Updates to the Permissible Ingredients Determination for listed medicines

Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018

16 April 2018

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in March 2018. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018.

Determination No. 1 of 2018 repeals and replaces the Therapeutic Goods (Permissible Ingredients) Determination No. 5 of 2017 which commenced in December 2017.

This update to the Determination has been undertaken under section 26BB of the Therapeutic Goods Act 1989 and its function remains the same.

A total of 64 changes have been made in the updated Determination. These changes include:

  • The addition of 4 new ingredients.
  • Changes to 56 existing ingredient entries, including:
    • making requirements for ingredients less restrictive, such as broadening the use to allow oral use when previously only for topical use;
    • making requirements for ingredients more restrictive, such as the inclusion of additional warning messages; and
    • making minor changes to make a number of entries clearer.
  • the removal of 4 ingredients that have been determined not to be suitable for inclusion in listed medicines or were synonymous with other existing ingredients to avoid duplication.

A complete list of changes to ingredient availability is below:

New ingredients

  • 2-HYDROXYACETOPHENONE
  • OCTYLDODECYL XYLOSIDE
  • PEG/PPG-14/7 DIMETHYL ETHER
  • PHENOXYACETALDEHYDE

Changed ingredients

A B C D F G H O R S T

Ingredient Update type Reason for update
A
ALOE FEROX Change Less restrictive requirements
ALOE PERRYI Change Less restrictive requirements
ALOE VERA Change Less restrictive requirements
ALOES CAPE Change Less restrictive requirements
ANTHOXANTHUM ODORATUM Change Correction of error
B
BUTYLATED HYDROXYANISOLE Change Less restrictive requirements
C
CASCARA DRY Change Less restrictive requirements
CASCARA POWDER Change Less restrictive requirements
CASSIA CINNAMON BARK DRY Change Correction of error
CASSIA FISTULA Change Less restrictive requirements
CETYLPYRIDINIUM CHLORIDE Change Less restrictive requirements
CINNAMOMUM CAMPHORA Change Correction of error
CINNAMOMUM CASSIA Change Correction of error
CINNAMOMUM VERUM Change Correction of error
CINNAMON BARK OIL Change Correction of error
CINNAMON DRY Change Correction of error
CINNAMON LEAF OIL Change Correction of error
CINNAMON POWDER Change Correction of error
D
DIPTERYX ODORATA Change Correction of error
F
FRANGULA BARK DRY Change Less restrictive requirements
FRANGULA BARK POWDER Change Less restrictive requirements
FRANGULA PURSHIANA Change Less restrictive requirements
G
GALIUM ODORATUM Change Correction of error
H
HYDROLYSED COLLAGEN Change Purpose expansion
O
OPOPANAX CHIRONIUM Change Purpose restriction; Purpose expansion
P
PIPER METHYSTICUM Change Clarification of requirements
PLANTAGO AFRA Change Correction of error
PLANTAGO ARENARIA Change Correction of error
PLANTAGO ASIATICA Change Correction of error
PLANTAGO LANCEOLATA Change Correction of error
PLANTAGO MAJOR Change Correction of error
PLANTAGO OVATA Change Correction of error
PURIFIED SILICEOUS EARTH Change Correction of error
R
RHAMNUS CATHARTICA Change Less restrictive requirements
RHAMNUS FRANGULA Change Less restrictive requirements
RHEUM OFFICINALE Change Less restrictive requirements
RHEUM PALMATUM Change Less restrictive requirements
RHEUM RHAPONTICUM Change Less restrictive requirements
RHEUM TANGUTICUM Change Less restrictive requirements
RHUBARB Change Less restrictive requirements
RHUBARB ROOT DRY Change Less restrictive requirements
RHUBARB ROOT POWDER Change Less restrictive requirements
S
SAFFRON Change Clarification of requirements; Less restrictive requirements
SENNA ALEXANDRINA Change Less restrictive requirements
SENNA FRUIT ALEXANDRIAN DRY Change Less restrictive requirements
SENNA FRUIT ALEXANDRIAN POWDER Change Less restrictive requirements
SENNA FRUIT TINNEVELLY DRY Change Less restrictive requirements
SENNA FRUIT TINNEVELLY POWDER Change Less restrictive requirements
SENNA LEAF DRY Change Less restrictive requirements
SENNA LEAF POWDER Change Less restrictive requirements
SENNA OCCIDENTALIS Change Less restrictive requirements
SENNA TORA Change Less restrictive requirements
SODIUM DEHYDROACETATE Change Less restrictive requirements
SODIUM PROPIONATE Change Less restrictive requirements
SUNSET YELLOW FCF Change Clarification of requirements; Less restrictive requirements
T
TILACTASE Change Correction of error

Removed ingredients

  • 2-OCTYLDODECANAL
  • COLA COTYLEDON DRY
  • COLA COTYLEDON POWDER
  • THEOBROMA PREPARED