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2 Interim decisions on proposed amendments referred to the Advisory Committee on Chemicals Scheduling (ACCS #7, March 2020)
2.2. Interim decision in relation to arbutin
Note
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Deleted text is shown as red, smaller font, with a strikethrough.
Interim decision
Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision to amend the current Poisons Standard in relation to arbutin as follows:
Schedule 6 - New entries
ARBUTIN (ALPHA) except:
- in preparations for application to the face containing 2 per cent or less alpha-arbutin with hydroquinone levels of 10mg/kg or less; or
- 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:
- when included in Schedule 4; or
- 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
| 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. |
|
| 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. |
||
Proposed date of effect of the proposed amendment
1 October 2020
Reasons for the interim decision (including findings on material questions of fact)
In making this interim decision, the Delegate considered the following material:
- The scheduling proposal to amend the current Poisons Standard with respect to arbutin;
- Advisory Committee on Chemicals Scheduling's advice;
- The public submissions received in response to the pre-meeting consultation;
- Section 52E of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and extent of use of a substance; (c) the toxicity of a substance; and (f) any other matters that the Secretary considers necessary to protect public health;
- Scheduling handbook: Guidance for amending the Poisons Standard; and
- Scheduling Policy Framework (SPF 2018).
Summary of ACCS advice/recommendations to the Delegate
The Committee recommended that new entries be created for arbutin (alpha, beta and deoxy or other derivatives) in Schedules 4 and 6 in the Poisons Standard as follows:
Schedule 6 - New entries
ARBUTIN (ALPHA) except:
- in preparations for application to the face containing 2 per cent or less alpha-arbutin with hydroquinone levels of 10mg/kg or less; or
- 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:
- when included in Schedule 4; or
- 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
| 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. |
|
| 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. |
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The Committee also recommended that the Chemicals scheduling delegate discuss the scheduling proposal with the medicines scheduling delegate given that the proposed amendment would impact medicines.
The Committee also recommended an implementation date of 1 October 2020.
The reasons for the advice included:
- risks and benefits of the use of a substance
- Benefits:
- used as a skin whitening agent and treatment of conditions such as chloasma.
- Risks:
- Potential for the hydrolysis of arbutin to hydroquinone and as a consequence cause exogenous ochronosis.
- Benefits:
- the purpose for which a substance is to be used and the extent of use
- Topical dermal use for skin whitening.
- Oral herbal use.
- the toxicity of a substance
- Risk of skin pigmentation with long term use.
- Acute toxicity is consistent with schedule 6 scheduling factors.
- For deoxy arbutin there is insufficient information for a scheduling cut-off.
- the dosage, formulation, labelling, packaging and presentation of a substance
- NIL.
- the potential for abuse of a substance
- NIL.
- any other matters that the Secretary considers necessary to protect public health
- Chemicals scheduling delegate to discuss the matter with the medicines scheduling delegate noting the previous discussion at the June 2019 meeting.
Reasons for the interim decision
I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are: (a) the risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and extent of use of a substance; (c) the toxicity of a substance; and (f) any other matters that the Secretary considers necessary to protect public health. In my view, the relevant parts of the Scheduling Policy Framework (SPF) 2018 are the Scheduling Factors for Schedule 6.
I note that in September 2019 the medicine's delegate published an interim decision to create a new Schedule 4 entry for oral preparations of arbutin that excluded herbal preparations containing 500 mg or less of arbutin per recommended daily dose. My current decision will incorporate that interim decision and I will not be amending it further, other than to distinguish herbal preparations of arbutin in their beta form. The reasons below will focus on my decision to amend the current Poisons Standard by creating new Schedule 6 entries for the topical use of arbutin (alpha, beta and deoxy or other derivatives).
I have taken into consideration that arbutin when used as a topical skincare product as a skin-lightening agent for the prevention of melanin formation, acts via a therapeutic mechanism (tyrosinase inhibition). This means that the terminology "cosmetic creams/lotions" used in the scheduling proposal, are not appropriate given that products containing arbutin would meet the definition of a therapeutic good. In view of this, I have decided to omit this terminology in the Schedule 6 entries.
In assessing the safety profile of topical arbutin, I have given consideration to the toxicological data assessed by the European Commission's Scientific Committee on Consumer Safety (SCCS) on the topical use of alpha, beta and deoxy arbutins. I have decided to adopt the arbutin cut-offs detailed in the SCCS report for safe consumer use, as I find that they do not have the potential to release significantly relevant amounts of hydroquinone. I find that there is insufficient information for a scheduling cut-off for deoxy arbutin.
I consider that the main concern around the topical use of arbutin is the release of hydroquinone, which has the potential risk of causing hydroquinone induced-exogenous ochronosis and leukomelanoderma. Due to the potential risk of ochronosis and leukomelanoderma, alpha, beta and deoxy arbutins meet the Schedule 6 Scheduling Factors when above the exempted cut-offs. They present a moderate to high toxicity and a moderate risk of producing irreversible toxicity. This potential harm is reduced through the use of distinctive packaging with strong warnings and safety directions on the label, with products supplied above the cut-off requiring Schedule 6 'Poison' labelling. I have decided to include warning statements, safety directions and first aid instructions which mirror those already outlined in the Poisons Standard for hydroquinone. I am satisfied that the weight of evidence supports that topical arbutin meets the scheduling Factors for Schedule 6. I note that should someone want to supply a topical product containing arbutin, it would be subject to assessment by the TGA, which would include an assessment of safety data. Scheduling could be reconsidered if warranted.
Implementation date
I have decided an implementation date of 1 October 2020 is appropriate.
I have made a decision to seek public comment on my interim decision in its totality. I have considered a request in the public submission for a separate implementation date of 1 June 2020 for the new Schedule 4 entry for arbutin-beta, to come into effect earlier than the other arbutin isomers under consideration. I have not identified evidence of an urgent public health need to justify an earlier implementation of 1 June 2020, as proposed in the public submission.