Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2021 (Cth)
Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2021
I, Cheryl McRae, as delegate of the Minister for Health and Aged Care, make the following determination.
Dated 11 August 2021
Cheryl McRae
Assistant Secretary
Complementary and Over the Counter Medicines Branch
Health Products Regulation Group
Department of Health
Contents
1 Name........................................................................................................................................ 2
2 Commencement........................................................................................................................ 2
3 Authority.................................................................................................................................. 2
4 Interpretation............................................................................................................................ 2
5 Permissible ingredients............................................................................................................. 3
6 Requirements in relation to permissible ingredients being contained in medicine..................... 3
7 Repeals..................................................................................................................................... 4
Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine......................................................................................................................................... 5
Schedule 2—Repeals................................................................................................................ 885
Note: This instrument is in 6 volumes:
Volume 1: Sections 1–7 (pages 2-4)
Schedule 1 (+-)-NARINGENIN–AZULENE (pages 5-134)
Volume 2: Schedule 1 BACILLUS COAGULANS–EVERNIA PRUNASTRI EXTRACT (pages 135-376)
Volume 3: Schedule 1 FABIANA IMBRICATA–JUSTICIA ADHATODA
(pages 377-490)
Volume 4: Schedule 1 KADSURA COCCINEA–OYSTER SHELL (pages 491-627)
Volume 5: Schedule 1 P-ALPHA-DIMETHYL STYRENE–TYROSINE
(pages 628-853)
Volume 6: Schedule 1 UBIDECARENONE–ZUCCHINI (pages 854-884)
Schedule 2 (page 885)
1 Name
This instrument is the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2021.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. The whole of this instrument 20 August 2021 20 August 2021
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under subsection 26BB(1) of the Therapeutic Goods Act 1989.
4 Interpretation
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) British Pharmacopoeia;
(b) European Pharmacopoeia;
(c) medicine;
(d) Register;
(e) United States Pharmacopeia-National Formulary.
(1) In this instrument:
Act means the Therapeutic Goods Act 1989.
active ingredient, or A, for a medicine, has the same meaning as in the Regulations.
code tables means the tables accessed via the Code Tables item in the Public TGA Information menu in TGA eBusiness Services.
excipient or E, for a medicine, 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.
homoeopathic preparation has the same meaning as in the Regulations.
homoeopathic preparation ingredient or H, means an ingredient that is a constituent of a homoeopathic preparation.
Regulations means the Therapeutic Goods Regulations 1990.
TGA eBusiness Services means TGA eBusiness Services on the Therapeutic Goods Administration website, which may be accessed on the internet at Goods Administration has the same meaning as in the Regulations.
(2) To avoid doubt, the terms set out in closed brackets in column 4 of the table in Schedule 1, which are associated with warning statements in relation to particular ingredients, are:
(a) terms from the code tables under the heading Product Warning; and
(b) not required to be reproduced in a warning statement on the label of a medicine.
Note: Examples of these terms include the following:
(a) (ARGIN1);
(b) (CHILD3);
(c) (GLUTEN);
(d) (PEANUT); and
(e) (PREGNT).
5 Permissible ingredients
The ingredients specified in column 2 of the table in Schedule 1 are specified for the purposes of paragraph 26BB(1)(a) of the Act.
6 Requirements in relation to permissible ingredients being contained in medicine
For an ingredient mentioned in column 2 of an item in the table in Schedule 1, the following requirements are specified for the purposes of paragraph 26BB(1)(b) of the Act:
(a) the ingredient must only be used in a medicine for a purpose specified in relation to the ingredient in column 3 of that item; and
(b) the ingredient must comply with the requirements specified in relation to the ingredient in column 4 of that item; and
(c) if the ingredient is derived from animal origin¾the safety of the ingredient must have been assessed against, and comply with, the principles and requirements 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.
7 Repeals
Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.
Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine
Note: See sections 5 and 6.
Permissible ingredients and requirements Column 1 Column 2 Column 3 Column 4 Item Ingredient name Purpose Specific requirements 1 (+-)-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%.
2 (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%.
3 (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%.
4 (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%.
5 (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%.
6 (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%.
7 (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%.
8 (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%.
9 (R)-ALPHA-TERPINYL ACETATE E (R)-alpha-terpinyl acetate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing (R)-alpha-terpinyl acetate must not be more than 1% of the total medicine.
10 (S)-LACTIC ACID A, E, H 11 (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)'
12 (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)'
13 (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)'
14 (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)'
15 (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)'
16 (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)'
17 (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)'
18 (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)'
19 (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)'
20 (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)'
21 (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%.
22 (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%.
23 1,1,1-TRICHLOROETHANE E The concentration in the medicine must be no more than 25%.
24 1,2,3,4,4A,5,8,8A-OCTAHYDRO-2,2,6,8-TETRAMETHYL-1-NAPHTHALENOL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
25 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%.
26 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%.
27 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%.
28 1,3-BUTYLENE GLYCOL E 29 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%.
30 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%.
31 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%
32 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%.
33 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%.
34 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%.
35 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%.
36 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%.
37 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%.
38 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%.
39 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%.
40 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%.
41 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%.
42 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%.
43 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%.
44 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%.
45 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%.
46 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%.
47 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%.
48 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%.
49 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%.
50 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%.
51 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%.
52 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%.
53 2'-FUCOSYLLACTOSE A Only to be used in a medicine where BASF Australia Ltd - Australia (Client ID 13479), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 1 March 2023.
Only for oral use.
The maximum recommended daily dose of the medicine must not provide more than:
(a) 5 g of 2’-fucosyllactose to individuals aged 18 years and older;
(b) 2 g of 2’-fucosyllactose to individuals aged between 4 to 17 years (inclusive); and
(c) 1.2 g of 2’-fucosyllactose to individuals aged between 1 to 3 years (inclusive).
Not permitted for use in children under the age of 12 months.
54 2,2'-METHYLENEBIS(4-METHYL-6-TERT-BUTYLPHENOL) E 2,2'-methylenebis(4-methyl-6-tert-butylphenol) must only be included in medicines when in combination with other permitted ingredients as a proprietary excipient formulation in medicines with a dermal route of administration for topical application.
55 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%.
56 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%.
57 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%.
58 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%.
59 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%.
60 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%.
61 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%.
62 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%.
63 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%.
64 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%.
65 2,3-DIHYDRO-1,1-DIMETHYL-1H-INDENE-AR-PROPANAL E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient. The total fragrance proprietary excipient formulation concentration in a medicine must not be more than 1%.
66 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%.
67 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%.
68 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%.
69 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%.
70 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%.
71 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%.
72 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%.
73 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.
74 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%.
75 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%.
76 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%.
77 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%.
78 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%.
79 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.
80 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.
