Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2021 (Cth)

Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2021

I, Cheryl McRae, as delegate of the Minister for Health and Aged Care, make the following determination.

Dated 23 February 2021

Cheryl McRae

Assistant Secretary

Complementary and Over the Counter Medicines Branch

Health Products Regulation Group

Department of Health

Contents

1  Name........................................................................................................................................ 2

2  Commencement........................................................................................................................ 2

3  Authority.................................................................................................................................. 2

4  Interpretation............................................................................................................................ 2

5  Permissible ingredients............................................................................................................. 3

6  Requirements in relation to permissible ingredients being contained in medicine..................... 3

7  Repeals..................................................................................................................................... 4

Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine......................................................................................................................................... 5

Schedule 2—Repeals................................................................................................................ 972

Note:       This instrument is in 6 volumes:

Volume 1:     Sections 1–7 (pages 2-4)

Schedule 1     (+-)-NARINGENIN–AZULENE (pages 5-144)

Volume 2:     Schedule 1     BACILLUS COAGULANS–EVERNIA PRUNASTRI EXTRACT (pages 145-412)

Volume 3:     Schedule 1     FABIANA IMBRICATA–JUSTICIA ADHATODA
(pages 413-537)

Volume 4:     Schedule 1     KADSURA COCCINEA–OYSTER SHELL (pages 538-686)

Volume 5:     Schedule 1     P-ALPHA-DIMETHYL STYRENE–TYROSINE
(pages 687-937)

Volume 6:     Schedule 1     UBIDECARENONE–ZUCCHINI (pages 938-971)

Schedule 2     (page 972)

1  Name

This instrument is the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2021.

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	1 March 2021	1 March 2021

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 heading 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	(+-)-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%.
2	(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%.
3	(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%.
4	(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%.
5	(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%.
6	(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%.
7	(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%.
8	(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%.
9	(R)-ALPHA-TERPINYL ACETATE	E	(R)-alpha-terpinyl acetate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing (R)-alpha-terpinyl acetate must not be more than 1% of the total medicine.
10	(S)-LACTIC ACID	A, E, H
11	(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)'
12	(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)'
13	(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)'
14	(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)'
15	(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)'
16	(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)'
17	(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)'
18	(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)'
19	(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)'
20	(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)'
21	(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%.
22	(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%.
23	1,1,1-TRICHLOROETHANE	E	The concentration in the medicine must be no more than 25%.
24	1,2,3,4,4A,5,8,8A-OCTAHYDRO-2,2,6,8-TETRAMETHYL-1-NAPHTHALENOL	E	Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
25	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%.
26	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%.
27	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%.
28	1,3-BUTYLENE GLYCOL	E
29	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%.
30	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%.
31	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%
32	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%.
33	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%.
34	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%.
35	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%.
36	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%.
37	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%.
38	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%.
39	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%.
40	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%.
41	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%.
42	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%.
43	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%.
44	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%.
45	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%.
46	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%.
47	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%.
48	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%.
49	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%.
50	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%.
51	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%.
52	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%.
53	2'-FUCOSYLLACTOSE	A	Only to be used in a medicine where BASF Australia Ltd - Australia (Client ID 13479), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine.  This paragraph ceases to be a requirement for this ingredient after 1 March 2023. Only for oral use. The maximum recommended daily dose of the medicine must not provide more than: (a) 5 g of 2’-fucosyllactose to individuals aged 18 years and older; (b) 2 g of 2’-fucosyllactose to individuals aged between 4 to 17 years (inclusive); and (c) 1.2 g of 2’-fucosyllactose to individuals aged between 1 to 3 years (inclusive). Not permitted for use in children under the age of 12 months.
54	2,2'-METHYLENEBIS(4-METHYL-6-TERT-BUTYLPHENOL)	E	2,2'-methylenebis(4-methyl-6-tert-butylphenol) must only be included in medicines when in combination with other permitted ingredients as a proprietary excipient formulation in medicines with a dermal route of administration for topical application.
55	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%.
56	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%.
57	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%.
58	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%.
59	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%.
60	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%.
61	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%.
62	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%.
63	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%.
64	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%.
65	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%.
66	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%.
67	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%.
68	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%.
69	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%.
70	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%.
71	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%.
72	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%.
73	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.
74	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%.
75	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%.
76	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%.
77	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%.
78	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%.
79	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.
80	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.
81	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%.
82	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%.
83	2,5-DIMETHYL-4-ETHOXY-3(2H)-FURANONE	E	Only for use in medicines in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must not be more than 5%.
84	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%.
85	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%.
86	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%
87	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%.
88	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%.
89	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%.
90	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%.
91	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%.
92	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%.
93	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%.
94	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%.
95	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%.
96	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%.
97	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%.
98	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%.
99	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%.
100	2-(6-METHYL-8-ISOPROPYL BICYCLO(2.2.2)OCT-5-ENE-2-YL-1,3-DIOXOLANE	E	2-(6-methyl-8-isopropyl bicyclo(2.2.2)oct-5-ene-2-yl)-1,3-dioxolane must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 2-(6-methyl-8-isopropyl bicyclo(2.2.2)oct-5-ene-2-yl)-1,3-dioxolane must not be more than 1% of the total medicine.
101	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%.
102	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%.
103	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%.
104	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%.
105	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%.
106	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%.
107	2-AMINO-2-METHYL-1-PROPANOL	E	Only for use in topical medicines for dermal application.
108	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%.
109	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%.
110	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%.
111	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%.
112	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%.
113	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%.
114	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%.
115	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%.
116	2-ETHOXY-9-METHYLENE-2,6,6-TRIMETHYLBICYCLO[3.3.1]NONANE	E	2-ethoxy-9-methylene-2,6,6-trimethylbicyclo[3.3.1]nonane must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 2-ethoxy-9-methylene-2,6,6-trimethylbicyclo[3.3.1]nonane must not be more than 1% of the total medicine.

