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Regulation relating to a recall for primary packaging

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SMM

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Posted 29 November 2021 - 04:27 PM

Hi,
 
I have a question, we are in food and we have a primary packaging (that touches the product) and the secondary packaging. The primary packaging in not traceable (any labeling from supplier), just the secondary packaging  is trackability. Like a cereal package, we sale always our product in primary and secondary package.
 
I need a regulation federal, or FDA, FSSC, HACCP, .... to approving any mock recall, or any real recall if there is a problem with the primary package.
 
Can you help me please?   

 

Hi all, and Happy New Year.

 

Yes, just like the term "high risk" BRC has put their own unique definition to a fairly common industry term - "primary packaging". Arguably a more unique term could have been used. The BRC definition, applied only to those facilities intending to undergo BRC certification, is in the standard, relatively clearly. That being said, I always encourage sites to look at the intended outcome, before worrying too much about the definition debate. In previous versions, there is the generic term "packaging" - then you look at a specific requirement and the endless debate about which pieces of packaging us that clause relevant to... one of the most debated was traceability. This gives much clearer direction, which I do appreciated. 

 

If you go through the 8th issue of the Standard, here is where the term "primary packaging" comes into play - and which clauses you can now see apply (to things like food contact packaging) and which don;t apply (typically things like shrink wrap on the outside of a pallet, or a pallet license plate).

 

What applies to "primary packaging"?

 

3.5 having an effective supplier approval program

3.5.1.1 perform a risk assessment on it as a raw material

3.5.1.2 create an effective supplier approval mechanism based on the risk assessment

3.5.1.5 do the same if you purchase the materials from a broker

3.5.1.6 ensure the supplier has a traceability program

3.5.2 have an effective, risk based receiving and acceptance program

3.6 have specifications for it

3.9 the site being certified needs to have some form of traceability on the materials

4.7.5 maintenance materials coming into contact with the materials should be approproate

5.5.1 potential product / package interactions or needs should be identified

 

Looking at the list, which is really just basic supplier management, you can see how using the definition gets the right material into a proper management system.


Edited by Charles.C, 30 November 2021 - 05:41 PM.
split from 34085


Scampi

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Posted 29 November 2021 - 04:58 PM

To be clear, you're looking for the regulation that speaks directly about recalls and packaging??


Please stop referring to me as Sir/sirs


SMM

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Posted 29 November 2021 - 05:46 PM

Yes, a regulation, that can help me to prove there is any problem if we will have a recall for our primary packaging.  

 

Thanks



SMM

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Posted 29 November 2021 - 05:47 PM

Yes, a regulation, that can help me to prove there is any problem if we will have a recall for our primary packaging.  

 

Thanks

To be clear, you're looking for the regulation that speaks directly about recalls and packaging??



Scampi

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Posted 01 December 2021 - 03:54 PM

This is from this link

https://inspection.c...5/1535516168226

 

I find it hard to believe that there is a packaging manufacturer in Canada that does not put a lot code of some sort on the carton and / or the core of the film your using

You must be able to trace primary packaging Step 3: Identify all food to be recalled

In addition to the food directly affected, determine if:

  • any other sizes, brands, or codes or unique identifiers of the same food are affected
  • any other food is affected

If this is the case, include this food in your recall.

Tips
  • Have a traceability system that will allow you to be best prepared for an effective recall. Refer to Part 5 of the SFCR for the regulatory requirements related to traceability.
  • Recalls can be triggered by ingredients that were incorporated into your food. To better target affected foods, consider documenting the lot codes or unique identifiers of each ingredient that you incorporate into your food.
  • Recalls may also be caused by unsafe packaging material. Ensure you can link packaging materials to the food lot codes you are responsible for. Consider documenting and implementing the following practices:
    • Associate packaging materials to their suppliers
    • Associate packaging materials to your food lot codes

Please stop referring to me as Sir/sirs


wtheriot

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Posted 03 December 2021 - 10:41 PM

I too find it hard to believe the primary packaging doesn't have some sort of Lot code. If it doesn't, then you will need to create your own. Perhaps each order you receive at time of receiving inspection, you give it Lot C1, the next time Lot 2 and so on, you also need to connect that internally created Lot number with the supplier BOL or PO, in the event you need to trace back.

 

You must show that you could trace all of it should the need arise. You will also need to link that packaging Lot to the production lot of your product when its used.

 

This is why its good practice to require suppliers to have traceability as part of your supplier approval program



Foodworker

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Posted 04 December 2021 - 10:11 AM

I don't know about any US or  Canadian legislation, but certainly EU food contact legislation is clear:

 

EC1935/2004

 

(18) The traceability of materials and articles intended to come into contact with food should be ensured at all stages in order to facilitate control, the recall of defective products, consumer information and the attribution of responsibility. Business operators should at least be able to identify the businesses from which, and to which, the materials and articles are supplied.

 

Without some form of lot number, this is not possible.

 

If your supplier were in the EU, they would absolutely be breaking the law.t. I would be amazed if there are no similar requirements in other major countries' legislation.

 

Get another supplier.





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