Update to the Permissible Ingredients Determination (No. 1 of 2024)

  • One new Active ingredient with exclusive use provisions for 2 years 
  • Two new Excipient ingredients 
  • Extension of use for one ingredient 
  • New warning statements for Curcuma spp (Turmerics), curcumin, & Camellia sinensis (green tea), new limits for some soy ingredients, and other changed requirements 

A new Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024, has been approved by the TGA and entered onto the Federal Register of Legislation here and commences today, Friday 1 March 2024. This instrument is made under section 26BB of the Therapeutic Goods Act 1989 and repeals the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2023

This Technical Alert includes a table of changes to the Determination to assist sponsors, manufacturers, raw material suppliers identify them, which includes:  

  • NEW ingredients, and specific requirements that apply to that ingredient; 
  • CHANGED ingredients comparing the original requirements and the new requirements; 
  • DELETED ingredients (if applicable).  

If members identify technical or transitional concerns, or errors with the changes to the Determination, please contact CMA at Lucy.Lang@cmaustralia.org.au or technical@cmaustralia.org.au.  

For ingredients that have changed:  

  • Sponsors should review changed compliance requirements against affected products; this may include increased or decreased requirements. 
  • Suppliers of raw materials especially proprietary ingredients, and manufacturers where relevant, should also ensure that changes to ingredients are checked against materials. Suppliers and manufacturers need to ensure they are providing up-to-date and relevant information to sponsors and other manufacturers so that sponsors can remain in compliance with their legal obligations under the Therapeutic Goods Act 1989. The TGA expect sponsors to obtain correct information from suppliers, and for suppliers to provide the necessary and correct information to sponsors, both at the time of supply and at any time there are changes to ingredients or requirements that may affect compliance. 

Summary of all changes to the Determination  

A number of changes have been made in the Determination. Please see the table below for more complete details. The changes include:  

NEW ingredients (to see all details including restrictions, please refer to the full table below

  • The addition of the following new ingredients for use in listed and assessed listed medicines. 
  • Addition of the new active ingredient theanine – Only to be used in a medicine where Trans Chem Pty Ltd (Client ID 21878), 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 2026. 
  • Addition of the new excipient ingredient ceramide 6 II;  
  • Addition of the new excipient ingredient sodium lauroyl lactylate;  

CHANGED ingredients (to see all details please refer to the full table below) 

  • updates to applicable specific requirements, as well as minor formatting changes and correction of minor grammatical errors, for the following ingredients. 

Note that these changes in effect immediately for medicines are listed in the Register on or after 1 March 2024; or for existing medicines, those released for supply on or after 1 March 2025

