Permissible ingredients and requirements

Column 1

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Item

Ingredient Name

Purpose

Specific requirements

749

BACILLUS COAGULANS

A

Only permitted for use in medicines:

(a) limited to oral routes of administration; and

(b) when the strain of Bacillus coagulans is confirmed to be:

(i) Microbial Type Culture Collection (MTCC) accession number 5260; and/or

(ii) MTCC accession number 5856.

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

When the strain of Bacillus coagulans is MTCC accession number 5260:

(a) the maximum recommended daily dose of the medicine must not provide more than 6 billion cfu of Bacillus coagulans strain MTCC accession number 5260; and

(b) the following warning statements are required on the medicine label:

- (CHILD2) ‘Not suitable for children’; and

- (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).'

When the strain of Bacillus coagulans is MTCC accession number 5856:

(a) the maximum recommended daily dose of the medicine must not provide more than 2 billion cfu of Bacillus coagulans strain MTCC accession number 5856; and

(b) the following warning statements are required on the medicine label:

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

- (CHILD2) ‘Not suitable for children’; and

- (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).'

750

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).

751

BACOPA MONNIERI

A, H

752

BALLOTA NIGRA

A, H

753

BALM OF GILEAD BUD DRY

A, H

754

BALM OF GILEAD BUD POWDER

A, H

755

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%.

756

BAMBUSA BREVIFLORA

A, E, H

757

BAMBUSA TEXTILIS

A, H

758

BANANA

E

759

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%.

760

BAPTISIA CONFUSA

A, H

761

BAPTISIA TINCTORIA

A, H

762

BARBAREA VULGARIS

A, H

763

BARIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

764

BARIUM CHLORIDE

H

Only for use as an active homoeopathic ingredient.

765

BARIUM SULFATE

E

Only for use in topical medicines for dermal application.

766

BARLEY

E

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

767

BARLEY LEAF

E

768

BASIC BUTYLATED METHACRYLATE COPOLYMER

E

Only for use in oral medicines.

769

BASIC FUCHSIN

E

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

770

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%.

771

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%.

772

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).

773

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).

774

BASSIA SCOPARIA

A, H

775

BATYL ALCOHOL

E

Only for use in topical medicines for dermal application.

776

BAY LEAF

E

777

BAY OIL

A, E, H

When the total concentration of bay oil in the medicine is more than 25%:

(a) the nominal capacity of the container must not be more than 25 mL;

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

(c) the following warning statements are required on the medicine label:

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

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

(d) when the nominal capacity of the container is greater than 15 mL, the container must also be fitted with a child resistant closure.

778

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%.

779

BEESWAX ALCOHOLS

A

Only to be used in a medicine where Rainbow and Nature Pty Ltd (Client ID 22307), 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 22 April 2024.

The route of administration for medicines that contain beeswax alcohols must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than 150 mg beeswax alcohols.

The following warning statements (or words to the same effect) are required on the medicine label:

(a) (PREGNT) ‘Not recommended for use by pregnant and lactating women’

(b) (CHILD2) ‘Not suitable for children’

780

BEET RED

E

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

781

BEETROOT

E, H

782

BEGONIA FIMBRISTIPULA

A, H

783

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.

784

BEHENIC ACID

E

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

785

BEHENOXY DIMETHICONE

E

Only for use in topical medicines for dermal application.

786

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%.

787

BEHENYL ALCOHOL

E

Only for use in topical medicines for dermal application.

788

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%.

789

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%.

790

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%.

791

BELLIS PERENNIS

A, H

792

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).

793

BENINCASA HISPIDA

A, E, H

794

BENTONITE

E

795

BENZALDEHYDE

E

796

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%.

797

BENZALKONIUM CHLORIDE

E

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

When benzalkonium chloride is used in a topical medicine for dermal application, the concentration in the medicine must not be more than 5%.

When benzalkonium chloride is used in a nasal spray dosage form, the concentration of benzalkonium chloride in the medicine must not be more than 0.03%.

When benzalkonium chloride is used in a nasal spray dosage form which is either:

(i) indicated for use in children; or

(ii) not specifically indicated for adults only;

the following warning statement is required on the medicine label:

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

798

BENZETHONIUM CHLORIDE

E

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

799

BENZOIC ACID

E, H

800

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%.

