Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019 (Cth)
Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019
made under subsection 26BB(1) of the
Therapeutic Goods Act 1989
Compilation No. 1
Compilation date: 2 September 2019
Includes amendments up to: Therapeutic Goods Amendment (Permissible Ingredients) Determination (No. 1) 2019
This compilation is in 6 volumes
Volume 1: Sections 1–6 (pages 1-2)
Schedule 1 (1,7,7-TRIMETHYLBICYCLO(2.2.1)HEPT-2-YL)-CYCLOHEXANOL)–AZULENE (pages 3 -161)
Volume 2: Schedule 1 BACILLUS COAGULANS–EVERNIA PRUNASTRA EXTRACT (pages 162-479)
Volume 3: Schedule 1 FABIANA IMBRICATA–JUSTICIA ADHATODA
(pages 480-640)
Volume 4: Schedule 1 KADSURA COCCINEA–OYSTER SHELL
(pages 641-817)
Volume 5: Schedule 1 P-ALPHA-DIMETHYL STYRENE–TYROSINE
(pages 818-1146)
Volume 6: Schedule 1 UBIDECARENONE–ZUCCHINI (pages 1147-1191)
Endnotes (pages 1192-1195)
About this compilation
This compilation
This is a compilation of the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019 that shows the text of the law as amended and in force on 2 September 2019 (the compilation date).
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register ( The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.
Self-repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
Contents
1 Name........................................................................................................................................ 1
3 Authority.................................................................................................................................. 1
4 Interpretation............................................................................................................................ 1
5 Permissible ingredients............................................................................................................. 2
6 Requirements in relation to permissible ingredients being contained in medicine..................... 2
Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine 3
Endnotes 1192
Endnote 1—About the endnotes.................................................................... 1192
Endnote 2—Abbreviation key....................................................................... 1193
Endnote 3—Legislation history..................................................................... 1194
Endnote 4—Amendment history.......................................................................................... 1195
Note: This compilation is in 6 volumes:
Volume 1: Sections 1–6 (pages 1-2)
Schedule 1 (1,7,7-TRIMETHYLBICYCLO(2.2.1)HEPT-2-YL)-CYCLOHEXANOL)–AZULENE (pages 3 -161)
Volume 2: Schedule 1 BACILLUS COAGULANS–EVERNIA PRUNASTRA EXTRACT (pages 162-479)
Volume 3: Schedule 1 FABIANA IMBRICATA–JUSTICIA ADHATODA
(pages 480-640)
Volume 4: Schedule 1 KADSURA COCCINEA–OYSTER SHELL
(pages 641-817)
Volume 5: Schedule 1 P-ALPHA-DIMETHYL STYRENE–TYROSINE
(pages 818-1146)
Volume 6: Schedule 1 UBIDECARENONE–ZUCCHINI
(pages 1147-1191)
Endnotes (pages 1192-1195)
1 Name
This instrument is the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019.
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; and
(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 to this instrument, which are associated with warning statements in relation to particular ingredients, are:
(a) terms from the code tables under the headings Indications or 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 to this instrument 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 to this instrument, 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;
(b) the ingredient must comply with the requirements specified in relation to the ingredient in column 4 of that item;
(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.
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 | (1,7,7-TRIMETHYLBICYCLO(2.2.1)HEPT-2-YL)-CYCLOHEXANOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 2 | (1R,2S,5R)-N-(4-METHOXYPHENYL)-5-METHYL-2-(1-METHYLETHYL) CYCLOHEXANECARBOXAMIDE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in the medicine must be no more than 5%. |
| 3 | (5E)-3-METHYL-5-CYCLOTETRADECEN-1-ONE | E | Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. |
| 4 | (5Z)-3-METHYL-5-CYCLOTETRADECEN-1-ONE | E | Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must be no more than 1%. |
| 5 | (E)-2-(3,5-DIMETHYLHEX-3-EN-2-YLOXY)-2-METHYLPROPYL CYCLOPROPANECARBOXYLATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 6 | (E)-3-METHYLCYCLOPENTADEC-5-EN-1-ONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 7 | (E, E)-2,6-NONADIENAL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. |
| 8 | (S)-LACTIC ACID | A, E, H | |
| 9 | (S)-S-ADENOSYLMETHIONINE DISULFATE DITOSYLATE DIHYDRATE | A | (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine disulfate ditosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' |
| 10 | (S)-S-ADENOSYLMETHIONINE DISULFATE TOSYLATE | A | (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine disulfate tosylate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' |
| 11 | (S)-S-ADENOSYLMETHIONINE DISULFATE TRITOSYLATE DIHYDRATE | A | (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine disulfate tritosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' |
| 12 | (S)-S-ADENOSYLMETHIONINE HEXASULFATE DIHYDRATE | A | (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine hexasulfate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' |
| 13 | (S)-S-ADENOSYLMETHIONINE HEXATOSYLATE DIHYDRATE | A | (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine hexatosylate dihydrate and must be declared in the application. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' |
| 14 | (S)-S-ADENOSYLMETHIONINE PENTASULFATE DIHYDRATE | A | (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine pentasulfate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: -(SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' |
| 15 | (S)-S-ADENOSYLMETHIONINE PENTATOSYLATE DIHYDRATE | A | (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine pentatosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' |
| 16 | (S)-S-ADENOSYLMETHIONINE TETRASULFATE DIHYDRATE | A | (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine tetrasulfate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' |
| 17 | (S)-S-ADENOSYLMETHIONINE TETRATOSYLATE DIHYDRATE | A | (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine tetratosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' |
| 18 | (S)-S-ADENOSYLMETHIONINE TRISULFATE DITOSYLATE DIHYDRATE | A | (S)-S-Adenosylmethionine is a mandatory component of (S)-S-Adenosylmethionine trisulfate ditosylate dihydrate. (S)-S-Adenosylmethionine in the form of sulfate tosylate or mixed sulfate/tosylate salts requires the following warning statement on the medicine label: - (SAME) 'Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a healthcare practitioner (or words to that effect)' |
| 19 | (Z)-HEX-3-ENYL 2-ETHYLBUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. |
| 20 | (Z, Z)-3,6-NONADIEN-1-OL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. |
| 21 | (±)-NARINGENIN | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. |
| 22 | 1,1,1-TRICHLOROETHANE | E | The concentration in the medicine must be no more than 25%. |
| 23 | 1,2-HEXANEDIOL | E | Only for use in topical medicines for dermal application and not to be included in topical products intended for use in the eye. The concentration in the medicine must be no more than 1%. |
| 24 | 1,3,4,6,7,8A-HEXAHYDRO-1,1,5,5-TETRAMETHYL-2H-2,4A-METHANONAPHTHALEN-8(5H)-ONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 25 | 1,3,5-UNDECATRIENE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. |
| 26 | 1,3-BUTYLENE GLYCOL | E | |
| 27 | 1,3-NONANEDIOL ACETATE, MIXED ESTERS | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. |
| 28 | 1,3-NONANEDIOL, DIACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 29 | 1,4-CINEOLE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1% |
| 30 | 1,4-DIOXACYCLOHEXADECANE-5,16-DIONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 31 | 1,5,9-TRIMETHYL-13-OXABICYCLO[10.1.0]TRIDECA-4,8-DIENE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 32 | 1,7,7-TRIMETHYLBICYCLO[4.4.0]DECAN-3-YL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 33 | 1-(2,2,6-TRIMETHYLCYCLOHEXYL)-3-HEXANOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 34 | 1-(2,6,6-TRIMETHYL-2-CYCLOHEXEN-1-YL)-1-PENTEN-3-ONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 35 | 1-(3,3-DIMETHYLCYCLOHEXYL)ETHYL FORMATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 36 | 1-(4-ISOPROPYLCYCLOHEXYL)ETHANOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 37 | 1-(5,5-DIMETHYL-1-CYCLOHEXEN-1-YL)-4-PENTEN-1-ONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 38 | 1-DODECANOL | E | Permitted for use: (a) only in combination with other permitted ingredients as a flavour; and (b) in topical medicines for dermal application. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. |
| 39 | 1-HEPTANOL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. |
| 40 | 1-HEXEN-3-OL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 41 | 1-METHOXY-4-PROPENYLBENZENE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. |
