Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient name

Purpose

Specific requirements

2822

KADSURA COCCINEA

A, H

2823

KAEMPFERIA GALANGA

A, H

2824

KALMIA LATIFOLIA

A, H

Arbutin is a mandatory component of Kalmia latifolia.

The concentration of arbutin in the medicine must be no more than 25 mg/Kg or 25mg /L or 0.0025 % unless used on the hair.

When for use on hair, the concentration of arbutin in the medicine must be no more than 0.74 %.

2825

KAOLIN

E

2826

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.

2827

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.

2828

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%.

2829

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%. 

2830

KHAYA SENEGALENSIS

A, E

Only to be used in a medicine where Bioactive Solutions Pty Ltd (Client ID 61631), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 27 September 2020.

The maximum daily dose of the medicine must not contain more than the equivalent of 1g dry bark of Khaya senegalensis.

The following warning statements are required on the medicine label:

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

- (LONGUSE) ‘Not for prolonged use. May harm liver';

- (GEN2) ‘If symptoms persist, seek the advice of a healthcare professional’;

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

- (7DAYS) 'Do not use for more than 7 days'.

2831

KIDNEY BEAN

E

2832

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%.

2833

KIWI FRUIT

E

2834

KNAUTIA ARVENSIS

A, H

2835

KOREAN GINSENG ROOT DRY

A, H

2836

KOREAN GINSENG ROOT POWDER

A, H

2837

KRAMERIA IXIENA

A, H

2838

KRAMERIA LAPPACEA

A, H

2839

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'.

2840

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%.

2841

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%.

2842

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%.

2843

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%.

2844

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%.

2845

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%.

2846

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%.

2847

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%.

2848

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%.

2849

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%.

2850

LABDANUM OIL

A, E, H

2851

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%.

2852

LACTALBUMIN

E

2853

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.

2854

LACTITOL

E

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

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

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

- (COWMK) 'Derived from cows milk'.

2855

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'.

2856

LACTOBACILLUS ACIDOPHILUS

A

2857

LACTOBACILLUS AMYLOVORUS

A

2858

LACTOBACILLUS BREVIS

A

2859

LACTOBACILLUS CASEI

A

2860

LACTOBACILLUS CASEI SUBSP. BIOVAR CASEI

A

2861

LACTOBACILLUS CRISPATUS

A

2862

LACTOBACILLUS DELBRUECKII SSP BULGARICUS

A

2863

LACTOBACILLUS DELBRUECKII SSP LACTIS

A

2864

LACTOBACILLUS FERMENTUM

A

2865

LACTOBACILLUS GALLINARUM

A

2866

LACTOBACILLUS GASSERI

A

2867

LACTOBACILLUS HELVETICUS

A

2868

LACTOBACILLUS JOHNSONII

A

2869

LACTOBACILLUS KEFIRANOFACIENS

A

2870

LACTOBACILLUS KEFIRGRANUM

A

2871

LACTOBACILLUS KEFIRI

A

2872

LACTOBACILLUS PARACASEI

A

2873

LACTOBACILLUS PARACASEI SUBSP. PARACASEI

A

2874

LACTOBACILLUS PLANTARUM

A

2875

LACTOBACILLUS REUTERI

A

2876

LACTOBACILLUS RHAMNOSUS

A

2877

LACTOBACILLUS SALIVARIUS SSP SALICINIUS

A

2878

LACTOBACILLUS SALIVARIUS SSP SALIVARIUS

A

2879

LACTOBIONIC ACID

E

Only for use in topical medicines for dermal application.

2880

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%.

2881

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]’.

2882

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]’.

2883

LACTUCA SATIVA

A, H

2884

LACTUCA VIROSA

A, H

2885

LACTULOSE

E

2886

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.

2887

LAGENARIA VULGARIS

A, H

2888

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.

2889

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.

2890

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.

2891

LAMIUM ALBUM

A, H

2892

LANETH-5

E

Only for use in topical medicines for dermal application.

