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HOW WE DETERMINE SCORES Learn more About EWG VERIFIED®

Data: Fair

Fd&C Yellow No. 5 (Ci 19140) Lake

  • Products with this ingredient are allowed for use in EWG VERIFIED but must meet use restrictions and warnings based on EWG review of company data.
  • This ingredient's score is higher if used in product forms that are inhalable (e.g., sprays, powders) because of respiratory concerns. The score is lower if used in product forms that have lower risk of inhalation (e.g., solids, liquids)
  • This ingredient's score is higher if used in products that may not meet industry safety guidelines or U.S. and international government requirements and may have contamination concerns from toxic impurities. The score will be lower if used in products that do meet these safety guidelines and requirements and EWG’s contamination restrictions.

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Other Concerns

Enhanced skin absorption, Use restrictions (low), Neurotoxicity (low_moderate), Endocrine disruption (low), Persistence and bioaccumulation (moderate), Non-reproductive organ system toxicity (low_moderate), and Contamination concerns (high)

SYNONYMS

● FD&C YELLOW NO. 5 ALUMINUM LAKE
● TARTRAZINE AL LAKE
● C.I. PIGMENT YELLOW 100
● ALUMINUM, 4,5-DIHYDRO-5-OXO-1-(4-SULFOPHENYL)-4-[(4-SULFOPHENYL)AZO]-1H-PYRAZOLE-3-CARBOXYLIC ACID COMPLEX
● D&C YELLOW 5 ZR LAKE
● D&C YELLOW 5 AL LAKE
● FD&C YELLOW 5 AL LAKE
● YELLOW 5 ALUMINUM LAKE
● FD&C YELLOW 5 (CI 19140) ALUMINUM LAKE
● FD&C YELLOW NO. 5 (CI 19140) LAKE

Restricted

Restricted: EWG VERIFIED products cannot contain this ingredient without adequate substantiation

In industrial production of colorants, 'lake' is a term used for pigments or dyes that are precipitated with metal salts such as aluminum, calcium, barium, or others. Some of the lake dyes may be derived from naturally occurring plant or animal ingredients but the vast majority of lakes is synthetically produced from coal tar or petroleum.

Common concerns

See how this product scores for common concerns.

  • LOW
    Cancer
  • LOW_MODERATE
    Allergies & Immunotoxicity
  • LOW
    Developmental and Reproductive Toxicity
  • LOW
    Use Restrictions

Ingredient concerns

  • CONCERNS
  • DATA SOURCES

Products with this Ingredient

Expand content Collapse content
facial moisturizer/treatment11 products
facial cleanser12 products
anti-aging2 products
around-eye cream2 products
conditioner13 products
eye shadow1218 products
shampoo18 products
nail polish1815 products
blush759 products
lipstick3993 products
eye liner511 products
lip balm757 products
lip liner473 products
lip gloss1297 products
facial powder108 products
bronzer/highlighter261 products
after sun product1 products
bar soap19 products
exfoliant/scrub55 products
toners/astringents3 products
fragrance for men3 products
makeup primer15 products
nail treatment25 products
foot moisturizer2 products
foundation213 products
mascara59 products
glitter42 products
body wash/cleanser24 products
concealer156 products
body art4 products
brow liner117 products
bath oil/salts/soak100 products
BB cream2 products
toothpaste1 products
hair styling aid7 products
moisturizer15 products
hair color and bleaching14 products
recreational sunscreen5 products
lip balm with SPF11 products
lip plumper163 products
setting powder/spray96 products
other eye makeup11 products
eyelash glue1 products
mouthwash4 products
bubble bath5 products
mask23 products
body oil16 products
nail glue6 products
Novelty Makeup1 products
damaged skin treatment2 products
makeup remover2 products
Bath and Body Wipes1 products
liquid hand soap2 products
body firming lotion5 products
hair spray1 products
body spray1 products
hand cream3 products
Lip Stain7 products
sunless tanning1 products
hair treatment/serum1 products
Nail Art and Jewelry1 products
Oils & Serums3 products
styling gel/lotion4 products
shaving cream1 products
body powder1 products
serums & essences3 products
Basecoats and Undercoats1 products
oil controller1 products
after shave1 products
Exfoliants2 products
Facial Cleansing Water1 products
Denture Care1 products
fragrance for women1 products
pore strips1 products
CC cream1 products
Hair Styling Gel1 products

