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FD&C Red No. 40 (CI 16035) Aluminum Lake
Score:
Data: Limited
- Other Concerns
- Functions
- About the Chemical
- Synonyms
-
Use restrictions (low), Neurotoxicity (low), Endocrine disruption (low), Persistence and bioaccumulation (low), Non-reproductive organ system toxicity (low), and Contamination concerns (high)
Cancer 
Cancer: Ingredients linked to cancer in government, industry or academic studies or assessments.
Developmental & Reproductive Toxicity
Developmental and reproductive toxicity: Ingredients linked to developmental and reproductive toxicity, a broad class of health effects that range from infertility and reproductive organ cancers to birth defects and developmental delays in children.
Allergies & Immunotoxicity
Allergies and immunotoxicity: Ingredients linked to harm to the immune system, a class of health problems that manifest as allergic reactions or an impaired capacity to fight disease and repair damaged tissue in the body.
Products with this Ingredient
| eye shadow | 304 products |
| lipstick | 295 products |
| blush | 138 products |
| lip gloss | 62 products |
| bronzer/highlighter | 53 products |
| eye liner | 37 products |
| facial powder | 25 products |
| concealer | 20 products |
| glitter | 17 products |
| foundation | 17 products |
| makeup primer | 14 products |
| bath oil/salts/soak | 13 products |
| exfoliant/scrub | 10 products |
| lip liner | 8 products |
| lip balm | 5 products |
| brow liner | 5 products |
| facial moisturizer/treatment | 4 products |
| mask | 4 products |
| 3 products | |
| facial cleanser | 2 products |
| lip balm with SPF | 2 products |
| setting powder/spray | 1 products |
| nail polish | 1 products |
| eyelash glue | 1 products |
Contamination concerns
Allergies/immunotoxicity
| Concern | Reference |
|---|---|
| Review article concluded that Red 40 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 Red No. 40; |
| FSA concludes that some sensitive individuals may experience allergic reactions at dose levels within the ADI. | European Food Safety Authority (EFSA) 2009. Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. EFSA Journal 7(11), 1327. |
| No evidence of skin sensitization in limited human and animal testing. | European Commission, Scientific Committee on Consumer Safety (SCCS) 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Curry Red. |
Neurotoxicity
| Concern | Reference |
|---|---|
| EFSA finds that there is "limited evidence" that Allura Red in a mixture with other synthetic colors 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 (EFSA) 2009. Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. EFSA Journal 7(11), 1327. |
| A peer-reviewed study reports nervous system effects at the acceptable daily dose for humans. | Ali Noorafshan, Maedeh Hashemi, Saied Karbalay-Doust & Fatemeh Karimi 2018. High dose Allura Red, rather than the ADI dose, induces structural and behavioral changes in the medial prefrontal cortex of rats and taurine can protect it. Acta histochemica 120(6), 586-594. |
Organ system toxicity (non-reproductive)
| Concern | Reference |
|---|---|
| Limited evidence of any toxicity | Klaassen, C, M. Amdur and J. Doull (eds.). Casarett and Doull |
| Classified as not expected to be potentially toxic or harmful | Environment Canada Domestic Substance List |
Cancer
| Concern | Reference |
|---|---|
| EFSA reports there is equivocal evidence of genotoxiciy. | European Food Safety Authority (EFSA) 2009. Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. EFSA Journal 7(11), 1327. |
| A review article reports equivocal evidence of carcinogenesis. | 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 Red No. 40; |
Use restrictions
| Concern | Reference |
|---|---|
| Color additive provisionally approved for use in cosmetics | US. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-099; Chemical_Name: D&C Lakes; ; |
Persistence and bioaccumulation
| Concern | Reference |
|---|---|
| Some data submitters indicate they consider this substance as Persistent, Bioaccumulative and Toxic | European Chemicals Agency (ECHA) 2020. GHS Data from ECHA Website. Appears as: ; cas_numbers: 25956-17-6 |
| Not suspected to be persistent | Environment Canada Domestic Substance List |
| Not suspected to be bioaccumulative | Environment Canada Domestic Substance List |
Endocrine disruption
| Concern | Reference |
|---|---|
| A peer-reviewed study reports that Red 40 affects the function of an enzyme important for the endocrine system. | Kanako Satoh, Rhouichi Nonaka, Fusako Ishikawa, Akio Ogata & Fumiko Nagai 2008. In vitro screening assay for detecting aromatase activity using rat ovarian microsomes and estrone ELISA. Biological & pharmaceutical bulletin 31(3), 357-62. |
Multiple, additive exposure sources
| Concern | Reference |
|---|---|
| Designated as safe for general or specific, limited use in food | FDA Everything Added to Food |
Informational
| Concern | Reference |
|---|---|
| Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - Color additive approved by FDA for use in cosmetics | FDA 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 Administration | CTFA International Cosmetic Ingredient Dictionary and Handbook |
Irritation (skin, eyes, or lungs)
| Concern | Reference |
|---|---|
| Not classified as a skin/eye irritant based on human, animal, and in vitro testing. | European Commission, Scientific Committee on Consumer Safety (SCCS) 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Curry Red. |
Ecotoxicology
| Concern | Reference |
|---|---|
| Not suspected to be an environmental toxin | Environment Canada Domestic Substance List |
Developmental/reproductive toxicity
| Concern | Reference |
|---|---|
| A review article reports a lack of evidence of developmental toxicity. | 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 Red No. 40; |
Data gaps
| Concern | Reference |
|---|---|
| 0 studies in PubMed science library may include information on the toxicity of this chemical | NLM PubMed |
Data Sources
- 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 Red No. 40;
- European Food Safety Authority (EFSA) 2009. Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. EFSA Journal 7(11), 1327.
- European Commission, Scientific Committee on Consumer Safety (SCCS) 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Curry Red.
- Ali Noorafshan, Maedeh Hashemi, Saied Karbalay-Doust & Fatemeh Karimi 2018. High dose Allura Red, rather than the ADI dose, induces structural and behavioral changes in the medial prefrontal cortex of rats and taurine can protect it. Acta histochemica 120(6), 586-594.
- 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.
- US. Food and Drug Administration (FDA). 2015. Color Additive Status. Appears as: listid: COLOR-099; Chemical_Name: D&C Lakes; ;
- European Chemicals Agency (ECHA) 2020. GHS Data from ECHA Website. Appears as: ; cas_numbers: 25956-17-6
- Kanako Satoh, Rhouichi Nonaka, Fusako Ishikawa, Akio Ogata & Fumiko Nagai 2008. In vitro screening assay for detecting aromatase activity using rat ovarian microsomes and estrone ELISA. Biological & pharmaceutical bulletin 31(3), 357-62.
- 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.
- FDA (U.S. Food and Drug Administration) 2006. Center for Food Safety and Applied Nutrition. Color Additive Status List. September 2006.
- CTFA (Cosmetic, Toiletry and Fragrance Association). 2006. International Cosmetic Ingredient Dictionary and Handbook, 11th Edition. Color Additive Information. Washington, DC.
- NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
- 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.
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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