81 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%.
82 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%.
83 2,5-DIMETHYL-4-ETHOXY-3(2H)-FURANONE E Only for use in medicines in combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total flavour proprietary excipient formulation in a medicine must not be more than 5%.
84 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%.
85 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%.
86 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%
87 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%.
88 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%.
89 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%.
90 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%.
91 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%.
92 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%.
93 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%.
94 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%.
95 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%.
96 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%.
97 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%.
98 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%.
99 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%.
100 2-(4-METHYLPHENOXY)-N-1H-PYRAZOL-3-YL-N-(2-THIENYLMETHYL)ACETAMIDE E The route of administration of a medicine containing 2-(4-methylphenoxy)-n-1h-pyrazol-3-yl-n-(2-thienylmethyl)acetamide must be limited to dental.
The total concentration of 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)acetamide in the medicine must not be more than 0.015%.
2-(4-Methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)acetamide must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation
The total concentration of flavour proprietary excipient formulations containing 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)acetamide must not be more than 5% of the total medicine.
101 2-(6-METHYL-8-ISOPROPYL BICYCLO(2.2.2)OCT-5-ENE-2-YL-1,3-DIOXOLANE E 2-(6-methyl-8-isopropyl bicyclo(2.2.2)oct-5-ene-2-yl)-1,3-dioxolane must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 2-(6-methyl-8-isopropyl bicyclo(2.2.2)oct-5-ene-2-yl)-1,3-dioxolane must not be more than 1% of the total medicine.
102 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%.
103 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%.
104 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%.
105 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%.
106 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%.
107 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%.
108 2-AMINO-2-METHYL-1-PROPANOL E Only for use in topical medicines for dermal application.
109 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%.
110 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%.
111 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%.
112 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%.
113 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%.
114 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%.
115 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%.
116 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%.
117 2-ETHOXY-9-METHYLENE-2,6,6-TRIMETHYLBICYCLO[3.3.1]NONANE E 2-ethoxy-9-methylene-2,6,6-trimethylbicyclo[3.3.1]nonane must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 2-ethoxy-9-methylene-2,6,6-trimethylbicyclo[3.3.1]nonane must not be more than 1% of the total medicine.
118 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%.
119 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%.
120 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%.
121 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%.
122 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%.
123 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%.
124 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%.
125 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%.
126 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%.
127 2-ETHYL-N-METHYL-N-(3-METHYLPHENYL) BUTANAMIDE E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
128 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%.
129 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%.
130 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%.
131 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%.
132 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%.
133 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%.
134 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%.
135 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%.
136 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%.
137 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%.
138 2-ISOPROPYLPHENOL E 2-Isopropylphenol must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total concentration of flavour proprietary excipient formulations containing 2-isopropylphenol must not be more than 5% of the total medicine.
139 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%.
140 2-METHOXY-3-(1-METHYLPROPYL)PYRAZINE E Permitted for use only in combination with 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-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%.
142 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%.
143 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%.
144 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%.
145 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%.
146 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%.
147 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%.
148 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%.
149 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%.
150 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%.
151 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%.
152 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.
153 2-METHYL-4-(2,2,3-TRIMETHYLCYCLOPENT-3-EN-1-YL)PENT-4-EN-1-OL E 2-Methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-1-ol must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-1-ol must not be more than 1% of the total medicine.
154 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%.
155 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%.
156 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%.
157 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%.
158 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%.
159 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%.
160 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%.
161 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%.
162 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%.
163 2-METHYLDECANAL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
164 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%.
165 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%.
166 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%.
167 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%.
168 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%.
169 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%.
170 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%.
171 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%.
172 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%.
173 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%.
174 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%.
175 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%.
176 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%.
177 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%.
178 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%.
179 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%.
180 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%.
181 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%.
182 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%.
183 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%.
184 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%.
185 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%.
186 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%.
187 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%.
188 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%.
189 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%.
190 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%.
191 3,4-DIMETHYL PHENYLACETALDEHYDE E 3,4-Dimethyl phenylacetaldehyde must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 3,4-dimethyl phenylacetaldehyde must not be more than 1% of the total medicine.
192 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%.
193 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%.
194 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%.
195 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%.
196 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%.
197 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%.
198 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%.
199 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%.
200 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%.
201 3,7-DIMETHYL-1-OCTEN-3-OL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
202 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%.
203 3,7-DIMETHYL-2,6-OCTADIENAL REACTION PRODUCTS WITH ETHANOL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
204 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%.
205 3-(1-BUTENYL)-PYRIDINE E 3-(1-Butenyl)-pyridine must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 3-(1-butenyl)-pyridine must not be more than 1% of the total medicine.
206 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%.
207 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%.
208 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%.
209 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%.
210 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%.
211 3-(METHYLTHIO) PROPIONALDEHYDE E 3-(Methylthio) propionaldehyde must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total concentration of flavour proprietary excipient formulations containing 3-(methylthio) propionaldehyde must not be more than 5% of the total medicine.
212 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%.
213 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%.
214 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%.
215 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%.
216 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%.
217 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%.
218 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%.
219 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%.
220 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%.
221 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%.
222 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%.
223 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%.
224 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%.
225 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%.
226 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%.
227 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%.
228 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%.
229 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%.
230 3-METHYLPENTANOIC ACID E 3-Methylpentanoic acid must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total concentration of the flavour proprietary excipient formulation containing 3-methylpentanoic acid must not be more than 5% of the total medicine.
231 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%.
232 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%.
233 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%.
234 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%.
235 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%.
236 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%.
237 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%.
238 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%.
239 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%.
240 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%.
241 4,4A,5,9B-TETRAHYDRO-2,4-DIMETHYL-INDENO(1,2-D)-1,3-DIOXIN E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
242 4,4A,5,9B-TETRAHYDROINDENO(1,2-D)-1,3-DIOXIN E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
243 4,5-DIMETHYL-3-HYDROXY-2(5H)FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
244 4,7-METHANO-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%.
245 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%.
246 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%.
247 4-(1-ETHOXYVINYL)-3,3,5,5-TETRAMETHYLCYCLOHEXANONE E 4-(1-Ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone must not be more than 1% of the total medicine.
248 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%.
249 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%.
250 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%.
251 4-(OCTAHYDRO-4,7-METHANO-5H-INDEN-5-YLIDENE)-BUTANAL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
252 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%.
253 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%.
254 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%.
255 4-CYCLOHEXYL-2-METHYL-2-BUTANOL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
256 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%.
257 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%.
258 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%.
259 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%.
260 4-ISOPROPYL-3-METHYLPHENOL 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%.
261 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%.
262 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%.
263 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%.
264 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%.
265 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%.
266 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 not be more than 4%.
The following warning statements are required on the 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).
267 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%.
