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.
Expert Verdict
CI 12085 is a well-characterized monoazo pigment approved in both EU and US for cosmetic use at up to 3% with no eye-area application. FDA permanently listed as D&C Red 36 with batch certification required; approved for externally applied cosmetics and lip products at max 3%. No evidence of carcinogenicity or genotoxicity under normal use conditions. Hair dye use forbidden under EU rules.
Regulatory Flags
Frequently Asked Questions
Is CI 12085 (Pigment Red 4 / D&C Red No. 36) safe in cosmetics?
CI 12085 is a well-characterized monoazo pigment approved in both EU and US for cosmetic use at up to 3% with no eye-area application. FDA permanently listed as D&C Red 36 with batch certification required; approved for externally applied cosmetics and lip products at max 3%. No evidence of carcinogenicity or genotoxicity under normal use conditions. Hair dye use forbidden under EU rules. The EU classifies CI 12085 (Pigment Red 4 / D&C Red No. 36) as "permitted". Safety rating: GOOD.
Is CI 12085 (Pigment Red 4 / D&C Red No. 36) allowed in the EU?
CI 12085 (Pigment Red 4 / D&C Red No. 36) EU regulatory status: permitted. Maximum allowed concentration: 3%. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 12085 (Pigment Red 4 / D&C Red No. 36) do in cosmetics?
CI 12085 (Pigment Red 4 / D&C Red No. 36) functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 2814-77-9.
What is the Margin of Safety for CI 12085 (Pigment Red 4 / D&C Red No. 36)?
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
Check CI 12085 (Pigment Red 4 / D&C Red No. 36) compliance across multiple jurisdictions:
Related Ingredients
Is CI 12085 (Pigment Red 4 / D&C Red No. 36) in Your Products?
Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.
Try Piro Free →Analyze Your Full Ingredient List
Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for CI 12085 (Pigment Red 4 / D&C Red No. 36) in your formulation.