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Final decisions amending, or not amending, the current Poisons Standard, April 2018

Scheduling medicines and poisons

10 April 2018

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3.6 Phenyl methyl pyrazolone

Part A - Final decisions on matters referred to an expert advisory committee (November 2017)

3. Advisory Committee on Chemicals Scheduling (ACCS #21)

3.6 Phenyl methyl pyrazolone

Delegate's final decision
Final decision:

The delegate’s final decision is to create a new Schedule 6 and Appendix E and F entries for phenyl methyl pyrazolone as follows:

Schedule 6 - New Entry

PHENYL METHYL PYRAZOLONE except when used in hair dye and eyebrow/eyelash preparations at a concentration of 0.25 per cent or less after mixing for use when the immediate container and primary pack are labelled with warning statements to the following effect:

KEEP OUT OF REACH OF CHILDREN, and

WARNING - This product contains ingredients which may cause skin sensitisation to certain individuals. A preliminary test according to the accompanying directions should be made before use.

written in letters not less than 1.5 mm in height.

Appendix E, Part 2 - New Entry

Standard Statements: 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)), S1 (If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water).

Appendix F, Part 3 - New Entry

Warning Statement: 28 ((Over) (repeated) exposure may cause sensitisation).

Safety Direction: 4 (Avoid contact with skin).

Implementation date: 1 June 2019
Reasons:

The delegate notes the public submissions on the interim decision. However, as no new evidence has been received to alter the interim decision for phenyl methyl pyrazolone, the delegate has confirmed that the final decision and reasons for the final decision are identical to the interim decision. However, the implementation date has been amended from 1 June 2018 to 1 June 2019 to allow for any necessary labelling changes.

Public submissions on the interim decision

Two (2) public submissions were received for phenyl methyl pyrazolone, both in support of the interim decision.

The main points in support were:
  • Phenyl methyl pyrazolone is not entered in the TGA eBS ingredients list, nor is it entered in the TGA Permitted Ingredients List. The Delegate's interim decision will therefore have no impact on the scheduling of therapeutic goods.
  • Regarding international alignment and labelling requirements:
    • Aligning the scheduling controls for phenyl methyl pyrazolone when used in cosmetics with those of the EU is supported.
    • It is important to harmonise any warning statements and safety directions as much as possible with those required in the EU given that the vast majority (if not all) hair dye products in Australia are imported. While the proposed warning statements in the proposed Schedule 6 entry for phenyl methyl pyrazolone are consistent with those for other Schedule 6 hair dye substances, changes to existing labels will nevertheless be required as current labels generally follow the EU labelling requirements. Given the extensive nature of the labelling already required for these products under the EU regulation, and the similarity of the EU warnings with the intent of those proposed, there should be flexibility in the Schedule entry to allow "words to the effect of" rather than mandating the warning statements verbatim. This flexible approach is already well established in the Poisons Standard both within specific "reverse scheduling" entries as well as in Appendix E and F where it is noted that "Standard statements specified in this Appendix may be varied provided that the intent is not changed."
  • Regarding implementation:
    • If the interim decision is implemented without change, a transition period of at least 24 months is required to allow for labelling changes. Any changes would affect products currently in the Australian market with an established history of safe use.
    • There is no evidence to suggest immediate action is required for the risk management of this substance.
Interim decision

The interim decision for phenyl methyl pyrazolone was published on the TGA website on 5 February 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2017 - 3.6. Phenyl methyl pyrazolone.

Scheduling proposal

The pre-meeting scheduling proposal for phenyl methyl pyrazolone was published on the TGA website on 6 September 2017 at Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, November 2017.

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