268 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%.
269 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%.
270 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%.
271 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%.
272 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%.
273 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%.
274 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%.
275 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%.
276 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%.
277 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%.
278 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%.
279 5-ETHYL-2,3-DIMETHYLPYRAZINE E 5-Ethyl-2,3,dimethylpyrazine must not be included in medicines for oral administration.
5-Ethyl-2,3,dimethylpyrazine must only be included in topical medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 5-ethyl-2,3,dimethylpyrazine must not be more than 1% of the total medicine.
280 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%.
281 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%.
282 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%.
283 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%.
284 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%.
285 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%.
286 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%.
287 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%.
288 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%.
289 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%.
290 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%.
291 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%.
292 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%.
293 6-ETHYLIDENEOCTAHYDRO 5,8-METHANO-2H-1-BENZOPYRAN E 6-Ethylideneoctahydro 5,8-methano-2H-1-benzopyran must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 6-ethylideneoctahydro 5,8-methano-2H-1-benzopyran must not be more than 1% of the total medicine.
294 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%.
295 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%.
296 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%.
297 6-METHYL-2-BUTEN-3-OL-2 E 298 6-METHYLQUINOLINE E 6-Methylquinoline must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total concentration of the flavour proprietary excipient formulation containing 6-methylquinoline must not be more than 5% of the total medicine.
299 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%.
300 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%.
301 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%.
302 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%.
303 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%.
304 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%.
305 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%.
306 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%.
307 ABELMOSCHUS MOSCHATUS A, H 308 ABELMOSCHUS MOSCHATUS SUBSP. MOSCHATUS A, H 309 ABIES BALSAMEA A, H 310 ABIES NIGRA A, H 311 ABIES PECTINATA A, H 312 ABIES SIBIRICA A, H 313 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.
314 ABUTILON THEOPHRASTI A, H 315 ACACIA A, E, H 316 ACACIA BAILEYANA A, H 317 ACACIA CATECHU A, H 318 ACACIA DEALBATA A, H 319 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%.
320 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%.
321 ACACIA LONGIFOLIA A, E, H 322 ACACIA NILOTICA A, E, H 323 ACACIA SENEGAL A, E, H 324 ACALYPHA INDICA A, H 325 ACANTHUS MOLLIS A, H 326 ACER CAMPESTRE A, H 327 ACER NEGUNDO A, H 328 ACER SACCHARINUM A, H 329 ACER SACCHARUM A, E, H 330 ACEROLA E 331 ACESULFAME POTASSIUM E 332 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%.
333 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%.
334 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%.
335 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%.
336 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%.
337 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%.
338 ACETIC ACID E, H The concentration in the medicine must be no more than 80%.
339 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%.
340 ACETOMENAPHTHONE A, E 341 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%.
342 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%.
343 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%.
344 ACETOXYDIHYDRODICYCLOPENTADIENE E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
345 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%.
346 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%.
347 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%.
348 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%.
349 ACETYL LEVOCARNITINE HYDROCHLORIDE A, E 350 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%.
351 ACETYLATED LANOLIN E Only for use in topical medicines for dermal application.
352 ACETYLATED LANOLIN ALCOHOL E Only for use in topical medicines for dermal application.
353 ACETYLATED MONOGLYCERIDES E 354 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%.
355 ACETYLCYSTEINE E Only for use in topical medicines for dermal application.
The concentration in the medicine must be no more than 0.001%.
356 ACHILLEA ERBA-ROTTA SUBSP. MOSCHATA A, H 357 ACHILLEA MILLEFOLIUM A, E, H Beta-arbutin is a mandatory component of Achillea millefolium.
When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.
When for dermal application exclusively to the face:
a) the concentration of beta-arbutin in the medicine must not be more than 7%;
b) hydroquinone is a mandatory component; and
c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.
When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
358 ACHILLEA PTARMICA A, H 359 ACHYRANTHES ASPERA A, H 360 ACHYRANTHES BIDENTATA A, H 361 ACHYRANTHES FAURIEI A, H 362 ACID GREEN 25 E Permitted for use only as a colour for topical use.
363 ACID RED 33 E Permitted for use only as a colour for topical use.
364 ACID RED 87 E, H Only for use as an active homoeopathic ingredient or for excipient use as a colour in topical medicines.
365 ACID TREATED WAXY MAIZE STARCH E 366 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%.
367 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.
368 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.
369 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.
370 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.
371 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%.
372 ACRYLAMIDES COPOLYMER E Only for use in topical medicines for dermal application.
373 ACRYLATES COPOLYMER E Only for use in topical medicines for dermal application.
374 ACRYLATES/ACRYLAMIDE COPOLYMER E Only for use in topical medicines for dermal application.
375 ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER E Only for use in topical medicines for dermal application.
376 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%.
377 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%.
378 ACRYLATES/OCTYLACRYLAMIDE COPOLYMER E Only for use in topical medicines for dermal application.
379 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%.
380 ACRYLATES/VA COPOLYMER E Only for use in topical medicines for dermal application.
381 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%.
382 ACTAEA CIMICIFUGA A, H 383 ACTAEA HERACLEIFOLIA A, H 384 ACTAEA PACHYPODA A, H 385 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.'
386 ACTAEA SIMPLEX A, H 387 ACTAEA SPICATA A, H 388 ACTINIDIA CHINENSIS A, H 389 ACTINIDIA DELICIOSA A, H 390 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.
391 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).
392 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)'
393 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)'
394 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)'
395 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)'
396 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)'
397 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)'
398 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)'
399 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)'
400 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)'
401 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)'
402 ADENOPHORA STRICTA A, H 403 ADENOPHORA TRIPHYLLA A, H 404 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%.
405 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%.
406 ADENOSINE TRIPHOSPHATE E Only for use in topical medicines for dermal application.
407 ADENOSINE TRIPHOSPHATE DISODIUM E Only for use in topical medicines for dermal application.
408 ADIANTUM CAPILLUS-VENERIS A, H 409 ADIPIC ACID E 410 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%.
411 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%.
412 ADRENALINE (EPINEPHRINE) H Only for use as an active homoeopathic ingredient.
413 ADZUKI BEAN E 414 AEGOPODIUM PODAGRARIA A, H 415 AESCULUS CHINENSIS A, H 416 AESCULUS GLABRA A, H 417 AESCULUS HIPPOCASTANUM A, H 418 AESCULUS X CARNEA A, H 419 AETHUSA CYNAPIUM H Only for use as an active homoeopathic ingredient.
420 AGAR A, E 421 AGASTACHE RUGOSA A, H 422 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%.
423 AGAVE AMERICANA A, E, H 424 AGRIMONIA EUPATORIA A, E, H 425 AGRIMONIA REPENS A, H 426 AGROSTIS TENUIS A, H 427 AILANTHUS ALTISSIMA A, H 428 AJUGA CHAMAEPITYS A, H 429 AJUGA REPTANS A, H 430 ALANINE A, E 431 ALANYLGLUTAMINE A Only for use in oral medicines.
