Column 1 Column 2 Column 3 Column 4 Purpose Specific ...

Schedule 1

Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2016 1

Column 1 Column 2

Ingredient Name

Column 3

Purpose

of the

ingredient

in the

medicine

Column 4

Specific requirement(s) applying to

the ingredient in Column 2

710 BACKHOUSIA

CITRIODORA

A,E,H The herbal substance must be derived

from leaf oil only.

Only for use in topical medicines for

dermal application.

The concentration in the medicine

must be no more than 10g/kg or 10g/L

or 1%.

The medicine requires the following

warning statements on the medicine

label:

- (IRRIT) 'If irritation develops -

discontinue use'

- (CHILD3) 'Use in children under 12

years is not recommended'

- (PREGNT) 'Not recommended for

use by pregnant and lactating women'

(or words to that effect).

711 BACOPA MONNIERI A,H

712 BALLOTA NIGRA A,H

713 BALM OF GILEAD

BUD DRY

A,H

714 BALM OF GILEAD

BUD POWDER

A,H

715 BALSAM COPAIBA E Permitted for use only in combination

with other permitted ingredients as a

fragrance.

If used in a fragrance the total

Authorised Version F2016L00588 registered 28/04/2016

Schedule 1


fragrance concentration in a medicine

must be no more than 1%.

716 BAMBUSA

BREVIFLORA

A,E,H

717 BAMBUSA TEXTILIS A,H

718 BANANA E

719 BANANA

DISTILLATE

E Permitted for use only in combination


flavour.

If used in a flavour the total flavour

concentration in a medicine must be

no more than 5%.

720 BAPHICACANTHUS

CUSIA

A,H

721 BAPTISIA CONFUSA A,H

722 BAPTISIA

TINCTORIA

A,H

723 BARBAREA

VULGARIS

A,H

724 BARIUM

CARBONATE

H Only for use as an active

homoeopathic ingredient.

725 BARIUM CHLORIDE H Only for use as an active


726 BARIUM SULFATE E Only for use in topical medicines for

dermal application.

727 BARLEY E Gluten is a mandatory component of

Barley when the route of

administration is other than topical and

mucosal.

When the route of administration is

other than topical or mucosal, the

medicine requires the following

warning statement on the medicine


Schedule 1


label:

- (GLUTEN) 'Contains [insert name of

ingredient]' or words to that effect.

728 BARLEY BRAN E Gluten is a mandatory component of

Barley bran when the route of


mucosal.





label:



729 BARLEY GERM E Gluten is a mandatory component of

Barley germ when the route of


mucosal.





label:



730 BARLEY LEAF E

731 BASIC BUTYLATED

METHACRYLATE

COPOLYMER

E Only for use in oral medicines.

732 BASIC FUCHSIN E Only for use as a colour ingredient in

topical medicines for dermal

application.

733 BASIC RED 1 E Only for use as a colour in topical

medicines for dermal application and

not to be included in medicines


Schedule 1


intended for use in the eye or on

damaged skin.


must be no more than 0.1%.

734 BASIC VIOLET 11:1 E Only for use as a colour in topical

medicines for dermal application and

not intended for use in the eye or on

damaged skin.



735 BASIL OIL

COMOROS

A,E,H Methyl chavicol is a mandatory

component of Basil oil Comoros.

When the concentration of Methyl

chavicol in the medicine is more than

5%, the nominal capacity of the

container must be no more than 25mL.



5% and the nominal capacity of the

container is 25mL or less, a restricted

flow insert must fitted on the

container, and the medicine requires

the following warning statement on

the medicine label:

- (CHILD) 'Keep out of reach of

children' (or words to that effect).

736 BASIL OIL

EUROPEAN

A,E,H Methyl chavicol is a mandatory

component of Basil oil European.




container must be no more than 25mL.




container is 25mL or less, a restricted


Schedule 1


flow insert must fitted on the

container, and the medicine requires


the medicine label:


children' (or words to that effect).

737 BASSIA SCOPARIA A,H

738 BATYL ALCOHOL E Only for use in topical medicines for

dermal application.

739 BAY LEAF E

740 BAY OIL A,E,H When the concentration of Bay oil in

the medicine is more than 25%, the

nominal capacity of the container must

be no more than 25 mL.

When the concentration of Bay oil in

the medicine is more than 25% and the

nominal capacity of the container is no

more than 15 mL, there must be a

restricted flow insert fitted on the

container.

When the concentration of Bay oil in

the medicine is more than 25% and the

nominal capacity of the container is

more than 15 mL, a child resistant

closure and restricted flow insert must

be fitted on the container.



label:


children' (or word to that effect)

- (NTAKEN) 'Not to be taken'

741 BEESWAX -

SYNTHETIC

E


Schedule 1


742 BEESWAX - WHITE E

743 BEESWAX -

YELLOW

E

744 BEESWAX

ABSOLUTE



flavour or a fragrance.



no more than 5%.



must be no more 1%.

745 BEET RED E Permitted for use as a colour for oral

and topical use.

746 BEETROOT E

747 BEGONIA

FIMBRISTIPULA

A,H

748 BEHENETH-10 E Only for use in topical medicines for

dermal application and not to be

included in topical medicines intended

for use in the eye.



Residual levels of ethylene oxide are

to be kept below the level of detection.

749 BEHENIC ACID E If used as an excipient ingredient, the

ingredient can only be in topical

medicines for dermal application.

If the medicine is for oral ingestion, it

must not contain more than 383.5 mg

of behenic acid per maximum

recommended daily dose.


Schedule 1


750 BEHENOXY

DIMETHICONE

E Only for use in topical medicines for

dermal application.

751 BEHENOYL STEARIC

ACID




for use in the eye.



752 BEHENYL ALCOHOL E Only for use in topical medicines for

dermal application.

753 BELLADONNA HERB

DRY

A,H Alkaloids calculated as hyoscyamine

and atropine are mandatory

components of Belladonna herb dry.

The concentration of alkaloids

calculated as hyoscyamine in the

medicine and must be no more than

300 micrograms/Kg or 300

micrograms/L or 0.00003%.

The concentration of atropine in the

medicine must be no more than 100

micrograms/kg or 100 micrograms/L

or 0.00001%.

754 BELLADONNA HERB

POWDER



components of Belladonna herb

powder.


calculated as hyoscyamine in the


micrograms/Kg or 300 micrograms/L

or 0.00003%.

The concentration of atropinein the


micrograms/kg or 100 micrograms/L

or 0.00001%.


Schedule 1


755 BELLADONNA HERB

PREPARED



components of Belladonna herb

prepared and must be declared in the

application.


calculated as hyoscyamine from all

ingredients in the product must be no

more than 300 micrograms/Kg or 300


The concentration of atropine from all


more than 100 micrograms/kg or 100


756 BELLIS PERENNIS A,H

757 BEMOTRIZINOL A Only for use as an active ingredient in

topical sunscreens for dermal

application.



758 BENINCASA

HISPIDA

A,E,H

759 BENTONITE E

760 BENZALDEHYDE E

761 BENZALDEHYDE

GLYCERYL ACETAL



flavour.



no more than 5%.

762 BENZALKONIUM

CHLORIDE


dermal application and nasal sprays.




Schedule 1


763 BENZETHONIUM

CHLORIDE

E Only for use as a preservative in

topical medicines for dermal

application.

The medicine requires the warning

statement:

- (BNZTHC) 'Contains Benzethonium

chloride' (or words to that effect).

764 BENZOIC ACID A,E,H Medicines containing benzoates

require the following warning

statement on the medicine label:

- (TBNZO8) ‘Contains benzoates' (or

words to this effect)’ if the medicine

contains two or more benzoate sources

or ‘Contains [insert the approved name

of benzoate used] (or words to this

effect)’ if product contains one

benzoate source.

765 BENZOIN E Permitted for use only in combination


fragrance.




766 BENZOIN SIAM A,E,H

767 BENZOIN SUMATRA A,E,H

768 BENZOPHENONE E Permitted for use only in combination





no more than 5%.




Schedule 1


must be no more 1%.

769 BENZYL ACETATE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

770 BENZYL ALCOHOL E The medicine requires the warning

statement:

- (BNZALC) 'Contains benzyl alcohol

[quantity]' (or words to that effect).

771 BENZYL BENZOATE E Only for use in topical medicines for

dermal application.

Medicines containing benzoates

require the warning statement:

- (TBNZO8) 'Contains benzoates' (or

words to this effect) if the medicine

contains two or more benzoate sources

or 'Contains [insert the approved name

of benzoate used]' (or words to this

effect) if product contains one

benzoate source.

772 BENZYL BUTYRATE E Permitted for use only in combination





no more than 5%.



must be no more 1%.


Schedule 1


773 BENZYL

CINNAMATE



included in medicines intended for use

in the eye.



774 BENZYL DIMETHYL

CARBINYL-N-

BUTYRATE



flavour.



no more than 5%.

775 BENZYL FORMATE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

776 BENZYL ISOAMYL

ETHER



fragrance.




777 BENZYL

ISOBUTYRATE






no more than 5%.




Schedule 1


must be no more 1%.

778 BENZYL

ISOVALERATE






no more than 5%.



must be no more 1%.

779 BENZYL LAURATE E Permitted for use only in combination


fragrance.




780 BENZYL

PHENYLACETATE






no more than 5%.



must be no more 1%.

781 BENZYL

PROPIONATE






no more than 5%.



must be no more 1%.


Schedule 1


782 BENZYL

SALICYLATE






no more than 5%.



must be no more 1%.

783 BENZYLIDENE

ACETONE






no more than 5%.




784 BENZYLIDENE

CAMPHOR

SULFONIC ACID

A Only for use as an active ingredient in

sunscreens for dermal application.

The concentration in the preparation

must be no more than 6% (as acid).

785 BERBERIS

AQUIFOLIUM

A,H

786 BERBERIS

ARISTATA

A Only for use in oral medicines.



label:

- (PREGNT) 'Not recommended for

use by pregnant and lactating women'


787 BERBERIS

VULGARIS

A,E,H


Schedule 1


788 BERGAMOT OIL E Permitted for use only in combination





no more than 5%.



must be no more 1%.

789 BERGAMOT OIL

BERGAPTEN-FREE






no more than 5%.



must be no more 1%.

790 BERGAMOT OIL

COLDPRESSED

A,E,H When for internal use, Oxedrine is a

mandatory component of bergamot oil

coldpressed.

The maximum recommended daily

dose must not provide more than 30

mg of Oxedrine.

The ingredient bergamot oil

coldpressed is subject to the following

conditions :

a) steam distilled or rectified;

b) in preparations for internal use;

c) in preparations containing 0.4 % or

less of bergamot oil;

d) in soaps or bath and shower gels

that are washed off the skin;

e) The medicine requires the following


Schedule 1



label:

- (SENS) 'Application to skin may

increase sensitivity to sunlight' (or

words to that effect).

791 BERGAMOT OIL

TERPENELESS



flavour.



no more than 5%.

792 BERTHOLLETIA

EXCELSA

A,E,H

793 BETA-

CARYOPHYLLENE






no more than 5%.



must be no more 1%.

794 BETA-

DAMASCENONE






no more than 5%.



must be no more 1%.

795 BETA-DAMASCONE E Permitted for use only in combination




Schedule 1




no more than 5%.



must be no more 1%.

796 BETA-HOMO

CYCLOCITRAL



flavour.



no more than 5%.

797 BETA-HYDROXY-

BETA-

METHYLBUTYRIC

ACID

A

798 BETA-IONONE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

799 BETA-ISO-METHYL

IONONE



fragrance.




800 BETA-METHYL

NAPHTHYL KETONE






Schedule 1



no more than 5%.



must be no more 1%.

801 BETA-N-METHYL

IONONE






no more than 5%.



must be no more 1%.

802 BETA-NAPHTHOL

ETHYLETHER






no more than 5%.



must be no more 1%.

803 BETA-NAPHTHOL

METHYL ETHER






no more than 5%.



must be no more 1%.

804 BETA-NAPHTHYL

ISOBUTYL ETHER




Schedule 1





no more than 5%.



must be no more 1%.

805 BETA-PINENE E Permitted for use only in combination


flavour or fragrance.



no more than 5%.




806 BETA-TOCOPHEROL E

807 BETA RAPA A,E,H

808 BETA VULGARIS A,E,H

809 BETA,4-

DIMETHYLCYCLOH

EX-3-ENE-1-

PROPAN-1-AL



fragrance.




810 BETACAROTENE A,E

811 BETADEX E

812 BETAGLUCAN E Only for use in topical medicines for



in the eye.



Schedule 1



813 BETAINE E Only for use in topical medicines for

dermal application.

814 BETAINE

HYDROCHLORIDE

E

815 BETULA LENTA A,H Methyl salicylate is a mandatory

component of Betula lenta.


dermal application.

The concentration of methyl salicylate

in the medicine must be no more than

0.001%.

When the concentration of methyl

salicylate in a liquid preparation is

more than 5%, and the dosage form is

other than spray, the medicine requires

child resistant packaging.




spray, the medicine does not require

child resistant packaging but the

delivery device must be engaged into

the container in such a way that

prevents it from being readily

removed, direct suction through the

delivery device results in delivery of

no more than one dosage unit, and

actuation of the spay device is

ergonomically difficult for young

children to accomplish.

816 BETULA NIGRA A,E,H

817 BETULA PENDULA A,E,H Methyl salicylate is a mandatory

component of Betula pendula.



Schedule 1


dermal application.

The concentration of methyl salicylate


0.001%.




other than spray, the medicine requires

child resistant packaging.




spray, the medicine does not require

child resistant packaging but the

delivery device must be engaged into

the container in such a way that

prevents it from being readily

removed, direct suction through the

delivery device results in delivery of

no more than one dosage unit, and

actuation of the spay device is

ergonomically difficult for young

children to accomplish.

818 BETULA PUBESCENS A,E,H

819 BICYCLO(2.2.1)HEPT

-5-ENE-2-

CARBOXYLIC ACID,

3-(1-

METHYLETHYL)-,

ETHYL ESTER,

(1R,2R,3R,4S)-REL-



fragrance.




820 BICYCLO(2.2.2)OCT-

5-ENE-2-

CARBOXALDEHYDE,

6-METHYL-8-(1-

METHYLETHYL)-



fragrance.





Schedule 1


821 BIFIDOBACTERIUM

ADOLESCENTIS

A

822 BIFIDOBACTERIUM

ANIMALIS

A

823 BIFIDOBACTERIUM

ANIMALIS SSP

ANIMALIS

A

824 BIFIDOBACTERIUM

ANIMALIS SSP

LACTIS

A

825 BIFIDOBACTERIUM

BIFIDUM

A

826 BIFIDOBACTERIUM

BREVE

A

827 BIFIDOBACTERIUM

INFANTIS

A

828 BIFIDOBACTERIUM

LACTIS

A

829 BIFIDOBACTERIUM

LONGUM

A

830 BILBERRY E

831 BIOSACCHARIDE

GUM-1




for use in the eye.



832 BIOTA ORIENTALIS A,H

833 BIOTIN A,E When used as an active ingredient and

the route of administration is oral or

sublingual, the medicine requires the

following warning statement on the

medicine label:


Schedule 1


- (VIT) ‘Vitamins can only be of

assistance if the dietary vitamin intake

is inadequate.’ or ‘Vitamin

supplements should not replace a

balanced diet.’

834 BIRCH LEAF DRY A,E,H

835 BIRCH TAR OIL

RECTIFIED

A,E,H

836 BIS-DIGLYCERYL

POLYACYLADIPATE

-2


dermal application.

837 BIS-ETHYLHEXYL

HYDROXYDIMETHO

XY

BENZYLMALONATE




in the eye.



838 BIS-MACROGOL 900

METHYL ETHER

DIMETHYL SILANE




in the eye or on damaged skin.



839 BIS-PEG-12

DIMETHICONE

BEESWAX




in the eye.



840 BIS-STEARYL

ETHYLENEDIAMINE/

NEOPENTYL

GLYCOL/STEARYL

HYDROGENATED

DIMER

DILINOLEATE




in the eye.



Schedule 1


COPOLYMER must be no more than 7%.

841 BISABOLENE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

842 BISABOLOL E If used as an excipient, the medicine is

only for use in topical medicines for

dermal application.

843 BITTER ALMOND

OIL



flavour.



no more than 5%.

The absence of amygdalin in the

medicine must be declared.

844 BIXA ORELLANA A,E,H

845 BLACK COHOSH

DRY

A,H The medicine requires the following


label:

- (BCOHOSH) 'Warning: In very rare

cases - black cohosh has been

associated with liver failure. If you are

experiencing yellowing of the skin or

whites of the eyes - dark urine - nausea

- vomiting - unusual tiredness -

weakness - stomach or abdominal pain

- and/or loss of appetite - you should

stop using this product and see your

doctor.'


Schedule 1


846 BLACK COHOSH

POWDER



label:

- (BCOHOSH) 'Warning: In very rare

cases - black cohosh has been

associated with liver failure. If you are

experiencing yellowing of the skin or

whites of the eyes - dark urine - nausea

- vomiting - unusual tiredness -

weakness - stomach or abdominal pain

- and/or loss of appetite - you should

stop using this product and see your

doctor.'

847 BLACK CURRANT E

848 BLACK CURRANT

ABSOLUTE






no more than 5%.



must be no more 1%.

849 BLACK CURRANT

FRESH

A,E,H

850 BLACK CURRANT

SEED OIL



flavour.



no more than 5%.

851 BLACK OF

CURACAO SPIDER



852 BLACK PEPPER OIL A,E,H


Schedule 1


853 BLACK RASPBERRY E Permitted for use only in combination


flavour.



no more than 5%.

854 BLACKBERRY E

855 BLACKBERRY OILS E Permitted for use only in combination


flavour.



no more than 5%.

856 BLACKBERRY WINE E Permitted for use only in combination


flavour.



no more than 5%.

857 BLACKCURRANT

ESTERS



flavour.



no more than 5%.

858 BLACKCURRANT

JUICE



flavour.



no more than 5%.

859 BLADDERWRACK

DRY

A,H Iodine is a mandatory component of

Bladderwrack dry.

Only for external use when the


Schedule 1


concentration of available iodine in the

medicine (excluding salts derivatives

or iodophors) is more than 2.5%.

Only for internal use when the

medicine contains less than 300

micrograms of iodine per maximum


The indication 'For mineral (may state

the mineral) supplementation' is only

permitted when the medicine is for

oral or sublingual use.

860 BLADDERWRACK

POWDER

A,E,H Iodine is a mandatory component of

Bladderwrack powder.













861 BLAINVILLEA

ACMELLA

A,E,H

862 BLETILLA STRIATA A,H

863 BLUE FLAG

RHIZOME DRY

A,H

864 BLUE FLAG

RHIZOME POWDER

A,H

865 BLUEBERRY E Permitted for use only in combination



Schedule 1


flavour.



no more than 5%.

866 BLUEBERRY JUICE E Permitted for use only in combination


flavour or fragrance.



no more than 5%.




867 BLUMEA LACERA A,H

868 BOEHMERIA NIVEA A,H

869 BOERHAVIA

DIFFUSA

A,H

870 BOERHAVIA REPENS A,H

871 BOGBEAN LEAF

DRY

A,H

872 BOGBEAN LEAF

POWDER

A,H

873 BOIS DE ROSE OIL A,E,H

874 BOMBAX CEIBA A,H

875 BORAGO

OFFICINALIS

A,E,H

876 BORAX A,E,H Boron is a mandatory component of

Borax.

