Therapeutic Goods (Permissible Ingredients) Determination No. 4 of 2017 (Cth)

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Therapeutic Goods (Permissible Ingredients) Determination No. 4 of 2017

made under subsection 26BB(1) of the

Therapeutic Goods Act 1989

I, Mark McDonald, 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. 3 of 2017; and

(b)Make the following determination specifying:

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

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

Dated this 8th September 2017

(Signed by)

Mark McDonald

Delegate of the Minister for Health

1  Name of Determination

                   This Determination is the Therapeutic Goods (Permissible Ingredients) Determination No.4 of 2017.

2  Commencement

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

3Interpretation

In this Determination:

Act means the Therapeutic Goods Act 1989.

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

European Pharmacopoeia is as defined under the Act.

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

4  Permissible ingredients and requirements applying to those ingredients

Permissible ingredients and requirements applying to those ingredients under Table 1

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

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

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

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

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

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

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

Note:  Examples of these acronyms are:

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

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

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

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

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

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

(section 4)

Part 1—Interpretation of Table 1

Definitions

At Table 1:

“A” means an active ingredient.

Act means the Therapeutic Goods Act 1989.

Active ingredient is as defined in the Regulations.

British Pharmacopoeia is as defined under the Act.

“E” means an excipient.

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

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

“H” means a homoeopathic preparation ingredient.

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

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

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

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

(ii)serial trituration in lactose.

Mother tincture is as defined in the Regulations.

Regulations means the Therapeutic Goods Regulations 1990.

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

Part 2 – Table 1

Column 1

Column 2

Ingredient Name

Column 3

Purpose of the ingredient in the medicine

Column 4

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

1

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

E

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

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

2

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

E

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

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

3

(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 tosylate.

(S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label:

- (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'

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

1,1,1-TRICHLOROETHANE

E

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

21

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%.

22

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%.

23

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%.

24

1,3-BUTYLENE GLYCOL

E

25

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%.

26

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%.

27

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%

28

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%.

29

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%.

30

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%.

31

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%.

32

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%.

33

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%.

34

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%.

35

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%.

36

1-DODECANOL

E

Permitted for use:

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

(b) in topical medicines for dermal application.

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

37

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%.

38

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%.

39

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%.

40

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%.

41

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%.

42

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%.

43

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%.

44

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%.

45

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%.

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

2,2,3-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%.

50

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%.

51

2,2-DIMETHYL-3-(3-METHYL-2,4-PENTADIENYL)-OXIRANE

E

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

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

52

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%.

53

2,2-DIMETHYL-5-(1-METHYLPROPEN-1-YL) TETRAHYDROFURAN

E

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

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

54

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%.

55

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%.

56

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%.

57

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%.

58

2,3-DIETHYLPYRAZINE

E

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

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

59

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%.

60

2,3-DIMETHYLPYRAZINE

E

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

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

61

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%.

62

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%.

63

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%.

64

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%.

65

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%.

66

2,4-DECADIENAL

E

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

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

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

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

67

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%.

68

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%.

69

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%.

70

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%.

71

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%.

72

2,4-HEPTADIENAL

E

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

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

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

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

73

2,4-HEXADIENOL

E

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

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

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

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

74

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%.

75

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%.

76

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%.

77

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%.

78

2,5-DIMETHYLPYRAZINE

E

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

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

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

If used in a printing ink the total printing ink concentration in a medicine must be no more than 0.1%

79

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%.

80

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%.

81

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%.

82

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%.

83

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%.

84

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%.

85

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%.

86

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%.

87

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%.

88

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%.

89

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%.

90

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%.

91

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%.

92

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%.

93

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%.

94

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%.

95

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%.

96

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%.

97

2-AMINO-2-METHYL-1-PROPANOL

E

Only for use in topical medicines for dermal application.

98

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%.

99

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%.

100

2-BUTYL-4,4,6-TRIMETHYL-1,3-DIOXANE

E

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

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

101

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%.

102

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%.

103

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%.

104

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%.

105

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%.

106

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%.

107

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%.

108

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%.

109

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%.

110

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%.

111

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%.

112

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%.

113

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%.

114

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%.

115

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%.

116

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%.

117

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%.

118

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%.

119

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%.

120

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%.

121

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%.

122

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%.

123

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%.

124

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%.

125

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%.

126

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%.

127

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%.

128

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%.

129

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%.

130

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%.

131

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%.

132

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%.

133

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%.

134

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%.

135

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%.

136

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%.

137

2-METHYL-4-(2,2,3-TRIMETHYL-3-CYCLOPENTENYL)-2-BUTEN-1-OL

E

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

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

Only for use in topical medicines for dermal application.

138

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%.

139

2-METHYL-4-(CAMPHENYL-8)-CYCLOHEXANONE

E

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

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

140

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%.

141

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%.

142

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%.

143

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%.

144

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%.

145

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%.

146

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%.

147

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%.

148

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%.

149

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%.

150

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%.

151

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%.

152

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%.

153

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%.

154

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%.

155

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%.

156

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%.

157

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%.

158

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%.

159

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%.

160

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%.

161

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%.

162

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%.

163

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%.

164

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%.

165

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%.

166

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%.

167

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%.

168

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%.

169

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%.

170

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%.

171

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%.

172

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%.

173

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%.

174

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%.

175

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%.

176

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%.

177

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%.

178

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%.

179

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%.

180

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%.

181

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%.

182

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%.

183

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%.

184

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%.

185

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%.

186

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%.

187

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%.

188

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%.

189

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%.

190

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%.

191

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%.

192

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%.

193

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%.

194

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%.

195

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%.

196

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%.

197

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%.

198

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%.

199

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%.

200

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%.

201

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%.

202

3-METHYL-5-PHENYLPENTANENITRILE

E

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

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

203

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%.

204

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%.

205

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%.

206

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%.

