730

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).

731

BACOPA MONNIERI

A, H

732

BALLOTA NIGRA

A, H

733

BALM OF GILEAD BUD DRY

A, H

734

BALM OF GILEAD BUD POWDER

A, H

735

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%.

736

BAMBUSA BREVIFLORA

A, E, H

737

BAMBUSA TEXTILIS

A, H

738

BANANA

E

739

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%.

740

BAPTISIA CONFUSA

A, H

741

BAPTISIA TINCTORIA

A, H

742

BARBAREA VULGARIS

A, H

743

BARIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

744

BARIUM CHLORIDE

H

Only for use as an active homoeopathic ingredient.

745

BARIUM SULFATE

E

Only for use in topical medicines for dermal application.

746

BARLEY

E

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

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.

747

BARLEY BRAN

E

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

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.

748

BARLEY GERM

E

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

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.

749

BARLEY LEAF

E

750

BASIC BUTYLATED METHACRYLATE COPOLYMER

E

Only for use in oral medicines.

751

BASIC FUCHSIN

E

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

752

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%.

753

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%.

754

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).

755

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).

756

BASSIA SCOPARIA

A, H

757

BATYL ALCOHOL

E

Only for use in topical medicines for dermal application.

758

BAY LEAF

E

759

BAY OIL

A, E, H

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

When the concentration of Bay oil in the medicine is more than 25% and the nominal capacity of the container is no more than 15 mL, there must be a restricted flow insert fitted on the container.

When the concentration of Bay oil in the medicine is more than 25% and the nominal capacity of the container is more than 15 mL, a child resistant closure and restricted flow insert must be fitted on the container.

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

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

- (NTAKEN) 'Not to be taken'

760

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%.

761

BEET RED

E

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

762

BEETROOT

E, H

763

BEGONIA FIMBRISTIPULA

A, H

764

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.

765

BEHENIC ACID

E

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

766

BEHENOXY DIMETHICONE

E

Only for use in topical medicines for dermal application.

767

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%.

768

BEHENYL ALCOHOL

E

Only for use in topical medicines for dermal application.

769

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%.

770

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%.

771

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%.

772

BELLIS PERENNIS

A, H

773

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 be no more than 10%.

When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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).

When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019:

- (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).

774

BENINCASA HISPIDA

A, E, H

775

BENTONITE

E

776

BENZALDEHYDE

E

777

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%.

778

BENZALKONIUM CHLORIDE

E

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

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

779

BENZETHONIUM CHLORIDE

E

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

780

BENZOIC ACID

E, H

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

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

781

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%.

782

BENZOIN SIAM

A, E, H

783

BENZOIN SUMATRA

A, E, H

784

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%.

785

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%.

786

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%.

787

BENZYL ALCOHOL

E

788

BENZYL BENZOATE

E

Only for use in topical medicines for dermal application.

Medicines containing benzoates require the warning statement:

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

789

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%.

790

BENZYL CINNAMATE

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 0.15%.

791

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%.

792

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%.

793

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%.

794

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%.

795

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%.

796

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%.

797

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%.

798

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%.

799

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%.

800

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%.

801

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%.

802

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 be no more than 6% (as acid).

When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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).

When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019:

- (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).

803

BERBERIS AQUIFOLIUM

A, H

804

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).

805

BERBERIS VULGARIS

A, E, H

806

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)

807

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%.

808

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.

809

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%.

810

BERTHOLLETIA EXCELSA

A, E, H

811

BETA RAPA

A, E, H

812

BETA VULGARIS

A, E, H

813

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%.

814

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%.

815

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%.

816

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%.

817

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%.

818

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%.

819

BETA-HYDROXY-BETA-METHYLBUTYRIC ACID

A

820

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%.

821

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%.

822

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%.

823

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%.

824

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%.

825

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%.

826

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%.

827

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%.

828

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%.

829

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%.

830

BETA-TOCOPHEROL

E

831

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.’

832

BETADEX

E

833

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%.

834

BETAINE

E

Only for use in topical medicines for dermal application.

835

BETAINE HYDROCHLORIDE

E

836

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

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

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

837

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

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

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

838

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.

