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Update to listed medicine ingredients in December 2020

Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2020
Published

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2020, which commenced on 16 December 2020. This determination replaces the previous instrument, the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2020.

This instrument is updated frequently and there may be a more recent version of the instrument. Ensure you are accessing the current version of the instrument through the Therapeutic Goods Determination page.

A complete list of the 84 changed ingredients is below.

Changed ingredients

IngredientChange typeChange reason
(R)-ALPHA-TERPINYL ACETATEAdditionSafety review
2-(6-METHYL-8-ISOPROPYL BICYCLO(2.2.2)OCT-5-ENE-2-YL)-1,3-DIOXOLANEAdditionSafety review
2,2'-METHYLENEBIS(4-METHYL-6-TERT-BUTYLPHENOL)AdditionSafety review
2-ETHOXY-9-METHYLENE-2,6,6-TRIMETHYLBICYCLO[3.3.1]NONANEAdditionSafety review
2-METHYL-4-(2,2,3-TRIMETHYLCYCLOPENT-3-EN-1-YL)PENT-4-EN-1-OLAdditionSafety review
3-(1-BUTENYL)-PYRIDINEAdditionSafety review
3,4-DIMETHYL PHENYLACETALDEHYDEAdditionSafety review
3-METHYLPENTANOIC ACIDAdditionSafety review
4-(1-ETHOXYVINYL)-3,3,5,5-TETRAMETHYLCYCLOHEXANONEAdditionSafety review
4-(4-HYDROXY-4-METHYLPENTYL)-3-CYCLOHEXENE CARBOXALDEHYDEChangeClarification of requirements
5-ETHYL-2,3-DIMETHYLPYRAZINEAdditionSafety review
6-ETHYLIDENEOCTAHYDRO 5,8-METHANO-2H-1-BENZOPYRANAdditionSafety review
6-METHYLQUINOLINEAdditionSafety review
ACHILLEA MILLEFOLIUMChangeClarification of requirements
ALPHA-SANTALOLAdditionSafety review
ARCTOSTAPHYLOS UVA-URSIChangeClarification of requirements
BENZOTHIAZOLEAdditionSafety review
BORAXChangeClarification of requirements
BORAX PENTAHYDRATEChangeClarification of requirements
BORIC ACIDChangeClarification of requirements
CAFFEINEChangeClarification of requirements
CAMELLIA SINENSISChangeClarification of requirements
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMERChangeRemoval of expired market exclusivity provision
Change of name from ASTER NOVI-BELGII to SYMPHYOTRICHUM NOVI-BELGIIChangeUpdate to ingredient name
Change of name from CALLISTEMON CITRINUS to MELALEUCA CITRINAChangeUpdate to ingredient name
Change of name from CUPRESSUS MACROCARPA to HESPEROCYPARIS MACROCARPAChangeUpdate to ingredient name
Change of name from EICHHORNIA CRASSIPES to PONTEDERIA CRASSIPESChangeUpdate to ingredient name
Change of name from MESPILUS GERMANICA to CRATAEGUS GERMANICAChangeUpdate to ingredient name
Change of name from PLATANUS X ACERIFOLIA to PLATANUS X HISPANICAChangeUpdate to ingredient name
Change of name from SORBUS DOMESTICA to CORMUS DOMESTICAChangeUpdate to ingredient name
Change of name from YUCCA WHIPPLEI to HESPEROYUCCA WHIPPLEIChangeUpdate to ingredient name
Change of name from ULMUS PROCERA to ULMUS MINORChangeUpdate to ingredient name
CHIMAPHILA UMBELLATAChangeClarification of requirements
CITRUS OIL TERPENES AND TERPENOIDSAdditionSafety review
COFFEA ARABICAChangeClarification of requirements
COFFEA CANEPHORAChangeClarification of requirements
COFFEEChangeClarification of requirements
COLA ACUMINATAChangeClarification of requirements
COLA NITIDAChangeClarification of requirements
COUMARINChangeClarification of requirements
DECAHYDRO-1,1,7-TRIMETHYL-3A,7-METHANO-3AH-CYCLOPENTACYCLOOCT-3-YL FORMATEAdditionSafety review
DIETHYL HYDROGEN 2-HYDROXYPROPANE-1,2,3-TRICARBOXYLATEAdditionSafety review
DIMETHYL SULFATERemovalSafety review
ETHYL PYRUVATEAdditionSafety review
FALLOPIA MULTIFLORARemovalSafety review
GLYCEROL ESTER OF PARTIALLY HYDROGENATED WOOD ROSINAdditionSafety review
ILEX PARAGUARIENSISChangeClarification of requirements
ISPAGHULA HUSK DRYChangeClarification of requirements
ISPAGHULA HUSK POWDERChangeClarification of requirements
KALMIA LATIFOLIAChangeClarification of requirements
KHAYA SENEGALENSISChangeRemoval of expired market exclusivity provision
LEDUM PALUSTREChangeClarification of requirements
MALUS PUMILAChangeClarification of requirements
MENTHADIENYL ACETATEAdditionSafety review
METHYLDIBROMO GLUTARONITRILERemovalSafety review
MONOMENTHYL SUCCINATEAdditionSafety review
N,N'-BIS(SALICYLIDENE)PROPYLENEDIAMINEAdditionSafety review
OCTYL CROTONATEAdditionSafety review
ORIGANUM MAJORANAChangeClarification of requirements
PARA-ETHYL CRESOXYACETATEAdditionSafety review
PAULLINIA CUPANAChangeClarification of requirements
PLANTAGO AFRAChangeClarification of requirements
PLANTAGO ARENARIAChangeClarification of requirements
PLANTAGO ASIATICAChangeClarification of requirements
PLANTAGO LANCEOLATAChangeClarification of requirements
PLANTAGO MAJORChangeClarification of requirements
PLANTAGO OVATAChangeClarification of requirements
PLANTAGO SEED DRYChangeClarification of requirements
PSYLLIUM HUSK DRYChangeClarification of requirements
PSYLLIUM HUSK POWDERChangeClarification of requirements
PSYLLIUM SEED DRYChangeClarification of requirements
PYRUS COMMUNISChangeClarification of requirements
PYRUS PYRIFOLIAChangeClarification of requirements
RHODODENDRON FERRUGINEUMChangeClarification of requirements
SODIUM PERBORATEChangeClarification of requirements
SODIUM POLYACRYLATE STARCHChangeRemoval of expired market exclusivity provision
TERPENE RESINAdditionSafety review
THEOBROMA CACAOChangeClarification of requirements
THYMOL METHYL ETHERAdditionSafety review
TRANS-2-OCTENALAdditionSafety review
TURNERA DIFFUSAChangeClarification of requirements
VACCINIUM VITIS-IDAEAChangeClarification of requirements
VITEX AGNUS-CASTUSChangeClarification of requirements
WITHANIA SOMNIFERAChangeClarification of requirements
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