Common list of colouring substances permitted for use in medicines in Australia and New Zealand

This document is a harmonised list of permitted colourings for use in medicines 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 as detailed below.

On this page
Table 1. Colouring substances allowed for topical use only
Table 2. Colouring substances allowed in medicines for oral or topical use
Table 1. Colouring substances allowed for topical use only
Name Colour Index (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 (Concentration must not exceed 0.05%)
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
Colour Index (CI) 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 (INS) 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 substances allowed in medicines for oral or topical 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
Tartrazine

Note: the presence of tartrazine must be declared on the label.

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 153Top of page
Content last updated: 17 March 2014

Content last reviewed: 17 March 2014

Web page last updated: 20 June 2014

URL: http://www.anztpa.org/projects/harmonisation-ingredients-colours-list.htm

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