Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2020 (Cth)

Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2020

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

Dated 19 February 2020

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.............................................................................................................. 1087

Note:       This instrument is in 6 volumes:

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

Schedule 1     (1,7,7-TRIMETHYLBICYCLO(2.2.1)HEPT-2-YL)-CYCLOHEXANOL)–AZULENE (pages 5 -138)

Volume 2:     Schedule 1     BACILLUS COAGULANS –EVERNIA PRUNASTRI EXTRACT (pages 139-437)

Volume 3:     Schedule 1     FABIANA IMBRICATA–JUSTICIA ADHATODA
(pages 438-585)

Volume 4:     Schedule 1     KADSURA COCCINEA–OYSTER SHELL (pages 586-743)

Volume 5:     Schedule 1     P-ALPHA-DIMETHYL STYRENE–TYROSINE
(pages 744-1047)

Volume 6:     Schedule 1     UBIDECARENONE–ZUCCHINI (pages 1048-1086)

Schedule 2     (page 1087)

1  Name

This instrument is the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2020.

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	2 March 2020.	2 March 2020

Note:          This table relates only to the provisions of this instrument as originally made.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

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

3  Authority

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

4  Interpretation

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

(a)    British Pharmacopoeia;

(b)    European Pharmacopoeia;

(c)    medicine;

(d)    Register; and

(e)    United States Pharmacopeia-National Formulary.

(1)  In this instrument:

Act means the Therapeutic Goods Act 1989.

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

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

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

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

homoeopathic preparation has the same meaning as in the Regulations.

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

Regulations means the Therapeutic Goods Regulations 1990.

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

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

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

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

Note:          Examples of these terms include the following:

(a)    (ARGIN1);

(b)    (CHILD3);

(c)    (GLUTEN);

(d)    (PEANUT); and

(e)    (PREGNT).

5  Permissible ingredients

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

6  Requirements in relation to permissible ingredients being contained in medicine

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

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

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

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

7  Repeals

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

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

Note:       See sections 5 and 6.

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

120	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%.
121	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%.
122	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%.
123	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%.
124	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%.
125	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%.
126	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%.
127	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%.
128	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%.
129	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%.
130	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%.
131	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%.
132	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%.
133	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%.
134	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%.
135	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%.
136	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%.
137	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%.
138	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%.
139	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%.
140	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%.
141	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%.
142	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%.
143	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%.
144	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.
145	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%.
146	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%.
147	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%.
148	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%.
149	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%.
150	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%.
151	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%.
152	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%.
153	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%.
154	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%.
155	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%.
156	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%.
157	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%.
158	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%.
159	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%.
160	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%.
161	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%.
162	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%.
163	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%.
164	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%.
165	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%.
166	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%.
167	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%.
168	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%.
169	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%.
170	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%.
171	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%.
172	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%.
173	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%.
174	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%.
175	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%.
176	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%.
177	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%.
178	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%.
179	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%.
180	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%.
181	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%.
182	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%.
183	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%.
184	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%.
185	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%.
186	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%.
187	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%.
188	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%.
189	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%.
190	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%.
191	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%.
192	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%.
193	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%.
194	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%.
195	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%.
196	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%.
197	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%.
198	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%.
199	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%.
200	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%.
201	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%.
202	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%.
203	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%.
204	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%.
205	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%.
206	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%.
207	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%.
208	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%.
209	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%.
210	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%.
211	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%.
212	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%.
213	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%.
214	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%.
215	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%.
216	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%.
217	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%.
218	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%.
219	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%.
220	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%.
221	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%.
222	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%.
223	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%.
224	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%.
225	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%.
226	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%.
227	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%.
228	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%.
229	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%.
230	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%.
231	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%.
232	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%.
233	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 supplied after 2 March 2021.
234	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%.
235	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%.
236	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%.
237	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%.
238	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%.
239	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%.
240	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%.
241	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%.
242	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%.
243	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%.
244	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%.
245	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%.
246	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%.
247	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%.
248	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%.
249	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%.
250	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%.
251	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).
252	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%.
253	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%.
254	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%.
255	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%.
256	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%.
257	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%.
258	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%.
259	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%.
260	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%.
261	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%.
262	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%.
263	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%.
264	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%.
265	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%.
266	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%.
267	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%.
268	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%.
269	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%.
270	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%.
271	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%.
272	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%.
273	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%.
274	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%.
275	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%.
276	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%.
277	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%.

