Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2017 (Cth)

Case
No judgment structure available for this case.

Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2017

made under subsection 26BB(1) of the

Therapeutic Goods Act 1989

I, Allison Jones, a delegate of the Minister for Health and Aged Care 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. 2 of 2016; 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 16 January 2017

(Signed by)

Allison Jones

Delegate of the Minister for Health and Aged Care

1  Name of Determination

This Determination is the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2017.

2Commencement

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 Tables are 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.

4Permissible ingredients and requirements applying to those ingredients

Permissible ingredients and requirements applying to those ingredients under Table 1

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

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

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

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

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

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

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

Note:  Examples of these acronyms are:

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

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

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

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

(b)  the safety of the ingredient must have been assessed against the principles and requirements detailed in the European 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 requirement(s) applying to the ingredient in Column 2

1

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

E

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

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

2

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

E

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

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

3

(E)-2-(3,5-DIMETHYLHEX-3-EN-2-YLOXY)-2-METHYLPROPYL CYCLOPROPANECARBOXYLATE

E

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

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

4

(E)-3-METHYLCYCLOPENTADEC-5-EN-1-ONE

E

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

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

5

(E, E)-2,6-NONADIENAL

E

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

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

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

6

(S)- LACTIC ACID

A,E,H

7

(S)-S-ADENOSYLMETHIONINE DISULFATE DITOSYLATE DIHYDRATE

A

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

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

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

8

(S)-S-ADENOSYLMETHIONINE DISULFATE TOSYLATE

A

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

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

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

9

(S)-S-ADENOSYLMETHIONINE DISULFATE TRITOSYLATE DIHYDRATE

A

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

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

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

10

(S)-S-ADENOSYLMETHIONINE HEXASULFATE DIHYDRATE

A

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

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

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

11

(S)-S-ADENOSYLMETHIONINE HEXATOSYLATE DIHYDRATE

A

(S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine hexatosylate dihydrate and must be declared in the application.

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

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

12

(S)-S-ADENOSYLMETHIONINE PENTASULFATE DIHYDRATE

A

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

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

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

13

(S)-S-ADENOSYLMETHIONINE PENTATOSYLATE DIHYDRATE

A

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

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

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

14

(S)-S-ADENOSYLMETHIONINE TETRASULFATE DIHYDRATE

A

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

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

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

15

(S)-S-ADENOSYLMETHIONINE TETRATOSYLATE DIHYDRATE

A

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

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

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

16

(S)-S-ADENOSYLMETHIONINE TRISULFATE DITOSYLATE DIHYDRATE

A

(S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine trisulfate ditosylate dihydrate.

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

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

17

(Z)-HEX-3-ENYL 2-ETHYLBUTYRATE

E

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

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

18

(Z, Z)-3,6-NONADIEN-1-OL

E

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

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

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

19

(±)-NARINGENIN

E

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

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

20

1-(2,2,6-TRIMETHYLCYCLOHEXYL)-3-HEXANOL

E

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

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

21

1-(2,6,6-TRIMETHYL-2-CYCLOHEXEN-1-YL)-1-PENTEN-3-ONE

E

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

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

22

1-(3,3-DIMETHYLCYCLOHEXYL)ETHYL FORMATE

E

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

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

23

1-(4-ISOPROPYLCYCLOHEXYL)ETHANOL

E

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

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

24

1-(5,5-DIMETHYL-1-CYCLOHEXEN-1-YL)-4-PENTEN-1-ONE

E

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

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

25

1-DODECANOL

E

Only for use in topical medicines for dermal application.

26

1-HEPTANOL

E

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

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

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

27

1-HEXEN-3-OL

E

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

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

28

1-METHOXY-4-PROPENYLBENZENE

E

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

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

29

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

E

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

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

30

1-METHYL-3-(2-METHYLPROPYL)-CYCLOHEXANOL

E

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

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

31

1-METHYL-4-(4-METHYL-3-PENTENYL)-3-CYCLOHEXENE-1-CARBOXALDEHYDE

E

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

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

32

1-OCTEN-3-ONE

E

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

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

33

1-P-MENTHENE-8-THIOL

E

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

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

34

1-PENTEN-3-OL

E

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

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

35

1,1,1-TRICHLOROETHANE

E

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

36

1,2-HEXANEDIOL

E

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

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

37

1,3-BUTYLENE GLYCOL

E

38

1,3-NONANEDIOL ACETATE, MIXED ESTERS

E

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

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

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

39

1,3-NONANEDIOL, DIACETATE

E

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

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

40

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

E

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

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

41

1,3,5-UNDECATRIENE

E

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

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

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

42

1,4-CINEOLE

E

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

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

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

43

1,4-DIOXACYCLOHEXADECANE-5,16-DIONE

E

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

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

44

1,5,9-TRIMETHYL-13-OXABICYCLO[10.1.0]TRIDECA-4,8-DIENE

E

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

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

45

1,7,7-TRIMETHYLBICYCLO[4.4.0]DECAN-3-YL ACETATE

E

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

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

46

10-UNDECEN-1-OL

E

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

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

47

10-UNDECENAL

E

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

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

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

48

16-HYDROXY-12-OXAHEXADECANOIC ACID, OMEGA-LACTONE

E

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

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

49

2-(1,1-DIMETHYLETHYL)-1,4-DIMETHOXY-BENZENE

E

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

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

50

2-(2-(4-METHYL-3-CYCLOHEXEN-1-YL)PROPYL CYCLOPENTANONE

E

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

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

51

2-ACETYLFURAN

E

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

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

52

2-ACETYLPYRAZINE

E

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

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

53

2-ACETYLPYRIDINE

E

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

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

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

54

2-AMINO-2-METHYL-1-PROPANOL

E

Only for use in topical medicines for dermal application.

