Titanium dioxide, a misinterpreted dyestuff - it's more about risk, not danger

MSDS-Europe – Chemical Safety Knowledge Base – Classification of titanium dioxide

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Update (December 2025)

Termination of the carcinogenic classification of titanium dioxide under the CLP Regulation

 

On 23 November 2022, the General Court of the European Union, in the joined cases T-279/20, T-283/20 and T-288/20, partly annulled Commission Delegated Regulation (EU) 2020/217, specifically with regard to the harmonised classification of titanium dioxide in powder form with certain particle-size characteristics as “Carc. 2; H351 (inhalation)”.

France and the European Commission lodged appeals against the judgment of the General Court, but on 1 August 2025 the Court of Justice of the European Union, in the joined cases C-71/23 P and C-82/23 P, dismissed the appeals and upheld the decision of the General Court.

Notice C/2025/6670 of the Official Journal of the European Union records the practical consequences of the judgments for Annex VI to the CLP Regulation.

As a consequence, the harmonised “Carc. 2; H351 (inhalation)” classification introduced under Regulation (EU) 2020/217 for titanium dioxide in powder form containing particles with an aerodynamic diameter ≤ 10 μm at a concentration of at least 1% has definitively ceased to apply, and the corresponding entry, as applied in this form, must be deleted from Annex VI to the CLP Regulation.

Following the judgment, ECHA updated its records:

  • the harmonised carcinogenic classification of titanium dioxide was removed from the C&L Inventory,
  • the entries in the Registry of Intentions were aligned accordingly,
  • the ECHA guidance on the classification of titanium dioxide was withdrawn.

 

What does this mean in practice?

In practice, this means that currently there is no valid harmonised “Carc. 2; H351 (inhalation)” entry for titanium dioxide in Annex VI to the CLP Regulation.

Companies may, of course, still carry out self-classification at their own responsibility if, based on the available data and the specific use of the product, they consider stricter hazard communication to be justified.

Importantly, the deletion of the CLP-based harmonised classification for titanium dioxide does not affect the ban on its use as a food additive (E171), which is based on separate food-law regulation and EFSA’s 2021 opinion.

 

Key facts about titanium dioxide

Titanium dioxide (also known as titanium(IV) oxide; chemical formula TiO₂) is a white, fine particulate powder that occurs naturally as the minerals rutile or anatase.

The main areas of use are paints and coatings, as well as paper and plastics manufacturing, which together account for around 80% of global titanium dioxide consumption. Other pigment applications, such as printing inks, rubber, cosmetic products and foods, account for a further few percent.

The remaining share is used in other applications, such as the production of technical-grade titanium, glass and glass-ceramics, electrical ceramics, metal patinas, catalysts, electrical conductors and chemical intermediates.

Titanium dioxide is a popular paint ingredient and, according to estimates, is present in a significant proportion of all commercial paints.

In cosmetics, it is used in small amounts as a thickener and opacifying agent; in larger amounts it serves as a physical UV filter in sunscreen creams, as titanium dioxide can also screen out harmful UV radiation.

 

Titanium dioxide as a food additive (E171)

Under Regulation (EC) No 1333/2008, titanium dioxide was previously authorised as a food additive (colour) under the designation E171. Its function was to intensify the colour of foods and improve the visual appearance of products.

Between 2016 and 2021, a large number of toxicological studies were published, with particular focus on food-grade TiO₂ batches that also contained nanoscale particles. In its opinion published on 6 May 2021, EFSA concluded that titanium dioxide could no longer be considered safe as a food additive, primarily because a genotoxic effect could not be excluded with sufficient certainty.

As a result, the European Commission adopted Commission Regulation (EU) 2022/63, amending Annexes II and III to Regulation (EC) No 1333/2008: titanium dioxide (E171) was removed from the Union list of authorised food additives. Under the Regulation, placing on the market new foods with added E171 has been prohibited since 7 February 2022, and after 7 August 2022 foods containing this additive could no longer remain on the market.

The ban on E171 therefore remains in force and is completely independent of the present annulment of the CLP classification of titanium dioxide for industrial uses.

 

How the CLP classification of titanium dioxide evolved – a brief overview

Commission Delegated Regulation (EU) 2020/217, adopted as the 14th ATP to the CLP Regulation (EC) No 1272/2008, was published in the Official Journal of the European Union on 18 February 2020 and has applied since 1 October 2021.

This amendment:

  • introduced a new entry for titanium dioxide in Table 3 of Part 3 of Annex VI to the CLP Regulation, classifying titanium dioxide in powder form containing at least 1% titanium dioxide with particles of aerodynamic diameter ≤ 10 μm as a Category 2 carcinogen (Carc. 2; H351 – “Suspected of causing cancer (inhalation)”);
  • also introduced two new supplemental hazard statements (EUH211 and EUH212), as well as a specific harmonised application of EUH210 for certain mixtures that are otherwise not classified as hazardous.

