Colourings used in medicines for topical and oral use

This guidance relates to:

• colourings in medicines for topical and oral use that do not require evaluation of data by the TGA
• the information required to evaluate a colouring that is not in:
  • Table 1 Colourings for use as excipients in medicines for topical use only
  • Table 2 Colourings for use in medicines for oral and topical use

Why colourings are used in medicines for topical and oral use

Colourings are inactive substances that may be used in topical or oral formulations of medicines, for various reasons such as:

• to distinguish between strengths, indications or markings
• to assist with identifying the medicine
• to distinguish between other medicines.

Colourings that do not require evaluation

Table 1 below lists the colourings (and their aluminium and calcium lakes) that:

• can be used in medicines for topical use only
• do not require evaluation of toxicology data.

Table 2 below lists the colourings (and their equivalents such as their aluminium and calcium lakes) that:

• can be used in medicines for oral and topical use
• do not require evaluation of toxicology data

Note

The synthetic equivalents need to be manufactured from colours that comply with the specifications in Table 2.

Compliance with monographs and other standards for colourings

For colourings that are covered by a default standard monograph

• The colourings are required to comply with the monograph specifications, unless an exemption is granted under section 14 of Therapeutic Goods Act 1989 (the Act).
• Apply to the TGA in writing, seeking an exemption under section 14 of the Act.

For colourings that do not have a default standard monograph

• The colourings need to conform to either:
  • the Food and Agriculture Organization (FAO)/World Health Organization (WHO) Combined compendium of food additive specifications
  • the European Union regulations - Laying down specifications for food additives No. 231/2012 (pdf,2.95Mb)*

Data requirements for new colourings

Using colourings in topical or orally administered medicines that are not in the published list

• Provide data to the TGA for evaluation and approval.
• Follow the data requirements for applications of this type detailed below.

All applications

Provide a complete and unambiguous identification of the colouring including:

• the chemical name
• any common names by which the chemical is known or identified in the technical literature
• any names under which the colouring has been or will be marketed (including trade names)
• the Colouring Index (CI) number
• the INS Food Additives number
• the Chemical Abstract Service (CAS) number.

Applications where Food Standards Australia New Zealand has evaluated data

For quality data (CTD Module 3)

Ensure the Quality data (consistent with Module 3 of the Common Technical Document [CTD]) includes:

• details of the test methods used during quality control of each batch, and the limits for results
• evidence of compliance with the standard approved by Food Standards Australia New Zealand (FSANZ) (i.e. test results from at least two batches of the colouring).

For nonclinical data (CTD Module 4)

Include:

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

For clinical data (CTD Module 5 if relevant)

Include reports of all human studies (if any) completed after the FSANZ evaluation that are relevant to the assessment of the chemical.

Applications where Food Standards Australia New Zealand has not evaluated data

For quality data (CTD Module 3)

Include:

• for colours included in the European Union regulations - Laying down specifications for food additives No. 231/2012 (pdf,2.95Mb)*; evidence of compliance with the directive
• for other new colourings, quality data requirements as outlined in 2.2.2 of the European Union Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product (EMEA/CHMP/QWP/396951/2006)

For nonclinical data (CTD Module 4)

For a colouring that has not been used previously in a topical and/or oral medicine, include:

• toxicology, pharmacology and pharmacokinetics data as required for a new drug substance
• any existing data to support the use of the new colouring in a topical and/or oral medicine - for example, toxicological data based on other uses (e.g. veterinary, agricultural and industrial chemicals), or animal toxicological and human safety data arising from its use as a food or food additive.

For clinical data (CTD Module 5)

• Include reports of all human clinical studies of the colouring.