Quality Certifications & Compliance

Modern TiO2 trade requires multiple layers of certification and regulatory compliance. SEMITI maintains the documentation portfolio needed for global export trade.

Quality management system:

Our supplier network operates under ISO 9001 quality management systems. Specific grades may have additional certifications: - ISO 14001 environmental management - ISO 45001 occupational health and safety - IATF 16949 (for automotive supply chain) - ISO 22000 / FSSC 22000 (for food-grade materials)

We provide supplier certification documentation on inquiry.

Regulatory registrations:

REACH (EU): - TiO2 registered as existing substance, EC 236-675-5, CAS 13463-67-7 - Supplier-side registration via Only Representative (OR) arrangement - REACH compliance letter provided with EU shipments - REACH-CRO documentation for occupational exposure scenarios

TSCA (US): - TiO2 listed in TSCA inventory; new use rule compliance verified - Supplier-side documentation for US imports

K-REACH (Korea): - TiO2 registered under Korean Chemical Substances Control Act - Documentation provided for Korean customers

China: - IECSC (Inventory of Existing Chemical Substances in China) listed - Domestic regulatory compliance under Chinese chemical management framework

Australia AICIS / NICNAS: - TiO2 listed; supplier-side compliance

Food contact compliance:

• FDA 21 CFR 178.3297: colorant for polymer FCM — all SEMITI grades meet
• EU Regulation 10/2011: plastic FCM — TiO2 listed in Union List, no SML
• China GB 9685-2016: FCM additive standard — compliance verified
• Migration testing: reports available for specific grades on request

Cosmetic regulations:

• EU Cosmetic Regulation 1223/2009: SEMITI NANO-30 compliant with Annex VI nano TiO2 sunscreen approval
• FDA OTC Sunscreen Monograph: SEMITI NANO-30 meets Category I active ingredient standards
• Australia TGA: nano TiO2 sunscreen approved
• ASEAN, K-NMPA, China NMPA: cosmetic ingredient documentation provided

Pharmaceutical excipient:

• ICH Q3D: elemental impurity limits met by chloride grades
• USP / EP / JP: pharmacopeial limits met by validated grades
• GMP supply chain: documentation supporting pharma packaging qualifications

Automotive industry:

• IMDS: material data submitted for automotive Tier-1 qualification
• GADSL: no prohibited substances in SEMITI grades
• REACH SVHC: no SVHC substances in TiO2 grades

Heavy metal certification:

Batch-by-batch certificates for: - Lead (Pb) — typically < 5 ppm for chloride, < 10 ppm for sulfate - Cadmium (Cd) — typically < 1 ppm - Arsenic (As) — typically < 2 ppm - Mercury (Hg) — typically < 1 ppm - Plus Sb, Ba on request

Customer-specific documentation:

We support customer requests for: - Specific substance declarations (Walmart, Apple, P&G chemical declarations) - Brand-specific ESG questionnaires - IMDS submissions for automotive - USP / EP excipient documentation for pharma - SEDEX, EcoVadis platform responses

Standard turnaround: 3–5 business days for documentation requests. Complex custom documentation may take 1–2 weeks.