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Updates to the Permissible Ingredients Determination for listed medicines

Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2019

30 April 2019

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in April 2019. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2019. A total of 16 changes have been made in the updated Determination. These changes include:

  • Addition of 8 new ingredient entries; and
  • Changes to 8 existing ingredient entries, including making requirements clearer and less restrictive.

A complete list of changes to ingredient is below.

New ingredients

  • C11-13 alkane
  • cetearyl nonanoate
  • dimeticonol/propylsilsesquioxane/silicate crosspolymer
  • disodium lauril sulfosuccinate
  • methyl heptanoate
  • polyglyceryl-2 caprate
  • polyquaternium-4
  • resveratrol

Changed ingredients

Ingredient Reason for update
BRASSICA CAMPESTRIS/ALEURITES FORDI OIL COPOLYMER Update to ingredient name
BRILLIANT BLUE FCF Less restrictive requirements
MAGNESIUM GLYCINATE DIHYDRATE Correction of error
METHYL SALICYLATE Correction of error
NEOPENTYL GLYCOL DIOCTANOATE Less restrictive requirements
POLYVINYL ACETATE Less restrictive requirements
SORBITOL Correction of error
STREPTOCOCCUS SALIVARIUS Less restrictive requirements