Formaldehyde and Formaldehyde-Releasing Preservatives
Formaldehyde and formaldehyde-releasing preservatives are used in many personal care products (i), particularly in shampoos and liquid body soaps. These chemicals help prevent bacteria from growing in water-based products, but can be absorbed through the skin and have been linked to both skin sensitivity and cancer.
Formaldehyde is used as an ingredient in nail polishes, nail glues, eyelash glues, hair gels and many other personal care products (ii), and has recently been found in hair-smoothing products. Personal care products such as baby shampoo, baby soap and body washes may contain formaldehyde even though it is not listed as an ingredient. That’s because these products may contain formaldehyde-releasing preservatives (FRPs).
The European Union restricts the use of formaldehyde in personal care products, and requires that products with formaldehyde or formaldehyde-release ingredients carry the label “contains formaldehyde (iii).” Canada also restricts the concentration of formaldehyde (iv), and it is banned from use in cosmetics and toiletries in both Japan and Sweden (v).
Formaldehyde can be added to products as an ingredient or released from formaldehyde-releasing preservatives such as quaternium-15 (vi). Formaldehyde-releasing preservatives are commonly used in place of formaldehyde, and release small amounts of formaldehyde over time (vii, viii). Quaternium-15 is the most sensitizing of these FRPs. Other formaldehyde-releasing preservatives include dimethyl-dimethyl (DMDM) hydantoin, imidazolidinyl urea, diazolidinyl urea, sodium hydroxymethylglycinate, and 2-bromo-2-nitropropane-1,3-diol (bronopol). Since low levels of formaldehyde can cause health concerns – at levels as low as 250 parts per million (x), and even lower levels in sensitized individuals (xi) – the slow release of small amounts of formaldehyde are cause for concern.
Formaldehyde in cosmetics is widely understood to cause allergic skin reactions and rashes in some people (xii, xiii, xiv). Although concentrations of formaldehyde in personal care products are generally low, everyday products can contain enough formaldehyde to trigger a reaction in people with formaldehyde sensitivities (xv). Formaldehyde sensitivity may develop over time, due to repeated low-level exposures from an early age (xvi).
Formaldehyde is considered a known human carcinogen by many expert and government bodies, including the United States Department of Health and Human Services (xvii) and the International Agency for Research on Cancer (xviii). A recent review of the literature on occupational exposures and formaldehyde shows a link between formaldehyde and leukemia (xix).
Most studies of the cancer potency of formaldehyde have focused on risks from inhaling it; cancer risks from ingesting formaldehyde or absorbing it through the skin are not as well studied (xx). When formaldehyde is present in personal care products, people can be exposed by inhaling the formaldehyde that is off-gassed from the product, by ingesting it or by absorbing it through the skin. Animal studies indicate that formaldehyde can be absorbed through the skin when formaldehyde-containing personal care products, including formaldehyde releasing preservatives, are applied (xxi).
i Moennich JN, Hanna DM, Jacob SE (2009). Formaldehyde-releasing preservative in baby and cosmetic products. Journal of the Dermatology Nurses’ Association 1:211-214.
ii Environmental Working Group. Skin Deep. Formaldehyde. Available online: http://www.cosmeticsdatabase.com/ingredient/702500/FORMALDEHYDE/. Accessed October 16, 2009.
iii Scientific Committee on Cosmetic Products and Non-food Products. Opinion concerning a clarification on the formaldehyde and para-formaldehyde entry in Directive 76/768/EEC on cosmetic products. Opinion: European Commission. 2002. Available at http://ec.europa.eu/food/fs/sc/sccp/out187_en.pdf. Accessed October 16, 2009.
iv Other uses of formaldehyde have different restrictions in Canada. For example, nail hardeners may contain concentrations equal to or less than 5% and oral care products may contain concentrations equal to or less than 0.1%. Formaldehyde is not permitted in aerosol cosmetics. See Canada’s Cosmetic Ingredient Hotlist, March 2007. www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-critique/hotlist-liste_1-eng.php. Accessed October 16, 2009.
