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
2839	KADSURA COCCINEA	A, H
2840	KAEMPFERIA GALANGA	A, H
2841	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 %.
2842	KAOLIN	E
2843	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.
2844	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.
2845	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%.
2846	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%.
2847	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'.
2848	KIDNEY BEAN	E
2849	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%.
2850	KIWI FRUIT	E
2851	KNAUTIA ARVENSIS	A, H
2852	KOREAN GINSENG ROOT DRY	A, H
2853	KOREAN GINSENG ROOT POWDER	A, H
2854	KRAMERIA IXIENA	A, H
2855	KRAMERIA LAPPACEA	A, H
2856	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'.
2857	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%.
2858	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%.
2859	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%.
2860	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%.
2861	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%.
2862	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%.
2863	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%.
2864	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%.
2865	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%.
2866	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%.
2867	LABDANUM OIL	A, E, H
2868	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%.
2869	LACTALBUMIN	E
2870	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.
2871	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'.
2872	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'.
2873	LACTOBACILLUS ACIDOPHILUS	A
2874	LACTOBACILLUS AMYLOVORUS	A
2875	LACTOBACILLUS BREVIS	A
2876	LACTOBACILLUS CASEI	A
2877	LACTOBACILLUS CASEI SUBSP. BIOVAR CASEI	A
2878	LACTOBACILLUS CRISPATUS	A
2879	LACTOBACILLUS DELBRUECKII SSP BULGARICUS	A
2880	LACTOBACILLUS DELBRUECKII SSP LACTIS	A
2881	LACTOBACILLUS FERMENTUM	A
2882	LACTOBACILLUS GALLINARUM	A
2883	LACTOBACILLUS GASSERI	A
2884	LACTOBACILLUS HELVETICUS	A
2885	LACTOBACILLUS JOHNSONII	A
2886	LACTOBACILLUS KEFIRANOFACIENS	A
2887	LACTOBACILLUS KEFIRGRANUM	A
2888	LACTOBACILLUS KEFIRI	A
2889	LACTOBACILLUS PARACASEI	A
2890	LACTOBACILLUS PARACASEI SUBSP. PARACASEI	A
2891	LACTOBACILLUS PLANTARUM	A
2892	LACTOBACILLUS REUTERI	A
2893	LACTOBACILLUS RHAMNOSUS	A
2894	LACTOBACILLUS SALIVARIUS SSP SALICINIUS	A
2895	LACTOBACILLUS SALIVARIUS SSP SALIVARIUS	A
2896	LACTOBIONIC ACID	E	Only for use in topical medicines for dermal application.
2897	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%.
2898	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]’.
2899	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]’.
2900	LACTUCA SATIVA	A, H
2901	LACTUCA VIROSA	A, H
2902	LACTULOSE	E
2903	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.
2904	LAGENARIA VULGARIS	A, H
2905	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.
2906	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.
2907	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.
2908	LAMIUM ALBUM	A, H
2909	LANETH-5	E	Only for use in topical medicines for dermal application.
2910	LANOLIN ALCOHOL	E	Only for use in topical medicines for dermal application.
2911	LANOLIN OIL	E	Only for use in topical medicines for dermal application.
2912	LANOLIN WAX	E	Only for use in topical medicines for dermal application.
2913	LANTANA CAMARA	A, H	The maximum recommended daily dose must contain no more than 1mg of the equivalent dry herbal material of Lantana camara.
2914	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%.
2915	LARIX DECIDUA	A, H
2916	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.
2917	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'.
2918	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.
2919	LAURAMINE OXIDE	E
2920	LAUREL LEAF OIL	A, H
2921	LAURETH-10	E	Only for use in topical medicines for dermal application.
2922	LAURETH-12	E	Only for use in topical medicines for dermal application.
2923	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.
2924	LAURETH-23	E	Only for use in topical medicines for dermal application.
2925	LAURETH-3	E	Only for use in topical medicines for dermal application.
2926	LAURETH-4	E	Only for use in topical medicines for dermal application.
2927	LAURETH-7	E	Only for use in topical medicines for dermal application.
2928	LAURETH-8	E
2929	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.
2930	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%.
2931	LAUROMACROGOL 400	E	Only for use in topical medicines for dermal application.
2932	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%.
2933	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'.
2934	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%.
2935	LAURYL BETAINE	E	Only for use in topical medicines for dermal application.
2936	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%.
2937	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.
2938	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%.
2939	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%.
2940	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%.
2941	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.
2942	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.
