
Restrictions
Phenethyl dimethicone Phenoxyethanol
Approved for topical use only. Concentration must not exceed 0.2%. Products for topical use require the label statement PHOETH. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Phenoxyethylparaben Phenyl dimethicone Phenylalanine Phenyl trimethicone
Approved only in topical preparations for localised effect. Concentration of phenols including cresols and xylenols and any other homologue of phenol boiling below 220 degrees centigrade should not exceed 3%. Requires the label statement PHENOL.
Phenylbenzimidazole sulfonic acid Phleum pratense Phloxine B
A, E A C A, E E
Products for oral ingestion require the label statement PKU. Products that contain more than 500 mg per daily dose require the label statement PREGNT2. Sunscreen active permitted only in topical products. Concentration must not exceed 4%.
Phloroglucinol derivatives calculated as humulone Phoenix dactylifera Phoma betae
A, E A, E
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Ingredient
Phoma herbarum
Use A, E C
Restrictions Approved for topical use only. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Approved for topical use only. Concentration must not exceed 20%. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Concentration in liquid preparations must not exceed 15%.
Phosphatidyl choline Phosphatidyl inositol Phospholipids Phosphorus Phosphoric acid
E, C
E E C
Photinia serrulata
Phragmites communis Phyllanthus amarus Phyllostachys nigra Physalis alkekengi Physalis pubescens
Phycomyces blakesleeanus Phyllanthus emblica
A, E A, E A, E A, E A, E A, E A, E A, E A
May be a native species if exporting this product please contact the DSEWPC. May be a native species if exporting this product please contact the DSEWPC.
Physostigma venenosum
Physostigmine is a mandatory component of this ingredient (see separate entry).
Page 207 of 305
Ingredient Phytantriol
Physostigmine
Use C E
Restrictions
Phytolacca decandra Phytomenadione Phytosphingosine
A E E E
Concentration from all ingredients must not exceed 10 mg/kg or 10 mg/L or 0.001%. Approved for topical use only. Concentration imust not exceed 0.5%. MRDD must contain 1 mg or less of the equivalent dry herbal material. PRV may only be used as an excipient in topical preparations.
Phytosterol complex - conifer Phytosteryl macadamiate Picea excelsea Picea mariana
A, E A
Phytosteryl/octyldodecyl lauroyl glutamate
Picrasma excelsa
A, E A, E A, E A, E A, E C
Picrorrhiza kurroa Picrotoxin
Picrorrhiza scrophulariflora
Species listed on CITES only whole and sliced roots and part of roots, excluding manufactured parts or derivatives such as powders, pills, extracts, tonics, teas and confectionary, are subject to the Convention if exporting or importing this product please contact the DSEWPC. Concentration from all ingredients must not exceed 10 mg/kg or 10 mg/L or 0.001%.
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Ingredient
Pigment blue 15
Use E E E E E E E E E C
Restrictions
Pigment green 18 Pigment green 7 Pigment red 4 Pigment red 53 Pigment red 57 Pigment red 63
PRV may only be used as an excipient in topical preparations. Colour permitted only in topical preparations. Colour permitted only in topical preparations. Colour permitted only in topical preparations. Colour permitted only in topical preparations.
PRV may only be used as an excipient in topical preparations. Colour permitted only in topical preparations.
Pigment white 26 Pilocarpine
Pigment yellow 12
Pilocarpus jaborandi
Pilocarpus microphyllus Pilocarpus pinnatifolius Pimenta fruit oil Pimenta leaf oil
A A A
Concentration of pilocarpine from all ingredients must not exceed 0.025%.
Pilocarpine is a mandatory component of this ingredient (see separate entry). Pilocarpine is a mandatory component of this ingredient (see separate entry).
Pimenta officinalis
A, E A, E A, E
Pilocarpine is a mandatory component of this ingredient (see separate entry).
Page 209 of 305
Ingredient
Pimenta racemosa
Use A, E
Restrictions
Pimpinella anisum Pimpinella saxifraga Pine oil aromatic Pine oil pumilio Pineapple Pinellia ternata Pinus contorta
A, E A, E A, E A, E A, E E A, E A, E A, E A, E A, E
Permitted without restriction in preparations containing 25% or less of bay oil. When the concentration of bay oil is greater than 25% and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. When the concentration of bay oil is greater than 25% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the product label must include the statements CHILD and NTAKEN. Permitted without restriction in preparations containing 50% or less of anise oil. When the concentration of anise oil is greater than 50%, the nominal capacity of the container must be 50 mL or less, a RFI must be fitted on the container and the product label must include the statement CHILD.
Pine needle oil scotch
Only Ananas sativus fruit flesh or fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Pinus massoniana Pinus monticola Pinus mugo
Page 210 of 305
Ingredient
Pinus pinaster Pinus radiata
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E
Restrictions
Pinus ponderosa Pinus strobus
Pinus sylvestris Piper chaba
Pinus tabulaeformis Piper cubeba
Piper futokadsura Piper longum
Piper methysticum
Piper nigrum
Piper sarmentosum
A, E A, E
When the container type is tea bag the maximum quantity per tea bag is 3 grams of dried rhizomes. Approved in topical preparations for use on the rectum, vagina or throat only when containing dried whole or peeled rhizome or containing aqueous dispersions or aqueous extracts of whole or peeled rhizome. Kavalactones (of Piper methysticum) is a mandatory component of this ingredient (see separate entry). Customs Prohibited Import requires an import permit/licence.
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Ingredient Piperonal
Piperine_(of piper nigrum) Piperonyl butoxide Piroctone olamine Piscidia piscipula Pistacia lentiscus Pisum sativum Plantago afra
Use C E E E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E
Restrictions PRV may only be used as an excipient in topical preparations.
Approved only in topical preparations for localised effect. Topical products require the label statement PIPBUT.
Approved for topical use only. Concentration must not exceed 0.5% in leave-on products and 1% in wash-on/wash-off products.
Plantago asiatica Plantago indica Plantago major Plantago ovata
Plantago lanceolata
Plantago seed dry
Platanus occidentalis
Page 212 of 305
Ingredient
Platanus racemosa
Use A, E A, E A, E E A, E A, E A, E A, E A, E A, E C C
Restrictions
Platanus X acerifolia Plum
Platycodon grandiflorum Plumbago europaea Plumeria alba Plumeria lancifolia Plumeria rubra Poa nemoralis Poa pratensis Podophyllin
Only Prunus cerasifera, P. domestica, P. instititia, P. salicina, P. spinosa and hybrids fruit flesh is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Podophyllotoxin
Podophyllum dry
Concentration from all ingredients must not exceed 1 mg/kg or 1 mg/L or 0.0001%.
Concentration from all ingredients must not exceed 10 mg/kg or 10 mg/L or 0.001%.
Podphyllin and Podophyllotoxin are mandatory components of this ingredient (see separate entries). Species may be listed on CITES if exporting or importing this product please contact the DSEWPC.
Page 213 of 305
Ingredient
Podophyllum emodi
Use A A A A E E E E E E
Restrictions
Podophyllum peltatum Podophyllum powder Podophyllum resin Pogostemon cablin Polacrilin
Podphyllin and Podophyllotoxin are mandatory components of this ingredient (see separate entries). Species may be listed on CITES if exporting or importing this product please contact the DSEWPC. Podphyllin and Podophyllotoxin are mandatory components of this ingredient (see separate entries). Podphyllin and Podophyllotoxin are mandatory components of this ingredient (see separate entries). Species may be listed on CITES if exporting or importing this product please contact the DSEWPC. Podphyllin and Podophyllotoxin are mandatory components of this ingredient (see separate entries). Species may be listed on CITES if exporting or importing this product please contact the DSEWPC.
Polacrilin potassium Pollack-liver oil Pollen Poloxamer
A, E
A, E
Poly C10-30 alkyl acrylate Polyacrylamide
If the ingredient is collected by bees then the product requires the label statement POLLEN. Approved for topical use only. Approved for topical use only. Concentration must not exceed 1%.
Approved only in topical preparations for localised effect. Acrylamide is a mandatory component of this ingredient in topical products.
Page 214 of 305
Ingredient
Polyacrylic acid
Use E E E E E E E E E
Restrictions Approved for topical use only. Approved for topical use only.
Polyamino sugar condensate Polyaminopropyl biguanide Polybutene
Polybutylene glycol/PPG-9/1 copolymer Polycaprolactone Polydecene Polydextrose Polyethylene
Polygala chinensis Polygala senega Polygala sibirica
Polyglyceryl-10 oleate
Polyglyceryl-10 pentastearate Polyglyceryl-2-PEG-4 stearate
PRV may only be used as an excipient in topical preparations. PRV may only be used as an excipient in topical preparations. Approved for topical use only.
Page 215 of 305
Ingredient
Polyglyceryl-2 dipolyhydroxystearate Polyglyceryl-2 diisostearate Polyglyceryl-3 diisostearate Polyglyceryl-3 oleate Polyglyceryl-2 triisostearate
Use E E E E E E E E E E E E
Restrictions
Approved for topical use only. Concentration must not exceed 5%. PRV may only be used as an excipient in topical preparations. PRV may only be used as an excipient in topical preparations. Approved for topical use only.
Polyglyceryl-3 methylglucose distearate Polyglyceryl-3 polydimethylsiloxyethyl dimethicone Polyglyceryl-3 polyricinoleate Polyglyceryl-4 isostearate Polyglyceryl-4 oleate
Polyglyceryl-3 polydimethylsiloxyethyl dimethicone is for dermal use only. The concentration of Polyglyceryl-3 polydimethylsiloxyethyl dimethicone is not to exceed 3%. Approved for topical use only. Concentration must not exceed 5%. Approved for topical use only. Approved for topical use only. Approved for topical use only. Concentration must not exceed 1%.
Polyglyceryl-6 polyricinoleate Polyglyceryl-6 ricinoleate Polygonatum officinale Polygonatum multiflorum Polygonatum sibiricum
A, E A, E A, E
Page 216 of 305
Ingredient
Polygonum aviculare Polygonum bistorta Polygonum chinense
Use A, E A, E A, E A, E A, E A, E A, E E E E E E E C E
Restrictions
Polygonum cuspidatum Polygonum odoratum
Polygonum multiflorum Polygonum tinctorium
Polyhydroxysteraric acid Polyisoprene
Polyisobutene - hydrogenated Polymethacrylic acid
Polymethyl methacrylate
Polymethylsilsesquioxane
Polyphenols calculated as catechin (of Oenothera biennis)
Polyphosphorylcholine glycol acrylate
Page 217 of 305
Ingredient
Polyporus umbellatus Polypropylene Polyquaternium-10 Polyquaternium-11 Polyquaternium-24 Polyquaternium-28 Polyquaternium-44 Polyquaternium-51 Polyquaternium-7 Polysilicone-11 Polysilicone-14 Polysilicone-15 Polysilicone-2
Approved for topical use only. Concentration must not exceed 0.3%. Approved for topical use only. Concentration must not exceed 5%. Approved for topical use only. PRV may only be used as an excipient in topical preparations.
Polysiphonia lanosa cell extract 1:3.1 in 100% W ICID 2004 Polysorbate 20
Approved for topical use only. Concentration must not exceed 10%. (?) PRV may only be used as an excipient in topical preparations.
Page 218 of 305
Ingredient
Polysorbate 40 Polysorbate 60 Polysorbate 65 Polysorbate 80 Polysorbate 85 Polytef
Use E E E E E E E E E E E E A, E A, E A, E
Restrictions
Polyvinyl acetate
Polyvinyl acetate phthalate Polyvinyl alcohol Pomegranate Ponceau SX Polyvinyl chloride
Poncirus trifoliata Populus alba Populus balsamiifera
Only Punica granatum fruit flesh is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Colour permitted only in topical preparations.
Page 219 of 305
Ingredient
Populus candicans Populus deltoides Populus nigra Populus tremula Poria cocos
Use A, E A, E A, E A, E A, E A, E E E C
Restrictions
Populus tremuloides
Porphyra yezoensis cytoplasm extract ICID 2004 Porphyridium purpureum cytoplasm extract ICID 2004 Portulaca oleracea Potassium Potassium acetate
PRV may only be used as an excipient in topical preparations. PRV may only be used as an excipient in topical preparations. May be a native species if exporting this product please contact the DSEWPC.
A, E E
Potassium ascorbate
Potassium ascorbate dihydrate Potassium ascorbyl tocopheryl phosphate
A, E A, E E
When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an active in oral or sublingual products, the label must include the statement VIT. Approved for topical use only.
Page 220 of 305
Ingredient
Potassium aspartate
Use A, E A, E A, E E E E E E, C E E
Restrictions
Potassium aspartate dihydrate Potassium bicarbonate Potassium carbomer Potassium carbonate Potassium chloride Potassium citrate
Potassium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of potassium is required on the product label. Potassium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of potassium is required on the product label. Potassium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of potassium is required on the product label. PRV may only be used as an excipient in topical preparations. Approved for topical use only.
Potassium aspartate monohydrate
Potassium cetyl phosphate
In solid preparations, the pH of a 10 gm/L aqueous solution must not be more than 11.5. In liquid or semi-solid preparations, the pH of the preparation must not exceed 11.5.
Potassium cocoyl hydrolysed collagen Potassium cocoyl hydrolysed soy protein Potassium gluconate
A, E
Potassium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of potassium is required on the product label. Approved for topical use only. Concentration must not exceed 0.15%.
Approved for topical use only. Concentration must not exceed 10%. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Potassium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of potassium is required on the product label.
A, E
Page 221 of 305
Ingredient
Potassium glycerophosphate Potassium hydroxide Potassium iodide
Use A, E E
Restrictions
Potassium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of potassium is required on the product label.
Potassium hydroxycitrate
Potassium metaphosphate Potassium orotate Potassium phosphate - dibasic Potassium phosphate - dibasic trihydrate
A E
Concentration must not exceed 5%. In solid preparations, the pH of a 10 gm/L aqueous solution must not be more than 11.5. In liquid or semi-solid preparations, the pH of the preparation must not exceed 11.5. Iodine is a mandatory component of this ingredient (see separate entry). Approved for topical use only. Concentration must not exceed 0.5%.
Potassium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of potassium is required on the product label. In solid preparations, the pH of a 10 gm/L aqueous solution must not exceed 11.5. In liquid or semisolid preparations, the pH of the preparation must not exceed 11.5.
Potassium phosphate - monobasic
Potassium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of potassium is required on the product label. In solid preparations, the pH of a 10 gm/L aqueous solution must not exceed 11.5. In liquid or semisolid preparations, the pH of the preparation must not exceed 11.5. Potassium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of potassium is required on the product label. In solid preparations, the pH of a 10 gm/L aqueous solution must not exceed 11.5. In liquid or semisolid preparations, the pH of the preparation must not exceed 11.5.
Page 222 of 305
Ingredient
Potassium phosphate - tribasic Potassium pyrophosphate Potassium sorbate Potassium sulfate Potato Potassium stearate
Use A, E E E E E
Restrictions
Potassium is a mandatory component of this ingredient. If used as an active AND intended as a mineral supplementation, the equivalent quantity of potassium is required on the product label. In solid preparations, the pH of a 10 gm/L aqueous solution must not exceed 11.5. In liquid or semisolid preparations, the pH of the preparation must not exceed 11.5. Approved for dental, oral, and topical use only. Not to be used in products intended for use in the eye. Concentration must not exceed 3%. Requires the label statement SORB8. Approved for topical use only.
A, E
Potentilla anserina Potentilla discolor Potentilla erecta Potentilla reptans
Potentilla chinensis
Only Solanum tuberosum tuber is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Steroidal alkaloids calculated as solanine is a mandatory component of this ingredient (see separate entry).
Poterium officinale
Page 223 of 305
Ingredient Povidone
Poterium sanguisorba
Restrictions
PPG-12/SMDI copolymer PPG-15 stearyl ether
PPG-15 stearyl ether benzoate PPG-2 lanolin alcohol ether
PPG-17/IPDI/DMPA Copolymer
Approved for topical use only. Concentration must not exceed 0.3%. PRV may only be used as an excipient in topical preparations. Approved for topical use only. Approved for topical use only.
PPG-2 myristyl ether propionate PPG-20 lanolin alcohol ether PPG-20 methyl glucose ether PPG-20 methyl glucose ether distearate PPG-3 myristyl ether PPG-5-ceteth-20 PPG-5-laureth-5
Approved only in topical preparations for localised effect. Concentration must not exceed 0.5%. Approved only in topical preparations for localised effect. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved only in topical preparations for localised effect. Concentration must not exceed 6%.
PPG-3 hydrogenated castor oil
Page 224 of 305
Ingredient
PPG-51/SMDI copolymer Prickly ash bark dry Primula veris Prickly ash bark powder Primula vulgaris
Use E A, E A, E A, E A, E A, E C C C C
Restrictions
Prinsepia unifloria
Proanthocyanidins calculated as procyanidine B1 (of Vaccinium macrocarpon) procyanidins (of Pinus pinaster) procyanidins (of Pinus radiata) procyanidins (of Vitis vinifera) Proline Propane
Propan-1-ol
A, E E E
Propionyllevocarnitine hydrochloride
A
Page 225 of 305
Ingredient Propolis
Use
Propolis balsam
A, E, C A, E, C A, E, C A, E, C A, E, C A, E, C E E E E E E
Restrictions
Lead is a mandatory component of this ingredient (see separate entry). Topical products require the label statement PROP1. Products other than for topical use require the label statement PROP2. Lead is a mandatory component of this ingredient (see separate entry). Topical products require the label statement PROP1. Products other than for topical use require the label statement PROP2. Lead is a mandatory component of this ingredient (see separate entry). Topical products require the label statement PROP1. Products other than for topical use require the label statement PROP2. Lead is a mandatory component of this ingredient (see separate entry). Topical products require the label statement PROP1. Products other than for topical use require the label statement PROP2. Lead is a mandatory component of this ingredient (see separate entry). Topical products require the label statement PROP1. Products other than for topical use require the label statement PROP2.
Propolis dry extract Propolis resin Propyl gallate
Propolis liquid extract Propolis tincture Propyl hydroxybenzoate Propylene carbonate Propylene glycol
Lead is a mandatory component of this ingredient (see separate entry). Topical products require the label statement PROP1. Products other than for topical use require the label statement PROP2. Topical products require the label statement TOTBNZ. Approved for topical use only.
Propylene glycol dicaprate
Propylene glycol dicaprylate
Page 226 of 305
Ingredient
Propylene glycol dicaprylate/dicaprate
Use E E E E E E E A, E A, C E C C
Restrictions
Propylene glycol dioctanoate Propylene glycol isostearate
Propylene glycol dipelargonate Propylene glycol monolaurate
Propylene glycol monostearate Prosopis juliflora Protease
Approved only in topical preparations for localised effect. Approved for topical use only. Approved for topical use only. Permitted only when derived from Aspergillus oryzae.
Propylene glycol myristyl ether acetate
Protein hydrolysate Protopine
Protodioscin (of Tribulus terrestris) Prunella vulgaris
If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL.
A, E
Page 227 of 305
Ingredient
Prunus africana
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E
Restrictions
Prunus armeniaca Prunus avium Prunus cerasifera Prunus cerasus Prunus dulcis Prunus domestica Prunus humilis
Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Species listed on CITES if exporting or importing this product please contact the DSEWPC. Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries).
Page 228 of 305
Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries).
Prunus insititia
Prunus japonica
Ingredient
Prunus laurocerasus Prunus mume Prunus persica
Use A, E A, E A, E A, E A, E E A, E A, E A, E A, E A, E A, E
Restrictions
Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Amygdalin and Hydrocyanic acid are mandatory components of this ingredient (see separate entries). Colour permitted only in topical preparations.
Prunus salicina
Prunus serotina Prunus spinosa Prussian blue
Pseudolarix kaempferi Pseudostellaria heterophylla Pseudotsuga menziesi Psidium guajava Pseudowintera colorata
If the plant part is stem bark or root and the preparation is for internal use, the MRDD must contain 1 mg or less of the equivalent dry stem bark or root. The stem bark and root used topically is listable without restriction. Plant parts other than stem bark or root are permitted only if the MRDD contains 1 mg or less of the dry herbal material.
Permitted only if the plant part is leaf.

