Excellent Cosmetic Ingredient

CI 40800 (Beta-Carotene)

INCI: CI 40800

CAS Number
7235-40-7 / 116-32-5 / 31797-85-0
Function
Colorant. Synthetic or naturally derived carotenoid pigment (Beta-Carotene, also known as Food Orange 5 and E160a). Imparts orange-yellow coloration to cosmetic products. Permitted for use across all cosmetic product types including eye area and lip products. Functions simultaneously as an antioxidant and provitamin A precursor. One of the most widely used and well-characterized carotenoid colorants in global cosmetics.
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes FDA permanently listed as an exempt-from-certification color additive under 21 CFR 73.2095 (Color Additives Exempt from Certification, Subpart C — Cosmetics). Approved for use in all cosmetics including products intended for the eye area, lip products, and external application. No concentration maximum specified beyond good manufacturing practice (GMP). Batch certification is not required.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

CI 40800 (Beta-Carotene) is one of the safest and most thoroughly characterized cosmetic colorants available. Permanently approved by FDA for all cosmetics including eye-area products without concentration restriction or batch certification requirement. EU Annex IV Entry IV/55 permits use in all cosmetic products with no maximum limit. Excellent regulatory standing across all major jurisdictions.

⚠️
Concern Level: None

Regulatory Flags

eu-annex-iv fda-exempt-from-certification all-cosmetics-permitted eye-area-approved provitamin-a carotenoid antioxidant food-additive-e160a natural-or-synthetic no-concentration-limit

Frequently Asked Questions

Is CI 40800 (Beta-Carotene) safe in cosmetics?

CI 40800 (Beta-Carotene) is one of the safest and most thoroughly characterized cosmetic colorants available. Permanently approved by FDA for all cosmetics including eye-area products without concentration restriction or batch certification requirement. EU Annex IV Entry IV/55 permits use in all cosmetic products with no maximum limit. Excellent regulatory standing across all major jurisdictions. The EU classifies CI 40800 (Beta-Carotene) as "permitted". Safety rating: EXCELLENT.

Is CI 40800 (Beta-Carotene) allowed in the EU?

CI 40800 (Beta-Carotene) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 40800 (Beta-Carotene) do in cosmetics?

CI 40800 (Beta-Carotene) functions as: Colorant. Synthetic or naturally derived carotenoid pigment (Beta-Carotene, also known as Food Orange 5 and E160a). Imparts orange-yellow coloration to cosmetic products. Permitted for use across all cosmetic product types including eye area and lip products. Functions simultaneously as an antioxidant and provitamin A precursor. One of the most widely used and well-characterized carotenoid colorants in global cosmetics.. It is classified as a cosmetic ingredient in our database. CAS number: 7235-40-7 / 116-32-5 / 31797-85-0.

What is the Margin of Safety for CI 40800 (Beta-Carotene)?

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.

Compliance Tools

Check CI 40800 (Beta-Carotene) compliance across multiple jurisdictions:

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Ingredient Decoder
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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
 ⚗️
Heavy Metal Limits
Compare limits across jurisdictions

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