2943	LAURYL PYRROLIDONE	E	Only for use in topical medicines for dermal application.
2944	LAURYLDIMONIUM HYDROXYPROPYL HYDROLYSED COLLAGEN	E	Only for use in topical medicines for dermal application.
2945	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%.
2946	LAURYLMETICONE COPOLYOL	E	Only for use in topical medicines for dermal application.
2947	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%.
2948	LAVANDIN OIL ABRIAL	A, E, H
2949	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%.
2950	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%.
2951	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%.
2952	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%.
2953	LAVENDER OIL	A, E, H
2954	LAWSONIA INERMIS	A, H
2955	LEAD	H	Only for use as an active homoeopathic ingredient. The concentration in the medicine must be no more than 0.001%.
2956	LEAD ACETATE	H	Only for use as an active homoeopathic ingredient.
2957	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%.
2958	LECITHIN	A, E
2959	LEDEBOURIELLA SESELOIDES	A, H
2960	LEDUM GROENLANDICUM	A, H
2961	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.
2962	LEMNA MINOR	A, H
2963	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.
2964	LEMON BALM LEAF DRY	A, H
2965	LEMON BALM LEAF POWDER	A, E, H
2966	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.
2967	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.
2968	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.
2969	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%.
2970	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.
2971	LEMONGRASS OIL	A, E, H
2972	LENS CULINARIS	A, H
2973	LENTIL	E
2974	LENTINULA EDODES	A, E, H
2975	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%.
2976	LEONURUS CARDIACA	A, E, H
2977	LEONURUS SIBIRICUS	A, E, H
2978	LEPIDIUM APETALUM	A, H
2979	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).
2980	LEPTOSPERMUM PETERSONII	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more 5%.
2981	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’
2982	LESPEDEZA CAPITATA	A, H
2983	LETTUCE	E
2984	LEUCINE	A, E
2985	LEUZEA UNIFLORUM	A, H
2986	LEVISTICUM OFFICINALE	A, H
2987	LEVOCARNITINE	A
2988	LEVOCARNITINE FUMARATE	A
2989	LEVOCARNITINE HYDROCHLORIDE	A
2990	LEVOCARNITINE MAGNESIUM CITRATE	A
2991	LEVOCARNITINE TARTRATE	A
2992	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)’.
2993	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).'
2994	LEVOTHYROXINE SODIUM	H	Only for use as an active homoeopathic ingredient.
2995	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%.
2996	LIGHT KAOLIN	E
2997	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.
2998	LIGHT MAGNESIUM OXIDE	A, E, H
2999	LIGUSTICUM SINENSE	A, H
3000	LIGUSTICUM STRIATUM	A, E, H
3001	LIGUSTRUM LUCIDUM	A, H
3002	LILIUM BROWNII	A, H
3003	LILIUM CANDIDUM	A, E, H
3004	LILIUM LANCIFOLIUM	A, H
3005	LILIUM LONGIFLORUM	A, H
3006	LIME FRUIT	E
3007	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%.
3008	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.
3009	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.
3010	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%.
3011	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%.
3012	LIME TREE FLOWER DRY	A, H
3013	LIME TREE FLOWER POWDER	A, H
3014	LIME, ESSENCE	E
3015	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%.
3016	LIMONENE	E	When for oral use, the quantity must be no more than 10 mg per maximum recommended daily dose.
3017	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%.
3018	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%.
3019	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%.
3020	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%.
3021	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%.
3022	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%.
3023	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%.
3024	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%.
3025	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%.
3026	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%.
3027	LINDERA STRYCHNIFOLIA	A, H
3028	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%.
3029	LINOLEIC ACID	E
3030	LINOLENIC ACID	E
3031	LINSEED DRY	A, E, H
3032	LINSEED OIL	A, E, H
3033	LINSEED POWDER	A, E, H
3034	LINUM USITATISSIMUM	A, E, H
3035	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.
3036	LIPPIA DULCIS	A, H
3037	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).
3038	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.
3039	LIQUIDAMBAR FORMOSANA	A, H
3040	LIQUIDAMBAR ORIENTALIS	A, H
3041	LIQUIDAMBAR STYRACIFLUA	A, E, H
3042	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%.
3043	LIQUIDAMBAR TAIWANIANA	A, H
3044	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%.
3045	LIQUORICE DRY	A, E, H
3046	LIQUORICE LIQUID EXTRACT	A, E, H
3047	LIQUORICE POWDER	A, E, H
3048	LITCHI CHINENSIS	A, H
3049	LITHIUM CARBONATE	H	Only for use as an active homoeopathic ingredient.
3050	LITHOSPERMUM OFFICINALE	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Lithospermum officinale.
3051	LITSEA CUBEBA	A, E, H
3052	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%.