Page 229 of 305
Ingredient
Psoralea corylifolia Psyllium husk dry Psyllium seed dry Ptelea trifoliata
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E C E E E E
Restrictions If a dose for children is stated, it must be followed by the label statement PSYLL. If a dose for children is stated, it must be followed by the label statement PSYLL. If a dose for children is stated, it must be followed by the label statement PSYLL.
Psyllium husk powder
Pterocarpus marsupium Pterocarpus santalinus Pueraria lobata Pulegone Pullulan Pumice
Pueraria pseudohirsuta
Pulsatilla vulgaris Pumpkin
A, E
Concentration must not exceed 4%.
Pumpkin seed
Only Cucurbita maxima, C. moschata and C. pepo fruit flesh orange and high in starch is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Only Cucurbita pepo seed is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 230 of 305
Ingredient
Pumpkin seed oil Punica granatum Punicalagins (of Punica granatum) PVM/MA copolymer
Use E C C
Restrictions
Purine alkaloids calculated as caffeine (of Paullinia cupana) PVM/MA decadiene crosspolymer PVP/eicosene copolymer PVP/VA copolymer Pyrethrins PVP/hexadecene copolymer
A, E
Only Cucurbita pepo seed oil fixed is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
E E E E E
Approved only in topical preparations for localised effect. Approved for topical use only. Approved for topical use only.
Pyridoxal 5-phosphate Pyridoxine
E, C C
A, E
Approved only in topical preparations for localised effect. Concentration must not exceed 10%. Requires the label statement PYRTH3. Pyridoxine is a mandatory component of this ingredient (see separate entry). When used as an active in oral or sublingual products, the label must include the statement VIT. RDD must not contain more than 200 mg. If the preparation contains more than 50 mg and less than 200 mg of pyridoxine per RDD the product requires the label statement VITB6.
Page 231 of 305
Ingredient
Pyridoxine hydrochloride Pyroglutamic acid Pyrola decorata Pyrrosia lingua
Use A, E E A, E A, E A, E A, E A, E A, E A, E A, E A, E E E E
Restrictions
Pyridoxine is a mandatory component of this ingredient unless present as an active homoeopathic (see separate entry). When used as an active in oral or sublingual products, the label must include the statement VIT.
Pyrrosia petilosa Pyrus communis Pyrus pyrifolia Quassia amara
Pyrrosia sheareri
Quassia wood jamaican dry Quaternium-15 Quaternium-18 Quaternium 52
Quassia wood jamaican powder
Approved only in topical preparations for localised effect. Requires the label statement QUAT15. PRV may only be used as an excipient in topical preparations. Approved for topical use onlyin wash on/wash off products. Concentration must not exceed 1%. Should not be used in products in which N-nitroso compounds may be formed.
Page 232 of 305
Ingredient
Quaternium-18 bentonite Quaternium-18 hectorite Quercetin Quercus acutissima Quercus alba Quercus palustris Quercus robur Quercus rubra Quillaia dry
Use E E
Restrictions
A, E A, E A, E A, E A, E A, E A, E A, E A, E E C C
Quercus virginiana Quillaia powder Quince
Quillaja saponaria Quinic acid Quinidine
Only Cydonia oblonga fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Concentration must not exceed 10 mg/kg or 10 mg/L or 0.001%.
Page 233 of 305
Ingredient Quinine Quinoline yellow
Use C E E
Restrictions
Quinoline yellow aluminium lake Quisqualis indica R-alpha lipoic acid Radish
MRDD must not exceed 50 mg.
R,S-alpha lipoic acid Ranunculus bulbosus Ranunculus ficaria Ranunculus ternatus
A, E A A E
A, E A, E A, E A, E E A, E A, E E
Only Raphanus sativus root is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Ranunculus zuccarini Rape seed oil Raspberry
Rape oil/tung oil copolymer Raphanus sativus
Allyl isothiocyanate is a mandatory component of this ingredient (see separate entry).
Only Rubus idaeus, R. occidentalis, R. parvifolius and hybrids fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 234 of 305
Ingredient
Rauwolfia serpentina
Use A A A
Restrictions
Rauwolfia serpentina dry
Concentration of equivalent dry herbal material must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Species listed on CITES if exporting or importing this product please contact the DSEWPC excluding chemical derivatives and finished pharmaceutical products. Concentration must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Species listed on CITES if exporting or importing this product please contact the DSEWPC excluding chemical derivatives and finished pharmaceutical products. Concentration must not exceed 10 mg/Kg or 10 mg/L or 0.001%. Species listed on CITES if exporting or importing this product please contact the DSEWPC excluding chemical derivatives and finished pharmaceutical products.
Rauwolfia serpentina powder Red clover flower dry Rehmannia glutinosa Red clover flower powder
A, E A, E A, E C C
Resveratrol (of Polygonum cupidatum) Retinol
Resveratrol (of Vitis vinifera) Retinyl acetate
A, E A, E E
Vitamin A is a mandatory component of this ingredient (see separate entry). When used as an active in oral or sublingual products, the label must include the statement VIT. PRV may only be used as an excipient in topical preparations.
Retinyl linoleate
Vitamin A is a mandatory component of this ingredient (see separate entry). When used as an active in oral or sublingual products, the label must include the statement VIT.
Page 235 of 305
Ingredient
Retinyl palmitate
Use A, E A A A A A C
Restrictions
Rhamnus catharticus Rhamnus frangula Rhatany root dry Rhein Rhamnus purshianus Rhatany root powder Rheum officinale
Vitamin A is a mandatory component of this ingredient (see separate entry). When used as an active in oral or sublingual products, the label must include the statement VIT.
Hydroxyanthracene derivatives is a mandatory component of this ingredient in oral preparations (see separate entry). Glucofrangulins calculated as glucofrangulin A is a mandatory component of this ingredient (see separate entry). Hydroxyanthracene derivatives calculated as cascaroside A is a mandatory component of this ingredient in oral preparations (see separate entry).
Rheum palmatum
A, E A, E A, E
Not permitted if the plant part contains leaf. Hydroxyanthracene derivatives calculated as rhein is a mandatory component of this ingredient in oral preparations when the plant part is not leaf (see separate entry). Not permitted if the plant part contains leaf. Hydroxyanthracene derivatives is a mandatory component of this ingredient in oral preparations when the plant part is not leaf (see separate entry).
Rheum rhaponticum
Not permitted if the plant part contains leaf. Hydroxyanthracene derivatives calculated as rhein is a mandatory component of this ingredient in oral preparations when the plant part is not leaf (see separate entry).
Page 236 of 305
Ingredient
Rheum tanguticum Rhizopus oryzae Rhodamine B Rhizopus stolonifer
Use A, E A, E A, E E A, E A, E A, E A, E A, E E A, E A, E A, E
Restrictions
Not permitted if the plant part contains leaf. Hydroxyanthracene derivatives is a mandatory component of this ingredient in oral preparations when the plant part is not leaf (see separate entry).
Rhododendron chrysantheum Rhododendron ferrugineum Rhododendron molle Rhodotorula glutinus Rhubarb
Rhodymenia palmata Rhubarb root dry Rhus aromatica
Only Rheum rhaponticum leaf stalk (petiole) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Hydroxyanthracene derivatives is a mandatory component of this ingredient in oral preparations (see separate entry).
Rhubarb root powder
Hydroxyanthracene derivatives calculated as rhein is a mandatory component of this ingredient in oral preparations (see separate entry). Hydroxyanthracene derivatives calculated as rhein is a mandatory component of this ingredient in oral preparations (see separate entry).
Page 237 of 305
Ingredient
Rhus diversiloba Rhus glabra Rhus radicans
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E E
Restrictions
Rhus semialata Rhus venenata Ribes nigrum Riboflavin
Rhus succedanea
Ribes grossularia
Riboflavin sodium phosphate Riboflavin tetraacetate Riboflavine
A, E, C
When used as an active in oral or sublingual products, the label must include the statement VIT. Approved for topical use only.
Riboflavine sodium phosphate Ribonucleic acid
A, E, C A, E E
When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. When used as an active in oral or sublingual products, the label must include the statement VIT. Approved for topical use only.
When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
Page 238 of 305
Ingredient Rice
Use E E E E E E A, E A, E A A, E
Restrictions
Rice - hydrolysed Rice bran Rice bran oil Rice vinegar Rice wine
A, E
Only Oryza sativa seed (grain) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Only Oryza sativa seed (grain) husk or seed coat (bran) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Rice bran wax
A, E
Only Oryza sativa seed (grain) husk or seed coat (bran) with/out seed embryo (germ) oil fixed is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Oryza sativa seed (grain) vinegar is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Approved for topical use only.
Ricinoleic acid
Ricinus communis Rohdea japonica Rosa alba
Only Oryza sativa seed (grain) fermented (wine) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Ethanol is a mandatory component of this ingredient (see separate entry). Approved only when the plant part is seed and the plant preparation is oil fixed. MRDD must contain 1 mg or less of the equivalent dry herbal material.
Robinia pseudoacacia
If the plant part is other than leaf or flower, the MRDD must contain 1 mg or less of the equivalent dry herbal material. If the plant part is leaf or flower, it is listable without restriction.
Page 239 of 305
Ingredient
Rosa arvensis Rosa canina
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E E A, E A, E A, E E A, E
Restrictions
Rosa centifolia
Rosa damascena Rosa eglanteria Rosa gallica Rosa indica
Rosa laevigata
Rosa multiflora Rosa rugosa Rosa villosa Rose hip Rose oil
Rosa roxburghii extract ICID97
Rose fruit fresh
Only Rosa arvensis, R. canina and R. villosa fruit flesh (hip) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 240 of 305
Ingredient
Rosemary oil Royal jelly
Use A, E A, E
Restrictions
Rosmarinus officinalis Royal jelly fresh Rubber natural
A, E, C A, E, C A, E, C E A, E A, E A, E A, E A, E A, E A, E A, E
Safrole is a mandatory component of this ingredient (see separate entry).
Camphor, Cineole and Safrole are mandatory components of this ingredient (see separate entries). Requires the label statements CHILD2 and ROYJ. 10-Hydroxy-2-decenoic acid is a mandatory component of this ingredient. Requires the label statements CHILD2 and ROYJ. 10-Hydroxy-2-decenoic acid is a mandatory component of this ingredient. Requires the label statements CHILD2 and ROYJ. 10-Hydroxy-2-decenoic acid is a mandatory component of this ingredient. Approved for topical use only.
Royal jelly lyophilised Rubia cordifolia Rubus chingii
Rubia tinctorum Rubus coreanus Rubus idaeus
Rubus fruticosus
Rubus occidentalis Rubus parvifolius
Page 241 of 305
Ingredient
Rubus rosifolius Rubus tokkura Rubus villosus Rue oil
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E C A, E A, E A, E A, E
Restrictions
Rudbeckia hirta Rumex acetosa Rumex acutus
Rumex acetosella Rumex crispus
Rumex pulcher Ruscogenin
Rumex scutatus
Ruscus aculeatus Ruta chalepensis Ruta graveolens Ruta montana
Page 242 of 305
Ingredient Rutin Rye
Use A, E E E C C
Restrictions Only Secale cereale seed (grain) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry). Only Secale cereale seed (grain) husk or seed coat (bran) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry). Requires the label statement SAME.
Rye bran S-Allyl-Cysteine (of Allium sativum) (S)-S-Adenosylmethionine (S)-S-Adenosylmethionine disulfate ditosylate dihydrate (S)-S-Adenosylmethionine disulfate tosylate (S)-S-Adenosylmethionine disulfate tritosylate dihydrate (S)-S-Adenosylmethionine hexatosylate dihydrate (S)-S-Adenosylmethionine pentasulfate dihydrate (S)-S-Adenosylmethionine hexasulfate dihydrate
A, C A, C A, C A, C A, C A, C
(S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry).
Page 243 of 305
Ingredient
(S)-S-Adenosylmethionine pentatosylate dihydrate (S)-S-Adenosylmethionine tetratosylate dihydrate Saccharin
Use A, C A, C A, C A, C E E
Restrictions
(S)-S-Adenosylmethionine tetrasulfate dihydrate (S)-S-Adenosylmethionine trisulfate ditosylate dihydrate Saccharin sodium
(S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry). Requires the label statement SACCH. (S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry).
Saccharomyces cerevisiae Saccharomyces cervisiae polysaccharides
Saccharomyces cerevisiae (Boulardii) Saccharomyces/magnesium ferment Saccharomyces/zinc ferment Saccharum officinarum
A, E A E E E
Requires the label statement SACCHS. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
A, E
Page 244 of 305
Ingredient Saffron Safrole
Safflower oil
Use A, E E C
Restrictions
Sage leaf dry
Sage leaf powder Sage oil spanish Salicin Salicylic acid Salix alba
Sage oil dalmation
A, E A, E A, E A, E C E
If the preparation is for internal use, the concentration from all ingredients must not exceed 0.1%. If the preparation is for topical use, the concentration from all ingredients must not exceed 1%. Customs Prohibited Import requires an import permit/licence. Thujone is a mandatory component of this ingredient (see separate entry). Thujone is a mandatory component of this ingredient (see separate entry). Thujone is a mandatory component of this ingredient (see separate entry).
Salix daphnoides Salix discolor Salix fragilis Salix nigra
Salix purpurea
Page 245 of 305
Ingredient Salsola kali
Salix purpurea MIS Salvia chinensis Salvia fruticosa
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E
Restrictions
Salvia hispanica
Salvia hispanorium Salvia miltiorrhiza Salvia officinalis Salvia sclarea
Salvia lavandulaefolia
Sambucus canadensis Sambucus ebulus Sambucus nigra
Thujone is a mandatory component of this ingredient (see separate entry).
Sandalwood oil east indian Sanguinaria canadensis Sanicula europaea
Page 246 of 305
Ingredient
Santalum album
Use A, E A, E A, E A, E A, E E A, E A, E A A, E A, E A, E A, E A, E A, E
Restrictions Permitted only if the plant part is root or stem wood, the plant preparation is oil, and the route of administration is topical or inhalation.
Santalum spicatum Sapium sebiferum Sarcosine
Sapindus mukorossi
Saponaria officinalis
Sargassum fusiforme Sargassum tortile
Sarothamnus scoparius Sassafras albidum Satureia montana Satureia hortensis
Iodine is a mandatory component of this ingredient (see separate entry). Iodine is a mandatory component of this ingredient (see separate entry).
Sparteine is a mandatory component of this ingredient (see separate entry). Safrole is a mandatory component of this ingredient (see separate entry).
Sauropus changianus Saururus chinensis Saussurea costus
Sponsors must confirm the absence of aristolochic acids or herbal species known to contain these acids. Species listed on CITES if exporting or importing this product please contact the DSEWPC.
Page 247 of 305
Ingredient
Savory oil summer Scabiosa arvensis
Use A, E A, E A, E A, E A, E A, E A, E A, E A E C A, E A, E A
Restrictions
Saxifraga granulata
Schefflera octophylla Schinopsis lorentzii Schinus molle
Schizandra chinensis
Schizonepeta tenuifolia Scleranthus annuus Sclerotium gum
Schoenocaulon officinale
MRDD must contain 1 mg or less of the equivalent dry herbal material. Approved only in topical preparations for localised effect.
Scolopendrium vulgare Scopolia carniolica
Scopoletin (of Urtica dioica) Scrophularia ningpoensis Scrophularia nodosa
A, E A, E
Page 248 of 305
Ingredient
Scurrula gracilifolia Scutellaria barbata
Use A, E A, E A, E A, E C E
Restrictions
Scutellaria baicalensis Scutellaria lateriflora Sea whip extract Secale cereale Sedum acre Selenium
Scutellarin (of Scutellaria lateriflora)
A, E A, E A, E C
Selaginella tamarisciana
Gluten is a mandatory component of this ingredient when the plant part is seed and the route of administration is other than topical and mucosal (see separate entry).
Selenocysteine
Selenomethionine
A A
When the product is intended for oral use and contains organic selenium sources only, the MRDD must not provide more than 26 micrograms of selenium. When the product contains inorganic selenium sources only, the MRDD must not provide more than 52 micrograms of selenium. When the product contains both inorganic and organic selenium materials, the sum of the organic selenium expressed as micrograms and half of the inorganic selenium expressed in micrograms contained in the RDD must be 26 micrograms or less. Other than oral use, selenium is listable without restrictions. Requires the label statement SELE. Selenium is a mandatory component of this ingredient (see separate entry). Selenium is a mandatory component of this ingredient (see separate entry).
Page 249 of 305
Ingredient
Semecarpus anacardium Semolina
Use A, E E
Restrictions
