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FDA Microbiology Limits

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a.hewitt

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Posted 04 November 2024 - 05:13 PM

Hi,

 

I am looking for the microbiology limits for shelf-life reporting. Two products of concern:

 

1. Ready to eat dressings/sauces 

2. Brine that contains raw product and requires cooking

 

Both have ph levels <4.4. 

 

Any help and guidance is greatly appreciated!


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ChristinaK

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Posted 04 November 2024 - 08:42 PM

Hello and welcome to the forum!

 

To my knowledge, the FDA has not published any regulations regarding microbiological limits for those foods. In general, they advise that sites establish their own limits based on scientific evidence. You can find many recommended limits from places such as third-party labs or universities. Whatever limits you establish, you will need supporting evidence.

 

Identifying the criteria for your products will involve knowing the raw materials, process, and end product, as those will all influence what microorganisms may be present in your end product. Testing and microbiological limits should include both pathogens and food spoilage organisms.

 

Here are some places to start your research, although this is not an exhaustive list:

  • Encyclopedia of Food Microbiology (Second Edition); H.B.D. Halkman, A.K. Halkman; 2014
  • A Guide to Acidified Foods: Thermal Processing, Microbiology and Regulatory Compliance; The NFL White Paper Series, Vol. 15; January 2015; The National Food Lab.
  • Fermented and Acidified Vegetables; Chapter 51; Compendium of Methods for the Microbiological Examination of Foods (CMMEF); September 2013.
  • Guidelines for the Microbiological Quality of Various Ready-to-Eat Foods; EMSL Analytical Inc.; published Feb. 3, 2011.
  • Microbial Guidelines for Ready-to-Eat Foods; Alberta Health Services; published June 2006, revised May 2011
  • Bacteriological Analytical Manual (FDA BAM); Edition 8; Revision A, 1998

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SophieS

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Posted 05 November 2024 - 12:51 AM

Since RTE are not further cooked before consumption, it’s crucial to control both spoilage microorganisms and pathogens

Pathogens: Given the pH is below 4.4 most bacterial pathogens (e.g., Salmonella, Listeria monocytogenes, E. coli. are unlikely to grow. However, performing tests at the start and at intervals during shelf life can verify safety. The focus here should be on stability and the risk of recontamination

Yeasts: < 100 CFU/g at end of shelf life.

Molds: < 100 CFU/g at end of shelf life.

 

for the Brine since this product is intended to be cooked before consumption, the focus is less on pathogens that would be inactivated by cooking and more on preventing spoilage before use.


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