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 - external site, which commenced on 2 March 2020. This determination replaces the previous instrument, the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2019 - external site.

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