Why people assume permitted ingredients are safe?

Most people assume that if an ingredient is permitted in sunscreen, it has been fully and recently assessed for safety. Sunscreen is widely recommended, used daily, and regarded as an essential public health tool. However, regulatory settings can sometimes lag behind evolving scientific understanding. This is the situation now being addressed for 4-Methylbenzylidene Camphor, commonly known as 4-MBC.

What 4-MBC is and how it behaves in the body?

4-MBC is a synthetic UVB filter that has been used in some chemical sunscreens. While effective at absorbing ultraviolet radiation, it is also known to penetrate the skin and enter the body. Scientific studies have shown that it can be detected in blood, urine, and fatty tissues, and that it interacts with hormone systems in experimental and mechanistic studies. These findings come from a combination of laboratory research, animal studies, and human biomonitoring data, which together informed regulatory conclusions on endocrine disruption potential.

What international scientific reviews have concluded

In recent years, several international scientific authorities have independently re-examined the safety of 4-MBC. The European Union Scientific Committee on Consumer Safety and the UK Scientific Advisory Group on Chemical Safety concluded that a safe level of use could not be established based on the available evidence. As a result, 4-MBC has been prohibited in cosmetics and sunscreens in the European Union and deemed unsuitable for use in the United Kingdom. It has never been approved for over-the-counter sunscreen use in the United States and is not permitted in a number of other jurisdictions.

Why Australia’s situation is different

In Australia, 4-MBC remains permitted for use in therapeutic sunscreens at defined concentrations, although its safety status is currently under regulatory review. This reflects historical regulatory settings that pre-date the most recent international reviews. Because sunscreen use patterns in Australia involve high application amounts and frequent reapplication, exposure considerations become especially important when evaluating ingredients that are systemically absorbed.

Why exposure and safety margins matter?

Using standard exposure models, systemic exposure to 4-MBC under typical Australian use conditions can exceed margins commonly used in regulatory risk assessment to define acceptable safety. In addition, substances that interfere with hormone systems are increasingly recognised as requiring a different risk assessment approach, as effects observed in experimental systems may occur at low doses and may not follow traditional threshold assumptions.

Why a regulatory submission has been made?

For these reasons, a formal regulatory submission has now been made seeking a re-evaluation of 4-MBC’s status, based on completed overseas scientific assessments and updated exposure considerations. The request focuses on aligning domestic settings with contemporary international evidence and best practice, rather than introducing new or speculative claims.

What this process is and is not about?

This process is not about assigning fault or questioning the value of sunscreen as a public health measure. Sunscreen remains an important tool for skin cancer prevention. The focus is on ensuring that the ingredients used in these products continue to meet modern safety expectations as scientific understanding evolves.

What happens next?

The review process is now ongoing. As it progresses, the focus remains on evidence, transparency, and public health outcomes, consistent with established regulatory practice. Continued engagement with emerging science helps ensure that consumer protection frameworks remain robust, up to date, and worthy of public trust.

About the Australian Sunscreen Council

The Australian Sunscreen Council (ASC) is dedicated to protecting public health by championing the highest standards in sunscreen safety, testing, use and transparency.

Our mission is to ensure that all sunscreen and related products available to Australians meet or exceed the latest scientific evidence on ultraviolet (UV) protection and human health.

We promote balanced, evidence-based sun safety guidance, recognising that sunscreen is only a small part of the overall picture when it comes to sun safety and health. Our approach is holistic: effective UV protection includes shade, clothing, behaviour, and thoughtful timing of exposure—not sunscreen alone.

The ASC also supports greater public awareness of the documented benefits of moderate sun exposure, including vitamin D synthesis, improved mental wellbeing, and nitric oxide release—a process linked to healthier cardiovascular function and improved blood pressure regulation. We believe Australians deserve clear, science-backed advice that helps them understand how to obtain these benefits safely.

The ASC works collaboratively with government agencies, dermatologists, and public health experts to improve sunscreen standards and to support balanced, science-driven sun safety advice for all Australians.

Learn more at www.australiansunscreencouncil.org