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Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018

made under subsection 26BB(1) of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date: 11 April 2018

Includes amendments up to: F2018L00476

 

This compilation is in 6 volumes

Volume 1: section 1–3, Schedule 1, Parts 1 and 2 (items 1–728)

Volume 2: Schedule 1, Part 2 (items 729–2135)

Volume 3: Schedule 1, Part 2 (items 2136—2812)

Volume 4: Schedule 1, Part 2 (items 2813–3598)

Volume 5: Schedule 1, Part 2 (items 3599–5010)

Volume 6: Schedule 1, Part 2 (items 5011–5216)

Each volume has its own contents

 

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018 that shows the text of the law as amended and in force on 11 April 2018 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self-repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 

 

 

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

(section 4)

 

Part 2 – Table 1

Column 1

Column 2

Ingredient Name

Column 3

Purpose of the ingredient in the medicine

Column 4

Specific requirements(s) applying to the ingredient in Column 2

729

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).

 

730

BACOPA MONNIERI

A, H

 

731

BALLOTA NIGRA

A, H

 

732

BALM OF GILEAD BUD DRY

A, H

 

733

BALM OF GILEAD BUD POWDER

A, H

 

734

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%.

 

735

BAMBUSA BREVIFLORA

A, E, H

 

736

BAMBUSA TEXTILIS

A, H

 

737

BANANA

E

 

738

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%.

 

739

BAPTISIA CONFUSA

A, H

 

740

BAPTISIA TINCTORIA

A, H

 

741

BARBAREA VULGARIS

A, H

 

742

BARIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

 

743

BARIUM CHLORIDE

H

Only for use as an active homoeopathic ingredient.

 

744

BARIUM SULFATE

E

Only for use in topical medicines for dermal application.

 

745

BARLEY

E

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

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

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

 

746

BARLEY BRAN

E

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

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

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

 

747

BARLEY GERM

E

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

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

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

 

748

BARLEY LEAF

E

 

749

BASIC BUTYLATED METHACRYLATE COPOLYMER

E

Only for use in oral medicines.

 

750

BASIC FUCHSIN

E

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

 

751

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%.

 

752

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%.

 

753

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).

 

754

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).

 

755

BASSIA SCOPARIA

A, H

 

756

BATYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

757

BAY LEAF

E

 

758

BAY OIL

A, E, H

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

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

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

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

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

- (NTAKEN) 'Not to be taken'

 

759

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%.

 

760

BEET RED

E

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

 

761

BEETROOT

E, H

 

762

BEGONIA FIMBRISTIPULA

A, H

 

763

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.

 

764

BEHENIC ACID

E

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

 

765

BEHENOXY DIMETHICONE

E

Only for use in topical medicines for dermal application.

 

766

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%.

 

767

BEHENYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

768

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%.

 

769

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%.

 

770

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%.

 

771

BELLIS PERENNIS

A, H

 

772

BEMOTRIZINOL

A

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

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

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

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

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

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

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

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

 

773

BENINCASA HISPIDA

A, E, H

 

774

BENTONITE

E

 

775

BENZALDEHYDE

E

 

776

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%.

 

777

BENZALKONIUM CHLORIDE

E

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

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

 

 

778

BENZETHONIUM CHLORIDE

E

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

The medicine requires the warning statement:

- (BNZTHC) 'Contains Benzethonium chloride' (or words to that effect).

 

779

BENZOIC ACID

E, H

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

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

 

780

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%.

 

781

BENZOIN SIAM

A, E, H

 

782

BENZOIN SUMATRA

A, E, H

 

783

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%.

 

784

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%.

 

785

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%.

 

786

BENZYL ALCOHOL

E

The medicine requires the warning statement:

- (BNZALC) 'Contains benzyl alcohol [quantity]' (or words to that effect).

 

787

BENZYL BENZOATE

E

Only for use in topical medicines for dermal application.

Medicines containing benzoates require the warning statement:

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

 

788

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%.

 

789

BENZYL CINNAMATE

E

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

The concentration in the medicine must be no more than 0.15%.

 

790

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%.

 

791

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%.

 

792

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%.

 

793

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%.

 

794

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%.

 

795

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%.

 

796

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%.

 

797

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%.

 

798

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%.

 

799

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%.

 

800

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%.

 

801

BENZYLIDENE CAMPHOR SULFONIC ACID

A

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

The concentration in the medicine must be no more than 6% (as acid).

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

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

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

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

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

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

 

802

BERBERIS AQUIFOLIUM

A, H

 

803

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).

 

804

BERBERIS VULGARIS

A, E, H

 

805

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)

 

806

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%.

 

807

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.

 

808

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%.

 

809

BERTHOLLETIA EXCELSA

A, E, H

 

810

BETA RAPA

A, E, H

 

811

BETA VULGARIS

A, E, H

 

812

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%.

 

813

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%.

 

814

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%.

 

815

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%.

 

816

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%.

 

817

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%.

 

818

BETA-HYDROXY-BETA-METHYLBUTYRIC ACID

A

 

819

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%.

 

820

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%.

 

821

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%.

 

822

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%.

 

823

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%.

 

824

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%.

 

825

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%.

 

826

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%.

 

827

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%.

 

828

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%.

 

829

BETA-TOCOPHEROL

E

 

830

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.’

 

 

831

BETADEX

E

 

832

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%.

 

833

BETAINE

E

Only for use in topical medicines for dermal application.

 

834

BETAINE HYDROCHLORIDE

E

 

835

BETULA LENTA

A, H

Methyl salicylate is a mandatory component of Betula lenta.

Not to be used orally, unless the concentration of methyl salicylate in the medicine is no more than 0.001%.

When the concentration of methyl salicylate in the medicine is more than 0.001%, 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.

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 but the delivery device must be 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.

 

 

 

836

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%.

Not to be used orally, unless the concentration of methyl salicylate in the medicine is no more than 0.001%.

When the concentration of methyl salicylate in the medicine is more than 0.001%, 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.

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 but the delivery device must be 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.

 

 

837

BETULA PENDULA

A, E, H

Methyl salicylate is a mandatory component of Betula pendula.

Not to be used orally, unless the concentration of methyl salicylate in the medicine is no more than 0.001%.

When the concentration of methyl salicylate in the medicine is more than 0.001%, 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.

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 but the delivery device must be 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.

 

 

 

838

BETULA PUBESCENS

A, E, H

 

839

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%.

 

840

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%.

 

841

BIFIDOBACTERIUM ADOLESCENTIS

A

 

842

BIFIDOBACTERIUM ANIMALIS

A

 

843

BIFIDOBACTERIUM ANIMALIS SSP ANIMALIS

A

 

844

BIFIDOBACTERIUM ANIMALIS SSP LACTIS

A

 

845

BIFIDOBACTERIUM BIFIDUM

A

 

846

BIFIDOBACTERIUM BREVE

A

 

847

BIFIDOBACTERIUM INFANTIS

A

 

848

BIFIDOBACTERIUM LACTIS

A

 

849

BIFIDOBACTERIUM LONGUM

A

 

850

BILBERRY

E

 

851

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%.

 

852

BIOTA ORIENTALIS

A, H

 

853

BIOTIN

A, E

 

854

BIRCH LEAF DRY

A, E, H

Methyl salicylate is a mandatory component of Birch leaf dry.

Not to be used orally, unless the concentration of methyl salicylate in the medicine is no more than 0.001%.

When the concentration of methyl salicylate in the medicine is more than 0.001%, 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.

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 but the delivery device must be 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.

 

 

855

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%.

 

 

856

BIS-DIGLYCERYL POLYACYLADIPATE-2

E

Only for use in topical medicines for dermal application.

 

857

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%.

 

858

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%.

 

859

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%.

 

860

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%.

 

861

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%.

 

862

BISABOLOL

E

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

 

863

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.

 

864

BIXA ORELLANA

A, E, H

 

865

BLACK BONED CHICKEN POWDER

A

 

866

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.'

 

867

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.'

 

868

BLACK CURRANT

E

 

869

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%.

 

870

BLACK CURRANT FRESH

A, E, H

 

871

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%.

 

872

BLACK OF CURACAO SPIDER

H

Only for use as an active homoeopathic ingredient.

 

873

BLACK PEPPER OIL

A, E, H

 

874

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%.

 

875

BLACK SNAKE

H

Only for use as an active homoeopathic ingredient.

 

876

BLACKBERRY

E

 

877

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%.

 

878

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%.

 

879

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%.

 

880

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%.

 

881

BLACKSTRAP MOLASSES

E

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

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

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

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

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

 

882

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.

 

 

883

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.

 

884

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%.

 

885

BLETILLA STRIATA

A, H

 

886

BLUE FLAG RHIZOME DRY

A, H

 

887

BLUE FLAG RHIZOME POWDER

A, H

 

888

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%.

 

889

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%.

 

890

BLUMEA LACERA

A, H

 

891

BOEHMERIA NIVEA

A, H

 

892

BOERHAVIA DIFFUSA

A, H

 

893

BOERHAVIA REPENS

A, H

 

894

BOGBEAN LEAF DRY

A, H

 

895

BOGBEAN LEAF POWDER

A, H

 

896

BOIS DE ROSE OIL

A, E, H

 

897

BOMBAX CEIBA

A, H

 

898

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.