117	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%.
118	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%.
119	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%.
120	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%.
121	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%.
122	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%.
123	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%.
124	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%.
125	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%.
126	2-ETHYL-N-METHYL-N-(3-METHYLPHENYL) BUTANAMIDE	E	Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
127	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%.
128	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%.
129	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%.
130	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%.
131	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%.
132	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%.
133	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%.
134	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%.
135	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%.
136	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%.
137	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%.
138	2-METHOXY-3-(1-METHYLPROPYL)PYRAZINE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
139	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%.
140	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%.
141	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%.
142	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%.
143	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%.
144	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%.
145	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%.
146	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%.
147	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%.
148	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%.
149	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%.
150	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.
151	2-METHYL-4-(2,2,3-TRIMETHYLCYCLOPENT-3-EN-1-YL)PENT-4-EN-1-OL	E	2-Methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-1-ol must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-1-ol must not be more than 1% of the total medicine.
152	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%.
153	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%.
154	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%.
155	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%.
156	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%.
157	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%.
158	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%.
159	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%.
160	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%.
161	2-METHYLDECANAL	E	Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
162	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%.
163	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%.
164	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%.
165	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%.
166	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%.
167	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%.
168	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%.
169	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%.
170	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%.
171	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%.
172	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%.
173	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%.
174	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%.
175	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%.
176	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%.
177	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%.
178	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%.
179	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%.
180	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%.
181	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%.
182	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%.
183	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%.
184	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%.
185	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%.
186	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%.
187	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%.
188	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%.
189	3,4-DIMETHYL PHENYLACETALDEHYDE	E	3,4-Dimethyl phenylacetaldehyde must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 3,4-dimethyl phenylacetaldehyde must not be more than 1% of the total medicine.
190	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%.
191	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%.
192	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%.
193	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%.
194	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%.
195	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%.
196	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%.
197	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%.
198	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%.
199	3,7-DIMETHYL-1-OCTEN-3-OL	E	Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
200	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%.
201	3,7-DIMETHYL-2,6-OCTADIENAL REACTION PRODUCTS WITH ETHANOL	E	Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
202	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%.
203	3-(1-BUTENYL)-PYRIDINE	E	3-(1-Butenyl)-pyridine must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 3-(1-butenyl)-pyridine must not be more than 1% of the total medicine.
204	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%.
205	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%.
206	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%.
207	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%.
208	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%.
209	3-(METHYLTHIO) PROPIONALDEHYDE	E	3-(Methylthio) propionaldehyde must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing 3-(methylthio) propionaldehyde must not be more than 5% of the total medicine.
210	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%.
211	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%.
212	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%.
213	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%.
214	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%.
215	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%.
216	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%.
217	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%.
218	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%.
219	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%.
220	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%.
221	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%.
222	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%.
223	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%.
224	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%.
225	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%.
226	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%.
227	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%.
228	3-METHYLPENTANOIC ACID	E	3-Methylpentanoic acid must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of the flavour proprietary excipient formulation containing 3-methylpentanoic acid must not be more than 5% of the total medicine.
229	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%.
230	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%.
231	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%.
232	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%.
233	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%.
234	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%.
235	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%.
236	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%.
237	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%.
238	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%.
239	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%.
240	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%.
241	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%.
242	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%.
243	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%.
244	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%.
245	4-(1-ETHOXYVINYL)-3,3,5,5-TETRAMETHYLCYCLOHEXANONE	E	4-(1-Ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone must not be more than 1% of the total medicine.
246	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%. A medicine that contains the ingredient must not be listed in the Register on or after 2 March 2020 or be released for supply after 2 March 2021.
247	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%.
248	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%.
249	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%.
250	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%.
251	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%.
252	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%.
253	4-CYCLOHEXYL-2-METHYL-2-BUTANOL	E	Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
254	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%.
255	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%.
256	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%.
257	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%.
258	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%.
259	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%.
260	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%.
261	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%.
262	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%.
263	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%.
264	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 not be more than 4%. The following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
265	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%.
266	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%.
267	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%.
268	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%.
269	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%.