278	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%.
279	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%.
280	6-METHYL-2-BUTEN-3-OL-2	E
281	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%.
282	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%.
283	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%.
284	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%.
285	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%.
286	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%.
287	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%.
288	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%.
289	ABELMOSCHUS MOSCHATUS	A, H
290	ABELMOSCHUS MOSCHATUS SUBSP. MOSCHATUS	A, H
291	ABIES BALSAMEA	A, H
292	ABIES NIGRA	A, H
293	ABIES PECTINATA	A, H
294	ABIES SIBIRICA	A, H
295	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.
296	ABUTILON THEOPHRASTI	A, H
297	ACACIA	A, E, H
298	ACACIA BAILEYANA	A, H
299	ACACIA CATECHU	A, H
300	ACACIA DEALBATA	A, H
301	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%.
302	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%.
303	ACACIA LONGIFOLIA	A, E, H
304	ACACIA NILOTICA	A, E, H
305	ACACIA SENEGAL	A, E, H
306	ACALYPHA INDICA	A, H
307	ACANTHUS MOLLIS	A, H
308	ACER CAMPESTRE	A, H
309	ACER NEGUNDO	A, H
310	ACER SACCHARINUM	A, H
311	ACER SACCHARUM	A, E, H
312	ACEROLA	E
313	ACESULFAME POTASSIUM	E
314	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%.
315	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%.
316	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%.
317	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%.
318	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%.
319	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%.
320	ACETIC ACID	E, H	The concentration in the medicine must be no more than 80%.
321	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%.
322	ACETOMENAPHTHONE	A, E
323	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%.
324	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%.
325	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%.
326	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%.
327	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%.
328	ACETYL GLUCOSAMINE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. If the ingredient is sourced from seafood, then the medicine requires the following warning statement on the medicine label: - (SFOOD) 'Derived from seafood'
329	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%.
330	ACETYL LEVOCARNITINE HYDROCHLORIDE	A, E
331	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%.
332	ACETYLATED LANOLIN	E	Only for use in topical medicines for dermal application.
333	ACETYLATED LANOLIN ALCOHOL	E	Only for use in topical medicines for dermal application.
334	ACETYLATED MONOGLYCERIDES	E
335	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%.
336	ACETYLCYSTEINE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.001%.
337	ACHILLEA ERBA-ROTTA SUBSP. MOSCHATA	A, H
338	ACHILLEA MILLEFOLIUM	A, E, H	Arbutin is a mandatory component of Achillea millefolium. The concentration of arbutin in the medicine must be no more than 25 mg/Kg or 25mg /L or 0.0025 % unless used on the hair. When for use on hair, the concentration of arbutin in the medicine must be no more than 0.74 %.
339	ACHILLEA PTARMICA	A, H
340	ACHYRANTHES ASPERA	A, H
341	ACHYRANTHES BIDENTATA	A, H
342	ACHYRANTHES FAURIEI	A, H
343	ACID GREEN 25	E	Permitted for use only as a colour for topical use.
344	ACID RED 33	E	Permitted for use only as a colour for topical use.
345	ACID RED 87	E, H	Only for use as an active homoeopathic ingredient or for excipient use as a colour in topical medicines.
346	ACID TREATED WAXY MAIZE STARCH	E
347	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%.
348	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.
349	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.
350	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.
351	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.
352	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%.
353	ACRYLAMIDES COPOLYMER	E	Only for use in topical medicines for dermal application.
354	ACRYLATES COPOLYMER	E	Only for use in topical medicines for dermal application.
355	ACRYLATES/ACRYLAMIDE COPOLYMER	E	Only for use in topical medicines for dermal application.
356	ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER	E	Only for use in topical medicines for dermal application.
357	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%.
358	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%.
359	ACRYLATES/OCTYLACRYLAMIDE COPOLYMER	E	Only for use in topical medicines for dermal application.
360	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%.
361	ACRYLATES/VA COPOLYMER	E	Only for use in topical medicines for dermal application.
362	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%.
363	ACTAEA CIMICIFUGA	A, H
364	ACTAEA HERACLEIFOLIA	A, H
365	ACTAEA PACHYPODA	A, H
366	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.'
367	ACTAEA SIMPLEX	A, H
368	ACTAEA SPICATA	A, H
369	ACTINIDIA CHINENSIS	A, H
370	ACTINIDIA DELICIOSA	A, H
371	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.
372	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).
373	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)'
374	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)'
375	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)'
376	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)'
377	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)'
