Updates to the Permissible Ingredients Determination for listed medicines

Therapeutic Goods (Permissible Ingredients) Determination No. 5 of 2017

28 November 2017

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in November 2017. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 5 of 2017.

Determination No. 5 of 2017 revokes and replaces the Therapeutic Goods (Permissible Ingredients) Determination No. 4 of 2017 which commenced in September 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 85 changes have been made in the updated Determination. These changes include:

  • The addition of 32 new ingredients.
  • Changes to 53 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.

A complete list of changes to ingredient availability in the table below.

New ingredients

New ingredients
(5E)-3-METHYL-5-CYCLOTETRADECEN-1-ONE
(5Z)-3-METHYL-5-CYCLOTETRADECEN-1-ONE
2-(2-METHYLPHENYL)ETHANOL
2-OCTYL-DODECANAL
2-PENTADECANONE
3-OCTYL ACETATE
4,7-METHANO-1H-INDENEMETHANOL, OCTAHYDRO-, ACETATE
6-METHOXYDICYCLOPENTADIENECARBOXALDEHYDE
ALPHA-2,2,6-TETRAMETHYL-CYCLOHEXENEBUTANAL
BENZYL TIGLATE
BETA-CARYOPHYLLENE ALCOHOL
BETA-IONONE EPOXIDE
BETA-NAPHTHYL ANTHRANILATE
CAMPHOLENIC ALDEHYDE
CHICKEN COMB EXTRACT
CYCLOHEXYLETHYL ACETATE
DIHYDROCUMINYL ALCOHOL
FARNESYL ACETATE
INULIN LAURYL CARBAMATE
ISOAMYL PHENYLETHYL ETHER
LACTITOL
METHYL CHAVICOL
NEROL OXIDE
NERONE
OCTENE-1
PARA-ETHYLPHENOL
PETITGRAIN OIL CITRONNIER
POLYPROPYLENE GLYCOL
STREPTOCOCCUS SALIVARIUS
TREEMOSS ABSOLUTE
VERATROL
VERTONAL

Changed ingredients

A B C D E F G-H-I K L M N O P-Q R S T-U-V-Z

Ingredient Reason for change
4-METHYLBENZYLIDENE CAMPHOR More restrictive requirements
B
BEMOTRIZINOL More restrictive requirements
BENZYLIDENE CAMPHOR SULFONIC ACID More restrictive requirements
BETULA LENTA More restrictive requirements
BETULA NIGRA More restrictive requirements
BETULA PENDULA More restrictive requirements
BIRCH LEAF DRY More restrictive requirements
BIRCH TAR OIL RECTIFIED Correction of error
BUTYL METHOXYDIBENZOYLMETHANE More restrictive requirements
C
CAMPHOR BENZALKONIUM METHOSULFATE More restrictive requirements
CHROMIUM NICOTINATE Correction of error
CINOXATE More restrictive requirements
D
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE More restrictive requirements
E
ERIOBOTRYA JAPONICA More restrictive requirements
ETHYLHEXYL TRIAZONE More restrictive requirements
F
FERRIC PYROPHOSPHATE Correction of error
FILIPENDULA ULMARIA More restrictive requirements
G-H-I
GAULTHERIA PROCUMBENS More restrictive requirements
HOMOSALATE More restrictive requirements
HONEY EXTRACT Less restrictive requirements
ISOAMYL METHOXYCINNAMATE More restrictive requirements
M
MEADOWSWEET HERB DRY More restrictive requirements
MEADOWSWEET HERB POWDER More restrictive requirements
MENTHYL ANTHRANILATE More restrictive requirements
METHYL SALICYLATE More restrictive requirements
METHYLCHLOROISOTHIAZOLINONE More restrictive requirements
METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL More restrictive requirements
METHYLISOTHIAZOLINONE Clarification of requirements; More restrictive requirements
O
OCTOCRYLENE More restrictive requirements
OCTYL METHOXYCINNAMATE More restrictive requirements
OCTYL SALICYLATE More restrictive requirements
OXYBENZONE More restrictive requirements
P-Q
PADIMATE O More restrictive requirements
PEG-25 PABA More restrictive requirements
PHENYLBENZIMIDAZOLE SULFONIC ACID More restrictive requirements
PIPER METHYSTICUM Clarification of requirements
POLYSILICONE-15 More restrictive requirements
POTASSIUM IODIDE Correction of error
PRUNUS AVIUM Purpose expansion
S
SODIUM ASCORBATE Less restrictive requirements
SODIUM CHLORIDE Less restrictive requirements
SODIUM SULFATE Less restrictive requirements
SODIUM SULFATE DECAHYDRATE Less restrictive requirements
SULISOBENZONE More restrictive requirements
SULISOBENZONE SODIUM More restrictive requirements
T-U-V-Z
TITANIUM DIOXIDE More restrictive requirements
TREHALOSE DIHYDRATE Less restrictive requirements
TRIS-BIPHENYL TRIAZINE More restrictive requirements
TROLAMINE SALICYLATE More restrictive requirements
VANILLIN Less restrictive requirements; Correction of error
WINTERGREEN OIL More restrictive requirements
ZINC OXIDE More restrictive requirements
ZINGIBER OFFICINALE Correction of error