270	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%.
271	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%.
272	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%.
273	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%.
274	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%.
275	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%.
276	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%.
277	5-ETHYL-2,3-DIMETHYLPYRAZINE	E	5-Ethyl-2,3,dimethylpyrazine must not be included in medicines for oral administration. 5-Ethyl-2,3,dimethylpyrazine must only be included in topical medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 5-ethyl-2,3,dimethylpyrazine must not be more than 1% of the total medicine.
278	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%.
279	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%.
280	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%.
281	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%.
282	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%.
283	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%.
284	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%.
285	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%.
286	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%.
287	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%.
288	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%.
289	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%.
290	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%.
291	6-ETHYLIDENEOCTAHYDRO 5,8-METHANO-2H-1-BENZOPYRAN	E	6-Ethylideneoctahydro 5,8-methano-2H-1-benzopyran must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing 6-ethylideneoctahydro 5,8-methano-2H-1-benzopyran must not be more than 1% of the total medicine.
292	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%.
293	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%.
294	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%.
295	6-METHYL-2-BUTEN-3-OL-2	E
296	6-METHYLQUINOLINE	E	6-Methylquinoline must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of the flavour proprietary excipient formulation containing 6-methylquinoline must not be more than 5% of the total medicine.
297	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%.
298	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%.
299	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%.
300	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%.
301	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%.
302	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%.
303	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%.
304	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%.
305	ABELMOSCHUS MOSCHATUS	A, H
306	ABELMOSCHUS MOSCHATUS SUBSP. MOSCHATUS	A, H
307	ABIES BALSAMEA	A, H
308	ABIES NIGRA	A, H
309	ABIES PECTINATA	A, H
310	ABIES SIBIRICA	A, H
311	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.
312	ABUTILON THEOPHRASTI	A, H
313	ACACIA	A, E, H
314	ACACIA BAILEYANA	A, H
315	ACACIA CATECHU	A, H
316	ACACIA DEALBATA	A, H
317	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%.
318	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%.
319	ACACIA LONGIFOLIA	A, E, H
320	ACACIA NILOTICA	A, E, H
321	ACACIA SENEGAL	A, E, H
322	ACALYPHA INDICA	A, H
323	ACANTHUS MOLLIS	A, H
324	ACER CAMPESTRE	A, H
325	ACER NEGUNDO	A, H
326	ACER SACCHARINUM	A, H
327	ACER SACCHARUM	A, E, H
328	ACEROLA	E
329	ACESULFAME POTASSIUM	E
330	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%.
331	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%.
332	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%.
333	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%.
334	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%.
335	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%.
336	ACETIC ACID	E, H	The concentration in the medicine must be no more than 80%.
337	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%.
338	ACETOMENAPHTHONE	A, E
339	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%.
340	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%.
341	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%.
342	ACETOXYDIHYDRODICYCLOPENTADIENE	E	Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
343	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%.
344	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%.
345	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%.
346	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%.
347	ACETYL LEVOCARNITINE HYDROCHLORIDE	A, E
348	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%.
349	ACETYLATED LANOLIN	E	Only for use in topical medicines for dermal application.
350	ACETYLATED LANOLIN ALCOHOL	E	Only for use in topical medicines for dermal application.
351	ACETYLATED MONOGLYCERIDES	E
352	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%.
353	ACETYLCYSTEINE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.001%.
354	ACHILLEA ERBA-ROTTA SUBSP. MOSCHATA	A, H
355	ACHILLEA MILLEFOLIUM	A, E, H	Beta-arbutin is a mandatory component of Achillea millefolium. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
356	ACHILLEA PTARMICA	A, H
357	ACHYRANTHES ASPERA	A, H
358	ACHYRANTHES BIDENTATA	A, H
359	ACHYRANTHES FAURIEI	A, H
360	ACID GREEN 25	E	Permitted for use only as a colour for topical use.
361	ACID RED 33	E	Permitted for use only as a colour for topical use.
362	ACID RED 87	E, H	Only for use as an active homoeopathic ingredient or for excipient use as a colour in topical medicines.
363	ACID TREATED WAXY MAIZE STARCH	E
364	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%.
365	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.
366	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.
367	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.
368	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.
369	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%.
370	ACRYLAMIDES COPOLYMER	E	Only for use in topical medicines for dermal application.
371	ACRYLATES COPOLYMER	E	Only for use in topical medicines for dermal application.
372	ACRYLATES/ACRYLAMIDE COPOLYMER	E	Only for use in topical medicines for dermal application.
373	ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER	E	Only for use in topical medicines for dermal application.
374	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%.
375	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%.
376	ACRYLATES/OCTYLACRYLAMIDE COPOLYMER	E	Only for use in topical medicines for dermal application.
377	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%.
378	ACRYLATES/VA COPOLYMER	E	Only for use in topical medicines for dermal application.
379	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%.
380	ACTAEA CIMICIFUGA	A, H
381	ACTAEA HERACLEIFOLIA	A, H
382	ACTAEA PACHYPODA	A, H
383	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.'
384	ACTAEA SIMPLEX	A, H
385	ACTAEA SPICATA	A, H
386	ACTINIDIA CHINENSIS	A, H
387	ACTINIDIA DELICIOSA	A, H
388	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.
389	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).
390	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)'
391	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)'
392	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)'
393	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)'
394	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)'
395	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)'
396	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)'
397	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)'
398	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)'
399	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)'
400	ADENOPHORA STRICTA	A, H
401	ADENOPHORA TRIPHYLLA	A, H
402	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%.
403	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%.
404	ADENOSINE TRIPHOSPHATE	E	Only for use in topical medicines for dermal application.
405	ADENOSINE TRIPHOSPHATE DISODIUM	E	Only for use in topical medicines for dermal application.
406	ADIANTUM CAPILLUS-VENERIS	A, H
407	ADIPIC ACID	E
408	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%.
409	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%.
410	ADRENALINE (EPINEPHRINE)	H	Only for use as an active homoeopathic ingredient.
411	ADZUKI BEAN	E
412	AEGOPODIUM PODAGRARIA	A, H
413	AESCULUS CHINENSIS	A, H
414	AESCULUS GLABRA	A, H
415	AESCULUS HIPPOCASTANUM	A, H
416	AESCULUS X CARNEA	A, H
417	AETHUSA CYNAPIUM	H	Only for use as an active homoeopathic ingredient.
418	AGAR	A, E
419	AGASTACHE RUGOSA	A, H
420	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%.
421	AGAVE AMERICANA	A, E, H
422	AGRIMONIA EUPATORIA	A, E, H
423	AGRIMONIA REPENS	A, H
424	AGROSTIS TENUIS	A, H
425	AILANTHUS ALTISSIMA	A, H
426	AJUGA CHAMAEPITYS	A, H
427	AJUGA REPTANS	A, H
428	ALANINE	A, E
429	ALANYLGLUTAMINE	A	Only for use in oral medicines.
430	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.
431	ALBIZIA JULIBRISSIN	A, H
432	ALBIZIA LEBBECK	A, H
433	ALCEA ROSEA	A, H
434	ALCHEMILLA ALPINA	A, H
435	ALCHEMILLA ARVENSIS	A, H
436	ALCHEMILLA VULGARIS	A, H
437	ALETRIS FARINOSA	A, H
438	ALETRIS SPICATA	A, H
439	ALEURITES MOLUCCANUS SEED OIL	E	Only for use in topical medicines for dermal application.
440	ALFADEX	A, E	Only for use in oral medicines. The maximum daily dose must provide no more than 6 g of alfadex.
441	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 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).
442	ALGINIC ACID	E
443	ALISMA ORIENTALE	A, H
444	ALISMA PLANTAGO AQUATICA	A, H
445	ALKANNA TINCTORIA	A, H
446	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%.
447	ALLANTOIN	E	Only for use in topical medicines for dermal application.
448	ALLIARIA PETIOLATA	A, H
449	ALLIUM CEPA	A, H
450	ALLIUM FISTULOSUM	A, H
451	ALLIUM HIEROCHUNTINUM	A, H
452	ALLIUM MACROSTEMON	A, H
453	ALLIUM ODORUM	A, H
454	ALLIUM PORRUM	A, H
455	ALLIUM SATIVUM	A, E, H
456	ALLIUM SCHOENOPRASUM	A, H
457	ALLIUM URSINUM	A, H
458	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%.
459	ALLURA RED AC	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
460	ALLURA RED AC ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use.
461	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%.
462	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%.
463	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%.
464	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%.
465	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%.
466	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%.
467	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%.
468	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%.
469	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%.
470	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%.
471	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%.
472	ALMOND	E
473	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%.
474	ALNUS GLUTINOSA	A, H
475	ALNUS INCANA SUBSP. RUGOSA	A, H
476	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'.
477	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'.
478	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'.
479	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'.