801

BENZOIN SIAM

A, E, H

802

BENZOIN SUMATRA

A, E, H

803

BENZOPHENONE

E

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

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

804

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.

805

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%.

806

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%.

807

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).

808

BENZYL BENZOATE

E

Only for use in topical medicines for dermal application.

809

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%.

810

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.

811

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%.

812

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%.

813

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%.

814

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%.

815

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%.

816

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%.

817

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%.

818

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%.

819

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%.

820

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%.

821

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%.

822

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).

823

BERBERIS AQUIFOLIUM

A, H

824

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).

825

BERBERIS VULGARIS

A, E, H

826

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)

827

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%.

828

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.

829

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%.

830

BERTHOLLETIA EXCELSA

A, E, H

831

BETA RAPA

A, E, H

832

BETA VULGARIS

A, E, H

833

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%.

834

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%.

835

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%.

836

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%.

837

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%.

838

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%.

839

BETA-HYDROXY-BETA-METHYLBUTYRIC ACID

A

840

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%.

841

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%.

842

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%.

843

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%.

844

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%.

845

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%.

846

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%.

847

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%.

848

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%.

849

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%.

850

BETA-TOCOPHEROL

E

851

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.’

852

BETADEX

E

853

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%.

854

BETAINE

E

Only for use in topical medicines for dermal application.

855

BETAINE HYDROCHLORIDE

E

856

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'.

857

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'.

858

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'.

859

BETULA PUBESCENS

A, E, H

860

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%.

861

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%.

862

BIFIDOBACTERIUM ADOLESCENTIS

A

863

BIFIDOBACTERIUM ANIMALIS

A

864

BIFIDOBACTERIUM ANIMALIS SSP ANIMALIS

A

865

BIFIDOBACTERIUM ANIMALIS SSP LACTIS

A

866

BIFIDOBACTERIUM BIFIDUM

A

867

BIFIDOBACTERIUM BREVE

A

868

BIFIDOBACTERIUM INFANTIS

A

869

BIFIDOBACTERIUM LACTIS

A

870

BIFIDOBACTERIUM LONGUM

A

871

BILBERRY

E

872

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%.

873

BIOTA ORIENTALIS

A, H

874

BIOTIN

A, E

875

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'.

876

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%.

877

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%.

878

BIS-DIGLYCERYL POLYACYLADIPATE-2

E

Only for use in topical medicines for dermal application.

879

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%.

880

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%.

881

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%.

882

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%.

883

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%.

884

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%.

885

BISABOLOL

E

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

886

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.

887

BITTERN

A, E, H

Magnesium is a mandatory component of bittern.

Only permitted for use in:

(a) medicines limited to oral routes of administration; and

(b) topical medicines for dermal administration.

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

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

the following warning statement is required on the medicine label:

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

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

888

BIXA ORELLANA

A, E, H

889

BLACK BONED CHICKEN POWDER

A

890

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.'

891

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.'

892

BLACK CURRANT

E

893

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%.

894

BLACK CURRANT FRESH

A, E, H

895

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%.

896

BLACK OF CURACAO SPIDER

H

Only for use as an active homoeopathic ingredient.

897

BLACK PEPPER OIL

A, E, H

898

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%.

899

BLACK SNAKE

H

Only for use as an active homoeopathic ingredient.

900

BLACKBERRY

E

901

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%.

902

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%.

903

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%.

904

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%.

905

BLACKSTRAP MOLASSES

E

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

906

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.

907

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.

908

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%.

909

BLETILLA STRIATA

A, H

910

BLUE FLAG RHIZOME DRY

A, H

911

BLUE FLAG RHIZOME POWDER

A, H

912

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%.

913

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%.

914

BLUMEA LACERA

A, H

915

BOEHMERIA NIVEA

A, H

916

BOERHAVIA DIFFUSA

A, H

917

BOERHAVIA REPENS

A, H

918

BOGBEAN LEAF DRY

A, H

919

BOGBEAN LEAF POWDER

A, H

920

BOIS DE ROSE OIL

A, E, H

921

BOMBAX CEIBA

A, H

922

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.

923

BORAX

A, E, H

Boron is a mandatory component of borax.

