Reviewed and Approved by Matt Traynor, PhD, Vice President, Innovation and Validation, Certified Laboratories
1-Minute Summary
- New York state enforces a 1,4-dioxane limit of 10 ppm in cosmetics and 1 ppm in personal care products.
- USP <467> and EPA Method 8270 aren’t sensitive enough without modification.
- Certified Laboratories offers a validated GC-MS method with a 0.5 ppm LOD.
- Sub-ppm testing helps you stay compliant today and prepare for lower limits tomorrow.
1,4-Dioxane Limits in New York are Strict – and Could Get Stricter
Cosmetic and personal care product manufacturers are well aware of New York’s 1,4-dioxane limit established in the state’s Environmental Conservation Law back in 2019. The legislation set maximum allowable levels of 1,4-dioxane in household cleansing, personal care products, and cosmetics at the following levels:
Household Cleansing and Personal Care Products
- ≤ 2 ppm after Dec. 31, 2022
- ≤ 1 ppm after Dec. 31, 2023
Cosmetics
- ≤ 10 ppm after Dec. 31, 2022
In addition, the law includes a “future-rule” clause, which allows the New York State Department of Environmental Conservation (NYS DEC) to lower these limits further if a lower level is determined to be technically feasible.
This means these strict limits could become even more strict.
A National Trend, Not Just a State Issue
New York is one of many states that have passed or are considering legislation that limits or bans certain potentially toxic compounds. We recently told you about the various state laws regarding heavy metals in cosmetics.
PFAS is also in the crosshairs of many states, as are formaldehyde and other compounds. For national brands, the lack of U.S. federal regulations (despite the enactment of MoCRA not long ago) is creating a regulatory patchwork that makes compliance even more difficult.
The Challenge of Detecting 1,4-Dioxane Down to 1 PPM
Speaking of difficulties, testing cosmetic and personal care products for 1,4-dioxane at levels of 1 PPM or lower certainly qualifies. Trying to detect any analyte at such minute levels is a challenge even with modern instruments and methods.
For years, many manufacturers relied on the USP <467> Residual Solvents method for 1,4-dioxane. However, this method offers a Limit of Detection (LOD) of only 380 ppm, depending on the matrix, which clearly doesn’t satisfy New York state law.
The New York State Department of Environmental Conservation refers to EPA Method 8270, which can technically detect 1,4-dioxane at much lower levels than USP <467>, but only with modifications, which introduces variability and can slow turnaround times.
As a result, manufacturers need a validated method with an LOD capable of meeting New York’s requirements (and potential future requirements of other jurisdictions) without the hassle of modifications.
Validated Method for 1,4-Dioxane Testing in Cosmetics and Personal Care Products
Certified Laboratories now offers an internally validated Gas Chromatography Mass Spectrometry (GC-MS) method with a Limit of Detection of 0.5 ppm for 1,4-dioxane.
- Designed for cosmetic and personal care product matrices.
- Provides sub-ppm detection capability.
- Meets today’s strict regulatory requirements while anticipating the regulatory demands of tomorrow.
- Competitive TAT across a wide range of matrices.
Contact our team now to discuss your testing needs.
Why 1,4-Dioxane Shows Up at All
It’s worth spending a couple minutes on a 1,4-dioxane refresher course.
Unlike intentionally added ingredients, 1,4-dioxane is a process-related contaminant. It forms as a by-product during ethoxylation, a chemical reaction used to make surfactants milder and more water-soluble.
Common ingredient categories that may carry residual 1,4-dioxane are identifiable by the following prefixes or words:
- PEG
- Polyethylene
- Polyethylene glycol
- Polyoxyethylene
- -eth-
- -oxynol-
These surfactants are used in many products including shampoos, facial cleansers, moisturizers, and bath products. Contamination typically originates in raw materials and carries through to finished goods.
The compound itself is classified as a Group 2B carcinogen (“possibly carcinogenic to humans”) by the International Agency for Research on Cancer.
Supplier Documentation Isn’t Always Enough
Manufacturers sometimes rely on a Certificates of Analysis (CoA) from the supplier to confirm compliance. However, many CoAs either don’t include tests for 1,4-dioxane or may reflect methods with detection limits above 1 ppm for personal care products or 10 ppm for cosmetics.
That leaves brands vulnerable to enforcement actions, including fines.
Independent verification from a cosmetic and personal care testing lab with the right method is essential. Certified Laboratories offers that assurance with our validated 1,4-dioxane testing method for cosmetics and personal care products.