Permissible ingredients and requirements

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Item

Ingredient Name

Purpose

Specific requirements

754

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).'

755

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).

756

BACOPA MONNIERI

A, H

757

BALLOTA NIGRA

A, H

758

BALM OF GILEAD BUD DRY

A, H

759

BALM OF GILEAD BUD POWDER

A, H

760

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%.

761

BAMBUSA BREVIFLORA

A, E, H

762

BAMBUSA TEXTILIS

A, H

763

BANANA

E

764

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%.

765

BAPTISIA CONFUSA

A, H

766

BAPTISIA TINCTORIA

A, H

767

BARBAREA VULGARIS

A, H

768

BARIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

769

BARIUM CHLORIDE

H

Only for use as an active homoeopathic ingredient.

770

BARIUM SULFATE

E

Only for use in topical medicines for dermal application.

771

BARLEY

E

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

772

BARLEY BRAN

E

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

773

BARLEY GERM

E

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

774

BARLEY LEAF

E

775

BASIC BUTYLATED METHACRYLATE COPOLYMER

E

Only for use in oral medicines.

776

BASIC FUCHSIN

E

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

777

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%.

778

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%.

779

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).

780

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).

781

BASSIA SCOPARIA

A, H

782

BATYL ALCOHOL

E

Only for use in topical medicines for dermal application.

783

BAY LEAF

E

784

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.

785

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%.

786

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’

787

BEET RED

E

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

788

BEETROOT

E, H

789

BEGONIA FIMBRISTIPULA

A, H

790

BEHENETH-10

E

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

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

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

791

BEHENIC ACID

E

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

792

BEHENOXY DIMETHICONE

E

Only for use in topical medicines for dermal application.

793

BEHENOYL STEARIC ACID

E

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

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

794

BEHENYL ALCOHOL

E

Only for use in topical medicines for dermal application.

795

BELLADONNA HERB DRY

A, H

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

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

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

796

BELLADONNA HERB POWDER

A, H

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

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

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

797

BELLADONNA HERB PREPARED

A, H

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

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

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

798

BELLIS PERENNIS

A, H

799

BEMOTRIZINOL

A

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

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

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

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

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

800

BENINCASA HISPIDA

A, E, H

801

BENTONITE

E

802

BENZALDEHYDE

E

803

BENZALDEHYDE GLYCERYL ACETAL

E

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

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

804

BENZALKONIUM CHLORIDE

E

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

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).

805

BENZETHONIUM CHLORIDE

E

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

806

BENZOIC ACID

E, H

807

BENZOIN

E

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

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

808

BENZOIN SIAM

A, E, H

809

BENZOIN SUMATRA

A, E, H

810

BENZOPHENONE

E

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

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

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

811

BENZOTHIAZOLE

E

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

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

812

BENZYL ACETATE

E

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

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

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

813

BENZYL ACETONE

E

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

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

814

BENZYL ALCOHOL

A, E

When used as an active ingredient:

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

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

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

815

BENZYL BENZOATE

E

Only for use in topical medicines for dermal application.

816

BENZYL BUTYRATE

E

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

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

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

817

BENZYL CINNAMATE

E

Only for use in:

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

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

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

818

BENZYL DIMETHYL CARBINYL-N-BUTYRATE

E

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

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

819

BENZYL FORMATE

E

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

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

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

820

BENZYL ISOAMYL ETHER

E

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

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

821

BENZYL ISOBUTYRATE

E

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

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

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

822

BENZYL ISOVALERATE

E

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

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

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

823

BENZYL LAURATE

E

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

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

824

BENZYL PHENYLACETATE

E

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

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

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

825

BENZYL PROPIONATE

E

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

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

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

826

BENZYL SALICYLATE

E

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

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

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

827

BENZYL TIGLATE

E

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

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

828

BENZYLIDENE ACETONE

E

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

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

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

829

BENZYLIDENE CAMPHOR SULFONIC ACID

A

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

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

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

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

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

830

BERBERIS AQUIFOLIUM

A, H

831

BERBERIS ARISTATA

A

Only for use in oral medicines.

