Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2022 (Cth)
Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2022
I, Cheryl McRae, as delegate of the Minister for Health and Aged Care, make the following determination.
Dated 26 July 2022
Dr Cheryl McRae
Assistant Secretary
Complementary and Over the Counter Medicines Branch
Health Products Regulation Group
Department of Health and Aged Care
Contents
1 Name........................................................................................................................................ 2
2 Commencement........................................................................................................................ 2
3 Authority.................................................................................................................................. 2
4 Interpretation............................................................................................................................ 2
5 Permissible ingredients............................................................................................................. 3
6 Requirements in relation to permissible ingredients being contained in medicine..................... 3
7 Repeals..................................................................................................................................... 4
Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine......................................................................................................................................... 5
Note: This instrument is in 6 volumes:
Volume 1: Sections 1–7
Schedule 1 (+-)-NARINGENIN–AZULENE
Volume 2: Schedule 1 BACILLUS COAGULANS–EVERNIA PRUNASTRI EXTRACT
Volume 3: Schedule 1 FABIANA IMBRICATA–JUSTICIA ADHATODA
Volume 4: Schedule 1 KADSURA COCCINEA–OYSTER SHELL
Volume 5: Schedule 1 P-ALPHA-DIMETHYL STYRENE–TYROSINE
Volume 6: Schedule 1 UBIDECARENONE–ZUCCHINI
1 Name
This instrument is the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2022.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. The whole of this instrument The day after this instrument is registered
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under subsection 26BB(1) of the Therapeutic Goods Act 1989.
4 Interpretation
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) British Pharmacopoeia;
(b) European Pharmacopoeia;
(c) medicine;
(d) Register;
(e) United States Pharmacopeia-National Formulary.
(1) In this instrument:
Act means the Therapeutic Goods Act 1989.
active ingredient, or A, for a medicine, has the same meaning as in the Regulations.
code tables means the tables accessed via the Code Tables item in the Public TGA Information menu in TGA eBusiness Services.
excipient or E, for a medicine, means an ingredient that is not an active ingredient or a homoeopathic preparation ingredient.
Note: An excipient includes an ingredient that provides flavour, fragrance or colour to the medicine.
homoeopathic preparation has the same meaning as in the Regulations.
homoeopathic preparation ingredient or H, means an ingredient that is a constituent of a homoeopathic preparation.
Regulations means the Therapeutic Goods Regulations 1990.
TGA eBusiness Services means TGA eBusiness Services on the Therapeutic Goods Administration website, which may be accessed on the internet at Goods Administration has the same meaning as in the Regulations.
(2) To avoid doubt, the terms set out in closed brackets in column 4 of the table in Schedule 1, which are associated with warning statements in relation to particular ingredients, are:
(a) terms from the code tables under the heading Product Warning; and
(b) not required to be reproduced in a warning statement on the label of a medicine.
Note: Examples of these terms include the following:
(a) (ARGIN1);
(b) (CHILD3);
(c) (GLUTEN);
(d) (PEANUT); and
(e) (PREGNT).
5 Permissible ingredients
The ingredients specified in column 2 of the table in Schedule 1 are specified for the purposes of paragraph 26BB(1)(a) of the Act.
6 Requirements in relation to permissible ingredients being contained in medicine
For an ingredient mentioned in column 2 of an item in the table in Schedule 1, the following requirements are specified for the purposes of paragraph 26BB(1)(b) of the Act:
(a) the ingredient must only be used in a medicine for a purpose specified in relation to the ingredient in column 3 of that item; and
(b) the ingredient must comply with the requirements specified in relation to the ingredient in column 4 of that item; and
(c) if the ingredient is derived from animal origin¾the safety of the ingredient must have been assessed against, and comply with, the principles and requirements in the European Pharmacopoeia general monograph 1483 Products with risk of transmitting agents of animal spongiform encephalopathies, including General Text 5.2.8: Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products.
7 Repeals
The Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2022 is repealed.
Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine
Note: See sections 5 and 6.
Permissible ingredients and requirements Column 1 Column 2 Column 3 Column 4 Item Ingredient name Purpose Specific requirements 1 (+-)-NARINGENIN E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.2 (-)-MENTHYL METHYL ETHER E (-)-Menthyl methyl ether must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total concentration of flavour proprietary excipient formulations containing (-)-menthyl methyl ether must not be more than 5% of the total medicine.
When the medicine is for internal use, the maximum recommended daily dose of the medicine must not provide more than 53 micrograms of (-)-menthyl methyl ether.3 (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%.4 (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%.5 (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%.6 (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%.7 (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%.8 (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%.9 (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%.10 (R)-ALPHA-TERPINYL ACETATE E (R)-alpha-terpinyl acetate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing (R)-alpha-terpinyl acetate must not be more than 1% of the total medicine.11 (S)-LACTIC ACID A, E, H 12 (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)'13 (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)'14 (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)'15 (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)'16 (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)'17 (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)'18 (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)'19 (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)'20 (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)'21 (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)'22 (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%.23 (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%.24 1,2,3,4,4A,5,8,8A-OCTAHYDRO-2,2,6,8-TETRAMETHYL-1-NAPHTHALENOL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.25 1,2-HEXANEDIOL E Only for use in topical medicines for dermal application and not to be included in topical products intended for use in the eye.
The concentration in the medicine must be no more than 1%.26 1,3,4,6,7,8A-HEXAHYDRO-1,1,5,5-TETRAMETHYL-2H-2,4A-METHANONAPHTHALEN-8(5H)-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.27 1,3,5-UNDECATRIENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.28 1,3-BUTYLENE GLYCOL E 29 1,3-NONANEDIOL ACETATE, MIXED ESTERS E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.30 1,3-NONANEDIOL, DIACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.31 1,4-CINEOLE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%32 1,4-DIOXACYCLOHEXADECANE-5,16-DIONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.33 1,5,9-TRIMETHYL-13-OXABICYCLO[10.1.0]TRIDECA-4,8-DIENE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.34 1,7,7-TRIMETHYLBICYCLO[4.4.0]DECAN-3-YL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.35 1-(2,2,6-TRIMETHYLCYCLOHEXYL)-3-HEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.36 1-(2,6,6-TRIMETHYL-2-CYCLOHEXEN-1-YL)-1-PENTEN-3-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.37 1-(3,3-DIMETHYLCYCLOHEXYL)ETHYL FORMATE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.38 1-(4-ISOPROPYLCYCLOHEXYL)ETHANOL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.39 1-(5,5-DIMETHYL-1-CYCLOHEXEN-1-YL)-4-PENTEN-1-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.40 1-DODECANOL E Permitted for use:
(a) only in combination with other permitted ingredients as a flavour; and
(b) in topical medicines for dermal application.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.41 1-HEPTANOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.42 1-HEXEN-3-OL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.43 1-METHOXY-4-PROPENYLBENZENE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.44 1-METHYL-2-[(1,2,2-TRIMETHYLBICYCLO[3.1.0]HEX-3-YL)METHYL]-CYCLOPROPANEMETHANOL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.45 1-METHYL-3-(2-METHYLPROPYL)-CYCLOHEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.46 1-METHYL-4-(4-METHYL-3-PENTENYL)-3-CYCLOHEXENE-1-CARBOXALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.47 1-OCTEN-3-ONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.48 1-P-MENTHENE-8-THIOL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.49 1-PENTEN-3-OL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.50 10-UNDECEN-1-OL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.51 10-UNDECENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.52 16-HYDROXY-12-OXAHEXADECANOIC ACID, OMEGA-LACTONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.53 2'-FUCOSYLLACTOSE A Only to be used in a medicine where BASF Australia Ltd - Australia (Client ID 13479), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 1 March 2023.
Only for oral use.
