A notice of final decisions has been published on the TGA website in relation to dichloromethane (also known as methylene chloride).

CMA is pleased to inform members that the Delegate has decided to vary the Interim Decisions to clarify the entry for dichloromethane in the Poisons Standard by including a new exemption for human therapeutic preparations in the Schedule 5 entry.

In our response to the original proposal and interim decision, CMA continued to seek alignment of the entry for dichloromethane in the Poisons Standard with the Determination, TGO 101 and ICH guideline Q3C (R8) for residual solvents, to ensure consistency of requirements across the regulatory framework.

Therefore, this final decision not only prevents the initially proposed total S10 ban on dichloromethane, it also resolves the issue of the Poisons Standard to-date not being aligned with other regulatory legislation. It prevents the unnecessary removal of complementary medicines from supply and assures the ongoing safe supply of the affected nutrient fractions and herbal extracts. It allows listed medicines with the affected nutrients and extracts to remain in legal supply, provided they remain compliant with the required cut-off limits in other regulatory requirements as described further in this alert.