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

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

832

BERBERIS VULGARIS

A, E, H

833

BERGAMOT OIL

E

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

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

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

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

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

834

BERGAMOT OIL BERGAPTEN-FREE

E

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

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

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

835

BERGAMOT OIL COLDPRESSED

A, E, H

When for internal use oxedrine is a mandatory component of bergamot oil coldpressed.

The maximum recommended daily dose must provide no more than 30 milligrams of oxedrine.

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

a) for internal use; or

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

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

836

BERGAMOT OIL TERPENELESS

E

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

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

837

BERTHOLLETIA EXCELSA

A, E, H

838

BETA RAPA

A, E, H

839

BETA VULGARIS

A, E, H

840

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

E

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

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

841

BETA-CARYOPHYLLENE

E

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

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

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

842

BETA-CARYOPHYLLENE ALCOHOL

E

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

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

843

BETA-DAMASCENONE

E

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

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

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

844

BETA-DAMASCONE

E

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

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

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

845

BETA-HOMO CYCLOCITRAL

E

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

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

846

BETA-HYDROXY-BETA-METHYLBUTYRIC ACID

A

847

BETA-IONONE

E

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

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

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

848

BETA-IONONE EPOXIDE

E

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

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

849

BETA-ISO-METHYL IONONE

E

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

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

850

BETA-METHYL NAPHTHYL KETONE

E

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

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

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

851

BETA-N-METHYL IONONE

E

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

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

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

852

BETA-NAPHTHOL ETHYLETHER

E

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

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

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

853

BETA-NAPHTHOL METHYL ETHER

E

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

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

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

854

BETA-NAPHTHYL ANTHRANILATE

E

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

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

855

BETA-NAPHTHYL ISOBUTYL ETHER

E

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

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

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

856

BETA-PINENE

E

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

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

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

857

BETA-TOCOPHEROL

E

858

BETACAROTENE

A, E

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

- (VITA3) ‘The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.’

859

BETADEX

E

860

BETAGLUCAN

E

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

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

861

BETAINE

E

Only for use in topical medicines for dermal application.

862

BETAINE HYDROCHLORIDE

E

863

BETULA LENTA

A, H

Methyl salicylate is a mandatory component of Betula lenta.

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

When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%.

When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging.

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

- the delivery device is engaged into the container in such a way that prevents it from being readily removed;

- direct suction through the delivery device results in delivery of no more than one dosage unit; and

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

The following warning statement is required on the medicine label:

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

When for use in topical medicines for dermal application:

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

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

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

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

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

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

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

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

864

BETULA NIGRA

A, H

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

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

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

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

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

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

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

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

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

- (NTAKEN) 'Not to be taken'.

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

When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%.

When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging.

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

- the delivery device is engaged into the container in such a way that prevents it from being readily removed;

- direct suction through the delivery device results in delivery of no more than one dosage unit; and

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

The following warning statement is required on the medicine label:

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

When for use in topical medicines for dermal application:

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

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

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

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

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

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

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

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

865

BETULA PENDULA

A, E, H

Methyl salicylate is a mandatory component of Betula pendula.

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

When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%.

When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging.

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

- the delivery device is engaged into the container in such a way that prevents it from being readily removed;

- direct suction through the delivery device results in delivery of no more than one dosage unit; and

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

The following warning statement is required on the medicine label:

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

When for use in topical medicines for dermal application:

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

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

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

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

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

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

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

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

866

BETULA PUBESCENS

A, E, H

867

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

E

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

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

868

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

E

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

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

869

BIFIDOBACTERIUM ADOLESCENTIS

A

870

BIFIDOBACTERIUM ANIMALIS

A

871

BIFIDOBACTERIUM ANIMALIS SSP ANIMALIS

A

872

BIFIDOBACTERIUM ANIMALIS SSP LACTIS

A

873

BIFIDOBACTERIUM BIFIDUM

A

874

BIFIDOBACTERIUM BREVE

A

875

BIFIDOBACTERIUM INFANTIS

A

876

BIFIDOBACTERIUM LACTIS

A

877

BIFIDOBACTERIUM LONGUM

A

878

BILBERRY

E

879

BIOSACCHARIDE GUM-1

E

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

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

880

BIOTA ORIENTALIS

A, H

881

BIOTIN

A, E

882

BIRCH LEAF DRY

A, E, H

Methyl salicylate is a mandatory component of birch leaf dry.

