The EPA has designated 1,4-dioxane as a suspected carcinogen. Consequently, New York regulations signed into law by Gov. Andrew Cuomo in December 2019 lower the acceptable amount of 1,4-dioxane allowed in household cleaning, cosmetics and personal care products over the next two years.
The ruling imposes the following limits, in parts per million, and manufacturer deadlines for compliance. California and other high-profile states are expected to follow the ruling as well.
2 ppm, by December 31, 2022
1 ppm, by December 31, 2023
Cosmetic products
10 ppm, by December 31, 2022
Personal care products
2 ppm, by December 31, 2022
1 ppm, by December 31, 2023
Manufacturers who are not in compliance face penalties up to $1,000 per day of violation, or $2,500 per day for a second violation.
Manufacturers and raw material suppliers of these products should be proactively initiating product testing to ensure compliance by the 2022 and 2023 deadlines, as testing and possible reformulation can be time consuming.
Using the correct method for the initial batch testing is critical to accurately quantify the amount of 1,4-dioxane your products contain at this time.
SGA: We’ve heard a lot lately about 1, 4-dioxane at different levels in a variety of consumer products. Are you finding anything new from your tests?
JM: “Well, we find 1, 4-dioxane all the time…but that’s definitely NOT something new! In fact, since the 1970’s its been known that 1,4-dioxane is present in ethoxylated surfactants. As a working grad student back in the late70’s and early 80’s, I was involved in a series of consumer product research initiatives and we found 1, 4-dioxane in almost all the samples. Some as high as 2000 to 3000 parts per million.”
They’re ethoxylated surfactants…it’s a side-chain impurity that forms during the manufacturing process…we all knew about that back then and it was no surprise.
What is new and somewhat surprising are the new limits being put into law pretty quickly in New York and how manufacturers are reacting. They’re looking at risk evaluation,
re-testing the final product as well as the ingredients and possibly even re-formulation… which can get expensive”.
SGA: What’s the first thing manufacturers should do in light of the new limits
and the testing deadline?
JM: “Check your raw materials. Check the actual ethoxylated material that you’re using…the surfactant itself…for impurities. You’d be surprised how many suppliers don’t monitor the product as well as you might think. And if you do find a problem from your batch testing…and you can’t get a better product from them…then you might have to change suppliers.
SGA: Is it possible for those suppliers to create a better product?
JM: “Well, they can force changes in the synthesis process through some highly specific controls. Additionally, they can use high-efficiency vacuum stripping to take off any dioxane that has formed in this small side-reaction…OR they can switch to a non-sulfated ethoxylate all together. All of these options are typically more expensive for everyone but there’s really no choice at this point in order to get the product out within the new limits.”
SGA: What’s the latest test data you’ve seen on all these personal care products?
What should manufacturers expect to find once testing starts?
JM: “We just finished our own internal study where we went out and pulled some common products, mostly body washes and shampoos, from a variety of retail stores including supermarkets, drug chains and even a dollar store.
And what we found was interesting. There were 15 products that had dioxane in a range from 3 ppm to 7 ppm. And there were 9 products that had no dioxane present at all!
This is where things can go wrong very quickly for companies that go with an inexperienced laboratory.
SGA: How’s that?
“You must be accurate and precise. Methods developed for air, water or soil won’t work for a personal care product. Labs using such methods versus methods specifically developed and validated for personal care products will produce dramatically different results. When it comes to accuracy with precision, there is no substitute for knowing the chemistry.”
SGA: What’s the ONE thing to remember to get ahead of this mandate?
JM: “I’d say the number one thing is to get the testing right. And that success is tied very tightly to method development. As an analytical chemist, you always want to ask yourself…Is the method I’m planning to use suitable for its intended purpose and use?
And the method we used was a validated method that our group developed for this kind of testing years ago – and we re-validated it for this study. We were able to see half a part per million, and we could have gone much lower but from a human risk assessment, it’s more than acceptable so we were fine with that quantitation limit.”
SGA: Is there anything else manufacturers should consider…looking forward?
JM: “Be proactive, not reactive. Once things are under control, set up a six or twelve-month monitoring schedule to check your raw materials as well as your finished products.”
Partner with us to stay ahead of evolving regulatory concerns and protect your brand with science-backed quality assurance.
For a Free Consultation, Call 800-448-2968 to speak with one of our experts.