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
2824	KADSURA COCCINEA	A, H
2825	KAEMPFERIA GALANGA	A, H
2826	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 %.
2827	KAOLIN	E
2828	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.
2829	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.
2830	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%.
2831	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%.
2832	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'.
2833	KIDNEY BEAN	E
2834	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%.
2835	KIWI FRUIT	E
2836	KNAUTIA ARVENSIS	A, H
2837	KOREAN GINSENG ROOT DRY	A, H
2838	KOREAN GINSENG ROOT POWDER	A, H
2839	KRAMERIA IXIENA	A, H
2840	KRAMERIA LAPPACEA	A, H
2841	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'.
2842	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%.
2843	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%.
2844	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%.
2845	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%.
2846	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%.
2847	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%.
2848	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%.
2849	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%.
2850	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%.
2851	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%.
2852	LABDANUM OIL	A, E, H
2853	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%.
2854	LACTALBUMIN	E
2855	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.
2856	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'.
2857	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'.
2858	LACTOBACILLUS ACIDOPHILUS	A
2859	LACTOBACILLUS AMYLOVORUS	A
2860	LACTOBACILLUS BREVIS	A
2861	LACTOBACILLUS CASEI	A
2862	LACTOBACILLUS CASEI SUBSP. BIOVAR CASEI	A
2863	LACTOBACILLUS CRISPATUS	A
2864	LACTOBACILLUS DELBRUECKII SSP BULGARICUS	A
2865	LACTOBACILLUS DELBRUECKII SSP LACTIS	A
2866	LACTOBACILLUS FERMENTUM	A
2867	LACTOBACILLUS GALLINARUM	A
2868	LACTOBACILLUS GASSERI	A
2869	LACTOBACILLUS HELVETICUS	A
2870	LACTOBACILLUS JOHNSONII	A
2871	LACTOBACILLUS KEFIRANOFACIENS	A
2872	LACTOBACILLUS KEFIRGRANUM	A
2873	LACTOBACILLUS KEFIRI	A
2874	LACTOBACILLUS PARACASEI	A
2875	LACTOBACILLUS PARACASEI SUBSP. PARACASEI	A
2876	LACTOBACILLUS PLANTARUM	A
2877	LACTOBACILLUS REUTERI	A
2878	LACTOBACILLUS RHAMNOSUS	A
2879	LACTOBACILLUS SALIVARIUS SSP SALICINIUS	A
2880	LACTOBACILLUS SALIVARIUS SSP SALIVARIUS	A
2881	LACTOBIONIC ACID	E	Only for use in topical medicines for dermal application.
2882	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%.
2883	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]’.
2884	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]’.
2885	LACTUCA SATIVA	A, H
2886	LACTUCA VIROSA	A, H
2887	LACTULOSE	E
2888	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.
2889	LAGENARIA VULGARIS	A, H
2890	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.
2891	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.
2892	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.
2893	LAMIUM ALBUM	A, H
2894	LANETH-5	E	Only for use in topical medicines for dermal application.
2895	LANOLIN ALCOHOL	E	Only for use in topical medicines for dermal application.
2896	LANOLIN OIL	E	Only for use in topical medicines for dermal application.
2897	LANOLIN WAX	E	Only for use in topical medicines for dermal application.
2898	LANTANA CAMARA	A, H	The maximum recommended daily dose must contain no more than 1mg of the equivalent dry herbal material of Lantana camara.
2899	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%.
2900	LARIX DECIDUA	A, H
2901	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.
2902	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'.
2903	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.
2904	LAURAMINE OXIDE	E
2905	LAUREL LEAF OIL	A, H
2906	LAURETH-10	E	Only for use in topical medicines for dermal application.
2907	LAURETH-12	E	Only for use in topical medicines for dermal application.
2908	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.
2909	LAURETH-23	E	Only for use in topical medicines for dermal application.
2910	LAURETH-3	E	Only for use in topical medicines for dermal application.
2911	LAURETH-4	E	Only for use in topical medicines for dermal application.
2912	LAURETH-7	E	Only for use in topical medicines for dermal application.
2913	LAURETH-8	E
2914	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.
2915	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%.
2916	LAUROMACROGOL 400	E	Only for use in topical medicines for dermal application.
2917	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%.
2918	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'.
2919	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%.
2920	LAURYL BETAINE	E	Only for use in topical medicines for dermal application.
2921	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%.
2922	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.
2923	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%.
2924	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%.
2925	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%.
2926	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.
2927	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.
2928	LAURYL PYRROLIDONE	E	Only for use in topical medicines for dermal application.
2929	LAURYLDIMONIUM HYDROXYPROPYL HYDROLYSED COLLAGEN	E	Only for use in topical medicines for dermal application.
2930	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%.
2931	LAURYLMETICONE COPOLYOL	E	Only for use in topical medicines for dermal application.
2932	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%.
2933	LAVANDIN OIL ABRIAL	A, E, H
2934	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%.
2935	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%.
2936	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%.
2937	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%.
2938	LAVENDER OIL	A, E, H
2939	LAWSONIA INERMIS	A, H
2940	LEAD	H	Only for use as an active homoeopathic ingredient. The concentration in the medicine must be no more than 0.001%.
2941	LEAD ACETATE	H	Only for use as an active homoeopathic ingredient.
2942	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%.
2943	LECITHIN	A, E
2944	LEDEBOURIELLA SESELOIDES	A, H
2945	LEDUM GROENLANDICUM	A, H
2946	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.
2947	LEMNA MINOR	A, H
2948	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.
2949	LEMON BALM LEAF DRY	A, H
2950	LEMON BALM LEAF POWDER	A, E, H
2951	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.
2952	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.
2953	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.
2954	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%.
2955	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.
2956	LEMONGRASS OIL	A, E, H
2957	LENS CULINARIS	A, H
2958	LENTIL	E
2959	LENTINULA EDODES	A, E, H
2960	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%.
2961	LEONURUS CARDIACA	A, E, H
2962	LEONURUS SIBIRICUS	A, E, H
2963	LEPIDIUM APETALUM	A, H
2964	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).
