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Consultation: Invitation for public comment - ACCS, ACMS and joint ACCS/ACMS meetings, March 2014

30 January 2014

Notice inviting public submissions under Regulation 42ZCZK of the Therapeutic Goods Regulations 1990

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 following scheduling proposals are 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.

Persons wishing to make a submission are strongly encouraged to submit them in electronic format (word or unsecured PDF) to the email address provided below by 20 February 2014.

Email: SMP@health.gov.au

The Secretary
Medicines & Poisons Scheduling
Office of Chemical Safety (MDP 88)
GPO Box 9848
CANBERRA ACT 2601

Facsimile: 02 6289 2650

Public submissions received after the closing date may or may not be considered by the advisory committee(s).

Public submissions must include the name of the person making the submission and preferably an email or postal address.

Please note that the submissions received on or before the closing date will be published following removal of confidential information. It is up to the person making the submission to highlight any information which they wish to be considered as confidential. Material claimed to be commercial-in-confidence will be considered against the guidelines for the use and release of confidential information set out in Chapter 6 of the Scheduling Policy Framework (SPF), issued by the National Coordinating Committee on Therapeutic Goods.

The relevant expert advisory committee(s) will then consider all valid submissions and provide advice to the delegate in relation to the proposed amendment. After considering this advice, the delegate will make an interim scheduling decision. This interim decision is expected to be published on 29 May 2014. The applicant and persons who made a submission in response to the original invitation received on or before the closing date will be invited to comment on the delegates' interim decision.

The current Poisons Standard is available at The Poisons Standard (the SUSMP). Queries can be directed to the Scheduling Secretariat at SMP@health.gov.au.

Proposed amendments to the poisons standard referred by the delegate for scheduling advice

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Chemicals Scheduling (ACCS).
Substance Proposal
1-Butanol In response to issues raised in the NICNAS Inventory Multi-Tiered Assessment and Prioritisation (IMAP) report No. 85, the scheduling proposal under consideration is to create new Schedules 5 and/or 6 entries with appropriate concentration cut-offs and associated warning statements.
1-Propanol In response to issues raised in the NICNAS IMAP report No. 47, the scheduling proposal under consideration is to create new Schedules 5 and/or 6 entries with appropriate concentration cut-offs and associated warning statements.
1,3,5,7-Tetraazatricyclo [3.3.1.13] decane In response to issues raised in NICNAS IMAP report No. 119, the scheduling proposal under consideration is to create a new Schedule 5 entry for 1,3,5,7-tetraazatricyclo [3.3.1.13] decane with a 0.15% concentration cut-off.
2,4-Diaminophenoxy ethanol sulfate In response to issues raised in NICNAS new chemical report No. LTD/1528, the scheduling proposal under consideration is to include 2,4-diaminophenoxyethanol in Schedule 6, and Appendix F, with appropriate cut-off to exempt for preparations with low concentrations.
Benzoic acid, 2-hydroxy-, (3Z)-1-methyl-3-hexen-1-YL ester In response to issues raised in NICNAS new chemical report No. LTD/1582, the scheduling proposal under consideration is to include benzoic acid, 2-hydroxy-,(3Z)-1-methyl-3-hexen-1-yl ester in Schedule 6, and Appendix F, with appropriate cut-off to exempt for preparations with low concentrations.
Dibutyl phthalate In response to issues raised in a NICNAS Priority Existing Chemical Report No.36, the scheduling proposal under consideration is to include cosmetic and personal care preparations containing dibutyl phthalate in Appendix C with appropriate concentration cut-offs.
Diethylene glygol monoethyl ether Proposal to develop a separate listing of diethyl glycol monoethyl ether in Schedule 6 to complement the current generic listing of ethylene glycol monoalkyl ethers and to consider restrictions on use in cosmetic preparations.
Ethanol, 2-phenoxy- In response to issues raised in a NICNAS IMAP report No. 529, the scheduling proposal under consideration is to create a new Schedule 5 entry for cosmetic preparations containing more than 1% of ethanol, 2-phenoxy-.
Hexanoic acid, 2-ethyl-, 2-ethylhexyl ester In response to issues raised in a NICNAS IMAP report No. 827, the scheduling proposal under consideration is to create a new Schedule 6 entry with appropriate low concentration exemption cut-off for hexanoic acid, 2-ethyl-, 2-ethylhexyl ester.
Lambda-cyhalothrin Proposal to amend the Schedule 6 entry for lambda-cyhalothrin to increase the concentration cut-off for (b) other preparations containing lambda-cyhlothrin for 1% or less to 1.6% or less of lambda-cyhalothrin.
Methylated spirits Proposal to include a new entry for methylated spirit in Appendix F to require a label warning statement such as: 'WARNING: do NOT attempt to refill methylate spirit burner while it is in use or still warm; it could lead to serious burn injury or death'.
Methyl isobutyl ketone

In response to issues raised in the NICNAS IMAP Report No. 88 the proposal is to:

  • Delete the current Schedule 5 entry for methyl isobutyl ketone; and
  • Include methyl isobutyl ketone in Schedule 6.
  • Consider listing methyl isobutyl ketone in Appendix I (Uniform Paint Standard)
Oxalic acid Proposal to amend the Schedule 6 oxalic acid entry to exempt from scheduling household and domestic cleaning preparations containing 8% or less of oxalic acid or to list such products in Schedule 5.
Ppg-1-peg-9 lauryl glycol ether In response to issues raised in NICNAS new chemical report No. LTD/1616, the scheduling proposal under consideration is to include PPG-1-PEG-9 lauryl glycol ether in Schedule 5 and Appendix F with appropriate cut-off to exempt for preparation with low concentrations.
Tillenal In response to issues raised in NICNAS new chemical report No. LTD/1617, the scheduling proposal under consideration is to include tillenal in Schedule 6, and Appendix F, with appropriate cut-off to exempt for preparations with low concentrations.
2. Proposed amendments referred by the delegates for scheduling advice for consideration by the Joint Advisory Committee on Chemicals Scheduling (ACCS) and the Advisory Committee on Medicines Scheduling (ACMS).
Substance Proposal
Sodium, ammonium and potassium lauryl sulfate In response to issues raised in a NICNAS IMAP report, the scheduling proposal under consideration is to amend the current Schedule 6 and Appendix E sodium lauryl sulfate entries to include ammonium lauryl sulfate and potassium lauryl sulfate.
3. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling (ACMS).
Substance Proposal
Diclofenac Proposal to amend the current Schedule 2 diclofenac entry to exempt dermal use preparations containing 2 per cent or less of diclofenac from scheduling. This would be more closely harmonised with its New Zealand medicine classification.
Perampanel Proposal for a new Schedule 8 entry for perampanel and possible inclusion in Appendix D Item 1.

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