Federal Register of Legislation - Australian Government

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Determinations/Health as made
This instrument revokes and replaces the Therapeutic Goods (Permissible Ingredients) Determination No. 3 of 2017, and has the effect of permitting the ingredients described in the determination, subject to the requirements described in the determination for an ingredient, to be contained in medicines or to be listed on the Australian Register of Therapeutic Goods.
Administered by: Health
Registered 20 Sep 2017
Tabling HistoryDate
Tabled HR16-Oct-2017
Tabled Senate16-Oct-2017
Date of repeal 28 Nov 2017
Repealed by Therapeutic Goods (Permissible Ingredients) Determination No. 5 of 2017
Table of contents.

Schedule 1Specified 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

2795

KADSURA COCCINEA

A, H

 

2796

KAEMPFERIA GALANGA

A, H

 

2797

KALMIA LATIFOLIA

A, H

 

2798

KAOLIN

E

 

2799

KELP DRY

A, H

Iodine is a mandatory component of Kelp 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.

 

2800

KELP POWDER

A, E, H

Iodine is a mandatory component of Kelp 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.

 

 

2801

KERATIN

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%.

 

2802

KEROSENE

E, H

Only for use as a homoeopathic ingredient. 

When used in liquid preparations, the concentration in the medicine must be no more than 25%. 

 

2803

KIDNEY BEAN

E

 

2804

KIRSCH

E

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

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

 

2805

KIWI FRUIT

E

 

2806

KNAUTIA ARVENSIS

A, H

 

2807

KOREAN GINSENG ROOT DRY

A, H

 

2808

KOREAN GINSENG ROOT POWDER

A, H

 

2809

KRAMERIA IXIENA

A, H

 

2810

KRAMERIA LAPPACEA

A, H

 

2811

KUNZEA AMBIGUA

A

Only for use when the plant preparation is essential oil.

Only for use when the route of administration is topical or inhalation.

When the dosage form is essential oil, a restricted flow insert must be fitted on the container and the medicine requires the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children'

- (EXTERN) 'For external use only'

- (UNDILU) 'Not to be applied undiluted to the skin except on the advice of a health care practitioner'.

When the dosage form is other than essential oil, the maximum concentration in topical medicines must be no more than 25% w/w and the medicine requires the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children'

- (EXTERN) 'For external use only'.

 

2812

L-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%.

 

2813

L-BORNYL ACETATE

E

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

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

 

2814

L-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%.

 

2815

L-LIMONENE

E

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

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

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

 

2816

L-LINALOOL

E

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

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

 

2817

L-MENTHONE

E

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

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

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

 

2818

L-MENTHYL 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%.

 

2819

L-ROSE 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%.

 

2820

LABDANUM 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%.

 

2821

LABDANUM GUM EXTRACT ETHYL ESTER

E

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

If used in a fragrance and the total fragrance concentration in a medicine is no more than 1%.

 

2822

LABDANUM OIL

A, E, H

 

2823

LABURNUM ANAGYROIDES

A, H

Sparteine is a mandatory component of Laburnum anagyroides.

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

 

2824

LACTALBUMIN

E

 

2825

LACTIC ACID

A, E, H

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 form time to time.

Sponsors should consider the impact of excipients containing alpha hydroxy acids on the sensitivity of the skin to sunlight and should ensure the finished medicine is safe for its intended purpose.

 

 

2826

LACTITOL MONOHYDRATE

E

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

- (SUGOLS) 'Medicines containing lactitol monohydrate may have a laxative effect or cause diarrhoea' (or words to that effect)

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

- (COWMK) 'Derived from cows milk'.

 

2827

LACTOBACILLUS ACIDOPHILUS

A

 

2828

LACTOBACILLUS AMYLOVORUS

A

 

2829

LACTOBACILLUS BREVIS

A

 

2830

LACTOBACILLUS CASEI

A

 

2831

LACTOBACILLUS CASEI SUBSP. BIOVAR CASEI

A

 

2832

LACTOBACILLUS CRISPATUS

A

 

2833

LACTOBACILLUS DELBRUECKII SSP BULGARICUS

A

 

2834

LACTOBACILLUS DELBRUECKII SSP LACTIS

A

 

2835

LACTOBACILLUS FERMENTUM

A

 

2836

LACTOBACILLUS GALLINARUM

A

 

2837

LACTOBACILLUS GASSERI

A

 

2838

LACTOBACILLUS HELVETICUS

A

 

2839

LACTOBACILLUS JOHNSONII

A

 

2840

LACTOBACILLUS KEFIRANOFACIENS

A

 

2841

LACTOBACILLUS KEFIRGRANUM

A

 

2842

LACTOBACILLUS KEFIRI

A

 

2843

LACTOBACILLUS PARACASEI

A

 

2844

LACTOBACILLUS PARACASEI SUBSP. PARACASEI

A

 

2845

LACTOBACILLUS PLANTARUM

A

 

2846

LACTOBACILLUS REUTERI

A

 

2847

LACTOBACILLUS RHAMNOSUS

A

 

2848

LACTOBACILLUS SALIVARIUS SSP SALICINIUS

A

 

2849

LACTOBACILLUS SALIVARIUS SSP SALIVARIUS

A

 

2850

LACTOBIONIC ACID

E

Only for use in topical medicines for dermal application.

 

2851

LACTOSCATONE

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%.

 

2852

LACTOSE

E

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]’.

 

2853

LACTOSE MONOHYDRATE

E

When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose monohydrate, 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 monohydrate then the medicine also requires the following warning statement on the medicine label:

- (LACT) ‘Contains lactose monohydrate [or words to that effect]’.

 

2854

LACTUCA SATIVA

A, H

 

2855

LACTUCA VIROSA

A, H

 

2856

LACTULOSE

E

 

2857

LACTULOSE SOLUTION

A

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 form time to time.

 

 

2858

LAGENARIA VULGARIS

A, H

 

2859

LAMINARIA CLOUSTONI

A, E, H

Iodine is a mandatory component of Laminaria cloustoni.

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.

 

 

 

2860

LAMINARIA DIGITATA

A, E, H

Iodine is a mandatory component of Laminaria digitata.

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.

 

 

2861

LAMINARIA JAPONICA

A, E, H

Iodine is a mandatory component of Laminaria japonica.

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.

 

2862

LAMIUM ALBUM

A, H

 

2863

LANETH-5

E

Only for use in topical medicines for dermal application.

 

2864

LANOLIN ALCOHOL

E

Only for use in topical medicines for dermal application.

 

2865

LANOLIN OIL

E

Only for use in topical medicines for dermal application.

 

2866

LANOLIN WAX

E

Only for use in topical medicines for dermal application.

 

2867

LANTANA CAMARA

A, H

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

 

2868

LARIX ARABINOGALACTAN

A, E

Only for use in oral medicines.

The ingredient must be derived from Larix occidentalis or Larix larcinia.

The maximum recommended daily dose must be no more than 15 grams.

The concentration of polysaccharides in the medicine must be equal to or more than 85%.

 

2869

LARIX DECIDUA

A, H

 

2870

LARIX KAEMPFERI

A, H

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

 

2871

LARREA TRIDENTATA

A, H

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

- (CHAP) 'WARNING: Chaparral may harm the liver in some people - use only under supervision of a health care professional'.

