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Herbal substances - Therapeutic Goods Administration

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HERBAL SUBSTANCES<br />

INGREDIENT NAME<br />

RESTRICTIONS COMMON<br />

NAME<br />

COMPONENTS<br />

NAMES<br />

Atractyloides<br />

japonica<br />

INVALID -----------> Atractylodes japonica<br />

Atractyloides lancea INVALID -----------> Atractylodes lancea<br />

Atractyloides<br />

macrocephala<br />

INVALID -----------> Atractylodes macrocephala<br />

Atractyloides ovata INVALID -----------> Atractylodes lancea<br />

Atropa belladonna AHN + part + prep Listable active if 100 nanograms or less of Belladonna<br />

atropine per mL or gram of product and total Deadly nightshade<br />

belladonna alkaloids concentration in the<br />

product is less than or equal to 10 microgram<br />

per gram or mL.<br />

Registrable if:<br />

0.25% or less of belladonna alkaloids in product<br />

other than as above. Refer Schedule 2 SUSDP.<br />

Or<br />

over 0.25% belladonna alkaloids in product.<br />

Refer Schedule 4 SUSDP.<br />

Dianqiecao<br />

Belladonna Herb AHS alone Atropa belladonna leaf or herb dry as in BP93 Atropa<br />

Dry<br />

[EP3]<br />

Listable active if 100 nanograms or less of<br />

atropine per mL or gram of product and total<br />

belladonna alkaloids concentration in the<br />

product is less than or equal to 10 microgram<br />

per gram or mL.<br />

Registrable if:<br />

0.25% or less of belladonna alkaloids in product<br />

other than as above. Refer Schedule 2 SUSDP.<br />

Or<br />

over 0.25% belladonna alkaloids in product.<br />

Refer Schedule 4 SUSDP.<br />

Belladonna Herb AHS alone Atropa belladonna leaf or herb powder as in<br />

Powder<br />

BP93 [EP3]<br />

Listable active if 100 nanograms or less of<br />

atropine per mL or gram of product and total<br />

belladonna alkaloids concentration in the<br />

product is less than or equal to 10 microgram<br />

per gram or mL.<br />

Registrable if:<br />

0.25% or less of belladonna alkaloids in product<br />

other than as above. Refer Schedule 2 SUSDP.<br />

Or<br />

over 0.25% belladonna alkaloids in product.<br />

Refer Schedule 4 SUSDP.<br />

Belladonna Herb AHS alone Atropa belladonna leaf or herb powder stand. as<br />

Prepared<br />

in BP93 [EP3]<br />

Listable active if 100 nanograms or less of<br />

atropine per mL or gram of product and total<br />

belladonna alkaloids concentration in the<br />

product is less than or equal to 10 microgram<br />

per gram or mL.<br />

Registrable if:<br />

0.25% or less of belladonna alkaloids in product<br />

other than as above. Refer Schedule 2 SUSDP.<br />

Or<br />

over 0.25% belladonna alkaloids in product.<br />

Refer Schedule 4 SUSDP.<br />

Aucklandia lappa INVALID -----------> Saussurea costus Costusroot<br />

Muxiang<br />

227

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