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

Note: See sections 5 and 6.

Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient Name

Purpose

Specific requirements

754

BACILLUS COAGULANS

A

Only permitted for use in medicines:

(a) limited to oral routes of administration; and

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

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

(ii) MTCC accession number 5856.

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

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

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

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

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

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

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

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

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

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

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

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

 

755

BACKHOUSIA CITRIODORA

A, E, H

The herbal substance must be derived from leaf oil only.

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 10g/kg or 10g/L or 1%.

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

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

- (CHILD3) 'Use in children under 12 years is not recommended'

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

 

756

BACOPA MONNIERI

A, H

 

757

BALLOTA NIGRA

A, H

 

758

BALM OF GILEAD BUD DRY

A, H

 

759

BALM OF GILEAD BUD POWDER

A, H

 

760

BALSAM COPAIBA

E

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

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

 

761

BAMBUSA BREVIFLORA

A, E, H

 

762

BAMBUSA TEXTILIS

A, H

 

763

BANANA

E

 

764

BANANA DISTILLATE

E

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

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

 

765

BAPTISIA CONFUSA

A, H

 

766

BAPTISIA TINCTORIA

A, H

 

767

BARBAREA VULGARIS

A, H

 

768

BARIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

 

769

BARIUM CHLORIDE

H

Only for use as an active homoeopathic ingredient.

 

770

BARIUM SULFATE

E

Only for use in topical medicines for dermal application.

 

771

BARLEY

E

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

 

772

BARLEY BRAN

E

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

 

773

BARLEY GERM

E

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

 

774

BARLEY LEAF

E

 

775

BASIC BUTYLATED METHACRYLATE COPOLYMER

E

Only for use in oral medicines.

 

776

BASIC FUCHSIN

E

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

 

777

BASIC RED 1

E

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

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

 

778

BASIC VIOLET 11:1

E

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

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

 

779

BASIL OIL COMOROS

A, E, H

Methyl chavicol is a mandatory component of Basil oil Comoros.

When the concentration of Methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL.

When the concentration of Methyl chavicol in the medicine is more than 5% and the nominal capacity of the container is 25mL or less, a restricted flow insert must fitted on the container, and the medicine requires the following warning statement on the medicine label:

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

 

780

BASIL OIL EUROPEAN

A, E, H

Methyl chavicol is a mandatory component of Basil oil European.

When the concentration of Methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL.

When the concentration of Methyl chavicol in the medicine is more than 5% and the nominal capacity of the container is 25mL or less, a restricted flow insert must fitted on the container, and the medicine requires the following warning statement on the medicine label:

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

 

781

BASSIA SCOPARIA

A, H

 

782

BATYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

783

BAY LEAF

E

 

784

BAY OIL

A, E, H

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

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

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

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

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

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

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

 

785

BEESWAX ABSOLUTE

E

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

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

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

 

786

BEESWAX ALCOHOLS

A

Only to be used in a medicine where Rainbow and Nature Pty Ltd (Client ID 22307), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 22 April 2024.

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

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

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

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

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

 

787

BEET RED

E

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

 

788

BEETROOT

E, H

 

789

BEGONIA FIMBRISTIPULA

A, H

 

790

BEHENETH-10

E

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

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

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

 

791

BEHENIC ACID

E

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

 

792

BEHENOXY DIMETHICONE

E

Only for use in topical medicines for dermal application.

 

793

BEHENOYL STEARIC ACID

E

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

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

 

794

BEHENYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

795

BELLADONNA HERB DRY

A, H

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

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

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

 

796

BELLADONNA HERB POWDER

A, H

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

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

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

 

797

BELLADONNA HERB PREPARED

A, H

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

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

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

 

798

BELLIS PERENNIS

A, H

 

799

BEMOTRIZINOL

A

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

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

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

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

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

 

800

BENINCASA HISPIDA

A, E, H

 

801

BENTONITE

E

 

802

BENZALDEHYDE

E

 

803

BENZALDEHYDE GLYCERYL ACETAL

E

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

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

 

804

BENZALKONIUM CHLORIDE

E

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

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

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

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

(i) indicated for use in children; or

(ii) not specifically indicated for adults only;

the following warning statement is required on the medicine label:

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

 

805

BENZETHONIUM CHLORIDE

E

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

 

806

BENZOIC ACID

E, H

 

807

BENZOIN

E

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

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

 

808

BENZOIN SIAM

A, E, H

 

809

BENZOIN SUMATRA

A, E, H

 

810

BENZOPHENONE

E

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

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

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

 

811

BENZOTHIAZOLE

E

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

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

 

812

BENZYL ACETATE

E

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

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

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

 

813

BENZYL ACETONE

E

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

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

 

814

BENZYL ALCOHOL

A, E

When used as an active ingredient:

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

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

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

 

815

BENZYL BENZOATE

E

Only for use in topical medicines for dermal application.

 

816

BENZYL BUTYRATE

E

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

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

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

 

817

BENZYL CINNAMATE

E

Only for use in:

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

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

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

 

818

BENZYL DIMETHYL CARBINYL-N-BUTYRATE

E

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

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

 

819

BENZYL FORMATE

E

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

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

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

 

820

BENZYL ISOAMYL ETHER

E

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

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

 

821

BENZYL ISOBUTYRATE

E

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

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

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

 

822

BENZYL ISOVALERATE

E

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

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

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

 

823

BENZYL LAURATE

E

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

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

 

824

BENZYL PHENYLACETATE

E

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

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

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

 

825

BENZYL PROPIONATE

E

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

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

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

 

826

BENZYL SALICYLATE

E

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

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

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

 

827

BENZYL TIGLATE

E

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

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

 

828

BENZYLIDENE ACETONE

E

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

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

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

 

829

BENZYLIDENE CAMPHOR SULFONIC ACID

A

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

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

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

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

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

 

830

BERBERIS AQUIFOLIUM

A, H

 

831

BERBERIS ARISTATA

A

Only for use in oral medicines.

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

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

 

832

BERBERIS VULGARIS

A, E, H

 

833

BERGAMOT OIL

E

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

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

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

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

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

 

834

BERGAMOT OIL BERGAPTEN-FREE

E

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

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

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

 

835

BERGAMOT OIL COLDPRESSED

A, E, H

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

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

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

a) for internal use; or

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

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

 

836

BERGAMOT OIL TERPENELESS

E

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

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

 

837

BERTHOLLETIA EXCELSA

A, E, H

 

838

BETA RAPA

A, E, H

 

839

BETA VULGARIS

A, E, H

 

840

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

E

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

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

 

841

BETA-CARYOPHYLLENE

E

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

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

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

 

842

BETA-CARYOPHYLLENE ALCOHOL

E

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

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

 

843

BETA-DAMASCENONE

E

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

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

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

 

844

BETA-DAMASCONE

E

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

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

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

 

845

BETA-HOMO CYCLOCITRAL

E

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

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

 

846

BETA-HYDROXY-BETA-METHYLBUTYRIC ACID

A

 

847

BETA-IONONE

E

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

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

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

 

848

BETA-IONONE EPOXIDE

E

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

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

 

849

BETA-ISO-METHYL IONONE

E

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

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

 

850

BETA-METHYL NAPHTHYL KETONE

E

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

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

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

 

851

BETA-N-METHYL IONONE

E

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

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

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

 

852

BETA-NAPHTHOL ETHYLETHER

E

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

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

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

 

853

BETA-NAPHTHOL METHYL ETHER

E

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

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

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

 

854

BETA-NAPHTHYL ANTHRANILATE

E

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

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

 

855

BETA-NAPHTHYL ISOBUTYL ETHER

E

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

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

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

 

856

BETA-PINENE

E

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

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

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

 

857

BETA-TOCOPHEROL

E

 

858

BETACAROTENE

A, E

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

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

 

859

BETADEX

E

 

860

BETAGLUCAN

E

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

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

 

861

BETAINE

E

Only for use in topical medicines for dermal application.

 

862

BETAINE HYDROCHLORIDE

E

 

863

BETULA LENTA

A, H

Methyl salicylate is a mandatory component of Betula lenta.

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

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

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

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

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

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

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

The following warning statement is required on the medicine label:

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

When for use in topical medicines for dermal application:

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

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

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

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

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

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

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

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

 

864

BETULA NIGRA

A, H

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

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

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

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

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

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

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

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

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

- (NTAKEN) 'Not to be taken'.

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

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

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

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

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

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

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

The following warning statement is required on the medicine label:

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

When for use in topical medicines for dermal application:

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

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

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

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

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

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

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

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

 

865

BETULA PENDULA

A, E, H

Methyl salicylate is a mandatory component of Betula pendula.

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

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

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

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

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

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

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

The following warning statement is required on the medicine label:

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

When for use in topical medicines for dermal application:

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

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

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

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

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

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

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

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

 

866

BETULA PUBESCENS

A, E, H

 

867

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

E

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

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

 

868

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

E

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

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

 

869

BIFIDOBACTERIUM ADOLESCENTIS

A

 

870

BIFIDOBACTERIUM ANIMALIS

A

 

871

BIFIDOBACTERIUM ANIMALIS SSP ANIMALIS

A

 

872

BIFIDOBACTERIUM ANIMALIS SSP LACTIS

A

 

873

BIFIDOBACTERIUM BIFIDUM

A

 

874

BIFIDOBACTERIUM BREVE

A

 

875

BIFIDOBACTERIUM INFANTIS

A

 

876

BIFIDOBACTERIUM LACTIS

A

 

877

BIFIDOBACTERIUM LONGUM

A

 

878

BILBERRY

E

 

879

BIOSACCHARIDE GUM-1

E

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

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

 

880

BIOTA ORIENTALIS

A, H

 

881

BIOTIN

A, E

 

882

BIRCH LEAF DRY

A, E, H

Methyl salicylate is a mandatory component of birch leaf dry.

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

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

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

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

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

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

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

The following warning statement is required on the medicine label:

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

When for use in topical medicines for dermal application:

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

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

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

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

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

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

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

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

 

883

BIRCH TAR OIL RECTIFIED

A, E, H

Cresol is a mandatory component of birch tar oil rectified.

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

 

884

BIS-BUTYLDIMETICONE POLYGLYCERYL-3

E

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

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

 

885

BIS-DIGLYCERYL POLYACYLADIPATE-2

E

Only for use in topical medicines for dermal application.

 

886

BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE

E

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

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

 

887

BIS-MACROGOL 900 METHYL ETHER DIMETHYL SILANE

E

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

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

 

888

BIS-PEG-12 DIMETHICONE BEESWAX

E

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

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

 

889

BIS-STEARYL DIMETICONE

E

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

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

 

890

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

E

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

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

 

891

BISABOLENE

E

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

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

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

 

892

BISABOLOL

E

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

 

893

BITTER ALMOND OIL

E

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

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

The absence of amygdalin in the medicine must be declared.

 

894

BITTERN

A, E, H

Magnesium is a mandatory component of bittern.

Only permitted for use in:

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

(b) topical medicines for dermal administration.

When used in a medicine:

(a) with an oral route of administration;

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

(c) where the maximum recommended daily dose for:

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

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

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

the following warning statement is required on the medicine label:

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

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

 

895

BIXA ORELLANA

A, E, H

 

896

BLACK BONED CHICKEN POWDER

A

 

897

BLACK COHOSH DRY

A, H

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

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

 

898

BLACK COHOSH POWDER

A, H

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

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

 

899

BLACK CURRANT

E

 

900

BLACK CURRANT ABSOLUTE

E

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

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

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

 

901

BLACK CURRANT FRESH

A, E, H

 

902

BLACK CURRANT SEED OIL

E

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

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

 

903

BLACK OF CURACAO SPIDER

H

Only for use as an active homoeopathic ingredient.

 

904

BLACK PEPPER OIL

A, E, H

 

905

BLACK RASPBERRY

E

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

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

 

906

BLACK SNAKE

H

Only for use as an active homoeopathic ingredient.

 

907

BLACKBERRY

E

 

908

BLACKBERRY OILS

E

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

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

 

909

BLACKBERRY WINE

E

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

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

 

910

BLACKCURRANT ESTERS

E

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

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

 

911

BLACKCURRANT JUICE

E

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

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

 

912

BLACKSTRAP MOLASSES

E

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

 

913

BLADDERWRACK DRY

A, H

Iodine is a mandatory component of Bladderwrack dry.

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

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

 

914

BLADDERWRACK POWDER

A, H

Iodine is a mandatory component of Bladderwrack powder.

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

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

 

915

BLAINVILLEA ACMELLA

A, E, H

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

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

 

916

BLETILLA STRIATA

A, H

 

917

BLUE FLAG RHIZOME DRY

A, H

 

918

BLUE FLAG RHIZOME POWDER

A, H

 

919

BLUEBERRY

E

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

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

 

920

BLUEBERRY JUICE

E

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

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

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

 

921

BLUMEA LACERA

A, H

 

922

BOEHMERIA NIVEA

A, H

 

923

BOERHAVIA DIFFUSA

A, H

 

924

BOERHAVIA REPENS

A, H

 

925

BOGBEAN LEAF DRY

A, H

 

926

BOGBEAN LEAF POWDER

A, H

 

927

BOIS DE ROSE OIL

A, E, H

 

928

BOMBAX CEIBA

A, H

 

929

BORAGO OFFICINALIS

A, E, H

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

 

930

BORAX

A, E, H

Boron is a mandatory component of borax.

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

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

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

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

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

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

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

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

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

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

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

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

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

 

931

BORAX PENTAHYDRATE

A, E

Boron is a mandatory component of borax pentahydrate.

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

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

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

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

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

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

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

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

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

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

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

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

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

 

932

BORIC ACID

A, H

Boron is a mandatory component of boric acid.

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

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

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

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

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

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

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

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

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

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

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

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

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

 

933

BORNEOL

E

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

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

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

 

934

BORNYL ACETATE

E

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

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

 

935

BORON NITRIDE

E

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

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

 

936

BORONIA ABSOLUTE

E

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

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

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

 

937

BORONIA MEGASTIGMA

E

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

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

 

938

BOSWELLIA CARTERII

A, E, H

 

939

BOSWELLIA SERRATA

A, E, H

 

940

BOSWELLIA THURIFERA

A, H

 

941

BOVINE CALCIUM CHONDROITIN SULFATE

A

 

942

BOVINE CHONDROITIN SULFATE

A

 

943

BOVINE COLOSTRUM POWDER

A

The following warning statement is required on the medicine label:

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

 

944

BOVINE LACTOFERRIN

A

 

945

BOVINE POTASSIUM CHONDROITIN SULFATE

A

 

946

BOVINE SODIUM CHONDROITIN SULFATE

A, E

When used as an excipient:

- only for use in topical medicines for dermal application;

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

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

 

947

BOVINE WHEY IG-RICH FRACTION

A

Only for use in oral medicines.

The following warning statement is required on the medicine label:

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

 

948

BRANDY

E

 

949

BRASSICA CAMPESTRIS/ALEURITES FORDI OIL COPOLYMER

E

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

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

 

950

BRASSICA CHINENSIS

A, H

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

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

 

951

BRASSICA JUNCEA

A, H

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

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

 

952

BRASSICA NAPUS

A, E, H

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

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

 

953

BRASSICA NIGRA

A, H

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

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

 

954

BRASSICA OLERACEA VAR. BOTRYTIS

A, E, H

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

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

 

955

BRASSICA OLERACEA VAR. CAPITATA

A, E, H

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

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

 

956

BRASSICA OLERACEA VAR. GEMMIFERA

A, H

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

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

 

957

BRASSICA OLERACEA VAR. ITALICA

A, H

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

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

 

958

BRASSICA OLERACEA VAR. VIRIDIS

A, H

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

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

 

959

BRASSICA PEKINENSIS

A, H

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

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

 

960

BRASSICA RAPA

A, E, H

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

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

 

961

BRAZIL NUT

E

 

962

BRILLIANT BLACK BN

E

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

 

963

BRILLIANT BLUE FCF

E

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

 

964

BRILLIANT BLUE FCF ALUMINIUM LAKE

E

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

 

965

BRILLIANT BLUE FCF BARIUM LAKE

E

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

 

966

BRILLIANT SCARLET 4R

E

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

 

967

BRILLIANT SCARLET 4R ALUMINIUM LAKE

E

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

 

968

BRIZA MEDIA

A, H

 

969

BROCCOLI

E

 

970

BROMELAINS

A

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

 

971

BROMOSTYROL

E

Not for use in infants

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

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

 

972

BROMUS CATHARTICUS

A, H

 

973

BROMUS INERMIS

A, H

 

974

BROMUS RAMOSUS SUBSP. RAMOSUS

A, H

 

975

BRONOPOL

E

Only for use in topical medicines for dermal application.