Based on molecular weights the

accepted percentage of Boron from

borax is 11.34%.


Schedule 1


The declared quantity of boron from

borax must be no less than 10.7% and

must be no more than 12.3% of the

Borax in the formulation. These

figures incorporate a 5% variance to

allow for rounding in calculations.


dose must provide no more than 3mg

of Boron.

In preparations for dermal use, which

are not for paediatric or antifungal use,

the concentration of boron in the


mg/kg or 3500 mg/L or 0.35%.



permitted for use when the medicine is

for oral or sublingual use.

877 BORAX

PENTAHYDRATE

A,E Boron is a mandatory component of

Borax pentahydrate.



borax pentahydrate is 14.84%. The

declared quantity of boron from borax

pentahydrate must be no less than

14.1% and must be no more than

15.6% of the Borax pentahydrate in

the formulation. These figures

incorporate a 5% variance to allow for

rounding in calculations.



of Boron.






Schedule 1


mg/kg or 3500 mg/L or 0.35%.





878 BORIC ACID A,H Boron is a mandatory component of

Boric acid.



boric acid is 17.49%. The declared

quantity of boron from boric acid must

be no less than 16.4% and must be no

more than 18.5% of the Boric acid in






of Boron.





mg/kg or 3500 mg/L or 0.35%





879 BORNEOL E Permitted for use only in combination





no more than 5%.




Schedule 1


must be no more 1%.

880 BORNYL ACETATE E Permitted for use only in combination


fragrance.




881 BORON H Only for use as an active


When for internal use, the maximum

recommended daily dose must not

provide more than 6 mg of boron.

When for dermal use, which are not

for paediatric or antifungal use, the

concentration of boron from all

ingredients in the product must not

exceed 3500 mg/kg or 3500 mg/L or

0.35%.

882 BORON NITRIDE E Only for use in topical medicines for



in the eye.



883 BORONIA

ABSOLUTE






no more than 5%.



must be no more 1%.

884 BORONIA E Permitted for use only in combination



Schedule 1


MEGASTIGMA flavour.



no more than 5%.

885 BOSWELLIA

CARTERII

A,E,H

886 BOSWELLIA

SERRATA

A,E,H

887 BOSWELLIA

THURIFERA

A,H

888 BOTRYTIS CINEREA A,H

889 BOVINE CALCIUM

CHONDROITIN

SULFATE

A

890 BOVINE POTASSIUM

CHONDROITIN

SULFATE

A

891 BOVINE WHEY IG-

RICH FRACTION




label:

- (COWMK) 'Derived from cows milk'

- (BABY3) 'Not suitable for use in

children under the age of 12 months -

except on the advice of a health

professional)'.

892 BRANDY E

893 BRASSICA

CHINENSIS

A,H Allyl isothiocyanate is a mandatory

component of Brassica chinensis when

the plant part is seed.




Schedule 1


mg of allyl isothiocyanate.

894 BRASSICA JUNCEA A,H Allyl isothiocyanate is a mandatory

component of Brassica juncea when

the plant part is seed.




895 BRASSICA NAPUS A,E,H Allyl isothiocyanate is a mandatory

component of Brassica napus when the

plant part is seed.




896 BRASSICA NIGRA A,H Allyl isothiocyanate is a mandatory

component of Brassica nigra when the

plant part is seed.




897 BRASSICA

OLERACEA VAR.

BOTRYTIS

A,E,H Allyl isothiocyanate is a mandatory

component of Brassica oleracea var.

botrytis when the plant part is seed.




898 BRASSICA

OLERACEA VAR.

CAPITATA

A,E,H Allyl isothiocyanate is a mandatory


capitata when the plant part is seed.




899 BRASSICA

OLERACEA VAR.

GEMMIFERA



gemmifera when the plant part is seed.


Schedule 1





900 BRASSICA

OLERACEA VAR.

ITALICA


component of Brassica oleracea var

italica when the plant part is seed.




901 BRASSICA

OLERACEA VAR.

VIRIDIS



viridis when the plant part is seed.




902 BRASSICA

PEKINENSIS


component of Brassica pekinensis

when the plant part is seed.




903 BRASSICA RAPA A,E,H Allyl isothiocyanate is a mandatory

component of Brassica rapa when the

plant part is seed.




904 BRAZIL NUT E

905 BRILLIANT BLACK

BN

E Permitted for use as a colour for oral

and topical use.

906 BRILLIANT BLUE

FCF


and topical use.

907 BRILLIANT BLUE

FCF ALUMINIUM


and topical use.


Schedule 1


LAKE

908 BRILLIANT BLUE

FCF BARIUM LAKE


and topical use.

909 BRILLIANT

SCARLET 4R


and topical use.

910 BRILLIANT

SCARLET 4R

ALUMINIUM LAKE


and topical use.

911 BRIZA MEDIA A,H

912 BROCCOLI E

913 BROMELAINS A May be derived from either the stem

or fruit of the pineapple (Ananas

comosus).

If used in a divided preparation, the

allowed units are papain units and

million papain units.

If used in an undivided preparation,

the allowed units are million papain

units per gram.

914 BROMINE H Only for use as an active


The concentration of bromine in the

preparation must be no more than

14mg/Kg or 14mg/L or 0.0014% for

oral and sublingual use.

915 BROMOSTYROL E Not for use in infants

Permitted for use only in combination


fragrance.





Schedule 1


916 BROMUS

CATHARTICUS

A,H

917 BROMUS INERMIS A,H

918 BROMUS RAMOSUS

SUBSP. RAMOSUS

A,H

919 BRONOPOL E Only for use as an excipient in topical


The medicine requires the warning

statement:

- (BRONOP) 'Contains bronopol

[quantity]' (or words to that effect).

920 BROUSSONETIA

PAPYRIFERA

A,H

921 BROWN FK E Permitted for use as a colour for

topical use.

922 BRUNFELSIA

UNIFLORA

A,H The maximum daily dose must be no

more than the equivalent of 1mg of the

dry herbal material.

923 BRUSSEL SPROUT E

924 BRYONIA ALBA A,H

925 BRYONIA DIOICA A,H

926 BUCHU LEAF DRY A,H

927 BUCHU LEAF OIL E Permitted for use only in combination





no more than 5%.



must be no more 1%.


Schedule 1


928 BUCHU LEAF

POWDER

A,E,H

929 BUCKWHEAT E,H Only for use as an active

homoeopathic or excipient ingredient.

930 BUDDLEJA

OFFICINALIS

A,H

931 BULNESIA

SARMIENTI

A,E,H

932 BUNIAS ORIENTALIS A,H

933 BUPLEURUM

FALCATUM

A,H

934 BURDOCK LEAF

DRY

A,H

935 BURDOCK LEAF

POWDER

A,H

936 BURDOCK ROOT

DRY

A,H

937 BURDOCK ROOT

POWDER

A,H

938 BUTAN-1-OL E The residual solvent limit for Butan-1-

ol is 50 mg per maximum




939 BUTANE E Only for use as an excipient propellant

ingredient.

940 BUTOXYETHANOL E Only for use in topical medicines for



in the eye.




Schedule 1


941 BUTTER E

942 BUTTER ACIDS E Permitted for use only in combination


flavour.



no more than 5%.

943 BUTTER ESTERS E Permitted for use only in combination


flavour.



no more than 5%.

944 BUTTER STARTER

DISTILLATE



flavour.



no more than 5%.

945 BUTTERMILK -

DRIED

E

946 BUTYL 2-

METHYLBUTYRATE



flavour.



no more than 5%.

947 BUTYL ACETATE E The residual solvent limit for Butyl

acetate is 50 mg per maximum




948 BUTYL BUTYRATE E Permitted for use only in combination



Schedule 1





no more than 5%.



must be no more 1%.

949 BUTYL BUTYRYL

LACTATE






no more than 5%.



must be no more 1%.

950 BUTYL CAPROATE E Permitted for use only in combination


flavour.



no more than 5%.

951 BUTYL ESTER OF

PVM/MA

COPOLYMER




in the eye.





label:

- (EYE) 'Avoid contact with eyes' (or

words to that effect)

- (EYE2) 'May be irritant to the eyes'


Schedule 1



952 BUTYL FORMATE E Permitted for use only in combination


flavour.



no more than 5%.

953 BUTYL

HYDROXYBENZOAT

E


dermal application.

Medicines containing

hydroxybenzoates require the


medicine label:

- (TOTBNZ) ‘Contains

hydroxybenzoates’ (or words to this

effect) if the medicine contains more

than one hydroxybenzoate source OR

‘Contains [insert the approved name of

hydroxybenzoate used]’ (or words to

this effect) if product contains one

hydroxybenzoate source.

954 BUTYL

ISOBUTYRATE



flavour.



no more than 5%.

955 BUTYL

ISOVALERATE



flavour.



no more than 5%.

956 BUTYL LACTATE E Permitted for use only in combination



Schedule 1


flavour.



no more than 5%.

957 BUTYL LEVULINATE E Permitted for use only in combination


flavour.



no more than 5%.

958 BUTYL

METHOXYDIBENZO

YLMETHANE


sunscreens for dermal application and


intended for use in the eye.

The concentration in preparation must

be no more than 5%.

959 BUTYL PROPIONATE E Permitted for use only in combination


flavour.



no more than 5%.

960 BUTYL STEARATE E Only for use in topical medicines for

dermal application.

961 BUTYL

UNDECYLENATE






no more than 5%.



must be no more 1%.

962 BUTYLATED E The medicine requires the warning


Schedule 1


HYDROXYANISOLE statement:

- (BHANIS) 'Contains butylated

hydroxyanisole' (or words to that

effect).

963 BUTYLATED

HYDROXYTOLUENE

E

964 BUTYLENE GLYCOL

DICAPRYLATE/DICA

PRATE




in the eye.



965 BUTYLENE/ETHYLE

NE/STYRENE

COPOLYMER -

HYDROGENATED


dermal application.

The combined concentration of

Butylene/ethylene/stryene copolymer -

hydrogenated and

ethylene/propylene/styrene copolymer

- hydrogenated in the medicine must

be no more than 9%.

966 BUTYLIDENE

PHTHALIDE



flavour.



no more than 5%.

967 BUTYLOCTYL

SALICYLATE




in the eye.



968 BUTYLPHENYL

METHYLPROPIONAL




Schedule 1





no more than 5%.



must be no more 1%.

969 BUTYRALDEHYDE E Permitted for use only in combination


flavour.



no more than 5%.

970 BUTYRIC ACID E Permitted for use only in combination





no more than 5%.



must be no more 1%.

971 C1-8 ALKYL

TETRAHYDROXYCY

CLOHEXANOATE




in the eye.



972 C10-12

ALKANE/CYCLOALK

ANE



fragrance.





Schedule 1


973 C10-30

CHOLESTEROL/LAN

OSTEROL ESTERS


dermal application.

974 C11-14-ISO-

ALCOHOL C-13 RICH



fragrance.




975 C12-13 PARETH-23 E Only for use in topical medicines for



in the eye.



Residual levels of 1,4-dioxane and

ethylene oxide (and related

substances) are to be kept below the

level of detection.




in the eye.



Residual levels of 1,4-dioxane and

ethylene oxide (and related

substances) are to be kept below the

level of detection.

977 C12-15 ALKYL

LACTATE




in the eye.




Schedule 1


978 C12-15 ALKYL

OCTANOATE


dermal application.

979 C12-20 ACID PEG-8

ESTER




in the eye.



980 C12-20 ALKYL

GLUCOSIDE




in the eye.



981 C13-14 ISOPARAFFIN E Only for use in topical medicines for

dermal application.

982 C14-22 ALCOHOLS E Only for use in topical medicines for



in the eye.



983 C15-19 ALKANE E Only for use in topical medicines for



in the eye.



984 C18-36 ACID

GLYCOL ESTER

E Only for use topical medicines for

dermal application.

985 C18-36 ACID

TRIGLYCERIDE


dermal application.

986 C2-OCTENAL E Permitted for use only in combination



Schedule 1


flavour.



no more than 5%.

987 C20-40 ALCOHOLS E Only for use in topical medicines for

dermal application.

988 C20-40 ALKYL

STEARATE




in the eye.






in the eye.






in the eye.



991 C30-45 ALKYL

CETEARYL

DIMETICONE

CROSSPOLYMER




in the eye.



992 C6-14 OLEFIN

POLYMERS -

HYDROGENATED




in the eye.


Schedule 1




993 C9-11 ISOPARAFFIN E Only for use in topical medicines for

dermal application.


dermal application.

995 C9-15 ALKYL

PHOSPHATE




in the eye.


must be no more than 0.12%

996 CABBAGE E

997 CABREUVA OIL E Permitted for use only in combination


fragrance.




998 CADE OIL A,E,H

999 CAESALPINIA

SAPPAN

A,H

1000 CAFFEINE A,E When used as an excipient, only for

use in topical medicines for dermal

application.

Only for use as an active ingredient for

oral use in adults when the medicine

consists principally of one or more

designated active ingredients

prescribed in Schedule 14 to the

Regulations 1990 (other than

caffeine); and contains no more than

100 mg of caffeine per maximum daily

dose.


Schedule 1


Medicines for oral use containing

caffeine as an active ingredient require


the medicine label:

- (ADULT) 'Adults only' (or words to

that effect).


oral or sublingual and the medicine

provides a maximum recommended

daily dose of:

a) more than 1 mg but no more than

10 mg of caffeine the medicine

requires the following warning


- (CAFFR) 'The recommended dose of

this medicine provides small amounts

of caffeine.'

b) more than 10 mg of caffeine the



label:

- (CAFF) 'Contains caffeine [state

quantity per dosage unit or per mL or

per gram of product]'.

1001 CAJUPUT OIL A,E,H Cineole is a mandatory component of

Cajuput oil.

When the concentration in the

medicine is more than 25%, the




medicine is more than 25% and the


more than 15 mL, a child resistant

closure and restricted flow insert must

be fitted on the container.


Schedule 1



medicine is more than 25% and the


less than 15 mL, a restricted flow

insert must be fitted to the container.


medicine is more than 25%, the



label:



- (NTAKEN) 'Not to be taken'.

When the concentration of cineole in

the preparation is more than 25%, the


not be more than 25 mL.


the preparation is more than 25% and

the nominal capacity of the container

is more than 15 mL but no more than

25mL, the medicine must have a child

resistant closure and restricted flow

insert fitted on the container and the



label:







is no more than 15 mL, the medicine

must have the restricted flow insert

fitted on the container and the



Schedule 1



label:




1002 CALAMINE A,E Only for use as an active or excipient

ingredient for dermal application.

When used as an active ingredient, can

only be supplied as an uncompounded

medicine substance packed for retail

sale and must comply with an

uncompounded substance monograph

of the British Pharmacopeia.

1003 CALCIFIED

LITHOTHAMNION

TOPHIFORME

A Only for oral use.

1004 CALCIUM AMINO

ACID CHELATE

A,E,H May only be used as a source of

calcium.

Calcium is a mandatory component of

Calcium amino acid chelate.

The concentration of Calcium in the

medicine must be no more than 25%

of the Calcium amino acid chelate in

the formulation.

The following indications are only


oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May

assist in the prevention and/or

treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium.

Women's calcium requirements are

increased after menopause. Calcium

supplementation may be of assistance

in the prevention and/or treatment of


Schedule 1


osteoporosis’

- (CALC1) ‘Source of calcium.


increased after menopause’

- (CALC2) ‘Source of calcium. A

calcium supplement formulated to

strengthen bone and tissue in growing

and mature users. (or) Source of

calcium. A calcium supplement

formulated to strengthen bone and

tissue for children and older adults’


Adequate dietary calcium in our youth

and throughout life is required to

maximise bone’

- (CALC4) ‘Source of calcium. A diet

deficient in calcium can lead to

osteoporosis in later life.’

The indication ‘For mineral (may state

the mineral) supplementation’ is only



1005 CALCIUM

ASCORBATE

A,E,H Based on molecular weights the

accepted percentage of Calcium from

Calcium ascorbate is 10.3%. The

declared quantity of Calcium from

Calcium ascorbate must be no less

than 9.8% and must be no more than

10.8% of the Calcium ascorbate in the

formulation. These figures incorporate

a 5% variance to allow for rounding in

calculations.


accepted percentage of Ascorbic acid

from Calcium ascorbate is 90.3%. The

declared quantity of Ascorbic acid

from Calcium ascorbate must be no

less than 84.9% and must be no more


Schedule 1


than 95.3% of the Calcium ascorbate

in the medicine. These figures














osteoporosis’














maximise bone’









Schedule 1


1006 CALCIUM

ASCORBATE

DIHYDRATE

A,E,H Based on molecular weights the

accepted percentage of Ascorbic acid

from Calcium ascorbate dihydrate is

82.7%. The declared quantity of

Ascorbic acid from Calcium ascorbate

dihydrate must be no less than 77.8%

and must be no more than 87.2% of

the Calcium ascorbate dihydrate in the

formulation. These figures





Calcium ascorbate dihdrate is 9.4%.

The declared quantity of Calcium from

Calcium ascorbate dihydrate must be

no less than 8.9% and must be no

more than 9.9% of the Calcium

ascorbate dihydrate in the formulation.

These figures incorporate a 5%

variance to allow for rounding in

calculations.












osteoporosis’







Schedule 1










maximise bone’








1007 CALCIUM

ASPARTATE

A Calcium is a mandatory component of

Calcium aspartate and availability is

restricted to use as a source of the

relevant mineral only.



Calcium aspartate must be no less than


24.59% of the Calcium aspartate in the



calculations.











Schedule 1




osteoporosis’














maximise bone’








1008 CALCIUM

ASPARTATE

HYDROCHLORIDE

DIHYDRATE


oral medicines.


Calcium aspartate hydrochloride

dihydrate and availability is restricted

to use as a source of the relevant

mineral only. Based on molecular

weights the declared quantity of

Calcium from Calcium aspartate

hydrochloride dihydrate must be no

less than 15.63% and no more than

17.27% of the Calcium aspartate

hydrochloride dihydrate in the



Schedule 1



calculations.












osteoporosis’














maximise bone’








1009 CALCIUM E Behenic acid is a mandatory


Schedule 1


BEHENATE component of Calcium behenate.

When for oral ingestion, the maximum

recommended daily dose must not

provide more than 383.5 mg of

Behenic acid.

1010 CALCIUM BETA-

HYDROXY-BETA-

METHYLBUTYRATE

A,H The declared quantity of Calcium from

Calcium beta-hydroxy-beta-

methylbutryate must be no less than


15.3% of the Calcium beta-hydroxy-

beta-methylbutryate in the



calculations.












osteoporosis’













Schedule 1




maximise bone’




1011 CALCIUM BETA-

HYDROXY-BETA-

METHYLBUTYRATE

MONOHYDRATE

A,H The declared quantity of Calcium from

Calcium beta-hydroxy-beta-

methylbutryate monohydrate must be


more than 14.45% of the Calciumbeta-

hydroxy-beta-methylbutryate

monohydrate in the formulation. These














osteoporosis’












Schedule 1





maximise bone’




1012 CALCIUM

CARBONATE

A,E,H If used as an active ingredient and the

medicine is intended as a mineral

supplementation, calcium is a

mandatory component of Calcium

carbonate.



