Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2019 (Cth)

Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2019

I, Michael Shum, as delegate of the Minister for Health, make the following determination.

Dated 18 April 2019

Michael Shum

Acting Assistant Secretary

Complementary and Over the Counter Medicines Branch

Health Products Regulation Group

Department of Health

Contents

1 Name........................................................................................................................................ 1
2 Commencement........................................................................................................................ 1
3 Authority.................................................................................................................................. 1
4 Interpretation............................................................................................................................ 1
5 Permissible ingredients............................................................................................................. 2
6 Requirements in relation to permissible ingredients being contained in medicine..................... 2
7 Repeals..................................................................................................................................... 3

Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine 4

Schedule 2¾Repeals 1047

Note: This instrument is in 6 volumes:

Volume 1: Sections 1–7 (pages 1-3)

Schedule 1 (1,7,7-TRIMETHYLBICYCLO(2.2.1)HEPT-2-YL)-CYCLOHEXANOL)–AZULENE (pages 4-121)

Volume 2: Schedule 1 BACKHOUSIA CITRIODORA)–EVERNIA PRUNASTRA EXTRACT (pages 122-380)

Volume 3: Schedule 1 FABIANA IMBRICATA–JUSTICIA ADHATODA
(pages 381-531)

Volume 4: Schedule 1 KADSURA COCCINEA–OYSTER SHELL (pages 532-700)

Volume 5: Schedule 1 P-ALPHA-DIMETHYL STYRENE–TYROSINE
(pages 701-1005)

Volume 6: Schedule 1 UBIDECARENONE–ZUCCHINI (pages 1006-1046)

Schedule 2 (page 1047)

1 Name

This instrument is the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2019.

2 Commencement

(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. The whole of this instrument	The day after this instrument is registered.

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

This instrument is made under subsection 26BB(1) of the Therapeutic Goods Act 1989.

4 Interpretation

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) British Pharmacopoeia;

(b) European Pharmacopoeia;

(c) medicine;

(d) Register; and

(e) United States Pharmacopeia-National Formulary.

(1) In this instrument:

Act means the Therapeutic Goods Act 1989.

active ingredient, or A, for a medicine, has the same meaning as in the Regulations.

code tables means the tables accessed via the Code Tables item in the Public TGA Information menu in TGA eBusiness Services.

excipient or E, for a medicine, means an ingredient that is not an active ingredient or a homoeopathic preparation ingredient.

Note: An excipient includes an ingredient that provides flavour, fragrance or colour to the medicine.

homoeopathic preparation has the same meaning as in the Regulations.

homoeopathic preparation ingredient or H, means an ingredient that is a constituent of a homoeopathic preparation.

Regulations means the Therapeutic Goods Regulations 1990.

TGA eBusiness Services means TGA eBusiness Services on the Therapeutic Goods Administration website which may be accessed on the internet at Goods Administration has the same meaning as in the Regulations.

(2) To avoid doubt, the terms set out in closed brackets in column 4 of the table in Schedule 1 to this instrument, which are associated with warning statements in relation to particular ingredients, are:

(a) terms from the code tables under the headings Indications or Product Warning; and

(b) not required to be reproduced in a warning statement on the label of a medicine.

Note: Examples of these terms include the following:

(a) (ARGIN1);

(b) (CHILD3);

(c) (GLUTEN);

(d) (PEANUT); and

(e) (PREGNT).

5 Permissible ingredients

The ingredients specified in column 2 of the table in Schedule 1 to this instrument are specified for the purposes of paragraph 26BB(1)(a) of the Act.

6 Requirements in relation to permissible ingredients being contained in medicine

For an ingredient mentioned in column 2 of an item in the table in Schedule 1 to this instrument, the following requirements are specified for the purposes of paragraph 26BB(1)(b) of the Act:

(a) the ingredient must only be used in a medicine for a purpose specified in relation to the ingredient in column 3 of that item;

(b) the ingredient must comply with the requirements specified in relation to the ingredient in column 4 of that item;

(c) if the ingredient is derived from animal origin¾the safety of the ingredient must have been assessed against, and comply with, the principles and requirements in the European Pharmacopoeia general monograph 1483 Products with risk of transmitting agents of animal spongiform encephalopathies, including General Text 5.2.8: Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products.

7 Repeals

Each instrument that is specified in Schedule 2 to this instrument is repealed as set out in the applicable items in that Schedule.

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
1	(1,7,7-TRIMETHYLBICYCLO(2.2.1)HEPT-2-YL)-CYCLOHEXANOL	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%.
2	(1R,2S,5R)-N-(4-METHOXYPHENYL)-5-METHYL-2-(1-METHYLETHYL) CYCLOHEXANECARBOXAMIDE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in the medicine must be no more than 5%.
3	(5E)-3-METHYL-5-CYCLOTETRADECEN-1-ONE	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%.
4	(5Z)-3-METHYL-5-CYCLOTETRADECEN-1-ONE	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%.
5	(E)-2-(3,5-DIMETHYLHEX-3-EN-2-YLOXY)-2-METHYLPROPYL CYCLOPROPANECARBOXYLATE	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%.
6	(E)-3-METHYLCYCLOPENTADEC-5-EN-1-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%.
7	(E, E)-2,6-NONADIENAL	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%.
8	(S)-LACTIC ACID	A, E, H
9	(S)-S-ADENOSYLMETHIONINE DISULFATE DITOSYLATE DIHYDRATE	A	(S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine disulfate ditosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
10	(S)-S-ADENOSYLMETHIONINE DISULFATE TOSYLATE	A	(S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine disulfate tosylate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
11	(S)-S-ADENOSYLMETHIONINE DISULFATE TRITOSYLATE DIHYDRATE	A	(S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine disulfate tritosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
12	(S)-S-ADENOSYLMETHIONINE HEXASULFATE DIHYDRATE	A	(S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine hexasulfate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
13	(S)-S-ADENOSYLMETHIONINE HEXATOSYLATE DIHYDRATE	A	(S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine hexatosylate dihydrate and must be declared in the application. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
14	(S)-S-ADENOSYLMETHIONINE PENTASULFATE DIHYDRATE	A	(S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine pentasulfate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: -(SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
15	(S)-S-ADENOSYLMETHIONINE PENTATOSYLATE DIHYDRATE	A	(S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine pentatosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
16	(S)-S-ADENOSYLMETHIONINE TETRASULFATE DIHYDRATE	A	(S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine tetrasulfate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
17	(S)-S-ADENOSYLMETHIONINE TETRATOSYLATE DIHYDRATE	A	(S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine tetratosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
18	(S)-S-ADENOSYLMETHIONINE TRISULFATE DITOSYLATE DIHYDRATE	A	(S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine trisulfate ditosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
19	(Z)-HEX-3-ENYL 2-ETHYLBUTYRATE	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%.
20	(Z, Z)-3,6-NONADIEN-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%.
21	(±)-NARINGENIN	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%.
22	1,1,1-TRICHLOROETHANE	E	The concentration in the medicine must be no more than 25%.
23	1,2-HEXANEDIOL	E	Only for use in topical medicines for dermal application and not to be included in topical products intended for use in the eye. The concentration in the medicine must be no more than 1%.
24	1,3,4,6,7,8A-HEXAHYDRO-1,1,5,5-TETRAMETHYL-2H-2,4A-METHANONAPHTHALEN-8(5H)-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%.
25	1,3,5-UNDECATRIENE	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%.
26	1,3-BUTYLENE GLYCOL	E
27	1,3-NONANEDIOL ACETATE, MIXED ESTERS	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%.
28	1,3-NONANEDIOL, DIACETATE	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%.
29	1,4-CINEOLE	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%
30	1,4-DIOXACYCLOHEXADECANE-5,16-DIONE	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%.
31	1,5,9-TRIMETHYL-13-OXABICYCLO[10.1.0]TRIDECA-4,8-DIENE	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%.
32	1,7,7-TRIMETHYLBICYCLO[4.4.0]DECAN-3-YL 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%.
33	1-(2,2,6-TRIMETHYLCYCLOHEXYL)-3-HEXANOL	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%.
34	1-(2,6,6-TRIMETHYL-2-CYCLOHEXEN-1-YL)-1-PENTEN-3-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%.
35	1-(3,3-DIMETHYLCYCLOHEXYL)ETHYL FORMATE	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%.
36	1-(4-ISOPROPYLCYCLOHEXYL)ETHANOL	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%.
37	1-(5,5-DIMETHYL-1-CYCLOHEXEN-1-YL)-4-PENTEN-1-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%.
38	1-DODECANOL	E	Permitted for use: (a) only in combination with other permitted ingredients as a flavour; and (b) in topical medicines for dermal application. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
39	1-HEPTANOL	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%.
40	1-HEXEN-3-OL	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%.
41	1-METHOXY-4-PROPENYLBENZENE	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%.
42	1-METHYL-2-[(1,2,2-TRIMETHYLBICYCLO[3.1.0]HEX-3-YL)METHYL]-CYCLOPROPANEMETHANOL	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%.
43	1-METHYL-3-(2-METHYLPROPYL)-CYCLOHEXANOL	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%.
44	1-METHYL-4-(4-METHYL-3-PENTENYL)-3-CYCLOHEXENE-1-CARBOXALDEHYDE	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%.
45	1-OCTEN-3-ONE	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%.
46	1-P-MENTHENE-8-THIOL	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%.
47	1-PENTEN-3-OL	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%.
48	10-UNDECEN-1-OL	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%.
49	10-UNDECENAL	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%.
50	16-HYDROXY-12-OXAHEXADECANOIC ACID, OMEGA-LACTONE	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%.
51	2,2,3-TRIMETHYLCYCLOPENT-3-ENE-1-ETHYL 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%.
52	2,2,5-TRIMETHYL-5-PENTYLCYCLOPENTANONE	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%.
53	2,2-DIMETHYL-3-(3-METHYL-2,4-PENTADIENYL)-OXIRANE	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%.
54	2,2-DIMETHYL-3-PHENYLPROPANOLL	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%.
55	2,2-DIMETHYL-5-(1-METHYLPROPEN-1-YL) TETRAHYDROFURAN	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%.
56	2,2-DIMETHYL-P-ETHYLPHENYL-PROPANENITRILE	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%.
57	2,3,4-TRIMETHYL-3-PENTANOL	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%.
58	2,3,5,6-TETRAMETHYLPYRAZINE	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%.
59	2,3,5-TRIMETHYLPYRAZINE	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%.
60	2,3-DIETHYLPYRAZINE	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%.
61	2,3-DIHYDRO-1,1-DIMETHYL-1H-INDENE-AR-PROPANAL	E	Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient. The total fragrance proprietary excipient formulation concentration in a medicine must not be more than 1%.
62	2,3-DIHYDRO-2,5-DIMETHYL-1H-INDENE-2-METHANOL	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%.
63	2,3-DIMETHYLPYRAZINE	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%.
64	2,3-HEXADIONE	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%.
65	2,3-HEXANEDIONE	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%.
66	2,3-PENTANEDIONE	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%.
67	2,4,5-TRIMETHYLTHIAZOLE	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%.
68	2,4,6-TRIMETHYL-4-PHENYL-1,3-DIOXANE	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%.
69	2,4-DECADIENAL	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 the medicine must be no more than 1%. The maximum daily dose must provide no more than 3 mg of 2,4-Decadienal.
70	2,4-DIMETHYL BUTADIENEACROLEIN	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%.
71	2,4-DIMETHYL THIAZOLE	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%.
72	2,4-DIMETHYL-3-CYCLOHEXENE CARBOXALDEHYDE	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%.
73	2,4-DIMETHYL-4,4A,5,9B-TETRAHYDROINDENO[1,2-D]-1,3-DIOXIN	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%.
74	2,4-DIMETHYL-4-PHENYL TETRAHYDROFURAN	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%.
75	2,4-HEPTADIENAL	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 the medicine must be no more than 1%. The maximum daily dose must provide no more than 3 mg of 2,4-Heptadienal.
76	2,4-HEXADIENOL	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 the medicine must be no more than 1%. The maximum daily dose must provide no more than 13.5 mg of 2,4-Hexadienol.
77	2,5-DIETHYLTETRAHYDROFURAN	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%.
78	2,5-DIMETHYL-2-OCTEN-6-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%.
79	2,5-DIMETHYL-4-HYDROXY-3(2H)-FURANONE	E	Permitted for use only in combination with other permitted ingredients as a flavour or fragrance. If used in a flavour the total flavour concentration in the medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
80	2,5-DIMETHYL-4-METHOXY-3(2H)-FURANONE	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%.
81	2,5-DIMETHYLPYRAZINE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance, or a printing ink. 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%. If used in a printing ink the total printing ink concentration in a medicine must be no more than 0.1%
82	2,6,6,TRIMETHYL-2-CYCLOHEXENE-1,4-DIONE	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%.
83	2,6,9,10-TETRAMETHYL-1-OXASPIRO(4.5)DECA-3,6-DIENE	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%.
84	2,6-DIMETHOXYPHENOL	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%.
85	2,6-DIMETHYL HEPTAN-2-OL	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%.
86	2,6-DIMETHYL-2-HEPTENAL-(7)	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%.
87	2,6-DIMETHYL-3,5-OCTADIEN-2-OL	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%.
88	2,6-DIMETHYL-4-HEPTYL 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%.
89	2,6-DIMETHYLPYRAZINE	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%.
90	2,6-NONADIEN-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%.
91	2,6-OCTADIENOIC ACID, 3,7-DIMETHYL-, METHYL ESTER, (2E)-	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%.
92	2-(1,1-DIMETHYLETHYL)-1,4-DIMETHOXY-BENZENE	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%.
93	2-(2-(4-METHYL-3-CYCLOHEXEN-1-YL)PROPYL CYCLOPENTANONE	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%.
94	2-(2-METHYLPHENYL)ETHANOL	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 use in the eye. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
95	2-[(3,7-DIMETHYL-6-OCTEN-1-YLIDENE)AMINO]BENZOIC ACID, METHYL 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%.
96	2-[1-(3,3-DIMETHYLCYCLOHEXYL)ETHOXY]-2-METHYLPROPYL] CYCLOPROPANECARBOXYLATE	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%.
97	2-[1-(3,3-DIMETHYLCYCLOHEXYL)ETHOXY]-2-OXOETHYL PROPANOATE	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%.
98	2-ACETYLFURAN	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%.
99	2-ACETYLPYRAZINE	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%.
100	2-ACETYLPYRIDINE	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%.
101	2-AMINO-2-METHYL-1-PROPANOL	E	Only for use in topical medicines for dermal application.
102	2-BENZYL-4,4,6-TRIMETHYL-1,3-DIOXANE	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%.
103	2-BUTEN-1-OL	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%.
104	2-BUTYL-4,4,6-TRIMETHYL-1,3-DIOXANE	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%.
105	2-CYCLOHEXYLIDENE-2-O-TOLYL-ACETONITRILE	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%.
106	2-DECENAL	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%.
107	2-DODECANOL	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%.
108	2-DODECENAL	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%.
109	2-ETHOXY-4-(METHOXYMETHYL)-PHENOL	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%.
110	2-ETHOXYETHANOL	E	The residual solvent limit for 2-Ethoxyethanol is 1.6 mg per maximum recommended daily dose. The concentration in the medicine must be no more than 0.016%.
111	2-ETHYL-1-HEXANOL	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%.
112	2-ETHYL-3,5-DIMETHYLPYRAZINE	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%.
113	2-ETHYL-3,6-DIMETHYLPYRAZINE	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%.
114	2-ETHYL-3-METHYLPYRAZINE	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%.
115	2-ETHYL-4-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)-2-BUTEN-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%.
116	2-ETHYL-4-HYDROXY-5-METHYL-3(2H)-FURANONE	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%.
117	2-ETHYL-4-METHYLTHIAZOLE	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%.
118	2-ETHYL-ALPHA,ALPHA-DIMETHYL-BENZENEPROPANAL	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%.
119	2-ETHYLBUTYRIC 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%.
120	2-HEPTANOL	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%.
121	2-HEPTANONE	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%.

