Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016 (Cth)

Case
No judgment structure available for this case.

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016

made under subsection 26BB(1) of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date:  6 October 2016

Includes amendments up to:            F2016L01588

Registered:   11 October 2016

This compilation is in 6 volumes

Volume 1:       section 1–3, Schedule 1, Parts 1 and 2 (items 1–714)

Volume 2:       Schedule 1, Part 2 (items 715–2122)
Volume 3:       Schedule 1, Part 2 (items 2123—2761)
Volume 4:       Schedule 1, Part 2 (items 2762–3543)
Volume 5:        Schedule 1, Part 2 (items 3544–4950)
Volume 6:       Schedule 1, Part 2 (items 4951–5160)

Each volume has its own contents

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016 that shows the text of the law as amended and in force on 6 October 2016 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register ( The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self-repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

1  Name of Determination

This Determination is the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016.

3Interpretation

In this Determination:

Act means the Therapeutic Goods Act 1989.

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

European Pharmacopeia is as defined under the Act.

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

4Permissible ingredients and requirements applying to those ingredients

Permissible ingredients and requirements applying to those ingredients under Table 1

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

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

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

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

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

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

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

Note:  Examples of these acronyms are:

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

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

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

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

(b)  the safety of the ingredient must have been assessed against the principles and requirements detailed in the European Pharmacopeia general monograph 1483: Products with risk of transmitting agents of animal spongiform encephalopathies, including General Text 5.2.8: Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products.

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

(section 4)

Part 1—Interpretation of Table 1

Definitions

At Table 1:

“A” means an active ingredient.

Act means the Therapeutic Goods Act 1989.

Active ingredient is as defined in the Regulations.

“E” means an excipient.

Excipient means an ingredient that is not an active ingredient or a homoeopathic preparation ingredient.

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

“H” means a homoeopathic preparation ingredient.

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

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

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

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

(ii)   serial trituration in lactose.

Mother tincture is as defined in the Regulations.

Regulations means the Therapeutic Goods Regulations 1990.

Part 2—Table 1

Column 1

Column 2

Ingredient Name

Column 3

Purpose of the ingredient in the medicine

Column 4

Specific requirement(s) applying to the ingredient in Column 2

1

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

E

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

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

2

(1R,2S,5R)-N-(4-METHOXYPHENYL)-5-METHYL-2-(1-METHYLETHYL) CYCLOHEXANECARBOXAMIDE

E

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

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

3

(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%.

4

(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%.

5

(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%.

6

(S)- LACTIC ACID

A,E,H

7

(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)'

8

(S)-S-ADENOSYLMETHIONINE DISULFATE TOSYLATE

A

(S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine disulfate tosilate.

(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)'

9

(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)'

10

(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)'

11

(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)'

12

(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)'

13

(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)'

14

(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)'

15

(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)'

16

(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)'

17

(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%.

18

(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%.

19

(±)-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%.

20

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%.

21

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%.

22

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%.

23

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%.

24

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%.

25

1-DODECANOL

E

Only for use in topical medicines for dermal application.

26

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%.

27

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%.

28

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%.

29

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%.

30

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%.

31

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%.

32

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%.

33

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%.

34

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%.

35

1,1,1-TRICHLOROETHANE

E

The concentration in the medicine must be no more than 25%.

36

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%.

37

1,3-BUTYLENE GLYCOL

E

38

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%.

39

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%.

40

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%.

41

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%.

42

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%

43

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%.

44

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%.

45

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%.

46

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%.

47

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%.

48

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%.

49

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%.

50

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%.

51

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%.

52

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%.

53

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%.

54

2-AMINO-2-METHYL-1-PROPANOL

E

Only for use in topical medicines for dermal application.

55

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%.

56

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%.

56A

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%.

57

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%.

58

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%.

59

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%.

60

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%.

61

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%.

62

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%.

63

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%.

64

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%.

65

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%.

66

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%.

67

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%.

68

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%.

69

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%.

70

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%.

71

2-ETHYL METHYL BUTYRATE

E

Permitted for use only in combination with 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-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%.

73

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%.

74

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%.

75

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%.

76

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%.

77

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%.

78

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%.

79

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%.

80

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%.

81

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%.

82

2-METHOXY-3-SECBUTYLPYRAZINE

E

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

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

83

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%.

84

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%.

85

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%.

86

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%.

87

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%.

88

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%.

89

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%.

90

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%.

91

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%.

91A

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.

92

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%.

92A

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%.

93

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%.

94

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%.

95

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%.

96

2-METHYL BUTYRIC ACID

E

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

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

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

97

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%.

98

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%.

99

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%.

100

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%.

101

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%.

102

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%.

103

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%.

104

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%.

105

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%.

106

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%.

107

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%.

108

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%.

109

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%.

110

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%.

111

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%.

112

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%.

113

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%.

114

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%.

115

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%.

116

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%.

117

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%.

118

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%.

119

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%.

120

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%.

121

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%.

122

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%.

123

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%.

124

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%.

125

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%.

126

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%.

127

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%.

127A

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%.

128

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%.

129

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%.

130

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%.

131

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%.

132

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%.

133

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%.

134

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%.

135

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%.

136

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%.

137

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%.

138

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%.

139

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%.

140

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%.

141

2,4-DECADIENAL

E

Permitted for use only in combination with 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

2,4-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%.

143

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%.

144

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%.

145

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%.

146

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%.

147

2,4-HEXADIENOL

E

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

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

148

2,4,5-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%.

149

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%.

150

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%.

151

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%.

152

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%.

153

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%.

154

2,5-DIMETHYLPYRAZINE

E

If used in a flavour the total flavour concentration in a 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%

155

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%.

156

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%.

157

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%.

158

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%.

159

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%.

160

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%.

161

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%.

162

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%.

163

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%.

164

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%.

165

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%.

166

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%.

167

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%.

168

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%.

169

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%.

170

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%.

171

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%.

172

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%.

173

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%.

174

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%.

175

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%.

176

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%.

177

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%.

178

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%.

179

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%.

180

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%.

181

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%.

182

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%.

183

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%.

184

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%.

185

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%.

186

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%.

187

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%.

188

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%.

189

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%.

190

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%.

191

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%.

192

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%.

193

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%.

194

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%.

195

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%.

196

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%.

197

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%.

198

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%.

199

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%.

200

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%.

201

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%.

202

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%.

203

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%.

204

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%.

205

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%.

206

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%.

207

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%.

208

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%.

209

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%.

210

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%.

211

4-(4-HYDROXY-4-METHYLPENTYL)-3-CYCLOHEXENE CARBOXALDEHYDE

E

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

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

212

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%.

213

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%.

214

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%.

215

4-(PARA-HYDROXYPHENYL)-2-BUTANONE

E

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

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

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

216

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%.

217

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%.

218

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%.

219

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%.

220

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%.

221

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%.

222

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%.

223

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%.

224

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%.

225

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%.

