Excellent Cosmetic Ingredient

Hydrated Silica

INCI: HYDRATED SILICA

CAS Number
1343-98-2
Function
Abrasive, thickener, opacifier, mineral exfoliant
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Permitted cosmetic ingredient; no pre-market FDA approval required. Listed in FDA Inactive Ingredient Database: max 3.4% w/w in topical creams, 0.25% w/w in topical gels. Silicon dioxide has GRAS status for food use under 21 CFR 172.480 (max 2% as anticaking agent). Not an active sunscreen ingredient.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
negligible
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Hydrated Silica is a synthetic amorphous silicon dioxide permitted in EU cosmetics under Regulation (EC) No. 1223/2009 for non-nano forms; it does not appear in Annex II, III, V, or VI. The CIR Expert Panel (2019) concluded it is safe for cosmetic use at reported concentrations (up to 33.8% in oral care, 10% in leave-on products), supported by non-sensitizing HRIPT data up to 45% and negligible dermal absorption. SCCS Opinion SCCS/1545/15 found safety inconclusive for nano forms due to insufficient physicochemical characterization data.

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Concern Level: Low

Regulatory Flags

eu-unrestricted cir-approved gras-fda nano-form eu_children_restricted ifra_fragrance

Frequently Asked Questions

Is Hydrated Silica safe in cosmetics?

Hydrated Silica is a synthetic amorphous silicon dioxide permitted in EU cosmetics under Regulation (EC) No. 1223/2009 for non-nano forms; it does not appear in Annex II, III, V, or VI. The CIR Expert Panel (2019) concluded it is safe for cosmetic use at reported concentrations (up to 33.8% in oral care, 10% in leave-on products), supported by non-sensitizing HRIPT data up to 45% and negligible dermal absorption. SCCS Opinion SCCS/1545/15 found safety inconclusive for nano forms due to insufficient physicochemical characterization data. The EU classifies Hydrated Silica as "permitted". Safety rating: EXCELLENT.

Is Hydrated Silica allowed in the EU?

Hydrated Silica EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Hydrated Silica do in cosmetics?

Hydrated Silica functions as: Abrasive, thickener, opacifier, mineral exfoliant. It is classified as a cosmetic ingredient in our database. CAS number: 1343-98-2.

What is the Margin of Safety for Hydrated Silica?

not established 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.

Compliance Tools

Check Hydrated Silica compliance across multiple jurisdictions:

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Ingredient Decoder
Paste a full ingredient list for instant analysis
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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