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. 3) 2020 and specifies those ingredients that may be contained in a medicine that is 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 15 Dec 2020
Tabling HistoryDate
Tabled HR02-Feb-2021
Tabled Senate02-Feb-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

751

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).'

 

752

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).

 

753

BACOPA MONNIERI

A, H

 

754

BALLOTA NIGRA

A, H

 

755

BALM OF GILEAD BUD DRY

A, H

 

756

BALM OF GILEAD BUD POWDER

A, H

 

757

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%.

 

758

BAMBUSA BREVIFLORA

A, E, H

 

759

BAMBUSA TEXTILIS

A, H

 

760

BANANA

E

 

761

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%.

 

762

BAPTISIA CONFUSA

A, H

 

763

BAPTISIA TINCTORIA

A, H

 

764

BARBAREA VULGARIS

A, H

 

765

BARIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

 

766

BARIUM CHLORIDE

H

Only for use as an active homoeopathic ingredient.

 

767

BARIUM SULFATE

E

Only for use in topical medicines for dermal application.

 

768

BARLEY

E

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

 

769

BARLEY BRAN

E

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

 

 

770

BARLEY GERM

E

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

 

771

BARLEY LEAF

E

 

772

BASIC BUTYLATED METHACRYLATE COPOLYMER

E

Only for use in oral medicines.

 

773

BASIC FUCHSIN

E

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

 

774

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%.

 

775

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%.

 

776

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).

 

777

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).

 

778

BASSIA SCOPARIA

A, H

 

779

BATYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

780

BAY LEAF

E

 

781

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'

 

782

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%.

 

783

BEET RED

E

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

 

784

BEETROOT

E, H

 

785

BEGONIA FIMBRISTIPULA

A, H

 

786

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.

 

787

BEHENIC ACID

E

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

 

788

BEHENOXY DIMETHICONE

E

Only for use in topical medicines for dermal application.

 

789

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%.

 

790

BEHENYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

791

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%.

 

792

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%.

 

793

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%.

 

794

BELLIS PERENNIS

A, H

 

795

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).

 

796

BENINCASA HISPIDA

A, E, H

 

797

BENTONITE

E

 

798

BENZALDEHYDE

E

 

799

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%.

 

800

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%.

 

 

801

BENZETHONIUM CHLORIDE

E

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

 

802

BENZOIC ACID

E, H

Medicines containing benzoates require the following warning statement on the medicine label:

- (TBNZO8) ‘Contains benzoates' (or words to this effect)’ if the medicine contains two or more benzoate sources or ‘Contains [insert the approved name of benzoate used] (or words to this effect)’ if product contains one benzoate source.

 

803

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%.

 

804

BENZOIN SIAM

A, E, H

 

805

BENZOIN SUMATRA

A, E, H

 

806

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%.

 

807

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.

 

808

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%.

 

809

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%.

 

810

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).

 

811

BENZYL BENZOATE

E

Only for use in topical medicines for dermal application.

Medicines containing benzoates require the warning statement:

- (TBNZO8) 'Contains benzoates' (or words to this effect) if the medicine contains two or more benzoate sources or 'Contains [insert the approved name of benzoate used]' (or words to this effect) if product contains one benzoate source.

 

812

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%.

 

813

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.

 

814

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%.

 

815

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%.

 

816

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%.

 

817

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%.

 

818

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%.

 

819

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%.

 

820

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%.

 

821

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%.

 

822

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%.

 

823

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%.

 

824

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%.

 

825

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).

 

826

BERBERIS AQUIFOLIUM

A, H

 

827

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).

 

828

BERBERIS VULGARIS

A, E, H

 

829

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)

 

830

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%.

 

831

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.

 

832

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%.

 

833

BERTHOLLETIA EXCELSA

A, E, H

 

834

BETA RAPA

A, E, H

 

835

BETA VULGARIS

A, E, H

 

836

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%.

 

837

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%.

 

838

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%.

 

839

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%.

 

840

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%.

 

841

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%.

 

842

BETA-HYDROXY-BETA-METHYLBUTYRIC ACID

A

 

843

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%.

 

844

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%.

 

845

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%.

 

846

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%.

 

847

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%.

 

848

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%.

 

849

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%.

 

850

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%.

 

851

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%.

 

852

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%.

 

853

BETA-TOCOPHEROL

E

 

854

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.’

 

 

855

BETADEX

E

 

856

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%.

 

857

BETAINE

E

Only for use in topical medicines for dermal application.

 

858

BETAINE HYDROCHLORIDE

E

 

859

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'.

 

860

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'.

 

861

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'.

 

862

BETULA PUBESCENS

A, E, H

 

863

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%.

 

864

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%.

 

865

BIFIDOBACTERIUM ADOLESCENTIS

A

 

866

BIFIDOBACTERIUM ANIMALIS

A

 

867

BIFIDOBACTERIUM ANIMALIS SSP ANIMALIS

A

 

868

BIFIDOBACTERIUM ANIMALIS SSP LACTIS

A

 

869

BIFIDOBACTERIUM BIFIDUM

A

 

870

BIFIDOBACTERIUM BREVE

A

 

871

BIFIDOBACTERIUM INFANTIS

A

 

872

BIFIDOBACTERIUM LACTIS

A

 

873

BIFIDOBACTERIUM LONGUM

A

 

874

BILBERRY

E

 

875

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%.

