The closing date for submissions was 25 June 2015.
On this page: Invitation to comment | Timetable | About the consultation | Content of submissions | What will happen | Privacy information | Enquiries
Invitation to comment
The TGA sought comments from interested parties on the following proposed amendments to the Poisons Standard referred by the delegate for scheduling advice to the Advisory Committee on Chemicals Scheduling (ACCS) and 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 | Proposal |
|---|---|
| 3-Hexanoic acid, cyclopoprylmethyl ester | To create a new entry for 3-Hexenoic acid, cyclopropylmethyl ester in Schedule 6 with an appropriate cut‐off to exempt from scheduling for preparations with low concentrations. |
| Bicyclopyrone | To create a new entry for bicyclopyrone in Schedule 6, with a cut-off to Schedule 5 in preparations containing 20 per cent or less of bicyclopyrone. |
| Carcinogenic amines | In response to issues raised in NICNAS IMAP reports for these substances, the scheduling proposal is to create new entries in Schedule 7 or Schedule 10/Appendix C such that the use for each of the chemicals listed in dyes or other products available to the public be restricted. |
| Clitoria ternatea extract | The scheduling proposal is to create a new Schedule 5 entry for Clitoria ternatea extract. |
| Cyclopentanepropanol, alpha, alpha-dimethyl | The scheduling proposal is to create a new Schedule 6 entry for cyclopentanepropanol, α,α-dimethyl- with an appropriate cut‐off to exempt from scheduling for preparations with low concentrations. |
| Hydramethylnon | The scheduling proposal is to amend the current Schedule 5 entry for hydramethylnon to include granular preparations containing 0.365 per cent or less of hydramethylnon in a shaker pack for domestic use containing 500g or less of the granular material. This would be a clause in addition to the current Schedule 5 entry that allows for solid baits containing 2 per cent or less of hydramethylnon in welded plastic labyrinths. |
| Momfluorothrin | To create a new Schedule 6 entry for momfluorothrin. |
| Phenol 2-amino-6-chloro-4-nitro | In response to issues raised in a NICNAS IMAP report human health Tier II assessment for Phenol, 2-amino-6-chloro-4-nitro- and its hydrochloride, the scheduling proposal is to create a new Schedule 6 entry for preparations of 2-amino-6-chloro-4-nitrophenol and to consider exemptions for preparations containing 2 per cent or less of 2-amino-6-chloro-4-nitrophenol. |
| Phenol 4-amino-3-methyl | In response to issues raised in a NICNAS IMAP report human health Tier II assessment for Phenol, 4-amino-3-methyl, the scheduling proposal is to create a new Schedule 6 entry for 4-amino-3-methyl-phenol except in hair dye, eyebrow and eyelash tinting preparations containing 1.5 per cent or less of 4-amino-3-methyl-phenol. |
| Phenol 5-amino-2-methyl | In response to issues raised in a NICNAS IMAP report for Phenol, 5-amino 2-methyl, to create a new Schedule 6, 7 or 10 entry for 5-amino 2-methyl-phenol in hair dyes and eyelash colouring products, with a possible exemption for preparations containing 1.5% or less of 5-amino 2-methyl-phenol. |
| Quinoline, 5,6,7,8-tetrahydro-8-(1-methylpropyl) | To create a new Schedule 6 entry for quinoline, 5,6,7,8-tetrahydro-8-(1-methylpropyl)- with an appropriate cut‐off to exempt from scheduling for preparations with low concentration levels. |
2. Proposed amendments referred by the delegate for scheduling advice for consideration by the joint committee of the ACCS and the Advisory Committee on Medicines Scheduling (ACMS).
| Substance | Proposal |
|---|---|
| Methylisothiazolinone | In response to issues raised in a NICNAS IMAP report for 3-isothiazolone, 2-methyl-, the scheduling proposal is to list methylisothiazolinone in Schedule 6 or Schedule 10/Appendix C with concentration exemption cut-offs for preparations containing low concentrations of methylisothiazolinone. Exemption cut-offs will be based on sensitisation potential and, for cosmetic products, will take into consideration 2013/14 reports from the European Union Scientific Committee on Consumer Safety (SCCS) and the US Cosmetic Ingredient Review (CIR) expert panel. Exemption cut-offs for other types of products will also be considered, including use in therapeutic goods (e.g. sunscreens). |
| Methylchloroisothiazolinone (MCI) | In response to issues raised in a NICNAS IMAP report for 3(2H)-isothiazolone, 5-chloro-2-methyl-, the scheduling proposal is to list methylchloroisothiazolinone (MCI) in Schedule 6 or Schedule 10/Appendix C with concentration exemption cut-offs for preparations containing low concentrations of methylchloroisothiazolinone. Exemption cut-offs will be based on sensitisation potential and, for cosmetic products, will take into consideration 2013/14 reports from the European Union Scientific Committee on Consumer Safety (SCCS) and the US Cosmetic Ingredient Review (CIR) expert panel. Exemption cut-offs for other types of products will also be considered, including use in therapeutic goods (e.g. sunscreens). |
Timetable
Document released for consultation on Thursday 28 May 2015.
Interested parties should respond by close of business Thursday 25 June 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 (Chemicals) 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.
Electronic submissions are preferred and should be emailed to Chemicals.Scheduling@health.gov.au. Please include 'Proposed Amendments to the Poisons Standard (Chemicals)' in the subject line of the email.
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 TGA Internet website: feedback on submissions will be provided through the TGA Internet site: Public submissions on scheduling matters
Scheduling decisions made by the Chemicals delegate following consideration of submissions from interested parties, along with advice from the Advisory Committee on Chemicals Scheduling (ACCS) 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 Chemicals.Scheduling@health.gov.au.