3 Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZR
Note
New text is shown as green, larger font, with a horizontal line above it.
Deleted text is shown as red, smaller font, with a strikethrough.
3.2 Final decisions on proposed amendments referred to the Advisory Committee on Chemicals Scheduling (ACCS #27, March 2020)
Final decision in relation to picramic acid (including its salts)
Final decision
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision and amend the current Poisons Standard in relation to picramic acid (including its salts) as follows:
Schedule 6 - New Entry
PICRAMIC ACID including its salts (excluding other derivatives) except when used in hair dye products at a concentration of 0.6 per cent or less of picramic acid after mixing for use when the immediate container and primary pack are labelled with the following statements:
KEEP OUT OF REACH OF CHILDREN, and
WARNING ‒ This product contains ingredients which may cause skin allergy to certain individuals. A preliminary test according to the accompanying directions should be made before use. This product must not be used for dyeing eyelashes or eyebrows; to do so may be injurious to the eye.
written in letters not less than 1.5 mm in height.
| Poison | Standard statements |
|---|---|
| PICRAMIC ACID including its salts (excluding other derivatives) | A, E1 |
|
A: For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once). E1: If in eyes wash out immediately with water. |
|
| Poison | Warning statements | Safety direction |
|---|---|---|
| PICRAMIC ACID including its salts (excluding other derivatives) | 28 | 5 |
|
Warning Statements 28: Repeated exposure may cause sensitisation. Safety Directions - General: 5: Wear protective gloves when mixing or using. |
||
Index - New Entry
PICRAMIC ACID (including its salts)
CROSS-REFERENCE: 2-amino 4 6 dinitrophenol
Schedule 6
Appendix E, Part 1
Appendix F, Part 2
Materials considered
In making this final decision, the Delegate considered the following material:
- The application to amend the current Poisons Standard with respect to picramic acid;
- The two public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
- The advice received from the Meeting of the Advisory Committee on Chemicals Scheduling (ACCS#27);
- The one public submission received in response to the interim decision consultation under regulation 42ZCZP of the Regulations;
- Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; and (c) the toxicity of a substance;
- The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
- The Scheduling handbook: Guidance for amending the Poisons Standard.
Reasons for the final decision (including findings on material questions of fact)
I have made a final decision to vary my interim decision to incorporate a minor amendment to clarify the inclusion of the Appendix E picramic acid listing in Part 2 as it was erroneously proposed to be included in Part 1 of Appendix E in my interim decision. I have also varied the Appendix F picramic acid listing to clarify its inclusion in Part 3 of Appendix F as it was erroneously proposed to be included in Part 2 of Appendix F in my interim decision. Notwithstanding the aforementioned editorial changes, my reasons for making the final decision are those set out in the interim decision.
In making my final decision, I have taken into account the material detailed in the interim decision and the one public submission received before the second closing date in response to the call for further submissions published on 10 June 2020 under regulation 42ZCZP of the Regulations.
I have considered the one public submission, which requests a change to the implementation date from 1 June 2021 to 1 October 2021. I am of the view that since no immediate health signals have been identified, a change in the implementation date to 1 October 2021 is appropriate. This new implementation date will allow industry approximately 13 months for compliance with any labelling and/or reformulation changes.
Date of effect of the decision
1 October 2021.