Tech alert: TGA Scheduling Interim Decision – Dichloromethane 

A public consultation on the interim decision for dichloromethane is now open, closing 24 November 2022.

Dichloromethane (also known as methylene chloride) is a solvent for some materials used in complementary medicines, particularly lipid soluble fractions of plant extracts, and is therefore a residual solvent relevant to some CM finished products.

In May 2022, the TGA consulted on a private applicant’s proposal to change the Scheduling of dichloromethane from Schedule 5: Caution; to Schedule 10: Substances of such danger to health as to warrant prohibition of sale, supply and use, effectively prohibiting any use of dichloromethane. 

After considering the submissions from 22 entities (17 opposed) including CMA, and advice from the Advisory Committee on Chemicals Scheduling (ACCS), a Delegate of the Secretary of the Department of Health and Aged Care has made an interim decision to not amend the current Poisons Standard in relation to dichloromethane. 

While this is positive news, there are ongoing considerations for listed medicines that have not been resolved by the interim decision, which members may wish to consider in relation to making further submissions.

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