3053	LOBARIA PULMONARIA	A, H
3054	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.
3055	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.
3056	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.
3057	LOLIUM PERENNE	A, H
3058	LOLIUM TEMULENTUM	A, H
3059	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%.
3060	LONICERA CAPRIFOLIUM	A, E, H
3061	LONICERA JAPONICA	A, E, H
3062	LONICERA PERICLYMENUM	A, H
3063	LOPHATHERUM GRACILE	A, H
3064	LOQUAT	E
3065	LORANTHUS PARASITICUS	A, H
3066	LOROPETALUM CHINENSIS	A, H
3067	LOTUS CORNICULATUS	A, H
3068	LOVAGE OIL	A, E, H
3069	LOVAGE ROOT DRY	A, H
3070	LOVAGE ROOT POWDER	A, H
3071	LUDWIGIA PROSTRATA	A, H
3072	LUFFA CYLINDRICA	A, H
3073	LUFFA PURGANS	A, H
3074	LUTEIN	A, E, H	When used as an excipient, permitted for use only as a colour in medicines limited to topical and oral routes of administration.
3075	LYCHEE	E
3076	LYCIUM BARBARUM	A, H
3077	LYCIUM CHINENSE	A, E, H
3078	LYCOPENE	A, E
3079	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.
3080	LYCOPODIUM ANNOTINUM	A, H
3081	LYCOPODIUM CLAVATUM	A, H
3082	LYCOPODIUM COMPLANATUM	A, H
3083	LYCOPUS EUROPAEUS	A, H
3084	LYCOPUS LUCIDUS	A, H
3085	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%.
3086	LYGODIUM JAPONICUM	A, H
3087	LYSIMACHIA CHRISTINAE	A, H
3088	LYSIMACHIA VULGARIS	A, H
3089	LYSINE	A, E
3090	LYSINE HYDROCHLORIDE	A, E
3091	LYTHRUM HYSSOPIFOLIA	A, H
3092	LYTHRUM SALICARIA	A, H
3093	LYTHRUM VERTICILLATUM	A, H
3094	MACADAMIA INTEGRIFOLIA	A, E
3095	MACADAMIA NUT	E
3096	MACADAMIA NUT OIL	E
3097	MACADAMIA TERNIFOLIA	A, E, H
3098	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%.
3099	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.
3100	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.
3101	MACROGOL 1000	E
3102	MACROGOL 1450	E	Only for use in topical medicines for dermal application.
3103	MACROGOL 1500	E
3104	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%.
3105	MACROGOL 200	E	Only for use in topical medicines for dermal application.
3106	MACROGOL 20000	E
3107	MACROGOL 300	E
3108	MACROGOL 3000	E
3109	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.
3110	MACROGOL 40	E	Only for use in topical medicines for dermal application.
3111	MACROGOL 400	E
3112	MACROGOL 4000	E
3113	MACROGOL 45000	E	Only for use in topical medicines for dermal application.
3114	MACROGOL 600	E
3115	MACROGOL 6000	E
3116	MACROGOL 600000	E
3117	MACROGOL 800	E
3118	MACROGOL 8000	E
3119	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%.
3120	MACROGOL POLY(VINYL ALCOHOL) GRAFTED POLYMER	E	Only for use in oral medicines. The concentration in the medicine must be no more than 5%.
3121	MACROPIPER EXCELSUM VAR EXCELSUM	A, H
3122	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.
3123	MAGNESIUM ASCORBATE	A, E, H
3124	MAGNESIUM ASCORBATE MONOHYDRATE	A, E, H
3125	MAGNESIUM ASCORBYL PHOSPHATE	E	Only for use in topical medicines for dermal application.
3126	MAGNESIUM ASPARTATE	A, E, H
3127	MAGNESIUM ASPARTATE DIHYDRATE	A, E, H
3128	MAGNESIUM ASPARTATE TETRAHYDRATE	A, E, H
3129	MAGNESIUM CARBONATE HYDRATE	A, E, H
3130	MAGNESIUM CHLORIDE 4.5-HYDRATE	A
3131	MAGNESIUM CHLORIDE HEXAHYDRATE	A, E, H
3132	MAGNESIUM CITRATE	A, E, H
3133	MAGNESIUM CITRATE NONAHYDRATE	A, E, H
3134	MAGNESIUM CITRATE TETRADECAHYDRATE	A, E, H
3135	MAGNESIUM DIGLUTAMATE	A, E, H
3136	MAGNESIUM GLUCONATE	A, E, H
3137	MAGNESIUM GLYCEROPHOSPHATE	A, E, H
3138	MAGNESIUM GLYCINATE	A	Only for use in oral medicines.
3139	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.