| 42 | 1-METHYL-2-[(1,2,2-TRIMETHYLBICYCLO[3.1.0]HEX-3-YL)METHYL]-CYCLOPROPANEMETHANOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 43 | 1-METHYL-3-(2-METHYLPROPYL)-CYCLOHEXANOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 44 | 1-METHYL-4-(4-METHYL-3-PENTENYL)-3-CYCLOHEXENE-1-CARBOXALDEHYDE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 45 | 1-OCTEN-3-ONE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. |
| 46 | 1-P-MENTHENE-8-THIOL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. |
| 47 | 1-PENTEN-3-OL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. |
| 48 | 10-UNDECEN-1-OL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. |
| 49 | 10-UNDECENAL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. |
| 50 | 16-HYDROXY-12-OXAHEXADECANOIC ACID, OMEGA-LACTONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 51 | 2,2,3-TRIMETHYLCYCLOPENT-3-ENE-1-ETHYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 52 | 2,2,5-TRIMETHYL-5-PENTYLCYCLOPENTANONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 53 | 2,2-DIMETHYL-3-(3-METHYL-2,4-PENTADIENYL)-OXIRANE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 54 | 2,2-DIMETHYL-3-PHENYLPROPANOLL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 55 | 2,2-DIMETHYL-5-(1-METHYLPROPEN-1-YL) TETRAHYDROFURAN | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. |
| 56 | 2,2-DIMETHYL-P-ETHYLPHENYL-PROPANENITRILE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 57 | 2,3,4-TRIMETHYL-3-PENTANOL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. |
| 58 | 2,3,5,6-TETRAMETHYLPYRAZINE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. |
| 59 | 2,3,5-TRIMETHYLPYRAZINE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. |
| 60 | 2,3-DIETHYLPYRAZINE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. |
| 61 | 2,3-DIHYDRO-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%. |
| 62 | 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%. |
| 63 | 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%. |
| 64 | 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%. |
| 65 | 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%. |
| 66 | 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%. |
| 67 | 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%. |
| 68 | 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%. |
| 69 | 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. |
| 70 | 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%. |
| 71 | 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%. |
| 72 | 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%. |
| 73 | 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%. |
| 74 | 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%. |
| 75 | 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. |
| 76 | 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. |
| 77 | 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%. |
| 78 | 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%. |
| 79 | 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%. |
| 80 | 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%. |
| 81 | 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% |
| 82 | 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%. |
| 83 | 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%. |
| 84 | 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%. |
| 85 | 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%. |
| 86 | 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%. |
| 87 | 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%. |
| 88 | 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%. |
| 89 | 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%. |
| 90 | 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%. |
| 91 | 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%. |
| 92 | 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%. |
| 93 | 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%. |
| 94 | 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%. |
| 95 | 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%. |
| 96 | 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%. |
| 97 | 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%. |
| 98 | 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%. |
| 99 | 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%. |
| 100 | 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%. |
| 101 | 2-AMINO-2-METHYL-1-PROPANOL | E | Only for use in topical medicines for dermal application. |
| 102 | 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%. |
| 103 | 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%. |
| 104 | 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%. |
| 105 | 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%. |
| 106 | 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%. |
| 107 | 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%. |
| 108 | 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%. |
| 109 | 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%. |
| 110 | 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%. |
| 111 | 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%. |
| 112 | 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%. |
| 113 | 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%. |
| 114 | 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%. |
| 115 | 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%. |
| 116 | 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%. |
| 117 | 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%. |
| 118 | 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%. |
| 119 | 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%. |
| 120 | 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%. |
| 121 | 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%. |
| 122 | 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%. |
| 123 | 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%. |
| 124 | 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%. |
| 125 | 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%. |
| 126 | 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%. |
| 127 | 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%. |
| 128 | 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%. |
| 129 | 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%. |
| 130 | 2-METHOXY-3-SECBUTYLPYRAZINE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 131 | 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%. |
| 132 | 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%. |
| 133 | 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%. |
| 134 | 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%. |
| 135 | 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%. |
| 136 | 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%. |
| 137 | 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%. |
| 138 | 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%. |
| 139 | 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%. |
| 140 | 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%. |
| 141 | 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%. |
| 142 | 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. |
| 143 | 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%. |
| 144 | 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%. |
| 145 | 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%. |
| 146 | 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%. |
| 147 | 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%. |
| 148 | 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%. |
| 149 | 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%. |
| 150 | 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%. |
| 151 | 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%. |
| 152 | 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%. |
| 153 | 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%. |
| 154 | 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%. |
| 155 | 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%. |
| 156 | 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%. |
| 157 | 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%. |
| 158 | 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%. |
| 159 | 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%. |
| 160 | 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%. |
| 161 | 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%. |
| 162 | 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%. |
| 163 | 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%. |
| 164 | 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%. |
| 165 | 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%. |
| 166 | 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%. |
| 167 | 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%. |
| 168 | 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%. |
| 169 | 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%. |
| 170 | 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%. |
| 171 | 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%. |