122	2-HEPTYL CYCLOPENTANONE	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%.
123	2-HEXENYL 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%.
124	2-HYDROXYACETOPHENONE	E	Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 1%.
125	2-ISOBUTYL-3-METHOXYPYRAZINE	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%.
126	2-ISOBUTYL-4-METHYLTETRAHYDRO-2H-PYRAN-4-OL	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%.
127	2-ISOPROPOXYETHYL SALICYLATE	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%.
128	2-ISOPROPYL-4-METHYLTHIAZOLE	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%.
129	2-MERCAPTOPROPIONIC 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%.
130	2-METHOXY-3-SECBUTYLPYRAZINE	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%.
131	2-METHOXY-4-VINYLPHENOL	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%.
132	2-METHYL BUTYRIC 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%.
133	2-METHYL HEPTANOIC 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%.
134	2-METHYL-2-PENTENOIC 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%.
135	2-METHYL-2-VINYL-5-ISOPROPENYLTETRAHYDROFURAN	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%.
136	2-METHYL-3-(3,4-METHYLENEDIOXYPHENYL)PROPANAL	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%.
137	2-METHYL-3-(4-METHOXYPHENYL)PROPANAL	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%.
138	2-METHYL-3-[4-(2-METHYLPROPYL)PHENYL]PROPANAL	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%.
139	2-METHYL-3-BUTEN-2-OL	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%.
140	2-METHYL-3-FURANTHIOL	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%.
141	2-METHYL-4-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)BUTANOL	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%.
142	2-METHYL-4-(2,2,3-TRIMETHYL-3-CYCLOPENTENYL)-2-BUTEN-1-OL	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%. Only for use in topical medicines for dermal application.
143	2-METHYL-4-(2,6,6-TRIMETHYL-1-CYCLOHEXEN-1-YL)-2-BUTENAL	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%.
144	2-METHYL-4-(CAMPHENYL-8)-CYCLOHEXANONE	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%.
145	2-METHYL-4-PROPYL-1,3-OXTHIANE	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%.
146	2-METHYL-5-(METHYLTHIO)FURAN	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%.
147	2-METHYL-5-PHENYLPENTANOL	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%.
148	2-METHYLBUTYL 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%.
149	2-METHYLBUTYL 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%.
150	2-METHYLBUTYL PHENYLETHYL ETHER	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%.
151	2-METHYLBUTYL SALICYLATE	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%.
152	2-METHYLHEXANOIC 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%.
153	2-METHYLPYRAZINE	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%.
154	2-METHYLTETRAHYDROFURAN-3-ONE	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%.
155	2-METHYLUNDECANAL	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%.
156	2-METHYLVALERIC 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%.
157	2-NONENAL	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%.
158	2-NONENENITRILE	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%.
159	2-OXOBUTYRIC 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%.
160	2-PENTADECANONE	E	Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%.
161	2-PENTANOL	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%.
162	2-PENTANONE	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%.
163	2-PENTENAL	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%.
164	2-PENTYL FURAN	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%.
165	2-PHENYLPROPIONALDEHYDE	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%.
166	2-PHENYLPROPIONALDEHYDE 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%.
167	2-PROPENOIC ACID	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%.
168	2-SEC-BUTYL CYCLOHEXANONE	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%.
169	2-TERT-BUTYLCYCLOHEXANOL	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%.
170	2-TERT-BUTYLCYCLOHEXYLOXY-2-BUTANOL	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%.
171	2-TRANS-6-CIS-NONADIENAL	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%.
172	2-TRIDECANONE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
173	2-TRIDECENAL	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%.
174	2-TRIDECENENITRILE	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%.
175	2-UNDECENAL	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%.
176	3,3-DIMETHYL-5-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)-4-PENTEN-2-OL	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%.
177	3,3-DIMETHYLACRYLIC 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%.
178	3,4,4A,5,8,8A-HEXAHYDRO-3',7-DIMETHYLSPIRO-1,4-METHANONAPHALENE-2(1H),2'-OXIRANE	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%.
179	3,4-DIMETHYL-1,2-CYCLOPENTADIONE	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%.
180	3,5,5-TRIMETHYL HEXANAL	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%.
181	3,5,5-TRIMETHYLHEXYL 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%.
182	3,5,6,6-TETRAMETHYL-4-METHYLENEHEPTAN-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%.
183	3,5-DIMETHOXYTOLUENE	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%.
184	3,5-DIMETHYL-3-CYCLOHEXENE-1-CARBOXALDEHYDE	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%.
185	3,6-DIMETHYL-3-CYCLOHEXENE-1-CARBOXALDEHYDE	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%.
186	3,7-DIMETHYL OCTANAL	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%.
187	3,7-DIMETHYL-1-OCTANOL	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%.
188	3,7-DIMETHYL-2,6-NONADIENENITRILE	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%.
189	3,7-DIMETHYL-7-METHOXYOCTAN-2-OL	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%.
190	3-(3-ISOPROPYLPHENYL)BUTANAL	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%.
191	3-(4-ETHYLPHENYL)-2,2-DIMETHYLPROPANAL	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%.
192	3-(4-HYDROXYPHENYL)-1-(2,4,6-TRIHYDROXYPHENYL)-1-PROPANONE	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%.
193	3-(4-TERT-BUTYLPHENYL)-PROPANAL	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%.
194	3-(ISO-CAMPHYL-5)-CYCLOHEXANOL	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%.
195	3-(METHYLTHIO)-1-HEXYL 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%.
196	3-CARENE	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%.
197	3-DODECENAL	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%.
198	3-ETHYLPYRIDINE	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%.
199	3-HEPTYLDIHYDRO-5-METHYL-2(3H)-FURANONE	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%.
200	3-HEXANONE	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%.
201	3-HEXEN-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%.
202	3-ISO-CAMPHYL-5-CYCLOHEXAN-1-OL	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%.
203	3-METHYL THIOPROPIONALDEHYDE ETHANOL	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%.
204	3-METHYL-2-(PENTYLOXY)CYCLOPENT-2-EN-1-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%.
205	3-METHYL-5-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)-4-PENTEN-2-OL	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%.
206	3-METHYL-5-PHENYL PENT-2-ENENITRILE	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%.
207	3-METHYL-5-PHENYLPENTANAL	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%.
208	3-METHYL-5-PHENYLPENTANENITRILE	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%.
209	3-METHYL-5-PHENYLPENTANOL	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%.
210	3-METHYL-5-PROPYL-2-CYCLOHEXEN-1-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%.
211	3-METHYLCYCLOPENTADECANONE	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%.
212	3-METHYLCYCLOPENTADECENONE	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%.
213	3-METHYLTHIOHEXANOL	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%.
214	3-OCTANOL	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%.
215	3-OCTYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%.
216	3-PENTYLTETRAHYDRO-2H-PYRAN-4-OL 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%.
217	3-PHENYLPROPIONALDEHYDE	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%.
218	3-PHENYLPROPYL 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%.
219	3-PHENYLPROPYL PROPIONATE	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%.
220	3-PROPYLIDENE PHTHALIDE	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%.
221	3-TRANS-ISOCAMPHYLCYCLOHEXANOL	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%.
222	3A,6,6,9A-TETRAMETHYLDODECAHYDRONAPHTHO[2,1-B] FURAN	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%.
223	4,4A,5,9B-TETRAHYDRO-2,4-DIMETHYL-INDENO(1,2-D)-1,3-DIOXIN	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%.
224	4,4A,5,9B-TETRAHYDROINDENO(1,2-D)-1,3-DIOXIN	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%.
225	4,5-DIMETHYL-3-HYDROXY-2(5H)FURANONE	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%.
226	4,7-METHANO-1H-INDENEMETHANOL, OCTAHYDRO-, ACETATE	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%.
227	4,7-METHANO-3A,4,5,6,7,7A-HEXAHYDRO-5 (OR 6) -INDENYL 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%.
228	4,8-DIMETHYL-3,7-NONADIEN-2-OL	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%.
229	4-(4-HYDROXY-4-METHYLPENTYL)-3-CYCLOHEXENE CARBOXALDEHYDE	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%.
230	4-(4-METHYL-3-PENTEN-1-YL)-3-CYCLOHEXENE-1-CARBOXALDEHYDE	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%.
231	4-(5,5,6-TRIMETHYLBICYCLO(2.2.1)HEPT-2-YL)-CYCLOHEXANOL	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%.
232	4-(METHYLTHIO)-4-METHYL-2-PENTANONE	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%.
233	4-(PARA-HYDROXYPHENYL)-2-BUTANONE	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%.
234	4-(PARA-METHOXYPHENYL)-2-BUTANONE	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%.
235	4-ACETYL-6-TERTIARY-BUTYL-1,1-DIMETHYLINDAN	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%.
236	4-ETHYL GUAIACOL	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%.
237	4-HEPTANONE	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%.
238	4-HYDROXYBENZALDEHYDE	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%.
239	4-HYDROXYBENZYL ALCOHOL	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%.
240	4-ISOPROPYL-3-METHYLPHENOL	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 0.1%.
241	4-METHOXY-2-METHYL-2-BUTANETHIOL	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%.
242	4-METHYL-3-DECEN-5-OL	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%.
243	4-METHYL-4-MERCAPTOPENTAN-2-ONE	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%.
244	4-METHYL-4-PHENYL-2-PENTYL 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%.
245	4-METHYL-5-THIAZOLETHANOL	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%.
246	4-METHYLBENZYLIDENE CAMPHOR	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
247	4-METHYLPENTANOIC 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%.
248	4-METHYLPHENYL OCTANOATE	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%.
249	4-PARA METHOXYPHENYL-3-BUTANONE	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%.
250	4-PENTENOIC 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%.
251	4-TERT-BUTYL-2,6-DIMETHYL ACETOPHENONE	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%.
252	4-TERT-BUTYLCYCLOHEXANOL	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 0.1%.
253	4-TERT-PENTYLCYCLOHEXANONE	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%.
254	5,6,7,8-TETRAHYDROQUINOXALINE	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%.
255	5,7-DIHYDRO-2-METHYLTHIENO (3,4D) PYRIMIDINE	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%.
256	5-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)-3-METHYLPENTAN-2-OL	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%.
257	5-ACETYL-1,1,2,3,3,6-HEXAMETHYL INDAN	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%.
258	5-CYCLOHEXADECEN-1-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%.
259	5-ETHYL-3-HYDOXY-4-METHYL-2(5H)-FURANONE	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%.
260	5-ETHYL-4-HYDROXY-2-METHYL-3(2H)-FURANONE	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%.
261	5-HYDROXY-4-METHYLHEXANOIC ACID DELTA-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%.
262	5-METHOXYPSORALEN	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%.
263	5-METHYL 2-PHENYL HEXEN-2-AL	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%.
264	5-METHYL-2-THIOPHENE CARBOXALDEHYDE	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%.
265	5-METHYL-3-BUTYLTETRAHYDROPYRAN-4-YL 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%.
266	5-METHYL-3-HEPTANONE OXIME	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%.
267	5-PENTYL-2(5H)-FURANONE	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%.
268	6,6-DIMETHOXY-2,5,5-TRIMETHYL-2-HEXENE	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%.
269	6,6-DIMETHYL-2-NORPINENEPROPIONALDEHYDE	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%.
270	6,7-DIHYDRO-1,1,2,3,3-PENTAMETHYL-4(5H)-INDANONE	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%.
271	6-BUTYL-3,6-DIHYDRO-2,4-DIMETHYL-2H-PYRAN	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%.
272	6-METHOXY-2,6-DIMETHYLHEPTAN-1-AL	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%.
273	6-METHOXYDICYCLOPENTADIENECARBOXALDEHYDE	E	Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. When included in a medicine for use on the lips the concentration of 6-methoxydicyclopentadiene carboxaldehyde must be no more than 0.1%. When included in dermal creams for infant use the concentration of 6-methoxydicyclopentadienecarboxaldehyde must be no more than 0.5%. When for dermal use or use on the hair the concentration of 6-methoxydicyclopentadienecarboxaldehyde must be no more than 0.5%. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
274	6-METHYL COUMARIN	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%.
275	6-METHYL-2-BUTEN-3-OL-2	E
276	7-ACETYL-1,1,3,4,4,6-HEXAMETHYL TETRAHYDRONAPHTHALENE	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%.
277	7-METHYL-2H-1,5-BENZODIOXEPIN-3(4H)-ONE	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%.