 

876

BIOTA ORIENTALIS

A, H

 

877

BIOTIN

A, E

 

878

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'.

 

879

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%.

 

 

880

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%.

 

881

BIS-DIGLYCERYL POLYACYLADIPATE-2

E

Only for use in topical medicines for dermal application.

 

882

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%.

 

883

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%.

 

884

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%.

 

885

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%.

 

886

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%.

 

887

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%.

 

888

BISABOLOL

E

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

 

889

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.

 

890

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 the medicine is:

(a) used in medicines with an oral route of administration;

(b) not promoted or marketed as laxative; and

(c) the recommended daily dose for:

(i) individuals greater than 9 years of age contains 250 mg or greater magnesium;

(ii) children aged between 4 and 8 years (inclusive) contains 110 mg or greater magnesium; or

(iii) children aged between 1 and 3 years (inclusive) contains 65 mg or greater magnesium;

the following warning statements are required on the label:

- (LAX5) 'This product contains magnesium'; and

- (LAX4) 'This product may have laxative effect'.

When the medicine is for an oral route of administration, the following warning statement is required on the label:

- (BABY2) 'Not suitable for infants under the age of twelve months' (or words to that effect).

 

891

BIXA ORELLANA

A, E, H

 

892

BLACK BONED CHICKEN POWDER

A

 

893

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.'

 

894

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.'

 

895

BLACK CURRANT

E

 

896

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%.

 

897

BLACK CURRANT FRESH

A, E, H

 

898

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%.

 

899

BLACK OF CURACAO SPIDER

H

Only for use as an active homoeopathic ingredient.

 

900

BLACK PEPPER OIL

A, E, H

 

901

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%.

 

902

BLACK SNAKE

H

Only for use as an active homoeopathic ingredient.

 

903

BLACKBERRY

E

 

904

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%.

 

905

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%.

 

906

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%.

 

907

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%.

 

908

BLACKSTRAP MOLASSES

E

When for oral or sublingual use, Sucrose is a mandatory component of Molasses - blackstrap.

When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label:

- (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars.

If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label:

- (LACT) ‘Contains lactose' (or words to that effect).

 

909

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.

 

 

910

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.

 

911

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%.

 

912

BLETILLA STRIATA

A, H

 

913

BLUE FLAG RHIZOME DRY

A, H

 

914

BLUE FLAG RHIZOME POWDER

A, H

 

915

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%.

 

916

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%.

 

917

BLUMEA LACERA

A, H

 

918

BOEHMERIA NIVEA

A, H

 

919

BOERHAVIA DIFFUSA

A, H

 

920

BOERHAVIA REPENS

A, H

 

921

BOGBEAN LEAF DRY

A, H

 

922

BOGBEAN LEAF POWDER

A, H

 

923

BOIS DE ROSE OIL

A, E, H

 

924

BOMBAX CEIBA

A, H

 

925

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.

 

926

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%.

The requirements specified in paragraphs (a) to (d) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 2 March 2020; or

- released for supply after 2 March 2021.

(a) 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).

(b) 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).

(c) 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).

(d) 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).

 

927

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%.

The requirements specified in paragraphs (a) to (d) below apply to a medicine that contains the ingredient that:

- is listed in the Register on or after 2 March 2020; or

- is released for supply after 2 March 2021.

(a) 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).

(b) 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).

(c) 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).

(d) 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).

 

 

928

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%.

The requirements specified in paragraphs (a) to (d) below apply to a medicine that contains the ingredient that:

- is listed in the Register on or after 2 March 2020; or

- is released for supply after 2 March 2021.

(a) 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).

(b) 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).

(c) 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).

(d) 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).

 

929

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%.

 

930

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%.

 

931

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%.

 

932

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%.

 

933

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%.

 

934

BOSWELLIA CARTERII

A, E, H

 

935

BOSWELLIA SERRATA

A, E, H

 

936

BOSWELLIA THURIFERA

A, H

 

937

BOVINE CALCIUM CHONDROITIN SULFATE

A

 

938

BOVINE CHONDROITIN SULFATE

A

 

939

BOVINE COLOSTRUM POWDER

A

The medicine requires the warning statement:

- (BOVCOL) 'Products containing bovine colostrum powder contain lactose and cow's milk proteins (or words to that effect). This product is not suitable for use in children under the age of 12 months except on professional health advice.'

 

940

BOVINE LACTOFERRIN

A

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

- (COWMK) 'Derived from cow's milk.'

 

941

BOVINE POTASSIUM CHONDROITIN SULFATE

A

 

942

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%.

 

943

BOVINE WHEY IG-RICH FRACTION

A

Only for use in oral medicines.

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

- (COWMK) 'Derived from cows milk'

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

 

944

BRANDY

E

 

945

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%.

 

946

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%.

 

947

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%.

 

948

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%.

