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If food contact packaging is approved according to EU regulation, does this automatically mean it meets FDA (21 CFR) regulation?

Food contact materials.

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#1 rdeboer1986

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Posted 28 May 2020 - 06:48 AM

Hi to all,

 

I'm posting this in the BRC/IOP topic hoping someone can give some guidance on the rules and regulations for food contact materials. We are a BRC Food certified company, and we produce different types of salmon and trout products. We use several types of food contact materials (vacuum film, blue bags, laminated board, skin pack etc.). 

 

For each material, we have the DoC's but, mostly they refer only to the relevant EU regulations, as the materials are produced in the EU. Most of our product goes to overseas markets as Asia, Australia and USA. 

 

A while ago we got a comment from an auditor during our BRC audit. He was commenting that if we sell for example vacuum packed salmon fillets, that we need to make sure that the vacuum film used, is also approved according the relevant FDA (21 CFR) regulations. We could only show it was approved according the EU regulation. We although did not get an NC for it.  

 

So, my question is, in case food contact material is approved according EU regulation, how does this relate this to FDA regulations? If it is approved according EU regulation, does this automatically mean it meets FDA (21 CFR) regulation?

 

Thank you.

 

 

 



#2 pHruit

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Posted 28 May 2020 - 08:18 AM

IMEX you're lucky that you escaped an NC there ;)

You could try wading through the US and EU regs and doing a detailed comparison / gap analysis, but you may find that after many hours of work, you don't actually have the relevant data on the packaging itself to be able to make the comparison.

In your position I'd turn this around the other way, and start by discussing with your suppliers (who should theoretically be very familiar with packaging regulation) - i.e. can they provide confirmation/evidence that the materials comply with the US requirements in addition to the EU ones?



#3 CMHeywood

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Posted 28 May 2020 - 05:53 PM

I work for a company in the USA that makes food contact packaging.  In my experience with dealing with FDA and EU regulations, if you comply with EU regulations, you should be complying with FDA regulations.

 

However, you have no written evidence of this.  As mentioned above, you need to get FDA compliance letters from your suppliers.  This functions as a declaration of compliance (DoC).



#4 beautiophile

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Posted 29 May 2020 - 01:15 AM

For each material, we have the DoC's but, mostly they refer only to the relevant EU regulations, as the materials are produced in the EU. Most of our product goes to overseas markets as Asia, Australia and USA. 

A while ago we got a comment from an auditor during our BRC audit. He was commenting that if we sell for example vacuum packed salmon fillets, that we need to make sure that the vacuum film used, is also approved according the relevant FDA (21 CFR) regulations. We could only show it was approved according the EU regulation. We although did not get an NC for it.

Saying from a point of view of a packaging manufacturer, we only prepare DoCs of packaging materials for the regions where we ship products to, i.e. locations of our customers, who make food. We, of course, have got no idea where the final packed food is on-shelf (other said: distribution) so that the preparation of any additional DoCs for consumers' countries is the responsibility of our customers.






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