207

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%.

208

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%.

209

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%.

210

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%.

211

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%.

212

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%.

213

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%.

214

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%.

215

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%.

216

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%.

217

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%.

218

4,5-DIMETHYL-3-HYDROXY-2(5H)FURANONE

E

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

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

219

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%.

220

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%.

221

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%.

222

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%.

223

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%.

224

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%.

225

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%.

226

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%.

227

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%.

228

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%.

229

4-HEPTANONE

E

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

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

230

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%.

231

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%.

232

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%.

233

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%.

234

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%.

235

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%.

236

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%.

237

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%.

238

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%.

239

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%.

240

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%.

241

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%.

242

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%.

243

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%.

244

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%.

245

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%.

246

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%.

247

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%.

248

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%.

249

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%.

250

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%.

251

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%.

252

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%.

253

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%.

254

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%.

255

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%.

256

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%.

257

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%.

258

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%.

259

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%.

260

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%.

261

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%.

262

6-BUTYL-3,6-DIHYDRO-2,4-DIMETHYL-2H-PYRAN

E

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

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

263

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%.

264

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%.

265

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

E

266

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%.

267

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%.

268

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%.

269

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%.

270

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%.

271

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%.

272

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%.

273

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%.

274

ABELMOSCHUS MOSCHATUS

A, H

275

ABELMOSCHUS MOSCHATUS SUBSP. MOSCHATUS

A, H

276

ABIES BALSAMEA

A, H

277

ABIES NIGRA

A, H

278

ABIES PECTINATA

A, H

279

ABIES SIBIRICA

A, H

280

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.

281

ABUTILON THEOPHRASTI

A, H

282

ACACIA

A, E, H

283

ACACIA BAILEYANA

A, H

284

ACACIA CATECHU

A, H

285

ACACIA DEALBATA

A, H

286

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%.

287

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%.

288

ACACIA LONGIFOLIA

A, E, H

289

ACACIA NILOTICA

A, E, H

290

ACACIA SENEGAL

A, E, H

291

ACALYPHA INDICA

A, H

292

ACANTHUS MOLLIS

A, H

293

ACER CAMPESTRE

A, H

294

ACER NEGUNDO

A, H

295

ACER SACCHARINUM

A, H

296

ACER SACCHARUM

A, E, H

297

ACEROLA

E

298

ACESULFAME POTASSIUM

E

299

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%.

300

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%.

301

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%.

302

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%.

303

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%.

304

ACETANISOLE

E

Permitted for use only:

(a) in topical medicines for dermal application; and

(b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

305

ACETIC ACID

E, H

The concentration in the medicine must be no more than 80%.

306

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%.

307

ACETOMENAPHTHONE

A, E

308

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%.

309

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%.

310

ACETOVANILLONE

E

Only for use in topical medicines for dermal application.

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

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

311

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%.

312

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%.

313

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'

314

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%.

315

ACETYL LEVOCARNITINE HYDROCHLORIDE

A, E

316

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%.

317

ACETYLATED LANOLIN

E

Only for use in topical medicines for dermal application.

318

ACETYLATED LANOLIN ALCOHOL

E

Only for use in topical medicines for dermal application.

319

ACETYLATED MONOGLYCERIDES

E

320

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%.

321

ACETYLCYSTEINE

E

Only for use in topical medicines for dermal application.

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

322

ACHILLEA ERBA-ROTTA SUBSP. MOSCHATA

A, H

323

ACHILLEA MILLEFOLIUM

A, E, H

324

ACHILLEA PTARMICA

A, H

325

ACHYRANTHES ASPERA

A, H

326

ACHYRANTHES BIDENTATA

A, H

327

ACHYRANTHES FAURIEI

A, H

328

ACID GREEN 25

E

Permitted for use only as a colour for topical use.

329

ACID RED 33

E

Permitted for use only as a colour for topical use.

330

ACID RED 87

E, H

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

331

ACID TREATED WAXY MAIZE STARCH

E

332

ACID-ISOMERISED LINALOOL

E

Permitted for use only when combined with other permitted ingredients as a fragrance.

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

333

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.

334

ACONITUM FEROX

A, H

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

The maximum amount of total alkaloids (of Aconitum spp.) must be no more than 0.02 milligrams per pack.

335

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.

336

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.

337

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%.

338

ACRYLAMIDES COPOLYMER

E

Only for use in topical medicines for dermal application.

339

ACRYLATES COPOLYMER

E

Only for use in topical medicines for dermal application.

340

ACRYLATES/ACRYLAMIDE COPOLYMER

E

Only for use in topical medicines for dermal application.

341

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

E

Only for use in topical medicines for dermal application.

342

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%.

343

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%.

344

ACRYLATES/OCTYLACRYLAMIDE COPOLYMER

E

Only for use in topical medicines for dermal application.

345

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%.

346

ACRYLATES/VA COPOLYMER

E

Only for use in topical medicines for dermal application.

347

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%.

348

ACTAEA CIMICIFUGA

A, H

349

ACTAEA HERACLEIFOLIA

A, H

350

ACTAEA PACHYPODA

A, H

351

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.'

352

ACTAEA SIMPLEX

A, H

353

ACTAEA SPICATA

A, H

354

ACTINIDIA CHINENSIS

A, H

355

ACTINIDIA DELICIOSA

A, H

356

ACTIVATED ATTAPULGITE

A

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

357

ACTIVATED CHARCOAL

A, E, H

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

- (ACCOAL) 'Products containing activated charcoal should be used with caution in children since it may interfere with absorption of nutrients. Activated charcoal may interact with other medicines. Activated charcoal is not recommended for long-term use' (or words to that effect).

