2.3. Interim decision in relation to MCPB

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 not to amend the current Poisons Standard in relation to MCPB.

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

I agree with the committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) 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; (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.

In my view, the relevant parts of the SPF, 2018 are the Scheduling Factors for Schedules 5 and 6.

Reasons for interim decision:

I have made an interim decision to not to amend the current Poisons Standard in relation to MCPB for the reasons set out below. Taking into account that the current schedule for MCPB applies to MCPB and its salts and derivatives, where the salts or derivatives are known to have different human health risk profile to the parent compound, I find it appropriate that a separate schedule entry be designated. Having considered that, Schedule 6 substances have a moderate to high toxicity, such that eye irritation is severe (SPF, 2018), I find that on balance the lack of information on the formulations used in testing the salts for eye irritation supplied by the Applicant made it difficult to determine if eye damage can solely be attributed to the salts. The toxicological summary states 'The product is damaging to the eye'. It is my understanding however that the formulation contains the actives as dimethylamine salt and a surfactant, where both dimethylamine and the surfactant are known to cause serious damage to the eye. In making my decision to not amend the Poisons Standard I have given substantial weight to the data gap on the identity of the formulation in the eye irritation study and the relevance of the dimethylamine and surfactant to the observed eye damage and the absence of an independent assessor report in the application.