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Consultation: Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2021-22

4 August 2021

This consultation closed on 15 September 2021.

The Therapeutic Goods (Permissible Ingredients) Determination ('the Determination') is a legislative instrument made under section 26BB of the Therapeutic Goods Act 1989 ('the Act'). 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.

The Therapeutic Goods Administration (TGA) sought feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination. The proposed changes address the following issues:

  1. Allergen statement for mollusc-derived ingredients.
  2. Peripheral neuropathy associated with lower dose vitamin B6.
  3. Risk to infants from nasal use of benzalkonium chloride.
  4. Artemisinin and pregnancy risk.

For more information on the proposals, and to participate in the consultation, please visit the consultation hub.


The consultation opened on Wednesday 4 August 2021. Interested parties responded by close of business Wednesday 15 September 2021.


For enquiries relating to the consultation paper or your submission please email