55

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

E

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

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

56

2-BUTEN-1-OL

E

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

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

57

2‑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%.

58

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%.

59

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%.

60

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%.

61

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%.

62

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%.

63

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%.

64

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%.

65

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%.

66

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%.

67

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%.

68

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%.

69

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%.

70

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%.

71

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%.

72

2-ETHYL METHYL BUTYRATE

E

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

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

73

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%.

74

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%.

75

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%.

76

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%.

77

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%.

78

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%.

79

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%.

80

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%.

81

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%.

82

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%.

83

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%.

84

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%.

85

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%.

86

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%.

87

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%.

88

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%.

89

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%.

90

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%.

91

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%.

92

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%.

93

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.

94

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%.

95

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%.

96

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%.

97

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%.

98

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%.

99

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%.

100

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%.

101

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%.

102

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%.

103

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%.

104

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%.

105

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%.

106

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%.

107

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%.

108

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%.

109

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%.

110

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%.

111

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%.

112

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%.

113

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%.

114

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%.

115

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%.

116

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%.

117

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%.

118

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%.

119

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%.

120

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%.

121

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%.

122

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%.

123

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%.

124

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%.

125

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%.

126

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%.

127

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%.

128

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.

129

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%.

130

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%.

131

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%.

132

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%.

133

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%.

134

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%.

135

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%.

136

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%.

137

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%.

138

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%.

139

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%.

140

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%.

141

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%.

142

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%.

143

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%.

144

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%.

145

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%.

146

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.

147

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%.

148

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%.

149

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%.

150

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%.

151

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%.

152

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.

153

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.

154

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%.

155

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%.

156

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%.

157

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%.

158

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%.

159

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%.

160

2,5-DIMETHYLPYRAZINE

E

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

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

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

161

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%.

162

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%.

163

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%.

164

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%.

165

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%.

166

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%.

167

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%.

168

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%.

169

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%.

170

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%.

171

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%.

172

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%.

173

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%.

174

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%.

175

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%.

176

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%.

177

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%.

178

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%.

179

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%.

180

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%.

181

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%.

182

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%.

183

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%.

184

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%.

185

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%.

186

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%.

187

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%.

188

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%.

189

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%.

190

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%.

191

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%.

192

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%.

193

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%.

194

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%.

195

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%.

196

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%.

197

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%.

198

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%.

199

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%.

200

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%.

201

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%.

202

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%.

203

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%.

204

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%.

205

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%.

206

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%.

207

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%.

208

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%.

209

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%.

210

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%.

211

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%.

212

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%.

213

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%.

214

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%.

215

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%.

216

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%.

217

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%.

218

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%.

219

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%.

220

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%.

221

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%.

222

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%.

223

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%.

224

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%.

225

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%.

226

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%.

227

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%.

228

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%.

229

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%.

230

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%.

231

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%.

232

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%.

233

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%.

234

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%.

235

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%.

236

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%.

237

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%.

238

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%.

239

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%.

240

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%.

241

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%.

242

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%.

243

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%.

244

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%.

245

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%.

246

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%.

247

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%.

248

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%.

249

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%.

250

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%.

251

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%.

252

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%.

253

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%.

254

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%.

255

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%.

256

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%.

257

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%.

258

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%.

259

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%.

260

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%.

261

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%.

262

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

E

263

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%.

264

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%.

265

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%.

266

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%.

267

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%.

268

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%.

269

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%.

270

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%.

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

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%.

274

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%.

275

ABELMOSCHUS MOSCHATUS

A,H

276

ABELMOSCHUS MOSCHATUS SUBSP. MOSCHATUS

A,H

277

ABIES BALSAMEA

A,H

278

ABIES NIGRA

A,H

279

ABIES PECTINATA

A,H

280

ABIES SIBIRICA

A,H

281

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.

282

ABSIDIA RAMOSA

A,H

283

ABUTILON THEOPHRASTI

A,H

284

ACACIA

A,E,H

285

ACACIA BAILEYANA

A,H

286

ACACIA CATECHU

A,H

287

ACACIA DEALBATA

A,H

288

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%.

289

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%.

290

ACACIA LONGIFOLIA

A,E,H

291

ACACIA NILOTICA

A,E,H

292

ACACIA SENEGAL

A,E,H

293

ACALYPHA INDICA

A,H

294

ACANTHUS MOLLIS

A,H

295

ACER CAMPESTRE

A,H

296

ACER NEGUNDO

A,H

297

ACER SACCHARINUM

A,H

298

ACER SACCHARUM

A,E,H

299

ACEROLA

E

300

ACESULFAME POTASSIUM

E

301

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%.

302

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%.

303

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%.

304

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%.

305

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%.

306

ACETANISOLE

E

Only for use in topical medicines for dermal application.

307

ACETIC ACID

E,H

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

308

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%.

309

ACETOMENAPHTHONE

A,E

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

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

310

ACETONE

E

The residual solvent limit for Acetone is 50 mg per maximum recommended daily dose.

311

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%.

312

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%.

313

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%.

314

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%.

315

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'

316

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%.