3140	MAGNESIUM HYDROGEN PHOSPHATE	H
3141	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, the following warning statements are required on the label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]' - (LAX4) 'This product may have laxative effect'.
3142	MAGNESIUM LYSINATE	A	Only for use in oral medicines.
3143	MAGNESIUM METHIONINATE	A	Only for use in oral medicines.
3144	MAGNESIUM NITRATE	E	Only for use in topical medicines for dermal application.
3145	MAGNESIUM OROTATE	A, E, H
3146	MAGNESIUM OROTATE DIHYDRATE	A, E, H
3147	MAGNESIUM OXIDE	A, E, H
3148	MAGNESIUM PHOSPHATE PENTAHYDRATE	A, E, H
3149	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.
3150	MAGNESIUM PYRUVATE	A	Only for use in oral medicines. The maximum recommended daily dose must be no more than 7 grams.
3151	MAGNESIUM STEARATE	E
3152	MAGNESIUM SULFATE DIHYDRATE	A, E, H	When used internally, the maximum recommended daily dose must be no more than 1.5g.
3153	MAGNESIUM SULFATE HEPTAHYDRATE	A, E, H	When used internally, the maximum recommended daily dose must be no more than 1.5g.
3154	MAGNESIUM SULFATE MONOHYDRATE	A, E, H	When used internally, the maximum recommended daily dose must be no more than 1.5g.
3155	MAGNESIUM SULFATE TRIHYDRATE	A, E, H	When used internally, the maximum recommended daily dose must be no more than 1.5g.
3156	MAGNESIUM TRISILICATE	E
3157	MAGNOLIA GLAUCA	A, H
3158	MAGNOLIA LILIFLORA	A, H
3159	MAGNOLIA OBOVATA	A, H
3160	MAGNOLIA OFFICINALIS	A, E, H
3161	MAGNOLIA SALICIFOLIA	A, H
3162	MAIZE	E
3163	MAIZE BRAN	E
3164	MAIZE OIL	A, E, H
3165	MAIZE STARCH	A, E, H
3166	MALACHITE GREEN	E	Permitted for use only as a colour for topical use.
3167	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.
3168	MALPIGHIA GLABRA	A, E, H
3169	MALT EXTRACT	E
3170	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]’.
3171	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).
3172	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.
3173	MALTOL	E
3174	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%.
3175	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).
3176	MALUS DOMESTICA	A, E, H	The concentration of amygdalin in the medicine must be no more than 0%.
3177	MALUS PUMILA	A, E, H	A medicine that contains the ingredient must not be listed in the Register on or after 2 March 2020 or be supplied after 2 March 2021.
3178	MALUS SYLVESTRIS	A, H
3179	MALVA MOSCHATA	A, H
3180	MALVA SYLVESTRIS	A, E, H
3181	MALVA VERTICILLATA	A, H
3182	MANDARIN	E
3183	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%.
3184	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.
3185	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%.
3186	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%.
3187	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%.
3188	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%.
3189	MANGANESE	H	Only for use as an active homoeopathic ingredient.
3190	MANGANESE (II) DIASPARTATE	A, H	Only for use in oral medicines.
3191	MANGANESE (II) GLYCINATE	A, H	Only for use in oral medicines.
3192	MANGANESE ACETATE TETRAHYDRATE	H	Only for use as an active homoeopathic ingredient.
3193	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.
3194	MANGANESE CHLORIDE TETRAHYDRATE	A, E, H
3195	MANGANESE DIASPARTATE	A, E, H	Only for use in oral medicines.
3196	MANGANESE GLUCONATE	A, E, H
3197	MANGANESE GLYCEROPHOSPHATE	A, E, H
3198	MANGANESE OXIDE	A, E, H
3199	MANGANESE SULFATE MONOHYDRATE	A, E, H
3200	MANGANESE SULFATE TETRAHYDRATE	A, E, H
3201	MANGIFERA INDICA	A, E, H
3202	MANGO	E, H
3203	MANIHOT ESCULENTA	A, H
3204	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).
3205	MARANTA ARUNDINACEA	A, H
3206	MARINE SPONGE	H	Only for use as an active homoeopathic ingredient.
3207	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).
3208	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).
3209	MARRUBIUM VULGARE	A, E, H
3210	MARSDENIA CUNDURANGO	A, H
3211	MARSHMALLOW ROOT DRY	A, H
3212	MARSHMALLOW ROOT POWDER	A, H
3213	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%.
3214	MASTIC	A, H
3215	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%.