278	7-OCTENE-1,6-DIOL, 3,7-DIMETHYL-	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%.
279	7-PROPYL-2H-1,5-BENZODIOXEPIN-3(4H)-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%.
280	8,13:13,20-DIEPOXY-14,15-BISNORLABDANE	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%.
281	8-METHYL-1-OXASPIRO(4,5)DECAN-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%.
282	8-OCIMENYL 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%.
283	9-DECEN-1-OL	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%.
284	ABELMOSCHUS MOSCHATUS	A, H
285	ABELMOSCHUS MOSCHATUS SUBSP. MOSCHATUS	A, H
286	ABIES BALSAMEA	A, H
287	ABIES NIGRA	A, H
288	ABIES PECTINATA	A, H
289	ABIES SIBIRICA	A, H
290	ABRUS CANTONIENSIS	A, H	If the herbal substance is derived from the seed, the maximum recommended daily dose of Abrus cantoniensis must be no more than 1mg of the dry seed.
291	ABUTILON THEOPHRASTI	A, H
292	ACACIA	A, E, H
293	ACACIA BAILEYANA	A, H
294	ACACIA CATECHU	A, H
295	ACACIA DEALBATA	A, H
296	ACACIA DECURRENS	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%.
297	ACACIA FARNESIANA	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%.
298	ACACIA LONGIFOLIA	A, E, H
299	ACACIA NILOTICA	A, E, H
300	ACACIA SENEGAL	A, E, H
301	ACALYPHA INDICA	A, H
302	ACANTHUS MOLLIS	A, H
303	ACER CAMPESTRE	A, H
304	ACER NEGUNDO	A, H
305	ACER SACCHARINUM	A, H
306	ACER SACCHARUM	A, E, H
307	ACEROLA	E
308	ACESULFAME POTASSIUM	E
309	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%.
310	ACETALDEHYDE	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%.
311	ACETALDEHYDE ETHYL LINALYL ACETAL	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%.
312	ACETALDEHYDE ETHYL PHENYLETHYL ACETAL	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%.
313	ACETALDEHYDE PHENYLETHYL PROPYL ACETAL	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%.
314	ACETANISOLE	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%.
315	ACETIC ACID	E, H	The concentration in the medicine must be no more than 80%.
316	ACETOIN	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%.
317	ACETOMENAPHTHONE	A, E
318	ACETONE	E	The residual solvent limit for Acetone is 50 mg per maximum recommended daily dose. The concentration in the medicine must be no more than 0.5%.
319	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%.
320	ACETOVANILLONE	E	Only for use in topical medicines for dermal application. 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%.
321	ACETYL	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%.
322	ACETYL DIPEPTIDE-1 CETYL ESTER	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 0.01%.
323	ACETYL GLUCOSAMINE	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%. If the ingredient is sourced from seafood, then the medicine requires the following warning statement on the medicine label: - (SFOOD) 'Derived from seafood'
324	ACETYL HEXAMETHYL TETRALIN	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%.
325	ACETYL LEVOCARNITINE HYDROCHLORIDE	A, E
326	ACETYL TRIFLUOROMETHYLPHENYL VALYLGLYCINE	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%.
327	ACETYLATED LANOLIN	E	Only for use in topical medicines for dermal application.
328	ACETYLATED LANOLIN ALCOHOL	E	Only for use in topical medicines for dermal application.
329	ACETYLATED MONOGLYCERIDES	E
330	ACETYLATED VETIVER OIL	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%.
331	ACETYLCYSTEINE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.001%.
332	ACHILLEA ERBA-ROTTA SUBSP. MOSCHATA	A, H
333	ACHILLEA MILLEFOLIUM	A, E, H	Arbutin is a mandatory component of Achillea millefolium. 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 %.
334	ACHILLEA PTARMICA	A, H
335	ACHYRANTHES ASPERA	A, H
336	ACHYRANTHES BIDENTATA	A, H
337	ACHYRANTHES FAURIEI	A, H
338	ACID GREEN 25	E	Permitted for use only as a colour for topical use.
339	ACID RED 33	E	Permitted for use only as a colour for topical use.
340	ACID RED 87	E, H	Only for use as an active homoeopathic ingredient or for excipient use as a colour in topical medicines.
341	ACID TREATED WAXY MAIZE STARCH	E
342	ACID-ISOMERISED LINALOOL	E	Permitted for use only when combined 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%.
343	ACONITUM CARMICHAELII	A, H	Total alkaloids (of Aconitum spp.) is a mandatory component of Aconitum carmichaelii. The maximum amount of total alkaloids (of Aconitum spp.) must be no more than 0.02 milligrams per pack.
344	ACONITUM FEROX	A, H	Total alkaloids (of Aconitum spp.) is a mandatory component of Aconitum ferox. The maximum amount of total alkaloids (of Aconitum spp.) must be no more than 0.02 milligrams per pack.
345	ACONITUM KUSNEZOFFI	A, H	Total alkaloids (of Aconitum spp.) is a mandatory component of Aconitum kusnezoffii. The maximum amount of total alkaloids (of Aconitum spp.) must be no more than 0.02 milligrams per pack.
346	ACONITUM NAPELLUS	A, H	Total alkaloids (of Aconitum spp.) is a mandatory component of Aconitum napellus. The maximum amount of total alkaloids (of Aconitum spp.) must be no more than 0.02 milligrams per pack.
347	ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER	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 1.7%.
348	ACRYLAMIDES COPOLYMER	E	Only for use in topical medicines for dermal application.
349	ACRYLATES COPOLYMER	E	Only for use in topical medicines for dermal application.
350	ACRYLATES/ACRYLAMIDE COPOLYMER	E	Only for use in topical medicines for dermal application.
351	ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER	E	Only for use in topical medicines for dermal application.
352	ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER	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%.
353	ACRYLATES/DIMETHICONE COPOLYMER	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%.
354	ACRYLATES/OCTYLACRYLAMIDE COPOLYMER	E	Only for use in topical medicines for dermal application.
355	ACRYLATES/STEARETH-20 METHACRYLATE COPOLYMER	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%.
356	ACRYLATES/VA COPOLYMER	E	Only for use in topical medicines for dermal application.
357	ACRYLIC ACID/VP CROSSPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2.5%.
358	ACTAEA CIMICIFUGA	A, H
359	ACTAEA HERACLEIFOLIA	A, H
360	ACTAEA PACHYPODA	A, H
361	ACTAEA RACEMOSA	A, H	When used in oral medicines, the medicine requires the following warning statement on the medicine label: - (BCOHOSH) 'Warning: In very rare cases - black cohosh has been associated with liver failure. If you are experiencing yellowing of the skin or whites of the eyes - dark urine - nausea - vomiting - unusual tiredness - weakness - stomach or abdominal pain - and/or loss of appetite - you should stop using this product and see your doctor.'
362	ACTAEA SIMPLEX	A, H
363	ACTAEA SPICATA	A, H
364	ACTINIDIA CHINENSIS	A, H
365	ACTINIDIA DELICIOSA	A, H
366	ACTIVATED ATTAPULGITE	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 from time to time.
367	ACTIVATED CHARCOAL	A, E, H	When for internal use, the medicine requires the following warning statement on the medicine label: - (ACCOAL) 'Products containing activated charcoal should be used with caution in children since it may interfere with absorption of nutrients. Activated charcoal may interact with other medicines. Activated charcoal is not recommended for long-term use' (or words to that effect).
368	ADEMETIONINE DISULFATE DITOSYLATE DIHYDRATE	A, H	(S)-S-Adenosylmethionine is a mandatory component of Ademetionine disulfate ditosylate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
369	ADEMETIONINE DISULFATE TOSYLATE	A, H	(S)-S-Adenosylmethionine is a mandatory component of Ademetionine disulfate tosylate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
370	ADEMETIONINE DISULFATE TRITOSYLATE DIHYDRATE	A, H	(S)-S-Adenosylmethionine is a mandatory component of Ademetionine disulfate tritosylate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
371	ADEMETIONINE HEXASULFATE DIHYDRATE	A, H	(S)-S-Adenosylmethionine is a mandatory component of Ademetionine hexasulfate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
372	ADEMETIONINE HEXATOSYLATE DIHYDRATE	A, H	(S)-S-Adenosylmethionine is a mandatory component of Ademetionine hexatosylate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
373	ADEMETIONINE PENTASULFATE DIHYDRATE	A, H	(S)-S-Adenosylmethionine is a mandatory component of Ademetionine pentasulfate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
374	ADEMETIONINE PENTATOSYLATE DIHYDRATE	A, H	(S)-S-Adenosylmethionine is a mandatory component of Ademetionine pentatosylate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
375	ADEMETIONINE TETRASULFATE DIHYDRATE	A, H	(S)-S-Adenosylmethionine is a mandatory component of Ademetionine tetrasulfate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
376	ADEMETIONINE TETRATOSYLATE DIHYDRATE	A, H	(S)-S-Adenosylmethionine is a mandatory component of Ademetionine tetratosylate dihydrate. Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
377	ADEMETIONINE TRISULFATE DITOSYLATE DIHYDRATE	A, H	(S)-S-Adenosylmethionine is a mandatory component of Ademetionine trisulfate ditosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'
378	ADENOPHORA STRICTA	A, H
379	ADENOPHORA TRIPHYLLA	A, H
380	ADENOSINE	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 0.04%.
381	ADENOSINE 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 0.1%.
382	ADENOSINE TRIPHOSPHATE	E	Only for use in topical medicines for dermal application.
383	ADENOSINE TRIPHOSPHATE DISODIUM	E	Only for use in topical medicines for dermal application.
384	ADIANTUM CAPILLUS-VENERIS	A, H
385	ADIPIC ACID	E
386	ADIPIC ACID/DIETHYLENE GLYCOL/GLYCERIN CROSSPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
387	ADONIS VERNALIS	A, H	The concentration of equivalent dry Adonis vernalis in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.
388	ADRENALINE (EPINEPHRINE)	H	Only for use as an active homoeopathic ingredient.
389	ADZUKI BEAN	E
390	AEGOPODIUM PODAGRARIA	A, H
391	AESCULUS CHINENSIS	A, H
392	AESCULUS GLABRA	A, H
393	AESCULUS HIPPOCASTANUM	A, H
394	AESCULUS X CARNEA	A, H
395	AETHUSA CYNAPIUM	H	Only for use as an active homoeopathic ingredient.
396	AGAR	A, E
397	AGASTACHE RUGOSA	A, H
398	AGATHOSMA BETULINA	A, E, H	Pulegone is a mandatory component of Agathosma betulina. The concentration of pulegone in the medicine must be no more than 4%.
399	AGAVE AMERICANA	A, E, H
400	AGRIMONIA EUPATORIA	A, E, H
401	AGRIMONIA REPENS	A, H
402	AGROSTIS TENUIS	A, H
403	AILANTHUS ALTISSIMA	A, H
404	AJUGA CHAMAEPITYS	A, H
405	AJUGA REPTANS	A, H
406	ALANINE	A, E
407	ALANYLGLUTAMINE	A	Only for use in oral medicines.
408	ALARIA ESCULENTA	A, H	Iodine is a mandatory component of Alaria esculenta. 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.
409	ALBIZIA JULIBRISSIN	A, H
410	ALBIZIA LEBBECK	A, H
411	ALCEA ROSEA	A, H
412	ALCHEMILLA ALPINA	A, H
413	ALCHEMILLA ARVENSIS	A, H
414	ALCHEMILLA VULGARIS	A, H
415	ALETRIS FARINOSA	A, H
416	ALETRIS SPICATA	A, H
417	ALEURITES MOLUCCANUS SEED OIL	E	Only for use in topical medicines for dermal application.
418	ALFADEX	A, E	Only for use in oral medicines. The maximum daily dose must provide no more than 6 g of alfadex.
419	ALGINATE-KONJAC-XANTHAN POLYSACCHARIDE COMPLEX	A	Only for use in oral medicines. Only for use when the dosage form is other than tablet. The maximum recommended daily dose must be no more than 13.5 g. 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).’ When a dose for children is stated, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect).
420	ALGINIC ACID	E
421	ALISMA ORIENTALE	A, H
422	ALISMA PLANTAGO AQUATICA	A, H
423	ALKANNA TINCTORIA	A, H
424	ALKYL (C12-15) BENZOATE	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 21%.
425	ALLANTOIN	E	Only for use in topical medicines for dermal application.
426	ALLIARIA PETIOLATA	A, H
427	ALLIUM CEPA	A, H
428	ALLIUM FISTULOSUM	A, H
429	ALLIUM HIEROCHUNTINUM	A, H
430	ALLIUM MACROSTEMON	A, H
431	ALLIUM ODORUM	A, H
432	ALLIUM PORRUM	A, H
433	ALLIUM SATIVUM	A, E, H
434	ALLIUM SCHOENOPRASUM	A, H
435	ALLIUM URSINUM	A, H
436	ALLO-OCIMENE	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%.
437	ALLURA RED AC	E	Permitted for use only as a colour for oral and topical use.
438	ALLURA RED AC ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use.
439	ALLYL ALPHA-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%.
440	ALLYL AMYL GLYCOLATE	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%.
441	ALLYL CAPRYLATE	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%.
442	ALLYL CYCLOHEXANEPROPIONATE	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%.
443	ALLYL CYCLOHEXYLOXYACETATE	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%.
444	ALLYL HEPTANOATE	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%.
445	ALLYL HEPTYLATE	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%.
446	ALLYL HEXANOATE	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%.
447	ALLYL ISOTHIOCYANATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. 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%.
448	ALLYL PHENOXYACETATE	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%.
449	ALLYL TIGLATE	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%.
450	ALMOND	E
451	ALMOND OIL	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Almond oil. The concentration of Amygdalin in the medicine must be 0%. The concentration of hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
452	ALNUS GLUTINOSA	A, H
453	ALNUS INCANA SUBSP. RUGOSA	A, H
454	ALOE FEROX	A, E, H	When the route of administration is oral or sublingual, Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of Aloe ferox. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect]. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' [or words to that effect]. When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' [or words to that effect]; and - (LAX2) 'Prolonged use may cause serious bowel problems'.
455	ALOE PERRYI	A, H	When the route of administration is oral or sublingual, Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of Aloe perryi. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect]. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' [or words to that effect]. When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' [or words to that effect]; and - (LAX2) 'Prolonged use may cause serious bowel problems'.
456	ALOE VERA	A, E, H	When the route of administration is oral or sublingual, Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of Aloe vera. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect]. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' [or words to that effect]. When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' [or words to that effect]; and - (LAX2) 'Prolonged use may cause serious bowel problems'.
457	ALOES CAPE	A, H	When the route of administration is oral or sublingual, Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of Aloes cape. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect]. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' [or words to that effect]. When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' [or words to that effect]; and - (LAX2) 'Prolonged use may cause serious bowel problems'.
458	ALOYSIA CITRODORA	A, H
459	ALPHA CASOZEPINE ENRICHED HYDROLYSED MILK PROTEIN	A	Only for use in oral medicines. The medicine requires the following warning statements on the medicine label: - (BABY3) 'Not suitable for use in children under the age of twelve months - except on professional advice' - (COWMK) 'Derived from cow's milk.'
460	ALPHA LIPOIC ACID	A
461	ALPHA-2,2,6-TETRAMETHYL-CYCLOHEXENEBUTANAL	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%.
462	ALPHA-AMYL CINNAMALDEHYDE	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%.
463	ALPHA-AMYL CINNAMYL ALCOHOL	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%.
464	ALPHA-CEDRENE EPOXIDE	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%.
465	ALPHA-DAMASCONE	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%.
466	ALPHA-FARNESENE	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%.
467	ALPHA-FURFURYL OCTANOATE	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%.
468	ALPHA-HEXYLCINNAMALDEHYDE	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%.
469	ALPHA-IONOL	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%.
470	ALPHA-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%.
471	ALPHA-IRONE	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%.
472	ALPHA-ISO-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%.
473	ALPHA-METHYL ANISALACETONE	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%.
474	ALPHA-METHYL BENZYL ALCOHOL	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%.
475	ALPHA-METHYL BUTYRALDEHYDE	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%.
476	ALPHA-METHYL BUTYRIC 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%.
477	ALPHA-METHYL CINNAMALDEHYDE	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%.
478	ALPHA-METHYL FURFURAL	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%.
479	ALPHA-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%.
480	ALPHA-METHYLCINNAMYL ALCOHOL	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%.
481	ALPHA-N-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%.
482	ALPHA-PHELLANDRENE	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%.
483	ALPHA-PINENE	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%.
484	ALPHA-SINENSAL	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%.