 

976

BROUSSONETIA PAPYRIFERA

A, H

 

977

BROWN FK

E

Permitted for use only as a colour for topical use.

 

978

BRUNFELSIA UNIFLORA

A, H

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

 

979

BRUSSEL SPROUT

E

 

980

BRYONIA ALBA

A, H

 

981

BRYONIA DIOICA

A, H

 

982

BUCHU LEAF DRY

A, H

 

983

BUCHU LEAF OIL

E

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

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

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

 

984

BUCHU LEAF POWDER

A, E, H

 

985

BUCKWHEAT

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

986

BUDDLEJA OFFICINALIS

A, H

 

987

BULNESIA SARMIENTI

A, E, H

 

988

BUNIAS ORIENTALIS

A, H

 

989

BUPLEURUM FALCATUM

A, H

 

990

BURDOCK LEAF DRY

A, H

 

991

BURDOCK LEAF POWDER

A, H

 

992

BURDOCK ROOT DRY

A, H

 

993

BURDOCK ROOT POWDER

A, H

 

994

BUSHMASTER SNAKE

H

Only for use as an active homoeopathic ingredient.

 

995

BUTAN-1-OL

E

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

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

 

996

BUTANE

E

Only for use as an excipient propellant ingredient.

 

997

BUTOXYETHANOL

E

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

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

 

998

BUTTER

E

 

999

BUTTER ACIDS

E

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

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

 

1000

BUTTER ESTERS

E

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

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

 

1001

BUTTER STARTER DISTILLATE

E

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

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

 

1002

BUTYL 2-METHYLBUTYRATE

E

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

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

 

1003

BUTYL ACETATE

E

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

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

 

1004

BUTYL BUTYRATE

E

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

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

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

 

1005

BUTYL BUTYRYL LACTATE

E

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

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

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

 

1006

BUTYL CAPROATE

E

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

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

 

1007

BUTYL ESTER OF PVM/MA COPOLYMER

E

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

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

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

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

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

 

1008

BUTYL FORMATE

E

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

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

 

1009

BUTYL HYDROXYBENZOATE

E

Only for use in topical medicines for dermal application.

 

1010

BUTYL ISOBUTYRATE

E

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

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

 

1011

BUTYL ISOVALERATE

E

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

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

 

1012

BUTYL LACTATE

E

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

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

 

1013

BUTYL LEVULINATE

E

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

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

 

1014

BUTYL METHOXYDIBENZOYLMETHANE

A

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

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

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

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

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

 

1015

BUTYL PROPIONATE

E

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

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

 

1016

BUTYL STEARATE

E

Only for use in topical medicines for dermal application.

 

1017

BUTYL UNDECYLENATE

E

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

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

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

 

1018

BUTYLATED HYDROXYANISOLE

E

 

1019

BUTYLATED HYDROXYTOLUENE

E

 

1020

BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE

E

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

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

 

1021

BUTYLIDENE PHTHALIDE

E

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

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

 

1022

BUTYLOCTYL SALICYLATE

E

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

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

 

1023

BUTYLPHENYL METHYLPROPIONAL

E

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

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

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

 

1024

BUTYRALDEHYDE

E

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

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

 

1025

BUTYRIC ACID

E

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

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

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

 

1026

C1-8 ALKYL TETRAHYDROXYCYCLOHEXANOATE

E

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

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

 

1027

C10-12 ALKANE/CYCLOALKANE

E

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

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

 

1028

C10-30 CHOLESTEROL/LANOSTEROL ESTERS

E

Only for use in topical medicines for dermal application.

 

1029

C11-13 ALKANE

E

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

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

 

1030

C11-14-ISO-ALCOHOL C-13 RICH

E

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

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

 

1031

C12-13 PARETH-23

E

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

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

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

 

1032

C12-13 PARETH-3

E

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

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

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

 

1033

C12-15 ALKYL LACTATE

E

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

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

 

1034

C12-15 ALKYL OCTANOATE

E

Only for use in topical medicines for dermal application.

 

1035

C12-20 ACID PEG-8 ESTER

E

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

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

 

1036

C12-20 ALKYL GLUCOSIDE

E

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

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

 

1037

C12-22 ALKYL ACRYLATE/HYDROXYETHYLACRYLATE COPOLYMER

E

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

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

 

1038

C13-14 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

 

1039

C14-22 ALCOHOLS

E

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

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

 

1040

C15-16 ISOPARAFFIN

E

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

(a) for dermal application; and

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

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

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

 

1041

C15-19 ALKANE

E

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

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

 

1042

C17-18 ISOPARAFFIN

E

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

(a) for dermal application; and

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

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

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

 

1043

C18-36 ACID GLYCOL ESTER

E

Only for use topical medicines for dermal application.

 

1044

C18-36 ACID TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

 

1045

C2-OCTENAL

E

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

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

 

1046

C20-40 ALCOHOLS

E

Only for use in topical medicines for dermal application.

 

1047

C20-40 ALKYL STEARATE

E

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

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

 

1048

C20-40 PARETH-24

E

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

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

 

1049

C20-40 PARETH-3

E

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

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

 

1050

C30-45 ALKYL CETEARYL DIMETICONE CROSSPOLYMER

E

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

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

 

1051

C9-11 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

 

1052

C9-11 PARETH-3

E

Only for use in topical medicines for dermal application.

 

1053

C9-15 ALKYL PHOSPHATE

E

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

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

 

1054

CABBAGE

E

 

1055

CABREUVA OIL

E

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

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

 

1056

CADE OIL

A, E, H

 

1057

CAESALPINIA SAPPAN

A, H

 

1058

CAFFEINE

A, E

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

1059

CAJUPUT OIL

A, E, H

Cineole is a mandatory component of Cajuput oil.

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

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

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

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

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

- (NTAKEN) 'Not to be taken'.

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

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

 

1060

CALAMINE

A, E

Only for use as an active or excipient ingredient for dermal application.

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

 

1061

CALANUS FINMARCHICUS OIL

A

Only to be used in a medicine where Blackmores Ltd (Client ID 10576), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 1 March 2025.

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

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

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

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

- (ADULT) ‘Adults only'.

 

1062

CALCIFEDIOL MONOHYDRATE

A

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

Only for use in oral medicines.

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

The medicine requires the following warning statements on the label:

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

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

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

 

1063

CALCIFIED LITHOTHAMNION SPECIES

A

Only for use in oral medicines.

 

1064

CALCIFIED LITHOTHAMNION TOPHIFORME

A

Only for oral use.

 

1065

CALCIUM ALGINATE

E

 

1066

CALCIUM AMINO ACID CHELATE

A, H

Calcium is a mandatory component of calcium amino acid chelate.

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

 

1067

CALCIUM ASCORBATE

A, E, H

 

1068

CALCIUM ASCORBATE DIHYDRATE

A, E, H

 

1069

CALCIUM ASPARTATE

A

 

1070

CALCIUM ASPARTATE HYDROCHLORIDE DIHYDRATE

A

Only for use in oral medicines.

 

1071

CALCIUM BEHENATE

E

Behenic acid is a mandatory component of Calcium behenate.

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

 

1072

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE

A, H

 

1073

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE

A, H

 

1074

CALCIUM CARBONATE

A, E, H

 

1075

CALCIUM CASEINATE

E

 

1076

CALCIUM CHLORIDE DIHYDRATE

E

 

1077

CALCIUM CITRATE

A, E, H

 

1078

CALCIUM CITRATE TETRAHYDRATE

A, E, H

 

1079

CALCIUM DIASPARTATE

A

Only for use in oral medicines.

 

1080

CALCIUM FLUORIDE

H

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

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

 

1081

CALCIUM FOLINATE

A

Folinic acid is a mandatory component of calcium folinate.

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

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

 

1082

CALCIUM GLUCONATE MONOHYDRATE

A, E, H

 

1083

CALCIUM GLYCEROPHOSPHATE

A, E, H

 

1084

CALCIUM GLYCINATE

A

Only for use in oral medicines.

 

1085

CALCIUM GLYCINATE DIHYDRATE

A

 

1086

CALCIUM HEXAFLUOROSILICATE

H

Only for use as an active homoeopathic ingredient.

 

1087

CALCIUM HYDROGEN PHOSPHATE

A, E, H

 

1088

CALCIUM HYDROGEN PHOSPHATE DIHYDRATE

A, E, H

 

1089

CALCIUM HYDROGEN PHOSPHATE MONOHYDRATE

A, E, H

 

1090

CALCIUM HYDROXIDE

A, E, H

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

 

1091

CALCIUM HYDROXYCITRATE

A, H

 

1092

CALCIUM HYPOPHOSPHITE

H

Only for use as an active homoeopathic ingredient.

 

1093

CALCIUM IODIDE

H

Only for use as an active homoeopathic ingredient.

 

1094

CALCIUM KETOGLUCONATE

E

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

The concentration must be no more than 1%

 

1095

CALCIUM L-THREONATE

A

Only for use in oral medicines.

 

1096

CALCIUM LACTATE

A, E, H

 

1097

CALCIUM LACTATE GLUCONATE

A, E, H

 

1098

CALCIUM LACTATE PENTAHYDRATE

A, E, H

 

1099

CALCIUM LACTATE TRIHYDRATE

A, E, H

 

1100

CALCIUM LYSINATE

A

Only for use in oral medicines.

 

1101

CALCIUM METHIONINATE

A

Only for use in oral medicines.

 

1102

CALCIUM OROTATE

A, E, H

 

1103

CALCIUM OXIDE

E

Only for use in topical medicines for dermal application.

 

1104

CALCIUM PANTOTHENATE

A, E, H

 

1105

CALCIUM PHOSPHATE

A, E, H

 

1106

CALCIUM PYRUVATE

A

 

1107

CALCIUM SACCHARATE

E

 

1108

CALCIUM SILICATE

E

 

1109

CALCIUM SODIUM CASEINATE

A, H

 

1110

CALCIUM SODIUM LACTATE

A, E, H

 

1111

CALCIUM STEARATE

E

 

1112

CALCIUM SUCCINATE

A, E, H

 

1113

CALCIUM SULFATE

A, E, H

 

1114

CALCIUM SULFATE DIHYDRATE

A, E, H

 

1115

CALCIUM SULFIDE

H

Only for use as an active homoeopathic ingredient.

 

1116

CALCIUM THREONINATE

A

 

1117

CALENDULA FLOWER DRY

A, E, H

 

1118

CALENDULA FLOWER POWDER

A, H

 

1119

CALENDULA OFFICINALIS

A, E, H

 

1120

CALLERYA RETICULATA

A, H

 

1121

CALLICARPA PEDUNCULATA

A, H

 

1122

CALLISTEPHUS CHINENSIS

A, H

 

1123

CALLITRIS COLUMELLARIS

E

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

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

 

1124

CALLITRIS COLUMELLARIS SUBSP. INTRATROPICA

E

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

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

 

1125

CALLITRIS RHOMBOIDEA

A, H

 

1126

CALLUNA VULGARIS

A, E, H

 

1127

CALOCHORTUS TOLMIEI

A, H

 

1128

CALTHA PALUSTRIS

A, H

 

1129

CALUMBA ROOT DRY

A, H

 

1130

CALUMBA ROOT POWDER

A, H

 

1131

CALVATIA GIGANTEA

A, E, H

 

1132

CALYCANTHUS FLORIDUS

A, H

 

1133

CALYCANTHUS PRAECOX

A, H

 

1134

CAMELLIA JAPONICA

A, H

 

1135

CAMELLIA OLEIFERA

A, E, H

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

 

1136

CAMELLIA SINENSIS

A, E, H

Caffeine is a mandatory component of Camellia sinensis.

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

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

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

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

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

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

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

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

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

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

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

 

1137

CAMPHENE

E

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

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

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

 

1138

CAMPHOLENIC ALDEHYDE

E

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

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

 

1139

CAMPHOR

A, E, H

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

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

 

1140

CAMPHOR BENZALKONIUM METHOSULFATE

A

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

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

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

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

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

 

1141

CAMPHOR OIL BROWN

A, H

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

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

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

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

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

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

 

1142

CAMPHOR OIL WHITE

A, E, H

Camphor and safrole are mandatory components of camphor oil white.

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

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

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

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

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

 

1143

CAMPSIS GRANDIFLORA

A, H

 

1144

CANADA BALSAM

A, H

 

1145

CANANGA ODORATA

A, E, H

 

1146

CANANGA OIL

A, E, H

 

1147

CANARIUM INDICUM

A, H

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

 

1148

CANARIUM LUZONICUM

A, H

 

1149

CANDELILLA WAX

A, E, H

 

1150

CANDIDA ALBICANS

H

Only for use as an active homoeopathic ingredient.

 

1151

CANDIDA UTILIS

A, E, H

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

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

 

1152

CANINE MILK

H

Only for use as an active homoeopathic ingredient.

 

1153

CANOLA OIL

A, E, H

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

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

 

1154

CANTHARIDES

H

Only available as an active homoeopathic ingredient.

 

1155

CANTHAXANTHIN

E

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

 

1156

CAPRIC ACID

E

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

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

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

 

1157

CAPROIC ALDEHYDE

E

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

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

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

 

1158

CAPRYLIC ALDEHYDE

E

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

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

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

 

1159

CAPRYLIC/CAPRIC/ISOSTEARIC/ADIPIC TRIGLYCERIDE

E

 

1160

CAPRYLIC/CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE

E

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

The concentration in the medicine is not to exceed 3%

 

1161

CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

 

1162

CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER

E

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

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

 

1163

CAPRYLOYL GLYCINE

E

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

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

 

1164

CAPRYLOYL SALICYLIC ACID

E

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

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

 

1165

CAPRYLYL GLYCOL

E

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

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

 

1166

CAPRYLYL METHICONE

E

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

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

 

1167

CAPSELLA BURSA-PASTORIS

A, H

 

1168

CAPSICUM

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

1169

CAPSICUM ANNUUM

A, E, H

 

1170

CAPSICUM DRY

A, E, H

 

1171

CAPSICUM FRUIT OLEORESIN

A, E

 

1172

CAPSICUM FRUTESCENS

A, E, H

 

1173

CAPSICUM POWDER

A, E, H

 

1174

CARALLUMA ADSCENDENS VAR. FIMBRIATA

A

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

 

1175

CARAMEL

E

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

 

1176

CARAPICHEA IPECACUANHA

A, H

Emetine is a mandatory component of Carapichea ipecacuanha.

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

 

1177

CARAWAY DRY

A, H

 

1178

CARAWAY OIL

A, E, H

 

1179

CARAWAY POWDER

A, H

 

1180

CARBOMER 1342

E

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

 

1181

CARBOMER 2001

E

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

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

 

1182

CARBOMER 934

E

Only for use in topical medicines for dermal application.

 

1183

CARBOMER 934P

E

Only for use in topical medicines for dermal application.

 

1184

CARBOMER 940

E

Only for use in topical medicines for dermal application.