317

ACETYL LEVOCARNITINE HYDROCHLORIDE

A,E

318

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%.

319

ACETYLATED LANOLIN

E

Only for use in topical medicines for dermal application.

320

ACETYLATED LANOLIN ALCOHOL

E

Only for use in topical medicines for dermal application.

321

ACETYLATED MONOGLYCERIDES

E

322

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%.

323

ACETYLCYSTEINE

E

Only for use in topical medicines for dermal application.

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

324

ACHILLEA ERBA-ROTTA SUBSP. MOSCHATA

A,H

325

ACHILLEA MILLEFOLIUM

A,E,H

326

ACHILLEA PTARMICA

A,H

327

ACHYRANTHES ASPERA

A,H

328

ACHYRANTHES BIDENTATA

A,H

329

ACHYRANTHES FAURIEI

A,H

330

ACID-ISOMERISED LINALOOL

E

331

ACID GREEN 25

E

Permitted for use as a colour for topical use.

332

ACID RED 33

E

Permitted for use as a colour for topical use.

333

ACID RED 87

E,H

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

334

ACID TREATED WAXY MAIZE STARCH

E

335

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.

336

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.

337

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.

338

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.

339

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%.

340

ACRYLAMIDES COPOLYMER

E

Only for use in topical medicines for dermal application.

341

ACRYLATES COPOLYMER

E

Only for use in topical medicines for dermal application.

342

ACRYLATES/ACRYLAMIDE COPOLYMER

E

Only for use in topical medicines for dermal application.

343

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

E

Only for use in topical medicines for dermal application.

344

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%.

345

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%.

346

ACRYLATES/OCTYLACRYLAMIDE COPOLYMER

E

Only for use in topical medicines for dermal application.

347

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%.

348

ACRYLATES/VA COPOLYMER

E

Only for use in topical medicines for dermal application.

349

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%.

350

ACTAEA CIMICIFUGA

A,H

351

ACTAEA HERACLEIFOLIA

A,H

352

ACTAEA PACHYPODA

A,H

353

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.'

354

ACTAEA SIMPLEX

A,H

355

ACTAEA SPICATA

A,H

356

ACTINIDIA CHINENSIS

A,H

357

ACTINIDIA DELICIOSA

A,H

358

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.

359

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).

360

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)'

361

ADEMETIONINE DISULFATE TOSYLATE

A,H

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

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

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

362

ADEMETIONINE DISULFATE TRITOSYLATE DIHYDRATE

A,H

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

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

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

363

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)'

364

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)'

365

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)'

366

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)'

367

ADEMETIONINE TETRASULFATE DIHYDRATE

A,H

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

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

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

368

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)'

369

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)'

370

ADENOPHORA STRICTA

A,H

371

ADENOPHORA TRIPHYLLA

A,H

372

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%.

373

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%.

374

ADENOSINE TRIPHOSPHATE

E

Only for use in topical medicines for dermal application.

375

ADENOSINE TRIPHOSPHATE DISODIUM

E

Only for use in topical medicines for dermal application.

376

ADIANTUM CAPILLUS-VENERIS

A,H

377

ADIPIC ACID

E

378

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%.

379

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%.

380

ADRENALINE (EPINEPHRINE)

H

Only for use as an active homoeopathic ingredient.

381

ADZUKI BEAN

E

382

AEGOPODIUM PODAGRARIA

A,H

383

AESCULUS CHINENSIS

A,H

384

AESCULUS GLABRA

A,H

385

AESCULUS HIPPOCASTANUM

A,H

386

AESCULUS X CARNEA

A,H

387

AETHUSA CYNAPIUM

H

Only for use as an active homoeopathic ingredient.

388

AGAR

A,E

389

AGASTACHE RUGOSA

A,H

390

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%.

391

AGAVE AMERICANA

A,E,H

392

AGRIMONIA EUPATORIA

A,E,H

393

AGRIMONIA REPENS

A,H

394

AGROSTIS TENUIS

A,H

395

AILANTHUS ALTISSIMA

A,H

396

AJUGA CHAMAEPITYS

A,H

397

AJUGA REPTANS

A,H

398

ALANINE

A,E

399

ALANYLGLUTAMINE

A

Only for use in oral medicines.

400

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.

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

401

ALBIZIA JULIBRISSIN

A,H

402

ALBIZIA LEBBECK

A,H

403

ALCEA ROSEA

A,H

404

ALCHEMILLA ALPINA

A,H

405

ALCHEMILLA ARVENSIS

A,H

406

ALCHEMILLA VULGARIS

A,H

407

ALETRIS FARINOSA

A,H

408

ALETRIS SPICATA

A,H

409

ALEURITES MOLUCCANUS SEED OIL

E

Only for use in topical medicines for dermal application.

410

ALFADEX

A

Only for use in oral medicines.

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

411

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).

412

ALGINIC ACID

E

413

ALISMA ORIENTALE

A,H

414

ALISMA PLANTAGO AQUATICA

A,H

415

ALKANNA TINCTORIA

A,H

416

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%.

417

ALLANTOIN

E

Only for use in topical medicines for dermal application.

418

ALLIARIA PETIOLATA

A,H

419

ALLIUM CEPA

A,H

420

ALLIUM FISTULOSUM

A,H

421

ALLIUM HIEROCHUNTINUM

A,H

422

ALLIUM MACROSTEMON

A,H

423

ALLIUM ODORUM

A,H

424

ALLIUM PORRUM

A,H

425

ALLIUM SATIVUM

A,E,H

426

ALLIUM SCHOENOPRASUM

A,H

427

ALLIUM URSINUM

A,H

428

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%.