 

949

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%.

 

950

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%.

 

951

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%.

 

952

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%.

 

953

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%.

 

954

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%.

 

955

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%.

 

956

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%.

 

957

BRAZIL NUT

E

 

958

BRILLIANT BLACK BN

E

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

 

959

BRILLIANT BLUE FCF

E

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

 

960

BRILLIANT BLUE FCF ALUMINIUM LAKE

E

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

 

961

BRILLIANT BLUE FCF BARIUM LAKE

E

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

 

962

BRILLIANT SCARLET 4R

E

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

 

963

BRILLIANT SCARLET 4R ALUMINIUM LAKE

E

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

 

964

BRIZA MEDIA

A, H

 

965

BROCCOLI

E

 

966

BROMELAINS

A

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

If used in a divided preparation, the allowed units are papain units and million papain units.

If used in an undivided preparation, the allowed units are million papain units per gram.

 

967

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.

 

968

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%.

 

969

BROMUS CATHARTICUS

A, H

 

970

BROMUS INERMIS

A, H

 

971

BROMUS RAMOSUS SUBSP. RAMOSUS

A, H

 

972

BRONOPOL

E

Only for use in topical medicines for dermal application.

 

973

BROUSSONETIA PAPYRIFERA

A, H

 

974

BROWN FK

E

Permitted for use only as a colour for topical use.

 

975

BRUNFELSIA UNIFLORA

A, H

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

 

976

BRUSSEL SPROUT

E

 

977

BRYONIA ALBA

A, H

 

978

BRYONIA DIOICA

A, H

 

979

BUCHU LEAF DRY

A, H

 

980

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%.

 

981

BUCHU LEAF POWDER

A, E, H

 

982

BUCKWHEAT

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

983

BUDDLEJA OFFICINALIS

A, H

 

984

BULNESIA SARMIENTI

A, E, H

 

985

BUNIAS ORIENTALIS

A, H

 

986

BUPLEURUM FALCATUM

A, H

 

987

BURDOCK LEAF DRY

A, H

 

988

BURDOCK LEAF POWDER

A, H

 

989

BURDOCK ROOT DRY

A, H

 

990

BURDOCK ROOT POWDER

A, H

 

991

BUSHMASTER SNAKE

H

Only for use as an active homoeopathic ingredient.

 

992

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%.

 

993

BUTANE

E

Only for use as an excipient propellant ingredient.

 

994

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%.

 

995

BUTTER

E

 

996

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%.

 

997

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%.

 

998

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%.

 

999

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%.

 

1000

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%.

 

1001

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%.

 

1002

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%.

 

1003

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%.

 

1004

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).

 

1005

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%.

 

1006

BUTYL HYDROXYBENZOATE

E

Only for use in topical medicines for dermal application.

Medicines containing hydroxybenzoates require the following warning statement on the medicine label:

- (TOTBNZ) ‘Contains hydroxybenzoates’ (or words to this effect) if the medicine contains more than one hydroxybenzoate source OR ‘Contains [insert the approved name of hydroxybenzoate used]’ (or words to this effect) if product contains one hydroxybenzoate source.

 

1007

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%.

 

1008

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%.

 

1009

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%.

 

1010

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%.

 

1011

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).

 

1012

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%.

 

1013

BUTYL STEARATE

E

Only for use in topical medicines for dermal application.

 

1014

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%.

 

1015

BUTYLATED HYDROXYANISOLE

E

 

1016

BUTYLATED HYDROXYTOLUENE

E

 

1017

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%.

 

1018

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%.

 

1019

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%.

 

1020

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%.

 

1021

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%.

 

1022

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%.

 

1023

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%.

 

1024

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%.

 

1025

C10-30 CHOLESTEROL/LANOSTEROL ESTERS

E

Only for use in topical medicines for dermal application.

 

1026

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%.

 

1027

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%.

 

1028

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.

 

1029

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.

 

1030

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%.

 

1031

C12-15 ALKYL OCTANOATE

E

Only for use in topical medicines for dermal application.

 

1032

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%.

 

1033

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%.

 

1034

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%.

 

1035

C13-14 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

 

1036

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%.

 

1037

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%.

 

1038

C18-36 ACID GLYCOL ESTER

E

Only for use topical medicines for dermal application.

 

1039

C18-36 ACID TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

 

1040

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%.

 

1041

C20-40 ALCOHOLS

E

Only for use in topical medicines for dermal application.

 

1042

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%.

 

1043

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%.

 

1044

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%.

 

1045

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%.

 

1046

C9-11 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

 

1047

C9-11 PARETH-3

E

Only for use in topical medicines for dermal application.

 

1048

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%

 

1049

CABBAGE

E

 

1050

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%.

 

1051

CADE OIL

A, E, H

 

1052

CAESALPINIA SAPPAN

A, H

 

1053

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 100mg 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%.

The requirements specified in paragraphs (a) to (d) below apply to a medicine that contains the ingredient that:

- is listed in the Register on or after 2 September 2019; or

- is released for supply after 2 March 2021.