480	ALOYSIA CITRODORA	A, H
481	ALPHA CASOZEPINE ENRICHED HYDROLYSED MILK PROTEIN	A	Only for use in oral medicines. The following warning statement is required on the medicine label: - (BABY3) 'Not suitable for use in children under the age of 12 months except on the advice of a health professional.’ (or words to that effect).
482	ALPHA LIPOIC ACID	A
483	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%.
484	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%.
485	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%.
486	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%.
487	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%.
488	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%.
489	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%.
490	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%.
491	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%.
492	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%.
493	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%.
494	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%.
495	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%.
496	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%.
497	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%.
498	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%.
499	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%.
500	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%.
501	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%.
502	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%.
503	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%.
504	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%.
505	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%.
506	ALPHA-SANTALOL	E	alpha-Santalol must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing alpha-santalol must not be more than 1% of the total medicine.
507	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%.
508	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%.
509	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%.
510	ALPINIA GALANGA	A, H
511	ALPINIA HAINANENSIS	A, H
512	ALPINIA OFFICINARUM	A, H
513	ALPINIA OXYPHYLLA	A, H
514	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.
515	ALSTONIA BOONEI	A, H
516	ALSTONIA CONSTRICTA	H	Only for use as an active homoeopathic ingredient.
517	ALTERNANTHERA PHILOXEROIDES	A, H
518	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%.
519	ALTHAEA OFFICINALIS	A, E, H
520	ALUM DODECAHYDRATE	A, E, H
521	ALUMINIUM CHLOROHYDRATE	E	Only for use in topical medicines for dermal application.
522	ALUMINIUM CITRATE	E	Only for use in topical medicines for dermal application.
523	ALUMINIUM DISTEARATE	E	Only for use in topical medicines for dermal application.
524	ALUMINIUM HYDROXIDE	E	Only for use in topical medicines for dermal application.
525	ALUMINIUM HYDROXIDE HYDRATE	E	Only for use in topical medicines for dermal application.
526	ALUMINIUM MAGNESIUM SILICATE	E	The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2021; or - released for supply after 1 March 2022. (a) Magnesium is a mandatory component of aluminium magnesium silicate. (b) When used in a medicine: (i) with an oral route of administration; (ii) not indicated for laxative (or related) use; and (iii) where the maximum recommended daily dose for: (A ) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts; (B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or (C) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label: - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect).  (c) When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.
527	ALUMINIUM MONOSTEARATE	E	Only for use in topical medicines for dermal application.
528	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.
529	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.
530	ALUMINIUM SODIUM SILICATE	E
531	ALUMINIUM STARCH OCTENYLSUCCINATE	E	The concentration in the medicine must be no more than 7%.
532	ALUMINIUM STEARATE	E	Only for use in topical medicines for dermal application.
533	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%.
534	AMARANTH	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
535	AMARANTH ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use
536	AMARANTHUS HYBRIDUS	A, H
537	AMARANTHUS RETROFLEXUS	A, H
538	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%.
539	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%.
540	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%.
541	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%.
542	AMBROSIA ARTEMISIIFOLIA	A, H
543	AMBROSIA PSILOSTACHYA	A, H
544	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%.
545	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%.
546	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%.
547	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%.
548	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%.
549	AMMONIO METHACRYLATE COPOLYMER	E	Only for use in oral medicines.
550	AMMONIUM ACRYLATES COPOLYMER	E	Only for use in topical medicines for dermal application.
551	AMMONIUM ACRYLATES/ACRYLONITROGENS COPOLYMER	E	Only for use in topical medicines for dermal application.
552	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%.
553	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%.
554	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.
555	AMMONIUM BROMIDE	H	Only for use as an active homoeopathic ingredient.
556	AMMONIUM CARBONATE	E, H	Only for use as an active homoeopathic or excipient ingredient.
557	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.
558	AMMONIUM GLYCYRRHIZINATE	E
559	AMMONIUM IODIDE	H	Only for use an active ingredient in homoeopathic medicines.
560	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%.
561	AMMONIUM LAURETH SULFATE	E	Only for use in topical medicines for dermal application.
562	AMMONIUM LAURYL SULFATE	E	Only for use in topical medicines for dermal application.
563	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%.
564	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%.
565	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%.
566	AMOMUM AROMATICUM	A, H
567	AMOMUM VILLOSUM	A, H
568	AMORPHOPHALLUS KONJAC	A, H	Only for use when the dosage form is not tablet.
569	AMPELODESMOS MAURITANICUS	A, H
570	AMPELOPSIS JAPONICA	A, H
571	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%.
572	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%.
573	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%.
574	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%.
575	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%.
576	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%.
577	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%.
578	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%.
579	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%.
580	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%.
581	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%.
582	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%.
583	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%.
584	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%.
585	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%.
586	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%.
587	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%.
588	AMYLASE	A	Amylase must be derived from Aspergillus oryzae, and comply with the relevant compositional guideline.
