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FD&C Red No. 40 (CI 16035)

Score:

Data: Limited

  • Other Concerns
  • Functions
  • About the Chemical
  • Synonyms
  • Neurotoxicity (low), Endocrine disruption (low), Persistence and bioaccumulation (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

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lipstick34 products
glitter16 products
eye shadow15 products
bath oil/salts/soak14 products
body wash/cleanser12 products
liquid hand soap10 products
bronzer/highlighter9 products
eye liner9 products
facial moisturizer/treatment8 products
lip gloss7 products
moisturizer7 products
mask5 products
conditioner5 products
blush4 products
moisturizer with SPF4 products
serums & essences4 products
exfoliant/scrub4 products
facial cleanser4 products
shampoo4 products
brow liner4 products
body firming lotion3 products
shaving cream3 products
around-eye cream3 products
sunless tanning3 products
concealer3 products
beach & sport sunscreen2 products
makeup primer2 products
mouthwash1 products
toothpaste1 products
styling gel/lotion1 products
fragrance for women1 products
mascara1 products
lip balm1 products
other eye makeup1 products
hair treatment/serum1 products
body art1 products

Contamination concerns

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Allergies/immunotoxicity

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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

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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.

Cancer

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Concern Reference
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;
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.

Persistence and bioaccumulation

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Concern Reference
Some data submitters indicate they consider this substance as Persistent, Bioaccumulative and ToxicEuropean Chemicals Agency (ECHA) 2020. GHS Data from ECHA Website. Appears as: ; cas_numbers: 25956-17-6
Not suspected to be persistentEnvironment Canada Domestic Substance List
Not suspected to be bioaccumulativeEnvironment Canada Domestic Substance List

Endocrine disruption

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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.

Data gaps

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Concern Reference
156 studies in PubMed science library may include information on the toxicity of this chemicalNLM PubMed

Developmental/reproductive toxicity

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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;

Ecotoxicology

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

Multiple, additive exposure sources

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

Informational

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

Irritation (skin, eyes, or lungs)

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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.

Organ system toxicity (non-reproductive)

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Concern Reference
Classified as not expected to be potentially toxic or harmfulEnvironment Canada Domestic Substance List

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.
  • European Chemicals Agency (ECHA) 2020. GHS Data from ECHA Website. Appears as: ; cas_numbers: 25956-17-6
  • EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
  • 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.
  • 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.
  • 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.

About this Ingredient's Score Range

  • Products with the EWG VERIFIED mark have met the program’s impurity restrictions based on EWG review of company data.

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