Federal Register of Legislation - Australian Government

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Determinations/Health as made
This instrument repeals and replaces the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2021 and specifies those ingredients that may be contained in a medicine that may be listed in the Australian Register of Therapeutic Goods under section 26A or 26AE of the Therapeutic Goods Act 1989, and requirements in relation to the inclusion of those ingredients in such medicines.
Administered by: Health
Registered 13 Aug 2021
Tabling HistoryDate
Tabled HR23-Aug-2021
Tabled Senate23-Aug-2021
Date of repeal 25 Oct 2021
Repealed by Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2021
Table of contents.

Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine

Note:       See sections 5 and 6.

Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient name

Purpose

Specific requirements

755

BACILLUS COAGULANS

A

Only to be used in a medicine where Pathway International Pty Ltd (Client ID 23355), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 2 September 2021.

Only permitted for use in medicines:

- limited to oral routes of administration; and

- when the strain of Bacillus coagulans is confirmed to be Microbial Type Culture Collection (MTCC) accession number 5260.

The strain of Bacillus coagulans must be declared on the label.

The maximum recommended daily dose of the medicine must not provide more than 6 billion CFU of Bacillus coagulans.

The following warning statements are required on the medicine label:

- (CHILD2) ‘Not suitable for children’.

- (BACCOAG) 'Bacillus coagulans may affect the way some medicines work, including immunosuppressants. Consult your health professional before taking with other medicines (or words to that effect).'

 

756

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).

 

757

BACOPA MONNIERI

A, H

 

758

BALLOTA NIGRA

A, H

 

759

BALM OF GILEAD BUD DRY

A, H

 

760

BALM OF GILEAD BUD POWDER

A, H

 

761

BALSAM COPAIBA

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

762

BAMBUSA BREVIFLORA

A, E, H

 

763

BAMBUSA TEXTILIS

A, H

 

764

BANANA

E

 

765

BANANA DISTILLATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

766

BAPTISIA CONFUSA

A, H

 

767

BAPTISIA TINCTORIA

A, H

 

768

BARBAREA VULGARIS

A, H

 

769

BARIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

 

770

BARIUM CHLORIDE

H

Only for use as an active homoeopathic ingredient.

 

771

BARIUM SULFATE

E

Only for use in topical medicines for dermal application.

 

772

BARLEY

E

Gluten is a mandatory component of Barley when the route of administration is other than topical and mucosal.

 

773

BARLEY BRAN

E

Gluten is a mandatory component of Barley bran when the route of administration is other than topical and mucosal.

 

774

BARLEY GERM

E

Gluten is a mandatory component of Barley germ when the route of administration is other than topical and mucosal.

 

775

BARLEY LEAF

E

 

776

BASIC BUTYLATED METHACRYLATE COPOLYMER

E

Only for use in oral medicines.

 

777

BASIC FUCHSIN

E

Only for use as a colour ingredient in topical medicines for dermal application.

 

778

BASIC RED 1

E

Only for use as a colour in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin.

The concentration in the medicine must be no more than 0.1%.

 

779

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.

The concentration in the medicine must be no more than 0.1%.

 

780

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.

When the concentration of Methyl chavicol in the medicine is more than 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).

 

781

BASIL OIL EUROPEAN

A, E, H

Methyl chavicol is a mandatory component of Basil oil European.

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.

When the concentration of Methyl chavicol in the medicine is more than 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).

 

782

BASSIA SCOPARIA

A, H

 

783

BATYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

784

BAY LEAF

E

 

785

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.

The medicine requires the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'

 

786

BEESWAX ABSOLUTE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

787

BEET RED

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

788

BEETROOT

E, H

 

789

BEGONIA FIMBRISTIPULA

A, H

 

790

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.

The concentration in the medicine must be no more than 1.5%.

Residual levels of ethylene oxide are to be kept below the level of detection.

 

791

BEHENIC ACID

E

When for oral ingestion, the maximum recommended daily dose must not provide more than 383.5 milligrams of behenic acid.

 

792

BEHENOXY DIMETHICONE

E

Only for use in topical medicines for dermal application.

 

793

BEHENOYL STEARIC ACID

E

Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye.

The concentration in the medicine must be no more than 2.4%.

 

794

BEHENYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

795

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%.

 

796

BELLADONNA HERB POWDER

A, H

Alkaloids calculated as hyoscyamine and atropine are mandatory components of Belladonna herb powder.

The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%.

The concentration of atropinei n the medicine must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%.

 

797

BELLADONNA HERB PREPARED

A, H

Alkaloids calculated as hyoscyamine and atropine are mandatory components of Belladonna herb prepared and must be declared in the application.

The concentration of alkaloids calculated as hyoscyamine from all ingredients in the product must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%.

The concentration of atropine from all ingredients in the product must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%.

 

798

BELLIS PERENNIS

A, H

 

799

BEMOTRIZINOL

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 10%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

800

BENINCASA HISPIDA

A, E, H

 

801

BENTONITE

E

 

802

BENZALDEHYDE

E

 

803

BENZALDEHYDE GLYCERYL ACETAL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

804

BENZALKONIUM CHLORIDE

E

Only for use in topical medicines for dermal application and nasal sprays.

The concentration in the medicine must be no more than 5%.

 

805

BENZETHONIUM CHLORIDE

E

Only for use as a preservative in topical medicines for dermal application.

 

806

BENZOIC ACID

E, H

 

807

BENZOIN

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

808

BENZOIN SIAM

A, E, H

 

809

BENZOIN SUMATRA

A, E, H

 

810

BENZOPHENONE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

811

BENZOTHIAZOLE

E

Benzothiazole must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing benzothiazole must not be more than 1% of the total medicine.

 

812

BENZYL ACETATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

813

BENZYL ACETONE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used as a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

814

BENZYL ALCOHOL

A, E

When used as an active ingredient:

a) permitted for use only in medicated throat lozenges; and

b) when the maximum recommended daily dose of the medicine provides more than 300mg, the following warning statement must be included on the medicine label:

- (PREGNT) ‘Not recommended for use by pregnant and lactating women’ (or words to that effect).

 

815

BENZYL BENZOATE

E

Only for use in topical medicines for dermal application.

 

816

BENZYL BUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

817

BENZYL CINNAMATE

E

Only for use in:

(a) topical medicines for dermal application when the concentration of benzyl cinnamate in the medicine is not greater than 0.15%; or

(b) medicines in combination with other permitted ingredients as a constituent of a flavour proprietary excipient formulation when the total flavour proprietary excipient formulation in the medicine is not more than 5%.

Not to be included in medicines intended for use in the eye.

 

818

BENZYL DIMETHYL CARBINYL-N-BUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

819

BENZYL FORMATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

820

BENZYL ISOAMYL ETHER

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

821

BENZYL ISOBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

822

BENZYL ISOVALERATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

823

BENZYL LAURATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

824

BENZYL PHENYLACETATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

825

BENZYL PROPIONATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

826

BENZYL SALICYLATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

827

BENZYL TIGLATE

E

Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

The total flavour proprietary excipient formulation in a medicine must be no more than 5%.

 

828

BENZYLIDENE ACETONE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

829

BENZYLIDENE CAMPHOR SULFONIC ACID

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 6% (as acid).

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

830

BERBERIS AQUIFOLIUM

A, H

 

831

BERBERIS ARISTATA

A

Only for use in oral medicines.

The medicine requires the following warning statement on the medicine label:

- (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect).

 

832

BERBERIS VULGARIS

A, E, H

 

833

BERGAMOT OIL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour, the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance, the total fragrance concentration in a medicine must be no more 1%.

The medicine requires the following warning statement on the medicine label:

- (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect)

 

834

BERGAMOT OIL BERGAPTEN-FREE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

835

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 provide no more than 30 milligrams of oxedrine.

The warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is:

a) for internal use; or

b) in preparations containing 0.4 per cent or less of bergamot oil coldpressed; or

c) for use in soaps or bath or shower gels that are washed off the skin.

 

836

BERGAMOT OIL TERPENELESS

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

837

BERTHOLLETIA EXCELSA

A, E, H

 

838

BETA RAPA

A, E, H

 

839

BETA VULGARIS

A, E, H

 

840

BETA,4-DIMETHYLCYCLOHEX-3-ENE-1-PROPAN-1-AL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

841

BETA-CARYOPHYLLENE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

842

BETA-CARYOPHYLLENE ALCOHOL

E

Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

The total flavour proprietary excipient formulation in a medicine must be no more than 5%.

 

843

BETA-DAMASCENONE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

844

BETA-DAMASCONE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

845

BETA-HOMO CYCLOCITRAL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

846

BETA-HYDROXY-BETA-METHYLBUTYRIC ACID

A

 

847

BETA-IONONE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

848

BETA-IONONE EPOXIDE

E

Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

The total flavour proprietary excipient formulation in a medicine must be no more than 5%.

 

849

BETA-ISO-METHYL IONONE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

850

BETA-METHYL NAPHTHYL KETONE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

851

BETA-N-METHYL IONONE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

852

BETA-NAPHTHOL ETHYLETHER

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

853

BETA-NAPHTHOL METHYL ETHER

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

854

BETA-NAPHTHYL ANTHRANILATE

E

Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

The total flavour proprietary excipient formulation in a medicine must be no more than 5%.

 

855

BETA-NAPHTHYL ISOBUTYL ETHER

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

856

BETA-PINENE

E

Permitted for use only in combination with other permitted ingredients as a flavour or fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

857

BETA-TOCOPHEROL

E

 

858

BETACAROTENE

A, E

When Vitamin A is declared as an equivalent of Betacarotene and the medicine is for oral or sublingual use in adults the medicine requires the following warning statement on the medicine label:

- (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.’

 

859

BETADEX

E

 

860

BETAGLUCAN

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.01%.

 

861

BETAINE

E

Only for use in topical medicines for dermal application.

 

862

BETAINE HYDROCHLORIDE

E

 

863

BETULA LENTA

A, H

Methyl salicylate is a mandatory component of Betula lenta.

Not to be included in medicines for use in the eye or on damaged skin.

When used internally, the concentration of methyl salicylate in the medicine must not be 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.

When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is spray, the medicine does not require child resistant packaging if:

- the delivery device is 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 spray device is ergonomically difficult for young children to accomplish.

The following warning statement is required on the medicine label:

- (METSAL) ‘Contains methyl salicylate’ (or words to that effect).

When for use in topical medicines for dermal application:

i) the concentration of methyl salicylate in the medicine must not be more than 25%;

ii) the following warning statements are required on the medicine label:

- (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect);

- (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less';

- (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect);

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect);

iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label:

- (IRRIT) 'If irritation develops, discontinue use'.

 

864

BETULA NIGRA

A, H

Cresol, eugenol and methyl salicylate are mandatory components of Betula nigra.

For external use only when the total concentration of cresols, xylenols and other phenol homologues in the medicine is greater than 3%.

When for internal use, the concentration of eugenol in the medicine must not exceed 0.06%.

When the concentration of eugenol in the medicine is more than 25%:

a) the nominal capacity of the container must be no more than 25 mL;

b) the medicine must be fitted with a restricted flow insert;

c) when the nominal capacity of the container is more than 15 mL, the medicine must be fitted with a child resistant closure; and

d) the medicine requires the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

Not to be included in medicines for use in the eye or on damaged skin.

When used internally, the concentration of methyl salicylate in the medicine must not be 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.

When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is spray, the medicine does not require child resistant packaging if:

- the delivery device is 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 spray device is ergonomically difficult for young children to accomplish.

