Federal Register of Legislation - Australian Government

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Determinations/Health as made
This instrument repeals and replaces the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019, and specifies those ingredients that may be contained in a medicine that is listed in the Australian Register of Therapeutic Goods, and requirements in relation to the inclusion of those ingredients in such medicines.
Administered by: Health
Registered 18 Nov 2019
Tabling HistoryDate
Tabled HR25-Nov-2019
Tabled Senate25-Nov-2019
Date of repeal 01 Jan 2020
Repealed by Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2019
Table of contents.

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

Note:       See sections 5 and 6.

Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient name

Purpose

Specific requirements

2829

KADSURA COCCINEA

A, H

 

2830

KAEMPFERIA GALANGA

A, H

 

2831

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 %.

 

2832

KAOLIN

E

 

2833

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.

 

2834

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.

 

2835

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%.

 

2836

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%. 

 

2837

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'.

 

 

2838

KIDNEY BEAN

E

 

2839

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%.

 

2840

KIWI FRUIT

E

 

2841

KNAUTIA ARVENSIS

A, H

 

2842

KOREAN GINSENG ROOT DRY

A, H

 

2843

KOREAN GINSENG ROOT POWDER

A, H

 

2844

KRAMERIA IXIENA

A, H

 

2845

KRAMERIA LAPPACEA

A, H

 

2846

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'.

 

2847

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%.

 

2848

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%.

 

2849

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%.

 

2850

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%.

 

2851

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%.

 

2852

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%.

 

2853

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%.

 

2854

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%.

 

2855

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%.

 

2856

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%.

 

2857

LABDANUM OIL

A, E, H

 

2858

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%.

 

2859

LACTALBUMIN

E

 

2860

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.

 

 

2861

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'.

 

2862

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'.

 

2863

LACTOBACILLUS ACIDOPHILUS

A

 

2864

LACTOBACILLUS AMYLOVORUS

A

 

2865

LACTOBACILLUS BREVIS

A

 

2866

LACTOBACILLUS CASEI

A

 

2867

LACTOBACILLUS CASEI SUBSP. BIOVAR CASEI

A

 

2868

LACTOBACILLUS CRISPATUS

A

 

2869

LACTOBACILLUS DELBRUECKII SSP BULGARICUS

A

 

2870

LACTOBACILLUS DELBRUECKII SSP LACTIS

A

 

2871

LACTOBACILLUS FERMENTUM

A

 

2872

LACTOBACILLUS GALLINARUM

A

 

2873

LACTOBACILLUS GASSERI

A

 

2874

LACTOBACILLUS HELVETICUS

A

 

2875

LACTOBACILLUS JOHNSONII

A

 

2876

LACTOBACILLUS KEFIRANOFACIENS

A

 

2877

LACTOBACILLUS KEFIRGRANUM

A

 

2878

LACTOBACILLUS KEFIRI

A

 

2879

LACTOBACILLUS PARACASEI

A

 

2880

LACTOBACILLUS PARACASEI SUBSP. PARACASEI

A

 

2881

LACTOBACILLUS PLANTARUM

A

 

2882

LACTOBACILLUS REUTERI

A

 

2883

LACTOBACILLUS RHAMNOSUS

A

 

2884

LACTOBACILLUS SALIVARIUS SSP SALICINIUS

A

 

2885

LACTOBACILLUS SALIVARIUS SSP SALIVARIUS

A

 

2886

LACTOBIONIC ACID

E

Only for use in topical medicines for dermal application.

 

2887

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%.

 

2888

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]’.

 

2889

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]’.

 

2890

LACTUCA SATIVA

A, H

 

2891

LACTUCA VIROSA

A, H

 

2892

LACTULOSE

E

 

2893

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.

 

 

2894

LAGENARIA VULGARIS

A, H

 

2895

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.

 

 

 

2896

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.

 

 

2897

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.

 

2898

LAMIUM ALBUM

A, H

 

2899

LANETH-5

E

Only for use in topical medicines for dermal application.

 

2900

LANOLIN ALCOHOL

E

Only for use in topical medicines for dermal application.