429

ALLURA RED AC

E

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

430

ALLURA RED AC ALUMINIUM LAKE

E

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

431

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%.

432

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%.

433

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%.

434

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%.

435

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%.

436

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%.

437

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%.

438

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%.

439

ALLYL ISOTHIOCYANATE

E

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

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

440

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%.

441

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%.

442

ALMOND

E

443

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%.

444

ALNUS GLUTINOSA

A,H

445

ALNUS INCANA SUBSP. RUGOSA

A,H

446

ALOE BARBADENSIS

A,E

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

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'

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

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect)

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

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect)

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect)

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'

- (LAX4) 'This product may have laxative effect'

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'

- (LAX1) 'Drink plenty of water' (or words to that effect)

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

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

447

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]'

448

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]'

449

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]'

450

ALOES BARBADOS

A,H

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

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'

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

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product [or words to that effect]'

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

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water [or words to that effect]'

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'

- (LAX4) 'This product may have laxative effect'

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'

- (LAX1) 'Drink plenty of water [or words to that effect]'

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

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

451

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]'

452

ALOYSIA CITRODORA

A,H

453

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.'

454

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%.

455

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%.

456

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%.

457

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%.

458

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%.

459

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%.

460

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%.

461

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%.

462

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%.

463

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%.

464

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%.

465

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%.

466

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%.

467

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%.

468

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%.

469

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%.

470

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%.

471

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%.

472

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%.

473

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%.

474

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%.

475

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%.

476

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%.

477

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%.

478

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%.

479

ALPHA LIPOIC ACID

A

480

ALPINIA GALANGA

A,H

481

ALPINIA HAINANENSIS

A,H

482

ALPINIA OFFICINARUM

A,H

483

ALPINIA OXYPHYLLA

A,H

484

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.

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

485

ALSTONIA BOONEI

A,H

486

ALSTONIA CONSTRICTA

H

Only for use as an active homoeopathic ingredient.

487

ALTERNANTHERA PHILOXEROIDES

A,H

488

ALTERNARIA ALTERNATA

A,H

489

ALTHAEA OFFICINALIS

A,E,H

490

ALUM DODECAHYDRATE

A,E,H

491

ALUMINIUM CHLOROHYDRATE

E

Only for use in topical medicines for dermal application.

492

ALUMINIUM CITRATE

E

Only for use in topical medicines for dermal application.

493

ALUMINIUM DISTEARATE

E

Only for use in topical medicines for dermal application.

494

ALUMINIUM HYDROXIDE

E

Only for use in topical medicines for dermal application.

495

ALUMINIUM HYDROXIDE HYDRATE

E

Only for use in topical medicines for dermal application.

496

ALUMINIUM MAGNESIUM SILICATE

E

497

ALUMINIUM MONOSTEARATE

E

Only for use in topical medicines for dermal application.

498

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.

499

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.

500

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).’

501

ALUMINIUM STARCH OCTENYLSUCCINATE

E

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

502

ALUMINIUM STEARATE

E

Only for use in topical medicines for dermal application.

503

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%.

504

AMARANTH

E

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

505

AMARANTH ALUMINIUM LAKE

E

Permitted for use as a colour for oral and topical use

506

AMARANTHUS HYBRIDUS

A,H

507

AMARANTHUS RETROFLEXUS

A,H

508

AMBERGRIS EXTRACT

E

509

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%.

510

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%.

511

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%.

512

AMBROSIA ARTEMISIIFOLIA

A,H

513

AMBROSIA PSILOSTACHYA

A,H

514

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%.

515

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%.

516

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%.

517

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%.

518

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%.

519

AMMONIO METHACRYLATE COPOLYMER

E

Only for use in oral medicines.

520

AMMONIUM ACRYLATES COPOLYMER

E

Only for use in topical medicines for dermal application.

521

AMMONIUM ACRYLATES/ACRYLONITROGENS COPOLYMER

E

Only for use in topical medicines for dermal application.

522

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%.

523

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%.

524

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.

525

AMMONIUM BROMIDE

H

Only for use as an active homoeopathic ingredient.

526

AMMONIUM CARBONATE

E,H

Only for use as an active homoeopathic or excipient ingredient.

527

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.

528

AMMONIUM GLYCYRRHIZINATE

E

529

AMMONIUM IODIDE

H

Only for use an active ingredient in homoeopathic medicines.

530

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%.

531

AMMONIUM LAURETH SULFATE

E

Only for use in topical medicines for dermal application.

532

AMMONIUM LAURYL SULFATE

E

Only for use in topical medicines for dermal application.

533

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%.

534

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%.

535

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%.

536

AMOMUM AROMATICUM

A,H

537

AMOMUM VILLOSUM

A,H

538

AMORPHOPHALLUS KONJAC

A,H

Only for use when the dosage form is not tablet.

539

AMPELODESMOS MAURITANICUS

A,H

540

AMPELOPSIS JAPONICA

A,H

541

AMYL ACETATE

E

Only for use in topical medicines for dermal application.

542

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%.

543

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%.

544

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%.

545

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%.

546

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%.

547

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%.

548

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%.

549

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%.

550

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%.

551

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%.

552

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%.

553

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%.