A medicine that contains the ingredient and that:

- was listed in the Register before 2 September 2019; and

- is released for supply before 2 March 2021;

may comply with the requirements in paragraphs (a) to (d) below.

a) 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%.

b) 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.

c) 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.’

d) 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).

 

1054

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'.

 

1055

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.

 

1056

CALCIFEDIOL MONOHYDRATE

A

Only to be used in a medicine where DSM Nutritional Products Pty Ltd (Client ID 31685), 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 30 June 2021.

 

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).

 

1057

CALCIFIED LITHOTHAMNION SPECIES

A

Only for use in oral medicines.

 

1058

CALCIFIED LITHOTHAMNION TOPHIFORME

A

Only for oral use.

 

1059

CALCIUM ALGINATE

E

 

1060

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.

 

 

1061

CALCIUM ASCORBATE

A, E, H

 

1062

CALCIUM ASCORBATE DIHYDRATE

A, E, H

 

1063

CALCIUM ASPARTATE

A

 

1064

CALCIUM ASPARTATE HYDROCHLORIDE DIHYDRATE

A

Only for use in oral medicines.

 

 

1065

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.

 

1066

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE

A, H

 

1067

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE

A, H

 

1068

CALCIUM CARBONATE

A, E, H

 

1069

CALCIUM CASEINATE

E

 

1070

CALCIUM CHLORIDE DIHYDRATE

E

 

1071

CALCIUM CITRATE

A, E, H

 

1072

CALCIUM CITRATE TETRAHYDRATE

A, E, H

 

1073

CALCIUM DIASPARTATE

A

Only for use in oral medicines.

 

1074

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%.

 

1075

CALCIUM FOLINATE

A

Folinic acid is a mandatory component of calcium folinate.

The maximum 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.

When used in preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects, the following warning statement is required on the medicine label:

- (NEUR) 'Warning: Do not exceed the stated dose except on medical advice. If you have had a baby with a neural tube defect/spina bifida - seek specific medical advice (or words to that effect).'

 

1076

CALCIUM GLUCONATE MONOHYDRATE

A, E, H

 

1077

CALCIUM GLYCEROPHOSPHATE

A, E, H

 

1078

CALCIUM GLYCINATE

A

Only for use in oral medicines.

 

 

1079

CALCIUM GLYCINATE DIHYDRATE

A

 

1080

CALCIUM HEXAFLUOROSILICATE

H

Only for use as an active homoeopathic ingredient.

 

1081

CALCIUM HYDROGEN PHOSPHATE

A, E, H

 

1082

CALCIUM HYDROGEN PHOSPHATE DIHYDRATE

A, E, H

 

1083

CALCIUM HYDROGEN PHOSPHATE MONOHYDRATE

A, E, H

 

1084

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.

 

 

1085

CALCIUM HYDROXYCITRATE

A, H

 

1086

CALCIUM HYPOPHOSPHITE

H

Only for use as an active homoeopathic ingredient.

 

1087

CALCIUM IODIDE

H

Only for use as an active homoeopathic ingredient.

 

1088

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%

 

1089

CALCIUM L-THREONATE

A

Only for use in oral medicines.

 

 

1090

CALCIUM LACTATE

A, E, H

 

1091

CALCIUM LACTATE GLUCONATE

A, E, H

 

1092

CALCIUM LACTATE PENTAHYDRATE

A, E, H

 

1093

CALCIUM LACTATE TRIHYDRATE

A, E, H

 

1094

CALCIUM LYSINATE

A

Only for use in oral medicines.

 

 

1095

CALCIUM METHIONINATE

A

Only for use in oral medicines.

 

 

1096

CALCIUM OROTATE

A, E, H

 

1097

CALCIUM OXIDE

E

Only for use in topical medicines for dermal application.

 

1098

CALCIUM PANTOTHENATE

A, E, H

 

1099

CALCIUM PHOSPHATE

A, E, H

 

1100

CALCIUM PYRUVATE

A

 

1101

CALCIUM SACCHARATE

E

 

1102

CALCIUM SILICATE

E

 

1103

CALCIUM SODIUM CASEINATE

A, H

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

 - (COWMK) 'Derived from cow's milk'.

 

1104

CALCIUM SODIUM LACTATE

A, E, H

 

1105

CALCIUM STEARATE

E

 

1106

CALCIUM SUCCINATE

A, E, H

 

1107

CALCIUM SULFATE

A, E, H

 

1108

CALCIUM SULFATE DIHYDRATE

A, E, H

 

1109

CALCIUM SULFIDE

H

Only for use as an active homoeopathic ingredient.

 

1110

CALCIUM THREONINATE

A

 

1111

CALENDULA FLOWER DRY

A, E, H

 

1112

CALENDULA FLOWER POWDER

A, H

 

1113

CALENDULA OFFICINALIS

A, E, H

 

1114

CALLERYA RETICULATA

A, H

 

1115

CALLICARPA PEDUNCULATA

A, H

 

1116

CALLISTEPHUS CHINENSIS

A, H

 

1117

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%.

 

1118

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%.