 

899

BORAX

A, E, H

Boron is a mandatory component of Borax.

The percentage of Boron from Borax should be calculated based on the molecular weight of Borax.

The maximum recommended daily dose must provide no more than 6mg of Boron.

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

 

 

900

BORAX PENTAHYDRATE

A, E

Boron is a mandatory component of Borax Pentahydrate.

The percentage of Boron from Borax pentahydrate should be calculated based on the molecular weight of Borax Pentahydrate.

The maximum recommended daily dose must provide no more than 6mg of Boron from Borax pentahydrate.

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

 

901

BORIC ACID

A, H

Boron is a mandatory component of Boric acid.

The percentage of Boron from Boric acid should be calculated based on the molecular weight of Boric acid.

The maximum recommended daily dose must provide no more than 6mg of Boron.

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

 

 

902

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%.

 

903

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%.

 

904

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%.

 

905

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%.

 

906

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%.

 

907

BOSWELLIA CARTERII

A, E, H

 

908

BOSWELLIA SERRATA

A, E, H

 

909

BOSWELLIA THURIFERA

A, H

 

910

BOVINE CALCIUM CHONDROITIN SULFATE

A

 

911

BOVINE CHONDROITIN SULFATE

A

 

912

BOVINE COLOSTRUM POWDER

A

The medicine requires the warning statement:

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

 

913

BOVINE LACTOFERRIN

A

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

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

 

914

BOVINE POTASSIUM CHONDROITIN SULFATE

A

 

915

BOVINE SODIUM CHONDROITIN SULFATE

A

 

916

BOVINE WHEY IG-RICH FRACTION

A

Only for use in oral medicines.

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

- (COWMK) 'Derived from cows milk'

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

 

917

BRANDY

E

 

918

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%.

 

919

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%.

 

920

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%.

 

921

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%.

 

922

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%.

 

923

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%.

 

924

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%.

 

925

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%.

 

926

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%.

 

927

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%.

 

928

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%.

 

929

BRAZIL NUT

E

 

930

BRILLIANT BLACK BN

E

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

 

931

BRILLIANT BLUE FCF

E

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

 

932

BRILLIANT BLUE FCF ALUMINIUM LAKE

E

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

 

933

BRILLIANT BLUE FCF BARIUM LAKE

E

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

 

934

BRILLIANT SCARLET 4R

E

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

 

935

BRILLIANT SCARLET 4R ALUMINIUM LAKE

E

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

 

936

BRIZA MEDIA

A, H

 

937

BROCCOLI

E

 

938

BROMELAINS

A

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

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

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

 

939

BROMINE

H

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

 

940

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%.

 

941

BROMUS CATHARTICUS

A, H

 

942

BROMUS INERMIS

A, H

 

943

BROMUS RAMOSUS SUBSP. RAMOSUS

A, H

 

944

BRONOPOL

E

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

The medicine requires the warning statement:

- (BRONOP) 'Contains bronopol [quantity]' (or words to that effect).

 

945

BROUSSONETIA PAPYRIFERA

A, H

 

946

BROWN FK

E

Permitted for use only as a colour for topical use.

 

947

BRUNFELSIA UNIFLORA

A, H

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

 

948

BRUSSEL SPROUT

E

 

949

BRYONIA ALBA

A, H

 

950

BRYONIA DIOICA

A, H

 

951

BUCHU LEAF DRY

A, H

 

952

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%.

 

953

BUCHU LEAF POWDER

A, E, H

 

954

BUCKWHEAT

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

955

BUDDLEJA OFFICINALIS

A, H

 

956

BULNESIA SARMIENTI

A, E, H

 

957

BUNIAS ORIENTALIS

A, H

 

958

BUPLEURUM FALCATUM

A, H

 

959

BURDOCK LEAF DRY

A, H

 

960

BURDOCK LEAF POWDER

A, H

 

961

BURDOCK ROOT DRY

A, H

 

962

BURDOCK ROOT POWDER

A, H

 

963

BUSHMASTER SNAKE

H

Only for use as an active homoeopathic ingredient.

 

964

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%.

 

965

BUTANE

E

Only for use as an excipient propellant ingredient.

 

966

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%.

 

967

BUTTER

E

 

968

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%.

 

969

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%.

 

970

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%.

 

971

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%.

 

972

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%.

 

973

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%.

 

974

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%.

 

975

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%.

 

976

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).

 

977

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%.

 

978

BUTYL HYDROXYBENZOATE

E

Only for use in topical medicines for dermal application.

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

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

 

979

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%.

 

980

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%.

 

981

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%.

 

982

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%.

 

983

BUTYL METHOXYDIBENZOYLMETHANE

A

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

The concentration in preparation must be no more than 5%.

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

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

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

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

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

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

 

984

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%.

 

985

BUTYL STEARATE

E

Only for use in topical medicines for dermal application.

 

986

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%.

 

987

BUTYLATED HYDROXYANISOLE

E

 

988

BUTYLATED HYDROXYTOLUENE

E

 

989

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%.

 

990

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%.

 

991

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%.

 

992

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%.

 

993

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%.

 

994

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%.

 

995

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%.

 

996

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%.

 

997

C10-30 CHOLESTEROL/LANOSTEROL ESTERS

E

Only for use in topical medicines for dermal application.

 

998

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%.

 

999

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.

 

1000

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.

 

1001

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%.

 

1002

C12-15 ALKYL OCTANOATE

E

Only for use in topical medicines for dermal application.

 

1003

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%.

 

1004

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%.

 

1005

C13-14 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

 

1006

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%.

 

1007

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%.

 

1008

C18-36 ACID GLYCOL ESTER

E

Only for use topical medicines for dermal application.

 

1009

C18-36 ACID TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

 

1010

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%.

 

1011

C20-40 ALCOHOLS

E

Only for use in topical medicines for dermal application.

 

1012

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%.

 

1013

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%.

 

1014

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%.

 

1015

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%.

 

1016

C9-11 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

 

1017

C9-11 PARETH-3

E

Only for use in topical medicines for dermal application.

 

1018

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%

 

1019

CABBAGE

E

 

1020

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%.

 

1021

CADE OIL

A, E, H

 

1022

CAESALPINIA SAPPAN

A, H

 

1023

CAFFEINE

A, E

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

Only for use as an active ingredient for oral use in adults when the medicine consists principally of one or more designated active ingredients prescribed in Schedule 14 to the Regulations (other than caffeine); and contains no more than 100 mg of caffeine per maximum daily dose.

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

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

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

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

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

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

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

 

1024

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'.

 

1025

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.

 

1026

CALCIFIED LITHOTHAMNION SPECIES

A

Only for use in oral medicines.

 

1027

CALCIFIED LITHOTHAMNION TOPHIFORME

A

Only for oral use.

 

1028

CALCIUM ALGINATE

E

 

1029

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.

 

 

1030

CALCIUM ASCORBATE

A, E, H

 

1031

CALCIUM ASCORBATE DIHYDRATE

A, E, H

 

1032

CALCIUM ASPARTATE

A

 

1033

CALCIUM ASPARTATE HYDROCHLORIDE DIHYDRATE

A

Only for use in oral medicines.

 

 

1034

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.

 

1035

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE

A, H

 

1036

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE

A, H

 

1037

CALCIUM CARBONATE

A, E, H

 

1038

CALCIUM CASEINATE

E

 

1039

CALCIUM CHLORIDE DIHYDRATE

E

 

1040

CALCIUM CITRATE

A, E, H

 

1041

CALCIUM CITRATE TETRAHYDRATE

A, E, H

 

1042

CALCIUM DIASPARTATE

A

Only for use in oral medicines.

 

1043

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%.

 

1044

CALCIUM FOLINATE

A

Folinic acid is a mandatory component of calcium folinate.

The maximum daily dose must provide no more than 500 micrograms of folinic acid.

When folic acid, folinic acid, levomefolate salts and/or their derivatives are used in combination, the medicine provides not more than a total of 500 micrograms of folic acid, folinic acid, levomefolate salts and/or their derivatives in total per daily dose.

When used in preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects, the following statement must be included on the label:

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

 

 

1045

CALCIUM GLUCONATE MONOHYDRATE

A, E, H

 

1046

CALCIUM GLYCEROPHOSPHATE

A, E, H

 

1047

CALCIUM GLYCINATE

A

Only for use in oral medicines.

 

 

1048

CALCIUM GLYCINATE DIHYDRATE

A

 

1049

CALCIUM HEXAFLUOROSILICATE

H

Only for use as an active homoeopathic ingredient.

 

1050

CALCIUM HYDROGEN PHOSPHATE

A, E, H

 

1051

CALCIUM HYDROGEN PHOSPHATE DIHYDRATE

A, E, H

 

1052

CALCIUM HYDROGEN PHOSPHATE MONOHYDRATE

A, E, H

 

1053

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.

 

 

1054

CALCIUM HYDROXYCITRATE

A, H

 

1055

CALCIUM HYPOPHOSPHITE

H

Only for use as an active homoeopathic ingredient.

 

1056

CALCIUM IODIDE

H

Only for use as an active homoeopathic ingredient.

 

1057

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%

 

1058

CALCIUM L-THREONATE

A

Only for use in oral medicines.

