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Does ISEGA comply with FDA regulations

Started by , Jan 22 2018 07:44 PM
4 Replies

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. 

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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

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. 

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.

1 Thank

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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