In addition, when the ingredient is included in a medicine that is listed in the Register:

- on or after 1 July 2018, the medicine must comply with all requirements under (a) & (b);

- before 1 July 2018 and supplied on or after 1 January 2020, the medicine must comply with all requirements under (a) & (b); or

- before 1 July 2018 and supplied before 1 January 2020, the medicine may comply with the requirements under (a) & (b).

a) The following warning statement is required on the medicine label:

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

b) When for use in topical medicines for dermal application, the concentration of methyl salicylate in the medicine must not be more than 25% and 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);

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

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

839

BETULA PUBESCENS

A, E, H

840

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%.

841

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%.

842

BIFIDOBACTERIUM ADOLESCENTIS

A

843

BIFIDOBACTERIUM ANIMALIS

A

844

BIFIDOBACTERIUM ANIMALIS SSP ANIMALIS

A

845

BIFIDOBACTERIUM ANIMALIS SSP LACTIS

A

846

BIFIDOBACTERIUM BIFIDUM

A

847

BIFIDOBACTERIUM BREVE

A

848

BIFIDOBACTERIUM INFANTIS

A

849

BIFIDOBACTERIUM LACTIS

A

850

BIFIDOBACTERIUM LONGUM

A

851

BILBERRY

E

852

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%.

853

BIOTA ORIENTALIS

A, H

854

BIOTIN

A, E

855

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.

In addition, when the ingredient is included in a medicine that is listed in the Register:

- on or after 1 July 2018, the medicine must comply with all requirements under (a) & (b);

- before 1 July 2018 and supplied on or after 1 January 2020, the medicine must comply with all requirements under (a) & (b); or

- before 1 July 2018 and supplied before 1 January 2020, the medicine may comply with the requirements under (a) & (b).

a) The following warning statement is required on the medicine label:

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

b) When for use in topical medicines for dermal application, the concentration of methyl salicylate in the medicine must not be more than 25% and 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);

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

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

856

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%.

857

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%.

858

BIS-DIGLYCERYL POLYACYLADIPATE-2

E

Only for use in topical medicines for dermal application.

859

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%.

860

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%.

861

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%.

862

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%.

863

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%.

864

BISABOLOL

E

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

865

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.

866

BIXA ORELLANA

A, E, H

867

BLACK BONED CHICKEN POWDER

A

868

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.'

869

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.'

870

BLACK CURRANT

E

871

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%.

872

BLACK CURRANT FRESH

A, E, H

873

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%.

874

BLACK OF CURACAO SPIDER

H

Only for use as an active homoeopathic ingredient.

875

BLACK PEPPER OIL

A, E, H

876

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%.

877

BLACK SNAKE

H

Only for use as an active homoeopathic ingredient.

878

BLACKBERRY

E

879

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%.

880

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%.

881

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%.

882

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%.

883

BLACKSTRAP MOLASSES

E

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

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

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

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

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

884

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.

885

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.

886

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%.

887

BLETILLA STRIATA

A, H

888

BLUE FLAG RHIZOME DRY

A, H

889

BLUE FLAG RHIZOME POWDER

A, H

890

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%.

891

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%.

892

BLUMEA LACERA

A, H

893

BOEHMERIA NIVEA

A, H

894

BOERHAVIA DIFFUSA

A, H

895

BOERHAVIA REPENS

A, H

896

BOGBEAN LEAF DRY

A, H

897

BOGBEAN LEAF POWDER

A, H

898

BOIS DE ROSE OIL

A, E, H

899

BOMBAX CEIBA

A, H

900

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.

901

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 provide no 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%.

902

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 provide no 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 be no more than 3500 mg/kg or 3500 g/L or 0.35%.

903

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 provide no 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%.

904

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%.

905

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%.

906

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%.

907

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%.

908

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%.

909

BOSWELLIA CARTERII

A, E, H

910

BOSWELLIA SERRATA

A, E, H

911

BOSWELLIA THURIFERA

A, H

912

BOVINE CALCIUM CHONDROITIN SULFATE

A

913

BOVINE CHONDROITIN SULFATE

A

914

BOVINE COLOSTRUM POWDER

A

The medicine requires the warning statement:

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

915

BOVINE LACTOFERRIN

A

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

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

916

BOVINE POTASSIUM CHONDROITIN SULFATE

A

917

BOVINE SODIUM CHONDROITIN SULFATE

A

918

BOVINE WHEY IG-RICH FRACTION

A

Only for use in oral medicines.

