Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
6 study endpoints found for Bismuth Oxychloride. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 500 mg/kg bw/day | dermal | code:3484 | dermal | REACH |
| NOAEL | 1000 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 5000 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 500 mg/kg bw/day | dermal | code:3484 | dermal | REACH |
| NOAEL | 500 mg/kg bw/day | dermal | code:3484 | dermal | REACH |
| NOAEL | 1000 mg/kg bw/day | oral | - | oral | REACH |
Expert Verdict
Bismuth oxychloride is a permitted colorant in EU cosmetics (Annex IV/Part 1) with no concentration limits, but prohibited in lip products. In the US, it is an FDA color additive exempt from certification under 21 CFR 73.2162, permitted in cosmetics including eye area but not permitted in lip products. Physical irritation from crystalline particles is possible, especially with sweat or pore accumulation.
Regulatory Flags
Frequently Asked Questions
Is Bismuth Oxychloride safe in cosmetics?
Bismuth oxychloride is a permitted colorant in EU cosmetics (Annex IV/Part 1) with no concentration limits, but prohibited in lip products. In the US, it is an FDA color additive exempt from certification under 21 CFR 73.2162, permitted in cosmetics including eye area but not permitted in lip products. Physical irritation from crystalline particles is possible, especially with sweat or pore accumulation. The EU classifies Bismuth Oxychloride as "permitted". Safety rating: GOOD. 6 toxicological study endpoint(s) are available in our database.
Is Bismuth Oxychloride allowed in the EU?
Bismuth Oxychloride EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Bismuth Oxychloride do in cosmetics?
Bismuth Oxychloride functions as: Synthetic pearlescent and iridescent pigment; provides satin/luminous finish in mineral makeup; opacity and slip agent; used in foundations, setting powders, and mineral makeup. It is classified as a Colorant in our database. CAS number: 7787-59-9.
What is the Margin of Safety for Bismuth Oxychloride?
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.
What is the NOAEL for Bismuth Oxychloride?
The NOAEL (No Observed Adverse Effect Level) for Bismuth Oxychloride is 500 mg/kg bw/day based on a dermal study via dermal route in code:3484. A total of 6 study endpoints are available. Source: REACH.
Compliance Tools
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Related Ingredients
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