Revised: 17 February 2014
Medicines
Permitted Colourings for use in Medicines and Related Products
This document is a harmonised list of permitted colourings for use in medicines and related products for oral and/or topical use in New Zealand and Australia.
The list was updated in February 2014 as part of the harmonisation activities for ANZTPA and provides manufacturers with an expanded list of permitted colours. All colours previously permitted have been retained.
The colouring agents listed in the following tables (and their aluminium and calcium lakes) are allowed to be used in medicines and related products as detailed below.
Table 1: Colouring agents allowed for external use only
| Name | CI Number |
|---|---|
| Acid green 25 | |
| Acid red 33 (name currently used in Australia) Acid Fuchsin D (name currently used in NZ) |
17200 |
| Alizarin cyanine green F | |
| Basic fuchsin | |
| Brown FK | |
| Eosine | |
| Food red 13 | |
| Malachite green | |
| Mordant red 11 1 | |
| Pigment blue 15 | |
| Pigment green 18 | |
| Pigment green 7 | |
| Pigment red 4 | |
| Pigment red 53 | |
| Pigment red 57 | |
| Pigment red 63 | |
| Pigment white 26 | |
| Pigment yellow 12 | |
| Ponceau SX | |
| Prussian blue | |
| Rhodamine B | |
| Solvent green 3 (name currently used in Australia) Quinizarin Green (name currently used in NZ) |
61565 |
| Solvent red 1 | |
| Solvent violet 13 | |
| Solvent yellow 172 | |
| Solvent yellow 33 | |
| Sudan III | |
| Sulfan blue | |
| Ultramarine blue | |
| Vat red 1 | |
| Vat red 5 | |
| Yellow 2G |
1 Concentration must not exceed 0.05%.
Colour Index number is the code of numbers published by the Society of Dyers and Colourists of the United Kingdom and the Association of Textile Chemists and Colorists of the United States of America.
The International Numbering System is an internationally agreed means of identifying food additives, as an alternative to providing complex chemical names and structures in ingredient lists. It is prepared by the Codex Alimentarius Commission, Codex Committee on Food Additives and Contaminants.
Table 2: Colouring agents allowed in medicines for both internal and external use
| Name | Synonyms | CI Number | INS Number |
|---|---|---|---|
| Allura Red AC | CI Food Red 17 FD&C Red No. 40 |
16035 | 129 |
| Amaranth | CI Food Red 9 FD&C Red No. 2 |
16185 | 123 |
| Annatto | Natural Orange 4 Bixin Norbixin Annatto Extracts (Oil and Alkali-extracted) Annatto Extracts (Solvent-extracted) |
75120 | 160b |
| Anthocyanins | Grapeskin extract (comprising Cyanidin, Peonidin, Malvidin, Delphinidin, Petunidin, Pelargonidin) |
- | 163 |
| Betanin (name currently used in NZ) Beet Red (name currently used in Australia) |
Beetroot Red | - | 162 |
| Beta -apo-8'-carotenal (C30) (name currently used in NZ) Food Orange 6 (name currently used in Australia) |
Apocarotenal | 40820 | 160e |
| Beta -apo-8'-carotenoic acid ethyl ester (name currently used
in NZ) Food Orange 7 (name currently used in Australia) |
40825 | 160f | |
| Beta-carotene (name currently used in NZ) Betacarotene (name currently used in Australia) |
CI Food Orange 5 | 40800 | 160a(ii) |
| Brilliant Black BN | CI Food Black 1 Brilliant Black PN |
28440 | 151 |
| Brilliant Blue FCF | CI Food Blue 2 FD&C Blue No. 1 Acid Blue 9 disodium salt |
42090 | 133 |
| Brown HT (name currently used in New Zealand) Chocolate Brown HT (name currently used in Australia) |
CI Food Brown 3 | 20285 | 155 |
| Calcium carbonate | CI Pigment White 18 Chalk |
77220 | 170 |
| Canthaxanthin | Food Orange 8 | 40850 | 161g |
| Caramel - Ammonia | Caramel III | - | 150c |
| Caramel - Caustic sulfite caramel | Caramel II | - | 150b |
| Caramel - Plain | CI Natural Brown 10 Caramel I Burnt sugar |
- | 150a |
| Caramel - Sulfite ammonia caramel | Caramel IV | - | 150d |
| Carmoisine | Ext. D&C Red No. 10 CI Food Red 3 Azorubine |
