Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2016 (Cth)

Case

Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2016

Therapeutic Goods Act 1989

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

(a)Revoke the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2015; and

(b)Make the following determination specifying:

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

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

Dated this 22nd April 2016

(Signed by)

Larry Kelly

Delegate of the Minister for Health

  1. Name of Determination

This Determination is the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2016.

  1. Commencement

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

3              Interpretation

In this Determination:

Act means the Therapeutic Goods Act 1989.

Code Tables are tables that can be accessed from the Therapeutic Goods Administration Business Service website at 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 ethanol 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%.

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%.

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%.

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%.

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

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%.

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.

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-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%.

134

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%.

135

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%.

136

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%.

137

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%.

138

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%.

139

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%.

140

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%.

141

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%.

142

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%.

143

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%.

144

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%.

145

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%.

146

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%.

147

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%.

148

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%.

149

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%.

150

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%.

151

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%.

152

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%.

153

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%

154

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%.

155

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%.

156

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%.

157

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%.

158

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%.

159

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%.

160

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%.

161

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%.

162

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%.

163

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%.

164

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%.

165

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%.

166

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%.

167

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%.

168

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%.

169

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%.

170

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%.

171

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%.

172

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%.

173

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%.

174

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%.

175

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%.

176

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%.

177

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%.

178

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%.

179

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%.

180

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%.

181

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%.

182

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%.

183

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%.

184

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%.

185

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%.

186

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%.

187

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%.

188

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%.

189

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%.

190

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%.

191

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%.

192

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%.

193

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%.

194

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%.

195

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%.

196

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%.

197

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%.

198

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%.

199

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%.

200

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%.

201

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%.

202

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%.

203

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%.

204

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%.

205

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%.

206

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%.

207

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%.

208

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%.

209

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%.

210

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%.

211

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%.

212

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%.

213

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%.

214

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%.

215

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%.

216

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%.

217

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%.

218

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%.

219

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%.

220

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%.

221

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%.

222

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%.

223

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%.

224

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%.

225

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%.

226

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%.

227

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%.

228

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%.

229

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%.

230

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%.

231

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%.

232

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%.

233

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%.

234

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%.

235

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%.

236

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%.

237

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%.

238

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%.

239

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%.

240

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%.

241

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%.

242

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%.

243

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%.

244

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%.

245

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%.

246

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%.

247

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%.

248

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%.

249

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%.

250

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%.

251

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

E

252

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%.

253

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%.

254

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%.

255

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%.

256

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%.

257

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%.

258

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%.

259

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%.

260

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%.

261

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%.

262

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%.

263

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%.

264

ABELMOSCHUS MOSCHATUS

A,H

265

ABELMOSCHUS MOSCHATUS SUBSP. MOSCHATUS

A,E,H

266

ABIES BALSAMEA

A,H

267

ABIES NIGRA

A,H

268

ABIES PECTINATA

A,H

269

ABIES SIBIRICA

A,H

270

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.

271

ABSIDIA RAMOSA

A,H

272

ABUTILON THEOPHRASTI

A,H

273

ACACIA

A,E,H

274

ACACIA BAILEYANA

A,H

275

ACACIA CATECHU

A,H

276

ACACIA DEALBATA

A,H

277

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%.

278

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%.

279

ACACIA LONGIFOLIA

A,E,H

280

ACACIA NILOTICA

A,H

281

ACACIA SENEGAL

A,E,H

282

ACALYPHA INDICA

A,H

283

ACANTHUS MOLLIS

A,H

284

ACER CAMPESTRE

A,H

285

ACER NEGUNDO

A,H

286

ACER SACCHARINUM

A,H

287

ACER SACCHARUM

A,E,H

288

ACEROLA

E

289

ACESULFAME POTASSIUM

E

290

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%.

291

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%.

292

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%.

293

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%.

294

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%.

295

ACETANISOLE

E

Only for use in topical medicines for dermal application.

296

ACETIC ACID

A,E,H

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

297

ACETIC ACID - GLACIAL

A,E,H

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

298

ACETOIN

E

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

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

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

299

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.'

300

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%.

301

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%.

302

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%.

303

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%.

304

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'

305

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%.

306

ACETYL LEVOCARNITINE HYDROCHLORIDE

A,E

307

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%.

308

ACETYLATED LANOLIN

E

Only for use in topical medicines for dermal application.

309

ACETYLATED LANOLIN ALCOHOL

E

Only for use in topical medicines for dermal application.

310

ACETYLATED MONOGLYCERIDES

E

311

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%.

312

ACETYLCYSTEINE

E

Only for use in topical medicines for dermal application.

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

313

ACHILLEA ERBA-ROTTA SUBSP. MOSCHATA

A,H

314

ACHILLEA MILLEFOLIUM

A,E,H

315

ACHILLEA PTARMICA

A,H

316

ACHYRANTHES ASPERA

A,H

317

ACHYRANTHES BIDENTATA

A,E,H

318

ACHYRANTHES FAURIEI

A,H

319

ACID-ISOMERISED LINALOOL

E

320

ACID GREEN 25

E

Permitted for use as a colour for topical use.