The following warning statement is required on the medicine label:

- (METSAL) ‘Contains methyl salicylate’ (or words to that effect).

When for use in topical medicines for dermal application:

i) the concentration of methyl salicylate in the medicine must not be more than 25%;

ii) the following warning statements are required on the medicine label:

- (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect);

- (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less';

- (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect);

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect);

iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label:

- (IRRIT) 'If irritation develops, discontinue use'.

 

865

BETULA PENDULA

A, E, H

Methyl salicylate is a mandatory component of Betula pendula.

Not to be included in medicines for use in the eye or on damaged skin.

When used internally, the concentration of methyl salicylate in the medicine must not be 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.

When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is spray, the medicine does not require child resistant packaging if:

- the delivery device is 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 spray device is ergonomically difficult for young children to accomplish.

The following warning statement is required on the medicine label:

- (METSAL) 'Contains methyl salicylate' (or words to that effect).

When for use in topical medicines for dermal application:

i) the concentration of methyl salicylate in the medicine must not be more than 25%

ii) the following warning statements are required on the medicine label:

- (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect);

- (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less';

- (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect);

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect);

iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label:

- (IRRIT) 'If irritation develops, discontinue use'.

 

866

BETULA PUBESCENS

A, E, H

 

867

BICYCLO(2.2.1)HEPT-5-ENE-2-CARBOXYLIC ACID, 3-(1-METHYLETHYL)-, ETHYL ESTER, (1R,2R,3R,4S)-REL-

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

868

BICYCLO(2.2.2)OCT-5-ENE-2-CARBOXALDEHYDE, 6-METHYL-8-(1-METHYLETHYL)-

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

869

BIFIDOBACTERIUM ADOLESCENTIS

A

 

870

BIFIDOBACTERIUM ANIMALIS

A

 

871

BIFIDOBACTERIUM ANIMALIS SSP ANIMALIS

A

 

872

BIFIDOBACTERIUM ANIMALIS SSP LACTIS

A

 

873

BIFIDOBACTERIUM BIFIDUM

A

 

874

BIFIDOBACTERIUM BREVE

A

 

875

BIFIDOBACTERIUM INFANTIS

A

 

876

BIFIDOBACTERIUM LACTIS

A

 

877

BIFIDOBACTERIUM LONGUM

A

 

878

BILBERRY

E

 

879

BIOSACCHARIDE GUM-1

E

Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye.

The concentration in the medicine must be no more than 5%.

 

880

BIOTA ORIENTALIS

A, H

 

881

BIOTIN

A, E

 

882

BIRCH LEAF DRY

A, E, H

Methyl salicylate is a mandatory component of birch leaf dry.

Not to be included in medicines for use in the eye or on damaged skin.

When used internally, the concentration of methyl salicylate in the medicine must not be 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.

When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is spray, the medicine does not require child resistant packaging if:

- the delivery device is 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 spray device is ergonomically difficult for young children to accomplish.

The following warning statement is required on the medicine label:

- (METSAL) 'Contains methyl salicylate' (or words to that effect).

When for use in topical medicines for dermal application:

i) the concentration of methyl salicylate in the medicine must not be more than 25%

ii) the following warning statements are required on the medicine label:

- (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect);

- (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less';

- (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect);

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect);

iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label:

- (IRRIT) 'If irritation develops, discontinue use'.

 

883

BIRCH TAR OIL RECTIFIED

A, E, H

Cresol is a mandatory component of birch tar oil rectified.

For external use only when the total concentration of cresols, xylenols and other phenol homologues in the medicine is greater than 3%.

 

884

BIS-BUTYLDIMETICONE POLYGLYCERYL-3

E

Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin.

The concentration in the medicine must be no more than 1.5%.

 

885

BIS-DIGLYCERYL POLYACYLADIPATE-2

E

Only for use in topical medicines for dermal application.

 

886

BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 4%.

 

887

BIS-MACROGOL 900 METHYL ETHER DIMETHYL SILANE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin.

The concentration in the medicine must be no more than 2.5%.

 

888

BIS-PEG-12 DIMETHICONE BEESWAX

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

 The concentration in the medicine must be no more than 0.2%.

 

889

BIS-STEARYL DIMETICONE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 2.30%.

 

890

BIS-STEARYL ETHYLENEDIAMINE/NEOPENTYL GLYCOL/STEARYL HYDROGENATED DIMER DILINOLEATE COPOLYMER

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 7%.

 

891

BISABOLENE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

892

BISABOLOL

E

If used as an excipient, the medicine is only for use in topical medicines for dermal application.

 

893

BITTER ALMOND OIL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

The absence of amygdalin in the medicine must be declared.

 

894

BITTERN

A, E, H

Only to be used in a medicine where WA Salt Koolyanobbing Pty Ltd- Australia (Client ID 69736), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 8 June 2022.

Magnesium is a mandatory component of bittern.

Only permitted for use in:

- medicines limited to oral routes of administration; and

- topical medicines for dermal administration.

When used in a medicine:

(a) with an oral route of administration;

(b) not indicated for laxative (or related) use; and

(c) where the maximum recommended daily dose for:

(i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

- (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect).

When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

895

BIXA ORELLANA

A, E, H

 

896

BLACK BONED CHICKEN POWDER

A

 

897

BLACK COHOSH DRY

A, H

The medicine requires the following warning statement on the medicine 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.'

 

898

BLACK COHOSH POWDER

A, H

The medicine requires the following warning statement on the medicine 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.'

 

899

BLACK CURRANT

E

 

900

BLACK CURRANT ABSOLUTE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

901

BLACK CURRANT FRESH

A, E, H

 

902

BLACK CURRANT SEED OIL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

903

BLACK OF CURACAO SPIDER

H

Only for use as an active homoeopathic ingredient.

 

904

BLACK PEPPER OIL

A, E, H

 

905

BLACK RASPBERRY

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

906

BLACK SNAKE

H

Only for use as an active homoeopathic ingredient.

 

907

BLACKBERRY

E

 

908

BLACKBERRY OILS

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

909

BLACKBERRY WINE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

910

BLACKCURRANT ESTERS

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

911

BLACKCURRANT JUICE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

912

BLACKSTRAP MOLASSES

E

When for oral or sublingual use, sucrose is a mandatory component of blackstrap molasses.

 

913

BLADDERWRACK DRY

A, H

Iodine is a mandatory component of Bladderwrack dry.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

914

BLADDERWRACK POWDER

A, H

Iodine is a mandatory component of Bladderwrack powder.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

915

BLAINVILLEA ACMELLA

A, E, H

When used as an excipient, permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

916

BLETILLA STRIATA

A, H

 

917

BLUE FLAG RHIZOME DRY

A, H

 

918

BLUE FLAG RHIZOME POWDER

A, H

 

919

BLUEBERRY

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

920

BLUEBERRY JUICE

E

Permitted for use only in combination with other permitted ingredients as a flavour or fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

921

BLUMEA LACERA

A, H

 

922

BOEHMERIA NIVEA

A, H

 

923

BOERHAVIA DIFFUSA

A, H

 

924

BOERHAVIA REPENS

A, H

 

925

BOGBEAN LEAF DRY

A, H

 

926

BOGBEAN LEAF POWDER

A, H

 

927

BOIS DE ROSE OIL

A, E, H

 

928

BOMBAX CEIBA

A, H

 

929

BORAGO OFFICINALIS

A, E, H

Only for use when the preparation is 'fixed oil' and the fixed oil is derived from seeds of Borago officinalis.

 

930

BORAX

A, E, H

Boron is a mandatory component of borax.

The percentage of boron from borax should be calculated based on the molecular weight of borax.

The maximum recommended daily dose must not provide more than 6mg of boron.

In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%.

 When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label:

- (NTAKEN12) 'Not to be taken by children under 12 years old' (or words to that effect); or

- (ADULT) 'Adults only' (or words to that effect).

When the maximum recommended daily dose of the medicine provides more than 1 mg boron and up to, and including, 3 mg of boron, and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label:

- (NTAKEN2) 'Not to be taken by children under 2 years old' (or words to that effect); or

- (ADULT) 'Adults only' (or words to that effect).

When for excipient use and the maximum recommended daily dose of the medicine provides more than 1 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:

- (BORON) 'Contains boron' (or words to that effect).

When the medicine is for topical use for dermal application, the following warning statement is required on the label:

- (BROKEN) 'Use on unbroken skin only' (or words to that effect).

 

931

BORAX PENTAHYDRATE

A, E

Boron is a mandatory component of borax pentahydrate.

The percentage of boron from borax pentahydrate should be calculated based on the molecular weight of borax pentahydrate.

The maximum recommended daily dose must not provide more than 6mg of boron from borax pentahydrate.

In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must not be more than 3500 mg/kg or 3500 g/L or 0.35%.

 When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label:

- (NTAKEN12) 'Not to be taken by children under 12 years old' (or words to that effect); or

- (ADULT) 'Adults only' (or words to that effect).

When the maximum recommended daily dose of the medicine provides more than 1 mg boron and up to, and including, 3 mg of boron, and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label:

- (NTAKEN2) 'Not to be taken by children under 2 years old' (or words to that effect); or

- (ADULT) 'Adults only' (or words to that effect).

When for excipient use and the maximum recommended daily dose of the medicine provides more than 1 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:

- (BORON) 'Contains boron' (or words to that effect).

When the medicine is for topical use for dermal application, the following warning statement is required on the label:

- (BROKEN) 'Use on unbroken skin only' (or words to that effect).

 

932

BORIC ACID

A, H

Boron is a mandatory component of boric acid.

The percentage of boron from boric acid should be calculated based on the molecular weight of boric acid.

The maximum recommended daily dose must not provide more than 6mg of boron.

In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must not be more than 3500 mg/kg or 3500 mg/L or 0.35%.

 When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label:

- (NTAKEN12) 'Not to be taken by children under 12 years old' (or words to that effect); or

- (ADULT) 'Adults only' (or words to that effect).

When the maximum recommended daily dose of the medicine provides more than 1 mg boron and up to, and including, 3 mg of boron, and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label:

- (NTAKEN2) 'Not to be taken by children under 2 years old' (or words to that effect); or

- (ADULT) 'Adults only' (or words to that effect).

When for excipient use and the maximum recommended daily dose of the medicine provides more than 1 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:

- (BORON) 'Contains boron' (or words to that effect).

When the medicine is for topical use for dermal application, the following warning statement is required on the label:

- (BROKEN) 'Use on unbroken skin only' (or words to that effect).

 

933

BORNEOL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

934

BORNYL ACETATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

935

BORON NITRIDE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.5%.

 

936

BORONIA ABSOLUTE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

937

BORONIA MEGASTIGMA

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

938

BOSWELLIA CARTERII

A, E, H

 

939

BOSWELLIA SERRATA

A, E, H

 

940

BOSWELLIA THURIFERA

A, H

 

941

BOVINE CALCIUM CHONDROITIN SULFATE

A

 

942

BOVINE CHONDROITIN SULFATE

A

 

943

BOVINE COLOSTRUM POWDER

A

The following warning statement is required on the medicine label:

- (BABY3) ‘Not suitable for use in children under the age of 12 months except on the advice of a health professional.’ (or words to that effect).

 

944

BOVINE LACTOFERRIN

A

 

945

BOVINE POTASSIUM CHONDROITIN SULFATE

A

 

946

BOVINE SODIUM CHONDROITIN SULFATE

A, E

When used as an excipient:

- only for use in topical medicines for dermal application;

- not to be included in medicines intended for use in the eye; and

- the concentration in the medicine must be no more than 0.001%.