432 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.
433 ALBIZIA JULIBRISSIN A, H 434 ALBIZIA LEBBECK A, H 435 ALCEA ROSEA A, H 436 ALCHEMILLA ALPINA A, H 437 ALCHEMILLA ARVENSIS A, H 438 ALCHEMILLA VULGARIS A, H 439 ALETRIS FARINOSA A, H 440 ALETRIS SPICATA A, H 441 ALEURITES MOLUCCANUS SEED OIL E Only for use in topical medicines for dermal application.
442 ALFADEX A, E Only for use in oral medicines.
The maximum daily dose must provide no more than 6 g of alfadex.
443 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 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).
444 ALGINIC ACID E 445 ALISMA ORIENTALE A, H 446 ALISMA PLANTAGO AQUATICA A, H 447 ALKANNA TINCTORIA A, H 448 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%.
449 ALLANTOIN E Only for use in topical medicines for dermal application.
450 ALLIARIA PETIOLATA A, H 451 ALLIUM CEPA A, H 452 ALLIUM FISTULOSUM A, H 453 ALLIUM HIEROCHUNTINUM A, H 454 ALLIUM MACROSTEMON A, H 455 ALLIUM ODORUM A, H 456 ALLIUM PORRUM A, H 457 ALLIUM SATIVUM A, E, H 458 ALLIUM SCHOENOPRASUM A, H 459 ALLIUM URSINUM A, H 460 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%.
461 ALLURA RED AC E Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
462 ALLURA RED AC ALUMINIUM LAKE E Permitted for use only as a colour for oral and topical use.
463 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%.
464 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%.
465 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%.
466 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%.
467 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%.
468 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%.
469 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%.
470 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%.
471 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%.
472 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%.
473 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%.
474 ALMOND E 475 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%.
476 ALNUS GLUTINOSA A, H 477 ALNUS INCANA SUBSP. RUGOSA A, H 478 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'.
479 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'.
480 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'.
481 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'.
482 ALOYSIA CITRODORA A, H 483 ALPHA CASOZEPINE ENRICHED HYDROLYSED MILK PROTEIN A Only for use in oral medicines.
The following warning statement is required on the medicine label:
- (BABY3) 'Not suitable for use in children under the age of 12 months except on the advice of a health professional.’ (or words to that effect).
484 ALPHA LIPOIC ACID A 485 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%.
486 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%.
487 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%.
488 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%.
489 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%.
490 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%.
491 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%.
492 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%.
493 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%.
494 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%.
495 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%.
496 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%.
497 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%.
498 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%.
499 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%.
500 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%.
501 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%.
502 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%.
503 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%.
504 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%.
505 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%.
506 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%.
507 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%.
508 ALPHA-SANTALOL E alpha-Santalol must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing alpha-santalol must not be more than 1% of the total medicine.
509 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%.
510 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%.
511 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%.
512 ALPINIA GALANGA A, H 513 ALPINIA HAINANENSIS A, H 514 ALPINIA OFFICINARUM A, H 515 ALPINIA OXYPHYLLA A, H 516 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.
517 ALSTONIA BOONEI A, H 518 ALSTONIA CONSTRICTA H Only for use as an active homoeopathic ingredient.
519 ALTERNANTHERA PHILOXEROIDES A, H 520 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%.
521 ALTHAEA OFFICINALIS A, E, H 522 ALUM DODECAHYDRATE A, E, H 523 ALUMINIUM CHLOROHYDRATE E Only for use in topical medicines for dermal application.
524 ALUMINIUM CITRATE E Only for use in topical medicines for dermal application.
525 ALUMINIUM DISTEARATE E Only for use in topical medicines for dermal application.
526 ALUMINIUM HYDROXIDE E Only for use in topical medicines for dermal application.
527 ALUMINIUM HYDROXIDE HYDRATE E Only for use in topical medicines for dermal application.
528 ALUMINIUM MAGNESIUM SILICATE E The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is:
- listed in the Register on or after 1 March 2021; or
- released for supply after 1 March 2022.
(a) Magnesium is a mandatory component of aluminium magnesium silicate.
(b) When used in a medicine:
(i) with an oral route of administration;
(ii) not indicated for laxative (or related) use; and
(iii) where the maximum recommended daily dose for:
(A ) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;
(B) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or
(C) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;
the following warning statement is required on the medicine label:
- (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect).
(c) When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.
529 ALUMINIUM MONOSTEARATE E Only for use in topical medicines for dermal application.
530 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.
531 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.
532 ALUMINIUM SODIUM SILICATE E 533 ALUMINIUM STARCH OCTENYLSUCCINATE E The concentration in the medicine must be no more than 7%.
534 ALUMINIUM STEARATE E Only for use in topical medicines for dermal application.
535 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%.
536 AMARANTH E Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
537 AMARANTH ALUMINIUM LAKE E Permitted for use only as a colour for oral and topical use
538 AMARANTHUS HYBRIDUS A, H 539 AMARANTHUS RETROFLEXUS A, H 540 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%.
541 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%.
542 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%.
543 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%.
544 AMBROSIA ARTEMISIIFOLIA A, H 545 AMBROSIA PSILOSTACHYA A, H 546 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%.
547 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%.
548 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%.
549 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%.
550 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%.
551 AMMONIO METHACRYLATE COPOLYMER E Only for use in oral medicines.
552 AMMONIUM ACRYLATES COPOLYMER E Only for use in topical medicines for dermal application.
553 AMMONIUM ACRYLATES/ACRYLONITROGENS COPOLYMER E Only for use in topical medicines for dermal application.
554 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%.
555 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%.
556 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.
557 AMMONIUM BROMIDE H Only for use as an active homoeopathic ingredient.
558 AMMONIUM CARBONATE E, H Only for use as an active homoeopathic or excipient ingredient.
559 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.
560 AMMONIUM GLYCYRRHIZINATE E 561 AMMONIUM IODIDE H Only for use an active ingredient in homoeopathic medicines.
562 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%.
563 AMMONIUM LAURETH SULFATE E Only for use in topical medicines for dermal application.
564 AMMONIUM LAURYL SULFATE E Only for use in topical medicines for dermal application.
565 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%.
566 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%.
567 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%.
568 AMOMUM AROMATICUM A, H 569 AMOMUM VILLOSUM A, H 570 AMORPHOPHALLUS KONJAC A, H Only for use when the dosage form is not tablet.
