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FORMALDEHYDE


image source: PubChem
Health Concerns of the Ingredient:
Overall Hazard
 
 
 
 
Developmental &
reproductive toxicity
 
 
 
Other HIGH concerns: Organ system toxicity (non-reproductive), Occupational hazards; Other LOW concerns: Data gaps, Ecotoxicology, Irritation (skin, eyes, or lungs)

About FORMALDEHYDE: 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 ... read more

Possible impurity in: DMDM HYDANTOIN (FORMALDEHYDE RELEASER) (2,754 products), DIAZOLIDINYL UREA (FORMALDEHYDE RELEASER) (2,433 products), IMIDAZOLIDINYL UREA (FORMALDEHYDE RELEASER) (1,172 products), TOSYLAMIDE/ FORMALDEHYDE RESIN (771 products), QUATERNIUM-15 (FORMALDEHYDE RELEASER) (588 products), SODIUM HYDROXYMETHYLGLYCINATE (FORMALDEHYDE RELEASER) (405 products), 2-BROMO-2-NITROPROPANE-1,3-DIOL (FORMALDEHYDE RELEASER) (191 products), POLYOXYMETHYLENE UREA (FORMALDEHYDE RELEASER) (85 products), 5-BROMO-5-NITRO-1,3 DIOXANE (FORMALDEHYDE RELEASER) (13 products), METHENAMINE (FORMALDEHYDE RELEASER) (8 products), see all ingredients | products

Function(s): Cosmetic Biocide; Denaturant; Preservative

Synoym(s): FORMALIN; FORMIC ALDEHYDE; MERTHALDEHYDE; METHANAL; METHYL ALDEHYDE; OXOMETHANE; OXYMETHYLENE; ALDEHYD MRAVENCI (CZECH) ; ALDEHYDE FORMIQUE (FRENCH) ; ALDEIDE FORMICA (ITALIAN) ; BFV

Cancer

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

Use restrictions

Concern Reference
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) (only for products that may be aerosolized (airborne))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 - CosIng
Determined safe for use in cosmetics, subject to concentration or use limitations - Safe for use in cosmetics with some qualificationsCosmetic Ingredient Review Assessments
Recommendation to minimize use in cosmetics - Keep concentration to minimum: warning from industry safety panelCosmetic Ingredient Review Assessments

Allergies/immunotoxicity

Concern Reference
Human immune and respiratory toxicant or allergen - strong evidence (only for )Association of Occupational and Environmental Clinics
Human skin toxicant or allergen - strong evidenceCosmetic Ingredient Review Assessments
Limited evidence of immune system toxicity or allergies (only for products for use on skin)European Union - Classification & Labelling
Limited evidence of immune system toxicity or allergiesNational Library of Medicine HazMap

Organ system toxicity (non-reproductive)

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 harmful (only for products for use on skin; products for use around the mouth; products for use on the lips; products that may be aerosolized (airborne))European Union - Classification & Labelling
Limited evidence of respiratory toxicityNational Library of Medicine HazMap
Limited evidence of sense organ toxicityEuropean Economic Community
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

Occupational hazards

Concern Reference
Allowed workplace exposures restricted to low dosesEuropean Union - Classification & Labelling

Irritation (skin, eyes, or lungs)

Concern Reference
Limited evidence of skin irritationNational Library of Medicine HazMap

Ecotoxicology

Concern Reference
Suspected to be an environmental toxinEnvironment Canada Domestic Substance List

Multiple, additive exposure sources

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

Miscellaneous

Concern Reference
Occupational hazards related to handlingEuropean Union - Classification & Labelling

Persistence and bioaccumulation

Concern Reference
Not suspected to be persistentEnvironment Canada Domestic Substance List
Not suspected to be bioaccumulativeEnvironment Canada Domestic Substance List

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 productCosmetic Ingredient Review Assessments
49,808 studies in PubMed science library may include information on the toxicity of this chemical see search results ->NLM PubMed

Data Sources

ACGIH (American Conference of Governmental Industrial Hygienists) 2008. ACGIH cancer classification system. www.acgih.org.
AOEC (Association of Occupational and Environmental Clinics). 2009. AEOC exposures codes and asthmagen designation.
CIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
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.
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.
EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.
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.
EPA (U.S. Environmental Protection Agency). 1999. Toxics Release Inventory Program. PBT Chemical Rule.
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). 2008. Integrated Risk Information System (IRIS). Evidence for human carcinogenicity based on 1986-2005 guidelines.
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/ .
European Economic Community. Sensitizing Substances in the EEC List of Dangerous Substances. Annex I to Council Directive 67/548/EEC. http://www.kemi.se/default_eng.cfm?page=klass_mark/klasshem_eng.htm, US EPA, Air Risk Information Support Center. Health Effects Notebook for Hazardous Air Pollutants. http://www.epa.gov/ttnatw01/hlthef/hapindex.html, Harvell, J., M. Bason and H. Maibach. Contact Urticaria and its Mechanisms. Food Chemistry and Toxicology 32(2): 103-112. 1994. (Table 2: Substances identified as capable of causing contact urticaria)., A Relational Database of Hazardous Chemicals and Occupational Diseases. Browse Haz-Map by Adverse Effects http://hazmap.nlm.nih.gov/hazmapadv.html, Klaassen, C., M. Amdur and J. Doull (eds.). Casarett and Doull's Toxicology. The Basic Science of Poisons, 5th Ed. Pergamon Press, NY. 1996., LaDou, J. (ed.). Occupational Medicine. Appleton & Lange, Norwalk, CN. 1990., California EPA, Office of Environmental Health Hazard Assessment. Acute Reference Exposure Levels (RELs), Averaging Times, and Toxicologic Endpoints. Includes all Acute Reference Exposure Levels (ARELs) developed by OEHHA through May 2000http://www.oehha.org/air/acute_rels/allAcRELs.html, California EPA, Office of Environmental Health Hazard Assessment. Air Toxics Hot Spots Program Risk Assessment Guidelines, Part III: Technical Support Document 'Determination of Noncancer Chronic Reference Exposure Levels'. Includes all Chronic Reference Exposure Levels (CRELs) adopted by OEHHA as of August 2003 (http://www.oehha.ca.gov/air/chronic_rels/AllChrels.html, plus draft CRELS proposed through March 2004 (http://www.oehha.ca.gov/air/chronic_rels/index.html., National Institute for Occupational Safety and Health's Registry of Toxic Effects of Chemical Substances. See Environmental Defense's Suspect Hazard Identification documentation.
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.
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.
Health Canada. 2007. List of Prohibited and Restricted Cosmetic Ingredients. Canada's Cosmetic Ingredient Hotlist. March 2007.
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).
NIOSH (National Institute for Occupational Safety and Health). 2006. NIOSH Carcinogens List (Potential occupational carcinogens). http://www.cdc.gov/niosh/npotocca.html.
NLM (National Library of Medicine). 2006. HazMap — Occupational Exposure to Hazardous Agents.
NLM (National Library of Medicine). 2012. PubMed online scientific bibliography data. http://www.pubmed.gov.
NTP (National Toxicology Program). 2005. Report on Carcinogens, Eleventh Edition; U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program.

About the ratings

EWG provides information on personal care product ingredients from the published scientific literature, to supplement incomplete data available from companies and the government. The ratings below indicate the relative level of concern posed by exposure to the ingredients in this product - not the product itself - compared to other product formulations. The ratings reflect potential health hazards but do not account for the level of exposure or individual susceptibility, factors which determine actual health risks, if any. Learn more | Legal Disclaimer