Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018

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Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018

- F2018L00260
No longer in force
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Determinations/Health as made

This instrument revokes and replaces the Therapeutic Goods (Permissible Ingredients) Determination No. 5 of 2017, and has the effect of permitting the ingredients described in the determination, subject to the requirements described in the determination for an ingredient, to be contained in medicines or to be listed on the Australian Register of Therapeutic Goods.

Administered by: Health

Registered

15 Mar 2018

Tabling History	Date
Tabled Senate	19-Mar-2018
Tabled HR	26-Mar-2018

Date of repeal

19 Jun 2018

Repealed by

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2018

Therapeutic Goods (Permissible Ingredients) Determination No. 1of 2018

made under subsection 26BB(1) of the

Therapeutic Goods Act 1989

I, Mayada Kayali a delegate of the Minister for Health for the purposes of subsection 26BB(1) of the Therapeutic Goods Act 1989 (the Act), HEREBY:

(a) Repeal the Therapeutic Goods (Permissible Ingredients) Determination No. 5 of 2017; and

(b) Make the following determination specifying:

(i) ingredients for the purposes of paragraph 26BB(1)(a) of the Act; and

(ii) requirements applying to those ingredients for the purposes of paragraph 26BB(1)(b) of the Act.

Dated this 13th March 2018

(Signed by)

Mayada Kayali

Delegate of the Minister for Health

1 Name of Determination

This Determination is the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018.

2 Commencement

This Determination commences on the day after registration of the instrument on the Federal Register of Legislation.

3 Interpretation

In this Determination:

Act means the Therapeutic Goods Act 1989.

Code Tables are tables that can be accessed from the Therapeutic Goods Administration Business Service website at www.ebs.tga.gov.au under the heading “Public TGA Information”.

European Pharmacopoeia is as defined under the Act.

Mandatory component is a naturally occurring constituent in a specified ingredient listed in column 2 of Table 1 of Schedule 1 to this Determination.

4 Permissible ingredients and requirements applying to those ingredients

Permissible ingredients and requirements applying to those ingredients under Table 1

(1) The ingredients specified in column 2 of Table 1 in Part 2 of Schedule 1 (Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine) to this Determination (Schedule 1) are specified for the purposes of paragraph 26BB(1)(a) of the Act.

(2) Subject to subsection (3), for the purposes of paragraph 26BB(1)(b) of the Act, the ingredients specified in column 2 of Table 1 in Part 2 of Schedule 1 are subject to the following requirements:

(a) they may only be used in a medicine for a purpose or purposes specified in column 3 of Table 1 in Part 2 of Schedule 1; and

(b) they must comply with the requirements set out in column 4 of Table 1 in Part 2 of Schedule 1.

(3) The requirements set out in column 4 in relation to a mandatory component of an ingredient listed in column 2 of Table 1 in Part 2 of Schedule 1 apply to that specified ingredient.

Indications and Product Warning Acronyms based on the electronic Code Table document

(4) The acronyms in column 4 of Table 1 in Part 2 of Schedule 1 in closed brackets that are associated with warning statements in relation to particular ingredients specified in column 2 of Table 1 in Part 2 of Schedule 1, are acronyms from the Code Tables under the headings “Indications” or “Product Warning” and are not required to be included on the label of the medicine.

Note: Examples of these acronyms are:

(CHILD3), (PREGNT), (GLUTEN), (PEANUT) and (ARGIN1).

Additional requirements applying to specified ingredients in Table 1 that are derived from animal origins

(5) Ingredients specified in column 2 of Table 1 in Part 2 of Schedule 1 that are derived from animal origins (non-human) must also comply with the following requirements, for the purposes of paragraph 26BB(1)(b) of the Act:

(a) a certification must be obtained under subsection 26A(4A) of the Act from the Secretary, prior to an application being made for the listing in the Australian Register of Therapeutic Goods, under section 26A of the Act, of a medicine that contains the ingredient, that the Secretary is satisfied of the safety of the ingredient;

(b) the safety of the ingredient must have been assessed against the principles and requirements detailed 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.

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

(section 4)

Part 1—Interpretation of Table 1

Definitions

At Table 1:

“A” means an active ingredient.

Act means the Therapeutic Goods Act 1989.

Active ingredient is as defined in the Regulations.

British Pharmacopoeia is as defined under the Act.

“E” means an excipient.

Excipient 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.

“H” means a homoeopathic preparation ingredient.

Homoeopathic preparation ingredient means an ingredient that is a constituent of a preparation that is:

(a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and

(b) prepared according to the practices of homoeopathic pharmacy using the methods of:

(i) serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or

(ii) serial trituration in lactose.

Mother tincture is as defined in the Regulations.

