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Update to listed medicine ingredients in March 2020

Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2020

10 March 2020

There has been a more recent update to this instrument. See Change to the Permissible Ingredients Determination for the current version of the instrument.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2020, which commenced on 2 March 2020. This determination replaces the previous instrument, the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2019.

A total of 108 changes have been made in the updated Determination. These changes include:

  • 2 new ingredients (hydrogenated polydextrose & citrulline) following applications under 26BE of the Act;
  • 3 new ingredients and 1 varied ingredient following evaluations for use as flavour/fragrance proprietary ingredients;
  • changes to 24 ingredients as part of the annual low-negligible risk framework;
  • changes to the ingredient coumarin, which provide permission and requirements for its use as a fragrance in topical products, following a TGA-initiated review;
  • changes to 32 ingredients used as colours to specify that all oral routes of administration, including dental use, are permitted;
  • removal of expired transition period provisions for 44 ingredients;
  • removal of one ingredient (oakmoss), as it is a synonym for another ingredient already available for the same use (oakmoss absolute).

A complete list of changed ingredients is given below.

Changed ingredients

Ingredient Change type Change reason
3,7-DIMETHYL-2,6-OCTADIENAL REACTION PRODUCTS WITH ETHANOL Addition Substance evaluation
4-CYCLOHEXYL-2-METHYL-2-BUTANOL Addition Substance evaluation
CITRULLINE Addition Substance evaluation
HYDROGENATED POLYDEXTROSE Addition Substance evaluation
METHYL 2,6,6-TRIMETHYLCYCLOHEX-2-ENE-1-CARBOXYLATE Addition Substance evaluation
BORAX Change Annual consultation
BORAX PENTAHYDRATE Change Annual consultation
BORIC ACID Change Annual consultation
SODIUM PERBORATE Change Annual consultation
4-(4-HYDROXY-4-METHYLPENTYL)-3-CYCLOHEXENE CARBOXALDEHYDE Change Annual consultation
MALUS PUMILA Change Annual consultation
CYMBOPOGON FLEXUOSUS Change Annual consultation
CYMBOPOGON MARTINI Change Annual consultation
CYMBOPOGON NARDUS Change Annual consultation
CYMBOPOGON SCHOENANTHUS Change Annual consultation
ISPAGHULA HUSK DRY Change Annual consultation
ISPAGHULA HUSK POWDER Change Annual consultation
PLANTAGO AFRA Change Annual consultation
PLANTAGO ARENARIA Change Annual consultation
PLANTAGO ASIATICA Change Annual consultation
PLANTAGO LANCEOLATA Change Annual consultation
PLANTAGO MAJOR Change Annual consultation
PLANTAGO OVATA Change Annual consultation
PLANTAGO SEED DRY Change Annual consultation
PSYLLIUM HUSK DRY Change Annual consultation
PSYLLIUM HUSK POWDER Change Annual consultation
PSYLLIUM SEED DRY Change Annual consultation
VITEX AGNUS-CASTUS Change Annual consultation
WITHANIA SOMNIFERA Change Annual consultation
ALLURA RED AC Change Clarify routes of admin
AMARANTH Change Clarify routes of admin
ANNATTO Change Clarify routes of admin
BEET RED Change Clarify routes of admin
BRILLIANT BLACK BN Change Clarify routes of admin
CANTHAXANTHIN Change Clarify routes of admin
CARAMEL Change Clarify routes of admin
CARBON BLACK Change Clarify routes of admin
CARMOISINE Change Clarify routes of admin
CARMOISINE ALUMINIUM LAKE Change Clarify routes of admin
CAROTENES Change Clarify routes of admin
CHOCOLATE BROWN HT Change Clarify routes of admin
