Regulatory Open Forum

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  • 1.  Proposition 65 (California)

    Posted 16-Nov-2018 04:30
    Can anyone help me understand the differences or similarities between Proposition 65 (The safe drinking water and toxic enforcement act) and the European RoHS? Specifically I focus on chrome-6 and stainless steel

    Thank you in advance

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    Dorthe Wallin
    Regulatory Compliance Officer
    Cortex Technology
    Denmark
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  • 2.  RE: Proposition 65 (California)

    Posted 16-Nov-2018 14:05
    They cannot really be compared side by side in my opinion.   RoHS regulates a specific total concentration limit for electronic items which is easily measured and understood by any 3rd party lab and there is always a clear pass/fail.  

    California Prop65 sets a consumer exposure limit and requires product labeling.  There is no clear pass/fail number you need to achieve, even if there is a NSRL/ MADL established for a substance.  A much more detailed exposure assessment (routes, absorbency, duration…) is required to conclude that you meet Prop65 requirements without labeling if your product contains a listed substance.  If no safe harbor limit (NSRL/MADL) has been published, this assessment becomes even more complicated.

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    Sarah Ware
    Minneapolis MN
    United States
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  • 3.  RE: Proposition 65 (California)

    Posted 19-Nov-2018 02:01
    Thanks. Now I know more about what to look for. 
    Do you know if any of this is included in a 510(k)?

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    Dorthe
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