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Priority review Consultation Amended Consultation

TGA Opens Consultation on Sunscreen Regulation Improvements

Favicon for www.tga.gov.au TGA Australia Media Releases
Published March 26th, 2026
Detected March 26th, 2026
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Summary

The Therapeutic Goods Administration (TGA) has opened an 8-week public consultation on proposed improvements to sunscreen regulation in Australia. The consultation seeks feedback on options to enhance SPF testing reliability, adopt new technologies, strengthen laboratory oversight, and improve labelling and quality assurance.

What changed

The Therapeutic Goods Administration (TGA) has initiated an 8-week public consultation period, ending May 23, 2026, to gather feedback on proposed enhancements to Australia's sunscreen regulatory framework. Key proposals include improving the reliability and transparency of SPF testing, enabling faster adoption of new testing technologies, strengthening oversight of testing laboratories, enhancing lifecycle quality assurance, simplifying SPF labelling, and updating Good Manufacturing Practice guidance. These changes aim to bolster consumer confidence in sunscreen performance, particularly given Australia's high skin cancer rates.

Interested parties, including manufacturers and consumers, are invited to submit responses by May 23, 2026. The TGA will host a webinar on April 14, 2026, to discuss the proposals. If accepted, the proposed changes would be implemented with appropriate transition periods. Compliance officers should review the consultation paper and prepare feedback to submit by the deadline, noting the potential impact on manufacturing processes, testing protocols, and product labelling.

What to do next

  1. Review the TGA's consultation paper on sunscreen regulation improvements.
  2. Submit feedback and responses by the comment close date of 2026-05-23.
  3. Attend the TGA webinar on 2026-04-14 for an overview of proposals.

Source document (simplified)

Improving the regulation of sunscreens in Australia

Published

26 March 2026

Given Australia has the highest rates of skin cancer and melanoma in the world, with around 2,000 people dying each year, it is critical that the regulatory settings are appropriate to ensure consumer confidence in sunscreens.

The consultation paper proposes a range of options to provide the following improvements to the current regulatory framework:

  • Improving reliability and transparency of SPF testing.
  • Enabling new testing technologies to be adopted in a timelier manner.
  • Strengthening oversight of testing laboratories.
  • Enhancing lifecycle quality assurance, including periodic testing, and ingredient standards.
  • Simplifying and clarifying SPF labelling.
  • Providing greater consistency with the indications that therapeutic and cosmetic sunscreens can make.
  • Updating Good Manufacturing Practice guidance to improve manufacturing quality. These proposals are intended to strengthen confidence in sunscreen performance. If accepted, options presented in this paper would be implemented in a proportionate and targeted manner, with appropriate transition periods incorporated.

The TGA will host a webinar on 14 April 2026 at 1 pm to provide stakeholders with an overview of the key proposals in the consultation paper. Attendees will be given the opportunity to ask questions of the TGA’s expert panel ahead of submitting their response to the consultation.

Consumers are encouraged to visit the TGA’s sunscreens hub to:

  • get tips on choosing the right sunscreen, applying it properly and understanding the label
  • learn about SPF testing, check the latest sunscreen recalls, and know what to do if your sunscreen has been recalled
  • find out how we're reviewing sunscreen ingredients and why you should continue to use sunscreen during this process.
    Contact for members of the media:

  • Email: news@health.gov.au

  • Phone: 02 6289 7400
    Topics

  • Sunscreens

  • Manufacturing

  • Labelling and packaging

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Named provisions

Improving reliability and transparency of SPF testing Enabling new testing technologies Strengthening oversight of testing laboratories Enhancing lifecycle quality assurance Simplifying and clarifying SPF labelling Updating Good Manufacturing Practice guidance

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
TGA
Published
March 26th, 2026
Comment period closes
May 23rd, 2026 (58 days)
Instrument
Consultation
Legal weight
Non-binding
Stage
Consultation
Change scope
Substantive

Who this affects

Applies to
Manufacturers Consumers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Product Testing Product Labelling Manufacturing Standards
Geographic scope
Australia AU

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Product Safety Consumer Protection Manufacturing Standards

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