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Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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International Risk Information

[Australia] Updated list of 'permissible ingredients' for use in listed medicines - list of affected ingredients (2016-10-12)
  • Registration Date 2016-10-13
  • Hit 661

New ingredients
•Active ingredients: ◦Calcified Lithothamnion Species

•Active and excipient ingredients ◦Polyglusam Derived From Aspergillus Niger

•Excipient ingredients: ◦Calcium Alginate
◦Silicified Microcrystalline Cellulose
◦2-Butyl-4,4,6-Trimethyl-1,3-Dioxane
◦2-Methyl-4-(2,2,3-Trimethyl-3-Cyclopentenyl)-2-Buten-1-Ol
◦2-Methyl-4-(Camphenyl-8)-Cyclohexanone
◦2,2-Dimethyl-3-(3-Methyl-2,4-Pentadienyl)-Oxirane
◦4,5-Dimethyl-3-Hydroxy-2(5H)Furanone
◦6-Butyl-3,6-Dihydro-2,4-Dimethyl-2H-Pyran
◦Dupical
◦Glyceryl Undecylenate


Removal of ingredients
•Removal of the name Ethyl Alcohol which is a synonym of another ingredient.

Changes to ingredient requirements
•Less restrictive requirements: ◦Dimethyl Sulfone
◦Glyceryl Behenate
◦Potassium Iodate
◦Ubidecarenone
◦Cistanche Deserticola
◦Cistanche Salsa

•Rewording to clarify existing ingredient requirements without introducing any new requirement: ◦Behenic Acid
◦Curcumin
◦Dioxybenzone
◦Disodium Phenyl Dibenzimidazole Tetrasulfonate
◦Drometrizole Trisiloxane
◦Ecamsule
◦Polygala Senega
◦Zinc Oxide
◦Deer Velvet Antler Powder
◦Deer Velvet Antler Slice
◦Glycerol Ester of Partially Hydrogenated Gum Rosin
◦Glyceryl Rosinate
◦Polyisobutylene

•Minor formatting and typographical corrections: ◦Camphor
◦Camphor Oil Brown
◦Camphor Oil White
◦Cinnamomum Camphora
◦Lavandula Angustifolia
◦Lavandula X Intermedia
◦Lavender Oil
◦Ocimum Kilimandscharicum
◦Racemic Camphor
◦Rosmarinus Officinalis
◦Spike Lavender Oil

•Change to requirements to bring the determination in line with Poisons Standard: ◦Bergamot Oil Coldpressed
◦Lemon Oil
◦Calcium Folinate
◦Lemon
◦Lemon Oil Distilled
◦Lemon Oil Terpenelesss
◦Lemon Peel Dried
◦Lemon Oil Coldpressed
◦Mandarin Oil Coldpressed
◦Orange Flower Oil
◦Orange Oil
◦Orange Oil Bitter Coldpressed
◦Orange Oil Distilled
◦Orange Oil Terpeneless
◦Orange Peel Dried Bitter
◦Petitgrain Oil Paraguay
◦Tangerine Oil Coldpressed


https://www.tga.gov.au/updated-list-permissible-ingredients-use-listed-medicines-list-affected-ingredients

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Written by Risk Information Division