Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023 (Cth)

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Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023

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

Dated: 14 April 2023

Dr Cheryl McRae

Assistant Secretary

Complementary and Over the Counter Medicines Branch

Health Products Regulation Group

Department of Health and Aged Care

Contents

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

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

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

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

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

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

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

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

Note:       This instrument is in 6 volumes:

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

Schedule 1     (+-)-NARINGENIN–AZULENE

Volume 2:     Schedule 1     BACILLUS COAGULANS–EVERNIA PRUNASTRI EXTRACT

Volume 3:     Schedule 1     FABIANA IMBRICATA–JUSTICIA ADHATODA

Volume 4:     Schedule 1     KADSURA COCCINEA–OYSTER SHELL

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

Volume 6:     Schedule 1     UBIDECARENONE–ZUCCHINI

1  Name

This instrument is the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023.

2  Commencement

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

Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1.  The whole of this instrument 1 May 2023. 1 May 2023

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

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

3  Authority

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

4  Interpretation

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

(a)    British Pharmacopoeia;

(b)    European Pharmacopoeia;

(c)    medicine;

(d)    Register;

(e)    United States Pharmacopeia-National Formulary.

(1)  In this instrument:

Act means the Therapeutic Goods Act 1989.

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

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

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

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

homoeopathic preparation has the same meaning as in the Regulations.

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

Regulations means the Therapeutic Goods Regulations 1990.

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

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

(a)  terms from the code tables under the heading Product Warning; and

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

Note:          Examples of these terms include the following:

(a)    (ARGIN1);

(b)    (CHILD3);

(c)    (GLUTEN);

(d)    (PEANUT); and

(e)    (PREGNT).

5  Permissible ingredients

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

6  Requirements in relation to permissible ingredients being contained in medicine

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

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

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

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

7  Repeals

  The Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023 is repealed.

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

Note:    See sections 5 and 6.

Permissible ingredients and requirements
Column 1 Column 2 Column 3 Column 4
Item Ingredient Name Purpose Specific requirements
1 (+-)-NARINGENIN E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
2 (-)-MENTHYL METHYL ETHER E

(-)-Menthyl methyl ether must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing (-)-menthyl methyl ether must not be more than 5% of the total medicine.

When the medicine is for internal use, the maximum recommended daily dose of the medicine must not provide more than 53 micrograms of (-)-menthyl methyl ether.
3 (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%.
4 (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%.
5 (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%.
6 (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%.
7 (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%.
8 (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%.
9 (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%.
10 (R)-ALPHA-TERPINYL ACETATE E

(R)-alpha-terpinyl acetate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing (R)-alpha-terpinyl acetate must not be more than 1% of the total medicine.
11 (S)-LACTIC ACID A, E, H
12 (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)'
13 (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)'
14 (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)'
15 (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)'
16 (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)'
17 (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)'
18 (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)'
19 (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)'
20 (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)'
21 (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)'
22 (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%.

23 (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%.
24 1,2,3,4,4A,5,8,8A-OCTAHYDRO-2,2,6,8-TETRAMETHYL-1-NAPHTHALENOL E

Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
25 1,2-HEXANEDIOL E

Only for use in topical medicines for dermal application and not to be included in topical products intended for use in the eye.

The concentration in the medicine must be no more than 1%.

26 1,3,4,6,7,8A-HEXAHYDRO-1,1,5,5-TETRAMETHYL-2H-2,4A-METHANONAPHTHALEN-8(5H)-ONE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
27 1,3,5-UNDECATRIENE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
28 1,3-BUTYLENE GLYCOL E
29 1,3-NONANEDIOL ACETATE, MIXED ESTERS E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
30 1,3-NONANEDIOL, DIACETATE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
31 1,4-CINEOLE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%
32 1,4-DIOXACYCLOHEXADECANE-5,16-DIONE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
33 1,5,9-TRIMETHYL-13-OXABICYCLO[10.1.0]TRIDECA-4,8-DIENE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
34 1,7,7-TRIMETHYLBICYCLO[4.4.0]DECAN-3-YL ACETATE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
35 1-(2,2,6-TRIMETHYLCYCLOHEXYL)-3-HEXANOL E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
36 1-(2,6,6-TRIMETHYL-2-CYCLOHEXEN-1-YL)-1-PENTEN-3-ONE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
37 1-(3,3-DIMETHYLCYCLOHEXYL)ETHYL FORMATE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
38 1-(4-ISOPROPYLCYCLOHEXYL)ETHANOL E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
39 1-(5,5-DIMETHYL-1-CYCLOHEXEN-1-YL)-4-PENTEN-1-ONE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
40 1-DODECANOL E

Permitted for use:

(a) only in combination with other permitted ingredients as a flavour; and

(b) in topical medicines for dermal application.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
41 1-HEPTANOL E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
42 1-HEXEN-3-OL E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
43 1-METHOXY-4-PROPENYLBENZENE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

44 1-METHYL-2-[(1,2,2-TRIMETHYLBICYCLO[3.1.0]HEX-3-YL)METHYL]-CYCLOPROPANEMETHANOL E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
45 1-METHYL-3-(2-METHYLPROPYL)-CYCLOHEXANOL E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
46 1-METHYL-4-(4-METHYL-3-PENTENYL)-3-CYCLOHEXENE-1-CARBOXALDEHYDE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
47 1-OCTEN-3-ONE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

48 1-P-MENTHENE-8-THIOL E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

49 1-PENTEN-3-OL E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

50 10-UNDECEN-1-OL E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

51 10-UNDECENAL E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
52 16-HYDROXY-12-OXAHEXADECANOIC ACID, OMEGA-LACTONE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
53 2'-FUCOSYLLACTOSE A

The route of administration for medicines that contain 2’-fucosyllactose must be limited to oral.

Lactose is a mandatory component of 2’-fucosyllactose.

The maximum recommended daily dose of the medicine must not provide more than:

a) 12 g of 2’-fucosyllactose to individuals aged 13 years and older;

b) 4 g of 2’-fucosyllactose to individuals aged between 1 and 12 years (inclusive); and

c) 1.2 g of 2’-fucosyllactose to individuals aged between 1 and 11 months (inclusive).

2’-fucosyllactose is not permitted for use in children under the age of 1 month.

One of the following statements is required on the medicine label:

a) When the medicine is only for use in individuals aged above 2 years: 'Not to be taken on the same day with other products containing 2'-fucosyllactose' (or words to that effect); or

b) When the medicine is for use in individuals up to and including 2 years of age: 'Not to be taken on the same day with breastmilk or other products containing 2'-fucosyllactose' (or words to that effect).
54 2,2'-METHYLENEBIS(4-METHYL-6-TERT-BUTYLPHENOL) E

2,2'-methylenebis(4-methyl-6-tert-butylphenol) must only be included in medicines when in combination with other permitted ingredients as a proprietary excipient formulation in medicines with a dermal route of administration for topical application.
55 2,2,3-TRIMETHYLCYCLOPENT-3-ENE-1-ETHYL ACETATE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
56 2,2,5-TRIMETHYL-5-PENTYLCYCLOPENTANONE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
57 2,2-DIMETHYL-3-(3-METHYL-2,4-PENTADIENYL)-OXIRANE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
58 2,2-DIMETHYL-3-PHENYLPROPANOLL E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
59 2,2-DIMETHYL-5-(1-METHYLPROPEN-1-YL) TETRAHYDROFURAN E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

60 2,2-DIMETHYL-P-ETHYLPHENYL-PROPANENITRILE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
61 2,3,4-TRIMETHYL-3-PENTANOL E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

62 2,3,5,6-TETRAMETHYLPYRAZINE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

63 2,3,5-TRIMETHYLPYRAZINE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

64 2,3-DIETHYLPYRAZINE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used as a flavour the total flavour concentration in a medicine must be no more than 5%.
65 2,3-DIHYDRO-1,1-DIMETHYL-1H-INDENE-AR-PROPANAL E

Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient. The total fragrance proprietary excipient formulation concentration in a medicine must not be more than 1%.
66 2,3-DIHYDRO-2,5-DIMETHYL-1H-INDENE-2-METHANOL E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
67 2,3-DIMETHYLPYRAZINE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
68 2,3-HEXADIONE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

69 2,3-HEXANEDIONE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

70 2,3-PENTANEDIONE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
71 2,4,5-TRIMETHYLTHIAZOLE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

72 2,4,6-TRIMETHYL-4-PHENYL-1,3-DIOXANE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
73 2,4-DECADIENAL E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in the medicine must be no more than 1%.