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

When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%.

When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging.

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

- the delivery device is engaged into the container in such a way that prevents it from being readily removed;

- direct suction through the delivery device results in delivery of no more than one dosage unit; and

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

The following warning statement is required on the medicine label:

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

When for use in topical medicines for dermal application:

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

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

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

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

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

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

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

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

883

BIRCH TAR OIL RECTIFIED

A, E, H

Cresol is a mandatory component of birch tar oil rectified.

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

884

BIS-BUTYLDIMETICONE POLYGLYCERYL-3

E

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

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

885

BIS-DIGLYCERYL POLYACYLADIPATE-2

E

Only for use in topical medicines for dermal application.

886

BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE

E

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

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

887

BIS-MACROGOL 900 METHYL ETHER DIMETHYL SILANE

E

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

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

888

BIS-PEG-12 DIMETHICONE BEESWAX

E

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

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

889

BIS-STEARYL DIMETICONE

E

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

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

890

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

E

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

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

891

BISABOLENE

E

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

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

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

892

BISABOLOL

E

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

893

BITTER ALMOND OIL

E

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

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

The absence of amygdalin in the medicine must be declared.

894

BITTERN

A, E, H

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.

895

BIXA ORELLANA

A, E, H

896

BLACK BONED CHICKEN POWDER

A

897

BLACK COHOSH DRY

A, H

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

- (BCOHOSH) 'Warning: In very rare cases - black cohosh has been associated with liver failure. If you are experiencing yellowing of the skin or whites of the eyes - dark urine - nausea - vomiting - unusual tiredness - weakness - stomach or abdominal pain - and/or loss of appetite - you should stop using this product and see your doctor.'

898

BLACK COHOSH POWDER

A, H

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

- (BCOHOSH) 'Warning: In very rare cases - black cohosh has been associated with liver failure. If you are experiencing yellowing of the skin or whites of the eyes - dark urine - nausea - vomiting - unusual tiredness - weakness - stomach or abdominal pain - and/or loss of appetite - you should stop using this product and see your doctor.'

899

BLACK CURRANT

E

900

BLACK CURRANT ABSOLUTE

E

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

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

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

901

BLACK CURRANT FRESH

A, E, H

902

BLACK CURRANT SEED OIL

E

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

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

903

BLACK OF CURACAO SPIDER

H

Only for use as an active homoeopathic ingredient.

904

BLACK PEPPER OIL

A, E, H

905

BLACK RASPBERRY

E

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

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

906

BLACK SNAKE

H

Only for use as an active homoeopathic ingredient.

907

BLACKBERRY

E

908

BLACKBERRY OILS

E

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

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

909

BLACKBERRY WINE

E

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

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

910

BLACKCURRANT ESTERS

E

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

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

911

BLACKCURRANT JUICE

E

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

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

912

BLACKSTRAP MOLASSES

E

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

913

BLADDERWRACK DRY

A, H

Iodine is a mandatory component of Bladderwrack dry.

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

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

914

BLADDERWRACK POWDER

A, H

Iodine is a mandatory component of Bladderwrack powder.

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

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

915

BLAINVILLEA ACMELLA

A, E, H

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

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

916

BLETILLA STRIATA

A, H

917

BLUE FLAG RHIZOME DRY

A, H

918

BLUE FLAG RHIZOME POWDER

A, H

919

BLUEBERRY

E

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

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

920

BLUEBERRY JUICE

E

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

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

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

921

BLUMEA LACERA

A, H

922

BOEHMERIA NIVEA

A, H

923

BOERHAVIA DIFFUSA

A, H

924

BOERHAVIA REPENS

A, H

925

BOGBEAN LEAF DRY

A, H

926

BOGBEAN LEAF POWDER

A, H

927

BOIS DE ROSE OIL

A, E, H

928

BOMBAX CEIBA

A, H

929

BORAGO OFFICINALIS

A, E, H

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

930

BORAX

A, E, H

Boron is a mandatory component of borax.

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

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

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

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

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

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

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

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

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

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

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

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

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

931

BORAX PENTAHYDRATE

A, E

Boron is a mandatory component of borax pentahydrate.