If the plant part is other than seed, the MRDD must contain 1 mg or less of the equivalent dry herbal material. If the plant part is seed, it is listable without restriction. May be a native species if exporting this product please contact the DSEWPC.
Sempervivum tectorum Senega root dry Senega root powder
A, E A, E A, E A A A A A A C
Only Triticum aestivum and T. durum seed endosperm (grain starch) middlings dry or powder is permitted. May only be used as a food excipient refer to introduction for permitted preparations. May be a native species if exporting this product please contact the DSEWPC. May be a native species if exporting this product please contact the DSEWPC.
Senna fruit alexandrian dry Senna fruit tinnevelly dry Senna leaf dry Sennoside A
Senna fruit alexandrian powder Senna fruit tinnevelly powder Senna leaf powder
Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of this ingredient in oral preparations (see separate entry). Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of this ingredient in oral preparations (see separate entry). Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of this ingredient in oral preparations (see separate entry). Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of this ingredient in oral preparations (see separate entry). Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of this ingredient in oral preparations (see separate entry).
Page 250 of 305
Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of this ingredient in oral preparations (see separate entry).
Ingredient
Sennosides A and B
Use C C
Restrictions
Sennosides calculated as sennoside B (of Cassia) Sequoia sempervirens Serenoa repens Serine Sesame oil Sequoiadendron giganteum
A, E A, E A, E A, E A, E E C C A, E
Serenoa repens is the correct AAN and replaces the name Serenoa serrulata.
Sesame seed
Sesamum indicum
Sesquiterpene lactones calculated as alantolactone Sesquiterpene lactones calculated as parthenolide Setaria italica Shark-liver oil
Only Sesamum indicum seed is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
A, E A, E
Page 251 of 305
Ingredient
Shark cartilage Shea butter Shellac Shea butter unsaponifiables Shepherd's purse herb dry Sigesbeckia orientalis Siler divaricatum
Use A, E E E E
Restrictions
Requires the label statement SHARK. May be a native species if exporting this product please contact the DSEWPC. Approved only in topical preparations for localised effect.
Only Butyrospermum parkii seed fat is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Shepherd's purse herb powder
A, E A, E A, E A, E A, E E E E C C
Silica - colloidal anhydrous Silica dimethyl silylate Silica silylate Silicon Silver
Not permitted if the route of administration is inhalation. Approved for topical use only.
Siliceous earth - purified Silicon dioxide
A, E, C
Not permitted if the route of administration is inhalation. Concentration from all ingredients must not exceed 1%.
Page 252 of 305
Ingredient Silver beet Silybin
Use E E C C A, E A, E E A, E A, E A, E A, E A, E A, E A, E
Restrictions
Silver borosilicate Silybum marianum Silymarin Simaba cedron Simethicone Sinapis alba
Only Beta vulgaris leaf blade or leaf is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Approved for topical use only. Concentration must not exceed 0.6%. Silver is a mandatory component of this ingredient in topical preparations (see separate entry).
Simmondsia chinensis Sinapis arvensis
Sinomenium acutum Siratia grosvenorii
Allyl isothiocyanate is a mandatory component of this ingredient alba when the plant part is seed (see separate entry).
Siphonestegia chinensis Sisymbrium officinale
Page 253 of 305
Ingredient Sitosterol
Sisymbrium sophia
Use A, E C C
Restrictions
Sitosterol and sitosterol glycosides calculated as sitosterol (of Prunus Africana) Skipjack-liver oil Slippery elm bark dry
Slippery elm bark powder Smilax aristolochiifolia Smilax china Smilax glabra
A, E A, E A, E A, E A, E A, E A, E A, E A, E C E
Smilax medica Smilax ornata Sodium
Smilax officinalis
Sodium acetate
When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
Page 254 of 305
Ingredient
Sodium acetylated hyaluronate Sodium acid citrate Sodium acrylates copolymer
Use E E E E E E A, E E E E
Restrictions
Sodium acrylates/C10-30 alkyl acrylates crosspolymer Sodium alginate
When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved for topical use only. Concentration must not exceed 0.8%. PRV may only be used as an excipient in topical preparations. PRV may only be used as an excipient in topical preparations.
Sodium acrylate/acryloyldimethyl taurate copolymer Sodium ascorbate Sodium ascorbyl phosphate Sodium benzoate
When used as an active in oral or sublingual products, the label must include the statement VIT. If used as an active AND intended as a mineral supplementation, the equivalent quantity of sodium is required on the product label. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved for topical use only. Concentration must not exceed 5%.
Sodium ascorbyl/cholesteryl phosphate
Approved for topical use only. Concentration must not exceed 0.1% in primary sunscreen products and 0.5% in other products. Requires the label statement TBNZO8. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
Page 255 of 305
Ingredient
Sodium beta-hydroxy-betamethylbutyrate
Use A A E E E E E E E E E E
Restrictions
Sodium beta-hydroxy-betamethylbutyrate monohydrate Sodium bicarbonate Sodium bisulfite
Sodium beta-sitosterol sulfate
When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved for topical use only. Topical products require the label statement TOTBNZ. Approved for topical use only.
Sodium butyl hydroxybenzoate Sodium carbonate anhydrous
Sodium C14-16 olefin sulfonate Sodium carbonate monohydrate Sodium carboxymethyl dextran Sodium carrageenan
Requires the label statement SULF. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved for topical use only. Concentration must not exceed 0.005%. PRV may only be used as an excipient in topical preparations.
Sodium carboxymethyl betaglucan
Page 256 of 305
Ingredient
Sodium cetostearyl sulfate Sodium chloride
Use E
Restrictions
A, E E E E E E E E E E
Approved for topical use only. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
Sodium chondroitin sulfate Sodium citrate
If used as an active AND intended as a mineral supplementation, the equivalent quantity of sodium is required in the application and also on the product label. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved for topical use only. Concentration must not exceed 0.001%. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved for topical use only. Concentration must not exceed 0.05%. Approved for topical use only. Approved only in topical preparations for localised effect.
Sodium citrate anhydrous
Sodium coco PG-dimonium chloride phosphate Sodium cocoamphoacetate Sodium cocoyl sarcosinate Sodium cyclamate Sodium DNA Sodium dehydroacetate
When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved only in topical preparations for localised effect. Requires the label statement SDACET. Approved for topical use only. Concentration must not exceed 0.1%.
Page 257 of 305
Ingredient
Sodium dodecylbenzenesulfonate Sodium erythorbate Sodium ethyl hydroxybenzoate Sodium fumarate
Use E E E E
Restrictions
When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Topical products require the label statement TOTBNZ. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
Sodium glycerophosphate Sodium hyaluronate Sodium hydroxide
A, E E E E A
If used as an active AND intended as a mineral supplementation, the equivalent quantity of sodium is required on the product label. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved for topical use only. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Approved for topical use only.
Sodium hydrogenated tallow glutamate
Sodium hydroxycitrate
Concentration must not exceed 5%. In solid preparations, the pH of a 10 gm/L aqueous solution must not be more than 11.5. In liquid or semi-solid preparations, the pH of the preparation must not exceed 11.5. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
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Ingredient
Sodium hydroxyethyl acrylate/acryloyldimethyl taurate copolymer Sodium hydroxymethylglycinate Sodium hypochlorite Sodium lactate Sodium isostearoyl lactylate Sodium laureth sulfate
Restrictions Approved for topical use only. The concentration of Sodium hydroxyethyl acrylate/acryloyldimethyl taurate copolymer is not to exceed 1.5%. Approved only in topical preparations for localised effect. Approved for topical use only.
Chlorine is a mandatory component of this ingredient (see separate entry). When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. PRV may only be used as an excipient in topical preparations. Approved for topical use only.
Sodium lauroyl lactylate
Sodium lauroyl sarcosinate Sodium lauryl phosphate Sodium lauryl sulfate
Sodium lauryl sulfoacetate
When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved for topical use only.
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Sodium magnesium silicate
Ingredient
Sodium mannose phosphate Sodium metabisulfite Sodium methyl hydroxybenzoate Sodium monofluorophosphate Sodium myreth sulfate
Use E E E
Restrictions
Requires the label statement SULF. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Topical products require the label statement TOTBNZ. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Fluoride is a mandatory component of this ingredient (see separate entry). Approved only in pastes, powders or gels for the cleaning of teeth that contain at least one other Listable therapeutically active ingredient. Any claims in relation to the fluoride content from this ingredient are restricted to those relating to improvements in oral hygiene or the use of fluoride for the prevention of tooth decay.
A E E
Sodium myristoyl glutamate Sodium pantothenate Sodium PCA Sodium perborate
PRV may only be used as an excipient in topical preparations. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved for topical use only. Boron is a mandatory component of this ingredient (see separate entry).
A, E E A
Approved for topical use only. Concentration must not exceed 0.0164%. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
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Ingredient
Sodium percarbonate
Use E A, E
Restrictions
Sodium phosphate - dibasic
Sodium phosphate - dibasic anhydrous
A, E
In solid preparations, the pH of a 10 gm/L aqueous solution must not be more than 11.5. In liquid or semi-solid preparations, the pH of the preparation must not exceed 11.5. If used as an active AND intended as a mineral supplementation, the equivalent quantity of sodium is required on the product label. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. In solid preparations, the pH of a 10 gm/L aqueous solution must not be more than 11.5. In liquid or semi-solid preparations, the pH of the preparation must not exceed 11.5. If used as an active AND intended as a mineral supplementation, the equivalent quantity of sodium is required on the product label. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. In solid preparations, the pH of a 10 gm/L aqueous solution must not be more than 11.5. In liquid or semi-solid preparations, the pH of the preparation must not exceed 11.5. If used as an active AND intended as a mineral supplementation, the equivalent quantity of sodium is required on the product label. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
Sodium phosphate dibasic dihydrate
A, E
Sodium phosphate - dibasic dodecahydrate
A, E
In solid preparations, the pH of a 10 gm/L aqueous solution must not be more than 11.5. In liquid or semi-solid preparations, the pH of the preparation must not exceed 11.5. If used as an active AND intended as a mineral supplementation, the equivalent quantity of sodium is required on the product label. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
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Ingredient
Sodium phosphate - dibasic monohydrate Sodium phosphate - monobasic
Use A, E
Restrictions
A, E
Sodium phosphate - monobasic dihydrate Sodium phosphate - tribasic Sodium polyacrylate
E E E E E
In solid preparations, the pH of a 10 gm/L aqueous solution must not be more than 11.5. In liquid or semi-solid preparations, the pH of the preparation must not exceed 11.5. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
Sodium polyaspartate
In solid preparations, the pH of a 10 gm/L aqueous solution must not be more than 11.5. In liquid or semi-solid preparations, the pH of the preparation must not exceed 11.5. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved for topical use only. PRV may only be used as an excipient in topical preparations.
Sodium polymetaphosphate
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Ingredient
Sodium propionate
Use E E E E A A A E E E E
Restrictions
Sodium propyl hydroxybenzoate Sodium riboflavin phosphate Sodium RNA Sodium selenate Sodium selenite Sodium silicate
Topical preparations require the label statement SPROP. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Topical preparations require the label statement TOTBNZ. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved for topical use only. Concentration must not exceed 0.1%. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Selenium is a mandatory component of this ingredient (see separate entry). Selenium is a mandatory component of this ingredient (see separate entry).
Sodium selenite pentahydrate
Selenium is a mandatory component of this ingredient (see separate entry).
Sodium starch glycollate Sodium stearate
In solid preparations, the pH of a 10 gm/L aqueous solution must not be more than 11.5. In liquid or semi-solid preparations, the pH of the preparation must not exceed 11.5. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved for topical use only. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM.
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Sodium starch glycollate type A
Ingredient
Sodium stearoyl glutamate Sodium stearyl 2-lactylate Sodium succinate Sodium sulfate
Use E E E E
Restrictions
Sodium stearyl phthalamate
PRV may only be used as an excipient in topical preparations. Approved for topical use only. Approved for topical use only.
Sodium sulfate anhydrous Sodium sulfite anhydrous Sodium tripolyphosphate Solanidine Solanine
A, E E E E C C
If used as an active AND intended as a mineral supplementation, the equivalent quantity of sodium is required on the product label. When included in a product that is not intended to be a laxative the product requires the label statement LAX4. If used as an active AND intended as a mineral supplementation, the equivalent quantity of sodium is required on the product label. When included in a product that is not intended to be a laxative the product requires the label statement LAX4. Requires the label statement SULF. When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. Approved for topical use only. Requires the label statement SULF. Approved for topical and buccal use only. Concentration must not exceed 5%.
Sodium sulfite heptahydrate
Solanum dulcamara
Steroidal alkaloids calculated as solanine is a mandatory component of this ingredient in products for internal use (see separate entry).
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Ingredient
Solanum ferox
Use A, E E A, E A, E A, E A, E A, E A, E E E E E E
Restrictions
Solanum lycocarpum ICID2000 fruit ext.1:5 in 50% butylene glycol : water Solanum melongena Solanum nigrum Solanum tuberosum Solidago gigantea Solidago gigantea MIS Solidago virgaurea Solvent green 3 Solvent red 1
Steroidal alkaloids calculated as solanine is a mandatory component of this ingredient in products for internal use (see separate entry). Approved for topical use only. Concentration must not exceed 0.02%. Steroidal alkaloids calculated as solanine is a mandatory component of this ingredient in products for internal use (see separate entry). Steroidal alkaloids calculated as solanine is a mandatory component of this ingredient in products for internal use (see separate entry). Steroidal alkaloids calculated as solanine is a mandatory component of this ingredient in products for internal use (see separate entry).
Solvent violet 13
Colour permitted only in topical preparations. Colour permitted only in topical preparations. Colour permitted only in topical preparations. Colour permitted only in topical preparations.
Solvent yellow 172 Solvent yellow 33
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Ingredient
Sophora angustifolia Sophora japonica Sorbic acid
Use A, E A, E A, E E E E E E E E E E E E E
Restrictions
Sophora subprostrata Sorbitan isostearate
Sorbitan mono-oleate
Requires the label statement SORB8. Approved for topical use only.
Sorbitan monolaurate Sorbitan oleate
Sorbitan monostearate Sorbitan olivate
Sorbitan palmitate
PRV may only be used as an excipient in topical preparations. Approved for topical use only. Approved for topical use only.
Sorbitan sesquiisostearate Sorbitan sesquioleate Sorbitan stearate Sorbitan tristearate
Approved for topical use only. Concentration must not exceed 10%. Approved only in topical preparations for localised effect.