2965	LEPTOSPERMUM PETERSONII	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more 5%.
2966	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’
2967	LESPEDEZA CAPITATA	A, H
2968	LETTUCE	E
2969	LEUCINE	A, E
2970	LEUZEA UNIFLORUM	A, H
2971	LEVISTICUM OFFICINALE	A, H
2972	LEVOCARNITINE	A
2973	LEVOCARNITINE FUMARATE	A
2974	LEVOCARNITINE HYDROCHLORIDE	A
2975	LEVOCARNITINE MAGNESIUM CITRATE	A
2976	LEVOCARNITINE TARTRATE	A
2977	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)’.
2978	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).'
2979	LEVOTHYROXINE SODIUM	H	Only for use as an active homoeopathic ingredient.
2980	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%.
2981	LIGHT KAOLIN	E
2982	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.
2983	LIGHT MAGNESIUM OXIDE	A, E, H
2984	LIGUSTICUM SINENSE	A, H
2985	LIGUSTICUM STRIATUM	A, E, H
2986	LIGUSTRUM LUCIDUM	A, H
2987	LILIUM BROWNII	A, H
2988	LILIUM CANDIDUM	A, E, H
2989	LILIUM LANCIFOLIUM	A, H
2990	LILIUM LONGIFLORUM	A, H
2991	LIME FRUIT	E
2992	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%.
2993	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.
2994	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.
2995	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%.
2996	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%.
2997	LIME TREE FLOWER DRY	A, H
2998	LIME TREE FLOWER POWDER	A, H
2999	LIME, ESSENCE	E
3000	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%.
3001	LIMONENE	E	When for oral use, the quantity must be no more than 10 mg per maximum recommended daily dose.
3002	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%.
3003	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%.
3004	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%.
3005	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%.
3006	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%.
3007	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%.
3008	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%.
3009	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%.
3010	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%.
3011	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%.
3012	LINDERA STRYCHNIFOLIA	A, H
3013	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%.
3014	LINOLEIC ACID	E
3015	LINOLENIC ACID	E
3016	LINSEED DRY	A, E, H
3017	LINSEED OIL	A, E, H
3018	LINSEED POWDER	A, E, H
3019	LINUM USITATISSIMUM	A, E, H
3020	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.
3021	LIPPIA DULCIS	A, H
3022	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).
3023	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.
3024	LIQUIDAMBAR FORMOSANA	A, H
3025	LIQUIDAMBAR ORIENTALIS	A, H
3026	LIQUIDAMBAR STYRACIFLUA	A, E, H
3027	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%.
3028	LIQUIDAMBAR TAIWANIANA	A, H
3029	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%.
3030	LIQUORICE DRY	A, E, H
3031	LIQUORICE LIQUID EXTRACT	A, E, H
3032	LIQUORICE POWDER	A, E, H
3033	LITCHI CHINENSIS	A, H
3034	LITHIUM CARBONATE	H	Only for use as an active homoeopathic ingredient.
3035	LITHOSPERMUM OFFICINALE	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Lithospermum officinale.
3036	LITSEA CUBEBA	A, E, H
3037	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%.
3038	LOBARIA PULMONARIA	A, H
3039	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.
3040	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.
3041	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.
3042	LOLIUM PERENNE	A, H
3043	LOLIUM TEMULENTUM	A, H
3044	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%.
3045	LONICERA CAPRIFOLIUM	A, E, H
3046	LONICERA JAPONICA	A, E, H
3047	LONICERA PERICLYMENUM	A, H
3048	LOPHATHERUM GRACILE	A, H
3049	LOQUAT	E
3050	LORANTHUS PARASITICUS	A, H
3051	LOROPETALUM CHINENSIS	A, H
3052	LOTUS CORNICULATUS	A, H
3053	LOVAGE OIL	A, E, H
3054	LOVAGE ROOT DRY	A, H
3055	LOVAGE ROOT POWDER	A, H
3056	LUDWIGIA PROSTRATA	A, H
3057	LUFFA CYLINDRICA	A, H
3058	LUFFA PURGANS	A, H
3059	LUTEIN	A, E, H	When used as an excipient, permitted for use as a colour for oral and topical use.
3060	LYCHEE	E
3061	LYCIUM BARBARUM	A, H
3062	LYCIUM CHINENSE	A, E, H
3063	LYCOPENE	A, E
3064	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.
3065	LYCOPODIUM ANNOTINUM	A, H
3066	LYCOPODIUM CLAVATUM	A, H
3067	LYCOPODIUM COMPLANATUM	A, H
3068	LYCOPUS EUROPAEUS	A, H
3069	LYCOPUS LUCIDUS	A, H
3070	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%.
3071	LYGODIUM JAPONICUM	A, H
3072	LYSIMACHIA CHRISTINAE	A, H
3073	LYSIMACHIA VULGARIS	A, H
3074	LYSINE	A, E
3075	LYSINE HYDROCHLORIDE	A, E
3076	LYTHRUM HYSSOPIFOLIA	A, H
3077	LYTHRUM SALICARIA	A, H
3078	LYTHRUM VERTICILLATUM	A, H
3079	MACADAMIA INTEGRIFOLIA	A, E
3080	MACADAMIA NUT	E
3081	MACADAMIA NUT OIL	E
3082	MACADAMIA TERNIFOLIA	A, E, H
3083	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%.
3084	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.
3085	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.
3086	MACROGOL 1000	E
3087	MACROGOL 1450	E	Only for use in topical medicines for dermal application.
3088	MACROGOL 1500	E
3089	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%.
3090	MACROGOL 200	E	Only for use in topical medicines for dermal application.
3091	MACROGOL 20000	E
3092	MACROGOL 300	E
3093	MACROGOL 3000	E
3094	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.
3095	MACROGOL 40	E	Only for use in topical medicines for dermal application.
3096	MACROGOL 400	E
3097	MACROGOL 4000	E
3098	MACROGOL 45000	E	Only for use in topical medicines for dermal application.
3099	MACROGOL 600	E
3100	MACROGOL 6000	E
3101	MACROGOL 600000	E
3102	MACROGOL 800	E
3103	MACROGOL 8000	E
3104	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%.
