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Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018

made under subsection 26BB(1) of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date: 11 April 2018

Includes amendments up to: F2018L00476

 

This compilation is in 6 volumes

Volume 1: section 1–3, Schedule 1, Parts 1 and 2 (items 1–728)

Volume 2: Schedule 1, Part 2 (items 729–2135)

Volume 3: Schedule 1, Part 2 (items 2136—2812)

Volume 4: Schedule 1, Part 2 (items 2813–3598)

Volume 5: Schedule 1, Part 2 (items 3599–5010)

Volume 6: Schedule 1, Part 2 (items 5011–5216)

Each volume has its own contents

 

 

 

 

 

 

Prepared by the Department of Health, Canberra

 

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 20188 that shows the text of the law as amended and in force on 11 April 2018 (the compilation date).

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

Uncommenced amendments

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

Application, saving and transitional provisions for provisions and amendments

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

Editorial changes

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

Modifications

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

Self-repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

 

 

 

1  Name of Determination

  This Determination is the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2018.

2  Commencement

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

3  Interpretation

In this Determination:

Act means the Therapeutic Goods Act 1989.

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

European Pharmacopoeia is as defined under the Act.

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

4  Permissible ingredients and requirements applying to those ingredients

Permissible ingredients and requirements applying to those ingredients under Table 1

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

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

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

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

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

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

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

 

Note:  Examples of these acronyms are:

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

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

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

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

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

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

(section 4)

Part 1—Interpretation of Table 1

 

Definitions

 

At Table 1:

 

“A” means an active ingredient.

Act means the Therapeutic Goods Act 1989.

Active ingredient is as defined in the Regulations.

British Pharmacopoeia is as defined under the Act.

“E” means an excipient.

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

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

“H” means a homoeopathic preparation ingredient.

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

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

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

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

(ii)   serial trituration in lactose.

Mother tincture is as defined in the Regulations.

Regulations means the Therapeutic Goods Regulations 1990.

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


Part 2 – Table 1

Column 1

Column 2

Ingredient Name

Column 3

Purpose of the ingredient in the medicine

Column 4

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

1

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

E

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

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

 

2

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

E

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

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

 

3

(5E)-3-METHYL-5-CYCLOTETRADECEN-1-ONE

E

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

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

 

 

4

(5Z)-3-METHYL-5-CYCLOTETRADECEN-1-ONE

E

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

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

 

5

(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%.

 

6

(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%.

 

7

(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%.

 

8

(S)- LACTIC ACID

A, E, H

 

9

(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)'

 

10

(S)-S-ADENOSYLMETHIONINE DISULFATE TOSYLATE

A

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

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

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

 

11

(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)'

 

12

(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)'

 

13

(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)'

 

14

(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)'

 

15

(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)'

 

16

(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)'

 

17

(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)'

 

18

(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)'

 

19

(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%.

 

20

(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%.

 

21

(±)-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%.

 

22

1,1,1-TRICHLOROETHANE

E

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

 

23

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%.

 

24

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%.

 

25

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%.

 

26

1,3-BUTYLENE GLYCOL

E

 

27

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%.

 

28

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%.

 

29

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%

 

30

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%.

 

31

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%.

 

32

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%.

 

33

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%.

 

34

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%.

 

35

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%.

 

36

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%.

 

37

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%.

 

38

1-DODECANOL

E

Permitted for use:

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

(b) in topical medicines for dermal application.

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

 

39

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%.

 

40

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%.

 

41

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%.

 

42

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%.

 

43

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%.

 

44

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%.

 

45

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%.

 

46

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%.

 

47

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%.

 

48

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%.

 

49

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%.

 

50

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%.

 

51

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%.

 

52

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%.

 

53

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%.

 

 

54

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%.

 

55

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%.

 

56

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%.

 

57

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%.

 

58

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%.

 

59

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%.

 

60

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%.

 

61

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%.

 

62

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%.

 

 

63

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%.

