Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2023-24

Closed 14 Sep 2023

Opened 3 Aug 2023

Contact

Complementary Medicines Evaluation Section

listed.medicines@health.gov.au

Feedback updated 1 Dec 2023

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. Curcuma species and curcumin and the risk of liver injury
  2. Green tea extract and the risk of liver injury
  3. Safe levels of benzophenone
  4. Clarification of the requirements for soy phosphatidylserine-enriched ingredients
  5. Clarification of the requirements for Terminalia ferdinandiana

You said

A total of 27 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:

  • 10 responses to the proposed liver warning statement for Curcuma species and curcumin
  • 7 responses to the proposed liver injury warning statement for Camellia sinensis
  • 16 responses to the proposed safety limit on benzophenone
  • 4 responses to the proposed update to the requirements for soy-phosphatidylserine enriched ingredients
  • 3 responses to the proposed update to the requirements for Terminalia ferdinandiana

The responses varied in stance and recommendations, however, the majority of respondents from the complementary medicines industry did not support or 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 2024. A 12-month transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2025.

Results updated 1 Dec 2023

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. The proposed restrictions for Curcuma species and curcumin will be implemented with minor amendments to provide clarity around exclusion of the label warning requirements for Curcuma species/curcumin when used as an excipient ingredient, to replace the word ‘rare’ with ‘very rare’ in the warning statement, and clarify the dosage restrictions for children are based on the chemical component, (1E,6E)-1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione.
  2. The changes to requirements for Green tea (Camellia sinensis) presented for consultation will be implemented with minor amendments to structuring of the wording to improve clarity regarding exceptions when the warning statement is not required and consistency throughout the Determination.
  3. The proposed changes regarding setting an acceptable regulatory limit for benzophenone in sunscreens has been deferred pending further consultation with relevant industry and professional bodies via future targeted consultation. The use of benzophenone as a flavour will be removed from the Determination as proposed in the consultation.
  4. The changes to requirements for soy phosphatidylserine-enriched ingredients which were presented in the consultation document will be implemented to include a maximum daily dose, however the restriction for a minimum of 15% soy phosphatidylserine content will be removed.
  5. Changes to requirements of T. ferdinandiana will be implemented as proposed when the ingredient is used as an active, with amendments to the restrictions to provide exceptions when the ingredient is used as a topical excipient for dermal use.

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. Curcuma species and curcumin and the risk of liver injury
  2. Green tea extract and the risk of liver injury
  3. Safe levels of benzophenone 
  4. Clarification of the requirements for soy phosphatidylserine-enriched ingredients
  5. Clarification of the requirements for Terminalia ferdinandiana

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 Friday 1 December 2023. 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 Friday 1 March 2024. 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 Saturday 1 March 2025 unless otherwise specified.

Audiences

  • Anyone from any background

Interests

  • Legislation
  • Regulatory policy
  • Non-prescription medicines