The maximum daily dose must provide no more than 3 mg of 2,4-Decadienal.
74 2,4-DIMETHYL BUTADIENEACROLEIN E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
75 2,4-DIMETHYL THIAZOLE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

76 2,4-DIMETHYL-3-CYCLOHEXENE CARBOXALDEHYDE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
77 2,4-DIMETHYL-4,4A,5,9B-TETRAHYDROINDENO[1,2-D]-1,3-DIOXIN E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
78 2,4-DIMETHYL-4-PHENYL TETRAHYDROFURAN E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
79 2,4-HEPTADIENAL E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in the medicine must be no more than 1%.

The maximum daily dose must provide no more than 3 mg of 2,4-Heptadienal.
80 2,4-HEXADIENOL E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in the medicine must be no more than 1%.

The maximum daily dose must provide no more than 13.5 mg of 2,4-Hexadienol.
81 2,5-DIETHYLTETRAHYDROFURAN E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

82 2,5-DIMETHYL-2-OCTEN-6-ONE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
83 2,5-DIMETHYL-4-ETHOXY-3(2H)-FURANONE E

Only for use in medicines in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total flavour proprietary excipient formulation in a medicine must not be more than 5%.
84 2,5-DIMETHYL-4-HYDROXY-3(2H)-FURANONE E

Permitted for use only in combination with other permitted ingredients as a flavour or fragrance.

If used in a flavour the total flavour concentration in the medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
85 2,5-DIMETHYL-4-METHOXY-3(2H)-FURANONE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

86 2,5-DIMETHYLPYRAZINE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance, or a printing ink.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

If used in a printing ink the total printing ink concentration in a medicine must be no more than 0.1%
87 2,6,6,TRIMETHYL-2-CYCLOHEXENE-1,4-DIONE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
88 2,6,9,10-TETRAMETHYL-1-OXASPIRO(4.5)DECA-3,6-DIENE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
89 2,6-DIMETHOXYPHENOL E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

90 2,6-DIMETHYL HEPTAN-2-OL E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
91 2,6-DIMETHYL-2-HEPTENAL-(7) E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
92 2,6-DIMETHYL-3,5-OCTADIEN-2-OL E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
93 2,6-DIMETHYL-4-HEPTYL ACETATE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
94 2,6-DIMETHYLPYRAZINE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
95 2,6-NONADIEN-1-OL E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
96 2,6-OCTADIENOIC ACID, 3,7-DIMETHYL-, METHYL ESTER, (2E)- E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
97 2-(1,1-DIMETHYLETHYL)-1,4-DIMETHOXY-BENZENE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
98 2-(2-(4-METHYL-3-CYCLOHEXEN-1-YL)PROPYL CYCLOPENTANONE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
99 2-(2-METHYLPHENYL)ETHANOL E

Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation.

The ingredient is not to be included in medicines intended for use in the eye.

The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
100 2-(4-METHYLPHENOXY)-N-1H-PYRAZOL-3-YL-N-(2-THIENYLMETHYL)ACETAMIDE E

The route of administration of a medicine containing 2-(4-methylphenoxy)-n-1h-pyrazol-3-yl-n-(2-thienylmethyl)acetamide must be limited to dental.

The total concentration of 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)acetamide in the medicine must not be more than 0.015%.

2-(4-Methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)acetamide must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation

The total concentration of flavour proprietary excipient formulations containing 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)acetamide must not be more than 5% of the total medicine.
101 2-(6-METHYL-8-ISOPROPYL BICYCLO(2.2.2)OCT-5-ENE-2-YL-1,3-DIOXOLANE E

2-(6-methyl-8-isopropyl bicyclo(2.2.2)oct-5-ene-2-yl)-1,3-dioxolane must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing 2-(6-methyl-8-isopropyl bicyclo(2.2.2)oct-5-ene-2-yl)-1,3-dioxolane must not be more than 1% of the total medicine.
102 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%.
103 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%.
104 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%.
105 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%.

106 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%.

107 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%.
108 2-AMINO-2-METHYL-1-PROPANOL E

Only for use in topical medicines for dermal application.
109 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%.
110 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%.
111 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%.
112 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%.
113 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%.

114 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%.
115 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%.
116 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%.
117 2-ETHOXY-9-METHYLENE-2,6,6-TRIMETHYLBICYCLO[3.3.1]NONANE E

2-ethoxy-9-methylene-2,6,6-trimethylbicyclo[3.3.1]nonane must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing 2-ethoxy-9-methylene-2,6,6-trimethylbicyclo[3.3.1]nonane must not be more than 1% of the total medicine.
118 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%.

119 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%.

120 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%.
121 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%.
122 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%.

123 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%.
124 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%.

125 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%.

126 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%.
127 2-ETHYL-N-METHYL-N-(3-METHYLPHENYL) BUTANAMIDE E

Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
128 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%.

129 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%.

130 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%.
131 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%.
132 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%.
133 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%.
134 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%.
135 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%.
136 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%.
137 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%.
138 2-ISOPROPYLPHENOL E

2-Isopropylphenol must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing 2-isopropylphenol must not be more than 5% of the total medicine.
139 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%.

140 2-METHOXY-3-(1-METHYLPROPYL)PYRAZINE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
141 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%.

142 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%.

143 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%.

144 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%.

145 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%.
146 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%.
147 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%.
148 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%.

149 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%.

150 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%.
151 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.
152 2-METHYL-4-(2,2,3-TRIMETHYLCYCLOPENT-3-EN-1-YL)PENT-4-EN-1-OL E

2-Methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-1-ol must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing 2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-1-ol must not be more than 1% of the total medicine.
153 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%.
154 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%.
155 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%.

156 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%.

157 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%.

158 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%.

159 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%.

160 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%.
161 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%.
162 2-METHYLDECANAL E

Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
163 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%.
164 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%.
165 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%.

166 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%.
167 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%.

168 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%.
169 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%.
170 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%.

171 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%.
172 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%.

173 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%.

174 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%.

175 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%.
176 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%.
177 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%.
178 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%.
179 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%.
180 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%.
181 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%.
182 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%.
183 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%.
184 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%.
185 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%.
186 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%.

187 3'-SIALYLLACTOSE SODIUM A

Only to be used in a medicine where Glycom A/S (Client ID 76983), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine.  This paragraph ceases to be a requirement for this ingredient after 25 October 2023.

Lactose and sodium are mandatory components of 3’-sialyllactose sodium.

The route of administration for medicines that contain 3’-sialyllactose sodium must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than:

(a) 0.2 g 3’-sialyllactose sodium in infants under 12 months;

(b) 0.15 g 3’-sialyllactose sodium in children aged 12-35 months; or

(c) 0.5 g 3’-sialyllactose sodium in individuals aged 3 years and older.

188 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%.
189 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%.

190 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%.
191 3,4-DIMETHYL PHENYLACETALDEHYDE E

3,4-Dimethyl phenylacetaldehyde must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing 3,4-dimethyl phenylacetaldehyde must not be more than 1% of the total medicine.
192 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%.

193 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%.
194 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%.
195 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%.
196 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%.
197 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%.
198 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%.
199 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%.
200 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%.
201 3,7-DIMETHYL-1-OCTEN-3-OL E

Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
202 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%.
203 3,7-DIMETHYL-2,6-OCTADIENAL REACTION PRODUCTS WITH ETHANOL E

Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
204 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%.
205 3-(1-BUTENYL)-PYRIDINE E

3-(1-Butenyl)-pyridine must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing 3-(1-butenyl)-pyridine must not be more than 1% of the total medicine.
206 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%.
207 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%.
208 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%.
209 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%.
210 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%.
211 3-(METHYLTHIO) PROPIONALDEHYDE E

3-(Methylthio) propionaldehyde must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing 3-(methylthio) propionaldehyde must not be more than 5% of the total medicine.
212 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%.

