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Prop 65 in CA
Just trying to prepare for the future… I know that Lipowax P ( Cetearyl Alcohol (and) Polysorbate 60) is suppose to contain Prop 65 components. What would be a decent replacement that wouldn’t flag Prop 65. It is being used in an OTC cream.
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10 Replies
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Cetearyl alcohol and Polysorbate 60 ain’t in Prop 65 list
https://oehha.ca.gov/media/downloads/proposition-65//p65list052518.pdf -
I got a letter from the vendor confirming the material may contain trace quantities of Prop 65 chemicals.
@Gunther
Can you offer an alternative? -
Polysorbate 60 is an ethoxylated compound which in the past did contain concerning levels of 1,4 Dioxane, a compound we now classify as a carcinogen. However, if you consult with a regulatory person, Prop 65 has a low permissible of 1,4 Dioxane. (Remember, it is the dose that makes the poison). New processing of these materials has greatly reduced the levels. If you look at a CofA for these materials, they quantify the level of 1,4 Dioxane with it generally being in the parts per million.I have some experience in this. Several clients over the years have called in a tizzy. In the end, we simply had to provide documentation showing the 1,4 Dioxane levels were below the permissible thresholds. -
@Microformulation
Thank you for the information. I hope you don’t mind me picking your brain a little more about the subject. I was trying to find out the permissible thresholds were. I have been told that even at “trace” ppm amounts you would still have to put the warning label on your products. I haven’t been able to confirm this. So is there a limit before you have to add the warning label? -
@Chemist5000 I am going to give you a better answer. The State of California has a number I call with questions and I have to admit that they are helpful. I found it with a few simple google searches but I don’t have it in front of me right now.Honestly dealing with VOC Testing was more of a burden than Prop 65.
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Questions about Proposition 65? Check our Frequently asked Questions page or contact the Proposition 65 office: (916) 445-6900 or email P65.Questions@oehha.ca.gov (link sends e-mail).
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@Microformulation
Thank you for the information. I do appreciate this!!! -
@Microformulation
I sent an email and got the most bland of replies in 3 paragraphs.. they tell me to examine Article 7 and Article 8 of Title 27, California Code of Regulations for safe harbors. Since my questioned is based on concentration they really stayed away from any sort of ranges.
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I disregarded the emails and called. Once you get through the phone maze, you will get someone who will help. A real person.
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how do you explain that at trace amounts well below 1 PPM of Prop 65 chemicals (0.005 PPM perhaps) do not present a significant exposure or health risk to a regulatory person?
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