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Public notice of final decisions - ACMS#29, ACCS#27, Joint ACMS-ACCS#24, March 2020

Scheduling medicines and poisons

24 August 2020

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3.2.2 Arbutin

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 arbutin

Final decision

Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to vary the interim decision and amend the current Poisons Standard in relation to arbutin as follows:

Schedule 6 - New entries

ARBUTIN (ALPHA) except:

  1. in preparations for application to the face containing 2 per cent or less alpha-arbutin with hydroquinone levels of 10mg/kg or less; or
  2. in preparations for application to the body containing 0.5 per cent or less alpha-arbutin with hydroquinone levels of 10mg/kg or less.

ARBUTIN (BETA) except:

  1. when included in Schedule 4; or
  2. oral herbal preparations containing 500 mg or less beta-arbutin per recommended daily dose; or
  3. in preparations for application to the face containing 7 per cent or less beta-arbutin with hydroquinone levels of 10mg/kg or less.

ARBUTIN (DEOXY OR OTHER DERIVATIVES).

Schedule 4 - New entry

ARBUTIN (BETA) in oral preparations except herbal preparations containing 500 mg or less beta-arbutin per recommended daily dose.

Index - New/Amended Entries

ARBUTIN (ALPHA)

Cross reference: ARBUTIN (BETA); ARBUTIN (DEOXY OR OTHER DERIVATIVES)

Schedule 6

ARBUTIN (BETA)

Cross reference: ARBUTIN (ALPHA); ARBUTIN (DEOXY OR OTHER DERIVATIVES)

Schedule 6

Schedule 4

ARBUTIN (DEOXY OR OTHER DERIVATIVES)

Cross reference: ARBUTIN (ALPHA); ARBUTIN (BETA)

Schedule 6

ARBUTIN

cross reference: HYDROQUINONE

Appendix E, Part 3 2 - New entries
Poison Standard statements
ARBUTIN when included in Schedule 6. A,G2,G3,E2,R2,S1

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).

G2: If swallowed, give activated charcoal if instructed. (Note - the words 'at once' to be added to instruction A).

G3: If swallowed, do NOT induce vomiting.

E2: If in eyes, hold eyelids apart and flush the eye continuously with running water. Continue flushing until advised to stop by a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor, or for at least 15 minutes.

R2: If swallowed or inhaled, remove from contaminated area. Apply artificial respiration if not breathing. Do not give direct mouth-to-mouth resuscitation. To protect rescuer, use air-viva, oxy-viva or one-way mask. Resuscitate in a well-ventilated area.

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

Appendix F, Part 3 - New entries
Poison Warning statements Safety direction
ARBUTIN when included in Schedule 6. 45 1,4

1: Avoid contact with eyes

4: Avoid contact with skin

45: WARNING - If a pigmented spot or mole has recently become darker, changed colour, become enlarged or itchy, or bleeds, do not use this product, see your doctor immediately. Do not use on children. Do not use near the eyes. Mild irritation may occur; stop use if it becomes severe. If fading is not evident in three months, seek doctor's advice.

Materials considered

In making this final decision, the Delegate considered the following material:

  • The scheduling proposal to amend the current Poisons Standard with respect to arbutin;
  • The five 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 three public submissions 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; (c) the toxicity of a substance; and (f) any other matters considered necessary to protect public health;
  • 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 a made a final decision to vary my interim decision to incorporate a minor amendment to clarify the exclusion of herbal preparations containing 500 mg or less beta-arbutin from the Schedule 6 arbutin (beta) entry. I have varied the Appendix E arbutin listing to clarify its inclusion in Part 2 as it was erroneously proposed to be included in Part 3 of Appendix E in my interim decision. Notwithstanding the aforementioned minor amendments, 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 three public submissions 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 statements made in the public submissions that oral herbal preparations containing 500 mg or less beta-arbutin should be clearly excluded from the Schedule 6 entry. I am in agreement that these preparations should be explicitly excluded from the Schedule 6 entry and I have amended my decision accordingly.

Date of effect of the decision

1 October 2020

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