Updates to the Permissible Ingredients Determination for listed medicines

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2017

21 April 2017

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in April 2017. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2017.

Determination No. 2 of 2017 revokes and replaces the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2017 which commenced in January 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 159 changes have been made in the updated Determination. These changes include:

  • The addition of 6 new ingredients.
  • Changes to 153 existing ingredient entries, including:
    • clarification of specific requirements for 50 ingredients;
    • making requirements for 2 ingredients less restrictive;
    • name changes for 10 ingredients to better align with international standards for approved ingredient names;
    • changes to the 'purpose of ingredient' of 14 ingredients; and
    • making requirements for 78 ingredients more restrictive.

A complete list of changes to ingredient availability is available below.

New ingredients

  • Active Ingredients
    • Sodium Selenate Decahydrate
  • Excipient Ingredients
    • Alteromonas Ferment Extract
    • Hylocereus Lemairei
    • Pigment Red 57 Barium Lake
    • Saccharide Isomerate
  • Active & Excipient Ingredients
    • Reynoutria Japonica

Changes to ingredients

1-9 A B C D E F G H I K L M N O P R S T U W Y Z

1-9
Ingredient name Applicable changes
1-dodecanol Ingredient requirements made more restrictive
2,5-dimethylpyrazine Clarification of specific requirements
A
Ingredient name Applicable changes
Acid green 25 Ingredient requirements made more restrictive
Acid red 33 Ingredient requirements made more restrictive
Acid-isomerised linalool Ingredient requirements made more restrictive
Allura red ac Ingredient requirements made more restrictive
Allura red ac aluminium lake Ingredient requirements made more restrictive
Allyl isothiocyanate Clarification of specific requirements
Amaranth Ingredient requirements made more restrictive
Amaranth aluminium lake Ingredient requirements made more restrictive
Ambergris extract Ingredient requirements made more restrictive
Annatto Ingredient requirements made more restrictive
Ascorbyl palmitate Clarification of specific requirements
Azovan blue Ingredient requirements made more restrictive
B
Ingredient name Applicable changes
Beet red Ingredient requirements made more restrictive
Betacarotene Ingredient requirements made more restrictive
Brassica chinensis Clarification of specific requirements
Brassica juncea Clarification of specific requirements
Brassica napus Clarification of specific requirements
Brassica nigra Clarification of specific requirements
Brassica oleracea var. Botrytis Clarification of specific requirements
Brassica oleracea var. Capitata Clarification of specific requirements
Brassica oleracea var. Gemmifera Clarification of specific requirements
Brassica oleracea var. Italica Clarification of specific requirements
Brassica oleracea var. Viridis Clarification of specific requirements
Brassica pekinensis Clarification of specific requirements
Brassica rapa Clarification of specific requirements
Brilliant black bn Ingredient requirements made more restrictive
Brilliant blue fcf Ingredient requirements made more restrictive
Brilliant blue fcf aluminium lake Ingredient requirements made more restrictive
Brilliant blue fcf barium lake Ingredient requirements made more restrictive
Brilliant scarlet 4r Ingredient requirements made more restrictive
Brilliant scarlet 4r aluminium lake Ingredient requirements made more restrictive
Brown fk Ingredient requirements made more restrictive
Butylated hydroxyanisole Clarification of specific requirements
C
Ingredient name Applicable changes
C12-13 pareth-3 Change to 'purpose of the ingredient'
Camphor Clarification of specific requirements
Camphor oil brown Clarification of specific requirements
Camphor oil white Clarification of specific requirements
Canola oil Clarification of specific requirements
Carmine Ingredient requirements made more restrictive
Chocolate brown ht Ingredient requirements made more restrictive
Cinnamomum camphora Clarification of specific requirements
Cinnamomum verum Clarification of specific requirements
Cocculus orbiculatus Name change
Cochineal Ingredient requirements made more restrictive
D
Ingredient name Applicable changes
Decahydrospiro(furan-2(3h),5'-(4,7)methano(5h)indene) Ingredient requirements made more restrictive
Dha/epa rich schizochytrium algal oil Ingredient requirements made more restrictive
Dibasic magnesium citrate tetrahydrate Name change
Dibasic magnesium phosphate trihydrate Name change
Dibasic potassium phosphate trihydrate Name change
E
Ingredient name Applicable changes
Eleocharis dulcis Name change
Ethyl isovalerate Ingredient requirements made more restrictive
Eugenol Ingredient requirements made less restrictive
F
Ingredient name Applicable changes
Fast green fcf Ingredient requirements made more restrictive
Food orange 6 Ingredient requirements made more restrictive
Food orange 7 Ingredient requirements made more restrictive
Food red 13 Ingredient requirements made more restrictive
Fortified wine Clarification of specific requirements
G
Ingredient name Applicable changes
Glycerol Ingredient requirements made more restrictive
Glyceryl behenate Change to 'purpose of the ingredient'
H
Ingredient name Applicable changes
High selenium yeast Clarification of specific requirements
Hirschfeldia incana Clarification of specific requirements
Hydrochloric acid Change to 'purpose of the ingredient'
Hydrogenated ethylene/propylene/styrene copolymer Clarification of specific requirements
I
Ingredient name Applicable changes
Indigo carmine Ingredient requirements made more restrictive