The maximum recommended daily dose of the medicine must not provide more than:
(a) 5 g of 2’-fucosyllactose to individuals aged 18 years and older;
(b) 2 g of 2’-fucosyllactose to individuals aged between 4 to 17 years (inclusive); and
(c) 1.2 g of 2’-fucosyllactose to individuals aged between 1 to 3 years (inclusive).
Not permitted for use in children under the age of 12 months.54 2,2'-METHYLENEBIS(4-METHYL-6-TERT-BUTYLPHENOL) E 2,2'-methylenebis(4-methyl-6-tert-butylphenol) must only be included in medicines when in combination with other permitted ingredients as a proprietary excipient formulation in medicines with a dermal route of administration for topical application.
55 2,2,3-TRIMETHYLCYCLOPENT-3-ENE-1-ETHYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.56 2,2,5-TRIMETHYL-5-PENTYLCYCLOPENTANONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.57 2,2-DIMETHYL-3-(3-METHYL-2,4-PENTADIENYL)-OXIRANE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.58 2,2-DIMETHYL-3-PHENYLPROPANOLL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.59 2,2-DIMETHYL-5-(1-METHYLPROPEN-1-YL) TETRAHYDROFURAN E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.60 2,2-DIMETHYL-P-ETHYLPHENYL-PROPANENITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.61 2,3,4-TRIMETHYL-3-PENTANOL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.62 2,3,5,6-TETRAMETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.63 2,3,5-TRIMETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.64 2,3-DIETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used as a flavour the total flavour concentration in a medicine must be no more than 5%.65 2,3-DIHYDRO-1,1-DIMETHYL-1H-INDENE-AR-PROPANAL E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient. The total fragrance proprietary excipient formulation concentration in a medicine must not be more than 1%.
66 2,3-DIHYDRO-2,5-DIMETHYL-1H-INDENE-2-METHANOL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.67 2,3-DIMETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.68 2,3-HEXADIONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.69 2,3-HEXANEDIONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.70 2,3-PENTANEDIONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.71 2,4,5-TRIMETHYLTHIAZOLE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.72 2,4,6-TRIMETHYL-4-PHENYL-1,3-DIOXANE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.73 2,4-DECADIENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in the medicine must be no more than 1%.
The maximum daily dose must provide no more than 3 mg of 2,4-Decadienal.74 2,4-DIMETHYL BUTADIENEACROLEIN E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.75 2,4-DIMETHYL THIAZOLE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.76 2,4-DIMETHYL-3-CYCLOHEXENE CARBOXALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.77 2,4-DIMETHYL-4,4A,5,9B-TETRAHYDROINDENO[1,2-D]-1,3-DIOXIN E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.78 2,4-DIMETHYL-4-PHENYL TETRAHYDROFURAN E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.79 2,4-HEPTADIENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in the medicine must be no more than 1%.
The maximum daily dose must provide no more than 3 mg of 2,4-Heptadienal.80 2,4-HEXADIENOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in the medicine must be no more than 1%.
The maximum daily dose must provide no more than 13.5 mg of 2,4-Hexadienol.81 2,5-DIETHYLTETRAHYDROFURAN E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.82 2,5-DIMETHYL-2-OCTEN-6-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.83 2,5-DIMETHYL-4-ETHOXY-3(2H)-FURANONE E Only for use in medicines in combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total flavour proprietary excipient formulation in a medicine must not be more than 5%.84 2,5-DIMETHYL-4-HYDROXY-3(2H)-FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour or fragrance.
If used in a flavour the total flavour concentration in the medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.85 2,5-DIMETHYL-4-METHOXY-3(2H)-FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.86 2,5-DIMETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance, or a printing ink.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
If used in a printing ink the total printing ink concentration in a medicine must be no more than 0.1%87 2,6,6,TRIMETHYL-2-CYCLOHEXENE-1,4-DIONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.88 2,6,9,10-TETRAMETHYL-1-OXASPIRO(4.5)DECA-3,6-DIENE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.89 2,6-DIMETHOXYPHENOL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.90 2,6-DIMETHYL HEPTAN-2-OL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.91 2,6-DIMETHYL-2-HEPTENAL-(7) E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.92 2,6-DIMETHYL-3,5-OCTADIEN-2-OL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.93 2,6-DIMETHYL-4-HEPTYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.94 2,6-DIMETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.95 2,6-NONADIEN-1-OL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.96 2,6-OCTADIENOIC ACID, 3,7-DIMETHYL-, METHYL ESTER, (2E)- E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.97 2-(1,1-DIMETHYLETHYL)-1,4-DIMETHOXY-BENZENE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.98 2-(2-(4-METHYL-3-CYCLOHEXEN-1-YL)PROPYL CYCLOPENTANONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.99 2-(2-METHYLPHENYL)ETHANOL E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation.
The ingredient is not to be included in medicines intended for use in the eye.
The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.100 2-(4-METHYLPHENOXY)-N-1H-PYRAZOL-3-YL-N-(2-THIENYLMETHYL)ACETAMIDE E The route of administration of a medicine containing 2-(4-methylphenoxy)-n-1h-pyrazol-3-yl-n-(2-thienylmethyl)acetamide must be limited to dental.
The total concentration of 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)acetamide in the medicine must not be more than 0.015%.
2-(4-Methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)acetamide must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation
The total concentration of flavour proprietary excipient formulations containing 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)acetamide must not be more than 5% of the total medicine.101 2-(6-METHYL-8-ISOPROPYL BICYCLO(2.2.2)OCT-5-ENE-2-YL-1,3-DIOXOLANE E 2-(6-methyl-8-isopropyl bicyclo(2.2.2)oct-5-ene-2-yl)-1,3-dioxolane must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 2-(6-methyl-8-isopropyl bicyclo(2.2.2)oct-5-ene-2-yl)-1,3-dioxolane must not be more than 1% of the total medicine.102 2-[(3,7-DIMETHYL-6-OCTEN-1-YLIDENE)AMINO]BENZOIC ACID, METHYL ESTER E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.103 2-[1-(3,3-DIMETHYLCYCLOHEXYL)ETHOXY]-2-METHYLPROPYL] CYCLOPROPANECARBOXYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.104 2-[1-(3,3-DIMETHYLCYCLOHEXYL)ETHOXY]-2-OXOETHYL PROPANOATE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.105 2-ACETYLFURAN E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.106 2-ACETYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.107 2-ACETYLPYRIDINE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.108 2-AMINO-2-METHYL-1-PROPANOL E Only for use in topical medicines for dermal application.
109 2-BENZYL-4,4,6-TRIMETHYL-1,3-DIOXANE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.110 2-BUTEN-1-OL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.111 2-BUTYL-4,4,6-TRIMETHYL-1,3-DIOXANE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.112 2-CYCLOHEXYLIDENE-2-O-TOLYL-ACETONITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.113 2-DECENAL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.114 2-DODECANOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
115 2-DODECENAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.116 2-ETHOXY-4-(METHOXYMETHYL)-PHENOL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.117 2-ETHOXY-9-METHYLENE-2,6,6-TRIMETHYLBICYCLO[3.3.1]NONANE E 2-ethoxy-9-methylene-2,6,6-trimethylbicyclo[3.3.1]nonane must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 2-ethoxy-9-methylene-2,6,6-trimethylbicyclo[3.3.1]nonane must not be more than 1% of the total medicine.118 2-ETHOXYETHANOL E The residual solvent limit for 2-Ethoxyethanol is 1.6 mg per maximum recommended daily dose.