3105	MACROGOL POLY(VINYL ALCOHOL) GRAFTED POLYMER	E	Only for use in oral medicines. The concentration in the medicine must be no more than 5%.
3106	MACROPIPER EXCELSUM VAR EXCELSUM	A, H
3107	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.
3108	MAGNESIUM ASCORBATE	A, E, H
3109	MAGNESIUM ASCORBATE MONOHYDRATE	A, E, H
3110	MAGNESIUM ASCORBYL PHOSPHATE	E	Only for use in topical medicines for dermal application.
3111	MAGNESIUM ASPARTATE	A, E, H
3112	MAGNESIUM ASPARTATE DIHYDRATE	A, E, H
3113	MAGNESIUM ASPARTATE TETRAHYDRATE	A, E, H
3114	MAGNESIUM CARBONATE HYDRATE	A, E, H
3115	MAGNESIUM CHLORIDE 4.5-HYDRATE	A
3116	MAGNESIUM CHLORIDE HEXAHYDRATE	A, E, H
3117	MAGNESIUM CITRATE	A, E, H
3118	MAGNESIUM CITRATE NONAHYDRATE	A, E, H
3119	MAGNESIUM CITRATE TETRADECAHYDRATE	A, E, H
3120	MAGNESIUM DIGLUTAMATE	A, E, H
3121	MAGNESIUM GLUCONATE	A, E, H
3122	MAGNESIUM GLYCEROPHOSPHATE	A, E, H
3123	MAGNESIUM GLYCINATE	A	Only for use in oral medicines.
3124	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.
3125	MAGNESIUM HYDROGEN PHOSPHATE	H
3126	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'.
3127	MAGNESIUM LYSINATE	A	Only for use in oral medicines.
3128	MAGNESIUM METHIONINATE	A	Only for use in oral medicines.
3129	MAGNESIUM NITRATE	E	Only for use in topical medicines for dermal application.
3130	MAGNESIUM OROTATE	A, E, H
3131	MAGNESIUM OROTATE DIHYDRATE	A, E, H
3132	MAGNESIUM OXIDE	A, E, H
3133	MAGNESIUM PHOSPHATE PENTAHYDRATE	A, E, H
3134	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.
3135	MAGNESIUM PYRUVATE	A	Only for use in oral medicines. The maximum recommended daily dose must be no more than 7 grams.
3136	MAGNESIUM STEARATE	E
3137	MAGNESIUM SULFATE DIHYDRATE	A, E, H	When used internally, the maximum recommended daily dose must be no more than 1.5g.
3138	MAGNESIUM SULFATE HEPTAHYDRATE	A, E, H	When used internally, the maximum recommended daily dose must be no more than 1.5g.
3139	MAGNESIUM SULFATE MONOHYDRATE	A, E, H	When used internally, the maximum recommended daily dose must be no more than 1.5g.
3140	MAGNESIUM SULFATE TRIHYDRATE	A, E, H	When used internally, the maximum recommended daily dose must be no more than 1.5g.
3141	MAGNESIUM TRISILICATE	E
3142	MAGNOLIA GLAUCA	A, H
3143	MAGNOLIA LILIFLORA	A, H
3144	MAGNOLIA OBOVATA	A, H
3145	MAGNOLIA OFFICINALIS	A, E, H
3146	MAGNOLIA SALICIFOLIA	A, H
3147	MAIZE	E
3148	MAIZE BRAN	E
3149	MAIZE OIL	A, E, H
3150	MAIZE STARCH	A, E, H
3151	MALACHITE GREEN	E	Permitted for use only as a colour for topical use.
3152	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.
3153	MALPIGHIA GLABRA	A, E, H
3154	MALT EXTRACT	E
3155	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]’.
3156	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).
3157	MALTODEXTRIN	E	Gluten is a mandatory component of Maltodextrin where the ingredient is derived from gluten containing grains such as wheat, barley, rye and oats. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).
3158	MALTOL	E
3159	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%.
3160	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).
3161	MALUS DOMESTICA	A, E, H	The concentration of amygdalin in the medicine must be no more than 0%.
3162	MALUS PUMILA	A, E, H
3163	MALUS SYLVESTRIS	A, H
3164	MALVA MOSCHATA	A, H
3165	MALVA SYLVESTRIS	A, E, H
3166	MALVA VERTICILLATA	A, H
3167	MANDARIN	E
3168	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%.
3169	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.
3170	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%.
3171	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%.
3172	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%.
3173	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%.
3174	MANGANESE	H	Only for use as an active homoeopathic ingredient.
3175	MANGANESE (II) DIASPARTATE	A, H	Only for use in oral medicines.
3176	MANGANESE (II) GLYCINATE	A, H	Only for use in oral medicines.
3177	MANGANESE ACETATE TETRAHYDRATE	H	Only for use as an active homoeopathic ingredient.
3178	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.
3179	MANGANESE CHLORIDE TETRAHYDRATE	A, E, H
3180	MANGANESE DIASPARTATE	A, E, H	Only for use in oral medicines.
3181	MANGANESE GLUCONATE	A, E, H
3182	MANGANESE GLYCEROPHOSPHATE	A, E, H
3183	MANGANESE OXIDE	A, E, H
3184	MANGANESE SULFATE MONOHYDRATE	A, E, H
3185	MANGANESE SULFATE TETRAHYDRATE	A, E, H
3186	MANGIFERA INDICA	A, E, H
3187	MANGO	E, H
3188	MANIHOT ESCULENTA	A, H
3189	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).
3190	MARANTA ARUNDINACEA	A, H
3191	MARINE SPONGE	H	Only for use as an active homoeopathic ingredient.
3192	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).
3193	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).
3194	MARRUBIUM VULGARE	A, E, H
3195	MARSDENIA CUNDURANGO	A, H
3196	MARSHMALLOW ROOT DRY	A, H
3197	MARSHMALLOW ROOT POWDER	A, H
3198	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%.
3199	MASTIC	A, H
3200	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%.
3201	MATRICARIA CHAMOMILLA	A, E, H
3202	MATRICARIA FLOWER DRY	A, E, H
3203	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).