 

947

BOVINE WHEY IG-RICH FRACTION

A

Only for use in oral medicines.

The following warning statement is required on the medicine label:

- (BABY3) 'Not suitable for use in children under the age of 12 months except on the advice of a health professional.’ (or words to that effect).

 

948

BRANDY

E

 

949

BRASSICA CAMPESTRIS/ALEURITES FORDI OIL COPOLYMER

E

Only for use in topical medicines for dermal application and not for use in topical medicines intended for use in the eye.

The concentration in the medicine must be no more than 1%.

 

950

BRASSICA CHINENSIS

A, H

Allyl isothiocyanate is a mandatory component of Brassica chinensis when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

951

BRASSICA JUNCEA

A, H

Allyl isothiocyanate is a mandatory component of Brassica juncea when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

952

BRASSICA NAPUS

A, E, H

Allyl isothiocyanate is a mandatory component of Brassica napus when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

953

BRASSICA NIGRA

A, H

Allyl isothiocyanate is a mandatory component of Brassica nigra when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

954

BRASSICA OLERACEA VAR. BOTRYTIS

A, E, H

Allyl isothiocyanate is a mandatory component of Brassica oleracea var. botrytis when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

955

BRASSICA OLERACEA VAR. CAPITATA

A, E, H

Allyl isothiocyanate is a mandatory component of Brassica oleracea var. capitata when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

956

BRASSICA OLERACEA VAR. GEMMIFERA

A, H

Allyl isothiocyanate is a mandatory component of Brassica oleracea var gemmifera when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

957

BRASSICA OLERACEA VAR. ITALICA

A, H

Allyl isothiocyanate is a mandatory component of Brassica oleracea var. italica when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

958

BRASSICA OLERACEA VAR. VIRIDIS

A, H

Allyl isothiocyanate is a mandatory component of Brassica oleracea var. viridis when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

959

BRASSICA PEKINENSIS

A, H

Allyl isothiocyanate is a mandatory component of Brassica pekinensis when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

960

BRASSICA RAPA

A, E, H

Allyl isothiocyanate is a mandatory component of Brassica rapa when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

961

BRAZIL NUT

E

 

962

BRILLIANT BLACK BN

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

963

BRILLIANT BLUE FCF

E

Permitted for use only as a colour for oral, topical and dental use.

 

964

BRILLIANT BLUE FCF ALUMINIUM LAKE

E

Permitted for use only as a colour for oral and topical use.

 

965

BRILLIANT BLUE FCF BARIUM LAKE

E

Permitted for use only as a colour for oral and topical use.

 

966

BRILLIANT SCARLET 4R

E

Permitted for use only as a colour in medicines for topical and oral routes of administration.

 

967

BRILLIANT SCARLET 4R ALUMINIUM LAKE

E

Permitted for use only as a colour in medicines for topical and oral routes of administration.

 

968

BRIZA MEDIA

A, H

 

969

BROCCOLI

E

 

970

BROMELAINS

A

May be derived from either the stem or fruit of the pineapple (Ananas comosus).

 

971

BROMINE

H

Only for use as an active homoeopathic ingredient. 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.

 

972

BROMOSTYROL

E

Not for use in infants

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

973

BROMUS CATHARTICUS

A, H

 

974

BROMUS INERMIS

A, H

 

975

BROMUS RAMOSUS SUBSP. RAMOSUS

A, H

 

976

BRONOPOL

E

Only for use in topical medicines for dermal application.

 

977

BROUSSONETIA PAPYRIFERA

A, H

 

978

BROWN FK

E

Permitted for use only as a colour for topical use.

 

979

BRUNFELSIA UNIFLORA

A, H

The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.

 

980

BRUSSEL SPROUT

E

 

981

BRYONIA ALBA

A, H

 

982

BRYONIA DIOICA

A, H

 

983

BUCHU LEAF DRY

A, H

 

984

BUCHU LEAF OIL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

985

BUCHU LEAF POWDER

A, E, H

 

986

BUCKWHEAT

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

987

BUDDLEJA OFFICINALIS

A, H

 

988

BULNESIA SARMIENTI

A, E, H

 

989

BUNIAS ORIENTALIS

A, H

 

990

BUPLEURUM FALCATUM

A, H

 

991

BURDOCK LEAF DRY

A, H

 

992

BURDOCK LEAF POWDER

A, H

 

993

BURDOCK ROOT DRY

A, H

 

994

BURDOCK ROOT POWDER

A, H

 

995

BUSHMASTER SNAKE

H

Only for use as an active homoeopathic ingredient.

 

996

BUTAN-1-OL

E

The residual solvent limit for Butan-1-ol is 50 mg per maximum recommended daily dose.

The concentration in the medicine must be no more than 0.5%.

 

997

BUTANE

E

Only for use as an excipient propellant ingredient.

 

998

BUTOXYETHANOL

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.1%.

 

999

BUTTER

E

 

1000

BUTTER ACIDS

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1001

BUTTER ESTERS

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1002

BUTTER STARTER DISTILLATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1003

BUTYL 2-METHYLBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1004

BUTYL ACETATE

E

The residual solvent limit for Butyl acetate is 50 mg per maximum recommended daily dose.

The concentration in the medicine must be no more than 0.5%.

 

1005

BUTYL BUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1006

BUTYL BUTYRYL LACTATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1007

BUTYL CAPROATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1008

BUTYL ESTER OF PVM/MA COPOLYMER

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 15%.

The medicine requires the following warning statements on the medicine label:

- (EYE) 'Avoid contact with eyes' (or words to that effect)

- (EYE2) 'May be irritant to the eyes' (or words to that effect).

 

1009

BUTYL FORMATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1010

BUTYL HYDROXYBENZOATE

E

Only for use in topical medicines for dermal application.

 

1011

BUTYL ISOBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1012

BUTYL ISOVALERATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1013

BUTYL LACTATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1014

BUTYL LEVULINATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1015

BUTYL METHOXYDIBENZOYLMETHANE

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in preparation must not be more than 5%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

1016

BUTYL PROPIONATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1017

BUTYL STEARATE

E

Only for use in topical medicines for dermal application.

 

1018

BUTYL UNDECYLENATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1019

BUTYLATED HYDROXYANISOLE

E

 

1020

BUTYLATED HYDROXYTOLUENE

E

 

1021

BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 10%.

 

1022

BUTYLIDENE PHTHALIDE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1023

BUTYLOCTYL SALICYLATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 7%.

 

1024

BUTYLPHENYL METHYLPROPIONAL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1025

BUTYRALDEHYDE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1026

BUTYRIC ACID

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1027

C1-8 ALKYL TETRAHYDROXYCYCLOHEXANOATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.012%.

 

1028

C10-12 ALKANE/CYCLOALKANE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1029

C10-30 CHOLESTEROL/LANOSTEROL ESTERS

E

Only for use in topical medicines for dermal application.

 

1030

C11-13 ALKANE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 10%.

 

1031

C11-14-ISO-ALCOHOL C-13 RICH

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1032

C12-13 PARETH-23

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.125%.

Residual levels of 1,4-dioxane and ethylene oxide (and related substances) are to be kept below the level of detection.

 

1033

C12-13 PARETH-3

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.125%.

Residual levels of 1,4-dioxane and ethylene oxide (and related substances) are to be kept below the level of detection.

 

1034

C12-15 ALKYL LACTATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 1.2%.

 

1035

C12-15 ALKYL OCTANOATE

E

Only for use in topical medicines for dermal application.

 

1036

C12-20 ACID PEG-8 ESTER

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.2%.

 

1037

C12-20 ALKYL GLUCOSIDE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.75%.

 

1038

C12-22 ALKYL ACRYLATE/HYDROXYETHYLACRYLATE COPOLYMER

E

Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin.

The concentration of C12-22 alkyl acrylate/hydroxyethylacrylate copolymer in the medicine must not be more than 5%.

 

1039

C13-14 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

 

1040

C14-22 ALCOHOLS

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 2.55%.

 

1041

C15-16 ISOPARAFFIN

E

C15-16 isoparaffin must only be included in topical medicines:

(a) for dermal application; and

(b) where the dosage form of the medicine is not spray.

The total concentration of C15-16 isoparaffin and C17-18 isoparaffin in the medicine must not be more than 50%.

When the nominal capacity of the container is more than 2 mL and the medicine is not a solid or semi-solid preparation, the total concentration of designated solvents (including C15-16 isoparaffin) in the medicine must not be more than 25%.

 

1042

C15-19 ALKANE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 7%.

 

1043

C17-18 ISOPARAFFIN

E

C17-18 isoparaffin must only be included in topical medicines:

(a) for dermal application; and

(b) where the dosage form of the medicine is not spray.

The total concentration of C15-16 isoparaffin and C17-18 isoparaffin in the medicine must not be more than 50%.

When the nominal capacity of the container is more than 2 mL and the medicine is not a solid or semi-solid preparation, the total concentration of designated solvents (including C17-18 isoparaffin) in the medicine must not be more than 25%.

 

1044

C18-36 ACID GLYCOL ESTER

E

Only for use topical medicines for dermal application.

 

1045

C18-36 ACID TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

 

1046

C2-OCTENAL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1047

C20-40 ALCOHOLS

E

Only for use in topical medicines for dermal application.

 

1048

C20-40 ALKYL STEARATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 2%.

 

1049

C20-40 PARETH-24

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.25%.

 

1050

C20-40 PARETH-3

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 2%.

 

1051

C30-45 ALKYL CETEARYL DIMETICONE CROSSPOLYMER

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 1%.

 

1052

C9-11 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

 

1053

C9-11 PARETH-3

E

Only for use in topical medicines for dermal application.

 

1054

C9-15 ALKYL PHOSPHATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.12%

 

1055

CABBAGE

E

 

1056

CABREUVA OIL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1057

CADE OIL

A, E, H

 

1058

CAESALPINIA SAPPAN

A, H

 

1059

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 (other than caffeine).

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 100 mg of caffeine from this ingredient.

When for internal use or oral application, the following warning statement is required on the medicine label:

- (ADULT) 'Adults only' (or words to that effect).

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 4%.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

1060

CAJUPUT OIL

A, E, H

Cineole is a mandatory component of Cajuput oil.

When the concentration in the medicine is more than 25%, the nominal capacity of the container must be no more than 25 mL.

When the concentration 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.

When the concentration in the medicine is more than 25% and the nominal capacity of the container is less than 15 mL, a restricted flow insert must be fitted to the container.

When the concentration in the medicine is more than 25%, the medicine requires the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'.

When the concentration of cineole in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 mL.

When the concentration of cineole in 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 medicine requires the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'.

When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 mL, the medicine must have the restricted flow insert fitted on the container and the medicine requires the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'.

 

1061

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 Pharmacopoeia, as in force or existing from time to time.

 

1062

CALCIFEDIOL MONOHYDRATE

A

The maximum recommended daily dose of the medicine must not provide more than 10 micrograms of calcifediol.

Only for use in oral medicines.

Calcifediol must not be used in medicines with other Vitamin D analogues; such as ergocalciferol or colecalciferol.

The medicine requires the following warning statements on the label:

- (CFEDIOL) 'Calcifediol may have similar effects to Vitamin D. Consult your health care professional before taking in combination with other medicines.' (or words to that effect);

- (OTHVITD) 'The medicine should not be taken in combination with supplements containing Vitamin D without medical advice' (or words to that effect);

- (CHILD9) 'Use in children under 9 years is not recommended' (or words to that effect).