 

 

1059

CALCIUM LACTATE

A, E, H

 

1060

CALCIUM LACTATE GLUCONATE

A, E, H

 

1061

CALCIUM LACTATE PENTAHYDRATE

A, E, H

 

1062

CALCIUM LACTATE TRIHYDRATE

A, E, H

 

1063

CALCIUM LYSINATE

A

Only for use in oral medicines.

 

 

1064

CALCIUM METHIONINATE

A

Only for use in oral medicines.

 

 

1065

CALCIUM OROTATE

A, E, H

 

1066

CALCIUM OXIDE

E

Only for use in topical medicines for dermal application.

 

1067

CALCIUM PANTOTHENATE

A, E, H

 

1068

CALCIUM PHOSPHATE

A, E, H

 

1069

CALCIUM PYRUVATE

A

 

1070

CALCIUM SACCHARATE

E

 

1071

CALCIUM SILICATE

E

 

1072

CALCIUM SODIUM CASEINATE

A, H

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

 - (COWMK) 'Derived from cow's milk'.

 

1073

CALCIUM SODIUM LACTATE

A, E, H

 

1074

CALCIUM STEARATE

E

 

1075

CALCIUM SUCCINATE

A, E, H

 

1076

CALCIUM SULFATE

A, E, H

 

1077

CALCIUM SULFATE DIHYDRATE

A, E, H

 

1078

CALCIUM SULFIDE

H

Only for use as an active homoeopathic ingredient.

 

1079

CALCIUM THREONINATE

A

 

1080

CALENDULA FLOWER DRY

A, E, H

 

1081

CALENDULA FLOWER POWDER

A, H

 

1082

CALENDULA OFFICINALIS

A, E, H

 

1083

CALLERYA RETICULATA

A, H

 

1084

CALLICARPA PEDUNCULATA

A, H

 

1085

CALLISTEMON CITRINUS

A, H

 

1086

CALLISTEPHUS CHINENSIS

A, H

 

1087

CALLITRIS INTRATROPICA

E

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

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

 

1088

CALLITRIS RHOMBOIDEA

A, H

 

1089

CALLUNA VULGARIS

A, E, H

 

1090

CALOCHORTUS TOLMIEI

A, H

 

1091

CALTHA PALUSTRIS

A, H

 

1092

CALUMBA ROOT DRY

A, H

 

1093

CALUMBA ROOT POWDER

A, H

 

1094

CALVATIA GIGANTEA

A, E, H

 

1095

CALYCANTHUS FLORIDUS

A, H

 

1096

CALYCANTHUS PRAECOX

A, H

 

1097

CAMELLIA JAPONICA

A, H

 

1098

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.

 

1099

CAMELLIA SINENSIS

A, E, H

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

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

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

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

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

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

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

 

1100

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%.

 

1101

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%.

 

1102

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%.

 

1103

CAMPHOR BENZALKONIUM METHOSULFATE

A

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

The concentration in the preparation must be no more than 6%.

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

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

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

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

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

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

 

1104

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.

 

1105

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.

 

1106

CAMPSIS GRANDIFLORA

A, H

 

1107

CANADA BALSAM

A, H

 

1108

CANANGA ODORATA

A, E, H

 

1109

CANANGA OIL

A, E, H

 

1110

CANARIUM INDICUM

A, H

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

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

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

 

1111

CANARIUM LUZONICUM

A, H

 

1112

CANDELILLA WAX

A, E, H

 

1113

CANDIDA ALBICANS

H

Only for use as an active homoeopathic ingredient.

 

1114

CANDIDA UTILIS

A, H

 

1115

CANINE MILK

H

Only for use as an active homoeopathic ingredient.

 

1116

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%.

 

1117

CANTHARIDES

H

Only available as an active homoeopathic ingredient.

 

1118

CANTHAXANTHIN

E

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

 

1119

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%.

 

1120

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%.

 

1121

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%.

 

1122

CAPRYLIC/CAPRIC GLYCERIDES

E

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

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

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

 

1123

CAPRYLIC/CAPRIC/ISOSTEARIC/ADIPIC TRIGLYCERIDE

E

 

1124

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%

 

1125

CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

 

1126

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%

 

1127

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%.

 

1128

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%

 

1129

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%.

 

1130

CAPSELLA BURSA-PASTORIS

A, H

 

1131

CAPSICUM

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

1132

CAPSICUM ANNUUM

A, E, H

 

1133

CAPSICUM DRY

A, E, H

 

1134

CAPSICUM FRUIT OLEORESIN

A, E

 

1135

CAPSICUM FRUTESCENS

A, E, H

 

1136

CAPSICUM POWDER

A, E, H

 

1137

CARALLUMA ADSCENDENS VAR. FIMBRIATA

A

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

 

1138

CARAMEL

E

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

 

1139

CARAPICHEA IPECACUANHA

A, H

Emetine is a mandatory component of Carapichea ipecacuanha.

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

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

 

1140

CARAWAY DRY

A, H

 

1141

CARAWAY OIL

A, E, H

 

1142

CARAWAY POWDER

A, H

 

1143

CARBOMER 1342

E

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

 

1144

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.

 

1145

CARBOMER 934

E

Only for use in topical medicines for dermal application.

 

1146

CARBOMER 934P

E

Only for use in topical medicines for dermal application.

 

1147

CARBOMER 940

E

Only for use in topical medicines for dermal application.

 

1148

CARBOMER 941

E

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

 

1149

CARBOMER 954

E

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

 

1150

CARBOMER 980

E

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

 

1151

CARBOMER 981

E

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

 

1152

CARBOMER COPOLYMER (TYPE B)

E

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

 

1153

CARBOMER HOMOPOLYMER (TYPE B)

E

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

 

1154

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%.

 

1155

CARBON

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

1156

CARBON BLACK

E

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

 

1157

CARBON DIOXIDE

E

 

1158

CARDAMOM FRUIT DRY

A, H

 

1159

CARDAMOM FRUIT POWDER

A, E, H

 

1160

CARDAMOM OIL

A, E, H

 

1161

CARDIOSPERMUM HALICACABUM

A, H

 

1162

CARICA PAPAYA

A, E, H

 

1163

CARLINA ACAULIS

A, H

 

1164

CARMELLOSE

E

 

1165

CARMELLOSE CALCIUM

E

 

1166

CARMELLOSE SODIUM

E

 

1167

CARMINE

E

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

 

1168

CARMOISINE

E

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

 

1169

CARMOISINE ALUMINIUM LAKE

E

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

 

1170

CARNAUBA WAX

A, E, H

 

1171

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%.

 

1172

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%.

 

1173

CAROB GUM

E

 

1174

CAROB POD

E

 

1175

CAROTENES

E

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

 

1176

CARPINUS BETULUS

A, H

 

1177

CARPINUS CORDATA

A, H

 

1178

CARRAGEENAN

E

 

1179

CARROT

E

 

1180

CARROT SEED OIL

A, E, H

 

1181

CARTHAMUS TINCTORIUS

A, E, H

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

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

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

 

1182

CARUM CARVI

A, H

 

1183

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%.

 

1184

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%.

 

1185

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%.

 

1186

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%.

 

1187

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%.

 

1188

CARYA ILLINOINENSIS

A, H

 

1189

CARYA OVATA

A, H

 

1190

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%.

 

1191

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’.

 

1192

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’.

 

1193

CASCARILLA OIL

A, H

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

 

1194

CASEIN

E

 

1195

CASHEW NUT

E

 

1196

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%.

 

1197

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%.

 

1198

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.

 

1199

CASSIA FISTULA

A, H

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

1200

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%.

 

1201

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%.

 

1202

CASTANEA MOLLISSIMA

A, H

 

1203

CASTANEA SATIVA

A, H

 

1204

CASTOR OIL

A, E

 

1205

CASTOREUM

H

Only permitted for use as an active homoeopathic ingredient.

 

 

1206

CASUARINA EQUISITIFOLIA

A, H

 

1207

CATALPA BIGNONIOIDES

A, H

 

1208

CATALPA OVATA

A, H

 

1209

CATECHU

A, H

 

1210

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%.

 

1211

CAULIFLOWER

E

 

1212

CAULOPHYLLUM THALICTROIDES

A, E, H

 

1213

CAUSTICUM

H

Only for use as an active homoeopathic ingredient.

 

1214

CEANOTHUS AMERICANUS

A, H

 

1215

CEDAR LEAF OIL

A, E, H

 

1216

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%.

 

1217

CEDARWOOD OIL ATLAS

E

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

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

 

1218

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%.

 

1219

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%.

 

1220

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%.

 

1221

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%.

 

1222

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%.

 

1223

CEDRUS ATLANTICA

A, E, H

 

1224

CEDRUS DEODARA

A, H

 

1225

CEDRUS LIBANI

H

Only for use as an active homoeopathic ingredient.

 

1226

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%.

 

1227

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%.

 

1228

CELERY LEAF

E, H

 

1229

CELERY SEED DRY

A, E, H

 

1230

CELERY SEED OIL

A, E, H

 

1231

CELERY SEED POWDER

A, H

 

1232

CELLACEFATE

E

 

1233

CELLULASE

A

Must be derived from Trichoderma longibrachiatum only.

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

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

 

1234

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%.