Contamination concerns

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Chemical
BIPHENYL-2-YLAMINE
CADMIUM
1-napthylamine

Neurotoxicity

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CONCERN REFERENCE
One or more human case studies show possible neurological effectsScientific Opinion on the re-evaluation Tartrazine (E 102)(2009-12-11)
One or more animal studies show effects at moderate dosesReproductive and neurobehavioural toxicity study of tartrazine administered to mice in the diet(2006-02-01)
One or more animal studies show effects at moderate dosesEffects of tartrazine on exploratory behavior in a three-generation toxicity study in mice(2008-10-01)
One or more human case studies show possible behavioral effectsSynthetic food coloring and behavior: a dose response effect in a double-blind, placebo-controlled, repeated-measures study(1994-11-01)
One or more human case studies show possible behavioral effectsFood additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community: a randomised, double-blinded, placebo-controlled trial(2007-11-03)
One or more animal studies show neurobehavioral effects at high dosesThe Potential Health Hazard of Tartrazine and Levels of Hyperactivity, Anxiety-Like Symptoms, Depression and Anti-social behaviour in Rats(2011-01-01)
One or more human case studies show significant behavioral effectsPeer Reviewed Literature

Allergies/immunotoxicity

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CONCERN REFERENCE
One or more human case studies show possible immune or allergenic effectsScientific Opinion on the re-evaluation Tartrazine (E 102)(2009-12-11)
One or more human case studies show equivocal immune or allergenic effectsOPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Acid Yellow 23(2004-04-23)
Human immune toxicant or allergen - moderate evidencePeer Reviewed Literature

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 cosmeticsUS Food and Drug Administration (FDA)
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - Color additive approved by FDA for cosmetics used around eyesUS Food and Drug Administration (FDA)
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - hair dyesEU Cosmetics Directive
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 AdministrationPersonal Care Products Council
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - anyUS Food and Drug Administration (FDA)
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 AdministrationPersonal Care Products Council

Multiple, additive exposure sources

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CONCERN REFERENCE
Designated as safe for general or specific, limited use in foodUS Food and Drug Administration (FDA)

Organ system toxicity (non-reproductive)

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CONCERN REFERENCE
Classified as not expected to be potentially toxic or harmfulEnvironment Canada
One or more animal studies show effects at high doses (low dose studies may be unavailable for this ingredient)Hepatic effects of tartrazine (E 102) after systemic exposure are independent of oestrogen receptor interactions in the mouse(2017-05-01)
Classified as medium human health priorityEnvironment Canada

Persistence and bioaccumulation

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CONCERN REFERENCE
Not suspected to be bioaccumulativeEnvironment Canada
Persistent or bioaccumulative and moderate to high toxicity concern in humansEnvironment Canada

Ecotoxicology

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CONCERN REFERENCE
Not suspected to be an environmental toxinEnvironment Canada

Use restrictions

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CONCERN REFERENCE
Determined safe for use in cosmetics, subject to concentration or use limitations - anyUS Food and Drug Administration (FDA)

Endocrine disruption

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CONCERN REFERENCE
One or more studies show weak endocrine disruptionTartrazine and sunset yellow are xenoestrogens in a new screening assay to identify modulators of human oestrogen receptor transcriptional activity(2012-08-16)
Associated with endocrine disruptionNational Toxicology Program (NTP)

Cancer

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CONCERN REFERENCE
One or more in vitro tests on cells show inconclusive, but potentially positive mutation resultsOPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Acid Yellow 23(2004-04-23)
Not likely to be carcinogenic in humansOPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Acid Yellow 23(2004-04-23)
One or more in vitro tests on mammalian cells show positive mutation resultsEffects on DNA repair in human lymphocytes exposed to the food dye tartrazine yellow(2015-03-01)
Not likely to be mutagenic in humansLack of genotoxic effect of food dyes amaranth, sunset yellow and tartrazine and their metabolites in the gut micronucleus assay in mice(2009-02-01)
Not likely to be mutagenic in humansLack of genotoxicity in vivo for food color additive Tartrazine(2017-07-01)
Cancer - limited evidencePeer Reviewed Literature