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Ingredient Sorbitol
Use
Sorbitol solution (70 per cent) (crystallising) Sorbus aucuparia Sorghum
A, E, C A, E A, E A, E A, E E A, E A, E A, E C E E E
Restrictions
When used as an active, this ingredient is only listable as an uncompounded BP substance. When the quantity of sugar alcohols per RDD exceeds 2 g, the quantity of the sugar alcohols must be declared on the label in addition to the label statement SUGOLS.
Sorbitol solution (70 per cent) (noncrystallising) Sorbus domestica
When used as an active, this ingredient is only listable as an uncompounded BP substance. Sorbitol is a mandatory component ot this ingredient (see separate entry). When used as an active, this ingredient is only listable as an uncompounded BP substance. Sorbitol is a mandatory component ot this ingredient (see separate entry).
Sorghum halepense Sorghum vulgare
Sorghum sudanense
Only Sorghum vulgare seed (grain) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Soy phosphatidylserine Soy polysaccharide Soy protein
Concentration must not exceed 15%.
Soy protein-hydrolysed
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Ingredient Soy sterol Soya bean Soya bran Soya oil
Use E E E E C A, E A, E A, E A, E A, E E A, E A A, E
Restrictions Only Glycine max seed (bean) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Soya oil - hydrogenated Sparteine
Only Glycine max seed (bean) husk or seed coat (bran) is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Sparganium stoloniferum Spartium junceum Spearmint oil
Spatholobus suberectus Sphingolipids
Concentration must not exceed 0.001%.
Spigelia anthelmia Spike lavender oil
Spigelia marilandica
Approved for topical use only. Concentration must not exceed 0.1%. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. MRDD must contain 1 mg or less of the equivalent dry herbal material.
Camphor is a mandatory component of this ingredient (see separate entry).

