Herbal ingredients

Herbal ingredients differ from pharmaceutical ingredients in that they are complex multi-component substances. 

Natural variation, modification or selective breeding of a plant can lead to changes in the chemical composition of herbal ingredients.

This may decrease the safety of the original, approved material. 

See: Guidance on the use of modified unprocessed herbal materials in complementary medicines.

Herbal components

Herbal components are a component or group of components found in herbal ingredients.

Herbal components are in the Ingredients Table - external site but are not an ingredient.

Herbal components are used to identify a component or group of components within parent herbal ingredients. 

You may need to declare a herbal component alongside its herbal ingredient in a medicine application if the ingredient requires it. 

Ingredient-component requirements are in the permissible ingredient determination connected to the herbal ingredient. You may not have to declare the component on the label.

Extracts can change herbal ingredients

You may use extracts with different extraction profiles for herbal ingredients.

Different solvents, solvent concentrations and extraction methods can change the safety and efficacy profiles of ingredients. 

You must check that your herbal ingredient is not changed by the extract used. 

See Guidance on equivalence of herbal extracts in complementary medicines.

Approved herbal names

All ingredients must have an Australian approved ingredient name. See Naming ingredients.

The Ingredients Table - external site has approved names for ingredients used in therapeutic goods. If an approved herbal name does not appear in this list you can apply for a new ingredient name. 

Some herbal ingredients must have a ‘complete approved herbal name’ present on the label and for use in applications. 

See Complete approved herbal names.

Using common names for herbal species

Plant species can have several common names. Use the scientific species name (Latin binomial name) as the approved name.

When plant species are closely related or are subspecies, varieties and cultivars you may include the common name for clarity.

For example, Brassica oleracea, has several subspecies including cabbage, broccoli, kale and cauliflower. For this ingredient common names are included. 

Common names must reflect common usage and understanding in Australia. For example, black cohosh is the common name for Actaea racemosa.

Use common names on medicine labels if:

• the complete approved name is present
• all other required information is present
• the extra information is correct and unlikely to mislead consumers.

Identification of herbal materials 

You must trace your herbal starting materials to a primary source or certified herb.

Identification testing must discriminate between related species and/or potential adulterants/substitutes. 

See Identification of herbal materials and extracts.

Applying to use a herbal ingredient

The TGA determines the eligibility of using a herbal ingredient.

See: 

• Application requirements for new substances in listed medicines.

• Request a new ingredient.