Hello!
Say you have an established product, but out of an abundance of caution (or because a new chemical was added to the Prop 65 list, or because your process changed and introduce new chemicals), you want to now put a Prop 65 warning label on it (when this was not deemed necessary in the past). Per the FDA's definition of "Label", this new label would fall into that definition, and therefore should be proven that it will remain legible, affixed, etc for the life of the product.
I'm curious how the experts here will recommend proceeding. I assume many companies buy pre-printed prop-65 labels which are significantly more cost effective than using the same material as our existing labels (using the same material would be easier to justify that they will stay affixed, legible, etc using equivalence). Seems you technically should not be putting those new off the shelf labels on the packaging until you validate that they will withstand the life of the product. I'm also assuming many companies would not delay a process improvement that they validated solely because they still needed to do additional packaging validation solely to prove that the new "prop 65 labels" will adhere for the life of the product.
That said, if you wanted to address the potential compliance concern of not having the prop 65 label on the product, I'd assume you may want to start labeling with it ASAP prior to validating it (perhaps justifying that the risk is low as the alternative is not having the customer have access to this information at all). Does anyone have any thoughts on how to go about reconciling this in a practical way? Maybe adding a temporary deviation to add a line to your "product label" that says to refer to your website for Prop 65 information, until you are able to qualify the new label? (on that note, while it seems the prop 65 standard is to put a label on the product, perhaps you can somehow argue that directing the customer to your website which has the info is providing sufficient awareness to the customer)
I realize Prop 65 is thought to be somwhat farcical at this point by many, but I am very curious to hear thoughts on this as I know I can apply them to other situations as well.
Say you have an established product, but out of an abundance of caution (or because a new chemical was added to the Prop 65 list, or because your process changed and introduce new chemicals), you want to now put a Prop 65 warning label on it (when this was not deemed necessary in the past). Per the FDA's definition of "Label", this new label would fall into that definition, and therefore should be proven that it will remain legible, affixed, etc for the life of the product.
I'm curious how the experts here will recommend proceeding. I assume many companies buy pre-printed prop-65 labels which are significantly more cost effective than using the same material as our existing labels (using the same material would be easier to justify that they will stay affixed, legible, etc using equivalence). Seems you technically should not be putting those new off the shelf labels on the packaging until you validate that they will withstand the life of the product. I'm also assuming many companies would not delay a process improvement that they validated solely because they still needed to do additional packaging validation solely to prove that the new "prop 65 labels" will adhere for the life of the product.
That said, if you wanted to address the potential compliance concern of not having the prop 65 label on the product, I'd assume you may want to start labeling with it ASAP prior to validating it (perhaps justifying that the risk is low as the alternative is not having the customer have access to this information at all). Does anyone have any thoughts on how to go about reconciling this in a practical way? Maybe adding a temporary deviation to add a line to your "product label" that says to refer to your website for Prop 65 information, until you are able to qualify the new label? (on that note, while it seems the prop 65 standard is to put a label on the product, perhaps you can somehow argue that directing the customer to your website which has the info is providing sufficient awareness to the customer)
I realize Prop 65 is thought to be somwhat farcical at this point by many, but I am very curious to hear thoughts on this as I know I can apply them to other situations as well.
