FDA Food Contact Compliance for TiO2

Food contact materials (FCM) — packaging plastic, paper coating, can lining — are regulated separately from food additives. TiO2 has broad approval as a colorant in plastic FCM globally.

US FDA — 21 CFR 178.3297: "Colorants for polymers" — establishes positive list of colorants permitted in polymer food contact materials. TiO2 is explicitly listed; permitted in all food contact polymer applications.

Requirements: - TiO2 used must be of commercial grade meeting standard pigment specifications - Heavy metal limits: Pb < 100 ppm, As < 25 ppm, Cd < 100 ppm (most commercial TiO2 well below) - Use must be at functional minimum levels (typical for FCM regulation) - No premarket approval required if used per the regulation

SEMITI compliance: all SEMITI grades meet FDA 21 CFR 178.3297 standards. Documentation provided on request.

EU Regulation 10/2011 (Plastic FCM): TiO2 is listed in the Union List with no Specific Migration Limit (SML). This means: - TiO2 is permitted in any plastic FCM - No quantitative migration limit - General safety obligation under Regulation 1935/2004 applies (substance should not transfer to food in amounts that endanger health)

This is the most favorable regulatory position possible — no SML means essentially unrestricted use in plastic FCM.

China GB 9685-2016: National standard for FCM additives. TiO2 (CAS 13463-67-7) is permitted in plastic food contact at up to 25% by weight in the polymer (no SML). Most commercial uses (1–5% TiO2) are well within this.

Japan Food Sanitation Act / JHOSPA: TiO2 approved for food contact use. JHOSPA self-imposed industry standards comply with global norms.

Korea, ASEAN, India: Generally aligned with FDA / EU positions. National regulations may have specific requirements; documentation provided on request.

Migration testing — when required: Most TiO2 food contact applications do not require explicit migration testing because: - TiO2 is highly insoluble in water and food simulants - TiO2 particles are well-embedded in the polymer matrix - The substance has no SML in EU

Migration testing is sometimes required for: - New product launches in major regulated markets (voluntary supplier validation) - High-loading applications (>10% TiO2 in food contact polymer) - Specific contact with aggressive foods (high fat, high acid) - Pharmaceutical packaging requiring additional compliance

Standard migration test protocol (EN 1186 series): - Sample preparation: representative plastic film/article - Food simulants: water, 3% acetic acid, 10% ethanol, 95% ethanol, olive oil - Test conditions: temperature and time per intended use - Analysis: ICP-OES or ICP-MS for total titanium leaching - Reporting: titanium concentration in food simulant (typically below detection limit)

Typical results for SEMITI TiO2 in food contact polymer: - Water simulant, 10 days at 40°C: < 0.01 mg/kg titanium (below detection) - 3% acetic acid, 10 days at 40°C: < 0.01 mg/kg titanium - Olive oil, 10 days at 40°C: < 0.01 mg/kg titanium

Documentation we provide: - DoC (Declaration of Compliance) for FDA 21 CFR 178.3297 - DoC for EU 10/2011 with substance listing reference - Heavy metal analysis certificate (Pb, As, Cd, Hg, Ba, Sb) - Migration test reports (if available for specific grade and application) - DoC for China GB 9685-2016 (Chinese-language available)

Food contact applications and grade selection: - Plastic food packaging (PP/PE bottles, containers): SEMITI 996, 2310, 960 all compliant - Food contact paper / cartons: SEMITI A100 (anatase, low heavy metals) preferred - PVC food packaging (cling film, bottles): limited use; SEMITI 2310 acceptable - Beverage can lining: SEMITI 826D durable rutile in epoxy or polyester linings - Pharmaceutical bottle: SEMITI 996 or 960 (food contact compliant)

Pitfalls: 1. Confusing E171 food additive ban (EU 2022) with FCM regulation — they're different; FCM is unaffected 2. Assuming all TiO2 grades meet food contact heavy metal limits — verify with batch CoA 3. Skipping migration testing for new applications — when in doubt, test