Your Monthly Regulations Radar: Titanium Dioxide - October 2024

What is Titanium Dioxide? 

Titanium dioxide is a naturally occurring mineral that plays a vital role in the cosmetic and personal care industry. It is extensively used in cosmetic products as a colorant, offering opacity and bright white pigment, and a UV filter in sunscreen to protect against the harmful UV rays from the sun. 

The Latest Regulation on Titanium Dioxide

The Scientific Committee on Consumer Safety (SCCS) recently published a Scientific Advice on titanium dioxide, and determined that the available evidence is not sufficient to exclude the genotoxic potential of almost all the types and grades of titanium dioxide used in cosmetic products. In particular, the SCCS considered the risk for oral exposure, e.g., lipstick, related to the unintended and incidental ingestion. 

How did we get here? 

In 2021, the European Food Safety Authority (EFSA) determined that genotoxicity could not be ruled out for the nano or non-nano form of titanium dioxide. We need some historical context to better understand why there has been so much spotlight around titanium dioxide over the last decade. It is important to note that this ingredient is already restricted under entry 27a of Annex VI as not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. 

That is because in 2010, the International Agency for Research on Cancer (IARC) concluded that titanium dioxide is a possible carcinogenic to humans (group 2B) based on animal bioassays and the increased incidence in lung cancer in humans. This is related to the inhalation hazard associated with particles that are not soluble or poorly water soluble and very fine particle size, typically less than 5-10 micrometer (µm). This “nuisance dust” is not unique to titanium dioxide and is also associated, for example, with carbon black or talc. 

The US FDA (2019) surprised many in the industry when they proposed an update to the sunscreen monograph that deemed only two UV filters, zinc oxide and titanium dioxide, met the threshold of being considered GRASE (Generally Regarded as Safe and Effective) including their nano forms. 

Takeaways 

As per the latest update on Titanium Dioxide, I would recommend avoiding it for lipsticks and formulations where there could be a risk of ingestion. If you are marketing in the USA, titanium dioxide is considered GRASE in sunscreen. However, in powder form, testing for the particle size distribution is recommended to ensure that there are less than 1% of particles below 10 µm and a risk assessment to ensure compliance with Prop65...

👉 How is titanium dioxide going to impact your business? Reach out to Christine Thiffault, PhD, DABT, ERT, at cthiffault@toxessential.com, Toxicology Expert at ToxEssential, or visit the website: toxessential.com

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