2893

LANOLIN ALCOHOL

E

Only for use in topical medicines for dermal application.

2894

LANOLIN OIL

E

Only for use in topical medicines for dermal application.

2895

LANOLIN WAX

E

Only for use in topical medicines for dermal application.

2896

LANTANA CAMARA

A, H

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

2897

LARIX ARABINOGALACTAN

A, E

The concentration of polysaccharides in the ingredient must be greater than or equal to 85%.

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

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

The maximum recommended daily dose of Larix arabinogalactan in oral medicines must not be more than 15 grams.

The concentration of Larix arabinogalactan in topical medicines for dermal application must not exceed 5.0%.

2898

LARIX DECIDUA

A, H

2899

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.

2900

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'.

2901

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.

2902

LAURAMINE OXIDE

E

2903

LAUREL LEAF OIL

A, H

2904

LAURETH-10

E

Only for use in topical medicines for dermal application.

2905

LAURETH-12

E

Only for use in topical medicines for dermal application.

2906

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.

2907

LAURETH-23

E

Only for use in topical medicines for dermal application.

2908

LAURETH-3

E

Only for use in topical medicines for dermal application.

2909

LAURETH-4

E

Only for use in topical medicines for dermal application.

2910

LAURETH-7

E

Only for use in topical medicines for dermal application.

2911

LAURETH-8

E

2912

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.

2913

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%.

2914

LAUROMACROGOL 400

E

Only for use in topical medicines for dermal application.

2915

LAUROYL LYSINE

E

Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 5.0%.

2916

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'.

2917

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%.

2918

LAURYL BETAINE

E

Only for use in topical medicines for dermal application.

2919

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%.

2920

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.

2921

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%.

2922

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%.

2923

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 or damaged skin. The concentration in the medicine must be no more than 3.5%.

2924

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.

2925

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.

2926

LAURYL PYRROLIDONE

E

Only for use in topical medicines for dermal application.

2927

LAURYLDIMONIUM HYDROXYPROPYL HYDROLYSED COLLAGEN

E

Only for use in topical medicines for dermal application.

2928

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%.

2929

LAURYLMETICONE COPOLYOL

E

Only for use in topical medicines for dermal application.

2930

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%.

2931

LAVANDIN OIL ABRIAL

A, E, H

2932

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%.

2933

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.

2934

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.

2935

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.

2936

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.

2937

LAWSONIA INERMIS

A, H

2938

LEAD

H

Only for use as an active homoeopathic ingredient.

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

2939

LEAD ACETATE

H

Only for use as an active homoeopathic ingredient.

2940

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%.

2941

LECITHIN

A, E

2942

LEDEBOURIELLA SESELOIDES

A, H

2943

LEDUM GROENLANDICUM

A, H

2944

LEDUM PALUSTRE

A, H

Arbutin is a mandatory component of Ledum palustre.

The concentration of arbutin in the medicine must be no more than 25 mg/Kg or 25mg /L or 0.0025 % unless used on the hair.

When for use on hair, the concentration of arbutin in the medicine must be no more than 0.74 %.

When the route of administration is other than topical, the maximum recommended daily dose must not contain more than 0.001mg of the equivalent dry herbal material of Ledum palustre.

2945

LEMNA MINOR

A, H

2946

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.

2947

LEMON BALM LEAF DRY

A, H

2948

LEMON BALM LEAF POWDER

A, E, H

2949

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.

2950

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.

2951

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.

2952

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%.

2953

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.

2954

LEMONGRASS OIL

A, E, H

2955

LENS CULINARIS

A, H

2956

LENTIL

E

2957

LENTINULA EDODES

A, E, H

2958

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%.

2959

LEONURUS CARDIACA

A, E, H

2960

LEONURUS SIBIRICUS

A, E, H

2961

LEPIDIUM APETALUM

A, H

2962

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).