The concentration in the medicine must be no more than 0.016%.119 2-ETHYL-1-HEXANOL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.120 2-ETHYL-3,5-DIMETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.121 2-ETHYL-3,6-DIMETHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.122 2-ETHYL-3-METHYLPYRAZINE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.123 2-ETHYL-4-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)-2-BUTEN-1-OL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.124 2-ETHYL-4-HYDROXY-5-METHYL-3(2H)-FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.125 2-ETHYL-4-METHYLTHIAZOLE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.126 2-ETHYL-ALPHA,ALPHA-DIMETHYL-BENZENEPROPANAL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.127 2-ETHYL-N-METHYL-N-(3-METHYLPHENYL) BUTANAMIDE E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.128 2-ETHYLBUTYRIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.129 2-HEPTANOL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.130 2-HEPTANONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.131 2-HEPTYL CYCLOPENTANONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.132 2-HEXENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.133 2-HYDROXYACETOPHENONE E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin.
The concentration in the medicine must be no more than 1%.134 2-ISOBUTYL-3-METHOXYPYRAZINE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.135 2-ISOBUTYL-4-METHYLTETRAHYDRO-2H-PYRAN-4-OL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.136 2-ISOPROPOXYETHYL SALICYLATE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.137 2-ISOPROPYL-4-METHYLTHIAZOLE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.138 2-ISOPROPYLPHENOL E 2-Isopropylphenol must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total concentration of flavour proprietary excipient formulations containing 2-isopropylphenol must not be more than 5% of the total medicine.139 2-MERCAPTOPROPIONIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.140 2-METHOXY-3-(1-METHYLPROPYL)PYRAZINE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.141 2-METHOXY-4-VINYLPHENOL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.142 2-METHYL 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%.143 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%.144 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%.145 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%.146 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%.147 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%.148 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%.149 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%.150 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%.151 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.152 2-METHYL-4-(2,2,3-TRIMETHYLCYCLOPENT-3-EN-1-YL)PENT-4-EN-1-OL E 2-Methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-1-ol must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-1-ol must not be more than 1% of the total medicine.153 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%.154 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%.155 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%.156 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%.157 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%.158 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%.159 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%.160 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%.161 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%.162 2-METHYLDECANAL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.163 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%.164 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%.165 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%.166 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%.167 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%.168 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%.169 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%.170 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%.171 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%.172 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%.173 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%.174 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%.175 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%.176 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%.177 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%.178 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%.179 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%.180 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%.181 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%.182 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%.183 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%.184 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%.185 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%.186 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%.187 3'-SIALYLLACTOSE SODIUM A Only to be used in a medicine where Glycom A/S (Client ID 76983), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 25 October 2023.
Lactose and sodium are mandatory components of 3’-sialyllactose sodium.
The route of administration for medicines that contain 3’-sialyllactose sodium must be limited to oral.
The maximum recommended daily dose of the medicine must not provide more than:
(a) 0.2 g 3’-sialyllactose sodium in infants under 12 months;
(b) 0.15 g 3’-sialyllactose sodium in children aged 12-35 months; or
(c) 0.5 g 3’-sialyllactose sodium in individuals aged 3 years and older.188 3,3-DIMETHYL-5-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)-4-PENTEN-2-OL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.189 3,3-DIMETHYLACRYLIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.190 3,4,4A,5,8,8A-HEXAHYDRO-3',7-DIMETHYLSPIRO-1,4-METHANONAPHALENE-2(1H),2'-OXIRANE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.191 3,4-DIMETHYL PHENYLACETALDEHYDE E 3,4-Dimethyl phenylacetaldehyde must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 3,4-dimethyl phenylacetaldehyde must not be more than 1% of the total medicine.192 3,4-DIMETHYL-1,2-CYCLOPENTADIONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.193 3,5,5-TRIMETHYL HEXANAL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.194 3,5,5-TRIMETHYLHEXYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.195 3,5,6,6-TETRAMETHYL-4-METHYLENEHEPTAN-2-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.196 3,5-DIMETHOXYTOLUENE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.197 3,5-DIMETHYL-3-CYCLOHEXENE-1-CARBOXALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.198 3,6-DIMETHYL-3-CYCLOHEXENE-1-CARBOXALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.199 3,7-DIMETHYL OCTANAL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.200 3,7-DIMETHYL-1-OCTANOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.201 3,7-DIMETHYL-1-OCTEN-3-OL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.202 3,7-DIMETHYL-2,6-NONADIENENITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.203 3,7-DIMETHYL-2,6-OCTADIENAL REACTION PRODUCTS WITH ETHANOL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.204 3,7-DIMETHYL-7-METHOXYOCTAN-2-OL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.205 3-(1-BUTENYL)-PYRIDINE E 3-(1-Butenyl)-pyridine must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 3-(1-butenyl)-pyridine must not be more than 1% of the total medicine.206 3-(3-ISOPROPYLPHENYL)BUTANAL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.207 3-(4-ETHYLPHENYL)-2,2-DIMETHYLPROPANAL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.208 3-(4-HYDROXYPHENYL)-1-(2,4,6-TRIHYDROXYPHENYL)-1-PROPANONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.209 3-(4-TERT-BUTYLPHENYL)-PROPANAL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.210 3-(ISO-CAMPHYL-5)-CYCLOHEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.211 3-(METHYLTHIO) PROPIONALDEHYDE E 3-(Methylthio) propionaldehyde must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total concentration of flavour proprietary excipient formulations containing 3-(methylthio) propionaldehyde must not be more than 5% of the total medicine.212 3-(METHYLTHIO)-1-HEXYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.213 3-CARENE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.214 3-DODECENAL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.215 3-ETHYLPYRIDINE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.216 3-HEPTYLDIHYDRO-5-METHYL-2(3H)-FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.217 3-HEXANONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.218 3-HEXEN-1-OL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.219 3-ISO-CAMPHYL-5-CYCLOHEXAN-1-OL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.220 3-METHYL THIOPROPIONALDEHYDE ETHANOL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.221 3-METHYL-2-(PENTYLOXY)CYCLOPENT-2-EN-1-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.222 3-METHYL-5-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)-4-PENTEN-2-OL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.223 3-METHYL-5-PHENYL PENT-2-ENENITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.224 3-METHYL-5-PHENYLPENTANAL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.225 3-METHYL-5-PHENYLPENTANENITRILE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.226 3-METHYL-5-PHENYLPENTANOL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.227 3-METHYL-5-PROPYL-2-CYCLOHEXEN-1-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.228 3-METHYLCYCLOPENTADECANONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.229 3-METHYLCYCLOPENTADECENONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.230 3-METHYLPENTANOIC ACID E 3-Methylpentanoic acid must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total concentration of the flavour proprietary excipient formulation containing 3-methylpentanoic acid must not be more than 5% of the total medicine.231 3-METHYLTHIOHEXANOL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.232 3-OCTANOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.233 3-OCTYL ACETATE E Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.
The total flavour proprietary excipient formulation in a medicine must be no more than 5%.234 3-PENTYLTETRAHYDRO-2H-PYRAN-4-OL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.235 3-PHENYLPROPIONALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.236 3-PHENYLPROPYL ACETATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.237 3-PHENYLPROPYL PROPIONATE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.238 3-PROPYLIDENE PHTHALIDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.239 3-TRANS-ISOCAMPHYLCYCLOHEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.240 3A,6,6,9A-TETRAMETHYLDODECAHYDRONAPHTHO[2,1-B] FURAN E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.241 4,4A,5,9B-TETRAHYDRO-2,4-DIMETHYL-INDENO(1,2-D)-1,3-DIOXIN E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.242 4,4A,5,9B-TETRAHYDROINDENO(1,2-D)-1,3-DIOXIN E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.243 4,5-DIMETHYL-3-HYDROXY-2(5H)FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.244 4,7-METHANO-1H-INDENEMETHANOL, OCTAHYDRO-, ACETATE E Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.245 4,7-METHANO-3A,4,5,6,7,7A-HEXAHYDRO-5 (OR 6) -INDENYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.246 4,8-DIMETHYL-3,7-NONADIEN-2-OL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.247 4-(1-ETHOXYVINYL)-3,3,5,5-TETRAMETHYLCYCLOHEXANONE E 4-(1-Ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone must not be more than 1% of the total medicine.248 4-(4-METHYL-3-PENTEN-1-YL)-3-CYCLOHEXENE-1-CARBOXALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.249 4-(5,5,6-TRIMETHYLBICYCLO(2.2.1)HEPT-2-YL)-CYCLOHEXANOL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.250 4-(METHYLTHIO)-4-METHYL-2-PENTANONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.251 4-(OCTAHYDRO-4,7-METHANO-5H-INDEN-5-YLIDENE)-BUTANAL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.252 4-(PARA-HYDROXYPHENYL)-2-BUTANONE E 4-(para-hydroxyphenyl)-2-butanone must only be included in medicines when:
(a) in combination with other permitted ingredients as a flavour proprietary excipient formulation;
(b) in combination with other permitted ingredients as a fragrance proprietary excipient formulation; and/or
(c) in topical medicines for dermal application that are not intended for use in the eye or on damaged skin.
