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

29 May 2014

This consultation closed on 26 June 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 26 June 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 18 September 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 (also known as the Standard for the Uniform Scheduling of Medicines and Poisons (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-propanaminium, N,N,N-trimethyl-3-(octadecyloxy)-, chloride (1:1) and 1-propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18 and C18-unsatd. acyl) derivs., inner salts In response to issues raised in a NICNAS New Chemicals Assessment report nos STD/1336 and LTD/1578, the scheduling proposal is to consider whether these chemicals meet the criteria for inclusion in the generic Schedule 5 and Schedule 6 entries for quaternary ammonium compounds or whether to create a new Schedule 6 and Appendix F entries for 1-propanaminium, N,N,N-trimethyl-3-(octadecyloxy)-, chloride (1:1) and/or 1-propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18 and C18-unsatd. acyl) derivs., inner salts.
2-butenedioic acid (2E)-, di-C12-15-alkyl esters (INCI name Di-C12-15 Alkyl fumarate) In response to issues raised in a NICNAS New Chemical Assessment report no. LTD/1509, the scheduling proposal is to create a new Schedule 6 and Appendix F entries for preparations containing 10 per cent or more of 2-butenedioic acid (2E)-, di-C12-15-alkyl esters.
2-hydroxypropyl methacrylate In response to issues raised in a NICNAS IMAP report no. 855, the scheduling proposal is to create a new Schedule 5 entry for 2-hydroxypropyl methacrylate with an appropriate cut-off to exempt from scheduling for preparations containing low concentrations of 2-hydroxypropyl methacrylate.
2-pentyl cyclopentanol To create a new Schedule 5 and Appendix F entries for 2-pentyl cyclopentanol with an appropriate cut-off to exempt from scheduling for preparations containing low concentrations of 2-pentyl cyclopentanol.
2-propyl heptanenitrile To create a new Schedule 6 and Appendix F entries for preparations containing 2-propyl heptanenitrile with an appropriate cut-off to exempt from scheduling for preparations containing low concentrations of 2-propyl heptanenitrile.
2,4,7-decatrienoic acid, ethyl ester To create a new Schedule 6 and Appendix F entries for 2,4,7-decatrienoic acid, ethyl ester with an appropriate cut-off to exempt from scheduling for preparations containing low concentrations of 2,4,7-decatrienoic acid, ethyl ester.
3-hexanone, 2-methyl oxime To create new Schedule 6 and Appendix F entries for preparations containing 3-hexanone, 2-methyl-, oxime.
3-isothiazolone, 2-methyl-(methylisothiazolone) In response to issues raised in a NICNAS IMAP report no. 1062, the scheduling proposal is to list 3-isothiazolone, 2-methyl- with an appropriate cut-off to exempt from scheduling for preparations containing low concentrations of 3-isothiazolone, 2-methyl- (methylisothiazolone).
Diethylene glycol monomethyl ether [Ethanol, 2(2-methoxyethoxy)]

In response to issues raised in a NICNAS IMAP report no. 76 the scheduling proposal under consideration is to develop a separate listing of diethylene 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.

Note: This submission has been deferred from the November 2013 and March 2014 ACCS meetings where it was inadvertently listed by incorrect names (ethylene glycol monomethyl ether and diethylene glycol monoethyl ether).