Developmental/reproductive toxicity

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CONCERN REFERENCE
One or more animal studies show effects at high dosesEffects of Tartrazine on Neural Tube Development in the Early Stage of Chicken Embryos(2020-01-01)
One or more animal studies show developmental effects at high dosesEmbryotoxic and Teratogenic Effects of Tartrazine in Rats(2019-01-01)
developmental toxicity - weight of evidence unknown/unassessed/unreviewedDevelopmental Toxicity Assay for Food Additive Tartrazine Using Zebrafish ( Danio rerio) Embryo Cultures(1900-01-01)
  • Scientific Opinion on the re-evaluation Tartrazine (E 102)(2009-12-11)
  • Reproductive and neurobehavioural toxicity study of tartrazine administered to mice in the diet(2006-02-01)
  • Effects of tartrazine on exploratory behavior in a three-generation toxicity study in mice(2008-10-01)
  • Synthetic food coloring and behavior: a dose response effect in a double-blind, placebo-controlled, repeated-measures study(1994-11-01)
  • Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community: a randomised, double-blinded, placebo-controlled trial(2007-11-03)
  • The Potential Health Hazard of Tartrazine and Levels of Hyperactivity, Anxiety-Like Symptoms, Depression and Anti-social behaviour in Rats(2011-01-01)
  • Peer Reviewed Literature
  • OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Acid Yellow 23(2004-04-23)
  • US Food and Drug Administration (FDA)
  • EU Cosmetics Directive
  • Personal Care Products Council
  • Environment Canada
  • Hepatic effects of tartrazine (E 102) after systemic exposure are independent of oestrogen receptor interactions in the mouse(2017-05-01)
  • Tartrazine and sunset yellow are xenoestrogens in a new screening assay to identify modulators of human oestrogen receptor transcriptional activity(2012-08-16)
  • National Toxicology Program (NTP)
  • Effects on DNA repair in human lymphocytes exposed to the food dye tartrazine yellow(2015-03-01)
  • Lack of genotoxic effect of food dyes amaranth, sunset yellow and tartrazine and their metabolites in the gut micronucleus assay in mice(2009-02-01)
  • Lack of genotoxicity in vivo for food color additive Tartrazine(2017-07-01)
  • Effects of Tartrazine on Neural Tube Development in the Early Stage of Chicken Embryos(2020-01-01)
  • Embryotoxic and Teratogenic Effects of Tartrazine in Rats(2019-01-01)
  • Developmental Toxicity Assay for Food Additive Tartrazine Using Zebrafish ( Danio rerio) Embryo Cultures(1900-01-01)

Understanding scores

Cosmetics and personal care products are not required to be tested for safety before being allowed on the market. The Skin Deep® scoring system was designed to help the public understand whether a product is safe to use or whether it contains ingredients of concern.

Every product and ingredient in Skin Deep gets a two-part score – one for hazard and one for data availability. The safest products score well by both measures, with a low hazard rating and a fair or better data availability rating.


HOW WE DETERMINE SCORES

Hazard score

The Skin Deep ingredient hazard score, from 1 to 10, reflects known and suspected hazards linked to the ingredients. The EWG Verified® mark means a product meets EWG’s strictest criteria for transparency and health.

Score legend
WEIGHT-OF-EVIDENCE APPROACH

A product’s hazard score is not an average of the ingredients’ hazard scores. It is calculated using a weight-of-evidence approach that factors in all of the hazards or health impacts associated with the ingredients.

Data availability

The Skin Deep data availability rating reflects the number of scientific studies about the product or ingredient in the published scientific literature.

NONE LIMITED FAIR GOOD ROBUST
Low Availability
Moderate Availability
High Availability
NONE

Ingredients have not been assessed.

LIMITED-FAIR

There is only a modest volume of research.

GOOD-ROBUST

Ingredients have been studied extensively.

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