 

1185

CARBOMER 941

E

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

 

1186

CARBOMER 954

E

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

 

1187

CARBOMER 980

E

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

 

1188

CARBOMER 981

E

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

 

1189

CARBOMER COPOLYMER (TYPE B)

E

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

 

1190

CARBOMER HOMOPOLYMER (TYPE B)

E

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

 

1191

CARBOMER U-10

E

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

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

 

1192

CARBON

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

1193

CARBON BLACK

E

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

 

1194

CARBON DIOXIDE

E

 

1195

CARDAMOM FRUIT DRY

A, H

 

1196

CARDAMOM FRUIT POWDER

A, E, H

 

1197

CARDAMOM OIL

A, E, H

 

1198

CARDIOSPERMUM HALICACABUM

A, H

 

1199

CARICA PAPAYA

A, E, H

 

1200

CARLINA ACAULIS

A, H

 

1201

CARMELLOSE

E

 

1202

CARMELLOSE CALCIUM

E

 

1203

CARMELLOSE SODIUM

E

 

1204

CARMINE

E

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

 

1205

CARMOISINE

E

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

 

1206

CARMOISINE ALUMINIUM LAKE

E

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

 

1207

CARNAUBA WAX

A, E, H

 

1208

CARNOSINE

E

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

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

 

1209

CAROB BEAN EXTRACT

E

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

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

 

1210

CAROB GUM

E

 

1211

CAROB POD

E

 

1212

CAROTENES

E

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

 

1213

CARPINUS BETULUS

A, H

 

1214

CARPINUS CORDATA

A, H

 

1215

CARRAGEENAN

E

 

1216

CARROT

E

 

1217

CARROT SEED OIL

A, E, H

 

1218

CARTHAMUS TINCTORIUS

A, E, H

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

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

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

 

1219

CARUM CARVI

A, H

 

1220

CARVACROL

E

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

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

 

1221

CARVACRYL METHYL ETHER

E

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

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

 

1222

CARVEOL

E

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

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

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

 

1223

CARVONE

E

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

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

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

 

1224

CARVYL ACETATE

E

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

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

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

 

1225

CARYA ILLINOINENSIS

A, H

 

1226

CARYA OVATA

A, H

 

1227

CARYOPHYLLENE OXIDE

E

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

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

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

 

1228

CASCARA DRY

A, H

Hydroxyanthracene derivatives calculated as cascaroside A is a mandatory component of cascara dry when the route of administration is oral.

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

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

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

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

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

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

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

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

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

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

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

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

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

 

1229

CASCARA POWDER

A, H

Hydroxyanthracene derivatives calculated as cascaroside A is a mandatory component of cascara powder when the route of administration is oral administration.

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

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

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

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

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

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

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

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

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

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

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

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

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

 

1230

CASCARILLA OIL

A, E, H

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

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

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

 

1231

CASEIN

E

 

1232

CASHEW NUT

E

 

1233

CASSIA ALATA LEAF EXTRACT

E

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

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%.

 

1234

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%.

 

1235

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.

 

1236

CASSIA FISTULA

A, E, 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’.

When Cassia fistula is for use as an excipient:

(a) the plant part must be fruit; and

(b) must only be included in medicines when in combination with other permitted ingredients as a:

(i) flavour proprietary excipient formulation when the plant preparation is an extract; and/or

(ii) fragrance proprietary excipient formulation when the plant preparation is an essential oil.

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

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

 

1237

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%.

 

1238

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%.

 

1239

CASTANEA MOLLISSIMA

A, H

 

1240

CASTANEA SATIVA

A, H

 

1241

CASTOR OIL

A, E

 

1242

CASTOREUM

H

Only permitted for use as an active homoeopathic ingredient.

 

1243

CASUARINA EQUISITIFOLIA

A, H

 

1244

CATALPA BIGNONIOIDES

A, H

 

1245

CATALPA OVATA

A, H

 

1246

CATECHU

A, H

 

1247

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%.

 

1248

CAULIFLOWER

E

 

1249

CAULOPHYLLUM THALICTROIDES

A, E, H

 

1250

CAUSTICUM

H

Only for use as an active homoeopathic ingredient.

 

1251

CEANOTHUS AMERICANUS

A, H

 

1252

CEDAR LEAF OIL

A, E, H

 

1253

CEDARWOOD OIL

E

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

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

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

 

1254

CEDARWOOD OIL TERPENES

E

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

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

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

 

1255

CEDARWOOD OIL VIRGINIA

E

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

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

 

1256

CEDRENOL

E

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

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

 

1257

CEDRENYLACETATE

E

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

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

 

1258

CEDROL

E

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

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

 

1259

CEDRUS ATLANTICA

A, E, H

 

1260

CEDRUS ATLANTICA WOOD 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%.

 

1261

CEDRUS DEODARA

A, H

 

1262

CEDRUS LIBANI

H

Only for use as an active homoeopathic ingredient.

 

1263

CEDRYL ACETATE

E

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

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

 

1264

CEDRYL METHYL ETHER

E

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

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

 

1265

CELERY LEAF

E, H

 

1266

CELERY SEED DRY

A, E, H

 

1267

CELERY SEED OIL

A, E, H

 

1268

CELERY SEED POWDER

A, H

 

1269

CELLACEFATE

E

 

1270

CELLULASE

A

Must be derived from Trichoderma longibrachiatum only.

 

1271

CELLULOSE

E

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

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

 

1272

CELOSIA ARGENTEA

A, H

 

1273

CELOSIA ARGENTEA L. VAR. CRISTATA

A, H

 

1274

CENTAUREA CYANUS

A, E, H

 

1275

CENTAURIUM ERYTHRAEA

A, H

 

1276

CENTELLA ASIATICA

A, E, H

 

1277

CENTELLA ASIATICA MERISTEM CELL CULTURE

E

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

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

 

1278

CENTIPEDA CUNNINGHAMII

A, E, H

 

1279

CENTIPEDA MINIMA

A, H

 

1280

CEPHALANOPSIS SEGETUM

A, H

 

1281

CERAMIDE 1

E

Only for use in topical medicines for dermal application.

 

1282

CERAMIDE 2

E

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

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

 

1283

CERAMIDE 3

E

Only for use in topical medicines for dermal application.

 

1284

CERATONIA SILIQUA

A, E, H

 

1285

CERATOSTIGMA WILLMOTTIANUM

A, H

 

1286

CERESIN

E

Only for use in topical medicines for dermal application.

 

1287

CESTRUM LATIFOLIUM

E

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

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

The concentration must be no more than 0.5%.

 

1288

CETEARETH-12

E

Only for use in topical medicines for dermal application.

 

1289

CETEARETH-2

E

Only for use in topical medicines for dermal application.

 

1290

CETEARETH-20

E

Only for use in topical medicines for dermal application.

 

1291

CETEARETH-25

E

Only for use in topical medicines for dermal application.

 

1292

CETEARETH-30

E

Only for use in topical medicines for dermal application.

 

1293

CETEARETH-33

E

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

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

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

 

1294

CETEARYL GLUCOSIDE

E

Only for use in topical medicines for dermal application.

 

1295

CETEARYL ISONONANOATE

E

Only for use in topical medicines for dermal application.

 

1296

CETEARYL NONANOATE

E

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

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

 

1297

CETEARYL OCTANOATE

E

Only for use in topical medicines for dermal application.

 

1298

CETETH-10

E

Only for use in topical medicines for dermal application.

 

1299

CETETH-2

E

Only for use in topical medicines for dermal application.

 

1300

CETETH-24

E

Only for use in topical medicines for dermal application.

 

1301

CETETH-5

E

Only for use in topical medicines for dermal application.

 

1302

CETOMACROGOL 1000

E

Only for use in topical medicines for dermal application.

 

1303

CETOMACROGOL 1000 PHOSPHATE

E

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

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

 

1304

CETOMACROGOL 500 PHOSPHATE

E

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

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

 

1305

CETOSTEARYL ALCOHOL

E

 

1306

CETOSTEARYL ALCOHOL/COCO-GLUCOSIDE COMPLEX

E

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

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

 

1307

CETRARIA ISLANDICA

A, H

 

1308

CETRIMONIUM BROMIDE

E

Only for use in topical medicines for dermal application.

 

1309

CETRIMONIUM CHLORIDE

E

Only for use in topical medicines for dermal application.

 

1310

CETYL ACETATE

E

Only for use in topical medicines for dermal application.

 

1311

CETYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

1312

CETYL DIMETHICONE COPOLYOL

E

Only for use in topical medicines for dermal application.

 

1313

CETYL DIMETICONE

E

Only for use in topical medicines for dermal application.

 

1314

CETYL DIMETICONE/BIS-VINYLDIMETICONE CROSSPOLYMER

E

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

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

 

1315

CETYL ESTERS WAX

E

Only for use in topical medicines for dermal application.

 

1316

CETYL HYDROXYETHYLCELLULOSE

E

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

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

 

1317

CETYL LACTATE

E

Only for use in topical medicines for dermal application.

 

1318

CETYL OCTANOATE

E

Only for use in topical medicines for dermal application.

 

1319

CETYL PALMITATE

E

Only for use in topical medicines for dermal application.

 

1320

CETYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

1321

CETYL-PG HYDROXYETHYL PALMITAMIDE

E

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

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

 

1322

CETYLPYRIDINIUM CHLORIDE

A, E

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

When used as an active ingredient:

a) permitted for use only in medicated throat lozenges;

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

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

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

 

1323

CHAENOMELES LAGENARIA

A, H

 

1324

CHAENOMELES SPECIOSA

A, H

 

1325

CHALK

A, E

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

 

1326

CHAMAECYPARIS LAWSONIANA

A, H

 

1327

CHAMAELIRIUM LUTEUM

A, H

 

1328

CHAMAEMELUM NOBILE

A, E, H

 

1329

CHAMOMILE FLOWER DRY

A, E, H

 

1330

CHAMOMILE OIL ENGLISH

A, E, H

 

1331

CHAMOMILE OIL GERMAN

A, E, H

 

1332

CHANGIUM SMYRNIOIDES

A, H

 

1333

CHEIRANTHUS CHEIRI

A, H

 

1334

CHELIDONIUM MAJUS

A, E, H

The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that is:

- listed in the Register before 1 March 2023; and

- released for supply before 1 March 2024:

(a) When the medicine is for oral or sublingual use, one of the following warning statements is required on the medicine label:

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

(ii) (CELAND1) 'In rare cases, Chelidonium majus may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine.'

The requirement specified in paragraph (b) below applies to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2023; or

- released for supply on or after 1 March 2024:

(b) When the medicine is for oral or sublingual use, the following warning statement is required on the medicine label:

(CELAND1) 'In rare cases, Chelidonium majus may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine.'

 

1335

CHELONE GLABRA

A, H

 

1336

CHENOPODIUM ALBUM

A, H

 

1337

CHENOPODIUM VULVARIA

A, H

 

1338

CHERRY

E

 

1339

CHERRY DISTILLATE

E

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

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

 

1340

CHESTNUT SWEET

E, H

 

1341

CHICKEN COMB EXTRACT

A

 

1342

CHILLI

E, H

 

1343

CHIMAPHILA UMBELLATA

A, H

Beta-arbutin is a mandatory component of Chimaphila umbellata.

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

When for dermal application exclusively to the face:

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

b) hydroquinone is a mandatory component; and

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

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

 

1344

CHIONANTHUS VIRGINICA

A, H

 

1345

CHLORELLA

E

Iodine is a mandatory component of Chlorella.

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

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

 

1346

CHLORELLA PYRENOIDOSA

E

 

1347

CHLORELLA VULGARIS

A, E

Iodine is a mandatory component of Chlorella vulgaris.

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

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

 

1348

CHLORHEXIDINE ACETATE

E

Only for use in topical medicines for dermal application.

 

1349

CHLORHEXIDINE GLUCONATE

E

Only for use in topical medicines for dermal application.

 

1350

CHLOROBUTANOL HEMIHYDRATE

E

Only for use in topical preparations for dermal application.

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

 

1351

CHLOROCRESOL

E

Only for use in topical medicines for dermal application.

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

 

1352

CHLOROFORM

E

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

 

1353

CHLOROPHYLL

A, E

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

 

1354

CHLOROPHYLL-COPPER COMPLEXES

E

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

 

1355

CHLOROPHYLLIN-COPPER COMPLEX

E

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

 

1356

CHLOROPHYLLIN-COPPER COMPLEX ALUMINIUM LAKE

E

Only for as a colour in oral and topical medicines.

 

1357

CHLOROXYLENOL

E

Only for use in topical medicines for dermal application.

 

1358

CHLORPHENESIN

E

Only for use in topical medicines for dermal application.

 

1359

CHOCOLATE BROWN HT

E

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

 

1360

CHOLESTEROL

E, H

Only for use as an active ingredient in homoeopathic medicines or an excipient ingredient in topical preparations.

 

1361

CHOLESTERYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

 

1362

CHOLESTERYL MACADAMIATE

E

Only for use in topical medicines for dermal application.

 

1363

CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.5%.

 

1364

CHOLETH-24

E

Only for use in topical medicines for dermal application.

 

1365

CHOLINE BITARTRATE

A, E

 

1366

CHOLINE DIHYDROGEN CITRATE

A

Only for use in oral medicines.

 

1367

CHONDRODENDRON TOMENTOSUM

A, H

The concentration of equivalent dry Chondrodendron tomentosum in the product must be no more than 10mg/Kg or 10mg/L or 0.001%.

 

1368

CHONDRUS CRISPUS

A, E, H

Iodine is a mandatory component of Chondrus crispus.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

1369

CHONDRUS DRY

A, E, H

Iodine is a mandatory component of Chondrus dry.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

1370

CHONDRUS EXTRACT

A, E, H

Iodine is a mandatory component of Chondrus extract.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

1371

CHROMIC CHLORIDE HEXAHYDRATE

A, H

When used as an active ingredient in a preparation for mineral supplementation, chromium is a mandatory component of chromic chloride hexahydrate.

The amount of chromium in the active ingredient should be calculated based on the molecular weight of chromic chloride hexahydrate.

The maximum recommended daily dose must provide 50 micrograms or less of chromium from organic sources (i.e. chromium picolinate, chromium nicotinate and high chromium yeast).

 

1372

CHROMIUM NICOTINATE

A

Chromium is a mandatory component of chromium nicotinate.

The maximum recommended daily dose must not provide more than 50 micrograms of chromium from organic sources.

Chromium nicotinate is considered to be an organic form of chromium.

 

1373

CHROMIUM PICOLINATE

A

Chromium is a mandatory component of Chromium picolinate.

The maximum recommended daily dose must not provide more than 50 micrograms of chromium from organic sources.

Chromium picolinate is considered to be an organic form of chromium.

 

1374

CHRYSANTHEMUM BALSAMITA

A, H

 

1375

CHRYSANTHEMUM INDICUM

A, H

 

1376

CHRYSANTHEMUM LEUCANTHEMUM

A, H

 

1377

CHRYSANTHEMUM MARSHALLII

A, H

 

1378

CHRYSANTHEMUM SINENSE

A, H

 

1379

CHRYSOPOGON ZIZANIOIDES

A, E, H

 

1380

CHRYSOSPORIUM PRUINOSUM

A, H

 

1381

CIBOTIUM BAROMETZ

A, H

 

1382

CICHORIUM INTYBUS

A, E, H

 

1383

CICUTA VIROSA

A, H

The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.

 

1384

CINCHONA BARK DRY

A, H

Quinidine and quinine are mandatory components of Cinchona bark dry.

The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL.

 

1385

CINCHONA BARK POWDER

A, H

Quinidine and quinine are mandatory components of Cinchona bark powder.

The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL.

 

1386

CINCHONA OFFICINALIS

A, H

Quinidine and quinine are mandatory components of Cinchona officinalis.

The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL.

 

1387

CINCHONA PUBESCENS

A, H

Quinidine and quinine are mandatory components of Cinchona pubescens.

The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL.

 

1388

CINEOLE

E

In liquid preparations when the concentration of cineole in the preparation is more than 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure.

 

1389

CINNAMALDEHYDE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1390

CINNAMIC ACID

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1391

CINNAMOMUM CAMPHORA

A, E, H

Camphor, cineole and safrole are mandatory components of Cinnamomum camphora.

In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%.

In liquid preparations other than essential oils or distillates, the concentration of camphor must be no more than 2.5%.

In essential oil preparations or distillates and the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25 millilitres and the following warning statements must be included on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect);

- (NTAKEN) 'Not to be taken'; and

- Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist'.

In essential oil preparations or distillates, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container.

In essential oil preparations or distillates, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container.

In essential oil preparations or distillates, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container.