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

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

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

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

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

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

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

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

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

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

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

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

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

924

BORAX PENTAHYDRATE

A, E

Boron is a mandatory component of borax pentahydrate.

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

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

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

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

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

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

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

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

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

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

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

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

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

925

BORIC ACID

A, H

Boron is a mandatory component of boric acid.

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

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

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

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

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

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

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

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

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

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

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

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

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

926

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%.

927

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%.

928

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%.

929

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%.

930

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%.

931

BOSWELLIA CARTERII

A, E, H

932

BOSWELLIA SERRATA

A, E, H

933

BOSWELLIA THURIFERA

A, H

934

BOVINE CALCIUM CHONDROITIN SULFATE

A

935

BOVINE CHONDROITIN SULFATE

A

936

BOVINE COLOSTRUM POWDER

A

The following warning statement is required on the medicine label:

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

937

BOVINE LACTOFERRIN

A

938

BOVINE POTASSIUM CHONDROITIN SULFATE

A

939

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%.

940

BOVINE WHEY IG-RICH FRACTION

A

Only for use in oral medicines.

The following warning statement is required on the medicine label:

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

941

BRANDY

E

942

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%.

943

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%.

944

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%.

945

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%.

946

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%.

947

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%.

948

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%.

949

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%.

950

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%.

951

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%.

952

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%.

953

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%.

954

BRILLIANT BLACK BN

E

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

955

BRILLIANT BLUE FCF

E

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

956

BRILLIANT BLUE FCF ALUMINIUM LAKE

E

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

957

BRILLIANT BLUE FCF BARIUM LAKE

E

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

958

BRILLIANT SCARLET 4R

E

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

959

BRILLIANT SCARLET 4R ALUMINIUM LAKE

E

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

960

BRIZA MEDIA

A, H

961

BROCCOLI

E

962

BROMELAINS

A

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

963

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%.

964

BROMUS CATHARTICUS

A, H

965

BROMUS INERMIS

A, H

966

BROMUS RAMOSUS SUBSP. RAMOSUS

A, H

967

BRONOPOL

E

Only for use in topical medicines for dermal application.

968

BROUSSONETIA PAPYRIFERA

A, H

969

BROWN FK

E

Permitted for use only as a colour for topical use.

970

BRUNFELSIA UNIFLORA

A, H

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

971

BRUSSEL SPROUT

E

972

BRYONIA ALBA

A, H

973

BRYONIA DIOICA

A, H

974

BUCHU LEAF DRY

A, H

975

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%.

976

BUCHU LEAF POWDER

A, E, H

977

BUCKWHEAT

E, H

Only for use as an active homoeopathic or excipient ingredient.

978

BUDDLEJA OFFICINALIS

A, H

979

BULNESIA SARMIENTI

A, E, H

980

BUNIAS ORIENTALIS

A, H

981

BUPLEURUM FALCATUM

A, H

982

BURDOCK LEAF DRY

A, H

983

BURDOCK LEAF POWDER

A, H

984

BURDOCK ROOT DRY

A, H

985

BURDOCK ROOT POWDER

A, H

986

BUSHMASTER SNAKE

H

Only for use as an active homoeopathic ingredient.

987

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%.

988

BUTANE

E

Only for use as an excipient propellant ingredient.

989

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%.

990

BUTTER

E

991

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%.

992

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%.

993

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%.

994

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%.

995

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%.

996

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%.

997

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%.

998

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%.

999

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).

1000

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%.

1001

BUTYL HYDROXYBENZOATE

E

Only for use in topical medicines for dermal application.

1002

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%.

1003

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%.

1004

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%.

1005

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%.

1006

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).

1007

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%.

1008

BUTYL STEARATE

E

Only for use in topical medicines for dermal application.

1009

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%.

1010

BUTYLATED HYDROXYANISOLE

E

1011

BUTYLATED HYDROXYTOLUENE

E

1012

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%.

1013

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%.

1014

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%.

1015

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%.

1016

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%.

1017

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%.

1018

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%.

1019

C10-12 ALKANE/CYCLOALKANE

E

Only permitted for use in solid or semi-solid medicines or in medicines:

(a) containing 25% or less of hydrocarbons, liquid; or

(b) when packed in pressurised spray packs; or

(c) when packed in containers with a capacity of 2 millilitres or less.