| 172 | 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%. |
| 173 | 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%. |
| 174 | 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%. |
| 175 | 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%. |
| 176 | 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%. |
| 177 | 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%. |
| 178 | 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%. |
| 179 | 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%. |
| 180 | 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%. |
| 181 | 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%. |
| 182 | 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%. |
| 183 | 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%. |
| 184 | 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%. |
| 185 | 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%. |
| 186 | 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%. |
| 187 | 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%. |
| 187A | 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%. |
| 188 | 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%. |
| 189 | 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%. |
| 190 | 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%. |
| 191 | 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%. |
| 192 | 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%. |
| 193 | 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%. |
| 194 | 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%. |
| 195 | 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%. |
| 196 | 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%. |
| 197 | 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%. |
| 198 | 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%. |
| 199 | 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%. |
| 200 | 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%. |
| 201 | 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%. |
| 202 | 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%. |
| 203 | 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%. |
| 204 | 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%. |
| 205 | 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%. |
| 206 | 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%. |
| 207 | 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%. |
| 208 | 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%. |
| 209 | 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%. |
| 210 | 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%. |
| 211 | 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%. |
| 212 | 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%. |
| 213 | 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%. |
| 214 | 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%. |
| 215 | 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%. |
| 216 | 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%. |
| 217 | 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%. |
| 218 | 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%. |
| 219 | 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%. |
| 220 | 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%. |
| 221 | 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%. |
| 222 | 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%. |
| 223 | 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%. |
| 224 | 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%. |
| 225 | 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%. |
| 226 | 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%. |
| 227 | 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%. |
| 228 | 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%. |
| 229 | 4-(4-HYDROXY-4-METHYLPENTYL)-3-CYCLOHEXENE CARBOXALDEHYDE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 230 | 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%. |
| 231 | 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%. |
| 232 | 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%. |
| 233 | 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%. |
| 234 | 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%. |
| 235 | 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%. |
| 236 | 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%. |
| 237 | 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%. |
| 238 | 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%. |
| 239 | 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%. |
| 240 | 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%. |
| 241 | 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%. |
| 242 | 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%. |
| 243 | 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%. |
| 244 | 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%. |
| 245 | 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%. |
| 246 | 4-METHYLBENZYLIDENE CAMPHOR | A | Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). |
| 247 | 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%. |
| 248 | 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%. |
| 249 | 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%. |
| 250 | 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%. |
| 251 | 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%. |
| 252 | 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%. |
| 253 | 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%. |
| 254 | 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%. |
| 255 | 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%. |
| 256 | 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%. |
| 257 | 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%. |
| 258 | 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%. |
| 259 | 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%. |
| 260 | 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%. |
| 261 | 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%. |
| 262 | 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%. |
| 263 | 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%. |
| 264 | 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%. |
| 265 | 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%. |
| 266 | 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%. |
| 267 | 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%. |
| 268 | 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%. |
| 269 | 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%. |
| 270 | 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%. |
| 271 | 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%. |
| 272 | 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%. |
| 273 | 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%. |
| 274 | 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%. |
| 275 | 6-METHYL-2-BUTEN-3-OL-2 | E | |
| 276 | 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%. |
| 277 | 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%. |
| 278 | 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%. |
| 279 | 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%. |
| 280 | 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%. |
| 281 | 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%. |
| 282 | 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%. |
| 283 | 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%. |
| 284 | ABELMOSCHUS MOSCHATUS | A, H | |
| 285 | ABELMOSCHUS MOSCHATUS SUBSP. MOSCHATUS | A, H | |
| 286 | ABIES BALSAMEA | A, H | |
| 287 | ABIES NIGRA | A, H | |
| 288 | ABIES PECTINATA | A, H | |
| 289 | ABIES SIBIRICA | A, H | |
| 290 | 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. |
| 291 | ABUTILON THEOPHRASTI | A, H | |
| 292 | ACACIA | A, E, H | |
| 293 | ACACIA BAILEYANA | A, H | |
| 294 | ACACIA CATECHU | A, H | |
| 295 | ACACIA DEALBATA | A, H | |
| 296 | 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%. |
| 297 | 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%. |
| 298 | ACACIA LONGIFOLIA | A, E, H | |
| 299 | ACACIA NILOTICA | A, E, H | |
| 300 | ACACIA SENEGAL | A, E, H | |
| 301 | ACALYPHA INDICA | A, H | |
| 302 | ACANTHUS MOLLIS | A, H | |
| 303 | ACER CAMPESTRE | A, H | |
| 304 | ACER NEGUNDO | A, H | |
| 305 | ACER SACCHARINUM | A, H | |
| 306 | ACER SACCHARUM | A, E, H | |
| 307 | ACEROLA | E | |
| 308 | ACESULFAME POTASSIUM | E | |
| 309 | 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%. |
| 310 | 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%. |
| 311 | 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%. |
| 312 | 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%. |
| 313 | 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%. |
| 314 | 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%. |
| 315 | ACETIC ACID | E, H | The concentration in the medicine must be no more than 80%. |
| 316 | 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%. |
| 317 | ACETOMENAPHTHONE | A, E | |
| 318 | 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%. |
| 319 | 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%. |
| 320 | 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%. |