2963

LEPTOSPERMUM PETERSONII

E

Only for use in topical medicines for dermal application.

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

2964

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’

2965

LESPEDEZA CAPITATA

A, H

2966

LETTUCE

E

2967

LEUCINE

A, E

2968

LEUZEA UNIFLORUM

A, H

2969

LEVISTICUM OFFICINALE

A, H

2970

LEVOCARNITINE

A

2971

LEVOCARNITINE FUMARATE

A

2972

LEVOCARNITINE HYDROCHLORIDE

A

2973

LEVOCARNITINE MAGNESIUM CITRATE

A

2974

LEVOCARNITINE TARTRATE

A

2975

LEVOMEFOLATE CALCIUM

A

Available for medicines intended for internal use only.

Levomefolic acid is a mandatory component of Levomefolate calcium.

The maximum recommended daily dose must not provide more than 500 micrograms of Levomefolic acid from Levomefolate calcium.

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

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

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

2976

LEVOMEFOLATE GLUCOSAMINE

A

Available for medicines intended for internal use only.

Levomefolic acid is a mandatory component of levomefolate glucosamine.

The maximum recommended daily dose must not provide more than 500 micrograms of levomefolic acid from levomefolate glucosamine.

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

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

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

2977

LEVOTHYROXINE SODIUM

H

Only for use as an active homoeopathic ingredient.

2978

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%.

2979

LIGHT KAOLIN

E

2980

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.

2981

LIGHT MAGNESIUM OXIDE

A, E, H

2982

LIGUSTICUM SINENSE

A, H

2983

LIGUSTICUM STRIATUM

A, E, H

2984

LIGUSTRUM LUCIDUM

A, H

2985

LILIUM BROWNII

A, H

2986

LILIUM CANDIDUM

A, E, H

2987

LILIUM LANCIFOLIUM

A, H

2988

LILIUM LONGIFLORUM

A, H

2989

LIME FRUIT

E

2990

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%.

2991

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.

2992

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.

2993

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%.

2994

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%.

2995

LIME TREE FLOWER DRY

A, H

2996

LIME TREE FLOWER POWDER

A, H

2997

LIME, ESSENCE

E

2998

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%.

2999

LIMONENE

E

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

3000

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%.

3001

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%.

3002

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%.

3003

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%.

3004

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%.

3005

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%.

3006

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%.

3007

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%.

3008

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%.

3009

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%.

3010

LINDERA STRYCHNIFOLIA

A, H

3011

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%.

3012

LINOLEIC ACID

E

3013

LINOLENIC ACID

E

3014

LINSEED DRY

A, E, H

3015

LINSEED OIL

A, E, H

3016

LINSEED POWDER

A, E, H

3017

LINUM USITATISSIMUM

A, E, H

3018

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.

3019

LIPPIA DULCIS

A, H

3020

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).

3021

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.

3022

LIQUIDAMBAR FORMOSANA

A, H

3023

LIQUIDAMBAR ORIENTALIS

A, H

3024

LIQUIDAMBAR STYRACIFLUA

A, E, H

3025

LIQUIDAMBAR 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%.

3026

LIQUIDAMBAR TAIWANIANA

A, H

3027

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%.

3028

LIQUORICE DRY

A, E, H

3029

LIQUORICE LIQUID EXTRACT

A, E, H

3030

LIQUORICE POWDER

A, E, H

3031

LITCHI CHINENSIS

A, H

3032

LITHIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

3033

LITHOSPERMUM OFFICINALE

A, H

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

3034

LITSEA CUBEBA

A, E, H

3035

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%.

3036

LOBARIA PULMONARIA

A, H

3037

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.

3038

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.

3039

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.

3040

LOLIUM PERENNE

A, H

3041

LOLIUM TEMULENTUM

A, H

3042

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%.