 

2901

LANOLIN OIL

E

Only for use in topical medicines for dermal application.

 

2902

LANOLIN WAX

E

Only for use in topical medicines for dermal application.

 

2903

LANTANA CAMARA

A, H

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

 

2904

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%.

 

2905

LARIX DECIDUA

A, H

 

2906

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.

 

2907

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'.

 

2908

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.

 

2909

LAURAMINE OXIDE

E

 

2910

LAUREL LEAF OIL

A, H

 

2911

LAURETH-10

E

Only for use in topical medicines for dermal application.

 

2912

LAURETH-12

E

Only for use in topical medicines for dermal application.

 

2913

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.

 

2914

LAURETH-23

E

Only for use in topical medicines for dermal application.

 

2915

LAURETH-3

E

Only for use in topical medicines for dermal application.

 

2916

LAURETH-4

E

Only for use in topical medicines for dermal application.

 

2917

LAURETH-7

E

Only for use in topical medicines for dermal application.

 

2918

LAURETH-8

E

 

2919

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.

 

2920

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%.

 

2921

LAUROMACROGOL 400

E

Only for use in topical medicines for dermal application.

 

2922

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%.

 

 

2923

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'.

 

 

2924

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%.

 

2925

LAURYL BETAINE

E

Only for use in topical medicines for dermal application.

 

2926

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%.

 

2927

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.

 

2928

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%.

 

2929

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%.

 

2930

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%.

 

 

2931

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.

 

2932

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.

 

2933

LAURYL PYRROLIDONE

E

Only for use in topical medicines for dermal application.

 

2934

LAURYLDIMONIUM HYDROXYPROPYL HYDROLYSED COLLAGEN

E

Only for use in topical medicines for dermal application.

 

2935

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%.

 

2936

LAURYLMETICONE COPOLYOL

E

Only for use in topical medicines for dermal application.

 

2937

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%.

 

2938

LAVANDIN OIL ABRIAL

A, E, H

 

2939

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%.

 

2940

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

 

2941

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

 

2942

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%.

 

2943

LAVENDER OIL

A, E, H

 

2944

LAWSONIA INERMIS

A, H

 

2945

LEAD

H

Only for use as an active homoeopathic ingredient.

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

 

 

2946

LEAD ACETATE

H

Only for use as an active homoeopathic ingredient.

 

2947

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%.

 

2948

LECITHIN

A, E

 

2949

LEDEBOURIELLA SESELOIDES

A, H

 

2950

LEDUM GROENLANDICUM

A, H

 

2951

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.

 

2952

LEMNA MINOR

A, H

 

2953

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.

 

2954

LEMON BALM LEAF DRY

A, H

 

2955

LEMON BALM LEAF POWDER

A, E, H

 

2956

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.

 

2957

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.

 

2958

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.

 

2959

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%.

 

2960

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.

 

2961

LEMONGRASS OIL

A, E, H

 

2962

LENS CULINARIS

A, H

 

2963

LENTIL

E

 

2964

LENTINULA EDODES

A, E, H

 

2965

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%.

 

2966

LEONURUS CARDIACA

A, E, H

 

2967

LEONURUS SIBIRICUS

A, E, H

 

2968

LEPIDIUM APETALUM

A, H

 

2969

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).

 

2970

LEPTOSPERMUM PETERSONII

E

Only for use in topical medicines for dermal application.

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

 

2971

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’

 

2972

LESPEDEZA CAPITATA

A, H

 

2973

LETTUCE

E

 

2974

LEUCINE

A, E

 

2975

LEUZEA UNIFLORUM

A, H

 

2976

LEVISTICUM OFFICINALE

A, H

 

2977

LEVOCARNITINE

A

 

2978

LEVOCARNITINE FUMARATE

A

 

2979

LEVOCARNITINE HYDROCHLORIDE

A

 

2980

LEVOCARNITINE MAGNESIUM CITRATE

A

 

2981

LEVOCARNITINE TARTRATE

A

 

2982

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)’.

 

2983

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).'

 

2984

LEVOTHYROXINE SODIUM

H

Only for use as an active homoeopathic ingredient.