378	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)'
379	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)'
380	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)'
381	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)'
382	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)'
383	ADENOPHORA STRICTA	A, H
384	ADENOPHORA TRIPHYLLA	A, H
385	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%.
386	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%.
387	ADENOSINE TRIPHOSPHATE	E	Only for use in topical medicines for dermal application.
388	ADENOSINE TRIPHOSPHATE DISODIUM	E	Only for use in topical medicines for dermal application.
389	ADIANTUM CAPILLUS-VENERIS	A, H
390	ADIPIC ACID	E
391	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%.
392	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%.
393	ADRENALINE (EPINEPHRINE)	H	Only for use as an active homoeopathic ingredient.
394	ADZUKI BEAN	E
395	AEGOPODIUM PODAGRARIA	A, H
396	AESCULUS CHINENSIS	A, H
397	AESCULUS GLABRA	A, H
398	AESCULUS HIPPOCASTANUM	A, H
399	AESCULUS X CARNEA	A, H
400	AETHUSA CYNAPIUM	H	Only for use as an active homoeopathic ingredient.
401	AGAR	A, E
402	AGASTACHE RUGOSA	A, H
403	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%.
404	AGAVE AMERICANA	A, E, H
405	AGRIMONIA EUPATORIA	A, E, H
406	AGRIMONIA REPENS	A, H
407	AGROSTIS TENUIS	A, H
408	AILANTHUS ALTISSIMA	A, H
409	AJUGA CHAMAEPITYS	A, H
410	AJUGA REPTANS	A, H
411	ALANINE	A, E
412	ALANYLGLUTAMINE	A	Only for use in oral medicines.
413	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.
414	ALBIZIA JULIBRISSIN	A, H
415	ALBIZIA LEBBECK	A, H
416	ALCEA ROSEA	A, H
417	ALCHEMILLA ALPINA	A, H
418	ALCHEMILLA ARVENSIS	A, H
419	ALCHEMILLA VULGARIS	A, H
420	ALETRIS FARINOSA	A, H
421	ALETRIS SPICATA	A, H
422	ALEURITES MOLUCCANUS SEED OIL	E	Only for use in topical medicines for dermal application.
423	ALFADEX	A, E	Only for use in oral medicines. The maximum daily dose must provide no more than 6 g of alfadex.
424	ALGINATE-KONJAC-XANTHAN POLYSACCHARIDE COMPLEX	A	Only for use in oral medicines. Only for use when the dosage form is other than tablet. The maximum recommended daily dose must be no more than 13.5 g. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’ When a dose for children is stated, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect).
425	ALGINIC ACID	E
426	ALISMA ORIENTALE	A, H
427	ALISMA PLANTAGO AQUATICA	A, H
428	ALKANNA TINCTORIA	A, H
429	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%.
430	ALLANTOIN	E	Only for use in topical medicines for dermal application.
431	ALLIARIA PETIOLATA	A, H
432	ALLIUM CEPA	A, H
433	ALLIUM FISTULOSUM	A, H
434	ALLIUM HIEROCHUNTINUM	A, H
435	ALLIUM MACROSTEMON	A, H
436	ALLIUM ODORUM	A, H
437	ALLIUM PORRUM	A, H
438	ALLIUM SATIVUM	A, E, H
439	ALLIUM SCHOENOPRASUM	A, H
440	ALLIUM URSINUM	A, H
441	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%.
442	ALLURA RED AC	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
443	ALLURA RED AC ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use.
444	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%.
445	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%.
446	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%.
447	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%.
448	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%.
449	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%.
450	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%.
451	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%.
452	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%.
453	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%.
454	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%.
455	ALMOND	E
456	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%.
457	ALNUS GLUTINOSA	A, H
458	ALNUS INCANA SUBSP. RUGOSA	A, H
459	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'.
460	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'.
461	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'.
462	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'.
463	ALOYSIA CITRODORA	A, H
464	ALPHA CASOZEPINE ENRICHED HYDROLYSED MILK PROTEIN	A	Only for use in oral medicines. The medicine requires the following warning statements on the medicine label: - (BABY3) 'Not suitable for use in children under the age of twelve months - except on professional advice' - (COWMK) 'Derived from cow's milk.'
465	ALPHA LIPOIC ACID	A
466	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%.
467	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%.
468	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%.
469	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%.
470	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%.
471	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%.
472	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%.
473	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%.
474	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%.
475	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%.
476	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%.
477	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%.
478	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%.
479	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%.
480	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%.
481	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%.
482	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%.
483	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%.