 

64

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%.

 

65

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%.

 

66

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%.

 

67

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%.

 

68

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.

 

69

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%.

 

70

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%.

 

71

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%.

 

72

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%.

 

73

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%.

 

74

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.

 

75

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.

 

76

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%.

 

77

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%.

 

78

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%.

 

79

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%.

 

80

2,5-DIMETHYLPYRAZINE

E

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

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

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

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

 

 

81

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%.

 

82

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%.

 

83

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%.

 

84

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%.

 

85

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%.

 

86

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%.

 

87

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%.

 

88

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%.

 

89

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%.

 

90

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%.

 

91

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%.

 

92

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%.

 

93

2-(2-METHYLPHENYL)ETHANOL

E

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

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

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

 

94

2-[(3,7-DIMETHYL-6-OCTEN-1-YLIDENE)AMINO]BENZOIC ACID, METHYL ESTER

E

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

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

 

95

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%.

 

96

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%.

 

97

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%.

 

98

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%.

 

99

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%.

 

100

2-AMINO-2-METHYL-1-PROPANOL

E

Only for use in topical medicines for dermal application.

 

101

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%.

 

102

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%.

 

103

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%.

 

 

104

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%.

 

105

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%.

 

106

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%.

 

107

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%.

 

108

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%.

 

109

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%.

 

110

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%.

 

111

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%.

 

112

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%.

 

113

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%.

 

114

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%.

 

115

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%.

 

116

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%.

 

117

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%.

 

118

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%.

 

119

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%.

 

120

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%.

 

121

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%.

 

122

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%.

 

123

2-HYDROXYACETOPHENONE

E

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

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

 

124

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%.

 

125

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%.

 

126

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%.

 

127

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%.

 

128

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%.

 

129

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%.

 

130

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%.

 

131

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%.

 

132

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%.

 

133

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%.

 

134

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%.

 

135

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%.

 

136

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%.

 

137

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%.

 

138

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%.

 

139

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%.

 

140

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%.

 

141

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.

 

142

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%.

 

143

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%.

 

 

144

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%.

 

145

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%.

 

146

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%.

 

147

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%.

 

148

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%.

 

149

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%.

 

150

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%.

 

151

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%.

 

152

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%.

 

153

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%.

 

154

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%.

 

155

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%.

 

156

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%.

 

157

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%.

 

158

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%.

 

159

2-PENTADECANONE

E

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

The total flavour proprietary excipient formulation in a medicine must be no more than 5%.

 

160

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%.

 

161

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%.

 

162

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%.

 

163

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%.

 

164

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%.

 

165

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%.

 

166

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%.

 

167

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%.

 

168

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%.

 

169

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%.

 

170

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%.

 

171

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%.

 

172

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%.

 

173

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%.

 

174

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%.

 

175

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%.

 

176

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%.

 

177

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%.

 

178

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%.

 

179

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%.

 

180

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%.

 

181

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%.

 

182

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%.

 

183

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%.

 

184

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%.

 

185

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%.

 

186

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%.

 

187

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%.

 

188

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%.

 

189

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%.

 

190

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%.

 

191

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%.

 

192

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%.

 

193

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%.

 

194

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%.

 

195

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%.

 

196

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%.

 

197

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%.

 

198

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%.

 

199

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%.

 

200

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%.

 

201

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%.

 

202

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%.

 

203

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%.

 

204

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%.

 

205

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%.

 

206

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%.

 

207

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%.

 

208

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%.

 

209

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%.

 

210

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%.

 

211

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%.

 

212

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%.

 

213

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%.

 

214

3-OCTYL ACETATE

E

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

The total flavour proprietary excipient formulation in a medicine must be no more than 5%.

 

215

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%.

 

216

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%.

 

217

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%.

 

218

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%.

 

219

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%.

 

220

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%.

 

221

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%.

 

222

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%.

 

223

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%.

 

224

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%.