 

2985

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%.

 

2986

LIGHT KAOLIN

E

 

2987

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.

 

2988

LIGHT MAGNESIUM OXIDE

A, E, H

 

2989

LIGUSTICUM SINENSE

A, H

 

2990

LIGUSTICUM STRIATUM

A, E, H

 

2991

LIGUSTRUM LUCIDUM

A, H

 

2992

LILIUM BROWNII

A, H

 

2993

LILIUM CANDIDUM

A, E, H

 

2994

LILIUM LANCIFOLIUM

A, H

 

2995

LILIUM LONGIFLORUM

A, H

 

2996

LIME FRUIT

E

 

2997

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%.

 

2998

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.

 

2999

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.

 

3000

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%.

 

3001

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%.

 

3002

LIME TREE FLOWER DRY

A, H

 

3003

LIME TREE FLOWER POWDER

A, H

 

3004

LIME, ESSENCE

E

 

3005

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%.

 

3006

LIMONENE

E

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

 

3007

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%.

 

3008

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%.

 

3009

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%.

 

3010

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%.

 

3011

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%.

 

3012

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%.

 

3013

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%.

 

3014

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%.

 

3015

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%.

 

3016

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%.

 

3017

LINDERA STRYCHNIFOLIA

A, H

 

3018

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%.

 

3019

LINOLEIC ACID

E

 

3020

LINOLENIC ACID

E

 

3021

LINSEED DRY

A, E, H

 

3022

LINSEED OIL

A, E, H

 

3023

LINSEED POWDER

A, E, H

 

3024

LINUM USITATISSIMUM

A, E, H

 

3025

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.

 

3026

LIPPIA DULCIS

A, H

 

3027

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).

 

3028

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.

 

3029

LIQUIDAMBAR FORMOSANA

A, H

 

3030

LIQUIDAMBAR ORIENTALIS

A, H

 

3031

LIQUIDAMBAR STYRACIFLUA

A, E, H

 

3032

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%.

 

3033

LIQUIDAMBAR TAIWANIANA

A, H

 

3034

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%.

 

3035

LIQUORICE DRY

A, E, H

 

3036

LIQUORICE LIQUID EXTRACT

A, E, H

 

3037

LIQUORICE POWDER

A, E, H

 

3038

LITCHI CHINENSIS

A, H

 

3039

LITHIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

 

3040

LITHOSPERMUM OFFICINALE

A, H

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

 

3041

LITSEA CUBEBA

A, E, H

 

3042

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%.

 

3043

LOBARIA PULMONARIA

A, H

 

3044

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.

 

3045

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.

 

3046

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.

 

3047

LOLIUM PERENNE

A, H

 

3048

LOLIUM TEMULENTUM

A, H

 

3049

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%.

 

3050

LONICERA CAPRIFOLIUM

A, E, H

 

3051

LONICERA JAPONICA

A, E, H

 

3052

LONICERA PERICLYMENUM

A, H

 

3053

LOPHATHERUM GRACILE

A, H

 

3054

LOQUAT

E

 

3055

LORANTHUS PARASITICUS

A, H

 

3056

LOROPETALUM CHINENSIS

A, H

 

3057

LOTUS CORNICULATUS

A, H

 

3058

LOVAGE OIL

A, E, H

 

3059

LOVAGE ROOT DRY

A, H

 

3060

LOVAGE ROOT POWDER

A, H

 

3061

LUDWIGIA PROSTRATA

A, H

 

3062

LUFFA CYLINDRICA

A, H

 

3063

LUFFA PURGANS

A, H

 

3064

LUTEIN

A, E, H

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

 

3065

LYCHEE

E

 

3066

LYCIUM BARBARUM

A, H

 

3067

LYCIUM CHINENSE

A, E, H

 

3068

LYCOPENE

A, E

 

3069

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.

 

3070

LYCOPODIUM ANNOTINUM

A, H

 

3071

LYCOPODIUM CLAVATUM

A, H

 

3072

LYCOPODIUM COMPLANATUM

A, H

 

3073

LYCOPUS EUROPAEUS

A, H

 

3074

LYCOPUS LUCIDUS

A, H

 

3075

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%.

