Update to listed medicine ingredients in March 2020

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2020, which commenced on 2 March 2020. This determination replaces the previous instrument, the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2019.

A total of 108 changes have been made in the updated Determination. These changes include:

• 2 new ingredients (hydrogenated polydextrose & citrulline) following applications under 26BE of the Act;
• 3 new ingredients and 1 varied ingredient following evaluations for use as flavour/fragrance proprietary ingredients;
• changes to 24 ingredients as part of the annual low-negligible risk framework;
• changes to the ingredient coumarin, which provide permission and requirements for its use as a fragrance in topical products, following a TGA-initiated review;
• changes to 32 ingredients used as colours to specify that all oral routes of administration, including dental use, are permitted;
• removal of expired transition period provisions for 44 ingredients;
• removal of one ingredient (oakmoss), as it is a synonym for another ingredient already available for the same use (oakmoss absolute).

A complete list of changed ingredients is given below.

Changed ingredients