 

1119

CALLITRIS RHOMBOIDEA

A, H

 

1120

CALLUNA VULGARIS

A, E, H

 

1121

CALOCHORTUS TOLMIEI

A, H

 

1122

CALTHA PALUSTRIS

A, H

 

1123

CALUMBA ROOT DRY

A, H

 

1124

CALUMBA ROOT POWDER

A, H

 

1125

CALVATIA GIGANTEA

A, E, H

 

1126

CALYCANTHUS FLORIDUS

A, H

 

1127

CALYCANTHUS PRAECOX

A, H

 

1128

CAMELLIA JAPONICA

A, H

 

1129

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.

 

1130

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%.

The requirements specified in paragraphs (a) to (e) below apply in relation to a medicine that contains the ingredient that:

- is listed in the Register on or after 2 September 2019; or

- is released for supply after 2 March 2021.

A medicine that contains the ingredient and that:

- was listed in the Register before 2 September 2019; and

- is released for supply before 2 March 2021;

may comply with the requirements in paragraphs (a) to (e) below.

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

b) 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%.

c) 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.

d) 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.’

e) 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).

 

1131

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%.

 

1132

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%.

 

1133

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%.

 

1134

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).

 

1135

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.

 

1136

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.

 

1137

CAMPSIS GRANDIFLORA

A, H

 

1138

CANADA BALSAM

A, H

 

1139

CANANGA ODORATA

A, E, H

 

1140

CANANGA OIL

A, E, H

 

1141

CANARIUM INDICUM

A, H

The plant part must be seed and the plant preparation is oil.

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

- (DERIVED) 'This product contains material derived from nuts' (or words to that effect).

 

1142

CANARIUM LUZONICUM

A, H

 

1143

CANDELILLA WAX

A, E, H

 

1144

CANDIDA ALBICANS

H

Only for use as an active homoeopathic ingredient.

 

1145

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%.

 

1146

CANINE MILK

H

Only for use as an active homoeopathic ingredient.

 

1147

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%.

 

1148

CANTHARIDES

H

Only available as an active homoeopathic ingredient.

 

1149

CANTHAXANTHIN

E

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

 

1150

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%.

 

1151

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%.

 

1152

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%.

 

1153

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%.

 

1154

CAPRYLIC/CAPRIC/ISOSTEARIC/ADIPIC TRIGLYCERIDE

E

 

1155

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%

 

1156

CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

 

1157

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%.

 

1158

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%

 

1159

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%.

 

1160

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%

 

1161

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%.

 

1162

CAPSELLA BURSA-PASTORIS

A, H

 

1163

CAPSICUM

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

1164

CAPSICUM ANNUUM

A, E, H

 

1165

CAPSICUM DRY

A, E, H

 

1166

CAPSICUM FRUIT OLEORESIN

A, E

 

1167

CAPSICUM FRUTESCENS

A, E, H

 

1168

CAPSICUM POWDER

A, E, H

 

1169

CARALLUMA ADSCENDENS VAR. FIMBRIATA

A

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

 

1170

CARAMEL

E

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

 

1171

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%.

 

1172

CARAWAY DRY

A, H

 

1173

CARAWAY OIL

A, E, H

 

1174

CARAWAY POWDER

A, H

 

1175

CARBOMER 1342

E

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

 

1176

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.

 

1177

CARBOMER 934

E

Only for use in topical medicines for dermal application.

 

1178

CARBOMER 934P

E

Only for use in topical medicines for dermal application.

 

1179

CARBOMER 940

E

Only for use in topical medicines for dermal application.

 

1180

CARBOMER 941

E

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

 

1181

CARBOMER 954

E

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

 

1182

CARBOMER 980

E

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

 

1183

CARBOMER 981

E

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

 

1184

CARBOMER COPOLYMER (TYPE B)

E

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

 

1185

CARBOMER HOMOPOLYMER (TYPE B)

E

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

 

1186

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%.

 

1187

CARBON

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

1188

CARBON BLACK

E

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

 

1189

CARBON DIOXIDE

E

 

1190

CARDAMOM FRUIT DRY

A, H

 

1191

CARDAMOM FRUIT POWDER

A, E, H

 

1192

CARDAMOM OIL

A, E, H

 

1193

CARDIOSPERMUM HALICACABUM

A, H

 

1194

CARICA PAPAYA

A, E, H

 

1195

CARLINA ACAULIS

A, H

 

1196

CARMELLOSE

E

 

1197

CARMELLOSE CALCIUM

E

 

1198

CARMELLOSE SODIUM

E

 

1199

CARMINE

E

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

 

1200

CARMOISINE

E

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

 

1201

CARMOISINE ALUMINIUM LAKE

E

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

 

1202

CARNAUBA WAX

A, E, H

 

1203

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%.

 

1204

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%.

 

1205

CAROB GUM

E

 

1206

CAROB POD

E

 

1207

CAROTENES

E

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

 

1208

CARPINUS BETULUS

A, H

 

1209

CARPINUS CORDATA

A, H

 

1210

CARRAGEENAN

E

 

1211

CARROT

E

 

1212

CARROT SEED OIL

A, E, H

 

1213

CARTHAMUS TINCTORIUS

A, E, H

Carthamus tinctorius (sunflower oil) when used as a solvent is restricted to topical or sunscreen preparations for dermal application only.

