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For web pubplication - was appendix 22 of ARGPM - Colours permitted in medicines for oral use
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Colourings used in medicines for oral
use
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This guidance relates to:
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
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Why are colourings used in medicines for oral use
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
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Colourings that do not require evaluation
1
colourings in medicines for oral use that do not require evaluation of data by the TGA
the information required to evaluate a colouring that is not in the published list of
permitted colours.
Explains the purpose of colourings in medicines for oral use.
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
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Compliance with monographs and other standards for colourings
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The data requirements for new colourings
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
Provides links to the list of colourings that do not require evaluation by the TGA.
Identifies the Standards that apply to colourings
provides guidance on what to do if a Standard does not exist or the colouring does not
comply with the applicable Standard.
Provides guidance on the quality, nonclinical and clinical data requirements for colouring
that require evaluation.
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Why are colourings used in medicines for oral
use
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Colourings are inactive substances that may be used in oral formulations of medicines, for
various reasons such as:
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to distinguish between strengths, indications or markings
to assist with identifying the medicine
to distinguish between other medicines.
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Colourings that do not require evaluation
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Table 1 lists the colours permitted in medicines for oral use that do not generally require
toxicology data to be submitted to the TGA when used in an oral medicine.
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Equivalents of the colours in Table 1 (such as the aluminium and calcium lakes [salts] of these
substances) are also acceptable and do not require evaluation of data by the TGA.
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The synthetic equivalents must be manufactured from colours that comply with the
specifications in Table 1.
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Table 1
For web pubplication - was appendix 22 of ARGPM - Colours permitted in medicines for oral use
Colours permitted in medicines for oral use
Australian Approved
Name
JECFA name (if
different)
Colour Index number
INS numbera
Allura Red AC
16035
129
Amaranth
16185
123
Annatto
Annatto Extracts (Oil
and Alkali-extracted)
Annatto Extracts
(Solvent-extracted)
75120
160b
Anthocyanins
Grape Skin Extract
–
163(ii)
Beet Red
–
162
Betacarotene
40800
160a(i)
28440
151
42090
133
16255
124
40850
161
Brilliant Black BN
Brilliant Black PN
Brilliant Blue FCF
Brilliant Scarlet 4R
Ponceau 4R
Canthaxanthin
Caramel
Caramel Colours
–
Class I: Plain Caramel,
caustic caramel
150a
Class II: Caustic sulfite
caramel
150b
Class III: Ammonia
caramel
150c
Class IV: Sulfite
ammonia caramel
150d
Carbon black
Vegetable carbon
77266
153
Carmoisine
Azorubine
14720
122
Carotenes
Carotenes (Algae)
Carotenes (Vegetable)
75130
160a(ii)
Chlorophylls
75810
140
Chlorophyllins – Copper
Complexes Sodium and
Potassium Salts
(previous AAN
Chlorophyllin – Copper
Complex)
75810
141(ii)
Chlorophylls – Copper
Complexes
75810
141(i)
20285
155
Cochineal
75470
120
Curcumin
75300
100(i)
Erythrosine
45430
127
Fast green FCF
42053
143
Chocolate Brown HT
2
Brown HT
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For web pubplication - was appendix 22 of ARGPM - Colours permitted in medicines for oral use
Food Orange 6
Beta-apo-8'-carotenal
40820
160e
Food Orange 7
Beta-apo-8’-carotenoic
Acid Ethyl Ether
40825
160f
44090
142
73015
132
Iron Oxide Black
77499
172(i)
Iron Oxide Red
77491
172(ii)
Iron Oxide Yellow
77492
172(iii)
Patent Blue V
42051
131
45410
–
Quinoline Yellow
47005
104
Riboflavin
–
101(i)
Saffron
75100
–
Sunset Yellow FCF
15985
110
Red 27
45410
–
Titanium Dioxide
77891
171
Green S
Indigo Carmine
Phloxine Bb
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36
37
38
39
40
41
42
43
Indigotine
(none allocated)
AAN = Australian Approved Name; INS = International Numbering System for Food Additives; JECFA =
Joint FAO/WHO Expert Committee on Food Additives
a The INS has been prepared by the Codex Alimentarius Commission, Codex Committee on Food
Additives and Contaminants, for the purpose of providing an agreed international numerical system for
identifying food additives in ingredient lists. The INS will largely use ‘E’ numbers (numerical
designations developed within the European Community for declaration of foodstuff additives), but
without the ‘E’.
b Because of the absence of a European specification, Phloxine B must comply with the specifications
detailed in the United States Code of Federal Regulations (Volume 21) for D&C Red 28 – Part (b) of
Section 74.1328
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46
Compliance with monographs and other
standards for colourings
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For colourings that are covered by a default standard monograph
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51
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For colourings that do not have a default standard monograph
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The colourings are required to comply with the monograph specifications, unless an
exemption is granted under section 14 of the Act.
Apply to the TGA in writing, seeking an exemption under section 14 of the Therapeutic
Goods Act 1989.
The colourings need to conform to either:
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the Food and Agriculture Organization (FAO)/World Health Organization (WHO)
Combined compendium of food additive specifications,
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the European Commission Directive Laying down specific purity criteria concerning
colours for use in foodstuffs (95/45/EC).
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Data requirements for new colourings
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Using colourings in orally administered medicines that are not in the published list
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All applications
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Provide a complete and unambiguous identification of the colouring including:
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•
•
•
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Applications where Food Standards Australia New Zealand has evaluated data
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For Quality data (CTD Module 3)
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Ensure the Quality data (consistent with the Common Technical Document [CTD] requirements
for Module 3) includes:
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details of the test methods used during quality control of each batch, and the limits for
results
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•
evidence of compliance with the standard approved by Food Standards Australia New
Zealand (FSANZ) (i.e. test results from at least two batches of the colouring).
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For nonclinical data (CTD Module 4)
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Include:
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FSANZ reports
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reports of all toxicology studies completed after the FSANZ evaluation that are relevant to
the assessment of the colouring.
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For clinical data (CTD Module 5 if relevant)
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Include:
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•
•
•
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Provide data to the TGA for evaluation and approval.
Follow the data requirements for applications of this type detailed below.
the chemical name
any common names by which the chemical is known or identified in the technical literature
any names under which the colouring has been or will be marketed (including trade
names)
the Colouring Index (CI) number
the International Numbering System for Food Additives (INS) number
the Chemical Abstract Service (CAS) number.
reports of all human studies (if any) completed after the FSANZ evaluation that are
relevant to the assessment of the chemical.
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Applications where Food Standards Australia New Zealand has not evaluated data
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For Quality data (CTD Module 3)
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Include:
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for colours included in the EU Commission Directive Laying down specific purity criteria
concerning colours for use in foodstuffs (95/45/EC), evidence of compliance with the
directive (i.e. test results from at least two batches of the colouring)
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for other new colourings, quality data requirements as outlined in 2.2.2 of the EU
Guideline on excipients in the dossier for application for marketing authorisation of a
medicinal product (EMEA/CHMP/QWP/396951/2006).
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For nonclinical data (CTD Module 4)
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For a colouring that has not been used previously in an oral medicine, include:
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toxicology and pharmacology data as required for a new drug substance
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any existing data to support the use of the new colouring in an oral medicine – for
example, toxicological data based on other uses (e.g. veterinary, agricultural and
industrial chemicals), or animal toxicological and human safety data arising from its use
as a food or food additive.
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For clinical data (CTD Module 5)
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Include:
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reports of all human clinical studies of the colouring.
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