321

ACID RED 33

E

Permitted for use as a colour for topical use.

322

ACID RED 87

E,H

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

323

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.

324

ACONITUM FEROX

A,H

Total alkaloids (of Aconitum spp.) is a mandatory component of Aconitum ferox.

325

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.

326

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.

327

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%.

328

ACRYLAMIDES COPOLYMER

E

Only for use in topical medicines for dermal application.

329

ACRYLATES COPOLYMER

E

Only for use in topical medicines for dermal application.

330

ACRYLATES/ACRYLAMIDE COPOLYMER

E

Only for use in topical medicines for dermal application.

331

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

E

Only for use in topical medicines for dermal application.

332

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%.

333

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%.

334

ACRYLATES/OCTYLACRYLAMIDE COPOLYMER

E

Only for use in topical medicines for dermal application.

335

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%.

336

ACRYLATES/VA COPOLYMER

E

Only for use in topical medicines for dermal application.

337

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%.

338

ACTAEA CIMICIFUGA

A,H

339

ACTAEA HERACLEIFOLIA

A,H

340

ACTAEA PACHYPODA

A,H

341

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.'

342

ACTAEA SIMPLEX

A,H

343

ACTAEA SPICATA

A,H

344

ACTINIDIA CHINENSIS

A,E,H

345

ACTINIDIA DELICIOSA

A

346

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)'

347

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)'

348

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)'

349

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)'

350

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)'

351

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)'

352

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)'

353

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)'

354

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)'

355

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)'

356

ADENOPHORA STRICTA

A,H

357

ADENOPHORA TRIPHYLLA

A,H

358

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%.

359

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%.

360

ADENOSINE TRIPHOSPHATE

E

Only for use in topical medicines for dermal application.

361

ADENOSINE TRIPHOSPHATE DISODIUM

E

Only for use in topical medicines for dermal application.

362

ADIANTUM CAPILLUS-VENERIS

A,H

363

ADIPIC ACID

E

364

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%.

365

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%.

366

ADRENALINE (EPINEPHRINE)

H

Only for use as an active homoeopathic ingredient.

367

ADZUKI BEAN

E

368

AEGOPODIUM PODAGRARIA

A,H

369

AESCULUS CHINENSIS

A,H

370

AESCULUS GLABRA

A,H

371

AESCULUS HIPPOCASTANUM

A,E,H

372

AESCULUS X CARNEA

A,H

373

AETHUSA CYNAPIUM

H

Only for use as an active homoeopathic ingredient.

374

AGAR

A,E

375

AGASTACHE RUGOSA

A,H

376

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%.

377

AGAVE AMERICANA

A,E,H

378

AGRIMONIA EUPATORIA

A,E,H

379

AGRIMONIA REPENS

A,H

380

AGROSTIS TENUIS

A,H

381

AILANTHUS ALTISSIMA

A,H

382

AJUGA CHAMAEPITYS

A,H

383

AJUGA REPTANS

A,H

384

ALANINE

A,E

385

ALANYLGLUTAMINE

A

Only for use in oral medicines.

386

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.

387

ALBIZIA JULIBRISSIN

A,H

388

ALBIZIA LEBBECK

A,H

389

ALCEA ROSEA

A,H

390

ALCHEMILLA ALPINA

A,H

391

ALCHEMILLA ARVENSIS

A,H

392

ALCHEMILLA VULGARIS

A,H

393

ALETRIS FARINOSA

A,H

394

ALETRIS SPICATA

A,H

395

ALEURITES MOLUCCANUS SEED OIL

E

Only for use in topical medicines for dermal application.

396

ALFADEX

A

Only for use in oral medicines.

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

397

ALGINIC ACID

E

398

ALISMA ORIENTALE

A,H

399

ALISMA PLANTAGO AQUATICA

A,H

400

ALKANNA TINCTORIA

A,H

401

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%.

402

ALLANTOIN

E

Only for use in topical medicines for dermal application.

403

ALLIARIA PETIOLATA

A,H

404

ALLIUM CEPA

E,H

405

ALLIUM FISTULOSUM

A,E,H

406

ALLIUM HIEROCHUNTINUM

A,H

407

ALLIUM MACROSTEMON

A,H

408

ALLIUM ODORUM

A,E,H

409

ALLIUM PORRUM

A,H

410

ALLIUM SATIVUM

A,E,H

411

ALLIUM SCHOENOPRASUM

A,H

412

ALLIUM URSINUM

A,H

413

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%.

414

ALLURA RED AC

E

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

415

ALLURA RED AC ALUMINIUM LAKE

E

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

416

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%.

417

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%.

418

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%.

419

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%.

420

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%.

421

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%.

422

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%.

423

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%.

424

ALLYL ISOTHIOCYANATE

E

The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate

425

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%.