 

3076

LYGODIUM JAPONICUM

A, H

 

3077

LYSIMACHIA CHRISTINAE

A, H

 

3078

LYSIMACHIA VULGARIS

A, H

 

3079

LYSINE

A, E

 

3080

LYSINE HYDROCHLORIDE

A, E

 

3081

LYTHRUM HYSSOPIFOLIA

A, H

 

3082

LYTHRUM SALICARIA

A, H

 

3083

LYTHRUM VERTICILLATUM

A, H

 

3084

MACADAMIA INTEGRIFOLIA

A, E

 

3085

MACADAMIA NUT

E

 

3086

MACADAMIA NUT OIL

E

 

3087

MACADAMIA TERNIFOLIA

A, E, H

 

3088

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%.

 

 

3089

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.

 

3090

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.

 

3091

MACROGOL 1000

E

 

3092

MACROGOL 1450

E

Only for use in topical medicines for dermal application.

 

3093

MACROGOL 1500

E

 

3094

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%.

 

3095

MACROGOL 200

E

Only for use in topical medicines for dermal application.

 

3096

MACROGOL 20000

E

 

3097

MACROGOL 300

E

 

3098

MACROGOL 3000

E

 

3099

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.

 

3100

MACROGOL 40

E

Only for use in topical medicines for dermal application.

 

3101

MACROGOL 400

E

 

3102

MACROGOL 4000

E

 

3103

MACROGOL 45000

E

Only for use in topical medicines for dermal application.

 

3104

MACROGOL 600

E

 

3105

MACROGOL 6000

E

 

3106

MACROGOL 600000

E

 

3107

MACROGOL 800

E

 

3108

MACROGOL 8000

E

 

3109

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%.

 

3110

MACROGOL POLY(VINYL ALCOHOL) GRAFTED POLYMER

E

Only for use in oral medicines.

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

 

3111

MACROPIPER EXCELSUM VAR EXCELSUM

A, H

 

3112

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.

 

 

 

3113

MAGNESIUM ASCORBATE

A, E, H

 

3114

MAGNESIUM ASCORBATE MONOHYDRATE

A, E, H

 

3115

MAGNESIUM ASCORBYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

3116

MAGNESIUM ASPARTATE

A, E, H

 

3117

MAGNESIUM ASPARTATE DIHYDRATE

A, E, H

 

3118

MAGNESIUM ASPARTATE TETRAHYDRATE

A, E, H

 

3119

MAGNESIUM CARBONATE HYDRATE

A, E, H

 

3120

MAGNESIUM CHLORIDE 4.5-HYDRATE

A

 

3121

MAGNESIUM CHLORIDE HEXAHYDRATE

A, E, H

 

3122

MAGNESIUM CITRATE

A, E, H

 

3123

MAGNESIUM CITRATE NONAHYDRATE

A, E, H

 

3124

MAGNESIUM CITRATE TETRADECAHYDRATE

A, E, H

 

3125

MAGNESIUM DIGLUTAMATE

A, E, H

 

3126

MAGNESIUM GLUCONATE

A, E, H

 

3127

MAGNESIUM GLYCEROPHOSPHATE

A, E, H

 

3128

MAGNESIUM GLYCINATE

A

Only for use in oral medicines.

 

3129

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.

 

3130

MAGNESIUM HYDROGEN PHOSPHATE

H

 

3131

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'.

 

 

3132

MAGNESIUM LYSINATE

A

Only for use in oral medicines.

 

3133

MAGNESIUM METHIONINATE

A

Only for use in oral medicines.

 

3134

MAGNESIUM NITRATE

E

Only for use in topical medicines for dermal application.

 

3135

MAGNESIUM OROTATE

A, E, H

 

3136

MAGNESIUM OROTATE DIHYDRATE

A, E, H

 

3137

MAGNESIUM OXIDE

A, E, H

 

3138

MAGNESIUM PHOSPHATE PENTAHYDRATE

A, E, H

 

3139

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.