554

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%.

555

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%.

556

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%.

557

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%.

558

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.

559

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%.

560

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%.

561

AMYRIS BALSAMIFERA

A,H

562

AMYRIS OIL WEST INDIAN

A,E,H

563

ANACARDIUM OCCIDENTALE

A,H

564

ANACYCLUS PYRETHRUM

A,H

565

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%.

566

ANAESTHETIC ETHER

H

Only for use as an active homoeopathic ingredient.

567

ANAGALLIS ARVENSIS

A,H

568

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%.

569

ANANAS COMOSUS

A,E,H

570

ANAPHALIS SINICA

A,H

571

ANDROGRAPHIS PANICULATA

A,H

572

ANEMARRHENA ASPHODELOIDES

A,E,H

573

ANEMONE ALTAICA

A,H

574

ANEMONE CHINENSIS

A,H

575

ANEMONE HEPATICA

A,H

576

ANEMONE PULSATILLA

A,H

577

ANEMONE RADDEANA

A,H

578

ANETHOLE

E

579

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%.

580

ANETHUM GRAVEOLENS

A,E,H

581

ANGELICA ACUTILOBA

A,H

582

ANGELICA ANOMALA

A,H

583

ANGELICA ARCHANGELICA

A,E,H

584

ANGELICA ATROPURPUREA

A,H

585

ANGELICA DAHURICA

A,E,H

586

ANGELICA DECURSIVA

A,H

587

ANGELICA POLYMORPHA

A,E,H

588

ANGELICA PUBESCENS

A,E,H

589

ANGELICA ROOT DRY

A,H

590

ANGELICA ROOT OIL

A,E,H

591

ANGELICA SEED OIL

A,E,H

592

ANGELICA STEM

E

593

ANIBA ROSAEODORA

A,E,H

594

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%.

595

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%.

596

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)'

597

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%.

598

ANISEED DRY

A,E,H

599

ANISEED POWDER

A,E,H

600

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%.

601

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%.

602

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%.

603

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%.

604

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%.

605

ANNATTO

E

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

606

ANOGEISSUS LATIFOLIA

A,E,H

607

ANTENNARIA DIOICA

A,E,H

608

ANTHOCYANINS

E

609

ANTHOXANTHUM ODORATUM

A,H

610

ANTHRISCUS CEREFOLIUM

A,H

611

ANTHYLLIS VULNERARIA

A,H

612

ANTIMONY POTASSIUM TARTRATE TRIHYDRATE

H

Only for use as an active homoeopathic ingredient.

613

ANTIMONY TRISULFIDE

H

Only for use as an active homoeopathic ingredient.

614

APIUM GRAVEOLENS

A,E,H

615

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%.

616

APOMORPHINE HYDROCHLORIDE HEMIHYDRATE

H

Only for use as an active homoeopathic ingredient.

617

APPLE

E

618

APPLE CIDER VINEGAR

E

619

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%.

620

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%.

621

APPLE FIBRE

E

622

APRICOT

E

623

APRICOT KERNEL OIL PEG-6 ESTERS

E

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

624

AQUILARIA MALACCENSIS

A,H

625

AQUILARIA SINENSIS

A,H

626

AQUILEGIA VULGARIS

A,H

627

ARACHIDONIC ACID

E

Only for use in topical medicines for dermal application.

628

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%.

629

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%.

630

ARACHIDYL PROPIONATE

E

Only for use in topical medicines for dermal application.

631

ARACHIS HYPOGAEA

A,E,H

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

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

632

ARACHIS OIL

A,E,H

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

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

633

ARALIA CORDATA

A,H

634

ARALIA HISPIDA

A,H

635

ARALIA NUDICAULIS

A,H

636

ARALIA RACEMOSA

A,H

637

ARCTIUM LAPPA

A,E,H

638

ARCTIUM MINUS

A,H

639

ARCTOSTAPHYLOS UVA-URSI

A,E,H

640

ARDISIA JAPONICA

A,H

641

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%.

642

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.

643

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.'

644

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%.

645

ARISAEMA ATRORUBENS

A,H

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

646

ARISAEMA CONSANGUINEUM

A,H

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

647

ARISAEMA JAPONICUM

A,H

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

648

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).

649

ARNEBIA EUCHROMA

A,H

650

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.

651

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.

652

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.

653

ARRHENATHERUM ELATIUS

A,H

654

ARROWROOT

A,E,H

655

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%.

656

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%.

657

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%.

658

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%.

659

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%.

660

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%.

661

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%.

662

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%.

663

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%.

664

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%.

665

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%.

666

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%.

667

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%.

668

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%.

669

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%.

670

ARTERY

H

Only for use as an active homoeopathic ingredient.

671

ARTHROSPIRA MAXIMA

A,H

672

ARTHROSPIRA PLATENSIS

A,H

673

ARUM MACULATUM

A,H

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

674

ASAFOETIDA GUM

A,H

675

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%.

676

ASARUM EUROPAEUM

A,H

677

ASARUM HETEROTROPOIDES

A,H

678

ASARUM OIL

E

679

ASARUM SIEBOLDII

A,E,H

680

ASCLEPIAS TUBEROSA

A,H

681

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.

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

682

ASCORBIC ACID

A,E

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

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

683

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%.

684

ASCORBYL METHYLSILANOL PECTINATE

E

Only for use in topical medicines for dermal application.

685

ASCORBYL PALMITATE

A,E

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

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

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

686

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%.