| 321 | 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%. |
| 322 | 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%. |
| 323 | ACETYL GLUCOSAMINE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. If the ingredient is sourced from seafood, then the medicine requires the following warning statement on the medicine label: - (SFOOD) 'Derived from seafood' |
| 324 | 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%. |
| 325 | ACETYL LEVOCARNITINE HYDROCHLORIDE | A, E | |
| 326 | 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%. |
| 327 | ACETYLATED LANOLIN | E | Only for use in topical medicines for dermal application. |
| 328 | ACETYLATED LANOLIN ALCOHOL | E | Only for use in topical medicines for dermal application. |
| 329 | ACETYLATED MONOGLYCERIDES | E | |
| 330 | 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%. |
| 331 | ACETYLCYSTEINE | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.001%. |
| 332 | ACHILLEA ERBA-ROTTA SUBSP. MOSCHATA | A, H | |
| 333 | ACHILLEA MILLEFOLIUM | A, E, H | Arbutin is a mandatory component of Achillea millefolium. The concentration of arbutin in the medicine must be no more than 25 mg/Kg or 25mg /L or 0.0025 % unless used on the hair. When for use on hair, the concentration of arbutin in the medicine must be no more than 0.74 %. |
| 334 | ACHILLEA PTARMICA | A, H | |
| 335 | ACHYRANTHES ASPERA | A, H | |
| 336 | ACHYRANTHES BIDENTATA | A, H | |
| 337 | ACHYRANTHES FAURIEI | A, H | |
| 338 | ACID GREEN 25 | E | Permitted for use only as a colour for topical use. |
| 339 | ACID RED 33 | E | Permitted for use only as a colour for topical use. |
| 340 | ACID RED 87 | E, H | Only for use as an active homoeopathic ingredient or for excipient use as a colour in topical medicines. |
| 341 | ACID TREATED WAXY MAIZE STARCH | E | |
| 342 | 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%. |
| 343 | 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. |
| 344 | 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. |
| 345 | 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. |
| 346 | 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. |
| 347 | 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%. |
| 348 | ACRYLAMIDES COPOLYMER | E | Only for use in topical medicines for dermal application. |
| 349 | ACRYLATES COPOLYMER | E | Only for use in topical medicines for dermal application. |
| 350 | ACRYLATES/ACRYLAMIDE COPOLYMER | E | Only for use in topical medicines for dermal application. |
| 351 | ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER | E | Only for use in topical medicines for dermal application. |
| 352 | 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%. |
| 353 | 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%. |
| 354 | ACRYLATES/OCTYLACRYLAMIDE COPOLYMER | E | Only for use in topical medicines for dermal application. |
| 355 | 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%. |
| 356 | ACRYLATES/VA COPOLYMER | E | Only for use in topical medicines for dermal application. |
| 357 | 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%. |
| 358 | ACTAEA CIMICIFUGA | A, H | |
| 359 | ACTAEA HERACLEIFOLIA | A, H | |
| 360 | ACTAEA PACHYPODA | A, H | |
| 361 | 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.' |
| 362 | ACTAEA SIMPLEX | A, H | |
| 363 | ACTAEA SPICATA | A, H | |
| 364 | ACTINIDIA CHINENSIS | A, H | |
| 365 | ACTINIDIA DELICIOSA | A, H | |
| 366 | 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. |
| 367 | 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). |
| 368 | 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)' |
| 369 | 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)' |
| 370 | 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)' |
| 371 | 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)' |
| 372 | 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)' |
| 373 | 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)' |
| 374 | 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)' |
| 375 | 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)' |
| 376 | 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)' |
| 377 | 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)' |
| 378 | ADENOPHORA STRICTA | A, H | |
| 379 | ADENOPHORA TRIPHYLLA | A, H | |
| 380 | 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%. |
| 381 | 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%. |
| 382 | ADENOSINE TRIPHOSPHATE | E | Only for use in topical medicines for dermal application. |
| 383 | ADENOSINE TRIPHOSPHATE DISODIUM | E | Only for use in topical medicines for dermal application. |
| 384 | ADIANTUM CAPILLUS-VENERIS | A, H | |
| 385 | ADIPIC ACID | E | |
| 386 | 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%. |
| 387 | 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%. |
| 388 | ADRENALINE (EPINEPHRINE) | H | Only for use as an active homoeopathic ingredient. |
| 389 | ADZUKI BEAN | E | |
| 390 | AEGOPODIUM PODAGRARIA | A, H | |
| 391 | AESCULUS CHINENSIS | A, H | |
| 392 | AESCULUS GLABRA | A, H | |
| 393 | AESCULUS HIPPOCASTANUM | A, H | |
| 394 | AESCULUS X CARNEA | A, H | |
| 395 | AETHUSA CYNAPIUM | H | Only for use as an active homoeopathic ingredient. |
| 396 | AGAR | A, E | |
| 397 | AGASTACHE RUGOSA | A, H | |
| 398 | 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%. |
| 399 | AGAVE AMERICANA | A, E, H | |
| 400 | AGRIMONIA EUPATORIA | A, E, H | |
| 401 | AGRIMONIA REPENS | A, H | |
| 402 | AGROSTIS TENUIS | A, H | |
| 403 | AILANTHUS ALTISSIMA | A, H | |
| 404 | AJUGA CHAMAEPITYS | A, H | |
| 405 | AJUGA REPTANS | A, H | |
| 406 | ALANINE | A, E | |
| 407 | ALANYLGLUTAMINE | A | Only for use in oral medicines. |
| 408 | 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. |
| 409 | ALBIZIA JULIBRISSIN | A, H | |
| 410 | ALBIZIA LEBBECK | A, H | |
| 411 | ALCEA ROSEA | A, H | |
| 412 | ALCHEMILLA ALPINA | A, H | |
| 413 | ALCHEMILLA ARVENSIS | A, H | |
| 414 | ALCHEMILLA VULGARIS | A, H | |
| 415 | ALETRIS FARINOSA | A, H | |
| 416 | ALETRIS SPICATA | A, H | |
| 417 | ALEURITES MOLUCCANUS SEED OIL | E | Only for use in topical medicines for dermal application. |
| 418 | ALFADEX | A, E | Only for use in oral medicines. The maximum daily dose must provide no more than 6 g of alfadex. |
| 419 | ALGINATE-KONJAC-XANTHAN POLYSACCHARIDE COMPLEX | A | Only for use in oral medicines. Only for use when the dosage form is other than tablet. The maximum recommended daily dose must be no more than 13.5 g. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’ When a dose for children is stated, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect). |
| 420 | ALGINIC ACID | E | |
| 421 | ALISMA ORIENTALE | A, H | |
| 422 | ALISMA PLANTAGO AQUATICA | A, H | |
| 423 | ALKANNA TINCTORIA | A, H | |
| 424 | 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%. |
| 425 | ALLANTOIN | E | Only for use in topical medicines for dermal application. |
| 426 | ALLIARIA PETIOLATA | A, H | |
| 427 | ALLIUM CEPA | A, H | |
| 428 | ALLIUM FISTULOSUM | A, H | |
| 429 | ALLIUM HIEROCHUNTINUM | A, H | |
| 430 | ALLIUM MACROSTEMON | A, H | |
| 431 | ALLIUM ODORUM | A, H | |
| 432 | ALLIUM PORRUM | A, H | |
| 433 | ALLIUM SATIVUM | A, E, H | |
| 434 | ALLIUM SCHOENOPRASUM | A, H | |
| 435 | ALLIUM URSINUM | A, H | |
| 436 | 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%. |
| 437 | ALLURA RED AC | E | Permitted for use only as a colour for oral and topical use. |
| 438 | ALLURA RED AC ALUMINIUM LAKE | E | Permitted for use only as a colour for oral and topical use. |
| 439 | 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%. |
| 440 | 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%. |
| 441 | 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%. |
| 442 | 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%. |
| 443 | 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%. |
| 444 | 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%. |
| 445 | 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%. |
| 446 | 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%. |
| 447 | 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%. |
| 448 | 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%. |
| 449 | 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%. |
| 450 | ALMOND | E | |
| 451 | 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%. |
| 452 | ALNUS GLUTINOSA | A, H | |
| 453 | ALNUS INCANA SUBSP. RUGOSA | A, H | |
| 454 | 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'. |
| 455 | 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'. |
| 456 | 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'. |
| 457 | 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'. |
| 458 | ALOYSIA CITRODORA | A, H | |
| 459 | ALPHA CASOZEPINE ENRICHED HYDROLYSED MILK PROTEIN | A | Only for use in oral medicines. The medicine requires the following warning statements on the medicine label: - (BABY3) 'Not suitable for use in children under the age of twelve months - except on professional advice' - (COWMK) 'Derived from cow's milk.' |
| 460 | ALPHA LIPOIC ACID | A | |
| 461 | 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%. |
| 462 | 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%. |