 

1235

CELOSIA ARGENTEA

A, H

 

1236

CELOSIA ARGENTEA L. VAR. CRISTATA

A, H

 

1237

CENTAUREA CYANUS

A, E, H

 

1238

CENTAURIUM ERYTHRAEA

A, H

 

1239

CENTELLA ASIATICA

A, E, H

 

1240

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%.

 

1241

CENTIPEDA CUNNINGHAMII

A, E, H

 

1242

CENTIPEDA MINIMA

A, H

 

1243

CEPHALANOPSIS SEGETUM

A, H

 

1244

CERAMIDE 1

E

Only for use in topical medicines for dermal application.

 

1245

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%.

 

1246

CERAMIDE 3

E

Only for use in topical medicines for dermal application.

 

1247

CERATONIA SILIQUA

A, E, H

 

1248

CERATOSTIGMA WILLMOTTIANUM

A, H

 

1249

CERESIN

E

Only for use in topical medicines for dermal application.

 

1250

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%.

 

1251

CETEARETH-12

E

Only for use in topical medicines for dermal application.

 

1252

CETEARETH-2

E

Only for use in topical medicines for dermal application.

 

1253

CETEARETH-20

E

Only for use in topical medicines for dermal application.

 

1254

CETEARETH-25

E

Only for use in topical medicines for dermal application.

 

1255

CETEARETH-30

E

Only for use in topical medicines for dermal application.

 

1256

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.

 

1257

CETEARYL GLUCOSIDE

E

Only for use in topical medicines for dermal application.

 

1258

CETEARYL ISONONANOATE

E

Only for use in topical medicines for dermal application.

 

1259

CETEARYL OCTANOATE

E

Only for use in topical medicines for dermal application.

 

1260

CETETH-10

E

Only for use in topical medicines for dermal application.

 

1261

CETETH-2

E

Only for use in topical medicines for dermal application.

 

1262

CETETH-24

E

Only for use in topical medicines for dermal application.

 

1263

CETETH-5

E

Only for use in topical medicines for dermal application.

 

1264

CETOMACROGOL 1000

E

Only for use in topical medicines for dermal application.

 

1265

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%.

 

1266

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%.

 

1267

CETOSTEARYL ALCOHOL

E

 

1268

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 %

 

1269

CETRARIA ISLANDICA

A, H

 

1270

CETRIMONIUM BROMIDE

E

Only for use in topical medicines for dermal application.

 

1271

CETRIMONIUM CHLORIDE

E

Only for use in topical medicines for dermal application.

 

1272

CETYL ACETATE

E

Only for use in topical medicines for dermal application.

 

1273

CETYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

1274

CETYL DIMETHICONE COPOLYOL

E

Only for use in topical medicines for dermal application.

 

1275

CETYL DIMETICONE

E

Only for use in topical medicines for dermal application.

 

1276

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%.

 

1277

CETYL ESTERS WAX

E

Only for use in topical medicines for dermal application.

 

1278

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%.

 

1279

CETYL LACTATE

E

Only for use in topical medicines for dermal application.

 

1280

CETYL OCTANOATE

E

Only for use in topical medicines for dermal application.

 

1281

CETYL PALMITATE

E

Only for use in topical medicines for dermal application.

 

1282

CETYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

1283

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%.

 

1284

CETYLPYRIDINIUM CHLORIDE

E

Only for use in topical medicines for dermal application.

 

1285

CHAENOMELES LAGENARIA

A, H

 

1286

CHAENOMELES SPECIOSA

A, H

 

1287

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.

 

1288

CHAMAECYPARIS LAWSONIANA

A, H

 

1289

CHAMAELIRIUM LUTEUM

A, H

 

1290

CHAMAEMELUM NOBILE

A, E, H

 

1291

CHAMOMILE FLOWER DRY

A, E, H

 

1292

CHAMOMILE OIL ENGLISH

A, E, H

 

1293

CHAMOMILE OIL GERMAN

A, E, H

 

1294

CHANGIUM SMYRNIOIDES

A, H

 

1295

CHEIRANTHUS CHEIRI

A, H

 

1296

CHELIDONIUM MAJUS

A, E, H

When for oral or sublingual use, the medicine requires the following warning statement on the medicine label:

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

 

1297

CHELONE GLABRA

A, H

 

1298

CHENOPODIUM ALBUM

A, H

 

1299

CHENOPODIUM VULVARIA

A, H

 

1300

CHERRY

E

 

1301

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%.

 

1302

CHESTNUT SWEET

E, H

 

1303

CHICKEN COMB EXTRACT

A

 

1304

CHILLI

E, H

 

1305

CHIMAPHILA UMBELLATA

A, H

 

1306

CHIONANTHUS VIRGINICA

A, H

 

1307

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.

 

1308

CHLORELLA PYRENOIDOSA

E

 

1309

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.

 

 

1310

CHLORHEXIDINE ACETATE

E

Only for use in topical medicines for dermal application.

 

1311

CHLORHEXIDINE GLUCONATE

E

Only for use in topical medicines for dermal application.

 

1312

CHLOROACETAMIDE

E

Only for use in topical medicines for dermal application.

 

1313

CHLOROBUTANOL HEMIHYDRATE

E

Only for use in topical preparations for localised effect.

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

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

- (CHLORB) 'Contains chlorbutol' (or words to that effect).

 

1314

CHLOROCRESOL

E

Only for use in topical medicines for dermal application.

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

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

- (CHLCRS) 'Contains chlorocresol [quantity]' (or words to that effect)

 

1315

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%.

 

1316

CHLOROPHYLL

A, E

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

 

1317

CHLOROPHYLL-COPPER COMPLEXES

E

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

 

1318

CHLOROPHYLLIN-COPPER COMPLEX

E

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

 

1319

CHLOROPHYLLIN-COPPER COMPLEX ALUMINIUM LAKE

E

Only for as a colour in oral and topical medicines.

 

1320

CHLOROXYLENOL

E

Only for use in topical medicines for dermal application.

 

1321

CHLORPHENESIN

E

Only for use in topical medicines for dermal application.

 

1322

CHOCOLATE BROWN HT

E

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

 

1323

CHOLESTEROL

E, H

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

 

1324

CHOLESTERYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

 

1325

CHOLESTERYL MACADAMIATE

E

Only for use in topical medicines for dermal application.

 

1326

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%.

 

1327

CHOLETH-24

E

Only for use in topical medicines for dermal application.

 

1328

CHOLINE BITARTRATE

A, E

 

1329

CHOLINE DIHYDROGEN CITRATE

A

Only for use in oral medicines.

 

1330

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%.

 

1331

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.

 

1332

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.

 

 

1333

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.

 

 

1334

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).

 

 

1335

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.

 

1336

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.

 

1337

CHRYSANTHEMUM BALSAMITA

A, H

 

1338

CHRYSANTHEMUM INDICUM

A, H

 

1339

CHRYSANTHEMUM LEUCANTHEMUM

A, H

 

1340

CHRYSANTHEMUM MARSHALLII

A, H

 

1341

CHRYSANTHEMUM SINENSE

A, H

 

1342

CHRYSOPOGON ZIZANIOIDES

A, E, H

 

1343

CHRYSOSPORIUM PRUINOSUM

A, H

 

1344

CIBOTIUM BAROMETZ

A, H

 

1345

CICHORIUM INTYBUS

A, E, H

 

1346

CICUTA VIROSA

A, H

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

 

1347

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.

 

1348

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.

 

1349

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.

 

1350

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.

 

1351

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.

 

1352

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%.

 

1353

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%.

 

1354

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, 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%.

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

 

1355

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%.

 

 

1356

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.

 

1357

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%.

 

1358

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%.

 

1359

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%.

 

1360

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%.

 

1361

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%.

 

1362

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%.

 

1363

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%.

 

1364

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%.

 

1365

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%.

 

1366

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%.

 

1367

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%.

 

1368

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%.

 

1369

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 be no more than 6%.

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

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

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

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

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

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

 

1370

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%.

 

1371

CIS-3-HEXEN-1-OL

E

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

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

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

 

1372

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%.

 

1373

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%.

 

1374

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%.

 

1375

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%.

 

1376

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%.

 

1377

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%.

 

1378

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%.

 

1379

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%.

 

1380

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%.

 

1381

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%.

 

1382

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%.

 

1383

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%.

 

1384

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%.

 

1385

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%.

 

1386

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%.

 

1387

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%.

 

1388

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%.

 

1389

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%.

 

1390

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%.

 

1391

CISTANCHE DESERTICOLA

A, H

 

1392

CISTANCHE SALSA

A, H

 

1393

CISTUS LADANIFERUS

A, E, H

 

1394

CITRAL

E

 

1395

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%.

 

1396

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%.

 

1397

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'

 

1398

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'

 

1399

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.'

 

1400

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%.

 

1401

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%.

 

1402

CITRON

E

 

1403

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'.

 

1404

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%.

 

1405

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%.

 

1406

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%.

 

1407

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%.

 

1408

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%.

 

1409

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%.

 

1410

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%.

 

1411

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%.

 

1412

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%.

 

1413

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%.

 

1414

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%.

 

1415

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%.

 

1416

CITRULLUS COLOCYNTHIS

H

Only for use as an active homoeopathic ingredient.

When for oral use, the concentration of Citrullus colocynthis must be more than 4X (i.e. 1X 2X 3X).

 

 

1417

CITRULLUS VULGARIS

A, H

 

1418

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.