 

2872

LATHYRUS SATIVUS

A, H

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

The medicine must not contain lathyrogenic amino acids.

 

2873

LAURAMINE OXIDE

E

 

2874

LAUREL LEAF OIL

A, H

 

2875

LAURETH-10

E

Only for use in topical medicines for dermal application.

 

2876

LAURETH-12

E

Only for use in topical medicines for dermal application.

 

2877

LAURETH-2

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 0.4%.

Residual levels of ethylene oxide (and related substances) must be kept below the level of detection.

 

2878

LAURETH-23

E

Only for use in topical medicines for dermal application.

 

2879

LAURETH-3

E

Only for use in topical medicines for dermal application.

 

2880

LAURETH-4

E

Only for use in topical medicines for dermal application.

 

2881

LAURETH-7

E

Only for use in topical medicines for dermal application.

 

2882

LAURETH-8

E

 

2883

LAURIC ACID

A, E

When for use as an active ingredient is for use in oral medicines only and the maximum recommended daily dose must not exceed 1500 mg.

 

2884

LAURIL MACROGOL 400 DIMETICONE

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%.

 

2885

LAUROMACROGOL 400

E

Only for use in topical medicines for dermal application.

 

2886

LAUROYL LYSINE

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%.

 

2887

LAURUS NOBILIS

A, E, H

When the plant preparation is oil or distillate, the nominal capacity of the container must be no more than 25 millilitres.

When the concentration of Laurus nobilis oil or distillate in the preparation is greater than 25% and the nominal capacity of the container is less than or equal to 15 millilitres, a restricted flow insert must be fitted on the container.

When the concentration of Laurus nobilis oil or distillate in the preparation is greater than 25% and the nominal capacity of the container is greater than 15 millilitres, a child resistant closure must be fitted on the container.

When the concentration of Laurus nobilis oil or distillate in the preparation is greater than 25%, 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'.

 

 

2888

LAURYL ALDEHYDE

E

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

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

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

 

2889

LAURYL BETAINE

E

Only for use in topical medicines for dermal application.

 

2890

LAURYL GLUCOSIDE

E

Only for use as an excipient ingredient 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 12%.

 

2891

LAURYL 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 3%.

Sponsors should consider the impact of excipients containing alpha hydroxy acids on the sensitivity of the skin to sunlight and should ensure the finished medicine is safe for its intended purpose.

 

2892

LAURYL PCA

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%.

 

2893

LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETICONE

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%.

 

2894

LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETICONE

E

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

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

 

2895

LAURYL PEG/PPG-18/18 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 9%.

Residual levels of ethylene oxide (and related substances) must be kept below the level of detection.

 

2896

LAURYL POLYGLUCOSE

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 must not exceed 1% in leave-on medicines and 3% in wash-on/wash-off medicines.

 

2897

LAURYL PYRROLIDONE

E

Only for use in topical medicines for dermal application.

 

2898

LAURYLDIMONIUM HYDROXYPROPYL HYDROLYSED COLLAGEN

E

Only for use in topical medicines for dermal application.

 

2899

LAURYLDIMONIUM HYDROXYPROPYL HYDROLYSED SOY PROTEIN

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 0.007%.

 

2900

LAURYLMETICONE COPOLYOL

E

Only for use in topical medicines for dermal application.

 

2901

LAVANDIN 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%.

 

2902

LAVANDIN OIL ABRIAL

A, E, H

 

2903

LAVANDIN OIL GROSSO

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%.

 

2904

LAVANDULA ANGUSTIFOLIA

A, E, H

Camphor is a mandatory component of Lavandula angustifolia.

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

In liquid preparations, the nominal capacity of the container must be no more than 25 millilitres.

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

In essential oil or distillate preparations when the concentration of camphor is more than 2.5%, 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 or distillate 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 also have a child resistant closure fitted on the container.

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

 

2905

LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA

A, E, H

Camphor is a mandatory component of Lavandula angustifolia subsp. angustifolia. In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%.

 In liquid preparations, the nominal capacity of the container must be no more than 25 millilitres.

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

In essential oil or distillate preparations when the concentration of camphor is more than 2.5%, 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 or distillate 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 also have a child resistant closure fitted on the container.

 

 

2906

LAVANDULA X INTERMEDIA

A, E, H

Camphor is a mandatory component of Lavandula x intermedia.

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

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

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

 

 

2907

LAVENDER OIL

A, E, H

Camphor is a mandatory component of lavender oil.

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'.

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

 

2908

LAWSONIA INERMIS

A, H

 

2909

LEAD

H

Only for use as an active homoeopathic ingredient.

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

 

 

2910

LEAD ACETATE

H

Only for use as an active homoeopathic ingredient.

 

2911

LEAF ACETAL

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%.

 

2912

LECITHIN

A, E

 

2913

LEDEBOURIELLA SESELOIDES

A, H

 

2914

LEDUM GROENLANDICUM

A, H

 

2915

LEDUM PALUSTRE

A, H

When the route of administration is other than topical, the maximum recommended daily dose must be no more than 0.001mg of the equivalent dry herbal material of Ledum palustre.

 

2916

LEMNA MINOR

A, H

 

2917

LEMON

E

When used internally, oxedrine is a mandatory component of lemon.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.

 

2918

LEMON BALM LEAF DRY

A, H

 

2919

LEMON BALM LEAF POWDER

A, E, H

 

2920

LEMON OIL

A, E, H

When used internally, oxedrine is a mandatory component of lemon oil.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.

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) steam distilled or rectified; or

b) for internal use; or

c) contains 0.05% or less of lemon oil; or

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

 

2921

LEMON OIL DISTILLED

A, E, H

When used internally, oxedrine is a mandatory component of lemon oil distilled.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.

 

2922

LEMON OIL TERPENELESS

A, E, H

When used internally, oxedrine is a mandatory component of lemon oil terpeneless.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.

 

2923

LEMON OIL TERPENES AND TERPENOIDS

E

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

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

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

 

2924

LEMON PEEL DRIED

A, E, H

When used internally, oxedrine is a mandatory component of lemon peel dried.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.

 

2925

LEMONGRASS OIL

A, E, H

 

2926

LENS CULINARIS

A, H

 

2927

LENTIL

E

 

2928

LENTINULA EDODES

A, E, H

 

2929

LEONTOPODIUM ALPINUM

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%.

 

2930

LEONURUS CARDIACA

A, E, H

 

2931

LEONURUS SIBIRICUS

A, E, H

 

2932

LEPIDIUM APETALUM

A, H

 

2933

LEPIDIUM MEYENII

A

Only for use in oral medicines when the plant part is tuber and the plant preparation is dry.

The maximum recommended daily dose must be no more than 3.5g of Lepidium meyenii dried tuber (or its extract equivalent).

 

2934

LEPTOSPERMUM PETERSONII

E

Only for use in topical medicines for dermal application.

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

 

2935

LEPTOSPERMUM SCOPARIUM OIL

A

Only for use as an active ingredient when the route of administration is topical or oral application in a mouthwash preparation.

