What is the current harmonised classification and labelling of titanium dioxide (CAS 13463-67-7) under CLP Annex VI, and what changed after the EU General Court and Court of Justice rulings? Give the entry, hazard classes and dates, with citations.
There is no harmonised CLP classification for titanium dioxide (CAS 13463-67-7) in force today. The Annex VI entry 022-006-00-2 (Carc. 2, H351 (inhalation)) was annulled by the General Court on 23 November 2022. The Court of Justice upheld that annulment on 1 August 2025, and the annulment took effect from that date. One thing doesn't line up: the EUR-Lex consolidated CLP text dated 1 July 2026 still prints the entry and the related notes.
Approach: I checked ECHA's Annex VI list, the CLP Regulation and its amending acts (including the 1 July 2026 consolidated version), and ECHA's CLH process registry. For the court rulings and their aftermath I used official CURIA, EUR-Lex and ECHA pages, some of which I could only read as search snippets.
The entry as adopted (Delegated Regulation (EU) 2020/217, the 14th ATP)
| Field | Value |
|---|---|
| Index No | 022-006-00-2 |
| Chemical name | titanium dioxide; [in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm] |
| EC / CAS | 236-675-5 / 13463-67-7 |
| Classification | Carc. 2, H351 (inhalation) |
| Labelling | GHS08, Wng; H351 (inhalation) |
| Notes | V, W, 10 |
- Note W: the carcinogenic hazard arises when respirable dust is inhaled in quantities that significantly impair particle clearance in the lung. The note is descriptive and is not a classification criterion.
- Note 10: the carcinogen-by-inhalation classification applies only to mixtures in powder form containing ≥ 1 % titanium dioxide as, or within, particles ≤ 10 μm. [1]
- Mixture labelling (new Annex II section 2.12):
- EUH211 for liquid mixtures with ≥ 1 % titanium dioxide particles ≤ 10 μm.
- EUH212 for solid mixtures with ≥ 1 % titanium dioxide.
- EUH210 for non-classified professional mixtures carrying EUH211 or EUH212. [2]
- Basis: the RAC opinion of 14 September 2017, which proposed Carc. 2 by inhalation and linked the effect to retention of poorly soluble respirable particles. [3]
- CLH process history: France submitted the dossier proposing Carc. 1B, H350i.
- Intention: 17 March 2015
- Final submission: 27 May 2016
- RAC opinion: 14 September 2017
- Case status: closed [4]
- Dates: the Regulation applied from 9 September 2021, with voluntary early application allowed before then. [5]
- Corrections: Regulation (EU) 2021/797 corrected language versions of section 2.12 and Note 10. [6][7]
What changed after the rulings
-
General Court, 23 November 2022 (Joined Cases T-279/20, T-283/20, T-288/20, CWS Powder Coatings and Others v Commission). The Court annulled Regulation 2020/217 insofar as it concerns the harmonised classification and labelling of titanium dioxide, on two grounds:
- RAC did not take account of a possible difference in particle density in the Heinrich study.
- Particle form and size are not intrinsic properties of the substance.
-
Court of Justice, 1 August 2025 (Joined Cases C-71/23 P and C-82/23 P). The Court dismissed the appeals by France and the Commission. It found that the General Court had exceeded the limits of its judicial review, but held that the annulment was still justified.
-
Commission notice (CELEX 52025XC06670). According to a search snippet, the notice states:
- titanium dioxide in the powder form described is no longer subject to harmonised classification as Carc. 2 via inhalation;
- the row for index 022-006-00-2 is annulled;
- Annexes I and II of Regulation 2020/217, and Notes W and 10 in its Annex III, are considered annulled.
Annex I is the act that inserted the EUH211/EUH212 mixture labelling, so that labelling falls with it. I couldn't read the full notice, so treat this list of annulled parts as snippet-level.
-
ECHA's follow-up. Search snippets of ECHA pages say that from 1 August 2025:
- ECHA withdrew its titanium dioxide classification and labelling guide;
- the harmonised classification was removed from the C&L Inventory;
- the CLH registry was updated.
This matches my own check: ECHA's Annex VI list has no record for CAS 13463-67-7 or index 022-006-00-2.
The consolidated text still shows the entry
The EUR-Lex consolidated CLP version 02008R1272-20260701 still lists 022-006-00-2 as Carc. 2, H351 (inhalation), GHS08, Wng, Notes V, W, 10 [8]. It also still contains Note 10 [9] and section 2.12 with EUH211/EUH212 [10].
I found no Commission act formally deleting these provisions. The annulment comes from the judgments themselves, as the Commission notice reflects. So the consolidated text currently overstates what is in force. Self-classification of titanium dioxide under CLP Article 4 still applies, as it does to any substance without a harmonised entry.
Sources:
SOURCES · 10
- [1]Annex III: Annex VI to Regulation (EC) No 1272/2008 is amended as follows: [CLP 32020R0217] · p.1CLP
- [2]Annex I: Part 2 of Annex II to Regulation (EC) No 1272/2008 is amended as follows: [CLP 32020R0217] · p.1CLP
- [3]Recital 5 [CLP 32020R0217] · p.1CLP
- [4]Titanium dioxide · p.2CLH
- [5]Article 3: Entry into force and application [CLP 32020R0217] · p.1CLP
- [6]Recital 1 [CLP 32021R0797] · p.1CLP
- [7]Recital 3 [CLP 32021R0797] · p.1CLP
- [8]titanium dioxide;; [in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm] (Annex VI Index 022-006-00-2, Table 3) [CLP 02008R1272-20260701] · p.1CLP
- [9]Annex VI: Harmonised classification and labelling for certain hazardous substances [CLP 02008R1272-20260701] · p.6CLP
- [10]Annex II: SPECIAL RULES FOR LABELLING AND PACKAGING OF CERTAIN SUBSTANCES AND MIXTURES [CLP 02008R1272-20260701] · p.3CLP