485	ALPHA-TERPINENE	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%.
486	ALPHA-TERPINEOL	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%.
487	ALPINIA GALANGA	A, H
488	ALPINIA HAINANENSIS	A, H
489	ALPINIA OFFICINARUM	A, H
490	ALPINIA OXYPHYLLA	A, H
491	ALSIDIUM HELMINTHOCHORTON	A, H	Iodine is a mandatory component of Alsidium helminthochorton. 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.
492	ALSTONIA BOONEI	A, H
493	ALSTONIA CONSTRICTA	H	Only for use as an active homoeopathic ingredient.
494	ALTERNANTHERA PHILOXEROIDES	A, H
495	ALTEROMONAS FERMENT EXTRACT	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin or in the eye. The concentration in the medicine must be no more than 0.3%.
496	ALTHAEA OFFICINALIS	A, E, H
497	ALUM DODECAHYDRATE	A, E, H
498	ALUMINIUM CHLOROHYDRATE	E	Only for use in topical medicines for dermal application.
499	ALUMINIUM CITRATE	E	Only for use in topical medicines for dermal application.
500	ALUMINIUM DISTEARATE	E	Only for use in topical medicines for dermal application.
501	ALUMINIUM HYDROXIDE	E	Only for use in topical medicines for dermal application.
502	ALUMINIUM HYDROXIDE HYDRATE	E	Only for use in topical medicines for dermal application.
503	ALUMINIUM MAGNESIUM SILICATE	E
504	ALUMINIUM MONOSTEARATE	E	Only for use in topical medicines for dermal application.
505	ALUMINIUM OXIDE	E, H	When used as an excipient ingredient, only for use in topical medicines for dermal application. When used as an active ingredient, only for use in homoeopathic medicines.
506	ALUMINIUM SILICATE	E, H	Only for use as an active homoeopathic or excipient ingredient. When used as an excipient ingredient, the medicine is only for use in topical medicines for dermal application.
507	ALUMINIUM SODIUM SILICATE	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).’
508	ALUMINIUM STARCH OCTENYLSUCCINATE	E	The concentration in the medicine must be no more than 7%.
509	ALUMINIUM STEARATE	E	Only for use in topical medicines for dermal application.
510	ALUMINIUM SULFATE HYDRATE	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%.
511	AMARANTH	E	Permitted for use only as a colour for oral and topical use.
512	AMARANTH ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use
513	AMARANTHUS HYBRIDUS	A, H
514	AMARANTHUS RETROFLEXUS	A, H
515	AMBERGRIS EXTRACT	E	Permitted for use only in combination with other permitted ingredients as a fragrance. The total fragrance concentration in a medicine must be no more than 1%.
516	AMBRETTE SEED OIL	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
517	AMBRETTOLIDE	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%.
518	AMBRINOL	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%.
519	AMBROSIA ARTEMISIIFOLIA	A, H
520	AMBROSIA PSILOSTACHYA	A, H
521	AMINOBENZOIC ACID	A	Only for use as an active ingredient in sunscreens. Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 15%.
522	AMINOCAPROIC 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%.
523	AMINOPROPYL ASCORBYL 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 0.1%.
524	AMMI VISNAGA	A, H	The concentration of equivalent dry Ammi visnaga in the product must be no more than 10mg/Kg or 10mg/L or 0.001%.
525	AMMONIA	E, H	Only for use as an active homoeopathic or excipient ingredient. When used as an excipient ingredient, the medicine is only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.5%.
526	AMMONIO METHACRYLATE COPOLYMER	E	Only for use in oral medicines.
527	AMMONIUM ACRYLATES COPOLYMER	E	Only for use in topical medicines for dermal application.
528	AMMONIUM ACRYLATES/ACRYLONITROGENS COPOLYMER	E	Only for use in topical medicines for dermal application.
529	AMMONIUM ACRYLOYLDIMETHYLTAURATE/STEARETH-8 METHACRYLATE COPOLYMER	E	Only for use 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 0.5%.
530	AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER	E	Only for use 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 5%.
531	AMMONIUM BICARBONATE	A, 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 from time to time.
532	AMMONIUM BROMIDE	H	Only for use as an active homoeopathic ingredient.
533	AMMONIUM CARBONATE	E, H	Only for use as an active homoeopathic or excipient ingredient.
534	AMMONIUM CHLORIDE	A, E, H	Only for use as an active ingredient in homoeopathic medicines or as an uncompounded medicine substance packed for retail sale. When used as an uncompounded medicine substance the ingredient must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. If used as an excipient ingredient then the medicine is only for topical use for dermal application.
535	AMMONIUM GLYCYRRHIZINATE	E
536	AMMONIUM IODIDE	H	Only for use an active ingredient in homoeopathic medicines.
537	AMMONIUM LACTATE	E	Only for use 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 0.1%.
538	AMMONIUM LAURETH SULFATE	E	Only for use in topical medicines for dermal application.
539	AMMONIUM LAURYL SULFATE	E	Only for use in topical medicines for dermal application.
540	AMMONIUM POLYACRYLATE	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 0.2%.
541	AMMONIUM POLYACRYLOYLDIMETHYL TAURATE	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 be no more than 3%.
542	AMMONIUM SULFIDE	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%.
543	AMOMUM AROMATICUM	A, H
544	AMOMUM VILLOSUM	A, H
545	AMORPHOPHALLUS KONJAC	A, H	Only for use when the dosage form is not tablet.
546	AMPELODESMOS MAURITANICUS	A, H
547	AMPELOPSIS JAPONICA	A, H
548	AMYL ACETATE	E	Only for use in: - topical medicines for dermal application; or - 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%.
549	AMYL 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%.
550	AMYL 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%.
551	AMYL BUTYRATE	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%.
552	AMYL CAPROATE	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%.
553	AMYL CINNAMATE	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%.
554	AMYL CINNAMIC ALCOHOL	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%.
555	AMYL 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%.
556	AMYL 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%.
557	AMYL ISOVALERATE	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%.
558	AMYL OCTANOATE	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%.
559	AMYL 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%.
560	AMYL PROPIONATE	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%.
561	AMYL SALICYLATE	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%.
562	AMYL VALERATE	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%.
563	AMYL VINYL CARBINOL	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%.
564	AMYL VINYL CARBINYL 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%.
565	AMYLASE	A	Amylase must be derived from Aspergillus oryzae, and comply with the relevant compositional guideline. When used in a divided preparation, the allowed unit is Alpha-amylase dextrinising unit or Thousand alpha-amylase dextrinising unit. When used as an undivided preparation, the allowed unit is Thousand alpha-amylase dextrinising unit per gram or Dextrinising unit per gram.
566	AMYLCYCLOHEXYL ACETATE (MIXED ISOMERS)	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%.
567	AMYLOPECTIN	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%.
568	AMYRIS BALSAMIFERA	A, H
569	AMYRIS OIL WEST INDIAN	A, E, H
570	ANACARDIUM OCCIDENTALE	A, H
571	ANACYCLUS PYRETHRUM	A, H
572	ANACYSTIS NIDULANS FERMENT	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 0.0025%.
573	ANAESTHETIC ETHER	H	Only for use as an active homoeopathic ingredient.
574	ANAGALLIS ARVENSIS	A, H
575	ANAMIRTA COCCULUS	A, H	Picrotoxin is a mandatory component of Anamirta cocculus. The concentration of picrotoxin in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%.
576	ANANAS COMOSUS	A, E, H
577	ANAPHALIS SINICA	A, H
578	ANDROGRAPHIS PANICULATA	A, H
579	ANEMARRHENA ASPHODELOIDES	A, E, H
580	ANEMONE ALTAICA	A, H
581	ANEMONE CHINENSIS	A, H
582	ANEMONE HEPATICA	A, H
583	ANEMONE PULSATILLA	A, H
584	ANEMONE RADDEANA	A, H
585	ANETHOLE	E
586	ANETHOLEA ANISATA	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%.
587	ANETHUM GRAVEOLENS	A, E, H
588	ANGELICA ACUTILOBA	A, H
589	ANGELICA ANOMALA	A, H
590	ANGELICA ARCHANGELICA	A, E, H
591	ANGELICA ATROPURPUREA	A, H
592	ANGELICA DAHURICA	A, E, H
593	ANGELICA DECURSIVA	A, H
594	ANGELICA POLYMORPHA	A, E, H
595	ANGELICA PUBESCENS	A, E, H
596	ANGELICA ROOT DRY	A, H
597	ANGELICA ROOT OIL	A, E, H
598	ANGELICA SEED OIL	A, E, H
599	ANGELICA STEM	E
600	ANIBA ROSAEODORA	A, E, H
601	ANISALDEHYDE	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%.
602	ANISE 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%.
603	ANISE OIL	A, E, H	When the concentration of Anise oil in the preparation is more than 50% the nominal capacity of the container must be no more than 50 mL. When the concentration of Anise oil in the preparation is more than 50% and the nominal capacity of the container is 50 mL or less, a restricted flow insert must be fitted on the container. The medicine requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children (or word to that effect)'
604	ANISEED	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
605	ANISEED DRY	A, E, H
606	ANISEED POWDER	A, E, H
607	ANISIC ACID	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%.
608	ANISYL 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%.
609	ANISYL ACETONE	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%.
610	ANISYL 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%.
611	ANISYL PROPIONATE	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%.
612	ANNATTO	E	Permitted for use only as a colour for oral and topical use.
613	ANOGEISSUS LATIFOLIA	A, E, H
614	ANTENNARIA DIOICA	A, E, H
615	ANTHOCYANINS	E
616	ANTHOXANTHUM ODORATUM	A, H	When used as an active ingredient, coumarin is a mandatory component of Anthoxanthum odoratum and the concentration of coumarin in the medicine must be no more than 0.001%.
617	ANTHRISCUS CEREFOLIUM	A, H
618	ANTHYLLIS VULNERARIA	A, H
619	ANTIMONY POTASSIUM TARTRATE TRIHYDRATE	H	Only for use as an active homoeopathic ingredient.
620	ANTIMONY TRISULFIDE	H	Only for use as an active homoeopathic ingredient.
621	APIUM GRAVEOLENS	A, E, H
622	APOCYNUM CANNABINUM	A, H	The concentration of equivalent dry Apocynum cannabinum in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.
