Personal Care and Cleaning Products Containing 1,4-Dioxane

We propose listing one or more Priority Products related to Personal Care and Cleaning Products Containing 1,4-Dioxane. These products fall within two product categories included in DTSC’s Priority Product Work Plan – the Beauty, Personal Care, and Hygiene Products category and the Cleaning Products category.

Rationale for Priority Product Listing

1,4-Dioxane is a persistent, mobile, and toxic (PMT) chemical that is a possible carcinogen and toxic to the liver, kidney, respiratory system, and nervous system. 1,4-Dioxane is very soluble in water and mobile in both water and soil.

The manufacture of ethoxylated surfactants produces 1,4-dioxane as a byproduct. Many personal care and cleaning products contain ethoxylated surfactants, which function as emulsifiers, wetting agents, detergents, foaming agents, or dispersants.

Californians who use personal care and cleaning products contaminated with 1,4-dioxane may be exposed to 1,4-dioxane from multiple exposure routes or various products. Home use of personal care and cleaning products containing 1,4-dioxane contributes to both inhalation and dermal exposures through activities such as dishwashing and bathing. Workers (e.g., janitors) who use cleaning products on a routine basis are expected to have greater exposure to 1,4-dioxane than the general population.

Consumer products are also a significant source of 1,4-dioxane in wastewater treatment plants and residential septic tank wastewater. Most standard forms of wastewater and drinking water treatment do not remove 1,4-dioxane. Concern about the presence of 1,4-dioxane in treated wastewater has grown as recycled water is increasingly reused for drinking water production.

Based on the criteria in the Safer Consumer Products Regulations, we have determined that personal care and cleaning products containing 1,4-dioxane have the potential to cause or contribute to exposures to 1,4-dioxane and associated significant and widespread adverse impacts to Californians — particularly those living in vulnerable communities, workers, and children — as well as to agencies that produce recycled water.

More details can be found in the Draft Product-Chemical Profile.

Public Engagement

On August 20, 2024 we held a workshop to receive public input on our proposal to regulate Personal Care and Cleaning Products Containing 1,4-Dioxane as Priority Products. The comment period for this proposal is open on the CalSAFER website until 11:59 p.m. PDT on September 17, 2024. Materials from this workshop are available on our 2024 Workshops and Events Webpage.

On June 28, 2019, we hosted a workshop to request public input on our Background Document on 1,4-dioxane in personal care and cleaning products. View here the workshop video and transcript.

On August 21, 2019, we hosted another workshop to receive input. This day-long meeting included presentations, round table discussion, and a panel discussion focused on options for and impediments to lowering 1,4-dioxane in personal care and cleaning products and considerations for setting an Alternatives Analysis Threshold. If interested, view the workshop video.

Our current regulatory proposal is informed by the input received during these two workshops and the public comment period between May 24 and August 30, 2019.

DTSC’s Safer Consumer Products program and Environmental Chemistry Lab worked with New York’s Department of Environmental Conservation (DEC) to develop draft Method Performance Criteria (MPC) for 1,4-dioxane. DEC has released the final MPC following a public comment period that informed their work on 1,4-dioxane.  These criteria will be incorporated into any regulations that DTSC pursues related to 1,4-dioxane as a part of larger guidance on the Alternatives Analysis Threshold (AAT).

1,4-Dioxane Question and Answer

What are the first products that DTSC will be regulating under this proposal?

DTSC is considering shampoo containing 1,4-dioxane and manual dishwashing soap containing 1,4-dioxane as the first two Priority Products.

We are considering limiting the scope of the proposed Priority Products to 1,4-dioxane in manual dishwashing soap that uses ethoxylated substances or 1,4-dioxane in shampoos that use ethoxylated, sulfated substances. These specific ingredients have a high likelihood of 1,4-dioxane being present as a contaminant.

What is an Alternatives Analysis Threshold level and what are the requirements?

The Alternatives Analysis Threshold (AAT) is the maximum concentration of a Chemical of Concern that a Priority Product may contain to request an exemption from the Alternatives Analysis requirement. When a Chemical of Concern is present in a Priority Product only as a contaminant at a concentration at or below the AAT, the product’s manufacturer may request an exemption from conducting an Alternatives Analysis by submitting an AAT Notification in addition to submitting a Priority Product Notification (PPN). While a PPN is due within 60 days of the effective date of a Priority Product listing regulation, the AAT Notification may be submitted along with the PPN or within 180 days of the effective date of a Priority Product listing regulation.

What is the timeline for the rulemaking?

We plan to initiate rulemaking for our first two Priority Products in 2025. The rulemaking process takes up to one year.

Will DTSC be providing a list of ingredients that contain 1,4-dioxane as an impurity?

Appendix C in the Draft Product-Chemical Profile includes a table with many ingredients that may contain 1,4-dioxane. However, we are not able to provide an exhaustive list of ingredients that may be contaminated with 1,4-dioxane.

Do chemical manufacturers or ingredient suppliers have to comply?

DTSC has not initiated the rulemaking process yet for any Priority Products containing 1,4-dioxane. However, once Priority Products are adopted through the rulemaking process, the responsibility to comply falls first on manufacturers of the Priority Product. If a manufacturer fails to comply, the responsibility shifts to importers or retailers, who may comply by ceasing to order noncompliant products.

The Safer Consumer Products (SCP) Regulations define a manufacturer as “any person who manufactures a product that is subject to the requirements of this chapter, or any person that controls the manufacturing process for, or specifies the use of chemicals to be included in, that product.” (See 22 CCR section 69501.1(a)(44).)

Will there be a grace period after the regulations go into effect before compliance testing begins?

Compliance testing may begin at any time after the effective date of a Priority Product listing regulation.

Are Alternatives Analysis Threshold Notification submissions made public? Can portions of them be protected as confidential business information?

Submissions are published through our CalSAFER website and made publicly available. If you desire to make any claims for trade secret protection, please refer to Article 9 of the SCP Regulations for guidance on asserting such claims. You can also reach out to us at SaferConsumerProducts@dtsc.ca.gov.

Is compliance required if 1,4-dioxane is not in the finished product?

DTSC has not yet listed any Priority Products containing 1,4-dioxane. However, once Priority Products are listed through rulemaking, a product that does not contain any amount of 1,4-dioxane is not considered a Priority Product and the manufacturer does not need to comply with the SCP Regulations’ requirements for that product.