The total concentration of flavour proprietary excipient formulations containing 4-(para-hydroxyphenyl)-2-butanone must not be more than 5% of the total medicine.
The total concentration of fragrance proprietary excipient formulations containing 4-(para-hydroxyphenyl)-2-butanone must not be more than 1% of the total medicine.
The concentration of 4-(para-hydroxyphenyl)-2-butanone in a topical medicine for dermal application must not be more than 1% of the total medicine.253 4-(PARA-METHOXYPHENYL)-2-BUTANONE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.254 4-ACETYL-6-TERTIARY-BUTYL-1,1-DIMETHYLINDAN E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.255 4-CYCLOHEXYL-2-METHYL-2-BUTANOL E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.256 4-ETHYL GUAIACOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.257 4-HEPTANONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used as a flavour the total flavour concentration in a medicine must be no more than 5%.258 4-HYDROXYBENZALDEHYDE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.259 4-HYDROXYBENZYL ALCOHOL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.260 4-ISOPROPYL-3-METHYLPHENOL E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 0.1%.261 4-METHOXY-2-METHYL-2-BUTANETHIOL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.262 4-METHYL-3-DECEN-5-OL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.263 4-METHYL-4-MERCAPTOPENTAN-2-ONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
264 4-METHYL-4-PHENYL-2-PENTYL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.265 4-METHYL-5-THIAZOLETHANOL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.266 4-METHYLBENZYLIDENE CAMPHOR A Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must not be more than 4%.
The following warning statements are required on the label:
- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and
- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).267 4-METHYLPENTANOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.268 4-METHYLPHENYL OCTANOATE E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.269 4-PARA METHOXYPHENYL-3-BUTANONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.270 4-PENTENOIC ACID E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.271 4-TERT-BUTYL-2,6-DIMETHYL ACETOPHENONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.272 4-TERT-BUTYLCYCLOHEXANOL E Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin.
The concentration in the medicine must be no more than 0.1%.273 4-TERT-PENTYLCYCLOHEXANONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.274 5,6,7,8-TETRAHYDROQUINOXALINE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.275 5,7-DIHYDRO-2-METHYLTHIENO (3,4D) PYRIMIDINE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.276 5-(2,2,3-TRIMETHYL-3-CYCLOPENTEN-1-YL)-3-METHYLPENTAN-2-OL E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.277 5-ACETYL-1,1,2,3,3,6-HEXAMETHYL INDAN E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.278 5-CYCLOHEXADECEN-1-ONE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.279 5-ETHYL-2,3-DIMETHYLPYRAZINE E 5-Ethyl-2,3,dimethylpyrazine must not be included in medicines for oral administration.
5-Ethyl-2,3,dimethylpyrazine must only be included in topical medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 5-ethyl-2,3,dimethylpyrazine must not be more than 1% of the total medicine.280 5-ETHYL-3-HYDOXY-4-METHYL-2(5H)-FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.281 5-ETHYL-4-HYDROXY-2-METHYL-3(2H)-FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.282 5-HYDROXY-4-METHYLHEXANOIC ACID DELTA-LACTONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.283 5-METHOXYPSORALEN E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.284 5-METHYL 2-PHENYL HEXEN-2-AL E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.285 5-METHYL-2-THIOPHENE CARBOXALDEHYDE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.286 5-METHYL-3-BUTYLTETRAHYDROPYRAN-4-YL ACETATE E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.287 5-METHYL-3-HEPTANONE OXIME E Permitted for use only in combination with other permitted ingredients as a fragrance.
If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.288 5-PENTYL-2(5H)-FURANONE E Permitted for use only in combination with other permitted ingredients as a flavour.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.289 6'-SIALYLLACTOSE SODIUM A Only to be used in a medicine where Glycom A/S (Client ID 76983), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 25 October 2023.
Lactose and sodium are mandatory components of 6’-sialyllactose sodium.
The route of administration for medicines that contain 6’-sialyllactose sodium must be limited to oral.
The maximum recommended daily dose of the medicine must not provide more than:
(a) 0.4 g 6’-sialyllactose sodium in infants under 12 months;
(b) 0.3 g 6’-sialyllactose sodium in children aged 12-35 months; or
(c) 1.0 g 6’-sialyllactose sodium in individuals aged 3 years and older.290 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%.291 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%.292 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%.293 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%.294 6-ETHYLIDENEOCTAHYDRO 5,8-METHANO-2H-1-BENZOPYRAN E 6-Ethylideneoctahydro 5,8-methano-2H-1-benzopyran must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing 6-ethylideneoctahydro 5,8-methano-2H-1-benzopyran must not be more than 1% of the total medicine.295 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%.296 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%.297 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%.298 6-METHYL-2-BUTEN-3-OL-2 E 299 6-METHYLQUINOLINE E 6-Methylquinoline must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total concentration of the flavour proprietary excipient formulation containing 6-methylquinoline must not be more than 5% of the total medicine.300 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%.301 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%.302 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%.303 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%.304 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%.305 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%.306 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%.307 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%.308 ABELMOSCHUS MOSCHATUS A, H 309 ABELMOSCHUS MOSCHATUS SUBSP. MOSCHATUS A, H 310 ABIES BALSAMEA A, H 311 ABIES NIGRA A, H 312 ABIES PECTINATA A, H 313 ABIES SIBIRICA A, H 314 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.
315 ABUTILON THEOPHRASTI A, H 316 ACACIA A, E, H 317 ACACIA BAILEYANA A, H 318 ACACIA CATECHU A, H 319 ACACIA DEALBATA A, H 320 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%.321 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%.322 ACACIA LONGIFOLIA A, E, H 323 ACACIA NILOTICA A, E, H 324 ACACIA SENEGAL A, E, H 325 ACALYPHA INDICA A, H 326 ACANTHUS MOLLIS A, H 327 ACER CAMPESTRE A, H 328 ACER NEGUNDO A, H 329 ACER SACCHARINUM A, H 330 ACER SACCHARUM A, E, H 331 ACEROLA E 332 ACESULFAME POTASSIUM E 333 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%.334 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%.335 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%.336 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%.337 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%.338 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%.339 ACETIC ACID E, H The concentration in the medicine must be no more than 80%.
340 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%.341 ACETOMENAPHTHONE A, E 342 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%.343 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%.344 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%.345 ACETOXYDIHYDRODICYCLOPENTADIENE E Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.346 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%.347 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%.348 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%.349 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%.350 ACETYL LEVOCARNITINE HYDROCHLORIDE A, E 351 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%.352 ACETYLATED LANOLIN E Only for use in topical medicines for dermal application.
353 ACETYLATED LANOLIN ALCOHOL E Only for use in topical medicines for dermal application.
354 ACETYLATED MONOGLYCERIDES E 355 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%.356 ACETYLCYSTEINE E Only for use in topical medicines for dermal application.