687

ASPALATHUS LINEARIS

A,E,H

688

ASPARAGINE

A,E

689

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%.

690

ASPARAGUS

E,H

Only for use as an active homoeopathic or excipient ingredient.

691

ASPARAGUS COCHINCHINENSIS

A,H

692

ASPARAGUS OFFICINALIS

A,E,H

693

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.

694

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'

695

ASPARTIC ACID

A,E

696

ASPERGILLUS ORYZAE

A,E,H

697

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).

698

ASTER NOVI-BELGII

A,H

699

ASTER TATARICUS

A,H

700

ASTRAGALUS ADSURGENS

A,H

701

ASTRAGALUS COMPLANATUS

A,H

702

ASTRAGALUS EXCARPUS

A,H

703

ASTRAGALUS GUMMIFER

A,E,H

704

ASTRAGALUS LENTIGINOSUS

A,H

705

ASTRAGALUS MEMBRANACEUS

A,E,H

706

ASTRAGALUS PENDULIFLORUS

A,H

707

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%.

708

ATRACTYLODES JAPONICA

A,H

709

ATRACTYLODES LANCEA

A,H

710

ATRACTYLODES MACROCEPHALA

A,H

711

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%.

712

ATROPINE SULFATE MONOHYDRATE

H

Only for use as an active homoeopathic ingredient.

713

ATTALEA SPECIOSA

E

Only for use in topical medicines for dermal application.

714

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%.

715

AUREOBASIDIUM PULLULANS

A,H

716

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.

717

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.

718

AVOCADO

E

719

AVOCADO OIL

E

720

AVOCADO OIL UNSAPONIFIABLES

E

Only for use in topical medicines for dermal application.

721

AZADIRACHTA INDICA

A,H

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

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

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

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

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

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

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

722

AZOVAN BLUE

E

Permitted for use as a colour for topical use.

723

AZULENE

E

Only for use in topical medicines for dermal application.
4891 TREFRIW WELLS MINERAL WATER A When for internal use, iron is a mandatory component of Trefriw Wells mineral water.
Solid dosage forms containing more than 5 milligrams of elemental iron in each dosage unit are required to have a child resistant closure.
Liquid Preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.
Only able to be used when presented in single use sachets for therapeutic use as an iron supplement.
The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use.
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.
The percentage of potassium from tribasic potassium phosphate should be calculated based on the molecular weight 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.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.
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-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%.
4938 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%.
4939 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%.
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 requirement(s) applying to the ingredient in Column 2
4981 UBIDECARENONE A,E When used as an excipient, the route of administration must be topical.
Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
When used as an excipient, the concentration in a medicine must be no more than 0.05%.
The maximum recommended daily dose must provide no more than 300 milligrams of ubidecarenone.
When used in combination with Ubiquinol‑10, the maximum recommended daily dose must provide no more than 300 milligrams of ubiquinol‑10 and ubidecarenone combined.
The medicine requires the following warning statement on the medicine label:
‑ (WARF) 'Do not take while on warfarin therapy without medical advice.'
4982 UBIQUINOL-10 A Only for use in oral medicines.
The maximum recommended daily dose must provide no more than 300 mg of ubiquinol-10.
When used in combination with ubidecarenone, the maximum recommended daily dose must provide no more than 300 mg of ubiquinol-10 and ubidecarenone combined.
requires the following warning statement on the medicine label:
- (WARF) 'Do not take while on warfarin therapy without medical advice.'
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 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 UNCARIA GAMBIR A,H
4995 UNCARIA RHYNCOPHYLLA A,H
4996 UNCARIA SINENSIS A,H
4997 UNCARIA TOMENTOSA A,H
4998 UNDARIA PINNATIFIDA A,H Whole dried Undaria pinnatifida must not contain the holdfast.
Only for use in oral medicines.
4999 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%.
5000 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%.
5001 UNDECENOIC ACID E
5002 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%.
5003 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%.
5004 UNDECYLENAMIDE DEA E
5005 UNDECYLENOYL PEG-5 PARABEN E Only for use in topical medicines for dermal application.
5006 URANIUM NITRATE H Only for use as an active homoeopathic ingredient. 
5007 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).
5008 URTICA DIOICA A,E,H
5009 URTICA URENS A,H
5010 USNEA BARBATA A,H
5011 UVA URSI LEAF DRY A,H
5012 UVA URSI LEAF POWDER A,E,H
5013 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%.
5014 VACCARIA SEGATALIS A,H
5015 VACCINIUM BRACTEATUM A,H
5016 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%.
5017 VACCINIUM MACROCARPON A,E,H
5018 VACCINIUM MYRTILLOIDES A,H
5019 VACCINIUM MYRTILLUS A,E,H
5020 VACCINIUM OXYCOCCUS A,H
5021 VACCINIUM VITIS-IDAEA A,H
5022 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%.
5023 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%.
5024 VALERIAN DRY A,H
5025 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%.
5026 VALERIAN POWDER A,H
5027 VALERIANA EDULIS A,H
5028 VALERIANA OFFICINALIS A,H
5029 VALERIANA SORBIFOLIA A,H
5030 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%.
5031 VALINE A,E
5032 VANADIUM H
5033 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%.
5034 VANILLA DRY A,E,H
5035 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%.
5036 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%.
5037 VANILLA PLANIFOLIA A,E,H
5038 VANILLA POWDER A,E,H
5039 VANILLA TAHITENSIS A,H
5040 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%.
5041 VANILLIN E Permitted for use as a flavour.
5042 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%.
5043 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%.
5044 VAT RED 1 E Permitted for use as a colour for topical use.
5045 VAT RED 1 ALUMINIUM LAKE E Permitted for use as a colour for topical use.
5046 VAT RED 5 E Permitted for use as a colour for topical use.
5047 VEGETABLE OIL E
5048 VEGETABLE OIL PHYTOSTEROL ESTERS A Only for use in oral medicines.
The medicine requires the following warning statements on the medicine label:
- (VOPE) 'There is no benefit from taking more than 3g/day of phytosterols from all sources'
- (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect).
5049 VEIN H Only for use as an active homoeopathic ingredient.
5050 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%.
5051 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%.
5052 VERBASCUM DENSIFLORUM A,H
5053 VERBASCUM THAPSUS A,H
5054 VERBENA OFFICINALIS A,H
5055 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%.