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Ingredient Spinach
Spilanthes acmella Spinacia oleracea Spirulina
Use A, E E A, E A, E E E
Restrictions Only Spinacia oleracea leaf blade or leaf is permitted. May only be used as a food excipient refer to introduction for permitted preparations. May be a native species if exporting this product please contact the DSEWPC.
Spirodela polyrrhiza
Squalane Squalene
Squill dry
Squill indian dry Squill powder
A, E, C A, E A, E A, E A, E A A
Only Arthrospira maxima and A. platensis cell (filament) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Iodine is a mandatory component of this ingredient (see separate entry). May be a native species if exporting this product please contact the DSEWPC. Spirulina maxima is not a valid name. Approved for topical use only.
Squill indian powder
St John's Wort herb dry
St John's Wort herb powder
Preparations for oral ingestion containing this ingredient as a herbal ingredient or a mother tincture require the label statement STJOHN. Preparations for oral ingestion containing this ingredient as a herbal ingredient or a mother tincture require the label statement STJOHN.
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Ingredient
Stachybotrys chartarum Stachys palustris Stannic oxide Stachyurus himalaicus
Use A, E A, E A, E E E E E
Restrictions
Starch - acid treated waxy maize Starch - gluten-free wheat Starch - hydrolysed maize Starch - maize
Starch - maize high amylose Starch - oxidised tapioca Starch - potato
A, E A, E E E E E E E E
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Starch - pregelatinised maize
Starch - pregelatinised potato Starch - pregelatinised wheat Starch - rice Starch - soluble maize
Ingredient
Starch - soluble potato Starch - tapioca Starch - wheat
Restrictions
Starch modified - potato Stearalkonium chloride Stearamide
Starch sodium octenyl succinate Stearalkonium hectorite
Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry). PRV may only be used as an excipient in topical preparations. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Stearamidoethyl diethylamine
Stearamidopropyl dimethylamine Stearamidopropyl PG-dimonium chloride phosphate Steareth-10 Steareth-2 Steareth-100 Steareth-20
Approved only in topical preparations for localised effect. Concentration must not exceed 2%. Requires the label statement EYE2. Approved for topical use only. Concentration must not exceed 1.5%. Approved for topical use only.
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Ingredient Steareth-5
Steareth-21 Stearic acid
Restrictions
Stearoxy dimethicone
Stearoxytrimethylsilane Stearyl acetate
Stearoyl macrogolglycerides Stearyl alcohol
Approved for topical use only. Concentration must not exceed 4%. Approved only in topical preparations for localised effect. Approved for topical use only.
Can only be used as an excipient in oral products. Concentration must not exceed 0.6%.
Stearyl dimethicone Stearyl heptanoate Stearyl stearate
Stearyl glycyrrhetinate
Approved only in topical preparations for localised effect. Concentration must not exceed 4.5%. Requires the label statements EYE and EYE2. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Stellaria chamaejasme Stellaria dichotoma Stellaria media
A, E A, E A, E
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Ingredient
Stemona japonica
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E C C A, E
Restrictions
Stemona sessilifolia (sessifolia is invalid) Stemphylium botryosum Stemphylium solani Stephania tetranda Sterculia
Stenotaphrum secundum
Sterculia platanifolia Sterculia scaphigera Sterculia urens
Sterculia tragacantha
Steroidal alkaloids calculated as solanine Stevia rebaudiana
Stevioside (of Stevia rebaudiana
Can only be used as a component and is not listable in its own right. MRDD must provide 10 mg or less.
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Ingredient
Stillingia sylvatica Storax prepared
Use A, E A, E A A E A A A
Restrictions
Stramonium leaf dry Strawberry
Stramonium leaf powder Streptococcus thermophilus Strophanthus hispidus Strychnos nux-vomica Styrax benzoin
Alkaloids calculated as hyoscyamine is a mandatory component of this ingredient (see separate entry). Alkaloids calculated as hyoscyamine is a mandatory component of this ingredient (see separate entry). Only Fragaria X ananassa, F. chiloensis, F. vesca, F. virginiana and hybrids fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Styrax paralleloneurus Styrax tonkinensis Succinic acid Sucralose
Styrene/acrylates copolymer
Page 274 of 305
Ingredient Sucrose
Use E, C E E E E E E E E E E
Restrictions
Sucrose cocoate Sucrose laurate
Sucrose distearate Sucrose octaacetate Sucrose palmitate Sucrose stearate Sudan III Sucrose polycottonseedate
When used as an excipient in oral products and the total amount of all sugars (glucose, invert sugar, lactose, maltose, and sucrose) exceeds 100 mg in the MDD of the product, the label requires the statement SUGARS. If one of the sugars is lactose the label also requires the statement LACT. Approved for topical use only. Concentration must not exceed 2%. Approved for topical use only. Sucrose is a mandatory component of this ingredient in oral and sublingual products (see separate entry).
Sucrose is a mandatory component of this ingredient in oral and sublingual products (see separate entry). Approved for topical use only. Sucrose is a mandatory component of this ingredient in oral and sublingual products (see separate entry). Approved for topical use only. Concentration must not exceed 0.25%. Colour permitted only in topical preparations.
Sucrose is a mandatory component of this ingredient in oral and sublingual products (see separate entry). Approved for topical use only. Concentration must not exceed 1%. Requires the label statements EYE and EYE2.
Sugar cane wax alcohols Sugarcane Sulfan blue
MRDD must not contain more than 12 mg. Requires the label statement PREGNT. Colour permitted only in topical preparations.
Only Saccharum officinarum stem (canes) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Sucrose is a mandatory component of this ingredient when used in oral and sublingual products (see separate entry).
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Ingredient
Sulfur dioxide
Use E A A E E E E E E C A, E A, E A, E
Restrictions
Sulisobenzone Sunflower oil
Sulisobenzone sodium Sunflower seed
Requires the label statement SULF.
A, E
Sunscreen active permitted only in topical products. Concentration must not exceed 10%. Sunscreen active permitted only in topical products.
Sunset yellow FCF
Sunset yellow FCF aluminium lake Superoxide dismutase Swede Sweet potato
Only Helianthus annuus seed is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Only Brassica napus var. napobrassica root is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Swertia chirata Swertiamarin
Only Ipomoea batatas tuberous root is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Swietenia mahogani
Symplocarpus foetidus
Page 276 of 305
Ingredient
Syncephalastrum racemosum Syringa reticulata Syringa vulgaris
Use A, E A, E A, E C C C
Restrictions
Syringaresinol diglucoside Syringin
Syringaresinol diglucosides (of Eleutherococcus senticosus) Syzygium aromaticum
A, E
Tabebuia avellanedae
Tabebuia heptophylla Tabebuia ipe
Tabebuia impetiginosa Tabebuia serratifolia Tagetes erecta
Permitted without restriction in preparations containing 25% or less of clove oil. When the concentration of clove oil is greater than 25% and the nominal capacity of the container is 15 mL or less, a RFI must be fitted on the container and the label must include the statements CHILD and NTAKEN. When the concentration of clove oil is greater than 25% and the nominal capacity of the container is greater than 15 mL but less than or equal to 25 mL, a CRC and RFI must be fitted on the container and the label must include the statements CHILD and NTAKEN.
Page 277 of 305
Ingredient
Tagetes minuta Talc - purified Tallow
Use A, E E E E E
Restrictions
Tallow glycerides Tamarix aphylla Tamarix gallica
Tallow glycerides-hydrogenated Tamarix chinensis Tamus communis
Approved for topical use only, If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Approved for topical use only. Concentration must not to exceed 3%.
A, E A, E A, E A, E A, E A, E A, E A, E E A, E
Tanacetum cineriifolium Tanacetum parthenium Tanacetum vulgare Tannic acid
If the plant part is fruit and root, the MRDD must contain 1 mg or less of the equivalent dry fruit and dry root. Plant parts other than root or fruit are listable without restriction.
Tangerine oil coldpressed Taraxacum mongolicum
Oil (of Tanacetum vulgare) is a mandatory component of this ingredient (see separate entry). Approved for topical use only as an excipient.
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Ingredient Taro
Taraxacum officinale Tarragon oil Tartrazine Taurine
Use A, E E E E C A, E
Restrictions Only Colocasia esculenta corm and tubers is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Tartaric acid
Taxifolin (of Pinus pinaster) Taxodium distichum TEA-lauryl sulfate TEA-stearate
A, E A, E E E
Approved for topical use only. Requires the label statement TART.
Terminalia catappa Terminalia chebula
Terminalia ferdinandiana Terpene resin - synthetic Terpineol
A, E A, E A E
A, E
Permitted only when the ingredient is the fruit flesh dry or aqueous extractions of the fruit flesh. Approved for topical use only.
Page 279 of 305
Ingredient
Tert-Butyl alcohol
Use E A, E A, E C E E E E E
Restrictions
Tetraclinis articulata
Tetracoccosporium paxianum Tetrahexyldecyl ascorbate
Tetracyclic oxindole alkaloids (of Uncaria tomentosa) Tetrahydrodiferuloylmethane Tetrapanax papyrifera
Tetrahydroxypropyl ethylenediamine Tetrasodium etidronate Teucrium chamaedrys Teucrium marum Teucrium scorodonia Thapsia garganica Thaumatin
Approved for topical use only. Concentration must not exceed 1%. Approved for topical use only. Approved for topical use only.
Tetrasodium pyrophosphate
A, E
A A A E
When used as an excipient in oral or sublingual products and the total amount of sodium from all ingredients in the MDD exceeds 120 mg, the product requires the label statement SODIUM. MRDD must contain 1 mg or less of the equivalent dry herbal material. MRDD must contain 1 mg or less of the equivalent dry herbal material. MRDD must contain 1 mg or less of the equivalent dry herbal material.
A, E
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Ingredient
Theanine (of Camellia sinensis) Themeda australis Theobroma cacao Theobroma oil
Use C A, E A, E A, E A, E E
Restrictions May be a native species if exporting this product please contact the DSEWPC.
Theobroma prepared Thiamine
Thermus thermophilyus concentrate Thiamine hydrochloride Thiamine nitrate
A, E, C A, E A, E A A E A, E A, E A, E
When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an active in oral or sublingual products, the label must include the statement VIT. Approved for topical use only. Concentration must not exceed 0.02%.
Thiamine phosphate acid ester chloride dihydrate Thiotaurine Threonine
Thiamine phosphoric acid ester chloride Thlaspi arvense
Thuja occidentalis
Page 281 of 305
Ingredient Thujone
Thuja plicata
Use A, E C
Restrictions Can only be used as a component and it is not listable in its own right. Permitted without restriction in preparations containing 4% or less. When the concentration is greater than 4%, the nominal capacity of the container must be 15 mL or less, a CRC and RFI must be fitted on the container and the label must include the statements CHILD and NTAKEN.
Thyme herb dry Thyme oil Thymol
A, E A, E A, E A, E A, E A, E A, E A, E A, E A, C
Permitted without restriction in preparations containing 50% or less. When the concentration is greater than 50%, the nominal capacity of the container must be 25 mL or less, a RFI must be fitted on the container and the label must include the statement CHILD. When used as an active, permitted only in Medicated Space Sprays or Medicated Throat Lozenges. Topical products containing thymol as an excipient require the label statement THYMOL. As per Thymus capitatus (see above). As per Thymus capitatus (see above). As per Thymus capitatus (see above). As per Thymus capitatus (see above). As per Thymus capitatus (see above). Permitted without restriction in preparations containing 50% or less of thyme oil. When the concentration of thyme oil is more than 50%, the nominal capacity of the container must be 25 mL or less, a RFI must be fitted on the container and the label must include the statement CHILD.
Thymus capitatus
Thymus mastichina Thymus serpyllum Thymus vulgaris Thymus zygis Tilactase
Thymus vulgaris mis
Permitted only when derived from Aspergillus oryzae.
Page 282 of 305
Ingredient
Tilia cordata
Use A, E A, E A, E A, E A, E A, E A, E E E
Restrictions
Tilia platyphyllos Tilia tomentosa Tilia x vulgaris
Tinospora cagillipes Tinospora sinensis Titanium dioxide Tococysteamide Tocofersolan
Not to be used in topical products intended for use in the eye. Concentration in topical products must not exceed 25%. For Sunscreen products only. Approved for topical use only. Concentration must not exceed 0.01%. Approved for topical use only. Concentration must not exceed 0.1%.
