A grade-by-grade breakdown of SEMISIL regulatory certifications covering ISO 9001, REACH, TSCA, FDA 21 CFR, and pharmacopoeia monographs.
ISO 9001 Quality managementREACH EU registered21 CFR FDA food contactUSP/NF/EP Pharma grades
All SEMISIL hydrophilic and hydrophobic fumed silica grades are manufactured under an ISO 9001:2015-certified quality management system. This certification covers the full production chain — from silicon tetrachloride feedstock handling through flame hydrolysis at 1000–1800 °C to final classification, surface treatment, and packaging. Batch-level certificates of analysis (CoA) report SiO₂ purity (≥99.8% for hydrophilic grades), BET surface area (ranging 150–380 m²/g depending on grade), tamped density, pH, and loss on ignition. Every shipment includes traceable lot documentation. ISO certification ensures consistent particle size distribution and surface chemistry batch to batch — critical when formulators qualify a thixotropic agent into a validated coating or sealant system.
SEMISIL fumed silica is registered under EU REACH (EC No. 231-545-4, CAS 112945-52-5 for synthetic amorphous silica) with full tonnage-band dossiers filed. The registration covers both hydrophilic (untreated) and hydrophobic (surface-modified with dimethyldichlorosilane or hexamethyldisilazane) variants. In the United States, all grades appear on the TSCA Inventory under CAS 112945-52-5 and 68611-44-9 (treated grades). China IECSC and Korea KECI listings are also maintained for Asia-Pacific distribution. REACH registration dossiers confirm no classification under CLP for carcinogenicity — synthetic amorphous silica is distinct from crystalline silica, with free quartz content held below 0.1% by weight across all SEMISIL grades.
Select SEMISIL hydrophilic grades comply with FDA 21 CFR §172.480 (direct food additive — silicon dioxide) and §178.3297 (indirect food contact as anti-caking agent). These grades maintain SiO₂ content ≥99.0%, heavy metals below 50 ppm (as Pb), and arsenic below 3 ppm per FDA specifications. For anti-caking applications in powdered foods, SEMISIL food-grade silica is used at 0.5–2.0% by weight, providing flowability without affecting taste or color. Formulators sourcing fumed silica for food and feed anti-caking applications should request the FDA compliance letter alongside the standard CoA. EU compliance under Regulation (EC) No 1333/2008 (E 551) is also documented.
SEMISIL pharmaceutical-grade fumed silica meets the monograph requirements of USP/NF (Colloidal Silicon Dioxide) and European Pharmacopoeia (EP, Silica Colloidalis Anhydrica). These monographs specify SiO₂ ≥99.0% (ignited basis), loss on drying ≤2.5%, loss on ignition ≤5.0%, and heavy metals ≤0.003%. BET surface areas of 200 ± 25 m²/g are standard for pharma-grade lots. In pharmaceutical formulations, these grades serve as glidants (0.1–1.0% w/w in tablet blends), viscosity modifiers in semi-solid dosage forms, and adsorbents for liquid-to-powder conversion. Each pharma lot ships with full monograph compliance documentation, including microbial limits and endotoxin data where required.
The table below maps each SEMISIL grade family to its regulatory coverage. Formulators should cross-reference this…
The table below maps each SEMISIL grade family to its regulatory coverage. Formulators should cross-reference this matrix with the regulatory overview for fumed silica to understand which certifications are mandatory for their target market and end-use sector.
| Grade Family | BET (m²/g) | ISO 9001 | REACH | TSCA | FDA 21 CFR | USP/NF/EP |
|---|---|---|---|---|---|---|
| SEMISIL 150 (Hydrophilic) | 150 ± 15 | ✓ | ✓ | ✓ | ✓ | — |
| SEMISIL 200 (Hydrophilic) | 200 ± 25 | ✓ | ✓ | ✓ | ✓ | ✓ |
| SEMISIL 300 (Hydrophilic) | 300 ± 30 | ✓ | ✓ | ✓ | — | — |
| SEMISIL 380 (Hydrophilic) | 380 ± 30 | ✓ | ✓ | ✓ | — | — |
| SEMISIL H-Series (Hydrophobic) | 140–260 | ✓ | ✓ | ✓ | — | — |
| SEMISIL H100 (Fumed Matting) | 100 ± 15 | ✓ | ✓ | ✓ | — | — |
For regulated applications in food contact or pharmaceuticals, specify SEMISIL 200 — it is the only grade family carrying simultaneous FDA 21 CFR, USP/NF, and EP compliance alongside standard REACH and TSCA registrations.
Yes, all SEMISIL grades are registered under EU REACH with CAS 112945-52-5 (synthetic amorphous silica). Full tonnage-band dossiers are filed covering both hydrophilic and hydrophobic variants. Free crystalline silica content is held below 0.1%, so no CLP carcinogenicity classification applies.
SEMISIL 150 and S-200 hydrophilic grades comply with FDA 21 CFR §172.480 and §178.3297 for use as direct and indirect food additives. These grades maintain SiO₂ ≥99.0% and heavy metals below 50 ppm. Request the FDA compliance letter with your order.
SEMISIL 200 meets USP/NF Colloidal Silicon Dioxide and EP Silica Colloidalis Anhydrica monographs. Key specs include SiO₂ ≥99.0% (ignited basis), loss on drying ≤2.5%, and BET surface area of 200 ± 25 m²/g. Pharma lots include microbial limits documentation.
All SEMISIL grades are manufactured under ISO 9001:2015 certification covering feedstock handling through flame hydrolysis, classification, surface treatment, and packaging. Each shipment includes a certificate of analysis with lot-traceable BET, purity, pH, and density data.
Yes, all SEMISIL fumed silica grades are listed on the TSCA Inventory under CAS 112945-52-5 (untreated) and CAS 68611-44-9 (surface-treated hydrophobic grades). Additional listings are maintained for China IECSC and Korea KECI.
Synthetic amorphous silica (CAS 112945-52-5) produced by flame hydrolysis contains no crystalline structure and carries no CLP carcinogenicity classification. SEMISIL grades hold free quartz below 0.1% by weight. Crystalline silica (quartz, CAS 14808-60-7) is classified as a Group 1 carcinogen by IARC.
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