358

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)'

359

ADEMETIONINE DISULFATE TOSYLATE

A, H

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

Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label:

- (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'

360

ADEMETIONINE DISULFATE TRITOSYLATE DIHYDRATE

A, H

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

Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label:

- (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'

361

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)'

362

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)'

363

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)'

364

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)'

365

ADEMETIONINE TETRASULFATE DIHYDRATE

A, H

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

Ademetionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label:

- (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)'

366

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)'

367

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)'

368

ADENOPHORA STRICTA

A, H

369

ADENOPHORA TRIPHYLLA

A, H

370

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%.

371

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%.

372

ADENOSINE TRIPHOSPHATE

E

Only for use in topical medicines for dermal application.

373

ADENOSINE TRIPHOSPHATE DISODIUM

E

Only for use in topical medicines for dermal application.

374

ADIANTUM CAPILLUS-VENERIS

A, H

375

ADIPIC ACID

E

376

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%.

377

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%.

378

ADRENALINE (EPINEPHRINE)

H

Only for use as an active homoeopathic ingredient.

379

ADZUKI BEAN

E

380

AEGOPODIUM PODAGRARIA

A, H

381

AESCULUS CHINENSIS

A, H

382

AESCULUS GLABRA

A, H

383

AESCULUS HIPPOCASTANUM

A, H

384

AESCULUS X CARNEA

A, H

385

AETHUSA CYNAPIUM

H

Only for use as an active homoeopathic ingredient.

386

AGAR

A, E

387

AGASTACHE RUGOSA

A, H

388

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%.

389

AGAVE AMERICANA

A, E, H

390

AGRIMONIA EUPATORIA

A, E, H

391

AGRIMONIA REPENS

A, H

392

AGROSTIS TENUIS

A, H

393

AILANTHUS ALTISSIMA

A, H

394

AJUGA CHAMAEPITYS

A, H

395

AJUGA REPTANS

A, H

396

ALANINE

A, E

397

ALANYLGLUTAMINE

A

Only for use in oral medicines.

398

ALARIA ESCULENTA

A, H

Iodine is a mandatory component of Alaria esculenta.

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

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

399

ALBIZIA JULIBRISSIN

A, H

400

ALBIZIA LEBBECK

A, H

401

ALCEA ROSEA

A, H

402

ALCHEMILLA ALPINA

A, H

403

ALCHEMILLA ARVENSIS

A, H

404

ALCHEMILLA VULGARIS

A, H

405

ALETRIS FARINOSA

A, H

406

ALETRIS SPICATA

A, H

407

ALEURITES MOLUCCANUS SEED OIL

E

Only for use in topical medicines for dermal application.

408

ALFADEX

A, E

Only for use in oral medicines.

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

409

ALGINATE-KONJAC-XANTHAN POLYSACCHARIDE COMPLEX

A

Only for use in oral medicines.

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

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

When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’

When a dose for children is stated, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect).

410

ALGINIC ACID

E

411

ALISMA ORIENTALE

A, H

412

ALISMA PLANTAGO AQUATICA

A, H

413

ALKANNA TINCTORIA

A, H

414

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%.

415

ALLANTOIN

E

Only for use in topical medicines for dermal application.

416

ALLIARIA PETIOLATA

A, H

417

ALLIUM CEPA

A, H

418

ALLIUM FISTULOSUM

A, H

419

ALLIUM HIEROCHUNTINUM

A, H

420

ALLIUM MACROSTEMON

A, H

421

ALLIUM ODORUM

A, H

422

ALLIUM PORRUM

A, H

423

ALLIUM SATIVUM

A, E, H

424

ALLIUM SCHOENOPRASUM

A, H

425

ALLIUM URSINUM

A, H

426

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%.

427

ALLURA RED AC

E

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

428

ALLURA RED AC ALUMINIUM LAKE

E

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

429

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%.

430

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%.

431

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%.

432

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%.

433

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%.

434

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%.

435

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%.

436

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%.

437

ALLYL ISOTHIOCYANATE

E

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

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

438

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%.

439

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%.

440

ALMOND

E

441

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%.

442

ALNUS GLUTINOSA

A, H

443

ALNUS INCANA SUBSP. RUGOSA

A, H

444

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]'

445

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]'

446

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]'

447

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]'

448

ALOYSIA CITRODORA

A, H

449

ALPHA CASOZEPINE ENRICHED HYDROLYSED MILK PROTEIN

A

Only for use in oral medicines.

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

- (BABY3) 'Not suitable for use in children under the age of twelve months - except on professional advice'

- (COWMK) 'Derived from cow's milk.'

450

ALPHA LIPOIC ACID

A

451

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%.

452

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%.

453

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%.

454

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%.

455

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%.

456

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%.

457

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%.

458

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%.

459

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%.

460

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%.

461

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%.

462

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%.

463

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%.

464

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%.

465

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%.

466

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%.

467

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%.

468

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%.

469

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%.

470

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%.

471

ALPHA-PHELLANDRENE

E

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

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

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

472

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%.

473

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%.

474

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%.

475

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%.

476

ALPINIA GALANGA

A, H

477

ALPINIA HAINANENSIS

A, H

478

ALPINIA OFFICINARUM

A, H

479

ALPINIA OXYPHYLLA

A, H

480

ALSIDIUM HELMINTHOCHORTON

A, H

Iodine is a mandatory component of Alsidium helminthochorton.

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

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

481

ALSTONIA BOONEI

A, H

482

ALSTONIA CONSTRICTA

H

Only for use as an active homoeopathic ingredient.

483

ALTERNANTHERA PHILOXEROIDES

A, H

484

ALTEROMONAS FERMENT EXTRACT

E

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

The concentration in the medicine must be no more than 0.3%.

485

ALTHAEA OFFICINALIS

A, E, H

486

ALUM DODECAHYDRATE

A, E, H

487

ALUMINIUM CHLOROHYDRATE

E

Only for use in topical medicines for dermal application.

488

ALUMINIUM CITRATE

E

Only for use in topical medicines for dermal application.