 

 

3140

MAGNESIUM PYRUVATE

A

Only for use in oral medicines.

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

 

3141

MAGNESIUM STEARATE

E

 

3142

MAGNESIUM SULFATE DIHYDRATE

A, E, H

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

 

 

3143

MAGNESIUM SULFATE HEPTAHYDRATE

A, E, H

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

 

3144

MAGNESIUM SULFATE MONOHYDRATE

A, E, H

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

 

 

3145

MAGNESIUM SULFATE TRIHYDRATE

A, E, H

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

 

3146

MAGNESIUM TRISILICATE

E

 

3147

MAGNOLIA GLAUCA

A, H

 

3148

MAGNOLIA LILIFLORA

A, H

 

3149

MAGNOLIA OBOVATA

A, H

 

3150

MAGNOLIA OFFICINALIS

A, E, H

 

3151

MAGNOLIA SALICIFOLIA

A, H

 

3152

MAIZE

E

 

3153

MAIZE BRAN

E

 

3154

MAIZE OIL

A, E, H

 

3155

MAIZE STARCH

A, E, H

 

3156

MALACHITE GREEN

E

Permitted for use only as a colour for topical use.

 

3157

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.

 

3158

MALPIGHIA GLABRA

A, E, H

 

3159

MALT EXTRACT

E

 

3160

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]’.

 

3161

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).

 

3162

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.

 

3163

MALTOL

E

 

3164

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%.

 

3165

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).

 

3166

MALUS DOMESTICA

A, E, H

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

 

3167

MALUS PUMILA

A, E, H

 

3168

MALUS SYLVESTRIS

A, H

 

3169

MALVA MOSCHATA

A, H

 

3170

MALVA SYLVESTRIS

A, E, H

 

3171

MALVA VERTICILLATA

A, H

 

3172

MANDARIN

E

 

3173

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%.

 

3174

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.

 

3175

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%.

 

3176

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%.

 

3177

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%.

 

3178

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%.

 

3179

MANGANESE

H

Only for use as an active homoeopathic ingredient.

 

3180

MANGANESE (II) DIASPARTATE

A, H

Only for use in oral medicines.

 

 

3181

MANGANESE (II) GLYCINATE

A, H

Only for use in oral medicines.

 

3182

MANGANESE ACETATE TETRAHYDRATE

H

Only for use as an active homoeopathic ingredient. 

 

3183

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.

 

3184

MANGANESE CHLORIDE TETRAHYDRATE

A, E, H

 

3185

MANGANESE DIASPARTATE

A, E, H

Only for use in oral medicines.

 

 

 

3186

MANGANESE GLUCONATE

A, E, H

 

3187

MANGANESE GLYCEROPHOSPHATE

A, E, H

 

3188

MANGANESE OXIDE

A, E, H

 

3189

MANGANESE SULFATE MONOHYDRATE

A, E, H

 

3190

MANGANESE SULFATE TETRAHYDRATE

A, E, H

 

3191

MANGIFERA INDICA

A, E, H

 

3192

MANGO

E, H

 

3193

MANIHOT ESCULENTA

A, H

 

3194

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).

 

3195

MARANTA ARUNDINACEA

A, H

 

3196

MARINE SPONGE

H

Only for use as an active homoeopathic ingredient.

 

3197

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).

 

3198

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).

 

3199

MARRUBIUM VULGARE

A, E, H

 

3200

MARSDENIA CUNDURANGO

A, H

 

3201

MARSHMALLOW ROOT DRY

A, H

 

3202

MARSHMALLOW ROOT POWDER

A, H

 

3203

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%.

 

3204

MASTIC

A, H

 

3205

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%.

 

3206

MATRICARIA CHAMOMILLA

A, E, H

 

3207

MATRICARIA FLOWER DRY

A, E, H

 

3208

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).

 

3209

MECOBALAMIN (CO-METHYLCOBALAMIN)

A

Only for use in oral medicines.

 

3210

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.

 

3211

MEDIUM CHAIN TRIGLYCERIDES

E

 

3212

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.

 

 

3213

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.

