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The TGA has been working on implementing the decisions and actions announced in October 2019 in response to the Review of chemical scheduling in relation to cosmetic and fragrance ingredients. An update on the TGA's progress to date and anticipated timeframes for implementing the outstanding decisions and actions are provided below.
Background
Following the publication of the Expert Panel Review of Medicines and Medical Devices Regulation (pdf,644kb) in July 2015, a review of the Scheduling Policy Framework (SPF) was accepted by Government and a targeted consultation with states and territory governments was undertaken by the Therapeutic Goods Administration (TGA), seeking feedback on current processes and scheduling decisions in relation to cosmetic and fragrance ingredients. The consultation intended to determine how closely Australia's decisions align with other regulators, in particular the European Union (EU). The consultation paper 'Review of chemical scheduling in relation to cosmetic and fragrance ingredients' (pdf,395kb) was distributed as a targeted consultation on 14 March 2019 and Outcomes of the review (pdf,222kb) were published in July 2019. The summary of the decisions and actions to be undertaken in response to these outcomes was published on TGA's website on 9 October 2019.
Update
The table below outlines the TGA's progress in implementing the decisions and actions arising from the review, and the anticipated timeframe for completing the remaining outcomes.
| Decision/Intended action | Outcome | Estimated completion |
|---|---|---|
| Completed | ||
| Intermediate term projects | ||
| Long term projects | ||
| The TGA to establish processes to ensure delegate and committee have information on overseas decisions and standards before making decisions. | Publication of information at the pre-meeting (public notice) stage and in committee papers on overseas decisions and standards. | Completed |
| Improve administrative processes to allow for better stakeholder feedback where proposals impact multiple industries. | Direct engagement with external stakeholders is more frequent, including:
| Completed |
| Improve engagement with ACCC/AICIS | Setup regular meetings with AICIS and ACCC | Completed |
| Update application form and application guidance to lift quality of applications. | New application form that can be filled electronically with accompanying guidance in consultation with stakeholders. This form will incorporate prompts regarding cut-offs (for impurities in cosmetic or other domestic substances). | January 2022 |
| Develop an electronic database to record scheduling decisions. | Searchable Poison Standard database that provides a substance-centric view of scheduling information. | March 2022 |
| Consider including all CAS names and numbers and other synonyms in Poisons Standard. | Feasibility determined as part of searchable Poison Standard database and implemented where possible. | March 2022 |
| Increase use of subject matter experts. | Lists of special advisors who have particular subject matter expertise. | March 2022 |
| Update guidance on the TGA website | Updated Handbook content and/or scheduling webpages as required. e.g. estimating acute risk when in dilute preparations. | June 2022 |
| Develop more explicit definitions of derivatives. | Updated definitions and/or guidance in consultation with relevant stakeholders. | June 2022 |
| Consider an approach for undertaking Class reviews of related substances and explore mechanisms to improve scheduling of fragrances/essential oils. | Specific criteria and framework for identification, prioritisation and conduct of related substance reviews in consultation with relevant stakeholders i.e. industry, consumers, and responsible government agencies. Working group to consider scheduling of essential oils. | September 2022 |
| Improve the mechanism for scheduling cosmetic and fragrance substances through the use of overseas standards or decisions. | Completed analysis of options, including regulatory impacts, for adopting the EU Cosmetic Regulations Annexes II and III in the Poisons Standard in consultation with stakeholders. | December 2022 |