Calcium carbonate is 40.1%. The


Calcium carbonate must be no less


42.3% of the Calcium carbonate in the



calculations.












osteoporosis’





Schedule 1












maximise bone’








1013 CALCIUM

CASEINATE

E

1014 CALCIUM

CHLORIDE

DIHYDRATE

E

1015 CALCIUM CITRATE A,E,H If used as an active ingredient and the




citrate.



Calcium citrate is 24.1%. The declared

quantity of calcium from Calcium

citrate must be no less than 22.9% and

must be no more than 25.3% of the

Calcium citrate in the formulation.




Schedule 1


calculations.












osteoporosis’














maximise bone’








1016 CALCIUM CITRATE

TETRAHYDRATE





Schedule 1


mandatory component of calcium

citrate tetrahydrate.

The amount of calcium in the active

ingredient should be calculated based

on the molecular weight of calcium

citrate tetrahydrate.












osteoporosis’














maximise bone’







Schedule 1




1017 CALCIUM

DIASPARTATE

A Only for use as active ingredient in

oral medicines. Calcium is a


diaspartate and availability is restricted

to use as a source of the relevant

mineral only.



Calcium diaspartate must be no less


13.83% of the Calcium diaspartate in















osteoporosis’











Schedule 1






maximise bone’








1018 CALCIUM FLUORIDE H Based on molecular weights the

accepted percentage of Fluoride from

Calcium fluoride is 48.7%. The

declared quantity of fluoride from

Calcium fluoride must be no less than


51.1% of the Calcium fluoride in the




In medicines for dental use, when

containing more than 1000 mg/kg or

1000 mg/L and less than 1500 mg/kg

or 1500mg/L of fluoride ion, the

product label must comply with the

requirements of the 'Required

Advisory Statements for Medicine

Labels' (RASML). The concentration

of fluoride in the product from all

ingredients must be no more than 15

mg/kg or 15 mg/L or 0.15%.

In products other than dental products,

the concentration of fluoride in the

product from all ingredients must be

no more than 15 mg/kg or 15 mg/L or

0.15%.


Schedule 1



statements on the medicine label:

- 'Do not swallow'

- 'Do not use [this product/insert name

of product] in children 6 years of age

or less'.

1019 CALCIUM FOLINATE A,E,H Folinic acid is a mandatory component

of Calcium folinate.

The maximum daily dose must

provide less than 500 micrograms of

folinic acid.

When levomefolate calcium, folic

acid, folinic acid (from Calcium

folinate) and/or their derivatives are

used in combination, the medicine

provides not more than a total of 500

mcg of folic acid, folinic acid and/or

their derivatives in total per daily dose.












osteoporosis’








Schedule 1









maximise bone’








When used as an active ingredient and




medicine label:





balanced diet.’

1020 CALCIUM

GLUCONATE

MONOHYDRATE





gluconate monohydrate.



calcium gluconate monohydrate is


calcium from calcium gluconate

monohydrate must be no less than

8.3% and must be no more than 9.5%

of the calcium gluconate monohydrate


Schedule 1


in the formulation. These figures














osteoporosis’














maximise bone’









Schedule 1


1021 CALCIUM

GLYCEROPHOSPHA

TE





glycerophosphate.



Calcium glycerophosphate is between

18.6% and 19.4%. The declared


glycerophosphate must be no less than


20.4% of the Calcium

glycerophosphate in the formulation.



calculations.












osteoporosis’











Schedule 1






maximise bone’








1022 CALCIUM

GLYCINATE


oral medicines.


Calcium glycinate and availability is





Calcium glycinate must be no less than

20.24% and no more than 22.37% of

the Calcium glycinate in the



calculations.













Schedule 1


osteoporosis’














maximise bone’








1023 CALCIUM

GLYCINATE

DIHYDRATE

A Calcium is a mandatory component of

Calcium glycinate dihydrate and

availability is restricted to use as a

source of the relevant mineral only.



Calcium glycinate dihydrate must be

no less than 17% and must be no more

than 18.8% of the Calcium glycinate

dihydrate in the formulation. These







Schedule 1










osteoporosis’














maximise bone’








1024 CALCIUM

HEXAFLUOROSILIC

ATE



1025 CALCIUM

HYDROGEN

PHOSPHATE






Schedule 1


hydrogen phosphate.



calcium hydrogen phosphate is 29.5%.

The declared quantity of calcium from

calcium hydrogen phosphate must be



hydrogen phosphate in the



calculations.












osteoporosis’















Schedule 1


maximise bone’








1026 CALCIUM

HYDROGEN

PHOSPHATE

DIHYDRATE





hydrogen phosphate dihydrate.



calcium hydrogen phosphate dihydrate

is 23.3%. The declared quantity of

calcium from calcium hydrogen

phosphate dihydrate must be no less


25.7% of the calcium hydrogen

phosphate dihydrate in the



calculations.












osteoporosis’


Schedule 1















maximise bone’








1027 CALCIUM

HYDROGEN

PHOSPHATE

MONOHYDRATE



supplementation, calcium isa


hydrogen phosphate monohydrate.



Calcium hydrogen phosphate

anhydrous is 29.5%. The declared


hydrogen phosphate anhydrous must



hydrogen phosphate anhydrous in the



calculations.


Schedule 1













osteoporosis’














maximise bone’








1028 CALCIUM

HYDROXIDE






Schedule 1


hydroxide.

When used as a standard active

ingredient, can only be supplied as an

uncompounded medicine substance

packed for retail sale, and must

comply with an uncompounded

substance monograph of the British

Pharmacopeia.












osteoporosis’














maximise bone’





Schedule 1






1029 CALCIUM

HYDROXYCITRATE

A,H If used as an active ingredient and the




hydroxycitrate.












osteoporosis’














maximise bone’




Schedule 1







1030 CALCIUM

HYPOPHOSPHITE



1031 CALCIUM IODIDE H Only for use as an active


1032 CALCIUM

KETOGLUCONATE





The concentration must be no more

than 1%

1033 CALCIUM L-

THREONATE



Calcium L-threonate.



Calcium L-threonate must be no less


13.57% of the Calcium L-threonate in














Schedule 1




osteoporosis’














maximise bone’








1034 CALCIUM LACTATE A,E,H If used as an active ingredient and the




lactate.



calcium lactate is 18.4%. The declared

quantity of calcium from calcium

lactate must be no less than 17.1%

and must be no more than 19.7% of

the calcium lactate in the formulation.




Schedule 1


calculations.












osteoporosis’














maximise bone’








1035 CALCIUM LACTATE

GLUCONATE





Schedule 1



lactate gluconate.



Calcium lactate gluconate is 13%. The

declared quantity of calcium from

Calcium lactate gluconate must be no


than 13.7% of the Calcium lactate

gluconate in the formulation. These














osteoporosis’















Schedule 1


maximise bone’









PENTAHYDRATE





lactate pentahydrate.



Calcium lactate pentahydrate is 13%.


Calcium lactate pentahydrate must be



lactate pentahydrate in the



calculations.












osteoporosis’



Schedule 1














maximise bone’









TRIHYDRATE


preparation is intended as a mineral



lactate trihydrate.



Calcium lactate trihydrate is 14.7%.


Calcium lactate trihydrate must not be

less than 13.7% and must not exceed

15.7% of the Calcium lactate

trihydrate in the formulation. These






Schedule 1











osteoporosis’














maximise bone’








1038 CALCIUM LYSINATE A Only for use as active ingredient in

oral medicines.


Calcium lysinate and availability is



Schedule 1





Calcium lysinate must be no less than


12.74% of the Calcium lysinate in the



calculations.












osteoporosis’














maximise bone’




Schedule 1







1039 CALCIUM

METHIONINATE


oral medicines.


Calcium methioninate and availability

is restricted to use as a source of the




Calcium methioninate must be no less


12.51% of the Calcium methioninate















osteoporosis’








Schedule 1









maximise bone’








1040 CALCIUM OROTATE A,E,H If used as an active ingredient and the




orotate.



Calcium orotate is 11.5%. The


Calcium orotate must be no less than


12.1% of the Calcium orotate in the



calculations.









Schedule 1






osteoporosis’














maximise bone’








1041 CALCIUM OXIDE E Only for use in topical medicines for

dermal application.

1042 CALCIUM

PANTOTHENATE





pantothenate.



Calcium pantothenate is 8%. The



Schedule 1


Calcium pantothenate must be no less


8.4% of the Calcium pantothenate in





accepted percentage of pantothenic

acid from Calcium pantothenate is

92%. The declared quantity of

pantothenic acid from Calcium

pantothenate must be no less than


97.6% of the Calcium pantothenate in















osteoporosis’











Schedule 1






maximise bone’








1043 CALCIUM

PHOSPHATE



supplementation, calcium is


phosphate.



Calcium phosphate is between 35 -

40%. The declared quantity of calcium

from Calcium phosphate must be no


than 42% of the Calcium phosphate in















Schedule 1



osteoporosis’














maximise bone’








1044 CALCIUM

PHOSPHATE -

MONOBASIC





phosphate - monobasic.



Calcium phosphate - monobasic is


calcium from Calcium phosphate -

monobasic must be no less than


18.1% of the Calcium phosphate -

monobasic in the formulation. These



Schedule 1














osteoporosis’














maximise bone’








1045 CALCIUM

PYRUVATE

A If used as an active ingredient and the




Schedule 1



pyruvate.



calcium pyruvate is 40.08%. The


calcium pyruvate must not be less than


19.65% of the calcium pyruvate in the















osteoporosis’















Schedule 1


maximise bone’








1046 CALCIUM

SACCHARATE

E

1047 CALCIUM SILICATE E

1048 CALCIUM SODIUM

CASEINATE



label:

- (COWMK) 'Derived from cow's

milk'.

1049 CALCIUM SODIUM

LACTATE





sodium lactate.



Calcium sodium lactate is between 7.5

- 8.5%. The declared quantity of

calcium from Calcium sodium lactate

must be no less than 7.1% and must be

no more than 8.9% of the Calcium

sodium lactate in the formulation.



calculations.






Schedule 1









osteoporosis’














maximise bone’








When for oral or sublingual use and

the total amount of sodium from all

ingredients in the maximum daily dose

is more than 120 mg, the medicine



- (SODIUM) ‘The recommended daily

dose of this medicine contains [state


Schedule 1


quantity and units] of sodium (or

words to that effect).’

1050 CALCIUM

STEARATE

E

1051 CALCIUM

SUCCINATE





succinate.



Calcium succinate is 25.7%. The


Calcium succinate must be no less


27% of the Calcium succinate in the



calculations.












osteoporosis’








Schedule 1









maximise bone’








1052 CALCIUM SULFATE A,E,H If used as an active ingredient and the




sulfate.

The amount of calcium in the active


on the molecular weight of calcium

sulfate.












osteoporosis’



Schedule 1














maximise bone’








1053 CALCIUM SULFATE -

DRIED





sulfate - dried.



Calcium sulfate - dried is 27.6%. The


Calcium sulfate - dried must be no less


29% of the Calcium sulfate - dried in







Schedule 1











osteoporosis’














maximise bone’








1054 CALCIUM SULFATE

DIHYDRATE





sulfate dihydrate.



Schedule 1



calcium sulfate dihydrate is 23.3%.


calcium sulfate dihydrate must be no


than 24.5% of the calcium sulfate

dihydrate in the formulation. These














osteoporosis’














maximise bone’




Schedule 1







1055 CALCIUM SULFIDE H Only for use as an active


1056 CALCIUM

THREONINATE

A Only for use as an active ingredient.


Calcium threoninate and availability is



Based on molecular weights, the


Calcium threoninate must be no less

than 13.78% and must be no less than

15.23% of the Calcium threoninate in















osteoporosis’






Schedule 1











maximise bone’








1057 CALENDULA

FLOWER DRY

A,E,H

1058 CALENDULA

FLOWER POWDER

A,H

1059 CALENDULA

OFFICINALIS

A,E,H

1060 CALLERYA

RETICULATA

A,H

1061 CALLICARPA

PEDUNCULATA

A,H

1062 CALLISTEMON

CITRINUS

A,H

1063 CALLISTEPHUS

CHINENSIS

A,H

1064 CALLITRIS

INTRATROPICA



fragrance.


Schedule 1





1065 CALLITRIS

RHOMBOIDEA

A,H

1066 CALLUNA

VULGARIS

A,E,H

1067 CALOCHORTUS

TOLMIEI

A,H

1068 CALTHA PALUSTRIS A,H

1069 CALUMBA ROOT

DRY

A,H

1070 CALUMBA ROOT

POWDER

A,H

1071 CALVATIA

GIGANTEA

A,H

1072 CALYCANTHUS

FLORIDUS

A,H

1073 CALYCANTHUS

PRAECOX

A,H

1074 CAMELLIA

JAPONICA

A,H

1075 CAMELLIA

OLEIFERA

A,E,H If Camellia oleifera (seed oil) is used

as a solvent, it is restricted to topical

or sunscreen preparations for dermal

application only.

1076 CAMELLIA SINENSIS A,E,H Caffeine is a mandatory component of

Camellia sinensis for oral use.

Medicines for oral or sublingual

administration that contain caffeine as

a component of a herbal substance and

that provide a maximum

recommended daily dose of:


Schedule 1


a) more than 1 mg but no more than 10

mg of caffeine require the following


label:



of caffeine.'

b) more than 10 mg of caffeine require


the medicine label:



per gram of product].'

Polyphenols calculated as gallic acid

(of Camellia sinensis) is only

permitted for use as a component

when the plant part is leaf.

1077 CAMPHENE E Permitted for use only in combination


coating solution, a flavour or a

fragrance.



no more than 5%.



must be no more 1%.

1078 CAMPHOR A,E,H In solid and semi solid preparations,

the concentration of camphor must be

no more than 12.5%.

In liquid preparations other than

essential oils, the concentration of

camphor must be no more than 2.5%.

In essential oil preparations, if the

concentration of camphor is more than

2.5% but less than or equal to 10%,


Schedule 1


and the nominal capacity of the

container is less than 25 mL, the

medicine must have a restricted flow

insert fitted on the container and

include the following warning



children (or word to that effect)'




10%, and the nominal capacity of the

container is more less than 15 mL, the











container is more than 15 mL but less

than or equal to 25 mL, the medicine

must have a restricted flow insert and

child resistant closure fitted on the

container and include the following


label:




1079 CAMPHOR

BENZALKONIUM

METHOSULFATE



The concentration in the preparation


Schedule 1



1080 CAMPHOR OIL

BROWN

A,H Camphor, cineole and safrole are

mandatory components of Camphor

oil brown.

In solid and semi solid preparations,

the concentration of Camphor must be

no more than 12.5%.



Camphor must be no more than 2.5%.




























Schedule 1








label:

























fitted on the container and include the

following warning statements on the

medicine label:




Schedule 1



When for internal use then the

concentration of safrole in the

medicine must be no more than 0.1%.

When for topical use then the


medicine must be no more than 1%.

1081 CAMPHOR OIL

WHITE

A,E,H Camphor and safrole are mandatory

components of Camphor oil white.



no more than 12.5%.


























Schedule 1













label:










1082 CAMPSIS

GRANDIFLORA

A,H

1083 CANADA BALSAM A,H

1084 CANANGA

ODORATA

A,E,H

1085 CANANGA OIL A,E,H

1086 CANARIUM

INDICUM

A,H The plant part must be seed and the

plant preparation is oil.



label:

- (DERIVED) 'This product contains

material derived from nuts' (or words


Schedule 1


to that effect).

1087 CANARIUM

LUZONICUM

A,H

1088 CANDELILLA WAX A,E,H

1089 CANDIDA ALBICANS H Only for use as an active


1090 CANDIDA UTILIS A,H

1091 CANINE MILK H Only for use as an active


1092 CANOLA OIL A,E,H Allyl isothiocyanate is a mandatory

component of Canola oil.



mg of Allyl isothiocyanate.

1093 CANTHARIDES H Only available as an active


1094 CANTHAXANTHIN E Permitted as an excipient ingredient as

a colour for oral and topical use.

1095 CAPRIC ACID E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1096 CAPROIC

ALDEHYDE







Schedule 1


no more than 5%.



must be no more 1%.

1097 CAPRYLIC

ALDEHYDE



coating solution, a flavour or a

fragrance.



no more than 5%.



must be no more 1%.

1098 CAPRYLIC/CAPRIC

GLYCERIDES






no more than 5%.



must be no more 1%.

1099 CAPRYLIC/CAPRIC/I

SOSTEARIC/ADIPIC

TRIGLYCERIDE

E

1100 CAPRYLIC/CAPRIC/

MYRISTIC/STEARIC

TRIGLYCERIDE




in the eye.

The concentration in the medicine is

not to exceed 3%

1101 CAPRYLIC/CAPRIC/S

TEARIC


dermal application.


Schedule 1


TRIGLYCERIDE

1102 CAPRYLOYL

GLYCINE




in the eye.


must not be more than 2%

1103 CAPRYLOYL

SALICYLIC ACID






must not be more than 0.3%.

1104 CAPRYLYL GLYCOL E Only for use in topical medicines for



in the eye.


must be no more than 2%

1105 CAPRYLYL

METHICONE




in the eye.



1106 CAPSELLA BURSA-

PASTORIS

A,H

1107 CAPSICUM E Only for use as an active


1108 CAPSICUM ANNUUM A,E,H

1109 CAPSICUM DRY A,E,H

1110 CAPSICUM FRUIT

OLEORESIN

A,E


Schedule 1


1111 CAPSICUM

FRUTESCENS

A,E,H

1112 CAPSICUM POWDER A,E,H

1113 CARALLUMA

ADSCENDENS VAR.

FIMBRIATA

A The plant part must be herb and the

plant preparation must be a

hydroethanolic extract.

1114 CARAMEL E Permitted as an excipient ingredient as


1115 CARAPICHEA

IPECACUANHA

A,H All strengths and pack sizes of

medicines containing Carapichea

ipecacuanha require child resistant

packaging.

Emetine is a mandatory component of

Carapichea ipecacuanha.

The concentration of emetine in the


1116 CARAWAY DRY A,H

1117 CARAWAY OIL A,E,H

1118 CARAWAY POWDER A,H

1119 CARBOMER -

SODIUM

E Only for use as an excipient in topical


1120 CARBOMER 1342 E Only for use as an excipient in topical


1121 CARBOMER 2001 E Only for use as an excipient ingredient

in topical medicines for dermal

application and not to be included in

medicines intended for use in the eye.


than 1% in formulations at pH 7

(approximately neutral) and 0.1% in

formulations at a different pH.

1122 CARBOMER 934 E Only for use in topical medicines for


Schedule 1


dermal application.

1123 CARBOMER 934P E Only for use in topical medicines for

dermal application.

1124 CARBOMER 940 E Only for use in topical medicines for

dermal application.









1129 CARBOMER

COPOLYMER (TYPE

B)



1130 CARBOMER

HOMOPOLYMER

(TYPE B)



1131 CARBOMER U-10 E Only for use in topical medicines for



in the eye.



