2.2. Interim decision in relation to N-methyl-2-pyrrolidone

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 N-methyl-2-pyrrolidone.

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 unable to be satisfactorily addressed due to insufficient evidence provided by the Applicant.

Reasons for interim decision:

I have made an interim decision to refer the proposed amendment for further advice from the Joint Advisory Committee on Medicines and Chemicals Scheduling and request further evidence on the reproductive toxicity data from the Applicant for the reasons set out below. Having considered the Application, my view is that there is a large amount of uncertainty regarding the likely exposure to N-methyl-2-pyrrolidone. I find that the lack of evidence supplied by the Applicant made it challenging for me to ascertain the reasonable foreseeable harm to consumers and assess the health hazard potential from repeated use. It was difficult for me to address the matters under section 52E of the Therapeutic Goods Act 1989.

Below I will set out matters that raised concern in my consideration of the proposed amendment: From my reading, the evidence that N-methyl-2-pyrrolidone is used in cosmetics available on the Australian market is limited, and I note this is contrary to the suggestion made in the application it is likely to be in cosmetic products including mascara, skin moisturiser, hair colour stain removal solution and nail products. I note that an industry report submitted as part of one of the public submissions indicated that there is only one product containing N-methyl-2-pyrrolidone sold on the Australian market. Again, this is contrary to the evidence supplied in the application. I am concerned with the lack of evidence on the concentration data available for N-methyl-2-pyrrolidone in any cosmetic product and the level of exposure for consumers and the actual risk.

In relation to the quantitative risk assessment provided by the Applicant, while I accept that the methodology used was correct, in the absence of real concentration data, however, my view is that the assessment may have overestimated consumer usage data for N-methyl-2-pyrrolidone. It is my understanding that the findings of the assessment are underpinned by the assumption that, a consumer is using three products containing N-methyl-2-pyrrolidone simultaneously, which in my view, is an unlikely scenario.

I find that the summary of the reproductive and developmental toxicity data lacked support from individual studies, which would benefit from additional clarification from the Applicant.

I have considered the evidence in support of a Schedule 6 entry on the basis of use at less than 2 per cent concentration and a 25 per cent cut-off in other preparations involving non-cosmetic use. I also note that the use of the margin of exposure to develop cut-offs would be consistent with the approach undertaken by the European Scientific Committee on Consumer Safety, however, this consideration was not material to my decision making under the provisions under section 52E of the Therapeutic Goods Act 1989. I have considered that public submissions have requested that for consistency and clarity, it would be useful to include the exception for "cosmetic preparations containing less than 2 per cent of the chemical" in the Schedule 5 entry as well as the Schedule 6 entry.

In exercising my powers under the Therapeutic Goods Act 1989 to amend the current Poisons Standard I must have regard for the provisions of section 52E of the Act. I find that, on the grounds that I am unable to satisfactorily address section 52E as a consequence of insufficient evidence as set out above, I have made the decision to seek further evidence from the Applicant to clarify the 52E reasons for their proposed amendment. In addition, having considered that there are medicines currently active on the Australian Register of Therapeutic Goods (ARTG) that contain N-methyl-2- pyrrolidone, I have decided to refer the matter to the Joint Advisory Committee on Medicines and Chemicals Scheduling for further advice and consideration of possible new evidence to be submitted by the Applicant.