571 AMPELODESMOS MAURITANICUS A, H 572 AMPELOPSIS JAPONICA A, H 573 AMYL ACETATE E Only for use in:
- topical medicines for dermal application; or
- combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total flavour proprietary excipient formulation in a medicine must not be more than 5%.
574 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%.
575 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%.
576 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%.
577 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%.
578 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%.
579 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%.
580 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%.
581 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%.
582 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%.
583 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%.
584 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%.
585 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%.
586 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%.
587 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%.
588 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%.
589 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%.
590 AMYLASE A Amylase must be derived from Aspergillus oryzae, and comply with the relevant compositional guideline.
591 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%.
592 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%.
593 AMYRIS BALSAMIFERA A, H 594 AMYRIS OIL WEST INDIAN A, E, H 595 ANACARDIUM OCCIDENTALE A, H 596 ANACYCLUS PYRETHRUM A, H 597 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%.
598 ANAESTHETIC ETHER H Only for use as an active homoeopathic ingredient.
599 ANAGALLIS ARVENSIS A, H 600 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%.
601 ANANAS COMOSUS A, E, H 602 ANAPHALIS SINICA A, H 603 ANDROGRAPHIS PANICULATA A, H The following warning statement is required on the label:
- (ANDROG) ‘Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis), stop use and seek immediate medical attention’ (or words to that effect).
The requirement specified in paragraph (a) below applies to medicines that contain the ingredient that are:
- listed in the Register on or after 1 March 2021; or
- released for supply after 1 March 2022.
(a) When for oral use, the following warning statement is required on the medicine label:
- (ANDROT) ‘Andrographis may cause taste disturbance including loss of taste. If you develop any adverse symptoms, stop use and seek medical advice’ (or words to that effect).
604 ANEMARRHENA ASPHODELOIDES A, E, H 605 ANEMONE ALTAICA A, H 606 ANEMONE CHINENSIS A, H 607 ANEMONE HEPATICA A, H 608 ANEMONE PULSATILLA A, H 609 ANEMONE RADDEANA A, H 610 ANETHOLE E 611 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%.
612 ANETHUM GRAVEOLENS A, E, H 613 ANGELICA ACUTILOBA A, H 614 ANGELICA ANOMALA A, H 615 ANGELICA ARCHANGELICA A, E, H 616 ANGELICA ATROPURPUREA A, H 617 ANGELICA DAHURICA A, E, H 618 ANGELICA DECURSIVA A, H 619 ANGELICA POLYMORPHA A, E, H 620 ANGELICA PUBESCENS A, E, H 621 ANGELICA ROOT DRY A, H 622 ANGELICA ROOT OIL A, E, H 623 ANGELICA SEED OIL A, E, H 624 ANGELICA STEM E 625 ANIBA ROSAEODORA A, E, H 626 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%.
627 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%.
628 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)'
629 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%.
630 ANISEED DRY A, E, H 631 ANISEED POWDER A, E, H 632 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%.
633 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%.
634 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%.
635 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%.
636 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%.
637 ANNATTO E Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
638 ANOGEISSUS LATIFOLIA A, E, H 639 ANTENNARIA DIOICA A, E, H 640 ANTHOCYANINS E 641 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%.
642 ANTHRISCUS CEREFOLIUM A, H 643 ANTHYLLIS VULNERARIA A, H 644 ANTIMONY POTASSIUM TARTRATE TRIHYDRATE H Only for use as an active homoeopathic ingredient.
645 ANTIMONY TRISULFIDE H Only for use as an active homoeopathic ingredient.
646 APIUM GRAVEOLENS A, E, H 647 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%.
648 APOMORPHINE HYDROCHLORIDE HEMIHYDRATE H Only for use as an active homoeopathic ingredient.
649 APPLE E 650 APPLE CIDER VINEGAR E 651 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%.
652 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%.
653 APPLE FIBRE E 654 APRICOT E 655 APRICOT KERNEL OIL PEG-6 ESTERS E Only for use as an excipient in topical medicines for dermal application.
656 AQUILARIA MALACCENSIS A, H 657 AQUILARIA SINENSIS A, H 658 AQUILEGIA VULGARIS A, H 659 ARACHIDONIC ACID E Only for use in topical medicines for dermal application.
660 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%.
661 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%.
662 ARACHIDYL PROPIONATE E Only for use in topical medicines for dermal application.
663 ARACHIS HYPOGAEA A, E, H 664 ARACHIS OIL A, E, H 665 ARALIA CORDATA A, H 666 ARALIA HISPIDA A, H 667 ARALIA NUDICAULIS A, H 668 ARALIA RACEMOSA A, H 669 ARCTIUM LAPPA A, E, H 670 ARCTIUM MINUS A, H 671 ARCTOSTAPHYLOS UVA-URSI A, E, H Beta-arbutin is a mandatory component of Arctostaphylos uva-ursi.
When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.
When for dermal application exclusively to the face:
a) the concentration of beta-arbutin in the medicine must not be more than 7%;
b) hydroquinone is a mandatory component; and
c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.
When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
672 ARDISIA JAPONICA A, H 673 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%.
674 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.
675 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.'
676 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%.
677 ARISAEMA ATRORUBENS A, H The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
678 ARISAEMA CONSANGUINEUM A, H The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
679 ARISAEMA JAPONICUM A, H The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
680 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).
681 ARNEBIA EUCHROMA A, H 682 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.
683 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.
684 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.
685 ARRHENATHERUM ELATIUS A, H 686 ARROWROOT A, E, H 687 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%.
688 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%.
689 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%.
690 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%.
The following warning statement is required on the medicine label:
- (PREGNT2) ‘Do not use if pregnant or likely to become pregnant.’
691 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%.
The following warning statement is required on the medicine label:
- (PREGNT2) ‘Do not use if pregnant or likely to become pregnant.’
692 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%.
693 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%.
694 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%.
695 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%.
696 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%.
697 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%.
698 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%.
699 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%.
700 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%.
701 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%.
702 ARTERY H Only for use as an active homoeopathic ingredient.
703 ARTHROSPIRA MAXIMA A, E, H 704 ARTHROSPIRA PLATENSIS A, E, H 705 ARUM MACULATUM A, H The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
706 ASAFOETIDA GUM A, H 707 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%.
708 ASARUM EUROPAEUM A, H 709 ASARUM HETEROTROPOIDES A, H 710 ASARUM OIL E 711 ASARUM SIEBOLDII A, E, H 712 ASCLEPIAS TUBEROSA A, H 713 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.
714 ASCORBIC ACID A, E 715 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%.
716 ASCORBYL METHYLSILANOL PECTINATE E Only for use in topical medicines for dermal application.
5073 TURNERA DIFFUSA A, E, H Beta-arbutin is a mandatory component of Turnera diffusa.
When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.