In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% the nominal capacity of the container must be no more than 25 millilitres and the medicine must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container.

In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container.

When for internal use then the concentration of safrole in a medicine must be no more than 0.1%.

When for uses other than internal use, the concentration of safrole in a medicine must be no more than 1.0%.

When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%.

 

1392

CINNAMOMUM CASSIA

A, E

Cassia oil is a mandatory component of Cinnamomum cassia if the plant preparation is an essential oil, distillate, fixed oil or infused oil.

The concentration of Cassia oil in the medicine must be no more than 2%.

When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%.

 

1393

CINNAMOMUM VERUM

A, E, H

When used as an active ingredient coumarin is a mandatory component of Cinnamomum verum and the concentration of coumarin in the medicine must be no more than 0.001%.

Cinnamon bark oil is a mandatory component of Cinnamomum verum when the plant part is bark and the plant preparation is essential oil, distillate, fixed oil or infused oil.

The concentration of cinnamon bark oil in the medicine must be no more than 2%.

Cinnamon leaf oil is a mandatory component of Cinnamomum verum when the plant part is leaf.

When the concentration of cinnamon leaf oil in the preparation is more than 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but no more than 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container.

When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the container must be fitted with a restricted flow insert.

 

1394

CINNAMON BARK OIL

A, E, H

The concentration of cinnamon bark oil in the product must be no more than 2%.

When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%.

 

1395

CINNAMON DRY

A, H

Cinnamon bark oil is a mandatory component of cinnamon dry.

The concentration of cinnamon bark oil in the product must be no more than 2%.

When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%.

 

1396

CINNAMON LEAF OIL

A, E, H

When the concentration of cinnamon leaf oil in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 mL.

When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL but no more than 25mL, the medicine must have a child resistant closure and restricted flow insert fitted on the container and requires the following warning statement on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect).

- (NTAKEN) 'Not to be taken'.

When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is no more than 15 mL, the container must be fitted with a restricted flow insert and requires the following warning statement on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect).

- (NTAKEN) 'Not to be taken'.

When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%.

 

1397

CINNAMON POWDER

A, E, H

Cinnamon bark oil is a mandatory component of cinnamon powder.

The concentration of cinnamon bark oil in the product must be no more than 2%.

When used as an active ingredient, the concentration of coumarin in the medicine must be no more than 0.001%.

 

1398

CINNAMYL ACETATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1399

CINNAMYL ALCOHOL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1400

CINNAMYL BUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1401

CINNAMYL CINNAMATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1402

CINNAMYL FORMATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1403

CINNAMYL ISOBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1404

CINNAMYL ISOVALERATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used as a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1405

CINNAMYL PROPIONATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1406

CINOXATE

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 6%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

1407

CIS-2-METHYL-4-PROPYL-1,3-OXATHIANE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1408

CIS-3-HEXEN-1-OL

E

cis-3-Hexen-1-ol must only be included in medicines when in combination with other permitted ingredients as a flavour or fragrance proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing cis-3-hexen-1-ol must not be more than 5% of the total medicine.

The total concentration of fragrance proprietary excipient formulations containing cis-3-hexen-1-ol must not be more than 1% of the total medicine.

 

1409

CIS-3-HEXENAL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1410

CIS-3-HEXENYL 2-METHYLBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1411

CIS-3-HEXENYL ACETATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1412

CIS-3-HEXENYL BENZOATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1413

CIS-3-HEXENYL BUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1414

CIS-3-HEXENYL FORMATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1415

CIS-3-HEXENYL HEXANOATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1416

CIS-3-HEXENYL ISOBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1417

CIS-3-HEXENYL ISOVALERATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1418

CIS-3-HEXENYL LACTATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1419

CIS-3-HEXENYL METHYL CARBONATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1420

CIS-3-HEXENYL SALICYLATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1421

CIS-3-HEXENYL TIGLATE

E

Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation.

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

 

1422

CIS-4-HEPTENAL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1423

CIS-6-NONEN-1-AL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1424

CIS-6-NONENOL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1425

CIS-BETA-OCIMENE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1426

CIS-HEXAHYDROCUMINYL ALCOHOL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1427

CIS-JASMONE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1428

CISTANCHE DESERTICOLA

A, H

 

1429

CISTANCHE SALSA

A, H

 

1430

CISTUS LADANIFER

A, E, H

 

1431

CITRAL

E

 

1432

CITRAL DIETHYL ACETAL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1433

CITRAL DIMETHYL ACETAL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1434

CITRIC ACID

A, E

Where intended for topical use, sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose.

When used as an active ingredient in preparations for topical use, the medicine requires the following warning statements on the medicine label:

- (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect)

- (SUNPRO) 'Wear protective clothing, hats and eyewear when exposed to the sun.' (or words to that effect)

- (IRRIT) 'If irritation develops, discontinue use.'

- (SKTEST) 'If you have sensitive skin, test this product on a small area of skin before applying it to a large area.'

- (CHILD3) 'Use in children under 12 years is not recommended'

 

1435

CITRIC ACID DIHYDRATE

A, E

Where intended for topical use, sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose.

When used as an active ingredient in preparations for topical use, the medicine requires the following warning statements on the medicine label:

- (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect)

- (SUNPRO) 'Wear protective clothing, hats and eyewear when exposed to the sun.' (or words to that effect)

- (IRRIT) 'If irritation develops, discontinue use.'

- (SKTEST) 'If you have sensitive skin, test this product on a small area of skin before applying it to a large area.'

- (CHILD3) 'Use in children under 12 years is not recommended'

 

1436

CITRIC ACID MONOHYDRATE

A, E

Where intended for topical use, sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose.

When used as an active ingredient in preparations for topical use, the medicine requires the following warning statements on the medicine label:

- (SENS) 'Application to skin may increase sensitivity to sunlight.' (or words to that effect)

- (SUNPRO) 'Wear protective clothing, hats and eyewear when exposed to the sun.' (or words to that effect)

- (IRRIT) 'If irritation develops, discontinue use.'

- (SKTEST) 'If you have sensitive skin, test this product on a small area of skin before applying it to a large area.'

- (CHILD3) 'Use in children under 12 years is not recommended.'

 

1437

CITRIC AND FATTY ACID ESTERS OF GLYCEROL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1438

CITROL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1439

CITRON

E

 

1440

CITRONELLA OIL

A, E, H

Medicines for topical use containing citronella oil require the following warning statement on the medicine label:

- (CITRON) 'Contains citronella oil'.

 

1441

CITRONELLA TERPENES

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1442

CITRONELLAL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1443

CITRONELLIC ACID

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1444

CITRONELLOL

E

Permitted for use only:

(a) in topical medicines for dermal application; and

(b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

 

1445

CITRONELLYL ACETATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1446

CITRONELLYL BUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1447

CITRONELLYL FORMATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1448

CITRONELLYL ISOBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1449

CITRONELLYL NITRILE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1450

CITRONELLYL OXYACETALDEHYDE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1451

CITRONELLYL PROPIONATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1452

CITRONELLYL TIGLATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1453

CITRULLINE

A

Only permitted for use in medicines:

(a) limited to oral routes of administration; and

(b) when the maximum recommended daily dose does not provide more than 6 g of citrulline.

 

1454

CITRULLUS COLOCYNTHIS

H

Citrullus colocynthis can only be included in medicines for oral use when the dilution of the mother tincture is 10,000 fold (4X) or more.

 

1455

CITRULLUS VULGARIS

A, H

 

1456

CITRUS AURANTIFOLIA

A, E, H

When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is:

a) for internal use; or

b) in preparations containing 0.5% or less of citrus aurantifolia oil or distillate; or

c) for use in soaps or bath or shower gels that are washed off the skin.

 

1457

CITRUS AURANTIUM

A, E, H

Oxedrine is a mandatory component of Citrus aurantium when intended for internal use.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 mg.

When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is:

a) for internal use; or

b) in preparations containing 1.4% or less of citrus aurantium oil or distillate; or

c) for use in soaps or bath or shower gels that are washed off the skin.

 

1458

CITRUS BIOFLAVONOIDS EXTRACT

A, E, H

 

1459

CITRUS CHACHIENSIS

A, H

 

1460

CITRUS EXTRACT

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1461

CITRUS FIBRE

E

 

1462

CITRUS LIMETTA

A, H

When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is:

a) for internal use; or

b) in preparations containing 0.5% or less of citrus limetta oil or distillate; or

c) for use in soaps or bath or shower gels that are washed off the skin.

 

1463

CITRUS LIMON

A, E, H

Oxedrine is a mandatory component of Citrus limon when intended for internal use.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.

When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is:

a) for internal use; or

b) in preparations containing 0.05% or less of citrus limon oil or distillate; or

c) for use in soaps or bath or shower gels that are washed off the skin.

 

1464

CITRUS MAXIMA

A, H

 

1465

CITRUS MEDICA

A, E, H

When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is:

a) for internal use; or

b) in preparations containing 0.05% or less of citrus medica oil or distillate; or

c) for use in soaps or bath or shower gels that are washed off the skin.

 

1466

CITRUS OIL DISTILLED

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1467

CITRUS OIL TERPENES AND TERPENOIDS

E

Citrus oil terpenes and terpenoids must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing citrus oil terpenes and terpenoids must not be more than 1% of the total medicine.

 

1468

CITRUS RETICULATA

A, E, H

Oxedrine is a mandatory component of Citrus reticulata when intended for internal use.

The quantity of Oxedrine in the recommended daily dose must be no more than 30 mg.

 

1469

CITRUS SINENSIS

A, E, H

Oxedrine is a mandatory component of Citrus sinensis when intended for internal use.

The quantity of Oxedrine in the recommended daily dose must be no more than 30 mg.

 

1470

CITRUS SINENSIS PEEL MOLASSES EXTRACT

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1471

CITRUS UNSHIU

A, E, H

Oxedrine is a mandatory component of Citrus unshiu when intended for internal use.

The quantity of Oxedrine in the recommended daily dose must be no more than 30 mg. 

 

1472

CITRUS X PARADISI

A, E, H

 

1473

CITRUS X WILSONII

A, H

 

1474

CIVET

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1475

CIVET ABSOLUTE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1476

CIVET SYNTHETIC

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1477

CIVETONE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1478

CLARY OIL

A, E, H

 

1479

CLEMATIS ARMANDII

A, H

 

1480

CLEMATIS CHINENSIS

A, E, H

 

1481

CLEMATIS RECTA

A, H

 

1482

CLEMATIS VITALBA

A, H

 

1483

CLERODENDRUM TRICHOTOMUM

A, H

 

1484

CLINOPODION POLYCEPHALUM

A, H

 

1485

CLINOPODIUM NEPETA SUBSP. GLANDULOSUM

A, H

 

1486

CLIVER HERB DRY

A, H

 

1487

CLIVER HERB POWDER

A, H

 

1488

CLOVE BUD OIL

A, E, H

When the total concentration of clove oils (including clove bud oil, clove leaf oil, and clove stem oil) in the medicine is more than 25%:

(a) the nominal capacity of the container must not be more than 25 mL;

(b) a restricted flow insert must be fitted on the container;

(c) the container must include the following warning statements on the medicine label:

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’; and

(d) When the nominal capacity of the container is more than 15 mL, a child resistant closure must also be fitted on the container.

 

1489

CLOVE DRY

A, E, H

 

1490

CLOVE LEAF OIL

A, E, H

When the total concentration of clove oils (including clove bud oil, clove leaf oil, and clove stem oil) in the medicine is more than 25%:

(a) the nominal capacity of the container must not be more than 25 mL;

(b) a restricted flow insert must be fitted on the container;

(c) the container must include the following warning statements on the medicine label:

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’; and

(d) When the nominal capacity of the container is more than 15 mL, a child resistant closure must also be fitted on the container.

 

1491

CLOVE OIL TERPENES

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1492

CLOVE POWDER

A, E, H

 

1493

CLOVE STEM OIL

A, E, H

When the total concentration of clove oils (including clove bud oil, clove leaf oil, and clove stem oil) in the medicine is more than 25%:

(a) the nominal capacity of the container must not be more than 25 mL;

(b) a restricted flow insert must be fitted on the container;

(c) the container must include the following warning statements on the medicine label:

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’; and

(d) When the nominal capacity of the container is more than 15 mL, a child resistant closure must also be fitted on the container.

 

1494

CLUPEA HARENGUS LIPID EXTRACT

A

Only for use in oral medicines.

The maximum recommended daily dose must not provide more than 2750 mg EPA, DHA and DPA combined, when used alone or in combination with other sources of omega-3 fatty acids.

 

1495

CNICUS BENEDICTUS

A, H

 

1496

CNICUS JAPONICUS

A, H

 

1497

CNIDIUM MONNIERI

A, H

 

1498

CNIDIUM OFFICINALE

A, H

 

1499

COBALTOUS NITRATE HEXAHYDRATE

H

Only for use as an active homoeopathic ingredient.

 

1500

COCAMIDE DEA

E

Only for use in topical medicines for dermal application.

 

1501

COCAMIDE MEA

E

Only for use in topical medicines for dermal application.

 

1502

COCAMIDOPROPYL BETAINAMIDE MEA CHLORIDE

E

Only for use in topical medicines for dermal application and not to be included in topical products intended for use in the eye.

The concentration in the medicine must be no more than 1%.

 

1503

COCAMIDOPROPYL BETAINE

E

Only for topical, mucous membrane (buccal mucosa) and dental use and not to be included in topical medicines intended for use in the eye.

The concentration in the medicine must be:

a) no more than 1% in leave on medicines

b) no more than 15% in wash on /wash off medicines

c) 1.2% for buccal mucosa and dental medicines.

Levels of impurities 3-dimethylaminopropylamine (DMAPA) and amidoamine (dimethylaminopropylcocoamide; AA) must be controlled to below the level of detection.

 

1504

COCCOLOBIA UVIFERA

A, H

 

1505

COCCULUS ORBICULATUS

A, H

 

1506

COCHINEAL

E, H

Only for use as an active homoeopathic ingredient or for excipient use only as a colour in oral and topical medicines.

 

1507

COCHLEARIA OFFICINALIS

A, H

 

1508

COCILLANA DRY

A, H

 

1509

COCILLANA POWDER

A, H

 

1510

COCO-BETAINE

E

Only for use in topical medicines for dermal application.

 

1511

COCO-CAPRYLATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration is to be no more than 12.5% in the medicine.

 

1512

COCO-GLUCOSIDE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.025%

 

1513

COCO-OCTANOATE/DECANOATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

 

1514

COCOA EXTRACT

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1515

COCOA POWDER

A, E, H

 

1516

COCOGLYCERIDES

E

 

1517

COCONUT

E

 

1518

COCONUT ACID

E

Only for use in topical medicines for dermal application.

 

1519

COCONUT OIL

A, E, H

 

1520

COCOS NUCIFERA

A, E, H

 

1521

COD-LIVER OIL

A, E

Vitamin A and colecalciferol are mandatory components of Cod-liver oil.

When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%.

When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents.

When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label:

- (VITA2) ‘WARNING: If you are pregnant - or considering becoming pregnant - do not take vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].’ NOTE: Position this warning at the beginning of the directions for use.

- (VITA4) ‘WARNING - When taken in excess of 3000 micrograms retinol equivalents - vitamin A can cause birth defects.’ NOTE: Position this warning at the beginning of the directions for use.

- (VITA3) ‘The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.’

When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of vitamin D.

 

1522

CODONOPSIS LANCEOLATA

A, H

 

1523

CODONOPSIS PILOSULA

A, H

 

1524

CODONOPSIS TANGSHEN

A, H

 

1525

COFFEA ARABICA

A, E, H

Caffeine is a mandatory component of Coffea arabica.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (ADULT) 'Adults only' (or words to that effect).

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80 mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

1526

COFFEA CANEPHORA

A, E, H

Caffeine is a mandatory component of Coffea canephora.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (ADULT) 'Adults only' (or words to that effect).

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80 mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

1527

COFFEE

E, H

Caffeine is a mandatory component of coffee.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (ADULT) 'Adults only' (or words to that effect).

