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Update to listed medicine ingredients in December 2019

Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2019

11 December 2019

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[1] .
  • Changes to 19 existing ingredient entries relating to menthol to make requirements clearer and less restrictive[1].
  • Changes to 1 existing ingredient entry following safety evaluation of Andrographis paniculata to make requirements more restrictive[2] .
  • 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[3].

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