3204	MECOBALAMIN (CO-METHYLCOBALAMIN)	A	Only for use in oral medicines.
3205	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.
3206	MEDIUM CHAIN TRIGLYCERIDES	E
3207	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.
3208	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.
3209	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.
3210	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.
3211	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.
3212	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.
3213	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.
3214	MELICOPE PTELEIFOLIA	A, H
3215	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%.
3216	MELISSA OFFICINALIS	A, E, H
3217	MELON	E
3218	MENADIONE SODIUM BISULFITE	E
3219	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.
3220	MENISPERMUM CANADENSE	A, H
3221	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.
3222	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.
3223	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.
3224	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.
3225	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.
3226	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.
3227	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.
3228	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.
3229	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.
3230	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%.
3231	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%.
3232	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%.
3233	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.
3234	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%.
3235	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%.
3236	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%.
3237	MENTHOXYPROPANEDIOL	E	For oral use only. The concentration in the medicine must be no more than 0.04%.
3238	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%.
3239	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%.
3240	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).
3241	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%.
3242	MENTHYL LACTATE	E
3243	MENYANTHES TRIFOLIATA	A, H
3244	MERCURIC CHLORIDE	H	Only for use as an active homoeopathic ingredient.
3245	MERCURY	H	Only for use as an active homoeopathic ingredient.
3246	MESPILUS GERMANICA	A, H
3247	METACRESOL	E	Only for use in topical medicines for dermal application.
3248	METHACRYLIC ACID COPOLYMER	E	Only for use in oral medicines.
3249	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%.
3250	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%.
3251	METHIONINE	A, E
3252	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%.
3253	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%.
3254	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%.
3255	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%.
3256	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%.
3257	METHYL ACETYL RICINOLEATE	E	Only for use in topical medicines for dermal application.
3258	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%.
3259	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%.
3260	METHYL BENZOATE	E	Only for use in topical medicines for dermal application.
3261	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%.
3262	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%.
3263	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%.
3264	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%.
3265	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%.
3266	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%.
3267	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%.
3268	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%.
3269	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%.
3270	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%.
3271	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%.
3272	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%.
3273	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%.
3274	METHYL ETHER	E	Only for use in topical medicines for dermal application.
3275	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%.
3276	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%.
3277	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%.
3278	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.
3279	METHYL GLUCETH-20	E	Only for use in topical medicines for dermal application.
3280	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%.
3281	METHYL GLUCETH-20 SESQUIHYDRATE	E	Only for use in topical medicines for dermal application.
3282	METHYL GLUCOSE DIOLEATE	E	Only for use in topical medicines for dermal application.
3283	METHYL GLUCOSE SESQUIOLEATE	E	Only for use in topical medicines for dermal application.
3284	METHYL GLUCOSE SESQUISTEARATE	E	Only for use in topical medicines for dermal application.
3285	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%.
3286	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%.
3287	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%.
3288	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%.
3289	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%.
3290	METHYL HYDROGENATED ROSINATE	E	Only for use in topical medicines for dermal application.
3291	METHYL HYDROJASMONATE	E	Only for use in topical medicines for dermal application.
3292	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.
3293	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%.
3294	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%.
3295	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%.
3296	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%.
3297	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%.
3298	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%.
3299	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%.
3300	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%.
3301	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%.
3302	METHYL METHACRYLATE	E
3303	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%.
3304	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%.
3305	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%.
3306	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%.
3307	METHYL NONYL KETONE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3308	METHYL NONYLENATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3309	METHYL OCTIN CARBONATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3310	METHYL PALMITATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3311	METHYL PHENYL CARBINOL	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3312	METHYL PHENYL CARBINYL-ISO-BUTYRATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3313	METHYL PHENYL GLYCIDATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3314	METHYL PHENYLACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3315	METHYL PHENYLCARBINYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3316	METHYL ROSINATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3317	METHYL SALICYLATE	A, E	Not to be included in medicines for use in the eye or on damaged skin. When used internally, the concentration 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).
3318	METHYL STEARATE	E
3319	METHYL THIOBUTYRATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3320	METHYL TRIMETICONE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
3321	METHYL-3-METHYLTHIOPROPIONATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3322	METHYL-BETA-METHYL THIOLPROPIONATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3323	METHYL-PARA-TERT-BUTYL PHENYLACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3324	METHYLBENZYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3325	METHYLCELLULOSE	A, E
3326	METHYLCHLOROISOTHIAZOLINONE	E	Only for use in topical medicines for dermal application that are rinsed off the skin. The total concentration of methylchloroisothiazolinone and methylisothiazolinone in the medicine must be no more than 0.0015%.
3327	METHYLCYCLOHEXADIENE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3328	METHYLDIBROMO GLUTARONITRILE	E	Only for use in topical medicines for dermal application.
3329	METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
3330	METHYLISOTHIAZOLINONE	E	Only for use in topical medicines for dermal application that are rinsed off the skin. The concentration of methylisothiazolinone in the medicine must be no more than 0.01%. When combined with methylchloroisothiazolinone, the total concentration of methylchloroisothiazolinone and methylisothiazolinone in the medicine must be no more than 0.0015%.
3331	METHYLMERCAPTAN	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3332	METHYLPROPANEDIOL	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%.
3333	METHYLSILANOL/SILICATE CROSSPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.1%.
3334	METHYLSTYRENE/VINYLTOLUENE COPOLYMER	E	Only for use in topical medicines for dermal application.
3335	MICA	E	Only for use when the route of administration is oral, dental or topical. The concentration in oral medicines must be no more than 2.5%. The concentration in dental toothpastes must be no more than 0.5%.
3336	MICROCALICIUM ARENARIUM	A, H
3337	MICROCOCCUS LUTEUS LYSATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.005%.
3338	MICROCOS PANICULATA	A, H
3339	MICROCRYSTALLINE CELLULOSE	E
3340	MICROCRYSTALLINE WAX	E	Only for use as an excipient in medicines for topical, oral or oral application routes of administration. When microcrystalline wax is used as an excipient ingredient, the route of administration 'oral' is only permitted when the dosage form is 'chewing gum'.