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

When the concentration is more than 25%, and the nominal capacity of the container less than 15mL, 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 word to that effect)

- (NTAKEN) ‘Not to be taken’

When the concentration is more than 25%, the nominal capacity of the container is more than 15 mL but no more than 25 mL, a child resistant closure and 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 word to that effect)

- (NTAKEN) ‘Not to be taken’

 

2936

LESPEDEZA CAPITATA

A, H

 

2937

LETTUCE

E

 

2938

LEUCINE

A, E

 

2939

LEUZEA UNIFLORUM

A, H

 

2940

LEVISTICUM OFFICINALE

A, H

 

2941

LEVOCARNITINE

A

 

2942

LEVOCARNITINE FUMARATE

A

 

2943

LEVOCARNITINE HYDROCHLORIDE

A

 

2944

LEVOCARNITINE MAGNESIUM CITRATE

A

 

2945

LEVOCARNITINE TARTRATE

A

 

2946

LEVOMEFOLATE CALCIUM

A

Only for use in oral medicines.

Levomefolic acid is a mandatory component of Levomefolate calcium.

The maximum recommended daily dose must provide no more than 500 micrograms of Levomefolic acid from Levomefolate calcium.

When folic acid, folinic acid, levomefolate salts and/or their derivatives are used in combination, the medicine must provide no more than a total of 500 micrograms of folic acid, folinic acid, levomefolate salts and/or their derivatives in total per maximum recommended daily dose.

When used in preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects:

a) the maximum daily dose must provide 400 – 500 micrograms of folic acid; and

b) 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)’.

 

 

2947

LEVOMEFOLATE GLUCOSAMINE

A

Only for use in oral medicines.

Levomefolic acid is a mandatory component of levomefolate glucosamine.

The maximum recommended daily dose must provide no more than 500

micrograms of levomefolic acid from levomefolate glucosamine. 

When used in combination with folic acid, folinic acid and/or their derivatives, the medicine must not provide more than a total of 500 micrograms of folic acid, folinic acid and/or their derivatives in total per maximum recommended daily dose. When used in preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects:

a) the maximum daily dose must provide 400-500 micrograms of folic acid; and

b) 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).'

 

2948

LEVOTHYROXINE SODIUM

H

Only for use as an active homoeopathic ingredient.

 

2949

LEVULINIC ACID

E

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

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

 

2950

LIGHT KAOLIN

E

 

2951

LIGHT LIQUID PARAFFIN

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.

 

2952

LIGHT MAGNESIUM OXIDE

A, E, H

 

2953

LIGUSTICUM SINENSE

A, H

 

2954

LIGUSTICUM STRIATUM

A, E, H

 

2955

LIGUSTRUM LUCIDUM

A, H

 

2956

LILIUM BROWNII

A, H

 

2957

LILIUM CANDIDUM

A, E, H

 

2958

LILIUM LANCIFOLIUM

A, H

 

2959

LILIUM LONGIFLORUM

A, H

 

2960

LIME FRUIT

E

 

2961

LIME 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%.

 

2962

LIME OIL COLDPRESSED

A, E, H

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) contains 0.5% or less of lime oil coldpressed; or

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

 

2963

LIME OIL DISTILLED

A, E, H

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) contains 0.5% or less of lime oil distilled; or

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

 

2964

LIME 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%.

 

2965

LIME OIL TERPENES AND TERPENOIDS

E

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

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

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

 

2966

LIME TREE FLOWER DRY

A, H

 

2967

LIME TREE FLOWER POWDER

A, H

 

2968

LIME, ESSENCE

E

 

2969

LIMES 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%.

 

2970

LIMONENE

E

When for oral use, the quantity must be no more than 10 mg per maximum recommended daily dose.

 

2971

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%.

 

2972

LINALOOL 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%.

 

2973

LINALYL ACETAL

E

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

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

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

 

2974

LINALYL ACETATE

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%.

 

2975

LINALYL BENZOATE

E

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

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

 

2976

LINALYL BUTYRATE

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%.

 

2977

LINALYL CINNAMATE

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%.

 

2978

LINALYL 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%.

 

2979

LINALYL 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%.

 

2980

LINALYL 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%.

 

2981

LINDERA STRYCHNIFOLIA

A, H

 

2982

LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE 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 0.5%.

 

2983

LINOLEIC ACID

E

 

2984

LINOLENIC ACID

E

 

2985

LINSEED DRY

A, E, H

 

2986

LINSEED OIL

A, E, H

 

2987

LINSEED POWDER

A, E, H

 

2988

LINUM USITATISSIMUM

A, E, H

 

2989

LIPASE

A

Lipase must only be derived from Rhizopus oryzae and must comply with the relevant compositional guideline

When used in an undivided preparation, the unit 'Thousand lipase units per gram' is permitted.

When used in a divided preparation, the unit 'Thousand lipase unit' is permitted.

 

2990

LIPPIA DULCIS

A, H

 

2991

LIQUID GLUCOSE

E

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).

 

2992

LIQUID PARAFFIN

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.

 

2993

LIQUIDAMBAR FORMOSANA

A, H

 

2994

LIQUIDAMBAR ORIENTALIS

A, H

 

2995

LIQUIDAMBAR STYRACIFLUA

A, E, H

 

2996

LIQUIDAMBAR TAIWANIANA

A, H

 

2997

LIQUIDAMBER STYRACIFLUA RESIN

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%.

 

2998

LIQUORICE

E

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

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

 

2999

LIQUORICE DRY

A, E, H

 

3000

LIQUORICE LIQUID EXTRACT

A, E, H

 

3001

LIQUORICE POWDER

A, E, H

 

3002

LITCHI CHINENSIS

A, H

 

3003

LITHIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

 

3004

LITHOSPERMUM OFFICINALE

A, H

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

 

3005

LITSEA CUBEBA

A, E, H

 

3006

LITSEA CUBEBA 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%.

 

3007

LOBARIA PULMONARIA

A, H

 

3008

LOBELIA DRY

A, H

The concentration in the medicine must be no more than 0.001% or 10mg/kg or 10ml/L or 10 ppm unless the medicine is administered by inhalation.

 

3009

LOBELIA INFLATA

A, H

The concentration in the medicine must be no more than 0.001% or 10mg/kg or 10ml/L or 10 ppm unless the medicine is administered by inhalation.

 

3010

LOBELIA POWDER

A, H

The concentration in the medicine must be no more than 0.001% or 10mg/kg or 10ml/L or 10 ppm unless the medicine is administered by inhalation.

 

3011

LOLIUM PERENNE

A, H

 

3012

LOLIUM TEMULENTUM

A, H

 

3013

LONGIFOLENE

E

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

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

 

3014

LONICERA CAPRIFOLIUM

A, E, H

 

3015

LONICERA JAPONICA

A, E, H

 

3016

LONICERA PERICLYMENUM

A, H

 

3017

LOPHATHERUM GRACILE

A, H

 

3018

LOQUAT

E

 

3019

LORANTHUS PARASITICUS

A, H

 

3020

LOROPETALUM CHINENSIS

A, H

 

3021

LOTUS CORNICULATUS

A, H

 

3022

LOVAGE 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%.