3043

LONICERA CAPRIFOLIUM

A, E, H

3044

LONICERA JAPONICA

A, E, H

3045

LONICERA PERICLYMENUM

A, H

3046

LOPHATHERUM GRACILE

A, H

3047

LOQUAT

E

3048

LORANTHUS PARASITICUS

A, H

3049

LOROPETALUM CHINENSIS

A, H

3050

LOTUS CORNICULATUS

A, H

3051

LOVAGE OIL

A, E, H

3052

LOVAGE ROOT DRY

A, H

3053

LOVAGE ROOT POWDER

A, H

3054

LUDWIGIA PROSTRATA

A, H

3055

LUFFA CYLINDRICA

A, H

3056

LUFFA PURGANS

A, H

3057

LUTEIN

A, E, H

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

3058

LYCHEE

E

3059

LYCIUM BARBARUM

A, H

3060

LYCIUM CHINENSE

A, E, H

3061

LYCOPENE

A, E

3062

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.

3063

LYCOPODIUM ANNOTINUM

A, H

3064

LYCOPODIUM CLAVATUM

A, H

3065

LYCOPODIUM COMPLANATUM

A, H

3066

LYCOPUS EUROPAEUS

A, H

3067

LYCOPUS LUCIDUS

A, H

3068

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%.

3069

LYGODIUM JAPONICUM

A, H

3070

LYSIMACHIA CHRISTINAE

A, H

3071

LYSIMACHIA VULGARIS

A, H

3072

LYSINE

A, E

3073

LYSINE HYDROCHLORIDE

A, E

3074

LYTHRUM HYSSOPIFOLIA

A, H

3075

LYTHRUM SALICARIA

A, H

3076

LYTHRUM VERTICILLATUM

A, H

3077

MACADAMIA INTEGRIFOLIA

A, E

3078

MACADAMIA NUT

E

3079

MACADAMIA NUT OIL

E

3080

MACADAMIA TERNIFOLIA

A, E, H

3081

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%.

3082

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.

3083

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.

3084

MACROGOL 1000

E

3085

MACROGOL 1450

E

Only for use in topical medicines for dermal application.

3086

MACROGOL 1500

E

3087

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%.

3088

MACROGOL 200

E

Only for use in topical medicines for dermal application.

3089

MACROGOL 20000

E

3090

MACROGOL 300

E

3091

MACROGOL 3000

E

3092

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.

3093

MACROGOL 40

E

Only for use in topical medicines for dermal application.

3094

MACROGOL 400

E

3095

MACROGOL 4000

E

3096

MACROGOL 45000

E

Only for use in topical medicines for dermal application.

3097

MACROGOL 600

E

3098

MACROGOL 6000

E

3099

MACROGOL 600000

E

3100

MACROGOL 800

E

3101

MACROGOL 8000

E

3102

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%.

3103

MACROGOL POLY(VINYL ALCOHOL) GRAFTED POLYMER

E

Only for use in oral medicines.

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

3104

MACROPIPER EXCELSUM VAR EXCELSUM

A, H

3105

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.

3106

MAGNESIUM ASCORBATE

A, E, H

3107

MAGNESIUM ASCORBATE MONOHYDRATE

A, E, H

3108

MAGNESIUM ASCORBYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

3109

MAGNESIUM ASPARTATE

A, E, H

3110

MAGNESIUM ASPARTATE DIHYDRATE

A, E, H

3111

MAGNESIUM ASPARTATE TETRAHYDRATE

A, E, H

3112

MAGNESIUM CARBONATE HYDRATE

A, E, H

3113

MAGNESIUM CHLORIDE 4.5-HYDRATE

A

3114

MAGNESIUM CHLORIDE HEXAHYDRATE

A, E, H

3115

MAGNESIUM CITRATE

A, E, H

3116

MAGNESIUM CITRATE NONAHYDRATE

A, E, H

3117

MAGNESIUM CITRATE TETRADECAHYDRATE

A, E, H

3118

MAGNESIUM DIGLUTAMATE

A, E, H

3119

MAGNESIUM GLUCONATE

A, E, H

3120

MAGNESIUM GLYCEROPHOSPHATE

A, E, H

3121

MAGNESIUM GLYCINATE

A

Only for use in oral medicines.

