Technically - a Prop 65 warning must be available and visible to the purchaser at the time of purchase and then again to the user at the time of use. So if the product is a single use product you could get away with only placing the warning on the outside packaging because the user would be alerted to the warning at the time of purchase as well as at the time of use since the packaging would presumably remain intact until use.
If on the other hand the product is meant to be used multiple times or if there are instructions/options to clean/sanitize/sterile the product such that the original packaging could be lost or discarded and subsequent users might not be alerted to the Prop 65 warning at the time of use then you need to have the warning both on the outer packaging as well as on the product itself.
Pretty straightforward (if anything involving Prop 65 can be straightforward!) regarding the requirement. General rule - if the user is not advised of the warning you have a potential liability to the state (and the user possibly under the California "private attorney general" or "bounty hunter" provisions of Prop 65) for violation of the requirement to provide adequate and timely warning of the exposure of the user to a chemical recognized by Prop 65.
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Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
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Original Message:
Sent: 08-Jan-2024 12:32
From: Wanda Dumont
Subject: Prop 65 requirements for EtO sterilized products
Hello,
I am trying to find if we are able to place the Prop65 warning on our case label and not the actual product label, what is the requirement?
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Wanda Dumont
Document Control Specialist
Dover NH
United States
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