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

- (COWMK) 'Derived from cows milk'

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

919

BRANDY

E

920

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%.

921

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%.

922

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%.

923

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%.

924

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%.

925

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%.

926

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%.

927

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%.

928

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%.

929

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%.

930

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%.

931

BRAZIL NUT

E

932

BRILLIANT BLACK BN

E

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

933

BRILLIANT BLUE FCF

E

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

934

BRILLIANT BLUE FCF ALUMINIUM LAKE

E

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

935

BRILLIANT BLUE FCF BARIUM LAKE

E

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

936

BRILLIANT SCARLET 4R

E

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

937

BRILLIANT SCARLET 4R ALUMINIUM LAKE

E

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

938

BRIZA MEDIA

A, H

939

BROCCOLI

E

940

BROMELAINS

A

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

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

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

941

BROMINE

H

Only for use as an active homoeopathic ingredient. The concentration of bromine in the preparation must be no more than 14mg/Kg or 14mg/L or 0.0014% for oral and sublingual use.

942

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%.

943

BROMUS CATHARTICUS

A, H

944

BROMUS INERMIS

A, H

945

BROMUS RAMOSUS SUBSP. RAMOSUS

A, H

946

BRONOPOL

E

Only for use in topical medicines for dermal application.

947

BROUSSONETIA PAPYRIFERA

A, H

948

BROWN FK

E

Permitted for use only as a colour for topical use.

949

BRUNFELSIA UNIFLORA

A, H

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

950

BRUSSEL SPROUT

E

951

BRYONIA ALBA

A, H

952

BRYONIA DIOICA

A, H

953

BUCHU LEAF DRY

A, H

954

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%.

955

BUCHU LEAF POWDER

A, E, H

956

BUCKWHEAT

E, H

Only for use as an active homoeopathic or excipient ingredient.

957

BUDDLEJA OFFICINALIS

A, H

958

BULNESIA SARMIENTI

A, E, H

959

BUNIAS ORIENTALIS

A, H

960

BUPLEURUM FALCATUM

A, H

961

BURDOCK LEAF DRY

A, H

962

BURDOCK LEAF POWDER

A, H

963

BURDOCK ROOT DRY

A, H

964

BURDOCK ROOT POWDER

A, H

965

BUSHMASTER SNAKE

H

Only for use as an active homoeopathic ingredient.

966

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%.

967

BUTANE

E

Only for use as an excipient propellant ingredient.

968

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%.

969

BUTTER

E

970

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%.

971

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%.

972

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%.

973

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%.

974

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%.

975

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%.

976

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%.

977

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%.

978

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).

979

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%.

980

BUTYL HYDROXYBENZOATE

E

Only for use in topical medicines for dermal application.

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

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

981

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%.

982

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%.

983

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%.

984

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%.

985

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 be no more than 5%.

When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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).

When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019:

- (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).

986

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%.

987

BUTYL STEARATE

E

Only for use in topical medicines for dermal application.

988

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%.

989

BUTYLATED HYDROXYANISOLE

E

990

BUTYLATED HYDROXYTOLUENE

E

991

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%.

992

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%.

993

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%.

994

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%.

995

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%.

996

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%.

997

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%.

998

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%.

999

C10-30 CHOLESTEROL/LANOSTEROL ESTERS

E

Only for use in topical medicines for dermal application.

1000

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%.

1001

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.

1002

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.

1003

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%.

1004

C12-15 ALKYL OCTANOATE

E

Only for use in topical medicines for dermal application.

1005

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%.

1006

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%.

1007

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%.

1008

C13-14 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

1009

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%.

1010

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%.

1011

C18-36 ACID GLYCOL ESTER

E

Only for use topical medicines for dermal application.

1012

C18-36 ACID TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

1013

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%.

1014

C20-40 ALCOHOLS

E

Only for use in topical medicines for dermal application.

1015

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%.

1016

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%.

1017

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%.

1018

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%.