  • Curcuma aromatica, Curcuma longa, Curcuma zanthorrhiza, Curcuma zedoaria and curcumin: to add a liver injury warning statement, and to add maximum recommended daily doses for children based on age and content of  (1E,6E)-1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione (curcumin); 
  • In very rare cases, Curcuma species may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.’ 
  • Camellia sinensis: to add warning statements relating to liver injury and to take with food, and to clarify the requirements for use as an excipient in flavour proprietary excipient formulations; 
  • (i) ‘In rare cases, Camellia sinensis may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes, or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.‘; and (ii) ‘To be taken with food.’ However there are some exceptions to including this warning statement which should be noted. 
  • benzophenone: to remove use as an excipient ingredient in flavour proprietary excipient formulations; 
  • soy phosphatidylserine-enriched soy lecithin liquid and soy phosphatidylserine-enriched soy lecithin powder: to amend the requirements regarding the maximum recommended daily dose to not provide more than 300 mg of soy phosphatidylserine. And to remove the requirement that the concentration of soy phosphatidylserine must be no more than 15% from 1 March 2025 for existing medicines; and 
  • Terminalia ferdinandiana (Kakadu plum): to clarify the requirements for the permitted plant part and preparation type when used as an active ingredient; 
  • minor formatting changes and other amendments to the specific requirements for the ingredient neohesperidin-dihydrochalcone, to permit oral use in listed and assessed listed medicines; 
  • amendments to the specific requirements for the ingredient hemp seed oil to align with the requirements in the Poisons Standard. Specifically, to specify the total concentration of cannabidiol and tetrahydrocannabinols in hemp seed as distinct from the total concentration of these substances in the medicine. 
  • update to the requirements for 14 ingredients on the Determination that have discrepancies with requirements in the Poisons Standard, and minor formatting changes and correction of minor typographical errors for the purpose of improving the internal consistency of the Determination; 
  • artemisia oil; 
  • C10-12 alkane/cycloalkane; 
  • cetylpyridinium chloride; 
  • ethyl methacrylate; 
  • furfural; 
  • hydrogenated C6-14 olefin polymers; 
  • lipase; 
  • phleum pratense; 
  • turpentine oil; 
  • zinc lactate; 
  • zinc lactate dihydrate; 
  • zinc para-phenolsulfonate; 
  • zinc stearate; and 
  • zinc valerate; 
  • minor amendments to five ingredients to reflect the expiry of transition periods for requirements relating to those ingredients (so medicines containing these ingredients must comply with all requirements): 
  • Chelidonium majus; 
  • Larrea tridentata; and 
  • valerian dry, valerian powder, and Valeriana officinalis; 
  • the removal of requirements for the following ingredients to reflect the expiry of periods of exclusive uses for the relevant sponsors, and minor formatting changes and correction of minor grammatical errors for the purpose of improving the internal consistency of the Determination: 
  • 3′-sialyllactose sodium; 
  • 6′-sialyllactose sodium; 
  • dihydrocapsiate; 
  • hydrolysed chicken cartilage extract; 
  • lacto-N-neotetraose; and 
  • lacto-N-tetraose; 
  • the removal of the transition period for labelling requirement for the ingredient ‘lacto-N-neotetraose’, and minor formatting changes and correction of minor grammatical errors for the purpose of improving the internal consistency of the Determination. 

!Always refer to the most current Permissible Ingredients Determination and other legislative documents including Therapeutic Goods Orders before making ingredient and product decisions. 

Resources 

  • TGA web page: Changes to the Permissible Ingredients Determination  

Note: The New purpose and Previous purpose columns use letters to denote the substance purpose i.e., A- Active, E -Excipient and H-Homeopathic. 