The concentration in the medicine must be no more than 0.001%.357 ACHILLEA ERBA-ROTTA SUBSP. MOSCHATA A, H 358 ACHILLEA MILLEFOLIUM A, E, H Beta-arbutin is a mandatory component of Achillea millefolium.
When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.
When for dermal application exclusively to the face:
a) the concentration of beta-arbutin in the medicine must not be more than 7%;
b) hydroquinone is a mandatory component; and
c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.
When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.359 ACHILLEA PTARMICA A, H 360 ACHYRANTHES ASPERA A, H 361 ACHYRANTHES BIDENTATA A, H 362 ACHYRANTHES FAURIEI A, H 363 ACID GREEN 25 E Permitted for use only as a colour for topical use.
364 ACID RED 33 E Permitted for use only as a colour for topical use.
365 ACID RED 87 E, H Only for use as an active homoeopathic ingredient or for excipient use as a colour in topical medicines.
366 ACID TREATED WAXY MAIZE STARCH E 367 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%.368 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.369 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.370 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.371 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.372 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%.373 ACRYLAMIDES COPOLYMER E Only for use in topical medicines for dermal application.
374 ACRYLATES COPOLYMER E Only for use in topical medicines for dermal application.
375 ACRYLATES/ACRYLAMIDE COPOLYMER E Only for use in topical medicines for dermal application.
376 ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER E Only for use in topical medicines for dermal application.
377 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%.378 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%.379 ACRYLATES/OCTYLACRYLAMIDE COPOLYMER E Only for use in topical medicines for dermal application.
380 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%.381 ACRYLATES/VA COPOLYMER E Only for use in topical medicines for dermal application.
382 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%.383 ACTAEA CIMICIFUGA A, H 384 ACTAEA HERACLEIFOLIA A, H 385 ACTAEA PACHYPODA A, H 386 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.'387 ACTAEA SIMPLEX A, H 388 ACTAEA SPICATA A, H 389 ACTINIDIA CHINENSIS A, H 390 ACTINIDIA DELICIOSA A, H 391 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.
392 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).393 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)'394 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)'395 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)'396 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)'397 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)'398 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)'399 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)'400 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)'401 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)'402 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)'403 ADENOPHORA STRICTA A, H 404 ADENOPHORA TRIPHYLLA A, H 405 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%.406 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%.407 ADENOSINE TRIPHOSPHATE E Only for use in topical medicines for dermal application.
408 ADENOSINE TRIPHOSPHATE DISODIUM E Only for use in topical medicines for dermal application.
409 ADIANTUM CAPILLUS-VENERIS A, H 410 ADIPIC ACID E 411 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%.412 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%.
413 ADRENALINE (EPINEPHRINE) H Only for use as an active homoeopathic ingredient.
414 ADZUKI BEAN E 415 AEGOPODIUM PODAGRARIA A, H 416 AESCULUS CHINENSIS A, H 417 AESCULUS GLABRA A, H 418 AESCULUS HIPPOCASTANUM A, H 419 AESCULUS X CARNEA A, H 420 AETHUSA CYNAPIUM H Only for use as an active homoeopathic ingredient.
421 AGAR A, E 422 AGASTACHE RUGOSA A, H 423 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%.424 AGAVE AMERICANA A, E, H 425 AGRIMONIA EUPATORIA A, E, H 426 AGRIMONIA REPENS A, H 427 AGROSTIS TENUIS A, H 428 AILANTHUS ALTISSIMA A, H 429 AJUGA CHAMAEPITYS A, H 430 AJUGA REPTANS A, H 431 ALANINE A, E 432 ALANYLGLUTAMINE A Only for use in oral medicines.
433 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.434 ALBIZIA JULIBRISSIN A, H 435 ALBIZIA LEBBECK A, H 436 ALCEA ROSEA A, H 437 ALCHEMILLA ALPINA A, H 438 ALCHEMILLA ARVENSIS A, H 439 ALCHEMILLA VULGARIS A, H 440 ALETRIS FARINOSA A, H 441 ALETRIS SPICATA A, H 442 ALEURITES MOLUCCANUS SEED OIL E Only for use in topical medicines for dermal application.
443 ALFADEX A, E Only for use in oral medicines.
The maximum daily dose must provide no more than 6 g of alfadex.444 ALGINATE-KONJAC-XANTHAN POLYSACCHARIDE COMPLEX A Only for use in oral medicines.
Only for use when the dosage form is other than tablet.
The maximum recommended daily dose must be no more than 13.5 g.
When a dose for children is stated, the medicine requires the following warning statement on the medicine label:
- (PSYLL) 'On medical advice' (or words to that effect).445 ALGINIC ACID E 446 ALISMA ORIENTALE A, H 447 ALISMA PLANTAGO AQUATICA A, H 448 ALKANNA TINCTORIA A, H 449 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%.450 ALLANTOIN E Only for use in topical medicines for dermal application.
451 ALLIARIA PETIOLATA A, H 452 ALLIUM CEPA A, H 453 ALLIUM FISTULOSUM A, H 454 ALLIUM HIEROCHUNTINUM A, H 455 ALLIUM MACROSTEMON A, H 456 ALLIUM ODORUM A, H 457 ALLIUM PORRUM A, H 458 ALLIUM SATIVUM A, E, H 459 ALLIUM SCHOENOPRASUM A, H 460 ALLIUM URSINUM A, H 461 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%.462 ALLURA RED AC E Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
463 ALLURA RED AC ALUMINIUM LAKE E Permitted for use only as a colour for oral and topical use.
464 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%.465 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%.466 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%.467 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%.468 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%.469 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%.470 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%.471 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%.472 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%.473 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%.474 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%.475 ALMOND E 476 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%.477 ALNUS GLUTINOSA A, H 478 ALNUS INCANA SUBSP. RUGOSA A, H 479 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'.480 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'.
481 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'.482 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'.483 ALOYSIA CITRODORA A, H 484 ALPHA CASOZEPINE ENRICHED HYDROLYSED MILK PROTEIN A Only for use in oral medicines.
The following warning statement is required on the medicine label:
- (BABY3) 'Not suitable for use in children under the age of 12 months except on the advice of a health professional.’ (or words to that effect).485 ALPHA LIPOIC ACID A 486 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%.487 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%.488 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%.489 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%.490 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%.491 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%.492 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%.493 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%.494 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%.495 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%.496 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%.497 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%.498 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%.499 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%.500 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%.501 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%.502 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%.503 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%.504 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%.505 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%.506 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%.507 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%.508 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%.509 ALPHA-SANTALOL E alpha-Santalol must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.
The total concentration of the fragrance proprietary excipient formulation containing alpha-santalol must not be more than 1% of the total medicine.510 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%.511 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%.512 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%.513 ALPINIA GALANGA A, H 514 ALPINIA HAINANENSIS A, H 515 ALPINIA OFFICINARUM A, H 516 ALPINIA OXYPHYLLA A, H 517 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.518 ALSTONIA BOONEI A, H 519 ALSTONIA CONSTRICTA H Only for use as an active homoeopathic ingredient.
520 ALTERNANTHERA PHILOXEROIDES A, H 521 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%.522 ALTHAEA OFFICINALIS A, E, H 523 ALUM DODECAHYDRATE A, E, H 524 ALUMINIUM CHLOROHYDRATE E Only for use in topical medicines for dermal application.
525 ALUMINIUM CITRATE E Only for use in topical medicines for dermal application.
526 ALUMINIUM DISTEARATE E Only for use in topical medicines for dermal application.
527 ALUMINIUM HYDROXIDE E Only for use in topical medicines for dermal application.
528 ALUMINIUM HYDROXIDE HYDRATE E Only for use in topical medicines for dermal application.
529 ALUMINIUM MAGNESIUM SILICATE E Magnesium is a mandatory component of aluminium magnesium silicate.
When used in a medicine:
(a) with an oral route of administration;
(b) not indicated for laxative (or related) use; and
(c) where the maximum recommended daily dose for:
(i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;
(ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or
(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;
the following warning statement is required on the medicine label:
- (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect).