484	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%.
485	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%.
486	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%.
487	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%.
488	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%.
489	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%.
490	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%.
491	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%.
492	ALPINIA GALANGA	A, H
493	ALPINIA HAINANENSIS	A, H
494	ALPINIA OFFICINARUM	A, H
495	ALPINIA OXYPHYLLA	A, H
496	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.
497	ALSTONIA BOONEI	A, H
498	ALSTONIA CONSTRICTA	H	Only for use as an active homoeopathic ingredient.
499	ALTERNANTHERA PHILOXEROIDES	A, H
500	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%.
501	ALTHAEA OFFICINALIS	A, E, H
502	ALUM DODECAHYDRATE	A, E, H
503	ALUMINIUM CHLOROHYDRATE	E	Only for use in topical medicines for dermal application.
504	ALUMINIUM CITRATE	E	Only for use in topical medicines for dermal application.
505	ALUMINIUM DISTEARATE	E	Only for use in topical medicines for dermal application.
506	ALUMINIUM HYDROXIDE	E	Only for use in topical medicines for dermal application.
507	ALUMINIUM HYDROXIDE HYDRATE	E	Only for use in topical medicines for dermal application.
508	ALUMINIUM MAGNESIUM SILICATE	E
509	ALUMINIUM MONOSTEARATE	E	Only for use in topical medicines for dermal application.
510	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.
511	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.
512	ALUMINIUM SODIUM SILICATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’
513	ALUMINIUM STARCH OCTENYLSUCCINATE	E	The concentration in the medicine must be no more than 7%.
514	ALUMINIUM STEARATE	E	Only for use in topical medicines for dermal application.
515	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%.
516	AMARANTH	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
517	AMARANTH ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use
518	AMARANTHUS HYBRIDUS	A, H
519	AMARANTHUS RETROFLEXUS	A, H
520	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%.
521	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%.
522	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%.
523	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%.
524	AMBROSIA ARTEMISIIFOLIA	A, H
525	AMBROSIA PSILOSTACHYA	A, H
526	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%.
527	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%.
528	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%.
529	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%.
530	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%.
531	AMMONIO METHACRYLATE COPOLYMER	E	Only for use in oral medicines.
532	AMMONIUM ACRYLATES COPOLYMER	E	Only for use in topical medicines for dermal application.
533	AMMONIUM ACRYLATES/ACRYLONITROGENS COPOLYMER	E	Only for use in topical medicines for dermal application.
534	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%.
535	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%.
536	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.
537	AMMONIUM BROMIDE	H	Only for use as an active homoeopathic ingredient.
538	AMMONIUM CARBONATE	E, H	Only for use as an active homoeopathic or excipient ingredient.
539	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.
540	AMMONIUM GLYCYRRHIZINATE	E
541	AMMONIUM IODIDE	H	Only for use an active ingredient in homoeopathic medicines.
542	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%.
543	AMMONIUM LAURETH SULFATE	E	Only for use in topical medicines for dermal application.
544	AMMONIUM LAURYL SULFATE	E	Only for use in topical medicines for dermal application.
545	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%.
546	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%.
547	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%.
548	AMOMUM AROMATICUM	A, H
549	AMOMUM VILLOSUM	A, H
550	AMORPHOPHALLUS KONJAC	A, H	Only for use when the dosage form is not tablet.
551	AMPELODESMOS MAURITANICUS	A, H
552	AMPELOPSIS JAPONICA	A, H
553	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%.
554	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%.
555	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%.
556	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%.
557	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%.
558	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%.
559	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%.
560	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%.
561	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%.
562	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%.
563	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%.
564	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%.
565	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%.
566	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%.
567	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%.
568	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%.