 

 

225

4,7-METHANO-1H-INDENEMETHANOL, OCTAHYDRO-, ACETATE

E

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

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

 

226

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%.

 

227

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%.

 

228

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%.

 

229

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%.

 

230

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%.

 

231

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%.

 

232

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%.

 

233

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%.

 

234

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%.

 

235

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%.

 

236

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%.

 

237

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%.

 

238

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%.

 

239

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%.

 

240

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%.

 

241

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%.

 

242

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%.

 

243

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%.

 

244

4-METHYLBENZYLIDENE CAMPHOR

A

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

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

When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label:

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

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

When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019:

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

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

 

245

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%.

 

246

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%.

 

247

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%.

 

248

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%.

 

249

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%.

 

250

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%.

 

251

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%.

 

252

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%.

 

253

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%.

 

254

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%.

 

255

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%.

 

256

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%.

 

257

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%.

 

258

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%.

 

259

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%.

 

260

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%.

 

261

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%.

 

262

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%.

 

263

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%.

 

264

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%.

 

265

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%.

 

266

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%.

 

267

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%.

 

268

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%.

 

269

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%.

 

 

270

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%.

 

271

6-METHOXYDICYCLOPENTADIENECARBOXALDEHYDE

E

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

When included in a medicine for use on the lips the concentration of 6-methoxydicyclopentadiene carboxaldehyde must be no more than 0.1%.

When included in dermal creams for infant use the concentration of 6-methoxydicyclopentadienecarboxaldehyde must be no more than 0.5%.

When for dermal use or use on the hair the concentration of 6-methoxydicyclopentadienecarboxaldehyde must be no more than 0.5%.

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

 

272

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%.

 

273

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

E

 

274

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%.

 

275

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%.

 

276

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%.

 

277

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%.

 

278

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%.

 

279

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%.

 

280

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%.

 

281

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%.

 

282

ABELMOSCHUS MOSCHATUS

A, H

 

283

ABELMOSCHUS MOSCHATUS SUBSP. MOSCHATUS

A, H

 

284

ABIES BALSAMEA

A, H

 

285

ABIES NIGRA

A, H

 

286

ABIES PECTINATA

A, H

 

287

ABIES SIBIRICA

A, H

 

288

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.

 

289

ABUTILON THEOPHRASTI

A, H

 

290

ACACIA

A, E, H

 

291

ACACIA BAILEYANA

A, H

 

292

ACACIA CATECHU

A, H

 

293

ACACIA DEALBATA

A, H

 

294

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%.

 

295

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%.

 

296

ACACIA LONGIFOLIA

A, E, H

 

297

ACACIA NILOTICA

A, E, H

 

298

ACACIA SENEGAL

A, E, H

 

299

ACALYPHA INDICA

A, H

 

300

ACANTHUS MOLLIS

A, H

 

301

ACER CAMPESTRE

A, H

 

302

ACER NEGUNDO

A, H

 

303

ACER SACCHARINUM

A, H

 

304

ACER SACCHARUM

A, E, H

 

305

ACEROLA

E

 

306

ACESULFAME POTASSIUM

E

 

307

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%.

 

308

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%.

 

309

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%.

 

310

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%.

 

311

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%.

 

312

ACETANISOLE

E

Permitted for use only:

(a) in topical medicines for dermal application; and

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

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

 

313

ACETIC ACID

E, H

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

 

314

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%.

 

315

ACETOMENAPHTHONE

A, E

 

316

ACETONE

E

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

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

 

317

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%.

 

318

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%.

 

319

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%.

 

320

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%.

 

321

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'

 

322

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%.

 

323

ACETYL LEVOCARNITINE HYDROCHLORIDE

A, E

 

324

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%.

 

325

ACETYLATED LANOLIN

E

Only for use in topical medicines for dermal application.

 

326

ACETYLATED LANOLIN ALCOHOL

E

Only for use in topical medicines for dermal application.

 

327

ACETYLATED MONOGLYCERIDES

E

 

328

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%.