489

ALUMINIUM DISTEARATE

E

Only for use in topical medicines for dermal application.

490

ALUMINIUM HYDROXIDE

E

Only for use in topical medicines for dermal application.

491

ALUMINIUM HYDROXIDE HYDRATE

E

Only for use in topical medicines for dermal application.

492

ALUMINIUM MAGNESIUM SILICATE

E

493

ALUMINIUM MONOSTEARATE

E

Only for use in topical medicines for dermal application.

494

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.

495

ALUMINIUM SILICATE

E, H

Only for use as an active homoeopathic or excipient ingredient.

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

496

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).’

497

ALUMINIUM STARCH OCTENYLSUCCINATE

E

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

498

ALUMINIUM STEARATE

E

Only for use in topical medicines for dermal application.

499

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%.

500

AMARANTH

E

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

501

AMARANTH ALUMINIUM LAKE

E

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

502

AMARANTHUS HYBRIDUS

A, H

503

AMARANTHUS RETROFLEXUS

A, H

504

AMBERGRIS EXTRACT

E

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

The total fragrance concentration in a medicine must be no more than 1%.

505

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%.

506

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%.

507

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%.

508

AMBROSIA ARTEMISIIFOLIA

A, H

509

AMBROSIA PSILOSTACHYA

A, H

510

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%.

511

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%.

512

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%.

513

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%.

514

AMMONIA

E, H

Only for use as an active homoeopathic or excipient ingredient.

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

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

515

AMMONIO METHACRYLATE COPOLYMER

E

Only for use in oral medicines.

516

AMMONIUM ACRYLATES COPOLYMER

E

Only for use in topical medicines for dermal application.

517

AMMONIUM ACRYLATES/ACRYLONITROGENS COPOLYMER

E

Only for use in topical medicines for dermal application.

518

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%.

519

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%.

520

AMMONIUM BICARBONATE

A, H

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

521

AMMONIUM BROMIDE

H

Only for use as an active homoeopathic ingredient.

522

AMMONIUM CARBONATE

E, H

Only for use as an active homoeopathic or excipient ingredient.

523

AMMONIUM CHLORIDE

A, E, H

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

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

524

AMMONIUM GLYCYRRHIZINATE

E

525

AMMONIUM IODIDE

H

Only for use an active ingredient in homoeopathic medicines.

526

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%.

527

AMMONIUM LAURETH SULFATE

E

Only for use in topical medicines for dermal application.

528

AMMONIUM LAURYL SULFATE

E

Only for use in topical medicines for dermal application.

529

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%.

530

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%.

531

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%.

532

AMOMUM AROMATICUM

A, H

533

AMOMUM VILLOSUM

A, H

534

AMORPHOPHALLUS KONJAC

A, H

Only for use when the dosage form is not tablet.

535

AMPELODESMOS MAURITANICUS

A, H

536

AMPELOPSIS JAPONICA

A, H

537

AMYL ACETATE

E

Only for use in topical medicines for dermal application.

538

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%.

539

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%.

540

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%.

541

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%.

542

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%.

543

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%.

544

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%.

545

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%.

546

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%.

547

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%.

548

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%.

549

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%.

550

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%.

551

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%.

552

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%.

553

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%.

554

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.

555

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%.

556

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%.

557

AMYRIS BALSAMIFERA

A, H

558

AMYRIS OIL WEST INDIAN

A, E, H

559

ANACARDIUM OCCIDENTALE

A, H

560

ANACYCLUS PYRETHRUM

A, H

561

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%.

562

ANAESTHETIC ETHER

H

Only for use as an active homoeopathic ingredient.

563

ANAGALLIS ARVENSIS

A, H

564

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%.

565

ANANAS COMOSUS

A, E, H

566

ANAPHALIS SINICA

A, H

567

ANDROGRAPHIS PANICULATA

A, H

568

ANEMARRHENA ASPHODELOIDES

A, E, H

569

ANEMONE ALTAICA

A, H

570

ANEMONE CHINENSIS

A, H

571

ANEMONE HEPATICA

A, H

572

ANEMONE PULSATILLA

A, H

573

ANEMONE RADDEANA

A, H

574

ANETHOLE

E

575

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%.

576

ANETHUM GRAVEOLENS

A, E, H

577

ANGELICA ACUTILOBA

A, H

578

ANGELICA ANOMALA

A, H

579

ANGELICA ARCHANGELICA

A, E, H

580

ANGELICA ATROPURPUREA

A, H

581

ANGELICA DAHURICA

A, E, H

582

ANGELICA DECURSIVA

A, H

583

ANGELICA POLYMORPHA

A, E, H

584

ANGELICA PUBESCENS

A, E, H

585

ANGELICA ROOT DRY

A, H

586

ANGELICA ROOT OIL

A, E, H

587

ANGELICA SEED OIL

A, E, H

588

ANGELICA STEM

E

589

ANIBA ROSAEODORA

A, E, H

590

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%.

591

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%.

592

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)'

593

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%.

594

ANISEED DRY

A, E, H

595

ANISEED POWDER

A, E, H

596

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%.

597

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%.

598

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%.

599

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%.

600

ANISYL PROPIONATE

E

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

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

601

ANNATTO

E

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

602

ANOGEISSUS LATIFOLIA

A, E, H

603

ANTENNARIA DIOICA

A, E, H

604

ANTHOCYANINS

E

605

ANTHOXANTHUM ODORATUM

A, H

When used as an active ingredient coumarin is a mandatory component of Anthoxanthum odoratum and the maximum daily dose of the medicine must contain no more than 0.001% of coumarin.

606

ANTHRISCUS CEREFOLIUM

A, H

607

ANTHYLLIS VULNERARIA

A, H

608

ANTIMONY POTASSIUM TARTRATE TRIHYDRATE

H

Only for use as an active homoeopathic ingredient.

