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Consultation: Proposed amendments to the Poisons Standard - ACCS and Joint ACCS/ACMS, July 2016

Public consultation on proposed amendments to the Poisons Standard

26 May 2016

This consultation closed on 24 June 2016.

Invitation to comment

The TGA sought comments from interested parties on the following proposed amendments to the Poisons Standard referred by the delegates for scheduling advice to the Advisory Committee on Medicines Scheduling (ACMS) or the Advisory Committee on Chemicals Scheduling (ACCS).

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Chemicals Scheduling (ACCS).
Substance Scheduling Proposal
Direct Red 254 To create a new Schedule 5, 6 or 7 entry for Direct Red 254
Aminopyralid To amend the Schedule 5 and 6 entries for aminopyralid to include reference to triisopropylammonium (TIPA) salt and investigate whether an appropriate exemption cut-off is required.
n-Hexane The scheduling proposal is to amend the Schedule 5 entry and create a specific Schedule 7 entry for n-hexane except when packed and labelled for industrial use.
Isoeugenol The scheduling proposal is to amend the existing Schedule 6 entry for isoeugenol to lower the concentration cut-off from 10 to 1%.
Phenoxymethyl oxirane The scheduling proposal is to create a new Schedule 6 entry for phenoxymethyl oxirane.
Quinoline The scheduling proposal is to create a new Schedule 6 entry for quinoline in preparations for use in cosmetics and domestic uses and investigate whether an appropriate exemption cut-off is required for preparations with low concentration levels.
Amyl and hexyl cinnamaldehyde The scheduling proposal is to create new Schedule 6 entries for amyl cinnamal (amyl cinnamaldehyde) and hexyl cinnamal (hexyl cinnamaldehyde) and investigate whether an appropriate exemption cut-off is required for preparations with low concentrations.
Metazachlor To create a new Schedule 5 entry for Metazachlor and investigate whether an appropriate exemption cut-off is required.
2. Proposed amendments referred by the delegates for scheduling advice for consideration by the Advisory Committees on Chemicals and Medicines Scheduling (Joint ACCS-ACMS).
Substance Proposal
Geraniol and related compounds The scheduling proposal is to create a new Schedule 5 or 6 entry for Geraniol and related compounds and investigate whether an appropriate exemption cut-off is required.
Phenol The scheduling proposal is to amend the existing Schedule 6 entry for phenol to include cosmetic use and investigate whether an appropriate exemption cut-off is required and to consider appropriate Appendix E and F statements.
Hexachlorophene The scheduling proposal is to create a new Schedule 10 entry to prohibit the use of hexachlorophene in cosmetics

Timetable

Document released for consultation on 26 May 2016.

Interested parties should respond by close of business 24 June 2016.

Feedback will be released following consideration of submissions. (See 'What will happen').

About the consultation

This consultation is inviting public submissions under subsection 42ZCZK/42ZCZL of the Therapeutic Goods Regulations 1990 (the Regulations).

The delegate of the Secretary of the Department of Health hereby gives notice that the proposed amendments to the current Poisons Standard contained in this notice will be referred for scheduling advice to relevant expert advisory committees.

Accordingly, the above scheduling proposals were open for public submissions. Submissions must be relevant to the proposed amendment, must address a matter mentioned in section 52E of the Therapeutic Goods Act 1989 and be received by the closing date.

Content of submissions

Submissions may address any, or all, of the proposed amendments to the Poisons Standard or other identified issues.

In addition, submissions might include:

  • Suggested improvements
  • Whether or not you support the amendment/s. If you do not support the amendment/s, you may make suggestions for an alternative acceptable to you.
  • An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

Scheduling decisions made by the chemicals and medicines delegates following consideration of submissions from interested parties, along with advice from the Advisory Committee on Medicines Scheduling (ACMS) or the Advisory Committee on Chemicals Scheduling (ACCS) will be published on the TGA website as interim or final decisions.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • 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.
    • 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).
    • Seek feedback about how the consultation was undertaken.
  • 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.
  • More information on consultations and privacy is included in the submission form and on our website.

Enquiries

Any questions relating to submissions should be directed by email to: