The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation in December 2019 and commences on 1 January 2020.
The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2019. A total of 33 changes have been made in the updated Determination. These changes include:
- Changes to 10 existing ingredient entries relating to methyl salicylate to make requirements clearer and less restrictive.
- Changes to 19 existing ingredient entries relating to menthol to make requirements clearer and less restrictive.
- Changes to 1 existing ingredient entry following safety evaluation of Andrographis paniculata to make requirements more restrictive.
- Changes to 2 existing herbal ingredient names to reflect changes to the Australian Approved Names List for Therapeutic Substances.
- Correction to 1 existing ingredient entry to align requirements relating to the declaration of gluten on the medicine label to be consistent with changes made in the previous Determination.
A complete list of changes to ingredients is below.
Changed ingredients
| Ingredient | Reason for update |
|---|---|
| ANDROGRAPHIS PANICULATA | More restrictive following safety evaluation of Andrographis paniculata |
| BETULA LENTA | Less restrictive following safety evaluation of methyl salicylate |
| BETULA NIGRA | Less restrictive following safety evaluation of methyl salicylate |
| BETULA PENDULA | Less restrictive following safety evaluation of methyl salicylate |
| BIRCH LEAF DRY | Less restrictive following safety evaluation of methyl salicylate |
| CALLITRIS COLUMELLARIS | Update to ingredient name from Callitris intratropica |
| EVERNIA PRUNASTRI EXTRACT | Update to ingredient name from Evernia prunastra extract |
| FILIPENDULA ULMARIA | Less restrictive following safety evaluation of methyl salicylate |
| GAULTHERIA PROCUMBENS | Less restrictive following safety evaluation of methyl salicylate |
| MEADOWSWEET HERB DRY | Less restrictive following safety evaluation of methyl salicylate |
| MENTHA AQUATICA | Less restrictive following safety evaluation of menthol |
| MENTHA ARVENSIS | Less restrictive following safety evaluation of menthol |
| MENTHA ARVENSIS LEAF OIL | Less restrictive following safety evaluation of menthol |
| MENTHA ARVENSIS OIL | Less restrictive following safety evaluation of menthol |
| MENTHA HAPLOCALYX | Less restrictive following safety evaluation of menthol |
| MENTHA PULEGIUM | Less restrictive following safety evaluation of menthol |
| MENTHA SPICATA | Less restrictive following safety evaluation of menthol |
| MENTHA X CARDIACA | Less restrictive following safety evaluation of menthol |
| MENTHA X PIPERITA | Less restrictive following safety evaluation of menthol |
| MENTHOL | Less restrictive following safety evaluation of menthol |
| METHYL SALICYLATE | Less restrictive following safety evaluation of methyl salicylate |
| MINT OIL DEMENTHOLISED | Less restrictive following safety evaluation of menthol |
| NYCTANTHES ARBOR-TRISTIS | Less restrictive following safety evaluation of methyl salicylate |
| PEPPERMINT AMERICAN EXT. | Less restrictive following safety evaluation of menthol |
| PEPPERMINT LEAF DRY | Less restrictive following safety evaluation of menthol |
| PEPPERMINT LEAF POWDER | Less restrictive following safety evaluation of menthol |
| PEPPERMINT OIL | Less restrictive following safety evaluation of menthol |
| PEPPERMINT OIL TERPENELESS | Less restrictive following safety evaluation of menthol |
| PEPPERMINT OIL TERPENES AND TERPENOIDS | Less restrictive following safety evaluation of menthol |
| RYE BRAN | Alignment of gluten requirement with labelling orders |
| SPEARMINT OIL | Less restrictive following safety evaluation of menthol |
| SPEARMINT OIL TERPENELESS | Less restrictive following safety evaluation of menthol |
| WINTERGREEN OIL | Less restrictive following safety evaluation of methyl salicylate |