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Introduction
Benzophenone is concluded by International Agency for Research on Cancer (IARC) Working Group as a possibly carcinogenic to humans (Group 2B). It is a known potential degradant of sunscreens containing octocrylene. Although USP monograph for octocrylene has limits for organic impurities in the raw material, the monograph does not specify a safe limit for benzophenone as a degradant in finished products. Therefore, the TGA has been reviewing available information to establish a safe permitted daily exposure and a limit for benzophenone as a degradant in therapeutic sunscreens.
In August 2023, the TGA held a public consultation to discuss safe levels of benzophenone in listed medicines. The consultation document proposed to amend the requirements for the use of benzophenone and octocrylene in these medicines. However, the decision to introduce a regulatory limit for benzophenone was deferred pending further consultation to develop a sunscreen exposure model specific to the Australian context.
In July 2024, the TGA conducted a subsequent public consultation to establish the Australian Sunscreen Exposure Model (ASEM), which more accurately estimates regular sunscreen exposure for Australians. The ASEM calculates a highest estimated average daily sunscreen exposure amount based on the highest use scenarios in the most vulnerable population (toddlers aged 1-2 years), ensuring it is applicable for general therapeutic sunscreens meant to be used by the whole population.
This updated safety review uses the ASEM to assess the risk of benzophenone as a degradant in sunscreens.