609

ANTIMONY TRISULFIDE

H

Only for use as an active homoeopathic ingredient.

610

APIUM GRAVEOLENS

A, E, H

611

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%.

612

APOMORPHINE HYDROCHLORIDE HEMIHYDRATE

H

Only for use as an active homoeopathic ingredient.

613

APPLE

E

614

APPLE CIDER VINEGAR

E

615

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%.

616

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%.

617

APPLE FIBRE

E

618

APRICOT

E

619

APRICOT KERNEL OIL PEG-6 ESTERS

E

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

620

AQUILARIA MALACCENSIS

A, H

621

AQUILARIA SINENSIS

A, H

622

AQUILEGIA VULGARIS

A, H

623

ARACHIDONIC ACID

E

Only for use in topical medicines for dermal application.

624

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%.

625

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%.

626

ARACHIDYL PROPIONATE

E

Only for use in topical medicines for dermal application.

627

ARACHIS HYPOGAEA

A, E, H

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

- (PEANUT) ‘Contains Peanut’ (or words to that effect).

628

ARACHIS OIL

A, E, H

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

- (PEANUT) ‘Contains Peanut’ (or words to that effect).

629

ARALIA CORDATA

A, H

630

ARALIA HISPIDA

A, H

631

ARALIA NUDICAULIS

A, H

632

ARALIA RACEMOSA

A, H

633

ARCTIUM LAPPA

A, E, H

634

ARCTIUM MINUS

A, H

635

ARCTOSTAPHYLOS UVA-URSI

A, E, H

636

ARDISIA JAPONICA

A, H

637

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%.

638

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.

639

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.'

640

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%.

641

ARISAEMA ATRORUBENS

A, H

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

642

ARISAEMA CONSANGUINEUM

A, H

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

643

ARISAEMA JAPONICUM

A, H

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

644

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).

645

ARNEBIA EUCHROMA

A, H

646

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.

647

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.

648

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.

649

ARRHENATHERUM ELATIUS

A, H

650

ARROWROOT

A, E, H

651

ARSENIC TRIIODIDE

H

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

652

ARSENIC TRIOXIDE

H

Only for use as an active homoeopathic ingredient.

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

653

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%.

654

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%.

655

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%.

656

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%.

657

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%.

658

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%.

659

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%.

660

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%.

661

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%.

662

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%.

663

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%.

664

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%.

665

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%.

666

ARTERY

H

Only for use as an active homoeopathic ingredient.

667

ARTHROSPIRA MAXIMA

A, H

668

ARTHROSPIRA PLATENSIS

A, H

669

ARUM MACULATUM

A, H

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

670

ASAFOETIDA GUM

A, H

671

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%.

672

ASARUM EUROPAEUM

A, H

673

ASARUM HETEROTROPOIDES

A, H

674

ASARUM OIL

E

675

ASARUM SIEBOLDII

A, E, H

676

ASCLEPIAS TUBEROSA

A, H

677

ASCOPHYLLUM NODOSUM

A, E, H

Iodine is a mandatory component of Ascophyllum nodosum.

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

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

678

ASCORBIC ACID

A, E

679

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%.

680

ASCORBYL METHYLSILANOL PECTINATE

E

Only for use in topical medicines for dermal application.

681

ASCORBYL PALMITATE

A, E

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

682

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%.

683

ASPALATHUS LINEARIS

A, E, H

684

ASPARAGINE

A, E

685

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%.

686

ASPARAGUS

E, H

Only for use as an active homoeopathic or excipient ingredient.

687

ASPARAGUS COCHINCHINENSIS

A, H

688

ASPARAGUS OFFICINALIS

A, E, H

689

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.

690

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'

691

ASPARTIC ACID

A, E

692

ASPERGILLUS ORYZAE

A, E, H

693

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).

694

ASTER NOVI-BELGII

A, H

695

ASTER TATARICUS

A, H

696

ASTRAGALUS ADSURGENS

A, H

697

ASTRAGALUS COMPLANATUS

A, H

698

ASTRAGALUS EXCARPUS

A, H

699

ASTRAGALUS GUMMIFER

A, E, H

700

ASTRAGALUS LENTIGINOSUS

A, H

701

ASTRAGALUS MEMBRANACEUS

A, E, H

702

ASTRAGALUS PENDULIFLORUS

A, H

703

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%.

704

ATRACTYLODES JAPONICA

A, H

705

ATRACTYLODES LANCEA

A, H

706

ATRACTYLODES MACROCEPHALA

A, H

707

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%.

708

ATROPINE SULFATE MONOHYDRATE

H

Only for use as an active homoeopathic ingredient.

709

ATTALEA SPECIOSA

E

Only for use in topical medicines for dermal application.

710

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%.

711

AUREOBASIDIUM PULLULANS

A, H

712

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.

713

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.

714

AVOCADO

E

715

AVOCADO OIL

E

716

AVOCADO OIL UNSAPONIFIABLES

E

Only for use in topical medicines for dermal application.

717

AZADIRACHTA INDICA

A, H

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

“Debitterised neem seed oil” means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids.

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

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

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

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

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

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

718

AZOVAN BLUE

E

Permitted for use only as a colour for topical use.

719

AZULENE

E

Only for use in topical medicines for dermal application.

4892

TREHALOSE DIHYDRATE

E

Only for use in topical medicines for dermal application.

4893

TREMELLA FUCIFORMIS

A, H

4894

TRIACETIN

E

4895

TRIACONTANYL PVP

E

Only for use in topical medicines for dermal application.

4896

TRIADICA SEBIFERA

A, H

4897

TRIBASIC POTASSIUM PHOSPHATE

A, E, H

When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of tribasic potassium phosphate.

When used in a solid medicine containing this ingredient, the pH of a 10 g/L aqueous solution must not be more than 11.5.

When used in a liquid or a semi-solid medicine containing this ingredient, the pH of the medicine must be no more than 11.5.