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

1528

COFFEE 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%.

 

1529

COFFEE SOLID EXTRACT

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1530

COGNAC OIL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1531

COGNAC OIL GREEN

A, E, H

 

1532

COGNAC OIL WHITE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1533

COIX LACHRYMA-JOBI

A, H

 

1534

COLA ACUMINATA

A, E, H

Caffeine is a mandatory component of Cola acuminata.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (ADULT) 'Adults only' (or words to that effect).

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

1535

COLA NITIDA

A, E, H

Caffeine is a mandatory component of Cola nitida.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (ADULT) 'Adults only' (or words to that effect).

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

1536

COLCHICUM AUTUMNALE

H

Only for use as an active homoeopathic ingredient.

The total concentration of Colchicum autumnale in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

 

1537

COLECALCIFEROL

A, E

When for internal use, the maximum recommended daily dose must not be more than 25 micrograms of Vitamin D.

 

1538

COLLAGEN

E

 

1539

COLLINSONIA CANADENSIS

A, H

 

1540

COLLOIDAL ANHYDROUS SILICA

A, E, H

Only for use when the route of administration is other than inhalation.

 

1541

COLOPHONY

A, E, H

 

1542

COMMIPHORA HABESSINICA

A, H

 

1543

COMMIPHORA KATAF

A, H

 

1544

COMMIPHORA MYRRHA

A, E, H

 

1545

COMMON INDIAN COBRA

H

Only for use as an active homoeopathic ingredient.

 

1546

CONCENTRATED FISH OMEGA-3 TRIGLYCERIDES

A

Only for oral use.

 

1547

CONCENTRATED SQUID OMEGA-3 TRIGLYCERIDES

A

Only for oral use.

'Concentrated squid omega-3-triglycerides' must be obtained from species of the order Teuthida of the class Cephalopoda AND be in combination with other ingredients in the preparation AND be presented in a therapeutic dosage form for therapeutic use.

The following warning statement is required on the medicine label:

- (MOLLUSC) ‘Contains mollusc’ or ’Contains mollusc products’.

 

1548

CONIFER GREEN NEEDLE COMPLEX

A

Only for topical and oral use. Must be made by petroleum ether extraction of needles of the conifer species Pinus sylvestris (Scotch Pine) and Picea abies (Norwegian Spruce).

 

1549

CONIFER PHYTOSTEROL COMPLEX

A

 

1550

CONIOSELIUM UNIVITTATUM

A, H

 

1551

CONIUM MACULATUM

H

Only for use as an active homoeopathic ingredient.

The homoeopathic potency of Conium maculatum in the final medicine must be 12X or greater.

 

1552

CONVALLARIA MAJALIS

A, H

 The concentration of equivalent dry Convallaria majalis in the product must be no more than 10mg/Kg or 10mg/L or 0.001%.

 

1553

CONYZA CANADENSIS

A, H

 

1554

COPAIBA OIL

A, E, H

 

1555

COPAIFERA LANGSDORFFII

A, E, H

 

1556

COPERNICIA CERIFERA

A, E, H

 

1557

COPOVIDONE

E

 

1558

COPPER

H

Only for use as an active homoeopathic ingredient.

When for internal use the maximum daily dose must not contain more than 5 mg of copper.

When for other than internal use, the concentration of copper compounds must be no more than 5%.

 

1559

COPPER (II) ASPARTATE

A, H

Copper is a mandatory component of copper (II) aspartate.

The percentage of copper from copper (II) aspartate should be calculated based on the molecular weight of copper (II) aspartate.

The concentration of copper compounds in products must be no more than 5%.

The maximum daily dose must not contain more than 5mg of copper.

 

1560

COPPER (II) GLYCINATE

A, H

Copper is a mandatory component of copper (II) glycinate.

The percentage of copper from copper (II) glycinate should be calculated based on the molecular weight of Copper (II) glycinate.

The concentration of copper compounds in products must be no more than 5%.

The maximum daily dose must not contain more than 5mg of copper.

 

1561

COPPER (II) LYSINATE

A, H

Copper is a mandatory component of copper (II) lysinate.

The percentage of copper from copper (II) lysinate should be calculated based on the molecular weight of Copper (II) lysinate.

The concentration of copper compounds in products must be no more than 5%.

The maximum daily dose must not contain more than 5mg of copper.

 

1562

COPPER ACETYL TYROSINATE METHYLSILANOL

E

Only for use in topical medicines for dermal application.

 

1563

COPPER CHLOROPHYLL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1564

COPPER CHLOROPHYLLIN

E

Only for use as a colour in oral and topical medicines.

 

1565

COPPER GLUCONATE

A, E

Copper is a mandatory component of copper gluconate.

The percentage of copper from copper gluconate should be calculated based on the molecular weight of copper gluconate.

When for internal use the maximum daily dose must not contain more than 5 mg of copper.

When for other than internal use, the concentration of copper compounds must be no more than 5%.

 

1566

COPPER TRIPEPTIDE-1

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 3%.

 

1567

COPTIS CHINENSIS

A, H

 

1568

COPTIS JAPONICA

A, H

 

1569

CORALLINA OFFICINALIS

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine is to be no more than 1%.

 

1570

CORDYCEPS SINENSIS

A, E, H

Must not contain material of animal origin such as insect larvae.

 

1571

CORIANDER DRY

A, H

 

1572

CORIANDER OIL

A, E, H

 

1573

CORIANDER POWDER

A, H

 

1574

CORIANDRUM SATIVUM

A, E, H

 

1575

CORMUS DOMESTICA

A, H

 

1576

CORN GLYCERIDES

E

 

1577

CORN SILK DRY

A, H

 

1578

CORN SILK POWDER

A, H

 

1579

CORN SYRUP

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1580

CORN SYRUP SOLIDS

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1581

CORNUS FLORIDA

A, H

 

1582

CORNUS OFFICINALIS

A, H

 

1583

CORTISONE ACETATE

H

Only available as an active homoeopathic ingredient.

 

1584

CORYDALIS AMBIGUA

A, E, H

 

1585

CORYDALIS BUNGEANA

A, H

 

1586

CORYDALIS CAVA

A, H

 

1587

CORYDALIS FABACEA

A, H

 

1588

CORYDALIS FORMOSA

A, H

 

1589

CORYDALIS TURTSCHANINOVII

A, H

 

1590

CORYLUS AMERICANA

A, H

 

1591

CORYLUS AVELLANA

A, H

 

1592

CORYMBIA CITRIODORA

A, E, H

Cineole is a mandatory component of Corymbia citriodora.

In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure.

 

1593

CORYMBIA FICIFOLIA

A, H

Cineole is a mandatory component of Corymbia ficifolia.

In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure.

 

1594

COSMOS BIPINNATUS

A, H

 

1595

COSTUS ROOT OIL

A, H

 

1596

COSTUS SPICATUS

A, H

 

1597

COTTONSEED OIL

A, E, H

 

1598

COUCH GRASS RHIZOME DRY

A, H

 

1599

COUCH GRASS RHIZOME POWDER

A, H

 

1600

COUMARIN

E, H

Only for use as an active homoeopathic ingredient or excipient ingredient.

The concentration of coumarin in the medicine must not be more than 0.001%.

When used as an excipient:

(a) must only be used in topical medicines for dermal application; and

(b) the label of the medicine must specify that the product should only be used by adults.

 

1601

CRANBERRY

E

 

1602

CRATAEGUS CUNEATA

A, E, H

 

1603

CRATAEGUS GERMANICA

A, H

 

1604

CRATAEGUS LAEVIGATA

A, E, H

 

1605

CRATAEGUS MONOGYNA

A, E, H

 

1606

CRATAEGUS PINNATIFIDA

A, E, H

 

1607

CRATEVA MAGNA

A, E, H

 

1608

CREATINE

A, E

 

1609

CREATINE MONOHYDRATE

A, E

 

1610

CREATINE PHOSPHATE

A, E

 

1611

CREATININE

E

Only for use in topical medicines for dermal application and not for use in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.2%.

 

1612

CREOSOL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1613

CREOSOTE

H

Only for use as an active homoeopathic ingredient.

 

1614

CRESOL

E

Only for use as a preservative in topical medicines.

The concentration of phenols (including cresols and xylenols and any other homologue of phenol) boiling below 220 degrees centigrade must be no more than 3%.

 

1615

CRESYL ISOBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1616

CRITHMUM MARITIMUM WHOLE PLANT EXTRACT

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.00341%.

 

1617

CROCUS SATIVUS

A, E, H

When Crocus sativus is used as an excipient:

(a) the ingredient must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation;

(b) the plant part must be stigma and/or style;

(c) the plant preparation must be fresh or dry; and

(d) the total concentration of flavour proprietary excipient formulations containing the ingredient must not be more than 5% of the total medicine.

 

1618

CROSCARMELLOSE SODIUM

E

 

1619

CROSPOVIDONE

E

 

1620

CROTON CASCARILLA

A, H

The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.

 

1621

CROTON ELUTERIA

A, H

The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.

 

1622

CRYPTOMERIA JAPONICA

A, H

 

1623

CUBEB OIL

A, H

 

1624

CUBEBENE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1625

CUCUMBER

E

 

1626

CUCUMIS MELO

A, H

 

1627

CUCUMIS SATIVUS

A, E, H

 

1628

CUCURBITA MAXIMA

A, E, H

 

1629

CUCURBITA MOSCHATA

A, H

 

1630

CUCURBITA PEPO

A, E, H

 

1631

CULLEN CORYLIFOLIUM

A, H

 

1632

CUMIC ALCOHOL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1633

CUMIN OIL

A, E, H

 

1634

CUMINALDEHYDE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1635

CUMINUM CYMINUM

A, H

 

1636

CUMINYL NITRILE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1637

CUPRESSUS ARIZONICA

A, H

 

1638

CUPRESSUS FUNEBRIS

A, E, H

 

1639

CUPRESSUS SEMPERVIRENS

A, E, H

 

1640

CUPRIC ACETATE MONOHYDRATE

H

Only for use as an active homoeopathic ingredient.

 

1641

CUPRIC ARSENITE

H

Only for use as an active homoeopathic ingredient.

 

1642

CUPRIC CITRATE

A, E, H

When for oral or sublingual use, copper is a mandatory component of cupric citrate.

The percentage of copper from cupric citrate should be calculated based on the molecular weight of cupric citrate.

The medicine must not contain more than 750 micrograms of copper from cupric citrate per the recommended daily dose or the medicine must not contain more than 1.86 milligrams of cupric citrate per the recommended daily dose.

 

1643

CUPRIC CITRATE HEMIPENTAHYDRATE

A, E, H

When for oral or sublingual use, copper is a mandatory component of cupric citrate hemipentahydrate.

The percentage of copper from cupric citrate hemipenthydrate should be calculated based on the molecular weight of cupric citrate hemipenthydrate.

The medicine must not contain more than 750 micrograms of copper from cupric citrate hemipentahydrate per the recommended daily dose OR the medicine must not contain more than 2.13 milligrams of cupric citrate hemipentahydrate per the recommended daily dose.

 

1644

CUPRIC OXIDE

A, E, H

When for oral or sublingual use, copper is a mandatory component of cupric oxide.

The percentage of copper from cupric oxide should be calculated based on the molecular weight of cupric oxide.

When for internal use the maximum daily dose must not contain more than 5 mg of copper.

When for other than internal use, the concentration of copper compounds must be no more than 5%.

 

1645

CUPRIC SULFATE

A, E, H

When for oral or sublingual use, copper is a mandatory component of cupric sulfate.

The percentage of copper from cupric sulfate should be calculated based on the molecular weight of cupric sulfate.

When for internal use the maximum daily dose must not contain more than 5 mg of copper.

When for other than internal use, the concentration of copper compounds must be no more than 5%.

 

1646

CUPRIC SULFATE MONOHYDRATE

A, E, H

When for oral or sublingual use, copper is a mandatory component of cupric sulfate monohydrate.

The percentage of copper from cupric sulfate monohydrate should be calculated based on the molecular weight of cupric sulfate monohydrate.

When for internal use the maximum daily dose must not contain more than 5 mg of copper.

When for other than internal use, the concentration of copper compounds must be no more than 5%.

When used topically, cupric sulfate is a mandatory component of cupric sulfate monohydrate.

 

1647

CUPRIC SULFATE PENTAHYDRATE

A, E, H

When for oral or sublingual use, copper is a mandatory component of cupric sulfate pentahydrate.

The percentage of copper from cupric sulfate pentahydrate should be calculated based on the molecular weight of cupric sulfate pentahydrate.

When for internal use the maximum daily dose must not contain more than 5 mg of copper.

When for other than internal use, the concentration of copper compounds must be no more than 5%.

When used topically cupric sulfate is a mandatory component of cupric sulfate pentahydrate.

The percentage of cupric sulfate from cupric sulfate pentahydrate should be calculated based on the molecular weight of cupric sulfate pentahydrate.

 

1648

CURCULIGO ORCHIOIDES

A, H

 

1649

CURCUMA AROMATICA

A, H

 

1650

CURCUMA LONGA

A, E, H

 

1651

CURCUMA ZANTHORRHIZA

A, H

 

1652

CURCUMA ZEDOARIA

A, H

 

1653

CURCUMIN

A, E, H

When for excipient use, only permitted for use as a colour in topical and oral medicines.

 

1654

CUSCUTA EPITHYMUM

A, H

 

1655

CUSCUTA EUROPAEA

A, H

 

1656

CUSCUTA HYGROPHILAE

A, H

 

1657

CUSCUTA RACEMOSA

A, H

 

1658

CUSPARIA FEBRIFUGA

A, H

 

1659

CYAMOPSIS TETRAGONOLOBA

A, E, H

 

1660

CYANOCOBALAMIN

A, E, H

 

1661

CYANOMETHYLPHENYL MENTHANE CARBOXAMIDE

E

For dental use only in proprietary ingredients.

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in the medicine must be no more than 5%.

 

1662

CYATHULA OFFICINALIS

A, H

 

1663

CYCLAMEN ALDEHYDE

E

Only for use as an excipient ingredient in topical medicines.

 

1664

CYCLAMEN PURPURASCENS

A, H

 

1665

CYCLOHEXADECENONE-8

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1666

CYCLOHEXANE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

1667

CYCLOHEXANE, 1-ETHENYL-1-METHYL-2-(1-METHYLETHENYL)-4-(1-METHYLETHYL)-, DIDEHYDRO DERIV.

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1668

CYCLOHEXANEETHANOL

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1669

CYCLOHEXYL ACETATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1670

CYCLOHEXYL BUTYRATE

E

Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation.

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

 

1671

CYCLOHEXYL PHENETHYL ETHER

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1672

CYCLOHEXYL SALICYLATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1673

CYCLOHEXYLETHYL ACETATE

E

Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation.

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

 

1674

CYCLOMETHICONE

E

Only for use as an excipient ingredient in topical medicines.

 

1675

CYCLOPENTADECANONE

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%.

 

1676

CYDONIA OBLONGA

A, H

 

1677

CYMBOPOGON FLEXUOSUS

A, E, H

When for topical use, aldehydes calculated as citral is a mandatory component of Cymbopogon flexuosus and the concentration of aldehydes calculated as citral in the medicine must not be more than 5%.

 

1678

CYMBOPOGON MARTINI

A, H

When for topical use, aldehydes calculated as citral is a mandatory component of Cymbopogon martini and the concentration of aldehydes calculated as citral in the medicine must be no more than 5%.

 

1679

CYMBOPOGON NARDUS

A, H

When for topical use, aldehydes calculated as citral is a mandatory component of Cymbopogon nardus and the concentration of aldehydes calculated as citral in the medicine must be no more than 5%.

 

1680

CYMBOPOGON SCHOENANTHUS

A, E, H

When for topical use, aldehydes calculated as citral is a mandatory component of Cymbopogon schoenanthus and the concentration of aldehydes calculated as citral in the medicine must be no more than 5%.

