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Updates to the Permissible Ingredients Determination for listed medicines

Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019

19 June 2019

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in June 2019. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019. A total of 23 changes have been made in the updated Determination. These changes include:

  • Addition of 4 new ingredient entries; and
  • Changes to 19 existing ingredient entries to make requirements clearer and less restrictive.

A complete list of changes to ingredient is below.

New ingredients

  • Calcifediol Monohydrate
  • Hexyl Propionate
  • Omega-3-Acid Ethyl Esters 60
  • VP/Acrylates/Lauryl Methacrylate Copolymer

Changed ingredients

Ingredient Reason for update
MENTHA AQUATICA Safety review, Less restrictive requirements/td>
MENTHA ARVENSIS Safety review, Less restrictive requirements
MENTHA ARVENSIS LEAF OIL Safety review, Less restrictive requirements
MENTHA ARVENSIS OIL Safety review, Less restrictive requirements
MENTHA HAPLOCALYX Safety review, Less restrictive requirements
MENTHA PULEGIUM Safety review, Less restrictive requirements
MENTHA SPICATA Safety review, Less restrictive requirements
MENTHA X CARDIACA Safety review, Less restrictive requirements
MENTHA X PIPERITA Safety review, Less restrictive requirements
MENTHOL Safety review, Less restrictive requirements
MENTHOL OIL DEMENTHOLISED Safety review, Less restrictive requirements
PEPPERMINT AMERICAN EXT. Safety review, Less restrictive requirements
PEPPERMINT LEAF DRY Safety review, Less restrictive requirements
PEPPERMINT LEAF POWDER Safety review, Less restrictive requirements
PEPPERMINT OIL Safety review, Less restrictive requirements
PEPPERMINT OIL TERPENELESS Safety review, Less restrictive requirements
PEPPERMINT OIL TERPENES AND TERPENOIDS Safety review, Less restrictive requirements
SPEARMINT OIL Safety review, Less restrictive requirements
SPEARMINT OIL TERPENELESS Safety review, Less restrictive requirements