CAS 13463-67-7 · REACH · European Union

Titanium dioxide under REACH

TiO2 · 二氧化钛

Status: Registered. Titanium dioxide is fully registered under REACH at the highest tonnage band (>1,000,000 tonnes/year). The substance has the most contested CLP classification history of any high-volume industrial chemical: Commission Delegated Regulation (EU) 2020/217 added TiO2 to the harmonised CLP list as Carcinogen Category 2 by inhalation (powder containing >=1 percent particles of diameter <=10 micrometers) effective 1 October 2021; the General Court of the EU ANNULLED this classification on 23 November 2022 in Joined Cases T-279/20, T-283/20 and T-288/20 (verified against https://curia.europa.eu/); appeals to the Court of Justice were dismissed (verify final ECJ judgment date against the Curia case database before relying on the prior dataset assertion of February 2024).

TiO2 is the most regulatorily-contested high-volume industrial chemical of the 2020s; the EU Carc Cat 2 classification controversy (Reg 2020/217 effective 1 October 2021, annulled by General Court 23 November 2022 in Joined Cases T-279/20 / T-283/20 / T-288/20, ECJ appeal dismissed) and the parallel E171 food-additive ban (Reg (EU) 2022/63 effective 7 February 2022 with phase-out to 7 August 2022) demonstrate how a single substance can carry multiple overlapping regulatory frameworks. The active EU anti-dumping case (Reg (EU) 2024/1923 provisional July 2024, Reg (EU) 2025/4 definitive from 9 January 2025, EUR-Lex https://eur-lex.europa.eu/eli/reg_impl/2025/4/oj/eng) imposes specific duties EUR 0.25 to 0.74 per kg per producer on Chinese-origin TiO2, materially affecting the EU lane economics. China dominates global TiO2 production (~50% capacity per ICIS / S&P 2024 estimates) led by Lomon Billions, CNNC HuaYuan Titanium White, Henan Bailong Aluminum, and Pangang Vanadium-Titanium; producer-specific AD margin tracking is the operator-relevant intelligence layer.

Listing and threshold

Substance Titanium dioxide (CAS 13463-67-7), TiO2
Regime EU Regulation (EC) No 1907/2006: Registration, Evaluation, Authorisation and Restriction of Chemicals
Jurisdiction European Union (EU-27 plus EEA: Iceland, Liechtenstein, Norway)
Status Registered
Tonnage threshold Registration required for any importer or manufacturer placing >1 t/year on the EU market

Classifications under this regime

  • NOT currently classified as Carc Cat 2 under harmonised CLP (the Reg 2020/217 classification was annulled by the General Court on 23 November 2022; Commission did not appeal)
  • Many SDS still carry the legacy Carc Cat 2 inhalation classification from 2021-2022 SDS updates; SDS should be updated to reflect annulment
  • Self-classified by some registrants as Eye Irrit. 2 (H319), particularly for fine-particle / nano grades
  • IARC Group 2B (possibly carcinogenic to humans, IARC Monograph 93, 2010) classification stands and is independently relevant for occupational health
  • GHS pictograms: NONE required under post-annulment harmonised CLP; some grades self-classify with GHS07
  • Signal word: NONE required under post-annulment harmonised CLP

Restrictions and conditions of use

  • NOT on REACH Annex XIV (Authorisation list)
  • EU Regulation (EU) 2022/63 of 14 January 2022 withdraws authorisation of TiO2 (E171) as a food additive: 6-month phase-out from 7 February 2022 to 7 August 2022, after which a full ban applies (food made before 7 February 2022 may remain on market until use-by date). Medicinal-product use of TiO2 as a colour remains authorised on a transitional basis. Verified against https://eur-lex.europa.eu/eli/reg/2022/63/oj/eng
  • EU Annex XVII Restriction 75 (CMR substances in tattoo inks and permanent make-up, introduced by Reg (EU) 2020/2081, effective 4 January 2022): TiO2 in tattoo / PMU inks subject to concentration limits per Appendix 13 of Annex XVII; verified against https://eur-lex.europa.eu/eli/reg/2020/2081
  • NOT classified as SVHC currently
  • NOT scheduled under EU Drug Precursors Regulation
  • Cosmetic Products Regulation (EC) No 1223/2009 Annex IV: TiO2 approved as colorant CI 77891 for cosmetic use (Annex IV List of allowed colorants); nano-TiO2 approved as UV filter under specific conditions per Annex VI entry 27

Importer obligations

A non-EU producer cannot register directly under REACH. The EU importer of record must hold a registration or rely on an Only Representative (OR). The post-annulment regulatory landscape for TiO2 is unusually complex: the harmonised Carc Cat 2 classification has been ANNULLED but many SDS, labelling, and downstream-product compositions were updated 2021-2022 to reflect it, and updates back to non-classified status take time. Food-grade E171 is BANNED in food (Reg 2022/63); cosmetic-grade CI 77891 is permitted under Annex IV; tattoo-ink-grade subject to Annex XVII Restriction 75. Industrial pigment, paint, plastics, paper, and ceramic applications carry no specific restriction.

Required documents

  • REACH registration number on the EU side (registrant or OR-appointed)
  • Safety Data Sheet (SDS) compliant with REACH Annex II in destination Member State language(s); SDS should reflect post-annulment status, not legacy Reg 2020/217
  • Cosmetic-grade compliance per Cosmetic Products Regulation (EC) No 1223/2009 (where cosmetic-grade)
  • Tattoo-ink-grade compliance per Annex XVII Restriction 75 (where tattoo-ink-grade)
  • NO food-grade applications (E171 banned)
  • Customs entry with HS code 32061100 (TiO2 anatase or rutile, ≥80% TiO2)

Common compliance traps

The pitfalls that have bitten importers on this lane in the past. None of these is theoretical.

  • The Carc Cat 2 inhalation classification was ANNULLED but legacy SDS still in circulation; verify the destination customer accepts post-annulment SDS, some downstream-compliance audit-systems lag the regulatory annulment
  • E171 food-additive ban is firm; do not market food-grade TiO2 in the EU
  • EU active anti-dumping case on Chinese-origin TiO2: Reg (EU) 2024/1923 provisional anti-dumping duties (July 2024) and Reg (EU) 2025/4 of 17 December 2024 imposing definitive anti-dumping duties (effective from 9 January 2025; specific duties EUR 0.25 to 0.74 per kg, NOT ad valorem percentages as some prior dataset drafts cited; verified against https://eur-lex.europa.eu/eli/reg_impl/2025/4/oj/eng) imposing duties on Chinese-origin TiO2; verify producer-specific duty rate before invoicing
  • Cosmetic-grade nano-TiO2 (Annex VI entry 27) has specific particle-size and coating requirements; verify before invoicing
  • EU CBAM does NOT include TiO2 in 2026 Phase 1 scope
  • IARC Group 2B classification stands independently of EU CLP and informs occupational-health rules in many EU Member States

Where to read next

For substance-level identifiers (formula, molecular weight, SMILES, InChIKey), GHS hazard profile, IMDG transport class, and full sourcing reference for titanium dioxide, see the CAS 13463-67-7 sourcing reference.

For grade-by-grade buying notes, freight maths, supplier-tier pricing, and a worked landed-cost example, the titanium dioxide cornerstone hub covers the full sourcing chain.

For the structure and history of REACH, see the REACH glossary entry.

Need cross-jurisdiction compliance support on this substance? Run it through the REACH / TSCA / IECSC / AICIS / K-REACH checker, or send us the substance and the destination and we will quote FOB China and CIF / DDP landed including the regulatory work on the destination side.

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Cross-jurisdiction profile and sourcing references

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