Regulations means the Therapeutic Goods Regulations 1990.

United States Pharmacopeia-National Formulary is as defined under the Act.

Part 2 – Table 1

Column 1	Column 2 Ingredient Name	Column 3 Purpose of the ingredient in the medicine	Column 4 Specific requirements(s) applying to the ingredient in Column 2
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-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%.
62	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%.
63	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%.
64	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%.
65	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%.
66	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%.
67	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%.
68	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.
69	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%.
70	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%.
71	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%.
72	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%.
73	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%.
74	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.
75	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.
76	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%.
77	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%.
78	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%.
79	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%.
80	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%
81	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%.
82	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%.
83	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%.
84	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%.
85	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%.
86	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%.
87	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%.
88	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%.
89	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%.
90	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%.
91	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%.
92	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%.
93	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%.
94	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%.
95	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%.
96	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%.
97	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%.
98	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%.
99	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%.
100	2-AMINO-2-METHYL-1-PROPANOL	E	Only for use in topical medicines for dermal application.
101	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%.
102	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%.
103	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%.
104	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%.
105	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%.
106	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%.
107	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%.
108	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%.
109	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%.
110	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%.
111	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%.
112	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%.
113	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%.
114	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%.
115	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%.
116	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%.
117	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%.
118	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%.
119	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%.
120	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%.
121	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%.
122	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%.
123	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%.
124	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%.
125	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%.
126	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%.
127	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%.
128	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%.
129	2-METHOXY-3-SECBUTYLPYRAZINE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
130	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%.
131	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%.
132	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%.
133	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%.
134	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%.
135	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%.
136	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%.
137	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%.
138	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%.
139	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%.
140	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%.
141	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.
142	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%.
143	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%.
144	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%.
145	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%.
146	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%.
147	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%.
148	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%.
149	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%.
150	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%.
151	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%.
152	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%.
153	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%.
154	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%.
155	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%.
156	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%.
157	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%.
158	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%.
159	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%.
160	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%.
161	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%.
162	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%.
163	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%.
164	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%.
165	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%.
166	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%.
167	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%.
168	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%.
169	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%.
170	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%.
171	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%.
172	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%.
173	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%.
174	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%.
175	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%.
176	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%.
177	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%.
178	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%.
179	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%.
180	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%.
181	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%.
182	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%.
183	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%.
184	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%.
185	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%.
186	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%.
187	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%.
188	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%.
189	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%.
190	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%.
191	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%.
192	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%.
193	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%.
194	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%.
195	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%.
196	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%.
197	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%.
198	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%.
