Titanium dioxide (TiO2) has been used safely in cosmetics worldwide for many decades
The unique properties of TiO2 make it an indispensable ingredient of many cosmetic products. TiO2 is an inert natural inorganic material. When used as a colourant in products like foundation and eye shadows it provides unsurpassed coverage power, which is a necessary attribute in many make-up products. TiO2 is also widely used in sunscreens and other products to reflect the sun’s harmful rays, protecting skin against damage and cancer.
TiO2 has been used safely in a broad range of cosmetic products worldwide for many decades, with no indications of harm to human users. It has been repeatedly assessed and approved by independent European and global safety authorities over the years and remains authorised for cosmetic uses throughout the world.
Notably, the European Union Committee on Consumer Safety (SCCS) has regularly reviewed the safety of TiO2 in different cosmetics applications. In October 2020 the SCCS confirmed the safety of TiO2 in a range of cosmetic applications, including face products in loose powder form and hair aerosol spray products. In their latest opinion published on December 2023, SCCS concluded that some types of TiO₂ are subject to additional testing. The only types of TiO₂ that were considered safe are the ones to have undergone testing according to the latest standards. Based on the SCCS Opinions, TiO2 is authorised both as colourant under entry 143 of Annex IV and as UV-filter under entries 27 and 27a (nano form) of Annex VI to Regulation (EC) No. 1223/2009 on cosmetic products.
The TDMA is looking at carrying out the same tests for other types of TiO2 used in cosmetics to reassure safety of its use. These studies are also in line with the TDMA Science Programme.
For information on the safety of sunscreens, click here.
TiO2 in cosmetics is safe
Despite the widespread consensus on the safety of TiO2 in cosmetic applications, concerns have recently been raised following the opinion delivered by the European Food Safety Authority (EFSA) in May 2021 on the food grade of TiO2 called E171, which is also used in cosmetics. E171 is a pure form of TiO2 used as a colourant ingredient.
The EFSA’s opinion was focused only on the use of TiO2 in food and not on its use in cosmetics. The opinion confirmed that there is no conclusive evidence showing harmful effects from the intake of E171. However, the EFSA raised a new concern about uncertainty in one area. With the latest data and studies, other global regulators have reaffirmed the safety of TiO2.
The World Health Organization (WHO), the Ministry of Health, Labour and Welfare of Japan (MHLW), National Institute of Health Sciences of Japan (NIHS), Health Canada, Food Standards Australia New Zealand (FSANZ), the United Kingdom Food Standards Agency (UK FSA) and the United States Food and Drug Administration (FDA) have all concluded that they do not have safety concerns for the use of TiO2 as a food additive and have allowed its continued use.
For more information on TiO2 in food, please click here.
The EFSA opinion and cosmetics
When it comes to cosmetics, the EFSA 2021 opinion does not address or question the safety of E171 in cosmetic applications. The use of E171 in cosmetics continues to be considered safe when used as approved, including in the European Union. This approval is based on exhaustive testing and assessments by independent European safety authorities.
In light of the latest scientific evidence and assessments by regulatory authorities confirming the safety of E171, the TDMA has called upon the European Commission to trigger a critical re-examination of the EFSA 2021 opinion. The TDMA recommends the conclusions and approach of the WTO, MHLW, NIHS, Health Canada, FSANZ, the UK FSA and the FDA are taken into consideration in the safety assessment of E171 and its continued use in cosmetics.
Will restrictions be placed on the use of TiO2 in cosmetics?
Restricting or limiting the use of TiO2 in cosmetic products would not have a scientific basis as the science continues to confirm the safety of TiO2 in cosmetics. Thus, there is no benefit to the consumer, only loss of an indispensable ingredient with few substitutes that can provide the unique coverage, sun protection and other qualities consumers need and want in cosmetics. Not only could consumers be presented with less choice, but the use of an alternative ingredient could potentially increase the risk of allergic reactions.
The European cosmetics industry is worth more than €77 billion and represents the world’s largest cosmetics market. Any moves to restrict the use of TiO2 would cause widespread disruption for businesses at a global scale – limiting the range of ingredients at their disposal, driving up the cost of cosmetic products and, ultimately, compromising the quality of the formulations for consumers.
