Titanium dioxide (TiO₂) is widely used across several industries, including cosmetics, paints, plastics, and food. For a period of time, it had been classified in the European Union as a suspected
Introduction
Titanium dioxide is one of the most widely used substances in industry, valued for its opacity, whiteness, and ability to reflect UV radiation. In cosmetics it is used as a colourant, a UV filter, and a mattifying ingredient. It is present in paints, plastics, pharmaceuticals, and it used to be used in food.
In pigment form, titanium dioxide appears as a fine white powder with strong opacity. The substance is chemically stable, insoluble in water, and known for having a high refractive index.
Across the past decade, regulators examined possible health risks related to inhaling very fine or nano particles of TiO₂. This triggered a complicated process involving scientific evaluations, EU agencies, and several court decisions. The developments eventually led to a classification of the ingredient as carcinogenic.
This article follows the regulatory history of titanium dioxide, starting with its classification as a suspected carcinogen and ending with the annulment by the Court of Justice of the European Union.
Inside the cosmetics industry, TiO₂ is mainly used for three functions:
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As a dye (CI 77891). It appears in Annex IV of Regulation (EC) No. 1223/2009 and gives colour to foundations, powders, lipsticks, toothpastes, and other decorative cosmetics.
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As a UV filter. It is authorised in Annex VI and used in sunscreens and skincare products that provide photoprotection. The ingredient reflects and scatters UVA and UVB rays. In nano form it allows transparent formulations without the typical “white cast”.
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As a mattifier and covering agent. It improves the visual texture of cosmetic formulas and helps create a more even complexion.
Outside cosmetics, titanium dioxide is used widely in other industries as well:
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Paint and coatings. It is the most widely used white pigment globally because of its covering power and light reflection.
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Plastics and paper. It improves gloss, durability, and opacity.
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Pharmaceutical products. It is used as an excipient in coatings for tablets and capsules.
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Food (E171). It was previously used as a colouring agent but is no longer authorised for food use in the European Union after precautionary concerns linked to potential genotoxicity of smaller particles.
The extensive use of TiO₂, especially in micronised and nano forms, attracted growing regulatory attention. Most of that attention focused on inhalation exposure and possible health impacts.
A series of regulatory discussions followed. Authorities and industry exchanged positions and this led to a negative evaluation of the ingredient and its classification as carcinogenic. The following sections explain the main steps in this process and describe the current regulatory situation.
A Technical-regulatory and Jurisprudential Chronology
Titanium Dioxide (TiO₂) EU Regulation and Carcinogenic Classification Timeline
Only recently, on 1 August, the Court of Justice of the European Union confirmed the annulment of the classification of titanium dioxide in certain powder forms as a substance suspected of being carcinogenic by inhalation.
The ruling closed a long regulatory and technical process that had started almost ten years earlier. The outcome affected multiple industrial sectors including cosmetics.
Below are the key stages of that process.
2016 — The Initial Proposal of ANSES
In May 2016, the Agence Nationale de Sécurité Sanitaire de L’alimentation, de L’environnement et du Travail (ANSES), the French health agency, submitted a proposal to the European Chemicals Agency (ECHA). The proposal asked for titanium dioxide to be classified as a category 1B carcinogen by inhalation under the REACH Regulation (EC) No. 1907/2006.
The proposal relied mainly on inhalation studies in rats. These studies showed that long exposure to high concentrations of fine TiO₂ particles caused lung overload, chronic inflammation, and eventually tumour formation.
The mechanism involved was not genotoxic. It was based on a physical and mechanical reaction rather than a chemical one. This point led to debate in the scientific community since its toxicological relevance for humans was considered low.
2017 — ECHA’s RAC Opinion
In June 2017, ECHA’s Committee for Risk Assessment (RAC), acting after the ANSES request, issued a favourable opinion supporting classification of TiO₂ as a category 2 carcinogen (Carc. 2) by inhalation.
RAC explained that the carcinogenic potential was not linked to the chemical nature of the substance. Instead it was related to the physical characteristics of the particles, including size, shape, and their persistence in the lungs.
2020 – Formal Classification in the EU via the 14th ATP of CLP
On 18 February 2020, the European Commission adopted Regulation (EU) 2020/217. This regulation was the 14th adaptation to technical progress of the CLP Regulation (EC No. 1272/2008).
The rule classified titanium dioxide powders that contain at least 1% of particles with an aerodynamic diameter of 10 μm or less as Carc. 2 for inhalation. It also required additional warning phrases on product labels.
One of the required statements was:
EUH211: “Warning! In case of dangerous dust formation, avoid inhaling the dust.”
The classification caused concern in many industries that use TiO₂ widely. These included paints, plastics, inks, paper, and cosmetics.
