Consultation: Invitation for public comment - ACCS and joint ACCS/ACMS meetings, November 2013

17 October 2013

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 14 November 2013.

Email: SMP@health.gov.au

The Secretary
Scheduling Secretariat
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 20 February 2014 at Reasons for scheduling delegate's interim decisions and invitations for further comment and will be open for further submissions from only the applicant and persons who made a submission in response to the original invitation received on or before the closing date. For more information on the scheduling process please see the SPF.

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 Scheduling proposal
1,3-Cyclohexadiene-1-carboxylic acid, 4,6,6-trimethyl-, ethyl ester Proposal to include 1,3-cyclohexadiene-1-carboxylic acid, 4,6,6-trimethyl-, ethyl ester in a schedule with exemption for cosmetic products and fragrances containing less than 1 per cent.
2-Amino-5-ethylphenol Proposal for a new Schedule 6 entry for 2-amino-5-ethylphenol preparations except when used in hair dye preparations containing 1 per cent or less of 2-amino-5-ethylphenol.
2-Butanone, oxime (also known as methyl ethyl ketone oxime) Proposal for a new Schedule 6 entry for 2-butanone, oxime, with consideration of an appropriate cut-off to unscheduled.
2-Furancarboxaldehyde (furfural) Proposal to include 2-furancarboxaldehyde in Schedule 6 (with an appropriate cut-off to exempt) to mitigate risk from its use in cosmetic and domestic products.
2-Nitrotoluene Proposal for a Schedule 6 or 7 entry for 2-nitro-toluene.
3,7-Dimethy-2,6-octadienal isomers (CITRAL, geranial and neral) Proposal for a new Schedule 5 entry with a yet to be determined low concentration cut-off.
Aminopyralid Proposal to amend the current Schedule 6 aminopyralid entry to include preparations containing 0.5 per cent or less aminopyralid in Schedule 5.
Benzidine-based dyes Proposal to include benzidine-based dyes in Schedule 7 or Appendix C.
C11-C15-secondary, ethoxylated, oxirane and oxirane, ethyl (oxirane) Proposal to include oxirane in Schedule 6 with consideration of an appropriate cut-off to unscheduled.
Diethylene glycol monobutyl ether Proposal to review the current Schedule 5 diethylene glycol monobutyl ether entry and to develop appropriate Appendix E & F label statements.
Ethylene glycol monomethyl ether Proposal to develop a separate listing of ethylene glycol monomethyl ether in Schedule 6 to complement the current generic listing of ethylene glycol monoalkyl ethers and to consider restrictions on use in cosmetic preparations.
Mercaptoacetic acid Proposal to include mercaptoacetic acid in Schedule 6 with a low concentration cut-off for preparations containing 11 per cent or less mercaptoacetic acid either in Schedule 5 or exempt from scheduling.
Methanol Proposal to revise the maximum authorised concentration in the finished cosmetic product to 5per cent calculated as a percentage of ethanol and isopropyl, bring Australian regulations into line with EU cosmetic directive 76/768/EEC Annex III Part 1.
Pentanoic acid, 3-methyl-2-oxo-, ethyl ester Proposal to include pentanoic acid, 3-methyl-2-oxo-, ethyl ester in Schedule 5.
Phosphonium, tributyloctyl-, chloride (1:1) Proposal to include phosphonium, tributyloctyl-, chloride (1:1) in Schedule 7.
Pyridine, 2-chloro-6-(trichloromethyl) Proposal for new Schedule 6 entry for 2-chloro-6-(trichloromethyl)-pyridine and inclusion in Appendix F, with warning statements to be determined.
Sulfites - i.e. Salts of sulfurous and disulfurous acids

Proposal to create a new Schedule 5 entry for sulfites, with appropriate amendments to the current Schedule 5 entry for sodium metabisulfite, to align with EU restrictions on the use of sulfites in cosmetics and to consider appropriate cut-offs to exemption from the proposed Schedule 5 entry.

Note: this should not impact of the use of sulfites as preservatives in food because of the generic Appendix A exemption for food additives in food.

Tetrahydrofuran Proposal to include tetrahydrofuran in Schedule 5.
Triethanolamine Proposal to amend the triethanolamine Schedule 5 entry to consider altering the scheduling cut-off clause for cosmetic preparations to 2.5 per cent or less of triethanolamine and to consider other restrictions on the use of triethanolamine in tattoo removal cosmetics applied intradermally.
Trisiloxane, 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]- A Schedule 5 listing for trisiloxane, 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]- with a low concentration cut-off for make-up, face care products and rinse-off preparations containing 34 per cent or less of trisiloxane, 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]- and lip preparations containing 20 per cent or less of trisiloxane, 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy.
Zinc lactate Proposal for new Schedule 6 entry for zinc lactate except in toothpastes containing 2.5 per cent or less of zinc lactate.
2. Proposed amendments referred by the delegate for scheduling advice for consideration by the Joint Advisory Committee on Chemicals Scheduling (ACCS) and the Advisory Committee on Medicines Scheduling (ACMS)
Substance Scheduling proposal
Cosmetic use
Personal care use
Proposal to include definitions, such as cosmetic use and/or personal care use, in Part 1 of the SUSMP to better define these terms and their intent and purpose.
Ethanol, 2-(dimethylamino)- Proposal to include ethanol, 2-(dimethylamino)- in Schedules 5 or 6 and to make relevant amendments to the current Schedule 4 entry for deanol.
Salicylic acid Proposal to amend the current Schedules 3 and 4 entries for salicylic acid and possibly create a new Schedule 5 entry to align with EU restrictions on the use of salicylic acid in cosmetics to a maximum concentration of 3 per cent.

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