3216	MATRICARIA CHAMOMILLA	A, E, H
3217	MATRICARIA FLOWER DRY	A, E, H
3218	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. The following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect). When for use in topical medicines for dermal application i) the concentration of methyl salicylate in the medicine must not be more than 25% ii) 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); - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect); iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label: - (IRRIT) 'If irritation develops, discontinue use'.
3219	MECOBALAMIN (CO-METHYLCOBALAMIN)	A	Only for use in oral medicines.
3220	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.
3221	MEDIUM CHAIN TRIGLYCERIDES	E
3222	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.
3223	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.
3224	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.
3225	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.
3226	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.
3227	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.
3228	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.
3229	MELICOPE PTELEIFOLIA	A, H
3230	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%.
3231	MELISSA OFFICINALIS	A, E, H
3232	MELON	E
3233	MENADIONE SODIUM BISULFITE	E
3234	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.
3235	MENISPERMUM CANADENSE	A, H
3236	MENTHA AQUATICA	A, H	Menthol is a mandatory component of Mentha aquatica. 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 statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, 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. (v) 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, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3237	MENTHA ARVENSIS	A, E, H	Menthol is a mandatory component of Mentha arvensis. 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 statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, 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. (v) 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, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3238	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%. Menthol is a mandatory component of Mentha arvensis leaf oil. 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 statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, 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. (v) 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, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3239	MENTHA ARVENSIS OIL	E	Permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must not be more than 5%. Menthol is a mandatory component of Mentha arvensis oil. 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 is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, 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. (v) 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, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3240	MENTHA HAPLOCALYX	A, E, H	Menthol is a mandatory component of Mentha haplocalyx. 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 statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, 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. (v) 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, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3241	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 statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). e) if the medicine delivers more than 1% total menthol when administered according to the directions for use, 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. f) 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.
3242	MENTHA SPICATA	A, E, H	Menthol is a mandatory component of Mentha spicata. 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 statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, 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. (v) 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, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3243	MENTHA X CARDIACA	A, E, H	Menthol is a mandatory component of Mentha x cardiaca. 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 statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, 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. (v) 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, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3244	MENTHA X PIPERITA	A, E, H	Menthol is a mandatory component of Mentha x piperita. 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 statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, 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. (v) 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, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3245	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%.
3246	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%.
3247	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%.
3248	MENTHOL	A, E	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 statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, 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. (v) 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, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3249	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%.
3250	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%.
3251	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%.
3252	MENTHOXYPROPANEDIOL	E	For oral use only. The concentration in the medicine must be no more than 0.04%.
3253	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%.
3254	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%.
3255	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 not be more than 5%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
3256	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%.
3257	MENTHYL LACTATE	E
3258	MENYANTHES TRIFOLIATA	A, H
3259	MERCURIC CHLORIDE	H	Only for use as an active homoeopathic ingredient.
3260	MERCURY	H	Only for use as an active homoeopathic ingredient.
3261	MESPILUS GERMANICA	A, H
3262	METACRESOL	E	Only for use in topical medicines for dermal application.
3263	METHACRYLIC ACID COPOLYMER	E	Only for use in oral medicines.
3264	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%.
3265	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%.
3266	METHIONINE	A, E
3267	METHYL 2,6,6-TRIMETHYLCYCLOHEX-2-ENE-1-CARBOXYLATE	E	Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
3268	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%.
3269	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%.
3270	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%.
3271	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%.
3272	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%.
3273	METHYL ACETYL RICINOLEATE	E	Only for use in topical medicines for dermal application.
3274	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%.
3275	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%.
3276	METHYL BENZOATE	E	Only for use in topical medicines for dermal application.
3277	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%.
3278	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%.
3279	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%.
3280	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%.
3281	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%.
3282	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%.
3283	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%.
3284	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%.
3285	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%.
3286	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%.
3287	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%.
3288	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%.
3289	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%.
3290	METHYL ETHER	E	Only for use in topical medicines for dermal application.
3291	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%.
3292	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%.
3293	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%.
3294	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.
3295	METHYL GLUCETH-20	E	Only for use in topical medicines for dermal application.
3296	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%.
3297	METHYL GLUCETH-20 SESQUIHYDRATE	E	Only for use in topical medicines for dermal application.
3298	METHYL GLUCOSE DIOLEATE	E	Only for use in topical medicines for dermal application.
3299	METHYL GLUCOSE SESQUIOLEATE	E	Only for use in topical medicines for dermal application.
3300	METHYL GLUCOSE SESQUISTEARATE	E	Only for use in topical medicines for dermal application.
3301	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%.
3302	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%.