199	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%.
200	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%.
201	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%.
202	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%.
203	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%.
204	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%.
205	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%.
206	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%.
207	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%.
208	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%.
209	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%.
210	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%.
211	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%.
212	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%.
213	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%.
214	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%.
215	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%.
216	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%.
217	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%.
218	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%.
219	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%.
220	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%.
221	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%.
222	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%.
223	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%.
224	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%.
225	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%.
226	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%.
227	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%.
228	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%.
229	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%.
230	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%.
231	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%.
232	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%.
233	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%.
234	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%.
235	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%.
236	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%.
237	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%.
238	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%.
239	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%.
240	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%.
241	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%.
242	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%.
243	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%.
244	4-METHYLBENZYLIDENE CAMPHOR	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
245	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%.
246	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%.
247	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%.
248	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%.
249	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%.
250	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%.
251	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%.
252	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%.
253	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%.
254	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%.
255	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%.
256	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%.
257	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%.
258	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%.
259	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%.
260	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%.
261	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%.
262	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%.
263	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%.
264	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%.
265	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%.
266	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%.
267	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%.
268	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%.
269	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%.
270	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%.
271	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%.
272	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%.
273	6-METHYL-2-BUTEN-3-OL-2	E
274	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%.
275	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%.
276	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%.
277	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%.
278	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%.
279	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%.
280	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%.
281	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%.
282	ABELMOSCHUS MOSCHATUS	A, H
283	ABELMOSCHUS MOSCHATUS SUBSP. MOSCHATUS	A, H
284	ABIES BALSAMEA	A, H
285	ABIES NIGRA	A, H
286	ABIES PECTINATA	A, H
287	ABIES SIBIRICA	A, H
288	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.
289	ABUTILON THEOPHRASTI	A, H
290	ACACIA	A, E, H
291	ACACIA BAILEYANA	A, H
292	ACACIA CATECHU	A, H
293	ACACIA DEALBATA	A, H
294	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%.
295	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%.
296	ACACIA LONGIFOLIA	A, E, H
297	ACACIA NILOTICA	A, E, H
298	ACACIA SENEGAL	A, E, H
299	ACALYPHA INDICA	A, H
300	ACANTHUS MOLLIS	A, H
301	ACER CAMPESTRE	A, H
302	ACER NEGUNDO	A, H
303	ACER SACCHARINUM	A, H
304	ACER SACCHARUM	A, E, H
305	ACEROLA	E
306	ACESULFAME POTASSIUM	E
307	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%.
308	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%.
309	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%.
310	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%.
311	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%.
312	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%.
313	ACETIC ACID	E, H	The concentration in the medicine must be no more than 80%.
314	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%.
315	ACETOMENAPHTHONE	A, E
316	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%.
317	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%.
318	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%.
319	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%.
320	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%.
321	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'
322	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%.
323	ACETYL LEVOCARNITINE HYDROCHLORIDE	A, E
324	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%.
325	ACETYLATED LANOLIN	E	Only for use in topical medicines for dermal application.
326	ACETYLATED LANOLIN ALCOHOL	E	Only for use in topical medicines for dermal application.
327	ACETYLATED MONOGLYCERIDES	E
328	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%.
329	ACETYLCYSTEINE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.001%.
330	ACHILLEA ERBA-ROTTA SUBSP. MOSCHATA	A, H
331	ACHILLEA MILLEFOLIUM	A, E, H
332	ACHILLEA PTARMICA	A, H
333	ACHYRANTHES ASPERA	A, H
334	ACHYRANTHES BIDENTATA	A, H
335	ACHYRANTHES FAURIEI	A, H
336	ACID GREEN 25	E	Permitted for use only as a colour for topical use.
337	ACID RED 33	E	Permitted for use only as a colour for topical use.
338	ACID RED 87	E, H	Only for use as an active homoeopathic ingredient or for excipient use as a colour in topical medicines.
339	ACID TREATED WAXY MAIZE STARCH	E
340	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%.
341	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.
342	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.
343	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.
344	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.
345	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%.
346	ACRYLAMIDES COPOLYMER	E	Only for use in topical medicines for dermal application.
347	ACRYLATES COPOLYMER	E	Only for use in topical medicines for dermal application.
348	ACRYLATES/ACRYLAMIDE COPOLYMER	E	Only for use in topical medicines for dermal application.
349	ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER	E	Only for use in topical medicines for dermal application.
350	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%.
351	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%.
352	ACRYLATES/OCTYLACRYLAMIDE COPOLYMER	E	Only for use in topical medicines for dermal application.
353	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%.