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

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

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

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

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

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

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

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

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

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

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

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

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

932

BORIC ACID

A, H

Boron is a mandatory component of boric acid.

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

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

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

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

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

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

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

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

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

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

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

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

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

933

BORNEOL

E

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

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

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

934

BORNYL ACETATE

E

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

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

935

BORON NITRIDE

E

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

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

936

BORONIA ABSOLUTE

E

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

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

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

937

BORONIA MEGASTIGMA

E

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

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

938

BOSWELLIA CARTERII

A, E, H

939

BOSWELLIA SERRATA

A, E, H

940

BOSWELLIA THURIFERA

A, H

941

BOVINE CALCIUM CHONDROITIN SULFATE

A

942

BOVINE CHONDROITIN SULFATE

A

943

BOVINE COLOSTRUM POWDER

A

The following warning statement is required on the medicine label:

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

944

BOVINE LACTOFERRIN

A

945

BOVINE POTASSIUM CHONDROITIN SULFATE

A

946

BOVINE SODIUM CHONDROITIN SULFATE

A, E

When used as an excipient:

- only for use in topical medicines for dermal application;

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

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

947

BOVINE WHEY IG-RICH FRACTION

A

Only for use in oral medicines.

The following warning statement is required on the medicine label:

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

948

BRANDY

E

949

BRASSICA CAMPESTRIS/ALEURITES FORDI OIL COPOLYMER

E

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

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

950

BRASSICA CHINENSIS

A, H

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

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

951

BRASSICA JUNCEA

A, H

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

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

952

BRASSICA NAPUS

A, E, H

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

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

953

BRASSICA NIGRA

A, H

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

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

954

BRASSICA OLERACEA VAR. BOTRYTIS

A, E, H

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

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

955

BRASSICA OLERACEA VAR. CAPITATA

A, E, H

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

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

956

BRASSICA OLERACEA VAR. GEMMIFERA

A, H

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

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

957

BRASSICA OLERACEA VAR. ITALICA

A, H

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

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

958

BRASSICA OLERACEA VAR. VIRIDIS

A, H

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

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

959

BRASSICA PEKINENSIS

A, H

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

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

960

BRASSICA RAPA

A, E, H

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

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

961

BRAZIL NUT

E

962

BRILLIANT BLACK BN

E

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

963

BRILLIANT BLUE FCF

E

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

964

BRILLIANT BLUE FCF ALUMINIUM LAKE

E

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

965

BRILLIANT BLUE FCF BARIUM LAKE

E

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

966

BRILLIANT SCARLET 4R

E

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

967

BRILLIANT SCARLET 4R ALUMINIUM LAKE

E

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

968

BRIZA MEDIA

A, H

969

BROCCOLI

E

970

BROMELAINS

A

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

971

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%.

972

BROMUS CATHARTICUS

A, H

973

BROMUS INERMIS

A, H

974

BROMUS RAMOSUS SUBSP. RAMOSUS

A, H

975

BRONOPOL

E

Only for use in topical medicines for dermal application.

976

BROUSSONETIA PAPYRIFERA

A, H

977

BROWN FK

E

Permitted for use only as a colour for topical use.

978

BRUNFELSIA UNIFLORA

A, H

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

979

BRUSSEL SPROUT

E

980

BRYONIA ALBA

A, H

981

BRYONIA DIOICA

A, H

982

BUCHU LEAF DRY

A, H

983

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%.

984

BUCHU LEAF POWDER

A, E, H

985

BUCKWHEAT

E, H

Only for use as an active homoeopathic or excipient ingredient.

986

BUDDLEJA OFFICINALIS

A, H

987

BULNESIA SARMIENTI

A, E, H

988

BUNIAS ORIENTALIS

A, H

989

BUPLEURUM FALCATUM

A, H

990

BURDOCK LEAF DRY

A, H

991

BURDOCK LEAF POWDER

A, H

992

BURDOCK ROOT DRY

A, H

993

BURDOCK ROOT POWDER

A, H

994

BUSHMASTER SNAKE

H

Only for use as an active homoeopathic ingredient.

995

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%.

