Titanium dioxide carcinogen classification overturned
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.
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.
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.
Conclusion
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.
References
i https://www.federalregister.gov/documents/2019/02/26/2019-03019/sunscreen-drug-products-for-over-the-counter-human-use
ii https://health.ec.europa.eu/system/files/2019-02/sccs_o_206_0.pdf
iii https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_136.pdf