 

1681

CYNANCHUM ATRATUM

A, H

 

1682

CYNANCHUM STAUNTONII

A, E, H

 

1683

CYNARA SCOLYMUS

A, E, H

 

1684

CYNODON DACTYLON

A, E, H

 

1685

CYNOMORIUM COCCINEUM SUBSP. SONGARICUM

A, H

 

1686

CYPERUS LONGUS

A, H

 

1687

CYPERUS ROTUNDUS

A, H

 

1688

CYPRESS 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%.

 

1689

CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS

A, H

 

1690

CYSTEINE

A

The maximum recommended daily dose must not contain more than 450 mg of cysteine.

When cysteine, cystine and/or their salts are used in combination, the medicine must not provide more than a total of 450 mg cysteine per maximum recommended daily dose.

 

1691

CYSTEINE HYDROCHLORIDE

A

The maximum recommended daily dose must contain no more than 585 mg of cysteine hydrochloride.

When cysteine, cystine and/or their salts are used in combination, the medicine must not provide more than a total of 450 mg cysteine per maximum recommended daily dose.

 

1692

CYSTEINE HYDROCHLORIDE MONOHYDRATE

A, E

When used as an excipient, permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient and the total flavour proprietary excipient formulation concentration in a medicine must not be more than 5%.

The maximum recommended daily dose must contain no more than 652 mg of cysteine hydrochloride monohydrate.

When cysteine, cystine and/or their salts are used in combination, the medicine must not provide more than a total of 450 mg cysteine per maximum recommended daily dose.

 

1693

CYSTINE

A

The maximum recommended daily dose must contain no more than 450 mg of cystine.

When cysteine, cystine and/or their salts are used in combination, the medicine must not provide more than a total of 450 mg cysteine per maximum recommended daily dose.

 

1694

CYTISUS SCOPARIUS

A, H

Sparteine is a mandatory component of Cytisus scoparius.

The concentration of Sparteine in the medicine must be no more than 0.001%.

 

1695

D-ALPHA-TOCOPHEROL

A, E

 

1696

D-ALPHA-TOCOPHERYL ACETATE

A, E, H

 

1697

D-ALPHA-TOCOPHERYL ACID SUCCINATE

A, E

 

1698

D-ALPHA-TOCOPHERYL PHOSPHATES

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 3%.

 

1699

D-BORNEOL

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%.

 

1700

D-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%.

 

1701

D-FENCHONE

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%.

 

1702

D-LIMONENE

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%.

 

1703

D-PULEGONE

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 concentration of d-pulegone in the medicine must not be more than 4%.

 

1704

D-RIBOSE-L-CYSTEINE

A

Only for use in oral medicines.

Cysteine is a mandatory component of D-Ribose-L-Cysteine.

The medicine must provide no more than 450 mg of cysteine per maximum recommended daily dose.

 

1705

DACTYLIS GLOMERATA

A, H

 

1706

DACTYLORHIZA INCARNATA SUBSP. INCARNATA

A, H

 

1707

DAEMONOROPS DRACO

A, E, H

 

1708

DAHLIA PINNATA

A, H

 

1709

DALBERGIA ODORIFERA

A, H

 

1710

DAMIANA LEAF POWDER

A

 

1711

DANDELION LEAF DRY

A, H

 

1712

DANDELION LEAF POWDER

A, H

 

1713

DANDELION ROOT DRY

A, H

 

1714

DANDELION ROOT POWDER

A, H

 

1715

DAPHNE GENKWA

A, H

 

1716

DAPHNE MEZEREUM

A, H

The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.

 

1717

DATE

E

 

1718

DATURA STRAMONIUM

A, H

Only for use in oral medicines.

Alkaloids calculated as hyoscyamine is a mandatory component of Datura stramonium.

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%.

 

1719

DAUCUS CAROTA

A, E, H

 

1720

DAVANA 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%.

 

1721

DEA-OLETH-3 PHOSPHATE

E

Only for use in topical medicines for dermal application and not be included in topical medicines intended for use in the eye.

The concentration in the medicine must be no more than 1%.

The medicine requires the following warning statements on the medicine label:

- (EYE) 'Avoid contact with eyes'

- (EYE2) 'May be irritant to the eyes' (or words to that effect).

 

1722

DECAHYDRO-1,1,7-TRIMETHYL-3A,7-METHANO-3AH-CYCLOPENTACYCLOOCT-3-YL FORMATE

E

Decahydro-1,1,7-trimethyl-3a,7-methano-3ah-cyclopentacyclooct-3-yl formate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing decahydro-1,1,7-trimethyl-3a,7-methano-3ah-cyclopentacyclooct-3-yl formate must not be more than 1% of the total medicine.

 

1723

DECAHYDRO-2,2,6,6,7,8,8-HEPTAMETHYL-2H-INDENO(4,5-B) FURAN

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%.

 

1724

DECAHYDRO-BETA-NAPHTHYLACETATE

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%.

 

1725

DECAHYDRO-BETA-NAPHTHYLFORMATE

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%.

 

1726

DECAHYDROSPIRO(FURAN-2(3H),5'-(4,7)METHANO(5H)INDENE)

E

Permitted for use only in combination with other permitted ingredients as a fragrance. The total fragrance concentration in a medicine must be no more than 1%.

 

1727

DECALACTONE

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%.

 

1728

DECANAL

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%.

 

1729

DECANAL DIMETHYL 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%.

 

1730

DECARBOXY CARNOISINE DIHYDROCHLORIDE

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 0.05.

 

1731

DECENAL

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%.

 

1732

DECYL 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%.

 

1733

DECYL ALCOHOL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

1734

DECYL GLUCOSIDE

E

Only for use in topical medicines for dermal application.

 

1735

DECYL OLEATE

E

Only for use in topical medicines for dermal application.

 

1736

DECYLENE GLYCOL

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin.

The concentration in the medicine must be no more than 0.5%.

 

1737

DEER ANTLER CARTILAGE

H

Only for use as an active homoeopathic ingredient. 

 

1738

DEER VELVET ANTLER POWDER

A

Medicines that contain 'deer velvet antler powder' as the therapeutically active ingredient are subject to the following conditions:

a) the medicines are for oral use only;

b) the antlers (including the velvet) are sourced only from red deer (Cervus elaphus), elk/wapiti (Cervus canadensis), or a crossbreed of these species;

c) the deer are sourced only from farmed stock bred and raised in New Zealand;

d) the deer are sourced only from herds farmed for food in accordance with the Animal Products Act 1999 (New Zealand) and the regulations made under that Act, as in force or existing from time to time;

e) the antlers are removed from the deer only according to the Animal Welfare Act 1999 (New Zealand) and the regulations made under that Act, as in force or existing from time to time.

 

1739

DEER VELVET ANTLER SLICE

A

Medicines that contain 'deer velvet antler slice' as the therapeutically active ingredient are subject to the following conditions:

a) the medicines are for oral use only;

b) the antlers (including the velvet) are sourced only from red deer (Cervus elaphus), elk/wapiti (Cervus canadensis), or a crossbreed of these species;

c) the deer are sourced only from farmed stock bred and raised in New Zealand;

d) the deer are sourced only from herds farmed for food in accordance with the Animal Products Act 1999 (New Zealand) and the regulations made under that Act, as in force or existing from time to time;

e) the antlers are removed from the deer only according to the Animal Welfare Act 1999 (New Zealand) and the regulations made under that Act, as in force or existing from time to time.

 

1740

DEERTONGUE ABSOLUTE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1741

DEHYDROACETIC ACID

E

Only for use in topical medicines for dermal application.

 

1742

DEHYDROMENTHOFUROLACTONE

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%.

 

1743

DEHYDROXANTHAN GUM

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%.

 

1744

DELPHINIUM STAPHISAGRIA

A, H

The concentration of the equivalent dry Delphinium staphisagria in the medicine must be no more than 0.2%.

 

1745

DELTA-DAMASCONE

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%.

 

1746

DELTA-DECALACTONE

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%.

 

1747

DELTA-DODECALACTONE

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%.

 

1748

DELTA-NONALACTONE

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%.

 

1749

DELTA-OCTALACTONE

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%.

 

1750

DELTA-TETRADECALACTONE

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%.

 

1751

DELTA-TOCOPHEROL

E

 

1752

DELTA-UNDECALACTONE

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%.

 

1753

DEMINERALISED FISH PROTEOGLYCAN EXTRACT

A

 

1754

DENATONIUM BENZOATE

E

 

1755

DENDROBIUM NOBILE

A, H

 

1756

DESCURAINIA SOPHIA

A, H

 

1757

DESMODIUM STYRACIFOLIUM

A, H

 

1758

DESMODIUM TRIQUETUM

A, H

 

1759

DEVIL'S CLAW TUBER DRY

A, H

 

1760

DEVIL'S CLAW TUBER POWDER

A, H

 

1761

DEXPANTHENOL

A, E

 

1762

DEXTRAN 20

E

Only for use in topical medicines for dermal application and not 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 0.3%.

 

1763

DEXTRAN 40

A, E

 

1764

DEXTRATES

E

 

1765

DEXTRIN

E

 

1766

DEXTRIN PALMITATE

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 3%.

 

1767

DHA/EPA RICH SCHIZOCHYTRIUM ALGAL OIL

A

Docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are mandatory components of DHA/EPA rich schizochytrium algal oil.

Only for use in oral medicines when in combination with other active or excipient ingredients.

The ratio of DHA to EPA must be 2:1.

 

1768

DI-C12-13 ALKYL MALATE

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%.

 

1769

DI-C12-15 ALKYL FUMARATE

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%.

 

1770

DI-N-PROPYL ISOCINCHOMERONATE

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 25%.

 

1771

DI-PPG-3 MYRISTYL ETHER ADIPATE

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%.

 

1772

DIACETIN

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%.

 

1773

DIACETYL

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%.

 

1774

DIACETYL TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES

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%.

 

1775

DIACETYLATED MONOGLYCERIDES

E

Permitted for use only in combination with other permitted ingredients as a coating solution.

 

1776

DIAMMONIUM LAURYL SULFOSUCCINATE

E

Only for use as an excipient ingredient in topical medicines.

 

1777

DIANTHUS SUPERBUS

A, H

 

1778

DIAZOLIDINYL UREA

E

Only for use in topical medicines for dermal application.

 

1779

DIBASIC MAGNESIUM CITRATE TETRAHYDRATE

A

Only for use in oral medicines.

 

1780

DIBASIC MAGNESIUM PHOSPHATE TRIHYDRATE

A, E, H

Magnesium is a mandatory component of dibasic magnesium phosphate trihydrate.

The percentage of magnesium from dibasic magnesium phosphate trihydrate should be calculated based on the molecular weight of dibasic magnesium phosphate trihydrate.

When used in a medicine:

(a) with an oral route of administration;

(b) not indicated for laxative (or related) use; and

(c) where the maximum recommended daily dose for:

(i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

- (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect).

When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

1781

DIBASIC POTASSIUM PHOSPHATE

A, E, H

When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of dibasic potassium phosphate.

When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5.

When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.

 

1782

DIBASIC POTASSIUM PHOSPHATE TRIHYDRATE

A, E, H

When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of dibasic potassium phosphate trihydrate.

When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5.

When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.

 

1783

DIBASIC SODIUM PHOSPHATE

A, E, H

When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate.

When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5.

When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.

 

1784

DIBASIC SODIUM PHOSPHATE DIHYDRATE

A, E, H

When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate dihydrate.

When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5.

When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.

 

1785

DIBASIC SODIUM PHOSPHATE DODECAHYDRATE

A, E, H

When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate dodecahydrate.

When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5.

When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.

 

1786

DIBASIC SODIUM PHOSPHATE HEPTAHYDRATE

A, E, H

When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate heptahydrate.

When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5.

When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.

 

1787

DIBASIC SODIUM PHOSPHATE MONOHYDRATE

A, E, H

When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate monohydrate.

When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5.

When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.

 

1788

DIBENZYL 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%.

 

1789

DIBUTYL ADIPATE

E

Only for use in topical medicines for dermal application.

 

1790

DIBUTYL SEBACATE

E

 

1791

DIBUTYLAMINE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in the medicine must be no more than 5%.

 

1792

DICAPRYLYL CARBONATE

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 34%.

 

1793

DICAPRYLYL ETHER

E

Only for use in topical medicines for dermal application.

 

1794

DICAPRYLYL MALEATE

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%.

 

1795

DICETYL PHOSPHATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin.

The concentration in the medicine must be no more than 2%.

 

1796

DICHLOROBENZYL ALCOHOL

E

 

1797

DICHLOROMETHANE

E

The concentration in the medicine must be no more than 0.06%.

The residual solvent limit for Dichloromethane is 6 mg per recommended daily dose.

 

1798

DICTAMNUS ALBUS

A, H

 

1799

DICTAMNUS DASYCARPUS

A, H

 

1800

DICYCLOHEXYL DISULFIDE

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%.

 

1801

DIEFFENBACHIA SEGUINE

H

Only for use as an active homoeopathic ingredient.

 

1802

DIETHANOLAMINE

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 5%.

 

1803

DIETHYL CITRACONATE

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%.

 

1804

DIETHYL HYDROGEN 2-HYDROXYPROPANE-1,2,3-TRICARBOXYLATE

E

Diethyl hydrogen 2-hydroxypropane-1,2,3-tricarboxylate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing diethyl hydrogen 2-hydroxypropane-1,2,3-tricarboxylate must not be more than 1% of the total medicine.

 

1805

DIETHYL MALONATE

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%.

 

1806

DIETHYL PHTHALATE

E

 

1807

DIETHYLAMINE

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%.

 

1808

DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 10%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

1809

DIETHYLAMINOMETHYLCOUMARIN

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 0.1%.

 

1810

DIETHYLDIMETHYL-2-CYCLOHEXENONE

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%.

 

1811

DIETHYLENE GLYCOL

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%.

 

1812

DIETHYLENE GLYCOL MONOETHYL ETHER

E

Only for use in topical medicines for dermal application.

 

1813

DIETHYLHEXYL CARBONATE

E

Only for use in topical medicines for dermal application and not be included in medicines intended for use in the eye or on damaged skin.

The concentration in the medicine must be no more than 3%.

 

1814

DIETHYLHEXYL SEBACATE

E

Only for use in topical medicines for dermal application.

 

1815

DIETHYLHEXYL SYRINGYLIDENEMALONATE

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%.

 

1816

DIETHYLHEXYL-2,6-NAPHTHALATE

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%.

The medicine requires the following warning statement on the medicine label:

- (EYE2) 'May be irritant to the eyes' (or words to that effect).

 

1817

DIETHYLTOLUAMIDE

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 20%.

The medicine requires the following warning statement on the medicine label:

- (DEET) 'WARNING: May be dangerous; particularly to children, if you use large amounts on the skin, clothes or bedding or on large areas of the body, especially if you keep using it for a long time.'

 

1818

DIGITALIS LEAF DRY

A, H

The concentration of Digitalis leaf dry in the product must be no more than 10mg/Kg or 10mg/L or 0.001%.

 

1819

DIGITALIS LEAF POWDER

A, H

The concentration of Digitalis leaf powder in the product must be no more than 10mg/Kg or 10mg/L or 0.001%.

 

1820

DIGITALIS PURPUREA

A, H

The concentration of equivalent dry Digitalis purpurea in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.

 

1821

DIGLYCOL/CHDM/ISOPHTHALATES/SIP COPOLYMER

E

Only for use in topical medicines for dermal application.

 

1822

DIHEXYL FUMARATE

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%.

 

1823

DIHYDRO JASMONE

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%.

 

1824

DIHYDRO TERPINYLACETATE

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%.

 

1825

DIHYDRO-ALPHA-TERPINEOL

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%.

 

1826

DIHYDRO-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%.

 

1827

DIHYDRO-ISOJASMONE

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%.

 

1828

DIHYDROACTINIDIOLIDE

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%.

 

1829

DIHYDROAMBRETTOLIDE

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%.

 

1830

DIHYDROCAPSIATE

A

Only to be used in a medicine where Ajinomoto Co Inc (Client ID 15631), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine.  This paragraph ceases to be a requirement for this ingredient after 25 October 2023.