1019

C9-11 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

1020

C9-11 PARETH-3

E

Only for use in topical medicines for dermal application.

1021

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%

1022

CABBAGE

E

1023

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%.

1024

CADE OIL

A, E, H

1025

CAESALPINIA SAPPAN

A, H

1026

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); and contains no more than 100 mg of caffeine per maximum daily dose.

Medicines for oral use containing caffeine as an active ingredient require the following warning statement on the medicine label:

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

When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of:

a)  more than 1 mg but no more than 10 mg of caffeine the medicine requires the following warning statement on the medicine label:

- (CAFFR) 'The recommended dose of this medicine provides small amounts of caffeine.'

b) more than 10 mg of caffeine the medicine requires the following warning statement on the medicine label:

- (CAFF) 'Contains caffeine [state quantity per dosage unit or per mL or per gram of product]'.

1027

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'.

1028

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.

1029

CALCIFIED LITHOTHAMNION SPECIES

A

Only for use in oral medicines.

1030

CALCIFIED LITHOTHAMNION TOPHIFORME

A

Only for oral use.

1031

CALCIUM ALGINATE

E

1032

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.

1033

CALCIUM ASCORBATE

A, E, H

1034

CALCIUM ASCORBATE DIHYDRATE

A, E, H

1035

CALCIUM ASPARTATE

A

1036

CALCIUM ASPARTATE HYDROCHLORIDE DIHYDRATE

A

Only for use in oral medicines.

1037

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.

1038

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE

A, H

1039

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE

A, H

1040

CALCIUM CARBONATE

A, E, H

1041

CALCIUM CASEINATE

E

1042

CALCIUM CHLORIDE DIHYDRATE

E

1043

CALCIUM CITRATE

A, E, H

1044

CALCIUM CITRATE TETRAHYDRATE

A, E, H

1045

CALCIUM DIASPARTATE

A

Only for use in oral medicines.

1046

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%.

1047

CALCIUM FOLINATE

A

Folinic acid is a mandatory component of calcium folinate.

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

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

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

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

1048

CALCIUM GLUCONATE MONOHYDRATE

A, E, H

1049

CALCIUM GLYCEROPHOSPHATE

A, E, H

1050

CALCIUM GLYCINATE

A

Only for use in oral medicines.

1051

CALCIUM GLYCINATE DIHYDRATE

A

1052

CALCIUM HEXAFLUOROSILICATE

H

Only for use as an active homoeopathic ingredient.

1053

CALCIUM HYDROGEN PHOSPHATE

A, E, H

1054

CALCIUM HYDROGEN PHOSPHATE DIHYDRATE

A, E, H

1055

CALCIUM HYDROGEN PHOSPHATE MONOHYDRATE

A, E, H

1056

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.

1057

CALCIUM HYDROXYCITRATE

A, H

1058

CALCIUM HYPOPHOSPHITE

H

Only for use as an active homoeopathic ingredient.

1059

CALCIUM IODIDE

H

Only for use as an active homoeopathic ingredient.

1060

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%

1061

CALCIUM L-THREONATE

A

Only for use in oral medicines.

1062

CALCIUM LACTATE

A, E, H

1063

CALCIUM LACTATE GLUCONATE

A, E, H

1064

CALCIUM LACTATE PENTAHYDRATE

A, E, H

1065

CALCIUM LACTATE TRIHYDRATE

A, E, H

1066

CALCIUM LYSINATE

A

Only for use in oral medicines.

1067

CALCIUM METHIONINATE

A

Only for use in oral medicines.

1068

CALCIUM OROTATE

A, E, H

1069

CALCIUM OXIDE

E

Only for use in topical medicines for dermal application.

1070

CALCIUM PANTOTHENATE

A, E, H

1071

CALCIUM PHOSPHATE

A, E, H

1072

CALCIUM PYRUVATE

A

1073

CALCIUM SACCHARATE

E

1074

CALCIUM SILICATE

E

1075

CALCIUM SODIUM CASEINATE

A, H

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

 - (COWMK) 'Derived from cow's milk'.