Substance name Determination Variation Type New Purpose Previous Purpose New Specific Requirements Previous Specific Requirements 
ceramide 6 II Addition  Ceramide 6 II must: (a) Only be used in topical medicines for dermal application; and (b) Not be included in medicines intended for use on broken skin or in the eye. The concentration in the medicine must be no more than 0.011%.   
sodium lauroyl lactylate Addition  Sodium lauroyl lactylate must: (a) Only be used in topical medicines for dermal application; and (b) Not be included in medicines intended for use on broken skin or in the eye. The concentration in the medicine must be no more than 0.2%.   
theanine  Addition  Only to be used in a medicine where Trans Chem Pty Ltd (Client ID 21878), 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 2026. The route of administration for medicines that contain theanine must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 450 mg of theanine. The following warning statements (or words to the same effect) are required on the medicine label: – (PREGNT) ‘Not recommended for use by pregnant and lactating women’; and – (ADULT) ‘Adults only’.   
3′-sialyllactose sodium Change 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.  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. 
6′-sialyllactose sodium Change 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.  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. 
artemisia oil Change Thujone is a mandatory component of artemisia oil. Only permitted for use in medicines containing 4% or less of thujone. Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must not be more than 5%. If used in a fragrance the total fragrance concentration in a medicine must not be more than 1%.  Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.  
benzophenone Change Permitted for topical use only in combination with other permitted ingredients as a fragrance. The total concentration of fragrance proprietary excipient formulations containing benzophenone must not be more than 1% of the total medicine.  Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. 
C10-12 alkane/cycloalkane Change Only permitted for use in solid or semi-solid medicines or in medicines: (a) containing 25% or less of hydrocarbons, liquid; or (b) when packed in pressurised spray packs; or (c) when packed in containers with a capacity of 2 millilitres or less. Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must not be more than 1%.  Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.  
Camellia sinensis Change A, E, H A, E, H Caffeine is a mandatory component of Camellia sinensis. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: – (ADULT) ‘Adults only’ (or words to that effect). – (CAFF) ‘Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.’ – (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’ When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: – (CAFFLMT) ‘Limit the use of caffeine-containing products (including tea and coffee) when taking this product.’ – (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect). The requirements specified in paragraphs (a) to (b) below apply to a medicine that contains the ingredient that is: – listed in the Register on or after 1 March 2024; or – released for supply on or after 1 March 2025. (a) When used in oral medicines, the following warning statements are required on the medicine label: (i) ‘In rare cases, Camellia sinensis may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes, or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.’; and (ii) (FOOD) ‘To be taken with food.’ unless when: (A) the preparation of Camellia sinensis is derived from an aqueous extract and contains 300 mg or less epigallocatechin-3-gallate per maximum recommended daily dose; or (B) Camellia sinensis is used in combination with other permitted ingredients as a flavour proprietary excipient formulation. (b) The total concentration of flavour proprietary excipient formulations containing Camellia sinensis must not be more than 5% of the total medicine.   Caffeine is a mandatory component of Camellia sinensis. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: – (ADULT) ‘Adults only’ (or words to that effect). – (CAFF) ‘Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.’ – (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’ When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: – (CAFFLMT) ‘Limit the use of caffeine-containing products (including tea and coffee) when taking this product.’ – (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).  
cetylpyridinium chloride Change A, E A, E Only permitted for use in medicines containing 5% or less of quaternary ammonium compounds. When used as an excipient ingredient, only for use in topical medicines for dermal application. When used as an active ingredient: (a) permitted for use only in medicated throat lozenges; (b) the medicine must not contain more than 2 milligrams of cetylpyridinium chloride per lozenge; (c) the maximum recommended daily dose of the medicine must not provide more than 24 milligrams of cetylpyridinium chloride; and (d) the medicine label must specify that the medicine is only to be used for 7 days (or less).  When used as an excipient ingredient, only for use in topical medicines for dermal application. When used as an active ingredient: a) permitted for use only in medicated throat lozenges; b) the medicine must not contain more than 2 mg of cetylpyridinium chloride per lozenge; c) the maximum recommended daily dose of the medicine must not provide more than 24 mg of cetylpyridinium chloride; and d) the medicine label must specify that the medicine is only to be used for 7 days (or less).  