226

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%.

227

4-METHYLBENZYLIDENE CAMPHOR

A

Only for use as an active ingredient in sunscreens.

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

The concentration in the medicine must be no more than 4%.

228

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%.

229

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%.

230

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%.

231

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%.

232

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%.

233

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%.

234

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%.

235

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%.

236

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%.

236A

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%.

237

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%.

238

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%.

239

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%.

240

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%.

241

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%.

242

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%.

243

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%.

244

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%.

245

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%.

246

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%.

247

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%.

248

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%.

249

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%.

250

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%.

251

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%.

252

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%.

252A

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%.

253

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%.

254

6-METHYL-2-BUTEN-3-OL-2

E

255

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%.

256

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%.

257

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%.

258

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%.

259

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%.

260

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%.

261

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%.

262

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%.

263

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%.

264

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%.

265

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%.

266

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%.

267

ABELMOSCHUS MOSCHATUS

A,H

268

ABELMOSCHUS MOSCHATUS SUBSP. MOSCHATUS

A,H

269

ABIES BALSAMEA

A,H

270

ABIES NIGRA

A,H

271

ABIES PECTINATA

A,H

272

ABIES SIBIRICA

A,H

273

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.

274

ABSIDIA RAMOSA

A,H

275

ABUTILON THEOPHRASTI

A,H

276

ACACIA

A,E,H

277

ACACIA BAILEYANA

A,H

278

ACACIA CATECHU

A,H

279

ACACIA DEALBATA

A,H

280

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%.

281

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%.

282

ACACIA LONGIFOLIA

A,E,H

283

ACACIA NILOTICA

A,E,H

284

ACACIA SENEGAL

A,E,H

285

ACALYPHA INDICA

A,H

286

ACANTHUS MOLLIS

A,H

287

ACER CAMPESTRE

A,H

288

ACER NEGUNDO

A,H

289

ACER SACCHARINUM

A,H

290

ACER SACCHARUM

A,E,H

291

ACEROLA

E

292

ACESULFAME POTASSIUM

E

293

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%.

294

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%.

295

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%.

296

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%.

297

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%.

298

ACETANISOLE

E

Only for use in topical medicines for dermal application.

299

ACETIC ACID

E,H

The concentration in the medicine must be no more than 1.5%.

300

ACETIC ACID - GLACIAL

E,H

The concentration in the medicine must be no more than 1.5%.

301

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%.

302

ACETOMENAPHTHONE

A,E

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) 'Vitamins can only be of assistance if the dietary vitamin intake is inadequate.' or 'Vitamin supplements should not replace a balanced diet.'

303

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%.

304

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%.

305

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%.

306

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%.

307

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%.

308

ACETYL GLUCOSAMINE

E

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

The concentration in the medicine must be no more than 0.5%.

If the ingredient is sourced from seafood, then the medicine requires the following warning statement on the medicine label:

- (SFOOD) 'Derived from seafood'

309

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%.

310

ACETYL LEVOCARNITINE HYDROCHLORIDE

A,E

311

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%.

312

ACETYLATED LANOLIN

E

Only for use in topical medicines for dermal application.

313

ACETYLATED LANOLIN ALCOHOL

E

Only for use in topical medicines for dermal application.

314

ACETYLATED MONOGLYCERIDES

E

315

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%.

316

ACETYLCYSTEINE

E

Only for use in topical medicines for dermal application.

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

317

ACHILLEA ERBA-ROTTA SUBSP. MOSCHATA

A,H

318

ACHILLEA MILLEFOLIUM

A,E,H

319

ACHILLEA PTARMICA

A,H

320

ACHYRANTHES ASPERA

A,H

321

ACHYRANTHES BIDENTATA

A,H

322

ACHYRANTHES FAURIEI

A,H

323

ACID-ISOMERISED LINALOOL

E

324

ACID GREEN 25

E

Permitted for use as a colour for topical use.

325

ACID RED 33

E

Permitted for use as a colour for topical use.

326

ACID RED 87

E,H

Only for use as an active homoeopathic ingredient or for excipient use as a colour in topical medicines.

327

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.

328

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.

329

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.

330

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.

331

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%.

332

ACRYLAMIDES COPOLYMER

E

Only for use in topical medicines for dermal application.

333

ACRYLATES COPOLYMER

E

Only for use in topical medicines for dermal application.

334

ACRYLATES/ACRYLAMIDE COPOLYMER

E

Only for use in topical medicines for dermal application.

335

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

E

Only for use in topical medicines for dermal application.

336

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%.

337

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%.

338

ACRYLATES/OCTYLACRYLAMIDE COPOLYMER

E

Only for use in topical medicines for dermal application.

339

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%.

340

ACRYLATES/VA COPOLYMER

E

Only for use in topical medicines for dermal application.

341

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%.

342

ACTAEA CIMICIFUGA

A,H

343

ACTAEA HERACLEIFOLIA

A,H

344

ACTAEA PACHYPODA

A,H

345

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.'

346

ACTAEA SIMPLEX

A,H

347

ACTAEA SPICATA

A,H

348

ACTINIDIA CHINENSIS

A,H

349

ACTINIDIA DELICIOSA

A,H

350

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)'

351

ADEMETIONINE DISULFATE TOSYLATE

A,H

(S)-S-Adenosylmethionine is a mandatory component of Ademetionine disulfate ditosylate.

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)'

352

ADEMETIONINE DISULFATE TRITOSYLATE DIHYDRATE

A,H

(S)-S-Adenosylmethionine is a mandatory component of Ademetionine trisulfate 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)'

353

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)'

354

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)'

355

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)'

356

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)'

357

ADEMETIONINE TETRASULFATE DIHYDRATE

A,H

(S)-S-Adenosylmethionine is a mandatory component of Ademetionine tetrasulfate 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)'

358

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)'

359

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)'

360

ADENOPHORA STRICTA

A,H

361

ADENOPHORA TRIPHYLLA

A,H

362

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%.

363

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%.

364

ADENOSINE TRIPHOSPHATE

E

Only for use in topical medicines for dermal application.

365

ADENOSINE TRIPHOSPHATE DISODIUM

E

Only for use in topical medicines for dermal application.

366

ADIANTUM CAPILLUS-VENERIS

A,H

367

ADIPIC ACID

E

368

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%.

369

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%.

370

ADRENALINE (EPINEPHRINE)

H

Only for use as an active homoeopathic ingredient.

371

ADZUKI BEAN

E

372

AEGOPODIUM PODAGRARIA

A,H

373

AESCULUS CHINENSIS

A,H

374

AESCULUS GLABRA

A,H

375

AESCULUS HIPPOCASTANUM

A,H

376

AESCULUS X CARNEA

A,H

377

AETHUSA CYNAPIUM

H

Only for use as an active homoeopathic ingredient.

378

AGAR

A,E

379

AGASTACHE RUGOSA

A,H

380

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%.

