Smart science to improve lives™
Personal Care
Personal Care

Titanium dioxide carcinogen classification overturned

The trend for mineral-only sunscreen formulations is on the rise. Although approved as safe for use in dermally applied sunscreens, certain powder forms of titanium dioxide were classified as carcinogenic by inhalation in the EU. However, this classification has just been overturned. In this blog I will explore what that means for cosmetics.

Edit: update 08 March 2023

On 13 February 2023, the French Government announced that it will appeal the judgment that is the subject of this blog. A press release with more information can be found here. The appeal process normally takes 1 to 2 years, and in practice, this means that the classification will remain in place until the end of the appeal process.

Titanium dioxide in sunscreens

Mineral only formulations are a hot topic in the sunscreen space. In the past 5 years the number of sunscreens launched containing titanium dioxide and/or zinc oxide alone has increased by 80% according to Mintel GNPD. This is largely driven by the fact that titanium dioxide and zinc oxide are the only two UV filters classified as Generally Recognized as Safe and Effective (GRASE) by the Food and Drug Administration (FDA). The FDAi, along with the EU ii iii, says that these UV filters largely do not penetrate the skin, irrespective of size, and are safe for use for dermally applied sunscreens.


Organic UV filters are under significant scrutiny by regulators and legislators alike. Two are already banned in certain territories due to concerns around coral bleaching. In addition, human safety is also under the spotlight. The FDA have requested additional information safety data on the organic filters approved in the US to support their GRASE status for human safety.

Coral bleaching and human safety of UV filters titanim dioxide carcinogenic

You can find more information about environmental and human safety of organics and mineral UV filters in our Myth Busters blogs.

However, mineral UV filters are not without controversy of their own. Certain powered grades of titanium dioxide had a hazard classification in Europe of category 2 carcinogen by inhalation. Although not applicable to Croda's Solaveil powders and dispersions, this created some uncertainty for some within the industry around their inhalation safety.

Why was the classification overturned?

On 23 November 2022 the EU court of justice ruled that this classification as a category 2 carcinogen is unlawful, and this classification has been overturned. 

This means it is not classified as a hazardous substance in the EU, and the obligations related to hazardous classification will not apply in future.

The principal reasons for the annulment were that an error had been made in the assessment of the reliability and acceptability of the study on which the classification was based, and that a classification can only apply to a substance that has the intrinsic property to cause cancer.

What is the titanium dioxide industry reaction to the ruling?

The Titanium Dioxide Manufacturers Association (TDMA) comments “The TDMA welcomes the outcome although recognises that there have also been some lessons learned for the TiO2 industry about improving the scientific communication related to the safety of TiO2.The TDMA will work with European and Member State authorities to address any concerns and the implications of the ruling for downstream users and applications. The TDMA has always been committed to improving worker safety and will continue to invest in the significant TDMA scientific programme, with the objective to generate additional safety data and to update studies to the latest guidelines and scientific techniques.”

What does this ruling mean for cosmetics in Europe?

The downstream impact on cosmetics of this ruling is not yet fully known. However, this ruling provides reassurance to the cosmetics industry and consumers that titanium dioxide is no different from any other dusty particle and does not have the intrinsic property to cause cancer.


Titanium dioxide carcinogenic what does this ruling mean for cosmetics


As well as keeping you, our customers updated about regulations, at Croda, we also contribute useful scientific information and data to relevant authorities to help shape legislation of the future. Since the launch of our first mineral UV filters back in 1985 we have been engaging proactively in evaluations along with our industry partners to support the continued safe use of titanium dioxide and zinc oxide.

UV filters, and their potential impact on human health and the environment, have always been under close scrutiny by regulators, and never more so than in recent years. And whilst no UV filter is completely safe from scrutiny, mineral filters are fortunately under less scrutiny than organics, and therefore continue to be the most increasingly used UV filters in sunscreens and skin care products. 

This ruling by the EU court of justice represents a significant positive step forward for titanium dioxide, reassuring the industry of the safety of this vital mineral sunscreen active.

If you would like any more information on the topics discussed in this blog, or support in your sun care developments, do not hesitate to contact us where our sales representative can put you in touch with one of our experts in your area.







food including pasta, marshmallows and a dip

Titanium dioxide food ban in Europe explained

UV filters, and their potential impact on human health and the environment, are receiving close scrutiny from regulators across the globe. Whilst use of mineral UV filters is on the rise due to controversies around organic sunscreens, inorganic particles are not without controversy of their own. One controversy is the ban of titanium dioxide in food in Europe and this blog explains all about it.

Titanium dioxide: carcinogenic classification overturned infographic

titanium dioxide classification carcinogenic infographic
1.9 MB

Discover our latest sun care blogs

solar formulating for china happy women outside sunlight in background

Formulating for the Chinese consumer - The science of sun care formulation development

Our solar experts have collated an in depth look into the science of sun defence, specifically focussed on the unique requirements of the China market and consumer preferences to aid your sun care...

Read more
solar protection skin cancer people with albanism africa

Protection against skin cancer for people with albinism in Africa

In sub-Saharan Africa, skin cancer ends the life of nine out of ten people with albinism before reaching the age of 30. Learn about how Croda is working with our partners to help improve the lives of...

Read more
Croda stand at in-cosmetics global 2023 in Barcelona representing Croda Personal Care brands Sederma, Crodarom, Alban Muller, Iberchem and Parfex

A journey of wellness with Croda at in cosmetics Global 2023

Discover the latest ingredient launches from Croda, Sederma, Crodarom and Alban Muller, together with a broad range of formulations that perfectly demonstrate how all of our personal care brands,...

Read more
beauty snacking trend: self-care cosmetics in beauty fridge

The Beauty Snacking trend: adding self-care moments to your beauty routine

The beauty snacking trend encourages consumers to take small self-care moments that improve their emotional wellbeing and the health of their skin and hair. Explore our ideas for making beauty...

Read more
Want to learn more about the key themes from this blog?