Other ConcernsUse restrictions (high), Non-reproductive organ system toxicity (high), Irritation (skin, eyes, or lungs) (low), and Occupational hazards (high)
SYNONYMSFORMALDEHYDE, FORMALIN, FORMIC ALDEHYDE, MERTHALDEHYDE, METHANAL, METHYL ALDEHYDE, OXOMETHANE, and OXYMETHYLENE
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, MennÃ© 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.
See how this product scores for common concerns.
MODERATEAllergies & Immunotoxicity
LOWDevelopmental and Reproductive Toxicity
- DATA SOURCES
Products with this Ingredient
Organ system toxicity (non-reproductive)
|Known human respiratory toxicant||EPA Hazardous Air Pollutants|
|One or more animal studies show classified as toxic effects at low doses||EPA Categorized List of Inert Pesticide Ingredients|
|Classified as toxic or harmful||CPS&Q - Classification & Labelling|
|Limited evidence of sense organ toxicity||Scorecard.org Toxicity Information|
|Limited evidence of respiratory toxicity||National 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 harmful||Environment Canada Domestic Substance List|
|Classified as a low human health priority||Environment Canada Domestic Substance List|
|Known human carcinogen||Int'l Agency for Research on Cancer (IARC) - Carcinogens|
|Known human carcinogen||NTP Report on Carcinogens, 11th Edition|
|Possible human carcinogen||EPA Integrated Risk Information System (IRIS)|
|Possible human carcinogen||California EPA Proposition 65|
|Possible human carcinogen||Amer Conf of Gov't Industrial Hygienists - Carcinogens|
|Limited evidence of carcinogenicity||NIOSH Occupational Carcinogens|
|Limited evidence of carcinogenicity||CPS&Q - Classification & Labelling|
|Violation of government restrictions - Banned or found unsafe for use in cosmetics||CosIng|
|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 cosmetics||Canada - Prohibited and Restricted Cosmetics Ingredients|
|Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - any||CosIng|
|Recommendation to minimize use in cosmetics - Keep concentration to minimum: warning from industry safety panel||Cosmetic Ingredient Review Assessments|
|Determined safe for use in cosmetics, subject to concentration or use limitations - Safe for use in cosmetics with some qualifications||Cosmetic Ingredient Review Assessments|
|Allowed workplace exposures restricted to low doses||CPS&Q - Classification & Labelling|
|Human immune and respiratory toxicant or allergen - strong evidence||Association of Occupational and Environmental Clinics|
|Human skin toxicant or allergen - strong evidence||Cosmetic Ingredient Review Assessments|
|Limited evidence of immune system toxicity or allergies||CPS&Q - Classification & Labelling|
|Limited evidence of immune system toxicity or allergies||National Library of Medicine HazMap|
Irritation (skin, eyes, or lungs)
|Limited evidence of skin irritation||National Library of Medicine HazMap|
|Suspected to be an environmental toxin||Environment Canada Domestic Substance List|
|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 Assessments|
|55688 studies in PubMed science library may include information on the toxicity of this chemical||NLM PubMed|
|Occupational hazards related to handling||CPS&Q - Classification & Labelling|
Multiple, additive exposure sources
|Designated as safe for general or specific, limited use in food||FDA Everything Added to Food|
|Designated as safe for general or specific, limited use in food||FDA Food Additive Status|
|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
|Not suspected to be persistent||Environment Canada Domestic Substance List|
|Not suspected to be bioaccumulative||Environment 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 — 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.
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
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.
The Skin Deep data availability rating reflects the number of scientific studies about the product or ingredient in the published scientific literature.