Chelidonium majus Change A, E, H A, E, H When the medicine is for oral or sublingual use, the following warning statement is required on the medicine label: (CELAND1) ‘In rare cases, Chelidonium majus may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine.’  The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that is: – listed in the Register before 1 March 2023; and – released for supply before 1 March 2024: (a)When the medicine is for oral or sublingual use, one of the following warning statements is required on the medicine label: (i)(CELAND) ‘WARNING: Greater Celandine may harm the liver in some people. Use only under the supervision of a healthcare professional’; or (ii)(CELAND1) ‘In rare cases, Chelidonium majus may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine.’ The requirement specified in paragraph (b) below applies to a medicine that contains the ingredient that is: – listed in the Register on or after 1 March 2023;  or – released for supply on or after 1 March 2024: (b)When the medicine is for oral or sublingual use, the following warning statement is required on the medicine label: (CELAND1) ‘In rare cases, Chelidonium majus may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine.’  
Curcuma aromatica Change A, H A, H The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is: – listed in the Register on or after 1 March 2024; or – released for supply on or after 1 March 2025. (a) When used in oral medicines as an active ingredient, the following warning statement is required on the medicine label: ‘In very rare cases, Curcuma species may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.’ (b) When used in oral medicines the maximum daily dose of (1E,6E)-1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione in the medicine must not provide more than: (i) 36 mg for children from 2-3 years (inclusive); (ii) 48 mg for children from 4-11 years (inclusive); and (iii) 123 mg for children from 12-17 years (inclusive). (c) Not permitted for use in children aged below 2 years.  
Curcuma longa Change A, E, H A, E, H The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is: – listed in the Register on or after 1 March 2024; or – released for supply on or after 1 March 2025. (a) When used in oral medicines as an active ingredient, the following warning statement is required on the medicine label: ‘In very rare cases, Curcuma species may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.’ (b) When used in oral medicines the maximum daily dose of (1E,6E)-1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione in the medicine must not provide more than: (i) 36 mg for children from 2-3 years (inclusive); (ii) 48 mg for children from 4-11 years (inclusive); and (iii) 123 mg for children from 12-17 years (inclusive). (c) Not permitted for use in children aged below 2 years.  
Curcuma zanthorrhiza Change A, H A, H The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is: – listed in the Register on or after 1 March 2024; or – released for supply on or after 1 March 2025. (a) When used in oral medicines as an active ingredient, the following warning statement is required on the medicine label: ‘In very rare cases, Curcuma species may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.’ (b) When used in oral medicines the maximum daily dose of (1E,6E)-1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione in the medicine must not provide more than: (i) 36 mg for children from 2-3 years (inclusive); (ii) 48 mg for children from 4-11 years (inclusive); and (iii) 123 mg for children from 12-17 years (inclusive). (c) Not permitted for use in children aged below 2 years.    
Curcuma zedoaria Change A, H A, H The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is: – listed in the Register on or after 1 March 2024; or – released for supply on or after 1 March 2025. (a) When used in oral medicines as an active ingredient, the following warning statement is required on the medicine label: ‘In very rare cases, Curcuma species may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.’ (b) When used in oral medicines the maximum daily dose of (1E,6E)-1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione in the medicine must not provide more than: (i) 36 mg for children from 2-3 years (inclusive); (ii) 48 mg for children from 4-11 years (inclusive); and (iii) 123 mg for children from 12-17 years (inclusive). (c) Not permitted for use in children aged below 2 years.  
curcumin Change A, E, H A, E, H When for excipient use, only permitted for use as a colour in topical and oral medicines. The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is: – listed in the Register on or after 1 March 2024; or – released for supply on or after 1 March 2025. (a) When used in oral medicines as an active ingredient, the following warning statement is required on the medicine label: ‘In very rare cases, curcumin may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.’ (b) When used in oral medicines the maximum daily dose of (1E,6E)-1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione in the medicine must not provide more than: (i) 36 mg for children from 2-3 years (inclusive); (ii) 48 mg for children from 4-11 years (inclusive); and (iii) 123 mg for children from 12-17 years (inclusive). (c) Not permitted for use in children aged below 2 years. When for excipient use, only permitted for use as a colour in topical and oral medicines. 
dihydrocapsiate Change The route of administration for medicines that contain dihydrocapsiate must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 9 mg dihydrocapsiate. The following warning statements (or words to the same effect) are required on the medicine label: – (ADULT) ‘Adults only’; and – (PREGNT) ‘Not recommended for use by pregnant and lactating women’.  Only to be used in a medicine where Ajinomoto Co Inc (Client ID 15631), 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. The route of administration for medicines that contain dihydrocapsiate must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 9 mg dihydrocapsiate. The following warning statements (or words to the same effect) are required on the medicine label: – (ADULT) ‘Adults only’; and – (PREGNT) ‘Not recommended for use by pregnant and lactating women’. 