381

AGAVE AMERICANA

A,E,H

382

AGRIMONIA EUPATORIA

A,E,H

383

AGRIMONIA REPENS

A,H

384

AGROSTIS TENUIS

A,H

385

AILANTHUS ALTISSIMA

A,H

386

AJUGA CHAMAEPITYS

A,H

387

AJUGA REPTANS

A,H

388

ALANINE

A,E

389

ALANYLGLUTAMINE

A

Only for use in oral medicines.

390

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 more than 2.5%.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

The indication 'For mineral (may state the mineral) supplementation' is only permitted for use when the medicine is for oral and sublingual use.

391

ALBIZIA JULIBRISSIN

A,H

392

ALBIZIA LEBBECK

A,H

393

ALCEA ROSEA

A,H

394

ALCHEMILLA ALPINA

A,H

395

ALCHEMILLA ARVENSIS

A,H

396

ALCHEMILLA VULGARIS

A,H

397

ALETRIS FARINOSA

A,H

398

ALETRIS SPICATA

A,H

399

ALEURITES MOLUCCANUS SEED OIL

E

Only for use in topical medicines for dermal application.

400

ALFADEX

A

Only for use in oral medicines.

The maximum daily dose must provide no more than 6 g of alfadex.

401

ALGINIC ACID

E

402

ALISMA ORIENTALE

A,H

403

ALISMA PLANTAGO AQUATICA

A,H

404

ALKANNA TINCTORIA

A,H

405

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%.

406

ALLANTOIN

E

Only for use in topical medicines for dermal application.

407

ALLIARIA PETIOLATA

A,H

408

ALLIUM CEPA

A,H

409

ALLIUM FISTULOSUM

A,H

410

ALLIUM HIEROCHUNTINUM

A,H

411

ALLIUM MACROSTEMON

A,H

412

ALLIUM ODORUM

A,H

413

ALLIUM PORRUM

A,H

414

ALLIUM SATIVUM

A,E,H

415

ALLIUM SCHOENOPRASUM

A,H

416

ALLIUM URSINUM

A,H

417

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%.

418

ALLURA RED AC

E

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

419

ALLURA RED AC ALUMINIUM LAKE

E

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

420

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%.

421

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%.

422

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%.

423

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%.

424

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%.

425

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%.

426

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%.

427

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%.

428

ALLYL ISOTHIOCYANATE

E

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

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

429

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%.

430

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%.

431

ALMOND

E

432

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%.

433

ALNUS GLUTINOSA

A,H

434

ALNUS INCANA SUBSP. RUGOSA

A,H

435

ALOE BARBADENSIS

A,E

When the route of administration is oral or sublingual, Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of Aloe barbadensis.

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'

- (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)

- (S) 'If symptoms persist consult your healthcare practitioner' (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:

- (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)]'

- (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)

- (LAX2) 'Prolonged use may cause serious bowel problems'

- (S) 'If symptoms persist consult your healthcare practitioner' (or words to that effect).

436

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'

- (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]'

- (S) 'If symptoms persist consult your healthcare practitioner [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)]'

- (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]'

- (LAX2) 'Prolonged use may cause serious bowel problems'

- (S) 'If symptoms persist consult your healthcare practitioner [or words to that effect]'

437

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'

- (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]'

- (S) 'If symptoms persist consult your healthcare practitioner [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)]'

- (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]'

- (LAX2) 'Prolonged use may cause serious bowel problems'

- (S) 'If symptoms persist consult your healthcare practitioner [or words to that effect]'

438

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'

- (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]'

- (S) 'If symptoms persist consult your healthcare practitioner [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)]'

- (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]'

- (LAX2) 'Prolonged use may cause serious bowel problems'

- (S) 'If symptoms persist consult your healthcare practitioner [or words to that effect]'

439

ALOES BARBADOS

A,H

When the route of administration is oral or sublingual, Hydroxyanthracene derivatives calculated as anhydrous barbaloin is a mandatory component of Aloes barbados.

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'

- (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]'

- (S) 'If symptoms persist consult your healthcare practitioner [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)]'

- (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]'

- (LAX2) 'Prolonged use may cause serious bowel problems'

- (S) 'If symptoms persist consult your healthcare practitioner [or words to that effect]'

440

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'

- (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]'

- (S) 'If symptoms persist consult your healthcare practitioner [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)]'

- (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]'

- (LAX2) 'Prolonged use may cause serious bowel problems'

- (S) 'If symptoms persist consult your healthcare practitioner [or words to that effect]'

441

ALOYSIA CITRODORA

A,H

442

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%.

443

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%.

444

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%.

445

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%.

446

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%.

447

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%.

448

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%.

449

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%.

450

ALPHA-IONONE

E

Only for use in topical medicines for dermal application.

451

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%.

452

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%.

453

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%.

454

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%.

455

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%.

456

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%.

457

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%.

458

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%.

459

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%.

460

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%.

461

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%.

462

ALPHA-PHELLANDRENE

E

Only for use in topical medicines for dermal application.

463

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%.

464

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%.

465

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%.

466

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%.

467

ALPHA LIPOIC ACID

A

468

ALPINIA GALANGA

A,H

469

ALPINIA HAINANENSIS

A,H

470

ALPINIA OFFICINARUM

A,H

471

ALPINIA OXYPHYLLA

A,H

472

ALSIDIUM HELMINTHOCHORTON

A,H

Iodine is a mandatory component of Alsidium helminthochorton.

Only for external use when the concentration of available iodine in the medicine (excluding salts derivatives or iodophors) is more than 2.5%.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

The indication 'For mineral (may state the mineral) supplementation' is only permitted for use when the medicine is for oral and sublingual use.

473

ALSTONIA BOONEI

A,H

474

ALSTONIA CONSTRICTA

H

Only for use as an active homoeopathic ingredient.

475

ALTERNANTHERA PHILOXEROIDES

A,H

476

ALTERNARIA ALTERNATA

A,H

477

ALTHAEA OFFICINALIS

A,E,H

478

ALUM DODECAHYDRATE

A,E,H

479

ALUMINIUM CHLOROHYDRATE

E

Only for use in topical medicines for dermal application.

480

ALUMINIUM CITRATE

E

Only for use in topical medicines for dermal application.

481

ALUMINIUM DISTEARATE

E

Only for use in topical medicines for dermal application.

482

ALUMINIUM HYDROXIDE

E

Only for use in topical medicines for dermal application.

483

ALUMINIUM HYDROXIDE HYDRATE

E

Only for use in topical medicines for dermal application.

484

ALUMINIUM MAGNESIUM SILICATE

E

485

ALUMINIUM MONOSTEARATE

E

Only for use in topical medicines for dermal application.

486

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.

487

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.

488

ALUMINIUM SODIUM SILICATE

E

When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label:

- (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’

489

ALUMINIUM STARCH OCTENYLSUCCINATE

E

The concentration in the medicine must be no more than 7%.