 

1063

CALCIFIED LITHOTHAMNION SPECIES

A

Only for use in oral medicines.

 

1064

CALCIFIED LITHOTHAMNION TOPHIFORME

A

Only for oral use.

 

1065

CALCIUM ALGINATE

E

 

1066

CALCIUM AMINO ACID CHELATE

A, H

Calcium is a mandatory component of calcium amino acid chelate.

The concentration of calcium in the calcium amino acid chelate must be no more than 25% w/w.

 

1067

CALCIUM ASCORBATE

A, E, H

 

1068

CALCIUM ASCORBATE DIHYDRATE

A, E, H

 

1069

CALCIUM ASPARTATE

A

 

1070

CALCIUM ASPARTATE HYDROCHLORIDE DIHYDRATE

A

Only for use in oral medicines.

 

1071

CALCIUM BEHENATE

E

Behenic acid is a mandatory component of Calcium behenate.

When for oral ingestion, the maximum recommended daily dose must not provide more than 383.5 mg of Behenic acid.

 

1072

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE

A, H

 

1073

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE

A, H

 

1074

CALCIUM CARBONATE

A, E, H

 

1075

CALCIUM CASEINATE

E

 

1076

CALCIUM CHLORIDE DIHYDRATE

E

 

1077

CALCIUM CITRATE

A, E, H

 

1078

CALCIUM CITRATE TETRAHYDRATE

A, E, H

 

1079

CALCIUM DIASPARTATE

A

Only for use in oral medicines.

 

1080

CALCIUM FLUORIDE

H

The percentage of fluoride from Calcium fluoride should be calculated based on the molecular weight of Calcium fluoride.

The concentration of fluoride in the product from all ingredients must be no more than 10mg/kg or 10mg/L or 0.1%.

 

1081

CALCIUM FOLINATE

A

Folinic acid is a mandatory component of calcium folinate.

The maximum recommended daily dose must not provide more than 500 micrograms of folinic acid.

When the medicine contains a combination of folic acid, folinic acid or levomefolic acid, the medicine must not provide more than a combined total of 500 micrograms of folic acid, folinic acid and levomefolic acid per maximum recommended daily dose.

 

1082

CALCIUM GLUCONATE MONOHYDRATE

A, E, H

 

1083

CALCIUM GLYCEROPHOSPHATE

A, E, H

 

1084

CALCIUM GLYCINATE

A

Only for use in oral medicines.

 

1085

CALCIUM GLYCINATE DIHYDRATE

A

 

1086

CALCIUM HEXAFLUOROSILICATE

H

Only for use as an active homoeopathic ingredient.

 

1087

CALCIUM HYDROGEN PHOSPHATE

A, E, H

 

1088

CALCIUM HYDROGEN PHOSPHATE DIHYDRATE

A, E, H

 

1089

CALCIUM HYDROGEN PHOSPHATE MONOHYDRATE

A, E, H

 

1090

CALCIUM HYDROXIDE

A, E, H

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 Pharmacopoeia as in force or existing from time to time.

 

1091

CALCIUM HYDROXYCITRATE

A, H

 

1092

CALCIUM HYPOPHOSPHITE

H

Only for use as an active homoeopathic ingredient.

 

1093

CALCIUM IODIDE

H

Only for use as an active homoeopathic ingredient.

 

1094

CALCIUM KETOGLUCONATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin.

The concentration must be no more than 1%

 

1095

CALCIUM L-THREONATE

A

Only for use in oral medicines.

 

1096

CALCIUM LACTATE

A, E, H

 

1097

CALCIUM LACTATE GLUCONATE

A, E, H

 

1098

CALCIUM LACTATE PENTAHYDRATE

A, E, H

 

1099

CALCIUM LACTATE TRIHYDRATE

A, E, H

 

1100

CALCIUM LYSINATE

A

Only for use in oral medicines.

 

1101

CALCIUM METHIONINATE

A

Only for use in oral medicines.

 

1102

CALCIUM OROTATE

A, E, H

 

1103

CALCIUM OXIDE

E

Only for use in topical medicines for dermal application.

 

1104

CALCIUM PANTOTHENATE

A, E, H

 

1105

CALCIUM PHOSPHATE

A, E, H

 

1106

CALCIUM PYRUVATE

A

 

1107

CALCIUM SACCHARATE

E

 

1108

CALCIUM SILICATE

E

 

1109

CALCIUM SODIUM CASEINATE

A, H

 

1110

CALCIUM SODIUM LACTATE

A, E, H

 

1111

CALCIUM STEARATE

E

 

1112

CALCIUM SUCCINATE

A, E, H

 

1113

CALCIUM SULFATE

A, E, H

 

1114

CALCIUM SULFATE DIHYDRATE

A, E, H

 

1115

CALCIUM SULFIDE

H

Only for use as an active homoeopathic ingredient.

 

1116

CALCIUM THREONINATE

A

 

1117

CALENDULA FLOWER DRY

A, E, H

 

1118

CALENDULA FLOWER POWDER

A, H

 

1119

CALENDULA OFFICINALIS

A, E, H

 

1120

CALLERYA RETICULATA

A, H

 

1121

CALLICARPA PEDUNCULATA

A, H

 

1122

CALLISTEPHUS CHINENSIS

A, H

 

1123

CALLITRIS COLUMELLARIS

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1124

CALLITRIS COLUMELLARIS SUBSP. INTRATROPICA

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1125

CALLITRIS RHOMBOIDEA

A, H

 

1126

CALLUNA VULGARIS

A, E, H

 

1127

CALOCHORTUS TOLMIEI

A, H

 

1128

CALTHA PALUSTRIS

A, H

 

1129

CALUMBA ROOT DRY

A, H

 

1130

CALUMBA ROOT POWDER

A, H

 

1131

CALVATIA GIGANTEA

A, E, H

 

1132

CALYCANTHUS FLORIDUS

A, H

 

1133

CALYCANTHUS PRAECOX

A, H

 

1134

CAMELLIA JAPONICA

A, H

 

1135

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.

 

1136

CAMELLIA SINENSIS

A, E, H

Caffeine is a mandatory component of Camellia sinensis.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 4%.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (ADULT) 'Adults only' (or words to that effect).

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

1137

CAMPHENE

E

Permitted for use only in combination with other permitted ingredients as a coating solution, a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1138

CAMPHOLENIC ALDEHYDE

E

Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

The total flavour proprietary excipient formulation in a medicine must be no more than 5%.

 

1139

CAMPHOR

A, E, H

In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%.

In liquid preparations, the concentration of camphor must be no more than 2.5%.

 

1140

CAMPHOR BENZALKONIUM METHOSULFATE

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the preparation must not be more than 6%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

1141

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%.

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%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

When the concentration of cineole in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres.

When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have the restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

When for internal use then the concentration of safrole in a medicine must be no more than 0.1%.

When for topical use then the concentration of safrole in a medicine must be no more than 1.0%.

If the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25mL.

 

1142

CAMPHOR OIL WHITE

A, E, H

Camphor and safrole are mandatory components of camphor oil white.

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%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

When for internal use then the concentration of safrole in a medicine must be no more than 0.1%.

When for topical use then the concentration of safrole in a medicine must be no more than 1.0%.

If the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25mL.

 

1143

CAMPSIS GRANDIFLORA

A, H

 

1144

CANADA BALSAM

A, H

 

1145

CANANGA ODORATA

A, E, H

 

1146

CANANGA OIL

A, E, H

 

1147

CANARIUM INDICUM

A, H

Only for use when the plant part is seed and the plant preparation is oil.

 

1148

CANARIUM LUZONICUM

A, H

 

1149

CANDELILLA WAX

A, E, H

 

1150

CANDIDA ALBICANS

H

Only for use as an active homoeopathic ingredient.

 

1151

CANDIDA UTILIS

A, E, H

When used as an excipient, only for use in medicines in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total flavour proprietary excipient formulation in a medicine must not be more than 5%.

 

1152

CANINE MILK

H

Only for use as an active homoeopathic ingredient.

 

1153

CANOLA OIL

A, E, H

Allyl isothiocyanate is a mandatory component of canola oil when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

1154

CANTHARIDES

H

Only available as an active homoeopathic ingredient.

 

1155

CANTHAXANTHIN

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

1156

CAPRIC ACID

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1157

CAPROIC ALDEHYDE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1158

CAPRYLIC ALDEHYDE

E

Permitted for use only in combination with other permitted ingredients as a coating solution, a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1159

CAPRYLIC/CAPRIC GLYCERIDES

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1160

CAPRYLIC/CAPRIC/ISOSTEARIC/ADIPIC TRIGLYCERIDE

E

 

1161

CAPRYLIC/CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine is not to exceed 3%

 

1162

CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

 

1163

CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 10%.

 

1164

CAPRYLOYL GLYCINE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 2%

 

1165

CAPRYLOYL SALICYLIC ACID

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin.

The concentration in the medicine must not be more than 0.3%.

 

1166

CAPRYLYL GLYCOL

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 2%

 

1167

CAPRYLYL METHICONE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 10%.

 

1168

CAPSELLA BURSA-PASTORIS

A, H

 

1169

CAPSICUM

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

1170

CAPSICUM ANNUUM

A, E, H

 

1171

CAPSICUM DRY

A, E, H

 

1172

CAPSICUM FRUIT OLEORESIN

A, E

 

1173

CAPSICUM FRUTESCENS

A, E, H

 

1174

CAPSICUM POWDER

A, E, H

 

1175

CARALLUMA ADSCENDENS VAR. FIMBRIATA

A

The plant part must be herb and the plant preparation must be a hydroethanolic extract.

 

1176

CARAMEL

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

1177

CARAPICHEA IPECACUANHA

A, H

Emetine is a mandatory component of Carapichea ipecacuanha.

The concentration of emetine in the medicine must not be more than 0.2%.

 

1178

CARAWAY DRY

A, H

 

1179

CARAWAY OIL

A, E, H

 

1180

CARAWAY POWDER

A, H

 

1181

CARBOMER 1342

E

Only for use as an excipient in topical medicines for dermal application.

 

1182

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.

The concentration must be no more than 1% in formulations at pH 7 (approximately neutral) and 0.1% in formulations at a different pH.

 

1183

CARBOMER 934

E

Only for use in topical medicines for dermal application.

 

1184

CARBOMER 934P

E

Only for use in topical medicines for dermal application.

 

1185

CARBOMER 940

E

Only for use in topical medicines for dermal application.

 

1186

CARBOMER 941

E

Only for use as an excipient in topical medicines for dermal application.

 

1187

CARBOMER 954

E

Only for use as an excipient in topical medicines for dermal application.

 

1188

CARBOMER 980

E

Only for use as an excipient in topical medicines for dermal application.

 

1189

CARBOMER 981

E

Only for use as an excipient in topical medicines for dermal application.

 

1190

CARBOMER COPOLYMER (TYPE B)

E

Only for use as an excipient in topical medicines for dermal application.

 

1191

CARBOMER HOMOPOLYMER (TYPE B)

E

Only for use as an excipient in topical medicines for dermal application.

 

1192

CARBOMER U-10

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 5%.

