Monascus Extract

INCI: MONASCUS EXTRACT

CAS Number
Not individually assigned
Function
Skin conditioning; colorant (natural red/orange pigments — monascin, rubropunctatin, ankaflavin)
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status restricted
US Notes If used for coloring, Monascus pigments are not FDA-approved color additives under 21 CFR Parts 73/74. Permitted only if coloring is incidental to function.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
negligible
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Citrinin contamination risk — Monascus species (especially M. purpureus) can produce citrinin, a nephrotoxic and potentially genotoxic mycotoxin. EU Commission Regulation 2019/1901 sets citrinin limits for food supplements (2 mg/kg); no cosmetic-specific limit exists but should be tested. US color additive status restricts coloring claims.

⚠️
Concern Level: High

Regulatory Flags

plant-extract colorant

Frequently Asked Questions

Is Monascus Extract safe in cosmetics?

Citrinin contamination risk — Monascus species (especially M. purpureus) can produce citrinin, a nephrotoxic and potentially genotoxic mycotoxin. EU Commission Regulation 2019/1901 sets citrinin limits for food supplements (2 mg/kg); no cosmetic-specific limit exists but should be tested. US color additive status restricts coloring claims. The EU classifies Monascus Extract as "permitted". Safety rating: MODERATE.

Is Monascus Extract allowed in the EU?

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

What does Monascus Extract do in cosmetics?

Monascus Extract functions as: Skin conditioning; colorant (natural red/orange pigments — monascin, rubropunctatin, ankaflavin). It is classified as a cosmetic ingredient in our database. CAS number: Not individually assigned.

What is the Margin of Safety for Monascus Extract?

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.

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