213 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%.
214 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%.
215 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%.

216 3-FUCOSYLLACTOSE A

Only to be used in a medicine where Glycom A/S (Client ID 76983), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 13 December 2024.

Lactose is a mandatory component of 3-fucosyllactose.

The route of administration for medicines that contain 3-fucosyllactose must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than:

(a) 2 g of 3-fucosyllactose to individuals aged 0 to 3 years (inclusive); and

(b) 5 g of 3-fucosyllactose to individuals aged 4 years and older.

One of the following statements is required on the medicine label:

(i) When the medicine is only for use in individuals aged 2 years and above: 'Not to be taken on the same day with other products containing 3-fucosyllactose' (or words to that effect); or

(ii) When the medicine is for use in children aged less than 2 years: 'Not to be taken on the same day with breastmilk, or other products containing 3-fucosyllactose' (or words to that effect).
217 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%.

218 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%.

219 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%.
220 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%.
221 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%.
222 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%.
223 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%.
224 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%.
225 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%.
226 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%.
227 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%.
228 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%.
229 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%.
230 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%.
231 3-METHYLPENTANOIC ACID E

3-Methylpentanoic acid must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of the flavour proprietary excipient formulation containing 3-methylpentanoic acid must not be more than 5% of the total medicine.
232 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%.

233 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%.
234 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%.
235 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%.
236 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%.
237 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%.
238 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%.

239 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%.
240 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%.
241 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%.
242 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%.
243 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%.
244 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%.
245 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%.
246 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%.
247 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%.
248 4-(1-ETHOXYVINYL)-3,3,5,5-TETRAMETHYLCYCLOHEXANONE E

4-(1-Ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing 4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone must not be more than 1% of the total medicine.
249 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%.
250 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%.
251 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%.

252 4-(OCTAHYDRO-4,7-METHANO-5H-INDEN-5-YLIDENE)-BUTANAL E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
253 4-(PARA-HYDROXYPHENYL)-2-BUTANONE E

4-(para-hydroxyphenyl)-2-butanone must only be included in medicines when:

(a) in combination with other permitted ingredients as a flavour proprietary excipient formulation;

(b) in combination with other permitted ingredients as a fragrance proprietary excipient formulation; and/or

(c) in topical medicines for dermal application that are not intended for use in the eye or on damaged skin.

The total concentration of flavour proprietary excipient formulations containing 4-(para-hydroxyphenyl)-2-butanone must not be more than 5% of the total medicine.

The total concentration of fragrance proprietary excipient formulations containing 4-(para-hydroxyphenyl)-2-butanone must not be more than 1% of the total medicine.

The concentration of 4-(para-hydroxyphenyl)-2-butanone in a topical medicine for dermal application must not be more than 1% of the total medicine.
254 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%.
255 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%.
256 4-CYCLOHEXYL-2-METHYL-2-BUTANOL E

Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
257 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%.
258 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%.
259 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%.
260 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%.

261 4-ISOPROPYL-3-METHYLPHENOL E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.1%.
262 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%.

263 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%.
264 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%.

265 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%.
266 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%.
267 4-METHYLBENZYLIDENE CAMPHOR A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 4%.

The following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
268 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%.

269 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%.
270 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%.

271 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%.

272 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%.
273 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%.
274 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%.
275 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%.

276 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%.

277 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%.
278 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%.
279 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%.
280 5-ETHYL-2,3-DIMETHYLPYRAZINE E

5-Ethyl-2,3,dimethylpyrazine must not be included in medicines for oral administration.

5-Ethyl-2,3,dimethylpyrazine must only be included in topical medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing 5-ethyl-2,3,dimethylpyrazine must not be more than 1% of the total medicine.
281 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%.

282 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%.

283 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%.

284 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%.
285 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%.

286 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%.

287 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%.
288 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%.
289 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%.
290 6'-SIALYLLACTOSE SODIUM A

Only to be used in a medicine where Glycom A/S (Client ID 76983), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine.  This paragraph ceases to be a requirement for this ingredient after 25 October 2023.

Lactose and sodium are mandatory components of 6’-sialyllactose sodium.

The route of administration for medicines that contain 6’-sialyllactose sodium must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than:

(a) 0.4 g 6’-sialyllactose sodium in infants under 12 months;

(b) 0.3 g 6’-sialyllactose sodium in children aged 12-35 months; or

(c) 1.0 g 6’-sialyllactose sodium in individuals aged 3 years and older.
291 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%.
292 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%.
293 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%.
294 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%.
295 6-ETHYLIDENEOCTAHYDRO 5,8-METHANO-2H-1-BENZOPYRAN E

6-Ethylideneoctahydro 5,8-methano-2H-1-benzopyran must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing 6-ethylideneoctahydro 5,8-methano-2H-1-benzopyran must not be more than 1% of the total medicine.
296 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%.
297 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%.
298 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%.

299 6-METHYL-2-BUTEN-3-OL-2 E
300 6-METHYLQUINOLINE E

6-Methylquinoline must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of the flavour proprietary excipient formulation containing 6-methylquinoline must not be more than 5% of the total medicine.
301 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%.
302 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%.
303 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%.
304 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%.
305 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%.
306 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%.
307 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%.
308 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%.
309 ABELMOSCHUS MOSCHATUS A, H
310 ABELMOSCHUS MOSCHATUS SUBSP. MOSCHATUS A, H
311 ABIES BALSAMEA A, H
312 ABIES NIGRA A, H
313 ABIES PECTINATA A, H
314 ABIES SIBIRICA A, H
315 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.
316 ABUTILON THEOPHRASTI A, H
317 ACACIA A, E, H
318 ACACIA BAILEYANA A, H
319 ACACIA CATECHU A, H
320 ACACIA DEALBATA A, H
321 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%.

322 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%.

323 ACACIA LONGIFOLIA A, E, H
324 ACACIA NILOTICA A, E, H
325 ACACIA SENEGAL A, E, H
326 ACALYPHA INDICA A, H
327 ACANTHUS MOLLIS A, H
328 ACER CAMPESTRE A, H
329 ACER NEGUNDO A, H
330 ACER SACCHARINUM A, H
331 ACER SACCHARUM A, E, H
332 ACEROLA E
333 ACESULFAME POTASSIUM E
334 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%.
335 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%.
336 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%.
337 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%.
338 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%.
339 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%.
340 ACETIC ACID E, H

The concentration in the medicine must be no more than 80%.
341 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%.
342 ACETOMENAPHTHONE A, E
343 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%.
344 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%.
345 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%.
346 ACETOXYDIHYDRODICYCLOPENTADIENE E

Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
347 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%.

348 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%.
349 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%.
350 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%.
351 ACETYL LEVOCARNITINE HYDROCHLORIDE A, E
352 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%.
353 ACETYLATED LANOLIN E

Only for use in topical medicines for dermal application.
354 ACETYLATED LANOLIN ALCOHOL E

Only for use in topical medicines for dermal application.
355 ACETYLATED MONOGLYCERIDES E
356 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%.
357 ACETYLCYSTEINE E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 0.001%.
358 ACHILLEA ERBA-ROTTA SUBSP. MOSCHATA A, H
359 ACHILLEA MILLEFOLIUM A, E, H

Beta-arbutin is a mandatory component of Achillea millefolium.

When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.

When for dermal application exclusively to the face:

a) the concentration of beta-arbutin in the medicine must not be more than 7%;

b) hydroquinone is a mandatory component; and

c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.

When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
360 ACHILLEA PTARMICA A, H
361 ACHYRANTHES ASPERA A, H
362 ACHYRANTHES BIDENTATA A, H
363 ACHYRANTHES FAURIEI A, H
364 ACID GREEN 25 E

Permitted for use only as a colour for topical use.
365 ACID RED 33 E

Permitted for use only as a colour for topical use.
366 ACID RED 87 E, H

Only for use as an active homoeopathic ingredient or for excipient use as a colour in topical medicines.
367 ACID TREATED WAXY MAIZE STARCH E
368 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%.
369 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.

370 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.

371 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.

372 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.

