Complete approved herbal names

To construct a complete name for your herbal ingredient, you will need to know the ingredient and tissue category it belongs to, see: Ingredient names.

Herbal substances (defined entity)

If your herbal ingredient is linked to a specific or individual monograph in a pharmacopoeia, then its name is already considered complete. 

There is no need to add further details about the plant part and plant preparation in the application or on the medicine label. For example, ‘Orange Oil’, as specified in the British Pharmacopoeia.

Your herbal ingredient is considered linked when:

• The herbal substance is derived from herbal raw material that has an approved name.
• The herbal ingredient is made from the herbal raw material identified in the specified monograph.

Most monographs name a single herb species and plant part from which the substance is to be prepared. In some cases, two or more herb species and/or two or more plant parts are named as suitable raw material to make the same herbal substance.

• The ingredient can be positively identified from the characteristics given in the monograph.

The monograph description of dry or powdered herbs usually includes the macroscopic and microscopic appearance of the herbal material and the expected results of physical and chemical identification tests. Oils are usually identified by physical characteristics such as optical rotation and specific density, chromatographic pattern and chemical identification tests.

• The first letter of each word is capitalised as it is the title of the monograph that describes and defines the ingredient. For example, 'Cedar Leaf Oil', 'Benzoin Sumatra' and 'Garlic Bulb Powder'.

Herbal substances (plant species)

Herbal ingredients not linked to a monograph in a pharmacopeia must construct a complete approved name using the following formula:

Latin species name + plant part + plant preparation

These are generally used for extracted herbal preparations, such as:

• 'Thymus serpyllum' + 'herb' + 'dry'
• 'Frangula purshiana' + 'stem bark' + 'tincture 1:5 in 35% E:W'
• 'Pulsatilla vulgaris' + 'whole plant' + '6X'.

This approach is used for both active ingredients and excipients.

How to correctly name the plant part

• Confirm the name of the plant part with the raw material supplier.
• Check the plant parts index for your plant part. 
• If:
  • there is only one bolded approved plant part name, and no other instructions, use that term.
  • there are two (or more) approved plant part names or instructions, select the term that most accurately describes the part(s) used.
  • there are no approved names listed for your plant part, follow the instructions under the 'Refer and compare' subheading to help determine the most correct plant part name.
  • the supplier's name for the part is not listed at all, contact TGA names by email: tganames@tga.gov.au to find out if this is a new plant part.

You can use more than one plant part if there is an approved plant part name available for that combination in the Code Tables. For example, 'root & rhizome', 'whole plant' and 'herb fruiting.'

If a combination of plant part names is not available (for example, 'leaf & root') name the two substances separately. For example:

• ingredient 1 - dandelion root: 'Taraxacum officinale root powder'
• ingredient 2 - dandelion leaf: 'Taraxacum officinale leaf powder'.

How to correctly name the plant preparation

• Confirm the plant preparation details with the raw material supplier.
• Check the plant preparations index to find your preparation type for example, 'tincture' or 'oil fixed'. 
• If an approved name is listed here (in bold), ensure this is used in applications and on product labels.
• You may need to include information on final extraction ratio and solvents, equivalent dry/fresh weight or component names.

Plant preparations can be a single term, such as 'fresh', 'dry', 'powder' and 'oil essential'. More complex preparations need additional information to fully describe the ingredient.

If the plant preparation is not an extract

If the plant preparation is not an extract, for example an essential oil or a powder, you don't need a dry or fresh weight equivalence statement.

If the plant preparation is an extract

The plant preparation name for non-oil extracts has two parts in addition to the type of plant preparation (for example, ext. dry conc.):

1. The extraction ratio and solvent details. For example, '(3:1 in 55% E:W [ethanol in water])'.
2. The type of raw material used. For example, 'dry' or 'fresh' (preceded by 'EQUIV.', the plant species name and the plant part); 'EQUIV.' means 'equivalent to'. A medicine application containing this type of raw material may need to include additional statements of fresh or dry weight equivalence.

Extraction ratio and solvent details

The concentration of preparations (for example, tinctures, extracts, spagyrics, infusions and decoctions) should be given as the ratio of the weight of the herbal material used as a starting material to the quantity of the final preparation that is the ingredient. Units for quantities of the raw herbal material and the final preparation in the extraction ratio are in Table 3.

For preparations that are 'concentrates', we express the final extraction ratio in the form 'x:1' and a dilute preparation as '1:x', as described in Table 4 and Table 5.

Solvents

Where the plant species is an active ingredient (and is an extract, spagyric, or tincture), the name and concentration of the solvents used to extract the herbal substance are usually required. This will be indicated in the plant preparations index.

For preparations that are infusions or decoctions, the solvent is always water, and this does not need to be stated.

For preparations that are tinctures, alcohol with or without water is used. For example, 40% ethanol in water would be expressed as 'in 40% E:W'.

Solvent names

Use the approved name for the solvent. Alternatively, solvent name abbreviations can be used in some applications (for example 'E' for ethanol). Abbreviations can only be used in conjunction with extraction ratios. State the relative solvent concentrations as percentages, as outlined in Table 11.

Examples for expression of extraction ratios and solvents are in Table 12.

The type and quantity of raw material

The type of raw material used is part of the plant preparation and the quantity used is a measure of the strength of the ingredient. This information is provided as a separate statement, which incorporates the plant species and plant part for the material.

If the ingredient is a liquid extract, decoction, infusion or juice concentrate:

• Name the type of raw material used to make the ingredient as indicated in the plant preparations index
• choose the appropriate term from 'dry', 'fresh', 'juice dry' or 'juice fresh'.

If the ingredient is a dry herbal material, equivalent fresh weight claims can also be made.