 

329

ACETYLCYSTEINE

E

Only for use in topical medicines for dermal application.

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

 

330

ACHILLEA ERBA-ROTTA SUBSP. MOSCHATA

A, H

 

331

ACHILLEA MILLEFOLIUM

A, E, H

 

332

ACHILLEA PTARMICA

A, H

 

333

ACHYRANTHES ASPERA

A, H

 

334

ACHYRANTHES BIDENTATA

A, H

 

335

ACHYRANTHES FAURIEI

A, H

 

336

ACID GREEN 25

E

Permitted for use only as a colour for topical use.

 

337

ACID RED 33

E

Permitted for use only as a colour for topical use.

 

338

ACID RED 87

E, H

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

 

339

ACID TREATED WAXY MAIZE STARCH

E

 

340

ACID-ISOMERISED LINALOOL

E

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

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

 

 

341

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.

 

342

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.

 

343

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.

 

344

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.

 

345

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%.

 

346

ACRYLAMIDES COPOLYMER

E

Only for use in topical medicines for dermal application.

 

347

ACRYLATES COPOLYMER

E

Only for use in topical medicines for dermal application.

 

348

ACRYLATES/ACRYLAMIDE COPOLYMER

E

Only for use in topical medicines for dermal application.

 

349

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER

E

Only for use in topical medicines for dermal application.

 

350

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%.

 

351

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%.

 

352

ACRYLATES/OCTYLACRYLAMIDE COPOLYMER

E

Only for use in topical medicines for dermal application.

 

353

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%.

 

354

ACRYLATES/VA COPOLYMER

E

Only for use in topical medicines for dermal application.

 

355

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%.

 

356

ACTAEA CIMICIFUGA

A, H

 

357

ACTAEA HERACLEIFOLIA

A, H

 

358

ACTAEA PACHYPODA

A, H

 

359

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.'

 

360

ACTAEA SIMPLEX

A, H

 

361

ACTAEA SPICATA

A, H

 

362

ACTINIDIA CHINENSIS

A, H

 

363

ACTINIDIA DELICIOSA

A, H

 

364

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.

 

365

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).

 

366

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)'

 

367

ADEMETIONINE DISULFATE TOSYLATE

A, H

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

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

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

 

368

ADEMETIONINE DISULFATE TRITOSYLATE DIHYDRATE

A, H

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

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

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

 

369

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)'

 

370

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)'

 

371

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)'

 

372

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)'

 

373

ADEMETIONINE TETRASULFATE DIHYDRATE

A, H

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

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

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

 

374

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)'

 

375

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)'

 

376

ADENOPHORA STRICTA

A, H

 

377

ADENOPHORA TRIPHYLLA

A, H

 

378

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%.

 

379

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%.

 

380

ADENOSINE TRIPHOSPHATE

E

Only for use in topical medicines for dermal application.

 

381

ADENOSINE TRIPHOSPHATE DISODIUM

E

Only for use in topical medicines for dermal application.

 

382

ADIANTUM CAPILLUS-VENERIS

A, H

 

383

ADIPIC ACID

E

 

384

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%.

 

385

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%.

 

386

ADRENALINE (EPINEPHRINE)

H

Only for use as an active homoeopathic ingredient.

 

387

ADZUKI BEAN

E

 

388

AEGOPODIUM PODAGRARIA

A, H

 

389

AESCULUS CHINENSIS

A, H

 

390

AESCULUS GLABRA

A, H

 

391

AESCULUS HIPPOCASTANUM

A, H

 

392

AESCULUS X CARNEA

A, H

 

393

AETHUSA CYNAPIUM

H

Only for use as an active homoeopathic ingredient.

 

394

AGAR

A, E

 

395

AGASTACHE RUGOSA

A, H

 

396

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%.