373 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%.
374 ACRYLAMIDES COPOLYMER E

Only for use in topical medicines for dermal application.
375 ACRYLATES COPOLYMER E

Only for use in topical medicines for dermal application.
376 ACRYLATES/ACRYLAMIDE COPOLYMER E

Only for use in topical medicines for dermal application.
377 ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER E

Only for use in topical medicines for dermal application.
378 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%.
379 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%.
380 ACRYLATES/OCTYLACRYLAMIDE COPOLYMER E

Only for use in topical medicines for dermal application.
381 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%.
382 ACRYLATES/VA COPOLYMER E

Only for use in topical medicines for dermal application.
383 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%.
384 ACTAEA CIMICIFUGA A, H
385 ACTAEA HERACLEIFOLIA A, H
386 ACTAEA PACHYPODA A, H
387 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.'
388 ACTAEA SIMPLEX A, H
389 ACTAEA SPICATA A, H
390 ACTINIDIA CHINENSIS A, H
391 ACTINIDIA DELICIOSA A, H
392 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.
393 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).

394 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)'
395 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)'
396 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)'
397 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)'
398 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)'
399 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)'
400 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)'
401 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)'
402 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)'
403 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)'
404 ADENOPHORA STRICTA A, H
405 ADENOPHORA TRIPHYLLA A, H
406 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%.
407 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%.
408 ADENOSINE TRIPHOSPHATE E

Only for use in topical medicines for dermal application.
409 ADENOSINE TRIPHOSPHATE DISODIUM E

Only for use in topical medicines for dermal application.
410 ADIANTUM CAPILLUS-VENERIS A, H
411 ADIPIC ACID E
412 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%.
413 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%.
414 ADRENALINE (EPINEPHRINE) H

Only for use as an active homoeopathic ingredient.
415 ADZUKI BEAN E
416 AEGOPODIUM PODAGRARIA A, H
417 AESCULUS CHINENSIS A, H
418 AESCULUS GLABRA A, H
419 AESCULUS HIPPOCASTANUM A, H
420 AESCULUS X CARNEA A, H
421 AETHUSA CYNAPIUM H

Only for use as an active homoeopathic ingredient.
422 AGAR A, E
423 AGASTACHE RUGOSA A, H
424 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%.
425 AGAVE AMERICANA A, E, H
426 AGRIMONIA EUPATORIA A, E, H
427 AGRIMONIA REPENS A, H
428 AGROSTIS TENUIS A, H
429 AILANTHUS ALTISSIMA A, H
430 AJUGA CHAMAEPITYS A, H
431 AJUGA REPTANS A, H
432 ALANINE A, E
433 ALANYLGLUTAMINE A

Only for use in oral medicines.
434 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.
435 ALBIZIA JULIBRISSIN A, H
436 ALBIZIA LEBBECK A, H
437 ALCEA ROSEA A, H
438 ALCHEMILLA ALPINA A, H
439 ALCHEMILLA ARVENSIS A, H
440 ALCHEMILLA VULGARIS A, H
441 ALETRIS FARINOSA A, H
442 ALETRIS SPICATA A, H
443 ALEURITES MOLUCCANUS SEED OIL E

Only for use in topical medicines for dermal application.
444 ALFADEX A, E

Only for use in oral medicines.

The maximum daily dose must provide no more than 6 g of alfadex.
445 ALGINATE-KONJAC-XANTHAN POLYSACCHARIDE COMPLEX A

Only for use in oral medicines.

Only for use when the dosage form is other than tablet.

The maximum recommended daily dose must be no more than 13.5 g.

When a dose for children is stated, the medicine requires the following warning statement on the medicine label:

- (PSYLL) 'On medical advice' (or words to that effect).
446 ALGINIC ACID E
447 ALISMA ORIENTALE A, H
448 ALISMA PLANTAGO AQUATICA A, H
449 ALKANNA TINCTORIA A, H
450 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%.
451 ALLANTOIN E

Only for use in topical medicines for dermal application.
452 ALLIARIA PETIOLATA A, H
453 ALLIUM CEPA A, H
454 ALLIUM FISTULOSUM A, H
455 ALLIUM HIEROCHUNTINUM A, H
456 ALLIUM MACROSTEMON A, H
457 ALLIUM ODORUM A, H
458 ALLIUM PORRUM A, H
459 ALLIUM SATIVUM A, E, H
460 ALLIUM SCHOENOPRASUM A, H
461 ALLIUM URSINUM A, H
462 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%.
463 ALLURA RED AC E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
464 ALLURA RED AC ALUMINIUM LAKE E

Permitted for use only as a colour for oral and topical use.

465 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%.
466 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%.
467 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%.

468 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%.
469 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%.
470 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%.
471 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%.

472 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%.
473 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%.
474 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%.
475 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%.
476 ALMOND E
477 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%.
478 ALNUS GLUTINOSA A, H
479 ALNUS INCANA SUBSP. RUGOSA A, H
480 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'.
481 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'.
482 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'.
483 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'.
484 ALOYSIA CITRODORA A, H
485 ALPHA CASOZEPINE ENRICHED HYDROLYSED MILK PROTEIN A

Only for use in oral medicines.

The following warning statement is required on the medicine label:

- (BABY3) 'Not suitable for use in children under the age of 12 months except on the advice of a health professional.’ (or words to that effect).
486 ALPHA LIPOIC ACID A
487 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%.
488 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%.
489 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%.
490 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%.
491 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%.
492 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%.
493 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%.

494 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%.
495 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%.
496 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%.

497 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%.
498 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%.
499 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%.

500 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%.
501 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%.

502 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%.
503 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%.
504 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%.

505 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%.
506 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%.
507 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%.
508 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%.
509 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%.
510 ALPHA-SANTALOL E

alpha-Santalol must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing alpha-santalol must not be more than 1% of the total medicine.
511 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%.

512 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%.
513 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%.
514 ALPINIA GALANGA A, H
515 ALPINIA HAINANENSIS A, H
516 ALPINIA OFFICINARUM A, H
517 ALPINIA OXYPHYLLA A, H
518 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.

519 ALSTONIA BOONEI A, H
520 ALSTONIA CONSTRICTA H

Only for use as an active homoeopathic ingredient.
521 ALTERNANTHERA PHILOXEROIDES A, H
522 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%.
523 ALTHAEA OFFICINALIS A, E, H
524 ALUM DODECAHYDRATE A, E, H
525 ALUMINIUM CHLOROHYDRATE E

Only for use in topical medicines for dermal application.
526 ALUMINIUM CITRATE E

Only for use in topical medicines for dermal application.
527 ALUMINIUM DISTEARATE E

Only for use in topical medicines for dermal application.
528 ALUMINIUM HYDROXIDE E

Only for use in topical medicines for dermal application.
529 ALUMINIUM HYDROXIDE HYDRATE E

Only for use in topical medicines for dermal application.
530 ALUMINIUM MAGNESIUM SILICATE E

Magnesium is a mandatory component of aluminium magnesium silicate.

When used in a medicine:

(a) with an oral route of administration;

(b) not indicated for laxative (or related) use; and

(c) where the maximum recommended daily dose for:

(i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

- (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect).

When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.
531 ALUMINIUM MONOSTEARATE E

Only for use in topical medicines for dermal application.
532 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.
533 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.
534 ALUMINIUM SODIUM SILICATE E
535 ALUMINIUM STARCH OCTENYLSUCCINATE E

The concentration in the medicine must be no more than 7%.
536 ALUMINIUM STEARATE E

Only for use in topical medicines for dermal application.
537 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%.

538 AMARANTH E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
539 AMARANTH ALUMINIUM LAKE E

Permitted for use only as a colour for oral and topical use
540 AMARANTHUS HYBRIDUS A, H
541 AMARANTHUS RETROFLEXUS A, H
542 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%.
543 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%.

544 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%.
545 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%.
546 AMBROSIA ARTEMISIIFOLIA A, H
547 AMBROSIA PSILOSTACHYA A, H
548 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%.

The total concentration of aminocaproic acid in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
549 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%.
550 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%.