426

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%.

427

ALMOND

E

428

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%.

429

ALNUS GLUTINOSA

A,H

430

ALNUS INCANA SUBSP. RUGOSA

A,H

431

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).

432

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]'

433

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]'

434

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]'

435

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]'

436

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]'

437

ALOYSIA CITRODORA

A,H

438

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%.

439

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%.

440

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%.

441

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%.

442

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%.

443

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%.

444

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%.

445

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%.

446

ALPHA-IONONE

E

Only for use in topical medicines for dermal application.

447

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%.

448

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%.

449

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%.

450

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%.

451

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%.

452

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%.

453

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%.

454

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%.

455

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%.

456

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%.

457

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%.

458

ALPHA-PHELLANDRENE

E

Only for use in topical medicines for dermal application.

459

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%.

460

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%.

461

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%.

462

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%.

463

ALPHA LIPOIC ACID

A

464

ALPINIA GALANGA

A,H

465

ALPINIA HAINANENSIS

A,H

466

ALPINIA OFFICINARUM

A,E,H

467

ALPINIA OXYPHYLLA

A,H

468

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.

469

ALSTONIA BOONEI

A,H

470

ALSTONIA CONSTRICTA

H

Only for use as an active homoeopathic ingredient.

471

ALTERNANTHERA PHILOXEROIDES

A,H

472

ALTERNARIA ALTERNATA

A,H

473

ALTHAEA OFFICINALIS

A,E,H

474

ALUM DODECAHYDRATE

A,E,H

475

ALUMINIUM CHLOROHYDRATE

E

Only for use in topical medicines for dermal application.

476

ALUMINIUM CITRATE

E

Only for use in topical medicines for dermal application.

477

ALUMINIUM DISTEARATE

E

Only for use in topical medicines for dermal application.

478

ALUMINIUM HYDROXIDE

E

Only for use in topical medicines for dermal application.

479

ALUMINIUM HYDROXIDE HYDRATE

E

Only for use in topical medicines for dermal application.

480

ALUMINIUM MAGNESIUM SILICATE

E

481

ALUMINIUM MONOSTEARATE

E

Only for use in topical medicines for dermal application.

482

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.

483

ALUMINIUM SILICATE

A,E,H

When used as an excipient ingredient, the medicine is only for use in topical medicines for dermal application.

484

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).’

485

ALUMINIUM STARCH OCTENYLSUCCINATE

E

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

486

ALUMINIUM STEARATE

E

Only for use in topical medicines for dermal application.

487

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%.

488

AMARANTH

E

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

489

AMARANTH ALUMINIUM LAKE

E

Permitted for use as a colour for oral and topical use

490

AMARANTHUS HYBRIDUS

A,H

491

AMARANTHUS RETROFLEXUS

A,H

492

AMBERGRIS EXTRACT

E

493

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%.

494

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%.

495

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%.

496

AMBROSIA ARTEMISIIFOLIA

A,H

497

AMBROSIA PSILOSTACHYA

A,H

498

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%.

499

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%.

500

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%.

501

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%.

502

AMMONIA

A,E,H

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%.

503

AMMONIO METHACRYLATE COPOLYMER

E

Only for use in oral medicines.

504

AMMONIUM ACRYLATES COPOLYMER

E

Only for use in topical medicines for dermal application.

505

AMMONIUM ACRYLATES/ACRYLONITROGENS COPOLYMER

E

Only for use in topical medicines for dermal application.

506

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%.

507

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%.

508

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. 

509

AMMONIUM BROMIDE

H

Only for use as an active homoeopathic ingredient.

510

AMMONIUM CARBONATE

E,H

Only for use as an active homoeopathic or excipient ingredient.

511

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.

512

AMMONIUM GLYCYRRHIZINATE

E

513

AMMONIUM IODIDE

H

514

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%.

515

AMMONIUM LAURETH SULFATE

E

Only for use in topical medicines for dermal application.

516

AMMONIUM LAURYL SULFATE

E

Only for use in topical medicines for dermal application.

517

AMMONIUM PHOSPHATE - MONOBASIC

E

Only for use in topical medicines for dermal application.

518

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%.

519

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%.

520

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%.

521

AMOMUM AROMATICUM

A,H

522

AMOMUM VILLOSUM

A,H

523

AMORPHOPHALLUS KONJAC

A,H

Only for use when the dosage form is not tablet.

524

AMPELODESMOS MAURITANICUS

A,H

525

AMPELOPSIS JAPONICA

A,H

526

AMYL ACETATE

E

Only for use in topical medicines for dermal application.

527

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%.

528

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%.

529

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%.

530

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%.

531

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%.

532

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%.

533

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%.

534

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%.

535

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%.

536

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%.

537

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%.

538

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%.

539

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%.

540

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%.

541

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%.

542

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%.

543

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.

544

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%.

545

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%.