Tocopherols concentrate - mixed (high-alpha type) Tocopheryl linoleate Tocoquinone
Tocopherols concentrate - mixed (lowalpha type) Tocopheryl nicotinate
A, E A, E E E E
When used as an active in oral or sublingual products, the label must include the statement VIT. When used as an active in oral or sublingual products, the label must include the statement VIT. Approved for topical use only. Approved for topical use only. Concentration must not exceed 0.1%. PRV may only be used as an excipient in topical preparations.
Page 283 of 305
Ingredient
Tocotrienols complex - palm Tolu balsam Toluene Tomato
Use A E E E A, E
Restrictions
Concentration must not exceed 0.089%. Residual solvent limit is 8.9 mg per MDD. PRV may only be used as an excipient in topical preparations.
Tourmaline
Toxicodendron radicans Tragacanth
Trachelospermum jasminoides Trametes versicolor Transglutaminase Treacle
Only Solanum lycopersicum fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations. RDD must contain 10 mg or less of steroidal alkaloids including solanine, solaneine and solanidine. MRDD must contain 1 mg or less of the equivalent dry herbal material.
A, E A, E A A E E E A, E
Trametes versicolor proteoglycan concentrate
Trametes versicolor hyphae dry extract must only be prepared using water. May only be used in oral preparations. PRV may only be used as an excipient in topical preparations. Approved for topical use only.
Trehalose dihydrate Tremella fuciformis
Sucrose is a mandatory component of this ingredient in oral and sublingual products (see separate entry).
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Ingredient Tribehenin Tribehenin PEG-20 esters Tribulus terrestris Tricaprylin Tricaprylyl citrate
Use E E E E E
Restrictions
A, E
Approved for topical use only. Concentration must not exceed 6%. Approved for topical use only. Concentration must not exceed 5%. Approved for topical use only. Concentration must not exceed 7%. Approved for topical use only.
Triceteareth-4 phosphate Trichoderma viride Trichosanthes kirilowii Trichothecium roseum Triclosan Tricontanyl PVP
A, E A, E A, E E E E E E E
Trideceth-4 phosphate Tridecyl behenate Tridecyl neopentanoate Tridecyl salicylate
Approved only in topical preparations for localised effect. Concentration must not exceed 1%. Requires the label statement TRICLO. Approved for topical use only. Approved for topical use only.
Approved for topical use only. Behenic acid is a mandatory component of this ingredient (see separate entry). Approved for topical use only. Concentration must not exceed 23%. Approved for topical use only. Concentration must not exceed 5%.
Page 285 of 305
Ingredient
Tridecyl stearate Triethanolamine
Use E E E E E E E E E A, E A, E A, E E E
Restrictions
Tridecyl trimellitate
Approved only in topical preparations for localised effect. Approved only in topical preparations for localised effect.
Triethanolamine carbomer Triethanolamine salicylate Triethoxycaprylylsilane Triethyl citrate Triethylene glycol
Triethanolamine lauryl sulfate
Sunscreen active permitted only in topical products. Concentration must not exceed 12%. Approved for topical use only. Concentration must not exceed 0.22%.
Trifluoromethyl c1-4 alkyl dimethicone Trifolium pratense Trifolium repens
Trigonella foenum-graecum Trihydroxystearin
Trihydroxypalmitamidohydroxypropyl myristyl ether
Page 286 of 305
Ingredient
Triisocetyl citrate Triisononanoin Triisostearin Trilaurin
Restrictions
Triisodecyl trimellitate
Approved for topical use only. Concentration must not exceed 5%. Approved for topical use only. Concentration must not exceed 5%. Approved only in topical preparations for localised effect. Approved for topical use only. PRV may only be used as an excipient in topical preparations.
Trilaureth-4 phosphate Trillium erectum
Trimethoxycaprylyl silane Trimethylolpropane tricaprylate/tricaprate Trimethylopropane trioctanoate Trimethylpentanediol/adipic acid/glycerin crosspolymer Trimethylsiloxysilicate Trioctanoin Trioctyldodecyl citrate
A, E
Approved for topical use only. Concentration must not exceed 0.25%. PRV may only be used as an excipient in topical preparations. Approved for topical use only. Approved for topical use only. Approved for topical use only.
Triosteum perfoliatum
A, E
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Ingredient
Trioxaundecanedioic acid Trisodium edetate Trisodium NTA Tristearin
Use E E E E E C C
Restrictions
Trisodium ethylenediamine disuccinate
Triterpene glycosides calc 27desoxyactein (of Cimicifugia racemosa) Triticum aestivum Triticum durum Triundecanoin Trometamol
Triterpenes: asiaticoside, asiatic acid and madecassic acid (of Centella asiatica)
A, E A, E E E A, E
Gluten is a mandatory component of this ingredient when plant part is seed and the route of administration is other than topical and mucosal (see separate entry). Gluten is a mandatory component of this ingredient when plant part is seed and the route of administration is other than topical and mucosal (see separate entry). PRV may only be used as an excipient in topical preparations.
Trollius chinensis
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Ingredient
Trometamol hydrochloride Tropaeolum majus Troxerutin Tsuga canadensis Tulipa edulis Turnip Turnera diffusa Turpentine oil
Use E C A, E A, E A, E A, E E A, E A, E A, E A, E A, E A, E A, E
Restrictions
Colchicine is a mandatory component of this ingredient (see separate entry).
Typha angustifolia Typha latifolia Tyrosine
Only Brassica rapa root is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Concentration must not exceed 25%.
Typhonium giganteum Ubidecarenone
Ulex europaeus
Approved for topical use only when present as an excipient. Must not be used in topical products intended for use in the eye. MRDD must not contain more than 150 mg. Concentration must not exceed 0.05%. Requires the label statement WARF.
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Ingredient
Ulmus americana Ulmus glabra
Use A, E A, E A, E A, E A, E A, E A, E E A, E A, E A, E A, E A, E A E
Restrictions
Ulmus campestris Ulmus parvifolia Ulmus procera Ulmus pumila Ulmus rubra Ulva lactuca
Ultramarine blue Uncaria gambir
Uncaria rhyncophylla Uncaria sinensis Uncaria tomentosa Undecenoic acid
Approved for topical use only (blade of plant/liquid extract concentration). Concentration must not exceed 0.1%. Iodine is a mandatory component of this ingredient (see separate entry). May be a native species if exporting this product please contact the DSEWPC.
Undaria pinnatifida
Permitted only in oral products. The plant part must not contain the holdfast. Approved for topical use only.
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Ingredient
Undecylenamide dea Urea
Use E E E
Restrictions
Undecylenoyl peg-5 paraben Urtica dioica Urtica urens
Usnea barbata
A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E C
Uva ursi leaf dry
Uva ursi leaf powder Vaccaria segatalis
Vaccinium bracteatum
Vaccinium macrocarpon Vaccinium myrtilloides Vaccinium myrtillus Vaccinium oxycoccus Valerenic acid
Vaccinium vitis-idaea
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Ingredient
Valerenic acids calc hydroxy/acetoxyvalerenic acid & valerenic acid Valerian dry Valerian powder Valeriana edulis
Use C
Restrictions
A, E A, E A, E A, E A, E C A, E A, E A, E A, E A, E E E E
Valeriana officinalis Valeriana sorbifolia Valeric acid Valine Vanilla dry
Vanilla planifolia Vanilla powder Vanillin
Vanilla tahitensis Vat red 1 Vat red 5
Species listed on CITES if exporting or importing this product please contact the DSEWPC. Species listed on CITES if exporting or importing this product please contact the DSEWPC. Colour permitted only in topical preparations. Colour permitted only in topical preparations.
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Ingredient
Vegetable oil
Use E E E C
Restrictions
Vegetable oil - hydrogenated Veratrum album
Vegetable protein - hydrolysed
Verbascoside (of Olea europaea) Verbascum densiflorum Verbascum thapsus Verbena officinalis
A, E A A, E A, E A, E A, E A, E A, E A, E A, E A, E
Veronica chamaedrys Veronica officinalis
Veronicastrum virginicum Verticillium albo-atrum Vetiveria zizanioides Viburnum opulus Vicia faba
Viburnum prunifolium
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Ingredient Vinblastine
Vigna radiata Vinca major Vincamine
Use A, E C A, E A, E C C C C C A, E
Restrictions Concentration must not exceed 10 mg/kg or 10 mg/L or 0.001%.
Vinca minor
Vincamine is a mandatory component of this ingredient (see separate entry). Concentration must not exceed 10 mg/kg or 10 mg/L or 0.001%.
Vincetoxicum officinale Vincristine Vindesine
Vincamine and Vincristine are mandatory components of this ingredient (see separate entries).
Vinorelbine
Vinyl acetate
Vinyldithiins (of Allium sativum) Viola odorata Viola tricolor
Concentration must not exceed 10 mg/kg or 10 mg/L or 0.001%. Concentration must not exceed 10 mg/kg or 10 mg/L or 0.001%. Approved for topical use only.
Viola yedoensis Viscum album
Viscum coloratum
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Ingredient Vitamin A
Viscum flavescens
Use A, E C
Restrictions Permitted as a component only. Listable as an active as Retinol, Retinyl acetate and Retinyl palmitate (see separate entries). Concentration in topical products must not exceed 1%. Products for internal use must not exceed 5000 IU in the MRDD and require the coded label statement VIT (see introduction). Products for internal use containing between 100 IU and 5000 IU in the MRDD and that are labelled for adult use require the coded label statements VITA1 and VITA2 (see introduction).
Vitex agnus-castus Vitex negundo Vitex trifolia Vitex rotundifolia
A, E A, E A, E A, E C A, E E E C C
Vitexin-2-rhamnoside Vitis vinifera
Vitreoscilla concentrate
Voandenzeia subterranea seed aqueous extract ICID 2004 Volatile oil components (of Chenopodium ambrosioides)
Volatile oil components (of Armoracia rusticana)
Can only be used as a component and it is not listable in its own right. MRDD must provide 20 mg or less. Can only be used as a component and it is not listable in its own right. MRDD must provide 10 mg or less.
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Ingredient
Volatile oil components (of Mentha pulegium) Wahlenbergia gracilis Walnut Walnut oil
Use C C
Restrictions
Volatile oil components (of Peumus boldus)
In topical products, the MRDD may only provide 150 mg or less of pennyroyal oil. In products other than topical, the MRDD may only provide 50 mg or less of pennyroyal oil.
A, E E E E E E E E E E
Can only be used as a component and it is not listable in its own right. MRDD must provide 100 mg or less. Only Juglans cinerea, J. nigra and J. regia seed (nut kernel) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Only Juglans cinerea, J. nigra and J. regia seed (nut kernel) oil fixed is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Water - potable Water melon
Water - purified Wax - emulsifying Wax - synthetic Wheat
Wax - microcrystalline
Only Citrullus vulgaris fruit or fruit flesh is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Approved for topical use only. Approved for topical use only.
Only Triticum aestivum and T. durum seed (grain) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry).
Page 296 of 305
Ingredient
Wheat bran Wheat germ Wheat germ glycerides Wheat germ protein Wheat leaf Wheat protein Wheat sprout
Use E E E E E E E E A, E
Restrictions
Only Triticum aestivum and T. durum seed (grain) husk or seed coat (bran) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry). Only Triticum aestivum and T. durum seed (grain) embryo (germ) is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry). PRV may only be used as an excipient in topical preparations. PRV may only be used as an excipient in topical preparations.
Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry). Only Triticum aestivum and T. durum leaf or herb is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Wheat protein - hydrolysed
Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry). Only Triticum aestivum and T. durum seed (grain) sprout is permitted. May only be used as a food excipient refer to introduction for permitted preparations. Gluten is a mandatory component of this ingredient when the route of administration is other than topical and mucosal (see separate entry).
Wheatgerm oil
Page 297 of 305
Ingredient
Whey powder Whey protein
Use E E
Restrictions
Lactose is a mandatory component of this ingredient in oral products (see separate entry). If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. Lactose is a mandatory component of this ingredient in oral products (see separate entry). If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL.
White horehound herb dry Wikstroemia viridifolia Wild carrot herb dry
White horehound herb powder
A, E A, E A, E A, E A, E A A A A E
Wild carrot herb powder Wild cherry bark dry Wild lettuce leaf dry Wine - fortified
Wild cherry bark powder Wild lettuce leaf powder Wintergreen oil
Withania somnifera
A, E A, E
Ethanol is a mandatory component of this ingredient (see separate entry).

