Consultation: Proposed Amendments to the Poisons Standard – ACCS, ACMS and Joint ACCS/ACMS meetings, March 2017

• Identified uses in cosmetic and domestic products in the Australian marketplace.
  • Included as an excipient (flavour/fragrance only with concentration restrictions) in 70 proprietary ingredients in the TGA database.
• International alignment.
  • Reported widespread use of anise alcohol in cosmetic and domestic products overseas at concentrations up to 2.5%.
  • EU concentration restrictions are 0.001% in leave-on and 0.01% in rinse-off products.

IFRA has restricted the use of Anise alcohol in finished products at concentrations of 0.04–2.5% depending on the product category

• Identified uses in cosmetic and domestic products in the Australian marketplace.
  • Listed in the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016 (26BB) for use as an active ingredient and an excipient. Use as an active ingredient is only for medicated space sprays and medicated throat lozenges.
  • Included as an excipient in 150 proprietary ingredients in the TGA database.
• International alignment.
  • No international restrictions identified but use is reported in cosmetic and domestic products overseas (particularly as a fragrance ingredient) at concentrations up to 10%.

• Identified uses in cosmetic and domestic products in the Australian marketplace.
  • Sodium α-olefin sulfonate is listed as an excipient in the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016 only for use in topical medicines for dermal application.
• International alignment.
  • Use is reported overseas in cosmetic and domestic products at concentrations up to 16.5%.
  • In Canada sodium α-olefin sulfonates are considered to be safe when used in rinse-off products and safe up to 2% in leave-on products.

• Identified uses in cosmetic and domestic products in the Australian marketplace.
  • Permitted in listed medicines for use only in combination with other permitted ingredients as a flavour (up to 5%) or a fragrance (up to 1%).
  • Included as an excipient in 230 proprietary ingredients.
• International alignment.
  • Use is reported overseas in cosmetic and domestic products. In particular, as a fragrance, solvent and UV light absorber at concentrations up to 7%.
  • The EU concentration restrictions for cosmetics and personal care products are 0.001% in leave-on products and 0.01% in rinse-off products.

• Identified uses as a flavour and fragrance in cosmetic and domestic products in the Australian marketplace.
  • Listed in the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016 for use as an excipient flavour (up to 5%) or fragrance (up to 1%).
• International alignment.
  • The New Zealand concentration restrictions for cosmetics are 0.001% in leave-on products and 0.01% in rinse-off products.
  • IFRA guidelines restrict use of cinnamaldehyde to concentrations of 0.02% in lip care and deodorant/anti-perspirant products, 0.04% in intimate wipes, 0.4% in mouthwashes and 0.05% in all other personal care products including fragrances.

A request has been made to amend the Schedule 3 entry for ibuprofen to include a modified release oral dose form of 600 mg of ibuprofen per dosage unit in packs of 32 or less dosage units when labelled:

1. with a recommended daily dose of 1200 mg or less of ibuprofen and
2. not for the treatment of children under 12 years of age

and include ibuprofen 600 mg in modified release dosage form in Appendix H.

To reconsider whether the Schedule 2 and Schedule 3 entries for dihydrocodeine should be amended or deleted, in view of the recent reconsideration of codeine scheduling.

Consideration may be given as to whether all current Schedule 2 and Schedule 3 entries for dihydrocodeine should be rescheduled to Schedule 4, or other scheduling options. Other scheduling options include amending or deleting the Schedule 2 entry and amending or deleting the Schedule 3 entry, reducing the pack size, and the inclusion of a label warning that dihydrocodeine can cause addiction.

Ethyl hexanediol is currently listed in Schedules 4 and 10 as follows:

• Schedule 10
  ETHYLHEXANEDIOL for human use.
• Schedule 4
  ETHYLHEXANEDIOL for animal use.

• Identified uses in cosmetic and domestic products in the Australian marketplace.
• International alignment.
  • International sources have determined that ethyl hexanediol is a safe cosmetic ingredient.

Climbazole is in Schedule 5 and Schedule 6 of the Poisons Standard.as follows:

• Schedule 6
  CLIMBAZOLE except:
  1. when included in Schedule 5; or
  2. in preparations containing 2 per cent or less of climbazole.
• Schedule 5
  CLIMBAZOLE in preparations containing 40 per cent or less of climbazole except in preparations containing 2 per cent or less of climbazole.

• Identified cosmetic and domestic uses in the Australian marketplace.
  • Permitted for use as both an excipient and active ingredient in biological and prescription medicines.
  • The use of climbazole was approved by the Medicines Evaluation Committee (MEC) in 2004 for dermal use only at up to 0.5% in leave-on, and up to 2% in rinse-off products.
• International alignment.
  • The EU concentration restrictions include up to 0.5% when used as a preservative in cosmetics, up to 2.0% in rinse-off and 0.5% in leave-on products when used as an anti-dandruff active agent in hair cosmetic preparations, and up to 0.5% when used in leave-on face creams.

The APVMA submitted a scheduling proposal to consider the need for scheduling a new biological fungicide containing two fungal strains of Aureobasidium pullulans (strains DSM 14940 and DSM 14941)*.

*The delegate has not cited the entire scheduling application and is awaiting further information from the APVMA to support this application. The delegate notes that this fungicide is available overseas with minimal restrictions and the seasonality of this product. Without further information to support this application early in the new year, it will be withdrawn from the March 2017 scheduling process.