1132 CARBON E,H Only for use as an active


1133 CARBON BLACK E Permitted as an excipient ingredient as


1134 CARBON DIOXIDE E

1135 CARDAMOM FRUIT

DRY

A,H


Schedule 1


1136 CARDAMOM FRUIT

POWDER

A,E,H

1137 CARDAMOM OIL A,E,H

1138 CARDIOSPERMUM

HALICACABUM

A,H

1139 CARICA PAPAYA A,E,H

1140 CARLINA ACAULIS A,H

1141 CARMELLOSE E

1142 CARMELLOSE

CALCIUM

E

1143 CARMELLOSE

SODIUM

E

1144 CARMINE E Permitted for use as a colour for oral

and topical use.

1145 CARMOISINE E Permitted as an excipient ingredient as


1146 CARMOISINE

ALUMINIUM LAKE

E Permitted as an excipient ingredient as


1147 CARNAUBA WAX A,E,H

1148 CARNOSINE E Only for use in topical medicines for



in the eye.



1149 CAROB BEAN

EXTRACT



flavour.



no more than 5%.


Schedule 1


1150 CAROB GUM E

1151 CAROB POD E

1152 CAROTENES E Permitted as an excipient ingredient as


1153 CARPINUS BETULUS A,H

1154 CARPINUS

CORDATA

A,H

1155 CARRAGEENAN E

1156 CARROT E

1157 CARROT SEED OIL A,E,H

1158 CARTHAMUS

TINCTORIUS

A,E,H Carthamus tinctorius (sunflower oil)

when used as a solvent is restricted to

topical or sunscreen preparations for

dermal application only.

If for oral use, the medicine requires


the medicine label:

- (PREGNT2) 'Do not use if pregnant

or likely to become pregnant' (or


1159 CARUM CARVI A,E,H

1160 CARVACROL E Permitted for use only in combination


flavour.



no more than 5%.

1161 CARVACRYL

METHYL ETHER



fragrance.




Schedule 1



1162 CARVEOL E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1163 CARVONE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1164 CARVYL ACETATE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1165 CARYA

ILLINOINENSIS

A,H

1166 CARYA OVATA A,H

1167 CARYOPHYLLENE

OXIDE





Schedule 1




no more than 5%.



must be no more 1%.

1168 CASCARA DRY A,H Hydroxyanthracene derivatives

calculated as cascaroside A is a

mandatory component of Cascara dry

when the route of administration is

oral.

When used in oral medicines, if the

maximum recommended daily dose

contains more than 10 mg of

hydroxyanthracene derivatives the



label:

- (CHILD3) ‘Use in children under 12

years is not recommended’

- (LAX2) ‘Prolonged use may cause

serious bowel problems’

- (LAX3) ‘Do not use when abdominal

pain, nausea or vomiting are present,

or if you develop diarrhoea. If you are

pregnant or breast feeding, seek the

advice of a healthcare professional

before taking this product' (or words to

that effect)

- (S) ‘If symptoms persist consult your

healthcare practitioner' (or words to

that effect).

When promoted or marketed as a

laxative, the medicine requires the


medicine label:

- (LAX1) ‘Drink plenty of water' (or


Schedule 1



When not promoted or marketed as



medicine label:

- (LAX5) ‘This product contains

[name of the herb(s) or the chemical

component(s)]’

- (LAX4) ‘This product may have

laxative effect’



contains less than 10 mg of

hydroxyanthracene derivatives and is

promoted or marketed as laxative, the



label:









that effect).

1169 CASCARA POWDER A,H Hydroxyanthracene derivatives

calculated as cascaroside A is a

mandatory component of Cascara

powder when the route of

administration is oral administration.






Schedule 1




label:











that effect)



that effect).




medicine label:






medicine label:



component(s)]’


laxative effect’






Schedule 1





label:









that effect).

1170 CASCARILLA OIL A,H The medicine must not contain more

than 1mg of the equivalent dry herbal

material per the maximum


1171 CASEIN E

1172 CASHEW NUT E

1173 CASSIA ALATA

LEAF EXTRACT

E Only for use as an excipient ingredient

in sunscreens for dermal application

and not to be intended for use in the

eye.

The extraction ratio of the Cassia alata

can only be 1:3 in 62.5%

glycerine:water.



1174 CASSIA CINNAMON

BARK DRY

A,H When used as an active ingredient, the

maximum daily dose of the medicine

must contain no more than 0.001% of

coumarin.

1175 CASSIA CINNAMON

BARK POWDER

A,H When used as an active ingredient, the



Schedule 1



coumarin.

1176 CASSIA FISTULA A,H Hydroxyanthracene glycosides

calculated as sennoside B is a

mandatory component of Cassia fistula

when the route of administration is

oral.







label:











that effect)



that effect).




medicine label:







Schedule 1


medicine label:



component(s)]’


laxative effect’








label:









that effect).

1177 CASSIA

OCCIDENTALIS

A,H Hydroxyanthracene glycosides

calculated as sennoside B is a

mandatory component of Cassia

occidentalis when the route of

administration is oral administration.







label:



Schedule 1










before taking this product [or words to

that effect]’


healthcare practitioner [or words to

that effect]’.




medicine label:

- (LAX1) ‘Drink plenty of water [or

words to that effect]




medicine label:



component(s)]’


laxative effect’






medicine the following warning




Schedule 1



- (LAX1) ‘Drink plenty of water [or

words to that effect]’




healthcare practitioner [or words to

that effect]’

1178 CASSIA OIL A,E,H The concentration of Cassia oil in the

product must be no more than 2%

unless the preparation is for dermal

use as a rubefacient, in which case the

concentration of cassia oil must be no

more than 5%.

1179 CASSIE ABSOLUTE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1180 CASTANEA

MOLLISSIMA

A,H

1181 CASTANEA SATIVA A,H

1182 CASTOR OIL A,E

1183 CASTOR OIL -

ETHOXYLATED

HYDROGENATED

E

1184 CASTOR OIL -

HYDROGENATED

A,E When used as an active ingredient, can





Schedule 1




1185 CASTOR OIL -

SULFATED


dermal application.

1186 CASTOREUM H Only permitted for use as an active


1187 CASUARINA

EQUISITIFOLIA

A,H

1188 CATALPA

BIGNONIOIDES

A,H

1189 CATALPA OVATA A,H

1190 CATECHU A,H

1191 CATHARANTHUS

ROSEUS

A,H Vinblastine, vincamine, vincristine,

vindesine, vinorelbine and yohimbine

are mandatory components of

Cantharanthus roseus.

The concentration of vinblastine,

vincamine, vincristine, vindesine,

vinorelbine and yohimbine in the

medicine must be no more than

10mg/kg or 10 mg/L or 0.001%.

1192 CAULIFLOWER E

1193 CAULOPHYLLUM

THALICTROIDES

A,E,H

1194 CAUSTICUM H Only for use as an active


1195 CEANOTHUS

AMERICANUS

A,H

1196 CEDAR LEAF OIL A,E,H

1197 CEDARWOOD OIL E Permitted for use only in combination



Schedule 1





no more than 5%.



must be no more 1%.

1198 CEDARWOOD OIL

ATLAS



fragrance.




1199 CEDARWOOD OIL

TERPENES






no more than 5%.



must be no more 1%.

1200 CEDARWOOD OIL

VIRGINIA



fragrance.




1201 CEDRENOL E Permitted for use only in combination


fragrance.





Schedule 1


1202 CEDRENYLACETAT

E



fragrance.




1203 CEDROL E Permitted for use only in combination


fragrance.




1204 CEDRUS

ATLANTICA

A,E,H

1205 CEDRUS DEODARA A,H

1206 CEDRUS LIBANI H Only for use as an active


1207 CEDRYL ACETATE E Permitted for use only in combination


fragrance.




1208 CEDRYL METHYL

ETHER



fragrance.




1209 CELERY LEAF E

1210 CELERY SEED DRY A,E,H

1211 CELERY SEED OIL A,E,H


Schedule 1


1212 CELERY SEED

POWDER

A,H

1213 CELLACEFATE E

1214 CELLULASE A Must be derived from Trichoderma

longibrachiatum only.

If used as an undivided preparation,

the allowed unit is Cellulase unit per

gram or Thousand cellulase unit per

gram.

If used as an divided preparation, the

allowed unit is Thousand cellulase unit

or cellulase unit.

1215 CELLULOSE E Permitted for use only in combination


flavour.



no more than 5%.

1216 CELLULOSE -

DISPERSIBLE

E

1217 CELLULOSE -

MICROCRYSTALLIN

E

A,E

1218 CELLULOSE -

POWDERED

E

1219 CELOSIA ARGENTEA A,H

1220 CELOSIA ARGENTEA

L. VAR. CRISTATA

A,H

1221 CENTAUREA

CYANUS

A,E,H

1222 CENTAURIUM

ERYTHRAEA

A,H


Schedule 1


1223 CENTELLA

ASIATICA

A,E,H

1224 CENTIPEDA

CUNNINGHAMII

A,E,H

1225 CENTIPEDA MINIMA A,H

1226 CEPHALANOPSIS

SEGETUM

A,H

1227 CERAMIDE 1 E Only for use in topical medicines for

dermal application.




for use in the eye.




dermal application.

1230 CERATONIA

SILIQUA

A,E,H

1231 CERATOSTIGMA

WILLMOTTIANUM

A,H

1232 CERESIN E Only for use in topical medicines for

dermal application.

1233 CESTRUM

LATIFOLIUM





The plant part must be leaf and must

be a water extract.


than 0.5%.

1234 CETEARETH-12 E Only for use in topical medicines for


Schedule 1


dermal application.


dermal application.


dermal application.


dermal application.


dermal application.

1239 CETEARETH-33 E Only for use as an excipient ingredient

for dermal application and not to be


in the eye.



Residual levels of 1,4-dioxane oxide

(and related substances) are to be kept

below the level of detection.

1240 CETEARYL

GLUCOSIDE


dermal application.

1241 CETEARYL

ISONONANOATE


dermal application.

1242 CETEARYL

OCTANOATE


dermal application.

1243 CETETH-10 E Only for use in topical medicines for

dermal application.


dermal application.


dermal application.


dermal application.


Schedule 1


1247 CETOMACROGOL

1000


dermal application.

1248 CETOMACROGOL

1000 PHOSPHATE







1249 CETOMACROGOL

500 PHOSPHATE







1250 CETOSTEARYL

ALCOHOL

E

1251 CETOSTEARYL

ALCOHOL/COCO-

GLUCOSIDE

COMPLEX






must be no more than 5.0 %

1252 CETRARIA

ISLANDICA

A,H

1253 CETRIMONIUM

BROMIDE


dermal application.

1254 CETRIMONIUM

CHLORIDE


dermal application.

1255 CETYL-PG

HYDROXYETHYL

PALMITAMIDE




in the eye.




Schedule 1


1256 CETYL ACETATE E Only for use in topical medicines for

dermal application.

1257 CETYL ALCOHOL E Only for use in topical medicines for

dermal application.

1258 CETYL

DIMETHICONE

COPOLYOL


dermal application.

1259 CETYL DIMETICONE E Only for use in topical medicines for

dermal application.

1260 CETYL

DIMETICONE/BIS-

VINYLDIMETICONE

CROSSPOLYMER







1261 CETYL ESTERS WAX E Only for use in topical medicines for

dermal application.

1262 CETYL

HYDROXYETHYLCE

LLULOSE




in the eye.



1263 CETYL LACTATE E Only for use in topical medicines for

dermal application.

1264 CETYL OCTANOATE E Only for use in topical medicines for

dermal application.

1265 CETYL PALMITATE E Only for use in topical medicines for

dermal application.

1266 CETYL PHOSPHATE E Only for use in topical medicines for

dermal application.

1267 CETYLPYRIDINIUM

CHLORIDE


dermal application.


Schedule 1


Medicines for topical use must include

the name of any antimicrobial

preservative in the goods.

1268 CHAENOMELES

LAGENARIA

A,H

1269 CHAENOMELES

SPECIOSA

A,H

1270 CHAETOMIUM

INDICUM

A,H

1271 CHALK A,E When used as an active ingredient, can






1272 CHAMAECYPARIS

LAWSONIANA

A,H

1273 CHAMAELIRIUM

LUTEUM

A,H

1274 CHAMAEMELUM

NOBILE

A,E,H

1275 CHAMOMILE

FLOWER DRY

A,E,H

1276 CHAMOMILE OIL

ENGLISH

A,E,H

1277 CHAMOMILE OIL

GERMAN

A,E,H

1278 CHANGIUM

SMYRNIOIDES

A,H

1279 CHARCOAL -

ACTIVATED

A,E,H When for internal use, the medicine



- (ACCOAL) 'Products containing


Schedule 1


activated charcoal should be used with

caution in children since it may

interfere with absorption of nutrients.

Activated charcoal may interact with

other medicines. Activated charcoal is

not recommended for long-term use'


1280 CHEIRANTHUS

CHEIRI

A,H

1281 CHELIDONIUM

MAJUS

A,E,H When for oral or sublingual use, the



label:

- (CELAND) 'WARNING: Greater

Celandine may harm the liver in some

people. Use only under the

supervision of a healthcare

professional'.

1282 CHELONE GLABRA A,H

1283 CHENOPODIUM

ALBUM

A,H

1284 CHENOPODIUM

VULVARIA

A,H

1285 CHERRY E

1286 CHERRY

DISTILLATE



flavour.



no more than 5%.

1287 CHESTNUT SWEET E

1288 CHICKEN POWDER -

BLACK BONED

A

1289 CHILLI E


Schedule 1


1290 CHIMAPHILA

UMBELLATA

A,H

1291 CHIONANTHUS

VIRGINICA

A,H

1292 CHLORELLA E Iodine is a mandatory component of

Chlorella.













1293 CHLORELLA

PYRENOIDOSA

E

1294 CHLORELLA

VULGARIS

A,E Iodine is a mandatory component of

Chlorella vulgaris.














Schedule 1


1295 CHLORHEXIDINE

ACETATE


dermal application.

1296 CHLORHEXIDINE

GLUCONATE


dermal application.

1297 CHLOROACETAMID

E


dermal application.

1298 CHLOROBUTANOL

HEMIHYDRATE

E Only for use in topical preparations for

localised effect.





label:

- (CHLORB) 'Contains chlorbutol' (or


1299 CHLOROCRESOL E Only for use in topical medicines for

dermal application.





label:

- (CHLCRS) 'Contains chlorocresol

[quantity]' (or words to that effect)

1300 CHLOROFORM E The residual solvent limit must be no

more than 0.6 mg per recommended

daily dose and the concentration in the


0.006%.

1301 CHLOROPHYLL A,E Only for use as a colour in oral and

topical medicines.

1302 CHLOROPHYLL-

COPPER

E Only for use as a colour in oral and

topical medicines.


Schedule 1


COMPLEXES

1303 CHLOROPHYLLIN-

COPPER COMPLEX


topical medicines.

1304 CHLOROPHYLLIN-

COPPER COMPLEX

ALUMINIUM LAKE

E Only for as a colour in oral and topical

medicines.

1305 CHLOROXYLENOL E Only for use in topical medicines for

dermal application.

1306 CHLORPHENESIN E Only for use in topical medicines for

dermal application.

1307 CHOCOLATE

BROWN HT


and topical use.

1308 CHOLESTEROL A,E,H Only for use as an active ingredient in

homoeopathic medicines or an

excipient ingredient in topical

preparations.

1309 CHOLESTERYL

HYDROXYSTEARAT

E


dermal application.

1310 CHOLESTERYL

MACADAMIATE


dermal application.

1311 CHOLESTERYL/BEH

ENYL/OCTYLDODEC

YL LAUROYL

GLUTAMATE




in the eye.



1312 CHOLETH-24 E Only for use in topical medicines for

dermal application.

1313 CHOLINE

BITARTRATE

A,E

1314 CHOLINE

DIHYDROGEN



Schedule 1


CITRATE

1315 CHONDRODENDRON

TOMENTOSUM

A,H The concentration of equivalent dry

Chondrodendron tomentosum in the

product must be no more than

10mg/Kg or 10mg/L or 0.001%.

1316 CHONDROITIN

SULFATE - BOVINE

A

1317 CHONDROITIN

SULFATE - BOVINE

SODIUM

A

1318 CHONDROITIN

SULFATE - SHARK

A

1319 CHONDROITIN

SULFATE - SHARK

SODIUM

A

1320 CHONDRUS CRISPUS A,E,H Iodine is a mandatory component of

Chondrus crispus.













1321 CHONDRUS DRY A,E,H Iodine is a mandatory component of

Chondrus dry.





Schedule 1











1322 CHONDRUS

EXTRACT

A,E,H Iodine is a mandatory component of

Chondrus extract.













1323 CHROMIC

CHLORIDE

HEXAHYDRATE

A,H If used as an active ingredient in a

preparation for mineral

supplementation, chromium is a

mandatory component of chromic

chloride hexahydrate.

The amount of chromium in the active


on the molecular weight of chromic

chloride hexahydrate.


dose must provide 50 micrograms or

less of chromium from organic sources

(ie chromium picolinate, chromium


Schedule 1


nicotinate and yeast - high chromium).





1324 CHROMIUM

NICOTINATE

A Chromium is a mandatory component

of Chromium nicotinate. Based on

molecular weights the accepted

percentage of Chromium from

Chromium nicotinate is 13.5%. The

declared quantity of Chromium from

Chromium nicotinate must be no less


14.2% of the Chromium nicotinate in






micrograms of chromium for all

dosage forms.





1325 CHROMIUM

PICOLINATE

A Chromium is a mandatory component

of Chromium picolinate. Based on

molecular weights the accepted

percentage of Chromium from

Chromium picolinate is 12.4%. The

declared quantity of Chromium from

Chromium picolinate must be no less


13% of the Chromium picolinate in the







Schedule 1


micrograms of chromium for all

dosage forms.





1326 CHRYSANTHEMUM

BALSAMITA

A,H

1327 CHRYSANTHEMUM

INDICUM

A,E,H

1328 CHRYSANTHEMUM

LEUCANTHEMUM

A,H

1329 CHRYSANTHEMUM

MARSHALLII

A,H

1330 CHRYSANTHEMUM

SINENSE

A,H

1331 CHRYSOPOGON

ZIZANIOIDES

A,E,H

1332 CHRYSOSPORIUM

PRUINOSUM

A,H

1333 CIBOTIUM

BAROMETZ

A,H

1334 CICHORIUM

INTYBUS

A,E,H

1335 CICUTA VIROSA A,H The maximum recommended daily

dose must be no more than the

equivalent of 1mg of the dry herbal

material.

1336 CINCHONA BARK

DRY

A,H Quinidine and quinine are mandatory

components of Cinchona bark dry.

The medicine must contain no more

than 50 micrograms of quinine and no

more than 10 micrograms


Schedule 1


concentration of quinidine per g or

mL.

1337 CINCHONA BARK

POWDER


components of Cinchona bark powder.





mL.

1338 CINCHONA

OFFICINALIS


components of Cinchona officinalis.





mL.

1339 CINCHONA

PUBESCENS


components of Cinchona pubescens.





mL.

1340 CINEOLE A,E Permitted for use only as an active

ingredient in medicated space sprays

and medicated throat lozenges.












