Guidelines & Codes
Permitted Colourings for use in Medicines and Related products
This document lists the permitted colourings for use in medicines and related products. The list replaces that previously contained in regulation 6 of the Medicines Regulations 1984, following revocation of regulation 6 by the Medicines Amendment Regulations 2011. It is effective from 1 August 2011.
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
| Preferred Name | Synonyms | CI1 Number | INS2 Number |
|---|---|---|---|
| Acid Fuchsin D | D&C Red No. 33 Red 33 |
17200 | - |
| Quinizarin Green SS | D&C Green No. 6 | 61565 | - |
- 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 for both internal and external use
| Preferred Name | Synonyms | CI1 Number | INS2 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 | Beetroot Red Beet Red |
- |
162 |
| Beta -apo-8'-carotenal (C30) | Food Orange 6 Apocarotenal |
40820 | 160e |
| Beta -apo-8'-carotenoic acid ethyl ester | Food Orange 7 | 40825 | 160f |
| Beta-carotene | CI Food Orange 5 Betacarotene |
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 | CI Food Brown 3 Chocolate Brown HT |
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 | CI Natural Green 5 Sodium Copper Chlorophyllin Potassium Copper Chlorophyllin |
75815 | 141(ii) |
| Copper Complexes of Chlorophylls | CI Natural Green 3 Copper Chlorophyll Copper Phaeophytin |
75815 | 141(i) |
| Curcumin | CI Natural Yellow 3 Turmeric Yellow Diferoyl Methane |
75300 | 100 |
| D&C Red No. 27 | Red 27 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 oxides and iron hydroxides | Iron Oxide Black CI Pigment Black 11 |
77499 | 172(i) |
| Iron Oxide Red CI Pigment Red 101 and 102 |
77491 | 172(ii) | |
| Iron Oxide Yellow CI Pigment Yellow 42 and 43 |
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 |
CI Food Red 7 New Coccine Brilliant Scarlet 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 |
| Tartrazine3 | CI Food Yellow 4 FD&C Yellow No. 5 |
19140 | 102 |
| Titanium dioxide | CI Pigment White 6 | 77891 | 171 |
| Vegetable carbon | Carbon Black Vegetable black D&C Black No. 2 |
77266 | 153 |
- 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).