 

1419

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.

 

1420

CITRUS BIOFLAVONOIDS EXTRACT

A, E, H

 

1421

CITRUS CHACHIENSIS

A, H

 

1422

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%.

 

1423

CITRUS FIBRE

E

 

1424

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.

 

1425

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.

 

1426

CITRUS MAXIMA

A, H

 

1427

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.

 

1428

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%.

 

1429

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.

 

1430

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.

 

1431

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%.

 

1432

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. 

 

1433

CITRUS X PARADISI

A, E, H

 

1434

CITRUS X WILSONII

A, H

 

1435

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%.

 

1436

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%.

 

1437

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%.

 

1438

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%.

 

1439

CLARY OIL

A, E, H

 

1440

CLEMATIS ARMANDII

A, H

 

1441

CLEMATIS CHINENSIS

A, E, H

 

1442

CLEMATIS RECTA

A, H

 

1443

CLEMATIS VITALBA

A, H

 

1444

CLERODENDRUM TRICHOTOMUM

A, H

 

1445

CLINOPODION POLYCEPHALUM

A, H

 

1446

CLINOPODIUM NEPETA SUBSP. GLANDULOSUM

A, H

 

1447

CLIVER HERB DRY

A, H

 

1448

CLIVER HERB POWDER

A, H

 

1449

CLOVE BUD OIL

A, E, H

When the concentration of Clove Bud Oil in the preparation is more than 25%, the nominal capacity of the container must be no more than 25 mL.

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

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’

When the concentration of clove bud oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL , a restricted flow insert must be fitted on the container and requires the following warning statement on the medicine label:

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’

 

1450

CLOVE DRY

A, E, H

 

1451

CLOVE LEAF OIL

A, E, H

When the concentration of Clove Leaf Oil in the preparation is more than 25%, the nominal capacity of the container must be no more than 25 mL.

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

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’

When the concentration of clove leaf oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL, a restricted flow insert must be fitted on the container and requires the following warning statement on the medicine label:

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’

 

1452

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%.

 

1453

CLOVE POWDER

A, E, H

 

1454

CLOVE STEM OIL

A, E, H

When the concentration of Clove Stem Oil in the preparation is more than 25%, the nominal capacity of the container must be no more than 25 mL.

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

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’

When the concentration of Clove Stem oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL , a restricted flow insert must be fitted on the container and requires the following warning statements on the medicine label:

- (CHILD) ‘Keep out of reach of children’ (or words to that effect)

- (NTAKEN) ‘Not to be taken’

 

1455

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.

 

1456

CNICUS BENEDICTUS

A, H

 

1457

CNICUS JAPONICUS

A, H

 

1458

CNIDIUM MONNIERI

A, H

 

1459

CNIDIUM OFFICINALE

A, H

 

1460

COBALTOUS NITRATE HEXAHYDRATE

H

Only for use as an active homoeopathic ingredient.

 

1461

COCAMIDE DEA

E

Only for use in topical medicines for dermal application.

 

1462

COCAMIDE MEA

E

Only for use in topical medicines for dermal application.

 

1463

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%.

 

1464

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.

 

1465

COCCOLOBIA UVIFERA

A, H

 

1466

COCCULUS ORBICULATUS

A, H

 

1467

COCHINEAL

E, H

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

 

1468

COCHLEARIA OFFICINALIS

A, H

 

1469

COCILLANA DRY

A, H

 

1470

COCILLANA POWDER

A, H

 

1471

COCO-BETAINE

E

Only for use in topical medicines for dermal application.

 

1472

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.

 

1473

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%

 

1474

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.

 

1475

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%.

 

1476

COCOA POWDER

A, E, H

 

1477

COCOGLYCERIDES

E

 

1478

COCONUT

E

 

1479

COCONUT ACID

E

Only for use in topical medicines for dermal application.

 

1480

COCONUT OIL

A, E, H

 

1481

COCOS NUCIFERA

A, E, H

 

1482

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.

 

 

1483

CODONOPSIS LANCEOLATA

A, H

 

1484

CODONOPSIS PILOSULA

A, H

 

1485

CODONOPSIS TANGSHEN

A, H

 

1486

COFFEA ARABICA

A, E, H

Caffeine is a mandatory component of Coffea arabica.

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

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

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

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

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

 

1487

COFFEA CANEPHORA

A, E, H

Caffeine is a mandatory component of Coffea canephora.

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

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

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

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

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

 

1488

COFFEE

E, H

Caffeine is a mandatory component of coffee.

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

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

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

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

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

 

1489

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%.

 

1490

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%.

 

1491

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%.

 

1492

COGNAC OIL GREEN

A, E, H

 

1493

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%.

 

1494

COIX LACHRYMA-JOBI

A, H

 

1495

COLA ACUMINATA

A, E, H

Caffeine is a mandatory component of Cola acuminata.

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

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

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

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

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

 

1496

COLA NITIDA

A, E, H

Caffeine is a mandatory component of Cola nitida.

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

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

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

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

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

 

1497

COLCHICUM AUTUMNALE

H

Only for use as an active homoeopathic ingredient.

 

 

1498

COLECALCIFEROL

A, E

When for internal use, the maximum recommended daily dose must not be more than 25 micrograms of Vitamin D.

 

1499

COLLAGEN

E

 

1500

COLLINSONIA CANADENSIS

A, H

 

1501

COLLOIDAL ANHYDROUS SILICA

A, E, H

Only for use when the route of administration is other than inhalation.

 

1502

COLOPHONY

A, E, H

 

1503

COMMIPHORA HABESSINICA

A, H

 

1504

COMMIPHORA KATAF

A, H

 

1505

COMMIPHORA MYRRHA

A, E, H

 

1506

COMMON INDIAN COBRA

H

Only for use as an active homoeopathic ingredient.

 

1507

CONCENTRATED FISH OMEGA-3 TRIGLYCERIDES

A

Only for oral use.

 

1508

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 medicine requires the following warning statement on the medicine label:

- (SFOOD) 'Derived from seafood'.

 

1509

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).

 

1510

CONIFER PHYTOSTEROL COMPLEX

A

 

1511

CONIOSELIUM UNIVITTATUM

A, H

 

1512

CONIUM MACULATUM

H

Only for use as an active homoeopathic ingredient.

The concentration must be no more than exceed 12X homoeopathic dilution.

 

 

1513

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%.

 

1514

CONYZA CANADENSIS

A, H

 

1515

COPAIBA OIL

A, E, H

 

1516

COPAIFERA LANGSDORFFII

A, E, H

 

1517

COPERNICIA CERIFERA

A, E, H

 

1518

COPOVIDONE

E

 

1519

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%.

 

 

1520

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.

 

 

1521

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.

 

 

1522

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.

 

 

1523

COPPER ACETYL TYROSINATE METHYLSILANOL

E

Only for use in topical medicines for dermal application.

 

1524

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%.

 

1525

COPPER CHLOROPHYLLIN

E

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

 

1526

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%.

 

 

1527

COPPER TRIPEPTIDE-1

E

Only for use in topical medicines for dermal application.

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

 

1528

COPTIS CHINENSIS

A, H

 

1529

COPTIS JAPONICA

A, H

 

1530

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%.

 

1531

CORDYCEPS SINENSIS

A, E, H

Must not contain material of animal origin such as insect larvae.

 

1532

CORIANDER DRY

A, H

 

1533

CORIANDER OIL

A, E, H

 

1534

CORIANDER POWDER

A, H

 

1535

CORIANDRUM SATIVUM

A, E, H

 

1536

CORN GLYCERIDES

E

 

1537

CORN SILK DRY

A, H

 

1538

CORN SILK POWDER

A, H

 

1539

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%.

 

1540

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%.

 

1541

CORNUS FLORIDA

A, H

 

1542

CORNUS OFFICINALIS

A, H

 

1543

CORTISONE ACETATE

H

Only available as an active homoeopathic ingredient.

 

1544

CORYDALIS AMBIGUA

A, E, H

 

1545

CORYDALIS BUNGEANA

A, H

 

1546

CORYDALIS CAVA

A, H

 

1547

CORYDALIS FABACEA

A, H

 

1548

CORYDALIS FORMOSA

A, H

 

1549

CORYDALIS TURTSCHANINOVII

A, H

 

1550

CORYLUS AMERICANA

A, H

 

1551

CORYLUS AVELLANA

A, H

 

1552

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.

 

1553

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.

 

1554

COSMOS BIPINNATUS

A, H

 

1555

COSTUS ROOT OIL

A, H

 

1556

COSTUS SPICATUS

A, H

 

1557

COTTONSEED OIL

A, E, H

 

1558

COUCH GRASS RHIZOME DRY

A, H

 

1559

COUCH GRASS RHIZOME POWDER

A, H

 

1560

COUMARIN

H

Only for use as an active homoeopathic ingredient.

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

 

 

1561

CRANBERRY

E

 

1562

CRATAEGUS CUNEATA

A, E, H

 

1563

CRATAEGUS LAEVIGATA

A, E, H

 

1564

CRATAEGUS MONOGYNA

A, E, H

 

1565

CRATAEGUS PINNATIFIDA

A, E, H

 

1566

CRATEVA MAGNA

A, E, H

 

1567

CREATINE

A, E

 

1568

CREATINE MONOHYDRATE

A, E

 

1569

CREATINE PHOSPHATE

A, E

 

1570

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%.