| 463 | 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%. |
| 464 | 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%. |
| 465 | 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%. |
| 466 | 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%. |
| 467 | 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%. |
| 468 | 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%. |
| 469 | 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%. |
| 470 | 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%. |
| 471 | 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%. |
| 472 | 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%. |
| 473 | 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%. |
| 474 | 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%. |
| 475 | 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%. |
| 476 | 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%. |
| 477 | 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%. |
| 478 | 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%. |
| 479 | 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%. |
| 480 | 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%. |
| 481 | 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%. |
| 482 | 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%. |
| 483 | 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%. |
| 484 | 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%. |
| 485 | 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%. |
| 486 | 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%. |
| 487 | ALPINIA GALANGA | A, H | |
| 488 | ALPINIA HAINANENSIS | A, H | |
| 489 | ALPINIA OFFICINARUM | A, H | |
| 490 | ALPINIA OXYPHYLLA | A, H | |
| 491 | 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. |
| 492 | ALSTONIA BOONEI | A, H | |
| 493 | ALSTONIA CONSTRICTA | H | Only for use as an active homoeopathic ingredient. |
| 494 | ALTERNANTHERA PHILOXEROIDES | A, H | |
| 495 | 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%. |
| 496 | ALTHAEA OFFICINALIS | A, E, H | |
| 497 | ALUM DODECAHYDRATE | A, E, H | |
| 498 | ALUMINIUM CHLOROHYDRATE | E | Only for use in topical medicines for dermal application. |
| 499 | ALUMINIUM CITRATE | E | Only for use in topical medicines for dermal application. |
| 500 | ALUMINIUM DISTEARATE | E | Only for use in topical medicines for dermal application. |
| 501 | ALUMINIUM HYDROXIDE | E | Only for use in topical medicines for dermal application. |
| 502 | ALUMINIUM HYDROXIDE HYDRATE | E | Only for use in topical medicines for dermal application. |
| 503 | ALUMINIUM MAGNESIUM SILICATE | E | |
| 504 | ALUMINIUM MONOSTEARATE | E | Only for use in topical medicines for dermal application. |
| 505 | 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. |
| 506 | 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. |
| 507 | ALUMINIUM SODIUM SILICATE | E | When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’ |
| 508 | ALUMINIUM STARCH OCTENYLSUCCINATE | E | The concentration in the medicine must be no more than 7%. |
| 509 | ALUMINIUM STEARATE | E | Only for use in topical medicines for dermal application. |
| 510 | 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%. |
| 511 | AMARANTH | E | Permitted for use only as a colour for oral and topical use. |
| 512 | AMARANTH ALUMINIUM LAKE | E | Permitted for use only as a colour for oral and topical use |
| 513 | AMARANTHUS HYBRIDUS | A, H | |
| 514 | AMARANTHUS RETROFLEXUS | A, H | |
| 515 | 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%. |
| 516 | 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%. |
| 517 | 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%. |
| 518 | 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%. |
| 519 | AMBROSIA ARTEMISIIFOLIA | A, H | |
| 520 | AMBROSIA PSILOSTACHYA | A, H | |
| 521 | 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%. |
| 522 | 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%. |
| 523 | 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%. |
| 524 | 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%. |
| 525 | 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%. |
| 526 | AMMONIO METHACRYLATE COPOLYMER | E | Only for use in oral medicines. |
| 527 | AMMONIUM ACRYLATES COPOLYMER | E | Only for use in topical medicines for dermal application. |
| 528 | AMMONIUM ACRYLATES/ACRYLONITROGENS COPOLYMER | E | Only for use in topical medicines for dermal application. |
| 529 | 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%. |
| 530 | 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%. |
| 531 | 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. |
| 532 | AMMONIUM BROMIDE | H | Only for use as an active homoeopathic ingredient. |
| 533 | AMMONIUM CARBONATE | E, H | Only for use as an active homoeopathic or excipient ingredient. |
| 534 | 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. |
| 535 | AMMONIUM GLYCYRRHIZINATE | E | |
| 536 | AMMONIUM IODIDE | H | Only for use an active ingredient in homoeopathic medicines. |
| 537 | 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%. |
| 538 | AMMONIUM LAURETH SULFATE | E | Only for use in topical medicines for dermal application. |
| 539 | AMMONIUM LAURYL SULFATE | E | Only for use in topical medicines for dermal application. |
| 540 | 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%. |
| 541 | 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%. |
| 542 | 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%. |
| 543 | AMOMUM AROMATICUM | A, H | |
| 544 | AMOMUM VILLOSUM | A, H | |
| 545 | AMORPHOPHALLUS KONJAC | A, H | Only for use when the dosage form is not tablet. |
| 546 | AMPELODESMOS MAURITANICUS | A, H | |
| 547 | AMPELOPSIS JAPONICA | A, H | |
| 548 | 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%. |
| 549 | 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%. |
| 550 | 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%. |
| 551 | 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%. |
| 552 | 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%. |
| 553 | 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%. |
| 554 | 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%. |
| 555 | 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%. |
| 556 | 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%. |
| 557 | 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%. |
| 558 | 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%. |
| 559 | 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%. |
| 560 | 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%. |
| 561 | 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%. |
| 562 | 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%. |
| 563 | 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%. |
| 564 | 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%. |
| 565 | AMYLASE | A | Amylase must be derived from Aspergillus oryzae, and comply with the relevant compositional guideline. When used in a divided preparation, the allowed unit is Alpha-amylase dextrinising unit or Thousand alpha-amylase dextrinising unit. When used as an undivided preparation, the allowed unit is Thousand alpha-amylase dextrinising unit per gram or Dextrinising unit per gram. |
| 566 | 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%. |
| 567 | 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%. |
| 568 | AMYRIS BALSAMIFERA | A, H | |
| 569 | AMYRIS OIL WEST INDIAN | A, E, H | |
| 570 | ANACARDIUM OCCIDENTALE | A, H | |
| 571 | ANACYCLUS PYRETHRUM | A, H | |
| 572 | 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%. |
| 573 | ANAESTHETIC ETHER | H | Only for use as an active homoeopathic ingredient. |
| 574 | ANAGALLIS ARVENSIS | A, H | |
| 575 | 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%. |
| 576 | ANANAS COMOSUS | A, E, H | |
| 577 | ANAPHALIS SINICA | A, H | |
| 578 | ANDROGRAPHIS PANICULATA | A, H | |
| 579 | ANEMARRHENA ASPHODELOIDES | A, E, H | |
| 580 | ANEMONE ALTAICA | A, H | |
| 581 | ANEMONE CHINENSIS | A, H | |
| 582 | ANEMONE HEPATICA | A, H | |
| 583 | ANEMONE PULSATILLA | A, H | |
| 584 | ANEMONE RADDEANA | A, H | |
| 585 | ANETHOLE | E | |
| 586 | 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%. |
| 587 | ANETHUM GRAVEOLENS | A, E, H | |
| 588 | ANGELICA ACUTILOBA | A, H | |
| 589 | ANGELICA ANOMALA | A, H | |
| 590 | ANGELICA ARCHANGELICA | A, E, H | |
| 591 | ANGELICA ATROPURPUREA | A, H | |
| 592 | ANGELICA DAHURICA | A, E, H | |
| 593 | ANGELICA DECURSIVA | A, H | |
| 594 | ANGELICA POLYMORPHA | A, E, H | |
| 595 | ANGELICA PUBESCENS | A, E, H | |
| 596 | ANGELICA ROOT DRY | A, H | |
| 597 | ANGELICA ROOT OIL | A, E, H | |
| 598 | ANGELICA SEED OIL | A, E, H | |
| 599 | ANGELICA STEM | E | |
| 600 | ANIBA ROSAEODORA | A, E, H | |
| 601 | 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%. |
| 602 | 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%. |
| 603 | 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)' |
| 604 | 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%. |
| 605 | ANISEED DRY | A, E, H | |
| 606 | ANISEED POWDER | A, E, H | |
| 607 | 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%. |