490

ALUMINIUM STEARATE

E

491

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%.

492

AMARANTH

E

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

493

AMARANTH ALUMINIUM LAKE

E

Permitted for use as a colour for oral and topical use

494

AMARANTHUS HYBRIDUS

A,H

495

AMARANTHUS RETROFLEXUS

A,H

496

AMBERGRIS EXTRACT

E

497

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%.

498

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%.

499

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%.

500

AMBROSIA ARTEMISIIFOLIA

A,H

501

AMBROSIA PSILOSTACHYA

A,H

502

AMINOBENZOIC ACID

A

Only for use as an active ingredient in sunscreens.

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

The concentration in the medicine must be no more than 15%.

503

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%.

504

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%.

505

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%.

506

AMMONIA

E,H

Only for use as an active homoepathic 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%.

507

AMMONIO METHACRYLATE COPOLYMER

E

Only for use in oral medicines.

508

AMMONIUM ACRYLATES COPOLYMER

E

Only for use in topical medicines for dermal application.

509

AMMONIUM ACRYLATES/ACRYLONITROGENS COPOLYMER

E

Only for use in topical medicines for dermal application.

510

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%.

511

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%.

512

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 Pharmacopeia. 

513

AMMONIUM BROMIDE

H

Only for use as an active homoeopathic ingredient.

514

AMMONIUM CARBONATE

E,H

Only for use as an active homoeopathic or excipient ingredient.

515

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 Pharmacopeia.

If used as an excipient ingredient then the medicine is only for topical use for dermal application.

516

AMMONIUM GLYCYRRHIZINATE

E

517

AMMONIUM IODIDE

H

Only for use an active ingredient in homoeopathic medicines.

518

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%.

519

AMMONIUM LAURETH SULFATE

E

Only for use in topical medicines for dermal application.

520

AMMONIUM LAURYL SULFATE

E

Only for use in topical medicines for dermal application.

521

AMMONIUM PHOSPHATE - MONOBASIC

E

Only for use in topical medicines for dermal application.

522

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%.

523

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%.

524

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%.

525

AMOMUM AROMATICUM

A,H

526

AMOMUM VILLOSUM

A,H

527

AMORPHOPHALLUS KONJAC

A,H

Only for use when the dosage form is not tablet.

528

AMPELODESMOS MAURITANICUS

A,H

529

AMPELOPSIS JAPONICA

A,H

530

AMYL ACETATE

E

Only for use in topical medicines for dermal application.

531

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%.

532

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%.

533

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%.

534

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%.

535

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%.

536

AMYL CINNAMIC ALCOHOL

E

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

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

537

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%.

538

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%.

539

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%.

540

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%.

541

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%.

542

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%.

543

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%.

544

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%.

545

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%.

546

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%.

547

AMYLASE

A

Amylase must be derived from Aspergillus oryzae, and comply with the relevant compositional guideline.

When used in a divided preparation, the allowed unit is Alpha-amylase dextrinising unit or Thousand alpha-amylase dextrinising unit.

When used as an undivided preparation, the allowed unit is Thousand alpha-amylase dextrinising unit per gram or Dextrinising unit per gram.

548

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%.

549

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%.

550

AMYRIS BALSAMIFERA

A,H

551

AMYRIS OIL WEST INDIAN

A,E,H

552

ANACARDIUM OCCIDENTALE

A,H

553

ANACYCLUS PYRETHRUM

A,H

554

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%.

555

ANAESTHETIC ETHER

H

Only for use as an active homoeopathic ingredient.

556

ANAGALLIS ARVENSIS

A,H

557

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%.

558

ANANAS COMOSUS

A,E,H

559

ANAPHALIS SINICA

A,H

560

ANDROGRAPHIS PANICULATA

A,H

561

ANEMARRHENA ASPHODELOIDES

A,E,H

562

ANEMONE ALTAICA

A,H

563

ANEMONE CHINENSIS

A,H

564

ANEMONE HEPATICA

A,H

565

ANEMONE PULSATILLA

A,H

566

ANEMONE RADDEANA

A,H

567

ANETHOLE

A,E

When used as an active ingredient, only for use in medicated space sprays and medicated throat lozenges.

568

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%.

569

ANETHUM GRAVEOLENS

A,E,H

570

ANGELICA ACUTILOBA

A,H

571

ANGELICA ANOMALA

A,H

572

ANGELICA ARCHANGELICA

A,E,H

573

ANGELICA ATROPURPUREA

A,H

574

ANGELICA DAHURICA

A,E,H

575

ANGELICA DECURSIVA

A,H

576

ANGELICA POLYMORPHA

A,E,H

577

ANGELICA PUBESCENS

A,E,H

578

ANGELICA ROOT DRY

A,H

579

ANGELICA ROOT OIL

A,E,H

580

ANGELICA SEED OIL

A,E,H

581

ANGELICA STEM

E

582

ANIBA ROSAEODORA

A,E,H

583

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%.

584

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%.

585

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)'

586

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%.

587

ANISEED DRY

A,E,H

588

ANISEED POWDER

A,E,H

589

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%.

590

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%.

591

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%.

592

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%.

593

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%.

594

ANNATTO

E

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

595

ANOGEISSUS LATIFOLIA

A,E,H

596

ANTENNARIA DIOICA

A,E,H

597

ANTHOCYANINS

E

598

ANTHOXANTHUM ODORATUM

A,H

599

ANTHRISCUS CEREFOLIUM

A,H

600

ANTHYLLIS VULNERARIA

A,H

601

ANTIMONY POTASSIUM TARTRATE TRIHYDRATE

H

Only for use as an active homoeopathic ingredient.

602

ANTIMONY TRISULFIDE

H

Only for use as an active homoeopathic ingredient.

603

APIUM GRAVEOLENS

A,E,H

604

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%.

605

APOMORPHINE HYDROCHLORIDE HEMIHYDRATE

H

Only for use as an active homoeopathic ingredient.

606

APPLE

E

607

APPLE CIDER VINEGAR

E

608

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%.

609

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%.

610

APPLE FIBRE

E

611

APRICOT

E

612

APRICOT KERNEL OIL PEG-6 ESTERS

E

Only for use as an excipient in topical medicines for dermal application.

613

AQUILARIA MALACCENSIS

A,H

614

AQUILARIA SINENSIS

A,H

615

AQUILEGIA VULGARIS

A,H

616

ARABINOGALACTAN - LARIX

A,E

Only for use in oral medicines.

The ingredient must be derived from Larix occidentalis or Larix larcinia.

The maximum recommended daily dose must be no more than 15 grams.

The concentration of polysaccharides in the medicine must be equal to or more than 85%.

617

ARACHIDONIC ACID

E

Only for use in topical medicines for dermal application.

618

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%.

619

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%.

620

ARACHIDYL PROPIONATE

E

Only for use in topical medicines for dermal application.