Fosthiazate Proposal to include fosthiazate in either Schedule 6 or 7.
Linear alkylbenzene sulfonates (C10-C16) In response to issues raised in a NICNAS IMAP report no. 939, the scheduling proposal is to develop a generic entry for linear alkylbenzene sulfonates (C10-C16), with an appropriate cut-off to exempt from scheduling for preparations with low concentrations. This may also require an amendment to the current Schedule 5 and Appendices E and F entries for sodium dodecylbenzene sulfonate to reflect this generic entry. A further proposal is to include liquid laundry detergents in capsule preparations containing linear alkylbenzene sulfonates (C10-C16) in Schedule 6.
Metofluthrin Proposal to amend the current Schedule 6 metofluthrin entry to exclude mosquito repellent preparations containing 312 g/kg or less of metofluthrin from scheduling.
Nickel, soluble salts In response to issues raised in a NICNAS IMAP report nos 839, 878 and 883, the scheduling proposal is to amend the current Schedule 6 nickel sulfate entry to read nickel, soluble salts.
N-hydroxy- octanamide (INCI name caprylhydroxamic acid) In response to issues raised in a NICNAS New Chemicals Assessment report no. LTD/1543, the scheduling proposal is to consider listing N-hydroxy octanamide in an appropriate Schedule with an appropriate cut-off to exempt from scheduling for preparations with low concentrations.
N-methyl-2-pyrrolidone In response to issues raised in a NICNAS IMAP report no. 91, the scheduling proposal is to amend the N-methyl-2-pyrrolidone Schedule 5 and Schedule 6 entries.
Phenol, 2-amino- (O-aminophenol) In response to issues raised in a NICNAS IMAP report no. 865, the scheduling proposal is to add restrictions for domestic use and to include phenol, 2-amino in Appendix C for cosmetic use.
Phenylenediamines To review the generic listings for phenylenediamines in Schedule 6 and Appendices C, E and F, taking into consideration recommendations contained in NICNAS IMAP reports relating to the isomers 1,2-benzenediamine (report nos 848 and 909) and 1,3-benzenediamine (report nos 832 and 910), as well as 1,4-benzenediamine-N-phenyl (report no. 893). This will include consideration of broadening the scope of the generic phenylenediamine listing to include aryl as well as alkyl derivatives.
Rosin
Resin acids and rosin acids, calcium salts
Resin acids and rosin acids, potassium salts
Resin acids and rosin acids, sodium salts
Rosin, polymerized
Rosin, hydrogenated

In response to issues raised in a NICNAS IMAP/PEC report no. 872, the scheduling proposal is to place rosin in Schedule 5 with an appropriate cut-off to exempt from scheduling for preparations containing low concentrations of rosins.

Note: There has been previous consideration of this issue by the former National Drugs & Poisons Scheduling Committee in 1997 and 1998 under the heading 'colophony', with no scheduling action proposed at that time.

Tetrahydro-4-methyl-2-phenyl 2H-pyran To create a new Schedule 6 and Appendix F entries for tetrahydro-4-methyl-2-phenyl 2H-pyran with an appropriate cut-off to exempt from scheduling for preparations with low concentrations.
Toluenediamines To review the generic listings for toluenediamine in Schedule 6 and Appendices C, E and F, taking into consideration recommendations contained in NICNAS IMAP reports relating to the isomers toluene 2,4-diamine (reports 831 and 936), toluene 2,5-diamine (report 869), and toluene 2,6-diamine (report 851).
2. Proposed amendments referred by the delegate for scheduling advice for consideration by the ACCS and the Advisory Committee on Medicines Scheduling (ACMS).
Substance Proposal
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.

Note: This submission was considered at the November 2013 ACCS meeting, but a decision was deferred pending the availability of further information (now received) on the extent of use and/or presence of these isomers in fragrances and in essential oils.

Triethanolamine

In response to issues raised in a NICNAS IMAP report no.427, the scheduling proposal under consideration is to include an entry for triethanolamine in Schedule 4 (or Appendix C) to address the potential use of this chemical in preparations for tattoo removal.

Note: Other uses of triethanolamine were considered at the November 2013 meeting of the ACCS, resulting in confirmation of the current Schedule 5 listing.

Zinc lactate

Proposal for new Schedule 6 entry for zinc lactate except in toothpastes containing 2.5 per cent or less of zinc lactate.

Note: This submission was considered at the November 2013 ACCS meeting, but the Delegate decided to set aside the interim scheduling decision and refer the matter back to a joint meeting of the ACCS & ACMS for further consideration of issues relating to the zinc exposure estimates associated with use in toothpastes.

3. Proposed amendments referred by the delegate for scheduling advice for consideration by the ACMS.
Substance Proposal
Calcium hydroxylapatite Proposal to include calcium hydroxylapatite in preparations for injection or implantation when used for tissue augmentation or for cosmetic use in Schedule 4.
Macitentan Proposal to include macitentan in Appendix D, Item 2 and Appendix L.
Polycaprolactone Proposal to include polycaprolactone in preparations for injection or implantation when used for tissue augmentation or for cosmetic use in Schedule 4.
Riociguat Proposal to include riociguat in Appendix D, Item 2 and Appendix L.
Suvorexant Proposal to include suvorexant in Appendix K.
Tofacitinib Proposal to include tofacitinib in Appendix L and Appendix D, with an appropriate Appendix D Item number to be determined.

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