| 608 | 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%. |
| 609 | 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%. |
| 610 | 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%. |
| 611 | 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%. |
| 612 | ANNATTO | E | Permitted for use only as a colour for oral and topical use. |
| 613 | ANOGEISSUS LATIFOLIA | A, E, H | |
| 614 | ANTENNARIA DIOICA | A, E, H | |
| 615 | ANTHOCYANINS | E | |
| 616 | 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%. |
| 617 | ANTHRISCUS CEREFOLIUM | A, H | |
| 618 | ANTHYLLIS VULNERARIA | A, H | |
| 619 | ANTIMONY POTASSIUM TARTRATE TRIHYDRATE | H | Only for use as an active homoeopathic ingredient. |
| 620 | ANTIMONY TRISULFIDE | H | Only for use as an active homoeopathic ingredient. |
| 621 | APIUM GRAVEOLENS | A, E, H | |
| 622 | 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%. |
| 623 | APOMORPHINE HYDROCHLORIDE HEMIHYDRATE | H | Only for use as an active homoeopathic ingredient. |
| 624 | APPLE | E | |
| 625 | APPLE CIDER VINEGAR | E | |
| 626 | 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%. |
| 627 | 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%. |
| 628 | APPLE FIBRE | E | |
| 629 | APRICOT | E | |
| 630 | APRICOT KERNEL OIL PEG-6 ESTERS | E | Only for use as an excipient in topical medicines for dermal application. |
| 631 | AQUILARIA MALACCENSIS | A, H | |
| 632 | AQUILARIA SINENSIS | A, H | |
| 633 | AQUILEGIA VULGARIS | A, H | |
| 634 | ARACHIDONIC ACID | E | Only for use in topical medicines for dermal application. |
| 635 | 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%. |
| 636 | 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%. |
| 637 | ARACHIDYL PROPIONATE | E | Only for use in topical medicines for dermal application. |
| 638 | ARACHIS HYPOGAEA | A, E, H | The medicine requires the following warning statement on the medicine label: - (PEANUT) ‘Contains Peanut’ (or words to that effect). |
| 639 | ARACHIS OIL | A, E, H | The medicine requires the following warning statement on the medicine label: - (PEANUT) ‘Contains Peanut’ (or words to that effect). |
| 640 | ARALIA CORDATA | A, H | |
| 641 | ARALIA HISPIDA | A, H | |
| 642 | ARALIA NUDICAULIS | A, H | |
| 643 | ARALIA RACEMOSA | A, H | |
| 644 | ARCTIUM LAPPA | A, E, H | |
| 645 | ARCTIUM MINUS | A, H | |
| 646 | ARCTOSTAPHYLOS UVA-URSI | A, E, H | Arbutin is a mandatory component of Arctostaphylos uva-ursi. The concentration of arbutin in the medicine must be no more than 25 mg/Kg or 25mg /L or 0.0025 % unless used on the hair. When for use on hair, the concentration of arbutin in the medicine must be no more than 0.74 %. |
| 647 | ARDISIA JAPONICA | A, H | |
| 648 | 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%. |
| 649 | 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. |
| 650 | 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.' |
| 651 | 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%. |
| 652 | ARISAEMA ATRORUBENS | A, H | The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material. |
| 653 | ARISAEMA CONSANGUINEUM | A, H | The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material. |
| 654 | ARISAEMA JAPONICUM | A, H | The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material. |
| 655 | 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). |
| 656 | ARNEBIA EUCHROMA | A, H | |
| 657 | 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. |
| 658 | 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. |
| 659 | 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. |
| 660 | ARRHENATHERUM ELATIUS | A, H | |
| 661 | ARROWROOT | A, E, H | |
| 662 | 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%. |
| 663 | 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%. |
| 664 | 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%. |
| 665 | 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%. |
| 666 | 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%. |
| 667 | 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%. |
| 668 | 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%. |
| 669 | 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%. |
| 670 | 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%. |
| 671 | 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%. |
| 672 | 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%. |
| 673 | 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%. |
| 674 | 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%. |
| 675 | 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%. |
| 676 | 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%. |
| 677 | ARTERY | H | Only for use as an active homoeopathic ingredient. |
| 678 | ARTHROSPIRA MAXIMA | A, E, H | |
| 679 | ARTHROSPIRA PLATENSIS | A, E, H | |
| 680 | ARUM MACULATUM | A, H | The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material. |
| 681 | ASAFOETIDA GUM | A, H | |
| 682 | 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%. |
| 683 | ASARUM EUROPAEUM | A, H | |
| 684 | ASARUM HETEROTROPOIDES | A, H | |
| 685 | ASARUM OIL | E | |
| 686 | ASARUM SIEBOLDII | A, E, H | |
| 687 | ASCLEPIAS TUBEROSA | A, H | |
| 688 | 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. |
| 689 | ASCORBIC ACID | A, E | |
| 690 | 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%. |
| 691 | ASCORBYL METHYLSILANOL PECTINATE | E | Only for use in topical medicines for dermal application. |
| 692 | ASCORBYL PALMITATE | A, E | When for oral use, the maximum recommended daily dose must contain no more than 100mg of ascorbyl palmitate. |
| 693 | ASCORBYL TOCOPHERYL MALEATE | E | Only for use as an ingredient in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.0575%. |
| 694 | ASPALATHUS LINEARIS | A, E, H | |
| 695 | ASPARAGINE | A, E | |
| 696 | ASPARAGOPSIS SULFATED GALACTANS | E | Only for use as an ingredient in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.0025%. |
| 697 | ASPARAGUS | E, H | Only for use as an active homoeopathic or excipient ingredient. |
| 698 | ASPARAGUS COCHINCHINENSIS | A, H | |
| 699 | ASPARAGUS OFFICINALIS | A, E, H | |
| 700 | ASPARAGUS RACEMOSUS | A, H | The plant part must be dried, peeled root, and water extracts or ethanol/water extracts (containing up to 45% ethanol) of the dried, peeled root. |
| 701 | ASPARTAME | E | When for oral use, the medicine requires the following warning statement on the medicine label: - (PKU) 'Phenylketonurics are warned that this product contains phenylalanine (or words to that effect)' The medicine requires the following warning statement on the medicine label: - (ASPAR) 'Contains aspartame' |
| 702 | ASPARTIC ACID | A, E | |
| 703 | ASPERGILLUS ORYZAE | A, E, H | |
| 704 | ASTAXANTHIN ESTERS EXTRACTED FROM HAEMATOCOCCUS PLUVIALIS | A | Only for use in oral medicines. Astaxanthin (of Haematococcus pluvialis) is a mandatory component of astaxanthin esters extracted from Haematococcus pluvialis. The maximum daily dose must contain no more than 12mg of Astaxanthin (of Haematococcus pluvialis). |
| 705 | ASTER NOVI-BELGII | A, H | |
| 706 | ASTER TATARICUS | A, H | |
| 707 | ASTRAGALUS ADSURGENS | A, H | |
| 708 | ASTRAGALUS COMPLANATUS | A, H | |
| 709 | ASTRAGALUS EXCARPUS | A, H | |
| 710 | ASTRAGALUS GUMMIFER | A, E, H | |
| 711 | ASTRAGALUS LENTIGINOSUS | A, H | |
| 712 | ASTRAGALUS MEMBRANACEUS | A, E, H | |
| 713 | ASTRAGALUS PENDULIFLORUS | A, H | |
| 714 | ASTROCARYUM MURUMURU SEED TRIGLYCERIDES | E | Only for use as an ingredient in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.21%. |
| 715 | ATRACTYLODES JAPONICA | A, H | |
| 716 | ATRACTYLODES LANCEA | A, H | |
| 717 | ATRACTYLODES MACROCEPHALA | A, H | |
| 718 | ATROPA BELLADONNA | A, H | Alkaloids calculated as hyoscyamine and atropine are mandatory components of Atropa belladonna. The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. The concentration of atropine in the medicine must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%. |
| 719 | ATROPINE SULFATE MONOHYDRATE | H | Only for use as an active homoeopathic ingredient. |
| 720 | ATTALEA SPECIOSA | E | Only for use in topical medicines for dermal application. |
| 721 | AURA B-AURANTIOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. |
| 722 | AUREOBASIDIUM PULLULANS | A, H | |
| 723 | AVENA FATUA | A, H | Gluten is a mandatory component of Avena fatua when the plant part is seed and the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect. |
| 724 | AVENA SATIVA | A, E, H | Gluten is a mandatory component of Avena sativa when the plant part is seed and the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect. |
| 725 | AVOCADO | E | |
| 726 | AVOCADO OIL | E | |
| 727 | AVOCADO OIL UNSAPONIFIABLES | E | Only for use in topical medicines for dermal application. |
| 728 | AZADIRACHTA INDICA | A, H | The ingredient can only be derived from the plant part seed and must be cold pressed or debitterised oil. “Debitterised neem seed oil” means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids. Cold pressed Azadirachta indica seed oil must be for topical use for dermal application only. When the concentration of cold pressed Azadirachta indica seed oil is more than 1%, a child resistant closure must be fitted to the container. The medicine requires the following warning statements on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant (or words to that effect).' - (NTAKEN) 'Not to be taken (or words to that effect).' - (CHILD) 'Keep out of reach of children (or words to that effect).’ |