551 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%.
552 AMMONIO METHACRYLATE COPOLYMER E

Only for use in oral medicines.
553 AMMONIUM ACRYLATES COPOLYMER E

Only for use in topical medicines for dermal application.
554 AMMONIUM ACRYLATES/ACRYLONITROGENS COPOLYMER E

Only for use in topical medicines for dermal application.
555 AMMONIUM ACRYLOYLDIMETHYLTAURATE/STEARETH-8 METHACRYLATE COPOLYMER E

Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.5%.
556 AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER E

Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye.

The concentration in the medicine must be no more than 5%.
557 AMMONIUM BICARBONATE A, H

When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time.
558 AMMONIUM BROMIDE H

Only for use as an active homoeopathic ingredient.
559 AMMONIUM CARBONATE E, H

Only for use as an active homoeopathic or excipient ingredient.
560 AMMONIUM CHLORIDE A, E, H

Only for use as an active ingredient in homoeopathic medicines or as an uncompounded medicine substance packed for retail sale. When used as an uncompounded medicine substance the ingredient must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time.

If used as an excipient ingredient then the medicine is only for topical use for dermal application.
561 AMMONIUM GLYCYRRHIZINATE E
562 AMMONIUM IODIDE H

Only for use an active ingredient in homoeopathic medicines.
563 AMMONIUM LACTATE E

Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.1%.
564 AMMONIUM LAURETH SULFATE E

Only for use in topical medicines for dermal application.
565 AMMONIUM LAURYL SULFATE E

Only for use in topical medicines for dermal application.
566 AMMONIUM POLYACRYLATE E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.2%.
567 AMMONIUM POLYACRYLOYLDIMETHYL TAURATE E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration must be no more than 3%.
568 AMMONIUM SULFIDE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

569 AMOMUM AROMATICUM A, H
570 AMOMUM VILLOSUM A, H
571 AMORPHOPHALLUS KONJAC A, H

Only for use when the dosage form is not tablet.

572 AMPELODESMOS MAURITANICUS A, H
573 AMPELOPSIS JAPONICA A, H
574 AMYL ACETATE E

Only for use in:

- topical medicines for dermal application; or

- combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total flavour proprietary excipient formulation in a medicine must not be more than 5%.
575 AMYL ALCOHOL E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
576 AMYL BENZOATE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
577 AMYL BUTYRATE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
578 AMYL CAPROATE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
579 AMYL CINNAMATE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

580 AMYL FORMATE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
581 AMYL ISOBUTYRATE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

582 AMYL ISOVALERATE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
583 AMYL OCTANOATE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

584 AMYL PHENYLACETATE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

585 AMYL PROPIONATE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

586 AMYL SALICYLATE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
587 AMYL VALERATE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
588 AMYL VINYL CARBINOL E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
589 AMYL VINYL CARBINYL ACETATE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
590 AMYLASE A

Amylase must be derived from Aspergillus oryzae, and comply with the relevant compositional guideline.
591 AMYLCYCLOHEXYL ACETATE (MIXED ISOMERS) E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
592 AMYLOPECTIN E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

593 AMYRIS BALSAMIFERA A, H
594 AMYRIS OIL WEST INDIAN A, E, H
595 ANACARDIUM OCCIDENTALE A, H
596 ANACYCLUS PYRETHRUM A, H
597 ANACYSTIS NIDULANS FERMENT E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.0025%.
598 ANAESTHETIC ETHER H

Only for use as an active homoeopathic ingredient.
599 ANAGALLIS ARVENSIS A, H
600 ANAMIRTA COCCULUS A, H

Picrotoxin is a mandatory component of Anamirta cocculus.

The concentration of picrotoxin in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%.
601 ANANAS COMOSUS A, E, H
602 ANAPHALIS SINICA A, H
603 ANDROGRAPHIS PANICULATA A, H

The following warning statement is required on the label:

- (ANDROG) ‘Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis), stop use and seek immediate medical attention’ (or words to that effect).

When for oral use, the following warning statement is required on the medicine label:

- (ANDROT) ‘Andrographis may cause taste disturbance including loss of taste. If you develop any adverse symptoms, stop use and seek medical advice’ (or words to that effect).
604 ANEMARRHENA ASPHODELOIDES A, E, H
605 ANEMONE ALTAICA A, H
606 ANEMONE CHINENSIS A, H
607 ANEMONE HEPATICA A, H
608 ANEMONE PULSATILLA A, H
609 ANEMONE RADDEANA A, H
610 ANETHOLE E
611 ANETHOLEA ANISATA E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

612 ANETHUM GRAVEOLENS A, E, H
613 ANGELICA ACUTILOBA A, H
614 ANGELICA ANOMALA A, H
615 ANGELICA ARCHANGELICA A, E, H
616 ANGELICA ATROPURPUREA A, H
617 ANGELICA DAHURICA A, E, H
618 ANGELICA DECURSIVA A, H
619 ANGELICA POLYMORPHA A, E, H
620 ANGELICA PUBESCENS A, E, H
621 ANGELICA ROOT DRY A, H
622 ANGELICA ROOT OIL A, E, H
623 ANGELICA SEED OIL A, E, H
624 ANIBA ROSAEODORA A, E, H
625 ANISALDEHYDE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
626 ANISE ALCOHOL E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
627 ANISE OIL A, E, H

When the concentration of Anise oil in the preparation is more than 50% the nominal capacity of the container must be no more than 50 mL.

When the concentration of Anise oil in the preparation is more than 50% and the nominal capacity of the container is 50 mL or less, a restricted flow insert must be fitted on the container.

The  medicine requires the following warning statement on the medicine label:

- (CHILD) 'Keep out of reach of children (or word to that effect)'
628 ANISEED E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
629 ANISEED DRY A, E, H
630 ANISEED POWDER A, E, H
631 ANISIC ACID E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
632 ANISYL ACETATE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
633 ANISYL ACETONE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
634 ANISYL FORMATE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
635 ANISYL PROPIONATE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used as a flavour the total flavour concentration in a medicine must be no more than 5%.
636 ANNATTO E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
637 ANOGEISSUS LATIFOLIA A, E, H
638 ANTENNARIA DIOICA A, E, H
639 ANTHOCYANINS E
640 ANTHOXANTHUM ODORATUM A, H

When used as an active ingredient, coumarin is a mandatory component of Anthoxanthum odoratum and the concentration of coumarin in the medicine must be no more than 0.001%.
641 ANTHRISCUS CEREFOLIUM A, H
642 ANTHYLLIS VULNERARIA A, H
643 ANTIMONY POTASSIUM TARTRATE TRIHYDRATE H

Only for use as an active homoeopathic ingredient.
644 ANTIMONY TRISULFIDE H

Only for use as an active homoeopathic ingredient.
645 APIUM GRAVEOLENS A, E, H
646 APOCYNUM CANNABINUM A, H

The concentration of equivalent dry Apocynum cannabinum in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.
647 APOMORPHINE HYDROCHLORIDE HEMIHYDRATE H

Only for use as an active homoeopathic ingredient.
648 APPLE E
649 APPLE CIDER VINEGAR E
650 APPLE ESSENCE NATURAL E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

651 APPLE EXTRACT E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

652 APPLE FIBRE E
653 APRICOT E
654 APRICOT KERNEL OIL PEG-6 ESTERS E

Only for use as an excipient in topical medicines for dermal application.
655 AQUILARIA MALACCENSIS A, H
656 AQUILARIA SINENSIS A, H
657 AQUILEGIA VULGARIS A, H
658 ARACHIDONIC ACID E

Only for use in topical medicines for dermal application.
659 ARACHIDYL ALCOHOL E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 1%.
660 ARACHIDYL GLUCOSIDE E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration must be no more than 0.5%.
661 ARACHIDYL PROPIONATE E

Only for use in topical medicines for dermal application.
662 ARACHIS HYPOGAEA A, E, H
663 ARACHIS OIL A, E, H
664 ARALIA CORDATA A, H
665 ARALIA HISPIDA A, H
666 ARALIA NUDICAULIS A, H
667 ARALIA RACEMOSA A, H
668 ARCTIUM LAPPA A, E, H
669 ARCTIUM MINUS A, H
670 ARCTOSTAPHYLOS UVA-URSI A, E, H

Beta-arbutin is a mandatory component of Arctostaphylos uva-ursi.