Schedule 1


insert fitted on the container and the



label:

- (CHILD) ‘Keep out of reach of

children (or words to that effect)’

- (NTAKEN) ‘Not to be taken’






fitted on the container and the



label:


children (or words to that effect)’


1341 CINNAMALDEHYDE E If used in a flavour the total flavour


no more than 5%.



must be no more 1%.

1342 CINNAMIC ACID E Permitted for use only in combination





no more than 5%.



must be no more 1%.


Schedule 1


1343 CINNAMOMUM

CAMPHORA

A,E,H Camphor, cineole, safrole and thujone

are mandatory components of

Cinnamomum camphora.



no more than 12.5%.














children' (or words to that effect)



















Schedule 1




container and requires the following


label:

























fitted on the container and requires the


medicine label:






Schedule 1







When used as an active ingredient, the



coumarin.

1344 CINNAMOMUM

CASSIA

A,E Cassia oil is a mandatory component

of Cinnamomum cassia if the plant

preparation is an essential oil, fixed oil

or infused oil.

The concentration of Cassia oil in the





coumarin.

1345 CINNAMOMUM

VERUM

A,E,H Cinnamon bark oil is a mandatory

component of Cinnamomum verum

when the plant part is bark and the

plant preparation is essential oil, fixed

oil or infused oil.

The concentration of cinnamon bark

oil in the medicine must be no more

than 2%.

Cinnamon leaf oil is a mandatory

component of Cinnamomum verum

when the plant part is leaf.

When the concentration of cinnamon

leaf oil in the preparation is more than


container must be no more than than

25 mL.



Schedule 1




container is more than 15 mL but no

more than 25mL, the medicine must

have a child resistant closure and




label:


children’ (or words to that effect)





container is no more than 15 mL, the

container must be fitted with a

restricted flow insert and requires the


medicine label:







coumarin.

1346 CINNAMON BARK

OIL

A,E,H The concentration of Cinnamon bark

oil in the product must be no more

than 2%.



must contain no more than 0.001%

Coumarin.

1347 CINNAMON DRY A,H Cinnamon bark oil is a mandatory

component of Cinnamon dry.


Schedule 1




than 2%.




Coumarin.

1348 CINNAMON LEAF

OIL

A,E,H When the concentration of cinnamon



container must not be more than 25

mL.




container is more than 15 mL but no

more than 25mL, the medicine must





label:







container is no more than 15 mL , the

container must be fitted with a

restricted flow insert and requires the


medicine label:






Schedule 1




Coumarin.

1349 CINNAMON

POWDER

A,E,H Cinnamon bark oil is a mandatory

component of Cinnamon powder.



than 2%.



must contain no more than 0.001%

Coumarin.

1350 CINNAMYL

ACETATE






no more than 5%.



must be no more 1%.

1351 CINNAMYL

ALCOHOL






no more than 5%.



must be no more 1%.

1352 CINNAMYL

BUTYRATE



flavour.




Schedule 1


no more than 5%.

1353 CINNAMYL

CINNAMATE



flavour.



no more than 5%.

1354 CINNAMYL

FORMATE



flavour.



no more than 5%.

1355 CINNAMYL

ISOBUTYRATE



flavour.



no more than 5%.

1356 CINNAMYL

PROPIONATE



fragrance.




1357 CINOXATE A Only for use as an active ingredient in

sunscreens for dermal application

only.

The concentration of the ingredient

must be no more than 6% and must not

be used in topical products intended

for use in the eye.

1358 CIS-2-METHYL-4-

PROPYL-1,3-




Schedule 1


OXATHIANE flavour or a fragrance.



no more than 5%.



must be no more 1%.

1359 CIS-3-HEXEN-1-OL E Permitted for use only in combination








must be no more 1%.

1360 CIS-3-HEXENAL E Permitted for use only in combination


flavour.



no more than 5%.

1361 CIS-3-HEXENYL 2-

METHYLBUTYRATE



flavour.



no more than 5%.

1362 CIS-3-HEXENYL

ACETATE






no more than 5%.


Schedule 1




must be no more 1%.

1363 CIS-3-HEXENYL

BENZOATE



fragrance.




1364 CIS-3-HEXENYL

BUTYRATE






no more than 5%.



must be no more 1%.

1365 CIS-3-HEXENYL

FORMATE



flavour.



no more than 5%.

1366 CIS-3-HEXENYL

HEXANOATE



flavour.



no more than 5%.

1367 CIS-3-HEXENYL

ISOBUTYRATE



fragrance.




Schedule 1



1368 CIS-3-HEXENYL

ISOVALERATE






no more than 5%.



must be no more 1%.

1369 CIS-3-HEXENYL

LACTATE



flavour.



no more than 5%.

1370 CIS-3-HEXENYL

METHYL

CARBONATE



fragrance.




1371 CIS-3-HEXENYL

SALICYLATE



fragrance.




1372 CIS-4-HEPTENAL E Permitted for use only in combination


flavour.



no more than 5%.


Schedule 1


1373 CIS-6-NONEN-1-AL E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1374 CIS-6-NONENOL E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1375 CIS-BETA-OCIMENE E Permitted for use only in combination


fragrance.




1376 CIS-

HEXAHYDROCUMIN

YL ALCOHOL



fragrance.




1377 CIS-JASMONE E Permitted for use only in combination






Schedule 1


no more than 5%.



must be no more 1%.

1378 CISTANCHE

DESERTICOLA

A,H Only for use as an active ingredient in


only.




for use in the eye.

1379 CISTANCHE SALSA A,E,H Only for use as an active ingredient in


only.




for use in the eye.

1380 CISTUS

LADANIFERUS

A,E,H

1381 CITRAL E

1382 CITRAL DIETHYL

ACETAL



fragrance.




1383 CITRAL DIMETHYL

ACETAL



fragrance.




1384 CITRIC ACID A,E Where intended for topical use,


Schedule 1


sponsors should consider the impact of

excipients on the sensitivity of the skin

to sunlight and should ensure the

finished product is safe for its intended

purpose.

1385 CITRIC ACID

DIHYDRATE

A,E

1386 CITRIC ACID

MONOHYDRATE

A,E Where intended for topical use,

sponsors should consider the impact of

excipients on the sensitivity of the skin

to sunlight and should ensure the

finished product is safe for its intended

purpose.

1387 CITRIC AND FATTY

ACID ESTERS OF

GLYCEROL



flavour.



no more than 5%.

1388 CITROL E Permitted for use only in combination


flavour.



no more than 5%.

1389 CITRON E

1390 CITRONELLA OIL A,E,H Medicines for topical use containing

citronella oil require the following


label:

- (CITRON) 'Contains citronella oil'.

1391 CITRONELLA

TERPENES



fragrance.



Schedule 1




1392 CITRONELLAL E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1393 CITRONELLIC ACID E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1394 CITRONELLOL E Only for use in topical medicines for

dermal application.

1395 CITRONELLYL

ACETATE






no more than 5%.



must be no more 1%.

1396 CITRONELLYL

BUTYRATE



flavour.


Schedule 1




no more than 5%.

1397 CITRONELLYL

FORMATE






no more than 5%.



must be no more 1%.

1398 CITRONELLYL

ISOBUTYRATE






no more than 5%.



must be no more 1%.

1399 CITRONELLYL

NITRILE



fragrance.




1400 CITRONELLYL

OXYACETALDEHYD

E



fragrance.




1401 CITRONELLYL E Permitted for use only in combination



Schedule 1


PROPIONATE flavour or a fragrance.



no more than 5%.



must be no more 1%.

1402 CITRONELLYL

TIGLATE



fragrance.




1403 CITRONNOL E Permitted for use only in combination


flavour.



no more than 5%.

1404 CITRULLUS

COLOCYNTHIS



When for oral use, the concentration

of Citrullus colocynthis must be more

than 4X (i.e. 1X 2X 3X).

1405 CITRULLUS

VULGARIS

A,E,H

1406 CITRUS

AURANTIFOLIA

A,E,H

1407 CITRUS

AURANTIUM

A,E,H Oxedrine is a mandatory component of

Citrus aurantium when intended for

internal use.

The quantity of Oxedrine in the

recommended daily dose of the

medicine must be no more than 30 mg.


Schedule 1


1408 CITRUS

BIOFLAVONOIDS

EXTRACT

A,E,H

1409 CITRUS

CHACHIENSIS

A,H

1410 CITRUS EXTRACT E Permitted for use only in combination


flavour.



no more than 5%.

1411 CITRUS FIBRE E

1412 CITRUS LIMETTA A,H

1413 CITRUS LIMON A,E,H Oxedrine is a mandatory component of

Citrus limon when intended for

internal use.

The quantity of oxedrine in the

recommended daily dose of the

medicine must be no more than 30 mg.

1414 CITRUS MAXIMA A,H

1415 CITRUS MEDICA A,E,H

1416 CITRUS OIL

DISTILLED



fragrance.




1417 CITRUS

RETICULATA

A,E,H Oxedrine is a mandatory component of

Citrus reticulata when intended for

internal use.


recommended daily dose must be no

more than 30 mg.


Schedule 1


1418 CITRUS SINENSIS A,E,H Oxedrine is a mandatory component of

Citrus sinensis when intended for

internal use.



more than 30 mg.

1419 CITRUS SINENSIS

PEEL MOLASSES

EXTRACT



flavour.



no more than 5%.

1420 CITRUS UNSHIU A,E,H Oxedrine is a mandatory component of

Citrus unshiu when intended for

internal use.



more than 30 mg.

1421 CITRUS X PARADISI A,E,H

1422 CITRUS X WILSONII A,E,H

1423 CIVET E Permitted for use only in combination


fragrance.




1424 CIVET ABSOLUTE E Permitted for use only in combination


fragrance.




1425 CIVET SYNTHETIC E Permitted for use only in combination



Schedule 1


fragrance.




1426 CIVETONE E Permitted for use only in combination


fragrance.




1427 CLARY OIL A,E,H

1428 CLAVICEPS

PURPUREA


Claviceps purpurea must be no more

than 10mg/Kg or 10mg/L or 0.001%.

1429 CLEMATIS

ARMANDII

A,H

1430 CLEMATIS

CHINENSIS

A,E,H

1431 CLEMATIS RECTA A,H

1432 CLEMATIS VITALBA A,H

1433 CLERODENDRUM

TRICHOTOMUM

A,H

1434 CLINOPODION

POLYCEPHALUM

A,H

1435 CLINOPODIUM

NEPETA SUBSP.

GLANDULOSUM

A,H

1436 CLIVER HERB DRY A,H

1437 CLIVER HERB

POWDER

A,H

1438 CLOVE BUD OIL A,E,H When the concentration of Clove Bud

Oil in the preparation is more than


Schedule 1



container must be no more than 25

mL.

When the concentration of Clove Bud



container is more 15 mL but no more

than 25mL, a child resistant closure

and restricted flow insert must be



medicine label:




When the concentration of clove bud

oil in the preparation is more than 25%


container is more than 15 mL , a

restricted flow insert must be fitted on

the container and requires the


medicine label:




1439 CLOVE DRY A,E,H

1440 CLOVE LEAF OIL A,E,H When the concentration of Clove Leaf




mL.

When the concentration of Clove Leaf






Schedule 1





medicine label:




When the concentration of clove leaf



container is more than 15 mL, a




medicine label:




1441 CLOVE OIL

TERPENES



flavour.



no more than 5%.

1442 CLOVE POWDER A,E,H

1443 CLOVE STEM OIL A,E,H When the concentration of Clove Stem




mL.

When the concentration of Clove Stem







Schedule 1


fitted on the container requires the


medicine label:




When the concentration of Clove Stem



container is more than 15 mL , a




medicine label:




1444 CNICUS

BENEDICTUS

A,H

1445 CNICUS JAPONICUS A,H

1446 CNIDIUM MONNIERI A,H

1447 CNIDIUM

OFFICINALE

A,E,H

1448 COBALTOUS

NITRATE

HEXAHYDRATE



1449 COCAMIDE DEA E Only for use in topical medicines for

dermal application.

1450 COCAMIDE MEA E Only for use in topical medicines for

dermal application.

1451 COCAMIDOPROPYL

BETAINAMIDE MEA

CHLORIDE



included in topical products intended


Schedule 1


for use in the eye.



1452 COCAMIDOPROPYL

BETAINE

E Only for topical, mucous membrane

(buccal mucosa) and dental use and

not to be included in topical medicines



must be:

a) no more than 1% in leave on

medicines

b) no more than 15% in wash on /wash

off medicines

c) 1.2% for buccal mucosa and dental

medicines.

Levels of impurities 3-

dimethylaminopropylamine (DMAPA)

and amidoamine

(dimethylaminopropylcocoamide; AA)

must be controlled to below the level

of detection.

1453 COCCOLOBIA

UVIFERA

A,H

1454 COCCULUS

SARMENTOSUS

A,H

1455 COCHINEAL A,E,H Permitted for use as a colour

ingredient for oral and topical use.

1456 COCHLEARIA

OFFICINALIS

A,H

1457 COCHLIOBOLUS

HETEROSTROPHUS

A,H

1458 COCILLANA DRY A,H


Schedule 1


1459 COCILLANA

POWDER

A,H

1460 COCO-BETAINE E Only for use in topical medicines for

dermal application.

1461 COCO-CAPRYLATE E Only for use in topical medicines for



in the eye.

The concentration is to be no more

than 12.5% in the medicine.

1462 COCO-GLUCOSIDE E Only for use in topical medicines for



in the eye.



1463 COCO-

OCTANOATE/DECAN

OATE




in the eye.

1464 COCOA EXTRACT E Permitted for use only in combination


flavour.



no more than 5%.

1465 COCOA POWDER A,E,H

1466 COCOGLYCERIDES E

1467 COCONUT E

1468 COCONUT ACID E Only for use in topical medicines for

dermal application.

1469 COCONUT OIL A,E,H


Schedule 1


1470 COCONUT OIL -

FRACTIONATED

E

1471 COCONUT OIL -

HYDROGENATED

E

1472 COCOS NUCIFERA A,E,H

1473 COD-LIVER OIL A,E Vitamin A and colecalciferol are

mandatory components of Cod-liver

oil.

When for use in topical medicines, the

concentration of Vitamin A in the


When for internal use, the maximum

daily dose must be no more than 3000

micrograms of Retinol Equivalents.

Divided preparations for internal use

must contain more than 33

micrograms of Retinol Equivalents per

dosage unit and no more than 3000

micrograms of Retinol Equivalents of

Vitamin A in the maximum daily dose.

Undivided preparations for internal

use must contain more than 33

micrograms Retinol Equivalents per

gram of vitamin A and no more than

3000 micrograms of Retinol

Equivalents of Vitamin A in the

maximum daily dose.

When for use in adults the medicine



- (VITA2) ‘WARNING: If you are

pregnant - or considering becoming

pregnant - do not take vitamin A

supplements without consulting your

doctor or pharmacist [or words to that

effect].’ NOTE: Position this warning


Schedule 1


at the beginning of the directions for

use.

- (VITA4) ‘WARNING - When taken

in excess of 3000 micrograms retinol

equivalents - vitamin A can cause birth

defects.’ NOTE: Position this warning

at the beginning of the directions for

use.

- (VITA3) ‘The recommended daily

amount of vitamin A from all sources

is 700 micrograms retinol equivalents

for women and 900 micrograms

retinol equivalents for men.’

When used as an active ingredient and




medicine label:





balanced diet.’

The indication ‘Vitamin D helps

calcium absorption (or words of like

intent)’ and ‘A diet deficient in

calcium can lead to osteoporosis in

later life’ are permitted only for oral

use.

1474 CODONOPSIS

LANCEOLATA

A,H

1475 CODONOPSIS

PILOSULA

A,H

1476 CODONOPSIS

TANGSHEN

A,H

1477 COFFEA ARABICA A,E,H Caffeine is a mandatory component of


Schedule 1


Coffea arabica.




daily dose of:







of caffeine.'




label:




1478 COFFEA

CANEPHORA

A,E,H Caffeine is a mandatory component of

Coffea canephora.




daily dose of:







of caffeine.'





Schedule 1


label:




1479 COFFEE A,E,H Caffeine is a mandatory component of

coffee.




daily dose of:







of caffeine.'




label:




1480 COFFEE OIL E Permitted for use only in combination


flavour.



no more than 5%.

1481 COFFEE SOLID

EXTRACT



flavour.




Schedule 1


no more than 5%.

1482 COGNAC OIL E Permitted for use only in combination


flavour.



no more than 5%.

1483 COGNAC OIL GREEN A,E,H

1484 COGNAC OIL WHITE E Permitted for use only in combination


flavour.



no more than 5%.

1485 COIX LACHRYMA-

JOBI

A,E,H

1486 COLA ACUMINATA A,E,H Caffeine is a mandatory component of

Cola acuminata.




daily dose of:



requires the warning statement:



of caffeine.'


medicine requires the warning

statement:





Schedule 1


1487 COLA COTYLEDON

DRY

A,H Caffeine is a mandatory component of

Cola cotyledon dry.




daily dose of:






of caffeine.'



statement:




1488 COLA COTYLEDON

POWDER

A,H Caffeine is a mandatory component of

Cola cotyledon powder.




daily dose of:






of caffeine.'



statement:




Schedule 1



1489 COLA NITIDA A,E,H Caffeine is a mandatory component of

Cola nitida.




daily dose of:






of caffeine.'



statement:




1490 COLCHICUM

AUTUMNALE



1491 COLECALCIFEROL A,E When used as an active ingredient and




medicine label:





balanced diet.’

The indication 'Vitamin D helps


intent) and a diet deficient in calcium


Schedule 1


can lead to osteoporosis in later life' is

only permitted for use when the


does is no more than 25 micrograms of

vitamin D.

1492 COLEUS

FORSKOHLII

A,E,H

1493 COLLAGEN E

1494 COLLAGEN -

HYDROLYSED

E

1495 COLLINSONIA

CANADENSIS

A,H

1496 COLOPHONY A,E,H

1497 COLOSTRUM

POWDER - BOVINE

A The medicine requires the warning

statement:

- (BOVCOL) 'Products containing

bovine colostrum powder contain

lactose and cow's milk proteins (or

words to that effect). This product is

not suitable for use in children under

the age of 12 months except on

professional health advice.'

1498 COMMIPHORA

HABESSINICA

A,H

1499 COMMIPHORA

KATAF

A,H

1500 COMMIPHORA

MYRRHA

A,E,H

1501 COMMON INDIAN

COBRA



1502 CONCENTRATED

OMEGA-3

TRIGLYCERIDES -



Schedule 1


FISH

1503 CONCENTRATED

OMEGA-3

TRIGLYCERIDES -

SQUID


'Concentrated omega-3-triglycerides -

squid' must be obtained from species

of the order Teuthida of the class

Cephalopoda AND be in combination

with other ingredients in the

preparation AND be presented in a

therapeutic dosage form for

therapeutic use.



label:

- (SFOOD) 'Derived from seafood'.

1504 CONIFER GREEN

NEEDLE COMPLEX

A Only for topical and oral use. Must be

made by petroleum ether extraction of

needles of the conifer species Pinus

sylvestris (Scotch Pine) and Picea

abies (Norwegian Spruce).

1505 CONIOSELIUM

UNIVITTATUM

A,H

1506 CONIUM

MACULATUM




than exceed 12X homoeopathic

dilution.