996

BUTANE

E

Only for use as an excipient propellant ingredient.

997

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%.

998

BUTTER

E

999

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%.

1000

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%.

1001

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%.

1002

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%.

1003

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%.

1004

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%.

1005

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%.

1006

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%.

1007

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).

1008

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%.

1009

BUTYL HYDROXYBENZOATE

E

Only for use in topical medicines for dermal application.

1010

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%.

1011

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%.

1012

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%.

1013

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%.

1014

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).

1015

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%.

1016

BUTYL STEARATE

E

Only for use in topical medicines for dermal application.

1017

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%.

1018

BUTYLATED HYDROXYANISOLE

E

1019

BUTYLATED HYDROXYTOLUENE

E

1020

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%.

1021

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%.

1022

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%.

1023

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%.

1024

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%.

1025

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%.

1026

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%.

1027

C10-12 ALKANE/CYCLOALKANE

E

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

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

1028

C10-30 CHOLESTEROL/LANOSTEROL ESTERS

E

Only for use in topical medicines for dermal application.

1029

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%.

1030

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%.

1031

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.

1032

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.

1033

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%.

1034

C12-15 ALKYL OCTANOATE

E

Only for use in topical medicines for dermal application.

1035

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%.

1036

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%.

1037

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%.

1038

C13-14 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

1039

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%.

1040

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%.

1041

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%.

1042

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%.

1043

C18-36 ACID GLYCOL ESTER

E

Only for use topical medicines for dermal application.

1044

C18-36 ACID TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

1045

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%.

1046

C20-40 ALCOHOLS

E

Only for use in topical medicines for dermal application.

1047

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%.

1048

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%.

1049

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%.

1050

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%.

1051

C9-11 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

1052

C9-11 PARETH-3

E

Only for use in topical medicines for dermal application.

1053

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%

1054

CABBAGE

E

1055

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%.

1056

CADE OIL

A, E, H

1057

CAESALPINIA SAPPAN

A, H

1058

CAFFEINE

A, E

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

Only for use as an active ingredient for oral use in adults when the medicine consists principally of one or more designated active ingredients prescribed in Schedule 14 to the Regulations (other than caffeine).

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

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

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

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

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

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

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

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

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

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

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

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

1059

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'.

1060

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.

1061

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'.

1062

CALCIFEDIOL MONOHYDRATE

A

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

Only for use in oral medicines.

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

The medicine requires the following warning statements on the label:

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

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

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

1063

CALCIFIED LITHOTHAMNION SPECIES

A

Only for use in oral medicines.

1064

CALCIFIED LITHOTHAMNION TOPHIFORME

A

Only for oral use.

1065

CALCIUM ALGINATE

E

1066

CALCIUM AMINO ACID CHELATE

A, H

Calcium is a mandatory component of calcium amino acid chelate.

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

1067

CALCIUM ASCORBATE

A, E, H

1068

CALCIUM ASCORBATE DIHYDRATE

A, E, H

1069

CALCIUM ASPARTATE

A

1070

CALCIUM ASPARTATE HYDROCHLORIDE DIHYDRATE

A

Only for use in oral medicines.

1071

CALCIUM BEHENATE

E

Behenic acid is a mandatory component of Calcium behenate.

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

1072

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE

A, H

1073

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE

A, H

1074

CALCIUM CARBONATE

A, E, H

1075

CALCIUM CASEINATE

E

1076

CALCIUM CHLORIDE DIHYDRATE

E

1077

CALCIUM CITRATE

A, E, H

1078

CALCIUM CITRATE TETRAHYDRATE

A, E, H

1079

CALCIUM DIASPARTATE

A

Only for use in oral medicines.

1080

CALCIUM FLUORIDE

H

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

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

1081

CALCIUM FOLINATE

A

Folinic acid is a mandatory component of calcium folinate.

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

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

1082

CALCIUM GLUCONATE MONOHYDRATE

A, E, H

1083

CALCIUM GLYCEROPHOSPHATE

A, E, H

1084

CALCIUM GLYCINATE

A

Only for use in oral medicines.

1085

CALCIUM GLYCINATE DIHYDRATE

A

1086

CALCIUM HEXAFLUOROSILICATE

H

Only for use as an active homoeopathic ingredient.