| 729 | AZOVAN BLUE | E | Permitted for use only as a colour for topical use. |
| 730 | AZULENE | E | Only for use in topical medicines for dermal application. |
Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019
made under subsection 26BB(1) of the
Therapeutic Goods Act 1989
Compilation No. 1
Compilation date: 2 September 2019
Includes amendments up to: Therapeutic Goods Amendment (Permissible Ingredients) Determination (No. 1) 2019
This compilation is in 6 volumes
Volume 1: Sections 1–6 (pages 1-2)
Schedule 1 (1,7,7-TRIMETHYLBICYCLO(2.2.1)HEPT-2-YL)-CYCLOHEXANOL)–AZULENE (pages 3 -161)
Volume 2: Schedule 1 BACILLUS COAGULANS–EVERNIA PRUNASTRA EXTRACT (pages 162-479)
Volume 3: Schedule 1 FABIANA IMBRICATA–JUSTICIA ADHATODA
(pages 480-640)
Volume 4: Schedule 1 KADSURA COCCINEA–OYSTER SHELL
(pages 641-817)
Volume 5: Schedule 1 P-ALPHA-DIMETHYL STYRENE–TYROSINE
(pages 818-1146)
Volume 6: Schedule 1 UBIDECARENONE–ZUCCHINI (pages 1147-1191)
Endnotes (pages 1192-1195)
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 |
| 5029 | 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'. |
| 5030 | 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.' |
| 5031 | ULEX EUROPAEUS | A, H | |
| 5032 | ULMUS AMERICANA | A, H | |
| 5033 | ULMUS CAMPESTRIS | A, H | |
| 5034 | ULMUS GLABRA | A, H | |
| 5035 | ULMUS PARVIFOLIA | A, H | |
| 5036 | ULMUS PROCERA | A, H | |
| 5037 | ULMUS PUMILA | A, H | |
| 5038 | ULMUS RUBRA | A, H | |
| 5039 | 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%. |
| 5040 | ULTRAMARINE BLUE | E | Permitted for use only as a colour for topical use. |
| 5041 | 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%. |
| 5042 | UMBELLULARIA CALIFORNICA | A, H | |
| 5043 | UNCARIA GAMBIR | A, H | |
| 5044 | UNCARIA RHYNCOPHYLLA | A, H | |
| 5045 | UNCARIA SINENSIS | A, H | |
| 5046 | UNCARIA TOMENTOSA | A, H | |
| 5047 | UNDARIA PINNATIFIDA | A, H | Whole dried Undaria pinnatifida must not contain the holdfast. Only for use in oral medicines. |
| 5048 | 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%. |
| 5049 | 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%. |
| 5050 | UNDECENOIC ACID | E | |
| 5051 | 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%. |
| 5052 | 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%. |
| 5053 | UNDECYLENAMIDE DEA | E | |
| 5054 | UNDECYLENOYL PEG-5 PARABEN | E | Only for use in topical medicines for dermal application. |
| 5055 | URANIUM NITRATE | H | Only for use as an active homoeopathic ingredient. |
| 5056 | 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). |
| 5057 | URTICA DIOICA | A, E, H | |
| 5058 | URTICA URENS | A, H | |
| 5059 | USNEA BARBATA | A, H | |
| 5060 | UVA URSI LEAF DRY | A, H | |
| 5061 | UVA URSI LEAF POWDER | A, E, H | |
| 5062 | 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%. |
| 5063 | VACCARIA SEGATALIS | A, H | |
| 5064 | VACCINIUM BRACTEATUM | A, H | |
| 5065 | 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%. |
| 5066 | VACCINIUM MACROCARPON | A, E, H | |
| 5067 | VACCINIUM MYRTILLOIDES | A, H | |
| 5068 | VACCINIUM MYRTILLUS | A, E, H | |
| 5069 | VACCINIUM OXYCOCCUS | A, H | |
| 5070 | VACCINIUM VITIS-IDAEA | A, H | Arbutin is a mandatory component of Vaccinium vitis-idaea. The concentration of arbutin in the medicine must be no more than 25 mg/Kg or 25mg /L or 0.0025 % unless used on the hair. When for use on hair, the concentration of arbutin in the medicine must be no more than 0.74 %. |
| 5071 | 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%. |
| 5072 | 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%. |
| 5073 | VALERIAN DRY | A, H | |
| 5074 | 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%. |
| 5075 | VALERIAN POWDER | A, H | |
| 5076 | VALERIANA EDULIS | A, H | |
| 5077 | VALERIANA OFFICINALIS | A, H | |
| 5078 | VALERIANA SORBIFOLIA | A, H | |
| 5079 | 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%. |
| 5080 | VALINE | A, E | |
| 5081 | VANADIUM | H | |
| 5082 | 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%. |
| 5083 | VANILLA DRY | A, E, H | |
| 5084 | 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%. |
| 5085 | 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%. |
| 5086 | VANILLA PLANIFOLIA | A, E, H | |
| 5087 | VANILLA POWDER | A, E, H | |
| 5088 | VANILLA TAHITENSIS | A, H | |
| 5089 | 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%. |
| 5090 | VANILLIN | E | |
| 5091 | 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%. |
| 5092 | 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%. |
| 5093 | VAT RED 1 | E | Permitted for use only as a colour for topical use. |
| 5094 | VAT RED 1 ALUMINIUM LAKE | E | Permitted for use only as a colour for topical use. |
| 5095 | VAT RED 5 | E | Permitted for use only as a colour for topical use. |
| 5096 | VEGETABLE OIL | E | |
| 5097 | 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).' |
| 5098 | VEIN | H | Only for use as an active homoeopathic ingredient. |
| 5099 | 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%. |
| 5100 | 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%. |
| 5101 | 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%. |
| 5102 | VERBASCUM DENSIFLORUM | A, H | |
| 5103 | VERBASCUM THAPSUS | A, H | |
| 5104 | VERBENA OFFICINALIS | A, H | |
| 5105 | 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%. |
| 5106 | VERONICA CHAMAEDRYS | A, H | |
| 5107 | VERONICA OFFICINALIS | A, H | |
| 5108 | VERONICASTRUM VIRGINICUM | A, E, H | |
| 5109 | 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%. |
| 5110 | 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%. |
| 5111 | 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%. |
| 5112 | VIBURNUM OPULUS | A, E, H | |
| 5113 | VIBURNUM PRUNIFOLIUM | A, E, H | |
| 5114 | VICIA FABA | A, H | Levodopa (of Vicia faba) is a mandatory component of Vicia faba. The concentration of Levodopa (of Vicia faba) from all ingredients in the medicine must be no more than 1mg/kg or 1mg/L or 0.1%. |
| 5115 | VIGNA ANGULARIS VAR. ANGULARIS | A, H | |
| 5116 | VIGNA RADIATA | A, H | |
| 5117 | VIGNA UMBELLATA | A, H | |
| 5118 | 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%. |
| 5119 | 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% |
| 5120 | VINCETOXICUM OFFICINALE | A, H | |
| 5121 | 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%. |
| 5122 | VIOLA ODORATA | A, E, H | |
| 5123 | VIOLA TRICOLOR | A, H | |
| 5124 | VIOLA YEDOENSIS | A, H | |
| 5125 | 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%. |
| 5126 | VIOLET LEAVES | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. |
| 5127 | VIPER | H | Only for use as an active homoeopathic ingredient. |
| 5128 | VISCUM ALBUM | A, E, H | |
| 5129 | VISCUM COLORATUM | A, H | |
| 5130 | VISCUM FLAVESCENS | A, H | |
| 5131 | VITELLARIA PARADOXA | A, E, H | |
| 5132 | VITEX AGNUS-CASTUS | A, E, H | |
| 5133 | VITEX NEGUNDO | A, H | |
| 5134 | VITEX ROTUNDIFOLIA | A, H | |
| 5135 | VITEX TRIFOLIA | A, H | |
| 5136 | VITIS VINIFERA | A, E, H | |
| 5137 | VITREOSCILLA CONCENTRATE | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%. |
| 5138 | 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%. |
| 5139 | WAHLENBERGIA GRACILIS | A, H | |
| 5140 | WALNUT | E | |
| 5141 | WALNUT OIL | E | |
| 5142 | WATER MELON | E | |
| 5143 | WHEAT | E | Gluten is a mandatory component of Wheat when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect. |
| 5144 | WHEAT BRAN | E | Gluten is a mandatory component of Wheat bran when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect. |
| 5145 | WHEAT DEXTRIN | A, E | Only for use when the dosage form is capsule, tablet or pill. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect. |
| 5146 | WHEAT GERM | E | Gluten is a mandatory component of Wheat germ when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect. |
| 5147 | WHEAT GERM GLYCERIDES | E | Gluten is a mandatory component of Wheat germ glycerides when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect. |
| 5148 | WHEAT LEAF | E | |
| 5149 | WHEAT SPROUT | E | Gluten is a mandatory component of Wheat sprout when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect. |
| 5150 | WHEAT STARCH | E | When the route of administration is other than topical or mucosal, gluten is a mandatory component of wheat starch. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect). |
| 5151 | WHEATGERM OIL | A, E, H | |
| 5152 | WHEY POWDER | E | Lactose is a mandatory component of Whey powder when the route of administration is oral. |
| 5153 | WHEY PROTEIN | E | Lactose is a mandatory component of Whey protein when the route of administration is oral. |
| 5154 | 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%. |
| 5155 | WHITE BEESWAX | E | |
| 5156 | WHITE HOREHOUND HERB DRY | A, H | |
| 5157 | WHITE HOREHOUND HERB POWDER | A, H | |
| 5158 | 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. |
