Public consultation on Camellia sinensis extracts, amygdalin and hydrocyanic acid in the Poisons Standard

Overview

Public consultation on amending the Poisons Standard regarding Camellia sinensis extract, amygdalin and hydrocyanic acid

Suggested scheduling amendments for Camellia sinensis extracts, amygdalin and hydrocyanic acid

This consultation is in relation to two proposals to:

• create a new entry for Camellia sinensis (green tea) extract in preparations for internal use, and
• amend the scheduling for amygdalin and hydrocyanic acid to exempt these substances when present as a component of Wild Cherry Bark.

These proposals were referred to expert advisory committees and consulted on with the public. The decision-maker made interim decisions to not amend the Poisons Standard and public consultations on the interim decisions were undertaken.

This consultation is seeking further advice from all interested parties on suggested changes to the Poisons Standard in relation to green tea extract, amygdalin and hydrocyanic acid. The suggested changes also include an accompanying new entry for Wild Cherry Bark.

Suggested amendments for Camellia sinensis

Schedule 5 - SUGGESTED New Entry

CAMELLIA SINENSIS for oral use except:

(a)  in products included on the Australian Register of Therapeutic Goods and, where applicable, compliant with the requirements for Camellia sinensis in the current Therapeutic Goods (Permissible Ingredients) Determination, or

(b)  in preparations containing not more than 300 mg of epigallocatechin-3-gallate per maximum recommended daily dose.

Requirements for first aid instructions and warning statements, with a similar intent to those included in the Determination, may also be included in Appendix E and Appendix F of the Poisons Standard.

Related documents

Green tea extract

• Scheduling advisory committees: Invitations for public comment
• Public notice of interim decisions on proposed amendments to the Poisons Standard - ACMS#40, ACCS#35, Joint ACMS-ACCS#32 - November 2022
• Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2023-24

Suggested amendments for amygdalin and hydrocyanic acid

Schedule 10 - SUGGESTED Amended Entry

AMYGDALIN for therapeutic use except in preparations containing 10 mg/kg or less of amygdalin.

Schedule 7 - SUGGESTED Amended Entry

HYDROCYANIC ACID, except:

(a)  when included in Schedule 4;
(b)  its salts and derivatives other than cyanides separately specified in this Schedule; or
(c)  in preparations containing 10 mg/kg or less of hydrocyanic acid.

Schedule 4 - SUGGESTED Amended Entry

HYDROCYANIC ACID for therapeutic use except in preparations containing 10 mg/kg or less of hydrocyanic acid.

Suggested accompanying amendment for Wild Cherry Bark

Schedule 10 - SUGGESTED New Entry

WILD CHERRY BARK for therapeutic use.

Related documents

Amygdalin and hydrocyanic acid

• Scheduling advisory committees: invitations for public comment
• Public notice of interim decisions on proposed amendments to the Poisons Standard - ACMS#42, Joint ACMS-ACCS#34 - June 2023

What happens next

This consultation closes on 12 April 2024.

All public submissions will be published on the TGA website at Public submissions on scheduling matters, unless marked confidential or indicated otherwise in the submission information (see Privacy and your Personal information).

Public submissions are an important part of the process for amending the Poison Standard, and are published on the TGA website using the consultation hub.  Submissions by the public may not reflect the views of the Department of Health and Aged Care or TGA.  Published submissions should not be taken as being endorsed by the Department or TGA.

Following consideration of public submissions received before the closing date, decisions on the proposed amendments are anticipated to be published as final decisions on the TGA website: Scheduling delegate's final decisions at a later date.