Indigo carmine aluminium lake Ingredient requirements made more restrictive
Iron oxide black Ingredient requirements made more restrictive
Iron oxide red Ingredient requirements made more restrictive
Iron oxide yellow Ingredient requirements made more restrictive
L
Ingredient name Applicable changes
Lavandula angustifolia Clarification of specific requirements
Lavandula x intermedia Clarification of specific requirements
Lavender oil Clarification of specific requirements
Levomefolate glucosamine Clarification of specific requirements
Lutein Ingredient requirements made more restrictive
M
Ingredient name Applicable changes
Mace Change to 'purpose of the ingredient'
Macropiper excelsum var excelsum Name change
Malachite green Ingredient requirements made more restrictive
Methyl octin carbonate Ingredient requirements made more restrictive
Monobasic sodium phosphate dihydrate Name change
Mordant red 11 Ingredient requirements made more restrictive
Mustard Clarification of specific requirements
Mustard oil Clarification of specific requirements
Mustard seed oil Clarification of specific requirements
N
Ingredient name Applicable changes
Nitric acid Clarification of specific requirements
O
Ingredient name Applicable changes
Onopordum acanthium Name change
P
Ingredient name Applicable changes
Patent blue v Ingredient requirements made more restrictive
Patent blue v aluminium lake Ingredient requirements made more restrictive
Phenoxyethanol Ingredient requirements made more restrictive
Phloxine b Ingredient requirements made more restrictive
Phloxine b aluminium lake Ingredient requirements made more restrictive
Phosphoric acid Clarification of specific requirements
Phyllanthus emblica Ingredient requirements made less restrictive
Pigment blue 15 Ingredient requirements made more restrictive
Pigment blue 15:1 Ingredient requirements made more restrictive
Pigment green 7 Ingredient requirements made more restrictive
Pigment red 4 Ingredient requirements made more restrictive
Pigment red 53 Ingredient requirements made more restrictive
Pigment red 57 Ingredient requirements made more restrictive
Pigment red 57 aluminium lake Ingredient requirements made more restrictive
Pigment red 63 Ingredient requirements made more restrictive
Pigment white 26 Ingredient requirements made more restrictive
Pigment yellow 12 Ingredient requirements made more restrictive
Ponceau sx Ingredient requirements made more restrictive
Proboscidea parviflora Name change
Protease Clarification of specific requirements
Prussian blue Ingredient requirements made more restrictive
Q
Ingredient name Applicable changes
Quinoline yellow Ingredient requirements made more restrictive
Quinoline yellow aluminium lake Ingredient requirements made more restrictive
R
Ingredient name Applicable changes
Racemic camphor Clarification of specific requirements
Radish Change to 'purpose of the ingredient'
Rape seed oil Clarification of specific requirements
Red 27 Ingredient requirements made more restrictive
Red 27 aluminium lake Ingredient requirements made more restrictive
Rhodamine b Ingredient requirements made more restrictive
Rosmarinus officinalis Clarification of specific requirements
S
Ingredient name Applicable changes
Saccharomyces cerevisiae (boulardii) Change to 'purpose of the ingredient'
Saffron Ingredient requirements made more restrictive
Selenium Clarification of specific requirements
Selenocysteine Clarification of specific requirements
Selenomethionine Clarification of specific requirements
Sinapis alba Clarification of specific requirements
Sodium carbonate monohydrate Change to 'purpose of the ingredient'
Sodium hypochlorite Change to 'purpose of the ingredient'
Sodium selenate Clarification of specific requirements
Sodium selenite Clarification of specific requirements
Sodium selenite pentahydrate Change to 'purpose of the ingredient', Clarification of specific requirements
Sodium sulfite Change to 'purpose of the ingredient'
Solvent green 3 Ingredient requirements made more restrictive
Solvent red 1 Ingredient requirements made more restrictive
Solvent violet 13 Ingredient requirements made more restrictive
Solvent yellow 172 Ingredient requirements made more restrictive
Solvent yellow 33 Ingredient requirements made more restrictive
Spike lavender oil Clarification of specific requirements
Sucrose Change to 'purpose of the ingredient'
Sudan III Ingredient requirements made more restrictive
Sunset yellow fcf Ingredient requirements made more restrictive
Sunset yellow fcf aluminium lake Ingredient requirements made more restrictive
T
Ingredient name Applicable changes
Tannic acid Change to 'purpose of the ingredient'
Tartaric acid Change to 'purpose of the ingredient'
Tartrazine Ingredient requirements made more restrictive
Tartrazine aluminium lake Ingredient requirements made more restrictive
Terminalia ferdinandiana Clarification of specific requirements
Titanium dioxide Clarification of specific requirements
Tomato Change to 'purpose of the ingredient'
U
Ingredient name Applicable changes
Ultramarine Blue Clarification of specific requirements
V
Ingredient name Applicable changes
Vanillin Ingredient requirements made more restrictive
Vat red 1 Ingredient requirements made more restrictive
Vat red 1 aluminium lake Ingredient requirements made more restrictive
Vat red 5 Ingredient requirements made more restrictive
W
Ingredient name Applicable changes
Whole dry milk Name change due to hyphen removal
Y
Ingredient name Applicable changes
Yellow 2G Ingredient requirements made more restrictive
Z
Ingredient name Applicable changes
Zinc methionine sulfate Clarification of specific requirements

A copy of the instrument can be found on the Therapeutic goods determinations page.

More information can be found at Permissible Ingredients Determination: Frequently asked questions.