1076

CALCIUM SODIUM LACTATE

A, E, H

1077

CALCIUM STEARATE

E

1078

CALCIUM SUCCINATE

A, E, H

1079

CALCIUM SULFATE

A, E, H

1080

CALCIUM SULFATE DIHYDRATE

A, E, H

1081

CALCIUM SULFIDE

H

Only for use as an active homoeopathic ingredient.

1082

CALCIUM THREONINATE

A

1083

CALENDULA FLOWER DRY

A, E, H

1084

CALENDULA FLOWER POWDER

A, H

1085

CALENDULA OFFICINALIS

A, E, H

1086

CALLERYA RETICULATA

A, H

1087

CALLICARPA PEDUNCULATA

A, H

1088

CALLISTEMON CITRINUS

A, H

1089

CALLISTEPHUS CHINENSIS

A, H

1090

CALLITRIS 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%.

1091

CALLITRIS RHOMBOIDEA

A, H

1092

CALLUNA VULGARIS

A, E, H

1093

CALOCHORTUS TOLMIEI

A, H

1094

CALTHA PALUSTRIS

A, H

1095

CALUMBA ROOT DRY

A, H

1096

CALUMBA ROOT POWDER

A, H

1097

CALVATIA GIGANTEA

A, E, H

1098

CALYCANTHUS FLORIDUS

A, H

1099

CALYCANTHUS PRAECOX

A, H

1100

CAMELLIA JAPONICA

A, H

1101

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.

1102

CAMELLIA SINENSIS

A, E, H

Caffeine is a mandatory component of Camellia sinensis for oral use.

Medicines for oral or sublingual administration that contain caffeine as a component of a herbal substance and that provide a maximum recommended daily dose of:

a) more than 1 mg but no more than 10 mg of caffeine require the following warning statement on the medicine label:

- (CAFFR) 'The recommended dose of this medicine provides small amounts of caffeine.'

b) more than 10 mg of caffeine require the following warning statement on the medicine label:

- (CAFF) 'Contains caffeine [state quantity per dosage unit or per mL or per gram of product].'

Polyphenols calculated as gallic acid (of Camellia sinensis) is only permitted for use as a component when the plant part is leaf.

1103

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%.

1104

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%.

1105

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%.

1106

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 be no more than 6%.

When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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).

When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019:

- (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).

1107

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.

1108

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.

1109

CAMPSIS GRANDIFLORA

A, H

1110

CANADA BALSAM

A, H

1111

CANANGA ODORATA

A, E, H

1112

CANANGA OIL

A, E, H

1113

CANARIUM INDICUM

A, H

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

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

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

1114

CANARIUM LUZONICUM

A, H

1115

CANDELILLA WAX

A, E, H

1116

CANDIDA ALBICANS

H

Only for use as an active homoeopathic ingredient.

1117

CANDIDA UTILIS

A, H

1118

CANINE MILK

H

Only for use as an active homoeopathic ingredient.

1119

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%.

1120

CANTHARIDES

H

Only available as an active homoeopathic ingredient.

1121

CANTHAXANTHIN

E

Permitted as an excipient ingredient as a colour for oral and topical use.

1122

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%.

1123

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%.

1124

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%.

1125

CAPRYLIC/CAPRIC GLYCERIDES

E

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

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

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

1126

CAPRYLIC/CAPRIC/ISOSTEARIC/ADIPIC TRIGLYCERIDE

E

1127

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%

1128

CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

1129

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%

1130

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%.

1131

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%

1132

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%.

1133

CAPSELLA BURSA-PASTORIS

A, H

1134

CAPSICUM

E, H

Only for use as an active homoeopathic or excipient ingredient.

1135

CAPSICUM ANNUUM

A, E, H

1136

CAPSICUM DRY

A, E, H

1137

CAPSICUM FRUIT OLEORESIN

A, E

1138

CAPSICUM FRUTESCENS

A, E, H

1139

CAPSICUM POWDER

A, E, H

1140

CARALLUMA ADSCENDENS VAR. FIMBRIATA

A

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

1141

CARAMEL

E

Permitted as an excipient ingredient as a colour for oral and topical use.

1142

CARAPICHEA IPECACUANHA

A, H

Emetine is a mandatory component of Carapichea ipecacuanha.

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

Except when used in a medicine containing only homoeopathic preparations, a child resistant closure must be fitted onto the container.