1087

CALCIUM HYDROGEN PHOSPHATE

A, E, H

1088

CALCIUM HYDROGEN PHOSPHATE DIHYDRATE

A, E, H

1089

CALCIUM HYDROGEN PHOSPHATE MONOHYDRATE

A, E, H

1090

CALCIUM HYDROXIDE

A, E, H

When used as a standard active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia as in force or existing from time to time.

1091

CALCIUM HYDROXYCITRATE

A, H

1092

CALCIUM HYPOPHOSPHITE

H

Only for use as an active homoeopathic ingredient.

1093

CALCIUM IODIDE

H

Only for use as an active homoeopathic ingredient.

1094

CALCIUM KETOGLUCONATE

E

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

The concentration must be no more than 1%

1095

CALCIUM L-THREONATE

A

Only for use in oral medicines.

1096

CALCIUM LACTATE

A, E, H

1097

CALCIUM LACTATE GLUCONATE

A, E, H

1098

CALCIUM LACTATE PENTAHYDRATE

A, E, H

1099

CALCIUM LACTATE TRIHYDRATE

A, E, H

1100

CALCIUM LYSINATE

A

Only for use in oral medicines.

1101

CALCIUM METHIONINATE

A

Only for use in oral medicines.

1102

CALCIUM OROTATE

A, E, H

1103

CALCIUM OXIDE

E

Only for use in topical medicines for dermal application.

1104

CALCIUM PANTOTHENATE

A, E, H

1105

CALCIUM PHOSPHATE

A, E, H

1106

CALCIUM PYRUVATE

A

1107

CALCIUM SACCHARATE

E

1108

CALCIUM SILICATE

E

1109

CALCIUM SODIUM CASEINATE

A, H

1110

CALCIUM SODIUM LACTATE

A, E, H

1111

CALCIUM STEARATE

E

1112

CALCIUM SUCCINATE

A, E, H

1113

CALCIUM SULFATE

A, E, H

1114

CALCIUM SULFATE DIHYDRATE

A, E, H

1115

CALCIUM SULFIDE

H

Only for use as an active homoeopathic ingredient.

1116

CALCIUM THREONINATE

A

1117

CALENDULA FLOWER DRY

A, E, H

1118

CALENDULA FLOWER POWDER

A, H

1119

CALENDULA OFFICINALIS

A, E, H

1120

CALLERYA RETICULATA

A, H

1121

CALLICARPA PEDUNCULATA

A, H

1122

CALLISTEPHUS CHINENSIS

A, H

1123

CALLITRIS COLUMELLARIS

E

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

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

1124

CALLITRIS COLUMELLARIS SUBSP. INTRATROPICA

E

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

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

1125

CALLITRIS RHOMBOIDEA

A, H

1126

CALLUNA VULGARIS

A, E, H

1127

CALOCHORTUS TOLMIEI

A, H

1128

CALTHA PALUSTRIS

A, H

1129

CALUMBA ROOT DRY

A, H

1130

CALUMBA ROOT POWDER

A, H

1131

CALVATIA GIGANTEA

A, E, H

1132

CALYCANTHUS FLORIDUS

A, H

1133

CALYCANTHUS PRAECOX

A, H

1134

CAMELLIA JAPONICA

A, H

1135

CAMELLIA OLEIFERA

A, E, H

If Camellia oleifera (seed oil) is used as a solvent, it is restricted to topical or sunscreen preparations for dermal application only.

1136

CAMELLIA SINENSIS

A, E, H

Caffeine is a mandatory component of Camellia sinensis.

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

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

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

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

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

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

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

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

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

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

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

1137

CAMPHENE

E

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

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

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

1138

CAMPHOLENIC ALDEHYDE

E

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

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

1139

CAMPHOR

A, E, H

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

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

1140

CAMPHOR BENZALKONIUM METHOSULFATE

A

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

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

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

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

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

1141

CAMPHOR OIL BROWN

A, H

camphor, cineole and safrole are mandatory components of camphor oil brown.

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

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

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

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

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

1142

CAMPHOR OIL WHITE

A, E, H

Camphor and safrole are mandatory components of camphor oil white.