 

1571

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%.

 

1572

CREOSOTE

H

Only for use as an active homoeopathic ingredient.

 

1573

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%.

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

- (CRESOL) 'Contains cresol' (or words to that effect)

 

1574

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%.

 

1575

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%.

 

1576

CROCUS SATIVUS

A, H

 

1577

CROSCARMELLOSE SODIUM

E

When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:

- (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’

 

1578

CROSPOVIDONE

E

 

1579

CROTON CASCARILLA

A, H

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

 

1580

CROTON ELUTERIA

A, H

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

 

1581

CRYPTOMERIA JAPONICA

A, H

 

1582

CUBEB OIL

A, H

 

1583

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%.

 

1584

CUCUMBER

E

 

1585

CUCUMIS MELO

A, H

 

1586

CUCUMIS SATIVUS

A, E, H

 

1587

CUCURBITA MAXIMA

A, E, H

 

1588

CUCURBITA MOSCHATA

A, H

 

1589

CUCURBITA PEPO

A, E, H

 

1590

CULLEN CORYLIFOLIUM

A, H

 

1591

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%.

 

1592

CUMIN OIL

A, E, H

 

1593

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%.

 

1594

CUMINUM CYMINUM

A, H

 

1595

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%.

 

1596

CUPRESSUS ARIZONICA

A, H

 

1597

CUPRESSUS FUNEBRIS

A, E, H

 

1598

CUPRESSUS MACROCARPA

A, H

 

1599

CUPRESSUS SEMPERVIRENS

A, E, H

 

1600

CUPRIC ACETATE MONOHYDRATE

H

Only for use as an active homoeopathic ingredient.

 

1601

CUPRIC ARSENITE

H

Only for use as an active homoeopathic ingredient.

 

1602

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.

 

1603

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.

 

1604

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%.

 

 

1605

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%.

 

 

1606

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.

 

1607

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.

1608

CURCULIGO ORCHIOIDES

A, H

 

1609

CURCUMA AROMATICA

A, H

 

1610

CURCUMA LONGA

A, E, H

 

1611

CURCUMA XANTHORRHIZA

A, H

 

1612

CURCUMA ZEDOARIA

A, H

 

1613

CURCUMIN

A, E, H

When for excipient use, only permitted for use as a colour in topical and oral medicines.

1615

CUSCUTA EPITHYMUM

A, H

 

1616

CUSCUTA EUROPAEA

A, H

 

1617

CUSCUTA HYGROPHILAE

A, H

 

1618

CUSCUTA RACEMOSA

A, H

 

1619

CUSPARIA FEBRIFUGA

A, H

 

1620

CYAMOPSIS TETRAGONOLOBA

A, E, H

 

1621

CYANOCOBALAMIN

A, E, H

 

1622

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%.

 

1623

CYATHULA OFFICINALIS

A, H

 

1624

CYCLAMEN ALDEHYDE

E

Only for use as an excipient ingredient in topical medicines.

 

1625

CYCLAMEN PURPURASCENS

A, H

 

1626

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%.

 

1627

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%.

 

1628

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%.

 

1629

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%.

 

1630

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%.

 

1631

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%.

 

1632

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%.

 

1633

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%.

 

1634

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%.

 

1635

CYCLOMETHICONE

E

Only for use as an excipient ingredient in topical medicines.

 

1636

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%.

 

1637

CYDONIA OBLONGA

A, H

 

1638

CYMBOPOGON FLEXUOSUS

A, E, H

The concentration or Aldehydes calculated as citral in the medicine must be no more than 5% for topical use.

 

1639

CYMBOPOGON MARTINI

A, H

The concentration or Aldehydes calculated as citral in the medicine must be no more than 5% for topical use.

 

1640

CYMBOPOGON NARDUS

A, H

The concentration or Aldehydes calculated as citral in the medicine must be no more than 5% for topical use.

 

1641

CYMBOPOGON SCHOENANTHUS

A, E, H

The concentration or Aldehydes calculated as citral in the medicine must be no more than 5% for topical use.

 

1642

CYNANCHUM ATRATUM

A, H

 

1643

CYNANCHUM STAUNTONII

A, E, H

 

1644

CYNARA SCOLYMUS

A, E, H

 

1645

CYNODON DACTYLON

A, E, H

 

1646

CYNOMORIUM COCCINEUM SUBSP. SONGARICUM

A, H

 

1647

CYPERUS LONGUS

A, H

 

1648

CYPERUS ROTUNDUS

A, H

 

1649

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%.

 

1650

CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS

A, H

 

1651

CYSTEINE

A

 

1652

CYSTEINE HYDROCHLORIDE

A

 

1653

CYSTEINE HYDROCHLORIDE MONOHYDRATE

A, E

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%.

 

 

1654

CYSTINE

A

 

1655

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%.

 

1656

D-ALPHA-TOCOPHEROL

A, E

 

1657

D-ALPHA-TOCOPHERYL ACETATE

A, E, H

 

1658

D-ALPHA-TOCOPHERYL ACID SUCCINATE

A, E

 

1659

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%.

 

1660

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%.

 

1661

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%.

 

1662

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%.

 

1663

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%.

 

1664

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%.

 

1665

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.

 

1666

DACTYLIS GLOMERATA

A, H

 

1667

DACTYLORHIZA INCARNATA SUBSP. INCARNATA

A, H

 

1668

DAEMONOROPS DRACO

A, E, H

 

1669

DAHLIA PINNATA

A, H

 

1670

DALBERGIA ODORIFERA

A, H

 

1671

DAMIANA LEAF POWDER

A

 

1672

DANDELION LEAF DRY

A, H

 

1673

DANDELION LEAF POWDER

A, H

 

1674

DANDELION ROOT DRY

A, H

 

1675

DANDELION ROOT POWDER

A, H

 

1676

DAPHNE GENKWA

A, H

 

1677

DAPHNE MEZEREUM

A, H

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

 

1678

DATE

E

 

1679

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%.

 

1680

DAUCUS CAROTA

A, E, H

 

1681

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%.

 

1682

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).

 

1683

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%.

 

1684

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%.

 

1685

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%.

 

1686

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%.

 

1687

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%.

 

1688

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%.

 

1689

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%.

 

1690

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.

 

1691

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%.

 

1692

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%.

 

1693

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%.

 

1694

DECYL GLUCOSIDE

E

Only for use in topical medicines for dermal application.

 

1695

DECYL OLEATE

E

Only for use in topical medicines for dermal application.

 

1696

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%.

 

1697

DEER ANTLER CARTILAGE

H

Only for use as an active homoeopathic ingredient. 

 

1698

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.

 

 

1699

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.

 

1700

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%.

 

1701

DEHYDROACETIC ACID

E

Only for use in topical medicines for dermal application.

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

- (DACACD) 'Contains dehydroacetic acid [quantity]' (or words to that effect).

 

1702

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%.

 

1703

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%.

 

1704

DELPHINIUM STAPHISAGRIA

A, H

The concentration of the equivalent dry Delphinium staphisagria in the medicine must be no more than 0.2%.

 

1705

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%.

 

1706

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%.

 

1707

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%.

 

1708

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%.

 

1709

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%.

 

1710

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%.

 

1711

DELTA-TOCOPHEROL

E

 

1712

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%.

 

1713

DEMINERALISED FISH PROTEOGLYCAN EXTRACT

A

 

1714

DENATONIUM BENZOATE

E

 

1715

DENDROBIUM NOBILE

A, H

 

1716

DESCURAINIA SOPHIA

A, H

 

1717

DESMODIUM STYRACIFOLIUM

A, H

 

1718

DESMODIUM TRIQUETUM

A, H

 

1719

DEVIL'S CLAW TUBER DRY

A, H

 

1720

DEVIL'S CLAW TUBER POWDER

A, H

 

1721

DEXPANTHENOL

A, E

 

1722

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%.

 

1723

DEXTRAN 40

A, E

 

1724

DEXTRATES

E

 

1725

DEXTRIN

E

 

1726

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%.

 

1727

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.

 

1728

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%.

 

1729

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%.

 

1730

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%.

 

1731

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%.

 

1732

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%.

 

1733

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%.

 

1734

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%.

 

1735

DIACETYLATED MONOGLYCERIDES

E

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

 

1736

DIAMMONIUM LAURYL SULFOSUCCINATE

E

Only for use as an excipient ingredient in topical medicines.

 

1737

DIANTHUS SUPERBUS

A, H

 

1738

DIAZOLIDINYL UREA

E

Only for use in topical medicines for dermal application.

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

- (DUREA) 'Contains diazolidinyl urea' (or words to that effect).

 

1739

DIBASIC MAGNESIUM CITRATE TETRAHYDRATE

A

Only for use in oral medicines.

 

 

1740

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.

 

1741

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.

 

 

1742

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.

 

 

1743

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.

When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:

- (SODIUM) 'The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).'

 

1744

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.

When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:

- (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).'

 

 

1745

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.

When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:

- (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).'

 

 

1746

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.

When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:

- (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).'

 

 

1747

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.

When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:

- (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).'

 

 

1748

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%.

 

1749

DIBUTYL ADIPATE

E

Only for use in topical medicines for dermal application.

