Consultation: Proposed amendments to Poisons Standard - ACCS and ACMS meetings, November 2015

9 October 2015

This consultation closed on 29 October 2015

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 Chemicals Scheduling (ACCS) and to the Advisory Committee on Medicines Scheduling (ACMS).

1. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Chemicals Scheduling (ACCS)
Substance / Item Scheduling proposal
1,3-Dichloropropene In response to issues raised in a public submission, the scheduling proposal is to amend the current Schedule 7 entry for 1,3-Dichloropropene, to exempt its presence in biocidal formulations at less than 0.3 per cent.
1,5-Napthalenediol In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report on 1,5-Napthalenediol, the scheduling proposal is to create a Schedule 6 entry for 1,5-Napthalenediol, with an appropriate exemption cut-off, to regulate its use in hair dyes and eyelash colouring products.
1-Naphthalenol In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report on 1-Napthalenol, the scheduling proposal is to create a Schedule 6 entry for 1-Napthalenol, with an appropriate exemption cut-off, to regulate its use in hair dyes and eyelash colouring products.
2,6-dimethoxy-3,5-pyridinediamine In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report on 3,5-Pyridinediamine, 2,6-dimethoxy-, dihydrochloride, the scheduling proposal is to create a Schedule 6 entry for 3,5-Pyridinediamine, 2,6-dimethoxy-, dihydrochloride, with an appropriate exemption cut-off, to regulate its use in hair dyes and eyelash colouring products.
2,7-Naphthalenediol In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report on 2,7-Napthalenediol, the scheduling proposal is to create a Schedule 6 entry for 2,7-Napthalenediol, with an appropriate exemption cut-off, to regulate its use in hair dyes and eyelash colouring products.
Amisulbrom The scheduling proposal is to create a new Schedule 6 entry for amisulbrom.

Azo dyes listed below that may release potentially carcinogenic aromatic amines by azo reduction:

  • 2,7-naphthalenedisulfonic acid, 3-hydroxy-4-((2,4,5-trimethylphenyl)azo)-, disodium salt (CAS #3564-09-8)
  • benzenesulfonic acid, 3-[[4-[(2-methoxy-5-methylphenyl)azo]-1-naphthalenyl]azo]-, sodium salt (CAS #75627-17-7)
  • amines, C10-14-branched and linear alkyl, [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]chromate(1-) (CAS #85186-64-7); and
  • amines, C10-14-branched and linear alkyl, bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]chromate(1-) (CAS #85186-66-9)
In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report for Dyes that could release selected carcinogenic amines (not listed on AICS), the scheduling proposal is to create new entries in Schedule 7 or Appendix C to restrict public access to dyes that can release potentially carcinogenic aromatic amines, or to products containing such dyes.
C.I. Direct Orange 1 In response to issues raised in a NICNAS IMAP human health Tier 2 assessment report for C.I. Direct Orange 1, the scheduling proposal is to add C.I. Direct Orange 1 to the existing entry for BENZIDINE-BASED AZO DYES in Schedule 7, consistent with scheduling decisions with other benzidine-based dyes.
Isethionate The scheduling proposal is to include isethionate (2-hydroxyethanesulfonic acid) in Schedule 5.
Musk ambrette In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report on Benzene, 1-(1,1-dimethylethyl)-2-methoxy-4-methyl-3,5-dinitro-the scheduling proposal is create a new schedule 10 entry for benzene, 1-(1,1-dimethylethyl)-2-methoxy-4-methyl-3,5-dinitro- (musk ambrette) in to prohibit its use in cosmetic and domestic products.
Oxathiapiprolin The scheduling proposal is to create a new Appendix B entry for oxathiapiprolin.

Part 2, Section 1 (Labels)

1.5 (Exemptions)

8 Paints

The proposal is to amend the current entry to remove labelling exemptions that do not relate to the "Labelling of Workplace Hazardous Chemicals - Code of Practice - December 2011". If agreed, the amended clause 1.5.8 of Part 2 would read:

  • The requirements of Section 1.3 do not apply to:
    • paint (other than a paint for therapeutic or cosmetic use) which
    • is labelled in accordance with the "Labelling of Workplace Hazardous Chemicals - Code of Practice - December 2011" (or as amended); or
    • a tinter which
    • is labelled in accordance with the "Labelling of Workplace Hazardous Chemicals - Code of Practice - December 2011" (or as amended).
Phenol, 4-amino-3-nitro In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report on phenol, 4-amino-3-nitro, the scheduling proposal is to create a Schedule 6 entry for phenol, 4-amino-3-nitro, with an appropriate exemption cut-off, to regulate its use in hair dyes and eyelash colouring products.
p-methylaminophenol In response to issues raised in a NICNAS IMAP Human Health Tier 2 assessment report on p-methylaminophenol and its sulfate, the scheduling proposal is to create a Schedule 6 entry for p-methylaminophenol, with an appropriate exemption cut-off, to regulate its use in hair dyes and eyelash colouring products.
Topramezone The scheduling proposal is to create a new Schedule 6 entry for topramezone.
2. Proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling (ACMS)
Substance Proposal
LANSOPRAZOLE

Proposal to amend the scheduling of lansoprazole to include oral preparations containing 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply in Schedule 2.

Consideration could include whether the scheduling of all the over-the-counter proton pump inhibitors (i.e. esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole) should be consistent.

OMEPRAZOLE

Proposal to amend the scheduling of omeprazole to include oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply in Schedule 2.

Consideration could include whether the scheduling of all the over-the-counter proton pump inhibitors (i.e. esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole) should be consistent.

RABEPRAZOLE

Proposal to amend the scheduling of rabeprazole to include oral preparations containing 10 mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply in Schedule 2.

Consideration could include whether the scheduling of all the over-the-counter proton pump inhibitors (i.e. esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole) should be consistent.

FLUBROMAZOLAM Although flubromazolam is currently covered by the Schedule 4 entry for benzodiazepines it is proposed to create an entry for flubromazolam in Schedule 9 due to its particular risks.
FIBROBLAST GROWTH FACTORS

Create new Schedule 4 and Appendix D, Item 5 entries for fibroblast growth factors to control the manner in which they are advertised, sold and accessed without legitimate purpose.

THYMOSIN BETA-4 AND TB-500

Create new Schedule 4 and Appendix D, Item 5 entries for thymosin beta-4 and TB-500 to control the manner in which they are advertised, sold and accessed without legitimate purpose.

Timetable

Document released for consultation on Thursday, 1 October 2015.

Interested parties should respond by close of business Thursday, 29 October 2015.

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 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.

Content of submissions

Submissions may address any, or all, of the proposed amendments to the Poisons Standard (Medicines) 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 the TGA Internet site unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

Submissions will be reviewed by the TGA and published on the Public submissions on scheduling matters page of the TGA website. Feedback on submissions will also be provided on this page.

Scheduling decisions made by the medicines delegate following consideration of submissions from interested parties, along with advice from the Advisory Committee on Chemicals Scheduling (ACCS) or the Advisory Committee on Medicines Scheduling (ACMS) will be published on the TGA website as interim 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).
  • The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the cover sheet).
  • Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
  • 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.

Enquiries

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