623	APOMORPHINE HYDROCHLORIDE HEMIHYDRATE	H	Only for use as an active homoeopathic ingredient.
624	APPLE	E
625	APPLE CIDER VINEGAR	E
626	APPLE ESSENCE NATURAL	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%.
627	APPLE 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%.
628	APPLE FIBRE	E
629	APRICOT	E
630	APRICOT KERNEL OIL PEG-6 ESTERS	E	Only for use as an excipient in topical medicines for dermal application.
631	AQUILARIA MALACCENSIS	A, H
632	AQUILARIA SINENSIS	A, H
633	AQUILEGIA VULGARIS	A, H
634	ARACHIDONIC ACID	E	Only for use in topical medicines for dermal application.
635	ARACHIDYL ALCOHOL	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%.
636	ARACHIDYL GLUCOSIDE	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 be no more than 0.5%.
637	ARACHIDYL PROPIONATE	E	Only for use in topical medicines for dermal application.
638	ARACHIS HYPOGAEA	A, E, H	The medicine requires the following warning statement on the medicine label: - (PEANUT) ‘Contains Peanut’ (or words to that effect).
639	ARACHIS OIL	A, E, H	The medicine requires the following warning statement on the medicine label: - (PEANUT) ‘Contains Peanut’ (or words to that effect).
640	ARALIA CORDATA	A, H
641	ARALIA HISPIDA	A, H
642	ARALIA NUDICAULIS	A, H
643	ARALIA RACEMOSA	A, H
644	ARCTIUM LAPPA	A, E, H
645	ARCTIUM MINUS	A, H
646	ARCTOSTAPHYLOS UVA-URSI	A, E, H	Arbutin is a mandatory component of Arctostaphylos uva-ursi. 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 %.
647	ARDISIA JAPONICA	A, H
648	ARECA CATECHU	A, H	Arecoline is a mandatory component of Areca catechu. The concentration of arecoline in the medicine must be no more than 10 mg/Kg or 10 mg/L or 0.001%.
649	ARGANIA SPINOSA KERNEL OIL	E	Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration must be no more than 5% in the medicine.
650	ARGININE	A, E, H	Only for use in topical medicines for dermal application. The medicine requires the following warning statement on the medicine label: - (ARGIN1) 'This medicine contains arginine and is intended to be applied to the skin only and not to the mucosa - vagina or rectum.'
651	ARGININE FERULATE	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 0.05%.
652	ARISAEMA ATRORUBENS	A, H	The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
653	ARISAEMA CONSANGUINEUM	A, H	The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
654	ARISAEMA JAPONICUM	A, H	The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
655	ARMORACIA RUSTICANA	A, E, H	Volatile oil components (of Armoracia rusticana) is a mandatory component of Armoracia rusticana. The maximum recommended daily dose must contain no more than 20 mg of volatile oil components (of Armoracia rusticana).
656	ARNEBIA EUCHROMA	A, H
657	ARNICA FLOWER DRY	A, H	When for use other than topically on unbroken skin, the maximum recommended daily dose must be no more than 1mg of the equivalent dry flower of Arnica montana.
658	ARNICA MOLLIS	A, H	When for use other than topically on unbroken skin, the maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.
659	ARNICA MONTANA	A, H	When for use other than topically on unbroken skin, the maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of arnica montana.
660	ARRHENATHERUM ELATIUS	A, H
661	ARROWROOT	A, E, H
662	ARSENIC TRIIODIDE	H	Only for use as an active homoeopathic ingredient. The concentration of arsenic in the medicine must be no more than 0.001%.
663	ARSENIC TRIOXIDE	H	Only for use as an active homoeopathic ingredient. The concentration of arsenic in the medicine must be no more than 0.001%.
664	ARTEMISIA ABROTANUM	A, H	Thujone is a mandatory component of Artemisia abrotanum. The concentration of thujone from Artemisia abrotanum in the medicine must be no more than 4%.
665	ARTEMISIA ABSINTHIUM	A, H	Thujone is a mandatory component of Artemisia absinthium. The concentration of thujone from Artemisia absinthium in the medicine must be no more than 4%.
666	ARTEMISIA ANNUA	A, H	Thujone is a mandatory component of Artemisia annua. The concentration of thujone from Artemisia annua in the medicine must be no more than 4%.
667	ARTEMISIA ARBORESCENS	A, H	Thujone is a mandatory component of Artemisia arborescens. The concentration of thujone from Artemisia arborescens in the medicine must be no more than 4%.
668	ARTEMISIA ARGYI	A, H	Thujone is a mandatory component of Artemisia argyi. The concentration of thujone from Artemisia argyi in the medicine must be no more than 4%.
669	ARTEMISIA DRACUNCULUS	A, E, H	Thujone is a mandatory component of Artemisia dracunculus. The concentration of thujone from Artemisia dracunculus in the medicine must be no more than 4%.
670	ARTEMISIA FRIGIDA	A, H	Thujone is a mandatory component of Artemisia frigida. The concentration of thujone from Artemisia frigida in the medicine must be no more than 4%.
671	ARTEMISIA HERBA-ALBA	A, H	Thujone is a mandatory component of Artemisia herba-alba. The concentration of thujone from Artemisia herba-alba in the medicine must be no more than 4%.
672	ARTEMISIA MARITIMA	A, H	Thujone is a mandatory component of Artemisia maritima. The concentration of thujone from Artemisia maritima in the medicine must be no more than 4%.
673	ARTEMISIA 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%.
674	ARTEMISIA PALLENS	A, E, H	Thujone is a mandatory component of Artemisia pallens. The concentration of thujone from Artemisia pallens in the medicine must be no more than 4%.
675	ARTEMISIA TRIDENTATA	A, H	Thujone is a mandatory component of Artemisia tridentata. The concentration of thujone from Artemisia tridentata in the medicine must be no more than 4%.
676	ARTEMISIA VULGARIS	A, E, H	Thujone is a mandatory component of Artemisia vulgaris. The concentration of thujone from Artemisia vulgaris in the medicine must be no more than 4%.
677	ARTERY	H	Only for use as an active homoeopathic ingredient.
678	ARTHROSPIRA MAXIMA	A, E, H
679	ARTHROSPIRA PLATENSIS	A, E, H
680	ARUM MACULATUM	A, H	The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
681	ASAFOETIDA GUM	A, H
682	ASAFOETIDA OIL	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
683	ASARUM EUROPAEUM	A, H
684	ASARUM HETEROTROPOIDES	A, H
685	ASARUM OIL	E
686	ASARUM SIEBOLDII	A, E, H
687	ASCLEPIAS TUBEROSA	A, H
688	ASCOPHYLLUM NODOSUM	A, E, H	Iodine is a mandatory component of Ascophyllum nodosum. 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.
689	ASCORBIC ACID	A, E
690	ASCORBYL GLUCOSIDE	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%.
691	ASCORBYL METHYLSILANOL PECTINATE	E	Only for use in topical medicines for dermal application.
692	ASCORBYL PALMITATE	A, E	When for oral use, the maximum recommended daily dose must contain no more than 100mg of ascorbyl palmitate.
693	ASCORBYL TOCOPHERYL MALEATE	E	Only for use as an ingredient 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 0.0575%.
694	ASPALATHUS LINEARIS	A, E, H
695	ASPARAGINE	A, E
696	ASPARAGOPSIS SULFATED GALACTANS	E	Only for use as an ingredient 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 0.0025%.
697	ASPARAGUS	E, H	Only for use as an active homoeopathic or excipient ingredient.
698	ASPARAGUS COCHINCHINENSIS	A, H
699	ASPARAGUS OFFICINALIS	A, E, H
700	ASPARAGUS RACEMOSUS	A, H	The plant part must be dried, peeled root, and water extracts or ethanol/water extracts (containing up to 45% ethanol) of the dried, peeled root.
701	ASPARTAME	E	When for oral use, the medicine requires the following warning statement on the medicine label: - (PKU) 'Phenylketonurics are warned that this product contains phenylalanine (or words to that effect)' The medicine requires the following warning statement on the medicine label: - (ASPAR) 'Contains aspartame'
702	ASPARTIC ACID	A, E
703	ASPERGILLUS ORYZAE	A, E, H
704	ASTAXANTHIN ESTERS EXTRACTED FROM HAEMATOCOCCUS PLUVIALIS	A	Only for use in oral medicines. Astaxanthin (of Haematococcus pluvialis) is a mandatory component of astaxanthin esters extracted from Haematococcus pluvialis. The maximum daily dose must contain no more than 12mg of Astaxanthin (of Haematococcus pluvialis).
705	ASTER NOVI-BELGII	A, H
706	ASTER TATARICUS	A, H
707	ASTRAGALUS ADSURGENS	A, H
708	ASTRAGALUS COMPLANATUS	A, H
709	ASTRAGALUS EXCARPUS	A, H
710	ASTRAGALUS GUMMIFER	A, E, H
711	ASTRAGALUS LENTIGINOSUS	A, H
712	ASTRAGALUS MEMBRANACEUS	A, E, H
713	ASTRAGALUS PENDULIFLORUS	A, H
714	ASTROCARYUM MURUMURU SEED TRIGLYCERIDES	E	Only for use as an ingredient 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 0.21%.
715	ATRACTYLODES JAPONICA	A, H
716	ATRACTYLODES LANCEA	A, H
717	ATRACTYLODES MACROCEPHALA	A, H
718	ATROPA BELLADONNA	A, H	Alkaloids calculated as hyoscyamine and atropine are mandatory components of Atropa belladonna. The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. The concentration of atropine in the medicine must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%.
719	ATROPINE SULFATE MONOHYDRATE	H	Only for use as an active homoeopathic ingredient.
720	ATTALEA SPECIOSA	E	Only for use in topical medicines for dermal application.
721	AURA B-AURANTIOL	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%.
722	AUREOBASIDIUM PULLULANS	A, H
723	AVENA FATUA	A, H	Gluten is a mandatory component of Avena fatua when the plant part is seed and the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
724	AVENA SATIVA	A, E, H	Gluten is a mandatory component of Avena sativa when the plant part is seed and the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
725	AVOCADO	E
726	AVOCADO OIL	E
727	AVOCADO OIL UNSAPONIFIABLES	E	Only for use in topical medicines for dermal application.
728	AZADIRACHTA INDICA	A, H	The ingredient can only be derived from the plant part seed and must be cold pressed or debitterised oil. “Debitterised neem seed oil” means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids. Cold pressed Azadirachta indica seed oil must be for topical use for dermal application only. When the concentration of cold pressed Azadirachta indica seed oil is more than 1%, a child resistant closure must be fitted to the container. The medicine requires the following warning statements on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant (or words to that effect).' - (NTAKEN) 'Not to be taken (or words to that effect).' - (CHILD) 'Keep out of reach of children (or words to that effect).’
729	AZOVAN BLUE	E	Permitted for use only as a colour for topical use.
730	AZULENE	E	Only for use in topical medicines for dermal application.

