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prop 65 safe harbour calculations help
Anyone have a cheat sheet they would like to share for calculating prop 65 daily limits? This stuff really confuses me for whatever reason.
Ex:
Ethylene Oxide listed as <1 ppm in the raw material. Safe harbor limit is 2 ug/day for NSRL and 20 ug/day for MADL.Probably would be using 2 - 3 g max of this product per day. This raw material is used at 1% in the formula.
Also, if there is a value for NSRL but no value is listed under MADL, what does that mean?
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7 Replies
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(daily product dosage in grams) x (percentage of raw material) x (ppm of ethylene oxide) ÷ 100 = daily exposure of ethylene oxide in μg -
@Bill_Toge that’s a lot more straightforward than I thought.. thank you!!
do you know about naturally occuring substances, do those require a prop 65 warning? for ex, eucalyptus essential oil contains myrcene and the coconut oil I am using contains aresenic, mercury, lead, cadmium, and nickel all at <0.1 ppm as a natural impurity. I see conflicting answers everywhere regarding if it will need to contain a warning, specifically for the myrcene (which doesn’t have a safe harbor level).
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Prop 65 is a never-ending headache, literally just talking about a similar issue yesterday and here’s what we found
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@EVchem I found the same document, the one below is longer but has the same information. So to me that sounds like no, it would not need to include a warning. However, the supplier of the essential oil (Prinova) said we must have a warning on the label because it is a consumer good. We are using it at 0.45% in the formula so it will be diluted but I would just like to have a for sure answer.
http://www.ahpa.org/Portals/0/PDFs/Member-Only/Prop_65_Herbal_Products.pdf
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@mhart123 the fact the coconut oil has figures for arsenic, mercury, lead etc. just means it’s been analysed for those metals; the fact those figures are all less than 0.1 ppm means the oil doesn’t contain arsenic, mercury, lead etc., as 0.1 ppm is the smallest amount that can be detected with that particular method
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@Bill_Toge this is what is listed on the TDS. I can just assume that the limits are low enough then so we won’t need to worry about calculating any safe harbor levels or including a prop 65 statement? (this is a face balm in stick format, so I would say they probably wouldn’t be using more than 1 g of product per day, coconut oil is at 20%)
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@mhart123 what Bill Toge is saying (nil heavy metals = no concern = nothing to report) applies to your greater need as well. Impurities and byproduct present at insignificant amounts need not be reported to CA. You are not reporting these in your INCI label copy, right? State of CA is not running everyone’s products through a GC/MS in their secret highly-staffed-with-pensions State Chemistry Lab. Just like CARB and “organic” claimants: it is the litigator trolls you have to watch out for, not state regulators.
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