14720 | 122 |
| Carotenes | CI Food Orange 5 Mixed carotenes Carotenes (Algae) Carotenes (Vegetable) |
75130 | 160a(i) |
| Chlorophyllins | CI Natural Green 5 Sodium chlorophyllin Potassium chlorophyllin |
75815 | 140(ii) |
| Chlorophylls | CI Natural Green 3 Magnesium chlorophyll Magnesium phaeophytin |
75810 | 140(i) |
| Cochineal | CI Natural Red 4 Carminic acid Carmines |
75470 | 120 |
| Copper Complexes of Chlorophyllins (name currently used in NZ) Chlorophyllins - Copper Complexes of Sodium and Potassium salts (name currently used in Australia) |
CI Natural Green 5 Sodium Copper Chlorophyllin Potassium Copper Chlorophyllin |
75815 (CI number in NZ) 75810 (CI number in Australia) |
141(ii) |
| Copper Complexes of Chlorophylls (name currently used in NZ) Chlorophylls - Copper (name currently used in Australia) |
CI Natural Green 3 Copper Chlorophyll Copper Phaeophytin |
75815 (CI number in NZ) 75810 (CI number in Australia) |
141(i) |
| Curcumin | CI Natural Yellow 3 Turmeric Yellow Diferoyl Methane |
75300 | 100 |
| D&C Red No. 27 (name currently used in NZ) Red 27 (name currently used in Australia) |
Phloxine B acid form | 45410:1 | - |
| Erythrosine | CI Food Red 14 FD&C Red No. 3 |
45430 | 127 |
| Fast Green FCF | CI Food Green 3 FD&C Green No. 3 |
42053 | 143 |
| Green S | CI Food Blue 4 Brilliant Green BS |
44090 | 142 |
| Indigo Carmine | CI Food Blue 1 FD&C Blue No. 2 Indigotine |
73015 | 132 |
| Iron Oxide Black | CI Pigment Black 11 Iron oxides and iron hydroxides |
77499 | 172(i) |
| Iron Oxide Red | CI Pigment Red 101 and 102 Iron oxides and iron hydroxides |
77491 | 172(ii) |
| Iron Oxide Yellow | CI Pigment Yellow 42 and 43 Iron oxides and iron hydroxides |
77492 | 172(iii) |
| Lutein | Mixed Carotenoids (comprising Xanthophylls and Zeaxanthin) |
- | 161b |
| Patent Blue V | CI Food Blue 5 | 42051 | 131 |
| Phloxine B | D&C Red No. 28 Acid Red 92 Eosin 10B Red 28 Phloxine B sodium salt |
45410 | - |
| Ponceau 4R (name currently used in NZ) Brilliant Scarlet 4R (name currently used in Australia) |
CI Food Red 7 New Coccine Cochineal Red A |
16255 | 124 |
| Quinoline Yellow | CI Food Yellow 13 D&C Yellow No. 10 Yellow 10 |
47005 | 104 |
| Riboflavin | Lactoflavin Vitamin B2 |
- | 101(i) |
| Riboflavin -5- phosphate | Vitamin B2 phosphate | - | 101(ii) |
| Saffron | CI Natural Yellow 6 Crocetin Crocin |
75100 | 164 |
| Sunset Yellow FCF | CI Food Yellow 3 Orange Yellow S FCF Orange Yellow FD&C Yellow No. 6 |
15985 | 110 |
| Tartrazine2 | CI Food Yellow 4 FD&C Yellow No. 5 |
19140 | 102 |
| Titanium dioxide | CI Pigment White 6 | 77891 | 171 |
| Vegetable carbon (name currently used in NZ) Carbon Black (name currently used in Australia) |
Vegetable black D&C Black No. 2 |
77266 | 153 |
2 The presence of tartrazine must be declared on the label.
Use of colours not on these lists
Where a sponsor wishes to use a colouring agent not included in these lists in a new or changed medicine or related product, the sponsor should provide a justification for its use.
A data package for that colouring agent should be submitted together with the new medicine/related product application, or changed medicine/related product notification.
- Quality data should be consistent with the Common Technical Document
(CTD) requirements for Module 3 and should include:
- requirements as outlined in 2.2.2 of the EU Guideline - Excipients in the Dossier for Application for Marketing Authorisation of a Medical Product (3AQ9a).
- Non-clinical data should be consistent with the CTD requirements
for Module 4 and should include:
- report of all toxicology studies that are relevant to the assessment of the chemical
- any FSANZ reports.
- Clinical data should be consistent with the CTD requirements for Module 5 and should include reports of all human studies (if any).
