Data: Robust
Formaldehyde
Other Concerns
Enhanced skin absorption, Use restrictions (high), Non-reproductive organ system toxicity (high), Irritation (skin, eyes, or lungs) (low), and Occupational hazards (moderate)SYNONYMS
Unacceptable
Unacceptable: EWG VERIFIED products cannot contain this ingredient
Formaldehyde is a carcinogenic impurity released by a number of cosmetic preservatives, including diazolidinyl urea, imidazolidinyl urea, DMDM hydantoin, quaternium-15, 2-bromo-2-nitropropane-1,3-diol, and sodium hydroxylmethylglycinate. According to reviews by the industry-funded Cosmetic Ingredient Review panel, these cosmetic ingredients can release formaldehyde at levels as high as one-tenth that of the original ingredient (CIR 2006). Successful treatment of formaldehyde-triggered contact allergic dermatitis through substitution of body care products free of these preservatives (Flyvholm 1992) is implicit confirmation of the presence of low levels of formaldehyde in these products.<br /><br />The International Agency for Research on Carcinogens (IARC) has classified formaldehyde as 'carcinogenic to humans,' and the U.S. National Toxicology Program has classified it as 'reasonably anticipated to be a human carcinogen,' based on emerging evidence in humans and robust evidence in animals (IARC 2004; NTP 2005). Occupational exposures to formaldehyde gas are linked to nasal and nasopharyngeal cancers (IARC 2004; NTP 2005). Animal studies confirm this link, and also suggest an association between formaldehyde in drinking water and stomach and gastrointestinal cancer and leukemia (NTP 2005). <br /><br />Despite the considerable health concerns associated with this carcinogen, until recently formaldehyde itself was a common ingredient of nail polish. Consumer pressure has now forced many major cosmetics manufacturers to voluntarily remove this ingredient from their nail products. European health protections now limit the concentration of formaldehyde in cosmetics to 0.2%, and require that body care products containing formaldehyde or formaldehyde-releasing ingredients be labeled with the warning 'contains formaldehyde' if the concentration of formaldehyde in the product exceeds 0.05% (SCCPNP 2002). <br /><br />Even the industry-funded Cosmetic Ingredient Review panel recommends that cosmetic products not contain more than 0.2% formaldehyde, and does not consider formaldehyde to be safe in aerosol products (CIR 2006). However, as it stands in the U.S. there are no restrictions on the levels of formaldehyde allowed in any body care products, no requirement to test products made with formaldehyde-releasing preservatives for levels of formaldehyde, and certainly no obligation to inform consumers that the products they use each day are likely to contain a cancer-causing chemical that does not appear on the list of ingredients.<br /><br /> References<br /><br />CIR (Cosmetics Ingredient Review). 2006. 2006 CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.<br /><br />Flyvholm MA, Menn퀌© T. 1992. Allergic contact dermatitis from formaldehyde. A case study focussing on sources of formaldehyde exposure. Contact Dermatitis. 1992 Jul;27(1):27-36.<br /><br />IARC (International Agency for Research on Carcinogens). 2004. Formaldehyde. IARC monographs on the evaluation of carcinogenic risks to humans / World Health Organization, International Agency for Research on Cancer 88.<br /><br />NTP (National Toxicology Program). 2005. National Toxicology Panel 11th Report on Carcinogens: Formaldehyde (Gas). Available: http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s089form.pdf [Accessed August 14, 2008].<br /><br />SCCPNP (Scientific Committee on Cosmetic Products and Non-food Products). 2002. Opinion concerning a clarification on the formaldehyde and para-formaldehyde entry in Directive 76/768/EEC on cosmetic products. Opinion: European Comission.
Common concerns
See how this product scores for common concerns.