546

AMYRIS BALSAMIFERA

A,H

547

AMYRIS OIL WEST INDIAN

A,E,H

548

ANACARDIUM OCCIDENTALE

A,H

549

ANACYCLUS PYRETHRUM

A,H

550

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%.

551

ANAESTHETIC ETHER

H

Only for use as an active homoeopathic ingredient.

552

ANAGALLIS ARVENSIS

A,H

553

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%.

554

ANANAS COMOSUS

A,E,H

555

ANAPHALIS SINICA

A,H

556

ANDROGRAPHIS PANICULATA

A,H

557

ANEMARRHENA ASPHODELOIDES

A,H

558

ANEMONE ALTAICA

A,H

559

ANEMONE CHINENSIS

A,H

560

ANEMONE HEPATICA

A,H

561

ANEMONE PULSATILLA

A,H

562

ANEMONE RADDEANA

A,H

563

ANETHOLE

A,E

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

564

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%.

565

ANETHUM GRAVEOLENS

A,E,H

566

ANGELICA ACUTILOBA

A,E,H

567

ANGELICA ANOMALA

A,H

568

ANGELICA ARCHANGELICA

A,E,H

569

ANGELICA ATROPURPUREA

A,H

570

ANGELICA DAHURICA

A,E,H

571

ANGELICA DECURSIVA

A,H

572

ANGELICA POLYMORPHA

A,E,H

573

ANGELICA PUBESCENS

A,E,H

574

ANGELICA ROOT DRY

A,H

575

ANGELICA ROOT OIL

A,E,H

576

ANGELICA SEED OIL

A,E,H

577

ANGELICA STEM

E

578

ANIBA ROSAEODORA

A,E,H

579

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%.

580

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%.

581

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)'

582

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%.

583

ANISEED DRY

A,E,H

584

ANISEED POWDER

A,E,H

585

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%.

586

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%.

587

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%.

588

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%.

589

ANNATTO

E

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

590

ANOGEISSUS LATIFOLIA

A,E,H

591

ANTENNARIA DIOICA

A,E,H

592

ANTHOCYANINS

E

593

ANTHOXANTHUM ODORATUM

A,H

594

ANTHRISCUS CEREFOLIUM

A,H

595

ANTHYLLIS VULNERARIA

A,E,H

596

ANTIMONY POTASSIUM TARTRATE TRIHYDRATE

H

Only for use as an active homoeopathic ingredient.

597

ANTIMONY TRISULFIDE

H

Only for use as an active homoeopathic ingredient.

598

APIUM GRAVEOLENS

A,E,H

599

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%.

600

APOMORPHINE HYDROCHLORIDE HEMIHYDRATE

H

Only for use as an active homoeopathic ingredient.

601

APPLE

E

602

APPLE CIDER VINEGAR

E

603

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%.

604

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%.

605

APPLE FIBRE

E

606

APRICOT

E

607

APRICOT KERNEL OIL PEG-6 ESTERS

E

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

608

AQUILARIA MALACCENSIS

A,H

609

AQUILARIA SINENSIS

A,H

610

AQUILEGIA VULGARIS

A,H

611

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%.

612

ARACHIDONIC ACID

E

Only for use in topical medicines for dermal application.

613

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%.

614

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%.

615

ARACHIDYL PROPIONATE

E

Only for use in topical medicines for dermal application.

616

ARACHIS HYPOGAEA

A,E,H

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

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

617

ARACHIS OIL

A,E,H

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

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

618

ARALIA CORDATA

A,H

619

ARALIA HISPIDA

A,H

620

ARALIA NUDICAULIS

A,H

621

ARALIA RACEMOSA

A,H

622

ARCTIUM LAPPA

A,E,H

623

ARCTIUM MINUS

A,E,H

624

ARCTOSTAPHYLOS UVA-URSI

A,E,H

625

ARDISIA JAPONICA

A,H

626

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%.

627

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.

628

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.'

629

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%.

630

ARISAEMA ATRORUBENS

A

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

631

ARISAEMA CONSANGUINEUM

A,H

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

632

ARISAEMA JAPONICUM

A,H

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

633

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).

634

ARNEBIA EUCHROMA

A,H

635

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.

636

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.

637

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.

638

ARRHENATHERUM ELATIUS

A,H

639

ARROWROOT

A,E,H

640

ARSENIC TRIIODIDE

H

Only for use as an active homoeopathic ingredient

641

ARSENIC TRIOXIDE

H

Only for use as an active homoeopathic ingredient

642

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%.

643

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%.

644

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%.

645

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%

646

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%.

647

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%.

648

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%.

649

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%.

650

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%.

651

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%.

652

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%.

653

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%.

654

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%.

655

ARTERY

H

Only for use as an active homoeopathic ingredient.

656

ARTHROSPIRA MAXIMA

A,H

657

ARTHROSPIRA PLATENSIS

A,H

658

ARUM MACULATUM

A,H

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

659

ASAFOETIDA GUM

A,H

660

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%.