569	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%.
570	AMYLASE	A	Amylase must be derived from Aspergillus oryzae, and comply with the relevant compositional guideline. When used in a divided preparation, the allowed unit is Alpha-amylase dextrinising unit or Thousand alpha-amylase dextrinising unit. When used as an undivided preparation, the allowed unit is Thousand alpha-amylase dextrinising unit per gram or Dextrinising unit per gram.
571	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%.
572	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%.
573	AMYRIS BALSAMIFERA	A, H
574	AMYRIS OIL WEST INDIAN	A, E, H
575	ANACARDIUM OCCIDENTALE	A, H
576	ANACYCLUS PYRETHRUM	A, H
577	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%.
578	ANAESTHETIC ETHER	H	Only for use as an active homoeopathic ingredient.
579	ANAGALLIS ARVENSIS	A, H
580	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%.
581	ANANAS COMOSUS	A, E, H
582	ANAPHALIS SINICA	A, H
583	ANDROGRAPHIS PANICULATA	A, H	When the ingredient is in a medicine that is listed in the Register on or after 1 January 2020, or that is supplied after 2 May 2020, 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).
584	ANEMARRHENA ASPHODELOIDES	A, E, H
585	ANEMONE ALTAICA	A, H
586	ANEMONE CHINENSIS	A, H
587	ANEMONE HEPATICA	A, H
588	ANEMONE PULSATILLA	A, H
589	ANEMONE RADDEANA	A, H
590	ANETHOLE	E
591	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%.
592	ANETHUM GRAVEOLENS	A, E, H
593	ANGELICA ACUTILOBA	A, H
594	ANGELICA ANOMALA	A, H
595	ANGELICA ARCHANGELICA	A, E, H
596	ANGELICA ATROPURPUREA	A, H
597	ANGELICA DAHURICA	A, E, H
598	ANGELICA DECURSIVA	A, H
599	ANGELICA POLYMORPHA	A, E, H
600	ANGELICA PUBESCENS	A, E, H
601	ANGELICA ROOT DRY	A, H
602	ANGELICA ROOT OIL	A, E, H
603	ANGELICA SEED OIL	A, E, H
604	ANGELICA STEM	E
605	ANIBA ROSAEODORA	A, E, H
606	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%.
607	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%.
608	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)'
609	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%.
610	ANISEED DRY	A, E, H
611	ANISEED POWDER	A, E, H
612	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%.
613	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%.
614	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%.
615	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%.
616	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%.
617	ANNATTO	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
618	ANOGEISSUS LATIFOLIA	A, E, H
619	ANTENNARIA DIOICA	A, E, H
620	ANTHOCYANINS	E
621	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%.
622	ANTHRISCUS CEREFOLIUM	A, H
623	ANTHYLLIS VULNERARIA	A, H
624	ANTIMONY POTASSIUM TARTRATE TRIHYDRATE	H	Only for use as an active homoeopathic ingredient.
625	ANTIMONY TRISULFIDE	H	Only for use as an active homoeopathic ingredient.
626	APIUM GRAVEOLENS	A, E, H
627	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%.
628	APOMORPHINE HYDROCHLORIDE HEMIHYDRATE	H	Only for use as an active homoeopathic ingredient.
629	APPLE	E
630	APPLE CIDER VINEGAR	E
631	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%.
632	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%.
633	APPLE FIBRE	E
634	APRICOT	E
635	APRICOT KERNEL OIL PEG-6 ESTERS	E	Only for use as an excipient in topical medicines for dermal application.
636	AQUILARIA MALACCENSIS	A, H
637	AQUILARIA SINENSIS	A, H
638	AQUILEGIA VULGARIS	A, H
639	ARACHIDONIC ACID	E	Only for use in topical medicines for dermal application.
640	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%.
641	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%.
642	ARACHIDYL PROPIONATE	E	Only for use in topical medicines for dermal application.
643	ARACHIS HYPOGAEA	A, E, H	The medicine requires the following warning statement on the medicine label: - (PEANUT) ‘Contains Peanut’ (or words to that effect).
644	ARACHIS OIL	A, E, H	The medicine requires the following warning statement on the medicine label: - (PEANUT) ‘Contains Peanut’ (or words to that effect).
645	ARALIA CORDATA	A, H
646	ARALIA HISPIDA	A, H
647	ARALIA NUDICAULIS	A, H
648	ARALIA RACEMOSA	A, H
649	ARCTIUM LAPPA	A, E, H
650	ARCTIUM MINUS	A, H
651	ARCTOSTAPHYLOS UVA-URSI	A, E, H	Arbutin is a mandatory component of Arctostaphylos uva-ursi. The concentration of arbutin in the medicine must be no more than 25 mg/Kg or 25mg /L or 0.0025 % unless used on the hair. When for use on hair, the concentration of arbutin in the medicine must be no more than 0.74 %.
652	ARDISIA JAPONICA	A, H
653	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%.
654	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.
655	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.'
656	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%.
657	ARISAEMA ATRORUBENS	A, H	The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
658	ARISAEMA CONSANGUINEUM	A, H	The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
659	ARISAEMA JAPONICUM	A, H	The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
660	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).