 

3023

LOVAGE OIL

A, E, H

 

3024

LOVAGE ROOT DRY

A, H

 

3025

LOVAGE ROOT POWDER

A, H

 

3026

LUDWIGIA PROSTRATA

A, H

 

3027

LUFFA CYLINDRICA

A, H

 

3028

LUFFA PURGANS

A, H

 

3029

LUTEIN

A, E, H

When used as an excipient, permitted for use as a colour for oral and topical use.

 

3030

LYCHEE

E

 

3031

LYCIUM BARBARUM

A, H

 

3032

LYCIUM CHINENSE

A, E, H

 

3033

LYCOPENE

A, E

 

3034

LYCOPERSICON ESCULENTUM

A, E, H

Steroidal alkaloids calculated as solanine is a mandatory component of Lycopersicon esculentum.

The maximum daily dose must not provide more than 10 mg of steroidal alkaloids calculated as solanine.

 

3035

LYCOPODIUM ANNOTINUM

A, H

 

3036

LYCOPODIUM CLAVATUM

A, H

 

3037

LYCOPODIUM COMPLANATUM

A, H

 

3038

LYCOPUS EUROPAEUS

A, H

 

3039

LYCOPUS LUCIDUS

A, H

 

3040

LYCOPUS VIRGINICUS

A, H

Pulegone is a mandatory component of Lycopus virginicus.

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

 

3041

LYGODIUM JAPONICUM

A, H

 

3042

LYSIMACHIA CHRISTINAE

A, H

 

3043

LYSIMACHIA VULGARIS

A, H

 

3044

LYSINE

A, E

 

3045

LYSINE HYDROCHLORIDE

A, E

 

3046

LYTHRUM HYSSOPIFOLIA

A, H

 

3047

LYTHRUM SALICARIA

A, H

 

3048

LYTHRUM VERTICILLATUM

A, H

 

3049

MACADAMIA INTEGRIFOLIA

A, E

 

3050

MACADAMIA NUT

E

 

3051

MACADAMIA NUT OIL

E

 

3052

MACADAMIA TERNIFOLIA

A, E, H

 

3053

MACE

E

Safrole is a mandatory component of Mace.

When used internally, the concentration of safrole in the medicine must be no more than 0.1%.

When used topically, the concentration of safrole in the medicine must be no more than 1.0%.

 

 

3054

MACE OIL

A, H

Safrole is a mandatory component of Mace oil.

When used internally, the concentration of safrole in the medicine must be no more than 0.1%.

When used topically, the concentration of safrole in the medicine must be no more than 1.0%.

When the concentration of mace oil in the preparation is more than 50% and the nominal capacity of the container is 25 mL or less, a restricted flow insert must be fitted on the container.

 

3055

MACROCYSTIS PYRIFERA

A, E, H

Iodine is a mandatory component of Macrocystis pyrifera.

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.

 

3056

MACROGOL 1000

E

 

3057

MACROGOL 1450

E

Only for use in topical medicines for dermal application.

 

3058

MACROGOL 1500

E

 

3059

MACROGOL 1500 CASTOR OIL

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%.

 

3060

MACROGOL 200

E

Only for use in topical medicines for dermal application.

 

3061

MACROGOL 20000

E

 

3062

MACROGOL 300

E

 

3063

MACROGOL 3000

E

 

3064

MACROGOL 3350

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 form time to time.

 

3065

MACROGOL 40

E

Only for use in topical medicines for dermal application.

 

3066

MACROGOL 400

E

 

3067

MACROGOL 4000

E

 

3068

MACROGOL 45000

E

Only for use in topical medicines for dermal application.

 

3069

MACROGOL 600

E

 

3070

MACROGOL 6000

E

 

3071

MACROGOL 600000

E

 

3072

MACROGOL 800

E

 

3073

MACROGOL 8000

E

 

3074

MACROGOL 900

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 0.95%.

 

3075

MACROGOL POLY(VINYL ALCOHOL) GRAFTED POLYMER

E

Only for use in oral medicines.

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

 

3076

MACROPIPER EXCELSUM VAR EXCELSUM

A, H

 

3077

MAGNESIUM AMINO ACID CHELATE

A, E, H

Only for use in oral medicines.

The concentration of Magnesium must be no more than 25% of the magnesium amino acid chelate.

 

 

 

3078

MAGNESIUM ASCORBATE

A, E, H

 

3079

MAGNESIUM ASCORBATE MONOHYDRATE

A, E, H

 

3080

MAGNESIUM ASCORBYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

3081

MAGNESIUM ASPARTATE

A, E, H

 

3082

MAGNESIUM ASPARTATE DIHYDRATE

A, E, H

 

3083

MAGNESIUM ASPARTATE TETRAHYDRATE

A, E, H

 

3084

MAGNESIUM CARBONATE HYDRATE

A, E, H

 

3085

MAGNESIUM CHLORIDE 4.5-HYDRATE

A

 

3086

MAGNESIUM CHLORIDE HEXAHYDRATE

A, E, H

 

3087

MAGNESIUM CITRATE

A, E, H

 

3088

MAGNESIUM CITRATE NONAHYDRATE

A, E, H

 

3089

MAGNESIUM CITRATE TETRADECAHYDRATE

A, E, H

 

3090

MAGNESIUM DIGLUTAMATE

A, E, H

 

3091

MAGNESIUM GLUCONATE

A, E, H

 

3092

MAGNESIUM GLYCEROPHOSPHATE

A, E, H

 

3093

MAGNESIUM GLYCINATE

A

Only for use in oral medicines.

 

3094

MAGNESIUM GLYCINATE DIHYDRATE

A

Only for use in oral medicines.

The purpose for use for all metal amino acid chelates is restricted to mineral supplementation.

Magnesium is a mandatory component of Magnesium glycinate dihydrate.

Based on molecular weights the declared quantity of Magnesium from Magnesium glycinate dihydrate must be no less than 11.1% and must be no more than 12.2% of the Magnesium glycinate dihydrate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations.

 

3095

MAGNESIUM HYDROGEN PHOSPHATE

H

 

3096

MAGNESIUM HYDROXIDE

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 medicine is not promoted or marketed as laxative, contains more than 2 g magnesium hydroxide per maximum recommended daily dose and the medicine is listed in the Register on or after 1 October 2017 the medicine must have the following statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'

- (LAX4) 'This product may have laxative effect'.

When the medicine is not promoted or marketed as laxative, contains more than 2 g magnesium hydroxide per maximum recommended daily dose and the medicine is listed in the Register before 1 October 2017 the medicine requires the following statements on the medicine label if supplied after 1 April 2019:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]

- (LAX4) 'This product may have laxative effect'.

 

 

3097

MAGNESIUM LYSINATE

A

Only for use in oral medicines.

 

3098

MAGNESIUM METHIONINATE

A

Only for use in oral medicines.

 

3099

MAGNESIUM NITRATE

E

Only for use in topical medicines for dermal application.

 

3100

MAGNESIUM OROTATE

A, E, H

 

3101

MAGNESIUM OROTATE DIHYDRATE

A, E, H

 

3102

MAGNESIUM OXIDE

A, E, H

 

3103

MAGNESIUM PHOSPHATE PENTAHYDRATE

A, E, H

 

3104

MAGNESIUM PHOSPHATE TRIBASIC

A, E, H

Magnesium is a mandatory component of Magnesium phosphate tribasic. The percentage of magnesium from magnesium phosphate tribasic should be calculated based on the molecular weight of magnesium phosphate tribasic.

