The Legislature enacted amendments to Environmental Conservation Law (ECL) Article 35 and Article 37 to establish limits on the amount of 1,4-dioxane that can be present in household cleansing, personal care, and cosmetic products sold or offered for sale in New York State. The law establishes a maximum allowable concentration of 2 ppm of 1,4 dioxane on December 31, 2022, and 1 ppm on December 31, 2023, for household cleansing and personal care products. The law also establishes maximum allowable concentration of 10 ppm of 1,4 dioxane on December 31, 2022, for cosmetics.
Regulations
On December 6, 2023, DEC proposed regulations that would add a new subpart 352-1 to implement the amendments to Article 35 and Article 37 of the ECL (the Law). Specifically, these regulations establish a process for the waiver provision provided for in the Law, define the scope of covered products, and establish a standardized method of quantifying the 1,4-dioxane in covered products. A public hearing was held on February 6, 2024.
The public comment period closed on February 12, 2024. Comments received were addressed and the final regulations were adopted on September 18, 2024. View the rulemaking documents
Covered Products
The regulations apply to cosmetic products, household cleansing products, and personal care products, as defined below:
"Cosmetic product" means any article (1) 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 (2) intended for use as a component of any such article. The term ‘cosmetic product’ shall not include any personal care product as defined in this section for which a prescription is required for distribution or dispensation as provided in section 281 of the Public Health Law or section 6810 of the Education Law.
"Household cleansing product" means any product, including but not limited to, soaps and detergents, which contain a surfactant as a wetting or dirt emulsifying agent and are used primarily for domestic or commercial cleaning purposes, including but not limited to, the cleansing of fabrics, dishes, food utensils, automobiles, and household and commercial premises. Household cleansing product shall not mean:
(1) foods, drugs, and cosmetics, and personal care products as defined in this Subpart;
(2) products labeled, advertised, marketed, and distributed for use primarily as pesticides, as defined in article 33 of the Environmental Conservation Law; or
(3) cleansing products used primarily in industrial manufacturing, production and assembling processes.
"Personal care product" means 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. The term ‘personal care product’ shall not include any product for which a prescription is required for distribution or dispensation as provided in section 281 of the Public Health Law or section 6810 of the Education Law.
1,4-Dioxane Waivers Expire December 30, 2025
The law and regulations allowed for a manufacturer to apply for a waiver from complying with the 1,4-dioxane limits based on the submission of proof to DEC that the manufacturer has taken steps to reduce the presence of 1,4-dioxane in their product or products and is still unable to comply with the limits in the law. Under the regulations, no waiver will be effective after December 30, 2025, and all products will need to comply with the limits.
Information about waivers, including waivers that expired in 2023, 2024 and that will expire in 2025, can be found here: 1,4-Dioxane Waivers. The information provided includes the name of the manufacturer, the product name, and the most recent amount of 1,4-dioxane present in each product, which was provided by the manufacturers in their waiver applications.
Questions about waivers may be directed to [email protected]
What is 1,4-Dioxane and Why Don’t I See it on Ingredient Labels?
1,4-dioxane is a clear liquid that has a faint, pleasant odor and mixes easily with water. The compound is often a trace contaminant found in certain products, such as cosmetic, personal care, and household cleansing products, and can be present in these products in extremely small amounts. It is important to monitor and test for this compound in products because it has been linked to adverse human health effects such as cancer and birth defects.
1,4-dioxane is not listed as an ingredient in products because it is a manufacturing byproduct, not an intentionally added ingredient. A manufacturing byproduct is a secondary, incidental material that is created during the production of a primary product that may be found in a finished product unless actions are taken to remove it.
1,4-dioxane primarily forms as a byproduct during the manufacturing process of certain ingredients such as detergents, foaming agents, and emulsifiers. The United States Food & Drug Administration (FDA) identified terms and phrases as indicators that the ingredients may contain 1,4-dioxane:
- PEG compounds;
- Polyethylene or Polyethylene glycol;
- Polyoxyethylene;
- “-eth-”;
- “-oxynol-”.
Other ingredients that could contribute to the formation of 1,4-dioxane include:
- Sodium laureth sulfate
- Ingredients containing the clauses “xynol,” “ceteareth,” and “oleth.”
An important note: Just because a product contains one of these ingredients does not mean that product contains 1,4-dioxane. A product needs to be tested to determine if it contains 1,4-dioxane.
Periodic Review
In accordance with section 35-0105, subdivision 5 and section 37-0117, subdivision 5 of the Environmental Conservation Law (ECL), the Department is required to review the trace concentration thresholds of 1,4-dioxane and determine whether such concentrations shall be lowered to better protect human health and the environment. This review is to take place by May 1, 2025, and every two years thereafter, and is to be conducted in consultation with the Department of Health.
The Department has completed this review and has found that the trace concentrations allowed under ECL sections 35-0105 and 37-0117 are sufficiently protective of human health and the environment. A memo documenting the review is provided (PDF).