661	ARNEBIA EUCHROMA	A, H
662	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.
663	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.
664	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.
665	ARRHENATHERUM ELATIUS	A, H
666	ARROWROOT	A, E, H
667	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%.
668	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%.
669	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%.
670	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%.
671	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%.
672	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%.
673	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%.
674	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%.
675	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%.
676	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%.
677	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%.
678	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%.
679	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%.
680	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%.
681	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%.
682	ARTERY	H	Only for use as an active homoeopathic ingredient.
683	ARTHROSPIRA MAXIMA	A, E, H
684	ARTHROSPIRA PLATENSIS	A, E, H
685	ARUM MACULATUM	A, H	The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
686	ASAFOETIDA GUM	A, H
687	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%.
688	ASARUM EUROPAEUM	A, H
689	ASARUM HETEROTROPOIDES	A, H
690	ASARUM OIL	E
691	ASARUM SIEBOLDII	A, E, H
692	ASCLEPIAS TUBEROSA	A, H
693	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.
694	ASCORBIC ACID	A, E
695	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%.
696	ASCORBYL METHYLSILANOL PECTINATE	E	Only for use in topical medicines for dermal application.
697	ASCORBYL PALMITATE	A, E	When for oral use, the maximum recommended daily dose must contain no more than 100mg of ascorbyl palmitate.
698	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%.
699	ASPALATHUS LINEARIS	A, E, H
700	ASPARAGINE	A, E
701	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%.
702	ASPARAGUS	E, H	Only for use as an active homoeopathic or excipient ingredient.
703	ASPARAGUS COCHINCHINENSIS	A, H
704	ASPARAGUS OFFICINALIS	A, E, H
705	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.
706	ASPARTAME	E	When for oral use, the medicine requires the following warning statement on the medicine label: - (PKU) 'Phenylketonurics are warned that this product contains phenylalanine (or words to that effect)' The medicine requires the following warning statement on the medicine label: - (ASPAR) 'Contains aspartame'
707	ASPARTIC ACID	A, E
708	ASPERGILLUS ORYZAE	A, E, H
709	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).
710	ASTER NOVI-BELGII	A, H
711	ASTER TATARICUS	A, H
712	ASTRAGALUS ADSURGENS	A, H
713	ASTRAGALUS COMPLANATUS	A, H
714	ASTRAGALUS EXCARPUS	A, H
715	ASTRAGALUS GUMMIFER	A, E, H
716	ASTRAGALUS LENTIGINOSUS	A, H
717	ASTRAGALUS MEMBRANACEUS	A, E, H
718	ASTRAGALUS PENDULIFLORUS	A, H
719	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%.
720	ATRACTYLODES JAPONICA	A, H
721	ATRACTYLODES LANCEA	A, H
722	ATRACTYLODES MACROCEPHALA	A, H
723	ATROPA BELLADONNA	A, H	Alkaloids calculated as hyoscyamine and atropine are mandatory components of Atropa belladonna. The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. The concentration of atropine in the medicine must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%.
724	ATROPINE SULFATE MONOHYDRATE	H	Only for use as an active homoeopathic ingredient.
725	ATTALEA SPECIOSA	E	Only for use in topical medicines for dermal application.
726	AURA B-AURANTIOL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
727	AUREOBASIDIUM PULLULANS	A, H
728	AVENA FATUA	A, H	Gluten is a mandatory component of Avena fatua when the plant part is seed and the route of administration is other than topical and mucosal.
729	AVENA SATIVA	A, E, H	Gluten is a mandatory component of Avena sativa when the plant part is seed and the route of administration is other than topical and mucosal.
730	AVOCADO	E
731	AVOCADO OIL	E
732	AVOCADO OIL UNSAPONIFIABLES	E	Only for use in topical medicines for dermal application.
733	AZADIRACHTA INDICA	A, H	The ingredient can only be derived from the plant part seed and must be cold pressed or debitterised oil. “Debitterised neem seed oil” means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids. Cold pressed Azadirachta indica seed oil must be for topical use for dermal application only. When the concentration of cold pressed Azadirachta indica seed oil is more than 1%, a child resistant closure must be fitted to the container. The medicine requires the following warning statements on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant (or words to that effect).' - (NTAKEN) 'Not to be taken (or words to that effect).' - (CHILD) 'Keep out of reach of children (or words to that effect).’
734	AZOVAN BLUE	E	Permitted for use only as a colour for topical use.
735	AZULENE	E	Only for use in topical medicines for dermal application.

