REACH Registration for Titanium Dioxide
Titanium dioxide is REACH-registered as an existing substance. All EU imports require registration coverage — typically provided by the supplier.
The EU's REACH Regulation (1907/2006) is the most comprehensive chemical regulation framework globally. Any chemical substance imported to the EU above 1 tonne per year must be REACH-registered. For TiO2 specifically, this is well-established — TiO2 has been registered since the REACH transition period, and the main practical question for buyers is how to obtain registration coverage without registering themselves.
Current REACH status and registration basics
Current REACH status: - TiO2 is registered as an existing substance under REACH - EC Number: 236-675-5 - CAS Number: 13463-67-7 - Registration covers all crystal forms (rutile, anatase, brookite) and all surface treatments - Multiple registrants from EU and non-EU producers
For importers to EU: You can be the importer of record if you import > 1 t/year directly. In that case, you need either: - Own REACH registration (expensive, multi-year process) - Coverage under a supplier's REACH registration (typical for most buyers) - Coverage under a consortium / lead registrant registration
Most TiO2 buyers in the EU rely on supplier-provided REACH coverage. SEMITI grades are covered under registrations from the underlying tier-1 Chinese producers (LB Group, CNNC, etc.) with formal Only Representative (OR) appointments in the EU.
REACH tonnage bands and downstream user obligations
REACH registration is tiered by annual import volume. TiO2 is registered at the highest tonnage band (≥ 1,000 t/year per registrant), which requires the most comprehensive data package: full ecotoxicological dossier, human health assessment, chemical safety report (CSR), and exposure scenarios (ES). This high-tonnage registration ensures the most rigorous safety assessment is on file at ECHA for all industrial and consumer uses.
Downstream user (DU) obligations: EU buyers who receive TiO2 from a supplier with OR coverage are classified as downstream users. Their obligations under REACH Article 37 are limited compared to registrants: - Review supplier SDS to confirm their specific use is covered by an identified use or exposure scenario - If their use is not listed, notify the supplier so the use can be added, or self-classify as a "use advised against" at their own risk - Apply the operational conditions (OCs) and risk management measures (RMMs) in the exposure scenario to their operations
For most TiO2 industrial uses (paint formulation, plastics compounding, ink manufacturing), the exposure scenarios in the REACH registration already cover the use. Buyers only need to confirm their process conditions match the ES.
REACH SVHC process: why TiO2 has not been listed
To be placed on the SVHC Candidate List, a substance must meet one of the criteria in REACH Article 57: carcinogenic (Cat 1A or 1B), mutagenic (Cat 1A or 1B), toxic for reproduction (Cat 1A or 1B), PBT (persistent, bioaccumulative, toxic), vPvB, or of equivalent concern. TiO2's Carc. 2 classification (Category 2, suspected carcinogen) does not meet the SVHC threshold, which requires Category 1A or 1B. This distinction is why TiO2 received the Carc. 2 hazard communication label without being elevated to SVHC status.
ECHA regularly screens substances for SVHC potential. As of 2025, there is no active SVHC proposal for TiO2 and no indication that one is forthcoming based on current scientific review.
The Only Representative system and EU buyer coverage
The Only Representative (OR) system: Non-EU manufacturers can appoint an EU-based legal entity as their Only Representative. The OR: - Holds the REACH registration on behalf of the non-EU manufacturer - Communicates with EU regulators - Provides registration coverage to EU customers
LB Group, CNNC Huayuan, and other major Chinese TiO2 producers have established OR arrangements. SEMITI customers benefit from this coverage automatically.
Documentation provided to EU buyers: - REACH letter confirming registration status and OR identity - Safety Data Sheet (SDS) per REACH Article 31 requirements - Substance identity profile - Exposure scenarios where applicable - CLP classification per Annex VI (Carc. 2; see related knowledge entry)
Use restrictions, SVHC status, and non-EU equivalents
Use-restriction considerations: REACH includes mechanisms (REACH Annex XIV authorization, Annex XVII restriction) that can restrict specific uses of substances. For TiO2: - No Annex XIV authorization requirement currently - No Annex XVII restriction for industrial TiO2 use - The 2022 CLP carcinogen classification is informational, not a use restriction - The 2022 EU ban on TiO2 as food additive E171 is under EU Food Regulation, not REACH
REACH-CRO (Risk Characterisation Outcomes): TDMA has published REACH-CRO documentation covering workplace exposure scenarios for TiO2 manufacturing, formulation, and end-use. These are accepted by ECHA for substance evaluation. SEMITI provides REACH-CRO references on inquiry.
SVHC list: TiO2 is NOT on the SVHC (Substances of Very High Concern) list. Inclusion would trigger additional notification obligations. The 2022 Carc. 2 classification did not result in SVHC listing.
Substance evaluation and dossier updates
REACH requires periodical substance evaluations by ECHA to identify potential concerns that may have emerged since initial registration. For TiO2, substance evaluations have focused on:
- Persistence and bioaccumulation (TiO2 is neither PBT nor vPvB — it is insoluble and does not bioaccumulate in organisms)
- Endocrine disruption potential (animal studies show no endocrine disruption at environmentally relevant doses)
- Carcinogenicity route assessment (the Carc. 2 inhalation classification, covered separately in the EU 2022 CLP entry)
Registrants are required to update dossiers at least every 10 years, with more frequent updates if new hazard data emerges. SEMITI TiO2 registrations are maintained current with ECHA, and we provide updated CSR and exposure scenarios on request.
For non-EU buyers (e.g., importing into UK, China, ASEAN):
UK REACH (post-Brexit): - Separate regulation, similar requirements to EU REACH - TiO2 grandfathered registration from EU REACH into UK system (March 2021 transition) - Non-UK suppliers may need to appoint UK OR if exporting directly to UK
China REACH (effective 2010): - Different requirements; typically less stringent for industrial chemicals - TiO2 registration handled domestically by Chinese producers; exemptions available for certain applications - Pre-export declarations to China Customs required for chemical imports
Korea K-REACH: - Korean equivalent; TiO2 registered domestically - Similar structure to EU REACH but with Korea-specific criteria - We provide documentation for Korean buyers on request
ASEAN countries (Thailand, Vietnam, Indonesia): - Varying regulatory frameworks; some have no equivalent to REACH - Import permits or notification may be required - We advise case-by-case on destination-specific requirements
Documentation request: For EU imports, request our standard REACH compliance package: - REACH letter confirming registration and OR identity - SDS (in destination country language if required) - Substance identity profile - Exposure scenarios for your use case - OR identification and contact information
Typical delivery 3–5 business days after request. For non-EU destinations, specify target country and we will provide destination-appropriate documentation.