When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.530 ALUMINIUM MONOSTEARATE E Only for use in topical medicines for dermal application.
531 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.532 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.533 ALUMINIUM SODIUM SILICATE E 534 ALUMINIUM STARCH OCTENYLSUCCINATE E The concentration in the medicine must be no more than 7%.
535 ALUMINIUM STEARATE E Only for use in topical medicines for dermal application.
536 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%.537 AMARANTH E Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
538 AMARANTH ALUMINIUM LAKE E Permitted for use only as a colour for oral and topical use
539 AMARANTHUS HYBRIDUS A, H 540 AMARANTHUS RETROFLEXUS A, H 541 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%.542 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%.543 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%.544 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%.545 AMBROSIA ARTEMISIIFOLIA A, H 546 AMBROSIA PSILOSTACHYA A, H 547 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%.548 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%.549 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%.550 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%.
551 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%.552 AMMONIO METHACRYLATE COPOLYMER E Only for use in oral medicines.
553 AMMONIUM ACRYLATES COPOLYMER E Only for use in topical medicines for dermal application.
554 AMMONIUM ACRYLATES/ACRYLONITROGENS COPOLYMER E Only for use in topical medicines for dermal application.
555 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%.556 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%.557 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.
558 AMMONIUM BROMIDE H Only for use as an active homoeopathic ingredient.
559 AMMONIUM CARBONATE E, H Only for use as an active homoeopathic or excipient ingredient.
560 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.561 AMMONIUM GLYCYRRHIZINATE E 562 AMMONIUM IODIDE H Only for use an active ingredient in homoeopathic medicines.
563 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%.564 AMMONIUM LAURETH SULFATE E Only for use in topical medicines for dermal application.
565 AMMONIUM LAURYL SULFATE E Only for use in topical medicines for dermal application.
566 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%.567 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%.568 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%.569 AMOMUM AROMATICUM A, H 570 AMOMUM VILLOSUM A, H 571 AMORPHOPHALLUS KONJAC A, H Only for use when the dosage form is not tablet.
572 AMPELODESMOS MAURITANICUS A, H 573 AMPELOPSIS JAPONICA A, H 574 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%.575 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%.576 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%.577 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%.578 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%.579 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%.580 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%.581 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%.582 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%.583 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%.584 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%.585 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%.586 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%.587 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%.588 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%.589 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%.590 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%.591 AMYLASE A Amylase must be derived from Aspergillus oryzae, and comply with the relevant compositional guideline.
592 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%.593 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%.594 AMYRIS BALSAMIFERA A, H 595 AMYRIS OIL WEST INDIAN A, E, H 596 ANACARDIUM OCCIDENTALE A, H 597 ANACYCLUS PYRETHRUM A, H 598 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%.599 ANAESTHETIC ETHER H Only for use as an active homoeopathic ingredient.
600 ANAGALLIS ARVENSIS A, H 601 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%.602 ANANAS COMOSUS A, E, H 603 ANAPHALIS SINICA A, H 604 ANDROGRAPHIS PANICULATA A, H The following warning statement is required on the label:
- (ANDROG) ‘Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis), stop use and seek immediate medical attention’ (or words to that effect).
When for oral use, the following warning statement is required on the medicine label:
- (ANDROT) ‘Andrographis may cause taste disturbance including loss of taste. If you develop any adverse symptoms, stop use and seek medical advice’ (or words to that effect).605 ANEMARRHENA ASPHODELOIDES A, E, H 606 ANEMONE ALTAICA A, H 607 ANEMONE CHINENSIS A, H 608 ANEMONE HEPATICA A, H 609 ANEMONE PULSATILLA A, H 610 ANEMONE RADDEANA A, H 611 ANETHOLE E 612 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%.613 ANETHUM GRAVEOLENS A, E, H 614 ANGELICA ACUTILOBA A, H 615 ANGELICA ANOMALA A, H 616 ANGELICA ARCHANGELICA A, E, H 617 ANGELICA ATROPURPUREA A, H 618 ANGELICA DAHURICA A, E, H 619 ANGELICA DECURSIVA A, H 620 ANGELICA POLYMORPHA A, E, H 621 ANGELICA PUBESCENS A, E, H 622 ANGELICA ROOT DRY A, H 623 ANGELICA ROOT OIL A, E, H 624 ANGELICA SEED OIL A, E, H 625 ANGELICA STEM E 626 ANIBA ROSAEODORA A, E, H 627 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%.628 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%.629 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)'630 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%.631 ANISEED DRY A, E, H 632 ANISEED POWDER A, E, H 633 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%.634 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%.635 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%.636 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%.637 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%.638 ANNATTO E Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
639 ANOGEISSUS LATIFOLIA A, E, H 640 ANTENNARIA DIOICA A, E, H 641 ANTHOCYANINS E 642 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%.
643 ANTHRISCUS CEREFOLIUM A, H 644 ANTHYLLIS VULNERARIA A, H 645 ANTIMONY POTASSIUM TARTRATE TRIHYDRATE H Only for use as an active homoeopathic ingredient.
646 ANTIMONY TRISULFIDE H Only for use as an active homoeopathic ingredient.
647 APIUM GRAVEOLENS A, E, H 648 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%.
649 APOMORPHINE HYDROCHLORIDE HEMIHYDRATE H Only for use as an active homoeopathic ingredient.
650 APPLE E 651 APPLE CIDER VINEGAR E 652 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%.653 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%.654 APPLE FIBRE E 655 APRICOT E 656 APRICOT KERNEL OIL PEG-6 ESTERS E Only for use as an excipient in topical medicines for dermal application.
657 AQUILARIA MALACCENSIS A, H 658 AQUILARIA SINENSIS A, H 659 AQUILEGIA VULGARIS A, H 660 ARACHIDONIC ACID E Only for use in topical medicines for dermal application.
661 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%.662 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%.663 ARACHIDYL PROPIONATE E Only for use in topical medicines for dermal application.
664 ARACHIS HYPOGAEA A, E, H 665 ARACHIS OIL A, E, H 666 ARALIA CORDATA A, H 667 ARALIA HISPIDA A, H 668 ARALIA NUDICAULIS A, H 669 ARALIA RACEMOSA A, H 670 ARCTIUM LAPPA A, E, H 671 ARCTIUM MINUS A, H 672 ARCTOSTAPHYLOS UVA-URSI A, E, H Beta-arbutin is a mandatory component of Arctostaphylos uva-ursi.
When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.
When for dermal application exclusively to the face:
a) the concentration of beta-arbutin in the medicine must not be more than 7%;
b) hydroquinone is a mandatory component; and
c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.
When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.673 ARDISIA JAPONICA A, H 674 ARGANIA SPINOSA KERNEL OIL E Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin.
The concentration must be no more than 5% in the medicine.675 ARGININE A, E, H Only for use in topical medicines for dermal application.
The medicine requires the following warning statement on the medicine label:
- (ARGIN1) 'This medicine contains arginine and is intended to be applied to the skin only and not to the mucosa - vagina or rectum.'676 ARGININE FERULATE E Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.
The concentration in the medicine must be no more than 0.05%.677 ARISAEMA ATRORUBENS A, H The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
678 ARISAEMA CONSANGUINEUM A, H The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
679 ARISAEMA JAPONICUM A, H The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.
680 ARMORACIA RUSTICANA A, E, H Volatile oil components (of Armoracia rusticana) is a mandatory component of Armoracia rusticana.