661

ASARUM EUROPAEUM

A,H

662

ASARUM HETEROTROPOIDES

A,H

663

ASARUM OIL

E

664

ASARUM SIEBOLDII

A,E,H

665

ASCLEPIAS TUBEROSA

A,H

666

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.

667

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.’

668

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%.

669

ASCORBYL METHYLSILANOL PECTINATE

E

Only for use in topical medicines for dermal application.

670

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.’

671

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%.

672

ASPALATHUS LINEARIS

A,E,H

673

ASPARAGINE

A,E

674

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%.

675

ASPARAGUS

E

Only for use as an active homoeopathic or excipient ingredient.

676

ASPARAGUS COCHINCHINENSIS

A,H

677

ASPARAGUS OFFICINALIS

A,E,H

678

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.

679

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'

680

ASPARTIC ACID

A,E

681

ASPERGILLUS ORYZAE

A,E,H

682

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).

683

ASTER NOVI-BELGII

A,H

684

ASTER TATARICUS

A,H

685

ASTRAGALUS ADSURGENS

A,H

686

ASTRAGALUS COMPLANATUS

A,H

687

ASTRAGALUS EXCARPUS

A,H

688

ASTRAGALUS GUMMIFER

A,E,H

689

ASTRAGALUS LENTIGINOSUS

A,H

690

ASTRAGALUS MEMBRANACEUS

A,E,H

691

ASTRAGALUS PENDULIFLORUS

A,H

692

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%.

693

ATRACTYLODES JAPONICA

A,H

694

ATRACTYLODES LANCEA

A,E,H

695

ATRACTYLODES MACROCEPHALA

A,H

696

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%.

697

ATROPINE SULFATE MONOHYDRATE

H

Only for use as an active homoeopathic ingredient.

698

ATTALEA SPECIOSA

E

Only for use in topical medicines for dermal application.

699

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. 

700

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%.

701

AUREOBASIDIUM PULLULANS

A,H

702

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.

703

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.

704

AVOCADO

E

705

AVOCADO OIL

E

706

AVOCADO OIL UNSAPONIFIABLES

E

Only for use in topical medicines for dermal application.

707

AZADIRACHTA INDICA

A,H

The ingredient can only be derived from the plant part seed and must be cold pressed and debitterised.

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

When the concentration of cold pressed debitterised neem (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)'

708

AZOVAN BLUE

E

Permitted for use as a colour for topical use.

