Just to add on to Kirsty's comment here, I would also suggest that if there is no safe harbor or MADL level listed in the regulation or in the list (most likely not going to be listed at this point if the chemical was just listed recently), you can have a qualified toxicologist perform the calculation for you and make a reasoned determination as well as petition OEHHA (the California government agency responsible for managing Prop 65) to adopt that calculation as the qualified safe harbor level. The key here is usually understanding the "exposure" of the user to the chemical. So, if this is a chemical that is used in a medical device that is encased in the mechanism where exposure to the chemical is limited or non-existent unless you open the machine up to repair or update it, the likelihood is that you don't have sufficient exposure to warrant a warning. If, however, your product is an ingestible drug then your likelihood of exposing the user to the chemical is pretty much certain and you need to really consider the requirements.
I would always engage with counsel experienced in handling Prop 65 issues/cases before making any decision or barring that route of review I would likely add the warning in general to the packaging. To be completely honest, I live 3000 miles from California (I'm in NY) and we are so used to seeing the Prop 65 warnings on what seems like everything in the marketplace that it honestly has gotten so out of hand that I don't even pay attention to it anymore (especially when it comes to things like lead in wires that are inside the electronics which I will never ever expose myself to.
One other key thought here - if you do decide to forego the warning language then make sure that you also do not repair or upgrade the equipment (if it is a device) in California otherwise you run the risk of still needing the warning because someone messing with the interior parts of the product would then be exposed to the Prop 65 chemical.
Hope some of this helps. Really strongly suggest engaging with experienced counsel in California who understand the rules. Remember - Prop 65 holds you responsible for everyday for every product unit on the market in California and the state doesn't have to be (and often isn't) the plaintiff in these cases!
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Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
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Original Message:
Sent: 06-Oct-2022 08:44
From: Kirsty Samuels
Subject: Prop 65 chemical
Hi,
The website https://oehha.ca.gov/proposition-65/chemicals allows you to search for the relevant chemical and it lists the safe harbor levels which include No Significant Risk Levels (NSRLs) for cancer-causing chemicals and Maximum Allowable Dose Levels (MADLs) for chemicals causing reproductive toxicity. If your chemical is present above these levels then a warning needs to be provided.
Hope this helps
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Kirsty Samuels
Alcester
United Kingdom
Original Message:
Sent: 05-Oct-2022 12:53
From: Anonymous Member
Subject: Prop 65 chemical
This message was posted by a user wishing to remain anonymous
Hello,
How do you address non compliant with prop 65..
One of chemical in our product just added to the list of prop 65 but the amount use is less than % wt is <0.1