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FDA rule on traceability of packaging container

Packaging containers traceability packaging food safety FDA Food

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#1 shivsingh


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Posted 21 August 2018 - 02:03 PM

I know there is a requirement to have full traceability of ingredients and packaging in the food industry. However, I've been challenged to reference any applicable FDA rule on traceability of packaging containers. If anyone has a link to reference the requirements for tracing/tracking of food contact packaging containers, I will greatly appreciate it. 

Edited by shivsingh, 21 August 2018 - 02:06 PM.

#2 Scampi



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Posted 21 August 2018 - 02:25 PM

ubpart C--Recalls (Including Product Corrections)--Guidance on Policy, Procedures, and Industry Responsibilities

Sec. 7.59 General industry guidance.

A recall can be disruptive of a firm's operation and business, but there are several steps a prudent firm can take in advance to minimize this disruptive effect. Notwithstanding similar specific requirements for certain products in other parts of this chapter, the following is provided by the Food and Drug Administration as guidance for a firm's consideration:

(a) Prepare and maintain a current written contingency plan for use in initiating and effecting a recall in accordance with 7.40 through 7.49, 7.53, and 7.55.

(b) Use sufficient coding of regulated products to make possible positive lot identification and to facilitate effective recall of all violative lots.

© Maintain such product distribution records as are necessary to facilitate location of products that are being recalled. Such records should be maintained for a period of time that exceeds the shelf life and expected use of the product and is at least the length of time specified in other applicable regulations concerning records retention.


I would think that packaging would fall under the item in red. You probably wont find legislation that requires you (GFSI program do however require it) but you'd be foolish not to 


Is your company seriously saying "WHY??"........so if you don't track lots of containers, and your supplier tells you they labelled non food grade as food grade...how are you going to recall??  OR are you prepared to just recall everything you've made??

Please stop referring to me as Sir/sirs

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#3 Ryan H.

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Posted 21 August 2018 - 02:57 PM

SQF Code Edition 8 (GFSI Standard) More and more companies demand these type of FSMS

i. Finished product is traceable to the customer (one up) and provides traceability through the process to the manufacturing supplier and date of receipt of raw materials, food contact packaging and materials and other inputs (one back);
ii. Traceability is maintained where product is reworked; and
iii. The effectiveness of the product trace system shall be reviewed at least annually as part of the product recall and withdrawal review (refer to Records of raw and packaging material receipt and use, and finished product dispatch and destination shall be maintained.


https://www.standupp...ackaging-recall     -      This link gives you good reason to trace your packaging! 

https://www.fda.gov/...s/ucm492260.htm  -  Here's another!


Good Luck! 

All the best, 


Ryan Heavner 

#4 shivsingh


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Posted 21 August 2018 - 03:16 PM

I appreciate the comments.

Scampi, Oh no everyone knows that containers need to be traced. Its just someone challenged me to find an FDA reference. I know the right thing and logical thing is to have traceability but there is always that one person needing to go black and white. 


Thanks for your comments.

#5 Fishlady


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Posted 30 August 2018 - 11:52 PM

The "FDA" rule is found in the Bioterrorism Act of 2002, which states that there needs to be traceability from the immediate source to the subsequent source, and that this applies also to direct food contact packaging.  Without re-reading the Act, I don't remember the exact reference off the top of my head.

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