 

1193

CARBON

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

1194

CARBON BLACK

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

1195

CARBON DIOXIDE

E

 

1196

CARDAMOM FRUIT DRY

A, H

 

1197

CARDAMOM FRUIT POWDER

A, E, H

 

1198

CARDAMOM OIL

A, E, H

 

1199

CARDIOSPERMUM HALICACABUM

A, H

 

1200

CARICA PAPAYA

A, E, H

 

1201

CARLINA ACAULIS

A, H

 

1202

CARMELLOSE

E

 

1203

CARMELLOSE CALCIUM

E

 

1204

CARMELLOSE SODIUM

E

 

1205

CARMINE

E

Permitted for use only as a colour for oral and topical use.

 

1206

CARMOISINE

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

1207

CARMOISINE ALUMINIUM LAKE

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

1208

CARNAUBA WAX

A, E, H

 

1209

CARNOSINE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. 

The concentration in the medicine must be no more than 0.2%.

 

1210

CAROB BEAN EXTRACT

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1211

CAROB GUM

E

 

1212

CAROB POD

E

 

1213

CAROTENES

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

1214

CARPINUS BETULUS

A, H

 

1215

CARPINUS CORDATA

A, H

 

1216

CARRAGEENAN

E

 

1217

CARROT

E

 

1218

CARROT SEED OIL

A, E, H

 

1219

CARTHAMUS TINCTORIUS

A, E, H

Carthamus tinctorius (safflower 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 following warning statement on the medicine label:

- (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect).

 

1220

CARUM CARVI

A, H

 

1221

CARVACROL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1222

CARVACRYL METHYL ETHER

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1223

CARVEOL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1224

CARVONE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1225

CARVYL ACETATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1226

CARYA ILLINOINENSIS

A, H

 

1227

CARYA OVATA

A, H

 

1228

CARYOPHYLLENE OXIDE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1229

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 medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’;

- (LAX2) ‘Prolonged use may cause serious bowel problems’; and

- (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].

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) ‘Drink plenty of water' [or words to that effect].

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) ‘This product contains [name of the herb(s) or the chemical component(s)]’; and

- (LAX4) ‘This product may have laxative effect’.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’;

- (LAX1) ‘Drink plenty of water' [or words to that effect]; and

- (LAX2) ‘Prolonged use may cause serious bowel problems’.

 

1230

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.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’;

- (LAX2) ‘Prolonged use may cause serious bowel problems’; and

- (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).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) ‘Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) ‘This product contains [name of the herb(s) or the chemical component(s)]’; and

- (LAX4) ‘This product may have laxative effect’.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’;

- (LAX1) ‘Drink plenty of water' (or words to that effect); and

- (LAX2) ‘Prolonged use may cause serious bowel problems’.

 

1231

CASCARILLA OIL

A, H

The medicine must not contain more than 1mg of the equivalent dry herbal material per the maximum recommended daily dose.

 

1232

CASEIN

E

 

1233

CASHEW NUT

E

 

1234

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.

The concentration in the medicine must be no more than 0.0275%.

 

1235

CASSIA CINNAMON BARK DRY

A, H

When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%.

 

1236

CASSIA CINNAMON BARK POWDER

A, H

When used as an active ingredient, the maximum daily dose of the medicine must contain no more than 0.001% of coumarin.

 

1237

CASSIA FISTULA

A, H

Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Cassia fistula 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 medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’;

- (LAX2) ‘Prolonged use may cause serious bowel problems’; and

- (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).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) ‘Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) ‘This product contains [name of the herb(s) or the chemical component(s)]’; and

- (LAX4) ‘This product may have laxative effect’.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’;

- (LAX1) ‘Drink plenty of water' (or words to that effect); and

- (LAX2) ‘Prolonged use may cause serious bowel problems’.

 

1238

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%.

 

1239

CASSIE ABSOLUTE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1240

CASTANEA MOLLISSIMA

A, H

 

1241

CASTANEA SATIVA

A, H

 

1242

CASTOR OIL

A, E

 

1243

CASTOREUM

H

Only permitted for use as an active homoeopathic ingredient.

 

1244

CASUARINA EQUISITIFOLIA

A, H

 

1245

CATALPA BIGNONIOIDES

A, H

 

1246

CATALPA OVATA

A, H

 

1247

CATECHU

A, H

 

1248

CATHARANTHUS ROSEUS

A, H

Vinblastine, vincamine, vincristine, vindesine, vinorelbine and yohimbine are mandatory components of Catharanthus 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%.

 

1249

CAULIFLOWER

E

 

1250

CAULOPHYLLUM THALICTROIDES

A, E, H

 

1251

CAUSTICUM

H

Only for use as an active homoeopathic ingredient.

 

1252

CEANOTHUS AMERICANUS

A, H

 

1253

CEDAR LEAF OIL

A, E, H

 

1254

CEDARWOOD OIL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1255

CEDARWOOD OIL ATLAS

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1256

CEDARWOOD OIL TERPENES

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1257

CEDARWOOD OIL VIRGINIA

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1258

CEDRENOL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1259

CEDRENYLACETATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1260

CEDROL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1261

CEDRUS ATLANTICA

A, E, H

 

1262

CEDRUS DEODARA

A, H

 

1263

CEDRUS LIBANI

H

Only for use as an active homoeopathic ingredient.

 

1264

CEDRYL ACETATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1265

CEDRYL METHYL ETHER

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1266

CELERY LEAF

E, H

 

1267

CELERY SEED DRY

A, E, H

 

1268

CELERY SEED OIL

A, E, H

 

1269

CELERY SEED POWDER

A, H

 

1270

CELLACEFATE

E

 

1271

CELLULASE

A

Must be derived from Trichoderma longibrachiatum only.

 

1272

CELLULOSE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1273

CELOSIA ARGENTEA

A, H

 

1274

CELOSIA ARGENTEA L. VAR. CRISTATA

A, H

 

1275

CENTAUREA CYANUS

A, E, H

 

1276

CENTAURIUM ERYTHRAEA

A, H

 

1277

CENTELLA ASIATICA

A, E, H

 

1278

CENTELLA ASIATICA MERISTEM CELL CULTURE

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 or on damaged skin.

The concentration in the medicine must be no more than 0.05%.

 

1279

CENTIPEDA CUNNINGHAMII

A, E, H

 

1280

CENTIPEDA MINIMA

A, H

 

1281

CEPHALANOPSIS SEGETUM

A, H

 

1282

CERAMIDE 1

E

Only for use in topical medicines for dermal application.

 

1283

CERAMIDE 2

E

Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.05%.

 

1284

CERAMIDE 3

E

Only for use in topical medicines for dermal application.

 

1285

CERATONIA SILIQUA

A, E, H

 

1286

CERATOSTIGMA WILLMOTTIANUM

A, H

 

1287

CERESIN

E

Only for use in topical medicines for dermal application.

 

1288

CESTRUM LATIFOLIUM

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin.

The plant part must be leaf and must be a water extract.

The concentration must be no more than 0.5%.

 

1289

CETEARETH-12

E

Only for use in topical medicines for dermal application.

 

1290

CETEARETH-2

E

Only for use in topical medicines for dermal application.

 

1291

CETEARETH-20

E

Only for use in topical medicines for dermal application.

 

1292

CETEARETH-25

E

Only for use in topical medicines for dermal application.

 

1293

CETEARETH-30

E

Only for use in topical medicines for dermal application.

 

1294

CETEARETH-33

E

Only for use as an excipient ingredient for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.2%.

Residual levels of 1,4-dioxane oxide (and related substances) are to be kept below the level of detection.

 

1295

CETEARYL GLUCOSIDE

E

Only for use in topical medicines for dermal application.

 

1296

CETEARYL ISONONANOATE

E

Only for use in topical medicines for dermal application.

 

1297

CETEARYL NONANOATE

E

Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye.

The concentration in the medicine must not be more than 5%.

 

1298

CETEARYL OCTANOATE

E

Only for use in topical medicines for dermal application.

 

1299

CETETH-10

E

Only for use in topical medicines for dermal application.

 

1300

CETETH-2

E

Only for use in topical medicines for dermal application.

 

1301

CETETH-24

E

Only for use in topical medicines for dermal application.

 

1302

CETETH-5

E

Only for use in topical medicines for dermal application.

 

1303

CETOMACROGOL 1000

E

Only for use in topical medicines for dermal application.

 

1304

CETOMACROGOL 1000 PHOSPHATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin.

The concentration in the medicine must be no more than 2%.

 

1305

CETOMACROGOL 500 PHOSPHATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin.

The concentration in the medicine must be no more than 2%.

 

1306

CETOSTEARYL ALCOHOL

E

 

1307

CETOSTEARYL ALCOHOL/COCO-GLUCOSIDE COMPLEX

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin.

The concentration in the medicine must be no more than 5.0 %

 

1308

CETRARIA ISLANDICA

A, H

 

1309

CETRIMONIUM BROMIDE

E

Only for use in topical medicines for dermal application.

 

1310

CETRIMONIUM CHLORIDE

E

Only for use in topical medicines for dermal application.

 

1311

CETYL ACETATE

E

Only for use in topical medicines for dermal application.

 

1312

CETYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

1313

CETYL DIMETHICONE COPOLYOL

E

Only for use in topical medicines for dermal application.

 

1314

CETYL DIMETICONE

E

Only for use in topical medicines for dermal application.

 

1315

CETYL DIMETICONE/BIS-VINYLDIMETICONE CROSSPOLYMER

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. 

The concentration in the medicine must be no more than 0.1%.

 

1316

CETYL ESTERS WAX

E

Only for use in topical medicines for dermal application.

 

1317

CETYL HYDROXYETHYLCELLULOSE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 1%.

 

1318

CETYL LACTATE

E

Only for use in topical medicines for dermal application.

 

1319

CETYL OCTANOATE

E

Only for use in topical medicines for dermal application.

 

1320

CETYL PALMITATE

E

Only for use in topical medicines for dermal application.

 

1321

CETYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

1322

CETYL-PG HYDROXYETHYL PALMITAMIDE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 8%.

 

1323

CETYLPYRIDINIUM CHLORIDE

A, E

When used as an excipient ingredient, only for use in topical medicines for dermal application.

When used as an active ingredient:

a) permitted for use only in medicated throat lozenges;

b) the medicine must not contain more than 2 mg of cetylpyridinium chloride per lozenge;

c) the maximum recommended daily dose of the medicine must not provide more than 24 mg of cetylpyridinium chloride; and

d) the medicine label must specify that the medicine is only to be used for 7 days (or less).

 

1324

CHAENOMELES LAGENARIA

A, H

 

1325

CHAENOMELES SPECIOSA

A, H

 

1326

CHALK

A, E

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 Pharmacopoeia, as in force or existing from time to time.

 

1327

CHAMAECYPARIS LAWSONIANA

A, H

 

1328

CHAMAELIRIUM LUTEUM

A, H

 

1329

CHAMAEMELUM NOBILE

A, E, H

 

1330

CHAMOMILE FLOWER DRY

A, E, H

 

1331

CHAMOMILE OIL ENGLISH

A, E, H

 

1332

CHAMOMILE OIL GERMAN

A, E, H

 

1333

CHANGIUM SMYRNIOIDES

A, H

 

1334

CHEIRANTHUS CHEIRI

A, H

 

1335

CHELIDONIUM MAJUS

A, E, H

When for oral or sublingual use, the medicine requires the following warning statement on the medicine label:

- (CELAND) 'WARNING: Greater Celandine may harm the liver in some people.  Use only under the supervision of a healthcare professional'.