621

ARACHIS HYPOGAEA

A,E,H

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

- (PEANUT) ‘Contains [insert ingredient name]’.

622

ARACHIS OIL

A,E,H

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

- (PEANUT) ‘Contains [insert ingredient name]’.

623

ARALIA CORDATA

A,H

624

ARALIA HISPIDA

A,H

625

ARALIA NUDICAULIS

A,H

626

ARALIA RACEMOSA

A,H

627

ARCTIUM LAPPA

A,E,H

628

ARCTIUM MINUS

A,H

629

ARCTOSTAPHYLOS UVA-URSI

A,E,H

630

ARDISIA JAPONICA

A,H

631

ARECA CATECHU

A,H

Arecoline is a mandatory component of Areca catechu.

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

632

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.

633

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.'

634

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%.

635

ARISAEMA ATRORUBENS

A,H

The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.

636

ARISAEMA CONSANGUINEUM

A,H

The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.

637

ARISAEMA JAPONICUM

A,H

The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.

638

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).

639

ARNEBIA EUCHROMA

A,H

640

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.

641

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.

642

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.

643

ARRHENATHERUM ELATIUS

A,H

644

ARROWROOT

A,E,H

645

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%.

646

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%.

647

ARTEMISIA ABROTANUM

A,H

Thujone is a mandatory component of Artemisia abrotanum. The concentration of thujone from Artemisia abrotanum in the medicine must be no more than 4%.

648

ARTEMISIA ABSINTHIUM

A,H

Thujone is a mandatory component of Artemisia absinthium.

The concentration of thujone from Artemisia absinthium in the medicine must be no more than 4%.

649

ARTEMISIA ANNUA

A,H

Thujone is a mandatory component of Artemisia annua.

The concentration of thujone from Artemisia annua in the medicine must be no more than 4%.

650

ARTEMISIA ARBORESCENS

A,H

Thujone is a mandatory component of Artemisia arborescens.

The concentration of thujone from Artemisia arborescens in the medicine must be no more than 4%.

651

ARTEMISIA ARGYI

A,H

Thujone is a mandatory component of Artemisia argyi.

The concentration of thujone from Artemisia argyi in the medicine must be no more than 4%.

652

ARTEMISIA DRACUNCULUS

A,E,H

Thujone is a mandatory component of Artemisia dracunculus.

The concentration of thujone from Artemisia dracunculus in the medicine must be no more than 4%.

653

ARTEMISIA FRIGIDA

A,H

Thujone is a mandatory component of Artemisia frigida.

The concentration of thujone from Artemisia frigida in the medicine must be no more than 4%.

654

ARTEMISIA HERBA-ALBA

A,H

Thujone is a mandatory component of Artemisia herba-alba.

The concentration of thujone from Artemisia herba-alba in the medicine must be no more than 4%.

655

ARTEMISIA MARITIMA

A,H

Thujone is a mandatory component of Artemisia maritima.

The concentration of thujone from Artemisia maritima in the medicine must be no more than 4%.

656

ARTEMISIA OIL

E

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

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

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

The concentration of thujone in the medicine must be no more than 4%.

657

ARTEMISIA PALLENS

A,E,H

Thujone is a mandatory component of Artemisia pallens.

The concentration of thujone from Artemisia pallens in the medicine must be no more than 4%.

658

ARTEMISIA TRIDENTATA

A,H

Thujone is a mandatory component of Artemisia tridentata.

The concentration of thujone from Artemisia tridentata in the medicine must be no more than 4%.

659

ARTEMISIA VULGARIS

A,E,H

Thujone is a mandatory component of Artemisia vulgaris.

The concentration of thujone from Artemisia vulgaris in the medicine must be no more than 4%.

660

ARTERY

H

Only for use as an active homoeopathic ingredient.

661

ARTHROSPIRA MAXIMA

A,H

662

ARTHROSPIRA PLATENSIS

A,H

663

ARUM MACULATUM

A,H

The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.

664

ASAFOETIDA GUM

A,H

665

ASAFOETIDA OIL

E

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

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

666

ASARUM EUROPAEUM

A,H

667

ASARUM HETEROTROPOIDES

A,H

668

ASARUM OIL

E

669

ASARUM SIEBOLDII

A,E,H

670

ASCLEPIAS TUBEROSA

A,H

671

ASCOPHYLLUM NODOSUM

A,E,H

Iodine is a mandatory component of Ascophyllum nodosum.

Only for external use when the concentration of available iodine in the medicine (excluding salts derivatives or iodophors) is more than 2.5%.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

The indication 'For mineral (may state the mineral) supplementation' is only permitted for use when the medicine is for oral or sublingual use.

672

ASCORBIC ACID

A,E

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

673

ASCORBYL GLUCOSIDE

E

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

The concentration in the medicine must be no more than 2%.

674

ASCORBYL METHYLSILANOL PECTINATE

E

Only for use in topical medicines for dermal application.

675

ASCORBYL PALMITATE

A,E

When used as an active ingredient for oral use, the maximum recommended daily dose must contain no more than 100mg of ascorbyl palmitate.

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

676

ASCORBYL TOCOPHERYL MALEATE

E

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

The concentration in the medicine must be no more than 0.0575%.

677

ASPALATHUS LINEARIS

A,E,H

678

ASPARAGINE

A,E

679

ASPARAGOPSIS SULFATED GALACTANS

E

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

The concentration in the medicine must be no more than 0.0025%.

680

ASPARAGUS

E,H

Only for use as an active homoeopathic or excipient ingredient.

681

ASPARAGUS COCHINCHINENSIS

A,H

682

ASPARAGUS OFFICINALIS

A,E,H

683

ASPARAGUS RACEMOSUS

A,H

The plant part must be dried, peeled root, and water extracts or ethanol/water extracts (containing up to 45% ethanol) of the dried, peeled root.

684

ASPARTAME

E

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

- (PKU) 'Phenylketonurics are warned that this product contains phenylalanine (or words to that effect)'

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

- (ASPAR) 'Contains aspartame'

685

ASPARTIC ACID

A,E

686

ASPERGILLUS ORYZAE

A,E,H

687

ASTAXANTHIN ESTERS EXTRACTED FROM HAEMATOCOCCUS PLUVIALIS

A

Only for use in oral medicines.

Astaxanthin (of Haematococcus pluvialis) is a mandatory component of astaxanthin esters extracted from Haematococcus pluvialis.

The maximum daily dose must contain no more than 12mg of Astaxanthin (of Haematococcus pluvialis).

688

ASTER NOVI-BELGII

A,H

689

ASTER TATARICUS

A,H

690

ASTRAGALUS ADSURGENS

A,H

691

ASTRAGALUS COMPLANATUS

A,H

692

ASTRAGALUS EXCARPUS

A,H

693

ASTRAGALUS GUMMIFER

A,E,H

694

ASTRAGALUS LENTIGINOSUS

A,H

695

ASTRAGALUS MEMBRANACEUS

A,E,H

696

ASTRAGALUS PENDULIFLORUS

A,H

697

ASTROCARYUM MURUMURU SEED TRIGLYCERIDES

E

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

The concentration in the medicine must be no more than 0.21%.