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
5043	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'.
5044	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.'
5045	ULEX EUROPAEUS	A, H
5046	ULMUS AMERICANA	A, H
5047	ULMUS CAMPESTRIS	A, H
5048	ULMUS GLABRA	A, H
5049	ULMUS PARVIFOLIA	A, H
5050	ULMUS PROCERA	A, H
5051	ULMUS PUMILA	A, H
5052	ULMUS RUBRA	A, H
5053	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%.
5054	ULTRAMARINE BLUE	E	Permitted for use only as a colour for topical use.
5055	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%.
5056	UMBELLULARIA CALIFORNICA	A, H
5057	UNCARIA GAMBIR	A, H
5058	UNCARIA RHYNCOPHYLLA	A, H
5059	UNCARIA SINENSIS	A, H
5060	UNCARIA TOMENTOSA	A, H
5061	UNDARIA PINNATIFIDA	A, H	Whole dried Undaria pinnatifida must not contain the holdfast. Only for use in oral medicines.
5062	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%.
5063	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%.
5064	UNDECENOIC ACID	E
5065	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%.
5066	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%.
5067	UNDECYLENAMIDE DEA	E
5068	UNDECYLENOYL PEG-5 PARABEN	E	Only for use in topical medicines for dermal application.
5069	URANIUM NITRATE	H	Only for use as an active homoeopathic ingredient.
5070	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).
5071	URTICA DIOICA	A, E, H
5072	URTICA URENS	A, H
5073	USNEA BARBATA	A, H
5074	UVA URSI LEAF DRY	A, H
5075	UVA URSI LEAF POWDER	A, E, H
5076	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%.
5077	VACCARIA SEGATALIS	A, H
5078	VACCINIUM BRACTEATUM	A, H
5079	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%.
5080	VACCINIUM MACROCARPON	A, E, H
5081	VACCINIUM MYRTILLOIDES	A, H
5082	VACCINIUM MYRTILLUS	A, E, H
5083	VACCINIUM OXYCOCCUS	A, H
5084	VACCINIUM VITIS-IDAEA	A, H	Arbutin is a mandatory component of Vaccinium vitis-idaea. The concentration of arbutin in the medicine must be no more than 25 mg/Kg or 25mg /L or 0.0025 % unless used on the hair. When for use on hair, the concentration of arbutin in the medicine must be no more than 0.74 %.
5085	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%.
5086	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%.
5087	VALERIAN DRY	A, H
5088	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%.
5089	VALERIAN POWDER	A, H
5090	VALERIANA EDULIS	A, H
5091	VALERIANA OFFICINALIS	A, H
5092	VALERIANA SORBIFOLIA	A, H
5093	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%.
5094	VALINE	A, E
5095	VANADIUM	H
5096	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%.
5097	VANILLA DRY	A, E, H
5098	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%.
5099	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%.
5100	VANILLA PLANIFOLIA	A, E, H
5101	VANILLA POWDER	A, E, H
5102	VANILLA TAHITENSIS	A, H
5103	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%.
5104	VANILLIN	E
5105	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%.
5106	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%.
5107	VAT RED 1	E	Permitted for use only as a colour for topical use.
5108	VAT RED 1 ALUMINIUM LAKE	E	Permitted for use only as a colour for topical use.
5109	VAT RED 5	E	Permitted for use only as a colour for topical use.
5110	VEGETABLE OIL	E
5111	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).'
5112	VEIN	H	Only for use as an active homoeopathic ingredient.
5113	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%.
5114	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%.
5115	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%.
5116	VERBASCUM DENSIFLORUM	A, H
5117	VERBASCUM THAPSUS	A, H
5118	VERBENA OFFICINALIS	A, H
5119	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%.
5120	VERONICA CHAMAEDRYS	A, H
5121	VERONICA OFFICINALIS	A, H
5122	VERONICASTRUM VIRGINICUM	A, E, H
5123	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%.
5124	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%.
5125	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%.
5126	VIBURNUM OPULUS	A, E, H
5127	VIBURNUM PRUNIFOLIUM	A, E, H
5128	VICIA FABA	A, H	Levodopa (of Vicia faba) is a mandatory component of Vicia faba. The concentration of Levodopa (of Vicia faba) from all ingredients in the medicine must be no more than 1mg/kg or 1mg/L or 0.1%.
5129	VIGNA ANGULARIS VAR. ANGULARIS	A, H
5130	VIGNA RADIATA	A, H
5131	VIGNA UMBELLATA	A, H
5132	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%.
5133	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%
5134	VINCETOXICUM OFFICINALE	A, H
5135	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%.
5136	VIOLA ODORATA	A, E, H
5137	VIOLA TRICOLOR	A, H
5138	VIOLA YEDOENSIS	A, H
5139	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%.
5140	VIOLET LEAVES	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5141	VIPER	H	Only for use as an active homoeopathic ingredient.
5142	VISCUM ALBUM	A, E, H
5143	VISCUM COLORATUM	A, H
5144	VISCUM FLAVESCENS	A, H
5145	VITELLARIA PARADOXA	A, E, H
5146	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 supplied 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).
5147	VITEX NEGUNDO	A, H
5148	VITEX ROTUNDIFOLIA	A, H
5149	VITEX TRIFOLIA	A, H
5150	VITIS VINIFERA	A, E, H
5151	VITREOSCILLA CONCENTRATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%.
5152	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%.
5153	WAHLENBERGIA GRACILIS	A, H
5154	WALNUT	E
5155	WALNUT OIL	E
5156	WATER MELON	E
5157	WHEAT	E	Gluten is a mandatory component of Wheat when the route of administration is other than topical and mucosal.