589	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%.
590	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%.
591	AMYRIS BALSAMIFERA	A, H
592	AMYRIS OIL WEST INDIAN	A, E, H
593	ANACARDIUM OCCIDENTALE	A, H
594	ANACYCLUS PYRETHRUM	A, H
595	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%.
596	ANAESTHETIC ETHER	H	Only for use as an active homoeopathic ingredient.
597	ANAGALLIS ARVENSIS	A, H
598	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%.
599	ANANAS COMOSUS	A, E, H
600	ANAPHALIS SINICA	A, H
601	ANDROGRAPHIS PANICULATA	A, H	The following warning statement is required on the label: - (ANDROG) ‘Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis), stop use and seek immediate medical attention’ (or words to that effect). The requirement specified in paragraph (a) below applies to medicines that contain the ingredient that are: - listed in the Register on or after 1 March 2021; or - released for supply after 1 March 2022. (a) When for oral use, the following warning statement is required on the medicine label: - (ANDROT) ‘Andrographis may cause taste disturbance including loss of taste. If you develop any adverse symptoms, stop use and seek medical advice’ (or words to that effect).
602	ANEMARRHENA ASPHODELOIDES	A, E, H
603	ANEMONE ALTAICA	A, H
604	ANEMONE CHINENSIS	A, H
605	ANEMONE HEPATICA	A, H
606	ANEMONE PULSATILLA	A, H
607	ANEMONE RADDEANA	A, H
608	ANETHOLE	E
609	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%.
610	ANETHUM GRAVEOLENS	A, E, H
611	ANGELICA ACUTILOBA	A, H
612	ANGELICA ANOMALA	A, H
613	ANGELICA ARCHANGELICA	A, E, H
614	ANGELICA ATROPURPUREA	A, H
615	ANGELICA DAHURICA	A, E, H
616	ANGELICA DECURSIVA	A, H
617	ANGELICA POLYMORPHA	A, E, H
618	ANGELICA PUBESCENS	A, E, H
619	ANGELICA ROOT DRY	A, H
620	ANGELICA ROOT OIL	A, E, H
621	ANGELICA SEED OIL	A, E, H
622	ANGELICA STEM	E
623	ANIBA ROSAEODORA	A, E, H
624	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%.
625	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%.
626	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)'
627	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%.
628	ANISEED DRY	A, E, H
629	ANISEED POWDER	A, E, H
630	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%.
631	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%.
632	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%.
633	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%.
634	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%.
635	ANNATTO	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
636	ANOGEISSUS LATIFOLIA	A, E, H
637	ANTENNARIA DIOICA	A, E, H
638	ANTHOCYANINS	E
639	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%.
640	ANTHRISCUS CEREFOLIUM	A, H
641	ANTHYLLIS VULNERARIA	A, H
642	ANTIMONY POTASSIUM TARTRATE TRIHYDRATE	H	Only for use as an active homoeopathic ingredient.
643	ANTIMONY TRISULFIDE	H	Only for use as an active homoeopathic ingredient.
644	APIUM GRAVEOLENS	A, E, H
645	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%.
646	APOMORPHINE HYDROCHLORIDE HEMIHYDRATE	H	Only for use as an active homoeopathic ingredient.
647	APPLE	E
648	APPLE CIDER VINEGAR	E
649	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%.
650	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%.
651	APPLE FIBRE	E
652	APRICOT	E
653	APRICOT KERNEL OIL PEG-6 ESTERS	E	Only for use as an excipient in topical medicines for dermal application.
654	AQUILARIA MALACCENSIS	A, H
655	AQUILARIA SINENSIS	A, H
656	AQUILEGIA VULGARIS	A, H
657	ARACHIDONIC ACID	E	Only for use in topical medicines for dermal application.
658	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%.
659	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%.
660	ARACHIDYL PROPIONATE	E	Only for use in topical medicines for dermal application.
661	ARACHIS HYPOGAEA	A, E, H
662	ARACHIS OIL	A, E, H
663	ARALIA CORDATA	A, H
664	ARALIA HISPIDA	A, H
665	ARALIA NUDICAULIS	A, H
666	ARALIA RACEMOSA	A, H
667	ARCTIUM LAPPA	A, E, H
668	ARCTIUM MINUS	A, H
669	ARCTOSTAPHYLOS UVA-URSI	A, E, H	Beta-arbutin is a mandatory component of Arctostaphylos uva-ursi. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
670	ARDISIA JAPONICA	A, H
671	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%.
672	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.
673	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.'
674	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%.
675	ARISAEMA ATRORUBENS	A, H	The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
676	ARISAEMA CONSANGUINEUM	A, H	The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
677	ARISAEMA JAPONICUM	A, H	The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
678	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).
679	ARNEBIA EUCHROMA	A, H
680	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.
681	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.
682	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.
683	ARRHENATHERUM ELATIUS	A, H
684	ARROWROOT	A, E, H
685	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%.
686	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%.
687	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%.
688	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%.
689	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%.
690	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%.
691	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%.
692	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%.
693	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%.
694	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%.
695	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%.
696	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%.
697	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%.
698	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%.
699	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%.
700	ARTERY	H	Only for use as an active homoeopathic ingredient.
701	ARTHROSPIRA MAXIMA	A, E, H
702	ARTHROSPIRA PLATENSIS	A, E, H
703	ARUM MACULATUM	A, H	The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
704	ASAFOETIDA GUM	A, H
705	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%.
706	ASARUM EUROPAEUM	A, H
707	ASARUM HETEROTROPOIDES	A, H
708	ASARUM OIL	E
709	ASARUM SIEBOLDII	A, E, H
710	ASCLEPIAS TUBEROSA	A, H
711	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.
712	ASCORBIC ACID	A, E
713	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%.
714	ASCORBYL METHYLSILANOL PECTINATE	E	Only for use in topical medicines for dermal application.
715	ASCORBYL PALMITATE	A, E	When for oral use, the maximum recommended daily dose must contain no more than 100mg of ascorbyl palmitate.
716	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%.
717	ASPALATHUS LINEARIS	A, E, H
718	ASPARAGINE	A, E
719	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%.
720	ASPARAGUS	E, H	Only for use as an active homoeopathic or excipient ingredient.
721	ASPARAGUS COCHINCHINENSIS	A, H
722	ASPARAGUS OFFICINALIS	A, E, H
723	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.
724	ASPARTAME	E
725	ASPARTIC ACID	A, E
726	ASPERGILLUS ORYZAE	A, E, H
727	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).
728	ASTER TATARICUS	A, H
729	ASTRAGALUS ADSURGENS	A, H
730	ASTRAGALUS COMPLANATUS	A, H
731	ASTRAGALUS EXCARPUS	A, H
732	ASTRAGALUS GUMMIFER	A, E, H
733	ASTRAGALUS LENTIGINOSUS	A, H
734	ASTRAGALUS MEMBRANACEUS	A, E, H
735	ASTRAGALUS PENDULIFLORUS	A, H
736	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%.