ethyl methacrylate Change Only for use in topical medicines for dermal application. Only permitted in medicines containing 1% or less of ethyl methacrylate as residual monomer in a polymer.  Only for use in topical medicines for dermal application. 
furfural Change Permitted for use only in medicines containing 0.1% or less of furfural and in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must not be more than 5%. If used in a fragrance the total fragrance concentration in a medicine must not be more than 1%.  Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.  
hemp seed oil Change A, E A, E Only to be used in a medicine where Elixinol Wellness (Byron Bay) Pty Ltd (Client ID 78778), 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 13 December 2024. Cannabidiol and tetrahydrocannabinols are mandatory components of hemp seed oil. The total concentration of cannabidiol in hemp seed oil must not be more than 75 mg/kg. The total concentration of tetrahydrocannabinols in hemp seed oil must not be more than 10 mg/kg. The route of administration for medicines that contain hemp seed oil must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 36 g of hemp seed oil. The following warning statements (or words to that effect) are required on the medicine label: – ‘Not for use in children under 2 years of age’; and – ‘Not to be taken on the same day with other products containing hemp seed oil, including food sources’.  Only to be used in a medicine where Elixinol Wellness (Byron Bay) Pty Ltd (Client ID 78778), 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 13 December 2024. Cannabidiol and tetrahydrocannabinols are mandatory components of hemp seed oil. The total concentration of cannabidiol in the medicine must not be more than 75 mg/kg. The total concentration of tetrahydrocannabinols in the medicine must not be more than 10 mg/kg. The route of administration for medicines that contain hemp seed oil must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 36 g of hemp seed oil. The following warning statements (or words to that effect) are required on the medicine label: – ‘Not for use in children under 2 years of age’; and – ‘Not to be taken on the same day with other products containing hemp seed oil, including food sources’.  
hydrogenated C6-14 olefin polymers Change Only permitted for use in solid or semi-solid medicines for dermal application or in topical medicines for dermal application: (a) containing 25% or less of hydrocarbons, liquid; or (b) when packed in pressurised spray packs; or (c) when packed in containers with a capacity of 2 millilitres or less. Not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 7%.  Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 7%.  
hydrolysed chicken cartilage extract Change The route of administration for medicines that contain hydrolysed chicken cartilage extract must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 2000 mg hydrolysed chicken cartilage extract. The following warning statement (or words to the same effect) is required on the medicine label: – (ADULT) ‘Adults only’.  Only to be used in a medicine where BioCell Technology LLC (Client ID 70666), 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. The route of administration for medicines that contain hydrolysed chicken cartilage extract must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 2000 mg hydrolysed chicken cartilage extract. The following warning statements (or words to the same effect) are required on the medicine label: – (ADULT) ‘Adults only’. 
lacto-N-neotetraose  Change Lactose is a mandatory component of lacto-N-neotetraose. The route of administration for medicines that contain lacto-N-neotetraose must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than: (a) 1.5 g of lacto-N-neotetraose to individuals aged 4 years and older; and (b) 0.6 g of lacto-N-neotetraose to individuals aged up to 3 years (inclusive). One of the following statements (or words to the same effect) is required on the medicine label: (a) When the medicine is only for use in individuals aged 2 years and above: ‘Not to be taken on the same day with other products containing lacto-N-neotetraose’; or (b) When the medicine is for use in children aged less than 2 years: ‘Not to be taken on the same day with breastmilk or other products containing lacto-N-neotetraose’.  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 20 August 2023. Lactose is a mandatory component of lacto-N-neotetraose. The route of administration for medicines that contain lacto-N-neotetraose must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than: (a) 1.5 g of lacto-N-neotetraose to individuals aged 4 years and older; and (b) 0.6 g of lacto-N-neotetraose to individuals aged up to 3 years (inclusive). The requirements specified in paragraph (a) below apply to a medicine that contains the ingredient that is released for supply after 20 August 2023: (a) One of the following statements is required on the medicine label: (i) When the medicine is only for use in individuals aged 2 years and above: ‘Not to be taken on the same day with other products containing lacto-N-neotetraose’ (or words to that effect); or (ii) When the medicine is for use in children aged less than 2 years: ‘Not to be taken on the same day with breastmilk or other products containing lacto-N-neotetraose’ (or words to that effect). 