709

AZULENE

E

Only for use in topical medicines for dermal application.
4877 TRIMETHYL UNDECYLENIC ALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4878 TRIMETHYLBENZENEPROPANOL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4879 TRIMETHYLHEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4880 TRIMETHYLOPROPANE TRIOCTANOATE E Only for use in topical medicines for dermal application.
4881 TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 5%.
4882 TRIMETHYLSILOXYSILICATE E Only for use in topical medicines for dermal application.
4883 TRINITROPHENOL H Only for use as an active homoeopathic ingredient. 
4884 TRIOCTANOIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 5%.
4885 TRIOCTYLDODECYL CITRATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 12%.
4886 TRIOLEIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 0.1%.
4887 TRIOSTEUM PERFOLIATUM A,H
4888 TRIOXAUNDECANEDIOIC ACID E
4889 TRIPAL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4890 TRIPEPTIDE-1 E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin.
The concentration in the medicine must be no more than 0.002%.
4891 TRIS-BIPHENYL TRIAZINE A 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 10%.
When used topically, the dosage form must not be spray.
4892 TRISILOXANE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 40%.
4893 TRISODIUM EDETATE E Only for use in topical medicines for dermal application.
4894 TRISODIUM ETHYLENEDIAMINE DISUCCINATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 0.2%.
4895 TRISODIUM NTA E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 0.005%.
4896 TRISTEARIN E
4897 TRITICUM AESTIVUM A,E,H Gluten is a mandatory component when the plant part is seed and the route of administration is other than topical and mucosal.
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).
4898 TRITICUM DURUM A,E,H Gluten is a mandatory component when the plant part is seed and the route of administration is other than topical and mucosal.
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).
4899 TRIUNDECANOIN E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 11.2%.
4900 TROLAMINE E Only for use in topical medicines for dermal application.
The concentration in the medicine must be no more than 5%.
4901 TROLAMINE LAURIL SULFATE E Only for use in topical medicines for dermal application.
4902 TROLAMINE SALICYLATE A Only for use as an active ingredient in sunscreens. 
Only for use in topical medicines for dermal application.
The concentration in the medicine must be no more than 12%.
4903 TROLLIUS CHINENSIS A,H
4904 TROMETAMOL E
4905 TROMETAMOL HYDROCHLORIDE E
4906 TROPAEOLUM MAJUS A,E,H
4907 TROPICAL RATTLESNAKE H Only for use as an active homoeopathic ingredient.
4908 TROPOLONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 0.01%.
4909 TSUGA CANADENSIS A,H
4910 TULIPA EDULIS A,H Colchicine is a mandatory component of Tulipa edulis.
The concentration of colchicine in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%.
4911 TURMERIC E Permitted for use only in combination with other permitted ingredients as a colour.
4912 TURNERA DIFFUSA A,E,H
4913 TURNIP E
4914 TURPENTINE OIL A,E The concentration in the medicine must be no more than 25%.
4915 TYPHA ANGUSTIFOLIA A,H
4916 TYPHA LATIFOLIA A,H
4917 TYPHONIUM GIGANTEUM A,H
4918 TYROSINE A,E
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
4919 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 the medicine must be no more than 0.05%.
The maximum recommended daily dose must provide no more than 150 mg of ubidecarenone.
When used in combination with Ubiquinol-10, the maximum recommended daily dose must provide no more than 300 mg of ubiquinol-10 and ubidecarenone combined.
The medicine requires the following warning statement on the medicine label:
- (WARF) 'Do not take while on warfarin therapy without medical advice.'
4920 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.'
4921 ULEX EUROPAEUS A,H
4922 ULMUS AMERICANA A,H
4923 ULMUS CAMPESTRIS A,H
4924 ULMUS GLABRA A,H
4925 ULMUS PARVIFOLIA A,H
4926 ULMUS PROCERA A,H
4927 ULMUS PUMILA A,H
4928 ULMUS RUBRA A,H
4929 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%.
4930 ULTRAMARINE BLUE E Permitted for use as a colour for topical use.
4931 ULVA LACTUCA A,E,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.
4932 UNCARIA GAMBIR A,H
4933 UNCARIA RHYNCOPHYLLA A,E,H
4934 UNCARIA SINENSIS A,H
4935 UNCARIA TOMENTOSA A,H
4936 UNDARIA PINNATIFIDA A,H Whole dried Undaria pinnatifida must not contain the holdfast.
Only for use in oral medicines.
4937 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%.
4938 UNDECENOIC ACID E
4939 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%.
4940 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%.
4941 UNDECYLENAMIDE DEA E
4942 UNDECYLENOYL PEG-5 PARABEN E Only for use in topical medicines for dermal application.
4943 URANIUM NITRATE H Only for use as an active homoeopathic ingredient. 
4944 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).
4945 URTICA DIOICA A,E,H
4946 URTICA URENS A,H
4947 USNEA BARBATA A,H
4948 UVA URSI LEAF DRY A,H
4949 UVA URSI LEAF POWDER A,E,H
4950 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%.
4951 VACCARIA SEGATALIS A,H
4952 VACCINIUM BRACTEATUM A,H
4953 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%.
4954 VACCINIUM MACROCARPON A,E,H
4955 VACCINIUM MYRTILLOIDES A,H
4956 VACCINIUM MYRTILLUS A,E,H
4957 VACCINIUM OXYCOCCUS A,E,H
4958 VACCINIUM VITIS-IDAEA A,H
4959 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%.
4960 VALERIAN DRY A,H
4961 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%.
4962 VALERIAN POWDER A,H
4963 VALERIANA EDULIS A,H
4964 VALERIANA OFFICINALIS A,H
4965 VALERIANA SORBIFOLIA A,H
4966 VALERIC ACID E
4967 VALINE A,E
4968 VANADIUM H
4969 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%.
4970 VANILLA DRY A,E,H
4971 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%.
4972 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%.
4973 VANILLA PLANIFOLIA A,E,H
4974 VANILLA POWDER A,E,H
4975 VANILLA TAHITENSIS A,H
4976 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%.
4977 VANILLIN E Permitted for use as a flavour.
4978 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%.