 

 

3105

MAGNESIUM PYRUVATE

A

Only for use in oral medicines.

The maximum recommended daily dose must be no more than 7 grams.

 

3106

MAGNESIUM STEARATE

E

 

3107

MAGNESIUM SULFATE DIHYDRATE

A, E, H

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

 

 

3108

MAGNESIUM SULFATE HEPTAHYDRATE

A, E, H

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

 

3109

MAGNESIUM SULFATE MONOHYDRATE

A, E, H

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

 

 

3110

MAGNESIUM SULFATE TRIHYDRATE

A, E, H

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

 

3111

MAGNESIUM TRISILICATE

E

 

3112

MAGNOLIA GLAUCA

A, H

 

3113

MAGNOLIA LILIFLORA

A, H

 

3114

MAGNOLIA OBOVATA

A, H

 

3115

MAGNOLIA OFFICINALIS

A, E, H

 

3116

MAGNOLIA SALICIFOLIA

A, H

 

3117

MAIZE

E

 

3118

MAIZE BRAN

E

 

3119

MAIZE OIL

A, E, H

 

3120

MAIZE STARCH

A, E, H

 

3121

MALACHITE GREEN

E

Permitted for use only as a colour for topical use.

 

3122

MALIC ACID

E

Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished medicine is safe for its intended purpose.

 

3123

MALPIGHIA GLABRA

A, E, H

 

3124

MALT EXTRACT

E

 

3125

MALTITOL

E

When the quantity of sugar alcohols per maximum recommended daily dose is more than 2g, the quantity of the sugar alcohols must be declared on the label and the medicine requires the following warning statement on the medicine label:

- (SUGOLS) ‘Products containing [insert name of sugar alcohol(s) may have a laxative effect or cause diarrhoea [or words to that effect]’.

 

3126

MALTITOL SOLUTION

E

When the quantity of sugar alcohols per maximum recommended daily dose is more than 2g, the quantity of the sugar alcohols must be declared on the label and the medicine requires the following warning statement on the medicine label:

- (SUGOLS) ‘Products containing [insert name of sugar alcohol(s)] may have a laxative effect or cause diarrhoea' (or words to that effect).

 

3127

MALTODEXTRIN

E

Gluten is a mandatory component of Maltodextrin where the ingredient is derived from gluten containing grains such as wheat, barley, rye and oats.

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).

 

3128

MALTOL

E

 

3129

MALTONE

E

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

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

 

3130

MALTOSE

E

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).

 

3131

MALUS DOMESTICA

A, E, H

The concentration of amygdalin in the medicine must be no more than 0%.

 

3132

MALUS PUMILA

A, E, H

 

3133

MALUS SYLVESTRIS

A, H

 

3134

MALVA MOSCHATA

A, H

 

3135

MALVA SYLVESTRIS

A, E, H

 

3136

MALVA VERTICILLATA

A, H

 

3137

MANDARIN

E

 

3138

MANDARIN 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%.

 

3139

MANDARIN OIL COLDPRESSED

A, E, H

When used internally, oxedrine is a mandatory component of mandarin oil coldpressed.

The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.

 

3140

MANDARIN 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%.

 

3141

MANDARIN RESIDUE

E

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

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

 

3142

MANDARINAL 32048

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%.

 

3143

MANDRAGORA OFFICINARUM

A, H

Atropine, hyoscine and hyoscyamine are mandatory components of Mandragora officinarum.

The concentration in the medicine must be no more than 10 mg/kg or 10 mL/L or 0.001%.

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

The concentration of hyoscine in the medicine must be no more than 300 micrograms/kg or 300 micrograms/L or 0.00003%.

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

 

3144

MANGANESE

H

Only for use as an active homoeopathic ingredient.

 

3145

MANGANESE (II) DIASPARTATE

A, H

Only for use in oral medicines.

 

 

3146

MANGANESE (II) GLYCINATE

A, H

Only for use in oral medicines.

 

3147

MANGANESE ACETATE TETRAHYDRATE

H

Only for use as an active homoeopathic ingredient. 

 

3148

MANGANESE AMINO ACID CHELATE

A, E, H

Only for use in oral medicines.

The concentration of Manganese must be no more than 25% of the manganese amino acid chelate.

 

3149

MANGANESE CHLORIDE TETRAHYDRATE

A, E, H

 

3150

MANGANESE DIASPARTATE

A, E, H

Only for use in oral medicines.

 

 

 

3151

MANGANESE GLUCONATE

A, E, H

 

3152

MANGANESE GLYCEROPHOSPHATE

A, E, H

 

3153

MANGANESE OXIDE

A, E, H

 

3154

MANGANESE SULFATE MONOHYDRATE

A, E, H

 

3155

MANGANESE SULFATE TETRAHYDRATE

A, E, H

 

3156

MANGIFERA INDICA

A, E, H

 

3157

MANGO

E, H

 

3158

MANIHOT ESCULENTA

A, H

 

3159

MANNITOL

E

When the quantity of sugar alcohols per maximum recommended daily dose is more than 2g, the quantity of the sugar alcohols must be declared on the label and the medicine requires the following warning statement on the medicine label:

- (SUGOLS) ‘Products containing [insert name of sugar alcohol(s)] may have a laxative effect or cause diarrhoea' (or words to that effect).

 

3160

MARANTA ARUNDINACEA

A, H

 

3161

MARINE SPONGE

H

Only for use as an active homoeopathic ingredient.

 

3162

MARJORAM OIL SPANISH

A, E, H

When the concentration in the preparation is more than 50%, the nominal capacity of the container must be no more than 50 mL, the medicine must have a restricted flow insert fitted to the container and requires the following warning statement on the medicine label:

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

 

3163

MARJORAM OIL SWEET

A, E, H

When the concentration in the preparation is more than 50%, the nominal capacity of the container must be no more than 50 mL, the medicine must have a restricted flow insert fitted to the container and  requires the following warning statement on the medicine label:

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

 

3164

MARRUBIUM VULGARE

A, E, H

 

3165

MARSDENIA CUNDURANGO

A, H

 

3166

MARSHMALLOW ROOT DRY

A, H

 

3167

MARSHMALLOW ROOT POWDER

A, H

 

3168

MASSOIA LACTONE

E

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

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

 

3169

MASTIC

A, H

 

3170

MATE 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%.

 

3171

MATRICARIA CHAMOMILLA

A, E, H

 

3172

MATRICARIA FLOWER DRY

A, E, H

 

3173

MEADOWSWEET HERB DRY

A, H

 

3174

MEADOWSWEET HERB POWDER

A, H

 

3175

MECOBALAMIN (CO-METHYLCOBALAMIN)

A

Only for use in oral medicines.

 

3176

MEDICAGO SATIVA

A, E, H

The level of l-canavanine must be no more than that of the dried leaf.

When fresh leaf extract is used and the extraction ratio is between 34:1 and 46:1, the quantity of l-canavanine in the extract must not be more than that in the fresh leaf.