lacto-N-tetraose  Change Lactose is a mandatory component of lacto-N-tetraose. The route of administration for medicines that contain lacto-N-tetraose must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than: a) 2 g of lacto-N-tetraose to individuals aged 1 year and older; and b) 0.6 g of lacto-N-tetraose to individuals aged more than 6 months to 11 months (inclusive); and c) 0.8 g of lacto-N-tetraose to individuals aged up to 6 months (inclusive). One of the following statements (or words to the same effect) is required on the medicine label: a) When the medicine is only for use in individuals aged 2 years and above: ‘Not to be taken on the same day with other products containing lacto-N-tetraose’; or b) When the medicine is for use in children aged less than 2 years: ‘Not to be taken on the same day with breastmilk or other products containing lacto-N-tetraose’. 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 24 January 2024. Lactose is a mandatory component of lacto-N-tetraose. The route of administration for medicines that contain lacto-N-tetraose must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than: a) 2 g of lacto-N-tetraose to individuals aged 1 year and older; and b) 0.6 g of lacto-N-tetraose to individuals aged more than 6 months to 11 months (inclusive); and c) 0.8 g of lacto-N-tetraose to individuals aged up to 6 months (inclusive). One of the following statements (or words to that effect) is required on the medicine label: a) When the medicine is only for use in individuals aged 2 years and above: ‘Not to be taken on the same day with other products containing lacto-N-tetraose’; or b) When the medicine is for use in children aged less than 2 years: ‘Not to be taken on the same day with breastmilk or other products containing lacto-N-tetraose’. 
larrea tridentata Change A, H A, H The following warning statement is required on the medicine label: (CHAP1) ‘In rare cases, Larrea tridentata may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine.’ The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that is: – listed in the Register before 1 March 2023; and – released for supply before 1 March 2024: (a) One of the following warning statements is required on the medicine label: (i)(CHAP) ‘WARNING: Chaparral may harm the liver in some people – use only under supervision of a health care professional’; or (ii)(CHAP1) ‘In rare cases, Larrea tridentata may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine.’  The requirement specified in paragraph (b) below applies to a medicine that contains the ingredient that is: – listed in the Register on or after 1 March 2023; or – released for supply on or after 1 March 2024. (b) The following warning statement is required on the medicine label: (CHAP1) ‘In rare cases, Larrea tridentata may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine.’ 
lipase Change Permitted for use only when derived from Rhizopus oryzae and in medicines containing 20,000 lipase units (equivalent to 20,000 BP units) or less of lipase activity per dosage unit. Lipase must comply with the relevant compositional guideline.  Lipase must only be derived from Rhizopus oryzae and must comply with the relevant compositional guideline. 
neohesperidin-dihydrochalcone Change The routes of administration for medicines that contain neohesperidin-dihydrochalcone must be limited to: (a) topical for dermal application; and (b) oral. When used in topical medicines for dermal application: (a) neohesperidin-dihydrochalcone must not be included in medicines intended for use in the eye or on damaged skin; and (b) the concentration of neohesperidin-dihydrochalcone in the medicine must not be more than 0.1%. When used in oral medicines: (a) the concentration in the medicine must not be more than 0.1%; and (b) the following warning statement (or words to that effect) is required on the medicine label: – (NTAKEN3) ‘Not to be taken by children under 3 years old’.  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 0.1%  
phleum pratense Change A, H A, H Only permitted in preparations other than phleum pratense pollen extract.  
soy phosphatidylserine-enriched soy lecithin liquid  Change Soy phosphatidylserine is a mandatory component of soy phosphatidylserine-enriched soy lecithin liquid. The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that is: – listed in the Register before 1 March 2024; and – released for supply before 1 March 2025. (a) The concentration of soy phosphatidylserine in the medicine must be no more than 15%. The requirement specified in paragraph (b) below applies to a medicine that contains the ingredient that is: – listed in the Register on or after 1 March 2024; or – released for supply on or after 1 March 2025. (b) The maximum recommended daily dose of the medicine must not provide more than 300 mg of soy phosphatidylserine.  Soy phosphatidylserine is a mandatory component of soy phosphatidylserine-enriched soy lecithin liquid. The concentration of soy phosphatidylserine in the medicine must be no more than 15%.  
soy phosphatidylserine-enriched soy lecithin powder Change   Soy phosphatidylserine is a mandatory component of soy phosphatidylserine-enriched soy lecithin powder. The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that is: – listed in the Register before 1 March 2024; and – released for supply before 1 March 2025. (a) The concentration of soy phosphatidylserine in the medicine must be no more than 15%. The requirement specified in paragraph (b) below applies to a medicine that contains the ingredient that is: – listed in the Register on or after 1 March 2024; or – released for supply on or after 1 March 2025. (b) The maximum recommended daily dose of the medicine must not provide more than 300 mg of soy phosphatidylserine. Soy phosphatidylserine is a mandatory component of soy phosphatidylserine-enriched soy lecithin powder. The concentration of soy phosphatidylserine in the medicine must be no more than 15%.  
