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This guidance relates to:
- colourings in medicines for topical and oral use that do not require evaluation of data by the TGA
- the information required to evaluate a colouring that is not in:
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
Excipients with colouring characteristics
Generally, ingredients that have colouring characteristics may be used without further evaluation of toxicology data, as long as they are available for excipient use in the relevant medicine type e.g. prescription medicines, listed medicines.
For example, if sponsors wish to use a fruit extract such as Vaccinium myrtillus (bilberry) as a natural colouring in medicines, no additional toxicological data is required.
Check the ingredient database in TGA Business services for excipient availability of ingredients for the intended application type.
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.
| 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.
| 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
- The colourings need to conform to either:
- the Food and Agriculture Organization (FAO)/World Health Organization (WHO) Combined compendium of food additive specifications
- the European Union regulations - Laying down specifications for food additives No. 231/2012 (pdf,2.95Mb)
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:
- 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, pharmacology and pharmacokinetics 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.