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Data: Robust

Formaldehyde

IMAGE SOURCE: PubChem

SEARCH PRODUCTS

Other Concerns

Use restrictions (high), Non-reproductive organ system toxicity (high), Irritation (skin, eyes, or lungs) (low), and Occupational hazards (high)

SYNONYMS

FORMALDEHYDE, FORMALIN, FORMIC ALDEHYDE, MERTHALDEHYDE, METHANAL, METHYL ALDEHYDE, OXOMETHANE, and OXYMETHYLENE

Restricted

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


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, Menné 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.

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

Ingredient concerns

  • CONCERNS
  • DATA SOURCES

Products with this Ingredient

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eyelash glue3 products
nail polish2 products
nail treatment2 products
hair treatment/serum1 products

Organ system toxicity (non-reproductive)

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CONCERN REFERENCE
Known human respiratory toxicantEPA Hazardous Air Pollutants
One or more animal studies show classified as toxic effects at low dosesEPA Categorized List of Inert Pesticide Ingredients
Classified as toxic or harmfulCPS&Q - Classification & Labelling
Limited evidence of sense organ toxicityScorecard.org Toxicity Information
Limited evidence of respiratory toxicityNational Library of Medicine HazMap
One or more animal studies show classified as toxic effects at moderate doses (low dose studies may be unavailable for this ingredient)EPA Toxic Release Inventory PBTs
Classified as not expected to be potentially toxic or harmfulEnvironment Canada Domestic Substance List
Classified as a low human health priorityEnvironment Canada Domestic Substance List

Cancer

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CONCERN REFERENCE
Known human carcinogenInt'l Agency for Research on Cancer (IARC) - Carcinogens
Known human carcinogenNTP Report on Carcinogens, 11th Edition
Possible human carcinogenEPA Integrated Risk Information System (IRIS)
Possible human carcinogenCalifornia EPA Proposition 65
Possible human carcinogenAmer Conf of Gov't Industrial Hygienists - Carcinogens
Limited evidence of carcinogenicityNIOSH Occupational Carcinogens
Limited evidence of carcinogenicityCPS&Q - Classification & Labelling

Use restrictions

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CONCERN REFERENCE
Violation of government restrictions - Banned or found unsafe for use in cosmeticsCosIng
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 Assessments
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Use is restricted in Canadian cosmeticsCanada - Prohibited and Restricted Cosmetics Ingredients
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - anyCosIng
Recommendation to minimize use in cosmetics - Keep concentration to minimum: warning from industry safety panelCosmetic Ingredient Review Assessments
Determined safe for use in cosmetics, subject to concentration or use limitations - Safe for use in cosmetics with some qualificationsCosmetic Ingredient Review Assessments

Occupational hazards

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CONCERN REFERENCE
Allowed workplace exposures restricted to low dosesCPS&Q - Classification & Labelling

Allergies/immunotoxicity

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CONCERN REFERENCE
Human immune and respiratory toxicant or allergen - strong evidenceAssociation of Occupational and Environmental Clinics
Human skin toxicant or allergen - strong evidenceCosmetic Ingredient Review Assessments
Limited evidence of immune system toxicity or allergiesCPS&Q - Classification & Labelling
Limited evidence of immune system toxicity or allergiesNational Library of Medicine HazMap

Irritation (skin, eyes, or lungs)

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CONCERN REFERENCE
Limited evidence of skin irritationNational Library of Medicine HazMap

Ecotoxicology

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CONCERN REFERENCE
Suspected to be an environmental toxinEnvironment Canada Domestic Substance List

Data gaps

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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 productCosmetic Ingredient Review Assessments
55688 studies in PubMed science library may include information on the toxicity of this chemicalNLM PubMed

Miscellaneous

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CONCERN REFERENCE
Occupational hazards related to handlingCPS&Q - Classification & Labelling

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
Designated as safe for general or specific, limited use in foodFDA Food Additive Status

Informational

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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 Assessments

Persistence and bioaccumulation

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CONCERN REFERENCE
Not suspected to be persistentEnvironment Canada Domestic Substance List
Not suspected to be bioaccumulativeEnvironment Canada Domestic Substance List
  • EPA (U.S. Environmental Protection Agency). 2005. Office of Air. The 112(b)1 Hazardous Air Pollutants List (as modified). Last modified: 12 Dec 2005.
  • EPA (U.S. Environmental Protection Agency). 1987 & 2005. Office of Pesticide Programs. Inert (other) Pesticide Ingredients in Pesticide Products - Categorized List of Inert (other) Pesticide Ingredients.
  • CPS&Q (Consumer Products Safety & Quality) formely known as ECB (European Chemicals Bureau). 2008. Classification and Labelling: Chemicals: Annex VI of Directive 67/548/EEC through the 31st ATP.
  • ED (Environmental Defense). 2006. Scorecard _ The Pollution Information Site. http://www.scorecard.org.
  • NLM (National Library of Medicine). 2006. HazMap &#8212; Occupational Exposure to Hazardous Agents.
  • EPA (U.S. Environmental Protection Agency). 1999. Toxics Release Inventory Program. PBT Chemical Rule.
  • EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
  • IARC (International Agency for Research on Cancer). 2008. Overall Evaluations of Carcinogenicity to Humans, as evaluated in IARC Monographs Volumes 1-99 (a total of 935 agents, mixtures and exposures).
  • NTP (National Toxicology Program). 2005. Report on Carcinogens, Eleventh Edition; U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program.
  • EPA (U.S. Environmental Protection Agency). 2008. Integrated Risk Information System (IRIS). Evidence for human carcinogenicity based on 1986-2005 guidelines.
  • California EPA (California Environmental Protection Agency). 9/2008. Office of Environmental Health Hazard Assessment. Safe Drinking Water and Toxic Enforcement Act of 1986. Chemicals known to the State to cause cancer or reproductive toxicity.
  • ACGIH (American Conference of Governmental Industrial Hygienists) 2008. ACGIH cancer classification system. www.acgih.org.
  • NIOSH (National Institute for Occupational Safety and Health). 2006. NIOSH Carcinogens List (Potential occupational carcinogens). http://www.cdc.gov/niosh/npotocca.html.
  • European Commission. 2013. Cosing, the European Commission database with information on cosmetic substances and ingredients. Accessed on March 1, 2013 at http://ec.europa.eu/consumers/cosmetics/cosing/ .
  • CIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
  • Health Canada. 2007. List of Prohibited and Restricted Cosmetic Ingredients. Canada's Cosmetic Ingredient Hotlist. March 2007.
  • AOEC (Association of Occupational and Environmental Clinics). 2009. AEOC exposures codes and asthmagen designation.
  • 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. Food Additive Status List. Downloaded from http://www.cfsan.fda.gov/%7Edms/opa-appa.html, Oct 16, 2006.

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

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

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