1143

CARAWAY DRY

A, H

1144

CARAWAY OIL

A, E, H

1145

CARAWAY POWDER

A, H

1146

CARBOMER 1342

E

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

1147

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.

1148

CARBOMER 934

E

Only for use in topical medicines for dermal application.

1149

CARBOMER 934P

E

Only for use in topical medicines for dermal application.

1150

CARBOMER 940

E

Only for use in topical medicines for dermal application.

1151

CARBOMER 941

E

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

1152

CARBOMER 954

E

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

1153

CARBOMER 980

E

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

1154

CARBOMER 981

E

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

1155

CARBOMER COPOLYMER (TYPE B)

E

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

1156

CARBOMER HOMOPOLYMER (TYPE B)

E

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

1157

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%.

1158

CARBON

E, H

Only for use as an active homoeopathic or excipient ingredient.

1159

CARBON BLACK

E

Permitted as an excipient ingredient as a colour for oral and topical use.

1160

CARBON DIOXIDE

E

1161

CARDAMOM FRUIT DRY

A, H

1162

CARDAMOM FRUIT POWDER

A, E, H

1163

CARDAMOM OIL

A, E, H

1164

CARDIOSPERMUM HALICACABUM

A, H

1165

CARICA PAPAYA

A, E, H

1166

CARLINA ACAULIS

A, H

1167

CARMELLOSE

E

1168

CARMELLOSE CALCIUM

E

1169

CARMELLOSE SODIUM

E

1170

CARMINE

E

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

1171

CARMOISINE

E

Permitted as an excipient ingredient as a colour for oral and topical use.

1172

CARMOISINE ALUMINIUM LAKE

E

Permitted as an excipient ingredient as a colour for oral and topical use.

1173

CARNAUBA WAX

A, E, H

1174

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%.

1175

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%.

1176

CAROB GUM

E

1177

CAROB POD

E

1178

CAROTENES

E

Permitted as an excipient ingredient as a colour for oral and topical use.

1179

CARPINUS BETULUS

A, H

1180

CARPINUS CORDATA

A, H

1181

CARRAGEENAN

E

1182

CARROT

E

1183

CARROT SEED OIL

A, E, H

1184

CARTHAMUS TINCTORIUS

A, E, H

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

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

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

1185

CARUM CARVI

A, H

1186

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%.

1187

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%.

1188

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%.

1189

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%.

1190

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%.

1191

CARYA ILLINOINENSIS

A, H

1192

CARYA OVATA

A, H

1193

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%.

1194

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’.

1195

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’.

1196

CASCARILLA OIL

A, H

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

1197

CASEIN

E

1198

CASHEW NUT

E

1199

CASSIA ALATA LEAF EXTRACT

E

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

The extraction ratio of the Cassia alata can only be 1:3 in 62.5% glycerine:water.

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

1200

CASSIA CINNAMON BARK DRY

A, H

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

1201

CASSIA CINNAMON BARK POWDER

A, H

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

1202

CASSIA FISTULA

A, H

Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Cassia fistula when the route of administration is oral.

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

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

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

- (LAX3) ‘Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

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

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

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

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

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

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

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

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

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

1203

CASSIA OIL

A, E, H

The concentration of Cassia oil in the product must be no more than 2% unless the preparation is for dermal use as a rubefacient, in which case the concentration of cassia oil must be no more than 5%.

1204

CASSIE ABSOLUTE

E

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

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

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

1205

CASTANEA MOLLISSIMA

A, H

1206

CASTANEA SATIVA

A, H

1207

CASTOR OIL

A, E

1208

CASTOREUM

H

Only permitted for use as an active homoeopathic ingredient.

1209

CASUARINA EQUISITIFOLIA

A, H

1210

CATALPA BIGNONIOIDES

A, H

1211

CATALPA OVATA

A, H

1212

CATECHU

A, H

1213

CATHARANTHUS ROSEUS

A, H

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

The concentration of vinblastine, vincamine, vincristine, vindesine, vinorelbine and yohimbine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%.

1214

CAULIFLOWER

E

1215

CAULOPHYLLUM THALICTROIDES

A, E, H

1216

CAUSTICUM

H

Only for use as an active homoeopathic ingredient.