4.4 Tetrahydrofurfuryl alcohol

4 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #26, November 2020)

4.4 Interim decision in relation to tetrahydrofurfuryl alcohol

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 tetrahydrofurfuryl (THFA) as follows:

Materials considered

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

• The application to amend the current Poisons Standard with respect to THFA;
• The 122 public submissions - external site, which included no written submissions, received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
• The advice received from the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #26);
• 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; (d) the dosage, formulation, labelling, packaging and presentation 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.

Summary of Joint ACMS-ACCS advice to the Delegate

The Committee recommended that THFA, excluding its derivatives, be entered in Schedule 6 of the Poisons Standard as follows:

The Committee also recommended an implementation date of 1 February 2021.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (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; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (f) any other matters considered necessary to protect public health.

The reasons for the advice included:

1. the risks and benefits of the use of a substance:
   • Risks
     • The toxicity of this substance
   • Benefits
     • Use in a wide variety of products
2. the purposes for which a substance is to be used and the extent of use of a substance:
   • THFA is intended for commercial/industrial use as a solvent in certain agricultural chemicals.
   • In Australia, THFA is listed as a proprietary ingredient flavouring in two ARTG products, and as a component of fragrances (which is not exclusive to cosmetics). In these preparations it is expected to be in concentrations of <1%.
   • Internationally, THFA is reported to be used as a solvent in a wide range of products, including adhesives, cosmetics, fertilisers and washing & cleaning products.
3. the toxicity of a substance:
   • Acute oral and inhalational toxicity.
   • Eye irritation (not reversible within 7 days).
   • Slight skin irritant.
   • Moderate reproductive toxicity (with effects on the male reproductive tract).
   • Developmental toxicity.
4. the dosage, formulation, labelling, packaging and presentation of a substance:

   Labelling:

   Appendix E, Part 1

   Standard Statement

   • E1 If in eyes wash out immediately with water

   Appendix F, Part 1

   Warning Statement

   • 67 Do not use if pregnant or likely to become pregnant

   Appendix F, Part 2

   Safety Direction

   • 1 Avoid contact with eyes
   • 31 Do not use on broken skin
5. any other matters considered necessary to protect public health:
   • There are currently no products containing THFA listed on the Public Chemical Registration Information System Search (PubCRIS). Its inclusion in formulations is currently protected information as it is not a scheduled solvent.

Reasons for the interim decision (including findings on material questions of fact)

I have made an interim decision to amend the current Poisons Standard and create a new Schedule 6 entry for THFA, excluding its derivatives. The reasons for my decision are set out below.

I have determined that THFA meets the Schedule 6 Scheduling Factors as outlined in the Scheduling Policy Framework (SPF) 2018. Concordant with the Scheduling Factors for inclusion in Schedule 6, THFA is of low acute oral (LC₅₀ >2000 mg/kg bw), dermal (LD₅₀ > 5000 mg/kg bw) and inhalation toxicity (LC₅₀ > 3100 mg/m³) and is not a skin sensitiser and is a slight skin irritant. However, THFA is a severe eye irritant and shows evidence of reproductive and developmental toxicity that are consistent with inclusion in Schedule 6. I am of the view that THFA poses a moderate health hazard and a moderate risk of producing irreversible toxicity.

The new entry in the Poisons Standard is required to mitigate the risk of the substance by including the corresponding "POISON" warning and the requirement of personal protective equipment on product label. This inclusion is important in providing suitable product-based safety directions to reduce reasonably foreseeable harm to users. The APVMA has confirmed that the management of health risks associated with AgVet use of THFA is achieved primarily via label directions, established from a consideration of the acute hazards of the product in conjunction with possible adverse health effects from repeated exposure to both workers and the general-public.

I have excluded THFA derivatives from the Schedule 6 entry, as there is evidence that they may have a different hazard profile to THFA. As of December 2020, THFA was listed as a proprietary ingredient in two ARTG products, and as a component of fragrances (which is not exclusive to cosmetics). In these preparations it is expected to be in concentrations of <1%. At present I am unable to implement a concentration cut-off or exemption for THFA in Schedule 6, as there is insufficient evidence to support reduced toxicity of THFA at lower concentrations.

Due to the widespread presence of the substance in many different products, I have decided on a later implementation date of 1 June 2021, to allow time for industry to implement appropriate labelling.

I note that no public submissions were received in response to the pre-meeting consultation under regulation 42ZCZK.

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; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.

Proposed implementation date

1 June 2021