However, the General Court’s judgment of 23 November 2022, followed by the Court of Justice of the European Union’s judgment of 1 August 2025, and the ECHA communications published thereafter definitively ended the harmonised carcinogenic classification of titanium dioxide.

 

Current classification status:

  • Annex VI to the CLP Regulation does not contain a harmonised “Carc. 2; H351 (inhalation)” classification for titanium dioxide,
  • the harmonised obligation to apply EUH211, EUH212 and the related EUH210 has ceased,
  • however, companies remain obliged to classify their products based on their own risk assessment and may, where necessary, voluntarily apply hazard statements.

 

Actions for companies using titanium dioxide

The termination of the harmonised carcinogenic classification does not mean that inhalation of titanium dioxide dust is risk-free. The change in the regulatory environment must therefore also be addressed in practice.

 

1. Review and update Safety Data Sheets (SDS)

  • Check whether the Carc. 2; H351 (inhalation) classification for titanium dioxide in the relevant substances/mixtures appears solely because the former harmonised CLP entry was adopted.
  • If so, with the harmonised classification no longer applicable, the reference to Annex VI of the CLP Regulation must be removed and the classification must be reassessed based on current knowledge – where necessary through self-classification.
  • Accordingly, Section 2 of the SDS (classification, label elements) must be amended, along with the affected H-statements and other hazard communication elements.

Need help?

With our SDS update or SDS authoring services, we ensure that your SDS complies with the latest REACH and CLP requirements (updated titanium dioxide status, the E171 ban, PCN obligations, etc.).

 

2. Update labels

  • If the product label included the EUH211/EUH212 statements (and the related EUH210) solely because of the former harmonised titanium dioxide classification, their use is no longer mandatory.
  • For newly produced packaging, it is advisable to use a simpler label that reflects the updated classification.
  • For products in stock bearing older labels, from an internal compliance perspective it is advisable to consider whether relabelling is necessary.

Need help?

Label design

3. Amend PCN notifications and records

If the final CLP classification changes (for example, the carcinogenic hazard class is removed, or the GHS08 pictogram is removed), then:

  • the PCN notifications (Poison Centre Notification),
  • the company substance and mixture inventories,
  • and the customer information materials (technical data sheets, product information sheets) must be aligned accordingly.

Need help?

Our PCN notification services

4. Inform the supply chain

It is advisable to inform suppliers and customers in writing about the change in classification and to provide the updated Safety Data Sheets. This is particularly important in sectors where titanium dioxide is a key component (paints, coatings, plastics, inks, construction materials, etc.).

 

5. Occupational safety: the risk of dust inhalation remains real

The court judgment is the outcome of a scientific and legal dispute, and it does not state that titanium dioxide dust is harmless. To reduce exposure associated with dust inhalation, the following are still necessary:

  • appropriate engineering controls (local exhaust ventilation, closed systems, dust-free/low-dust technologies),
  • organisational measures (work-time limitation, cleaning schedules, training),
  • and appropriate personal protective equipment (PPE) (respiratory protection, protective clothing).

These measures are driven not by the former harmonised CLP classification, but by actual exposure – i.e., they are based on risk, not solely on hazard.

 

Frequently asked questions

What is the current CLP classification of titanium dioxide (after 2025)?

Currently, Annex VI to the CLP Regulation does not contain a harmonised carcinogenic classification for titanium dioxide. The “Carc. 2; H351 (inhalation)” entry for titanium dioxide in powder form containing ≥ 1% titanium dioxide and particles ≤ 10 μm was annulled by the General Court’s judgment of 23 November 2022, and this was definitively upheld by the Court of Justice of the European Union on 1 August 2025.

This means that titanium dioxide is not mandatorily classified as a harmonised carcinogen via inhalation. However, manufacturers and importers may still prepare their own self-classification based on the available scientific data if they assess that the form or use of a specific product justifies stricter hazard communication.

Do EUH211 or EUH212 warnings currently have to be shown on the label?

The supplemental hazard statements EUH211 (“Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.”) and EUH212 (“Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.”) were introduced in connection with the former harmonised classification of titanium dioxide by Regulation (EU) 2020/217 (Annex I).

Since that harmonised classification has ceased to apply as a result of the court judgments, the use of EUH211 and EUH212 (and the related EUH210) solely due to the presence of titanium dioxide is no longer mandatory.

However, based on their own risk assessment, manufacturers may decide to continue using these statements voluntarily, particularly for strongly dusting applications or aerosol uses.

Is titanium dioxide safe as a food additive (E171)?

Based on EFSA’s 2021 opinion, titanium dioxide (E171) can no longer be considered safe as a food additive, primarily due to uncertainties related to genotoxicity.

Subsequently, the European Commission adopted Regulation (EU) 2022/63 which, by amending Annexes II and III to Regulation (EC) No 1333/2008, withdrew the authorisation for E171: since 7 August 2022, products containing titanium dioxide as a food additive may no longer be placed on the EU market.

This food-law ban is completely independent of the annulment of the CLP classification of titanium dioxide; the court judgment concerns only hazardous substance classification for industrial uses and does not affect the E171 ban.

 

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