If for oral use, the medicine requires the following warning statement on the medicine label:

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

 

1214

CARUM CARVI

A, H

 

1215

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%.

 

1216

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%.

 

1217

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%.

 

1218

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%.

 

1219

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%.

 

1220

CARYA ILLINOINENSIS

A, H

 

1221

CARYA OVATA

A, H

 

1222

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%.

 

1223

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’.

 

1224

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’.

 

1225

CASCARILLA OIL

A, H

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

 

1226

CASEIN

E

 

1227

CASHEW NUT

E

 

1228

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%.

 

1229

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%.

 

1230

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.

 

1231

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’.

 

1232

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%.

 

1233

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%.

 

1234

CASTANEA MOLLISSIMA

A, H

 

1235

CASTANEA SATIVA

A, H

 

1236

CASTOR OIL

A, E

 

1237

CASTOREUM

H

Only permitted for use as an active homoeopathic ingredient.

 

 

1238

CASUARINA EQUISITIFOLIA

A, H

 

1239

CATALPA BIGNONIOIDES

A, H

 

1240

CATALPA OVATA

A, H

 

1241

CATECHU

A, H

 

1242

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%.

 

1243

CAULIFLOWER

E

 

1244

CAULOPHYLLUM THALICTROIDES

A, E, H

 

1245

CAUSTICUM

H

Only for use as an active homoeopathic ingredient.

 

1246

CEANOTHUS AMERICANUS

A, H

 

1247

CEDAR LEAF OIL

A, E, H

 

1248

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%.

 

1249

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%.

 

1250

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%.

 

1251

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%.

 

1252

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%.

 

1253

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%.

 

1254

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%.

 

1255

CEDRUS ATLANTICA

A, E, H

 

1256

CEDRUS DEODARA

A, H

 

1257

CEDRUS LIBANI

H

Only for use as an active homoeopathic ingredient.

 

1258

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%.

 

1259

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%.

 

1260

CELERY LEAF

E, H

 

1261

CELERY SEED DRY

A, E, H

 

1262

CELERY SEED OIL

A, E, H

 

1263

CELERY SEED POWDER

A, H

 

1264

CELLACEFATE

E

 

1265

CELLULASE

A

Must be derived from Trichoderma longibrachiatum only.

If used as an undivided preparation, the allowed unit is Cellulase unit per gram or Thousand cellulase unit per gram.

If used as an divided preparation, the allowed unit is Thousand cellulase unit or cellulase unit.

 

1266

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%.

 

1267

CELOSIA ARGENTEA

A, H

 

1268

CELOSIA ARGENTEA L. VAR. CRISTATA

A, H

 

1269

CENTAUREA CYANUS

A, E, H

 

1270

CENTAURIUM ERYTHRAEA

A, H

 

1271

CENTELLA ASIATICA

A, E, H

 

1272

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%.

 

1273

CENTIPEDA CUNNINGHAMII

A, E, H

 

1274

CENTIPEDA MINIMA

A, H

 

1275

CEPHALANOPSIS SEGETUM

A, H

 

1276

CERAMIDE 1

E

Only for use in topical medicines for dermal application.

 

1277

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%.

 

1278

CERAMIDE 3

E

Only for use in topical medicines for dermal application.

 

1279

CERATONIA SILIQUA

A, E, H

 

1280

CERATOSTIGMA WILLMOTTIANUM

A, H

 

1281

CERESIN

E

Only for use in topical medicines for dermal application.

 

1282

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%.

 

1283

CETEARETH-12

E

Only for use in topical medicines for dermal application.

 

1284

CETEARETH-2

E

Only for use in topical medicines for dermal application.

 

1285

CETEARETH-20

E

Only for use in topical medicines for dermal application.

 

1286

CETEARETH-25

E

Only for use in topical medicines for dermal application.

 

1287

CETEARETH-30

E

Only for use in topical medicines for dermal application.

 

1288

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.

 

1289

CETEARYL GLUCOSIDE

E

Only for use in topical medicines for dermal application.

 

1290

CETEARYL ISONONANOATE

E

Only for use in topical medicines for dermal application.

 

1291

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%.

 

1292

CETEARYL OCTANOATE

E

Only for use in topical medicines for dermal application.

 

1293

CETETH-10

E

Only for use in topical medicines for dermal application.

 

1294

CETETH-2

E

Only for use in topical medicines for dermal application.

 

1295

CETETH-24

E

Only for use in topical medicines for dermal application.

 

1296

CETETH-5

E

Only for use in topical medicines for dermal application.

 

1297

CETOMACROGOL 1000

E

Only for use in topical medicines for dermal application.

 

1298

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%.

 

1299

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%.

 

1300

CETOSTEARYL ALCOHOL

E

 

1301

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 %

 

1302

CETRARIA ISLANDICA

A, H

 

1303

CETRIMONIUM BROMIDE

E

Only for use in topical medicines for dermal application.

