Titanium dioxide (TiO₂) remains one of the most emblematic ingredients in the cosmetics industry. Its high refractive index, opacity, and ability to absorb and scatter UVA and UVB radiation make it an essential component in makeup, facial creams, sunscreens, and oral care products.
For decades, its effectiveness as a white pigment and inorganic UV filter has been undisputed. However, recent scientific findings and growing concerns about its potential genotoxicity have led European authorities to reassess its safety and usage conditions, particularly in oral applications.
The new mandate issued by the Scientific Committee on Consumer Safety (SCCS) in September 2025 marks a major turning point in the regulation of TiO₂, setting new scientific and technical challenges for manufacturers and cosmetic laboratories.
Titanium Dioxide: Current Regulatory Context
Titanium Dioxide: Classification and Use Authorization
Under Regulation (EC) No 1223/2009, titanium dioxide is currently authorized as:
- Colorant (Annex IV, entry 143).
- UV filter (Annex VI, entries 27 and 27a, including its nano form).
This dual classification reflects the ingredient’s versatility—used both for its optical properties and its protective function against UV radiation.
The Genotoxicity Concern
In 2021, the European Food Safety Authority (EFSA) concluded that the genotoxic potential of titanium dioxide (E171) could not be excluded when used as a food additive. Although that assessment focused on food applications, it raised significant concerns for other uses, including cosmetics.
Subsequently, in May 2024, the SCCS issued an opinion indicating that the genotoxic risk could not be ruled out for most titanium dioxide grades—both nano and non-nano—used in oral products, with the exception of grades RM09 and RM11.
The New SCCS Mandate (September 2025)
In September 2025, the European Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) formally requested the SCCS to re-evaluate the safety of titanium dioxide in cosmetics following the submission of new industry data (June 2025).
Approved on 14 September 2025, the mandate poses three key questions:
- Safety in oral products: Can TiO₂ be considered safe for use in oral cosmetics under the proposed conditions?
- Concentration limits: If a risk is identified, can safe maximum concentrations be defined by product category?
- Additional scientific considerations: Are there other issues that should be examined based on the new evidence?
The SCCS has 12 months to deliver its final opinion, expected by September 2026.
Titanium Dioxide: Scientific and Technical Implications
Genotoxicity
The central issue remains the potential genotoxicity of titanium dioxide, even in non-nano grades. Current data are insufficient to fully exclude risk upon contact with the oral mucosa, especially in products such as toothpastes and lipsticks.
Titanium Dioxide Nanoparticles and Absorption
The SCCS has requested additional data on absorption and cellular effects in the oral mucosa. Some pigmentary grades of TiO₂ contain more than 50% nano-sized particles (by number), requiring further studies on their bioavailability and toxicokinetics.
Titanium Dioxide Oral Exposure Risk
Although titanium dioxide is insoluble and chemically inert, repeated oral exposure may lead to direct contact with epithelial tissues. This potential interaction justifies a precautionary approach, including lower concentration limits and analytical verification of material properties.
At this stage, advanced analytical instrumentation becomes crucial for accurate characterization of particle size distribution, purity, and trace contaminants.
One notable example is the S2 PUMA, recently incorporated into SHAPYPRO, which enables high-precision elemental analysis of cosmetics using X-ray fluorescence (XRF).
📖 Learn more in our article: S2 PUMA: A Technological Leap In The Analysis Of Cosmetics And Pharmaceuticals.
Implications For The Cosmetics Industry
The SCCS mandate will directly affect manufacturers of oral and lip products, particularly in three main areas:
- Scientific Evidence Of Safety
Companies must provide robust toxicological data demonstrating that the grades of TiO₂ used do not pose genotoxic risks. - Raw Material Traceability
Suppliers must guarantee detailed batch characterization, including nano fraction content and production method. - Assessment Of Alternatives
In anticipation of potential restrictions, some manufacturers are already exploring alternative mineral pigments or mixed metal oxides that could reduce regulatory exposure.
Recommended Strategies For Laboratories And Manufacturers
- Review Formulations
Identify all products containing titanium dioxide—particularly oral and lip applications—and verify both concentration and material grade used.
- Generate New Data
Conduct specific genotoxicity and absorption studies on the TiO₂ grades used. Proprietary data strengthen regulatory defense and safety assessments.
- Analytical Control Of Raw Materials
Implement XRF or energy-dispersive spectroscopy techniques to verify elemental composition and particle size. Instruments like the S2 PUMA are especially effective for this type of analysis in solid or semi-solid cosmetic samples.
- Participate In Regulatory Consultation
Companies should actively engage in SCCS consultations, providing relevant data to help define realistic concentration limits.
- Transparent Communication
Consumer trust depends on clear, evidence-based communication. Explaining safety measures and regulatory compliance reinforces credibility and corporate responsibility.
Future Outlook for Titanium Dioxide Regulation
The final SCCS opinion on titanium dioxide will set a major regulatory precedent for all ingredients containing nano-scale materials. It is expected that differentiated limits by product type and exposure level will be introduced, strengthening the precautionary principle that guides European cosmetic legislation.
In parallel, the cosmetics industry must prepare for enhanced analytical traceability and closer regulatory scrutiny of nanomaterials in the coming years.
Advanced analytical tools, such as the S2 PUMA, will be indispensable for laboratories aiming to anticipate these requirements, providing reliable, reproducible data aligned with the expectations of the European Commission and national authorities.
Conclusion: Titanium Dioxide and the Cosmetics Sector
The SCCS 2025 mandate on titanium dioxide represents a defining moment for the European cosmetics sector. Although TiO₂ remains a cornerstone ingredient in sunscreens, makeup, and oral care products, the new regulatory framework demands greater scientific evidence, traceability, and vigilance.
At SHAPYPRO, we support laboratories and manufacturers through:
- Tailored regulatory assessments.
- Proficiency testing programs aligned with European standards.
- Technical assistance for impurity and particle analysis.
The combination of scientific rigor, analytical innovation, and transparency will be essential to ensure consumer safety and sustain the responsible use of titanium dioxide in cosmetics.