When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.

When for dermal application exclusively to the face:

a) the concentration of beta-arbutin in the medicine must not be more than 7%;

b) hydroquinone is a mandatory component; and

c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.

When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
671 ARDISIA JAPONICA A, H
672 ARGANIA SPINOSA KERNEL OIL E

Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin.

The concentration must be no more than 5% in the medicine.
673 ARGININE A, E, H

Only for use in topical medicines for dermal application.

The medicine requires the following warning statement on the medicine label:

- (ARGIN1) 'This medicine contains arginine and is intended to be applied to the skin only and not to the mucosa - vagina or rectum.'
674 ARGININE FERULATE E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.05%.
675 ARISAEMA ATRORUBENS A, H

The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
676 ARISAEMA CONSANGUINEUM A, H

The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
677 ARISAEMA JAPONICUM A, H

The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
678 ARMORACIA RUSTICANA A, E, H

Volatile oil components (of Armoracia rusticana) is a mandatory component of Armoracia rusticana.

The maximum recommended daily dose must contain no more than 20 mg of volatile oil components (of Armoracia rusticana).
679 ARNEBIA EUCHROMA A, H
680 ARNICA FLOWER DRY A, H

When for use other than topically on unbroken skin, the maximum recommended daily dose must be no more than 1mg of the equivalent dry flower of Arnica montana.
681 ARNICA MOLLIS A, H

When for use other than topically on unbroken skin, the maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.
682 ARNICA MONTANA A, H

When for use other than topically on unbroken skin, the maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of arnica montana.
683 ARRHENATHERUM ELATIUS A, H
684 ARROWROOT A, E, H
685 ARSENIC TRIIODIDE H

Only for use as an active homoeopathic ingredient. The concentration of arsenic in the medicine must be no more than 0.001%.
686 ARSENIC TRIOXIDE H

Only for use as an active homoeopathic ingredient.

The concentration of arsenic in the medicine must be no more than 0.001%.

5037 TRISILOXANE E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 40%.
5038 TRISODIUM EDETATE E

Only for use in topical medicines for dermal application.
5039 TRISODIUM ETHYLENEDIAMINE DISUCCINATE E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.2%.

5040 TRISODIUM NTA E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.005%.
5041 TRISTEARIN E
5042 TRITICUM AESTIVUM A, E, H

Gluten is a mandatory component when the plant part is seed and the route of administration is other than topical and mucosal.
5043 TRITICUM DURUM A, E, H

Gluten is a mandatory component when the plant part is seed and the route of administration is other than topical and mucosal.
5044 TRIUNDECANOIN E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 11.2%.
5045 TROLAMINE E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 5%.
5046 TROLAMINE LAURIL SULFATE E

Only for use in topical medicines for dermal application.
5047 TROLAMINE SALICYLATE A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 12%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
5048 TROLLIUS CHINENSIS A, H
5049 TROMETAMOL E
5050 TROMETAMOL HYDROCHLORIDE E
5051 TROPAEOLUM MAJUS A, E, H
5052 TROPICAL RATTLESNAKE H

Only for use as an active homoeopathic ingredient.
5053 TROPOLONE E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.01%.
5054 TSUGA CANADENSIS A, H
5055 TULIPA EDULIS A, H

Colchicine is a mandatory component of Tulipa edulis.

The concentration of colchicine in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%.
5056 TURMERIC E

Permitted for use only in combination with other permitted ingredients as a colour.
5057 TURNERA DIFFUSA A, E, H

Beta-arbutin is a mandatory component of Turnera diffusa.

When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.

When for dermal application exclusively to the face:

a) the concentration of beta-arbutin in the medicine must not be more than 7%;

b) hydroquinone is a mandatory component; and

c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.

When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
5058 TURNIP E
5059 TURPENTINE OIL A, E

The concentration in the medicine must be no more than 25%.
5060 TYPHA ANGUSTIFOLIA A, H
5061 TYPHA LATIFOLIA A, H
5062 TYPHONIUM GIGANTEUM A, H
5063 TYROSINE A, E

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

Note:       See sections 5 and 6.

Permissible ingredients and requirements
Column 1 Column 2 Column 3 Column 4
Item Ingredient Name Purpose Specific requirements
5064 UBIDECARENONE A, E

When used as an excipient, the route of administration must be topical and the concentration in the medicine must not be more than 0.05%.

Not to be included in medicines intended for use in the eye.

When for internal use, the maximum recommended daily dose must not provide more than 300 milligrams of ubidecarenone.

When for internal use in combination with Ubiquinol-10, the maximum recommended daily dose must not provide more than 300 milligrams of ubiquinol-10 and ubidecarenone combined.

When for internal use, the following warning statement is required on the medicine label:

- (WARF) 'Do not take while on warfarin therapy without medical advice'.
5065 UBIQUINOL-10 A, E

When used as an excipient, the route of administration must be topical and the concentration in the medicine must be no more than 0.05%.

Not to be included in medicines intended for use in the eye.

When for internal use, the maximum recommended daily dose must provide no more than 300 milligrams of ubiquinol-10.

When used in combination with ubidecarenone, the maximum recommended daily dose must provide no more than 300 mg of ubiquinol-10 and ubidecarenone combined.

The medicine requires the following warning statement on the medicine label:

- (WARF) 'Do not take while on warfarin therapy without medical advice.'
5066 ULEX EUROPAEUS A, H
5067 ULMUS AMERICANA A, H
5068 ULMUS CAMPESTRIS A, H
5069 ULMUS GLABRA A, H
5070 ULMUS MINOR A, H
5071 ULMUS PARVIFOLIA A, H
5072 ULMUS PUMILA A, H
5073 ULMUS RUBRA A, H
5074 ULTRALIDE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5075 ULTRAMARINE BLUE E

Permitted for use only as a colour for topical use.
5076 ULVA LACTUCA A, H

Iodine is a mandatory component of Ulva lactuca.

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.1%.
5077 UMBELLULARIA CALIFORNICA A, H
5078 UNCARIA GAMBIR A, H
5079 UNCARIA RHYNCOPHYLLA A, H
5080 UNCARIA SINENSIS A, H
5081 UNCARIA TOMENTOSA A, H
5082 UNDARIA PINNATIFIDA A, H

Whole dried Undaria pinnatifida must not contain the holdfast.

Only for use in oral medicines.

5083 UNDECANAL E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5084 UNDECANOIC ACID E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used as a flavour the total flavour concentration in a medicine must be no more than 5%.
5085 UNDECENOIC ACID E
5086 UNDECYL ALCOHOL E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5087 UNDECYLCRYLENE DIMETICONE E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 10%.
5088 UNDECYLENAMIDE DEA E
5089 UNDECYLENOYL PEG-5 PARABEN E

Only for use in topical medicines for dermal application.
5090 URANIUM NITRATE H

Only for use as an active homoeopathic ingredient. 

5091 UREA A, E, H

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 10% (w/w).

5092 URTICA DIOICA A, E, H
5093 URTICA URENS A, H
5094 USNEA BARBATA A, H
5095 UVA URSI LEAF DRY A, H
5096 UVA URSI LEAF POWDER A, E, H
5097 VA/BUTYL MALEATE/ISOBORNYL ACRYLATE COPOLYMER E

Vinyl acetate is a mandatory component of VA/butyl maleate/isobornyl acrylate copolymer.

The concentration of vinyl acetate in the medicine must be no more than 0.01% or 100 ppm.

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 5%.

5098 VACCARIA SEGATALIS A, H
5099 VACCINIUM BRACTEATUM A, H
5100 VACCINIUM CORYMBOSUM E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5101 VACCINIUM MACROCARPON A, E, H
5102 VACCINIUM MYRTILLOIDES A, H
5103 VACCINIUM MYRTILLUS A, E, H
5104 VACCINIUM OXYCOCCUS A, H
5105 VACCINIUM VITIS-IDAEA A, H

Beta-arbutin is a mandatory component of Vaccinium vitis-idaea.

When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.