1507 CONVALLARIA

MAJALIS

A The concentration of equivalent dry

Convallaria majalis in the product

must be no more than 10mg/Kg or

10mg/L or 0.001%.

1508 CONYZA

CANADENSIS

A,H

1509 COPAIBA OIL A,E,H

1510 COPAIFERA A,E,H


Schedule 1


LANGSDORFFII

1511 COPERNICIA

CERIFERA

A,E,H

1512 COPOVIDONE E

1513 COPPER H Only for use as an active


The maximum daily dose must not

contain more than 5mg of copper.

1514 COPPER ACETYL

TYROSINATE

METHYLSILANOL


dermal application.

1515 COPPER

CHLOROPHYLL



fragrance.




1516 COPPER

CHLOROPHYLLIN


topical medicines.

1517 COPPER

GLUCONATE

A,E Copper is a mandatory component of

copper gluconate.


accepted percentage of copper from

copper gluconate is 14%. The

declared quantity of copper from

copper gluconate must be no less than

13.0% and must be no more 15.0% of

the copper gluconate in the


incorporate a 5% variance on the USP

reference to allow for rounding in

calculations.

The concentration of copper

compounds in products must be no


Schedule 1


more than 5%.

The maximum daily dose must not

contain more than 5mg of copper.




for oral and sublingual use.

1518 COPPER

TRIPEPTIDE-1


dermal application.



1519 COPTIS CHINENSIS A,H

1520 COPTIS JAPONICA A,H

1521 CORAL - RED H Only for use as an active


1522 CORALLINA

OFFICINALIS




in the eye.

The concentration in the medicine is to

be no more than 1%.

1523 CORDYCEPS

SINENSIS

A,E,H Must not contain material of animal

origin such as insect larvae.

1524 CORIANDER DRY A,H

1525 CORIANDER OIL A,E,H

1526 CORIANDER

POWDER

A,H

1527 CORIANDRUM

SATIVUM

A,E,H

1528 CORN GLYCERIDES E

1529 CORN SILK DRY A,H


Schedule 1


1530 CORN SILK POWDER A,E,H

1531 CORN SYRUP E Permitted for use only in combination


flavour.



no more than 5%.

1532 CORN SYRUP

SOLIDS



flavour.



no more than 5%.

1533 CORNUS FLORIDA A,H

1534 CORNUS

OFFICINALIS

A,E,H

1535 CORTISONE

ACETATE

H Only available as an active


1536 CORYDALIS

AMBIGUA

A,E,H

1537 CORYDALIS

BUNGEANA

A,H

1538 CORYDALIS CAVA A,H

1539 CORYDALIS

FABACEA

A,H

1540 CORYDALIS

FORMOSA

A,H

1541 CORYDALIS

TURTSCHANINOVII

A,H

1542 CORYLUS

AMERICANA

A,E,H


Schedule 1


1543 CORYLUS

AVELLANA

A,E,H

1544 CORYMBIA

CITRIODORA

A,E,H Cineole is a mandatory component of

Corymbia citriodora.

When the plant preparation is oil and

the concentration of the oil in the

preparation is more than 25%, the


be no more than than 25 mL.





25mL, a child resistant closure and




medicine label:







is no more than 15 mL, the container

must be fitted with a restricted flow

insert and requires the following


label:




1545 CORYMBIA

FICIFOLIA

A,H Cineole is a mandatory component of

Corymbia ficicolia.


the concentration of the oil in the


Schedule 1













medicine label:







is no more than 15 mL, the container

must be fitted with a restricted flow

insert and requires the following


label:




1546 COSMOS

BIPINNATUS

A,H

1547 COSTUS ROOT OIL A,E,H

1548 COSTUS SPICATUS A,H

1549 COTTONSEED OIL A,E,H

1550 COTTONSEED OIL -

HYDROGENATED

E

1551 COUCH GRASS A,H


Schedule 1


RHIZOME DRY

1552 COUCH GRASS

RHIZOME POWDER

A,H

1553 COUMARIN H Only for use as an active




1554 CRANBERRY E

1555 CRATAEGUS

CUNEATA

A,E,H

1556 CRATAEGUS

LAEVIGATA

A,E,H

1557 CRATAEGUS

MONOGYNA

A,E,H

1558 CRATAEGUS

PINNATIFIDA

A,E,H

1559 CRATEVA NURVALA A,E,H

1560 CREATINE A,E The medicine requires the following


label:

- (PROFES) 'Seek professional advice

before long term use'.

1561 CREATINE

MONOHYDRATE

A,E The medicine requires the following


label:



1562 CREATINE

PHOSPHATE

A,E The medicine requires the following


label:



Schedule 1



1563 CREATININE E Only for use in topical medicines for

dermal application and not for use in

medicines intended for use in the eye.



1564 CREOSOL E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1565 CREOSOTE H Only for use as an active


1566 CRESOL E Only for use as a preservative in

topical medicines.

The concentration of phenols

(including cresols and xylenols and

any other homologue of phenol)

boiling below 220 degrees centigrade




label:

- (CRESOL) 'Contains cresol' (or


1567 CRESYL

ISOBUTYRATE



fragrance.




Schedule 1



1568 CRITHMUM

MARITIMUM

WHOLE PLANT

EXTRACT




in the eye.



1569 CROCUS SATIVUS A,H

1570 CROSCARMELLOSE

SODIUM

E When for oral or sublingual use and










1571 CROSPOVIDONE E

1572 CROTON

CASCARILLA

A,H The maximum recommended daily



material.

1573 CROTON ELUTERIA A,H The maximum recommended daily



material.

1574 CRYPTOMERIA

JAPONICA

A,H

1575 CUBEB OIL A,H

1576 CUBEBENE E Permitted for use only in combination


flavour.



Schedule 1



no more than 5%.

1577 CUCUMBER E

1578 CUCUMIS MELO A,E,H

1579 CUCUMIS SATIVUS A,E,H

1580 CUCURBITA

MAXIMA

A,E,H

1581 CUCURBITA

MOSCHATA

A,H

1582 CUCURBITA PEPO A,E,H

1583 CULLEN

CORYLIFOLIUM

A,H

1584 CUMIC ALCOHOL E Permitted for use only in combination


fragrance.




1585 CUMIN OIL A,E,H

1586 CUMINALDEHYDE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1587 CUMINUM

CYMINUM

A,E,H

1588 CUMINYL NITRILE E Permitted for use only in combination



Schedule 1


fragrance.




1589 CUPRESSUS

ARIZONICA

A,H

1590 CUPRESSUS

FUNEBRIS

A,E,H

1591 CUPRESSUS

MACROCARPA

A,H

1592 CUPRESSUS

SEMPERVIRENS

A,E,H

1593 CUPRIC ACETATE

MONOHYDRATE



1594 CUPRIC ARSENITE H Only for use as an active


1595 CUPRIC CITRATE A,E,H When for oral or sublingual use,

copper is a mandatory component of

Cupric citrate.



cupric citrate is 40.4%. The declared

quantity of copper from cupric citrate

must be no less than 38.4% and must

be no more than 42.4% of the Cupric

citrate in the formulation. These



The medicine must not contain more

than 750 micrograms of copper from

Cupric citrate per the recommended

daily dose or the medicine must not

contain more than 1.86 milligrams of

cupric citrate per the recommended

daily dose.


Schedule 1






1596 CUPRIC CITRATE

HEMIPENTAHYDRA

TE

A,E,H When for oral or sublingual use,


Cupric citrate hemipentahydrate.

The medicine must not contain more

than 750 micrograms of copper from

cupric citrate hemipentahydrate per the

recommended daily dose OR the

medicine must not contain more than

2.13 milligrams of cupric citrate

hemipentahydrate per the




cupric citrate hemipentahydrate is


copper from cupric citrate

hemipentahydrate must be no less than

33.4% and must be no more than 37%

of the Cupric citrate hemipentahydrate








1597 CUPRIC OXIDE A,E,H When for oral or sublingual use,


Cupric oxide. Based on molecular

weights the accepted percentage of

copper from cupric oxide is 79.9%.

The declared quantity of copper from

cupric oxide must be no less than


83.9% of the Cupric oxide in the


Schedule 1




calculations.

When for other than internal use, the

concentration of cupric oxide from all

ingredients must be no more than 5%.





1598 CUPRIC SULFATE A,E,H When for oral or sublingual use,


cupric sulfate.



cupric sulfate is 39.9%. The declared

quantity of copper from cupric sulfate

must be no less than 37.5% and must

be no more than 42.3% of the cupric

sulfate in the formulation. These



For external use the concentration of

cupric sulfate from all ingredients in

the product must be no more than 5%.





1599 CUPRIC SULFATE

MONOHYDRATE

A,E,H When for oral or sublingual use,


Cupric sulfate monohydrate.



cupric sulfate monohydrate is 35.8%.


cupric sulfate monohydrate must be no


Schedule 1



than 38% of the Cupric sulfate




When used topically, Cupric sulfate

anhydrous is a mandatory component

of Cupric sulfate monohydrate.


accepted percentage of cupric sulfate

from cupric sulfate monohydrate is

89.9%. The declared quantity of cupric

sulfate from cupric sulfate

monohydrate must be no less than


95.3% of the Cupric sulfate








1600 CUPRIC SULFATE

PENTAHYDRATE

A,E,H Where for oral or sublingual use,


Cupric sulfate pentahydrate.



cupric sulfate pentahydrate is 25.5%.


cupric sulfate pentahydrate must be no


than 27% of the Cupric sulfate

penathydrate in the formulation. These



When used topically Cupric sulfate

anhydrous is a mandatory component


Schedule 1


of Cupric sulfate pentahydrate.


accepted percentage of cupric sulfate

anhydrous from cupric sulfate

pentahydrate is 64%. The declared

quantity of cupric sulfate anhydrous

from cupric sulfate pentahydrate must


more than 67.9% of the Cupric sulfate

pentahydrate in the formulation. These







1601 CURCULIGO

ORCHIOIDES

A,H

1602 CURCUMA

AROMATICA

A,H

1603 CURCUMA LONGA A,E,H

1604 CURCUMA

XANTHORRHIZA

A,H

1605 CURCUMA

ZEDOARIA

A,H

1606 CURCUMIN A,E,H Permitted for excipient use as a colour

in topical and oral medicines.

1607 CUSCUTA

EPITHYMUM

A,H

1608 CUSCUTA

EUROPAEA

A,H

1609 CUSCUTA

HYGROPHILAE

A,H

1610 CUSCUTA A,H


Schedule 1


RACEMOSA

1611 CUSPARIA

FEBRIFUGA

A,H

1612 CYAMOPSIS

TETRAGONOLOBA

A,E,H

1613 CYANOCOBALAMIN A,E,H When used as an active ingredient and




medicine label:





balanced diet.’

The following indications are

permitted for the medicine:

- (VIT3) 'May assist in the

management of dietary vitamin B12

deficiency.'

- (VB121) 'Source of vitamin B12.

Can assist in maintaining normal

blood.'

- (VB122) 'Source of vitamin B12.

Can assist in maintaining normal

blood. Blood tonic.'

1614 CYANOMETHYLPHE

NYL MENTHANE

CARBOXAMIDE

E For dental use only in proprietary

ingredients.



flavour.


concentration in the medicine must be

no more than 5%.


Schedule 1


1615 CYATHULA

OFFICINALIS

A,H

1616 CYCLAMEN

ALDEHYDE


in topical medicines.

1617 CYCLAMEN

PURPURASCENS

A,H

1618 CYCLOHEXADECEN

ONE-8



fragrance.




1619 CYCLOHEXANE E Permitted for use only in combination


flavour.



no more than 5%.

1620 CYCLOHEXANE, 1-

ETHENYL-1-

METHYL-2-(1-

METHYLETHENYL)-

4-(1-

METHYLETHYL)-,

DIDEHYDRO DERIV.



fragrance.




1621 CYCLOHEXANEETH

ANOL



fragrance.




1622 CYCLOHEXYL

ACETATE



fragrance.



Schedule 1




1623 CYCLOHEXYL

PHENETHYL ETHER



fragrance.




1624 CYCLOHEXYL

SALICYLATE



fragrance.




1625 CYCLOMETHICONE E Only for use as an excipient ingredient


1626 CYCLOPENTADECA

NONE



fragrance.




1627 CYDONIA OBLONGA A,H

1628 CYMBOPOGON

FLEXUOSUS

A,E,H The concentration or Aldehydes

calculated as citral in the medicine

must be no more than 5% for topical

use.

1629 CYMBOPOGON

MARTINI

A,H The concentration or Aldehydes



use.

1630 CYMBOPOGON

NARDUS

A,H The concentration or Aldehydes




Schedule 1


use.

1631 CYMBOPOGON

SCHOENANTHUS

A,E,H The concentration or Aldehydes



use.

1632 CYNANCHUM

ATRATUM

A,H

1633 CYNANCHUM

STAUNTONII

A,E,H

1634 CYNARA

SCOLYMUS

A,E,H

1635 CYNODON

DACTYLON

A,E,H

1636 CYNOMORIUM

SONGARICUM

A,H

1637 CYPERUS LONGUS A,H

1638 CYPERUS

ROTUNDUS

A,H

1639 CYPRESS OIL E Permitted for use only in combination


fragrance.




1640 CYPRIPEDIUM

PARVIFLORUM VAR.

PUBESCENS

A,H

1641 CYSTEINE A

1642 CYSTEINE

HYDROCHLORIDE

A

1643 CYSTEINE

HYDROCHLORIDE

A


Schedule 1


MONOHYDRATE

1644 CYSTINE A

1645 CYTISUS

SCOPARIUS

A,H Sparteine is a mandatory component

of Cytisus scoparius.

The concentration of Spartiene in the


0.001%.

1646 D-ALPHA-

TOCOPHEROL

A,E When used as an active ingredient and




medicine label:





balanced diet.’

1647 D-ALPHA-

TOCOPHERYL

ACETATE

A,E,H When used as an active ingredient and




medicine label:





balanced diet.’

1648 D-ALPHA-

TOCOPHERYL ACID

SUCCINATE

A,E When used as an active ingredient and




medicine label:






Schedule 1


balanced diet.’

1649 D-ALPHA-

TOCOPHERYL

PHOSPHATES







1650 D-BORNEOL E Permitted for use only in combination


fragrance.




1651 D-CARVONE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1652 D-FENCHONE E Permitted for use only in combination


flavour.



no more than 5%.

1653 D-LIMONENE E Permitted for use only in combination





no more than 5%.


Schedule 1




must be no more 1%.

1654 D-PULEGONE E When the nominal capacity of the

container is more than 15 mL, the

concentration of D-Pulegone in the


When the concentration of D-Pulegone

in the preparation is more than 4% and


is 15 mL or less, the medicine must





label:




1655 DACTYLIS

GLOMERATA

A,H

1656 DACTYLORHIZA

INCARNATA SUBSP.

INCARNATA

A,H

1657 DAEMONOROPS

DRACO

A,E,H

1658 DAHLIA PINNATA A,H

1659 DALBERGIA

ODORIFERA

A,H

1660 DAMIANA LEAF

POWDER

A

1661 DANDELION LEAF

DRY

A,H

1662 DANDELION LEAF A,H


Schedule 1


POWDER

1663 DANDELION ROOT

DRY

A,H

1664 DANDELION ROOT

POWDER

A,H

1665 DAPHNE GENKWA A,H

1666 DAPHNE

MEZEREUM




material.

1667 DATE E

1668 DATURA

STRAMONIUM

A,H Only for use in oral medicines.

Alkaloids calculated as hyoscyamine

is a mandatory component of Datura

stramonium.


calculated as hyoscyamine from all


more than 300 micrograms/Kg or 300


1669 DAUCUS CAROTA A,E,H

1670 DAVANA OIL E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1671 DEA-OLETH-3

PHOSPHATE


dermal application and not be included

in topical medicines intended for use


Schedule 1


in the eye.





label:

- (EYE) 'Avoid contact with eyes'



1672 DECAHYDRO-

2,2,6,6,7,8,8-

HEPTAMETHYL-2H-

INDENO(4,5-B)

FURAN



fragrance.




1673 DECAHYDRO-BETA-

NAPHTHYLACETAT

E



fragrance.




1674 DECAHYDRO-BETA-

NAPHTHYLFORMAT

E



fragrance.




1675 DECAHYDROSPIRO(

FURAN-2(3H),5'-

(4,7)METHANO(5H)IN

DENE)

E

1676 DECALACTONE E Permitted for use only in combination




Schedule 1




no more than 5%.



must be no more 1%.

1677 DECANAL E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1678 DECANAL

DIMETHYL ACETAL



flavour.



no more than 5%.

1679 DECARBOXY

CARNOISINE

DIHYDROCHLORIDE




in the eye.


must be no more than 0.05.

1680 DECENAL E Permitted for use only in combination


fragrance.




1681 DECYL ACETATE E Permitted for use only in combination



Schedule 1





no more than 5%.



must be no more 1%.

1682 DECYL ALCOHOL E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1683 DECYL GLUCOSIDE E Only for use in topical medicines for

dermal application.

1684 DECYL OLEATE E Only for use in topical medicines for

dermal application.

1685 DECYLENE GLYCOL E Only for use in topical medicines for






1686 DEER - RED A

1687 DEER ANTLER

CARTILAGE



1688 DEER VELVET

ANTLER POWDER

A Medicines that contain 'deer velvet

antler powder' as the therapeutically

active ingredient are subject to the

following conditions:


Schedule 1


(i) the medicines are for oral use only;

(ii) the antlers (including the velvet)

are sourced only from red deer

(Cervus elaphus), elk/wapiti (Cervus

canadensis), or a crossbreed of these

species;

(iii) the deer are sourced only from

farmed stock bred and raised in New

Zealand;

(iv) the deer are sourced only from

herds farmed for food in accordance

with the Animal Products Act 1999

(New Zealand) and the regulations

made under that Act; and

(v) the antlers are removed from the

deer only according to the Animal

Welfare Act 1999 (New Zealand) and

the regulations made under that Act.

1689 DEER VELVET

ANTLER SLICE

A Medicines that contain 'deer velvet

antler slice' as the therapeutically

active ingredient are subject to the

following conditions:

(i) the medicines are for oral use only;

(ii) the antlers (including the velvet)

are sourced only from red deer

(Cervus elaphus), elk/wapiti (Cervus

canadensis), or a crossbreed of these

species;

(iii) the deer are sourced only from

farmed stock bred and raised in New

Zealand;

(iv) the deer are sourced only from

herds farmed for food in accordance

with the Animal Products Act 1999

(New Zealand) and the regulations

made under that Act; and


Schedule 1


(v) the antlers are removed from the

deer only according to the Animal

Welfare Act 1999 (New Zealand) and

the regulations made under that Act.

1690 DEERTONGUE

ABSOLUTE



fragrance.




1691 DEHYDROACETIC

ACID


dermal application.



label:

- (DACACD) 'Contains dehydroacetic

acid [quantity]' (or words to that

effect).

1692 DEHYDROMENTHOF

UROLACTONE



flavour.



no more than 5%.

1693 DEHYDROXANTHAN

GUM




in the eye.



1694 DELPHINIUM

STAPHISAGRIA

A,H The concentration of the equivalent

dry Delphinium staphisagria in the


1695 DELTA- E Permitted for use only in combination



Schedule 1


DAMASCONE fragrance.