4898

TRIBASIC SODIUM PHOSPHATE

E

When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5.

When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.

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).

4899

TRIBEHENIN

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 6%.

4900

TRIBEHENIN PEG-20 ESTERS

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 6%.

4901

TRIBULUS TERRESTRIS

A, E, H

4902

TRIBUTYL ACETYLCITRATE

E

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

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

4903

TRICALCIUM PHOSPHATE

E

4904

TRICAPRYLIN

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%.

4905

TRICAPRYLYL 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 7%.

4906

TRICETEARETH-4 PHOSPHATE

E

Only for use in topical medicines for dermal application.

4907

TRICHLOROMETHYLPHENYLCARBINYL 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%.

4908

TRICHODERMA VIRIDE

A, E, H

4909

TRICHOSANTHES KIRILOWII

A, E, H

4910

TRICLOSAN

E

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

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

- (TRICLO) 'Contains triclosan [quantity]' (or words to that effect).

4911

TRICYCLODECENYL PROPIONATE

E

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

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

4912

TRIDECANAL

E

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

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

4913

TRIDECETH-4 PHOSPHATE

E

Only for use in topical medicines for dermal application.

4914

TRIDECETH-6

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 0.5%.

4915

TRIDECYL ALCOHOL

E

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

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

4916

TRIDECYL BEHENATE

E

Behenic acid is a mandatory component of Tridecyl behenate.

Only for use in topical medicines for dermal application.

4917

TRIDECYL NEOPENTANOATE

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 23%.

4918

TRIDECYL SALICYLATE

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%.

4919

TRIDECYL STEARATE

E

Only for use in topical medicines for dermal application.

4920

TRIDECYL TRIMELLITATE

E

Only for use in topical medicines for dermal application.

4921

TRIETHOXYCAPRYLYLSILANE

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 1%.

4922

TRIETHYL CITRATE

E

4923

TRIETHYLENE GLYCOL

E

4924

TRIFOLIUM PRATENSE

A, E, H

4925

TRIFOLIUM REPENS

A, H

4926

TRIGONELLA FOENUM-GRAECUM

A, E, H

4927

TRIHYDROXYPALMITAMIDOHYDROXYPROPYL MYRISTYL ETHER

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 0.02%.

4928

TRIHYDROXYSTEARIN

E

Only for use in topical medicines for dermal application.

4929

TRIISOCETYL CITRATE

E

Only for use in topical medicines for dermal application.

4930

TRIISODECYL TRIMELLITATE

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%.

4931

TRIISONONANOIN

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%.

4932

TRIISOSTEARIN

E

Only for use in topical medicines for dermal application.

4933

TRILAURIN

E

Only for use in topical medicines for dermal application.

4934

TRILISA ODORATISSIMA

A, H

4935

TRILLIUM ERECTUM

A, H

4936

TRIMETHOXYCAPRYLYL SILANE

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 0.25%.

4937

TRIMETHYL HYDROXYPENTYL ISOBUTYRATE

E

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

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

4938

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%.

4939

TRIMETHYL-BICYCLO-HEPTANE-SPIROCYCLOHEXENONE

E

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

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

4940

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%.

4941

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%.

4942

TRIMETHYLOPROPANE TRIOCTANOATE

E

Only for use in topical medicines for dermal application.

4943

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%.

4944

TRIMETHYLSILOXYSILICATE

E

Only for use in topical medicines for dermal application.

4945

TRINITROPHENOL

H

Only for use as an active homoeopathic ingredient. 

4946

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%.

4947

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%.

4948

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%.

4949

TRIOSTEUM PERFOLIATUM

A, H

4950

TRIOXAUNDECANEDIOIC ACID

E

4951

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%.

4952

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%.

4953

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.

4954

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%.

4955

TRISODIUM EDETATE

E

Only for use in topical medicines for dermal application.

4956

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%.

4957

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%.

4958

TRISTEARIN

E

4959

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).

4960

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).

4961

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%.

4962

TROLAMINE

E

Only for use in topical medicines for dermal application.

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

4963

TROLAMINE LAURIL SULFATE

E

Only for use in topical medicines for dermal application.

4964

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%.

4965

TROLLIUS CHINENSIS

A, H

4966

TROMETAMOL

E

4967

TROMETAMOL HYDROCHLORIDE

E

4968

TROPAEOLUM MAJUS

A, E, H

4969

TROPICAL RATTLESNAKE

H

Only for use as an active homoeopathic ingredient.

4970

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%.

4971

TSUGA CANADENSIS

A, H

4972

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%.

4973

TURMERIC

E

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

4974

TURNERA DIFFUSA

A, E, H

4975

TURNIP

E

4976

TURPENTINE OIL

A, E

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

4977

TYPHA ANGUSTIFOLIA

A, H

4978

TYPHA LATIFOLIA

A, H

4979

TYPHONIUM GIGANTEUM

A, H

4980

TYROSINE

A, E

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

(section 4)

Part 2 – Table 1

Column 1

Column 2

Ingredient Name

Column 3

Purpose of the ingredient in the medicine

Column 4

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

4981

UBIDECARENONE

A, E

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

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

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

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

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

- (WARF) 'Do not take while on warfarin therapy without medical advice.'

4982

UBIQUINOL-10

A, E

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

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

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

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

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

- (WARF) 'Do not take while on warfarin therapy without medical advice.'

4983

ULEX EUROPAEUS

A, H

4984

ULMUS AMERICANA

A, H

4985

ULMUS CAMPESTRIS

A, H

4986

ULMUS GLABRA

A, H

4987

ULMUS PARVIFOLIA

A, H

4988

ULMUS PROCERA

A, H

4989

ULMUS PUMILA

A, H

4990

ULMUS RUBRA

A, H

4991

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%.

