Titanium Dioxide in Cosmetics: Use, Safety and Regulatory Updates
Titanium Dioxide, also known as TiO₂, is an inorganic compound widely used in different industrial sectors.
It is generally found as a white powder and is appreciated for its high covering power, opacity and high refractive index. In cosmetic products, these properties make it useful in make-up, skin care products, sunscreens and formulations intended to provide UV protection.
Titanium Dioxide in Cosmetics
In the cosmetic sector, Titanium Dioxide may have two main functions:
- colourant, to provide whiteness, coverage and opacity;
- UV filter, to help protect the skin from ultraviolet radiation.
Under Regulation (EC) No 1223/2009, Titanium Dioxide is authorised both as a colourant and as a UV filter. The nano form, Titanium Dioxide [nano], is also authorised as a UV filter under specific conditions.
The nano form is mainly used in sunscreen products because it provides UV protection while reducing the white effect on the skin compared with some traditional pigmentary forms.
Titanium Dioxide [nano]
Titanium Dioxide in nano form is subject to specific regulatory attention.
Cosmetic ingredients classified as nanomaterials must comply with dedicated requirements concerning safety assessment, labelling and notification. On the label, ingredients present in nano form must be indicated with the word [nano] after the INCI name.
Titanium Dioxide [nano] is authorised as a UV filter up to a maximum concentration of 25%, subject to the conditions laid down in the Cosmetics Regulation.
However, it must not be used in applications that may lead to exposure of the end-user’s lungs by inhalation. The SCCS confirmed that this restriction already applies to the nano form of TiO₂ under entry 27a of Annex VI to Regulation (EC) No 1223/2009.
The Issue of Inhalation Exposure
One of the most important safety aspects concerning Titanium Dioxide is possible exposure by inhalation.
The issue does not concern every cosmetic product containing Titanium Dioxide in general, but products where particles may be inhaled by the consumer.
This is particularly relevant for:
- loose powder products;
- aerosol products;
- spray products;
- hair styling sprays;
- products that may generate lung exposure.
In its opinion on Titanium Dioxide used in cosmetic products that may lead to exposure by inhalation, the SCCS assessed the safety of pigmentary TiO₂ in products such as loose powders and aerosol hair sprays.
Loose Powders and Spray Products
According to the SCCS, the use of pigmentary Titanium Dioxide up to a maximum concentration of 25% in a typical loose powder face make-up product was considered safe for the general consumer.
For aerosol hair styling products, the SCCS concluded that the use of pigmentary TiO₂ was safe up to a maximum concentration of:
| Product type | Maximum concentration considered safe |
|---|---|
| Aerosol hair styling products for general consumers | 1.4% |
| Aerosol hair styling products for professional users / hairdressers | 1.1% |
These conclusions apply to specific product types and to the type of Titanium Dioxide assessed in the SCCS opinion. Therefore, they should not be automatically extended to all Titanium Dioxide grades or all cosmetic applications without an appropriate safety assessment.
Titanium Dioxide and Carcinogenic Classification
In recent years, Titanium Dioxide has been at the centre of an important regulatory debate.
In 2017, ECHA’s Risk Assessment Committee supported the classification of Titanium Dioxide as a suspected carcinogen by inhalation. In 2019, the European Commission adopted a harmonised classification for Titanium Dioxide in certain powder forms containing 1% or more of particles with an aerodynamic diameter equal to or below 10 μm.
However, the legal situation has since changed. On 1 August 2025, the Court of Justice of the European Union upheld the annulment of the classification of Titanium Dioxide in certain powder forms as a carcinogenic substance.
This is an important update. Nevertheless, it does not remove the need to carefully assess inhalation exposure in cosmetic products, especially powders, aerosols and sprays.
Recent SCCS Scientific Advice
Titanium Dioxide continues to be subject to scientific evaluation, especially in relation to oral cosmetic products.
In its 2024 scientific advice, the SCCS considered that the available evidence was not sufficient to exclude the genotoxicity potential of almost all TiO₂ grades used in oral cosmetic products, with the exception of two specific nano grades for which the available data did not indicate a genotoxicity concern.
The SCCS also stated that more information is needed on the potential uptake and cellular effects of nano grades in the oral mucosa before considering them safe for use in oral-care products.
At the same time, the SCCS confirmed that previous conclusions on dermally applied cosmetic products remain unchanged for the TiO₂ grades and coatings already evaluated.
Oral Cosmetic Products
A specific point of attention concerns oral cosmetic products, such as toothpastes and products that may involve incidental oral exposure.
Cosmetic products are not intended to be swallowed, but accidental ingestion may occur. For this reason, the safety assessment of Titanium Dioxide in oral products must consider possible absorption, retention, translocation and effects of nanoparticles in the oral mucosa.
In 2025, the European Commission requested a new SCCS opinion on the safety of Titanium Dioxide in oral cosmetic products, taking into account new data submitted by industry. The deadline for the SCCS opinion is December 2026.
What Cosmetic Companies Should Check
Companies using Titanium Dioxide in cosmetic products should carefully assess:
- the function of the ingredient in the formula;
- whether the form used is nano or non-nano;
- particle size and technical specifications;
- possible presence of respirable particles;
- the type of cosmetic product;
- possible inhalation exposure;
- possible oral exposure;
- concentration of use;
- compliance with the relevant annexes of the Cosmetics Regulation;
- correct labelling, including [nano] where applicable;
- consistency between formula, PIF, CPSR, label and CPNP notification.
A proper assessment should not be limited to the presence of Titanium Dioxide in the formula. It should consider the specific grade of the raw material, the product type, the conditions of use and the consumer exposure profile.
Titanium Dioxide: Safety and Compliance
Titanium Dioxide remains a widely used and important cosmetic ingredient, both as a colourant and as a UV filter.
Current regulatory and scientific attention does not mean that Titanium Dioxide is generally prohibited in cosmetics. However, its use requires careful technical evaluation, especially when the product may lead to inhalation exposure or when Titanium Dioxide is used in oral cosmetic products.
For this reason, companies should keep product documentation up to date, verify raw material specifications and ensure consistency between formulation, safety assessment, labelling and CPNP notification.
Sources: Regulation (EC) No 1223/2009; Commission Regulation (EU) 2021/850; SCCS Opinion on Titanium Dioxide, SCCS/1617/20; SCCS Scientific Advice on Titanium Dioxide, SCCS/1661/23; European Commission Request for Scientific Opinion on Titanium Dioxide; Court of Justice of the European Union, judgment of 1 August 2025; EFSA Opinion on Titanium Dioxide E171; SCCS Guidance on the Safety Assessment of Nanomaterials in Cosmetics