1696 DELTA-

DECALACTONE






no more than 5%.



must be no more 1%.

1697 DELTA-

DODECALACTONE






no more than 5%.



must be no more 1%.

1698 DELTA-

NONALACTONE






no more than 5%.



must be no more 1%.

1699 DELTA-

OCTALACTONE





Schedule 1




no more than 5%.



must be no more 1%.

1700 DELTA-

TETRADECALACTO

NE



flavour.



no more than 5%.

1701 DELTA-

TOCOPHEROL

E

1702 DELTA-

UNDECALACTONE






no more than 5%.




1703 DEMINERALISED

FISH

PROTEOGLYCAN

EXTRACT

A

1704 DENATONIUM

BENZOATE

E

1705 DENDROBIUM

NOBILE

A,H

1706 DESCURAINIA

SOPHIA

A,H

1707 DESMODIUM A,H


Schedule 1


STYRACIFOLIUM

1708 DESMODIUM

TRIQUETUM

A,H

1709 DEVIL'S CLAW

TUBER DRY

A,H

1710 DEVIL'S CLAW

TUBER POWDER

A,H

1711 DEXPANTHENOL A,E When used as an active ingredient and




medicine label:





balanced diet.’

1712 DEXTRAN 20 E Only for use in topical medicines for






1713 DEXTRAN 40 A,E

1714 DEXTRATES E

1715 DEXTRIN E

1716 DEXTRIN

PALMITATE




in the eye.



1717 DHA/EPA RICH

SCHIZOCHYTRIUM

A Only for use in oral medicines. The

ratio of docosahexaenoic acid (DHA)


Schedule 1


ALGAL OIL to eicosapentaenoic acid (EPA) must

be 2:1, and must be present in

combination with other ingredients.

1718 DI-C12-13 ALKYL

MALATE




in the eye.



1719 DI-C12-15 ALKYL

FUMARATE

E Only for use in topical medicines forr



in the eye.



1720 DI-N-PROPYL

ISOCINCHOMERONA

TE


dermal application.



1721 DI-PPG-3 MYRISTYL

ETHER ADIPATE




in the eye.



1722 DIACETIN E Permitted for use only in combination





no more than 5%.



must be no more 1%.


Schedule 1


1723 DIACETYL E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1724 DIACETYL

TARTARIC ACID

ESTERS OF MONO-

AND DIGLYCERIDES



flavour.



no more than 5%.

1725 DIAMMONIUM

LAURYL

SULFOSUCCINATE



1726 DIANTHUS

SUPERBUS

A,H

1727 DIAZOLIDINYL

UREA


dermal application.

The medicine requires requires the


medicine label:

- (DUREA) 'Contains diazolidinyl

urea' (or words to that effect).

1728 DIBASIC SODIUM

PHOSPHATE


the preparation is intended as a

mineral supplementation, sodium is a

mandatory component of dibasic

sodium phosphate.


accepted percentage of sodium from

dibasic sodium phosphate is 32.4%.


Schedule 1


The declared quantity of sodium from

dibasic sodium phosphate must not be

less than 30.8% and must not exceed

34.0% of the dibasic sodium

phosphate in the formulation. These



When used in a solid preparation, the

pH of a 10 g/L aqueous solution must

not be more than 11.5.

When used in a liquid or a semi-solid

preparation, the pH of the preparation

must not exceed 11.5.









quantity and units] of sodium’ (or






1729 DIBASIC SODIUM

PHOSPHATE

DIHYDRATE





sodium phosphate dihydrate.



dibasic sodium phosphate dihydrate is


sodium from dibasic sodium

phosphate dihydrate must not be less


Schedule 1


than 24.6% and must not exceed

27.2% of the dibasic sodium

phosphate dihydrate in the
























1730 DIBASIC SODIUM

PHOSPHATE

DODECAHYDRATE





sodium phosphate dodecahydrate.



dibasic sodium phosphate

dodecahydrate is 12.9%. The declared

quantity of sodium from dibasic

sodium phosphate dodecahydrate must

not be less than 12.2% and must not


Schedule 1


exceed 13.5% of the dibasic sodium

phosphate dodecahydrate in the
























1731 DIBASIC SODIUM

PHOSPHATE

HEPTAHYDRATE





sodium phosphate heptahydrate.

The amount of sodium in the active


on the molecular weight of dibasic

sodium phosphate heptahydrate.





Schedule 1



















1732 DIBASIC SODIUM

PHOSPHATE

MONOHYDRATE





sodium phosphate monohydrate.



dibasic sodium phosphate

monohydrate is 28.8%. The declared

quantity of sodium from dibasic

sodium phosphate monohydrate must

not be less than 27.3% and must not

exceed 30.2% of the dibasic sodium

phosphate monohydrate in the









Schedule 1


















1733 DIBENZYL KETONE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1734 DIBUTYL ADIPATE E Only for use in topical medicines for

dermal application.

1735 DIBUTYL

PHTHALATE


dermal application.

1736 DIBUTYL SEBACATE E

1737 DIBUTYLAMINE E Permitted for use only in combination


flavour.


concentration in the medicine must be


Schedule 1


no more than 5%.

1738 DICAPRYLYL

CARBONATE


dermal application.



1739 DICAPRYLYL ETHER E Only for use in topical medicines for

dermal application.

1740 DICAPRYLYL

MALEATE




in the eye.



1741 DICETYL

PHOSPHATE







1742 DICHLOROBENZYL

ALCOHOL

E

1743 DICHLOROMETHAN

E

E The concentration in the medicine


The residual solvent limit for

Dichloromethane is 6 mg per


1744 DICTAMNUS ALBUS A,H

1745 DICTAMNUS

DESYCARPUS

A,H

1746 DICYCLOHEXYL

DISULFIDE



flavour.



Schedule 1



no more than 5%.

1747 DIEFFENBACHIA

SEGUINE



1748 DIETHANOLAMINE E Only for use in topical medicines for

dermal application.



1749 DIETHYL

CITRACONATE



flavour.



no more than 5%.

1750 DIETHYL

MALONATE






no more than 5%.



must be no more 1%.

1751 DIETHYL

PHTHALATE

E

1752 DIETHYLAMINO

HYDROXYBENZOYL

HEXYL BENZOATE


sunscreens for dermal application and





1753 DIETHYLAMINOMET

HYLCOUMARIN


dermal application.



Schedule 1



1754 DIETHYLDIMETHYL

-2-

CYCLOHEXENONE



fragrance.




1755 DIETHYLENE

GLYCOL



fragrance.




1756 DIETHYLENE

GLYCOL

MONOETHYL ETHER


dermal application.

1757 DIETHYLHEXYL-2,6-

NAPHTHALATE




in the eye.





label:



1758 DIETHYLHEXYL

CARBONATE



in medicines intended for use in the

eye or on damaged skin.



1759 DIETHYLHEXYL E Only for use in topical medicines for


Schedule 1


SEBACATE dermal application.

1760 DIETHYLHEXYL

SYRINGYLIDENEMA

LONATE




in the eye.



1761 DIETHYLTOLUAMID

E


dermal application.





label:

- (DEET) 'WARNING: May be

dangerous; particularly to children, if

you use large amounts on the skin,

clothes or bedding or on large areas of

the body, especially if you keep using

it for a long time.'

1762 DIGITALIS LEAF

DRY

A,H The concentration of Digitalis leaf dry

in the product must be no more than

10mg/Kg or 10mg/L or 0.001%.

1763 DIGITALIS LEAF

POWDER

A,H The concentration of Digitalis leaf

powder in the product must be no

more than 10mg/Kg or 10mg/L or

0.001%.

1764 DIGITALIS

PURPUREA


Digitalis purpurea in the medicine

must be no more than 10mg/Kg or

10mg/L or 0.001%.

1765 DIGLYCOL/CHDM/IS

OPHTHALATES/SIP

COPOLYMER


dermal application.


Schedule 1


1766 DIHEXYL

FUMARATE



fragrance.




1767 DIHYDRO-ALPHA-

TERPINEOL



flavour.



no more than 5%.

1768 DIHYDRO-BETA-

IONONE






no more than 5%.



must be no more 1%.

1769 DIHYDRO-

ISOJASMONE



fragrance.




1770 DIHYDRO JASMONE E Permitted for use only in combination


fragrance.




1771 DIHYDRO E Permitted for use only in combination



Schedule 1


TERPINYLACETATE fragrance.




1772 DIHYDROACTINIDIO

LIDE



flavour.



no more than 5%.

1773 DIHYDROAMBRETT

OLIDE



fragrance.




1774 DIHYDROCARVYL

ACETATE



flavour.



no more than 5%.

1775 DIHYDROCOUMARI

N






no more than 5%.



must be no more 1%.

1776 DIHYDROEUGENOL E Permitted for use only in combination


fragrance.


Schedule 1





1777 DIHYDROGENATED

TALLOW PHTHALIC

ACID AMIDE




in the eye.



1778 DIHYDROINDENYL-

2,4-DIOXANE



fragrance.




1779 DIHYDROLINALOOL E Permitted for use only in combination


fragrance.




1780 DIHYDROMYRCENO

L






no more than 5%.



must be no more 1%.

1781 DIHYDROMYRCENY

L ACETATE



fragrance.




Schedule 1



1782 DIHYDROXYACETO

NE


dermal application.

1783 DIISOPROPYL

ADIPATE




in the eye.



1784 DIISOPROPYL

SEBACATE




eye.



1785 DIISOSTEARYL

DIMER

DILINOLEATE


dermal application.

1786 DILAURYL

THIODIPROPIONATE


dermal application.

1787 DILL HERB OIL A,E,H

1788 DILL SEED OIL A,E,H

1789 DILL WEED OIL E Permitted for use only in combination


flavour.



no more than 5%.

1790 DIMER

DISTEARYLTRICAR

BONATE


dermal application and not to be used


eye.



Schedule 1



1791 DIMETHICONE 12500 E

1792 DIMETHICONE 4000 E Only for use in topical medicines for



in the eye.



1793 DIMETHICONE

CROSSPOLYMER







1794 DIMETHICONE

SILYLATE




in the eye.



1795 DIMETHICONE/MET

HICONE

COPOLYMER




in the eye.



1796 DIMETHICONE/VINY

L DIMETHICONE

CROSSPOLYMER




in the eye.



1797 DIMETHYL 3-

CYCLOHEXENE-1-




Schedule 1


CARBOXALDEHYDE fragrance.




1798 DIMETHYL

ANTHRANILATE






no more than 5%.



must be no more 1%.

1799 DIMETHYL BENZYL

CARBINOL



fragrance.





CARBINYL

ACETATE






no more than 5%.



must be no more 1%.


CARBINYL

BUTYRATE






no more than 5%.


Schedule 1




must be no more 1%.


CARBINYL

ISOBUTYRATE



fragrance.




1803 DIMETHYL

PHENYLETHYL

CARBINOL



fragrance.




1804 DIMETHYL

PHTHALATE



fragrance.




1805 DIMETHYL

POLYSILOXANE



flavour.



no more than 5%.

1806 DIMETHYL

SUCCINATE



flavour.



no more than 5%.

1807 DIMETHYL SULFATE E Permitted for use only in combination



Schedule 1


flavour.



no more than 5%.

1808 DIMETHYL SULFIDE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1809 DIMETHYL

SULFONE


1810 DIMETHYL

SULFOXIDE



flavour.



no more than 5%.

1811 DIMETHYLACETAL E Permitted for use only in combination


flavour.



no more than 5%.

1812 DIMETHYLCYCLOH

EXYLETHOXY

ISOBUTYLPROPANO

ATE



fragrance.




1813 DIMETHYLGLYCINE A Only for use in oral medicines.


Schedule 1


HYDROCHLORIDE

1814 DIMETHYLOL

DIMETHYL

HYDANTOIN


dermal application.

1815 DIMETICONE 1.5 E Only for use in topical medicines for

dermal application.



1816 DIMETICONE 10 E

1817 DIMETICONE 100 E Only for use in topical medicines for

dermal application.

1818 DIMETICONE 1000 E

1819 DIMETICONE 1510 E Permitted for use only in combination


printing ink.

If used in a printing ink the total

printing ink concentration in a

medicine must be no more than 0.1%


dermal application.




dermal application.


dermal application.




in the eye.

The concentration is the medicine



Schedule 1


1824 DIMETICONE 350 E Only for use in topical and oral

medicines.

When used orally, the maximum daily

dose must be no more than 7.5mg.


dermal application.


dermal application.


dermal application.




dermal application.


dermal application.




in the eye.



1831 DIMETICONE

COPOLYOL


dermal application.

1832 DIMETICONE

COPOLYOL

PHOSPHATE


dermal application.

1833 DIMETICONE

CROSSPOLYMER-3








Schedule 1


1834 DIMETICONE/PEG-

10/15

CROSSPOLYMER




in the eye.



1835 DIMETICONOL E Only for use in topical medicines for

dermal application.

1836 DIMETICONOL

STEARATE




in the eye.



1837 DIMOCARPUS

LONGAN

A,H

1838 DIOCTYL ADIPATE E Only for use in topical medicines for

dermal application.

1839 DIOCTYL MALEATE E Only for use in topical medicines for

dermal application.

1840 DIOCTYL

SUCCINATE


dermal application.

1841 DIOCTYL

TEREPHTHALATE






no more than 5%.



must be no more 1%.

1842 DIOLAMINE C8-18

PERFLUOROALKYLE

THYL PHOSPHATE





Schedule 1


in the eye.



1843 DIOLAMINE CETYL

PHOSPHATE




in the eye.

1844 DIOSCOREA

COLLETTII

A,H

1845 DIOSCOREA

COLLETTII VAR.

HYPOGLAUCA

A,H

1846 DIOSCOREA

JAPONICA

A,E,H

1847 DIOSCOREA

OPPOSITIFOLIA

A,H

1848 DIOSCOREA

POLYSTACHYA

A,H

1849 DIOSCOREA

SEPTEMLOBA

A,H

1850 DIOSCOREA

VILLOSA

A,E,H

1851 DIOSPYROS KAKI A,E,H

1852 DIOXYBENZONE A Only for use as an active ingredient in






label:

- (AVOID) 'Avoid prolonged exposure

in the sun' (or words to this effect)


Schedule 1


- (SUNPRO) 'Wear protective clothing

- hats and eyewear when exposed to

the sun' (or words to this effect).

1853 DIPENTAERYTHRIT

YL

HEXACAPRYLATE/H

EXACAPRATE




on damaged skin.




YL

TETRAHYDROXYST

EARATE/TETRAISOS

TEARATE




in the eye.




YL TRI-

POLYHYDROXYSTE

ARATE




in the eye.



1856 DIPHENYL

DIMETHICONE


dermal application.

1857 DIPHENYL

METHANE



fragrance.




1858 DIPHENYL OXIDE E Permitted for use only in combination






Schedule 1


no more than 5%.



must be no more 1%.

1859 DIPOTASSIUM

GLYCYRRHIZATE




in the eye.



1860 DIPROPIONYL E Permitted for use only in combination


flavour.



no more than 5%.

1861 DIPROPYLENE

GLYCOL


dermal application.

1862 DIPROPYLENE

GLYCOL

DIBENZOATE




in the eye.



1863 DIPROPYLENE

GLYCOL

SALICYLATE


dermal application.

1864 DIPSACUS ASPER A,H

1865 DIPSACUS

JAPONICUS

A,H

1866 DIPTERYX

ODORATA

A,E,H

1867 DISODIUM

ASCORBYL



Schedule 1


SULFATE dermal application.











1868 DISODIUM

COCOAMPHODIACE

TATE


dermal application.











1869 DISODIUM

COCOAMPHODIPRO

PIONATE




in the eye.



1870 DISODIUM

DIMETICONE

COPOLYOL

SULFOSUCCINATE




in the eye.





Schedule 1











1871 DISODIUM EDETATE E When for oral or sublingual use and










1872 DISODIUM

ETHYLENE

DICOCAMIDE PEG-15

DISULFATE







1873 DISODIUM

GUANYLATE



flavour.



no more than 5%.

1874 DISODIUM

INOSINATE



flavour.




Schedule 1


no more than 5%.

1875 DISODIUM

LAURIMINODIPROPI

ONATE

TOCOPHERYL

PHOSPHATES




in the eye.



1876 DISODIUM NADH E Only for use in topical medicines for

dermal application.



1877 DISODIUM

OLEAMIDO PEG-2

SULFOSUCCINATE


dermal application.













1878 DISODIUM PHENYL

DIBENZIMIDAZOLE

TETRASULFONATE







label:


in the sun' (or words to that effect)


Schedule 1





1879 DISODIUM

RICINOLEAMIDO

MEA-

SULFOSUCCINATE




in the eye.



1880 DISODIUM RUTINYL

DISULFATE




in the eye.



1881 DISODIUM

STEAROYL

GLUTAMATE




in the eye.



1882 DISTARCH

PHOSPHATE




in the eye.



1883 DISTEARDIMONIUM

HECTORITE



included for medicines intended for

use in the eye.



1884 DISTEARETH-6

DIMONIUM



Schedule 1


CHLORIDE dermal application.

1885 DISTEARYL

PHTHALIC ACID

AMIDE




in the eye.



1886 DISTEARYLDIMONI

UM CHLORIDE




in the eye.



1887 DIVINYLDIMETHICO

NE/DIMETHICONE

COPOLYMER




in the eye.



1888 DL-ALPHA-

TOCOPHEROL





medicine label:





balanced diet.’

1889 DL-ALPHA-

TOCOPHERYL

ACETATE





medicine label:




Schedule 1




balanced diet.’

1890 DL-ALPHA-

TOCOPHERYL ACID

SUCCINATE





medicine label:





balanced diet.’

1891 DL-BORNEOL E

1892 DL-LIMONENE E Only for use in topical medicines for

dermal application.

1893 DL-THREONINE A,E

1894 DOCOSAHEXAENOI

C ACID (DHA) - RICH

OIL DERIVED FROM

MICROALGAE

SCHIZOCHYTRIUM

SP.

A Only for use in oral medicines and

must be present in combination with

other ingredients.

1895 DOCUSATE SODIUM E

1896 DODECAHYDRO-

3A,6,6,9A-

TETRAMETHYLNAP

HTHO(2,1-B)FURAN



fragrance.




1897 DODECANENITRILE E Permitted for use only in combination


fragrance.




Schedule 1



1898 DODECENAL E Permitted for use only in combination





no more than 5%.



must be no more 1%.

1899 DODECENE E Only for use in topical medicines for



in the eye.



1900 DODECYL ACETATE E Permitted for use only in combination


flavour.



no more than 5%.

1901 DODECYL

ISOBUTYRATE



flavour.



no more than 5%.

1902 DOLICHOS LABLAB A,H

1903 DOLOMITE A,E,H The following indications are only


for oral and sublingual use:

(SCI-BONDIOP-PR) 'Provides a

minimum daily dose of 290mg of


Schedule 1


elemental calcium. A diet deficient in

calcium can lead to osteoporosis in

later life'

(SCI-NUMCALE-AP) 'Provides a

minimum daily dose of 290mg of

elemental calcium which may assist in

the prevention of osteoporosis when

dietary intake is inadequate.'