3303	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%.
3304	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%.
3305	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%.
3306	METHYL HYDROGENATED ROSINATE	E	Only for use in topical medicines for dermal application.
3307	METHYL HYDROJASMONATE	E	Only for use in topical medicines for dermal application.
3308	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.
3309	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%.
3310	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%.
3311	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%.
3312	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%.
3313	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%.
3314	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%.
3315	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%.
3316	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%.
3317	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%.
3318	METHYL METHACRYLATE	E
3319	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%.
3320	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%.
3321	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%.
3322	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%.
3323	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%.
3324	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%.
3325	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%.
3326	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%.
3327	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%.
3328	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%.
3329	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%.
3330	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%.
3331	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%.
3332	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%.
3333	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. The following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect). When for use in topical medicines for dermal application: i) the concentration of methyl salicylate in the medicine must not be more than 25%; ii) 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); - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect); iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label: - (IRRIT) 'If irritation develops, discontinue use'.
3334	METHYL STEARATE	E
3335	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%.
3336	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%.
3337	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%.
3338	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%.
3339	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%.
3340	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%.
3341	METHYLCELLULOSE	A, E
3342	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%.
3343	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%.
3344	METHYLDIBROMO GLUTARONITRILE	E	Only for use in topical medicines for dermal application.
3345	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 not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
3346	METHYLISOTHIAZOLINONE	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%.
3347	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%.
3348	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%.
3349	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%.
3350	METHYLSTYRENE/VINYLTOLUENE COPOLYMER	E	Only for use in topical medicines for dermal application.
3351	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%.
3352	MICROCALICIUM ARENARIUM	A, H
3353	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%.
3354	MICROCOS PANICULATA	A, H
3355	MICROCRYSTALLINE CELLULOSE	E
3356	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'.
3357	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%.
3358	MILK THISTLE FRUIT DRY	A, H
3359	MILK THISTLE FRUIT POWDER	A, H
3360	MILLET	E
3361	MILLETTIA DIELSIANA	A, H
3362	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%.
3363	MIMULUS GUTTATUS	A, H
3364	MINT OIL DEMENTHOLISED	A, E, H	Menthol is a mandatory component of mint oil dementholised. 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 statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, 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. (v) 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, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3365	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%.
3366	MITCHELLA REPENS	A, H
3367	MIXED (HIGH-ALPHA TYPE) TOCOPHEROLS CONCENTRATE	A, E
3368	MIXED (LOW-ALPHA TYPE) TOCOPHEROLS CONCENTRATE	A, E
3369	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%.
3370	MODIFIED FOOD STARCH	E
3371	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%.
3372	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.
3373	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.
3374	MOMORDICA BALSAMINA	A, H
3375	MOMORDICA CHARANTIA	A, H
3376	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.
3377	MONARDA DIDYMA	A, H
3378	MONO- AND DI- GLYCERIDES	E
3379	MONOBASIC AMMONIUM PHOSPHATE	E	Only for use in topical medicines for dermal application.
3380	MONOBASIC CALCIUM PHOSPHATE	A, E, H
3381	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.
3382	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).'
3383	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).
3384	MONOETHANOLAMINE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%.
3385	MONOPHOSPHOTHIAMINE	A
3386	MONOPHOSPHOTHIAMINE DIHYDRATE	A
3387	MONOPOTASSIUM GLUTAMATE	A, E
3388	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).’
3389	MONOSODIUM GLUTAMATE MONOHYDRATE	A, E
3390	MONSTERA DELICIOSA	A, H
3391	MONTAN WAX	E
3392	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%..
3393	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).
3394	MORINDA OFFICINALIS	A, H
3395	MORINGA OLEIFERA	A, H
3396	MORUS ALBA	A, H
3397	MORUS BOMBYCIS	A, H
3398	MORUS NIGRA	A, E, H
3399	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%.
3400	MOTHERWORT HERB DRY	A, H
3401	MOTHERWORT HERB POWDER	A, H
3402	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%.
3403	MULBERRY	E
3404	MUNG BEAN	E
3405	MURRAYA KOENIGII	A, H
3406	MURRAYA PANICULATA	A, H
3407	MUSA X PARADISIACA	A, H
3408	MUSK KETONE	E	Only for use in topical medicines for dermal application.
3409	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%.
3410	MUSK XYLOL	E	Only for use in topical medicines for dermal application.
3411	MUSKS	H	Only for use as an active homoeopathic ingredient.
3412	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%.
3413	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%.
3414	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%.
3415	MYOSOTIS ARVENSIS	A, H
3416	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%.
3417	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%.
