Regulatory Status
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Safety Data
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Expert Verdict
Nigella Sativa Seed Extract (CAS 90064-32-7) is permitted for general cosmetic use in the EU under Regulation (EC) No 1223/2009 and permitted in the US under FDCA/MoCRA provisions. However, significant safety concerns exist: thymoquinone and p-cymene are primary sensitizing constituents with documented cases of severe acute contact dermatitis mimicking Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome. No formal margin of safety exists; whole-extract dermal absorption data is lacking. Responsible parties must conduct robust safety substantiation including patch testing.
Regulatory Flags
Frequently Asked Questions
Is Nigella Sativa Seed Extract safe in cosmetics?
Nigella Sativa Seed Extract (CAS 90064-32-7) is permitted for general cosmetic use in the EU under Regulation (EC) No 1223/2009 and permitted in the US under FDCA/MoCRA provisions. However, significant safety concerns exist: thymoquinone and p-cymene are primary sensitizing constituents with documented cases of severe acute contact dermatitis mimicking Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome. No formal margin of safety exists; whole-extract dermal absorption data is lacking. Responsible parties must conduct robust safety substantiation including patch testing. The EU classifies Nigella Sativa Seed Extract as "permitted". Safety rating: MODERATE.
Is Nigella Sativa Seed Extract allowed in the EU?
Nigella Sativa Seed Extract EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Nigella Sativa Seed Extract do in cosmetics?
Nigella Sativa Seed Extract functions as: Skin Conditioning, Perfuming, Anti-inflammatory, Antioxidant. It is classified as a Active Ingredient in our database. CAS number: 90064-32-7.
What is the Margin of Safety for Nigella Sativa Seed 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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