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Medicines

Revised: 17 February 2014

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
  1. 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.

  1. 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).
  2. 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.
  3. Clinical data should be consistent with the CTD requirements for Module 5 and should include reports of all human studies (if any).

 

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