terminalia ferdinandiana Change A, E, H A, E, H The requirements specified in paragraphs (a) to (c) below apply to a medicine that contains the ingredient that is: – listed in the Register before 1 March 2024; and – released for supply before 1 March 2025. (a) Only for use when the plant part is fruit flesh, fruit flesh dry or the preparation is as an aqueous extract of the fruit flesh. (b) When used as an excipient, the ingredient is 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. (c) When used as an excipient, the concentration in the medicine must be no more than 0.3%. The requirements specified in paragraphs (d) to (e) below apply to a medicine that contains the ingredient that is: – listed in the Register on or after 1 March 2024; or – released for supply on or after 1 March 2025. (d) When used as an active ingredient, the plant part must be limited to fruit flesh and seed, and the plant preparation must be limited to fresh, dry, or an aqueous extract. (e) When used as an excipient ingredient: (i) the route of administration for medicines that contain Terminalia ferdinandiana must be limited to topical for dermal use; (ii) medicines that contain Terminalia ferdinandiana are not to be intended for use on damaged skin or in the eye; and (iii) the concentration of Terminalia ferdinandiana in the medicine must not be more than 0.3%. Only for use when the plant part is fruit flesh, fruit flesh dry or the preparation is as an aqueous extract of the fruit flesh. When used as an excipient, the ingredient is 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. When used as an excipient, the concentration in the medicine must be no more than 0.3%.  
turpentine oil Change A, E A, E Only permitted for use when turpentine oil is derived from sources other than mineral turpentine. The concentration in the medicine must not be more than 25%. The concentration in the medicine must be no more than 25%. 
valerian dry Change A, H A, H The following warning statement is required on the medicine label when the medicine is for oral use: (VALER) ‘In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.’ The requirement specified below applies to a medicine that contains the ingredient that is: – listed in the Register on or after 1 March 2023; or – released for supply on or after 1 March 2024: The following warning statement is required on the medicine label when the medicine is for oral use: (VALER) ‘In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.’ 
valerian powder Change A, H A, H The following warning statement is required on the medicine label when the medicine is for oral use: (VALER) ‘In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.’  The requirement specified below applies to a medicine that contains the ingredient that is: – listed in the Register on or after 1 March 2023; or – released for supply on or after 1 March 2024: The following warning statement is required on the medicine label when the medicine is for oral use: (VALER) ‘In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.’ 
valeriana officinalis Change A, H A, H The following warning statement is required on the medicine label when the medicine is for oral use: (VALER) ‘In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.’  The requirement specified below applies to a medicine that contains the ingredient that is: – listed in the Register on or after 1 March 2023; or – released for supply on or after 1 March 2024: The following warning statement is required on the medicine label when the medicine is for oral use: (VALER) ‘In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.’ 
zinc lactate Change 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 not be more than 2%. The concentration of zinc lactate in a medicine for ‘dental’ use in toothpaste medicines must not be 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 (or words to the same effect) on the medicine label: – (CHILD3) ‘Use in children under 12 years is not recommended’.  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’.  
zinc lactate dihydrate Change 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 not be more than 2%. The concentration of zinc lactate dihydrate in a medicine for ‘dental’ use in toothpaste medicines must not be 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 dihydrate for dental use require the following warning statement (or words to the same effect) on the medicine label: – (CHILD3) ‘Use in children under 12 years is not recommended’.  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’.  
zinc para-phenolsulfonate Change Only permitted for use in topical medicines for dermal use. The concentration of zinc para-phenolsulfonate in the medicine must not exceed 5%.  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). 
zinc stearate Change 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. When for internal use, the maximum recommended daily dose must not provide more than 50 milligrams of zinc. When for internal use and the maximum recommended daily dose is more than 25 milligrams but not more than 50 milligrams of zinc, the medicine requires the following warning statement (or words to the same effect) 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’  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.  
zinc valerate Change Only for use as an active homoeopathic ingredient. When 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. When for internal use, the maximum recommended daily dose must not provide more than 50 milligrams of zinc. When for internal use and the maximum recommended daily dose is more than 25 milligrams but not more than 50 milligrams of zinc, the medicine requires the following warning statement (or words to the same effect) 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’.  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.  
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