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Update to listed medicine ingredients in June 2019

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

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

IngredientReason for update
MENTHA AQUATICASafety review, Less restrictive requirements
MENTHA ARVENSISSafety review, Less restrictive requirements
MENTHA ARVENSIS LEAF OILSafety review, Less restrictive requirements
MENTHA ARVENSIS OILSafety review, Less restrictive requirements
MENTHA HAPLOCALYXSafety review, Less restrictive requirements
MENTHA PULEGIUMSafety review, Less restrictive requirements
MENTHA SPICATASafety review, Less restrictive requirements
MENTHA X CARDIACASafety review, Less restrictive requirements
MENTHA X PIPERITASafety review, Less restrictive requirements
MENTHOLSafety review, Less restrictive requirements
MENTHOL OIL DEMENTHOLISEDSafety review, Less restrictive requirements
PEPPERMINT AMERICAN EXT.Safety review, Less restrictive requirements
PEPPERMINT LEAF DRYSafety review, Less restrictive requirements
PEPPERMINT LEAF POWDERSafety review, Less restrictive requirements
PEPPERMINT OILSafety review, Less restrictive requirements
PEPPERMINT OIL TERPENELESSSafety review, Less restrictive requirements
PEPPERMINT OIL TERPENES AND TERPENOIDSSafety review, Less restrictive requirements
SPEARMINT OILSafety review, Less restrictive requirements
SPEARMINT OIL TERPENELESSSafety review, Less restrictive requirements
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