Regulatory Status
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Safety Data
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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.
Regulatory Flags
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.
Compliance Tools
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Related Ingredients
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