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Analog Cheese Microbiology and TCS

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Posted 29 July 2016 - 08:28 PM

We are a small dairy operation that produces an analogy (imitation) style cheese using casein and whey proteins, water, and other ingredients.  There has recently been question of introducing actual cheese rework into this process as there is no identity claim.  Upon reviewing a previous FDA inspection (before my time) it was stated that this product did NOT need to be a TCS product but it was suggested that water activity be monitored as a CCP with set limits (less than 0.92).  If we choose to add cheese to this product as a metered rework my concerns are as follows:


1.  Regardless of our ability to demonstrate low water activity in this analog and low micro load, would this product need to be cooled at the typical 40 degree range as required for other cheese products?


2.  Doesn't the introduction of reworked cheese (which would undergo and additional cooking step) require this product to retain its original expiration date?  I wouldn't think we could extend this product life cycle by using it as an ingredient.  Based on this argument, you could extend product life cycles indefinitely.


3.  Similar to question 2, it seems the burden would be on us to validate new shelf life studies for every addition of rework we add to this product as it differs from the original established shelf life?


4.  Would nutritional data need to be validated to assess the change in product composition?


5.  Any other things I haven't thought about?


If this seems like a very obvious answer to these questions, it likely is, I am just getting pressure from senior management to make this work despite my misgivings.  Any suggestions are welcome.



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Posted 02 August 2016 - 02:21 AM

Hi Guitardr85,

A lot of your questions will depend on your process, your recipe and the final product characteristics to prevent micro growth so Aw, acidity/pH and salt level for example.

Based on the information given I would suggest the product is likely to be a TCS product.

Introduction of rework adds new problems in terms of product quality and safety control. Will it affect the product quality? Will it affect the product safety? - regardless of how you process there could be opportunity for toxin production and as such you will need to complete a new HACCP study which includes rework addition.

Rework is normally carried out on a like for like basis so it doesn't affect ingredient declaration and nutritional data and also at a maximum prescribed addition rate.

You should validate all your data based on the worst possible conditions for control of rework and maximum addition rate, not every time you add rework (this will be verified by final product analysis).


Kind regards,



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