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 not be more than 1%.

1020

C10-30 CHOLESTEROL/LANOSTEROL ESTERS

E

Only for use in topical medicines for dermal application.

1021

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%.

1022

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%.

1023

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.

1024

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.

1025

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%.

1026

C12-15 ALKYL OCTANOATE

E

Only for use in topical medicines for dermal application.

1027

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%.

1028

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%.

1029

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%.

1030

C13-14 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

1031

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%.

1032

C15-16 ISOPARAFFIN

E

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

(a) for dermal application; and

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

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

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

1033

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%.

1034

C17-18 ISOPARAFFIN

E

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

(a) for dermal application; and

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

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

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

1035

C18-36 ACID GLYCOL ESTER

E

Only for use topical medicines for dermal application.

1036

C18-36 ACID TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

1037

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%.

1038

C20-40 ALCOHOLS

E

Only for use in topical medicines for dermal application.

1039

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%.

1040

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%.

1041

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%.

1042

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%.

1043

C9-11 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

1044

C9-11 PARETH-3

E

Only for use in topical medicines for dermal application.

1045

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%

1046

CABBAGE

E

1047

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%.

1048

CADE OIL

A, E, H

1049

CAESALPINIA SAPPAN

A, H

1050

CAFFEINE

A, E, H

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

Only for use as an active ingredient for:

(a) 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); and

(b) Topical medicines for dermal application that are directed for use in adults only.

When for topical application:

(a) the concentration of total caffeine in the medicine must not be more than 1%; and

(b) the medicine must not be intended for use on broken skin.

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

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

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

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

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

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

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

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

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

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

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

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

1051

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'.

1052

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.

1053

CALANUS FINMARCHICUS OIL

A

Only to be used in a medicine where Blackmores Ltd (Client ID 10576), 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 1 March 2025.

The route of administration for medicines that contain Calanus finmarchicus oil must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than 2.3 g of Calanus finmarchicus oil.

The following warning statements (or words to that effect) are required on the medicine label:

- (PREGNT) 'Not recommended for use by pregnant and lactating women'; and

- (ADULT) ‘Adults only'.

1054

CALCIFEDIOL MONOHYDRATE

A

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

Only for use in oral medicines.

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

The medicine requires the following warning statements on the label:

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

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

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

1055

CALCIFIED LITHOTHAMNION SPECIES

A

Only for use in oral medicines.

1056

CALCIFIED LITHOTHAMNION TOPHIFORME

A

Only for oral use.

1057

CALCIUM ALGINATE

E

1058

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.

1059

CALCIUM ASCORBATE

A, E, H

1060

CALCIUM ASCORBATE DIHYDRATE

A, E, H

1061

CALCIUM ASPARTATE

A

1062

CALCIUM ASPARTATE HYDROCHLORIDE DIHYDRATE

A

Only for use in oral medicines.

1063

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.

1064

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE

A, H

1065

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE

A, H

1066

CALCIUM CARBONATE

A, E, H

1067

CALCIUM CASEINATE

E

1068

CALCIUM CHLORIDE DIHYDRATE

E

1069

CALCIUM CITRATE

A, E, H

1070

CALCIUM CITRATE TETRAHYDRATE

A, E, H

1071

CALCIUM DIASPARTATE

A

Only for use in oral medicines.

1072

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%.

1073

CALCIUM FOLINATE

A

Folinic acid is a mandatory component of calcium folinate.

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

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

1074

CALCIUM FRUCTOBORATE TETRAHYDRATE

A

Only to be used in a medicine where VDF FutureCeuticals Inc (Client ID 62256), 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 25 October 2025.

Boron is a mandatory component of calcium fructoborate tetrahydrate.

The percentage of boron from calcium fructoborate tetrahydrate should be calculated based on the molecular weight of calcium fructoborate tetrahydrate.

The route of administration for medicines that contain calcium fructoborate tetrahydrate must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than:

(a) 220 mg of calcium fructoborate tetrahydrate; and

(b) 6 mg of boron.

The following warning statements (or words to the same effect) are required on the medicine label:

- (PREGNT) 'Not recommended for use by pregnant and lactating women'; and

- (ADULT) ‘Adults only'.