 

397

AGAVE AMERICANA

A, E, H

 

398

AGRIMONIA EUPATORIA

A, E, H

 

399

AGRIMONIA REPENS

A, H

 

400

AGROSTIS TENUIS

A, H

 

401

AILANTHUS ALTISSIMA

A, H

 

402

AJUGA CHAMAEPITYS

A, H

 

403

AJUGA REPTANS

A, H

 

404

ALANINE

A, E

 

405

ALANYLGLUTAMINE

A

Only for use in oral medicines.

 

406

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.

 

407

ALBIZIA JULIBRISSIN

A, H

 

408

ALBIZIA LEBBECK

A, H

 

409

ALCEA ROSEA

A, H

 

410

ALCHEMILLA ALPINA

A, H

 

411

ALCHEMILLA ARVENSIS

A, H

 

412

ALCHEMILLA VULGARIS

A, H

 

413

ALETRIS FARINOSA

A, H

 

414

ALETRIS SPICATA

A, H

 

415

ALEURITES MOLUCCANUS SEED OIL

E

Only for use in topical medicines for dermal application.

 

416

ALFADEX

A, E

Only for use in oral medicines.

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

 

417

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).

 

418

ALGINIC ACID

E

 

419

ALISMA ORIENTALE

A, H

 

420

ALISMA PLANTAGO AQUATICA

A, H

 

421

ALKANNA TINCTORIA

A, H

 

422

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%.

 

423

ALLANTOIN

E

Only for use in topical medicines for dermal application.

 

424

ALLIARIA PETIOLATA

A, H

 

425

ALLIUM CEPA

A, H

 

426

ALLIUM FISTULOSUM

A, H

 

427

ALLIUM HIEROCHUNTINUM

A, H

 

428

ALLIUM MACROSTEMON

A, H

 

429

ALLIUM ODORUM

A, H

 

430

ALLIUM PORRUM

A, H

 

431

ALLIUM SATIVUM

A, E, H

 

432

ALLIUM SCHOENOPRASUM

A, H

 

433

ALLIUM URSINUM

A, H

 

434

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%.

 

435

ALLURA RED AC

E

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

 

436

ALLURA RED AC ALUMINIUM LAKE

E

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

 

437

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%.

 

438

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%.

 

439

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%.

 

440

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%.

 

441

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%.

 

442

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%.

 

443

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%.

 

444

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%.

 

445

ALLYL ISOTHIOCYANATE

E

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

 

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

 

446

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%.

 

447

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%.

 

448

ALMOND

E

 

449

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%.

 

450

ALNUS GLUTINOSA

A, H

 

451

ALNUS INCANA SUBSP. RUGOSA

A, H

 

452

ALOE FEROX

A, E, H

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

453

ALOE PERRYI

A, H

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

454

ALOE VERA

A, E, H

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

455

ALOES CAPE

A, H

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

456

ALOYSIA CITRODORA

A, H

 

457

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.'

 

458

ALPHA LIPOIC ACID

A

 

459

ALPHA-2,2,6-TETRAMETHYL-CYCLOHEXENEBUTANAL

E

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

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

 

460

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%.

 

461

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%.

 

462

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%.

 

463

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%.

 

464

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%.

 

465

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%.

 

466

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%.

 

467

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%.

 

468

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%.

 

 

469

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%.

 

470

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%.

 

471

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%.

 

472

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%.

 

473

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%.

 

474

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%.

 

475

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%.

 

476

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%.

 

477

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%.

 

478

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%.

 

479

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%.

 

480

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%.

 

 

481

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%.

 

482

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%.

 

483

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%.

 

484

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%.

 

485

ALPINIA GALANGA

A, H

 

486

ALPINIA HAINANENSIS

A, H

 

487

ALPINIA OFFICINARUM

A, H

 

488

ALPINIA OXYPHYLLA

A, H

 

489

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.

 

490

ALSTONIA BOONEI

A, H

 

491

ALSTONIA CONSTRICTA

H

Only for use as an active homoeopathic ingredient.