3341	MILK FAT	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3342	MILK THISTLE FRUIT DRY	A, H
3343	MILK THISTLE FRUIT POWDER	A, H
3344	MILLET	E
3345	MILLETTIA DIELSIANA	A, H
3346	MIMOSA ABSOLUTE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3347	MIMULUS GUTTATUS	A, H
3348	MINT OIL DEMENTHOLISED	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 mint oil dementholised. 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.
3349	MINTLACTONE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3350	MITCHELLA REPENS	A, H
3351	MIXED (HIGH-ALPHA TYPE) TOCOPHEROLS CONCENTRATE	A, E
3352	MIXED (LOW-ALPHA TYPE) TOCOPHEROLS CONCENTRATE	A, E
3353	MIXED TERPENES	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3354	MODIFIED FOOD STARCH	E
3355	MOLASSES	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3356	MOLYBDENUM	H	Only for use as an active homoeopathic ingredient. When Molybdenum is sourced from Molybdenum trioxide then the maximum daily dose must be no more than 125 micrograms. When Molybdenum is sourced from yeast - high molybdenum then the maximum recommended daily dose must be no more than 62.5 micrograms.
3357	MOLYBDENUM TRIOXIDE	A	Molybdenum is a mandatory component of Molybdenum trioxide. The maximum daily dose of molybdenum from Molybdenum trioxide must be no more than 125 micrograms. The percentage of molybdenum from molybdenum trioxide should be calculated based on the molecular weight of molybdenum trioxide.
3358	MOMORDICA BALSAMINA	A, H
3359	MOMORDICA CHARANTIA	A, H
3360	MOMORDICA COCHINCHINENSIS	A, H	When Lycopene, Lutein or Betocarotene are declared as components, the plant part is restricted to fruit flesh, fruit peel or seed aril.
3361	MONARDA DIDYMA	A, H
3362	MONO- AND DI- GLYCERIDES	E
3363	MONOBASIC AMMONIUM PHOSPHATE	E	Only for use in topical medicines for dermal application.
3364	MONOBASIC CALCIUM PHOSPHATE	A, E, H
3365	MONOBASIC POTASSIUM PHOSPHATE	A, E, H	When used in a solid medicine containing this ingredient, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid medicine containing this ingredient, the pH of the medicine must be no more than 11.5.
3366	MONOBASIC SODIUM PHOSPHATE	A, E, H	When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).'
3367	MONOBASIC SODIUM PHOSPHATE DIHYDRATE	E	When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
3368	MONOETHANOLAMINE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%.
3369	MONOPHOSPHOTHIAMINE	A
3370	MONOPHOSPHOTHIAMINE DIHYDRATE	A
3371	MONOPOTASSIUM GLUTAMATE	A, E
3372	MONOSODIUM DIHYDROGEN CITRATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’
3373	MONOSODIUM GLUTAMATE MONOHYDRATE	A, E
3374	MONSTERA DELICIOSA	A, H
3375	MONTAN WAX	E
3376	MORDANT RED 11	E	Permitted for use only as a colour for topical use. The concentration in the medicine must be no more than 0.05%..
3377	MORINDA CITRIFOLIA	A, H	Only for use when the plant part is fruit and the plant preparation is fruit juice or fruit powder. Fruit powder must be produced by freeze drying the whole fruit (excluding the seeds).
3378	MORINDA OFFICINALIS	A, H
3379	MORINGA OLEIFERA	A, H
3380	MORUS ALBA	A, H
3381	MORUS BOMBYCIS	A, H
3382	MORUS NIGRA	A, E, H
3383	MOSKENE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3384	MOTHERWORT HERB DRY	A, H
3385	MOTHERWORT HERB POWDER	A, H
3386	MUCUNA PRURIENS	A, H	Levodopa (of Mucuna pruriens) is a mandatory component of Mucuna pruriens. The concentration of Levodopa (of Mucuna pruriens) in the medicine must be no more than 1mg/kg or 1mg/L or 0.1%.
3387	MULBERRY	E
3388	MUNG BEAN	E
3389	MURRAYA KOENIGII	A, H
3390	MURRAYA PANICULATA	A, H
3391	MUSA X PARADISIACA	A, H
3392	MUSK KETONE	E	Only for use in topical medicines for dermal application.
3393	MUSK TIBETENE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3394	MUSK XYLOL	E	Only for use in topical medicines for dermal application.
3395	MUSKS	H	Only for use as an active homoeopathic ingredient.
3396	MUSTARD	E	Allyl isothiocyanate is a mandatory component of mustard when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.
3397	MUSTARD OIL	E	Allyl isothiocyanate is a mandatory component of mustard oil when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.
3398	MUSTARD SEED OIL	E	Allyl isothiocyanate is a mandatory component of mustard seed oil when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.
3399	MYOSOTIS ARVENSIS	A, H
3400	MYRCENE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3401	MYRCENYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3402	MYRICA CERIFERA	A, E, H
3403	MYRISTIC ACID	E
3404	MYRISTIC ALDEHYDE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3405	MYRISTICA FRAGRANS	A, E, H	Safrole is a mandatory component of Myristica fragrans. When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%. When the plant preparation is oil or distillate and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect).
3406	MYRISTYL ALCOHOL	E	Only for use in topical medicines for dermal application.
3407	MYRISTYL LACTATE	E	Only for use in topical medicines for dermal application.
3408	MYRISTYL MYRISTATE	E	Only for use in topical medicines for dermal application.
3409	MYROXYLON BALSAMUM	A, E, H
3410	MYROXYLON BALSAMUM VAR. PEREIRAE	A, H
3411	MYRRH	A, H
3412	MYRRH OIL	A, E, H
3413	MYRRH RESIN	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3414	MYRRHIS ODORATA	A, H
3415	MYRSINE AFRICANA	A, H
3416	MYRTENAL	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3417	MYRTENYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3418	MYRTLE ESSENCE MAX	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3419	MYRTLE OIL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used as a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3420	MYRTUS COMMUNIS	A, E, H
3421	N-BUTYL SULFIDE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3422	N-GLUCONYL ETHANOLAMINE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3423	N-HEXYL 2-BUTENOATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3424	N-NONYL ALCOHOL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3425	NAPHTHALENE	H	Only for use as an active homoeopathic ingredient.
