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Does ISEGA comply with FDA regulations


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craiglbc

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Posted 22 January 2018 - 07:44 PM

We are currently BRC certified for Packaging.  We are looking at a vendor from China which certifies their paper to ISEGA, but we are in the US and everything needs to be compliant with FDA regulations.  I need to find out if we can accept ISEGA compliance even though we are in the United States. 



Tony-C

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Posted 23 January 2018 - 06:31 AM

Hi craiglbc,

 

My understanding is that ISEGA certify products by assessing the formulation and analysis. Would the facility not need to be compliant with the required standards (verified by independent audit or certification) as well?

 

Kind regards,

 

Tony



craiglbc

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Posted 23 January 2018 - 03:46 PM

Tony,

Yes that would be my understanding is that I must verify their quality system, I was just unsure if I would have to do any independent testing on the paper to assure it meets FDA requirements.  I am just unfamiliar with ISEGA all together. 



newbalance55

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Posted 24 January 2018 - 12:16 PM

Hi craiglbc,

 

Regarding compliance with FDA requirements about product, ISEGA is an independent third part laboratory which will be assess the formulation and test (if needed, depending on the conditions stated in FDA 21 cfr 176.170 and 180) the paper. IMHO, you don´t need another third part laboratory.

 

FYI, ISEGA is probably one of the most respected laboratories in Europe when talking about food contact.



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craiglbc

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Posted 24 January 2018 - 05:00 PM

Thank you for the feedback, being from the US I was just unfamiliar with ISEGA.  Now that I know they are a well respected laboratory I feel much better about coming to a decision to let them pursue the supplier. 






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