The route of administration for medicines that contain dihydrocapsiate must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than 9 mg dihydrocapsiate.

The following warning statements (or words to the same effect) are required on the medicine label:

- (ADULT) 'Adults only’; and

- (PREGNT) 'Not recommended for use by pregnant and lactating women'.

 

1831

DIHYDROCARVYL ACETATE

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%.

 

1832

DIHYDROCOUMARIN

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%.

 

1833

DIHYDROCUMINYL ALCOHOL

E

Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation.

The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

 

1834

DIHYDROEUGENOL

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%.

 

1835

DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE

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%.

 

1836

DIHYDROINDENYL-2,4-DIOXANE

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%.

 

1837

DIHYDROLINALOOL

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%.

 

1838

DIHYDROMYRCENOL

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%.

 

1839

DIHYDROMYRCENYL 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%.

 

1840

DIHYDROXYACETONE

E

Only for use in topical medicines for dermal application.

 

1841

DIISOPROPYL ADIPATE

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%.

 

1842

DIISOPROPYL SEBACATE

E

Only for use in topical medicines for dermal application and not be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 10%.

 

1843

DIISOSTEARYL DIMER DILINOLEATE

E

Only for use in topical medicines for dermal application.

 

1844

DILAURYL THIODIPROPIONATE

E

Only for use in topical medicines for dermal application.

 

1845

DILL HERB OIL

A, E, H

 

1846

DILL SEED OIL

A, E, H

 

1847

DIMER DISTEARYLTRICARBONATE

E

Only for use in topical medicines for dermal application and not to be used in medicines intended for use in the eye.

The concentration in the medicine must be no more than 4%.

 

1848

DIMETHICONE 12500

E

 

1849

DIMETHICONE 4000

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 3%.

 

1850

DIMETHICONE CROSSPOLYMER

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin.

The concentration in the medicine must be no more than 15%.

 

1851

DIMETHICONE SILYLATE

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%.

 

1852

DIMETHICONE/METHICONE 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 4%.

 

1853

DIMETHICONE/VINYL DIMETHICONE 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 1.5%.

 

1854

DIMETHYL 3-CYCLOHEXENE-1-CARBOXALDEHYDE

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%.

 

1855

DIMETHYL ANTHRANILATE

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%.

 

1856

DIMETHYL BENZYL CARBINOL

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%.

 

1857

DIMETHYL BENZYL CARBINYL 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%.

 

1858

DIMETHYL BENZYL CARBINYL 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%.

 

1859

DIMETHYL BENZYL CARBINYL ISOBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

1860

DIMETHYL PHENYLETHYL CARBINOL

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%.

 

1861

DIMETHYL PHTHALATE

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%.

 

1862

DIMETHYL POLYSILOXANE

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%.

 

1863

DIMETHYL SUCCINATE

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%.

 

1864

DIMETHYL SULFIDE

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%.

 

1865

DIMETHYL SULFONE

A

Only for use in oral and topical medicines.

 

1866

DIMETHYL SULFOXIDE

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%.

 

1867

DIMETHYLACETAL

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%.

 

1868

DIMETHYLCYCLOHEXYLETHOXY ISOBUTYLPROPANOATE

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%.

 

1869

DIMETHYLGLYCINE HYDROCHLORIDE

A

Only for use in oral medicines.

 

1870

DIMETHYLOL DIMETHYL HYDANTOIN

E

Only for use in topical medicines for dermal application.

 

1871

DIMETICONE 1.5

E

Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin.

The concentration in the medicine must not be more than 23%.

 

1872

DIMETICONE 10

E

 

1873

DIMETICONE 100

E

Only for use in topical medicines for dermal application.

 

1874

DIMETICONE 1000

E

 

1875

DIMETICONE 1510

E

Permitted for use only in combination with other permitted ingredients as a printing ink.

If used in a printing ink the total printing ink concentration in a medicine must be no more than 0.1%

 

1876

DIMETICONE 2

E

Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin.

The concentration in the medicine must be no more than 9.602%.

 

1877

DIMETICONE 20

E

Only for use in topical medicines for dermal application.

 

1878

DIMETICONE 200

E

Only for use in topical medicines for dermal application.

 

1879

DIMETICONE 30

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%.

 

1880

DIMETICONE 350

E

Only for use in topical and oral medicines.

When used orally, the maximum daily dose must be no more than 7.5mg.

 

1881

DIMETICONE 360

E

Only for use in topical medicines for dermal application.

 

1882

DIMETICONE 450

E

Only for use in topical medicines for dermal application.

 

1883

DIMETICONE 5

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 10%.

 

1884

DIMETICONE 50

E

Only for use in topical medicines for dermal application.

 

1885

DIMETICONE 5000

E

Only for use in topical medicines for dermal application.

 

1886

DIMETICONE 6

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%.

 

1887

DIMETICONE COPOLYOL

E

Only for use in topical medicines for dermal application.

 

1888

DIMETICONE COPOLYOL PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

1889

DIMETICONE CROSSPOLYMER-3

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 15%.

 

1890

DIMETICONE/PEG-10/15 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%.

 

1891

DIMETICONOL

E

Only for use in topical medicines for dermal application.

 

1892

DIMETICONOL 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%.

 

1893

DIMETICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or damaged skin.

The concentration in the medicine must not be more than 10%.

 

1894

DIMOCARPUS LONGAN

A, H

 

1895

DIOCTYL ADIPATE

E

Only for use in topical medicines for dermal application.

 

1896

DIOCTYL MALEATE

E

Only for use in topical medicines for dermal application.

 

1897

DIOCTYL SUCCINATE

E

Only for use in topical medicines for dermal application.

 

1898

DIOCTYL TEREPHTHALATE

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%.

 

1899

DIOLAMINE C8-18 PERFLUOROALKYLETHYL PHOSPHATE

E

Only for use in topical medicines for dermal application and not be included in topical medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.7%

 

1900

DIOLAMINE CETYL PHOSPHATE

E

Only for use in topical medicines for dermal application and not be included in topical medicines intended for use in the eye.

 

1901

DIOSCOREA COLLETTII

A, H

 

1902

DIOSCOREA COLLETTII VAR. HYPOGLAUCA

A, H

 

1903

DIOSCOREA JAPONICA

A, H

 

1904

DIOSCOREA OPPOSITIFOLIA

A, H

 

1905

DIOSCOREA POLYSTACHYA

A, H

 

1906

DIOSCOREA SEPTEMLOBA

A, H

 

1907

DIOSCOREA VILLOSA

A, E, H

 

1908

DIOSPYROS KAKI

A, E, H

 

1909

DIOXYBENZONE

A

Only for use as an active ingredient in sunscreens for dermal application.

The concentration in the medicine must be no more than 3%.

When used in primary sunscreen products, the medicine requires the following warning statements on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

1910

DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin.

The concentration in the medicine must be no more than 0.5%.

 

1911

DIPENTAERYTHRITYL TETRAHYDROXYSTEARATE/TETRAISOSTEARATE

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%.

 

1912

DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE

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%.

 

1913

DIPHENYL DIMETHICONE

E

Only for use in topical medicines for dermal application.

 

1914

DIPHENYL METHANE

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%.

 

1915

DIPHENYL 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%.

 

1916

DIPOTASSIUM GLYCYRRHIZATE

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%.

 

1917

DIPROPIONYL

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%.

 

1918

DIPROPYLENE GLYCOL

E

Only for use in topical medicines for dermal application.

 

1919

DIPROPYLENE GLYCOL DIBENZOATE

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 4.2%.

 

1920

DIPROPYLENE GLYCOL SALICYLATE

E

Only for use in topical medicines for dermal application.

 

1921

DIPSACUS ASPER

A, H

 

1922

DIPSACUS JAPONICUS

A, H

 

1923

DIPTERYX ODORATA

A, E, H

When used as an active ingredient coumarin is a mandatory component of Dipteryx odorata and the concentration of coumarin in the medicine must be no more than 0.001%.

 

1924

DISODIUM ASCORBYL SULFATE

E

Only for use in topical medicines for dermal application.

 

1925

DISODIUM COCOAMPHODIACETATE

E

 Only for use in topical medicines for dermal application.

 

1926

DISODIUM COCOAMPHODIPROPIONATE

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%.

 

1927

DISODIUM DIMETICONE COPOLYOL SULFOSUCCINATE

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 14%.

 

1928

DISODIUM EDETATE

E

Edetic acid is a mandatory component of disodium edetate.

The total concentration of edetic acid in the medicine must not be more than 0.25%.

 

1929

DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE

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 1%.

 

1930

DISODIUM GUANYLATE

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%.

 

1931

DISODIUM INOSINATE

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%.

 

1932

DISODIUM LAURIL SULFOSUCCINATE

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 0.35%.

 

1933

DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES

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 3%.

 

1934

DISODIUM NADH

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 0.02%.

 

1935

DISODIUM OLEAMIDO PEG-2 SULFOSUCCINATE

E

Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye.

The concentration in the medicine must be no more than 1%.

 

1936

DISODIUM PHENYL DIBENZIMIDAZOLE TETRASULFONATE

A

Only for use as an active ingredient in sunscreens for dermal application.

The concentration in the medicine must be no more than 10%.

When used in primary sunscreen products, the medicine requires the following warning statements on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

1937

DISODIUM RICINOLEAMIDO MEA-SULFOSUCCINATE

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 3%.

 

1938

DISODIUM RUTINYL DISULFATE

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 0.05%.

 

1939

DISODIUM STEAROYL GLUTAMATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. 

The concentration in the medicine must be no more than 1%.

 

1940

DISPERSIBLE CELLULOSE

E

 

1941

DISTARCH 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 4%.

 

1942

DISTEARDIMONIUM HECTORITE

E

Only for use in topical medicines for dermal application and not to be included for medicines intended for use in the eye.

The concentration in the medicine must be no more than 2%.

 

1943

DISTEARETH-6 DIMONIUM CHLORIDE

E

Only for use in topical medicines for dermal application.

 

1944

DISTEARYL PHTHALIC ACID AMIDE

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%.

 

1945

DISTEARYLDIMONIUM CHLORIDE

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%.

 

1946

DIVINYLDIMETHICONE/DIMETHICONE 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 1.5%.

 

1947

DL-ALPHA-TOCOPHEROL

A, E

 

1948

DL-ALPHA-TOCOPHERYL ACETATE

A, E, H

 

1949

DL-ALPHA-TOCOPHERYL ACID SUCCINATE

A, E, H

 

1950

DL-BORNEOL

E

 

1951

DL-LIMONENE

E

Only for use in topical medicines for dermal application.

 

1952

DL-THREONINE

A, E

 

1953

DOCOSAHEXAENOIC ACID (DHA)-RICH OIL DERIVED FROM MICROALGAE SCHIZOCHYTRIUM SP.

A

Only for use in oral medicines and must be present in combination with other ingredients.

 

1954

DOCUSATE SODIUM

E

 

1955

DODECAHYDRO-3A,6,6,9A-TETRAMETHYLNAPHTHO(2,1-B)FURAN

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%.

 

1956

DODECANENITRILE

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%.

 

1957

DODECENAL

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%.

 

1958

DODECENE

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%.

 

1959

DODECYL ACETATE

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%.

 

1960

DODECYL 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%.

 

1961

DOLICHOS LABLAB

A, H

 

1962

DOLOMITE

A, E, H

 

1963

DRACAENA DRACO

A, H

 

1964

DRIED BUTTERMILK

E

 

1965

DRIED CALCIUM SULFATE

A, E, H

 

1966

DRIED MAGNESIUM SULFATE

A, E, H

When used internally, the maximum recommended daily dose must be no more than 1.5g.

Magnesium is a mandatory component of dried magnesium sulfate.

When used in a medicine:

(a) with an oral route of administration;

(b) not indicated for laxative (or related) use; and

(c) where the maximum recommended daily dose for:

(i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

- (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect).

When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

1967

DRIMIA INDICA

A, H

 

1968

DRIMIA MARITIMA

A, H

 

1969

DROMETRIZOLE TRISILOXANE

A

Only for use as an active ingredient in sunscreens for dermal application.

The concentration in a medicine must be no more than 10%.

When used in primary sunscreen products, the medicine requires the following warning statements on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when

exposed to the sun' (or words to this effect).

 

1970

DROSERA ANGLICA

A, H

 

1971

DROSERA BURMANNI

A, H

 

1972

DROSERA INTERMEDIA

A, H

 

1973

DROSERA RAMENTACIA

A, H

 

1974

DROSERA ROTUNDIFOLIA

A, E, H

 

1975

DROSERA ROTUNDIFOLIA MIS

A, H

 

1976

DRYNARIA FORTUNEI

A, H

 

1977

DRYOBALANOPS AROMATICA

A, H

 

1978

DRYOPTERIS FILIX-MAS

H

Only for use as an active homoeopathic ingredient.

 

1979

DULACIA INOPIFLORA

A, H

 

1980

DUNALIELLA SALINA

A, E, H

 

1981

DURVILLAEA ANTARCTICA EXTRACT

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 0.1%.

 

1982

DWARF PINE-NEEDLE 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%.

 

1983

DYSPHANIA AMBROSIOIDES

A, H

Volatile oil components (of Dysphania ambrosioides) are mandatory components of Dysphania ambrosioides.

 

1984

ECAMSULE

A

Only for use as an active ingredient in sunscreens for dermal application.

The concentration in the medicine must be no more than 10%.

When used in primary sunscreen products, the medicine requires the following warning statements on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

1985

ECHINACEA ANGUSTIFOLIA

A, E, H

 

1986

ECHINACEA PALLIDA

A, E, H

 

1987

ECHINACEA PURPUREA

A, E, H

 

1988

ECHINOPA SPINOSISSIMUS

A, H

 

1989

ECLIPTA PROSTRATA

A, H

 

1990

ECTOINE

E

Only for use as an excipient ingredient in topical medicines for dermal application and not to be used in topical medicines intended for use in the eye.

The concentration in the medicine must be no more than 3%.

 

1991

EDETATE SODIUM

E

Only for use in topical medicines for dermal application and nasal medicines.

The concentration in the medicine must be no more than 0.2%.

 

1992

EDETIC ACID

E

The concentration in the medicine must be no more than 0.25%.

 

1993

EGG LECITHIN

A, E

 

1994

EGGSHELL MEMBRANE HYDROLYSATE

A

 

1995

EGGSHELL MEMBRANE POWDER

A

 

1996

ELAEAGNUS ANGUSTIFOLIA

A, H

 

1997

ELAEIS GUINEENSIS

A, E, H

 

1998

ELASTIN

E

Only for use in topical medicines for dermal application.

 

1999

ELDER FLOWER ABSOLUTE

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%.

 

2000

ELDER FLOWER BLACK DRY

A, E, H

 

2001

ELDER FLOWER BLACK POWDER

A, H

 

2002

ELECAMPANE RHIZOME DRY

A, H

 

2003

ELECAMPANE RHIZOME POWDER

A, H

 

2004

ELEMI 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%.

 

2005

ELEMI RESINOID

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%.

 

2006

ELEMOL

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%.

 

2007

ELEOCHARIS DULCIS

A, H

 

2008

ELETTARIA CARDAMOMUM

A, E, H

 

2009

ELEUTHEROCOCCUS NODIFLORUS

A, H

 

2010

ELEUTHEROCOCCUS ROOT DRY

A, H

 

2011

ELEUTHEROCOCCUS ROOT POWDER

A, H

 

2012

ELEUTHEROCOCCUS SENTICOSUS

A, H

 

2013

ELSHOLTZIA SPLENDENS

A, H

 

2014

ELYMUS REPENS

A, E, H

 

2015

EMU OIL

A, E

Emu oil ingredients must meet the following two requirements:

1) the manufacturing process is to include steps such as cooking, fat drying or deodorising which ensures the temperature of the oil reaches at least 60 degrees C for a minimum 5 minutes or at least 100 degrees C for a minimum of 1 minute, and

2) the sponsor is to hold a veterinary certificate indicating that the emus from which the raw material was extracted were healthy and fit for human consumption.

 

2016

EMULSIFYING WAX

E

 

2017

ENOXOLONE

E

Only for use in topical medicines for dermal application.