Page 298 of 305
Ingredient
Withanolides (of Withania somnifera) Wool alcohols Wool fat
Use C E
Restrictions Approved for topical use only. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL.
Wool fat - hydrous Xanthan gum Xanthium sibiricum
A, E A, E E A, E A, E A, E C A, E E E E
If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. For Uncompounded BP Substances. If derived from Bovine, Deer, Goat, or Sheep from BSE High Risk Countries, this ingredient requires pre-clearance from TGAL. For Uncompounded BP Substances.
Xanthium strumarium Xanthophyll Xylene Xylitol Xylose
Xanthomona campestris
Xerophyllum asphodeloides
Concentration must not exceed 0.217%. Residual solvent limit is 21.7 mg per MDD. Approved for topical use only.
When the quantity of sugar alcohols per recommended daily dose exceeds 2 g, the quantity of the sugar alcohols must be declared on the label in addition to the label statement SUGOLS. Customs Prohibited Import requires an import permit/licence.
Page 299 of 305
Ingredient Yam
Use E
Restrictions
Yarrow herb dry
Yarrow herb powder
Yeast - high chromium Yeast - high selenium Yeast - hydrolysed Yeast dried Yellow 2G
A, E A, E A, E A, E A E E C
Only Dioscorea japonica and D. opposita tuber/tuberous root is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Yeast - high molybdenum
Chromium is a mandatory component of this ingredient (see separate entry). Selenium is a mandatory component of this ingredient (see separate entry). PRV may only be used as an excipient in topical preparations. Colour permitted only in topical preparations.
Molybdenum is a mandatory component of this ingredient. The MDD of molybdenum from yeast high molybdenum must not exceed 62.5 micrograms.
Ylang ylang oil Yohimbine Yucca baccata Yucca elata
Concentration must not exceed 10 mg/kg or 10 mg/L or 0.001%. Customs Prohibited Import requires an import permit/licence.
Yucca filamentosa
Page 300 of 305
Ingredient
Yucca gloriosa
Use A, E A, E A, E A, E A, E A, E A, E A, E A, E A, E E C
Restrictions
Yucca whipplei
Zanthoxylum americanum Zanthoxylum bungeanum Zanthoxylum nitidum
Zanthoxylum clava-herculis Zanthoxylum piperitum Zanthoxylum simulans Zea mays Zein Zinc Zeaxanthin
Zanthoxylum schinifolium
A, E, C
Zinc amino acid chelate Zinc ascorbate
A, E A, E
For internal use, the MRDD must not provide more than 50 mg. For internal use, if the MRDD provides more than 25 mg but less than or equal to 50 mg of zinc, the product requires the label statement ZINC. When used internally, zinc is a mandatory component of this ingredient (see separate entry). Zinc is a mandatory component of this ingredient (see separate entry).
Page 301 of 305
Ingredient
Zinc chloride Zinc citrate Zinc citrate dihydrate Zinc gluconate Zinc lactate Zinc oxide Zinc myristate
Use A, E A, E A, E A, E A, E E E E E E
Restrictions
Concentration must not exceed 5%. Zinc is a mandatory component of this ingredient (see separate entry). Zinc is a mandatory component of this ingredient (see separate entry). Zinc is a mandatory component of this ingredient (see separate entry). Zinc is a mandatory component of this ingredient (see separate entry). Approved for topical use only. Concentration must not exceed 2%. Approved for topical use only. Concentration must not exceed 0.1%. Zinc is a mandatory component of this ingredient (see separate entry).
Zinc citrate trihydrate
Zinc para-phenolsulfonate Zinc ricinoleate Zinc stearate Zinc sulfate Zinc succinate
A, E
Zinc is a mandatory component of this ingredient (see separate entry). PRV may only be used as an excipient in topical preparations. Approved for topical use only.
Approved for topical use only. Concentration must not exceed 5%. Zinc is a mandatory component of this ingredient (see separate entry).
A, E A, E A, E
Zinc is a mandatory component of this ingredient (see separate entry). Zinc is a mandatory component of this ingredient (see separate entry).
Zinc sulfate hexahydrate
Concentration must not exceed 5%. Zinc is a mandatory component of this ingredient (see separate entry).
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Ingredient
Zinc sulfate monohydrate Zingiber officinale Zizyphus jujuba Zizyphus sativa Zostera marina Zucchini
Use A, E A, E A, E A, E A, E A, E E
Restrictions
Concentration must not exceed 5%. Zinc is a mandatory component of this ingredient (see separate entry).
When the extraction ratio is 25:1 or higher AND the equivalent dry weight per dosage unit is 2 g or higher this ingredient requires the label statement GINGER.
Zizyphus spinosa
Ingredient Use: A = active; E = excipient; C = component.
Only Cucurbita pepo var. melopepo cv. zucchini fruit is permitted. May only be used as a food excipient refer to introduction for permitted preparations.
Page 303 of 305
Abbreviations:
BP British Pharmacopoeia
BSE
CITES CRC
Bovine Spongiform Encephalopathy Child Resistant Closure Maximum Daily Dose
DSEWPC MDD PRV RFI MRDD RDD
Convention on International Trade in Endangered Species of Wild Flora and Fauna Department of Sustainability, Environment, Water, Population and Communities: http://www.environment.gov.au/biodiversity/trade-use/cites/index.html Maximum Recommended Daily Dose Recommended Daily Dose Restricted Flow Insert
Provisional Ingredient For further information on conditions related to PRVs, refer to the Australian Regulatory Guidelines for OTC Medicines: http://www.tga.gov.au/industry/otc-argom.htm
SUSMP TGAL
Standard for the Uniform Scheduling of Medicines and Poisons Therapeutic Goods Administration Laboratories
Page 304 of 305
PO Box 100 Woden ACT 2606 Australia Email: info@tga.gov.au Phone: 02 6232 8444 Fax: 02 6232 8605 www.tga.gov.au