 

3177

MEDIUM CHAIN TRIGLYCERIDES

E

 

3178

MELALEUCA ALTERNIFOLIA

A, E, H

Cineole is a mandatory component of Melaleuca alternifolia.

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.

 

 

3179

MELALEUCA CAJUPUTI

A, E, H

Cineole is a mandatory component of Melaleuca cajuputi.

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.

 

3180

MELALEUCA DISSITIFLORA

A, H

Cineole is a mandatory component of Melaleuca dissitiflora.

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.

 

3181

MELALEUCA ERICIFOLIA

A, E, H

Cineole is a mandatory component of Melaleuca ericifolia.

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.

 

3182

MELALEUCA LINARIIFOLIA

A, H

Cineole is a mandatory component of Melaleuca linariifolia.

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.

 

3183

MELALEUCA OIL

A, E, H

Cineole and cajuput oil are a mandatory components of Melaleuca Oil.

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

Where the nominal capacity of the container is more than 15 mL but less than or equal to 25 mL, then a child resistant closure and restricted flow insert must be fitted on the container.

 

3184

MELALEUCA QUINQUENERVIA

A, E, H

Cineole is a mandatory component of Melaleuca quinquenervia.

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.

 

3185

MELICOPE PTELEIFOLIA

A, H

 

3186

MELILOTUS OFFICINALIS

A, E, H

Coumarin is a mandatory component of Melilotus officinalis.

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

 

3187

MELISSA OFFICINALIS

A, E, H

 

3188

MELON

E

 

3189

MENADIONE SODIUM BISULFITE

E

 

3190

MENAQUINONE 7

A

For oral use only.

The medicine must not provide more than 180 micrograms per maximum daily dose in adults, 90 micrograms per maximum daily dose in children between 10-18 years, and 45 micrograms per maximum daily dose in children less than 10 years of age.

 

3191

MENISPERMUM CANADENSE

A, H

 

3192

MENTHA AQUATICA

A, H

 

3193

MENTHA ARVENSIS

A, E, H

 

3194

MENTHA ARVENSIS 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 than 1%.

 

3195

MENTHA ARVENSIS 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%.

 

3196

MENTHA HAPLOCALYX

A, E, H

 

3197

MENTHA PULEGIUM

A, H

D-Pulegone and volatile oil components (of Mentha pulegium) are mandatory components of Mentha pulegium.

When the nominal capacity of the container is more than 15 millilitres, the concentration of D-pulegone in the medicine must be no more than 4%.

When the concentration of D-Pulegone in the preparation is more than 4% and the nominal capacity of the container is 15 millilitres or less, the medicine must have a child resistant closure and restricted flow insert fitted on the container. The medicine requires the following warning statements on the medicine label: - (NTAKEN) 'Not to be taken' - (CHILD) 'Keep out of reach of children' (or words to that effect). When the medicine is for topical use, the maximum recommended daily dose must be no more than 150 mg of Mentha pulegium oil or distillate.

When the medicine is for a use other than topical, the maximum recommended daily dose must be no more than 50 mg of Mentha pulegium oil or distillate.

 

3198

MENTHA SPICATA

A, E, H

 

3199

MENTHA X CARDIACA

A, E, H

 

3200

MENTHA X PIPERITA

A, E, H

 

3201

MENTHA X PIPERITA NOTHOSUBSP. CITRATA

A, H

 

3202

MENTHADIENYL 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%.

 

3203

MENTHANYL 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%.

 

3204

MENTHOFURAN

E

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

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

 

3205

MENTHOL

A, E

When used as an active ingredient, permitted only in medicated space sprays and medicated lozenges.

 

3206

MENTHONE

E

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

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

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

 

3207

MENTHONE GLYCERINE 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%.

 

3208

MENTHONE THIOL FRACTION

E

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

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

 

3209

MENTHOXYPROPANEDIOL

E

For oral use only.

The concentration in the medicine must be no more than 0.04%.

 

3210

MENTHYL 2-HYDROXYETHYL CARBONATE

E

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

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

 

3211

MENTHYL 2-HYDROXYPROPYL CARBONATE

E

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

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

 

3212

MENTHYL ANTHRANILATE

A

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%.

 

3213

MENTHYL 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%.

 

3214

MENTHYL LACTATE

E

 

3215

MENYANTHES TRIFOLIATA

A, H

 

3216

MERCURIC CHLORIDE

H

Only for use as an active homoeopathic ingredient.

 

3217

MERCURY

H

Only for use as an active homoeopathic ingredient.

 

3218

MESPILUS GERMANICA

A, H

 

3219

METACRESOL

E

Only for use in topical medicines for dermal application.

 

3220

METHACRYLIC ACID COPOLYMER

E

Only for use in oral medicines.

 

3221

METHANOL

E

The residual solvent limit is 30 mg per recommended daily dose.

The concentration in the medicine must be no more than 0.3%.

 

3222

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 1%.

 

3223

METHIONINE

A, E

 

3224

METHYL 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%.

 

3225

METHYL 2-OCTYNOATE

E

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

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

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

 

3226

METHYL 3,6-DIMETHYLRESORCYLATE

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%.

 

3227

METHYL ACETATE

E

The residual solvent limit is 50 mg per recommended daily dose.

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

 

3228

METHYL ACETOPHENONE

E

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

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

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

 

3229

METHYL ACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

 

3230

METHYL ANISATE

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%.

 

3231

METHYL 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%.

 

3232

METHYL BENZOATE

E

Only for use in topical medicines for dermal application.

 

3233

METHYL 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%.

 

3234

METHYL 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%.

 

3235

METHYL CAPRYLATE

E

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

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

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

 

3236

METHYL CARBITOL

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%.

 

3237

METHYL CEDRYL KETONE

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%.

 

3238

METHYL CINNAMATE

E

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

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

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

 

3239

METHYL CIS-5-OCTENOATE

E

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

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

 

3240

METHYL CYCLOPENTENOLONE

E

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

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

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

 

3241

METHYL CYCLOPENTYLIDENEACETATE

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%.

 

3242

METHYL DI-TERT-BUTYL-4-HYDROXYHYDROCINNAMATE

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%.

 

3243

METHYL DIHYDROABIETATE

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%.

 

3244

METHYL DIISOPROPYL PROPIONAMIDE

E

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

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

 

3245

METHYL ETHER

E

Only for use in topical medicines for dermal application.

 

3246

METHYL ETHYL KETONE

E

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

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

 

3247

METHYL EUGENOL

E

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

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

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

 

3248

METHYL FUROATE

E

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

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

 

3249

METHYL GLUCETH-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 3%.

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

 

3250

METHYL GLUCETH-20

E

Only for use in topical medicines for dermal application.

 

3251

METHYL GLUCETH-20 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%.

 

3252

METHYL GLUCETH-20 SESQUIHYDRATE

E

Only for use in topical medicines for dermal application.

 

3253

METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

 

3254

METHYL GLUCOSE SESQUIOLEATE

E

Only for use in topical medicines for dermal application.

 

3255

METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

 

3256

METHYL HEPTENONE

E

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

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

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

 

3257

METHYL HEPTYL 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%.

