Clarification and updates to the regulation of sunscreens

In April - May 2023, the TGA undertook a public consultation on potential clarification and updates to the regulation of sunscreens.

The proposed regulatory clarification and updates included:

1. Adoption of the Australian/New Zealand Standard Sunscreen products – Evaluation and classification AS/NZS 2604:2021 Amd 1:2022 (the 2021 Sunscreen Standard) which specifies the current testing and labelling requirements for sunscreens.
2. Removal of the category of ‘exempt’ sunscreens and previous transitional arrangements from the Therapeutic Goods Regulations 1990 (the Regulations) which enables sunscreen products with less than SPF4 (that were supplied in the market prior to 9 November 2012) to comply with the superseded Australian/New Zealand Standard Sunscreen products - Evaluation and classification AS/NZS 2604:1998 (the 1998 Sunscreen Standard) and be exempt from the requirement to be included in the ARTG.
3. Clarification on the indications (therapeutic uses) that sunscreens can make.

A total of 19 submissions were received from the therapeutic goods industry (sponsors, manufacturer, industry organisations and regulatory agents), government organisations, non-profit organisations, healthcare professional groups, consumer groups and individuals.

Submissions that consented to being published are available through the ‘view submitted responses’ link below. 

The TGA would like to thank those who responded to the consultation.

The feedback we received for each proposal is summarised below.

1. Adoption of the 2021 Sunscreen Standard

The majority of stakeholders supported the adoption of the 2021 Sunscreen Standard as this ensures alignment with international sunscreen testing methodology. A few key points were raised in the consultation response:

• Aerosol/spray pump pack sunscreens: A number of respondents, representing health professionals and consumers, expressed concerns that the introduction of additional labelling instructions for the application of aerosol and spray pump pack sunscreens (as per the 2021 Sunscreen Standard) will not be sufficient to address the risk of sunburn and inhalation for consumers using these products. One respondent considered that aerosol sunscreens should be removed from the market altogether.
• Transition period for compliance with new testing requirements: While the majority of respondents agreed that all new sunscreens should be required to comply with the 2021 Sunscreen Standard from the adoption commencement date, there were concerns raised by industry with the 3-year transition timeframe proposed in the consultation for sunscreens already in the market. The concerns related to testing and supply pressure and the potential shortage of sunscreens in the peak sunscreen use season, as well as concerns with overseas stock production due to ongoing political issues in the European Union. Industry respondents highlighted that the updated standard includes the adoption of new technical testing methodologies, rather than addressing any safety or quality concerns with the previous standard. Given this, they indicated that risk to consumers should be considered low and thus support a longer transition period.
• Transition period for new labelling requirements for aerosol/spray pump pack sunscreens: While there was broad support for a shorter transition time for new labelling requirements for aerosol and spray pump pack sunscreens, some respondents expressed concern that the timing of the commencement and end of the proposed transition period (9 January 2023 and January 2024, respectively) occurs in the peak of sunscreen use season and requested the transition period be extended to avoid the peak summer season.

2. Removal of the outdated exemption for sunscreens with less than SPF4

All respondents were supportive of this proposal and removal of exemption provisions for sunscreens less than SPF4, with no industry stakeholder stating that this would represent a regulatory burden to them.

3. Clarification on sunscreen indications

Respondents were presented with three possible options to consider for clarifying the use of indications for sunscreens:

• Option 1: clarify that listed sunscreens can only use indications permitted for sunscreens (status quo).
• Option 2: allow listed sunscreens to use any permitted indications relating to dermal application.
• Option 3: allow listed sunscreens to use additional specified permitted indications relating to dermal application.

The majority of respondents (67%) from a variety of stakeholders supported maintaining the status quo (Option 1), stating that Australia has an excellent system in place for regulating sunscreens which should be maintained. A number of respondents emphasised the critical importance of primary prevention efforts to reduce the incidence of skin cancer, adding that permitting other indications for sunscreens is likely to lead to confusion for consumers. It was also raised that additional ingredients for other indications may interact with sunscreen ingredients, decreasing efficacy and increasing toxicity, skin absorption and allergenicity.

Some industry respondents supported maintaining the status quo, but request clarification in TGA guidance on what cosmetic claims sunscreens can make.

The industry respondents who supported Options 2 or 3 outlined that this will enable innovation and marketing advantage for sunscreen sponsors to distinguish their products from other sunscreens. Some industry respondents suggested different or additional permitted indications to be allowed for sunscreens as part of their response. Respondents representing health professionals and consumers expressed concerns that the implementation of Options 2 or 3 would result in consumer confusion leading to detrimental effects on sun protective behaviour.

The TGA considered all feedback received from the consultation.

1. Adoption of the 2021 Sunscreen Standard

While some health professional and consumer groups raised concerns that the new labelling requirements in the 2021 Sunscreen Standard for aerosol/spray pump pack sunscreens do not go far enough to address safety concerns associated with these goods, the TGA considers the new usage instructions will provide important information on the correct application of these goods that, if followed by consumers, should reduce the adverse events associated with these products. When /if the 2021 Sunscreen Standard is adopted, the TGA will continue to monitor adverse events to sunscreens in the marketplace and reassess if these measures are adequate as required.

In consideration of the potential regulatory impact for industry of imposing new testing requirements for sunscreens, and appropriate transition times, the TGA is developing an Impact Analysis which will be submitted to the Office of Impact Analysis by the end of 2023. The Impact Analysis will assist the Government to make a decision on the adoption of the 2021 Sunscreen Standard and the appropriate transition period. It is anticipated that the Impact Analysis and Government decision will be published early 2024.

2. Removal of the outdated exemption for sunscreens with less than SPF4

Given there were no objections raised in the consultation responses, we have received Government approval to proceed with the implementation of this proposal. The removal of the exemption provisions for sunscreens with less than SPF 4 from the Therapeutic Goods Regulations 1980 (the Regulations) is scheduled to occur on 1 January 2024 and will apply to all new sunscreen products released for supply from 1 January 2024.

Transition arrangements included in the Regulations will enable any sponsors who have stock in the market before 1 January 2024 to continue to supply those products for 3 years. From 1 January 2027 products with less than SPF 4 will not be able to be released onto the market with any product label claims relating to sun screening.

3. Clarification on sunscreen indications

Based on the majority of stakeholder support for the TGA’s current framework for sunscreens, the TGA will clarify in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021 when next updated, that listed sunscreens can only use therapeutic indications specified in the Determination for  use in sunscreens.

The TGA will also clarify what non-therapeutic claims (e.g., cosmetic claims) can be included on a sunscreen label in the next update to the Australian Regulatory Guidelines for Sunscreens.