Menu Close Menu

Menu

FD&C Yellow No. 6 (CI 15985) Aluminum Lake

Score:

Data: Limited

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Use restrictions (high), Neurotoxicity (low), Endocrine disruption (low), Non-reproductive organ system toxicity (low), and Contamination concerns (high)

Cancer

Cancer concern is LOW

Developmental & Reproductive Toxicity

Developmental & reproductive toxicity concern is LOW

Allergies & Immunotoxicity

Allergies & immunotoxicity concern is LOW_MODERATE

Products with this Ingredient

Expand content Collapse content
lipstick528 products
lip liner79 products
lip gloss63 products
lip balm54 products
blush20 products
bronzer/highlighter17 products
facial powder16 products
foundation14 products
lip balm with SPF7 products
concealer4 products
bath oil/salts/soak3 products
eye shadow2 products
lip plumper1 products
glitter1 products
shaving cream1 products
beach & sport sunscreen1 products
facial cleanser1 products
makeup primer1 products

Contamination concerns

Expand content Collapse content

Use restrictions

Expand content Collapse content
Concern Reference
Color additive not approved by FDA for cosmetics used around eyesUS. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-138; Chemical_Name: FD&C Yellow 6; ;
Determined safe for use in cosmetics, subject to concentration or use limitations - anyFDA Color Additive Status

Allergies/immunotoxicity

Expand content Collapse content
Concern Reference
Review article concluded that chemical caused hypersensitivity reactions.Peer Reviewed Literature 2020. Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46.. Appears as: Substance Name: FD&C Yellow No. 6;
EFSA concludes that some sensitive individuals may experience allergic reactions at dose levels within the ADI.European Food Safety Authority 2009. Scientific Opinion on the re-evaluation of Sunset Yellow FCF (E 110) as a food additive. EFSA Journal 7(11), 1330.

Neurotoxicity

Expand content Collapse content
Concern Reference
EFSA concludes there is limited evidence that Yellow 6 in a mixture with other synthetic colours and sodium benzoate has a "small and statistically significant effect on activity and attention in children selected from the general population"European Food Safety Authority 2009. Scientific Opinion on the re-evaluation of Sunset Yellow FCF (E 110) as a food additive. EFSA Journal 7(11), 1330.

Developmental/reproductive toxicity

Expand content Collapse content
Concern Reference
The European Food Safety Authority concluded that this substance had the potential to impact testicular health.European Food Safety Authority 2009. Scientific Opinion on the re-evaluation of Sunset Yellow FCF (E 110) as a food additive. EFSA Journal 7(11), 1330.
A review article reports evidence of impacts on male gonads in rats.Peer Reviewed Literature 2020. Amchova, P., H. Kotolova & J. Ruda-Kucerova. 2015. Health safety issues of synthetic food colorants. Regulatory toxicology and pharmacology : RTP 73(3), 914-22. . Appears as: Chemical_name: FD&C Yellow No. 6;

Organ system toxicity (non-reproductive)

Expand content Collapse content
Concern Reference
Limited evidence of any toxicityKlaassen, C, M. Amdur and J. Doull (eds.). Casarett and Doull
Classified as not expected to be potentially toxic or harmfulEnvironment Canada Domestic Substance List

Endocrine disruption

Expand content Collapse content
Concern Reference
A peer-reviewed study reports this substance shows estrogenic activity in a human cell line.Andrew Axon, Felicity E B. May, Luke E. Gaughan, Faith M. Williams, Peter G. Blain & Matthew C. Wright. 2012. Tartrazine and sunset yellow are xenoestrogens in a new screening assay to identify modulators of human oestrogen receptor transcriptional activity. Toxicology 298(1-3), 40-51.
Evidence of endocrine activity from cellular assays.National Toxicology Program (NTP) 2015. EWG Toxcast Analysis. Appears as: CAS: 2783-94-0; Chemical_Name: FD&C Yellow 6

Cancer

Expand content Collapse content
Concern Reference
A review article reports mixed evidence of genotoxicity.Peer Reviewed Literature 2020. Amchova, P., H. Kotolova & J. Ruda-Kucerova. 2015. Health safety issues of synthetic food colorants. Regulatory toxicology and pharmacology : RTP 73(3), 914-22. . Appears as: Chemical_name: FD&C Yellow No. 6;
Limited or incomplete evidence of cancer according to safety/hazard data – government assessment cannot classify as human carcinogen due to data gapsWorld Health Organization, International Agency for Research on Cancer IARC Monographs Programme on the Evaluation of Carcinogenic Risks to Humans. Lists of Group 1, 2a, and 2b substances can be obtained. http://monographs.iarc.fr/ENG/Classification/index.php; Vol 8, Suppl. 7 ;1987