1075

CALCIUM GLUCONATE MONOHYDRATE

A, E, H

1076

CALCIUM GLYCEROPHOSPHATE

A, E, H

1077

CALCIUM GLYCINATE

A

Only for use in oral medicines.

1078

CALCIUM GLYCINATE DIHYDRATE

A

1079

CALCIUM HEXAFLUOROSILICATE

H

Only for use as an active homoeopathic ingredient.

1080

CALCIUM HYDROGEN PHOSPHATE

A, E, H

1081

CALCIUM HYDROGEN PHOSPHATE DIHYDRATE

A, E, H

1082

CALCIUM HYDROGEN PHOSPHATE MONOHYDRATE

A, E, H

1083

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.

1084

CALCIUM HYDROXYCITRATE

A, H

1085

CALCIUM HYPOPHOSPHITE

H

Only for use as an active homoeopathic ingredient.

1086

CALCIUM IODIDE

H

Only for use as an active homoeopathic ingredient.

1087

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%

1088

CALCIUM L-THREONATE

A

Only for use in oral medicines.

1089

CALCIUM LACTATE

A, E, H

1090

CALCIUM LACTATE GLUCONATE

A, E, H

1091

CALCIUM LACTATE PENTAHYDRATE

A, E, H

1092

CALCIUM LACTATE TRIHYDRATE

A, E, H

1093

CALCIUM LYSINATE

A

Only for use in oral medicines.

1094

CALCIUM METHIONINATE

A

Only for use in oral medicines.

1095

CALCIUM OROTATE

A, E, H

1096

CALCIUM OXIDE

E

Only for use in topical medicines for dermal application.

1097

CALCIUM PANTOTHENATE

A, E, H

1098

CALCIUM PHOSPHATE

A, E, H

1099

CALCIUM PYRUVATE

A

1100

CALCIUM SACCHARATE

E

1101

CALCIUM SILICATE

E

1102

CALCIUM SODIUM CASEINATE

A, H

1103

CALCIUM SODIUM LACTATE

A, E, H

1104

CALCIUM STEARATE

E

1105

CALCIUM SUCCINATE

A, E, H

1106

CALCIUM SULFATE

A, E, H

1107

CALCIUM SULFATE DIHYDRATE

A, E, H

1108

CALCIUM SULFIDE

H

Only for use as an active homoeopathic ingredient.

1109

CALCIUM THREONINATE

A

1110

CALENDULA FLOWER DRY

A, E, H

1111

CALENDULA FLOWER POWDER

A, H

1112

CALENDULA OFFICINALIS

A, E, H

1113

CALLERYA RETICULATA

A, H

1114

CALLICARPA PEDUNCULATA

A, H

1115

CALLISTEPHUS CHINENSIS

A, H

1116

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%.

1117

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%.

1118

CALLITRIS RHOMBOIDEA

A, H

1119

CALLUNA VULGARIS

A, E, H

1120

CALOCHORTUS TOLMIEI

A, H

1121

CALTHA PALUSTRIS

A, H

1122

CALUMBA ROOT DRY

A, H

1123

CALUMBA ROOT POWDER

A, H

1124

CALVATIA GIGANTEA

A, E, H

1125

CALYCANTHUS FLORIDUS

A, H

1126

CALYCANTHUS PRAECOX

A, H

1127

CAMELLIA JAPONICA

A, H

1128

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.

1129

CAMELLIA SINENSIS

A, E, H

Caffeine is a mandatory component of Camellia sinensis.

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

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

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

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

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

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

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

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

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicine 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).

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

- listed in the Register on or after 1 March 2024; or

- released for supply on or after 1 March 2025.

(a) When used in oral medicines, the following warning statements are required on the medicine label:

(i) 'In rare cases, Camellia sinensis may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes, or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.'; and

(ii) (FOOD) ‘To be taken with food.’

unless when:

(A) the preparation of Camellia sinensis is derived from an aqueous extract and contains 300 mg or less epigallocatechin-3-gallate per maximum recommended daily dose; or

(B) Camellia sinensis is used in combination with other permitted ingredients as a flavour proprietary excipient formulation.

(b) The total concentration of flavour proprietary excipient formulations containing Camellia sinensis must not be more than 5% of the total medicine. 