3122

MAGNESIUM GLYCINATE DIHYDRATE

A

Only for use in oral medicines.

Magnesium is a mandatory component of Magnesium glycinate dihydrate.

The percentage of Magnesium from Magnesium glycinate dihydrate should be calculated based on the molecular weight of Magnesium glycinate dihydrate.

3123

MAGNESIUM HYDROGEN PHOSPHATE

H

3124

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'.

3125

MAGNESIUM LYSINATE

A

Only for use in oral medicines.

3126

MAGNESIUM METHIONINATE

A

Only for use in oral medicines.

3127

MAGNESIUM NITRATE

E

Only for use in topical medicines for dermal application.

3128

MAGNESIUM OROTATE

A, E, H

3129

MAGNESIUM OROTATE DIHYDRATE

A, E, H

3130

MAGNESIUM OXIDE

A, E, H

3131

MAGNESIUM PHOSPHATE PENTAHYDRATE

A, E, H

3132

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.

3133

MAGNESIUM PYRUVATE

A

Only for use in oral medicines.

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

3134

MAGNESIUM STEARATE

E

3135

MAGNESIUM SULFATE DIHYDRATE

A, E, H

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

3136

MAGNESIUM SULFATE HEPTAHYDRATE

A, E, H

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

3137

MAGNESIUM SULFATE MONOHYDRATE

A, E, H

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

3138

MAGNESIUM SULFATE TRIHYDRATE

A, E, H

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

3139

MAGNESIUM TRISILICATE

E

3140

MAGNOLIA GLAUCA

A, H

3141

MAGNOLIA LILIFLORA

A, H

3142

MAGNOLIA OBOVATA

A, H

3143

MAGNOLIA OFFICINALIS

A, E, H

3144

MAGNOLIA SALICIFOLIA

A, H

3145

MAIZE

E

3146

MAIZE BRAN

E

3147

MAIZE OIL

A, E, H

3148

MAIZE STARCH

A, E, H

3149

MALACHITE GREEN

E

Permitted for use only as a colour for topical use.

3150

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.

3151

MALPIGHIA GLABRA

A, E, H

3152

MALT EXTRACT

E

3153

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]’.

3154

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).

3155

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).

3156

MALTOL

E

3157

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%.

3158

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).

3159

MALUS DOMESTICA

A, E, H

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

3160

MALUS PUMILA

A, E, H

3161

MALUS SYLVESTRIS

A, H

3162

MALVA MOSCHATA

A, H

3163

MALVA SYLVESTRIS

A, E, H

3164

MALVA VERTICILLATA

A, H

3165

MANDARIN

E

3166

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%.

3167

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.

3168

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%.

3169

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%.

3170

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%.

3171

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%.

3172

MANGANESE

H

Only for use as an active homoeopathic ingredient.

3173

MANGANESE (II) DIASPARTATE

A, H

Only for use in oral medicines.

3174

MANGANESE (II) GLYCINATE

A, H

Only for use in oral medicines.

3175

MANGANESE ACETATE TETRAHYDRATE

H

Only for use as an active homoeopathic ingredient. 

3176

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.

3177

MANGANESE CHLORIDE TETRAHYDRATE

A, E, H

3178

MANGANESE DIASPARTATE

A, E, H

Only for use in oral medicines.

3179

MANGANESE GLUCONATE

A, E, H

3180

MANGANESE GLYCEROPHOSPHATE

A, E, H

3181

MANGANESE OXIDE

A, E, H

3182

MANGANESE SULFATE MONOHYDRATE

A, E, H

3183

MANGANESE SULFATE TETRAHYDRATE

A, E, H

3184

MANGIFERA INDICA

A, E, H

3185

MANGO

E, H

3186

MANIHOT ESCULENTA

A, H

3187

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).

