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Methods to complete an approved herbal name
TGA approved terminology for therapeutic goods
Herbal ingredient names used in an application or on medicine labels must be the full or 'complete' name. The category of your ingredient will determine what you need to do to construct the complete name. Hyperlinks in Table 7 take you to the relevant section.
|Ingredient category||Method used to complete name|
|AHN||AHN + the plant part + the plant preparation|
|AHS||These are considered complete names|
|AFN||AFN + the food preparation|
Method 1: AHN + plant part + plant preparation
This method is 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'.
Approved Herbal Names (AHNs)
In the botanical name:
- the first word is the genus name
- the second word is the species name (specific epithet)
- both words together are needed to name the plant species
- the botanical name is written in italics, with the first letter of the genus name capitalised.
For example: Hypericum perforatum.
The Plant Part section on the Code Tables contains all TGA approved plant part names.
For more information on searching the Code Tables, refer to Appendix 3.2.1.
Ensuring you use the most correct plant part name
- Confirm the name of the plant part with the raw material supplier.
- Check the Herbal ingredients plant parts index (Appendix 1) 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: email@example.com to find out if this is a new plant part.
Using the plant part in applications and medicine labels
Plant parts in medicine applications
Use the approved name for your plant part.
Plant parts on medicine labels
Use the approved name, or an acceptable alternative if one is listed for that plant part in the plant parts index.
AHNs on medicine labels can differ from the approved name used in the ARTG in the following ways:
- special names may be used. For example, instead of 'fruit', other words such as 'berry', 'hip', 'capsule', 'legume', 'follicle' or 'pod' may be used
- the plural can be used, e.g. 'leaves'
- the word order can be changed and words can be written in full to achieve plain English, e.g. 'flowering herb top'
- simplifications may be used, e.g. 'flowering tops'.
Further information can be found in section 7.5 Additional information on medicine labels.
Using combinations of plant parts
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 e.g. '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'.
The Plant Preparations section on the Code Tables contains all TGA approved preparation names.
For more information on searching the Code Tables, refer to Appendix 3.2.1.
Ensuring you use the most correct plant preparation name
- Confirm the plant preparation details with the raw material supplier.
- Check the Herbal ingredient plant preparations index (see Appendix 2) to find your preparation type e.g. 'tincture' or 'oil fixed'. If:
- an approved name is listed here (in bold), ensure this is used in applications and on product labels.
- there is limited space on your label, you may be able to select an optional name or abbreviation (if one or more is listed).
- You may need to include information on final extraction ratio and solvents, equivalent dry/fresh weight or component names.
- Some information on the plant preparation must be included in applications but does not need to be included on a medicine label.
If a new plant preparation is required
Contact TGA names by email for advice: firstname.lastname@example.org.
Using plant preparations in medicine applications
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 ingredient is not an extract
If the ingredient is not an extract, e.g. an essential oil or a powder, you don't need a dry or fresh weight equivalence statement.
If the ingredient is an extract
The complete plant preparation name for non-oil extracts has two parts in addition to the type of plant preparation (e.g. ext. dry conc.):
- The extraction ratio and solvent details. For example, '(3:1 in 55% E:W [ethanol in water])'.
- The type of raw material used. For example, 'dry' or 'fresh' (preceded by 'EQUIV.', the AHN 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.
See below for more information about plant preparations.
Extraction ratio and solvent details
The concentration of preparations (e.g. 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 8.
|Herbal raw material unit||Final preparation (i.e. extracted ingredient) unit|
|kg||kg or L|
|g||g or mL|
|mg||mg or microlitres|
For preparations that are 'concentrates', the final extraction ratio is expressed in the form 'x:1' and a dilute preparation as '1:x', as described in Table 9 and Table 10.
|1:10||One (1) part of dry herb is used to make ten (10) parts of preparation.||1 g of dry herb is used to make 10 mL of tincture.|
|1:1||One (1) part of dry herb is used to make one (1) part of preparation.||
1 g of dry herb is used to make 1 g of dry extract.
1 g of dry herb is used to make 1 mL of liquid extract.
|3:1||Three (3) parts of dry herb is used to make one (1) part of a concentrated preparation.||
3 g of dry herb is used to make 1 g of dry extract.
3 g of dry herb is used to make 1 mL of liquid extract.
|fresh 1:5||1 part of fresh herb is used to make 5 parts of preparation|
|fresh 4:1||4 parts of fresh herb is made into 1 part of a concentrated preparation|
Where the herbal substance 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 Appendix 2: Herbal Ingredients 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'.
Use the AAN for the solvent name. Alternatively, solvent name abbreviations can be used in some applications (e.g. '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.
|Number of solvents||Examples||Comments|
|1||'in 100% W'|
|2||'in 45% E:W'||The percentage figure refers to the proportion of the first-named solvent.|
|3||'in glyc:E:W 15:20:QS'||The % sign is not necessary. The last of the solvents used to make up the total volume is indicated as 'QS' (from the Latin, quantum sufficit).|
Examples for expression of extraction ratios and solvents are in Table 12.
|(1:4 in 15% E:W)||A 1:4 aqueous - alcohol tincture made using 15% ethanol in water.||Any preservative, such as additional ethanol, should not be named or quantified here.|
|(fresh 1:1 in 27% pr-gl:ether)||A 1:1 fresh plant extract made using 27% propylene glycol in ether.||Any diluent, such as lactose or ethanol and water, should not be named here.|
|(6:1 in glyc:E:W 10:25:QS)||A 6:1 concentrated extract made using 10% glycerol and 25% ethanol in water.|
|(4:1 in 35% E:W; in 40% p-gl:E)||A 4:1 concentrated extract made in two stages: initially using 35% ethanol in water and then using 40% propylene glycol in ethanol.||Where a series of extractions occurs, each solvent mix is detailed in turn.|
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 AHN and plant part for the material.