 

3258

METHYL HEXYL CARBINOL

E

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

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

 

3259

METHYL HEXYL 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%.

 

3260

METHYL HYDROGENATED ROSINATE

E

Only for use in topical medicines for dermal application.

 

3261

METHYL HYDROJASMONATE

E

Only for use in topical medicines for dermal application.

 

3262

METHYL 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.

 

3263

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%.

 

3264

METHYL ISOBUTYL KETONE

E

The residual solvent limit is 50 mg per maximum daily dose.

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

 

3265

METHYL ISOEUGENOL

E

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

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

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

 

3266

METHYL 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%.

 

3267

METHYL JASMONATE

E

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

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

 

3268

METHYL LAURATE

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%.

 

3269

METHYL LINOLEATE

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%.

 

3270

METHYL LINOLENATE

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%.

 

3271

METHYL MAGNESIUM CHLORIDE

E

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

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

 

3272

METHYL METHACRYLATE

E

 

3273

METHYL METHACRYLATE 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%.

 

3274

METHYL METHOXY PYRAZINE

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%.

 

3275

METHYL MYRISTATE

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%.

 

3276

METHYL NAPHTHYL KETONE

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%.

 

3277

METHYL NONYL 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%.

 

3278

METHYL NONYLENATE

E

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

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

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

 

3279

METHYL OCTIN CARBONATE

E

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

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

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

 

3280

METHYL PALMITATE

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%.

 

3281

METHYL PHENYL CARBINOL

E

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

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

 

3282

METHYL PHENYL CARBINYL-ISO-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%.

 

3283

METHYL PHENYL GLYCIDATE

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%.

 

3284

METHYL 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%.

 

3285

METHYL PHENYLCARBINYL 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%.

 

3286

METHYL ROSINATE

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%.

 

3287

METHYL SALICYLATE

E

Only for use in topical medicines for dermal application.

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

For topical use, when the concentration in a liquid preparation is more than 5%, and the dosage form is other than spray, the medicine requires child resistant packaging.

For topical use, when the concentration 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 spay device is ergonomically difficult for young children to accomplish.

 

3288

METHYL STEARATE

E

 

3289

METHYL THIOBUTYRATE

E

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

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

 

3290

METHYL TRIMETICONE

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%.

 

3291

METHYL-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%.

 

3292

METHYL-BETA-METHYL THIOLPROPIONATE

E

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

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

 

3293

METHYL-PARA-TERT-BUTYL PHENYLACETATE

E

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

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

 

3294

METHYLBENZYL 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%.

 

3295

METHYLCELLULOSE

A, E

 

3296

METHYLCHLOROISOTHIAZOLINONE

E

Only for use in topical medicines for dermal application.

The total concentration of methylchloroisothiazolinone and methylisothiazolinone in the medicine must be no more than 0.0015%.

 

3297

METHYLCYCLOHEXADIENE

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%.

 

3298

METHYLDIBROMO GLUTARONITRILE

E

Only for use in topical medicines for dermal application.

 

3299

METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL

A

Only for use as an active ingredient in sunscreens.

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%.

 

3300

METHYLISOTHIAZOLINONE

E

Only for use in topical medicines for dermal application.

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

The total concentration of methylchloroisothiazolinone and methylisothiazolinone in the medicine must be no more than 0.0015%.

 

3301

METHYLMERCAPTAN

E

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

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

 

3302

METHYLPROPANEDIOL

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%.

 

3303

METHYLSILANOL/SILICATE CROSSPOLYMER

E

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

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

 

3304

METHYLSTYRENE/VINYLTOLUENE COPOLYMER

E

Only for use in topical medicines for dermal application.

 

3305

MICA

E

Only for use when the route of administration is oral, dental or topical.

The concentration in oral medicines must be no more than 2.5%.

The concentration in dental toothpastes must be no more than 0.5%.

 

3306

MICROCALICIUM ARENARIUM

A, H

 

3307

MICROCOCCUS LUTEUS LYSATE

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 0.005%.

 

3308

MICROCOS PANICULATA

A, H

 

3309

MICROCRYSTALLINE CELLULOSE

E

 

3310

MICROCRYSTALLINE WAX

E

Only for use as an excipient in medicines for topical, oral or oral application routes of administration.

When microcrystalline wax is used as an excipient ingredient, the route of administration 'oral' is only permitted when the dosage form is 'chewing gum'.

 

3311

MILK FAT

E

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

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

 

3312

MILK THISTLE FRUIT DRY

A, H

 

3313

MILK THISTLE FRUIT POWDER

A, H

 

3314

MILLET

E

 

3315

MILLETTIA DIELSIANA

A, H

 

3316

MIMOSA 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%.

 

3317

MIMULUS GUTTATUS

A, H

 

3318

MINT OIL DEMENTHOLISED

A, E, H

 

3319

MINTLACTONE

E

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

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

 

3320

MITCHELLA REPENS

A, H

 

3321

MIXED (HIGH-ALPHA TYPE) TOCOPHEROLS CONCENTRATE

A, E

 

3322

MIXED (LOW-ALPHA TYPE) TOCOPHEROLS CONCENTRATE

A, E

 

3323

MIXED 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%.

 

3324

MODIFIED FOOD STARCH

E

 

3325

MOLASSES

E

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

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

 

3326

MOLYBDENUM

H

Only for use as an active homoeopathic ingredient. 

When Molybdenum is sourced from Molybdenum trioxide then the maximum daily dose must be no more than 125 micrograms.

When Molybdenum is sourced from yeast - high molybdenum then the maximum recommended daily dose must be no more than 62.5 micrograms.

 

3327

MOLYBDENUM TRIOXIDE

A

Molybdenum is a mandatory component of Molybdenum trioxide.

The maximum daily dose of molybdenum from Molybdenum trioxide must be no more than 125 micrograms.

The percentage of molybdenum from molybdenum trioxide should be calculated based on the molecular weight of molybdenum trioxide.

 

 

3328

MOMORDICA BALSAMINA

A, H

 

3329

MOMORDICA CHARANTIA

A, H

 

3330

MOMORDICA COCHINCHINENSIS

A, H

When Lycopene, Lutein or Betocarotene are declared as components, the plant part is restricted to fruit flesh, fruit peel or seed aril.

 

3331

MONARDA DIDYMA

A, H

 

3332

MONO- AND DI- GLYCERIDES

E

 

3333

MONOBASIC AMMONIUM PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

3334

MONOBASIC CALCIUM PHOSPHATE

A, E, H

 

3335

MONOBASIC POTASSIUM PHOSPHATE

A, E, H

When used in a solid medicine containing this ingredient, 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 medicine containing this ingredient, the pH of the medicine must be no more than 11.5.

 

3336

MONOBASIC SODIUM PHOSPHATE

A, E, H

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).'

 

 

3337

MONOBASIC SODIUM PHOSPHATE DIHYDRATE

E

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).

 

3338

MONOETHANOLAMINE

E

Only for use in topical medicines for dermal application.

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

 

3339

MONOPHOSPHOTHIAMINE

A

 

3340

MONOPHOSPHOTHIAMINE DIHYDRATE

A

 

3341

MONOPOTASSIUM GLUTAMATE

A, E

 

3342

MONOSODIUM DIHYDROGEN CITRATE

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).’