1904 DRACAENA DRACO A,H

1905 DRECHSLERA

SOROKINIANA

A,H

1906 DRIMIA INDICA A,H

1907 DRIMIA MARITIMA A,H

1908 DROMETRIZOLE

TRISILOXANE







label:






1909 DROSERA ANGLICA A,H

1910 DROSERA

BURMANNI

A,H

1911 DROSERA

INTERMEDIA

A,H

1912 DROSERA

RAMENTACIA

A,H


Schedule 1


1913 DROSERA

ROTUNDIFOLIA

A,E,H

1914 DROSERA

ROTUNDIFOLIA MIS

A,H

1915 DRYNARIA

FORTUNEI

A,H

1916 DRYOBALANOPS

AROMATICA

A,E,H

1917 DRYOPTERIS FILIX-

MAS



1918 DULACIA

INOPIFLORA

A,E,H

1919 DUNALIELLA

SALINA

A,E,H

1920 DWARF PINE-

NEEDLE OIL






no more than 5%.



must be no more 1%.

1921 DYSPHANIA

AMBROSIOIDES

A,H Volatile oil components (of Dysphania

ambrosioides) is a mandatory

component of Dysphania

ambrosioides.

1922 ECAMSULE A Only for use as an active ingredient in






Schedule 1



label:






1923 ECHINACEA

ANGUSTIFOLIA

A,E,H

1924 ECHINACEA

PALLIDA

A,E,H

1925 ECHINACEA

PURPUREA

A,E,H

1926 ECHINOPS SPINOSUS A,H

1927 ECLIPTA

PROSTRATA

A,H

1928 ECTOIN E Only for use as an excipient ingredient

in topical medicines for dermal

application and not to be used in

topical medicines intended for use in

the eye.



1929 EDETATE SODIUM E Only for use in topical medicines for

dermal application and nasal

medicines.



1930 EDETIC ACID E The concentration in the medicine


1931 EICHHORNIA

CRASSIPES

A,H


Schedule 1


1932 ELAEAGNUS

ANGUSTIFOLIA

A,H

1933 ELAEIS GUINEENSIS A,E,H

1934 ELASTIN E Only for use in topical medicines for

dermal application.

1935 ELDER FLOWER

ABSOLUTE



flavour.



no more than 5%.

1936 ELDER FLOWER

BLACK DRY

A,E,H

1937 ELDER FLOWER

BLACK POWDER

A,H

1938 ELECAMPANE

RHIZOME DRY

A,H

1939 ELECAMPANE

RHIZOME POWDER

A,H

1940 ELEMI OIL E Permitted for use only in combination


fragrance.




1941 ELEMI RESINOID E Permitted for use only in combination


fragrance.




1942 ELEMOL E Permitted for use only in combination



Schedule 1


fragrance.




1943 ELEOCHARIS

TUBEROSA

A,H

1944 ELETTARIA

CARDAMOMUM

A,E,H

1945 ELEUTHEROCOCCU

S NODIFLORUS

A,H

1946 ELEUTHEROCOCCU

S ROOT DRY

A,H

1947 ELEUTHEROCOCCU

S ROOT POWDER

A,H

1948 ELEUTHEROCOCCU

S SENTICOSUS

A,H

1949 ELSHOLTZIA

SPLENDENS

A,H

1950 ELYMUS REPENS A,E,H

1951 EMU OIL A,E Emu oil ingredients must meet the

following two requirements:

1) the manufacturing process is to

include steps such as cooking, fat

drying or deodorising which ensures

the temperature of the oil reaches at

least 60 degrees C for a minimum 5

minutes or at least 100 degrees C for a

minimum of 1 minute, and

2) the sponsor is to hold a veterinary

certificate indicating that the emus

from which the raw material was

extracted were healthy and fit for

human consumption.


Schedule 1


1952 ENOXOLONE E Only for use in topical medicines for

dermal application.

1953 ENZYME MODIFIED

CREAM



flavour.



no more than 5%.

1954 EPHEDRA

DISTACHYA

A,H Ephedrine and Pseudoephedrine (of

Ephedra distachya) are mandatory

components of Ephedra distachya and

must be declared in the application.

The concentration of ephedrine from

all ingredients in the product must be


0.001%.

1955 EPHEDRA SINICA A,H Ephedrine and Pseudoephedrine (of

Ephedra sinica) are mandatory

components of Ephedra sinica.

The concentration of ephedrine from

all ingredients in the product must be


0.001%.

1956 EPIGAEA REPENS A,H

1957 EPILOBIUM

ANGUSTIFOLIUM

E Only for use in topical sunscreens for



in the eye.

The extract must be processed from

the flower, leaf and stem (herb top

flowering) of the plant.

The extracts used must be: 1:20 in

100% water or 1:2 in 100% water.

The concentrations of Epilobium

angustifolium must be no more than


Schedule 1


0.75% for a 1:2 extract in 100% water,

and 5% for a 1:20 extract in 100%

water.

1958 EPILOBIUM

PALUSTRE

A,H

1959 EPILOBIUM

PARVIFLORUM

A,H

1960 EPIMEDIUM

BREVICORNU

A,H

1961 EPIMEDIUM

GRANDIFLORUM

A,H

1962 EPIMEDIUM

SAGITTATUM

A,H

1963 EPOXY CEDRENE E Permitted for use only in combination


fragrance.




1964 EQUISETUM

ARVENSE

A,E,H

1965 EQUISETUM

HIEMALE

A,H

1966 ERGOCALCIFEROL A,E When used as an active ingredient and




medicine label:





balanced diet.’

The indication 'Vitamin D helps


Schedule 1



intent) and a diet deficient in calcium

can lead to osteoporosis in later life' is

only permitted for use when the

maximum recommended daily dose is

no more than 25 micrograms of

vitamin D.

1967 ERGOTHIONEINE E Only for use in topical medicines for



in the eye.



1968 ERIGERON

BREVISCAPUS

A,H

1969 ERIOBOTRYA

JAPONICA

A,H

1970 ERIOCAULON

BUERGERIANUM

A,H

1971 ERIODICTYON

CRASSIFOLIUM

A,H

1972 ERIODICTYON

GLUTINOSUM

A,H

1973 ERODIUM

CICUTARIUM

A,H

1974 ERUCA SATIVA A,H

1975 ERYTHORBIC ACID E Permitted for use only in combination


flavour.



no more than 5%.

1976 ERYTHRITOL E Only for use in topical medicines for



Schedule 1



in the eye.



1977 ERYTHROSINE E Only for use as a colour for oral and

topical use.

1978 ERYTHROSINE

ALUMINIUM LAKE

E Only for use as a colour for oral and

topical use.

1979 ERYTHRULOSE E Only for use in topical medicines for



in the eye.





label:

- (EYE) 'Avoid contact with eyes'.

1980 ESCHSCHOLZIA

CALIFORNICA

A,H

1981 ESTRONE H Only for use as an active


1982 ETHANOL A,E When used as an active ingredient, can






When the concentration of ethanol

from all ingredients in the medicine is

more than 3%, the medicine requires


the medicine label:

- (ETHAN) 'Contains ethanol or


Schedule 1


contains alcohol'.

1983 ETHANOL -

ABSOLUTE

A,E When used as an active ingredient, can






When the concentration of ethanol

from all ingredients in the medicine is

more than 3%, the medicine requires


the medicine label:

- (ETHAN) 'Contains ethanol or

contains alcohol'

1984 ETHER E The concentration of ether in the


1985 ETHOHEXADIOL E Only for use in topical medicines for

dermal application.



label:

- (EHEXAD) 'Contains ethohexadiol'


1986 ETHOXYLATED

NONYLPHENOL



fragrance.




1987 ETHOXYMETHOXY

CYCLODODECANE







Schedule 1


no more than 5%.



must be no more 1%.

1988 ETHYL-2-METHYL-

1,3-DIOXOLANE-2-

ACETATE



fragrance.




1989 ETHYL-2-METHYL-4-

PENTENOATE






no more than 5%.



must be no more 1%.

1990 ETHYL-2-

METHYLPENTENOA

TE



flavour.



no more than 5%.

1991 ETHYL (2,4-

DIMETHYL-[1,3]

DIOXOLAN-2-YL)

ACETATE



fragrance.




1992 ETHYL

(3AR,4S,7R,7AR)-

REL- OCTAHYDRO-

4,7-



fragrance.


Schedule 1


METHANO[3AH]IND

ENE-3A-

CARBOXYLATE




1993 ETHYL 2-

BUTENOATE



flavour.



no more than 5%.

1994 ETHYL 2-ETHYL-6,6-

DIMETHYL-2-

CYCLOHEXENECAR

BOXYLATE



fragrance.




1995 ETHYL 2-HEXYL

ACETOACETATE



fragrance.




1996 ETHYL 2-

METHYLBUTYRATE






no more than 5%.



must be no more 1%.

1997 ETHYL 2-

METHYLPENTANOA

TE







Schedule 1


no more than 5%.



must be no more 1%.

1998 ETHYL 2,3,6,6-

TETRAMETHYL-2-

CYCLOHEXENECAR

BOXYLATE



fragrance.




1999 ETHYL

2,6,6,TRIMETHYL-

1,3-

CYCLOHEXADIENE-

1-CARBOXYLATE



fragrance.




2000 ETHYL 3-

HEXENOATE



flavour.



no more than 5%.

2001 ETHYL 3-

HYDROXYBUTYRAT

E



flavour.



no more than 5%.

2002 ETHYL 3-

HYDROXYHEXANO

ATE



flavour.



no more than 5%.


Schedule 1


2003 ETHYL 3-

MERCAPTOPROPION

ATE



flavour.



no more than 5%.

2004 ETHYL 3-

METHYLTHIOPROPI

ONATE



flavour.



no more than 5%.

2005 ETHYL 4,7-

OCTADIENOATE



flavour.



no more than 5%.

2006 ETHYL ACETATE E The residual solvent limit for ethyl

acetate is 50 mg per recommended

daily dose.



2007 ETHYL

ACETOACETATE






no more than 5%.



must be no more 1%.

2008 ETHYL ACRYLATE E

2009 ETHYL ALCOHOL E Permitted for use only in combination


Schedule 1






no more than 5%.



must be no more 1%.

2010 ETHYL AMYL

KETONE






no more than 5%.



must be no more 1%.

2011 ETHYL

ANTHRANILATE



flavour.



no more than 5%.

2012 ETHYL BENZOATE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

2013 ETHYL BENZOYL

ACETATE




Schedule 1


fragrance.




2014 ETHYL

BUTYLACETYLAMI

NOPROPIONATE


dermal application. The concentration


7.5%.



label:

- (EYE2) 'May be irritant to the eyes

(or words to that effect)'.

2015 ETHYL BUTYRATE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

2016 ETHYL CAPRATE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

2017 ETHYL CAPROATE E Permitted for use only in combination




Schedule 1




no more than 5%.



must be no more 1%.

2018 ETHYL CAPRYLATE E Permitted for use only in combination


flavour.



no more than 5%.

2019 ETHYL CINNAMATE E Permitted for use only in combination


flavour.



no more than 5%.

2020 ETHYL CROTONATE E Permitted for use only in combination


flavour.



no more than 5%.

2021 ETHYL ENANTATE E Permitted for use only in combination





no more than 5%.




2022 ETHYL FORMATE E Permitted for use only in combination



Schedule 1


flavour.



no more than 5%.

2023 ETHYL

HYDROXYBENZOAT

E

E Medicines containing

hydroxybenzoates require the


medicine label:

- (TOTBNZ) ‘Contains

hydroxybenzoates’ (or words to this

effect) if the medicine contains more

than one hydroxybenzoate source OR

‘Contains [insert the approved name of

hydroxybenzoate used]’ (or words to

this effect) if product contains one

hydroxybenzoate source.

2024 ETHYL

ISOBUTYRATE






no more than 5%.



must be no more 1%.

2025 ETHYL

ISOVALERATE

E

2026 ETHYL LACTATE E Permitted for use only in combination





no more than 5%.




Schedule 1


must be no more 1%.

2027 ETHYL LAURATE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

2028 ETHYL LEVULATE E Permitted for use only in combination


flavour.



no more than 5%.

2029 ETHYL LEVULINATE E Permitted for use only in combination


flavour.



no more than 5%.

2030 ETHYL LINALOOL E Permitted for use only in combination





no more than 5%.



must be no more 1%.

2031 ETHYL LINALYL

ACETATE



fragrance.


Schedule 1





2032 ETHYL LINOLEATE E Only for use in topical medicines for

dermal application.

2033 ETHYL LINOLENATE E Only for use in topical medicines for

dermal application.

2034 ETHYL

MACADAMIATE




in the eye.



2035 ETHYL MALTOL E

2036 ETHYL MENTHANE

CARBOXAMIDE



flavour.



no more than 5%.

2037 ETHYL

METHACRYLATE


dermal application.

2038 ETHYL

METHYLPHENYLGL

YCIDATE






no more than 5%.



must be no more 1%.

2039 ETHYL METICONE E Only for use in topical medicines for




Schedule 1


in the eye.



2040 ETHYL MYRISTATE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

2041 ETHYL OLEATE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

2042 ETHYL ORTHO-

METHOXYBENZYL

ETHER



fragrance.




2043 ETHYL

OXYHYDRATE






no more than 5%.



Schedule 1



must be no more 1%.

2044 ETHYL PALMITATE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

2045 ETHYL

PELARGONATE






no more than 5%.



must be no more 1%.

2046 ETHYL

PHENYLACETATE






no more than 5%.



must be no more 1%.

2047 ETHYL PROPIONATE E Permitted for use only in combination






Schedule 1


no more than 5%.



must be no more 1%.

2048 ETHYL

RICINOLEATE



fragrance.




2049 ETHYL SALICYLATE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

2050 ETHYL SEBACATE E Permitted for use only in combination


flavour.



no more than 5%.

2051 ETHYL STEARATE E Permitted for use only in combination





no more than 5%.

2052 ETHYL SUCCINATE E Permitted for use only in combination


flavour.


Schedule 1




no more than 5%.

2053 ETHYL TARTRATE E Permitted for use only in combination


fragrance.




2054 ETHYL TRANS-2,

CIS-4-

DECADIENOATE



flavour.



no more than 5%.

2055 ETHYL TRANS-3-

HEXENOATE



flavour.



no more than 5%.

2056 ETHYL

UNDECYLENATE



fragrance.




2057 ETHYL VALERATE E Permitted for use only in combination


fragrance.




2058 ETHYL VANILLIN E


Schedule 1


2059 ETHYLBISIMINOME

THYL GUAIACOL

MANGANESE

CHLORIDE


dermal application.



2060 ETHYLCELLULOSE E

2061 ETHYLENE

BRASSYLATE



fragrance.




2062 ETHYLENE GLYCOL E The residual solvent limit for ethylene

glycol is 6.2 mg per recommended

daily dose.



2063 ETHYLENE GLYCOL

MONOPALMITOSTE

ARATE


dermal application.

2064 ETHYLENE/ACRYLI

C ACID COPOLYMER







2065 ETHYLENE/PROPYL

ENE/STYRENE

COPOLYMER -

HYDROGENATED

E The combined concentration of

ethylene/propylene/styrene copolymer

- hydrogenated must be no more than

9%.

2066 ETHYLENE/VINYL

ACETATE

COPOLYMER




in the eye.



Schedule 1



2067 ETHYLENEDIAMINE E Only for use in topical medicines for

dermal application.

2068 ETHYLENEDIAMINE/

HYDROGENATED

DIMER

DILINOLEATE

COPOLYMER BIS-DI-

C14-18 ALKYL

AMIDE




in the eye.



2069 ETHYLENEDIAMINE/

STEARYL DIMER

DILINOLEATE

COPOLYMER







2070 ETHYLHEXYL

BENZOATE







2071 ETHYLHEXYL

METHOXYCRYLENE




in the eye.



2072 ETHYLHEXYL

TRIAZONE


sunscreens.




in the eye.



Schedule 1



2073 ETHYLHEXYLGLYC

ERIN




in the eye.



2074 ETIDRONIC ACID E Only for use in topical medicines for

dermal application only.



2075 EUCALYPTUS DIVES A,E,H Cineole is a mandatory component of

Eucalyptus dives.


the total concentration of the oil in the






preparation is more than 25% and the


more than 15 mL but no more than



the container. The medicine requires

the following warning statements on

the medicine label:




When the concentration of the oil in



is no more than 15 mL, a restricted

flow insert must be fitted on the


Schedule 1


container. The medicine requires the


medicine label:




2076 EUCALYPTUS

FRUTICETORUM


Eucalyptus fruticetorum.















the medicine label:











medicine label:




Schedule 1



2077 EUCALYPTUS

GLOBULUS


Eucalyptus globulus.















the medicine label:











medicine label:




2078 EUCALYPTUS

MACRORHYNCHA


Eucalyptus macrorhyncha.




Schedule 1














the medicine label:











medicine label:




2079 EUCALYPTUS OIL A,E,H Cineole is a mandatory component of

Eucalyptus oil.










Schedule 1








the medicine label:











medicine label:




2080 EUCALYPTUS

RADIATA


Eucalyptus radiata.
















Schedule 1


the medicine label:











medicine label:




2081 EUCALYPTUS

ROSTRATA


Eucalyptus rostrata.















the medicine label:





Schedule 1









medicine label:




2082 EUCALYPTUS

TERETICORTIS


Eucalyptus tereticortis.















the medicine label:











Schedule 1



medicine label:




2083 EUCOMMIA

ULMOIDES

A,E,H

2084 EUGENOL E Only for use in topical medicines for

dermal application.

When the concentration of Eugenol in












the medicine label:







is no more than 15mL, a restricted




medicine label:




Schedule 1



2085 EUGENYL ACETATE E Permitted for use only in combination





no more than 5%.



must be no more 1%.

2086 EUONYMUS

ATROPURPUREUS

A,H

2087 EUONYMUS

EUROPAEUS




material.

2088 EUPATORIUM

FORTUNEI

A,H

2089 EUPATORIUM

JAPONICUM

A,H

2090 EUPATORIUM

PERFOLIATUM

A,H

2091 EUPATORIUM

PURPUREUM

A,H

2092 EUPHAUSIA

SUPERBA OIL




label:

- (SFOOD) 'Derived from seafood'

or

- (SHELL) 'Contains crustacean

shellfish'.


Schedule 1


2093 EUPHORBIA

CYPARISSIAS

A,H

2094 EUPHORBIA DRY A,H

2095 EUPHORBIA

HETERODOXA

A,H

2096 EUPHORBIA HIRTA A,H

2097 EUPHORBIA

LATHYRIS

A,H Levodopa (of Euphorbia lathyris) is a

mandatory component of Euphorbia

lathyris.

The concentration of Levodopa (of

Euphorbia lathyris) in the medicine

must be no more than 10mg/kg or

10mg/L or 0.001%.

2098 EUPHORBIA

PEKINENSIS

A,H

2099 EUPHORBIA PEPLUS H Only for use as an active


2100 EUPHORBIA

POWDER

A,H

2101 EUPHORBIA

RESINIFERA

A,H

2102 EUPHORBIA

SIEBOLDIANA

A,H

2103 EUPHRASIA

OFFICINALIS

A,H

2104 EUROPEAN HORNET H Only for use as an active


2105 EURYALE FEROX A,H

2106 EVENING PRIMROSE

OIL

A,E,H

2107 EVERNIA

PRUNASTRA




Schedule 1


EXTRACT fragrance.





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