 

492

ALTERNANTHERA PHILOXEROIDES

A, H

 

493

ALTEROMONAS FERMENT EXTRACT

E

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

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

 

494

ALTHAEA OFFICINALIS

A, E, H

 

495

ALUM DODECAHYDRATE

A, E, H

 

496

ALUMINIUM CHLOROHYDRATE

E

Only for use in topical medicines for dermal application.

 

497

ALUMINIUM CITRATE

E

Only for use in topical medicines for dermal application.

 

498

ALUMINIUM DISTEARATE

E

Only for use in topical medicines for dermal application.

 

499

ALUMINIUM HYDROXIDE

E

Only for use in topical medicines for dermal application.

 

500

ALUMINIUM HYDROXIDE HYDRATE

E

Only for use in topical medicines for dermal application.

 

501

ALUMINIUM MAGNESIUM SILICATE

E

 

502

ALUMINIUM MONOSTEARATE

E

Only for use in topical medicines for dermal application.

 

503

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.

 

504

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.

 

505

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).’

 

506

ALUMINIUM STARCH OCTENYLSUCCINATE

E

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

 

507

ALUMINIUM STEARATE

E

Only for use in topical medicines for dermal application.

 

508

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%.

 

509

AMARANTH

E

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

 

510

AMARANTH ALUMINIUM LAKE

E

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

 

511

AMARANTHUS HYBRIDUS

A, H

 

512

AMARANTHUS RETROFLEXUS

A, H

 

513

AMBERGRIS EXTRACT

E

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

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

 

514

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%.

 

515

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%.

 

516

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%.

 

517

AMBROSIA ARTEMISIIFOLIA

A, H

 

518

AMBROSIA PSILOSTACHYA

A, H

 

519

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%.

 

520

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%.

 

521

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%.

 

522

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%.

 

523

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%.

 

524

AMMONIO METHACRYLATE COPOLYMER

E

Only for use in oral medicines.

 

525

AMMONIUM ACRYLATES COPOLYMER

E

Only for use in topical medicines for dermal application.

 

526

AMMONIUM ACRYLATES/ACRYLONITROGENS COPOLYMER

E

Only for use in topical medicines for dermal application.

 

527

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%.

 

528

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%.

 

529

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.

 

530

AMMONIUM BROMIDE

H

Only for use as an active homoeopathic ingredient.

 

531

AMMONIUM CARBONATE

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

532

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.

 

533

AMMONIUM GLYCYRRHIZINATE

E

 

534

AMMONIUM IODIDE

H

Only for use an active ingredient in homoeopathic medicines.

 

535

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%.

 

536

AMMONIUM LAURETH SULFATE

E

Only for use in topical medicines for dermal application.

 

537

AMMONIUM LAURYL SULFATE

E

Only for use in topical medicines for dermal application.

 

538

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%.

 

539

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%.

 

540

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%.

 

541

AMOMUM AROMATICUM

A, H

 

542

AMOMUM VILLOSUM

A, H

 

543

AMORPHOPHALLUS KONJAC

A, H

Only for use when the dosage form is not tablet.

 

544

AMPELODESMOS MAURITANICUS

A, H

 

545

AMPELOPSIS JAPONICA

A, H

 

546

AMYL ACETATE

E

Only for use in topical medicines for dermal application.

 

547

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%.

 

548

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%.

 

549

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%.

 

550

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%.

 

551

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%.

 

552

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%.

 

553

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%.

 

554

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%.

 

555

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%.

 

556

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%.

 

557

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%.

 

558

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%.

 

559

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%.

 

560

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%.

 

561

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%.

 

562

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%.

 

563

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.

 

564

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%.

 

565

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%.

 

566

AMYRIS BALSAMIFERA

A, H

 

567

AMYRIS OIL WEST INDIAN

A, E, H

 

568

ANACARDIUM OCCIDENTALE

A, H

 

569

ANACYCLUS PYRETHRUM

A, H

 

570

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%.