ERYTHROSINE Change Clarify routes of admin
ERYTHROSINE ALUMINIUM LAKE Change Clarify routes of admin
FAST GREEN FCF Change Clarify routes of admin
FOOD ORANGE 6 Change Clarify routes of admin
FOOD ORANGE 7 Change Clarify routes of admin
INDIGO CARMINE Change Clarify routes of admin
INDIGO CARMINE ALUMINIUM LAKE Change Clarify routes of admin
IRON OXIDE BLACK Change Clarify routes of admin
IRON OXIDE RED Change Clarify routes of admin
IRON OXIDE YELLOW Change Clarify routes of admin
LUTEIN Change Clarify routes of admin
PATENT BLUE V Change Clarify routes of admin
PATENT BLUE V ALUMINIUM LAKE Change Clarify routes of admin
PHLOXINE B Change Clarify routes of admin
PHLOXINE B ALUMINIUM LAKE Change Clarify routes of admin
RED 27 Change Clarify routes of admin
RED 27 ALUMINIUM LAKE Change Clarify routes of admin
SUNSET YELLOW FCF ALUMINIUM LAKE Change Clarify routes of admin
TARTRAZINE Change Clarify routes of admin
TARTRAZINE ALUMINIUM LAKE Change Clarify routes of admin
ANDROGRAPHIS PANICULATA Change Correct formatting
POLIGLUSAM Change Remove expired transition
WOLFIPORIA COCOS Change Remove expired transition
TITANIUM DIOXIDE Change Remove expired transition; clarify routes of admin
CYSTEINE Change Remove expired transition
CYSTEINE HYDROCHLORIDE Change Remove expired transition
CYSTEINE HYDROCHLORIDE MONOHYDRATE Change Remove expired transition
CYSTINE Change Remove expired transition
FENNEL BITTER SEED DRY Change Remove expired transition
FENNEL OIL Change Remove expired transition
FENNEL SWEET SEED DRY Change Remove expired transition
FOENICULUM VULGARE Change Remove expired transition
FERRIC AMMONIUM CITRATE Change Remove expired transition
IRON Change Remove expired transition
IRON (II) BISGLYCINE SULFATE TRIHYDRATE Change Remove expired transition
IRON (II) GLYCINATE Change Remove expired transition
IRON (III) GLYCINATE Change Remove expired transition
IRON AMINO ACID CHELATE Change Remove expired transition
IRON PHOSPHATE Change Remove expired transition
MAGNESIUM HYDROXIDE Change Remove expired transition
4-METHYLBENZYLIDENE CAMPHOR Change Remove expired transition
BEMOTRIZINOL Change Remove expired transition
BENZYLIDENE CAMPHOR SULFONIC ACID Change Remove expired transition
BUTYL METHOXYDIBENZOYLMETHANE Change Remove expired transition
CAMPHOR BENZALKONIUM METHOSULFATE Change Remove expired transition
CINOXATE Change Remove expired transition
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE Change Remove expired transition
ETHYLHEXYL TRIAZONE Change Remove expired transition
HOMOSALATE Change Remove expired transition
ISOAMYL METHOXYCINNAMATE Change Remove expired transition
MENTHYL ANTHRANILATE Change Remove expired transition
METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL Change Remove expired transition
OCTOCRYLENE Change Remove expired transition
OCTYL METHOXYCINNAMATE Change Remove expired transition
OCTYL SALICYLATE Change Remove expired transition
OXYBENZONE Change Remove expired transition
PADIMATE O Change Remove expired transition
PEG-25 PABA Change Remove expired transition
PHENYLBENZIMIDAZOLE SULFONIC ACID Change Remove expired transition
POLYSILICONE-15 Change Remove expired transition
SULISOBENZONE Change Remove expired transition
SULISOBENZONE SODIUM Change Remove expired transition
TRIS-BIPHENYL TRIAZINE Change Remove expired transition
TROLAMINE SALICYLATE Change Remove expired transition
ZINC OXIDE Change Remove expired transition
COUMARIN Change Safety review
PROPAN-1-OL Change Substance evaluation
OAKMOSS Removal Synonym of oakmoss absolute