When for dermal application exclusively to the face:

a) the concentration of beta-arbutin in the medicine must not be more than 7%;

b) hydroquinone is a mandatory component; and

c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.

When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
5106 VALENCENE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

5107 VALERALDEHYDE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5108 VALERIAN DRY A, H

The requirement specified below applies to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2023; or

- released for supply on or after 1 March 2024:

The following warning statement is required on the medicine label when the medicine is for oral use:

(VALER) 'In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.'
5109 VALERIAN OIL E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

5110 VALERIAN POWDER A, H

The requirement specified below applies to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2023; or

- released for supply on or after 1 March 2024:

The following warning statement is required on the medicine label when the medicine is for oral use:

(VALER) 'In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.'
5111 VALERIANA EDULIS A, H
5112 VALERIANA OFFICINALIS A, H

The requirement specified below applies to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2023; or

- released for supply on or after 1 March 2024:

The following warning statement is required on the medicine label when the medicine is for oral use:

(VALER) 'In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.'
5113 VALERIANA SORBIFOLIA A, H
5114 VALERIC ACID E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5115 VALINE A, E
5116 VANADIUM H
5117 VANILLA E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5118 VANILLA DRY A, E, H
5119 VANILLA EXTRACT E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

5120 VANILLA OLEORESIN E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

5121 VANILLA PLANIFOLIA A, E, H
5122 VANILLA POWDER A, E, H
5123 VANILLA TAHITENSIS A, H
5124 VANILLIC ACID E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

5125 VANILLIN E
5126 VANILLIN ACETATE E

Vanillin acetate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing vanillin acetate must not be more than 5% of the total medicine.

The maximum recommended daily dose of the medicine must not provide more than 1.8 micrograms of vanillin acetate.
5127 VANILLIN ISOBUTYRATE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5128 VANILLYL ALCOHOL E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

5129 VAT RED 1 E

Permitted for use only as a colour for topical use.
5130 VAT RED 1 ALUMINIUM LAKE E

Permitted for use only as a colour for topical use.
5131 VAT RED 5 E

Permitted for use only as a colour for topical use.
5132 VEGETABLE OIL E
5133 VEGETABLE OIL PHYTOSTEROL ESTERS A

Only for use in oral medicines.

The medicine requires the following warning statement on the medicine label:

- (PREGNT) 'Not recommended for use by pregnant and lactating women (or words to that effect).'
5134 VEIN H

Only for use as an active homoeopathic ingredient.
5135 VERATRALDEHYDE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5136 VERATROL E

Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation.

The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
5137 VERATRUM ALBUM A, H

Solanidine is a mandatory component of Veratrum album.

The concentration of equivalent dry Veratrum album in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.

5138 VERBASCUM DENSIFLORUM A, H
5139 VERBASCUM THAPSUS A, H
5140 VERBENA OFFICINALIS A, H
5141 VERBENA OIL E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

5142 VERONICA CHAMAEDRYS A, H
5143 VERONICA OFFICINALIS A, H
5144 VERONICASTRUM VIRGINICUM A, E, H
5145 VERTONAL E

Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation.

When included in a medicine for use on the lips the concentration of vertonal must be no more than 0.2%.

The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
5146 VETIVER OIL E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5147 VETIVERYL ACETATE E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5148 VIBURNUM OPULUS A, E, H
5149 VIBURNUM PRUNIFOLIUM A, E, H
5150 VICIA FABA A, H

Levodopa is a mandatory component of Vicia faba.

The concentration of levodopa in the  medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
5151 VIGNA ANGULARIS VAR. ANGULARIS A, H
5152 VIGNA RADIATA A, H
5153 VIGNA UMBELLATA A, H
5154 VINCA MAJOR A, H

Vincamine is a mandatory component of Vinca major.

The concentration of vincamine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%.
5155 VINCA MINOR A, H

Vincamine and vincristine are mandatory components of Vinca minor.

The concentration of vincamine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%.

The concentration of Vincristine in the medicine must be no more than 10mg/kg or 10mg/L or 0.001%
5156 VINCETOXICUM OFFICINALE A, H
5157 VINEGAR E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

5158 VIOLA ODORATA A, E, H
5159 VIOLA TRICOLOR A, H
5160 VIOLA YEDOENSIS A, H
5161 VIOLET LEAF ABSOLUTE E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5162 VIPER H

Only for use as an active homoeopathic ingredient. 

5163 VISCUM ALBUM A, E, H
5164 VISCUM COLORATUM A, H
5165 VISCUM FLAVESCENS A, H
5166 VITELLARIA PARADOXA A, E, H
5167 VITEX AGNUS-CASTUS A, E, H

When the ingredient is in a medicine that is for internal use, the following warning statement is required on the label:

- (VAC) 'Vitex agnus-castus may affect hormones and medicines such as oral contraceptives. Consult your health professional before use' (or words to that effect).
5168 VITEX NEGUNDO A, H
5169 VITEX ROTUNDIFOLIA A, H
5170 VITEX TRIFOLIA A, H
5171 VITIS VINIFERA A, E, H
5172 VITREOSCILLA CONCENTRATE E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 0.1%.
5173 VP/ACRYLATES/LAURYL METHACRYLATE COPOLYMER E

Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye.

The concentration in the medicine must not be more than 2.00%.
5174 WAHLENBERGIA GRACILIS A, H
5175 WALNUT E
5176 WALNUT OIL E
5177 WATER MELON E
5178 WHEAT E

Gluten is a mandatory component of Wheat when the route of administration is other than topical and mucosal.
5179 WHEAT BRAN E

Gluten is a mandatory component of Wheat bran when the route of administration is other than topical and mucosal.
5180 WHEAT DEXTRIN A, E

Gluten is a mandatory component of wheat dextrin.

Only for use when the dosage form is capsule, tablet or pill.
5181 WHEAT GERM E

Gluten is a mandatory component of Wheat germ when the route of administration is other than topical and mucosal.
5182 WHEAT GERM GLYCERIDES E

Gluten is a mandatory component of wheat germ glycerides when the route of administration is other than topical and mucosal.
5183 WHEAT LEAF E
5184 WHEAT STARCH E

When the route of administration is other than topical or mucosal, gluten is a mandatory component of wheat starch.
5185 WHEATGERM OIL A, E, H
5186 WHEY POWDER E

Lactose is a mandatory component of Whey powder when the route of administration is oral.
5187 WHEY PROTEIN E

Lactose is a mandatory component of Whey protein when the route of administration is oral.
5188 WHEY PROTEIN CONCENTRATE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

5189 WHITE BEESWAX E
5190 WHITE HOREHOUND HERB DRY A, H
5191 WHITE HOREHOUND HERB POWDER A, H
5192 WHITE SOFT PARAFFIN A, E

When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time.
5193 WHOLE DRY MILK E
5194 WIKSTROEMIA VIRIDIFLORA A, H
5195 WILD CARROT HERB DRY A, E, H
5196 WILD CARROT HERB POWDER A, H
5197 WILD CHERRY BARK DRY A, H
5198 WILD CHERRY BARK POWDER A, H
5199 WILD LETTUCE LEAF DRY A, H
5200 WILD LETTUCE LEAF POWDER A, H
5201 WINTERGREEN OIL A, E, H

Methyl salicylate is a mandatory component of wintergreen oil.

Not to be included in medicines for use in the eye or on damaged skin.

When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%.

When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging.

When the concentration of methyl salicylate in a liquid preparation is more than 5%, and the dosage form is spray, the medicine does not require child resistant packaging if:

- the delivery device is engaged into the container in such a way that prevents it from being readily removed;

- direct suction through the delivery device results in delivery of no more than one dosage unit; and

- actuation of the spray device is ergonomically difficult for young children to accomplish.

The following warning statement is required on the medicine label:

- (METSAL) 'Contains methyl salicylate' (or words to that effect).