5158	WHEAT BRAN	E	Gluten is a mandatory component of Wheat bran when the route of administration is other than topical and mucosal.
5159	WHEAT DEXTRIN	A, E	Gluten is a mandatory component of wheat dextrin. Only for use when the dosage form is capsule, tablet or pill.
5160	WHEAT GERM	E	Gluten is a mandatory component of Wheat germ when the route of administration is other than topical and mucosal.
5161	WHEAT GERM GLYCERIDES	E	Gluten is a mandatory component of wheat germ glycerides when the route of administration is other than topical and mucosal.
5162	WHEAT LEAF	E
5163	WHEAT SPROUT	E	Gluten is a mandatory component of Wheat sprout when the route of administration is other than topical and mucosal.
5164	WHEAT STARCH	E	When the route of administration is other than topical or mucosal, gluten is a mandatory component of wheat starch.
5165	WHEATGERM OIL	A, E, H
5166	WHEY POWDER	E	Lactose is a mandatory component of Whey powder when the route of administration is oral.
5167	WHEY PROTEIN	E	Lactose is a mandatory component of Whey protein when the route of administration is oral.
5168	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%.
5169	WHITE BEESWAX	E
5170	WHITE HOREHOUND HERB DRY	A, H
5171	WHITE HOREHOUND HERB POWDER	A, H
5172	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.
5173	WHOLE DRY MILK	E	If the product is for oral ingestion and contains lactose, then the medicine requires the following warning statement on the medicine label: - (LACT) 'Contains lactose' (or words to that effect).
5174	WIKSTROEMIA VIRIDIFLORA	A, H
5175	WILD CARROT HERB DRY	A, E, H
5176	WILD CARROT HERB POWDER	A, H
5177	WILD CHERRY BARK DRY	A, H
5178	WILD CHERRY BARK POWDER	A, H
5179	WILD LETTUCE LEAF DRY	A, H
5180	WILD LETTUCE LEAF POWDER	A, H
5181	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'.
5182	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 supplied 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.
5183	WOLFIPORIA COCOS	A, E, H
5184	WOOL ALCOHOLS	E	Only for use in topical medicines for dermal application.
5185	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.
5186	XANTHAN GUM	E
5187	XANTHIUM SIBIRICUM	A, H
5188	XANTHIUM STRUMARIUM	A, H
5189	XANTHOMONA CAMPESTRIS	A, H
5190	XEROPHYLLUM ASPHODELOIDES	A, H
5191	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%.
5192	XYLITOL	E	When the quantity of sugar alcohols per maximum recommended daily dose is more than 2g, the quantity of the sugar alcohols must be declared on the label and the medicine requires the following warning statement on the medicine label: - (SUGOLS) ‘Products containing [insert name of sugar alcohol(s) may have a laxative effect or cause diarrhoea [or words to that effect]’.
5193	XYLOSE	E
5194	YAM	E
5195	YARROW HERB DRY	A, H
5196	YARROW HERB POWDER	A, H
5197	YEAST AUTOLYSATE	E
5198	YEAST DRIED	A, E, H
5199	YELLOW 2G	E	Permitted for use only as a colour for topical use.
5200	YELLOW BEESWAX	E
5201	YELLOW MERCURIC OXIDE	H	Only for use as an active homoeopathic ingredient.
5202	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.
5203	YLANG YLANG OIL	A, E, H
5204	YUCCA BACCATA	A, H
5205	YUCCA ELATA	A, H
5206	YUCCA FILAMENTOSA	A, H
5207	YUCCA GLORIOSA	A, H
5208	YUCCA WHIPPLEI	A, H
5209	ZANTHOXYLUM AMERICANUM	A, H
5210	ZANTHOXYLUM BUNGEANUM	A, E, H
5211	ZANTHOXYLUM CLAVA-HERCULIS	A, H
5212	ZANTHOXYLUM NITIDUM	A, H
5213	ZANTHOXYLUM PIPERITUM	A, H
5214	ZANTHOXYLUM SIMULANS	A, H
5215	ZEA MAYS	A, E, H
5216	ZEAXANTHIN	A, E
5217	ZEIN	E
5218	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)'.
5219	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).'
5220	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).'
5221	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)'.
5222	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).'
5223	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).'
5224	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).'
5225	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).'
5226	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).'
5227	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).'
5228	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).'
5229	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)'.
5230	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'.
5231	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'.
5232	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).'
5233	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).'
5234	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%.
5235	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).
5236	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).
5237	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.
5238	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).'
5239	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).'
5240	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).'
5241	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).'
5242	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).'
5243	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.
5244	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%.
5245	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'.
5246	ZIZIPHUS JUJUBA	A, H
5247	ZIZIPHUS JUJUBA VAR. SPINOSA	A, H
5248	ZIZYPHUS SATIVA	A, H
5249	ZOSTERA MARINA	A, H
5250	ZUCCHINI	E

Schedule 2—Repeals

Note:       See section 7.

Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2019

1  The whole of the instrument

Repeal the instrument.