 

3214

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.

 

3215

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.

 

3216

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.

 

3217

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.

 

3218

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.

 

3219

MELICOPE PTELEIFOLIA

A, H

 

3220

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%.

 

3221

MELISSA OFFICINALIS

A, E, H

 

3222

MELON

E

 

3223

MENADIONE SODIUM BISULFITE

E

 

3224

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.

 

3225

MENISPERMUM CANADENSE

A, H

 

3226

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 for dermal application:

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

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(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;

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

(iv) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

 

3227

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 for dermal application:

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

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(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;

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

(iv) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

 

3228

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 for dermal application:

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

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(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;

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

(iv) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

 

3229

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 be 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 for dermal application:

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

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(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; 

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

(iv) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

 

3230

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 for dermal application:

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

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(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;

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

(iv) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

 

3231

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';

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

When the medicine is for topical use for dermal application:

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 medicine must not deliver more than 25% total menthol when administered according to the directions for use;

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;

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

e) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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;

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

 

3232

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 for dermal application:

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

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(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;

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

(iv) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

 

3233

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 for dermal application:

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

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(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;

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

(iv) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

 

3234

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 for dermal application:

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

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(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;

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

(iv) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

 

3235

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%.

 

3236

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%.

 

3237

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%.

 

3238

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 for dermal application:

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

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(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;

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

(iv) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

 

3239

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%.

 

3240

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%.

 

3241

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%.

 

3242

MENTHOXYPROPANEDIOL

E

For oral use only.

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

 

3243

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%.

 

3244

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%.

 

3245

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).

 

3246

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%.

 

3247

MENTHYL LACTATE

E

 

3248

MENYANTHES TRIFOLIATA

A, H

 

3249

MERCURIC CHLORIDE

H

Only for use as an active homoeopathic ingredient.

 

3250

MERCURY

H

Only for use as an active homoeopathic ingredient.

 

3251

MESPILUS GERMANICA

A, H

 

3252

METACRESOL

E

Only for use in topical medicines for dermal application.

 

3253

METHACRYLIC ACID COPOLYMER

E

Only for use in oral medicines.

 

3254

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%.

 

3255

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%.

 

3256

METHIONINE

A, E

 

3257

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%.

 

3258

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%.

 

3259

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%.

 

3260

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%.

 

3261

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%.

 

3262

METHYL ACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

 

3263

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%.

 

3264

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%.

 

3265

METHYL BENZOATE

E

Only for use in topical medicines for dermal application.

 

3266

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%.

 

3267

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%.

 

3268

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%.

 

3269

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%.

 

3270

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%.

 

3271

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%.

 

3272

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%.

 

3273

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%.

 

3274

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%.

 

3275

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%.

 

3276

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%.

 

3277

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%.

 

3278

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%.

 

3279

METHYL ETHER

E

Only for use in topical medicines for dermal application.

 

3280

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%.

 

3281

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%.

 

3282

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%.

 

3283

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.

 

3284

METHYL GLUCETH-20

E

Only for use in topical medicines for dermal application.

 

3285

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%.

 

3286

METHYL GLUCETH-20 SESQUIHYDRATE

E

Only for use in topical medicines for dermal application.

 

3287

METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

 

3288

METHYL GLUCOSE SESQUIOLEATE

E

Only for use in topical medicines for dermal application.

 

3289

METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

 

3290

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%.

 

3291

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%.

 

3292

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%.

 

3293

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%.

 

3294

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%.

 

3295

METHYL HYDROGENATED ROSINATE

E

Only for use in topical medicines for dermal application.

 

3296

METHYL HYDROJASMONATE

E

Only for use in topical medicines for dermal application.

 

3297

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.

 

3298

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%.

 

3299

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%.

 

3300

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%.

 

3301

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%.

 

3302

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%.

 

3303

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%.

 

3304

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%.

 

3305

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%.

 

3306

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%.

 

3307

METHYL METHACRYLATE

E

 

3308

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%.

 

3309

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%.

 

3310

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%.

 

3311

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%.

 

3312

METHYL NONYL KETONE

E