Consultation: 2024-2025 Proposed changes to the Permissible Ingredients Determination – Low-negligible risk

While the consultation is open you can make a submission at our consultation hub. We then review the submissions. After that the submissions and our decision will be available on the same consultation page.

We are conducting a public consultation and seeking feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines. The proposals address the following issues:

1. Herbal ingredients with pregnancy contraindications and other toxic effects
2. Garcinia species, hydroxycitric acid, hydroxycitrate complex and salts, and risk of liver injury
3. Xanthium species
4. Phenoxyethanol
5. Clarification of hydration state for Rutoside.

These ingredients are included in the Therapeutic Goods (Permissible Ingredients) Determination ('the Determination'). This is a legislative instrument made under section 26BB of the Therapeutic Goods Act 1989. This instrument specifies all of the ingredients that are available for use in listed medicines and the requirements for their use. The Determination is continually reviewed by the TGA to ensure that all ingredients are safe for use in low-risk medicines. 

Timetable

The consultation opens on Friday 2 August 2024. Interested parties must respond by close of business Friday 13 September 2024. 

Please see the Schedule for annual low-negligible risk changes.

Enquiries

For enquiries relating to the consultation document or your submission, please email listed.medicines@health.gov.au.