4992

ULTRAMARINE BLUE

E

Permitted for use only as a colour for topical use.

4993

ULVA LACTUCA

A, H

Iodine is a mandatory component of Ulva lactuca.

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

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

4994

UMBELLULARIA CALIFORNICA

A, H

4995

UNCARIA GAMBIR

A, H

4996

UNCARIA RHYNCOPHYLLA

A, H

4997

UNCARIA SINENSIS

A, H

4998

UNCARIA TOMENTOSA

A, H

4999

UNDARIA PINNATIFIDA

A, H

Whole dried Undaria pinnatifida must not contain the holdfast.

Only for use in oral medicines.

5000

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%.

5001

UNDECANOIC ACID

E

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

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

5002

UNDECENOIC ACID

E

5003

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%.

5004

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%.

5005

UNDECYLENAMIDE DEA

E

5006

UNDECYLENOYL PEG-5 PARABEN

E

Only for use in topical medicines for dermal application.

5007

URANIUM NITRATE

H

Only for use as an active homoeopathic ingredient. 

5008

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).

5009

URTICA DIOICA

A, E, H

5010

URTICA URENS

A, H

5011

USNEA BARBATA

A, H

5012

UVA URSI LEAF DRY

A, H

5013

UVA URSI LEAF POWDER

A, E, H

5014

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%.

5015

VACCARIA SEGATALIS

A, H

5016

VACCINIUM BRACTEATUM

A, H

5017

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%.

5018

VACCINIUM MACROCARPON

A, E, H

5019

VACCINIUM MYRTILLOIDES

A, H

5020

VACCINIUM MYRTILLUS

A, E, H

5021

VACCINIUM OXYCOCCUS

A, H

5022

VACCINIUM VITIS-IDAEA

A, H

5023

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%.

5024

VALERALDEHYDE

E

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

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

5025

VALERIAN DRY

A, H

5026

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%.

5027

VALERIAN POWDER

A, H

5028

VALERIANA EDULIS

A, H

5029

VALERIANA OFFICINALIS

A, H

5030

VALERIANA SORBIFOLIA

A, H

5031

VALERIC ACID

E

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

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

5032

VALINE

A, E

5033

VANADIUM

H

5034

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%.

5035

VANILLA DRY

A, E, H

5036

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%.

5037

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%.

5038

VANILLA PLANIFOLIA

A, E, H

5039

VANILLA POWDER

A, E, H

5040

VANILLA TAHITENSIS

A, H

5041

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%.

5042

VANILLIN

E

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

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

5043

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%.

5044

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%.

5045

VAT RED 1

E

Permitted for use only as a colour for topical use.

5046

VAT RED 1 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

5047

VAT RED 5

E

Permitted for use only as a colour for topical use.

5048

VEGETABLE OIL

E

5049

VEGETABLE OIL PHYTOSTEROL ESTERS

A

Only for use in oral medicines.

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

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

5050

VEIN

H

Only for use as an active homoeopathic ingredient.

5051

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%.

5052

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%.

5053

VERBASCUM DENSIFLORUM

A, H

5054

VERBASCUM THAPSUS

A, H

5055

VERBENA OFFICINALIS

A, H

5056

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%.

5057

VERONICA CHAMAEDRYS

A, H

5058

VERONICA OFFICINALIS

A, H

5059

VERONICASTRUM VIRGINICUM

A, E, H

5060

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%.

5061

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%.

5062

VIBURNUM OPULUS

A, E, H

5063

VIBURNUM PRUNIFOLIUM

A, E, H

5064

VICIA FABA

A, H

Levodopa (of Vicia faba) is a mandatory component of Vicia faba.

The concentration of Levodopa (of Vicia faba) from all ingredients in the medicine must be no more than 1mg/kg or 1mg/L or 0.1%.

5065

VIGNA ANGULARIS VAR. ANGULARIS

A, H

5066

VIGNA RADIATA

A, H

5067

VIGNA UMBELLATA

A, H

5068

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%.

5069

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%

5070

VINCETOXICUM OFFICINALE

A, H

5071

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%.

5072

VIOLA ODORATA

A, E, H

5073

VIOLA TRICOLOR

A, H

5074

VIOLA YEDOENSIS

A, H

5075

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%.

5076

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%.

5077

VIPER

H

Only for use as an active homoeopathic ingredient. 

5078

VISCUM ALBUM

A, E, H

5079

VISCUM COLORATUM

A, H

5080

VISCUM FLAVESCENS

A, H

5081

VITELLARIA PARADOXA

A, E, H

5082

VITEX AGNUS-CASTUS

A, E, H

5083

VITEX NEGUNDO

A, H

5084

VITEX ROTUNDIFOLIA

A, H

5085

VITEX TRIFOLIA

A, H

5086

VITIS VINIFERA

A, E, H

5087

VITREOSCILLA CONCENTRATE

E

Only for use in topical medicines for dermal application.

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

5088

WAHLENBERGIA GRACILIS

A, H

5089

WALNUT

E

5090

WALNUT OIL

E

5091

WATER MELON

E

5092

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.

5093

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.

5094

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.

5095

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.

5096

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.

5097

WHEAT LEAF

E

5098

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.

5099

WHEAT STARCH

E

When the route of administration is other than topical or mucosal, gluten is a mandatory component of wheat starch.

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).

5100

WHEATGERM OIL

A, E, H

5101

WHEY POWDER

E

Lactose is a mandatory component of Whey powder when the route of administration is oral.

5102

WHEY PROTEIN

E

Lactose is a mandatory component of Whey protein when the route of administration is oral.

5103

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%.

5104

WHITE BEESWAX

E

5105

WHITE HOREHOUND HERB DRY

A, H

5106

WHITE HOREHOUND HERB POWDER

A, H

5107

WHITE SOFT PARAFFIN

A, E

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

5108

WHOLE DRY MILK

E

If the product is for oral ingestion and contains lactose, then the medicine requires the following warning statement on the medicine label:

- (LACT) 'Contains lactose' (or words to that effect).