 

1750

DIBUTYL PHTHALATE

E

Only for use in topical medicines for dermal application.

 

1751

DIBUTYL SEBACATE

E

 

1752

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%.

 

1753

DICAPRYLYL CARBONATE

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 34%.

 

1754

DICAPRYLYL ETHER

E

Only for use in topical medicines for dermal application.

 

1755

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%.

 

1756

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%.

 

1757

DICHLOROBENZYL ALCOHOL

E

 

1758

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.

 

1759

DICTAMNUS ALBUS

A, H

 

1760

DICTAMNUS DESYCARPUS

A, H

 

1761

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%.

 

1762

DIEFFENBACHIA SEGUINE

H

Only for use as an active homoeopathic ingredient.

 

1763

DIETHANOLAMINE

E

Only for use in topical medicines for dermal application.

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

 

1764

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%.

 

1765

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%.

 

1766

DIETHYL PHTHALATE

E

 

1767

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%.

 

 

1768

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 be no more than 10%.

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

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

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

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

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

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

 

1769

DIETHYLAMINOMETHYLCOUMARIN

E

Only for use in topical medicines for dermal application.

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

 

1770

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%.

 

1771

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%.

 

1772

DIETHYLENE GLYCOL MONOETHYL ETHER

E

Only for use in topical medicines for dermal application.

 

1773

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%.

 

1774

DIETHYLHEXYL SEBACATE

E

Only for use in topical medicines for dermal application.

 

1775

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%.

 

1776

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).

 

1777

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.'

 

1778

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%.

 

1779

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%.

 

1780

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%.

 

1781

DIGLYCOL/CHDM/ISOPHTHALATES/SIP COPOLYMER

E

Only for use in topical medicines for dermal application.

 

1782

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%.

 

1783

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%.

 

1784

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%.

 

1785

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%.

 

1786

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%.

 

1787

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%.

 

1788

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%.

 

1789

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%.

 

1790

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%.

 

1791

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%.

 

1792

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%.

 

1793

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%.

 

1794

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%.

 

1795

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%.

 

1796

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%.

 

1797

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%.

 

1798

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%.

 

1799

DIHYDROXYACETONE

E

Only for use in topical medicines for dermal application.

 

1800

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%.

 

1801

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%.

 

1802

DIISOSTEARYL DIMER DILINOLEATE

E

Only for use in topical medicines for dermal application.

 

1803

DILAURYL THIODIPROPIONATE

E

Only for use in topical medicines for dermal application.

 

1804

DILL HERB OIL

A, E, H

 

1805

DILL SEED OIL

A, E, H

 

1806

DILL WEED 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%.

 

1807

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%.

 

1808

DIMETHICONE 12500

E

 

1809

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%.

 

1810

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%.

 

1811

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%.

 

1812

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%.

 

1813

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%.

 

1814

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%.

 

1815

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%.

 

1816

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%.

 

1817

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%.

 

1818

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%.

 

1819

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%.

 

1820

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%.

 

1821

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%.

 

1822

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%.

 

1823

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%.

 

1824

DIMETHYL SULFATE

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%.

 

1825

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%.

 

1826

DIMETHYL SULFONE

A

Only for use in oral and topical medicines.

 

1827

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%.

 

1828

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%.

 

1829

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%.

 

1830

DIMETHYLGLYCINE HYDROCHLORIDE

A

Only for use in oral medicines.

 

1831

DIMETHYLOL DIMETHYL HYDANTOIN

E

Only for use in topical medicines for dermal application.

 

1832

DIMETICONE 1.5

E

Only for use in topical medicines for dermal application.

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

 

1833

DIMETICONE 10

E

 

1834

DIMETICONE 100

E

Only for use in topical medicines for dermal application.

 

1835

DIMETICONE 1000

E

 

1836

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%

 

1837

DIMETICONE 2

E

Only for use in topical medicines for dermal application.

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

 

1838

DIMETICONE 20

E

Only for use in topical medicines for dermal application.

 

1839

DIMETICONE 200

E

Only for use in topical medicines for dermal application.

 

1840

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%.

 

1841

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.

 

1842

DIMETICONE 360

E

Only for use in topical medicines for dermal application.

 

1843

DIMETICONE 450

E

Only for use in topical medicines for dermal application.

 

1844

DIMETICONE 5

E

Only for use in topical medicines for dermal application.

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

 

1845

DIMETICONE 50

E

Only for use in topical medicines for dermal application.

 

1846

DIMETICONE 5000

E

Only for use in topical medicines for dermal application.

 

1847

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%.

 

1848

DIMETICONE COPOLYOL

E

Only for use in topical medicines for dermal application.

 

1849

DIMETICONE COPOLYOL PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

1850

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%.

 

1851

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%.

 

1852

DIMETICONOL

E

Only for use in topical medicines for dermal application.

 

1853

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%.

 

1854

DIMOCARPUS LONGAN

A, H

 

1855

DIOCTYL ADIPATE

E

Only for use in topical medicines for dermal application.

 

1856

DIOCTYL MALEATE

E

Only for use in topical medicines for dermal application.

 

1857

DIOCTYL SUCCINATE

E

Only for use in topical medicines for dermal application.

 

1858

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%.

 

1859

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%

 

1860

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.

 

1861

DIOSCOREA COLLETTII

A, H

 

1862

DIOSCOREA COLLETTII VAR. HYPOGLAUCA

A, H

 

1863

DIOSCOREA JAPONICA

A, H

 

1864

DIOSCOREA OPPOSITIFOLIA

A, H

 

1865

DIOSCOREA POLYSTACHYA

A, H

 

1866

DIOSCOREA SEPTEMLOBA

A, H

 

1867

DIOSCOREA VILLOSA

A, E, H

 

1868

DIOSPYROS KAKI

A, E, H

 

1869

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).

 

1870

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%.

 

1871

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%.

 

1872

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%.

 

1873

DIPHENYL DIMETHICONE

E

Only for use in topical medicines for dermal application.

 

1874

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%.

 

1875

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%.

 

1876

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%.

 

1877

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%.

 

1878

DIPROPYLENE GLYCOL

E

Only for use in topical medicines for dermal application.

 

1879

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%.

 

1880

DIPROPYLENE GLYCOL SALICYLATE

E

Only for use in topical medicines for dermal application.

 

1881

DIPSACUS ASPER

A, H

 

1882

DIPSACUS JAPONICUS

A, H

 

1883

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%.

 

1884

DISODIUM ASCORBYL SULFATE

E

Only for use in topical medicines for dermal application.

 

1885

DISODIUM COCOAMPHODIACETATE

E

 Only for use in topical medicines for dermal application.

 

1886

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%.

 

1887

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%.

 

1888

DISODIUM EDETATE

E

When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:

- (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’

 

1889

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%.

 

1890

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%.

 

1891

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%.

 

1892

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%.

 

1893

DISODIUM NADH

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 0.02%.

 

1894

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%.

 

1895

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).

 

1896

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%.

 

1897

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%.

 

1898

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%.

 

1899

DISPERSIBLE CELLULOSE

E

 

1900

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%.

 

1901

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%.

 

1902

DISTEARETH-6 DIMONIUM CHLORIDE

E

Only for use in topical medicines for dermal application.

 

1903

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%.

 

1904

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%.

 

1905

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%.

 

1906

DL-ALPHA-TOCOPHEROL

A, E

 

1907

DL-ALPHA-TOCOPHERYL ACETATE

A, E, H

 

1908

DL-ALPHA-TOCOPHERYL ACID SUCCINATE

A, E, H

 

1909

DL-BORNEOL

E

 

1910

DL-LIMONENE

E

Only for use in topical medicines for dermal application.

 

1911

DL-THREONINE

A, E

 

1912

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.

 

1913

DOCUSATE SODIUM

E

 

1914

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%.

 

1915

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%.

 

1916

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%.

 

1917

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%.

 

1918

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%.

 

1919

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%.

 

1920

DOLICHOS LABLAB

A, H

 

1921

DOLOMITE

A, E, H

 

1922

DRACAENA DRACO

A, H

 

1923

DRIED BUTTERMILK

E

 

1924

DRIED CALCIUM SULFATE

A, E, H

 

1925

DRIED MAGNESIUM SULFATE

A, E, H

When used internally, the maximum recommended daily dose must be no more than 1.5g.

 

 

1926

DRIMIA INDICA

A, H

 

1927

DRIMIA MARITIMA

A, H

 

1928

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).

 

 

1929

DROSERA ANGLICA

A, H

 

1930

DROSERA BURMANNI

A, H

 

1931

DROSERA INTERMEDIA

A, H

 

1932

DROSERA RAMENTACIA

A, H

 

1933

DROSERA ROTUNDIFOLIA

A, E, H

 

1934

DROSERA ROTUNDIFOLIA MIS

A, H

 

1935

DRYNARIA FORTUNEI

A, H

 

1936

DRYOBALANOPS AROMATICA

A, H

 

1937

DRYOPTERIS FILIX-MAS

H

Only for use as an active homoeopathic ingredient.

 

1938

DULACIA INOPIFLORA

A, H

 

1939

DUNALIELLA SALINA

A, E, H

 

1940

DUPICAL

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%.

 

 

1941

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%.

 

1942

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%.