v Amparo S and Chisvert A, editors. Analysis of Cosmetic Products. Elsevier. Amsterdam. 2007. p. 215.
vi Environmental Working Group. Skin Deep. Formaldehyde. Available online: http://www.cosmeticsdatabase.com/ingredient/705478/QUATERNIUM-15/. Accessed October 16, 2009.
vii Moennich JN, Hanna DM, Jacob SE (2009). Formaldehyde-releasing preservative in baby and cosmetic products. Journal of the Dermatology Nurses’ Association 1:211-214.
viii Jacob SE, Breithaupt A (2009). Environmental Exposures – A pediatric perspective on allergic contact dermatitis. Skin & Aging. July 2009: 28-36.
ix Moennich JN, Hanna DM, Jacob SE (2009). Formaldehydy-releasing preservative in baby and cosmetic products. Journal of the Dermatology Nurses’ Association 1:211-214.
x Flyvholm MA, Hall BM, Agner T, Tiedemann E, Greenhill P, Vanderveken W, Freeberg FE, Menné T. Threshold for occluded formaldehyde patch test in formaldehyde-sensitive patients. Relationship to repeated open application test with a product containing formaldehyde releaser. Contact Dermatitis. 1997;36(1):26-33.
xi Jordan WP Jr., Sherman WT, King SE. Threshold responses in formaldehyde-sensitive subjects. J Am Acad Dermatol. 1979;1(1):44- 8. Also confirmed by personal communication between Dr. Sharon Jacob and Stacy Malkan, February 26, 2009.
xii Flyvholm MA, Menné T. Allergic contact dermatitis from formaldehyde. A case study focusing on sources of formaldehyde exposure. Contact Dermatitis. 1992 Jul;27(1):27-36.
xiii Boyvat A, Akyol A, Gürgey E. Contact sensitivity to preservatives in Turkey. Contact Dermatitis. 2005;52(6):333-337.
xiv Pratt MD, Belsito DV, DeLeo VA, Fowler JF Jr, Fransway AF, Maibach HI, Marks JG, Mathias CG, Rietschel RL, Sasseville D, Sherertz EF, Storrs FJ, Taylor JS, Zug K. North American Contact Dermatitis Group patch-test results, 2001-2002 study period. Dermatitis. 2004;15(4):176-83. Erratum in: Dermatitis. 2005;16(2):106.
xv Australian Government Department of Health and Ageing. Priority Existing Chemical Assessment Report No. 28: Formaldehyde. November 2006. Page 193. Available at: http://www.nicnas.gov.au/Publications/CAR/PEC/PEC28/PEC_28_Full_Report_PDF.pdf. Accessed January 9, 2009.
xvi Jacob SE and Steele T. Avoiding Formaldehyde Allergic Reactions In Children. Pediatric Annals 2007;36(1):55-6.
xvii U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program. ”Formaldehyde (Gas) CAS No. 50-00-0: Reasonably anticipated to be a human carcinogen.” Eleventh Report on Carcinogens. December 2002. Available at: http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s089form.pdf. Accessed October 16, 2009.
xviii International Agency for Research on Cancer. “IARC classifies formaldehyde as carcinogenic to humans.” Press release. June 15, 2004. www.iarc.fr/en/Media-Centre/IARC-Press-Releases/Archives-2006-2004/2004/IARC-classifies-formaldehyde-as-carcinogenic-to-humans. Accessed January 9, 2009.
xix Zhang et al 2009. Meta-analysis of formaldehyde and hematologic cancers in humans. Mutation Research 681: 150-168.
xx Australian Government Department of Health and Ageing. Priority Existing Chemical Assessment Report No. 28: Formaldehyde. November 2006. Page 68. Available at: http://www.nicnas.gov.au/Publications/CAR/PEC/PEC28/PEC_28_Full_Report_PDF.pdf. Accessed January 9, 2009.
xxi Bartnik FG, Gloxhuber C, Zimmermann V. Percutaneous absorption of formaldehyde in rats. Toxicol Lett. 1985;25(2):167-72.