3426	NARDOSTACHYS CHINENSIS	A, H
3427	NARINGIN	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3428	NASTURTIUM OFFICINALE	A, E, H
3429	NATURAL FISH OIL	A, E	When therapeutic indications for this product are made against Vitamin A or colecalciferol (Vitamin D), they are mandatory components of natural fish oil. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) 'WARNING: If you are pregnant - or considering becoming pregnant - do not take vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].' NOTE: Position this warning at the beginning of the directions for use. - (VITA4) 'WARNING - When taken in excess of 3000 micrograms retinol equivalents - vitamin A can cause birth defects.' NOTE: Position this warning at the beginning of the directions for use. - (VITA3) 'The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.' When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D.
3430	NAUCLEA OFFICINALIS	A, H
3431	NELUMBO NUCIFERA	A, H
3432	NELUMBO NUCIFERA FLOWER WAX	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.1%.
3433	NEOHESPERIDIN-DIHYDROCHALCONE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.1%
3434	NEOMENTHOL	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3435	NEOPENTYL GLYCOL DIHEPTANOATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 25%.
3436	NEOPENTYL GLYCOL DIISOSTEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
3437	NEOPENTYL GLYCOL DIOCTANOATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 8.1%. When the concentration of neopentyl glycol dioctanoate is greater than 5%, the medicine must not be intended for use on damaged skin.
3438	NEOPENTYL GLYCOL DIOCTANOATE/DIDECANOATE	E	Only for use in topical medicines for dermal application.
3439	NEOPICRORHIZA SCROPHULARIIFLORA	A, H
3440	NEPETA CATARIA	A, H	Pulegone is a mandatory component of Nepeta cataria and must be declared in the application. The concentration of pulegone in the medicine must be no more than 4%.
3441	NERAL	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3442	NERIUM OLEANDER	A, H	The concentration of equivalent dry Nerium oleander in the product must be no more than 1mg/Kg or 1mg/L or 0.0001%.
3443	NEROL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3444	NEROL OXIDE	E	Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
3445	NEROLIDOL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3446	NERONE	E	Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
3447	NERYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3448	NERYL-ISO-BUTYRATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3449	NICKEL	H	Only for use as an active homoeopathic ingredient.
3450	NICOTIANA TABACUM	H	Only for use as an active homoeopathic ingredient.
3451	NICOTINAMIDE	A, E, H
3452	NICOTINAMIDE ASCORBATE	A, E
3453	NICOTINIC ACID	A, E	The medicine must contain no more than 100 mg of nicotinic acid per dosage unit.
3454	NIGELLA DAMASCENA	A, H
3455	NIGELLA SATIVA	A, E, H
3456	NITRIC ACID	E, H	The concentration of nitric acid in the medicine must be no more than 0.5%.
3457	NONADIENOL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3458	NONANAL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3459	NONANOIC ACID	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3460	NONFAT DRY MILK	E, H	If the product is for oral ingestion and contains lactose, then the medicine requires the following warning statement on the medicine label: - (LACT) 'Contains lactose' (or words to that effect).
3461	NONIVAMIDE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3462	NONOXINOL 10	E	Only for use in topical medicines for dermal application.
3463	NONOXINOL 12	E	For use in hand scrub formulations for healthcare professionals only. Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
3464	NONOXINOL 5	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3465	NONOXINOL 9	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 25%.
3466	NONYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3467	NOOTKATONE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3468	NOPYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3469	NORDIHYDROGUAIARETIC ACID	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.3%.
3470	NOTOPTERYGIUM FORBESII	A, H
3471	NOTOPTERYGIUM INCISIUM	A, H
3472	NUPHAR JAPONICA	A, H
3473	NUPHAR LUTEA	A, H
3474	NUTMEG DRY	A, E, H	Safrole is a mandatory component of Nutmeg Dry. When for internal use then the concentration of safrole from all ingredients in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole from all ingredients in the medicine must be no more than 1%.
3475	NUTMEG OIL	A, E, H	Safrole is a mandatory component of Nutmeg oil. When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%. When the concentration of Nutmeg oil in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, the medicine must have a restricted flow insert fitted on the container and requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect).
3476	NUTMEG POWDER	A, E, H	Safrole is a mandatory component of Nutmeg powder. When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%.
3477	NUX VOMICA DRY	A, H	Strychnine (of Strychnos spp.) is a mandatory component of Nux Vomica Dry. The concentration of in the medicine must be no more than 1mg/Kg or 1mg/L or 0.0001%.
3478	NUX VOMICA POWDER	H	Only for use as an active homoeopathic ingredient. Strychnine (of Strychnos spp.) is a mandatory component of Nux vomica powder. The concentration in the medicine must be no more than 1mg/Kg or 1mg/L or 0.0001%.
3479	NYCTANTHES ARBOR-TRISTIS	A, H	When the plant part is leaf: a) methyl salicylate is a mandatory component of Nyctanthes arbor-tristis; b) not to be included in medicines for use in the eye or on damaged skin; c) when used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%; d) 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; e) 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; f) the following warning statement is required on the medicine label: - (METSAL) ‘Contains methyl salicylate’ (or words to that effect); and g) 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).
3480	NYLON	E	Only for use in topical medicines for dermal application.
3481	NYLON 6/12	E	Only for use in topical medicines for dermal application.
3482	NYLON-12	E	Only for use in topical medicines for dermal application.
3483	NYMPHAEA ALBA	A, E, H
3484	NYMPHAEA CAERULEA	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 to be no more than 0.3%. Only for use in liquid extracts where the plant part is the flower and the solvent in 100% water.
3485	NYMPHAEA ODORATA	A, H
3486	OAK CHIPS EXTRACT	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3487	OAKMOSS	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3488	OAKMOSS 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%.
3489	OAT	E, H	Only for use as a homoeopathic ingredient. Gluten is a mandatory component of Oat when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the warning statement: - (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).
