Regulatory Open Forum

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  • 1.  Prop 65 requirements for EtO sterilized products

    Posted 08-Jan-2024 12:32

    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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  • 2.  RE: Prop 65 requirements for EtO sterilized products

    Posted 08-Jan-2024 13:38

    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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  • 3.  RE: Prop 65 requirements for EtO sterilized products

    Posted 08-Jan-2024 13:41

    Forgot to mention - if the case will be or can be broken down into single packages (e.g. a case of syringes that are individually packed and sterilized but packaged in a case format of 50 syringes per case) then you are really likely to need to include the warning at the product label level as well as the case level.  Again - all has to do with ensuring that the user of the product is advised of the exposure at or before the actual exposure occurrence.  Sorry for the multiple posts - hit "Post" a second too quickly.



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    Victor Mencarelli MS
    Global Director Regulatory Affairs
    New YorkNY
    United States
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  • 4.  RE: Prop 65 requirements for EtO sterilized products

    Posted 08-Jan-2024 13:44

    Thank you - that is clear and makes sense.  Appreciate your response.



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    Wanda Dumont
    Document Control Specialist
    Dover NH
    United States
    ------------------------------