 

3343

MONOSODIUM GLUTAMATE MONOHYDRATE

A, E

 

3344

MONSTERA DELICIOSA

A, H

 

3345

MONTAN WAX

E

 

3346

MORDANT RED 11

E

Permitted for use only as a colour for topical use.

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

 

3347

MORINDA CITRIFOLIA

A, H

Only for use when the plant part is fruit and the plant preparation is fruit juice or fruit powder.

Fruit powder must be produced by freeze drying the whole fruit (excluding the seeds).

 

3348

MORINDA OFFICINALIS

A, H

 

3349

MORINGA OLEIFERA

A, H

 

3350

MORUS ALBA

A, H

 

3351

MORUS BOMBYCIS

A, H

 

3352

MORUS NIGRA

A, E, H

 

3353

MOSKENE

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%.

 

3354

MOTHERWORT HERB DRY

A, H

 

3355

MOTHERWORT HERB POWDER

A, H

 

3356

MUCUNA PRURIENS

A, H

Levodopa (of Mucuna pruriens) is a mandatory component of Mucuna pruriens.

The concentration of Levodopa (of Mucuna pruriens) in the medicine must be no more than 1mg/kg or 1mg/L or 0.1%.

 

3357

MULBERRY

E

 

3358

MUNG BEAN

E

 

3359

MURRAYA KOENIGII

A, H

 

3360

MURRAYA PANICULATA

A, H

 

3361

MUSA X PARADISIACA

A, H

 

3362

MUSK KETONE

E

Only for use in topical medicines for dermal application.

 

3363

MUSK TIBETENE

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%.

 

3364

MUSK XYLOL

E

Only for use in topical medicines for dermal application.

 

3365

MUSKS

H

Only for use as an active homoeopathic ingredient. 

 

3366

MUSTARD

E

Allyl isothiocyanate is a mandatory component of mustard 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%.

 

3367

MUSTARD OIL

E

Allyl isothiocyanate is a mandatory component of mustard 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%.

 

3368

MUSTARD SEED OIL

E

Allyl isothiocyanate is a mandatory component of mustard seed 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%.

 

3369

MYOSOTIS ARVENSIS

A, H

 

3370

MYRCENE

E

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

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

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

 

3371

MYRCENYL 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%.

 

3372

MYRICA CERIFERA

A, E, H

 

3373

MYRISTIC ACID

E

 

3374

MYRISTIC 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%.

 

3375

MYRISTICA FRAGRANS

A, E, H

Safrole is a mandatory component of Myristica fragrans.

When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%.

When the plant preparation is oil or distillate and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 millilitres, the medicine must have a 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 word to that effect).

 

3376

MYRISTYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

3377

MYRISTYL LACTATE

E

Only for use in topical medicines for dermal application.

 

3378

MYRISTYL MYRISTATE

E

Only for use in topical medicines for dermal application.

 

3379

MYROXYLON BALSAMUM

A, E, H

 

3380

MYROXYLON BALSAMUM VAR. PEREIRAE

A, H

 

3381

MYRRH

A, H

 

3382

MYRRH OIL

A, E, H

 

3383

MYRRH RESIN

E

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

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

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

 

3384

MYRRHIS ODORATA

A, H

 

3385

MYRSINE AFRICANA

A, H

 

3386

MYRTENAL

E

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

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

 

3387

MYRTENYL 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%.

 

3388

MYRTLE ESSENCE MAX

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%.

 

3389

MYRTLE OIL

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%.

 

3390

MYRTUS COMMUNIS

A, E, H

 

3391

N-BUTYL 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%.

 

3392

N-GLUCONYL ETHANOLAMINE

E

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

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

 

 

3393

N-HEXYL 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%.

 

3394

N-NONYL 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%.

 

3395

NAPHTHALENE

H

Only for use as an active homoeopathic ingredient. 

 

3396

NARDOSTACHYS CHINENSIS

A, H

 

3397

NARINGIN

E

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

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

 

3398

NASTURTIUM OFFICINALE

A, E, H

 

3399

NATURAL CHERRY FLAVOUR

E

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

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

 

3400

NATURAL FISH OIL

A, E

When therapeutic indications for this product are made against Vitamin A or colecalciferol (Vitamin D), they are mandatory components of natural fish 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.

 

3401

NAUCLEA OFFICINALIS

A, H

 

3402

NELUMBO NUCIFERA

A, H

 

3403

NELUMBO NUCIFERA FLOWER WAX

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%.

 

3404

NEOHESPERIDIN-DIHYDROCHALCONE

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%

 

3405

NEOMENTHOL

E

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

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

 

3406

NEOPENTYL GLYCOL DIHEPTANOATE

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 25%.

 

3407

NEOPENTYL GLYCOL DIISOSTEARATE

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%. 

 

3408

NEOPENTYL GLYCOL DIOCTANOATE

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%.

 

3409

NEOPENTYL GLYCOL DIOCTANOATE/DIDECANOATE

E

Only for use in topical medicines for dermal application.

 

3410

NEOPICRORHIZA SCROPHULARIIFLORA

A, H

 

3411

NEPETA CATARIA

A, H

Pulegone is a mandatory component of Nepeta cataria and must be declared in the application.

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

 

3412

NERAL

E

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

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

 

3413

NERIUM OLEANDER

A, H

The concentration of equivalent dry Nerium oleander in the product must be no more than 1mg/Kg or 1mg/L or 0.0001%.

 

3414

NEROL

E

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

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

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

 

3415

NEROLIDOL

E

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

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

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

 

3416

NERYL 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%.

 

3417

NERYL-ISO-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%.

 

3418

NICKEL

H

Only for use as an active homoeopathic ingredient.

 

3419

NICOTIANA TABACUM

H

Only for use as an active homoeopathic ingredient.

 

3420

NICOTINAMIDE

A, E, H

 

3421

NICOTINAMIDE ASCORBATE

A, E

 

3422

NICOTINIC ACID

A, E

The medicine must contain no more than 100 mg of nicotinic acid per dosage unit.

 

3423

NIGELLA DAMASCENA

A, H

 

3424

NIGELLA SATIVA

A, E, H

 

3425

NITRIC ACID

E, H

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

 

3426

NONADIENOL

E

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

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

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

 

3427

NONANAL

E

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

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

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

 

3428

NONANOIC 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%.

 

3429

NONFAT DRY MILK

E, H

If the product is for oral ingestion and contains lactose, then the medicine requires the following warning statement on the medicine label:

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

 

3430

NONIVAMIDE

E

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

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

 

3431

NONOXINOL 10

E

Only for use in topical medicines for dermal application.

 

3432

NONOXINOL 12

E

For use in hand scrub formulations for healthcare professionals only.

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%.

 

3433

NONOXINOL 5

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%.

 

3434

NONOXINOL 9

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 25%.

 

3435

NONYL 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%.

 

3436

NOOTKATONE

E

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

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

 

3437

NOPYL 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%.

 

3438

NORDIHYDROGUAIARETIC ACID

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 0.3%.

 

3439

NOTOPTERYGIUM FORBESII

A, H

 

3440

NOTOPTERYGIUM INCISIUM

A, H

 

3441