 

1304

CETRIMONIUM CHLORIDE

E

Only for use in topical medicines for dermal application.

 

1305

CETYL ACETATE

E

Only for use in topical medicines for dermal application.

 

1306

CETYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

1307

CETYL DIMETHICONE COPOLYOL

E

Only for use in topical medicines for dermal application.

 

1308

CETYL DIMETICONE

E

Only for use in topical medicines for dermal application.

 

1309

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%.

 

1310

CETYL ESTERS WAX

E

Only for use in topical medicines for dermal application.

 

1311

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%.

 

1312

CETYL LACTATE

E

Only for use in topical medicines for dermal application.

 

1313

CETYL OCTANOATE

E

Only for use in topical medicines for dermal application.

 

1314

CETYL PALMITATE

E

Only for use in topical medicines for dermal application.

 

1315

CETYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

1316

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%.

 

1317

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).

 

1318

CHAENOMELES LAGENARIA

A, H

 

1319

CHAENOMELES SPECIOSA

A, H

 

1320

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.

 

1321

CHAMAECYPARIS LAWSONIANA

A, H

 

1322

CHAMAELIRIUM LUTEUM

A, H

 

1323

CHAMAEMELUM NOBILE

A, E, H

 

1324

CHAMOMILE FLOWER DRY

A, E, H

 

1325

CHAMOMILE OIL ENGLISH

A, E, H

 

1326

CHAMOMILE OIL GERMAN

A, E, H

 

1327

CHANGIUM SMYRNIOIDES

A, H

 

1328

CHEIRANTHUS CHEIRI

A, H

 

1329

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'.

 

1330

CHELONE GLABRA

A, H

 

1331

CHENOPODIUM ALBUM

A, H

 

1332

CHENOPODIUM VULVARIA

A, H

 

1333

CHERRY

E

 

1334

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%.

 

1335

CHESTNUT SWEET

E, H

 

1336

CHICKEN COMB EXTRACT

A

 

1337

CHILLI

E, H

 

1338

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%.

 

1339

CHIONANTHUS VIRGINICA

A, H

 

1340

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.

 

1341

CHLORELLA PYRENOIDOSA

E

 

1342

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.

 

 

1343

CHLORHEXIDINE ACETATE

E

Only for use in topical medicines for dermal application.

 

1344

CHLORHEXIDINE GLUCONATE

E

Only for use in topical medicines for dermal application.

 

1345

CHLOROACETAMIDE

E

Only for use in topical medicines for dermal application.

 

1346

CHLOROBUTANOL HEMIHYDRATE

E

Only for use in topical preparations for dermal application.

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

 

 

 

1347

CHLOROCRESOL

E

Only for use in topical medicines for dermal application.

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

 

 

 

1348

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%.

 

1349

CHLOROPHYLL

A, E

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

 

1350

CHLOROPHYLL-COPPER COMPLEXES

E

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

 

1351

CHLOROPHYLLIN-COPPER COMPLEX

E

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

 

1352

CHLOROPHYLLIN-COPPER COMPLEX ALUMINIUM LAKE

E

Only for as a colour in oral and topical medicines.

 

1353

CHLOROXYLENOL

E

Only for use in topical medicines for dermal application.

 

1354

CHLORPHENESIN

E

Only for use in topical medicines for dermal application.

 

1355

CHOCOLATE BROWN HT

E

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

 

1356

CHOLESTEROL

E, H

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

 

1357

CHOLESTERYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

 

1358

CHOLESTERYL MACADAMIATE

E

Only for use in topical medicines for dermal application.

 

1359

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%.

 

1360

CHOLETH-24

E

Only for use in topical medicines for dermal application.

 

1361

CHOLINE BITARTRATE

A, E

 

1362

CHOLINE DIHYDROGEN CITRATE

A

Only for use in oral medicines.

 

1363

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%.

 

1364

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.

 

1365

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.

 

 

1366

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.

 

 

1367

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).

 

 

1368

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.

 

1369

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.

 

1370

CHRYSANTHEMUM BALSAMITA

A, H

 

1371

CHRYSANTHEMUM INDICUM

A, H

 

1372

CHRYSANTHEMUM LEUCANTHEMUM

A, H

 

1373

CHRYSANTHEMUM MARSHALLII

A, H

 

1374

CHRYSANTHEMUM SINENSE

A, H

 

1375

CHRYSOPOGON ZIZANIOIDES

A, E, H

 

1376

CHRYSOSPORIUM PRUINOSUM

A, H

 

1377

CIBOTIUM BAROMETZ

A, H

 

1378

CICHORIUM INTYBUS

A, E, H

 

1379

CICUTA VIROSA

A, H

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

 

1380

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.

 

1381

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.

 

1382

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.

 

1383

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.

 

1384

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.

 

1385

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%.

 

1386

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%.

 

1387

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%.

 

1388

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%.

 

 

1389

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.

 

1390

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%.

 

1391

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%.

 

1392

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%.

 

1393

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%.

 

1394

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%.

 

1395

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%.

 

1396

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%.

 

1397

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%.

 

1398

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%.

 

1399

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%.

