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Do foreign supplier verification FSMA requirements apply to packaging?

foreign supplier verification FSMA

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#1 zac2944

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Posted 22 July 2016 - 08:00 PM

I'm manufacturing direct food contact flexible packaging.  A typical packaging structure would be something like: lacquer/ink/paper/poly/foil/poly. If the foil in that structure comes from overseas do I now have to meet all the foreign supplier verification program (FSVP) requirements of FSMA

 

The foil is part of the packaging, and is certified food grade and meeting FDA CFR requirements, but it is not the actual contact surface. 

 

I find the FDA definition of "food" confusing at times.  Some rules seem to apply to packing materials and other don't (ex: packaging suppliers don't need to register).  Since I'm not importing finished packaging material, but rather raw materials that will make up the packaging, does FSVP apply?


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#2 Kellio

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Posted 22 July 2016 - 08:56 PM

I will say yes because you may be challenged to prove the integrity and safety of the product. To the very list you must have the specifications available of the product and maintain records.  FSMA Sections are connected to other updates in the F&D A. Assessment of the materials you are using will be a good start to find any potential risk if FDA has issues with it.

 

GFSI has some Certifications that can help you putting a Supplier Approval Program dedicated only for Packaging.

 

I hope this helps.


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#3 ncorliss

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Posted 25 July 2016 - 04:26 PM

With FSMA the classification of food packaging varies based on the program. For the purposes of registering your facility and requiring a Preventative Control Qualified Individual, the FDA does NOT classify packaging as a "food ingredient" at this time. For the purposes of the Foreign Supplier Verification Program, the FDA DOES classify packaging (and any raw materials used to produce the packaging) as a "food ingredient". The FSVP states that the owner of the packaging materials at the time the materials arrive at the ports is responsible for having an FSVP program in place. The verbiage is as stated: "An importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent."

 

If you do not own the materials at the time of entry in the US, then ultimately you don't have to have an FSVP program. However as mentioned by Kellio, it would be in your best interest to have the necessary inspection, testing, and regulatory documentation in place.

 

I have started training my suppliers on the FSVP program. If anything, I want them to be prepared in the event they are audited. I am also putting together the plan as if it does apply to us, just in case our suppliers are audited and we can support them, thus avoiding any possible delays. I would also recommend including your foreign suppliers in your risk assessment and any mitigating steps.


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#4 zac2944

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Posted 25 July 2016 - 08:08 PM

 FDA DOES classify packaging (and any raw materials used to produce the packaging) as a "food ingredient".

 

That answers my question.  Thanks.

 

I know that the finished packaging my company sells is considered "food", but wasn't sure if my raw materials (paper, foil, resin, ink, etc.) were considered "food" as well. Since they are I'll need a FSVP.  Fun.


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#5 charbear

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Posted 31 May 2017 - 05:27 PM

Almost a year later and our company is just finding out about this. We just began the steps to SQF level 2 and our also a food contact company. How did you go about requesting FSVP from  your suppliers?


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