Demystifying 1,4 Dioxane: What you need to know

Lately, the regulatory spotlight has been shining on one particularly confusing chemical in consumer products: 1,4-dioxane.

Both California and New York have already issued new guidance targeting 1,4 dioxane. These new restrictions will mean that both retailers and suppliers need to pay attention to where the substance may be, and be ready to confirm that it is not in their products at a certain level.  So, we’ve put together a quick look at the reasons behind the urgency around 1,4 dioxane and some tips for how to stay ahead of the curve.

1,4 dioxane: What is it? And why does it matter?

1,4-dioxane is a substance that can be created when making detergents, soaps, and creams, and it’s now considered an environmental contaminant and a probable human carcinogen. 1,4-dioxane contamination can occur rather easily – as a byproduct of the manufacturing processes when making these products. It is also intentionally used at higher concentrations as a solvent in industrial manufacturing processes. Studies have also shown that the harmful substance can easily dissolve in water, which means it could be found in unsafe amounts in drinking water.

All of this has, naturally, made consumers and regulatory bodies worried about finding it in things they use and its possible effects on our health. However a risk evaluation published by the US EPA in 2020 found no unreasonable risks to consumers or bystanders from any conditions of use, including eight consumer uses of surface cleaners, laundry/dishwashing detergents, and paint/floor lacquer where 1,4-dioxane is present as a byproduct.

Regulatory changes and how to keep up

While there is still a lot of unknown around the future of 1,4 dioxane, specific new regulations have started to gain traction. The Food and Drug Administration had previously encouraged suppliers to minimize 1,4-dioxane content, but New York has now taken a proactive approach by implementing a restriction on dioxane contamination levels in products. As of December 31, 2022, cleaning and personal care products are limited to 2 parts per million (ppm), while cosmetics are limited to 10 ppm. And the cleaning and personal care limit was set to reduce to 1 ppm by December 31, 2023.

1,4-dioxane has also been getting attention because of the California Cleaning Product Right-To-Know Act of 2017. Under this new regulation, it must be disclosed on a products website as a “nonfunctional constituent” when  it's present at or above 10 parts per million (ppm). Since this chemical is also a carcinogen on the California Proposition 65 list, it might be subject to labeling requirements even below this threshold.

There a few simple - but crucial - steps both suppliers and retailers can take to stay ahead of these changes:

• Brush up on which product categories are affected by these bans. You can find product categories that are likely to fall under the ban on the NY State Department of Conservation website.
• Suppliers: Be ready with specific evidence proving the dioxane content for your products is below the allowable threshold. If a product uses a “ethoxylated” ingredient (commonly employed in the production of personal care, household care products) it might contain a regulated amount of 1,4 dioxane. Determine which products you have contain these ingredients, so you can narrow down which items you need to obtain evidence for and make sure you have that on-hand.
• Retailers: Maintain an open-line of communication with suppliers. Your suppliers know their products’ best and have the information you need to prove that the dioxane levels are below allowable thresholds.

The NY Dioxane Ban, along with evolving regulatory guidelines, can be confusing to navigate and leave more questions than answers. Lean on your suppliers, retailers and regulatory partners to help translate and prepare for these new guidelines as effectively as possible.

By staying informed and maintaining close collaboration with your partners, you can successfully navigate these regulations, avoid costly fines or product delays, and provide consumers with safe and transparent choices.

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