3188

MARANTA ARUNDINACEA

A, H

3189

MARINE SPONGE

H

Only for use as an active homoeopathic ingredient.

3190

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).

3191

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).

3192

MARRUBIUM VULGARE

A, E, H

3193

MARSDENIA CUNDURANGO

A, H

3194

MARSHMALLOW ROOT DRY

A, H

3195

MARSHMALLOW ROOT POWDER

A, H

3196

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%.

3197

MASTIC

A, H

3198

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%.

3199

MATRICARIA CHAMOMILLA

A, E, H

3200

MATRICARIA FLOWER DRY

A, E, H

3201

MEADOWSWEET HERB DRY

A, H

Methyl salicylate is a mandatory component of meadowsweet herb dry.

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

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

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

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

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

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

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

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

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

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

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

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

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

b) When for use in topical medicines for dermal application, the concentration of methyl salicylate in the medicine must not be more than 25% and the following warning statements are required on the medicine label:

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

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

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

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

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

3202

MECOBALAMIN (CO-METHYLCOBALAMIN)

A

Only for use in oral medicines.

3203

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.

3204

MEDIUM CHAIN TRIGLYCERIDES

E

3205

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.

3206

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.

3207

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.

3208

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.

3209

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.

3210

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.

3211

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.

3212

MELICOPE PTELEIFOLIA

A, H

3213

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%.

3214

MELISSA OFFICINALIS

A, E, H

3215

MELON

E

3216

MENADIONE SODIUM BISULFITE

E

3217

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.

3218

MENISPERMUM CANADENSE

A, H

3219

MENTHA AQUATICA

A, H

When the ingredient is included in a medicine that is listed in the Register:

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

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

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

a) Menthol is a mandatory component of Mentha aquatica.

b) When the medicine is for topical use:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the maximum concentration of menthol must not exceed 5%; and

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

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

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

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

c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3220

MENTHA ARVENSIS

A, E, H

When the ingredient is included in a medicine that is listed in the Register:

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

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

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

a) Menthol is a mandatory component of Mentha arvensis.

b) When the medicine is for topical use:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the maximum concentration of menthol must not exceed 5%; and

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

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

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

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

c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3221

MENTHA ARVENSIS LEAF OIL

E

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

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

The total fragrance proprietary excipient formulation in a medicine must be no more 1%.

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

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

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

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

a) Menthol is a mandatory component of Mentha arvensis leaf oil.

b) When the medicine is for topical use:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the maximum concentration of menthol must not exceed 5%; and

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

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

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

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

c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3222

MENTHA ARVENSIS OIL

E

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

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

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

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

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

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

a) Menthol is a mandatory component of Mentha arvensis oil,

b) When the medicine is for topical use:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the maximum concentration of menthol must not exceed 5%; and

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

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

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

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

c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3223

MENTHA HAPLOCALYX

A, E, H

When the ingredient is included in a medicine that is listed in the Register:

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

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

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

a) Menthol is a mandatory component of Mentha haplocalyx.

b) When the medicine is for topical use:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the maximum concentration of menthol must not exceed 5%; and

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

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

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

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

c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3224

MENTHA PULEGIUM

A, H

D-Pulegone, menthol 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'; and

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

When the medicine is for topical use:

a) the maximum recommended daily dose must not contain more than 150 mg of Mentha pulegium oil or distillate;

b) the medicine must not be intended for use in the eye or on damaged skin;

c) the maximum concentration of menthol must not exceed 5%; and

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

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

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

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

When the medicine is for internal use:

a) the maximum recommended daily dose must not contain more than 50 mg of Mentha pulegium oil or distillate; and

b) the maximum recommended daily dose must not contain more than 1 gram of menthol.

