Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Silica. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 1600 mg/kg bw/day | oral | rabbit | Developmental | COSMOS_DB |
| NOAEL | 1600 mg/kg bw/day | oral | hamster | Developmental | COSMOS_DB |
| NOAEL | 1340 mg/kg bw/day | oral | mouse | Developmental | COSMOS_DB |
| NOAEL | 1350 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 800 mg/kg bw/day | oral | dog | Short Term Toxicity | COSMOS_DB |
| NOAEL | 5000 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 500 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 100 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS_DB |
| NOAEL | 500 mg/kg bw/day | oral | rat | Reproductive | COSMOS_DB |
Expert Verdict
Amorphous fumed silica (pyrogenic) used as a rheology modifier and thickener in aqueous and oil matrices. Forms hydrogen-bonded particle networks delivering non-Newtonian, shear-thinning, thixotropic behavior with temperature-independent rheological effects. Non-crystalline structure presents no silicosis risk. Inorganic mineral exempt from EU REACH SPM restriction. Nano-grade products require EU nano labeling. Typical use level 1–5%.
Regulatory Flags
Frequently Asked Questions
Is Silica safe in cosmetics?
Amorphous fumed silica (pyrogenic) used as a rheology modifier and thickener in aqueous and oil matrices. Forms hydrogen-bonded particle networks delivering non-Newtonian, shear-thinning, thixotropic behavior with temperature-independent rheological effects. Non-crystalline structure presents no silicosis risk. Inorganic mineral exempt from EU REACH SPM restriction. Nano-grade products require EU nano labeling. Typical use level 1–5%. The EU classifies Silica as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.
Is Silica allowed in the EU?
Silica EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Silica do in cosmetics?
Silica functions as: rheology modifier, thickener, anticaking agent, opacifier. It is classified as a cosmetic ingredient in our database. CAS number: 7631-86-9.
What is the Margin of Safety for Silica?
adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
What is the NOAEL for Silica?
The NOAEL (No Observed Adverse Effect Level) for Silica is 1600 mg/kg bw/day based on a Developmental study via oral route in rabbit. A total of 10 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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Related Ingredients
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