Updates to the Permissible Ingredients Determination for listed medicines

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018

9 July 2018

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination and subsequent amendment were respectively registered on the Federal Register of Legislation (FRL) in June and July 2018. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018. A total of 88 changes have been made in the updated Determination and amendment. These changes include:

  • The addition of 9 new ingredients.
  • Changes to 75 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 requiring warning statements with transitional provisions for existing listed medicines;
    • reflecting existing requirements from the Poisons Standard (SUSMP); 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.
  • Amendment to correct an error that affected 11 existing ingredients that were changed in the original update. This error related to the concentration limits for the mandatory component, arbutin.

The Determination provides transitional arrangements for medicines that are currently listed in the Register to comply with new requirements for ingredients included in the previous Determination, such as new concentration limits or safety information required on product labels. The transitional provisions do not apply to new products that are entered into the Register after the introduction of the new requirements.

A complete list of changes to ingredient availability is below:

New ingredients

  • 2,3-dihydro-1,1-dimethyl-1H-indene-ar-propanal
  • Bis-butyldimeticone polyglyceryl-3
  • C12-22 alkyl acrylate/hydroxyethylacrylate copolymer
  • PEG-10 dimeticone
  • PEG-9 polydimethylsiloxyethyl dimeticone
  • Piperine
  • Sodium metaphosphate
  • Sucrose tristearate
  • Tinospora cordifolia

Removed ingredients

The following ingredients are not currently used in any products and there is either a more appropriate Australian Approved Name available or the ingredient name was insufficiently characterised.

  • Lovage extract
  • Meadowsweet herb powder
  • Mentha x piperita nothosubsp. citrata
  • Raisin

Changed ingredients

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

Ingredient Reason for update
A
ACHILLEA MILLEFOLIUM Reflection of Poisons Standard requirements[1]
ARCTOSTAPHYLOS UVA-URSI Reflection of Poisons Standard requirements[1]
ASTRAGALUS MONGHOLICUS Synonym replacement
B
BENZETHONIUM CHLORIDE Less restrictive requirements
BENZYL ALCOHOL Less restrictive requirements
BETULA LENTA More restrictive requirements
BETULA NIGRA More restrictive requirements
BETULA PENDULA More restrictive requirements
BIRCH LEAF DRY More restrictive requirements
BRONOPOL Less restrictive requirements
C
CALCIUM FOLINATE Clarification of requirements
CHIMAPHILA UMBELLATA Reflection of Poisons Standard requirements[1]
CHLOROBUTANOL HEMIHYDRATE Less restrictive requirements
CHLOROCRESOL Less restrictive requirements
CRESOL Less restrictive requirements
CYSTINE More restrictive requirements
CYSTEINE HYDROCHLORIDE More restrictive requirements
CYSTEINE HYDROCHLORIDE MONOHYDRATE More restrictive requirements
CYSTINE More restrictive requirements
D
DEHYDROACETIC ACID Less restrictive requirements
DIAZOLIDINYL UREA Less restrictive requirements
DIMETICONE 1.5 Less restrictive requirements
DIMETICONE 2 Less restrictive requirements
F
FILIPENDULA ULMARIA More restrictive requirements
FOLIC ACID Clarification of requirements
G
GAULTHERIA PROCUMBENS More restrictive requirements
H
HYDROXYPROPYL DISTARCH PHOSPHATE Less restrictive requirements
I
IMIDUREA Less restrictive requirements
ISOJASMONE Less restrictive requirements
K
KALMIA LATIFOLIA Reflection of Poisons Standard requirements[1]
L
LAUROYL LYSINE Less restrictive requirements
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETICONE Less restrictive requirements
LEDUM PALUSTRE Reflection of Poisons Standard requirements[1]
LEVOMEFOLATE CALCIUM Clarification of requirements
LEVOMEFOLATE GLUCOSAMINE Clarification of requirements
M
MEADOWSWEET HERB DRY More restrictive requirements
MENTHA AQUATICA More restrictive requirements
MENTHA ARVENSIS More restrictive requirements
MENTHA ARVENSIS LEAF OIL More restrictive requirements
MENTHA ARVENSIS OIL More restrictive requirements
MENTHA HAPLOCALYX More restrictive requirements
MENTHA PULEGIUM More restrictive requirements
MENTHA SPICATA More restrictive requirements
MENTHA X CARDIACA More restrictive requirements
MENTHA X PIPERITA More restrictive requirements
MENTHOL More restrictive requirements
METHYL SALICYLATE More restrictive requirements, Purpose expansion
MINT OIL DEMENTHOLISED More restrictive requirements
N
NYCTANTHES ARBOR-TRISTIS More restrictive requirements
O
ORIGANUM MAJORANA Reflection of Poisons Standard requirements[1]
P
PEPPERMINT AMERICAN EXT. More restrictive requirements
PEPPERMINT LEAF DRY More restrictive requirements
PEPPERMINT LEAF POWDER More restrictive requirements
PEPPERMINT OIL More restrictive requirements
PEPPERMINT OIL TERPENELESS More restrictive requirements
PEPPERMINT OIL TERPENES AND TERPENOIDS More restrictive requirements
PHENETHYL ALCOHOL Less restrictive requirements
PHENOL Less restrictive requirements
PHENOXYETHANOL Less restrictive requirements
POLIGLUSAM More restrictive requirements
POTASSIUM IODIDE Correction of error
PYRUS COMMUNIS Reflection of Poisons Standard requirements[1]
PYRUS PYRIFOLIA Reflection of Poisons Standard requirements[1]
Q
QUATERNIUM-15 Less restrictive requirements
R
RHODODENDRON FERRUGINEUM Reflection of Poisons Standard requirements[1]
S
SALICYLIC ACID Reflection of Poisons Standard requirements
SPEARMINT OIL More restrictive requirements
SPEARMINT OIL TERPENELESS More restrictive requirements
T
THYMOL Less restrictive requirements
TRICLOSAN Less restrictive requirements
TURNERA DIFFUSA Reflection of Poisons Standard requirements[1]
U
UBIDECARENONE Clarification of requirements
v
VACCINIUM VITIS-IDAEA Reflection of Poisons Standard requirements[1]
W
WINTERGREEN OIL More restrictive requirements
WOLFIPORIA COCOS Synonym replacement

Footnote

  1. Correction of concentration limits for arbutin.