5030	TRILISA ODORATISSIMA	A, H
5031	TRILLIUM ERECTUM	A, H
5032	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%.
5033	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%.
5034	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%.
5035	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%.
5036	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%.
5037	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%.
5038	TRIMETHYLOPROPANE TRIOCTANOATE	E	Only for use in topical medicines for dermal application.
5039	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%.
5040	TRIMETHYLSILOXYSILICATE	E	Only for use in topical medicines for dermal application.
5041	TRINITROPHENOL	H	Only for use as an active homoeopathic ingredient.
5042	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%.
5043	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%.
5044	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%.
5045	TRIOSTEUM PERFOLIATUM	A, H
5046	TRIOXAUNDECANEDIOIC ACID	E
5047	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%.
5048	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%.
5049	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 not be more than 10%. When used topically, the dosage form must not be spray. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
5050	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%.
5051	TRISODIUM EDETATE	E	Only for use in topical medicines for dermal application.
5052	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%.
5053	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%.
5054	TRISTEARIN	E
5055	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.
5056	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.
5057	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%.
5058	TROLAMINE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%.
5059	TROLAMINE LAURIL SULFATE	E	Only for use in topical medicines for dermal application.
5060	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 not be more than 12%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
5061	TROLLIUS CHINENSIS	A, H
5062	TROMETAMOL	E
5063	TROMETAMOL HYDROCHLORIDE	E
5064	TROPAEOLUM MAJUS	A, E, H
5065	TROPICAL RATTLESNAKE	H	Only for use as an active homoeopathic ingredient.
5066	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%.
5067	TSUGA CANADENSIS	A, H
5068	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%.
5069	TURMERIC	E	Permitted for use only in combination with other permitted ingredients as a colour.
5070	TURNERA DIFFUSA	A, E, H	Beta-arbutin is a mandatory component of Turnera diffusa. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
5071	TURNIP	E
5072	TURPENTINE OIL	A, E	The concentration in the medicine must be no more than 25%.
5073	TYPHA ANGUSTIFOLIA	A, H
5074	TYPHA LATIFOLIA	A, H
5075	TYPHONIUM GIGANTEUM	A, H
5076	TYROSINE	A, E

