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Colourings permitted in medicines for oral use

Version 1.2

4 May 2011

Version history

Version Description of change Author Effective date
V1.0 Initial publication OCM 16/06/04
V1.1 Addition of D&C Red27 OCM 04/12/09
V1.2

Transferred to new template

Updated links to external websites

OPSS

OCM

04/05/11

Colourings permitted in medicines for oral use

The colouring agents detailed in the list below may be used in orally administered (prescription, over-the-counter and complementary) medicines, without the requirement for sponsors to submit an application for evaluation by the TGA.

Equivalents of the colours detailed below (such as the aluminium and calcium lakes (salts) of these substances) are also considered acceptable and do not require further evaluation. The synthetic equivalents must be manufactured from colours that comply with the specifications indicated below.

In the absence of a British Pharmacopoeia (BP) monograph, colours shall conform to either the specifications in the Food and Agriculture Organization (FAO) / World Health Organization (WHO) Compendium of Food Additive Specifications, as published by the Joint FAO / WHO Expert Committee on Food Additives (JECFA) on its website1 or those defined in the European Commission Directive 95/45/EC2 (specific purity criteria concerning colours for use in foodstuffs).

Where there is a BP monograph, the colour must comply with the BP specifications (unless otherwise justified3).

  1. http://www.fao.org/docrep/009/a0691e/a0691e00.htm
  2. http://ec.europa.eu/food/fs/sfp/addit_flavor/flav13_en.pdf (pdf,364kb)
  3. Sponsors attempting to justify non-compliance with a prescribed standard (e.g. BP) should apply to the TGA in writing, seeking an exemption under section 14 of the Therapeutic Goods Act 1989. Section 14 Exemption requests should explain why the standard cannot be met and detail what alternative is proposed and why. The delegate of the Secretary will review the request and sponsors will be advised in writing of the delegate's decision.
Australian Approved Name (AAN) JECFA1 name (if different) CI4 Number INS5 Number
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
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)
Chlorophylls 75810 140
Chlorophyllins - Copper Complexes Sodium and Potassium Salts (previous AAN Chlorophyllin - Copper Complex) 75810 141(ii)
Chlorophylls - Copper 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)
Iron Oxide Red 77491 172(ii)
Iron Oxide Yellow 77492 172(iii)
Patent Blue V 42051 131
Phloxine B6 (none allocated - see footnote) 45410 -
Quinoline Yellow 47005 104
Riboflavin * - 101(i)
Saffron 75100 -
Sunset Yellow FCF 15985 110
Red 27 45410 -
Titanium Dioxide * 77891 171

*A BP monograph exists for this colour. Compliance is required with BP specification.

  1. CI is the code used in the Colour Index Volumes (for more information see http://www.colour-index.org/)
  2. International Numbering System for food additives. The INS has been prepared by the Codex Alimentarius Commission, Codex Committee on Food Additives and Contaminants, for the purpose of providing an agreed international numerical system for identifying food additives in ingredient lists. The INS will largely use 'E numbers (numerical designations developed within the European Community for declaration of foodstuff additives), but without the "E".
  3. Because of the absence of a European specification, Phloxine B must comply with the specifications detailed in the United States Code of Federal Regulations (Volume 21) for D&C Red 28 – Part (b) of Section 74.1328

Indicative data requirements for new colours

Sponsors wishing to use new colours (that is, those not included in the previous table) in orally administered medicinal products must lodge an application for evaluation by the TGA. The requirements for applications of this type are detailed below.

All applications

A complete and unambiguous identification of the colour must be provided. This should include the chemical name, common names by which the chemical is known or identified in the technical literature, names under which the colour has been or will be marketed (including trade names), the Colour Index (CI) Number, International Number System (INS) number and the Chemical Abstract Service (CAS) Number.

Application for evaluation of a colour where Food Standards Australia New Zealand (FSANZ) has made an evaluation

Quality data (consistent with the Common Technical Document7 (CTD) requirements for Module 3) should include:

  • evidence as to the standard approved by FSANZ
  • details of the test methods used during quality control of each batch and the limits for results
  • evidence as to compliance with the standard approved FSANZ (e.g. at least two sample certificates of analysis).

Non-clinical data (consistent with the CTD requirements for Module 4) should include:

  • FSANZ reports
  • report of all toxicology studies completed after the FSANZ evaluation that are relevant to the assessment of the chemical.

Clinical data (consistent with the CTD requirements for Module 5) should include reports of all human studies (if any) completed after the FSANZ evaluation that are relevant to the assessment of the chemical.

Application for assessment of a colour for which an FSANZ evaluation is not available

Quality data should include:

  • for colours included in EU Commission Directive 95/45/EC, evidence of compliance with the directive (e.g. at least two sample certificates of analysis)8;
  • for other new colours, quality data 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)9.

Non-clinical data should fulfil the following requirements.

  • The toxicology and pharmacology of an excipient used for the first time in a therapeutic good should be investigated as if it were a new active substance.
  • There may be extensive toxicological data based on other uses (for example, veterinary, agricultural and industrial chemicals). There also may be animal toxicological and human safety data arising from use as a food or food additive. Such data may be used to support the use of a new colour in a therapeutic good.

Clinical data should include reports of all clinical human studies of the colour.

  1. http://www.tga.gov.au/industry/pm-ctd.htm
  2. http://ec.europa.eu/food/fs/sfp/addit_flavor/flav13_en.pdf (pdf,364kb)
  3. http://www.tga.gov.au/pdf/euguide/vol3a/3aq9aen.pdf [replaced in May 2010 by EMEA/CHMP/QWP/396951/2006]

About the Therapeutic Goods Administration (TGA)

  • The TGA is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.
  • The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.
  • The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.
  • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. The TGA investigates reports received by it to determine any necessary regulatory action.
  • To report a problem with a medicine or medical device, please see the information on the TGA website.

© Commonwealth of Australia 2011

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