| 5159 | WHOLE DRY MILK | E | If the product is for oral ingestion and contains lactose, then the medicine requires the following warning statement on the medicine label: - (LACT) 'Contains lactose' (or words to that effect). |
| 5160 | WIKSTROEMIA VIRIDIFLORA | A, H | |
| 5161 | WILD CARROT HERB DRY | A, E, H | |
| 5162 | WILD CARROT HERB POWDER | A, H | |
| 5163 | WILD CHERRY BARK DRY | A, H | |
| 5164 | WILD CHERRY BARK POWDER | A, H | |
| 5165 | WILD LETTUCE LEAF DRY | A, H | |
| 5166 | WILD LETTUCE LEAF POWDER | A, H | |
| 5167 | 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. In addition, when the ingredient is included in a medicine that is listed in the Register: - on or after 1 July 2018, the medicine must comply with all requirements under (a) & (b); - before 1 July 2018 and supplied on or after 1 January 2020, the medicine must comply with all requirements under (a) & (b); or - before 1 July 2018 and supplied before 1 January 2020, the medicine may comply with the requirements under (a) & (b). a) The following warning statement is required on the medicine label: - (METSAL) 'Contains methyl salicylate' (or words to that effect). b) When for use in topical medicines for dermal application, the concentration of methyl salicylate in the medicine must not be more than 25% and 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); - (IRRIT) 'If irritation develops, discontinue use.'; and - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect). |
| 5168 | WITHANIA SOMNIFERA | A, E, H | |
| 5169 | WOLFIPORIA COCOS | A, E, H | When the ingredient is included in a medicine that is listed in the Register before 1 July 2018 and supplied before 1 January 2020, the medicine label may refer to the ingredient name as 'Poria cocos' instead of 'Wolfiporia cocos'. |
| 5170 | WOOL ALCOHOLS | E | Only for use in topical medicines for dermal application. |
| 5171 | 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. |
| 5172 | XANTHAN GUM | E | |
| 5173 | XANTHIUM SIBIRICUM | A, H | |
| 5174 | XANTHIUM STRUMARIUM | A, H | |
| 5175 | XANTHOMONA CAMPESTRIS | A, H | |
| 5176 | XEROPHYLLUM ASPHODELOIDES | A, H | |
| 5177 | 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%. |
| 5178 | XYLITOL | E | When the quantity of sugar alcohols per maximum recommended daily dose is more than 2g, the quantity of the sugar alcohols must be declared on the label and the medicine requires the following warning statement on the medicine label: - (SUGOLS) ‘Products containing [insert name of sugar alcohol(s) may have a laxative effect or cause diarrhoea [or words to that effect]’. |
| 5179 | XYLOSE | E | |
| 5180 | YAM | E | |
| 5181 | YARROW HERB DRY | A, H | |
| 5182 | YARROW HERB POWDER | A, H | |
| 5183 | YEAST AUTOLYSATE | E | |
| 5184 | YEAST DRIED | A, E, H | |
| 5185 | YELLOW 2G | E | Permitted for use only as a colour for topical use. |
| 5186 | YELLOW BEESWAX | E | |
| 5187 | YELLOW MERCURIC OXIDE | H | Only for use as an active homoeopathic ingredient. |
| 5188 | 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. |
| 5189 | YLANG YLANG OIL | A, E, H | |
| 5190 | YUCCA BACCATA | A, H | |
| 5191 | YUCCA ELATA | A, H | |
| 5192 | YUCCA FILAMENTOSA | A, H | |
| 5193 | YUCCA GLORIOSA | A, H | |
| 5194 | YUCCA WHIPPLEI | A, H | |
| 5195 | ZANTHOXYLUM AMERICANUM | A, H | |
| 5196 | ZANTHOXYLUM BUNGEANUM | A, E, H | |
| 5197 | ZANTHOXYLUM CLAVA-HERCULIS | A, H | |
| 5198 | ZANTHOXYLUM NITIDUM | A, H | |
| 5199 | ZANTHOXYLUM PIPERITUM | A, H | |
| 5200 | ZANTHOXYLUM SIMULANS | A, H | |
| 5201 | ZEA MAYS | A, E, H | |
| 5202 | ZEAXANTHIN | A, E | |
| 5203 | ZEIN | E | |
| 5204 | 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)'. |
| 5205 | 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).' |
| 5206 | 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).' |
| 5207 | 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)'. |
| 5208 | 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).' |
| 5209 | 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).' |
| 5210 | 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).' |
| 5211 | 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).' |
| 5212 | 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).' |
| 5213 | 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).' |
| 5214 | 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).' |
| 5215 | 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)'. |
| 5216 | 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'. |
| 5217 | 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'. |
| 5218 | 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).' |
| 5219 | 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).' |
| 5220 | 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%. |
| 5221 | 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 and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect). |
| 5222 | 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). |
| 5223 | 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. |
| 5224 | 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).' |
| 5225 | 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).' |
| 5226 | 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).' |
| 5227 | 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).' |
| 5228 | 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).' |
| 5229 | 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. |
| 5230 | 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%. |
| 5231 | 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'. |
| 5232 | ZIZIPHUS JUJUBA | A, H | |
| 5233 | ZIZIPHUS JUJUBA VAR. SPINOSA | A, H | |
| 5234 | ZIZYPHUS SATIVA | A, H | |
| 5235 | ZOSTERA MARINA | A, H | |
| 5236 | ZUCCHINI | E |
Endnotes
Endnote 1—About the endnotes
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Abbreviation key—Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.
Misdescribed amendments
A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.
If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.
Endnote 2—Abbreviation key
| ad = added or inserted | o = order(s) |
| am = amended | Ord = Ordinance |
| amdt = amendment | orig = original |
| c = clause(s) | par = paragraph(s)/subparagraph(s) |
| C[x] = Compilation No. x | /sub‑subparagraph(s) |
| Ch = Chapter(s) | pres = present |
| def = definition(s) | prev = previous |
| Dict = Dictionary | (prev…) = previously |
| disallowed = disallowed by Parliament | Pt = Part(s) |
| Div = Division(s) | r = regulation(s)/rule(s) |
| ed = editorial change | reloc = relocated |
| exp = expires/expired or ceases/ceased to have | renum = renumbered |
| effect | rep = repealed |
| F = Federal Register of Legislation | rs = repealed and substituted |
| gaz = gazette | s = section(s)/subsection(s) |
| LA = Legislation Act 2003 | Sch = Schedule(s) |
| LIA = Legislative Instruments Act 2003 | Sdiv = Subdivision(s) |
| (md) = misdescribed amendment can be given | SLI = Select Legislative Instrument |
| effect | SR = Statutory Rules |
| (md not incorp) = misdescribed amendment | Sub‑Ch = Sub‑Chapter(s) |
| cannot be given effect | SubPt = Subpart(s) |
| mod = modified/modification | underlining = whole or part not |
| No. = Number(s) | commenced or to be commenced |
Endnote 3—Legislation history
| Name | Registration | Commencement | Application, saving and transitional provisions |
| Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019 | 18 Jun 2019 (F2019L00834) | 19 Jun 2019 | - |
| Therapeutic Goods Amendment (Permissible Ingredients) Determination (No. 1) 2019 | 28 Aug 2019 (F2019L01113) | 2 Sep 2019 | - |
Endnote 4—Amendment history
| Provision affected | How affected |
| s 2......................................... | rep LA s 48D |
| s 7......................................... | rep LA s 48C |
| Schedule 1 | |
| Item 187A............................. | ad F2019L01113 |
| Item 730A............................. | ad F2019L01113 |
| Item 938................................ | rs F2019L01113 |
| Item 939................................ | rs F2019L01113 |
| Item 1029.............................. | rs F2019L01113 |
| Item 1106.............................. | rs F2019L01113 |
| Item 1495.............................. | rs F2019L01113 |
| Item 1496.............................. | rs F2019L01113 |
| Item 1497.............................. | rs F2019L01113 |
| Item 1504.............................. | rs F2019L01113 |
| Item 1505.............................. | rs F2019L01113 |
| Item 2649.............................. | rs F2019L01113 |
| Item 2935.............................. | rs F2019L01113 |
| Item 2936.............................. | rs F2019L01113 |
| Item 2937.............................. | rs F2019L01113 |
| Item 2938.............................. | rs F2019L01113 |
| Item 3575.............................. | rs F2019L01113 |
| Item 3686.............................. | rs F2019L01113 |
| Item 3967A........................... | ad F2019L01113 |
| Item 4864.............................. | rs F2019L01113 |
| Item 4877.............................. | rs F2019L01113 |
| Schedule 2............................. | rep LA s 48C |
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