698

ATRACTYLODES JAPONICA

A,H

699

ATRACTYLODES LANCEA

A,H

700

ATRACTYLODES MACROCEPHALA

A,H

701

ATROPA BELLADONNA

A,H

Alkaloids calculated as hyoscyamine and atropine are mandatory components of Atropa belladonna.

The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%.

The concentration of atropine in the medicine must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%.

702

ATROPINE SULFATE MONOHYDRATE

H

Only for use as an active homoeopathic ingredient.

703

ATTALEA SPECIOSA

E

Only for use in topical medicines for dermal application.

704

ATTAPULGITE - ACTIVATED

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 Pharmacopeia. 

705

AURA B-AURANTIOL

E

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

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

706

AUREOBASIDIUM PULLULANS

A,H

707

AVENA FATUA

A,H

Gluten is a mandatory component of Avena fatua when the plant part is seed and the route of administration is other than topical and mucosal.

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.

708

AVENA SATIVA

A,E,H

Gluten is a mandatory component of Avena sativa when the plant part is seed and the route of administration is other than topical and mucosal.

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.

709

AVOCADO

E

710

AVOCADO OIL

E

711

AVOCADO OIL UNSAPONIFIABLES

E

Only for use in topical medicines for dermal application.

712

AZADIRACHTA INDICA

A,H

The ingredient can only be derived from the plant part seed and must be cold pressed or debitterised oil. “Debitterised neem seed oil” means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids.

Cold pressed Azadirachta indica seed oil must be for topical use for dermal application only.

When the concentration of cold pressed Azadirachta indica seed oil is more than 1%, a child resistant closure and restricted flow insert must be fitted to the container.

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

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

- (NTAKEN) 'Not to be taken (or words to that effect)'

- (CHILD) 'Keep out of reach of children (or words to that effect)’

713

AZOVAN BLUE

E

Permitted for use as a colour for topical use.

714

AZULENE

E

Only for use in topical medicines for dermal application.

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register ( The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self-repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

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

(section 4)

Part 2—Table 1

Column 1

Column 2

Ingredient Name

Column 3

Purpose of the ingredient in the medicine

Column 4

Specific requirement(s) applying to the ingredient in Column 2
4951 UBIDECARENONE A,E When used as an excipient, the route of administration must be topical.
Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
When used as an excipient, the concentration in a medicine must be no more than 0.05%.
The maximum recommended daily dose must provide no more than 300 milligrams of ubidecarenone.
When used in combination with Ubiquinol‑10, the maximum recommended daily dose must provide no more than 300 milligrams 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.'
4952 UBIQUINOL-10 A Only for use in oral medicines.
The maximum recommended daily dose must provide no more than 300 mg 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.
requires the following warning statement on the medicine label:
- (WARF) 'Do not take while on warfarin therapy without medical advice.'
4953 ULEX EUROPAEUS A,H
4954 ULMUS AMERICANA A,H
4955 ULMUS CAMPESTRIS A,H
4956 ULMUS GLABRA A,H
4957 ULMUS PARVIFOLIA A,H
4958 ULMUS PROCERA A,H
4959 ULMUS PUMILA A,H
4960 ULMUS RUBRA A,H
4961 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%.
4962 ULTRAMARINE BLUE E Permitted for use as a colour for topical use.
4963 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%.
Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is more than 2.5%.
Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.
The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use.
4964 UNCARIA GAMBIR A,H
4965 UNCARIA RHYNCOPHYLLA A,H
4966 UNCARIA SINENSIS A,H
4967 UNCARIA TOMENTOSA A,H
4968 UNDARIA PINNATIFIDA A,H Whole dried Undaria pinnatifida must not contain the holdfast.
Only for use in oral medicines.
4969 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%.
4970 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%.
4971 UNDECENOIC ACID E
4972 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%.
4973 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%.
4974 UNDECYLENAMIDE DEA E
4975 UNDECYLENOYL PEG-5 PARABEN E Only for use in topical medicines for dermal application.
4976 URANIUM NITRATE H Only for use as an active homoeopathic ingredient. 
4977 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).
4978 URTICA DIOICA A,E,H
4979 URTICA URENS A,H
4980 USNEA BARBATA A,H
4981 UVA URSI LEAF DRY A,H
4982 UVA URSI LEAF POWDER A,E,H
4983 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%.
4984 VACCARIA SEGATALIS A,H
4985 VACCINIUM BRACTEATUM A,H
4986 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%.
4987 VACCINIUM MACROCARPON A,E,H
4988 VACCINIUM MYRTILLOIDES A,H
4989 VACCINIUM MYRTILLUS A,E,H
4990 VACCINIUM OXYCOCCUS A,H
4991 VACCINIUM VITIS-IDAEA A,H
4992 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%.
4993 VALERIAN DRY A,H
4994 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%.
4995 VALERIAN POWDER A,H
4996 VALERIANA EDULIS A,H
4997 VALERIANA OFFICINALIS A,H
4998 VALERIANA SORBIFOLIA A,H
4999 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%.
5000 VALINE A,E
5001 VANADIUM H
5002 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%.
5003 VANILLA DRY A,E,H
5004 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%.
5005 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%.
5006 VANILLA PLANIFOLIA A,E,H
5007 VANILLA POWDER A,E,H
5008 VANILLA TAHITENSIS A,H
5009 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%.
5010 VANILLIN E Permitted for use as a flavour.
5011 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%.
5012 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%.
5013 VAT RED 1 E Permitted for use as a colour for topical use.
5014 VAT RED 1 ALUMINIUM LAKE E Permitted for use as a colour for topical use.
5015 VAT RED 5 E Permitted for use as a colour for topical use.
5016 VEGETABLE OIL E
5017 VEGETABLE OIL - HYDROGENATED E
5018 VEGETABLE OIL PHYTOSTEROL ESTERS A Only for use in oral medicines.
The medicine requires the following warning statements on the medicine label:
- (VOPE) 'There is no benefit from taking more than 3g/day of phytosterols from all sources'
- (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect).
5019 VEGETABLE PROTEIN - HYDROLYSED E
5020 VEIN H Only for use as an active homoeopathic ingredient.
5021 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%.
5022 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%.
5023 VERBASCUM DENSIFLORUM A,H
5024 VERBASCUM THAPSUS A,H
5025 VERBENA OFFICINALIS A,H
5026 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%.