3418	MYRICA CERIFERA	A, E, H
3419	MYRISTIC ACID	E
3420	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%.
3421	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).
3422	MYRISTYL ALCOHOL	E	Only for use in topical medicines for dermal application.
3423	MYRISTYL LACTATE	E	Only for use in topical medicines for dermal application.
3424	MYRISTYL MYRISTATE	E	Only for use in topical medicines for dermal application.
3425	MYROXYLON BALSAMUM	A, E, H
3426	MYROXYLON BALSAMUM VAR. PEREIRAE	A, H
3427	MYRRH	A, H
3428	MYRRH OIL	A, E, H
3429	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%.
3430	MYRRHIS ODORATA	A, H
3431	MYRSINE AFRICANA	A, H
3432	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%.
3433	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%.
3434	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%.
3435	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%.
3436	MYRTUS COMMUNIS	A, E, H
3437	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%.
3438	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%.
3439	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%.
3440	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%.
3441	NAPHTHALENE	H	Only for use as an active homoeopathic ingredient.
3442	NARDOSTACHYS CHINENSIS	A, H
3443	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%.
3444	NASTURTIUM OFFICINALE	A, E, H
3445	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.
3446	NAUCLEA OFFICINALIS	A, H
3447	NELUMBO NUCIFERA	A, H
3448	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%.
3449	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%
3450	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%.
3451	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%.
3452	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%.
3453	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.
3454	NEOPENTYL GLYCOL DIOCTANOATE/DIDECANOATE	E	Only for use in topical medicines for dermal application.
3455	NEOPICRORHIZA SCROPHULARIIFLORA	A, H
3456	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%.
3457	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%.
3458	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%.
3459	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%.
3460	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%.
3461	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%.
3462	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%.
3463	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%.
3464	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%.
3465	NICKEL	H	Only for use as an active homoeopathic ingredient.
3466	NICOTIANA TABACUM	H	Only for use as an active homoeopathic ingredient.
3467	NICOTINAMIDE	A, E, H
3468	NICOTINAMIDE ASCORBATE	A, E
3469	NICOTINAMIDE RIBOSIDE CHLORIDE	A	Only to be used in a medicine where Chromadex Inc (Client ID 68566), 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 02 December 2021. Ribose is a mandatory component of Nicotinamide riboside chloride. Only permitted for use in medicines limited to oral routes of administration. The maximum recommended daily dose of the medicine must not contain more than 300mg of Nicotinamide riboside chloride. The following warning statement is required on the medicine label: - (CHILD3) ‘Not for use in children under the age of 12’. When the maximum recommended daily dose of the medicine provides greater than 230mg of nicotinamide riboside chloride, the following warning statement is required on the medicine label: - (PREG) ‘Not recommended for use during pregnancy or lactation’.
3470	NICOTINIC ACID	A, E	The medicine must contain no more than 100 mg of nicotinic acid per dosage unit.
3471	NIGELLA DAMASCENA	A, H
3472	NIGELLA SATIVA	A, E, H
3473	NITRIC ACID	E, H	The concentration of nitric acid in the medicine must be no more than 0.5%.
3474	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%.
3475	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%.
3476	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%.
3477	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).
3478	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%.
3479	NONOXINOL 10	E	Only for use in topical medicines for dermal application.
3480	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%.
3481	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%.
3482	NONOXINOL 9	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 25%.
3483	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%.
3484	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%.
3485	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%.
3486	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%.
3487	NOTOPTERYGIUM FORBESII	A, H
3488	NOTOPTERYGIUM INCISIUM	A, H
3489	NUPHAR JAPONICA	A, H
3490	NUPHAR LUTEA	A, H
3491	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%.
3492	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).
3493	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%.
3494	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%.
3495	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%.
3496	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: i) the concentration of methyl salicylate in the medicine must not be more than 25% ii) 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); - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect); iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label: - (IRRIT) 'If irritation develops, discontinue use'.
3497	NYLON	E	Only for use in topical medicines for dermal application.
3498	NYLON 6/12	E	Only for use in topical medicines for dermal application.
3499	NYLON-12	E	Only for use in topical medicines for dermal application.
3500	NYMPHAEA ALBA	A, E, H
3501	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.
3502	NYMPHAEA ODORATA	A, H
3503	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%.
3504	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%.
3505	OAT	E, H	Only for use as an active homoeopathic or excipient ingredient. Gluten is a mandatory component of Oat when the route of administration is other than topical and mucosal.
3506	OAT BRAN	E	Gluten is a mandatory component of Oat bran when the route of administration is other than topical and mucosal.