 

571

ANAESTHETIC ETHER

H

Only for use as an active homoeopathic ingredient.

 

572

ANAGALLIS ARVENSIS

A, H

 

573

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%.

 

574

ANANAS COMOSUS

A, E, H

 

575

ANAPHALIS SINICA

A, H

 

576

ANDROGRAPHIS PANICULATA

A, H

 

577

ANEMARRHENA ASPHODELOIDES

A, E, H

 

578

ANEMONE ALTAICA

A, H

 

579

ANEMONE CHINENSIS

A, H

 

580

ANEMONE HEPATICA

A, H

 

581

ANEMONE PULSATILLA

A, H

 

582

ANEMONE RADDEANA

A, H

 

583

ANETHOLE

E

 

584

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%.

 

585

ANETHUM GRAVEOLENS

A, E, H

 

586

ANGELICA ACUTILOBA

A, H

 

587

ANGELICA ANOMALA

A, H

 

588

ANGELICA ARCHANGELICA

A, E, H

 

589

ANGELICA ATROPURPUREA

A, H

 

590

ANGELICA DAHURICA

A, E, H

 

591

ANGELICA DECURSIVA

A, H

 

592

ANGELICA POLYMORPHA

A, E, H

 

593

ANGELICA PUBESCENS

A, E, H

 

594

ANGELICA ROOT DRY

A, H

 

595

ANGELICA ROOT OIL

A, E, H

 

596

ANGELICA SEED OIL

A, E, H

 

597

ANGELICA STEM

E

 

598

ANIBA ROSAEODORA

A, E, H

 

599

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%.

 

600

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%.

 

601

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)'

 

602

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%.

 

603

ANISEED DRY

A, E, H

 

604

ANISEED POWDER

A, E, H

 

605

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%.

 

606

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%.

 

607

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%.

 

608

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%.

 

609

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%.

 

610

ANNATTO

E

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

 

611

ANOGEISSUS LATIFOLIA

A, E, H

 

612

ANTENNARIA DIOICA

A, E, H

 

613

ANTHOCYANINS

E

 

614

ANTHOXANTHUM ODORATUM

A, H

When used as an active ingredient, coumarin is a mandatory component of Anthoxanthum odoratum and the concentration of coumarin in the medicine must be no more than 0.001%.

 

615

ANTHRISCUS CEREFOLIUM

A, H

 

616

ANTHYLLIS VULNERARIA

A, H

 

617

ANTIMONY POTASSIUM TARTRATE TRIHYDRATE

H

Only for use as an active homoeopathic ingredient.

 

618

ANTIMONY TRISULFIDE

H

Only for use as an active homoeopathic ingredient.

 

619

APIUM GRAVEOLENS

A, E, H

 

620

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%.

 

621

APOMORPHINE HYDROCHLORIDE HEMIHYDRATE

H

Only for use as an active homoeopathic ingredient.

 

622

APPLE

E

 

623

APPLE CIDER VINEGAR

E

 

624

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%.

 

625

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%.

 

626

APPLE FIBRE

E

 

627

APRICOT

E

 

628

APRICOT KERNEL OIL PEG-6 ESTERS

E

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

 

629

AQUILARIA MALACCENSIS

A, H

 

630

AQUILARIA SINENSIS

A, H

 

631

AQUILEGIA VULGARIS

A, H

 

632

ARACHIDONIC ACID

E

Only for use in topical medicines for dermal application.

 

633

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%.

 

634

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%.

 

635

ARACHIDYL PROPIONATE

E

Only for use in topical medicines for dermal application.

 

636

ARACHIS HYPOGAEA

A, E, H

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

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

 

637

ARACHIS OIL

A, E, H

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

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

 

638

ARALIA CORDATA

A, H

 

639

ARALIA HISPIDA

A, H

 

640

ARALIA NUDICAULIS

A, H

 

641

ARALIA RACEMOSA

A, H

 

642

ARCTIUM LAPPA

A, E, H

 

643

ARCTIUM MINUS

A, H

 

644

ARCTOSTAPHYLOS UVA-URSI

A, E, H

 

645

ARDISIA JAPONICA

A, H

 

646

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%.