5027 VERONICA CHAMAEDRYS A,H
5028 VERONICA OFFICINALIS A,H
5029 VERONICASTRUM VIRGINICUM A,E,H
5030 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%.
5031 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%.
5032 VIBURNUM OPULUS A,E,H
5033 VIBURNUM PRUNIFOLIUM A,E,H
5034 VICIA FABA A,H Levodopa (of Vicia faba) is a mandatory component of Vicia faba.
The concentration of Levodopa (of Vicia faba) from all ingredients in the medicine must be no more than 1mg/kg or 1mg/L or 0.1%.
5035 VIGNA ANGULARIS VAR. ANGULARIS A,H
5036 VIGNA RADIATA A,H
5037 VIGNA UMBELLATA A,H
5038 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%.
5039 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%
5040 VINCETOXICUM OFFICINALE A,H
5041 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%.
5042 VIOLA ODORATA A,E,H
5043 VIOLA TRICOLOR A,H
5044 VIOLA YEDOENSIS A,H
5045 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%.
5046 VIOLET LEAVES E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5047 VIPER H Only for use as an active homoeopathic ingredient. 
5048 VISCUM ALBUM A,E,H
5049 VISCUM COLORATUM A,H
5050 VISCUM FLAVESCENS A,H
5051 VITELLARIA PARADOXA A,E,H
5052 VITEX AGNUS-CASTUS A,E,H
5053 VITEX NEGUNDO A,H
5054 VITEX ROTUNDIFOLIA A,H
5055 VITEX TRIFOLIA A,H
5056 VITIS VINIFERA A,E,H
5057 VITREOSCILLA CONCENTRATE E Only for use in topical medicines for dermal application.
The concentration in the medicine must be no more than 0.1%.
5058 WAHLENBERGIA GRACILIS A,H
5059 WALNUT E
5060 WALNUT OIL E
5061 WATER - POTABLE E
5062 WATER - PURIFIED E
5063 WATER MELON E
5064 WAX - EMULSIFYING E
5065 WAX - MICROCRYSTALLINE E Only for use as an excipient in medicines for topical, oral or oral application routes of administration.
When microcrystalline wax is used as an excipient ingredient, the route of administration 'oral' is only permitted when the dosage form is 'chewing gum'.
5066 WAX - SYNTHETIC E
5067 WHEAT E Gluten is a mandatory component of Wheat when the route of administration is other than topical and mucosal.
When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:
- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
5068 WHEAT BRAN E Gluten is a mandatory component of Wheat bran when the route of administration is other than topical and mucosal.
When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:
- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
5069 WHEAT DEXTRIN A,E Only for use when the dosage form is capsule, tablet or pill.
When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:
- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
5070 WHEAT GERM E Gluten is a mandatory component of Wheat germ when the route of administration is other than topical and mucosal.
When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:
- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
5071 WHEAT GERM GLYCERIDES E Gluten is a mandatory component of Wheat germ glycerides when the route of administration is other than topical and mucosal.
When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:
- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
5072 WHEAT LEAF E
5073 WHEAT PROTEIN - HYDROLYSED E When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:
- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
5074 WHEAT SPROUT E Gluten is a mandatory component of Wheat sprout when the route of administration is other than topical and mucosal.
When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:
- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.
5075 WHEATGERM OIL A,E,H
5076 WHEY POWDER E Lactose is a mandatory component of Whey powder when the route of administration is oral.
5077 WHEY PROTEIN E Lactose is a mandatory component of Whey protein when the route of administration is oral.
5078 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%.
5079 WHITE HOREHOUND HERB DRY A,H
5080 WHITE HOREHOUND HERB POWDER A,H
5081 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 Pharmacopeia.
5082 WIKSTROEMIA VIRIDIFLORA A,H
5083 WILD CARROT HERB DRY A,E,H
5084 WILD CARROT HERB POWDER A,H
5085 WILD CHERRY BARK DRY A,H
5086 WILD CHERRY BARK POWDER A,H
5087 WILD LETTUCE LEAF DRY A,H
5088 WILD LETTUCE LEAF POWDER A,H
5089 WINE - FORTIFIED E Ethanol is a mandatory component of Wine - fortified.
When the concentration of ethanol in the medicine is more than 3%, the medicine requires the following warning statement on the medicine label:
- (ETHAN) 'Contains ethanol or contains alcohol'
5090 WINTERGREEN OIL A,E,H Methyl salicylate is a mandatory component of Wintergreen oil.
The concentration of Methyl salicylate in the medicine must be no 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 but the delivery device must be 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 spay device is ergonomically difficult for young children to accomplish.
5091 WITHANIA SOMNIFERA A,E,H
5092 WOOL ALCOHOLS E Only for use in topical medicines for dermal application.
5093 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 Pharmacopeia.
5094 WOOL FAT - HYDROUS 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 Pharmacopeia.
5095 XANTHAN GUM E
5096 XANTHIUM SIBIRICUM A,H
5097 XANTHIUM STRUMARIUM A,H
5098 XANTHOMONA CAMPESTRIS A,H
5099 XEROPHYLLUM ASPHODELOIDES A,H
5100 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%.
5101 XYLITOL E When the quantity of sugar alcohols per maximum recommended daily dose is more than 2g, the quantity of the sugar alcohols must be declared on the label and the medicine requires the following warning statement on the medicine label:
- (SUGOLS) ‘Products containing [insert name of sugar alcohol(s) may have a laxative effect or cause diarrhoea [or words to that effect]’.
5102 XYLOSE E
5103 YAM E
5104 YARROW HERB DRY A,H
5105 YARROW HERB POWDER A,H
5106 YEAST - HIGH CHROMIUM A,E Chromium is a mandatory component of Yeast - high chromium.
The maximum daily dose of chromium from Yeast - high chromium must be no more than 50 micrograms as Yeast - high chromium is considered to be an organic form of chromium.
The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use.
5107 YEAST - HIGH MOLYBDENUM A,E Molybdenum is a mandatory component of Yeast - high molybdenum.
The maximum daily dose of molybdenum from yeast - high molybdenum must be no more than 62.5 micrograms.
The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use.
5108 YEAST - HIGH SELENIUM A When for oral or sublingual use, selenium is a mandatory component of Yeast - high selenium.
Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose.
When for oral use, the medicine requires the following warning statement on the medicine label:
- (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 mcg for adults of selenium from dietary supplements should not be exceeded'.
The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use.
5109 YEAST AUTOLYSATE E
5110 YEAST DRIED A,E,H
5111 YELLOW 2G E Permitted for use as a colour for topical use.
5112 YELLOW MERCURIC OXIDE H Only for use as an active homoeopathic ingredient.
5113 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 Pharmacopeia.
5114 YLANG YLANG OIL A,E,H
5115 YUCCA BACCATA A,H
5116 YUCCA ELATA A,H
5117 YUCCA FILAMENTOSA A,H
5118 YUCCA GLORIOSA A,H
5119 YUCCA WHIPPLEI A,H
5120 ZANTHOXYLUM AMERICANUM A,H
5121 ZANTHOXYLUM BUNGEANUM A,E,H
5122 ZANTHOXYLUM CLAVA-HERCULIS A,H
5123 ZANTHOXYLUM NITIDUM A,H
5124 ZANTHOXYLUM PIPERITUM A,H
5125 ZANTHOXYLUM SIMULANS A,H
5126 ZEA MAYS A,E,H
5127 ZEAXANTHIN A,E
5128 ZEIN E
5129 ZINC H Only for use as an active homeopathic 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)'.
5130 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%.
The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use.
5131 ZINC ASCORBATE A,E,H When used internally, zinc is a mandatory component of zinc ascorbate.
The percentage of zinc from zinc ascorbate should be calculated based on the molecular weight 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)'.       
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.
5132 ZINC ASCORBATE MONOHYDRATE A,E,H When used internally, zinc is a mandatory component of zinc ascorbate monohydrate.
The percentage of zinc from Zinc ascorbate monohydrate should be calculated based on the molecular weight 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)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5133 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. The percentage of zinc from zinc chloride should be calculated based on the molecular weight 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)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.           
5134 ZINC CITRATE A,E,H When used internally, zinc is a mandatory component of zinc citrate . The percentage of zinc from zinc citrate should be calculated based on the molecular weight 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)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.                 
5135 ZINC CITRATE DIHYDRATE A,E,H When used internally, zinc is a mandatory component of zinc citrate dihydrate.
The percentage of zinc from zinc citrate dihydrate should be calculated based on the molecular weight 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)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.           
5136 ZINC CITRATE TRIHYDRATE A,E,H When used internally, zinc is a mandatory component of zinc citrate trihydrate. The percentage of zinc from Zinc citrate trihydrate should be calculated based on the molecular weight 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)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5137 ZINC DIASPARTATE A When used internally, zinc is a mandatory component of zinc diaspartate and availability is restricted to use as a source of the relevant mineral only.
The percentage of zinc from Zinc diaspartate should be calculated based on the molecular weight 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)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5138 ZINC GLUCONATE A,E,H When used internally, zinc is a mandatory component of zinc gluconate.
The percentage of zinc from Zinc gluconate should be calculated based on the molecular weight 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)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5139 ZINC GLYCINATE A When used internally, zinc is a mandatory component of Zinc glycinate and availability is restricted to use as a source of the relevant mineral only.
The percentage of zinc from Zinc glycinate should be calculated based on the molecular weight 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)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5140 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'.
5141 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'.
5142 ZINC LYSINATE A When used internally, zinc is a mandatory component of Zinc lysinate and availability is restricted to use as a source of the relevant mineral only.
The percentage of zinc from Zinc lysinate should be calculated based on the molecular weight 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)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5143 ZINC METHIONINE SULFATE A For topical use, the concentration of zinc sulfate must be no more than 5%.
When used internally, zinc is a mandatory component of Zinc methionine sulfate and availability is restricted to use as a source of the relevant mineral only.
The percentage of zinc from Zinc methionine sulfate should be calculated based on the molecular weight 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)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5144 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%.
5145 ZINC OXIDE A,E,H When used internally, zinc is a mandatory component of zinc oxide.
The percentage of zinc from zinc oxide should be calculated based on the molecular weight of zinc oxide.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.
5146 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.
Based on molecular weights the accepted percentage of zinc from zinc para-phenolsulfate is 15.9%.  The declared quantity of zinc from zinc para-phenolsulfate must be no less than 15.1% and must be no more than 16.7% of the zinc para-phenolsulfate in the formulation.  These figures incorporate a 5% variance to allow for rounding in calculations.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.
5147 ZINC STEARATE E When used internally, zinc is a mandatory component of zinc stearate.
Based on molecular weights the accepted percentage of zinc from zinc stearate is  between 10% and 12%.  The declared quantity of zinc from zinc stearate must be no less than 9.5% and mustbe no more than 12.6% of the zinc stearate in the formulation.  These figures incorporate a 5% variance to allow for rounding in calculations.
5148 ZINC SUCCINATE A,E,H When used internally, zinc is a mandatory component of zinc succinate.
The percentage of zinc from Zinc succinate should be calculated based on the molecular weight 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)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5149 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.
The percentage of zinc from Zinc sulfate should be calculated based on the molecular weight 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)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5150 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.
The percentage of zinc from Zinc sulfate heptahydrate should be calculated based on the molecular weight 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)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5151 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.
The percentage of zinc from Zinc sulfate heptahydrate should be calculated based on the molecular weight 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)'.
5152 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)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5153 ZINC VALERATE H Only for use as an active homeopathic ingredient.
For internal use, zinc is a mandatory component of zinc valerate.
Based on molecular weights the accepted percentage of zinc from zinc valerate is 24.5%. The declared quantity of zinc from zinc valerate must be no less than 23.2% and must be no more than 25.7% of the zinc valerate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations.
5154 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%.
5155 ZINGIBER OFFICINALE A,E,H When for oral use AND the extract ratio is equal to or more than 25:1 OR 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'
5156 ZIZIPHUS JUJUBA A,H
5157 ZIZIPHUS JUJUBA VAR. SPINOSA A,H
5158 ZIZYPHUS SATIVA A,H
5159 ZOSTERA MARINA A,H
5160 ZUCCHINI E

