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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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3.5 1-Deoxy-1-(methylamino)-D-glucitol N-C10-16 acyl derivatives

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

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

3.5 1-Deoxy-1-(methylamino)-D-glucitol N-C10-16 acyl derivatives

Delegate's final decision
The delegate has decided to set aside the final decision for 1-deoxy-1-(methylamino)-D-glucitol N-C10-16 acyl derivatives pending wider review on the scheduling of surfactants.
Public submissions on the interim decision

Two (2) public submissions were received for 1-deoxy-1-(methylamino)-D-glucitol N-C10- 16 acyl derivatives, one (1) in support and one (1) opposed.

The main point in support was:
  • 1-Deoxy-1-(methylamino)-D-glucitol N-C10- 16 acyl derivatives 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.
The main points opposed were:
  • Several surfactant substances were recently found not to require scheduling (including docusate sodium, sodium α- olefin sulfonates and sodium alkyl sulfates). It is imperative that a consistent, evidence-based approach is applied to the consideration of surfactant substances.
  • Consideration of this substance for scheduling imposes stricter unnecessary controls on new, less hazardous surfactants when compared with older chemicals such as the lauryl sulfate salts.
  • The risks of surfactants are already well managed. The public have a good understanding that surfactant-based products such as shampoos, soaps and detergents are irritating to skin and eyes and will instinctively rinse their eyes in case of accidental contact, without being prompted by the label. In fact, if accidental eye contact did occur, attempting to read any instructions on the product label at that stage may prove to be problematic.
  • The NICNAS secondary notification report does not identify any significant public health risks that would require risk management through scheduling of these substances.
  • The scheduling of surfactants is out of step with international requirements.
  • The level of regulatory intervention for these low risk substances is disproportionate. Scheduling will result in extensive compliance activities for manufacturers including re-packaging and re-labelling, including the signal heading 'POISON', as well as other storage and handling requirements.
  • Given the low risk presented by these products it is confusing for consumers when trying to reconcile the actual level of risk of using a product, when such 'POISON' warnings are carried by much more hazardous products.
  • The scheduling of these substances should be considered in the context of the lauryl sulfate salts entry. As sodium lauryl sulfate (SLS) is known to be one of the harshest surfactants in use, there should be higher concentration cut-offs for less hazardous substances such as 1-deoxy-1-(methylamino)-D-glucitol N-C10- 16 acyl derivatives.
  • A longer transition period of at least 12 months - i.e. an implementation date of 1 June 2019 at the earliest - is requested.
    • The proposed implementation date only allows 2 months from the date of final decision publication. This is inadequate to accommodate any changes required to the labelling and/or reformulation of products.
    • Any changes would affect products currently in the Australian market with an established history of safe use.
    • There is no evidence that would suggest immediate action is required for the risk management of these substances.
  • A wider review of the scheduling of surfactant substances is supported.
Interim decision

The interim decision for 1-deoxy-1-(methylamino)-D-glucitol N-C10-16 acyl derivatives was published on the TGA website on 5 February 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2017 – 3.5. 1-Deoxy-1-(methylamino)-D-glucitol N-C10-16 acyl derivatives.

Scheduling proposal

The pre-meeting scheduling proposal for 1-deoxy-1-(methylamino)-D-glucitol N-C10-16 acyl derivatives 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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