3225

MENTHA SPICATA

A, E, H

When the ingredient is included in a medicine that is listed in the Register:

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

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

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

a) Menthol is a mandatory component of Mentha spicata.

b) When the medicine is for topical use:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the maximum concentration of menthol must not exceed 5%; and

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

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

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

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

c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3226

MENTHA X CARDIACA

A, E, H

When the ingredient is included in a medicine that is listed in the Register:

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

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

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

a) Menthol is a mandatory component of Mentha x cardiaca.

b) When the medicine is for topical use:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the maximum concentration of menthol must not exceed 5%; and

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

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

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

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

c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3227

MENTHA X PIPERITA

A, E, H

When the ingredient is included in a medicine that is listed in the Register:

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

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

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

a) Menthol is a mandatory component of Mentha x piperita.

b) When the medicine is for topical use:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the maximum concentration of menthol must not exceed 5%; and

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

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

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

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

c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3228

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%.

3229

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%.

3230

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%.

3231

MENTHOL

A, E

When the ingredient is included in a medicine that is listed in the Register:

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

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

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

a) When the medicine is for topical use:

(i) the medicine must not to be intended for use in the eye or on damaged skin;

(ii) the maximum concentration of menthol must not exceed 5%; and

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

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

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

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

b) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3232

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%.

3233

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%.

3234

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%.

3235

MENTHOXYPROPANEDIOL

E

For oral use only.

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

3236

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%.

3237

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%.

3238

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%.

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

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

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

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

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

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

3239

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%.

3240

MENTHYL LACTATE

E

3241

MENYANTHES TRIFOLIATA

A, H

3242

MERCURIC CHLORIDE

H

Only for use as an active homoeopathic ingredient.

3243

MERCURY

H

Only for use as an active homoeopathic ingredient.

3244

MESPILUS GERMANICA

A, H

3245

METACRESOL

E

Only for use in topical medicines for dermal application.

3246

METHACRYLIC ACID COPOLYMER

E

Only for use in oral medicines.

3247

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%.

3248

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%.

3249

METHIONINE

A, E

3250

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%.

3251

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%.

3252

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%.

3253

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%.

3254

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%.

3255

METHYL ACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

3256

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%.

3257

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%.

3258

METHYL BENZOATE

E

Only for use in topical medicines for dermal application.

3259

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%.

3260

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%.

3261

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%.

3262

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%.

3263

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%.

3264

METHYL CHAVICOL

E

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

The ingredient is not to be included in medicines intended for oral use.

The quantity of methyl chavicol in a medicine must be no more than 0.01%.

The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

3265

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%.

3266

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%.

3267

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%.

3268

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%.

3269

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%.

3270

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%.

3271

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%.

3272

METHYL ETHER

E

Only for use in topical medicines for dermal application.

3273

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%.

3274

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%.

3275

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%.

3276

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.

3277

METHYL GLUCETH-20

E

Only for use in topical medicines for dermal application.

3278

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%.

3279

METHYL GLUCETH-20 SESQUIHYDRATE

E

Only for use in topical medicines for dermal application.

3280

METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

3281

METHYL GLUCOSE SESQUIOLEATE

E

Only for use in topical medicines for dermal application.

3282

METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

3283

METHYL HEPTANOATE

E

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

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

3284

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%.

3285

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%.

3286

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%.

3287

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%.

3288

METHYL HYDROGENATED ROSINATE

E

Only for use in topical medicines for dermal application.

3289

METHYL HYDROJASMONATE

E

Only for use in topical medicines for dermal application.

3290

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.

3291

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%.

3292

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%.

3293

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%.

3294

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%.

3295

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%.

3296

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%.

3297

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%.

3298

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%.

3299

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%.

3300

METHYL METHACRYLATE

E

3301

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.

When the concentration of methyl methacrylate crosspolymer is greater than 1%, the medicine must not be intended for use on damaged skin.

The concentration in the medicine must not be more than 4.85%.

3302

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%.

3303

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%.

3304

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%.

3305

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%.

3306

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%.

3307