When for dermal application exclusively to the face:
a) the concentration of beta-arbutin in the medicine must not be more than 7%;
b) hydroquinone is a mandatory component; and
c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.
When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
5074 TURNIP E 5075 TURPENTINE OIL A, E The concentration in the medicine must be no more than 25%.
5076 TYPHA ANGUSTIFOLIA A, H 5077 TYPHA LATIFOLIA A, H 5078 TYPHONIUM GIGANTEUM A, H 5079 TYROSINE A, E
Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine
Note: See sections 5 and 6.
Permissible ingredients and requirements Column 1 Column 2 Column 3 Column 4 Item Ingredient name Purpose Specific requirements 5080 UBIDECARENONE A, E When used as an excipient, the route of administration must be topical and the concentration in the medicine must not be more than 0.05%.
Not to be included in medicines intended for use in the eye.
When for internal use, the maximum recommended daily dose must not provide more than 300 milligrams of ubidecarenone.
When for internal use in combination with Ubiquinol-10, the maximum recommended daily dose must not provide more than 300 milligrams of ubiquinol-10 and ubidecarenone combined.
When for internal use, the following warning statement is required on the medicine label:
- (WARF) 'Do not take while on warfarin therapy without medical advice'.
5081 UBIQUINOL-10 A, E When used as an excipient, the route of administration must be topical and the concentration in the medicine must be no more than 0.05%.
Not to be included in medicines intended for use in the eye.
When for internal use, the maximum recommended daily dose must provide no more than 300 milligrams of ubiquinol-10.
When used in combination with ubidecarenone, the maximum recommended daily dose must provide no more than 300 mg of ubiquinol-10 and ubidecarenone combined.
The medicine requires the following warning statement on the medicine label:
- (WARF) 'Do not take while on warfarin therapy without medical advice.'
5082 ULEX EUROPAEUS A, H 5083 ULMUS AMERICANA A, H 5084 ULMUS CAMPESTRIS A, H 5085 ULMUS GLABRA A, H 5086 ULMUS MINOR A, H 5087 ULMUS PARVIFOLIA A, H 5088 ULMUS PUMILA A, H 5089 ULMUS RUBRA A, H 5090 ULTRALIDE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5091 ULTRAMARINE BLUE E Permitted for use only as a colour for topical use.
5092 ULVA LACTUCA A, H Iodine is a mandatory component of Ulva lactuca.
Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 0.1%.
5093 UMBELLULARIA CALIFORNICA A, H 5094 UNCARIA GAMBIR A, H 5095 UNCARIA RHYNCOPHYLLA A, H 5096 UNCARIA SINENSIS A, H 5097 UNCARIA TOMENTOSA A, H 5098 UNDARIA PINNATIFIDA A, H Whole dried Undaria pinnatifida must not contain the holdfast.
Only for use in oral medicines.
5099 UNDECANAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5100 UNDECANOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour.
If used as a flavour the total flavour concentration in a medicine must be no more than 5%.
5101 UNDECENOIC ACID E 5102 UNDECYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5103 UNDECYLCRYLENE DIMETICONE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 10%.
5104 UNDECYLENAMIDE DEA E 5105 UNDECYLENOYL PEG-5 PARABEN E Only for use in topical medicines for dermal application.
5106 URANIUM NITRATE H Only for use as an active homoeopathic ingredient.
5107 UREA A, E, H Only for use in topical medicines for dermal application.
The concentration in the medicine must be no more than 10% (w/w).
5108 URTICA DIOICA A, E, H 5109 URTICA URENS A, H 5110 USNEA BARBATA A, H 5111 UVA URSI LEAF DRY A, H 5112 UVA URSI LEAF POWDER A, E, H 5113 VA/BUTYL MALEATE/ISOBORNYL ACRYLATE COPOLYMER E Vinyl acetate is a mandatory component of VA/butyl maleate/isobornyl acrylate copolymer.
The concentration of vinyl acetate in the medicine must be no more than 0.01% or 100 ppm.
Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 5%.
5114 VACCARIA SEGATALIS A, H 5115 VACCINIUM BRACTEATUM A, H 5116 VACCINIUM CORYMBOSUM E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5117 VACCINIUM MACROCARPON A, E, H 5118 VACCINIUM MYRTILLOIDES A, H 5119 VACCINIUM MYRTILLUS A, E, H 5120 VACCINIUM OXYCOCCUS A, H 5121 VACCINIUM VITIS-IDAEA A, H Beta-arbutin is a mandatory component of Vaccinium vitis-idaea.
When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.
When for dermal application exclusively to the face:
a) the concentration of beta-arbutin in the medicine must not be more than 7%;
b) hydroquinone is a mandatory component; and
c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.
When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
5122 VALENCENE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5123 VALERALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5124 VALERIAN DRY A, H 5125 VALERIAN OIL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5126 VALERIAN POWDER A, H 5127 VALERIANA EDULIS A, H 5128 VALERIANA OFFICINALIS A, H 5129 VALERIANA SORBIFOLIA A, H 5130 VALERIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5131 VALINE A, E 5132 VANADIUM H 5133 VANILLA E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5134 VANILLA DRY A, E, H 5135 VANILLA EXTRACT E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5136 VANILLA OLEORESIN E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5137 VANILLA PLANIFOLIA A, E, H 5138 VANILLA POWDER A, E, H 5139 VANILLA TAHITENSIS A, H 5140 VANILLIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5141 VANILLIN E 5142 VANILLIN ISOBUTYRATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5143 VANILLYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5144 VAT RED 1 E Permitted for use only as a colour for topical use.
5145 VAT RED 1 ALUMINIUM LAKE E Permitted for use only as a colour for topical use.
5146 VAT RED 5 E Permitted for use only as a colour for topical use.
5147 VEGETABLE OIL E 5148 VEGETABLE OIL PHYTOSTEROL ESTERS A Only for use in oral medicines.
The medicine requires the following warning statement on the medicine label:
- (PREGNT) 'Not recommended for use by pregnant and lactating women (or words to that effect).'
5149 VEIN H Only for use as an active homoeopathic ingredient.
5150 VERATRALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5151 VERATROL 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%.
5152 VERATRUM ALBUM A, H Solanidine is a mandatory component of Veratrum album.
The concentration of equivalent dry Veratrum album in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.
5153 VERBASCUM DENSIFLORUM A, H 5154 VERBASCUM THAPSUS A, H 5155 VERBENA OFFICINALIS A, H 5156 VERBENA OIL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5157 VERONICA CHAMAEDRYS A, H 5158 VERONICA OFFICINALIS A, H 5159 VERONICASTRUM VIRGINICUM A, E, H 5160 VERTONAL 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 vertonal must be no more than 0.2%.
