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Written By: Brettlyn Miller
Research and Writing Editor, American Journal of Trial Advocacy
Recently, the New York legislature voted to amend New York’s environmental conservation act in order to provide more stringent regulations on cosmetic and personal care products containing the ingredient 1,4-dioxane. [1]
In this legislation, New York distinguishes cosmetic products from personal care products, defining a cosmetic product as “any article (a) intended to be rubbed, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for beautifying, promoting attractiveness, or altering the appearance, and (b) intended for use as a component of any such article.” [2] A cosmetic product, the legislature notes, is not a personal care product, which is defined as “any product intended for cleaning or cleansing any part of the body, such as the skin and hair, and including but not limited to, hair shampoo, hair conditioner, soap, bath gels and other bath products.” [3]
This amendment prohibits the sale of any cosmetic product that contains 1,4-dioxane exceeding a concentration of ten parts per million (0.001%) by December 31, 2022. [4] Further, any personal care products for sale in New York will not contain a higher 1,4-dioxane concentration than two parts per million (0.0002%) by December 31, 2022. [5] This requirement becomes more strict the following year, such that the concentration should not exceed one part per million (0.0001%) by December 31, 2023. [6] Violations of this rule are punishable by a fine no greater than $1,000 per day in which a violation occurs. [7]
It should be noted that the Food and Drug Administration (“FDA”) does not have to approve cosmetic products before they can be sold, whereas personal care products are approved with the FDA before they are cleared for public sale. [8] This is why, oftentimes, suspected toxins are banned from personal care products before they are banned from cosmetic products, as the FDA regulates personal care products and not cosmetic products. [9]
So, what exactly makes this solvent, 1,4-dioxane, a suspicious ingredient in both cosmetic and personal care products? 1,4-dioxane has been called a “probable carcinogen” by the Environmental Protection Agency (“EPA”). [10] To be more specific, 1,4-dioxane was classified by the EPA in 2005 as a Group B2 Agent, meaning it is “probably carcinogenic to humans” but there is “little or no human data” to sufficiently prove its carcinogenic nature. [11]
In 2011, The U.S. Department of Health and Human Services, through the National Toxicology Program, described 1,4-dioxane as “reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity from studies in experimental animals.” [12] This decision was based on multiple animal tests, which produced tumors and cancer in various species of experimental animal subjects. [13] Cancerous tumors and developments occurred whether the 1,4-dioxane exposure was via dermal exposure, oral administration, inhalation, or drinking water. [14]
Though 1,4-dioxane is not bioaccumulative nor is it bioconcentrative, meaning it does not collect, remain, or concentrate in the body for long periods of time, exposure from more than one source would likely produce more egregious effects in the long run. [15] Hence, New York’s limiting consumer exposure to 1,4-dioxane in cosmetic and personal care products comes at a good time, as the state is also unrolling a new standard for drinking water, limiting 1,4-dioxane concentration in drinking water at 1 part per billion. [16] This standard is the strictest in the nation for limiting 1,4-dioxane exposure in drinking water. [17]
The safety of certain ingredients that are commonplace in cosmetic and personal care items has been called into question before; however, New York, in providing a stringent regulation on 1,4-dioxane, helps pave the way for safer, less toxic cosmetic and personal care products throughout the nation.
[1] 2020 N.Y. Sess. Laws 6940 (McKinney).
[2] Id.
[3] Id.
[4] Id.
[5] Id.
[6] Id.
[7] Id.
[8] Matt McMillen, Banned from Soap, Is Triclosan in Your Toothpaste?, WebMD Health News (July 5, 2018), https://www.webmd.com/beauty/news/20180705/banned-from-soap-triclosan-in-toothpaste.
[9] Id.
[10] EPA, 1,4-Dioxane (1,4-Diethyleneoxide), https://www.epa.gov/sites/production/files/2016-09/documents/1-4-dioxane.pdf.
[11] EPA, Risk Assessment for Carcinogenic Effects, https://www.epa.gov/fera/risk-assessment-carcinogenic-effects.
[12] U.S. Department of Health and Human Services National Toxicology Program, Report on Carcinogens, Wayback Machine (Apr. 25, 2014), https://web.archive.org/web/20140425233701/http://ntp.niehs.nih.gov/ntp/roc/twelfth/roc12.pdf.
[13] Id.
[14] Id.
[15] EPA, Technical Fact Sheet—1,4-Dioxane Nov. 2017, https://www.epa.gov/sites/production/files/2014-03/documents/ffrro_factsheet_contaminant_14-dioxane_january2014_final.pdf.
[16] Governor’s Press Office, Governor Cuomo Announces First in the Nation Drinking Water Standard for Emerging Contaminant 1,4-Dioxane, New York State (July 30, 2020), https://www.governor.ny.gov/news/governor-cuomo-announces-first-nation-drinking-water-standard-emerging-contaminant-14-dioxane.
American Journal of Trial Advocacy 