 

1336

CHELONE GLABRA

A, H

 

1337

CHENOPODIUM ALBUM

A, H

 

1338

CHENOPODIUM VULVARIA

A, H

 

1339

CHERRY

E

 

1340

CHERRY DISTILLATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1341

CHESTNUT SWEET

E, H

 

1342

CHICKEN COMB EXTRACT

A

 

1343

CHILLI

E, H

 

1344

CHIMAPHILA UMBELLATA

A, H

Beta-arbutin is a mandatory component of Chimaphila umbellata.

When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.

When for dermal application exclusively to the face:

a) the concentration of beta-arbutin in the medicine must not be more than 7%;

b) hydroquinone is a mandatory component; and

c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.

When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

 

1345

CHIONANTHUS VIRGINICA

A, H

 

1346

CHLORELLA

E

Iodine is a mandatory component of Chlorella.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

1347

CHLORELLA PYRENOIDOSA

E

 

1348

CHLORELLA VULGARIS

A, E

Iodine is a mandatory component of Chlorella vulgaris.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

1349

CHLORHEXIDINE ACETATE

E

Only for use in topical medicines for dermal application.

 

1350

CHLORHEXIDINE GLUCONATE

E

Only for use in topical medicines for dermal application.

 

1351

CHLOROBUTANOL HEMIHYDRATE

E

Only for use in topical preparations for dermal application.

The concentration in the medicine must be no more than 0.5%.

 

1352

CHLOROCRESOL

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 3%.

 

1353

CHLOROFORM

E

The residual solvent limit must be no more than 0.6 mg per recommended daily dose and the concentration in the medicine must be no more than 0.006%.

 

1354

CHLOROPHYLL

A, E

Only for use as a colour in oral and topical medicines.

 

1355

CHLOROPHYLL-COPPER COMPLEXES

E

Only for use as a colour in oral and topical medicines.

 

1356

CHLOROPHYLLIN-COPPER COMPLEX

E

Only for use as a colour in oral and topical medicines.

 

1357

CHLOROPHYLLIN-COPPER COMPLEX ALUMINIUM LAKE

E

Only for as a colour in oral and topical medicines.

 

1358

CHLOROXYLENOL

E

Only for use in topical medicines for dermal application.

 

1359

CHLORPHENESIN

E

Only for use in topical medicines for dermal application.

 

1360

CHOCOLATE BROWN HT

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

1361

CHOLESTEROL

E, H

Only for use as an active ingredient in homoeopathic medicines or an excipient ingredient in topical preparations.

 

1362

CHOLESTERYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

 

1363

CHOLESTERYL MACADAMIATE

E

Only for use in topical medicines for dermal application.

 

1364

CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.5%.

 

1365

CHOLETH-24

E

Only for use in topical medicines for dermal application.

 

1366

CHOLINE BITARTRATE

A, E

 

1367

CHOLINE DIHYDROGEN CITRATE

A

Only for use in oral medicines.

 

1368

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%.

 

1369

CHONDRUS CRISPUS

A, E, H

Iodine is a mandatory component of Chondrus crispus.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

1370

CHONDRUS DRY

A, E, H

Iodine is a mandatory component of Chondrus dry.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

1371

CHONDRUS EXTRACT

A, E, H

Iodine is a mandatory component of Chondrus extract.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

1372

CHROMIC CHLORIDE HEXAHYDRATE

A, H

When 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 ingredient should be calculated based on the molecular weight of chromic chloride hexahydrate.

The maximum recommended daily dose must provide 50 micrograms or less of chromium from organic sources (i.e. chromium picolinate, chromium nicotinate and high chromium yeast).

 

1373

CHROMIUM NICOTINATE

A

Chromium is a mandatory component of chromium nicotinate.

The maximum recommended daily dose must not provide more than 50 micrograms of chromium from organic sources.

Chromium nicotinate is considered to be an organic form of chromium.

 

1374

CHROMIUM PICOLINATE

A

Chromium is a mandatory component of Chromium picolinate.

The maximum recommended daily dose must not provide more than 50 micrograms of chromium from organic sources.

Chromium picolinate is considered to be an organic form of chromium.

 

1375

CHRYSANTHEMUM BALSAMITA

A, H

 

1376

CHRYSANTHEMUM INDICUM

A, H

 

1377

CHRYSANTHEMUM LEUCANTHEMUM

A, H

 

1378

CHRYSANTHEMUM MARSHALLII

A, H

 

1379

CHRYSANTHEMUM SINENSE

A, H

 

1380

CHRYSOPOGON ZIZANIOIDES

A, E, H

 

1381

CHRYSOSPORIUM PRUINOSUM

A, H

 

1382

CIBOTIUM BAROMETZ

A, H

 

1383

CICHORIUM INTYBUS

A, E, H

 

1384

CICUTA VIROSA

A, H

The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.

 

1385

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 concentration of quinidine per g or mL.

 

1386

CINCHONA BARK POWDER

A, H

Quinidine and quinine are mandatory components of Cinchona bark powder.

The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL.

 

1387

CINCHONA OFFICINALIS

A, H

Quinidine and quinine are mandatory components of Cinchona officinalis.

The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL.

 

1388

CINCHONA PUBESCENS

A, H

Quinidine and quinine are mandatory components of Cinchona pubescens.

The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL.

 

1389

CINEOLE

E

In liquid preparations when the concentration of cineole in the preparation is more than 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure.

 

1390

CINNAMALDEHYDE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1391

CINNAMIC ACID

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1392

CINNAMOMUM CAMPHORA

A, E, H

Camphor, cineole and safrole are mandatory components of Cinnamomum camphora.

In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%.

In liquid preparations other than essential oils or distillates, the concentration of camphor must be no more than 2.5%.

In essential oil preparations or distillates and the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25 millilitres and the following warning statements must be included on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect);

- (NTAKEN) 'Not to be taken'; and

- Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist'.

In essential oil preparations or distillates, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container.

In essential oil preparations or distillates, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container.

In essential oil preparations or distillates, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container.

In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% the nominal capacity of the container must be no more than 25 millilitres and the medicine must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container.

In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container.

When for internal use then the concentration of safrole in a medicine must be no more than 0.1%.

When for uses other than internal use, the concentration of safrole in a medicine must be no more than 1.0%.

When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%.

 

1393

CINNAMOMUM CASSIA

A, E

Cassia oil is a mandatory component of Cinnamomum cassia if the plant preparation is an essential oil, distillate, fixed oil or infused oil.

The concentration of Cassia oil in the medicine must be no more than 2%.

When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%.

 

 

1394

CINNAMOMUM VERUM

A, E, H

When used as an active ingredient coumarin is a mandatory component of Cinnamomum verum and the concentration of coumarin in the medicine must be no more than 0.001%.

Cinnamon bark oil is a mandatory component of Cinnamomum verum when the plant part is bark and the plant preparation is essential oil, distillate, 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 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but no more than 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container.

When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the container must be fitted with a restricted flow insert.

 

1395

CINNAMON BARK OIL

A, E, H

The concentration of cinnamon bark oil in the product must be no more than 2%.

When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%.

 

1396

CINNAMON DRY

A, H

Cinnamon bark oil is a mandatory component of cinnamon dry.

The concentration of cinnamon bark oil in the product must be no more than 2%.

When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%.

 

1397

CINNAMON LEAF OIL

A, E, H

When the concentration of cinnamon leaf oil in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 mL.

When the concentration of cinnamon leaf oil in 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 requires the following warning statement on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect).

- (NTAKEN) 'Not to be taken'.

When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is no more than 15 mL, the container must be fitted with a restricted flow insert and requires the following warning statement on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect).

- (NTAKEN) 'Not to be taken'.

When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%.

 

1398

CINNAMON POWDER

A, E, H

Cinnamon bark oil is a mandatory component of cinnamon powder.

The concentration of cinnamon bark oil in the product must be no more than 2%.

When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%.

 

1399

CINNAMYL ACETATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1400

CINNAMYL ALCOHOL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1401

CINNAMYL BUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1402

CINNAMYL CINNAMATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1403

CINNAMYL FORMATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1404

CINNAMYL ISOBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1405

CINNAMYL ISOVALERATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used as a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1406

CINNAMYL PROPIONATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1407

CINOXATE

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 6%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

1408

CIS-2-METHYL-4-PROPYL-1,3-OXATHIANE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1409

CIS-3-HEXEN-1-OL

E

cis-3-Hexen-1-ol must only be included in medicines when in combination with other permitted ingredients as a flavour or fragrance proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing cis-3-hexen-1-ol must not be more than 5% of the total medicine.

The total concentration of fragrance proprietary excipient formulations containing cis-3-hexen-1-ol must not be more than 1% of the total medicine.

 

1410

CIS-3-HEXENAL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1411

CIS-3-HEXENYL 2-METHYLBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1412

CIS-3-HEXENYL ACETATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1413

CIS-3-HEXENYL BENZOATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1414

CIS-3-HEXENYL BUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1415

CIS-3-HEXENYL FORMATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1416

CIS-3-HEXENYL HEXANOATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1417

CIS-3-HEXENYL ISOBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1418

CIS-3-HEXENYL ISOVALERATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1419

CIS-3-HEXENYL LACTATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1420

CIS-3-HEXENYL METHYL CARBONATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1421

CIS-3-HEXENYL SALICYLATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1422

CIS-3-HEXENYL TIGLATE

E

Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation.

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

 

1423

CIS-4-HEPTENAL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1424

CIS-6-NONEN-1-AL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1425

CIS-6-NONENOL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1426

CIS-BETA-OCIMENE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1427

CIS-HEXAHYDROCUMINYL ALCOHOL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1428

CIS-JASMONE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1429

CISTANCHE DESERTICOLA

A, H

 

1430

CISTANCHE SALSA

A, H

 

1431

CISTUS LADANIFERUS

A, E, H

 

1432

CITRAL

E

 

1433

CITRAL DIETHYL ACETAL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1434

CITRAL DIMETHYL ACETAL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1435

CITRIC ACID

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.

When used as an active ingredient in preparations for topical use, the medicine requires the following warning statements on the medicine label:

- (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect)

- (SUNPRO) 'Wear protective clothing, hats and eyewear when exposed to the sun.' (or words to that effect)

- (IRRIT) 'If irritation develops, discontinue use.'

- (SKTEST) 'If you have sensitive skin, test this product on a small area of skin before applying it to a large area.'

- (CHILD3) 'Use in children under 12 years is not recommended'

 

1436

CITRIC ACID DIHYDRATE

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.

When used as an active ingredient in preparations for topical use, the medicine requires the following warning statements on the medicine label:

- (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect)

- (SUNPRO) 'Wear protective clothing, hats and eyewear when exposed to the sun.' (or words to that effect)

- (IRRIT) 'If irritation develops, discontinue use.'

- (SKTEST) 'If you have sensitive skin, test this product on a small area of skin before applying it to a large area.'

- (CHILD3) 'Use in children under 12 years is not recommended'

 

1437

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.

When used as an active ingredient in preparations for topical use, the medicine requires the following warning statements on the medicine label:

- (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect)

- (SUNPRO) 'Wear protective clothing, hats and eyewear when exposed to the sun.' (or words to that effect)

- (IRRIT) 'If irritation develops, discontinue use.'

- (SKTEST) 'If you have sensitive skin, test this product on a small area of skin before applying it to a large area.'

- (CHILD3) 'Use in children under 12 years is not recommended.'

 

1438

CITRIC AND FATTY ACID ESTERS OF GLYCEROL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1439

CITROL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1440

CITRON

E

 

1441

CITRONELLA OIL

A, E, H

Medicines for topical use containing citronella oil require the following warning statement on the medicine label:

- (CITRON) 'Contains citronella oil'.