The maximum recommended daily dose must contain no more than 20 mg of volatile oil components (of Armoracia rusticana).681 ARNEBIA EUCHROMA A, H 682 ARNICA FLOWER DRY A, H When for use other than topically on unbroken skin, the maximum recommended daily dose must be no more than 1mg of the equivalent dry flower of Arnica montana.
683 ARNICA MOLLIS A, H When for use other than topically on unbroken skin, the maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.
684 ARNICA MONTANA A, H When for use other than topically on unbroken skin, the maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of arnica montana.
685 ARRHENATHERUM ELATIUS A, H 686 ARROWROOT A, E, H 687 ARSENIC TRIIODIDE H Only for use as an active homoeopathic ingredient. The concentration of arsenic in the medicine must be no more than 0.001%.
688 ARSENIC TRIOXIDE H Only for use as an active homoeopathic ingredient.
The concentration of arsenic in the medicine must be no more than 0.001%.689 ARTEMISIA ABROTANUM A, H Thujone is a mandatory component of Artemisia abrotanum. The concentration of thujone from Artemisia abrotanum in the medicine must be no more than 4%.
690 ARTEMISIA ABSINTHIUM A, H Thujone is a mandatory component of Artemisia absinthium.
The concentration of thujone from Artemisia absinthium in the medicine must be no more than 4%.
The following warning statement is required on the medicine label:
- (PREGNT2) ‘Do not use if pregnant or likely to become pregnant.’691 ARTEMISIA ANNUA A, H Thujone is a mandatory component of Artemisia annua.
The concentration of thujone from Artemisia annua in the medicine must be no more than 4%.
The following warning statement is required on the medicine label:
- (PREGNT2) ‘Do not use if pregnant or likely to become pregnant.’692 ARTEMISIA ARBORESCENS A, H Thujone is a mandatory component of Artemisia arborescens.
The concentration of thujone from Artemisia arborescens in the medicine must be no more than 4%.693 ARTEMISIA ARGYI A, H Thujone is a mandatory component of Artemisia argyi.
The concentration of thujone from Artemisia argyi in the medicine must be no more than 4%.694 ARTEMISIA DRACUNCULUS A, E, H Thujone is a mandatory component of Artemisia dracunculus.
The concentration of thujone from Artemisia dracunculus in the medicine must be no more than 4%.
The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that is:
- listed in the Register on or after 1 March 2022; or
- released for supply on or after 1 March 2023.
(a) The following warning statement is required on the medicine label:
- (PREGNT2) ‘Do not use if pregnant or likely to become pregnant’ (or words to that effect);
unless the ingredient is:
(i) a steam-distilled essential oil; and
(ii) for use in combination with other permitted ingredients as part of a fragrance or flavour proprietary excipient formulation where:
(A) the total concentration of fragrance proprietary excipient formulations containing Artemisia dracunculus is not more than 1% of the total medicine; or
(B) the total concentration of flavour proprietary excipient formulations containing Artemisia dracunculus is not more than 5% of the total medicine.695 ARTEMISIA FRIGIDA A, H Thujone is a mandatory component of Artemisia frigida.
The concentration of thujone from Artemisia frigida in the medicine must be no more than 4%.
The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that is:
- listed in the Register on or after 1 March 2022; or
- released for supply on or after 1 March 2023.
(a) The following warning statement is required on the medicine label:
- (PREGNT2) ‘Do not use if pregnant or likely to become pregnant’ (or words to that effect).696 ARTEMISIA HERBA-ALBA A, H Thujone is a mandatory component of Artemisia herba-alba.
The concentration of thujone from Artemisia herba-alba in the medicine must be no more than 4%.697 ARTEMISIA MARITIMA A, H Thujone is a mandatory component of Artemisia maritima.
The concentration of thujone from Artemisia maritima in the medicine must be no more than 4%.698 ARTEMISIA OIL E Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.
If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
5079 TYPHA LATIFOLIA A, H 5080 TYPHONIUM GIGANTEUM A, H 5081 TYROSINE A, E
Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine
Note: See sections 5 and 6.
Permissible ingredients and requirements Column 1 Column 2 Column 3 Column 4 Item Ingredient name Purpose Specific requirements 5082 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'.5083 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.'5084 ULEX EUROPAEUS A, H 5085 ULMUS AMERICANA A, H 5086 ULMUS CAMPESTRIS A, H 5087 ULMUS GLABRA A, H 5088 ULMUS MINOR A, H 5089 ULMUS PARVIFOLIA A, H 5090 ULMUS PUMILA A, H 5091 ULMUS RUBRA A, H 5092 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%.5093 ULTRAMARINE BLUE E Permitted for use only as a colour for topical use.
5094 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%.5095 UMBELLULARIA CALIFORNICA A, H 5096 UNCARIA GAMBIR A, H 5097 UNCARIA RHYNCOPHYLLA A, H 5098 UNCARIA SINENSIS A, H 5099 UNCARIA TOMENTOSA A, H 5100 UNDARIA PINNATIFIDA A, H Whole dried Undaria pinnatifida must not contain the holdfast.
Only for use in oral medicines.5101 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%.5102 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%.5103 UNDECENOIC ACID E 5104 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%.5105 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%.5106 UNDECYLENAMIDE DEA E 5107 UNDECYLENOYL PEG-5 PARABEN E Only for use in topical medicines for dermal application.
5108 URANIUM NITRATE H Only for use as an active homoeopathic ingredient.
5109 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).5110 URTICA DIOICA A, E, H 5111 URTICA URENS A, H 5112 USNEA BARBATA A, H 5113 UVA URSI LEAF DRY A, H 5114 UVA URSI LEAF POWDER A, E, H 5115 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%.5116 VACCARIA SEGATALIS A, H 5117 VACCINIUM BRACTEATUM A, H 5118 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%.5119 VACCINIUM MACROCARPON A, E, H 5120 VACCINIUM MYRTILLOIDES A, H 5121 VACCINIUM MYRTILLUS A, E, H 5122 VACCINIUM OXYCOCCUS A, H 5123 VACCINIUM VITIS-IDAEA A, H Beta-arbutin is a mandatory component of Vaccinium vitis-idaea.
When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.
When for dermal application exclusively to the face:
a) the concentration of beta-arbutin in the medicine must not be more than 7%;
b) hydroquinone is a mandatory component; and
c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.
When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.5124 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%.5125 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%.5126 VALERIAN DRY A, H 5127 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%.5128 VALERIAN POWDER A, H 5129 VALERIANA EDULIS A, H 5130 VALERIANA OFFICINALIS A, H 5131 VALERIANA SORBIFOLIA A, H 5132 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%.5133 VALINE A, E 5134 VANADIUM H 5135 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%.5136 VANILLA DRY A, E, H 5137 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%.5138 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%.5139 VANILLA PLANIFOLIA A, E, H 5140 VANILLA POWDER A, E, H 5141 VANILLA TAHITENSIS A, H 5142 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%.5143 VANILLIN E 5144 VANILLIN ACETATE E Vanillin acetate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total concentration of flavour proprietary excipient formulations containing vanillin acetate must not be more than 5% of the total medicine.
The maximum recommended daily dose of the medicine must not provide more than 1.8 micrograms of vanillin acetate.5145 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%.5146 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%.5147 VAT RED 1 E Permitted for use only as a colour for topical use.
5148 VAT RED 1 ALUMINIUM LAKE E Permitted for use only as a colour for topical use.
5149 VAT RED 5 E Permitted for use only as a colour for topical use.
5150 VEGETABLE OIL E 5151 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).'5152 VEIN H Only for use as an active homoeopathic ingredient.
