Regulatory Compliance Across Jurisdictions
SEMITI maintains regulatory compliance documentation across major export jurisdictions.
Modern TiO2 trade spans multiple regulatory regimes. SEMITI maintains the documentation portfolio needed for export to major jurisdictions globally.
EU regulatory framework:
REACH (Regulation 1907/2006): - TiO2 registered as existing substance - Supplier-side registration via Only Representative - REACH compliance letter provided - Annex VI CLP classification (Carc. 2 for respirable powder forms) - REACH-CRO occupational exposure data available
Cosmetic Regulation 1223/2009: - Annex VI listing for nano TiO2 sunscreen use - INCI labeling support including [nano] designation - Safety dossier available for SEMITI NANO-30
Plastic FCM Regulation 10/2011: - TiO2 listed in Union List, no SML - Migration testing data on request
Food Additive (E171): - EU ban effective 2022 — SEMITI grades cannot be sold for E171 food additive use in EU - Industrial / non-food applications unaffected
UK (post-Brexit): - UK REACH compliance separately maintained - UK CLP (mirrors EU CLP largely) - UK cosmetic regulation aligned with EU
US regulatory framework:
TSCA: - TiO2 listed on TSCA inventory - No specific reporting requirements for routine import - SEMITI grades comply with TSCA new use rules
FDA: - 21 CFR 178.3297 colorant for polymer FCM - 21 CFR 73.575 cosmetic / OTC use - Sunscreen Monograph (SEMITI NANO-30 as Category I active) - 21 CFR 73 food color additive — TiO2 approved for food coloring use
California Prop 65: - TiO2 not specifically listed for cancer warning (despite EU classification) - Documentation supporting California sales available
Asia regulatory framework:
China: - IECSC listed substance - GB 9685-2016 food contact compliance - China NMPA cosmetic ingredient regulation - GB 1706 / GB 28304 industrial pigment standards
Korea (K-REACH): - TiO2 registered under Chemical Substances Control Act - K-Cosmetic regulation alignment
Japan: - METI/ISHL chemical substances listed - Cosmetic / pharmaceutical regulatory alignment with ICH
ASEAN: - Generally follows EU or US frameworks - Country-specific documentation as needed (Singapore, Thailand, Vietnam, Malaysia, Indonesia, Philippines)
India: - BIS not currently mandating TiO2 certification - FSSAI compliance for food contact - DGCI for pharma applications
Middle East: - GCC (Saudi, UAE, Qatar, Kuwait, Oman, Bahrain) common framework - SASO certification for Saudi - Israel SII certification
Africa: - Limited harmonization; country-by-country approach - SABS South Africa, KEBS Kenya, SON Nigeria — major standards bodies
Latin America: - Mercosur common framework - ANVISA Brazil for cosmetic/pharma - COFEPRIS Mexico for cosmetic/pharma
Documentation provided:
For each shipment, we include all applicable regulatory documentation. For customer-specific requests, our regulatory team prepares custom documentation typically within 3–10 business days.
Where we cannot fully comply:
Some jurisdictions have evolving or unclear regulatory frameworks. We provide what documentation exists and work with customers to identify gaps. Customers serving heavily-regulated markets (EU automotive, EU pharma, US food) may need to perform additional verification beyond our supplier-side compliance.