 

1442

CITRONELLA TERPENES

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1443

CITRONELLAL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1444

CITRONELLIC ACID

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1445

CITRONELLOL

E

Permitted for use only:

(a) in topical medicines for dermal application; and

(b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

 

1446

CITRONELLYL ACETATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1447

CITRONELLYL BUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1448

CITRONELLYL FORMATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1449

CITRONELLYL ISOBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1450

CITRONELLYL NITRILE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1451

CITRONELLYL OXYACETALDEHYDE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1452

CITRONELLYL PROPIONATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1453

CITRONELLYL TIGLATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1454

CITRULLINE

A

Only to be used in a medicine where Kyowa Hakko Bio Co Ltd (Client ID 11072), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 2 March 2022.

Only permitted for use in medicines:

- limited to oral routes of administration; and

- when the maximum recommended daily dose does not provide more than 6g of citrulline.

 

1455

CITRULLUS COLOCYNTHIS

H

Citrullus colocynthis can only be included in medicines for oral use when the dilution of the mother tincture is 10,000 fold (4X) or more.

 

1456

CITRULLUS VULGARIS

A, H

 

1457

CITRUS AURANTIFOLIA

A, E, H

When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is:

a) for internal use; or

b) in preparations containing 0.5% or less of citrus aurantifolia oil or distillate; or

c) for use in soaps or bath or shower gels that are washed off the skin.

 

1458

CITRUS AURANTIUM

A, E, H

Oxedrine is a mandatory component of Citrus aurantium when intended for internal use.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 mg.

When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is:

a) for internal use; or

b) in preparations containing 1.4% or less of citrus aurantium oil or distillate; or

c) for use in soaps or bath or shower gels that are washed off the skin.

 

1459

CITRUS BIOFLAVONOIDS EXTRACT

A, E, H

 

1460

CITRUS CHACHIENSIS

A, H

 

1461

CITRUS EXTRACT

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1462

CITRUS FIBRE

E

 

1463

CITRUS LIMETTA

A, H

When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is:

a) for internal use; or

b) in preparations containing 0.5% or less of citrus limetta oil or distillate; or

c) for use in soaps or bath or shower gels that are washed off the skin.

 

1464

CITRUS LIMON

A, E, H

Oxedrine is a mandatory component of Citrus limon when intended for internal use.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.

When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is:

a) for internal use; or

b) in preparations containing 0.05% or less of citrus limon oil or distillate; or

c) for use in soaps or bath or shower gels that are washed off the skin.

 

1465

CITRUS MAXIMA

A, H

 

1466

CITRUS MEDICA

A, E, H

When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is:

a) for internal use; or

b) in preparations containing 0.05% or less of citrus medica oil or distillate; or

c) for use in soaps or bath or shower gels that are washed off the skin.

 

1467

CITRUS OIL DISTILLED

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1468

CITRUS OIL TERPENES AND TERPENOIDS

E

Citrus oil terpenes and terpenoids must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing citrus oil terpenes and terpenoids must not be more than 1% of the total medicine.

 

1469

CITRUS RETICULATA

A, E, H

Oxedrine is a mandatory component of Citrus reticulata when intended for internal use.

The quantity of Oxedrine in the recommended daily dose must be no more than 30 mg.

 

1470

CITRUS SINENSIS

A, E, H

Oxedrine is a mandatory component of Citrus sinensis when intended for internal use.

The quantity of Oxedrine in the recommended daily dose must be no more than 30 mg.

 

1471

CITRUS SINENSIS PEEL MOLASSES EXTRACT

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1472

CITRUS UNSHIU

A, E, H

Oxedrine is a mandatory component of Citrus unshiu when intended for internal use.

The quantity of Oxedrine in the recommended daily dose must be no more than 30 mg. 

 

1473

CITRUS X PARADISI

A, E, H

 

1474

CITRUS X WILSONII

A, H

 

1475

CIVET

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1476

CIVET ABSOLUTE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1477

CIVET SYNTHETIC

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1478

CIVETONE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1479

CLARY OIL

A, E, H

 

1480

CLEMATIS ARMANDII

A, H

 

1481

CLEMATIS CHINENSIS

A, E, H

 

1482

CLEMATIS RECTA

A, H

 

1483

CLEMATIS VITALBA

A, H

 

1484

CLERODENDRUM TRICHOTOMUM

A, H

 

1485

CLINOPODION POLYCEPHALUM

A, H

 

1486

CLINOPODIUM NEPETA SUBSP. GLANDULOSUM

A, H

 

1487

CLIVER HERB DRY

A, H

 

1488

CLIVER HERB POWDER

A, H

 

1489

CLOVE BUD OIL

A, E, H

When the concentration of Clove Bud Oil in the preparation is more than 25%, the nominal capacity of the container must be no more than 25 mL.

When the concentration of Clove Bud Oil in the preparation is more than 25% and the nominal capacity of the container is more 15 mL but no more than 25mL, a child resistant closure and restricted flow insert must be fitted on the container and requires the following warning statement on the medicine label:

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’

When the concentration of clove bud oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL , a restricted flow insert must be fitted on the container and requires the following warning statement on the medicine label:

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’

 

1490

CLOVE DRY

A, E, H

 

1491

CLOVE LEAF OIL

A, E, H

When the concentration of Clove Leaf Oil in the preparation is more than 25%, the nominal capacity of the container must be no more than 25 mL.

When the concentration of Clove Leaf Oil in the preparation is more than 25% and the nominal capacity of the container is more 15 mL but no more than 25mL, a child resistant closure and restricted flow insert must be fitted on the container and requires the following warning statement on the medicine label:

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’

When the concentration of clove leaf oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL, a restricted flow insert must be fitted on the container and requires the following warning statement on the medicine label:

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’

 

1492

CLOVE OIL TERPENES

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1493

CLOVE POWDER

A, E, H

 

1494

CLOVE STEM OIL

A, E, H

When the concentration of Clove Stem Oil in the preparation is more than 25%, the nominal capacity of the container must be no more than 25 mL.

When the concentration of Clove Stem Oil in the preparation is more than 25% and the nominal capacity of the container is more 15 mL but no more than 25mL, a child resistant closure and restricted flow insert must be fitted on the container requires the following warning statements on the medicine label:

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’

When the concentration of Clove Stem oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL , a restricted flow insert must be fitted on the container and requires the following warning statements on the medicine label:

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’

 

1495

CLUPEA HARENGUS LIPID EXTRACT

A

Only for use in oral medicines.

The maximum recommended daily dose must not provide more than 2750 mg EPA, DHA and DPA combined, when used alone or in combination with other sources of omega-3 fatty acids.

 

1496

CNICUS BENEDICTUS

A, H

 

1497

CNICUS JAPONICUS

A, H

 

1498

CNIDIUM MONNIERI

A, H

 

1499

CNIDIUM OFFICINALE

A, H

 

1500

COBALTOUS NITRATE HEXAHYDRATE

H

Only for use as an active homoeopathic ingredient.

 

1501

COCAMIDE DEA

E

Only for use in topical medicines for dermal application.

 

1502

COCAMIDE MEA

E

Only for use in topical medicines for dermal application.

 

1503

COCAMIDOPROPYL BETAINAMIDE MEA CHLORIDE

E

Only for use in topical medicines for dermal application and not to be included in topical products intended for use in the eye.

The concentration in the medicine must be no more than 1%.

 

1504

COCAMIDOPROPYL BETAINE

E

Only for topical, mucous membrane (buccal mucosa) and dental use and not to be included in topical medicines intended for use in the eye.

The concentration in the medicine 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.

 

1505

COCCOLOBIA UVIFERA

A, H

 

1506

COCCULUS ORBICULATUS

A, H

 

1507

COCHINEAL

E, H

Only for use as an active homoeopathic ingredient or for excipient use only as a colour in oral and topical medicines.

 

1508

COCHLEARIA OFFICINALIS

A, H

 

1509

COCILLANA DRY

A, H

 

1510

COCILLANA POWDER

A, H

 

1511

COCO-BETAINE

E

Only for use in topical medicines for dermal application.

 

1512

COCO-CAPRYLATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration is to be no more than 12.5% in the medicine.

 

1513

COCO-GLUCOSIDE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.025%

 

1514

COCO-OCTANOATE/DECANOATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

 

1515

COCOA EXTRACT

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1516

COCOA POWDER

A, E, H

 

1517

COCOGLYCERIDES

E

 

1518

COCONUT

E

 

1519

COCONUT ACID

E

Only for use in topical medicines for dermal application.

 

1520

COCONUT OIL

A, E, H

 

1521

COCOS NUCIFERA

A, E, H

 

1522

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 medicine must be no more than 1%.

When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents.

When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label:

- (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 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 for internal use, the maximum recommended daily dose must be no more than 25 micrograms of vitamin D.

 

1523

CODONOPSIS LANCEOLATA

A, H

 

1524

CODONOPSIS PILOSULA

A, H

 

1525

CODONOPSIS TANGSHEN

A, H

 

1526

COFFEA ARABICA

A, E, H

Caffeine is a mandatory component of Coffea arabica.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 4%.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (ADULT) 'Adults only' (or words to that effect).

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

1527

COFFEA CANEPHORA

A, E, H

Caffeine is a mandatory component of Coffea canephora.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 4%.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (ADULT) 'Adults only' (or words to that effect).

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

1528

COFFEE

E, H

Caffeine is a mandatory component of coffee.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 4%.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (ADULT) 'Adults only' (or words to that effect).

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

1529

COFFEE OIL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1530

COFFEE SOLID EXTRACT

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1531

COGNAC OIL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1532

COGNAC OIL GREEN

A, E, H

 

1533

COGNAC OIL WHITE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1534

COIX LACHRYMA-JOBI

A, H

 

1535

COLA ACUMINATA

A, E, H

Caffeine is a mandatory component of Cola acuminata.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 4%.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (ADULT) 'Adults only' (or words to that effect).

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

1536

COLA NITIDA

A, E, H

Caffeine is a mandatory component of Cola nitida.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 4%.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (ADULT) 'Adults only' (or words to that effect).

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

1537

COLCHICUM AUTUMNALE

H

Only for use as an active homoeopathic ingredient.

 

1538

COLECALCIFEROL

A, E

When for internal use, the maximum recommended daily dose must not be more than 25 micrograms of Vitamin D.

 

1539

COLLAGEN

E

 

1540

COLLINSONIA CANADENSIS

A, H

 

1541

COLLOIDAL ANHYDROUS SILICA

A, E, H

Only for use when the route of administration is other than inhalation.

 

1542

COLOPHONY

A, E, H

 

1543

COMMIPHORA HABESSINICA

A, H

 

1544

COMMIPHORA KATAF

A, H

 

1545

COMMIPHORA MYRRHA

A, E, H

 

1546

COMMON INDIAN COBRA

H

Only for use as an active homoeopathic ingredient.

 

1547

CONCENTRATED FISH OMEGA-3 TRIGLYCERIDES

A

Only for oral use.

 

1548

CONCENTRATED SQUID OMEGA-3 TRIGLYCERIDES

A

Only for oral use.

'Concentrated squid omega-3-triglycerides' 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. 

The medicine requires the following warning statement on the medicine label:

- (SFOOD) 'Derived from seafood'.

 

1549

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).

 

1550

CONIFER PHYTOSTEROL COMPLEX

A

 

1551

CONIOSELIUM UNIVITTATUM

A, H

 

1552

CONIUM MACULATUM

H

Only for use as an active homoeopathic ingredient.