5056 VERONICA CHAMAEDRYS A,H
5057 VERONICA OFFICINALIS A,H
5058 VERONICASTRUM VIRGINICUM A,E,H
5059 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%.
5060 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%.
5061 VIBURNUM OPULUS A,E,H
5062 VIBURNUM PRUNIFOLIUM A,E,H
5063 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%.
5064 VIGNA ANGULARIS VAR. ANGULARIS A,H
5065 VIGNA RADIATA A,H
5066 VIGNA UMBELLATA A,H
5067 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%.
5068 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%
5069 VINCETOXICUM OFFICINALE A,H
5070 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%.
5071 VIOLA ODORATA A,E,H
5072 VIOLA TRICOLOR A,H
5073 VIOLA YEDOENSIS A,H
5074 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%.
5075 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%.
5076 VIPER H Only for use as an active homoeopathic ingredient. 
5077 VISCUM ALBUM A,E,H
5078 VISCUM COLORATUM A,H
5079 VISCUM FLAVESCENS A,H
5080 VITELLARIA PARADOXA A,E,H
5081 VITEX AGNUS-CASTUS A,E,H
5082 VITEX NEGUNDO A,H
5083 VITEX ROTUNDIFOLIA A,H
5084 VITEX TRIFOLIA A,H
5085 VITIS VINIFERA A,E,H
5086 VITREOSCILLA CONCENTRATE E Only for use in topical medicines for dermal application.
The concentration in the medicine must be no more than 0.1%.
5087 WAHLENBERGIA GRACILIS A,H
5088 WALNUT E
5089 WALNUT OIL E
5090 WATER MELON E
5091 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.
5092 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.
5093 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.
5094 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.
5095 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.
5096 WHEAT LEAF E
5097 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.
5098 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).
5099 WHEATGERM OIL A,E,H
5100 WHEY POWDER E Lactose is a mandatory component of Whey powder when the route of administration is oral.
5101 WHEY PROTEIN E Lactose is a mandatory component of Whey protein when the route of administration is oral.
5102 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%.
5103 WHITE BEESWAX E
5104 WHITE HOREHOUND HERB DRY A,H
5105 WHITE HOREHOUND HERB POWDER A,H
5106 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.
5107 WIKSTROEMIA VIRIDIFLORA A,H
5108 WILD CARROT HERB DRY A,E,H
5109 WILD CARROT HERB POWDER A,H
5110 WILD CHERRY BARK DRY A,H
5111 WILD CHERRY BARK POWDER A,H
5112 WILD LETTUCE LEAF DRY A,H
5113 WILD LETTUCE LEAF POWDER A,H
5114 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.
5115 WITHANIA SOMNIFERA A,E,H
5116 WOOL ALCOHOLS E Only for use in topical medicines for dermal application.
5117 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.
5118 XANTHAN GUM E
5119 XANTHIUM SIBIRICUM A,H
5120 XANTHIUM STRUMARIUM A,H
5121 XANTHOMONA CAMPESTRIS A,H
5122 XEROPHYLLUM ASPHODELOIDES A,H
5123 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%.
5124 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]’.
5125 XYLOSE E
5126 YAM E
5127 YARROW HERB DRY A,H
5128 YARROW HERB POWDER A,H
5129 YEAST AUTOLYSATE E
5130 YEAST DRIED A,E,H
5131 YELLOW 2G E Permitted for use as a colour for topical use.
5132 YELLOW BEESWAX E
5133 YELLOW MERCURIC OXIDE H Only for use as an active homoeopathic ingredient.
5134 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.
5135 YLANG YLANG OIL A,E,H
5136 YUCCA BACCATA A,H
5137 YUCCA ELATA A,H
5138 YUCCA FILAMENTOSA A,H
5139 YUCCA GLORIOSA A,H
5140 YUCCA WHIPPLEI A,H
5141 ZANTHOXYLUM AMERICANUM A,H
5142 ZANTHOXYLUM BUNGEANUM A,E,H
5143 ZANTHOXYLUM CLAVA-HERCULIS A,H
5144 ZANTHOXYLUM NITIDUM A,H
5145 ZANTHOXYLUM PIPERITUM A,H
5146 ZANTHOXYLUM SIMULANS A,H
5147 ZEA MAYS A,E,H
5148 ZEAXANTHIN A,E
5149 ZEIN E
5150 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)'.
5151 ZINC AMINO ACID CHELATE A,E,H When used internally, zinc is a mandatory component of zinc amino acid chelate.
The concentration of zinc in zinc amino acid chelate must be no more than 30%.
The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use.
5152 ZINC ASCORBATE A,E,H When used internally, zinc is a mandatory component of zinc ascorbate.
The percentage of zinc from zinc ascorbate should be calculated based on the molecular weight of zinc ascorbate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.  
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.
5153 ZINC ASCORBATE MONOHYDRATE A,E,H When used internally, zinc is a mandatory component of zinc ascorbate monohydrate.
The percentage of zinc from Zinc ascorbate monohydrate should be calculated based on the molecular weight of Zinc ascorbate monohydrate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5154 ZINC CHLORIDE A,E,H The concentration of zinc chloride in the medicine must be no more than 5%.
When used internally, zinc is a mandatory component of zinc chloride. The percentage of zinc from zinc chloride should be calculated based on the molecular weight of zinc chloride.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.           
5155 ZINC CITRATE A,E,H When used internally, zinc is a mandatory component of zinc citrate . The percentage of zinc from zinc citrate should be calculated based on the molecular weight of zinc citrate .
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.                 