2021 – Impact on the Cosmetics Sector: Ban and Derogations
Titanium dioxide is widely used in cosmetics for its opaque, mattifying, and photoprotective properties.
It appears in two annexes of Regulation (EC) No. 1223/2009:
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Annex IV as a colouring agent (CI 77891)
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Annex VI as a UV filter with defined conditions of use
After the Carc. 2 classification and the related ATP update, the European Commission adopted Regulation (EU) 2021/850. This third “CMR” Regulation modified Annex II of the Cosmetics Regulation.
The amendment prohibited TiO₂ in forms classified as carcinogenic but introduced certain exceptions.
A derogation allowed its use in products that cannot be inhaled, such as creams and toothpastes. These products do not expose users to respirable powder forms.
The classification created confusion because the same substance could be authorised in some uses and prohibited in others. The difference depended on particle size and the physical form of the ingredient.
2022 — The General Court of the European Union Annuls the Classification
Several economic operators challenged the classification before the General Court of the European Union. These included producers, importers, downstream users of TiO₂, and industry associations. The cases included Case T279/20 and related proceedings.
The applicants argued that:
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The classification relied on flawed scientific data.
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The hazard criteria were not fully met because the mechanism was not directly relevant to humans.
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The Commission had misapplied the CLP rules, which do not allow classification based on particular particle shapes.
On 23 November 2022, the General Court annulled the classification and labelling. The Court identified a clear error of assessment by the Commission and by RAC.
The Court criticised the way the reliability of the main scientific study had been evaluated and pointed to the absence of a complete assessment of all relevant factors.
2023–2025 — Appeal and Final Judgment of the CJEU
France and the European Commission appealed the decision before the Court of Justice of the European Union. The joined cases were C-71/23 and C-82/23.
On 1 August 2025, the CJEU rejected the appeals and confirmed the annulment.
The Court concluded that:
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RAC had not considered all available scientific evidence.
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The evaluation of the key study contained methodological errors.
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The precautionary principle cannot justify classification without sufficient scientific evidence consistent with CLP criteria.
Conclusions: Between Scientific Rigor and Protection of Public Health
The titanium dioxide case is an important judicial precedent.
Several points stand out:
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It shows the limits of the CLP hazard-based classification system when the hazard depends on physical conditions and exposure.
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It reinforces the need for rigorous scientific evaluation when substances are widely used.
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It highlights the role of judicial review in European regulatory decisions.
For the cosmetics sector, the issue reopens discussion about the balance between consumer safety and industrial sustainability. The regulatory environment is paying increasing attention to scientific transparency and the traceability of regulatory decisions.
Key Takeaways: Titanium Dioxide Regulation in the EU
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Titanium dioxide uses. It is widely used in cosmetics, paints, plastics, inks, paper, pharmaceuticals, and was previously used in food as E171.
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Initial classification. ANSES proposed the classification in 2016 as a suspected carcinogen by inhalation after rat inhalation studies.
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EU CLP classification. In 2020, TiO₂ powders with particles 10 µm or smaller were classified as Carc. 2 under the 14th ATP of the CLP Regulation.
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Cosmetic impact. The classification led to partial bans for inhalable forms but allowed derogations for creams, toothpastes, and other non-inhalable products.
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Legal challenge. Appeals resulted in the General Court annulling the classification in 2022 and the CJEU confirming this decision in 2025.
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Current status. Since 1 August 2025, TiO₂ is no longer classified as a suspected carcinogen by inhalation for those powder forms, though regulatory monitoring continues.
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Regulatory lesson. The case highlights the importance of scientific rigour, evaluation based on exposure, and judicial review within EU chemical regulation.
FAQs: Titanium Dioxide (TiO₂) Regulation in the EU
Is titanium dioxide classified as carcinogenic in the EU?
Titanium dioxide was classified in 2020 as a suspected carcinogen by inhalation (Carc. 2) for certain powder forms. The Court of Justice of the European Union annulled that classification on 1 August 2025.
Why was titanium dioxide classified as a suspected carcinogen?
The classification came from rat inhalation studies. These studies showed lung overload and tumour formation after exposure to high concentrations of fine TiO₂ particles.
Does the classification apply to all forms of titanium dioxide?
No. The classification applied only to powder forms containing particles 10 μm or smaller and only in relation to inhalation exposure.
Is titanium dioxide still allowed in cosmetics?
Yes. Titanium dioxide remains authorised as a colourant (CI 77891) and as a UV filter. Restrictions exist for products that could create inhalable exposure.
Why did the EU courts annul the classification?
The courts identified methodological errors and concluded that the scientific assessment supporting the classification was incomplete.
What is the current regulatory status of titanium dioxide?
From 1 August 2025 onward, titanium dioxide is no longer classified as a suspected carcinogen by inhalation under EU law.