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

Endnote 2—Abbreviation key

ad = added or inserted o = order(s)
am = amended Ord = Ordinance
amdt = amendment orig = original
c = clause(s) par = paragraph(s)/subparagraph(s)
C[x] = Compilation No. x     /sub‑subparagraph(s)
Ch = Chapter(s) pres = present
def = definition(s) prev = previous
Dict = Dictionary (prev…) = previously
disallowed = disallowed by Parliament Pt = Part(s)
Div = Division(s) r = regulation(s)/rule(s)
ed = editorial change reloc = relocated
exp = expires/expired or ceases/ceased to have renum = renumbered
    effect rep = repealed
F = Federal Register of Legislation rs = repealed and substituted
gaz = gazette s = section(s)/subsection(s)
LA = Legislation Act 2003 Sch = Schedule(s)
LIA = Legislative Instruments Act 2003 Sdiv = Subdivision(s)
(md) = misdescribed amendment can be given SLI = Select Legislative Instrument
    effect SR = Statutory Rules
(md not incorp) = misdescribed amendment Sub‑Ch = Sub‑Chapter(s)
    cannot be given effect SubPt = Subpart(s)
mod = modified/modification underlining = whole or part not
No. = Number(s)     commenced or to be commenced

Endnote 3—Legislation history

Name Registration Commencement Application, saving and transitional provisions
Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016 1 Aug 2016 (F2016L01253) 2 Aug 2016 (s 2)
Therapeutic Goods (Permissible Ingredients) Amendment (2016 Measures No. 1) Determination 2016 5 Oct 2016 (F2016L01588) 6 Oct 2016 (s 2(1) item 1) —

Endnote 4—Amendment history

Provision affected How affected
s 2........................................ rep LA s 48D
Schedule 1
Part 2
Part 2................................... am No F2016L01588
Actions
Download as PDF Download as Word Document
Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0