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
5077	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'.
5078	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.'
5079	ULEX EUROPAEUS	A, H
5080	ULMUS AMERICANA	A, H
5081	ULMUS CAMPESTRIS	A, H
5082	ULMUS GLABRA	A, H
5083	ULMUS MINOR	A, H
5084	ULMUS PARVIFOLIA	A, H
5085	ULMUS PUMILA	A, H
5086	ULMUS RUBRA	A, H
5087	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%.
5088	ULTRAMARINE BLUE	E	Permitted for use only as a colour for topical use.
5089	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%.
5090	UMBELLULARIA CALIFORNICA	A, H
5091	UNCARIA GAMBIR	A, H
5092	UNCARIA RHYNCOPHYLLA	A, H
5093	UNCARIA SINENSIS	A, H
5094	UNCARIA TOMENTOSA	A, H
5095	UNDARIA PINNATIFIDA	A, H	Whole dried Undaria pinnatifida must not contain the holdfast. Only for use in oral medicines.
5096	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%.
5097	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%.
5098	UNDECENOIC ACID	E
5099	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%.
5100	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%.
5101	UNDECYLENAMIDE DEA	E
5102	UNDECYLENOYL PEG-5 PARABEN	E	Only for use in topical medicines for dermal application.
5103	URANIUM NITRATE	H	Only for use as an active homoeopathic ingredient.
5104	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).
5105	URTICA DIOICA	A, E, H
5106	URTICA URENS	A, H
5107	USNEA BARBATA	A, H
5108	UVA URSI LEAF DRY	A, H
5109	UVA URSI LEAF POWDER	A, E, H
5110	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%.
5111	VACCARIA SEGATALIS	A, H
5112	VACCINIUM BRACTEATUM	A, H
5113	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%.
5114	VACCINIUM MACROCARPON	A, E, H
5115	VACCINIUM MYRTILLOIDES	A, H
5116	VACCINIUM MYRTILLUS	A, E, H
5117	VACCINIUM OXYCOCCUS	A, H
5118	VACCINIUM VITIS-IDAEA	A, H	Beta-arbutin is a mandatory component of Vaccinium vitis-idaea. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
5119	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%.
5120	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%.
5121	VALERIAN DRY	A, H
5122	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%.
5123	VALERIAN POWDER	A, H
5124	VALERIANA EDULIS	A, H
5125	VALERIANA OFFICINALIS	A, H
5126	VALERIANA SORBIFOLIA	A, H
5127	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%.
5128	VALINE	A, E
5129	VANADIUM	H
5130	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%.
5131	VANILLA DRY	A, E, H
5132	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%.
5133	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%.
5134	VANILLA PLANIFOLIA	A, E, H
5135	VANILLA POWDER	A, E, H
5136	VANILLA TAHITENSIS	A, H
5137	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%.
5138	VANILLIN	E
5139	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%.
5140	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%.
5141	VAT RED 1	E	Permitted for use only as a colour for topical use.
5142	VAT RED 1 ALUMINIUM LAKE	E	Permitted for use only as a colour for topical use.
5143	VAT RED 5	E	Permitted for use only as a colour for topical use.
5144	VEGETABLE OIL	E
5145	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).'
5146	VEIN	H	Only for use as an active homoeopathic ingredient.
5147	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%.
5148	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%.
5149	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%.
5150	VERBASCUM DENSIFLORUM	A, H
5151	VERBASCUM THAPSUS	A, H
5152	VERBENA OFFICINALIS	A, H
5153	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%.
5154	VERONICA CHAMAEDRYS	A, H
5155	VERONICA OFFICINALIS	A, H
5156	VERONICASTRUM VIRGINICUM	A, E, H
5157	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%.
5158	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%.
5159	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%.
5160	VIBURNUM OPULUS	A, E, H
5161	VIBURNUM PRUNIFOLIUM	A, E, H
5162	VICIA FABA	A, H	Levodopa is a mandatory component of Vicia faba. The concentration of levodopa in the  medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
5163	VIGNA ANGULARIS VAR. ANGULARIS	A, H
5164	VIGNA RADIATA	A, H
5165	VIGNA UMBELLATA	A, H
5166	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%.
5167	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%
5168	VINCETOXICUM OFFICINALE	A, H
5169	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%.
5170	VIOLA ODORATA	A, E, H
5171	VIOLA TRICOLOR	A, H
5172	VIOLA YEDOENSIS	A, H
5173	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%.
5174	VIPER	H	Only for use as an active homoeopathic ingredient.
5175	VISCUM ALBUM	A, E, H
5176	VISCUM COLORATUM	A, H
5177	VISCUM FLAVESCENS	A, H
5178	VITELLARIA PARADOXA	A, E, H
5179	VITEX AGNUS-CASTUS	A, E, H	When the ingredient is in a medicine that is for internal use and is listed in the Register on or after 2 March 2020, or that is released for supply after 2 March 2021, the following warning statement is required on the label: - (VAC) 'Vitex agnus-castus may affect hormones and medicines such as oral contraceptives. Consult your health professional before use' (or words to that effect).
5180	VITEX NEGUNDO	A, H
5181	VITEX ROTUNDIFOLIA	A, H
5182	VITEX TRIFOLIA	A, H
5183	VITIS VINIFERA	A, E, H
5184	VITREOSCILLA CONCENTRATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%.
5185	VP/ACRYLATES/LAURYL 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 not be more than 2.00%.
5186	WAHLENBERGIA GRACILIS	A, H
5187	WALNUT	E
5188	WALNUT OIL	E
5189	WATER MELON	E
5190	WHEAT	E	Gluten is a mandatory component of Wheat when the route of administration is other than topical and mucosal.
5191	WHEAT BRAN	E	Gluten is a mandatory component of Wheat bran when the route of administration is other than topical and mucosal.
5192	WHEAT DEXTRIN	A, E	Gluten is a mandatory component of wheat dextrin. Only for use when the dosage form is capsule, tablet or pill.
