Update to the Permissible Ingredients Determination (No. 2 of 2024)

New Permissible Ingredients Determination published (No. 2 of 2024) 

  • One new Active ingredient with exclusive use provisions for 2 years 
  • Four new Excipient ingredients; one for use in flavour proprietary excipient formulations 
  • Removal of requirements for two ingredients to reflect the expiry of periods of exclusive use, and other changed requirements 

A new Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2024, has been approved by the TGA and entered onto the Federal Register of Legislation here, commencing Friday 14 June 2024. This instrument is made under section 26BB of the Therapeutic Goods Act 1989 and repeals the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023

This Technical Alert includes a table of changes to the Determination to assist sponsors, manufacturers, raw material suppliers identify them, and 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 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 Bacillus subtilis Only to be used in a medicine where ADM Australia Pty Ltd (Client ID 33326), 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 14 June 2026. 
  • Addition of the new excipient ingredient behentrimonium metilsulfate
  • Addition of the new excipient ingredient D-glucose, polymer with xylitol
  • Addition of the new excipient ingredient polyglyceryl-2 isostearate.  
  • Addition of the new excipient ingredient 1,8,12-bisabolatriene for use in flavour proprietary excipient formulations. 

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

  • Amendments to introduce specific requirements for the ingredient Litchi chinensis, in relation toits use in flavour proprietary excipient formulations. 
  • Amendments to the specific requirements for the ingredient nonivamide, in relation to its use in fragrance proprietary excipient formulations, and minor formatting changes for the purposes of improving the internal consistency of the Determination.  
  • 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: 
  • Euglena gracilis whole cell dry
  • Beeswax alcohols

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

Resources 

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 
BACILLUS SUBTILIS Addition  Only to be used in a medicine where ADM Australia Pty Ltd (Client ID 33326), 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 14 June 2026. The route of administration for medicines that contain Bacillus subtilis must be limited to oral. Only permitted for use in medicines when the strain of Bacillus subtilis is confirmed to be Agricultural Research Service Culture Collection (NRRL) accession number B-67989. The strain of Bacillus subtilis must be declared on the label. Bacillus subtilis is not permitted for use in children under the age of 2 years. The maximum recommended daily dose of the medicine must not provide more than: (a) 1 billion cfu Bacillus subtilis in individuals aged 2 to 17 years (inclusive); and (b) 5 billion cfu Bacillus subtilis in individuals aged 18 years and above. 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’; – (ANTIBI1) ‘To be administered 2-3 hours before or after antibiotics’; and – (IMMUNO2) ‘May not be suitable for someone taking immunomodulators. Consult your health professional before taking with other medicines’.   
BEHENTRIMONIUM METILSULFATE Addition  Behentrimonium metilsulfate 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 not be more than 1.06%.   
D-GLUCOSE, POLYMER WITH XYLITOL Addition  The route of administration for medicines that contain D-glucose, polymer with xylitol must be limited to topical for dermal use. The total concentration of D-glucose, polymer with xylitol in the medicine must not be more than 5%. The following warning statements (or words to the same effect) are required on the medicine label: – (EYE) ‘Avoid contact with eyes’; and – (BROKEN) ‘Use on unbroken skin only’.   
POLYGLYCERYL-2 ISOSTEARATE Addition  Polyglyceryl-2 isostearate 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 2.5%.    
1,8,12-BISABOLATRIENE Addition  1,8,12-bisabolatriene 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 1,8,12-bisabolatriene must not be more than 5% of the total medicine.    
LITCHI CHINENSIS Change A, E, H A, H When used as an excipient, Litchi chinensis must only be included in medicines when the plant part is fruit, in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing Litchi chinensis must not be more than 5% of the total medicine.   
NONIVAMIDE Change Nonivamide must only be included in medicines when in combination with other permitted ingredients as a flavour or fragrance proprietary excipient formulation. The ingredient is not to be included in medicines intended for use in the eye. The total concentration of flavour proprietary excipient formulations containing nonivamide must not be more than 5% of the total medicine. The total concentration of fragrance proprietary excipient formulations containing nonivamide must not be more than 1% of the total medicine.  Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.  
EUGLENA GRACILIS WHOLE CELL DRY Change The route of administration for medicines that contain Euglena gracilis whole cell dry must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than: (a) 100 mg of Euglena gracilis whole cell dry for children aged between 1 and 3 years (inclusive); (b) 150 mg of Euglena gracilis whole cell dry for children aged between 4 and 8 years (inclusive); (c) 225 mg of Euglena gracilis whole cell dry for individuals aged between 9 and 18 years (inclusive); and (d) 375 mg of Euglena gracilis whole cell dry for adults aged 19 years or older. The following warning statement (or words to the same effect) must be included on the medicine label: – (BABY2) ‘Not suitable for infants under the age of twelve months’.  Only to be used in a medicine where Kemin Foods LC (Client ID 29988), 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 2024. The route of administration for medicines that contain Euglena gracilis whole cell dry must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than: (a) 100 mg of Euglena gracilis whole cell dry for children aged between 1 and 3 years (inclusive); (b) 150 mg of Euglena gracilis whole cell dry for children aged between 4 and 8 years (inclusive); (c) 225 mg of Euglena gracilis whole cell dry for individuals aged between 9 and 18 years (inclusive); and (d) 375 mg of Euglena gracilis whole cell dry for adults aged 19 years or older. The following warning statement (or words to the same effect) must be included on the medicine label: – (BABY2) ‘Not suitable for infants under the age of twelve months’.  
BEESWAX ALCOHOLS Change The route of administration for medicines that contain beeswax alcohols must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 150 mg beeswax alcohols. 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 – (CHILD2) ‘Not suitable for children’.  Only to be used in a medicine where Rainbow and Nature Pty Ltd (Client ID 22307), 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 22 April 2024. The route of administration for medicines that contain beeswax alcohols must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 150 mg beeswax alcohols. The following warning statements (or words to the same effect) are required on the medicine label: (a) (PREGNT) ‘Not recommended for use by pregnant and lactating women’ (b) (CHILD2) ‘Not suitable for children’  
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