 

647

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.

 

648

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.'

 

649

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%.

 

650

ARISAEMA ATRORUBENS

A, H

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

 

651

ARISAEMA CONSANGUINEUM

A, H

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

 

652

ARISAEMA JAPONICUM

A, H

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

 

653

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).

 

654

ARNEBIA EUCHROMA

A, H

 

655

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.

 

656

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.

 

657

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.

 

658

ARRHENATHERUM ELATIUS

A, H

 

659

ARROWROOT

A, E, H

 

660

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%.

 

661

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%.

 

 

662

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%.

 

663

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%.

 

664

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%.

 

665

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%.

 

666

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%.

 

667

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%.

 

668

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%.

 

669

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%.

 

670

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%.

 

671

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%.

 

 

672

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%.

 

673

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%.

 

674

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%.

 

675

ARTERY

H

Only for use as an active homoeopathic ingredient.

 

676

ARTHROSPIRA MAXIMA

A, H

 

677

ARTHROSPIRA PLATENSIS

A, H

 

678

ARUM MACULATUM

A, H

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

 

679

ASAFOETIDA GUM

A, H

 

680

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%.

 

681

ASARUM EUROPAEUM

A, H

 

682

ASARUM HETEROTROPOIDES

A, H

 

683

ASARUM OIL

E

 

684

ASARUM SIEBOLDII

A, E, H

 

685

ASCLEPIAS TUBEROSA

A, H

 

686

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.

 

 

687

ASCORBIC ACID

A, E

 

688

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%.

 

689

ASCORBYL METHYLSILANOL PECTINATE

E

Only for use in topical medicines for dermal application.

 

690

ASCORBYL PALMITATE

A, E

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

 

 

691

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%.

 

692

ASPALATHUS LINEARIS

A, E, H

 

693

ASPARAGINE

A, E

 

694

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%.

 

695

ASPARAGUS

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

696

ASPARAGUS COCHINCHINENSIS

A, H

 

697

ASPARAGUS OFFICINALIS

A, E, H

 

698

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.

 

699

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'

 

700

ASPARTIC ACID

A, E

 

701

ASPERGILLUS ORYZAE

A, E, H

 

702

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).

 

703

ASTER NOVI-BELGII

A, H

 

704

ASTER TATARICUS

A, H

 

705

ASTRAGALUS ADSURGENS

A, H

 

706

ASTRAGALUS COMPLANATUS

A, H

 

707

ASTRAGALUS EXCARPUS

A, H

 

708

ASTRAGALUS GUMMIFER

A, E, H

 

709

ASTRAGALUS LENTIGINOSUS

A, H

 

710

ASTRAGALUS MEMBRANACEUS

A, E, H

 

711

ASTRAGALUS PENDULIFLORUS

A, H

 

712

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%.

 

713

ATRACTYLODES JAPONICA

A, H

 

714

ATRACTYLODES LANCEA

A, H

 

715

ATRACTYLODES MACROCEPHALA

A, H

 

716

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%.

 

717

ATROPINE SULFATE MONOHYDRATE

H

Only for use as an active homoeopathic ingredient.

 

718

ATTALEA SPECIOSA

E

Only for use in topical medicines for dermal application.

 

719

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%.

 

720

AUREOBASIDIUM PULLULANS

A, H

 

721

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.

 

722

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.

 

723

AVOCADO

E

 

724

AVOCADO OIL

E

 

725

AVOCADO OIL UNSAPONIFIABLES

E

Only for use in topical medicines for dermal application.

 

726

AZADIRACHTA INDICA

A, H

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

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

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

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

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

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

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

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

 

727

AZOVAN BLUE

E

Permitted for use only as a colour for topical use.

 

728

AZULENE

E

Only for use in topical medicines for dermal application.