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Final decisions amending, or not amending, the current Poisons Standard, November 2018

Part A - Amendments to the Poisons Standard referred to expert advisory committee

29 November 2018

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2.3. Aliphatic allyl esters

2. Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS/ACMS #19)

Delegate's final decision

The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend the current Poisons Standard in relation to aliphatic allyl esters as follows:

Note

New text is shown as green, larger font, with a horizontal line above it.

Schedule 7 – Amend Entry

ALLYL ALCOHOL except

  1. in preparations containing 5 per cent or less of allyl esters with 0.1 per cent or less of free allyl alcohol by weight of allyl ester; or
  2. when separately specified in these Schedules.

Schedule 6 - New Entry

ALLYL ESTERS (excluding derivatives) being: ALLYL CYCLOHEXANEACETATE (CAS No. 4728-82-9) ALLYL CYCLOHEXANEPROPIONATE (CAS No. 2705-87-5) ALLYL HEPTANOATE/ALLYL HEPTYLATE (CAS No. 142-19-8) ALLYL HEXANOATE (CAS No. 123-68-2) ALLYL ISOVALERATE (CAS No. 2835-39-4) ALLYL NONANOATE (CAS No. 7493-72-3) ALLYL OCTANOATE (CAS No. 4230-97-1) ALLYL PHENYLACETATE (CAS No. 1797-74-6) ALLYL TRIMETHYLHEXANOATE (CAS No. 68132-80-9) in preparations containing 0.1 per cent or less of free allyl alcohol by weight of allyl ester except in preparations containing 5 per cent or less of allyl esters with 0.1 per cent or less of free allyl alcohol by weight of allyl esters.

Appendix J, Part 2

ALLYL ALCOHOL

Conditions for availability and use: 1 (Not to be available except to authorised or licensed persons).

Index – new entries

ALLYL ESTERS (excluding derivatives) Schedule 6 ALLYL CYCLOHEXANEACETATE (CAS No. 4728-82-9) Schedule 6 ALLYL CYCLOHEXANEPROPIONATE (CAS No. 2705-87-5) Schedule 6 ALLYL HEPTANOATE/ALLYL HEPTYLATE (CAS No. 142-19-8) Schedule 6 ALLYL HEXANOATE (CAS No. 123-68-2) Schedule 6 ALLYL ISOVALERATE (CAS No. 2835-39-4) Schedule 6 ALLYL NONANOATE (CAS No. 7493-72-3) Schedule 6 ALLYL OCTANOATE (CAS No. 4230-97-1) Schedule 6 ALLYL PHENYLACETATE (CAS No. 1797-74-6) Schedule 6 ALLYL TRIMETHYLHEXANOATE (CAS No. 68132-80-9) Schedule 6

Implementation date: 1 February 2019

Reasons:

The delegate has amended the interim decision after considering the public submission, and confirms that the reasons for the final decision align with the reasons for the interim decision.

Additional reasons for the final decision are the following:

  • The scheduling of nine substances specifically (i.e. by CAS number) is preferred over an unqualified 'allyl esters' entry.

Public submissions on the interim decision

One (1) public submission was received before the second closing date in response to an invitation published on 10 September 2018 under regulation 42ZCZP of the Regulations. The public submission opposed the proposal.

The main points provided in opposition of the amendment were:

  • The scheduling of the 9 substances specifically (i.e. by CAS number) is preferred over an unqualified 'allyl esters' entry.
  • The 5% concentration limit proposed for allyl esters does not align with overseas restrictions, higher concentrations of use would not necessarily pose risks to public health for these different use patterns i.e. domestic products not intended for direct skin contact.
  • Align with overseas standards i.e. the requirement to ensure the level of free allyl alcohol is less than 0.1%.
  • Proposed an amendment to delete 5% cut-off and include specific entries for all 9 allyl esters

Interim decision

The interim decision was published on the TGA website on 10 September 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACCS, September 2018 – 2.3 Aliphatic allyl esters.

Scheduling proposal

The pre-meeting scheduling proposal for codeine was published on the TGA website on 10 April 2018 at Consultation: Proposed amendments to the Poisons Standard being referred to the June 2018 meetings of the ACCS, ACMS and Joint ACCS/ACMS.

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