Improvements to the regulation of sunscreens in Australia

Overview

Seeking feedback on improvements to the regulation of sunscreens in Australia

Recent international and domestic developments have highlighted a number of matters in relation to the current regulation of sunscreens. 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 TGA is seeking feedback on proposed changes to improve the regulation of therapeutic sunscreens in Australia. The consultation paper proposes a number of options to provide the following improvements to the current regulatory framework:

• improving reliability and transparency of sun protection factor (SPF) testing
• enabling new testing technologies to be adopted in a more timely manner
• strengthening oversight of testing laboratories
• enhancing lifecycle quality assurance (periodic testing, ingredient standards)
• simplifying and clarifying SPF labelling
• providing greater consistency with the indications that therapeutic and cosmetic sunscreens can make, and
• updating Good Manufacturing Practice (GMP) 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.

The proposed changes are detailed in the Consultation document.

To respond to this consultation please click the 'Online Survey' link below.

You can respond to any or all of the proposed changes. Responses can be entered directly into the text boxes provided, or submitted as a single PDF or Word document upload. 

Privacy and your personal information

The TGA collects your personal information in this submission in order to:

1. Clarify any issues raised in your submission or to confirm whether you consent to certain information being made publicly available.
2. Help provide context about your submission. For example, whether you are responding as an individual, a director of a company or representing an interest group.

Please do not include personal information about other individuals in the body of your submission. Personal information in this context means, information or an opinion about an identified individual, or an individual who is reasonably identifiable, from the information or opinion. The TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.

Online publication of submissions

The TGA may disclose your full name, work title, company/organisation and submission on the Internet (i.e. make this information publicly available) with your consent.

You may specify whether there is anything in your submission which you would prefer to not be published online (e.g. names, email addresses, proprietary information) by:

1. Providing an additional, redacted copy of your submission; or
2. Providing details of content not to be published e.g. “Do not publish pages 3-5”, “Please redact contact details”; or
3. Identifying any text within your submission to remain confidential by having it clearly marked 'IN CONFIDENCE' and highlighted in grey.

Why your views matter

The TGA is seeking feedback on proposed reforms aimed at strengthening the regulation of therapeutic sunscreens in Australia. The TGA will use feedback from this consultation to inform future regulatory decisions and potential reforms aimed at ensuring that sunscreens supplied in Australia continue to be safe, of good quality, efficacious and accurately labelled, and that the regulatory framework maintains public trust while supporting innovation and supply continuity.