When for use in topical medicines for dermal application:

i) the concentration of methyl salicylate in the medicine must not be more than 25%;

ii) the following warning statements are required on the medicine label:

- (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect);

- (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less';

- (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect);

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect);

iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label:

- (IRRIT) 'If irritation develops, discontinue use'.
5202 WITHANIA SOMNIFERA A, E, H

The medicine requires the following warning statement on the label:

- (WITHANIA) 'If you are pregnant, or considering becoming pregnant, do not take without consulting a health professional' (or words to that effect)

unless:

(a) the plant part is root;

(b) the plant preparation is an extract;

(c) the extraction solvents are only water, ethanol or methanol; and

(d) the maximum recommended daily dose of the medicine contains no more than the equivalent quantity of 12 g dry root.
5203 WOLFIPORIA COCOS A, E, H
5204 WOOL ALCOHOLS E

Only for use in topical medicines for dermal application.
5205 WOOL FAT A, E

When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time.
5206 XANTHAN GUM E
5207 XANTHIUM SIBIRICUM A, H
5208 XANTHIUM STRUMARIUM A, H
5209 XANTHOMONA CAMPESTRIS A, H
5210 XEROPHYLLUM ASPHODELOIDES A, H
5211 XYLENE E

The residual solvent limit for xylene is 21.7 mg per maximum recommended daily dose.

 The concentration in the medicine must be no more than 0.217%.
5212 XYLITOL E
5213 XYLOSE E
5214 YAM E
5215 YARROW HERB DRY A, H
5216 YARROW HERB POWDER A, H
5217 YEAST AUTOLYSATE E
5218 YEAST DRIED A, E, H
5219 YELLOW 2G E

Permitted for use only as a colour for topical use.
5220 YELLOW BEESWAX E
5221 YELLOW MERCURIC OXIDE H

Only for use as an active homoeopathic ingredient.
5222 YELLOW SOFT PARAFFIN A, E

Only for use in topical medicines for dermal application.

When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time.
5223 YLANG YLANG OIL A, E, H
5224 YUCCA BACCATA A, H
5225 YUCCA ELATA A, H
5226 YUCCA FILAMENTOSA A, H
5227 YUCCA GLORIOSA A, H
5228 Z-BETA-DAMASCONE E

Z – beta damascone must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing Z – beta damascone must not be more than 5% of the total medicine.
5229 ZANTHOXYLUM AMERICANUM A, H
5230 ZANTHOXYLUM BUNGEANUM A, E, H
5231 ZANTHOXYLUM CLAVA-HERCULIS A, H
5232 ZANTHOXYLUM NITIDUM A, H
5233 ZANTHOXYLUM PIPERITUM A, H
5234 ZANTHOXYLUM SIMULANS A, H
5235 ZEA MAYS A, E, H
5236 ZEAXANTHIN A, E
5237 ZEIN E
5238 ZINC H

Only for use as an active homoeopathic ingredient.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
5239 ZINC AMINO ACID CHELATE A, E, H

When used internally, zinc is a mandatory component of zinc amino acid chelate.

The concentration of zinc in zinc amino acid chelate must be no more than 30%.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5240 ZINC ASCORBATE A, E, H

When used internally, zinc is a mandatory component of zinc ascorbate.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'

5241 ZINC ASCORBATE MONOHYDRATE A, E, H

When used internally, zinc is a mandatory component of zinc ascorbate monohydrate.

 When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

 When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

 - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
5242 ZINC CHLORIDE A, E, H

The concentration of zinc chloride in the medicine must be no more than 5%.

When used internally, zinc is a mandatory component of zinc chloride.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5243 ZINC CITRATE A, E, H

When used internally, zinc is a mandatory component of zinc citrate.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5244 ZINC CITRATE DIHYDRATE A, E, H

When used internally, zinc is a mandatory component of zinc citrate dihydrate.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5245 ZINC CITRATE TRIHYDRATE A, E, H

When used internally, zinc is a mandatory component of zinc citrate trihydrate.  When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5246 ZINC DIASPARTATE A

When used internally, zinc is a mandatory component of zinc diaspartate.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5247 ZINC GLUCONATE A, E, H

When used internally, zinc is a mandatory component of zinc gluconate.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5248 ZINC GLYCINATE A

When used internally, zinc is a mandatory component of Zinc glycinate.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5249 ZINC GLYCINATE MONOHYDRATE A

When used internally, zinc is a mandatory component of Zinc glycinate monohydrate.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
5250 ZINC LACTATE E

Only for use in topical and dental medicines and not to be included in medicines intended for use in the eye.

The concentration of zinc lactate in a medicine intended for topical use should be no more than 2%.

The concentration of Zinc lactate in a medicine for 'dental' use in toothpaste medicines must be no more than 2.5%.

Zinc lactate is not to be included in dental / toothpaste medicines intended for use by children less than 12 years old.  

Medicines containing Zinc lactate for dental use require the following warning statement on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'.
5251 ZINC LACTATE DIHYDRATE E

Only for use in topical and dental medicines and not to be included in medicines intended for use in the eye.

The concentration of Zinc lactate dihydrate in a medicine intended for topical use should be no more than 2%.

The concentration of Zinc lactate dihydrate in a medicine for 'dental' use in toothpaste medicines must be no more than 2.5%.

Zinc lactate dihydrate is not to be included in dental / toothpaste medicines intended for use by children less than 12 years old.

 Medicines containing Zinc lactate for dental use require the following warning statement on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'.
5252 ZINC LYSINATE A

When used internally, zinc is a mandatory component of Zinc lysinate.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5253 ZINC METHIONINE SULFATE A

For topical use, the concentration of zinc methionine sulfate must be no more than 5%.

When used internally, zinc is a mandatory component of zinc methionine sulfate.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5254 ZINC MYRISTATE E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.1%.
5255 ZINC OXIDE A, E, H

When used internally, zinc is a mandatory component of zinc oxide.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR

-'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period’ (or words to that effect).

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
5256 ZINC PARA-PHENOLSULFONATE E

The concentration of zinc para-phenolsulfonate in the medicine must not exceed 5%.

When used internally, zinc is a mandatory component of zinc para-phenolsulfate.

The percentage of zinc from zinc para-phenolsulfonate should be calculated based on the molecular weight of zinc para-phenolsulfonate.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period. OR WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period' (or words to that effect).
5257 ZINC STEARATE E

When used internally, zinc is a mandatory component of zinc stearate.

The percentage of zinc from zinc stearate should be calculated based on the molecular weight of zinc stearate.
5258 ZINC SUCCINATE A, E, H

When used internally, zinc is a mandatory component of zinc succinate.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' or

- 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'

5259 ZINC SULFATE A, E

For topical use, the concentration of zinc sulfate must be no more than 5%.

For internal use, zinc is a mandatory component of zinc sulfate.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR

- 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'

5260 ZINC SULFATE HEPTAHYDRATE A, E

For topical use, the concentration of zinc sulfate must be no more than 5%.

For internal use, zinc is a mandatory component of zinc sulfate heptahydrate.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR

- 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5261 ZINC SULFATE HEXAHYDRATE A, E, H

For topical use, the concentration of zinc sulfate must be no more than 5%.

For internal use, zinc is a mandatory component of zinc sulfate hexahydrate.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR

- 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5262 ZINC SULFATE MONOHYDRATE A, E, H

When the route of administration is topical the concentration of zinc sulfate in the medicine must be no more than 5%.

When the medicine is for internal use, zinc is a mandatory component of zinc sulfate monohydrate.

When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.

When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:

- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR

- 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5263 ZINC VALERATE H

Only for use as an active homoeopathic ingredient.

For internal use, zinc is a mandatory component of zinc valerate.

The percentage of zinc from zinc valerate should be calculated based on the molecular weight of zinc valerate.
5264 ZINGERONE E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

5265 ZINGIBER OFFICINALE A, E, H

When for oral use AND the extract ratio is equal to or more than 25:1 AND the equivalent dry weight per dosage unit is equal to or more than 2g, the medicine requires the following warning statement on the medicine label:

- (GINGER) 'Individuals taking anticoagulants should seek medical advice before taking this medicine.' AND 'Individuals at risk of bleeding problems should seek advice from their healthcare practitioner prior to taking this medicine'.
5266 ZIZIPHUS JUJUBA A, H
5267 ZIZIPHUS JUJUBA VAR. SPINOSA A, H
5268 ZIZYPHUS SATIVA A, H
5269 ZOSTERA MARINA A, H
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