4979 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%.
4980 VAT RED 1 E Permitted for use as a colour for topical use.
4981 VAT RED 1 ALUMINIUM LAKE E Permitted for use as a colour for topical use.
4982 VAT RED 5 E Permitted for use as a colour for topical use.
4983 VEGETABLE OIL E
4984 VEGETABLE OIL - HYDROGENATED E
4985 VEGETABLE OIL PHYTOSTEROL ESTERS A,E 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).
4986 VEGETABLE PROTEIN - HYDROLYSED E
4987 VEIN H Only for use as an active homoeopathic ingredient.
4988 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%.
4989 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%.
4990 VERBASCUM DENSIFLORUM A,H
4991 VERBASCUM THAPSUS A,H
4992 VERBENA OFFICINALIS A,H
4993 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%.
4994 VERONICA CHAMAEDRYS A,H
4995 VERONICA OFFICINALIS A,H
4996 VERONICASTRUM VIRGINICUM A,E,H
4997 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%.
4998 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%.
4999 VIBURNUM OPULUS A,E,H
5000 VIBURNUM PRUNIFOLIUM A,E,H
5001 VICIA FABA A,E,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%.
5002 VIGNA ANGULARIS VAR. ANGULARIS A,H
5003 VIGNA RADIATA A,E,H
5004 VIGNA UMBELLATA A,H
5005 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%.
5006 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%
5007 VINCETOXICUM OFFICINALE A,H
5008 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%.
5009 VIOLA ODORATA A,E,H
5010 VIOLA TRICOLOR A,E,H
5011 VIOLA YEDOENSIS A,H
5012 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%.
5013 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%.
5014 VIPER H Only for use as an active homoeopathic ingredient. 
5015 VISCUM ALBUM A,E,H
5016 VISCUM COLORATUM A,H
5017 VISCUM FLAVESCENS A,H
5018 VITELLARIA PARADOXA A,E,H
5019 VITEX AGNUS-CASTUS A,E,H
5020 VITEX NEGUNDO A,H
5021 VITEX ROTUNDIFOLIA A,H
5022 VITEX TRIFOLIA A,H
5023 VITIS VINIFERA A,E,H
5024 VITREOSCILLA CONCENTRATE E Only for use in topical medicines for dermal application.
The concentration in the medicine must be no more than 0.1%.
5025 WAHLENBERGIA GRACILIS A,H
5026 WALNUT E
5027 WALNUT OIL E
5028 WATER - POTABLE E
5029 WATER - PURIFIED E
5030 WATER MELON E
5031 WAX - EMULSIFYING E
5032 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'.
5033 WAX - SYNTHETIC E
5034 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.
5035 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.
5036 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.
5037 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.
5038 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.
5039 WHEAT LEAF E
5040 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.
5041 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.
5042 WHEATGERM OIL A,E,H
5043 WHEY POWDER E Lactose is a mandatory component of Whey powder when the route of administration is oral.
5044 WHEY PROTEIN E Lactose is a mandatory component of Whey protein when the route of administration is oral.
5045 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%.
5046 WHITE HOREHOUND HERB DRY A,H
5047 WHITE HOREHOUND HERB POWDER A,H
5048 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.
5049 WIKSTROEMIA VIRIDIFLORA A,H
5050 WILD CARROT HERB DRY A,E,H
5051 WILD CARROT HERB POWDER A,H
5052 WILD CHERRY BARK DRY A,H
5053 WILD CHERRY BARK POWDER A,H
5054 WILD LETTUCE LEAF DRY A,H
5055 WILD LETTUCE LEAF POWDER A,H
5056 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'
5057 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.
5058 WITHANIA SOMNIFERA A,E,H
5059 WOOL ALCOHOLS E Only for use in topical medicines for dermal application.
5060 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.
5061 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.
5062 XANTHAN GUM E
5063 XANTHIUM SIBIRICUM A,H
5064 XANTHIUM STRUMARIUM A,H
5065 XANTHOMONA CAMPESTRIS A,H
5066 XEROPHYLLUM ASPHODELOIDES A,H
5067 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%.
5068 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]’.
5069 XYLOSE E
5070 YAM E
5071 YARROW HERB DRY A,H
5072 YARROW HERB POWDER A,H
5073 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.
5074 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.
5075 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.
5076 YEAST AUTOLYSATE E
5077 YEAST DRIED A,E,H
5078 YELLOW 2G E Permitted for use as a colour for topical use.
5079 YELLOW MERCURIC OXIDE H Only for use as an active homoeopathic ingredient.
5080 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.
5081 YLANG YLANG OIL A,E,H
5082 YUCCA BACCATA A,H
5083 YUCCA ELATA A,H
5084 YUCCA FILAMENTOSA A,H
5085 YUCCA GLORIOSA A,H
5086 YUCCA WHIPPLEI A,H
5087 ZANTHOXYLUM AMERICANUM A,H
5088 ZANTHOXYLUM BUNGEANUM A,E,H
5089 ZANTHOXYLUM CLAVA-HERCULIS A,H
5090 ZANTHOXYLUM NITIDUM A,H
5091 ZANTHOXYLUM PIPERITUM A,H
5092 ZANTHOXYLUM SIMULANS A,E,H
5093 ZEA MAYS A,E,H
5094 ZEAXANTHIN A,E
5095 ZEIN E
5096 ZINC A,H 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)'.
5097 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.
5098 ZINC ASCORBATE A,E,H When used internally, zinc is a mandatory component of zinc ascorbate.
Based on molecular weights the accepted percentage of zinc from zinc ascorbate is 15.8%. The declared quantity of zinc from zinc ascorbate must be no less than 15% and must be no more than 16.6% of the zinc ascorbate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations.
Based on molecular weights the accepted percentage of ascorbic acid from zinc ascorbate is 84.2%. The declared quantity of ascorbic acid from zinc ascorbate must be no less than 80% and must not exceed 88.4% of the zinc ascorbate 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.
5099 ZINC ASCORBATE MONOHYDRATE A,E,H When used internally, zinc is a mandatory component of zinc ascorbate.
Based on molecular weights the accepted percentage of zinc from zinc ascorbate is 15.8%. The declared quantity of zinc from zinc ascorbate must be no less than 15% and must be no more than 16.6% of the zinc ascorbate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations.
Based on molecular weights the accepted percentage of ascorbic acid from zinc ascorbate is 84.2%. The declared quantity of ascorbic acid from zinc ascorbate must be no less than 80% and must not exceed 88.4% of the zinc ascorbate 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.