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Substances that may be used in Listed medicines in Australia

Therapeutic Goods Administration

About the Therapeutic Goods Administration (TGA)

Copyright Commonwealth of Australia 2011

Substances that may be used in Listed medicines in Australia December 2007

Therapeutic Goods Administration

Substances that may be used in Listed medicines in Australia

Substances that may be used in Listed medicines in Australia December 2007

Therapeutic Goods Administration

1-Methylheptyl isostearate 1,1,1-Trichloroethane 1,2-Hexanediol 1,3-Butylene glycol 2-Ethoxyethanol

Approved for topical use only.

PRV may only be used as an excipient in topical preparations.

Substances that may be used in Listed medicines in Australia December 2007

Therapeutic Goods Administration

Abrus cantoniensis Absidia ramosa Acacia Abutilon avicennae Acacia arabica

Acacia baileyana Acacia catechu Acacia dealbata Acacia senegal

Acacia longifolia Acalypha indica

Acanthopanax gracilistylus Acanthus mollis

Substances that may be used in Listed medicines in Australia December 2007

Acemannan (of Aloe barbadensis)

Therapeutic Goods Administration

Acer campestre Acer negundo

Acer saccharinum Acer saccharum Acerola

Acesulfame potassium Acetanisole Acetic acid

Acetic acid glacial Acetone

Acetomenaphthone Acetyl dipeptide-1 cetyl ester Acetyl glucosamine Acetyl hexapeptide-3

Substances that may be used in Listed medicines in Australia December 2007

Therapeutic Goods Administration

Acetyl trifluoromethylphenyl valylglycine Acetylated lanolin Acetylated lanolin alcohol Acetylcysteine

Acetyllevocarnitine hydrochloride Achillea millefolium Achillea moschata Achillea ptarmica

Achyranthes aspera Achyranthes fauriei Acid green 25 Acid red 33

Substances that may be used in Listed medicines in Australia December 2007

Colour permitted only in topical preparations.

Colour permitted only in topical preparations.

Therapeutic Goods Administration

Aconitum kusnezoffi Aconitum napellus Acrylamide

Acrothecium arenarium Acrylamides copolymer Acrylates copolymer

Acrylates/C12-22 alkyl methacrylate copolymer Acrylates/dimethicone copolymer

Substances that may be used in Listed medicines in Australia December 2007

Therapeutic Goods Administration

Acrylates/octylacrylamide copolymer Acrylates/steareth-20 methacrylate copolymer Actaea pachypoda Actaea spicata

Approved for topical use only.

Ademetionine disulfate ditosylate dihydrate Ademetionine disulfate tosylate

Ademetionine disulfate tritosylate dihydrate

Ademetionine hexasulfate dihydrate

Ademetionine hexatosylate dihydrate Ademetionine pentasulfate dihydrate Ademetionine tetrasulfate dihydrate

Ademetionine pentatosylate dihydrate Ademetionine tetratosylate dihydrate

Substances that may be used in Listed medicines in Australia December 2007

Therapeutic Goods Administration

(S)-S-Adenosylmethionine is a mandatory component of this ingredient (see separate entry).

Adenosine triphosphate Adhatoda vasica Adipic acid

Adenosine triphosphate disodium Adiantum capillus veneris

Adipic acid/diethylene glycol/glycerin crosspolymer Adonis vernalis Adzuki bean

Substances that may be used in Listed medicines in Australia December 2007

Therapeutic Goods Administration

Aesculus chinensis Aesculus glabra

Agrimonia eupatoria Agrimonia repens Agrostis tenuis Agropyron repens

Ailanthus altissima Ajuga chamaepitys Ajuga reptans

Substances that may be used in Listed medicines in Australia December 2007

Therapeutic Goods Administration

Ajuga turkestanica whole plant extract Alantolactone

Alaria esculenta Albizia lebbek Albumen