4977	TRIISOSTEARIN	E	Only for use in topical medicines for dermal application.
4978	TRILAURIN	E	Only for use in topical medicines for dermal application.
4979	TRILISA ODORATISSIMA	A, H
4980	TRILLIUM ERECTUM	A, H
4981	TRIMETHOXYCAPRYLYL SILANE	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 0.25%.
4982	TRIMETHYL HYDROXYPENTYL ISOBUTYRATE	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%.
4983	TRIMETHYL UNDECYLENIC ALDEHYDE	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%.
4984	TRIMETHYL-BICYCLO-HEPTANE-SPIROCYCLOHEXENONE	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%.
4985	TRIMETHYLBENZENEPROPANOL	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%.
4986	TRIMETHYLHEXANOL	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%.
4987	TRIMETHYLOPROPANE TRIOCTANOATE	E	Only for use in topical medicines for dermal application.
4988	TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
4989	TRIMETHYLSILOXYSILICATE	E	Only for use in topical medicines for dermal application.
4990	TRINITROPHENOL	H	Only for use as an active homoeopathic ingredient.
4991	TRIOCTANOIN	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%.
4992	TRIOCTYLDODECYL CITRATE	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 12%.
4993	TRIOLEIN	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 0.1%.
4994	TRIOSTEUM PERFOLIATUM	A, H
4995	TRIOXAUNDECANEDIOIC ACID	E
4996	TRIPAL	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%.
4997	TRIPEPTIDE-1	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 0.002%.
4998	TRIS-BIPHENYL TRIAZINE	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. When used topically, the dosage form must not be spray. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
4999	TRISILOXANE	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 40%.
5000	TRISODIUM EDETATE	E	Only for use in topical medicines for dermal application.
5001	TRISODIUM ETHYLENEDIAMINE DISUCCINATE	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 0.2%.
5002	TRISODIUM NTA	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%.
5003	TRISTEARIN	E
5004	TRITICUM AESTIVUM	A, E, H	Gluten is a mandatory component when the plant part is seed and the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).
5005	TRITICUM DURUM	A, E, H	Gluten is a mandatory component when the plant part is seed and the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).
5006	TRIUNDECANOIN	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 11.2%.
5007	TROLAMINE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%.
5008	TROLAMINE LAURIL SULFATE	E	Only for use in topical medicines for dermal application.
5009	TROLAMINE SALICYLATE	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 12%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
5010	TROLLIUS CHINENSIS	A, H
5011	TROMETAMOL	E
5012	TROMETAMOL HYDROCHLORIDE	E
5013	TROPAEOLUM MAJUS	A, E, H
5014	TROPICAL RATTLESNAKE	H	Only for use as an active homoeopathic ingredient.
5015	TROPOLONE	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 0.01%.
5016	TSUGA CANADENSIS	A, H
5017	TULIPA EDULIS	A, H	Colchicine is a mandatory component of Tulipa edulis. The concentration of colchicine in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%.
5018	TURMERIC	E	Permitted for use only in combination with other permitted ingredients as a colour.
5019	TURNERA DIFFUSA	A, E, H	Arbutin is a mandatory component of Turnera diffusa. 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 %.
5020	TURNIP	E
5021	TURPENTINE OIL	A, E	The concentration in the medicine must be no more than 25%.
5022	TYPHA ANGUSTIFOLIA	A, H
5023	TYPHA LATIFOLIA	A, H
5024	TYPHONIUM GIGANTEUM	A, H
5025	TYROSINE	A, E

Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2019

This instrument is in 6 volumes:

Volume 1: Sections 1–7

Schedule 1 (1,7,7-TRIMETHYLBICYCLO(2.2.1)HEPT-2-YL)-CYCLOHEXANOL)–AZULENE

Volume 2: Schedule 1 BACKHOUSIA CITRIODORA–EVERNIA PRUNASTRA EXTRACT

Volume 3: Schedule 1 FABIANA IMBRICATA–JUSTICIA ADHATODA

Volume 4: Schedule 1 KADSURA COCCINEA–OYSTER SHELL

Volume 5: Schedule 1 P-ALPHA-DIMETHYL STYRENE–TYROSINE

Volume 6: Schedule 1 UBIDECARENONE–ZUCCHINI

Schedule 2

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
5026	UBIDECARENONE	A, E	When used as an excipient, the route of administration must be topical and the concentration in the medicine must not be more than 0.05%. Not to be included in medicines intended for use in the eye. When for internal use, the maximum recommended daily dose must not provide more than 300 milligrams of ubidecarenone. When for internal use in combination with Ubiquinol-10, the maximum recommended daily dose must not provide more than 300 milligrams of ubiquinol-10 and ubidecarenone combined. When for internal use, the following warning statement is required on the medicine label: - (WARF) 'Do not take while on warfarin therapy without medical advice'.
5027	UBIQUINOL-10	A, E	When used as an excipient, the route of administration must be topical and the concentration in the medicine must be no more than 0.05%. Not to be included in medicines intended for use in the eye. When for internal use, the maximum recommended daily dose must provide no more than 300 milligrams of ubiquinol-10. When used in combination with ubidecarenone, the maximum recommended daily dose must provide no more than 300 mg of ubiquinol-10 and ubidecarenone combined. The medicine requires the following warning statement on the medicine label: - (WARF) 'Do not take while on warfarin therapy without medical advice.'
5028	ULEX EUROPAEUS	A, H
5029	ULMUS AMERICANA	A, H
5030	ULMUS CAMPESTRIS	A, H
5031	ULMUS GLABRA	A, H
5032	ULMUS PARVIFOLIA	A, H
5033	ULMUS PROCERA	A, H
5034	ULMUS PUMILA	A, H
5035	ULMUS RUBRA	A, H
5036	ULTRALIDE	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%.
5037	ULTRAMARINE BLUE	E	Permitted for use only as a colour for topical use.
5038	ULVA LACTUCA	A, H	Iodine is a mandatory component of Ulva lactuca. 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 0.1%.
5039	UMBELLULARIA CALIFORNICA	A, H
5040	UNCARIA GAMBIR	A, H
5041	UNCARIA RHYNCOPHYLLA	A, H
5042	UNCARIA SINENSIS	A, H
5043	UNCARIA TOMENTOSA	A, H
5044	UNDARIA PINNATIFIDA	A, H	Whole dried Undaria pinnatifida must not contain the holdfast. Only for use in oral medicines.
5045	UNDECANAL	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%.
5046	UNDECANOIC ACID	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%.
5047	UNDECENOIC ACID	E
5048	UNDECYL 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%.
5049	UNDECYLCRYLENE DIMETICONE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%.
5050	UNDECYLENAMIDE DEA	E
5051	UNDECYLENOYL PEG-5 PARABEN	E	Only for use in topical medicines for dermal application.
5052	URANIUM NITRATE	H	Only for use as an active homoeopathic ingredient.
5053	UREA	A, E, H	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 10% (w/w).
5054	URTICA DIOICA	A, E, H
5055	URTICA URENS	A, H
5056	USNEA BARBATA	A, H
5057	UVA URSI LEAF DRY	A, H
5058	UVA URSI LEAF POWDER	A, E, H
5059	VA/BUTYL MALEATE/ISOBORNYL ACRYLATE COPOLYMER	E	Vinyl acetate is a mandatory component of VA/butyl maleate/isobornyl acrylate copolymer. The concentration of vinyl acetate in the medicine must be no more than 0.01% or 100 ppm. 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%.
5060	VACCARIA SEGATALIS	A, H
5061	VACCINIUM BRACTEATUM	A, H
5062	VACCINIUM CORYMBOSUM	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%.
5063	VACCINIUM MACROCARPON	A, E, H
5064	VACCINIUM MYRTILLOIDES	A, H
5065	VACCINIUM MYRTILLUS	A, E, H
5066	VACCINIUM OXYCOCCUS	A, H
5067	VACCINIUM VITIS-IDAEA	A, H	Arbutin is a mandatory component of Vaccinium vitis-idaea. 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 %.
5068	VALENCENE	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%.
5069	VALERALDEHYDE	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%.
5070	VALERIAN DRY	A, H
5071	VALERIAN OIL	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5072	VALERIAN POWDER	A, H
5073	VALERIANA EDULIS	A, H
5074	VALERIANA OFFICINALIS	A, H
5075	VALERIANA SORBIFOLIA	A, H
5076	VALERIC 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%.
5077	VALINE	A, E
5078	VANADIUM	H
5079	VANILLA	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%.
5080	VANILLA DRY	A, E, H
5081	VANILLA 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%.
5082	VANILLA OLEORESIN	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%.
5083	VANILLA PLANIFOLIA	A, E, H
5084	VANILLA POWDER	A, E, H
5085	VANILLA TAHITENSIS	A, H
5086	VANILLIC 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%.
5087	VANILLIN	E
5088	VANILLIN 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%.
5089	VANILLYL ALCOHOL	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%.
5090	VAT RED 1	E	Permitted for use only as a colour for topical use.
5091	VAT RED 1 ALUMINIUM LAKE	E	Permitted for use only as a colour for topical use.
5092	VAT RED 5	E	Permitted for use only as a colour for topical use.
5093	VEGETABLE OIL	E
5094	VEGETABLE OIL PHYTOSTEROL ESTERS	A	Only for use in oral medicines. 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).'
5095	VEIN	H	Only for use as an active homoeopathic ingredient.
5096	VERATRALDEHYDE	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%.
5097	VERATROL	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%.
5098	VERATRUM ALBUM	A, H	Solanidine is a mandatory component of Veratrum album. The concentration of equivalent dry Veratrum album in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.
5099	VERBASCUM DENSIFLORUM	A, H
5100	VERBASCUM THAPSUS	A, H
5101	VERBENA OFFICINALIS	A, H
5102	VERBENA OIL	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5103	VERONICA CHAMAEDRYS	A, H
5104	VERONICA OFFICINALIS	A, H
5105	VERONICASTRUM VIRGINICUM	A, E, H
5106	VERTONAL	E	Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. When included in a medicine for use on the lips the concentration of vertonal must be no more than 0.2%. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
5107	VETIVER 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%.
5108	VETIVERYL 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%.
5109	VIBURNUM OPULUS	A, E, H
5110	VIBURNUM PRUNIFOLIUM	A, E, H
5111	VICIA FABA	A, H	Levodopa (of Vicia faba) is a mandatory component of Vicia faba. The concentration of Levodopa (of Vicia faba) from all ingredients in the medicine must be no more than 1mg/kg or 1mg/L or 0.1%.
5112	VIGNA ANGULARIS VAR. ANGULARIS	A, H
5113	VIGNA RADIATA	A, H
5114	VIGNA UMBELLATA	A, H
5115	VINCA MAJOR	A, H	Vincamine is a mandatory component of Vinca major. The concentration of vincamine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%.
5116	VINCA MINOR	A, H	Vincamine and vincristine are mandatory components of Vinca minor. The concentration of vincamine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%. The concentration of Vincristine in the medicine must be no more than 10mg/kg or 10mg/L or 0.001%
5117	VINCETOXICUM OFFICINALE	A, H
5118	VINEGAR	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%.
5119	VIOLA ODORATA	A, E, H
5120	VIOLA TRICOLOR	A, H
5121	VIOLA YEDOENSIS	A, H
5122	VIOLET LEAF 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%.
5123	VIOLET LEAVES	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%.
5124	VIPER	H	Only for use as an active homoeopathic ingredient.
5125	VISCUM ALBUM	A, E, H
5126	VISCUM COLORATUM	A, H
5127	VISCUM FLAVESCENS	A, H
5128	VITELLARIA PARADOXA	A, E, H
5129	VITEX AGNUS-CASTUS	A, E, H
5130	VITEX NEGUNDO	A, H
5131	VITEX ROTUNDIFOLIA	A, H
5132	VITEX TRIFOLIA	A, H
5133	VITIS VINIFERA	A, E, H
5134	VITREOSCILLA CONCENTRATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%.
5135	WAHLENBERGIA GRACILIS	A, H
5136	WALNUT	E
5137	WALNUT OIL	E
5138	WATER MELON	E
5139	WHEAT	E	Gluten is a mandatory component of Wheat when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
5140	WHEAT BRAN	E	Gluten is a mandatory component of Wheat bran when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
5141	WHEAT DEXTRIN	A, E	Only for use when the dosage form is capsule, tablet or pill. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
5142	WHEAT GERM	E	Gluten is a mandatory component of Wheat germ when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
5143	WHEAT GERM GLYCERIDES	E	Gluten is a mandatory component of Wheat germ glycerides when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
5144	WHEAT LEAF	E
5145	WHEAT SPROUT	E	Gluten is a mandatory component of Wheat sprout when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
5146	WHEAT STARCH	E	When the route of administration is other than topical or mucosal, gluten is a mandatory component of wheat starch. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).
5147	WHEATGERM OIL	A, E, H
5148	WHEY POWDER	E	Lactose is a mandatory component of Whey powder when the route of administration is oral.
5149	WHEY PROTEIN	E	Lactose is a mandatory component of Whey protein when the route of administration is oral.
5150	WHEY PROTEIN CONCENTRATE	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%.
5151	WHITE BEESWAX	E
5152	WHITE HOREHOUND HERB DRY	A, H
5153	WHITE HOREHOUND HERB POWDER	A, H
5154	WHITE SOFT 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.
5155	WHOLE DRY MILK	E	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).
5156	WIKSTROEMIA VIRIDIFLORA	A, H
5157	WILD CARROT HERB DRY	A, E, H
5158	WILD CARROT HERB POWDER	A, H
5159	WILD CHERRY BARK DRY	A, H
5160	WILD CHERRY BARK POWDER	A, H
5161	WILD LETTUCE LEAF DRY	A, H
5162	WILD LETTUCE LEAF POWDER	A, H