 

1400

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%.

 

1401

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%.

 

1402

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).

 

1403

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%.

 

1404

CIS-3-HEXEN-1-OL

E

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

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

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

 

1405

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%.

 

1406

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%.

 

1407

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%.

 

1408

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%.

 

1409

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%.

 

1410

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%.

 

1411

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%.

 

1412

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%.

 

1413

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%.

 

1414

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%.

 

1415

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%.

 

1416

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%.

 

1417

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%.

 

1418

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%.

 

1419

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%.

 

1420

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%.

 

1421

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%.

 

1422

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%.

 

1423

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%.

 

1424

CISTANCHE DESERTICOLA

A, H

 

1425

CISTANCHE SALSA

A, H

 

1426

CISTUS LADANIFERUS

A, E, H

 

1427

CITRAL

E

 

1428

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%.

 

1429

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%.

 

1430

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'

 

1431

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'

 

1432

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.'

 

1433

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%.

 

1434

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%.

 

1435

CITRON

E

 

1436

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'.

 

1437

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%.

 

1438

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%.

 

1439

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%.

 

1440

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%.

 

1441

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%.

 

1442

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%.

 

1443

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%.

 

1444

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%.

 

1445

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%.

 

1446

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%.

 

1447

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%.

 

1448

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%.

 

1449

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.

 

1450

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.

 

1451

CITRULLUS VULGARIS

A, H

 

1452

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.

 

1453

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.

 

1454

CITRUS BIOFLAVONOIDS EXTRACT

A, E, H

 

1455

CITRUS CHACHIENSIS

A, H

 

1456

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%.

 

1457

CITRUS FIBRE

E

 

1458

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.

 

1459

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.

 

1460

CITRUS MAXIMA

A, H

 

1461

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.

 

1462

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%.

 

1463

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.

 

1464

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.

 

1465

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.

 

1466

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%.

 

1467

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. 

 

1468

CITRUS X PARADISI

A, E, H

 

1469

CITRUS X WILSONII

A, H

 

1470

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%.

 

1471

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%.

 

1472

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%.

 

1473

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%.

 

1474

CLARY OIL

A, E, H

 

1475

CLEMATIS ARMANDII

A, H

 

1476

CLEMATIS CHINENSIS

A, E, H

 

1477

CLEMATIS RECTA

A, H

 

1478

CLEMATIS VITALBA

A, H

 

1479

CLERODENDRUM TRICHOTOMUM

A, H

 

1480

CLINOPODION POLYCEPHALUM

A, H

 

1481

CLINOPODIUM NEPETA SUBSP. GLANDULOSUM

A, H

 

1482

CLIVER HERB DRY

A, H

 

1483

CLIVER HERB POWDER

A, H

 

1484

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’

 

1485

CLOVE DRY

A, E, H

 

1486

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’

 

1487

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%.

 

1488

CLOVE POWDER

A, E, H

 

1489

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’

 

1490

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.

 

1491

CNICUS BENEDICTUS

A, H

 

1492

CNICUS JAPONICUS

A, H

 

1493

CNIDIUM MONNIERI

A, H

 

1494

CNIDIUM OFFICINALE

A, H

 

1495

COBALTOUS NITRATE HEXAHYDRATE

H

Only for use as an active homoeopathic ingredient.

 

1496

COCAMIDE DEA

E

Only for use in topical medicines for dermal application.

 

1497

COCAMIDE MEA

E

Only for use in topical medicines for dermal application.

 

1498

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%.

 

1499

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.

 

1500

COCCOLOBIA UVIFERA

A, H

 

1501

COCCULUS ORBICULATUS

A, H

 

1502

COCHINEAL

E, H

Only for use as an active homoeopathic ingredient or for excipient use only as a colour in oral and topical medicines.

 

1503

COCHLEARIA OFFICINALIS

A, H

 

1504

COCILLANA DRY

A, H

 

1505

COCILLANA POWDER

A, H

 

1506

COCO-BETAINE

E

Only for use in topical medicines for dermal application.

 

1507

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.

 

1508

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%

 

1509

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.

 

1510

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%.

 

1511

COCOA POWDER

A, E, H

 

1512

COCOGLYCERIDES

E

 

1513

COCONUT

E

 

1514

COCONUT ACID

E

Only for use in topical medicines for dermal application.

 

1515

COCONUT OIL

A, E, H

 

1516

COCOS NUCIFERA

A, E, H

 

1517

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.

 

 

1518

CODONOPSIS LANCEOLATA

A, H

 

1519

CODONOPSIS PILOSULA

A, H

 

1520

CODONOPSIS TANGSHEN

A, H

 

1521

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%.

The requirements specified in paragraphs (a) to (e) below apply in relation to a medicine that contains the ingredient that:

- is listed in the Register on or after 2 September 2019; or

- is released for supply after 2 March 2021.

A medicine that contains the ingredient and that:

- was listed in the Register before 2 September 2019; and

- is released for supply before 2 March 2021;

may comply with the requirements in paragraphs (a) to (e) below.

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

b) 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%.

c) 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.

d) 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.’

e) 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