3507	OATMEAL COLLOIDAL	A, E	Gluten is a mandatory component of Oatmeal colloidal when the route of administration is other than topical and mucosal.
3508	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%.
3509	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%.
3510	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%.
3511	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.
3512	OCIMUM MINIMUM	A, H
3513	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%.
3514	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%.
3515	OCTACOSANOL	E
3516	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%.
3517	OCTADECENE/MA COPOLYMER	E	Only for use in topical medicines for dermal application.
3518	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%.
3519	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%.
3520	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%.
3521	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%.
3522	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%.
3523	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%.
3524	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%.
3525	OCTHILINONE	E	Only for use in topical medicines for dermal application.
3526	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 not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
3527	OCTOXINOL 10	E	Only for use in topical medicines for dermal application.
3528	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%.
3529	OCTYL HYDROXYSTEARATE	E	Only for use in topical medicines for dermal application.
3530	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%.
3531	OCTYL ISONONANOATE	E	Only for use in topical medicines for dermal application.
3532	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 not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
3533	OCTYL PALMITATE	E	Only for use in topical medicines for dermal application.
3534	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 not be more than 5%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
3535	OCTYL STEARATE	E	Only for use in topical medicines for dermal application.
3536	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).
3537	OCTYLDODECANOL	E	Only for use in topical medicines for dermal application.
3538	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.
3539	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%.
3540	OCTYLDODECYL NEOPENTANOATE	E	Only for use in topical medicines for dermal application.
3541	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%.
3542	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%.
3543	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%.
3544	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.
3545	OENANTHE CROCATA	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material.
3546	OENOTHERA BIENNIS	A, E, H
3547	OENOTHERA STRICTA	A, H
3548	OKOUBAKA AUBREVILLEI	A, H
3549	OLDENLANDIA DIFFUSA	A, E, H
3550	OLEA EUROPAEA	A, E, H
3551	OLEIC ACID	E
3552	OLETH-10	E	Only for use in topical medicines for dermal application.
3553	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%.
3554	OLETH-20	E	Only for use in topical medicines for dermal application.
3555	OLETH-3	E	Only for use in topical medicines for dermal application.
3556	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%.
3557	OLETH-5	E	Only for use in topical medicines for dermal application.
3558	OLEYL ALCOHOL	E	Only for use in topical medicines for dermal application.
3559	OLIBANUM OIL	A, E, H
3560	OLIGOFRUCTOSE	A, E
3561	OLIVE	E
3562	OLIVE OIL	A, E, H
3563	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).'
3564	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).
3565	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).
3566	ONION	E
3567	ONION OIL	A, H
3568	ONONIS SPINOSA	A, E, H
3569	ONOPORDUM ACANTHIUM	A, H
3570	ONOSMODIUM VIRGINIANUM	A, H
3571	OPHIOPOGON JAPONICUS	A, H
3572	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%.
3573	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%.
3574	OPUNTIA FICUS-INDICA	A, H
3575	ORANGE	E
3576	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%.
3577	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.
3578	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%.
3579	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%.
3580	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.
3581	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.
3582	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.
3583	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%.
3584	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.
3585	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%.
3586	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.
3587	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%.
3588	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.
3589	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%.
3590	ORANGE ROUGHY OIL	E	Only for use in topical medicines for dermal application.
3591	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).
3592	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%.
3593	ORIGANUM OIL SPANISH	A, E, H
3594	ORIGANUM VULGARE	A, E, H
3595	ORNITHINE	A, E
3596	ORNITHINE ASPARTATE	A, E
3597	ORNITHINE MONOHYDROCHLORIDE	A, E
3598	ORNITHOGALUM UMBELLATUM	A, H
3599	OROSTACHYS FIMBRIATA	A, H
3600	OROXYLUM INDICUM	A, H
3601	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%.
3602	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%.
3603	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%.
3604	ORRIS ROOT OIL	A, E, H
3605	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%.
3606	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%.
3607	ORTHOSIPHON ARISTATUS	A, H
3608	ORYZA SATIVA	A, E, H
3609	ORYZANOL	E
3610	OSBECKIA CHINENSIS	A, H
3611	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%.
3612	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%.
3613	OTTELIA ALISMOIDES	A, H
3614	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%.
3615	OXACYCLOHEXADECAN-2-ONE	E	Only for use in topical medicines for dermal application.
3616	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%.
3617	OXALIC ACID	H	Only for use as an active homoeopathic ingredient.
3618	OXALIS ACETOSELLA	A, H
3619	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%.
3620	OXIDISED TAPIOCA STARCH	E
3621	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 not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
3622	OYSTER	E
3623	OYSTER SHELL	A, E, H