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

This consultation closed on 13 September 2024. The outcome of the consultation was published to the consultation hub on 2 December 2024.

We conducted a public consultation and sought feedback from interested parties on proposed changes to the requirements of ingredient used in listed (low‑risk) medicines. The proposals addressed 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.

Enquiries

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