5193	WHEAT GERM	E	Gluten is a mandatory component of Wheat germ when the route of administration is other than topical and mucosal.
5194	WHEAT GERM GLYCERIDES	E	Gluten is a mandatory component of wheat germ glycerides when the route of administration is other than topical and mucosal.
5195	WHEAT LEAF	E
5196	WHEAT SPROUT	E	Gluten is a mandatory component of Wheat sprout when the route of administration is other than topical and mucosal.
5197	WHEAT STARCH	E	When the route of administration is other than topical or mucosal, gluten is a mandatory component of wheat starch.
5198	WHEATGERM OIL	A, E, H
5199	WHEY POWDER	E	Lactose is a mandatory component of Whey powder when the route of administration is oral.
5200	WHEY PROTEIN	E	Lactose is a mandatory component of Whey protein when the route of administration is oral.
5201	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%.
5202	WHITE BEESWAX	E
5203	WHITE HOREHOUND HERB DRY	A, H
5204	WHITE HOREHOUND HERB POWDER	A, H
5205	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.
5206	WHOLE DRY MILK	E
5207	WIKSTROEMIA VIRIDIFLORA	A, H
5208	WILD CARROT HERB DRY	A, E, H
5209	WILD CARROT HERB POWDER	A, H
5210	WILD CHERRY BARK DRY	A, H
5211	WILD CHERRY BARK POWDER	A, H
5212	WILD LETTUCE LEAF DRY	A, H
5213	WILD LETTUCE LEAF POWDER	A, H
5214	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. The following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect). When for use in topical medicines for dermal application: i) the concentration of methyl salicylate in the medicine must not be more than 25%; ii) the following warning statements are required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect); - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less'; - (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect); - (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect); iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label: - (IRRIT) 'If irritation develops, discontinue use'.
5215	WITHANIA SOMNIFERA	A, E, H	The requirements specified in paragraph (a) below apply in relation to a medicine that contains the ingredient that: - is listed in the Register on or after 2 March 2020; or - is released for supply after 2 March 2021. (a) The medicine requires the following warning statement on the label: - (WITHANIA) 'If you are pregnant, or considering becoming pregnant, do not take without consulting a health professional' (or words to that effect) unless: (i) the plant part is root; (ii) the plant preparation is an extract; (iii) the extraction solvents are only water, ethanol or methanol; and (iv) the maximum recommended daily dose of the medicine contains no more than the equivalent quantity of 12 g dry root.
5216	WOLFIPORIA COCOS	A, E, H
5217	WOOL ALCOHOLS	E	Only for use in topical medicines for dermal application.
5218	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.
5219	XANTHAN GUM	E
5220	XANTHIUM SIBIRICUM	A, H
5221	XANTHIUM STRUMARIUM	A, H
5222	XANTHOMONA CAMPESTRIS	A, H
5223	XEROPHYLLUM ASPHODELOIDES	A, H
5224	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%.
5225	XYLITOL	E
5226	XYLOSE	E
5227	YAM	E
5228	YARROW HERB DRY	A, H
5229	YARROW HERB POWDER	A, H
5230	YEAST AUTOLYSATE	E
5231	YEAST DRIED	A, E, H
5232	YELLOW 2G	E	Permitted for use only as a colour for topical use.
5233	YELLOW BEESWAX	E
5234	YELLOW MERCURIC OXIDE	H	Only for use as an active homoeopathic ingredient.
5235	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.
5236	YLANG YLANG OIL	A, E, H
5237	YUCCA BACCATA	A, H
5238	YUCCA ELATA	A, H
5239	YUCCA FILAMENTOSA	A, H
5240	YUCCA GLORIOSA	A, H
5241	ZANTHOXYLUM AMERICANUM	A, H
5242	ZANTHOXYLUM BUNGEANUM	A, E, H
5243	ZANTHOXYLUM CLAVA-HERCULIS	A, H
5244	ZANTHOXYLUM NITIDUM	A, H
5245	ZANTHOXYLUM PIPERITUM	A, H
5246	ZANTHOXYLUM SIMULANS	A, H
5247	ZEA MAYS	A, E, H
5248	ZEAXANTHIN	A, E
5249	ZEIN	E
5250	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)'.
5251	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).'
5252	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).'
5253	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)'.
5254	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).'
5255	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).'
5256	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).'
5257	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).'
5258	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).'
5259	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).'
5260	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).'
5261	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)'.
5262	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'.
5263	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'.
5264	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).'
5265	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).'
5266	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%.
5267	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, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

5268	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).
5269	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.
5270	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).'
5271	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).'
5272	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).'
5273	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).'
5274	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).'
5275	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.
5276	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%.
5277	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'.
5278	ZIZIPHUS JUJUBA	A, H
5279	ZIZIPHUS JUJUBA VAR. SPINOSA	A, H
5280	ZIZYPHUS SATIVA	A, H
5281	ZOSTERA MARINA	A, H
5282	ZUCCHINI	E

Schedule 2—Repeals

Note:       See section 7.

Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2020

1  The whole of the instrument

Repeal the instrument.