5109

WIKSTROEMIA VIRIDIFLORA

A, H

5110

WILD CARROT HERB DRY

A, E, H

5111

WILD CARROT HERB POWDER

A, H

5112

WILD CHERRY BARK DRY

A, H

5113

WILD CHERRY BARK POWDER

A, H

5114

WILD LETTUCE LEAF DRY

A, H

5115

WILD LETTUCE LEAF POWDER

A, H

5116

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.

5117

WITHANIA SOMNIFERA

A, E, H

5118

WOOL ALCOHOLS

E

Only for use in topical medicines for dermal application.

5119

WOOL FAT

A, E

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

5120

XANTHAN GUM

E

5121

XANTHIUM SIBIRICUM

A, H

5122

XANTHIUM STRUMARIUM

A, H

5123

XANTHOMONA CAMPESTRIS

A, H

5124

XEROPHYLLUM ASPHODELOIDES

A, H

5125

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%.

5126

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]’.

5127

XYLOSE

E

5128

YAM

E

5129

YARROW HERB DRY

A, H

5130

YARROW HERB POWDER

A, H

5131

YEAST AUTOLYSATE

E

5132

YEAST DRIED

A, E, H

5133

YELLOW 2G

E

Permitted for use only as a colour for topical use.

5134

YELLOW BEESWAX

E

5135

YELLOW MERCURIC OXIDE

H

Only for use as an active homoeopathic ingredient.

5136

YELLOW SOFT PARAFFIN

A, E

Only for use in topical medicines for dermal application.

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

5137

YLANG YLANG OIL

A, E, H

5138

YUCCA BACCATA

A, H

5139

YUCCA ELATA

A, H

5140

YUCCA FILAMENTOSA

A, H

5141

YUCCA GLORIOSA

A, H

5142

YUCCA WHIPPLEI

A, H

5143

ZANTHOXYLUM AMERICANUM

A, H

5144

ZANTHOXYLUM BUNGEANUM

A, E, H

5145

ZANTHOXYLUM CLAVA-HERCULIS

A, H

5146

ZANTHOXYLUM NITIDUM

A, H

5147

ZANTHOXYLUM PIPERITUM

A, H

5148

ZANTHOXYLUM SIMULANS

A, H

5149

ZEA MAYS

A, E, H

5150

ZEAXANTHIN

A, E

5151

ZEIN

E

5152

ZINC

H

Only for use as an active homoeopathic ingredient.

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

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

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

5153

ZINC AMINO ACID CHELATE

A, E, H

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

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

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

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

5154

ZINC ASCORBATE

A, E, H

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

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

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

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

5155

ZINC ASCORBATE MONOHYDRATE

A, E, H

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

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

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

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

5156

ZINC CHLORIDE

A, E, H

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

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

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

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

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

5157

ZINC CITRATE

A, E, H

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

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

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

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

5158

ZINC CITRATE DIHYDRATE

A, E, H

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

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

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

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

5159

ZINC CITRATE TRIHYDRATE

A, E, H

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

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

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

5160

ZINC DIASPARTATE

A

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

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

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

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

5161

ZINC GLUCONATE

A, E, H

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

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

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

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

5162

ZINC GLYCINATE

A

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

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

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

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

5163

ZINC GLYCINATE MONOHYDRATE

A

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

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

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

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

5164

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'.

5165

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'.

5166

ZINC LYSINATE

A

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

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

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

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

5167

ZINC METHIONINE SULFATE

A

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

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

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

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

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

5168

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%.

5169

ZINC OXIDE

A, E, H

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

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

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

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

5170

ZINC PARA-PHENOLSULFONATE

E

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

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

The percentage of zinc from zinc para-phenolsulfonate should be calculated based on the molecular weight of zinc para-phenolsulfonate.

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

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

5171

ZINC STEARATE

E

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

The percentage of zinc from zinc stearate should be calculated based on the molecular weight of zinc stearate.

5172

ZINC SUCCINATE

A, E, H

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

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

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

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

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

5173

ZINC SULFATE

A, E

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

For internal use, zinc is a mandatory component of zinc sulfate.

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

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

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

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

5174

ZINC SULFATE HEPTAHYDRATE

A, E

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

For internal use, zinc is a mandatory component of zinc sulfate heptahydrate.

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

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

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

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

5175

ZINC SULFATE HEXAHYDRATE

A, E, H

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

For internal use, zinc is a mandatory component of zinc sulfate hexahydrate.

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

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

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

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

5176

ZINC SULFATE MONOHYDRATE

A, E, H

When the route of administration is topical the concentration of zinc sulfate in the medicine must be no more than 5%.

When the medicine is for internal use, zinc is a mandatory component of zinc sulfate monohydrate.

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

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

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

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

5177

ZINC VALERATE

H

Only for use as an active homoeopathic ingredient.

For internal use, zinc is a mandatory component of zinc valerate.

The percentage of zinc from zinc valerate should be calculated based on the molecular weight of zinc valerate.

5178

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%.

5179

ZINGIBER OFFICINALE

A, E, H

When for oral use AND the extract ratio is equal to or more than 25:1 OR the equivalent dry weight per dosage unit is equal to OR more than 2g,  the medicine requires the following warning statement on the medicine label:

- (GINGER) 'Individuals taking anticoagulants should seek medical advice before taking this medicine.' AND 'Individuals at risk of bleeding problems should seek advice from their healthcare practitioner prior to taking this medicine'

5180

ZIZIPHUS JUJUBA

A, H

5181

ZIZIPHUS JUJUBA VAR. SPINOSA

A, H

5182

ZIZYPHUS SATIVA

A, H

5183

ZOSTERA MARINA

A, H

5184

ZUCCHINI

E
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