2. Joint meeting of the Advisory Committee on Chemicals and Medicines Scheduling (ACCS-ACMS #2) - Final decision made pursuant to regulation 42ZCZR
2.1 Final decision in relation to arbutin
In considering the public submissions received on the interim decision in relation to arbutin, the Delegate of the Secretary, under regulation 42ZCZQ of the Regulations, has decided to seek additional advice on the scheduling of arbutin before coming to a final decision. A summary of the public submissions received in response to the interim decision can be found below.
Seven (7) public submissions were received before the second closing date in response to the call for further submissions published on 12 September 2019 under regulation 42ZCZP of the Regulations. Six (6) submissions were in support and one (1) submission was in opposition of the proposed amendments.
The main points in support of the proposed amendment were:
- The public submission expressed support for the delegate's interim decision to permit 500 mg or less of arbutin in oral herbal preparations to be available for access and the removal of the cross reference of arbutin to hydroquinone.
- The public submission noted that they would also like to see restrictions lifted for registered Chinese Medicine Practitioners for herbs like prepared Fu Zi (Radix aconiti lateralis preparata), and Ma Huang (Herba Ephedrae). These herbs have no danger when prepared correctly and combined with other herbs in a prepared Chinese Herbal Medicine Formula and prescribed by a registered practitioner.
The main points in opposition of the proposed amendment were:
- It is frustrating that the cosmetic use of arbutin is captured within the hydroquinone schedule entry as a 'derivative', but it is not being considered now when the substance is being carved out of the hydroquinone schedule entry.
- The risks and benefits of the use of arbutin in cosmetic and topical dermal therapeutic products have not been considered by the regulatory system, despite the restrictions being in place.
- Noted the European Commission's Scientific Committee on Consumer Safety (SCCS) conclusion on α-arbutin and β-arbutin cut-offs.
- The discussion section of the SCCS opinion for α-arbutin notes that the total internal value of hydroquinone (released from &lpha;-arbutin) used for safety assessment related to ochronosis and other end points is 42 times lower than the internal exposure resulting from the use of a product containing 1% hydroquinone, a concentration at which ochronosis may occur. For β-arbutin it is 174 times lower.