 

2018

ENZYME MODIFIED CREAM

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%.

 

2019

EPA-RICH NANNOCHLOROPSIS OCULATA OIL

A, E

Only to be used in a medicine where Lipa Pharmaceuticals Ltd (Client ID 23299), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 15 August 2024.

The route of administration for medicines that contain EPA-rich Nannochloropsis oculata oil must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than 2000 mg of EPA-rich Nannochloropsis oculata oil.

The following warning statements (or words to the same effect) must be included on the medicine label:

- (PREGNT) 'Not recommended for use by pregnant and lactating women'; and

- (ADULT) ‘Adults only'.

 

2020

EPHEDRA DISTACHYA

A, H

Ephedrine and Pseudoephedrine (of Ephedra distachya) are mandatory components of Ephedra distachya and must be declared in the application.

The concentration of ephedrine from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

2021

EPHEDRA SINICA

A, H

Ephedrine and Pseudoephedrine (of Ephedra sinica) are mandatory components of Ephedra sinica.

The concentration of ephedrine from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

2022

EPIGAEA REPENS

A, H

 

2023

EPILOBIUM ANGUSTIFOLIUM

E

Only for use in topical sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The extract must be processed from the flower, leaf and stem (herb top flowering) of the plant.

The extracts used must be: 1:20 in 100% water or 1:2 in 100% water.

The concentrations of Epilobium angustifolium must be no more than 0.75% for a 1:2 extract in 100% water, and 5% for a 1:20 extract in 100% water.

 

2024

EPILOBIUM PALUSTRE

A, H

 

2025

EPILOBIUM PARVIFLORUM

A, H

 

2026

EPIMEDIUM BREVICORNU

A, H

 

2027

EPIMEDIUM GRANDIFLORUM

A, H

 

2028

EPIMEDIUM SAGITTATUM

A, H

 

2029

EQUISETUM ARVENSE

A, E, H

 

2030

EQUISETUM HIEMALE

A, H

 

2031

ERGOCALCIFEROL

A, E

When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D.

 

2032

ERGOTHIONEINE

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 0.0005%.

 

2033

ERIGERON BREVISCAPUS

A, H

 

2034

ERIOBOTRYA JAPONICA

A, H

Amygdalin and hydrocyanic acid are mandatory components.

The concentration of amygdalin in the medicine must be 0%.

The concentration of hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

2035

ERIOCAULON BUERGERIANUM

A, H

 

2036

ERIODICTYON CRASSIFOLIUM

A, H

 

2037

ERIODICTYON GLUTINOSUM

A, H

 

2038

ERODIUM CICUTARIUM

A, H

 

2039

ERUCA SATIVA

A, H

 

2040

ERYTHORBIC ACID

E

 

2041

ERYTHRITOL

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%.

 

2042

ERYTHROSINE

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

2043

ERYTHROSINE ALUMINIUM LAKE

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

2044

ERYTHRULOSE

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%.

The medicine requires the following warning statement on the medicine label:

- (EYE) 'Avoid contact with eyes'.

 

2045

ESCHSCHOLZIA CALIFORNICA

A, H

 

2046

ESTRONE

H

Only for use as an active homoeopathic ingredient.

The total concentration of estrone in the medicine must not be more than 100 micrograms/kg or 100 micrograms/L or 0.00001%.

 

2047

ETHANOL

A, E

When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time.

 

2048

ETHANOL ABSOLUTE

A, E

When ethanol absolute is 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.

 

2049

ETHER

E

The concentration of ether in the medicine must be no more than 10%.

 

2050

ETHOHEXADIOL

E

Only for use in topical medicines for dermal application.

The total concentration of ethohexadiol in the medicine must not be more than 5%.

 

2051

ETHOXYLATED HYDROGENATED CASTOR OIL

E

 

2052

ETHOXYLATED NONYLPHENOL

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%.

 

2053

ETHOXYMETHOXY CYCLODODECANE

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%.

 

2054

ETHYL (2,4-DIMETHYL-[1,3] DIOXOLAN-2-YL) 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%.

 

2055

ETHYL (3AR,4S,7R,7AR)-REL- OCTAHYDRO-4,7-METHANO[3AH]INDENE-3A-CARBOXYLATE

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%.

 

2056

ETHYL 2,3,6,6-TETRAMETHYL-2-CYCLOHEXENECARBOXYLATE

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%.

 

2057

ETHYL 2,6,6,TRIMETHYL-1,3-CYCLOHEXADIENE-1-CARBOXYLATE

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%.

 

2058

ETHYL 2-BUTENOATE

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%.

 

2059

ETHYL 2-ETHYL-6,6-DIMETHYL-2-CYCLOHEXENECARBOXYLATE

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%.

 

2060

ETHYL 2-HEXYL ACETOACETATE

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%.

 

2061

ETHYL 2-METHYLBUTYRATE

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%.

 

2062

ETHYL 2-METHYLPENTANOATE

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%.

 

2063

ETHYL 3-HEXENOATE

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%.

 

2064

ETHYL 3-HYDROXYBUTYRATE

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%.

 

2065

ETHYL 3-HYDROXYHEXANOATE

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%.

 

2066

ETHYL 3-MERCAPTOPROPIONATE

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%.

 

2067

ETHYL 3-METHYLTHIOPROPIONATE

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%.

 

2068

ETHYL 4,7-OCTADIENOATE

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%.

 

2069

ETHYL ACETATE

E

The residual solvent limit for ethyl acetate is 50 mg per recommended daily dose.

The concentration in the medicine must be no more than 0.5%.

 

2070

ETHYL ACETOACETATE

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%.

 

2071

ETHYL ACRYLATE

E

 

2072

ETHYL AMYL 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%.

 

2073

ETHYL ANTHRANILATE

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%.

 

2074

ETHYL BENZOATE

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%.

 

2075

ETHYL BENZOYL 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%.

 

2076

ETHYL BUTYLACETYLAMINOPROPIONATE

E

Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 7.5%.

The medicine requires the following warning statement on the medicine label:

- (EYE2) 'May be irritant to the eyes (or words to that effect)'.

 

2077

ETHYL 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%.

 

2078

ETHYL CAPRATE

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%.

 

2079

ETHYL CAPROATE

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%.

 

2080

ETHYL CAPRYLATE

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%.

 

2081

ETHYL CINNAMATE

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

 

2082

ETHYL CROTONATE

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%.

 

2083

ETHYL ENANTATE

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%.

 

2084

ETHYL 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%.

 

2085

ETHYL HYDROXYBENZOATE

E

 

2086

ETHYL 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%.

 

2087

ETHYL 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%.

 

2088

ETHYL 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%.

 

2089

ETHYL LAURATE

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%.

 

2090

ETHYL LEVULATE

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%.

 

2091

ETHYL 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%.

 

2092

ETHYL LINALOOL

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%.

 

2093

ETHYL LINALYL 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%.

 

2094

ETHYL LINOLEATE

E

Only for use in topical medicines for dermal application.

 

2095

ETHYL LINOLENATE

E

Only for use in topical medicines for dermal application.

 

2096

ETHYL MACADAMIATE

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%.

 

2097

ETHYL MALTOL

E

 

2098

ETHYL MENTHANE CARBOXAMIDE

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%.

 

2099

ETHYL METHACRYLATE

E

Only for use in topical medicines for dermal application.

 

2100

ETHYL METHYLPHENYLGLYCIDATE

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%.

 

2101

ETHYL METICONE

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 3%.

 

2102

ETHYL MYRISTATE

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%.

 

2103

ETHYL OLEATE

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%.

 

2104

ETHYL ORTHO-METHOXYBENZYL 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%.

 

2105

ETHYL OXYHYDRATE

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%.

 

2106

ETHYL PALMITATE

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%.

 

2107

ETHYL PARA-ANISATE

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%.

 

2108

ETHYL PELARGONATE

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%.

 

2109

ETHYL 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%.

 

2110

ETHYL PHENYLGLYCIDATE

E

Ethyl phenylglycidate must only be used in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The concentration of ethyl phenylglycidate in a medicine must not be more than 0.0000024% w/w (equivalent to 24 parts per billion).

 

2111

ETHYL 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%.

 

2112

ETHYL PYRUVATE

E

Ethyl pyruvate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of the flavour proprietary excipient formulation containing ethyl pyruvate must not be more than 5% of the total medicine.

 

2113

ETHYL RICINOLEATE

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%.

 

2114

ETHYL 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%.

 

2115

ETHYL SEBACATE

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%.

 

2116

ETHYL STEARATE

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%.

 

2117

ETHYL SUCCINATE

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%.

 

2118

ETHYL TARTRATE

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%.

 

2119

ETHYL TRANS-2, CIS-4-DECADIENOATE

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%.

 

2120

ETHYL TRANS-2-HEXENOATE

E

Ethyl trans-2-hexenoate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing ethyl trans-2-hexenoate must not be more than 5% of the total medicine.

 

2121

ETHYL TRANS-3-HEXENOATE

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%.

 

2122

ETHYL UNDECYLENATE

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%.

 

2123

ETHYL VALERATE

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%.

 

2124

ETHYL VANILLIN

E

 

2125

ETHYL-2-METHYL-1,3-DIOXOLANE-2-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%.

 

2126

ETHYL-2-METHYL-4-PENTENOATE

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%.

 

2127

ETHYL-2-METHYLPENTENOATE

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%.

 

2128

ETHYLBISIMINOMETHYL GUAIACOL MANGANESE CHLORIDE

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 0.002%.

 

2129

ETHYLCELLULOSE

E

 

2130

ETHYLENE BRASSYLATE

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%.

 

2131

ETHYLENE GLYCOL

E

The residual solvent limit for ethylene glycol is 6.2 mg per recommended daily dose.

The concentration in the medicine must be no more than 0.062%.

 

2132

ETHYLENE GLYCOL MONOPALMITOSTEARATE

E

Only for use in topical medicines for dermal application.

 

2133

ETHYLENE/ACRYLIC ACID COPOLYMER

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. 

The concentration in the medicine must be no more than 2%.

 

2134

ETHYLENE/VINYL ACETATE 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 16%.

 

2135

ETHYLENEDIAMINE

E

Only for use in topical medicines for dermal application.

 

2136

ETHYLENEDIAMINE/HYDROGENATED DIMER DILINOLEATE COPOLYMER BIS-DI-C14-18 ALKYL AMIDE

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%.

 

2137

ETHYLENEDIAMINE/STEARYL 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 or on damaged skin. 

The concentration in the medicine must be no more than 6%.

 

2138

ETHYLHEXYL BENZOATE

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 3.5%.

 

2139

ETHYLHEXYL METHOXYCRYLENE

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%.

 

2140

ETHYLHEXYL TRIAZONE

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 5%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

2141

ETHYLHEXYLGLYCERIN

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%.

 

2142

ETIDRONIC ACID

E

Only for use in topical medicines for dermal application only.

The concentration in the medicine must be no more than 1%.

 

2143

EUCALYPTUS DIVES

A, E, H

Cineole is a mandatory component of Eucalyptus dives.

In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure.

 

2144

EUCALYPTUS FRUTICETORUM

A, E, H

Cineole is a mandatory component of Eucalyptus fruticetorum.

In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure.

 

2145

EUCALYPTUS GLOBULUS

A, E, H

Cineole is a mandatory component of Eucalyptus globulus.

In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure.

 

2146

EUCALYPTUS MACRORHYNCHA

A, E, H

Cineole is a mandatory component of Eucalyptus macrorhyncha.

In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure.

 

2147

EUCALYPTUS OIL

A, E, H

Cineole is a mandatory component of Eucalyptus oil.

When the plant preparation is oil and the total concentration of the oil in the preparation is more than 25%, the nominal capacity of the container must be no more than 25 mL.

When the plant preparation is oil and the total concentration of the oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL but no more than 25mL, 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 words to that effect)

- (NTAKEN) ‘Not to be taken’

When the concentration of the oil in the preparation is more than 25% and the nominal capacity of the container is no more than 15 mL, a 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 words to that effect)

- (NTAKEN) ‘Not to be taken’

 

2148

EUCALYPTUS RADIATA

A, E, H

Cineole is a mandatory component of Eucalyptus radiata.

In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure.

 

2149

EUCALYPTUS ROSTRATA

A, E, H

Cineole is a mandatory component of Eucalyptus rostrata.

In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure.

 

2150

EUCALYPTUS TERETICORNIS

A, E, H

Cineole is a mandatory component of Eucalyptus tereticornis.

In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%:

a) the nominal capacity of the container must be no more than 25 millilitres;

b) a restricted flow insert must be fitted on the container; and

c) the container must include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure.

 

2151

EUCOMMIA ULMOIDES

A, H

 

2152

EUGENOL

E

When for oral ingestion, eugenol must not comprise more than 0.06% of the formulation.

When used in topical medicines for dermal application, the following apply:

a) When the concentration of Eugenol in the preparation is more than 25%, the nominal capacity of the container must be no more than 25 mL.

b) When the concentration of Eugenol in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL but no more than 25mL, 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 words to that effect)

- (NTAKEN) ‘Not to be taken’

c) When the concentration of Eugenol in the preparation is more than 25% and the nominal capacity of the container is no more than 15mL, a 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 words to that effect)

- (NTAKEN) ‘Not to be taken’

 

2153

EUGENYL 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%.

 

2154

EUGLENA GRACILIS WHOLE CELL DRY

A

Only to be used in a medicine where Kemin Foods LC (Client ID 29988), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 1 March 2024.

The route of administration for medicines that contain Euglena gracilis whole cell dry must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than:

(a) 100 mg of Euglena gracilis whole cell dry for children aged between 1 and 3 years (inclusive);

(b) 150 mg of Euglena gracilis whole cell dry for children aged between 4 and 8 years (inclusive);

(c) 225 mg of Euglena gracilis whole cell dry for individuals aged between 9 and 18 years (inclusive); and

(d) 375 mg of Euglena gracilis whole cell dry for adults aged 19 years or older.

The following warning statement (or words to the same effect) must be included on the medicine label:

- (BABY2) 'Not suitable for infants under the age of twelve months'.

 

2155

EUONYMUS ATROPURPUREUS

A, H

 

2156

EUONYMUS EUROPAEUS

A, H

The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.

 

2157

EUPATORIUM FORTUNEI

A, H

 

2158

EUPATORIUM JAPONICUM

A, H

 

2159

EUPATORIUM PERFOLIATUM

A, H

 

2160

EUPATORIUM PURPUREUM

A, H

 

2161

EUPHAUSIA SUPERBA OIL

A

Only for use in oral medicines.

 

2162

EUPHORBIA CYPARISSIAS

A, H

 

2163

EUPHORBIA DRY

A, H

 

2164

EUPHORBIA HETERODOXA

A, H

 

2165

EUPHORBIA HIRTA

A, H

 

2166

EUPHORBIA LATHYRIS

A

Levodopa is a mandatory component of Euphorbia lathyris.

The concentration of levodopa in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

 

2167

EUPHORBIA PEKINENSIS

A, H

 

2168

EUPHORBIA PEPLUS

H

Only for use as an active homoeopathic ingredient.

 

2169

EUPHORBIA POWDER

A, H

 

2170

EUPHORBIA RESINIFERA

A, H

 

2171

EUPHORBIA SIEBOLDIANA

A, H

 

2172

EUPHRASIA OFFICINALIS

A, H

 

2173

EUROPEAN GARDEN SPIDER

H

Only for use as an active homoeopathic ingredient.

 

2174

EUROPEAN HORNET

H

Only for use as an active homoeopathic ingredient.

 

2175

EURYALE FEROX

A, H

 

2176

EUTERPE OLERACEA

A, E

The plant part must be derived from the fruit.

When used as an excipient:

-  permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation;

-  the total flavour proprietary excipient formulation in a medicine must not be more than 5%; and

-  the following warning statement is required on the medicine label:

-  (ACAI) ‘Contains acai’.

 

2177

EVENING PRIMROSE OIL

A, E, H

 

2178

EVERNIA PRUNASTRI EXTRACT

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%.