Last Updated on July 7, 2022 by Ithos Global Regulatory Team
As of January 1, 2022, New York State has banned all but trace amounts of 1,4 Dioxane in cosmetics, personal care, and cleaning products. The ban starts with a phase-down schedule: permissible levels of the substance will start at 10 parts per million (ppm) for cosmetics, going down to 1ppm for certain personal care and cleaning products by the end of 2023.
Though the 1,4 Dioxane is not added directly to consumer product formulas, the synthetic industrial chemical can be introduced as a trace contaminant in certain ingredients, most significantly detergents, foaming agents, emulsifiers and solvents. They are identifiable as:
- Polyethylene Glycol
The law has separate limitations for three categories of consumer products: cosmetics, personal care, and household products. The latter two are known to generally contain higher levels of 1,4 Dioxane.
How to Comply, Suggested Next Steps, and Tips
To meet the law’s phase-down schedule, Ithos recommends the following:
- Determine the specification of 1,4 Dioxane in your raw materials, especially the ones that fall into the above categories. This should be based on a guaranteed maximum specification and not a one time test level.
- Review each formula and determine/calculate the total 1,4 Dioxane content in ppm. Analytical testing on certain bases or formulas can also help to get an idea of levels of 1,4 Dioxane. Remember that levels can vary lot to lot.
- Compare the result in Step 2 to the product category and the maximum allowable limit for the relevant product classification.
- Work with your raw material supplier to try to set a lower maximum level if possible.
- Update your internal ingredient policy and train internal technical teams, suppliers, and third party manufacturers on the updates to the policy.
- Reformulate as required. Utilize restages where possible to formulate without sulfates.
Have questions? Contact us.
Manufacturers may apply for a one-year waiver for a specific product if they are able to submit proof that they have taken steps to reduce the presence of 1,4 Dioxane and are still unable to meet the statutory limits.
Upon the expiration of a waiver, any product that contains 1,4-dioxane in excess of the maximum trace concentrations in the law cannot be sold in the State.
Non-compliance with this law can result in these civil penalties:
- $1000 per day per violation
- $2500 per day per violation for second violations
More detail about the 1,4 Dioxane ban
The law describes cosmetics as any article 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, as well as any substance intended for use as a component of a cosmetic product
Personal care products will be defined under the new New York State law 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. This does not include any products that require a prescription for distribution.
The law also sets limits for 1,4 Dioxane in household cleaning products, which includes soaps and detergents containing a surfactant as an emulsifying agent, and used primarily for domestic or commercial cleaning purposes.
- March 2019: New York State bill is introduced.
- June 2019: Bill passed by NY State Assembly and Senate.
- December 2019: Signed into law by Governor Cuomo.
- January 1, 2022: Law goes into effect. The maximum amount of 1,4 Dioxane allowed will be:
- Cosmetics: 10 ppm by December 31, 2022.
- Personal care and household cleaning products: 2 ppm by December 31, 2022, further reduced to 1 ppm by December 31, 2023.
Every two years after the bill goes into effect, trace concentration thresholds will be reviewed and determined whether such concentration needs to be lowered to better protect human health and the environment.
This is not the first time 1,4 Dioxane has become subject to regulation. In California, the substance is on the CA Prop 65 list and may be entered into raw material attributes in the IIN, if applicable.
1,4 Dioxane has an NSRL (no significant risk level) of 30 micrograms/day. To ensure full compliance with CA Prop 65 labeling requirements, a calculation should be done to determine the micrograms/day of exposure based on the 1,4 Dioxane level and reasonably expected maximum daily use of the product.
Please watch the Ithos Newsletter for any updates. Please contact Ithos if you need assistance with the NYS 1,4 Dioxane waiver process.
For more information on the 1,4 Dioxane ban, visit the New York State Department of Environmental Conservation.