Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2024-25

Closed 13 Sep 2024

Opened 2 Aug 2024

Feedback updated 2 Dec 2024

We asked

The TGA sought feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination. The proposed changes were intended to 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.

You said

A total of 9 submissions were received in response to this consultation. All submissions that gave permission to be published on the TGA website are available through the ‘View submitted responses’ link below.

The TGA received:

  • 6 responses to the proposed changes for herbal ingredients with pregnancy contraindications and other toxic effects
  • 4 responses to the proposed liver warning statement for Garcinia species and related ingredients
  • 7 responses to the proposed removal of Xanthium species
  • 6 responses to the proposed update to the requirements for phenoxyethanol
  • 4 responses to the proposed update to clarify the requirements for Rutoside.

The responses varied in stance and recommendations. The feedback from professional medical groups was supportive of most of the proposals, however the majority of respondents from the complementary medicines industry only partially supported the proposals, with many suggesting rewording or clarification of the proposed warning statements and requirements. See the Final Decisions Document for details of issues raised by respondents and the TGA’s response.

We did

The feedback and recommendations provided by respondents were taken into consideration in making the final decisions to amend the Permissible Ingredients Determination for the ingredients discussed in the consultation. The final changes incorporate variation compared to the original proposals.

The final changes will commence on 1 March 2025. A 12-month transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2026.

Results updated 2 Dec 2024

The TGA thanks all stakeholders who participated in this consultation.

Please see the Final Decisions Document for specific details about the changes described below.

Overview of final decisions

  1. (a) The TGA will implement new requirements for R. graveolens and rue oil which reflect the feedback received. Specifically, the current availability of the ingredients for active and homoeopathic use will be maintained but restricted to homoeopathic preparations for oral and topical for dermal use. However, active homoeopathic preparations at homoeopathic potency of 12X or lower will require a warning statement contraindicating use in those who are planning to fall pregnant, are pregnant and lactating. For homeopathic preparations for dermal use, warning statements advising consumers of the increased sensitivity to sunlight will also be implemented. R. graveolens will retain its excipient use, while rue oil will be expanded for excipient use, however, will both be restricted to topical medicines with a 0.15% concentration limit when used as a fragrance in proprietary formulations, where such formulations are limited to 1% of the total medicine. (b) The TGA will amend the entries for parsley ingredients in the Determination to require warning statements contraindicating use in pregnancy for medicines containing these ingredients, except for products containing very low concentrations of parsley.
  2. The TGA will implement new requirements for Garcinia gummi-gutta and other HCA-containing ingredients as presented for consultation with minor amendments to replace “rare” with “very rare”. Provisions will be made through the preamble of the Determination to permit combined liver-related warnings for multiple ingredients where a similar warning is required for more than one ingredient in a medicine. In addition, the plant part for Garcinia gummi-gutta will be changed from “rind of the fruit” to “fruit peel” to align with the plant parts in the TGA Code Tables.
  3. The TGA has decided not to remove Xanthium spp. from the Determination. Going forward, sponsors will need to declare the mandatory components in the medicine, limit recommended maximum daily dose, restrict the plant part and preparations, and ensure products are not directed for use in children and those who are likely to become pregnant, pregnant, and lactating.
  4. The proposed changes for phenoxyethanol will be implemented as proposed in the consultation.
  5. The ingredient will be changed from “rutoside” to “rutoside trihydrate” and sponsors of affected medicines will be informed of the proposal to vary their ARTG entry under subsection 9D(1) of the Therapeutic Goods Act 1989, and arrangements will be made for consent to supply therapeutic goods that do not conform with paragraphs 8(1)(b) and 9(1)(b) of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines commencing 1 March 2025 for a specified period.

View the public Consultation Document.

Published responses

View submitted responses where consent has been given to publish the response.

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination. The proposed changes 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

To view the details of the proposed changes and respond to this consultation please click the link under 'View Consultation and Submit Response' at the bottom of this page.

You can respond to any or all of the proposed changes. Responses may be typed into the provided text boxes, or you can upload your response as a single or multiple PDF or Word document/s. 

Privacy and your personal information

The TGA collects your personal information in this submission in order to:

  1. Contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
  2. Help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).

Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion. The TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.

Online publication of submissions

The TGA may disclose your full name, work title, company/organisation and submission on the Internet (i.e. make this information publicly available) with your consent.

You may specify whether there is anything in your submission which you would prefer to not be published online (e.g. names, email addresses, proprietary information) by:

  1. Providing an additional, redacted copy of your submission; or
  2. Providing details of content not to be published e.g. “Do not publish pages 3-5”, “Please redact contact details”; or
  3. Identifying any text within your submission to remain confidential by having it clearly marked 'IN CONFIDENCE' and highlighted in grey.

Why your views matter

The TGA is requesting feedback to help ensure that the proposed changes are appropriate and support the safety and quality of listed and assessed listed medicines.

What happens next

All public submissions will be considered after the end of the consultation period.

Final decisions on the proposed changes will be published by Monday 2 December 2024. Public submissions received as part of the consultation may be published if consent was given.

Finalised changes will be included in an update to the Permissible Ingredients Determination on Saturday 1 March 2025. A transition period of 12 months from the commencement of the new Determination will be provided to allow sponsors of existing listed and assessed listed medicines to bring their products into compliance. The transition period will end on Sunday 1 March 2026 unless otherwise specified.

Audiences

  • Anyone from any background

Interests

  • Legislation
  • Regulatory policy
  • Non-prescription medicines