The homoeopathic potency of Conium maculatum in the final medicine must be 12X or greater.

 

1553

CONVALLARIA MAJALIS

A, H

 The concentration of equivalent dry Convallaria majalis in the product must be no more than 10mg/Kg or 10mg/L or 0.001%.

 

1554

CONYZA CANADENSIS

A, H

 

1555

COPAIBA OIL

A, E, H

 

1556

COPAIFERA LANGSDORFFII

A, E, H

 

1557

COPERNICIA CERIFERA

A, E, H

 

1558

COPOVIDONE

E

 

1559

COPPER

H

Only for use as an active homoeopathic ingredient.

When for internal use the maximum daily dose must not contain more than 5 mg of copper.

When for other than internal use, the concentration of copper compounds must be no more than 5%.

 

1560

COPPER (II) ASPARTATE

A, H

Copper is a mandatory component of copper (II) aspartate.

The percentage of copper from copper (II) aspartate should be calculated based on the molecular weight of copper (II) aspartate.

The concentration of copper compounds in products must be no more than 5%.

The maximum daily dose must not contain more than 5mg of copper.

 

1561

COPPER (II) GLYCINATE

A, H

Copper is a mandatory component of copper (II) glycinate.

The percentage of copper from copper (II) glycinate should be calculated based on the molecular weight of Copper (II) glycinate.

The concentration of copper compounds in products must be no more than 5%.

The maximum daily dose must not contain more than 5mg of copper.

 

1562

COPPER (II) LYSINATE

A, H

Copper is a mandatory component of copper (II) lysinate.

The percentage of copper from copper (II) lysinate should be calculated based on the molecular weight of Copper (II) lysinate.

The concentration of copper compounds in products must be no more than 5%.

The maximum daily dose must not contain more than 5mg of copper.

 

1563

COPPER ACETYL TYROSINATE METHYLSILANOL

E

Only for use in topical medicines for dermal application.

 

1564

COPPER CHLOROPHYLL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1565

COPPER CHLOROPHYLLIN

E

Only for use as a colour in oral and topical medicines.

 

1566

COPPER GLUCONATE

A, E

Copper is a mandatory component of copper gluconate.

The percentage of copper from copper gluconate should be calculated based on the molecular weight of copper gluconate.

When for internal use the maximum daily dose must not contain more than 5 mg of copper.

When for other than internal use, the concentration of copper compounds must be no more than 5%.

 

1567

COPPER TRIPEPTIDE-1

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 3%.

 

1568

COPTIS CHINENSIS

A, H

 

1569

COPTIS JAPONICA

A, H

 

1570

CORALLINA OFFICINALIS

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine is to be no more than 1%.

 

1571

CORDYCEPS SINENSIS

A, E, H

Must not contain material of animal origin such as insect larvae.

 

1572

CORIANDER DRY

A, H

 

1573

CORIANDER OIL

A, E, H

 

1574

CORIANDER POWDER

A, H

 

1575

CORIANDRUM SATIVUM

A, E, H

 

1576

CORMUS DOMESTICA

A, H

 

1577

CORN GLYCERIDES

E

 

1578

CORN SILK DRY

A, H

 

1579

CORN SILK POWDER

A, H

 

1580

CORN SYRUP

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1581

CORN SYRUP SOLIDS

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1582

CORNUS FLORIDA

A, H

 

1583

CORNUS OFFICINALIS

A, H

 

1584

CORTISONE ACETATE

H

Only available as an active homoeopathic ingredient.

 

1585

CORYDALIS AMBIGUA

A, E, H

 

1586

CORYDALIS BUNGEANA

A, H

 

1587

CORYDALIS CAVA

A, H

 

1588

CORYDALIS FABACEA

A, H

 

1589

CORYDALIS FORMOSA

A, H

 

1590

CORYDALIS TURTSCHANINOVII

A, H

 

1591

CORYLUS AMERICANA

A, H

 

1592

CORYLUS AVELLANA

A, H

 

1593

CORYMBIA CITRIODORA

A, E, H

Cineole is a mandatory component of Corymbia citriodora.

In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure.

 

1594

CORYMBIA FICIFOLIA

A, H

Cineole is a mandatory component of Corymbia ficifolia.

In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure.

 

1595

COSMOS BIPINNATUS

A, H

 

1596

COSTUS ROOT OIL

A, H

 

1597

COSTUS SPICATUS

A, H

 

1598

COTTONSEED OIL

A, E, H

 

1599

COUCH GRASS RHIZOME DRY

A, H

 

1600

COUCH GRASS RHIZOME POWDER

A, H

 

1601

COUMARIN

E, H

Only for use as an active homoeopathic ingredient or excipient ingredient.

The concentration of coumarin in the medicine must not be more than 0.001%.

When used as an excipient:

(a) must only be used in topical medicines for dermal application; and

(b) the label of the medicine must specify that the product should only be used by adults.

 

1602

CRANBERRY

E

 

1603

CRATAEGUS CUNEATA

A, E, H

 

1604

CRATAEGUS GERMANICA

A, H

 

1605

CRATAEGUS LAEVIGATA

A, E, H

 

1606

CRATAEGUS MONOGYNA

A, E, H

 

1607

CRATAEGUS PINNATIFIDA

A, E, H

 

1608

CRATEVA MAGNA

A, E, H

 

1609

CREATINE

A, E

 

1610

CREATINE MONOHYDRATE

A, E

 

1611

CREATINE PHOSPHATE

A, E

 

1612

CREATININE

E

Only for use in topical medicines for dermal application and not for use in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.2%.

 

1613

CREOSOL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1614

CREOSOTE

H

Only for use as an active homoeopathic ingredient.

 

1615

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 must be no more than 3%.

 

1616

CRESYL ISOBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1617

CRITHMUM MARITIMUM WHOLE PLANT EXTRACT

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.00341%.

 

1618

CROCUS SATIVUS

A, H

 

1619

CROSCARMELLOSE SODIUM

E

 

1620

CROSPOVIDONE

E

 

1621

CROTON CASCARILLA

A, H

The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.

 

1622

CROTON ELUTERIA

A, H

The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.

 

1623

CRYPTOMERIA JAPONICA

A, H

 

1624

CUBEB OIL

A, H

 

1625

CUBEBENE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1626

CUCUMBER

E

 

1627

CUCUMIS MELO

A, H

 

1628

CUCUMIS SATIVUS

A, E, H

 

1629

CUCURBITA MAXIMA

A, E, H

 

1630

CUCURBITA MOSCHATA

A, H

 

1631

CUCURBITA PEPO

A, E, H

 

1632

CULLEN CORYLIFOLIUM

A, H

 

1633

CUMIC ALCOHOL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1634

CUMIN OIL

A, E, H

 

1635

CUMINALDEHYDE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1636

CUMINUM CYMINUM

A, H

 

1637

CUMINYL NITRILE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1638

CUPRESSUS ARIZONICA

A, H

 

1639

CUPRESSUS FUNEBRIS

A, E, H

 

1640

CUPRESSUS SEMPERVIRENS

A, E, H

 

1641

CUPRIC ACETATE MONOHYDRATE

H

Only for use as an active homoeopathic ingredient.

 

1642

CUPRIC ARSENITE

H

Only for use as an active homoeopathic ingredient.

 

1643

CUPRIC CITRATE

A, E, H

When for oral or sublingual use, copper is a mandatory component of cupric citrate.

The percentage of copper from cupric citrate should be calculated based on the molecular weight of cupric citrate.

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.

 

1644

CUPRIC CITRATE HEMIPENTAHYDRATE

A, E, H

When for oral or sublingual use, copper is a mandatory component of cupric citrate hemipentahydrate.

The percentage of copper from cupric citrate hemipenthydrate should be calculated based on the molecular weight of cupric citrate hemipenthydrate.

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 recommended daily dose.

 

1645

CUPRIC OXIDE

A, E, H

When for oral or sublingual use, copper is a mandatory component of cupric oxide.

The percentage of copper from cupric oxide should be calculated based on the molecular weight of cupric oxide.

When for internal use the maximum daily dose must not contain more than 5 mg of copper.

When for other than internal use, the concentration of copper compounds must be no more than 5%.

 

1646

CUPRIC SULFATE

A, E, H

When for oral or sublingual use, copper is a mandatory component of cupric sulfate.

The percentage of copper from cupric sulfate should be calculated based on the molecular weight of cupric sulfate.

When for internal use the maximum daily dose must not contain more than 5 mg of copper.

When for other than internal use, the concentration of copper compounds must be no more than 5%.

 

1647

CUPRIC SULFATE MONOHYDRATE

A, E, H

When for oral or sublingual use, copper is a mandatory component of cupric sulfate monohydrate.

The percentage of copper from cupric sulfate monohydrate should be calculated based on the molecular weight of cupric sulfate monohydrate.

When for internal use the maximum daily dose must not contain more than 5 mg of copper.

When for other than internal use, the concentration of copper compounds must be no more than 5%.

When used topically, cupric sulfate is a mandatory component of cupric sulfate monohydrate.

 

1648

CUPRIC SULFATE PENTAHYDRATE

A, E, H

When for oral or sublingual use, copper is a mandatory component of cupric sulfate pentahydrate.

The percentage of copper from cupric sulfate pentahydrate should be calculated based on the molecular weight of cupric sulfate pentahydrate.

When for internal use the maximum daily dose must not contain more than 5 mg of copper.

When for other than internal use, the concentration of copper compounds must be no more than 5%.

When used topically cupric sulfate is a mandatory component of cupric sulfate pentahydrate.

The percentage of cupric sulfate from cupric sulfate pentahydrate should be calculated based on the molecular weight of cupric sulfate pentahydrate.

 

1649

CURCULIGO ORCHIOIDES

A, H

 

1650

CURCUMA AROMATICA

A, H

 

1651

CURCUMA LONGA

A, E, H

 

1652

CURCUMA XANTHORRHIZA

A, H

 

1653

CURCUMA ZEDOARIA

A, H

 

1654

CURCUMIN

A, E, H

When for excipient use, only permitted for use as a colour in topical and oral medicines.

 

1655

CUSCUTA EPITHYMUM

A, H

 

1656

CUSCUTA EUROPAEA

A, H

 

1657

CUSCUTA HYGROPHILAE

A, H

 

1658

CUSCUTA RACEMOSA

A, H

 

1659

CUSPARIA FEBRIFUGA

A, H

 

1660

CYAMOPSIS TETRAGONOLOBA

A, E, H

 

1661

CYANOCOBALAMIN

A, E, H

 

1662

CYANOMETHYLPHENYL MENTHANE CARBOXAMIDE

E

For dental use only in proprietary ingredients.

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in the medicine must be no more than 5%.

 

1663

CYATHULA OFFICINALIS

A, H

 

1664

CYCLAMEN ALDEHYDE

E

Only for use as an excipient ingredient in topical medicines.

 

1665

CYCLAMEN PURPURASCENS

A, H

 

1666

CYCLOHEXADECENONE-8

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1667

CYCLOHEXANE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1668

CYCLOHEXANE, 1-ETHENYL-1-METHYL-2-(1-METHYLETHENYL)-4-(1-METHYLETHYL)-, DIDEHYDRO DERIV.

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1669

CYCLOHEXANEETHANOL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1670

CYCLOHEXYL ACETATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1671

CYCLOHEXYL BUTYRATE

E

Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation.

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

 

1672

CYCLOHEXYL PHENETHYL ETHER

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1673