Modified and applied to consumer product safety in mid-2000's. Prop 65 regulates ~900 chemicals and compounds, but heavy metals (Pb, As, Cd, Sb, Hg, Cr (Hex), Ni) and orthophthalates (DEHP, DBP, BBP DiNP, DiBP, DPENP, DHEXP, DCHP are of specific concern to consumer goods importers.
Unlike CPSIA or RoHS, products can be compliant with Prop 65 even if above maximal limits (calculated as total content and specific routes of exposure). Labeling in an option for Prop 65 compliance: A product containing threatening levels of Prop 65 regulated chemicals can be compliant via attachment of a "Prop 65 warning label".
Prop 65 utilizes Civil Enforcement in the form of a civil action by a private citizen of CA, or a non-profit foundation. Practically speaking, enforcement is actually done mostly by specialty law firms, who are surveying and searching the market all the time for violative products where they can bring civil action for financial gain. In aggregate these firms filed >1,500 actions in 2018.
Unlike CPSIA or RoHS, Prop 65 is not a "total content" standard. The standard is a maximal exposure level, as measured in the bloodstream. The formula is Total Content + Typical use of Product + Transference (dermal, oral, inhalation) = blood level exposure. These levels are then subjected to a Maximum Allowable Daily Limit (MADL) or a No Significant Risk Level (NSRL). This requires a laboratory test and a toxicology assessment.
Penalty amounts are calculated for every piece sold X every day it was in the public. For this reason, they can be staggeringly high and MUST BE SETTLED. Few risk these extraordinary numbers in court. The first "action" taken is called a "60-day notice" [of intent to file a complaint]. After the 60-day period, the plaintiff files a Notice of Violation and the negotiation begins. The options are to reformulate without the violative chemical, or label appropriately. Reformulation is the result of the vast majority of these negotiations. In all cases, there is a negotiated penalty amount (generally a small fraction of the calculated amount), and legal fees, which generally amount to 80% or more of the settlement value.
Out of court settlements were eliminated; the court is now involved in all cases. This increases scrutiny on settlements, and results in a greater-than-ever need to enact a program for compliance using XRF and FTIR. Moreover, the update also extended the regulations on labeling specifics, making labeling a less-desirable option. A proper reformulation requires a testing program, and Actus is here to help.
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