The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
5161 VETIVER OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5162 VETIVERYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5163 VIBURNUM OPULUS A, E, H 5164 VIBURNUM PRUNIFOLIUM A, E, H 5165 VICIA FABA A, H Levodopa is a mandatory component of Vicia faba.
The concentration of levodopa in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
5166 VIGNA ANGULARIS VAR. ANGULARIS A, H 5167 VIGNA RADIATA A, H 5168 VIGNA UMBELLATA A, H 5169 VINCA MAJOR A, H Vincamine is a mandatory component of Vinca major.
The concentration of vincamine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%.
5170 VINCA MINOR A, H Vincamine and vincristine are mandatory components of Vinca minor.
The concentration of vincamine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%.
The concentration of Vincristine in the medicine must be no more than 10mg/kg or 10mg/L or 0.001%
5171 VINCETOXICUM OFFICINALE A, H 5172 VINEGAR E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5173 VIOLA ODORATA A, E, H 5174 VIOLA TRICOLOR A, H 5175 VIOLA YEDOENSIS A, H 5176 VIOLET LEAF ABSOLUTE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5177 VIPER H Only for use as an active homoeopathic ingredient.
5178 VISCUM ALBUM A, E, H 5179 VISCUM COLORATUM A, H 5180 VISCUM FLAVESCENS A, H 5181 VITELLARIA PARADOXA A, E, H 5182 VITEX AGNUS-CASTUS A, E, H When the ingredient is in a medicine that is for internal use, the following warning statement is required on the label:
- (VAC) 'Vitex agnus-castus may affect hormones and medicines such as oral contraceptives. Consult your health professional before use' (or words to that effect).
5183 VITEX NEGUNDO A, H 5184 VITEX ROTUNDIFOLIA A, H 5185 VITEX TRIFOLIA A, H 5186 VITIS VINIFERA A, E, H 5187 VITREOSCILLA CONCENTRATE E Only for use in topical medicines for dermal application.
The concentration in the medicine must be no more than 0.1%.
5188 VP/ACRYLATES/LAURYL 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 not be more than 2.00%.
5189 WAHLENBERGIA GRACILIS A, H 5190 WALNUT E 5191 WALNUT OIL E 5192 WATER MELON E 5193 WHEAT E Gluten is a mandatory component of Wheat when the route of administration is other than topical and mucosal.
5194 WHEAT BRAN E Gluten is a mandatory component of Wheat bran when the route of administration is other than topical and mucosal.
5195 WHEAT DEXTRIN A, E Gluten is a mandatory component of wheat dextrin.
Only for use when the dosage form is capsule, tablet or pill.
5196 WHEAT GERM E Gluten is a mandatory component of Wheat germ when the route of administration is other than topical and mucosal.
5197 WHEAT GERM GLYCERIDES E Gluten is a mandatory component of wheat germ glycerides when the route of administration is other than topical and mucosal.
5198 WHEAT LEAF E 5199 WHEAT SPROUT E Gluten is a mandatory component of Wheat sprout when the route of administration is other than topical and mucosal.
5200 WHEAT STARCH E When the route of administration is other than topical or mucosal, gluten is a mandatory component of wheat starch.
5201 WHEATGERM OIL A, E, H 5202 WHEY POWDER E Lactose is a mandatory component of Whey powder when the route of administration is oral.
5203 WHEY PROTEIN E Lactose is a mandatory component of Whey protein when the route of administration is oral.
5204 WHEY PROTEIN CONCENTRATE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5205 WHITE BEESWAX E 5206 WHITE HOREHOUND HERB DRY A, H 5207 WHITE HOREHOUND HERB POWDER A, H 5208 WHITE SOFT PARAFFIN A, E When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time.
5209 WHOLE DRY MILK E 5210 WIKSTROEMIA VIRIDIFLORA A, H 5211 WILD CARROT HERB DRY A, E, H 5212 WILD CARROT HERB POWDER A, H 5213 WILD CHERRY BARK DRY A, H 5214 WILD CHERRY BARK POWDER A, H 5215 WILD LETTUCE LEAF DRY A, H 5216 WILD LETTUCE LEAF POWDER A, H 5217 WINTERGREEN OIL A, E, H Methyl salicylate is a mandatory component of wintergreen oil.
Not to be included in medicines for use in the eye or on damaged skin.
When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%.
When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging.
When the concentration of methyl salicylate in a liquid preparation is more than 5%, and the dosage form is spray, the medicine does not require child resistant packaging if:
- the delivery device is engaged into the container in such a way that prevents it from being readily removed;
- direct suction through the delivery device results in delivery of no more than one dosage unit; and
- actuation of the spray device is ergonomically difficult for young children to accomplish.
The following warning statement is required on the medicine label:
- (METSAL) 'Contains methyl salicylate' (or words to that effect).
When for use in topical medicines for dermal application:
i) the concentration of methyl salicylate in the medicine must not be more than 25%;
ii) the following warning statements are required on the medicine label:
- (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect);
- (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less';
- (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect);
- (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect);
iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label:
- (IRRIT) 'If irritation develops, discontinue use'.
5218 WITHANIA SOMNIFERA A, E, H The medicine requires the following warning statement on the label:
- (WITHANIA) 'If you are pregnant, or considering becoming pregnant, do not take without consulting a health professional' (or words to that effect)
unless:
(a) the plant part is root;
(b) the plant preparation is an extract;
(c) the extraction solvents are only water, ethanol or methanol; and
(d) the maximum recommended daily dose of the medicine contains no more than the equivalent quantity of 12 g dry root.
5219 WOLFIPORIA COCOS A, E, H 5220 WOOL ALCOHOLS E Only for use in topical medicines for dermal application.
5221 WOOL FAT A, E When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time.
5222 XANTHAN GUM E 5223 XANTHIUM SIBIRICUM A, H 5224 XANTHIUM STRUMARIUM A, H 5225 XANTHOMONA CAMPESTRIS A, H 5226 XEROPHYLLUM ASPHODELOIDES A, H 5227 XYLENE E The residual solvent limit for xylene is 21.7 mg per maximum recommended daily dose.
The concentration in the medicine must be no more than 0.217%.
5228 XYLITOL E 5229 XYLOSE E 5230 YAM E 5231 YARROW HERB DRY A, H 5232 YARROW HERB POWDER A, H 5233 YEAST AUTOLYSATE E 5234 YEAST DRIED A, E, H 5235 YELLOW 2G E Permitted for use only as a colour for topical use.
5236 YELLOW BEESWAX E 5237 YELLOW MERCURIC OXIDE H Only for use as an active homoeopathic ingredient.
5238 YELLOW SOFT PARAFFIN A, E Only for use in topical medicines for dermal application.
When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time.