5163	WINTERGREEN OIL	A, E, H	Methyl salicylate is a mandatory component of wintergreen oil. Not to be included in medicines for use in the eye or on damaged skin. When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%. When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging. When the concentration of methyl salicylate in a liquid preparation is more than 5%, and the dosage form is spray, the medicine does not require child resistant packaging if: - the delivery device is engaged into the container in such a way that prevents it from being readily removed; - direct suction through the delivery device results in delivery of no more than one dosage unit; and - actuation of the spray device is ergonomically difficult for young children to accomplish. In addition, when the ingredient is included in a medicine that is listed in the Register: - on or after 1 July 2018, the medicine must comply with all requirements under (a) & (b); - before 1 July 2018 and supplied on or after 1 January 2020, the medicine must comply with all requirements under (a) & (b); or - before 1 July 2018 and supplied before 1 January 2020, the medicine may comply with the requirements under (a) & (b). a) The following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect). b) When for use in topical medicines for dermal application, the concentration of methyl salicylate in the medicine must not be more than 25% and the following warning statements are required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less'; - (SENS) 'Application to skin may increase sensitivity to sunlight'. (or words to that effect); - (IRRIT) 'If irritation develops, discontinue use.'; and - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect).
5164	WITHANIA SOMNIFERA	A, E, H
5165	WOLFIPORIA COCOS	A, E, H	When the ingredient is included in a medicine that is listed in the Register before 1 July 2018 and supplied before 1 January 2020, the medicine label may refer to the ingredient name as 'Poria cocos' instead of 'Wolfiporia cocos'.
5166	WOOL ALCOHOLS	E	Only for use in topical medicines for dermal application.
5167	WOOL FAT	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.
5168	XANTHAN GUM	E
5169	XANTHIUM SIBIRICUM	A, H
5170	XANTHIUM STRUMARIUM	A, H
5171	XANTHOMONA CAMPESTRIS	A, H
5172	XEROPHYLLUM ASPHODELOIDES	A, H
5173	XYLENE	E	The residual solvent limit for xylene is 21.7 mg per maximum recommended daily dose. The concentration in the medicine must be no more than 0.217%.
5174	XYLITOL	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]’.
5175	XYLOSE	E
5176	YAM	E
5177	YARROW HERB DRY	A, H
5178	YARROW HERB POWDER	A, H
5179	YEAST AUTOLYSATE	E
5180	YEAST DRIED	A, E, H
5181	YELLOW 2G	E	Permitted for use only as a colour for topical use.
5182	YELLOW BEESWAX	E
5183	YELLOW MERCURIC OXIDE	H	Only for use as an active homoeopathic ingredient.
5184	YELLOW SOFT PARAFFIN	A, E	Only for use in topical medicines for dermal application. 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.
5185	YLANG YLANG OIL	A, E, H
5186	YUCCA BACCATA	A, H
5187	YUCCA ELATA	A, H
5188	YUCCA FILAMENTOSA	A, H
5189	YUCCA GLORIOSA	A, H
5190	YUCCA WHIPPLEI	A, H
5191	ZANTHOXYLUM AMERICANUM	A, H
5192	ZANTHOXYLUM BUNGEANUM	A, E, H
5193	ZANTHOXYLUM CLAVA-HERCULIS	A, H
5194	ZANTHOXYLUM NITIDUM	A, H
5195	ZANTHOXYLUM PIPERITUM	A, H
5196	ZANTHOXYLUM SIMULANS	A, H
5197	ZEA MAYS	A, E, H
5198	ZEAXANTHIN	A, E
5199	ZEIN	E
5200	ZINC	H	Only for use as an active homoeopathic ingredient. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
5201	ZINC AMINO ACID CHELATE	A, E, H	When used internally, zinc is a mandatory component of zinc amino acid chelate. The concentration of zinc in zinc amino acid chelate must be no more than 30%. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5202	ZINC ASCORBATE	A, E, H	When used internally, zinc is a mandatory component of zinc ascorbate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5203	ZINC ASCORBATE MONOHYDRATE	A, E, H	When used internally, zinc is a mandatory component of zinc ascorbate monohydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
5204	ZINC CHLORIDE	A, E, H	The concentration of zinc chloride in the medicine must be no more than 5%. When used internally, zinc is a mandatory component of zinc chloride. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5205	ZINC CITRATE	A, E, H	When used internally, zinc is a mandatory component of zinc citrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5206	ZINC CITRATE DIHYDRATE	A, E, H	When used internally, zinc is a mandatory component of zinc citrate dihydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5207	ZINC CITRATE TRIHYDRATE	A, E, H	When used internally, zinc is a mandatory component of zinc citrate trihydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5208	ZINC DIASPARTATE	A	When used internally, zinc is a mandatory component of zinc diaspartate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5209	ZINC GLUCONATE	A, E, H	When used internally, zinc is a mandatory component of zinc gluconate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5210	ZINC GLYCINATE	A	When used internally, zinc is a mandatory component of Zinc glycinate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5211	ZINC GLYCINATE MONOHYDRATE	A	When used internally, zinc is a mandatory component of Zinc glycinate monohydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
5212	ZINC LACTATE	E	Only for use in topical and dental medicines and not to be included in medicines intended for use in the eye. The concentration of zinc lactate in a medicine intended for topical use should be no more than 2%. The concentration of Zinc lactate in a medicine for 'dental' use in toothpaste medicines must be no more than 2.5%. Zinc lactate is not to be included in dental / toothpaste medicines intended for use by children less than 12 years old. Medicines containing Zinc lactate for dental use require the following warning statement on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'.
5213	ZINC LACTATE DIHYDRATE	E	Only for use in topical and dental medicines and not to be included in medicines intended for use in the eye. The concentration of Zinc lactate dihydrate in a medicine intended for topical use should be no more than 2%. The concentration of Zinc lactate dihydrate in a medicine for 'dental' use in toothpaste medicines must be no more than 2.5%. Zinc lactate dihydrate is not to be included in dental / toothpaste medicines intended for use by children less than 12 years old. Medicines containing Zinc lactate for dental use require the following warning statement on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'.

5214	ZINC LYSINATE	A	When used internally, zinc is a mandatory component of Zinc lysinate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5215	ZINC METHIONINE SULFATE	A	For topical use, the concentration of zinc methionine sulfate must be no more than 5%. When used internally, zinc is a mandatory component of zinc methionine sulfate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5216	ZINC MYRISTATE	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 0.1%.
5217	ZINC OXIDE	A, E, H	When used internally, zinc is a mandatory component of zinc oxide. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR -'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).' When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
5218	ZINC PARA-PHENOLSULFONATE	E	The concentration of zinc para-phenolsulfonate in the medicine must not exceed 5%. When used internally, zinc is a mandatory component of zinc para-phenolsulfate. The percentage of zinc from zinc para-phenolsulfonate should be calculated based on the molecular weight of zinc para-phenolsulfonate. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period. OR WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period' (or words to that effect).
5219	ZINC STEARATE	E	When used internally, zinc is a mandatory component of zinc stearate. The percentage of zinc from zinc stearate should be calculated based on the molecular weight of zinc stearate.
5220	ZINC SUCCINATE	A, E, H	When used internally, zinc is a mandatory component of zinc succinate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' or - 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5221	ZINC SULFATE	A, E	For topical use, the concentration of zinc sulfate must be no more than 5%. For internal use, zinc is a mandatory component of zinc sulfate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR - 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5222	ZINC SULFATE HEPTAHYDRATE	A, E	For topical use, the concentration of zinc sulfate must be no more than 5%. For internal use, zinc is a mandatory component of zinc sulfate heptahydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR - 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5223	ZINC SULFATE HEXAHYDRATE	A, E, H	For topical use, the concentration of zinc sulfate must be no more than 5%. For internal use, zinc is a mandatory component of zinc sulfate hexahydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR - 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5224	ZINC SULFATE MONOHYDRATE	A, E, H	When the route of administration is topical the concentration of zinc sulfate in the medicine must be no more than 5%. When the medicine is for internal use, zinc is a mandatory component of zinc sulfate monohydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR - 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5225	ZINC VALERATE	H	Only for use as an active homoeopathic ingredient. For internal use, zinc is a mandatory component of zinc valerate. The percentage of zinc from zinc valerate should be calculated based on the molecular weight of zinc valerate.
5226	ZINGERONE	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%.
5227	ZINGIBER OFFICINALE	A, E, H	When for oral use AND the extract ratio is equal to or more than 25:1 AND the equivalent dry weight per dosage unit is equal to or more than 2g, the medicine requires the following warning statement on the medicine label: - (GINGER) 'Individuals taking anticoagulants should seek medical advice before taking this medicine.' AND 'Individuals at risk of bleeding problems should seek advice from their healthcare practitioner prior to taking this medicine'.
5228	ZIZIPHUS JUJUBA	A, H
5229	ZIZIPHUS JUJUBA VAR. SPINOSA	A, H
5230	ZIZYPHUS SATIVA	A, H
5231	ZOSTERA MARINA	A, H
5232	ZUCCHINI	E

Schedule 2—Repeals

Note: See section 7.

Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018

1 The whole of the instrument

Repeal the instrument.