Colourings used in medicines for topical and oral use

Previously ARGPM Appendix 22: Colourings used in medicines for oral use, July 2013

16 June 2016

This guidance relates to:

Why colourings are used in medicines for topical and oral use

Colourings are inactive substances that may be used in topical or oral formulations of medicines, for various reasons such as:

  • to distinguish between strengths, indications or markings
  • to assist with identifying the medicine
  • to distinguish between other medicines.

Colourings that do not require evaluation

Table 1 below lists the colourings (and their aluminium and calcium lakes) that:

  • can be used in medicines for topical use only
  • do not require evaluation of toxicology data.
Table 1 Colourings for use as excipients in medicines for topical use only
Australian approved name Colour Index number CAS Number Restrictions
Acid green 25 4403-90-1
Acid red 33 17200 3567-66-6
Alizarin cyanine green 4403-90-1
Basic fuchsin
Basic red 1 45160 989-38-8
Basic violet 11:1 45174 73398-89-7
Brown FK 8062-14-4
Eosine 548-26-5
Food red 13 2150-33-6
Malachite green
Mordant red 11 72-48-0 Concentration not to exceed 0.05%
Pigment blue 15 147-14-8
Pigment green 18
Pigment green 7 1328-53-6
Pigment red 4 2814-77-9
Pigment red 53 2092-56-0
Pigment red 57
Pigment red 63 2416-46-6
Pigment white 26 8005-37-6
Pigment yellow 12 6358-85-6
Ponceau SX 4548-53-2
Prussian blue 14038-43-8
Rhodamine B 81-88-9
Solvent green 3 61565 128-80-3
Solvent red 1 1229-55-6
Solvent violet 13 81-48-1
Solvent yellow 172 68427-35-0
Solvent yellow 33 8003-22-3
Sudan III 85-86-9
Sulfan blue 68238-36-8
Ultramarine blue 1317-97-1
Vat red 1
Vat red 5 6371-18-2
Yellow 2G 6359-98-4

Table 2 below lists the colourings (and their equivalents such as their aluminium and calcium lakes) that:

  • can be used in medicines for oral and topical use
  • do not require evaluation of toxicology data

Note

The synthetic equivalents need to be manufactured from colours that comply with the specifications in Table 2.

Table 2 Colourings for use in medicines for oral and topical use
Australian approved name JECFA name (if different) Colour Index number INS number Restrictions
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)
Brilliant Black BN Brilliant Black PN 28440 151
Brilliant Blue FCF 42090 133
Brilliant Scarlet 4R Ponceau 4R 16255 124
Calcium carbonate 77220 170
Canthaxanthin 40850 161
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)
Chlorophyllins 75815 140(ii)
Chlorophyllins - Copper Complexes Sodium and Potassium Salts (previous AAN Chlorophyllin - Copper Complex) 75810 141(ii)
Chlorophylls 75810 140
Chlorophylls - Copper Complexes 75810 141(i)
Chocolate Brown HT Brown HT 20285 155
Cochineal 75470 120
Curcumin 75300 100(i)
Erythrosine 45430 127
Fast green FCF 42053 143
Food Orange 6 Beta-apo-8'-carotenal 40820 160e
Food Orange 7 Beta-apo-8'-carotenoic Acid Ethyl Ether 40825 160f
Green S 44090 142
Indigo Carmine Indigotine 73015 132
Iron Oxide Black 77499 172(i)

In divided preparations for oral use: concentration not exceed 10mg per dosage unit.

In undivided preparations for oral use: the concentration is part of the iron content if it exceeds 1%.

Iron Oxide Red 77491 172(ii)
Iron Oxide Yellow 77492 172(iii)
Lutein 161(iii)
Patent Blue V 42051 131
Phloxine B (none allocated) 45410 - Phloxine to comply with the specifications in the US Code of Federal Regulations (Volume 21) for D&C Red 28 - Part (b) of Section 74.1328
Quinoline Yellow 47005 104
Red 27 45410 -
Riboflavin - 101(i)
Riboflavin-5-phosphate 101(ii)
Saffron 75100 -
Sunset Yellow FCF 15985 110
Tartrazine 19140 102 The presence of tartrazine must be declared on the label
Titanium Dioxide 77891 171

Compliance with monographs and other standards for colourings

For colourings that are covered by a default standard monograph

  • The colourings are required to comply with the monograph specifications, unless an exemption is granted under section 14 of Therapeutic Goods Act 1989 (the Act).
  • Apply to the TGA in writing, seeking an exemption under section 14 of the Act.

For colourings that do not have a default standard monograph

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Data requirements for new colourings

Using colourings in topical or orally administered medicines that are not in the published list

  • Provide data to the TGA for evaluation and approval.
  • Follow the data requirements for applications of this type detailed below.

All applications

Provide a complete and unambiguous identification of the colouring including:

  • 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 INS Food Additives number
  • the Chemical Abstract Service (CAS) number.

Applications where Food Standards Australia New Zealand has evaluated data

For quality data (CTD Module 3)

Ensure the Quality data (consistent with Module 3 of the Common Technical Document [CTD]) includes:

  • details of the test methods used during quality control of each batch, and the limits for results
  • 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).
For nonclinical data (CTD Module 4)

Include:

  • FSANZ reports
  • reports of all toxicology studies completed after the FSANZ evaluation that are relevant to the assessment of the colouring.
For clinical data (CTD Module 5 if relevant)

Include reports of all human studies (if any) completed after the FSANZ evaluation that are relevant to the assessment of the chemical.

Applications where Food Standards Australia New Zealand has not evaluated data

For quality data (CTD Module 3)

Include:

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  • for colours included in the European Union regulations - Laying down specifications for food additives No. 231/2012 (pdf,2.95Mb)*; evidence of compliance with the directive
  • for other new colourings, quality data requirements as outlined in 2.2.2 of the European Union Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product (EMEA/CHMP/QWP/396951/2006)
For nonclinical data (CTD Module 4)

For a colouring that has not been used previously in a topical and/or oral medicine, include:

  • toxicology and pharmacology data as required for a new drug substance
  • any existing data to support the use of the new colouring in a topical and/or 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.
For clinical data (CTD Module 5)
  • Include reports of all human clinical studies of the colouring.

Version history

Version Description of change Author Effective date
V1.0 Original publication Office of Medicines Authorisation 01/07/2013
V2.0

Updated to include:

Office of Medicines Authorisation 30/05/2014
V2.1

Updated 'Colourings for use as excipients in medicines for topical use only' table to include:

  • Basic red 1
  • Basic violet 11:1
Scientific Evaluation Branch 26/05/2016