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. The key point many buyers miss: the EU E171 food additive ban does not affect TiO2 in food packaging — these are separate regulatory frameworks with separate rules.

US FDA compliance: 21 CFR 178.3297

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, China, Japan and other jurisdiction approvals

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 and SEMITI documentation

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

Declaration of Compliance (DoC) requirements and content

Under EU Regulation 10/2011 Article 15, businesses placing plastic food contact materials on the EU market must issue a written Declaration of Compliance (DoC) at each stage of the supply chain. For TiO2 suppliers, the DoC must state:

• Identity of the substance (TiO2, CAS 13463-67-7, EC 236-675-5)
• Reference to the Union List entry (Regulation 10/2011 Annex I, substance number 793)
• Confirmation that the substance meets the purity criteria of the relevant food additive specification (where applicable)
• Confirmation that the substance is used in compliance with the restrictions and specifications in Regulation 10/2011
• Adequate information relating to the substance to enable downstream operators to comply

SEMITI provides DoC documents for EU Regulation 10/2011 on request, covering all SEMITI grades used in food contact plastic applications. The DoC is issued per grade (not per batch) and remains valid unless the substance's regulatory status changes.

Practical guidance: grade selection by food contact substrate

Selecting the right SEMITI grade for food contact applications depends on the polymer type, processing temperature, and end-use contact conditions.

Polyolefin packaging (PP, HDPE, LDPE): SEMITI 996 or SEMITI 2310 are the standard choices. Both are chloride-process rutile with low heavy metals (Pb < 5 ppm, Cd < 1 ppm) and thermally stable at polyolefin processing temperatures (180–230°C). Both carry food contact DoC for FDA and EU 10/2011. Loading typically 1–5% in the packaging polymer.

PET bottles and films: SEMITI 996 is compatible with PET processing at 260–280°C. Surface treatment must be thermally stable — SEMITI 996's alumina + silica treatment passes the 280°C stability requirement. PET food contact applications (beverage bottles, food trays) require low-heavy-metal CoA verification per batch.

Rigid PVC for food containers: SEMITI 2310 (plastics-grade chloride rutile) is preferred. PVC food contact applications require verification that no SVHC-listed stabilizers are present in the full compound — the TiO2 itself is not the limiting factor. Soft PVC cling film for food wrapping uses TiO2 at very low levels (< 1%) primarily for opacity.

Paper and board food contact: SEMITI A100 or A101 (anatase grades) are preferred for paper coating and board applications. Anatase's cooler white undertone (b* 1.0–1.6) is preferred for bright white food cartons and bakery paper. SEMITI A101 is specifically formulated with ultra-low heavy metals for applications where the paper contacts acidic foods (fruit juice cartons, citrus packaging) where trace metal migration is a concern.

High-temperature food contact (oven trays, microwave packaging): Applications above 200°C require verification that TiO2 surface treatment is thermally stable at the service temperature. SEMITI 826D (with ZrO2 surface treatment) is acceptable for high-temperature food contact packaging where standard grades may show surface treatment decomposition above 220°C.

Australia, Canada, and emerging market compliance

Beyond FDA and EU, several additional markets require specific documentation:

Australia FSANZ Standard 1.3.3: TiO2 is listed as a permitted food contact substance under Australia-New Zealand food standards. No migration limit. DoC referencing FSANZ 1.3.3 available on request.

Canada Health Canada: TiO2 listed in the Permitted Colourants table (B.16.100) as permitted in food contact materials. US FDA DoC is generally accepted by Canadian authorities as equivalent; separate Canadian DoC available on request.

Brazil ANVISA: Resolução RDC 21/2008 covers plastic food contact materials. TiO2 is listed as permitted pigment. Brazilian-Portuguese language DoC available for shipments to Brazil.

India FSSAI: Food Safety and Standards Authority of India permits TiO2 in food contact materials under FSS (Packaging and Labelling) Regulations 2011. Technical file available on request.