3490	OAT BRAN	E	Gluten is a mandatory component of Oat bran when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).
3491	OATMEAL COLLOIDAL	A, E	Gluten is a mandatory component of Oatmeal colloidal when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).
3492	OCIMENE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3493	OCIMENYL 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%.
3494	OCIMUM BASILICUM	A, E, H	When the plant preparation is oil or distillate, Methyl chavicol, eugenol, methyleugenol and cineole are mandatory components of Ocimum basilicum. The concentration of methyleugenol in the medicine must not exceed 1%. When the concentration of Methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25 millilitres. When the concentration of Methyl chavicol in the medicine is more than 5% and the nominal capacity of the container is 25 millilitres or less, a restricted flow insert must be fitted on the container, and requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). When the concentration of cineole OR eugenol in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres and the following warning statements must be included on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. When the concentration of cineole OR eugenol in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container. When the concentration of cineole OR eugenol in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container. When the preparation is for topical use in the mouth, the preparation may not contain more than 5 millilitres of eugenol and the concentration of eugenol in the product must not be greater than 25%.
3495	OCIMUM KILIMANDSCHARICUM	A, H	Camphor is a mandatory component of Ocimum kilimandscharicum. In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%. In liquid preparations, the nominal capacity of the container must be no more than 25 millilitres. In liquid preparations other than essential oils or distillates, the concentration of camphor must be no more than 2.5%. In essential oil or distillate preparations when the concentration of camphor is more than 2.5%, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In essential oil or distillate preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must also have a child resistant closure fitted on the container.
3496	OCIMUM MINIMUM	A, H
3497	OCIMUM TENUIFLORUM	A, H	When the plant part is oil or distillate, eugenol is a mandatory component of Ocimum tenuiflorum. When the concentration of eugenol in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres and the following warning statements must be included on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. When the concentration of eugenol in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container. When the concentration of eugenol in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container. When the preparation is for topical use in the mouth, the preparation may not contain more than 5 mL of eugenol and the concentration of eugenol in the product must not be greater than 25%.
3498	OCOTEA ODORIFERA	A, H	Safrole is a mandatory component of Ocotea odorifera. When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%.
3499	OCTACOSANOL	E
3500	OCTADECANAL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3501	OCTADECENE/MA COPOLYMER	E	Only for use in topical medicines for dermal application.
3502	OCTAHYDRO-4,7-METHANO-3AH-INDENE-3A-CARBOXYLIC ACID, ETHYL ESTER	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3503	OCTAHYDROCOUMARIN	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3504	OCTAN-1-OL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3505	OCTANAL DIMETHYL 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%.
3506	OCTANOHYDROXAMIC ACID	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%.
3507	OCTANOIC ACID	A, E	When for topical use, the concentration in the medicine must be no more than 2% (w/w). When for excipient use, permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
3508	OCTENE-1	E	Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
3509	OCTHILINONE	E	Only for use in topical medicines for dermal application.
3510	OCTOCRYLENE	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
3511	OCTOXINOL 10	E	Only for use in topical medicines for dermal application.
3512	OCTYL 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%.
3513	OCTYL HYDROXYSTEARATE	E	Only for use in topical medicines for dermal application.
3514	OCTYL ISOBUTYRATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3515	OCTYL ISONONANOATE	E	Only for use in topical medicines for dermal application.
3516	OCTYL METHOXYCINNAMATE	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
3517	OCTYL PALMITATE	E	Only for use in topical medicines for dermal application.
3518	OCTYL SALICYLATE	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
3519	OCTYL STEARATE	E	Only for use in topical medicines for dermal application.
3520	OCTYLBICYCLOHEPTENEDICARBOXIMIDE	E	Only for use in topical medicines for dermal application. The medicine requires the following warning statement on the medicine label: - (OBCARB) 'Contains octylbicycloheptenedicarboximide' (or words to that effect).
3521	OCTYLDODECANOL	E	Only for use in topical medicines for dermal application.
3522	OCTYLDODECETH-25	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%. Residual levels of 1,4-dioxane and ethylene oxide (and related substances) are to be kept below the level of detection.
3523	OCTYLDODECYL CITRATE CROSSPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 12%.
3524	OCTYLDODECYL NEOPENTANOATE	E	Only for use in topical medicines for dermal application.
3525	OCTYLDODECYL STEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%.
3526	OCTYLDODECYL XYLOSIDE	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 1.5%.
3527	OENANTHATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3528	OENANTHE AQUATICA	H	Only for use as an active homoeopathic ingredient. The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material.
3529	OENANTHE CROCATA	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material.
3530	OENOTHERA BIENNIS	A, E, H
3531	OENOTHERA STRICTA	A, H
3532	OKOUBAKA AUBREVILLEI	A, H
3533	OLDENLANDIA DIFFUSA	A, E, H
3534	OLEA EUROPAEA	A, E, H
3535	OLEIC ACID	E
3536	OLETH-10	E	Only for use in topical medicines for dermal application.
3537	OLETH-2	E	Only for use in topical medicines for dermal application. Dioxane and Ethylene oxide are mandatory components of Oleth-2. The concentration of Dioxane in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%. The concentration of Ethylene oxide in the medicine must be no more than 1 mg/kg or 1 mg/L or 0.0001%.
3538	OLETH-20	E	Only for use in topical medicines for dermal application.
3539	OLETH-3	E	Only for use in topical medicines for dermal application.
3540	OLETH-3 PHOSPHATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.12%.
3541	OLETH-5	E	Only for use in topical medicines for dermal application.
3542	OLEYL ALCOHOL	E	Only for use in topical medicines for dermal application.
3543	OLIBANUM OIL	A, E, H
3544	OLIGOFRUCTOSE	A, E
3545	OLIVE	E
3546	OLIVE OIL	A, E, H
3547	OMEGA-3 FISH OIL PHYTOSTEROL ESTERS	A	The medicine requires the following warning statement on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women (or words to that effect).'