5100 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. Based on molecular weights the accepted percentage of zinc from zinc chloride is 48%. The declared quantity of zinc from zinc chloride must be no less than 43.3% and must be no more than 50.7% of the zinc chloride 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.
5101 ZINC CITRATE A,E,H When used internally, zinc is a mandatory component of zinc citrate. Based on molecular weights the accepted percentage of zinc from zinc citrate is 34.2%.  The declared quantity of zinc from zinc citrate must be no less than 32.5% and must be no more than 35.9% of the zinc citrate 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.
5102 ZINC CITRATE DIHYDRATE A,E,H When used internally, zinc is a mandatory component of zinc citrate dihydrate. Based on molecular weights the accepted percentage of zinc from zinc citrate dihydrate is 32.2%.  The declared quantity of zinc from zinc citrate dihydrate must be no less than 30.6% and must be no more than 33.8% of the zinc citrate dihydrate 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.
5103 ZINC CITRATE TRIHYDRATE A,E,H When used internally, zinc is a mandatory component of zinc citrate trihydrate.
Based on molecular weights the accepted percentage of zinc from zinc citrate trihydrate is 31.3%.  The declared quantity of zinc from zinc citrate trihydrate must be no less than 29.7% and must be no more than 32.9% of the zinc citrate trihydrate 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.
5104 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.
Based on molecular weights, the declared quantity of zinc from Zinc diaspartate must be no less than 18.85% and must be no more than 20.83% of the Zinc diaspartate 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.
5105 ZINC GLUCONATE A,E,H When used internally, zinc is a mandatory component of zinc gluconate. Based on molecular weights the accepted percentage of zinc from zinc gluconate is 14.4%.  The declared quantity of zinc from zinc gluconate must be no less than 11.7% and must be no more than 15.4% of the zinc gluconate 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.
5106 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.
Based on molecular weights, the declared quantity of zinc from Zinc glycinate must be no less than 29.1% and must be no more than 32.16% of the Zinc glycinate 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.
5107 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'.
5108 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'.
5109 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. Based on molecular weights, the declared quantity of zinc from Zinc lysinate must be no less than 17.47% and must be no more than 19.3% of the Zinc lysinate 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.
5110 ZINC METHIONINE SULFATE A 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.
Based on molecular weights, the declared quantity of zinc from Zinc methionine sulfate must be no less than 20% and must not exceed 22.1% of the Zinc methionine sulfate 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.
5111 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%.
5112 ZINC OXIDE A,E,H When used internally, zinc is a mandatory component of zinc oxide.
Based on molecular weights the accepted percentage of zinc from zinc oxide is 80.4%.  The declared quantity of zinc from zinc oxide must be no less than 75.6% and must be no more than 84.8% of the zinc oxide in the formulation.  These figures incorporate a 5% variance to allow for rounding in calculations.
The medicine requires the following warning statements on the medicine label:
- (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect)
- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.
5113 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.
5114 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 must be no more than 12.6% of the zinc stearate in the formulation.  These figures incorporate a 5% variance to allow for rounding in calculations.
5115 ZINC SUCCINATE A,E,H When used internally, zinc is a mandatory component of zinc succinate.
Based on molecular weights the accepted percentage of zinc from zinc succinate is 36.1%. The declared quantity of zinc from zinc succinate must be no less than 34.3% and must be no more than 37.9% of the zinc succinate 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.
5116 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.
Based on molecular weights the accepted percentage of zinc from zinc sulfate is 22.8%. The declared quantity of zinc from zinc sulfate must be no less than 21.4% and must be no more than 24.9% of the zinc sulfate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations.
5117 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.
Based on molecular weights the accepted percentage of zinc from zinc sulfate is 22.8%. The declared quantity of zinc from zinc sulfate must be no less than 21.4% and must be no more than 24.9% of the zinc sulfate 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.
5118 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.
Based on molecular weights the accepted percentage of zinc from zinc sulfate is 22.8%. The declared quantity of zinc from zinc sulfate must be no less than 21.4% and must be no more than 24.9% of the zinc sulfate 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.
5119 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.
 Based on molecular weights the accepted percentage of zinc from zinc sulfate monohydrate is 36.5%. The declared quantity of zinc from zinc sulfate must be no less than 34.3% and must be no more than 39.9% of the zinc sulfate 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.
5120 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.
5121 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%.
5122 ZINGIBER OFFICINALE A,E,H When 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'
5123 ZIZIPHUS JUJUBA A,E,H
5124 ZIZIPHUS JUJUBA VAR. SPINOSA A,H
5125 ZIZYPHUS SATIVA A,H
5126 ZOSTERA MARINA A,H
5127 ZUCCHINI E
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