Data gaps

Expand content Collapse content
Concern Reference
0 studies in PubMed science library may include information on the toxicity of this chemicalNLM PubMed

Ecotoxicology

Expand content Collapse content
Concern Reference
Not suspected to be an environmental toxinEnvironment Canada Domestic Substance List

Multiple, additive exposure sources

Expand content Collapse content
Concern Reference
Designated as safe for general or specific, limited use in foodFDA Everything Added to Food

Informational

Expand content Collapse content
Concern Reference
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - anyFDA Color Additive Status
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - Color Additives Lakes - Batch Certified by the U.S. Food and Drug AdministrationCTFA International Cosmetic Ingredient Dictionary and Handbook

Persistence and bioaccumulation

Expand content Collapse content
Concern Reference
Not suspected to be persistentEnvironment Canada Domestic Substance List
Not suspected to be bioaccumulativeEnvironment Canada Domestic Substance List

Data Sources

  • US. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-138; Chemical_Name: FD&C Yellow 6; ;
  • FDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
  • Peer Reviewed Literature 2020. Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46.. Appears as: Substance Name: FD&C Yellow No. 6;
  • European Food Safety Authority 2009. Scientific Opinion on the re-evaluation of Sunset Yellow FCF (E 110) as a food additive. EFSA Journal 7(11), 1330.
  • Peer Reviewed Literature 2020. Amchova, P., H. Kotolova & J. Ruda-Kucerova. 2015. Health safety issues of synthetic food colorants. Regulatory toxicology and pharmacology : RTP 73(3), 914-22. . Appears as: Chemical_name: FD&C Yellow No. 6;
  • Klaassen, C, M. Amdur and J. Doull (eds.). Casarett and Doull
  • EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
  • Andrew Axon, Felicity E B. May, Luke E. Gaughan, Faith M. Williams, Peter G. Blain & Matthew C. Wright. 2012. Tartrazine and sunset yellow are xenoestrogens in a new screening assay to identify modulators of human oestrogen receptor transcriptional activity. Toxicology 298(1-3), 40-51.
  • National Toxicology Program (NTP) 2015. EWG Toxcast Analysis. Appears as: CAS: 2783-94-0; Chemical_Name: FD&C Yellow 6
  • World Health Organization, International Agency for Research on Cancer IARC Monographs Programme on the Evaluation of Carcinogenic Risks to Humans. Lists of Group 1, 2a, and 2b substances can be obtained. http://monographs.iarc.fr/ENG/Classification/index.php; Vol 8, Suppl. 7 ;1987
  • NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
  • FDA (U.S. Food and Drug Administration). 2008. EAFUS [Everything Added to Food]: A Food Additive Database. FDA Office of Food Safety and Applied Nutrition.
  • CTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.

About this Ingredient's Score Range

  • This ingredient’s score is higher if used in products that are inhalable (e.g., sprays, powders) because of respiratory concerns.
  • Products with the EWG VERIFIED mark have met the program’s impurity and use restrictions based on EWG's review of the company's data.

ABOUT THE SKIN DEEP® RATINGS

EWG provides information on personal care product ingredients from the published scientific literature, to supplement incomplete data available from companies and the government. The ratings below indicate the relative level of concern posed by exposure to the ingredients in this product - not the product itself - compared to other product formulations. The ratings reflect potential health hazards but do not account for the level of exposure or individual susceptibility, factors which determine actual health risks, if any. Learn more | Legal Disclaimer

ABOUT EWG VERIFIED™

Beyond providing Skin Deep® as an educational tool for consumers, EWG offers its EWG VERIFIED™ mark as a quick and easily identifiable way of conveying personal care products that meet EWG's strict health criteria. Before a company can use EWG VERIFIED™ on such products, the company must show that it fully discloses the products' ingredients on their labels or packaging, they do not contain EWG ingredients of concern, and are made with good manufacturing practices, among other criteria. Note that EWG receives licensing fees from all EWG VERIFIED™ member companies that help to support the important work we do. Learn more | Legal Disclaimer