5153 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%.5154 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%.5155 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%.5156 VERBASCUM DENSIFLORUM A, H 5157 VERBASCUM THAPSUS A, H 5158 VERBENA OFFICINALIS A, H 5159 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%.5160 VERONICA CHAMAEDRYS A, H 5161 VERONICA OFFICINALIS A, H 5162 VERONICASTRUM VIRGINICUM A, E, H 5163 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%.5164 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%.5165 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%.5166 VIBURNUM OPULUS A, E, H 5167 VIBURNUM PRUNIFOLIUM A, E, H 5168 VICIA FABA A, H Levodopa is a mandatory component of Vicia faba.
The concentration of levodopa in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.5169 VIGNA ANGULARIS VAR. ANGULARIS A, H 5170 VIGNA RADIATA A, H 5171 VIGNA UMBELLATA A, H 5172 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%.5173 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%5174 VINCETOXICUM OFFICINALE A, H 5175 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%.5176 VIOLA ODORATA A, E, H 5177 VIOLA TRICOLOR A, H 5178 VIOLA YEDOENSIS A, H 5179 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%.5180 VIPER H Only for use as an active homoeopathic ingredient.
5181 VISCUM ALBUM A, E, H 5182 VISCUM COLORATUM A, H 5183 VISCUM FLAVESCENS A, H 5184 VITELLARIA PARADOXA A, E, H 5185 VITEX AGNUS-CASTUS A, E, H When the ingredient is in a medicine that is for internal use, the following warning statement is required on the label:
- (VAC) 'Vitex agnus-castus may affect hormones and medicines such as oral contraceptives. Consult your health professional before use' (or words to that effect).5186 VITEX NEGUNDO A, H 5187 VITEX ROTUNDIFOLIA A, H 5188 VITEX TRIFOLIA A, H 5189 VITIS VINIFERA A, E, H 5190 VITREOSCILLA CONCENTRATE E Only for use in topical medicines for dermal application.
The concentration in the medicine must be no more than 0.1%.5191 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%.5192 WAHLENBERGIA GRACILIS A, H 5193 WALNUT E 5194 WALNUT OIL E 5195 WATER MELON E 5196 WHEAT E Gluten is a mandatory component of Wheat when the route of administration is other than topical and mucosal.
5197 WHEAT BRAN E Gluten is a mandatory component of Wheat bran when the route of administration is other than topical and mucosal.
5198 WHEAT DEXTRIN A, E Gluten is a mandatory component of wheat dextrin.
Only for use when the dosage form is capsule, tablet or pill.5199 WHEAT GERM E Gluten is a mandatory component of Wheat germ when the route of administration is other than topical and mucosal.
5200 WHEAT GERM GLYCERIDES E Gluten is a mandatory component of wheat germ glycerides when the route of administration is other than topical and mucosal.
5201 WHEAT LEAF E 5202 WHEAT SPROUT E Gluten is a mandatory component of Wheat sprout when the route of administration is other than topical and mucosal.
5203 WHEAT STARCH E When the route of administration is other than topical or mucosal, gluten is a mandatory component of wheat starch.
5204 WHEATGERM OIL A, E, H 5205 WHEY POWDER E Lactose is a mandatory component of Whey powder when the route of administration is oral.
5206 WHEY PROTEIN E Lactose is a mandatory component of Whey protein when the route of administration is oral.
5207 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%.5208 WHITE BEESWAX E 5209 WHITE HOREHOUND HERB DRY A, H 5210 WHITE HOREHOUND HERB POWDER A, H 5211 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.
5212 WHOLE DRY MILK E 5213 WIKSTROEMIA VIRIDIFLORA A, H 5214 WILD CARROT HERB DRY A, E, H 5215 WILD CARROT HERB POWDER A, H 5216 WILD CHERRY BARK DRY A, H 5217 WILD CHERRY BARK POWDER A, H 5218 WILD LETTUCE LEAF DRY A, H 5219 WILD LETTUCE LEAF POWDER A, H 5220 WINTERGREEN OIL A, E, H Methyl salicylate is a mandatory component of wintergreen oil.
Not to be included in medicines for use in the eye or on damaged skin.
When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%.
When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging.
When the concentration of methyl salicylate in a liquid preparation is more than 5%, and the dosage form is spray, the medicine does not require child resistant packaging if:
- the delivery device is engaged into the container in such a way that prevents it from being readily removed;
- direct suction through the delivery device results in delivery of no more than one dosage unit; and
- actuation of the spray device is ergonomically difficult for young children to accomplish.
The following warning statement is required on the medicine label:
- (METSAL) 'Contains methyl salicylate' (or words to that effect).
When for use in topical medicines for dermal application:
i) the concentration of methyl salicylate in the medicine must not be more than 25%;
ii) the following warning statements are required on the medicine label:
- (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect);
- (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less';
- (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect);
- (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect);
iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label:
- (IRRIT) 'If irritation develops, discontinue use'.5221 WITHANIA SOMNIFERA A, E, H The medicine requires the following warning statement on the label:
- (WITHANIA) 'If you are pregnant, or considering becoming pregnant, do not take without consulting a health professional' (or words to that effect)
unless:
(a) the plant part is root;
(b) the plant preparation is an extract;
(c) the extraction solvents are only water, ethanol or methanol; and
(d) the maximum recommended daily dose of the medicine contains no more than the equivalent quantity of 12 g dry root.5222 WOLFIPORIA COCOS A, E, H 5223 WOOL ALCOHOLS E Only for use in topical medicines for dermal application.
5224 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.
5225 XANTHAN GUM E 5226 XANTHIUM SIBIRICUM A, H 5227 XANTHIUM STRUMARIUM A, H 5228 XANTHOMONA CAMPESTRIS A, H 5229 XEROPHYLLUM ASPHODELOIDES A, H 5230 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%.5231 XYLITOL E 5232 XYLOSE E 5233 YAM E 5234 YARROW HERB DRY A, H 5235 YARROW HERB POWDER A, H 5236 YEAST AUTOLYSATE E 5237 YEAST DRIED A, E, H 5238 YELLOW 2G E Permitted for use only as a colour for topical use.
5239 YELLOW BEESWAX E 5240 YELLOW MERCURIC OXIDE H Only for use as an active homoeopathic ingredient.
5241 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.5242 YLANG YLANG OIL A, E, H 5243 YUCCA BACCATA A, H 5244 YUCCA ELATA A, H 5245 YUCCA FILAMENTOSA A, H 5246 YUCCA GLORIOSA A, H 5247 Z-BETA-DAMASCONE E Z – beta damascone must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.
The total concentration of flavour proprietary excipient formulations containing Z – beta damascone must not be more than 5% of the total medicine.5248 ZANTHOXYLUM AMERICANUM A, H 5249 ZANTHOXYLUM BUNGEANUM A, E, H 5250 ZANTHOXYLUM CLAVA-HERCULIS A, H 5251 ZANTHOXYLUM NITIDUM A, H 5252 ZANTHOXYLUM PIPERITUM A, H 5253 ZANTHOXYLUM SIMULANS A, H 5254 ZEA MAYS A, E, H 5255 ZEAXANTHIN A, E 5256 ZEIN E 5257 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)'.5258 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).'5259 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).'5260 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)'.5261 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).'5262 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).'5263 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).'5264 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).'5265 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).'5266 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).'5267 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).'5268 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)'.5269 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'.5270 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'.5271 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).'5272 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).'5273 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%.5274 ZINC OXIDE A, E, H When used internally, zinc is a mandatory component of zinc oxide.
When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label:
- (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR
-'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period’ (or words to that effect).
When used in primary sunscreen products, the following warning statements are required on the label:
- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and
- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).5275 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).5276 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.5277 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).'5278 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).'5279 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).'5280 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).'5281 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).'5282 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.5283 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%.5284 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'.5285 ZIZIPHUS JUJUBA A, H 5286 ZIZIPHUS JUJUBA VAR. SPINOSA A, H 5287 ZIZYPHUS SATIVA A, H 5288 ZOSTERA MARINA A, H 5289 ZUCCHINI E
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