5156 ZINC CITRATE DIHYDRATE A,E,H When used internally, zinc is a mandatory component of zinc citrate dihydrate.
The percentage of zinc from zinc citrate dihydrate should be calculated based on the molecular weight of zinc citrate dihydrate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.           
5157 ZINC CITRATE TRIHYDRATE A,E,H When used internally, zinc is a mandatory component of zinc citrate trihydrate. The percentage of zinc from Zinc citrate trihydrate should be calculated based on the molecular weight of Zinc citrate trihydrate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5158 ZINC DIASPARTATE A When used internally, zinc is a mandatory component of zinc diaspartate and availability is restricted to use as a source of the relevant mineral only.
The percentage of zinc from Zinc diaspartate should be calculated based on the molecular weight of Zinc diaspartate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
5159 ZINC GLUCONATE A,E,H When used internally, zinc is a mandatory component of zinc gluconate.
The percentage of zinc from Zinc gluconate should be calculated based on the molecular weight of Zinc gluconate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5160 ZINC GLYCINATE A When used internally, zinc is a mandatory component of Zinc glycinate and availability is restricted to use as a source of the relevant mineral only.
The percentage of zinc from Zinc glycinate should be calculated based on the molecular weight of Zinc glycinate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5161 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'.
5162 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'.
5163 ZINC LYSINATE A When used internally, zinc is a mandatory component of Zinc lysinate and availability is restricted to use as a source of the relevant mineral only.
The percentage of zinc from Zinc lysinate should be calculated based on the molecular weight of Zinc lysinate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5164 ZINC METHIONINE SULFATE A For topical use, the concentration of zinc sulfate must be no more than 5%.
When used internally, zinc is a mandatory component of Zinc methionine sulfate and availability is restricted to use as a source of the relevant mineral only.
The percentage of zinc from Zinc methionine sulfate should be calculated based on the molecular weight of Zinc methionine sulfate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5165 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%.
5166 ZINC OXIDE A,E,H When used internally, zinc is a mandatory component of zinc oxide.
The percentage of zinc from zinc oxide should be calculated based on the molecular weight of zinc oxide.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.
5167 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-phenolsulfonate.
The percentage of zinc from zinc para-phenolsulfonate should be calculated based on the molecular weight of zinc para-phenolsulfonate.
5168 ZINC STEARATE E When used internally, zinc is a mandatory component of Zinc stearate.
The percentage of zinc from zinc stearate should be calcuated based on the molecular weight of zinc stearate.
5169 ZINC SUCCINATE A,E,H When used internally, zinc is a mandatory component of zinc succinate.
The percentage of zinc from Zinc succinate should be calculated based on the molecular weight of Zinc succinate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5170 ZINC SULFATE A,E For topical use, the concentration of zinc sulfate must be no more than 5%.
For internal use, zinc is a mandatory component of zinc sulfate.
The percentage of zinc from Zinc sulfate should be calculated based on the molecular weight of Zinc sulfate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5171 ZINC SULFATE HEPTAHYDRATE A,E For topical use, the concentration of zinc sulfate must be no more than 5%.
For internal use, zinc is a mandatory component of zinc sulfate heptahydrate.
The percentage of zinc from Zinc sulfate heptahydrate should be calculated based on the molecular weight of Zinc sulfate heptahydrate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5172 ZINC SULFATE HEXAHYDRATE A,E,H For topical use, the concentration of zinc sulfate must be no more than 5%.
For internal use, zinc is a mandatory component of zinc sulfate hexahydrate.
The percentage of zinc from Zinc sulfate heptahydrate should be calculated based on the molecular weight of Zinc sulfate hexahydrate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5173 ZINC SULFATE MONOHYDRATE A,E,H When the route of administration is topical the concentration of zinc sulfate in the medicine must be no more than 5%.
When the medicine is for internal use, zinc is a mandatory component of zinc sulfate monohydrate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  
5174 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.
5175 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%.
5176 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'
5177 ZIZIPHUS JUJUBA A,H
5178 ZIZIPHUS JUJUBA VAR. SPINOSA A,H
5179 ZIZYPHUS SATIVA A,H
5180 ZOSTERA MARINA A,H
5181 ZUCCHINI E
Actions
Download as PDF Download as Word Document
Cases Citing This Decision

0

Cases Cited

0

Statutory Material Cited

0