Supporting references for approved ingredient names

The naming reference is the publication we have used to source a proposed name. For example, a monograph found in a Pharmacopoeia. 

Naming references usually include the definition or description of the substance. These reference definitions provide us with a guide to analyse the substance's characteristics and verify that it is correctly identified.

In most cases, the TGA will adopt the name stated in the title of the monograph (or other reference) as the Australian approved name for the ingredient.

Naming reference versus quality standard

Using a particular reference to define a name does not always mean that it is also the standard that defines the quality of the substance. 

For example, Merck is used as a naming reference but is not a quality standard (Examples of quality standards include the Therapeutic Goods Orders or default standards like monographs in the British Pharmacopoeia or the United States Pharmacopeia-National Formulary).

In some instances, the naming reference is a standard, but it may not be the only relevant default standard. 

For example, the naming reference for 'nicotinamide' may be the British Pharmacopoeia, however a default standard that may be used to define the quality of the ingredient could be the monograph in the United States Pharmacopeia - National Formulary which refers to the same ingredient as 'niacinamide.' 

In these circumstances, the alternative ingredient name may be included as a synonym to assist with searchability in the Ingredients Table.

Default references for naming chemical and biological substances

International Non-proprietary name (INN) terminology, maintained by the World Health Organization (WHO), is the default naming reference for chemical ingredients and biological ingredients derived from human or animal materials.

If you want to use a different name

If an ingredient has an INN and you want to use a different name:

• you will need to justify the use of a different name
• we will review the suitability of alternative names on a case-by-case basis.

Further guidance on INN naming

• WHO Guidance on INN

Additional references for chemical and biological ingredient names

If no INN is available, we prefer the following alternative references:

• British Pharmacopoeia (BP)
• European Pharmacopoeia (EP)
• United States Pharmacopeia - National Formulary (USP)
• British Approved Names (BAN)
• United States Adopted Name (USAN)
• Other internationally recognised references include Martindale, Food Chemicals Codex, International Cosmetic Ingredient Dictionary, Chemical Abstracts Service and the Merck Index. The full list of references are available on ingredient proposal forms and the Code Tables.

If no monograph is available

If the ingredient does not have an entry in any of the references above, we will consider other references, preferably well-recognised, peer-reviewed journals.

Further information on preferred references is available at Forms for new ingredient names and proprietary ingredients.

When there are no supporting references

When there is no INN for a chemical ingredient, or suitable entry in any of our accepted references, use the reference code 'TGA <year>'.

To view the full list of reference codes, refer to the Code Tables homepage on the TGA Business Services website (TBS).

Approved herbal name references

Herbal substances (plant species) are named using Latin binomial nomenclature, including genus and species. For example, the Latin binomial for sage is Salvia officinalis.

Where an herbal is better defined using the subspecies (as it gives greater specificity of the plant) or where the different species are therapeutically relevant (such as Brassica oleracea var. botrytis for cauliflower or Brassica oleracea var. italica for broccoli) then the name can include the subspecies.

While we use many naming references to name herbal species, the Kew Science Medicinal Plant Name Services is the preferred reference. This is because it is regularly updated and actively maintained. Other preferred herbal naming references are in Table 2.

Fungi, yeasts and algae 

The International Code of Botanical Nomenclature treats fungi, yeasts, and algae as plants. See Table 3 for the preferred references for fungi, yeasts and algae.

Herbal substances (defined entity)

Where an herbal substance is linked to a specific monograph, the usual naming references may not apply. Instead, the identity and quality of the substance must comply with the specific monograph.