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

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

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

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

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

1143

CAMPSIS GRANDIFLORA

A, H

1144

CANADA BALSAM

A, H

1145

CANANGA ODORATA

A, E, H

1146

CANANGA OIL

A, E, H

1147

CANARIUM INDICUM

A, H

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

1148

CANARIUM LUZONICUM

A, H

1149

CANDELILLA WAX

A, E, H

1150

CANDIDA ALBICANS

H

Only for use as an active homoeopathic ingredient.

1151

CANDIDA UTILIS

A, E, H

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

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

1152

CANINE MILK

H

Only for use as an active homoeopathic ingredient.

1153

CANOLA OIL

A, E, H

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

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

1154

CANTHARIDES

H

Only available as an active homoeopathic ingredient.

1155

CANTHAXANTHIN

E

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

1156

CAPRIC ACID

E

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

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

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

1157

CAPROIC ALDEHYDE

E

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

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

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

1158

CAPRYLIC ALDEHYDE

E

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

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

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

1159

CAPRYLIC/CAPRIC/ISOSTEARIC/ADIPIC TRIGLYCERIDE

E

1160

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%

1161

CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

1162

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%.

1163

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%

1164

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%.

1165

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%

1166

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%.

1167

CAPSELLA BURSA-PASTORIS

A, H

1168

CAPSICUM

E, H

Only for use as an active homoeopathic or excipient ingredient.

1169

CAPSICUM ANNUUM

A, E, H

1170

CAPSICUM DRY

A, E, H

1171

CAPSICUM FRUIT OLEORESIN

A, E

1172

CAPSICUM FRUTESCENS

A, E, H

1173

CAPSICUM POWDER

A, E, H

1174

CARALLUMA ADSCENDENS VAR. FIMBRIATA

A

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

1175

CARAMEL

E

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

1176

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%.

1177

CARAWAY DRY

A, H

1178

CARAWAY OIL

A, E, H

1179

CARAWAY POWDER

A, H

1180

CARBOMER 1342

E

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

1181

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.

1182

CARBOMER 934

E

Only for use in topical medicines for dermal application.

1183

CARBOMER 934P

E

Only for use in topical medicines for dermal application.

1184

CARBOMER 940

E

Only for use in topical medicines for dermal application.

1185

CARBOMER 941

E

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

1186

CARBOMER 954

E

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

1187

CARBOMER 980

E

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

1188

CARBOMER 981

E

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

1189

CARBOMER COPOLYMER (TYPE B)

E

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

1190

CARBOMER HOMOPOLYMER (TYPE B)

E

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

1191

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%.

1192

CARBON

E, H

Only for use as an active homoeopathic or excipient ingredient.

1193

CARBON BLACK

E

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

1194

CARBON DIOXIDE

E

1195

CARDAMOM FRUIT DRY

A, H

1196

CARDAMOM FRUIT POWDER

A, E, H

1197

CARDAMOM OIL

A, E, H

1198

CARDIOSPERMUM HALICACABUM

A, H

1199

CARICA PAPAYA

A, E, H

1200

CARLINA ACAULIS

A, H

1201

CARMELLOSE

E

1202

CARMELLOSE CALCIUM

E

1203

CARMELLOSE SODIUM

E

1204

CARMINE

E

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

1205

CARMOISINE

E

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

1206

CARMOISINE ALUMINIUM LAKE

E

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

1207

CARNAUBA WAX

A, E, H

1208

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%.

1209

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%.

1210

CAROB GUM

E

1211

CAROB POD

E

1212

CAROTENES

E

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

1213

CARPINUS BETULUS

A, H

1214

CARPINUS CORDATA

A, H

1215

CARRAGEENAN

E

1216

CARROT

E

1217

CARROT SEED OIL

A, E, H

1218

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).

1219

CARUM CARVI

A, H

1220

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%.

1221

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%.

1222

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%.

1223

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%.

1224

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%.

1225

CARYA ILLINOINENSIS

A, H

1226

CARYA OVATA

A, H

1227

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%.

1228

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’.

1229

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’.

1230

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.

1231

CASEIN

E

1232

CASHEW NUT

E

1233

CASSIA ALATA LEAF EXTRACT

E

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