If the ingredient is a liquid extract, decoction, infusion or juice concentrate:
- the type of raw material used to make the ingredient is to be named as indicated in Appendix 2: Herbal ingredient 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.
Further information on listed medicine applications
For further information, refer to the Listed medicines application and submission user guide.
Using plant preparations on medicine labels
For information on the inclusion of plant preparations on labels of finished goods, refer to the labelling orders and associated guidance.
Details of the solvents used in the extraction of herbal materials are not required on medicine labels. This does not remove the need to declare the presence of any alcohol in the medicine. Disclosure of product alcohol content on labels must be in accordance with the labelling orders.
The type and quantity of raw material
Use metric units as stated in the labelling Orders, noting that
- where there is only one ingredient in the product, use '1 g/g' or '1 mL/mL'.
The equivalent dry/fresh weight is calculated as follows:
extraction ratio (as fraction) × quantity of ext./tinct. = equivalent dry/fresh weight
Use comparable units. For example:
- quantity of tincture in microlitres gives dry/fresh weight in ml
- quantity of dry extract in mg gives dry/fresh weight in mg.
Examples are in Table 13.
|Name||Equivalent dry or fresh extract||Extraction ratio||Quantity of extract/tincture||Equivalent dry/fresh weight|
|Gentiana lutea root tinct. (1:5 in 40% E:W)||EQUIV. Gentiana lutea root dry||1:05||200 microlitre/mL||1/5 x 200 microlitre/mL = 40 mg/mL|
|Chamaemelum nobile flower ext. dry (fresh 1:1 in 35% E:W)||EQUIV. Chamaemelum nobile flower fresh||1:01||500 mg/g||1/1 x 500 mg/g = 500 mg/g|
|Frangula purshiana bark ext. dry conc. (3:1 in 30% E:W)||EQUIV. Frangula purshiana bark dry||3:01||70 mg/g||3/1 x 70 mg/g = 210 mg/g|
Method 2: AHS
The Approved Herbal Substance (AHS) is the only complete approved name for a herbal ingredient. For example:
- 'Orange Oil', as specified in the BP.
Approved Herbal Substance Names (AHSs)
Relevant monograph for AHS ingredients
AHS names are linked to a specific or individual monograph in a pharmacopoeia e.g. BP 2014.
The monograph reference is not part of the AHS name.
Capitalising each word in an AHS
The first letter of each word in an AHS is capitalised as it is the title of the monograph that describes and defines the ingredient.
- 'Cedar Leaf Oil', 'Benzoin Sumatra' and 'Garlic Bulb Powder'.
Database of AHS ingredients
To search the full list of AHS ingredients, go to the ingredients list on the TGA Business Services website.
Selecting the AHS
You can only use an AHS to name the herbal ingredient where the:
- Herbal substance is derived from herbal raw material that has an AHN.
- 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.
- 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.
Where there is an appropriate monograph in the current edition of a pharmacopoeia (pursuant to the definition of a standard in the Act), the herbal substance must comply with the description and requirements specified in the monograph. The AHS name is used in this instance.
Using the AHS
If you use the AHS in your medicine, there is no need to add further details about the plant part and plant preparation in the application or on the medicine label. Ensure the AHS is stated on a label exactly as it appears in the Ingredients Table.
Method 3: AFN + food preparation
Approved Food Names (AFNs)
AFNs use common names to refer to edible substances fit for human consumption. In some instances, these names include a plant part or preparation.
The AFN format has been superseded and no new AFNs will be created.
You should use a plant's Latin binomial name (the AHN) in place of an AFN where possible.
AFNs can only be used to name excipient ingredients, not active ingredients.
When using AFNs
- If the food preparation name is included in the AFN do not repeat the preparation name; for example, 'walnut oil' and 'apple cider vinegar'.
- Where the preparation is not specified in the AFN, add a food preparation to complete the name; for example, apple (AFN) + fresh (food preparation) = apple fresh.
- Do not capitalise. This helps to distinguish them from AHSs.
Only fresh, dry and powdered plant material and fresh, dry and concentrated juices are named with AFNs.
For example, the AFN 'apple', is the edible fruit of any of the varieties of Malus × domestica, can be used to name the following food excipients;
- apple fresh
- apple dry
- apple powder
- apple juice fresh
- apple juice dry (including powder, flour, meal)
- apple juice concentrate (partially but not completely dried).
Approved food preparation names
Only the following food preparation names are approved:
- juice dry
- juice fresh
- juice concentrate
You can only name juice preparations where the fresh plant part has a high water content.
AFNs are not generally adopted for extracted preparations other than oils.