354	ACRYLATES/VA COPOLYMER	E	Only for use in topical medicines for dermal application.
355	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%.
356	ACTAEA CIMICIFUGA	A, H
357	ACTAEA HERACLEIFOLIA	A, H
358	ACTAEA PACHYPODA	A, H
359	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.'
360	ACTAEA SIMPLEX	A, H
361	ACTAEA SPICATA	A, H
362	ACTINIDIA CHINENSIS	A, H
363	ACTINIDIA DELICIOSA	A, H
364	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.
365	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).
366	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)'
367	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)'
368	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)'
369	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)'
370	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)'
371	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)'
372	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)'
373	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)'
374	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)'
375	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)'
376	ADENOPHORA STRICTA	A, H
377	ADENOPHORA TRIPHYLLA	A, H
378	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%.
379	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%.
380	ADENOSINE TRIPHOSPHATE	E	Only for use in topical medicines for dermal application.
381	ADENOSINE TRIPHOSPHATE DISODIUM	E	Only for use in topical medicines for dermal application.
382	ADIANTUM CAPILLUS-VENERIS	A, H
383	ADIPIC ACID	E
384	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%.
385	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%.
386	ADRENALINE (EPINEPHRINE)	H	Only for use as an active homoeopathic ingredient.
387	ADZUKI BEAN	E
388	AEGOPODIUM PODAGRARIA	A, H
389	AESCULUS CHINENSIS	A, H
390	AESCULUS GLABRA	A, H
391	AESCULUS HIPPOCASTANUM	A, H
392	AESCULUS X CARNEA	A, H
393	AETHUSA CYNAPIUM	H	Only for use as an active homoeopathic ingredient.
394	AGAR	A, E
395	AGASTACHE RUGOSA	A, H
396	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%.
397	AGAVE AMERICANA	A, E, H
398	AGRIMONIA EUPATORIA	A, E, H
399	AGRIMONIA REPENS	A, H
400	AGROSTIS TENUIS	A, H
401	AILANTHUS ALTISSIMA	A, H
402	AJUGA CHAMAEPITYS	A, H
403	AJUGA REPTANS	A, H
404	ALANINE	A, E
405	ALANYLGLUTAMINE	A	Only for use in oral medicines.
406	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.
407	ALBIZIA JULIBRISSIN	A, H
408	ALBIZIA LEBBECK	A, H
409	ALCEA ROSEA	A, H
410	ALCHEMILLA ALPINA	A, H
411	ALCHEMILLA ARVENSIS	A, H
412	ALCHEMILLA VULGARIS	A, H
413	ALETRIS FARINOSA	A, H
414	ALETRIS SPICATA	A, H
415	ALEURITES MOLUCCANUS SEED OIL	E	Only for use in topical medicines for dermal application.
416	ALFADEX	A, E	Only for use in oral medicines. The maximum daily dose must provide no more than 6 g of alfadex.
417	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).
418	ALGINIC ACID	E
419	ALISMA ORIENTALE	A, H
420	ALISMA PLANTAGO AQUATICA	A, H
421	ALKANNA TINCTORIA	A, H
422	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%.
423	ALLANTOIN	E	Only for use in topical medicines for dermal application.
424	ALLIARIA PETIOLATA	A, H
425	ALLIUM CEPA	A, H
426	ALLIUM FISTULOSUM	A, H
427	ALLIUM HIEROCHUNTINUM	A, H
428	ALLIUM MACROSTEMON	A, H
429	ALLIUM ODORUM	A, H
430	ALLIUM PORRUM	A, H
431	ALLIUM SATIVUM	A, E, H
432	ALLIUM SCHOENOPRASUM	A, H
433	ALLIUM URSINUM	A, H
434	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%.
435	ALLURA RED AC	E	Permitted for use only as a colour for oral and topical use.
436	ALLURA RED AC ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use.
437	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%.
438	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%.
439	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%.
440	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%.
441	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%.
442	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%.
443	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%.
444	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%.
445	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%.
446	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%.
447	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%.
448	ALMOND	E
449	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%.
450	ALNUS GLUTINOSA	A, H
451	ALNUS INCANA SUBSP. RUGOSA	A, H
452	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'.
453	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'.
454	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'.
455	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'.
456	ALOYSIA CITRODORA	A, H
457	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.'
458	ALPHA LIPOIC ACID	A
459	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%.
460	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%.
461	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%.
462	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%.
463	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%.
464	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%.
465	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%.
466	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%.
467	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%.
468	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%.
469	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%.
470	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%.
471	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%.
472	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%.
473	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%.
474	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%.
475	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%.
476	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%.
477	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%.
478	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%.
479	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%.
480	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%.
481	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%.
482	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%.
483	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%.
484	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%.
485	ALPINIA GALANGA	A, H
486	ALPINIA HAINANENSIS	A, H
487	ALPINIA OFFICINARUM	A, H
488	ALPINIA OXYPHYLLA	A, H
489	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.
490	ALSTONIA BOONEI	A, H
491	ALSTONIA CONSTRICTA	H	Only for use as an active homoeopathic ingredient.
492	ALTERNANTHERA PHILOXEROIDES	A, H
493	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%.
494	ALTHAEA OFFICINALIS	A, E, H
495	ALUM DODECAHYDRATE	A, E, H
496	ALUMINIUM CHLOROHYDRATE	E	Only for use in topical medicines for dermal application.
497	ALUMINIUM CITRATE	E	Only for use in topical medicines for dermal application.
498	ALUMINIUM DISTEARATE	E	Only for use in topical medicines for dermal application.
499	ALUMINIUM HYDROXIDE	E	Only for use in topical medicines for dermal application.
500	ALUMINIUM HYDROXIDE HYDRATE	E	Only for use in topical medicines for dermal application.
501	ALUMINIUM MAGNESIUM SILICATE	E
502	ALUMINIUM MONOSTEARATE	E	Only for use in topical medicines for dermal application.
503	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.
504	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.
505	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).’
506	ALUMINIUM STARCH OCTENYLSUCCINATE	E	The concentration in the medicine must be no more than 7%.
507	ALUMINIUM STEARATE	E	Only for use in topical medicines for dermal application.
508	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%.
509	AMARANTH	E	Permitted for use only as a colour for oral and topical use.
510	AMARANTH ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use
511	AMARANTHUS HYBRIDUS	A, H
512	AMARANTHUS RETROFLEXUS	A, H
513	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%.
514	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%.
515	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%.
516	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%.
517	AMBROSIA ARTEMISIIFOLIA	A, H
518	AMBROSIA PSILOSTACHYA	A, H
519	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%.
520	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%.
521	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%.
522	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%.
523	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%.
524	AMMONIO METHACRYLATE COPOLYMER	E	Only for use in oral medicines.
525

Federal Register of Legislation - Australian Government

Primary content

Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018