5239 YLANG YLANG OIL A, E, H 5240 YUCCA BACCATA A, H 5241 YUCCA ELATA A, H 5242 YUCCA FILAMENTOSA A, H 5243 YUCCA GLORIOSA A, H 5244 Z-BETA-DAMASCONE E Z – beta damascone must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total concentration of flavour proprietary excipient formulations containing Z – beta damascone must not be more than 5% of the total medicine.
5245 ZANTHOXYLUM AMERICANUM A, H 5246 ZANTHOXYLUM BUNGEANUM A, E, H 5247 ZANTHOXYLUM CLAVA-HERCULIS A, H 5248 ZANTHOXYLUM NITIDUM A, H 5249 ZANTHOXYLUM PIPERITUM A, H 5250 ZANTHOXYLUM SIMULANS A, H 5251 ZEA MAYS A, E, H 5252 ZEAXANTHIN A, E 5253 ZEIN E 5254 ZINC H Only for use as an active homoeopathic ingredient.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
5255 ZINC AMINO ACID CHELATE A, E, H When used internally, zinc is a mandatory component of zinc amino acid chelate.
The concentration of zinc in zinc amino acid chelate must be no more than 30%.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5256 ZINC ASCORBATE A, E, H When used internally, zinc is a mandatory component of zinc ascorbate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5257 ZINC ASCORBATE MONOHYDRATE A, E, H When used internally, zinc is a mandatory component of zinc ascorbate monohydrate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
5258 ZINC CHLORIDE A, E, H The concentration of zinc chloride in the medicine must be no more than 5%.
When used internally, zinc is a mandatory component of zinc chloride.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5259 ZINC CITRATE A, E, H When used internally, zinc is a mandatory component of zinc citrate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5260 ZINC CITRATE DIHYDRATE A, E, H When used internally, zinc is a mandatory component of zinc citrate dihydrate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5261 ZINC CITRATE TRIHYDRATE A, E, H When used internally, zinc is a mandatory component of zinc citrate trihydrate. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5262 ZINC DIASPARTATE A When used internally, zinc is a mandatory component of zinc diaspartate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5263 ZINC GLUCONATE A, E, H When used internally, zinc is a mandatory component of zinc gluconate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5264 ZINC GLYCINATE A When used internally, zinc is a mandatory component of Zinc glycinate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5265 ZINC GLYCINATE MONOHYDRATE A When used internally, zinc is a mandatory component of Zinc glycinate monohydrate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect)'.
5266 ZINC LACTATE E Only for use in topical and dental medicines and not to be included in medicines intended for use in the eye.
The concentration of zinc lactate in a medicine intended for topical use should be no more than 2%.
The concentration of Zinc lactate in a medicine for 'dental' use in toothpaste medicines must be no more than 2.5%.
Zinc lactate is not to be included in dental / toothpaste medicines intended for use by children less than 12 years old.
Medicines containing Zinc lactate for dental use require the following warning statement on the medicine label:
- (CHILD3) 'Use in children under 12 years is not recommended'.
5267 ZINC LACTATE DIHYDRATE E Only for use in topical and dental medicines and not to be included in medicines intended for use in the eye.
The concentration of Zinc lactate dihydrate in a medicine intended for topical use should be no more than 2%.
The concentration of Zinc lactate dihydrate in a medicine for 'dental' use in toothpaste medicines must be no more than 2.5%.
Zinc lactate dihydrate is not to be included in dental / toothpaste medicines intended for use by children less than 12 years old.
Medicines containing Zinc lactate for dental use require the following warning statement on the medicine label:
- (CHILD3) 'Use in children under 12 years is not recommended'.
5268 ZINC LYSINATE A When used internally, zinc is a mandatory component of Zinc lysinate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5269 ZINC METHIONINE SULFATE A For topical use, the concentration of zinc methionine sulfate must be no more than 5%.
When used internally, zinc is a mandatory component of zinc methionine sulfate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5270 ZINC MYRISTATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 0.1%.
5271 ZINC OXIDE A, E, H When used internally, zinc is a mandatory component of zinc oxide.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR
-'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period’ (or words to that effect).
When used in primary sunscreen products, the following warning statements are required on the 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).
5272 ZINC PARA-PHENOLSULFONATE E The concentration of zinc para-phenolsulfonate in the medicine must not exceed 5%.
When used internally, zinc is a mandatory component of zinc para-phenolsulfate.
The percentage of zinc from zinc para-phenolsulfonate should be calculated based on the molecular weight of zinc para-phenolsulfonate.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period. OR WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period' (or words to that effect).
5273 ZINC STEARATE E When used internally, zinc is a mandatory component of zinc stearate.
The percentage of zinc from zinc stearate should be calculated based on the molecular weight of zinc stearate.
5274 ZINC SUCCINATE A, E, H When used internally, zinc is a mandatory component of zinc succinate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' or
- 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5275 ZINC SULFATE A, E For topical use, the concentration of zinc sulfate must be no more than 5%.
For internal use, zinc is a mandatory component of zinc sulfate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR
- 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5276 ZINC SULFATE HEPTAHYDRATE A, E For topical use, the concentration of zinc sulfate must be no more than 5%.
For internal use, zinc is a mandatory component of zinc sulfate heptahydrate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR
- 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5277 ZINC SULFATE HEXAHYDRATE A, E, H For topical use, the concentration of zinc sulfate must be no more than 5%.
For internal use, zinc is a mandatory component of zinc sulfate hexahydrate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR
- 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5278 ZINC SULFATE MONOHYDRATE A, E, H When the route of administration is topical the concentration of zinc sulfate in the medicine must be no more than 5%.
When the medicine is for internal use, zinc is a mandatory component of zinc sulfate monohydrate.
When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR
- 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period (or words to that effect).'
5279 ZINC VALERATE H Only for use as an active homoeopathic ingredient.
For internal use, zinc is a mandatory component of zinc valerate.
The percentage of zinc from zinc valerate should be calculated based on the molecular weight of zinc valerate.
5280 ZINGERONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
5281 ZINGIBER OFFICINALE A, E, H When for oral use AND the extract ratio is equal to or more than 25:1 AND the equivalent dry weight per dosage unit is equal to or more than 2g, the medicine requires the following warning statement on the medicine label:
- (GINGER) 'Individuals taking anticoagulants should seek medical advice before taking this medicine.' AND 'Individuals at risk of bleeding problems should seek advice from their healthcare practitioner prior to taking this medicine'.
5282 ZIZIPHUS JUJUBA A, H 5283 ZIZIPHUS JUJUBA VAR. SPINOSA A, H 5284 ZIZYPHUS SATIVA A, H 5285 ZOSTERA MARINA A, H 5286 ZUCCHINI E
Schedule 2—Repeals
Note: See section 7.
Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2021
1 The whole of the instrument
Repeal the instrument.
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