1130

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%.

1131

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%.

1132

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%.

1133

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).

1134

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.

1135

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.

1136

CAMPSIS GRANDIFLORA

A, H

1137

CANADA BALSAM

A, H

1138

CANANGA ODORATA

A, E, H

1139

CANANGA OIL

A, E, H

1140

CANARIUM INDICUM

A, H

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

1141

CANARIUM LUZONICUM

A, H

1142

CANDELILLA WAX

A, E, H

1143

CANDIDA ALBICANS

H

Only for use as an active homoeopathic ingredient.

1144

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%.

1145

CANINE MILK

H

Only for use as an active homoeopathic ingredient.

1146

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%.

1147

CANTHARIDES

H

Only available as an active homoeopathic ingredient.

1148

CANTHAXANTHIN

E

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

1149

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%.

1150

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%.

1151

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%.

1152

CAPRYLIC/CAPRIC/ISOSTEARIC/ADIPIC TRIGLYCERIDE

E

1153

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%

1154

CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

1155

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%.

1156

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%

1157

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%.

1158

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%

1159

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%.

1160

CAPSELLA BURSA-PASTORIS

A, H

1161

CAPSICUM

E, H

Only for use as an active homoeopathic or excipient ingredient.

1162

CAPSICUM ANNUUM

A, E, H

1163

CAPSICUM DRY

A, E, H

1164

CAPSICUM FRUIT OLEORESIN

A, E

1165

CAPSICUM FRUTESCENS

A, E, H

1166

CAPSICUM POWDER

A, E, H

1167

CARALLUMA ADSCENDENS VAR. FIMBRIATA

A

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

1168

CARAMEL

E

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

1169

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%.

1170

CARAWAY DRY

A, H

1171

CARAWAY OIL

A, E, H

1172

CARAWAY POWDER

A, H

1173

CARBOMER 1342

E

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

1174

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.

1175

CARBOMER 934

E

Only for use in topical medicines for dermal application.

1176

CARBOMER 934P

E

Only for use in topical medicines for dermal application.

1177

CARBOMER 940

E

Only for use in topical medicines for dermal application.

1178

CARBOMER 941

E

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

1179

CARBOMER 954

E

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

1180

CARBOMER 980

E

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

1181

CARBOMER 981

E

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

1182

CARBOMER COPOLYMER (TYPE B)

E

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

1183

CARBOMER HOMOPOLYMER (TYPE B)

E

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

1184

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%.

1185

CARBON

E, H

Only for use as an active homoeopathic or excipient ingredient.

1186

CARBON BLACK

E

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

1187

CARBON DIOXIDE

E

1188

CARDAMOM FRUIT DRY

A, H

1189

CARDAMOM FRUIT POWDER

A, E, H

1190

CARDAMOM OIL

A, E, H

1191

CARDIOSPERMUM HALICACABUM

A, H

1192

CARICA PAPAYA

A, E, H

1193

CARLINA ACAULIS

A, H

1194

CARMELLOSE

E

1195

CARMELLOSE CALCIUM

E

1196

CARMELLOSE SODIUM

E

1197

CARMINE

E

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

1198

CARMOISINE

E

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

1199

CARMOISINE ALUMINIUM LAKE

E

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

1200

CARNAUBA WAX

A, E, H

1201

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%.

1202

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%.

1203

CAROB GUM

E

1204

CAROB POD

E

1205

CAROTENES

E

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

1206

CARPINUS BETULUS

A, H

1207

CARPINUS CORDATA

A, H

1208

CARRAGEENAN

E

1209

CARROT

E

1210

CARROT SEED OIL

A, E, H

1211

CARTHAMUS TINCTORIUS

A, E, H

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

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

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

1212

CARUM CARVI

A, H

1213

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%.

1214

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%.

1215

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%.

1216

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%.

1217

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%.

1218

CARYA ILLINOINENSIS

A, H

1219

CARYA OVATA

A, H

1220

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%.

1221

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’.

1222

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’.

1223

CASCARILLA OIL

A, E, H

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

When for use as an excipient ingredient, cascarilla oil must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing cascarilla oil must not be more than 5% of the total medicine.

1224

CASEIN