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HIGHCancer
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MODERATEAllergies & Immunotoxicity
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LOWDevelopmental and Reproductive Toxicity
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HIGHUse Restrictions
Ingredient concerns
- CONCERNS
- DATA SOURCES
Products with this Ingredient
eyelash glue | 10 products |
nail treatment | 16 products |
nail polish | 6 products |
brow liner | 1 products |
nail glue | 1 products |
conditioner | 1 products |
hair treatment/serum | 1 products |
Allergies/immunotoxicity
CONCERN | REFERENCE |
---|---|
Possible human dermal toxicant or allergen | EU GHS Hazard Labeling Codes |
Human skin toxicant or allergen - strong evidence | Cosmetic Ingredient Review (CIR) |
Limited evidence of immune system toxicity or allergies | US. National Library of Medicine, |
Limited evidence of dermal toxicity or allergies | European Chemicals Agency (ECHA) |
Human immune and respiratory toxicant or allergen - strong evidence | Association of Occupational and Environmental Clinics (AOEC) |
Cancer
CONCERN | REFERENCE |
---|---|
Possible human carcinogen | California OEHHA (Office of Environmental Health Hazard Assessment) |
Known human carcinogen | International Agency for Research on Cancer (IARC) |
Limited evidence of carcinogenicity | EU GHS Hazard Labeling Codes |
Possible human carcinogen | American Conference of Governmental Industrial Hygienists (ACGIH) |
Possible human carcinogen | Environmental Protection Agency (EPA) |
Limited evidence of carcinogenicity | Centers for Disease Control and Prevention (CDC) |
Known human carcinogen | National Toxicology Program (NTP) |
Organ system toxicity (non-reproductive)
CONCERN | REFERENCE |
---|---|
Classified as toxic or harmful | EU GHS Hazard Labeling Codes |
Classified as not expected to be potentially toxic or harmful | Environment Canada |
Classified as a low human health priority | Environment Canada |
Known human respiratory toxicant | Environmental Protection Agency (EPA) |
Limited evidence of respiratory toxicity | US. National Library of Medicine, |
One or more animal studies show classified as toxic effects at low doses | Environmental Protection Agency (EPA) |
One or more animal studies show classified as toxic effects at moderate doses (low dose studies may be unavailable for this ingredient) | Environmental Protection Agency (EPA) |
Occupational hazards
CONCERN | REFERENCE |
---|---|
Allowed workplace exposures restricted to low doses | EU GHS Hazard Labeling Codes |
Miscellaneous
CONCERN | REFERENCE |
---|---|
Occupational hazards related to handling | EU GHS Hazard Labeling Codes |
Prohibited for use in food | US. Food and Drug Administration (FDA) |
Multiple, additive exposure sources
CONCERN | REFERENCE |
---|---|
Designated as safe for general or specific, limited use in food | US. Food and Drug Administration (FDA) |
Use restrictions
CONCERN | REFERENCE |
---|---|
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Use is restricted in Canadian cosmetics | Health Canada |
Violation of industry recommendations - Restricted in cosmetics; use, concentration, or manufacturing restrictions - Not safe for use in products intended to be aerosolized, according to industry safety panel (Cosmetic Ingredient Review, CIR) | Cosmetic Ingredient Review (CIR) |
Determined safe for use in cosmetics, subject to concentration or use limitations - Safe concentration varies based on where applied (e.g., skin versus eyes), according to industry safety panel (Cosmetic Ingredient Review, CIR) | Cosmetic Ingredient Review (CIR) |
Determined safe for use in cosmetics, subject to concentration or use limitations - Safe for use in cosmetics with some qualifications | Cosmetic Ingredient Review (CIR) |
Recommendation to minimize use in cosmetics - Keep concentration to minimum: warning from industry safety panel | Cosmetic Ingredient Review (CIR) |
Violation of government restrictions - Restricted in cosmetics; use, concentration, or manufacturing restrictions - any | EU Cosmetics Directive |
Violation of government restrictions - Banned or found unsafe for use in cosmetics | EU Cosmetics Directive |
Data gaps
CONCERN | REFERENCE |
---|---|
Risk assessment method deficiencies and data gaps - Maximum reported 'as used' concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product | Cosmetic Ingredient Review (CIR) |
Informational
CONCERN | REFERENCE |
---|---|
Industry or government recommendations for safe use: restrictions on concentration, impurities, product types, or manufacturing methods - Not safe for use in products intended to be aerosolized, according to industry safety panel (Cosmetic Ingredient Review, CIR) | Cosmetic Ingredient Review (CIR) |
Persistence and bioaccumulation
CONCERN | REFERENCE |
---|---|
Not suspected to be persistent | Environment Canada |
Not suspected to be bioaccumulative | Environment Canada |
Ecotoxicology
CONCERN | REFERENCE |
---|---|
Suspected to be an environmental toxin | Environment Canada |
Irritation (skin, eyes, or lungs)
CONCERN | REFERENCE |
---|---|
Limited evidence of skin irritation | US. National Library of Medicine, |
- EU GHS Hazard Labeling Codes
- Cosmetic Ingredient Review (CIR)
- US. National Library of Medicine,
- European Chemicals Agency (ECHA)
- Association of Occupational and Environmental Clinics (AOEC)
- California OEHHA (Office of Environmental Health Hazard Assessment)
- International Agency for Research on Cancer (IARC)
- American Conference of Governmental Industrial Hygienists (ACGIH)
- Environmental Protection Agency (EPA)
- Centers for Disease Control and Prevention (CDC)
- National Toxicology Program (NTP)
- Environment Canada
- US. Food and Drug Administration (FDA)
- Health Canada
- EU Cosmetics Directive
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.
Data availability
The Skin Deep data availability rating reflects the number of scientific studies about the product or ingredient in the published scientific literature.