3548	OMEGA-3-ACID ETHYL ESTERS 60	A	Docosahexaenoic acid, docosapentaenoic acid and eicosapentaenoic acid are mandatory components of omega-3-acid ethyl esters 60. Only to be used in a medicine where DSM Nutritional Products Pty Ltd (Client ID 31685), 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 30 June 2021. Only permitted for use in medicines that are for oral routes of administration. The maximum recommended daily dose of the medicine must not provide more than 3750 milligrams of docosahexaenoic acid, docosapentaenoic acid and eicosapentaenoic acid combined. The following warning statements are required on the medicine label: - (PREGNT) ‘Not recommended for use by pregnant and lactating women’ (or words to that effect); - (ACOAG) ‘Individuals taking anticoagulants should seek medical advice before taking this product’ (or words to that effect); - (CHILD3) 'Use in children under 12 years is not recommended’; - (FOOD) 'To be taken with food’ (or words to that effect).
3549	OMEGA-3-ACID ETHYL ESTERS 90	A	Only for use in oral medicines. The maximum recommended daily dose must not exceed 4000 mg of Omega-3-acid ethyl esters 90, AND must not provide more than 3750 mg EPA, DHA and DPA combined, when used alone or in combination with other sources of omega-3 fatty acids. The medicine requires the following warning statements on the medicine label: -‘Individuals taking anticoagulants should seek medical advice before taking this product’ (or words to that effect). -‘To be taken with food’ (or words to that effect). - 'Not recommended for used by pregnant and lactating women' (or words to that effect). - 'Use in children under 12 years is not recommended' (or words to that effect).
3550	ONION	E
3551	ONION OIL	A, H
3552	ONONIS SPINOSA	A, E, H
3553	ONOPORDUM ACANTHIUM	A, H
3554	ONOSMODIUM VIRGINIANUM	A, H
3555	OPHIOPOGON JAPONICUS	A, H
3556	OPOPANAX CHIRONIUM	A, E, H	When used as an excipient, permitted for use only in combination with other permitted ingredients as part of a flavour or a fragrance proprietary excipient formulation. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3557	OPOPANAX 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%.
3558	OPUNTIA FICUS-INDICA	A, H
3559	ORANGE	E
3560	ORANGE FLOWER 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%.
3561	ORANGE FLOWER OIL	A, E, H	When used internally, oxedrine is a mandatory component of orange flower oil. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.
3562	ORANGE JUICE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3563	ORANGE JUICE 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%.
3564	ORANGE OIL	A, E, H	When used internally, oxedrine is a mandatory component of orange oil. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.
3565	ORANGE OIL BITTER	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavor, the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance, the total fragrance concentration in a medicine must be no more 1%. The warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' or words to that effect must be include on the medicine label unless the medicine is: a) for internal use; b) in preparations containing 1.4% or less of orange oil bitter; c) for use in soaps or bath or shower gels that are washed off the skin.
3566	ORANGE OIL BITTER COLDPRESSED	A, E, H	When used internally, oxedrine is a mandatory component of orange oil bitter coldpressed. 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) for internal use; or b) in preparations containing 1.4% or less of orange oil bitter coldpressed; or c) for use in soaps or bath or shower gels that are washed off the skin.
3567	ORANGE OIL COLD PRESSED	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3568	ORANGE OIL DISTILLED	A, E, H	When used internally, oxedrine is a mandatory component of orange oil distilled. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.
3569	ORANGE OIL SWEET	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3570	ORANGE OIL TERPENELESS	A, E, H	When used internally, oxedrine is a mandatory component of orange oil terpeneless. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.
3571	ORANGE PEEL	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3572	ORANGE PEEL DRIED BITTER	A, E, H	When used internally, oxedrine is a mandatory component of orange peel dried bitter. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.
3573	ORANGE PEEL OIL SWEET TERPENELESS	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3574	ORANGE ROUGHY OIL	E	Only for use in topical medicines for dermal application.
3575	ORIGANUM MAJORANA	A, H	Arbutin is a mandatory component of Origanum majorana. The concentration of arbutin in the medicine must be no more than 25mg/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 plant preparation is oil or distillate and the concentration of Origanum majoranum oil or distillate within the medicine is greater than 50%: a) the nominal capacity of the container must be no more than 50 millilitre; b) a restricted flow insert must be fitted on the container; and c) the following warning statement is required on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect).
3576	ORIGANUM OIL	E	Permitted for use only in combination with other ingredients as a fragrance. If used as a fragrance the total concentration in the medicine must be no more than 1%.
3577	ORIGANUM OIL SPANISH	A, E, H
3578	ORIGANUM VULGARE	A, E, H
3579	ORNITHINE	A, E
3580	ORNITHINE ASPARTATE	A, E
3581	ORNITHINE MONOHYDROCHLORIDE	A, E
3582	ORNITHOGALUM UMBELLATUM	A, H
3583	OROSTACHYS FIMBRIATA	A, H
3584	OROXYLUM INDICUM	A, H
3585	ORRIS	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3586	ORRIS CONCRETE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3587	ORRIS ROOT EXTRACT	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3588	ORRIS ROOT OIL	A, E, H
3589	ORRIS ROOT RESIN	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3590	ORTHO-TERT-BUTYLCYCLOHEXYL 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%.
3591	ORTHOSIPHON ARISTATUS	A, H
3592	ORYZA SATIVA	A, E, H
3593	ORYZANOL	E
3594	OSBECKIA CHINENSIS	A, H
3595	OSMANTHUS 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%.
3596	OSMANTHUS FRAGRANS	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3597	OTTELIA ALISMOIDES	A, H
3598	OXACYCLOHEPTADEC-11-EN-2-ONE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3599	OXACYCLOHEXADECAN-2-ONE	E	Only for use in topical medicines for dermal application.
3600	OXACYCLOHEXADECEN-2-ONE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3601	OXALIC ACID	H	Only for use as an active homoeopathic ingredient.
3602	OXALIS ACETOSELLA	A, H
3603	OXIDISED MAIZE STARCH	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3604	OXIDISED TAPIOCA STARCH	E
3605	OXYBENZONE	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
3606	OYSTER	E
3607	OYSTER SHELL	A, E, H