 

1943

DYSPHANIA AMBROSIOIDES

A, H

Volatile oil components (of Dysphania ambrosioides) are mandatory components of Dysphania ambrosioides.

 

1944

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).

 

1945

ECHINACEA ANGUSTIFOLIA

A, E, H

 

1946

ECHINACEA PALLIDA

A, E, H

 

1947

ECHINACEA PURPUREA

A, E, H

 

1948

ECHINOPA SPINOSISSIMUS

A, H

 

1949

ECLIPTA PROSTRATA

A, H

 

1950

ECTOIN

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%.

 

1951

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%.

 

1952

EDETIC ACID

E

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

 

1953

EGG LECITHIN

A, E

 

1954

EGGSHELL MEMBRANE HYDROLYSATE

A

 

1955

EGGSHELL MEMBRANE POWDER

A

 

1956

EICHHORNIA CRASSIPES

A, H

 

1957

ELAEAGNUS ANGUSTIFOLIA

A, H

 

1958

ELAEIS GUINEENSIS

A, E, H

 

1959

ELASTIN

E

Only for use in topical medicines for dermal application.

 

1960

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%.

 

1961

ELDER FLOWER BLACK DRY

A, E, H

 

1962

ELDER FLOWER BLACK POWDER

A, H

 

1963

ELECAMPANE RHIZOME DRY

A, H

 

1964

ELECAMPANE RHIZOME POWDER

A, H

 

1965

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%.

 

1966

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%.

 

1967

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%.

 

1968

ELEOCHARIS DULCIS

A, H

 

1969

ELETTARIA CARDAMOMUM

A, E, H

 

1970

ELEUTHEROCOCCUS NODIFLORUS

A, H

 

1971

ELEUTHEROCOCCUS ROOT DRY

A, H

 

1972

ELEUTHEROCOCCUS ROOT POWDER

A, H

 

1973

ELEUTHEROCOCCUS SENTICOSUS

A, H

 

1974

ELSHOLTZIA SPLENDENS

A, H

 

1975

ELYMUS REPENS

A, E, H

 

1976

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.

 

1977

EMULSIFYING WAX

E

 

1978

ENOXOLONE

E

Only for use in topical medicines for dermal application.

 

1979

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%.

 

1980

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%.

 

1981

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%.

 

1982

EPIGAEA REPENS

A, H

 

1983

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.

 

1984

EPILOBIUM PALUSTRE

A, H

 

1985

EPILOBIUM PARVIFLORUM

A, H

 

1986

EPIMEDIUM BREVICORNU

A, H

 

1987

EPIMEDIUM GRANDIFLORUM

A, H

 

1988

EPIMEDIUM SAGITTATUM

A, H

 

1989

EPOXY CEDRENE

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%.

 

1990

EQUISETUM ARVENSE

A, E, H

 

1991

EQUISETUM HIEMALE

A, H

 

1992

ERGOCALCIFEROL

A, E

When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D.

 

1993

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%.

 

1994

ERIGERON BREVISCAPUS

A, H

 

1995

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%.

 

1996

ERIOCAULON BUERGERIANUM

A, H

 

1997

ERIODICTYON CRASSIFOLIUM

A, H

 

1998

ERIODICTYON GLUTINOSUM

A, H

 

1999

ERODIUM CICUTARIUM

A, H

 

2000

ERUCA SATIVA

A, H

 

2001

ERYTHORBIC ACID

E

 

2002

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%.

 

2003

ERYTHROSINE

E

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

 

2004

ERYTHROSINE ALUMINIUM LAKE

E

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

 

2005

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'.

 

2006

ESCHSCHOLZIA CALIFORNICA

A, H

 

2007

ESTRONE

H

Only for use as an active homoeopathic ingredient.

 

2008

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.

When the concentration of ethanol from all ingredients in the medicine is more than 3%, the medicine requires the following warning statement on the medicine label:

- (ETHAN) 'Contains ethanol or contains alcohol'.

 

2009

ETHANOL ABSOLUTE

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.

When the concentration of ethanol from all ingredients in the medicine is more than 3%, the medicine requires the following warning statement on the medicine label:

- (ETHAN) 'Contains ethanol or contains alcohol'

 

2010

ETHER

E

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

 

2011

ETHOHEXADIOL

E

Only for use in topical medicines for dermal application.

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

- (EHEXAD) 'Contains ethohexadiol' (or words to that effect).

 

2012

ETHOXYLATED HYDROGENATED CASTOR OIL

E

 

2013

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%.

 

2014

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%.

 

2015

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%.

 

2016

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%.

 

2017

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%.

 

2018

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%.

 

2019

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%.

 

2020

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%.

 

2021

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%.

 

2022

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%.

 

2023

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%.

 

2024

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%.

 

2025

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%.

 

2026

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%.

 

2027

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%.

 

2028

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%.

 

2029

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%.

 

2030

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%.

 

2031

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%.

 

2032

ETHYL ACRYLATE

E

 

2033

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%.

 

2034

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%.

 

2035

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%.

 

2036

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%.

 

2037

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)'.

 

2038

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%.

 

2039

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%.

 

2040

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%.

 

2041

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%.

 

2042

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%.

 

2043

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%.

 

2044

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%.

 

2045

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%.

 

2046

ETHYL HYDROXYBENZOATE

E

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

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

 

2047

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%.

 

2048

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%.

 

2049

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%.

 

2050

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%.

 

2051

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%.

 

2052

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%.

 

2053

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%.

 

2054

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%.

 

2055

ETHYL LINOLEATE

E

Only for use in topical medicines for dermal application.

 

2056

ETHYL LINOLENATE

E

Only for use in topical medicines for dermal application.

 

2057

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%.

 

2058

ETHYL MALTOL

E

 

2059

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%.

 

2060

ETHYL METHACRYLATE

E

Only for use in topical medicines for dermal application.

 

2061

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%.

 

2062

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%.

 

2063

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%.

 

2064

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%.

 

2065

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%.

 

2066

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%.

 

2067

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%.

 

2068

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%.

 

2069

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%.

 

2070

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%.

 

2071

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%.

 

2072

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%.

 

2073

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%.

 

2074

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%.

 

2075

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%.

 

2076

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%.

 

2077

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%.

 

2078

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%.

 

2079

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%.

 

2080

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%.

 

2081

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%.

 

2082

ETHYL VANILLIN

E

 

2083

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%.

 

2084

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%.

 

2085

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%.

 

2086

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%.

 

2087

ETHYLCELLULOSE

E

 

2088

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%.

 

2089

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%.

 

2090

ETHYLENE GLYCOL MONOPALMITOSTEARATE

E

Only for use in topical medicines for dermal application.

 

2091

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%.

 

2092

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%.

 

2093

ETHYLENEDIAMINE

E

Only for use in topical medicines for dermal application.

 

2094

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%.

 

2095

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%.

 

2096

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%.

 

2097

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%.

 

2098

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 be no more than 5%.

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

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

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

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

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

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

 

2099

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%.

 

2100

ETIDRONIC ACID

E

Only for use in topical medicines for dermal application only.

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

 

2101

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.

 

2102

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.

 

2103

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.

 

2104

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.

 

2105

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’

 

2106

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.

 

2107

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.

 

2108

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.

 

2109

EUCOMMIA ULMOIDES

A, H

 

2110

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’

 

 

2111

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%.

 

2112

EUONYMUS ATROPURPUREUS

A, H

 

2113

EUONYMUS EUROPAEUS

A, H

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

 

2114

EUPATORIUM FORTUNEI

A, H

 

2115

EUPATORIUM JAPONICUM

A, H

 

2116

EUPATORIUM PERFOLIATUM

A, H

 

2117

EUPATORIUM PURPUREUM

A, H

 

2118

EUPHAUSIA SUPERBA OIL

A

Only for use in oral medicines.

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

- (SFOOD) 'Derived from seafood'

or

- (SHELL) 'Contains crustacean shellfish'.

 

2119

EUPHORBIA CYPARISSIAS

A, H

 

2120

EUPHORBIA DRY

A, H

 

2121

EUPHORBIA HETERODOXA

A, H

 

2122

EUPHORBIA HIRTA

A, H

 

2123

EUPHORBIA LATHYRIS

A, H

Levodopa (of Euphorbia lathyris) is a mandatory component of Euphorbia lathyris.

The concentration of Levodopa (of Euphorbia lathyris) in the medicine must be no more than 10mg/kg or 10mg/L or 0.001%.

 

2124

EUPHORBIA PEKINENSIS

A, H

 

2125

EUPHORBIA PEPLUS

H

Only for use as an active homoeopathic ingredient.

 

2126

EUPHORBIA POWDER

A, H

 

2127

EUPHORBIA RESINIFERA

A, H

 

2128

EUPHORBIA SIEBOLDIANA

A, H

 

2129

EUPHRASIA OFFICINALIS

A, H

 

2130

EUROPEAN GARDEN SPIDER

H

Only for use as an active homoeopathic ingredient.

 

2131

EUROPEAN HORNET

H

Only for use as an active homoeopathic ingredient.

 

2132

EURYALE FEROX

A, H

 

2133

EUTERPE OLERACEA

A

The herbal substance must be derived from the fruit only.

 

2134

EVENING PRIMROSE OIL

A, E, H

 

2135

EVERNIA PRUNASTRA 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%.