Process Authority: FAQ and Answers
The Eurofins team of process authorities routinely provides expert guidance to food manufacturers to prepare microbiologically safe products. The role of the process authority is multi-faceted, including but not limited to:
- Consulting and support, primarily in evaluating a processing technologies ability to kill microorganisms on the food, in the food, or on the packaging.
- Facilitating interactions with the FDA and assisting with regulatory compliance.
- Assessing a food formulation’s ability to prevent growth or survival of microorganisms.
In this service, we encounter many questions that span across a variety of food products and manufacturing processes. Here we list and will continue to compile our most common questions and answers.
Q: Can I use preservatives in lieu of a thermal process?
Martha Kimber:
"It might be possible, but you will need data to support what you are hoping to achieve. The first step would be to clearly define your performance criteria for success. For example, is the preservative intended to:
- Suppress spoilage organism growth?
- Suppress pathogen growth?
- Reduce populations of pertinent pathogens?
In some cases, we can refer to the scientific literature and do pathogen modeling to predict success, however, the gold standard would be to perform inoculated challenge studies with the new product formulation containing preservatives, in order to determine if the performance criteria are met. Notably, the challenge study design and execution would differ depending upon the applicable regulations and performance criteria."
Q: Do I need to file my beverage product as an acidified food per 21 CFR 114?
Martha Kimber:
"Navigating the regulatory classification of acidified vs. acid foods can be murky at times. Our team can perform an assessment to determine if a product may be categorized as an acid or an acidified food by closely examining the composition and pH of individual ingredients and the finished product formulation as a whole. Based on our assessment, we can prepare a process authority opinion letter. Acidified foods are required to be filed with the FDA per 21CFR114. Other products that are naturally acidic, refrigerated, carbonated, fermented, etc., may be exempt from 21CFR114 (but will still be covered by 21CFR117)."
Q: I am making a coffee beverage that is intended for sale under refrigerated conditions, however, it might occasionally be distributed under ambient conditions. Does this need to be filed with the FDA?
Shirin Abd:
"Yes, if the product has a pH >4.6 and is held at ambient conditions, then you will need to file with the FDA under the low acid canned foods regulations (LACF; 21CFR113)."
Q: Can you help me establish a cold-fill-hold process for my portfolio of acidified foods?
Martha Kimber:
"Absolutely! To start, we can assist by reviewing each product formulation and by grouping similar formulations together. We can then select representative formulations from each grouping for subsequent challenge studies which will be designed based upon guidance from the FDA and applicable scientific literature. Finally, we can provide process authority letters based upon the grouping and challenge study results, and even provide filing assistance, if required."
Q: Can you please help me validate the high pressure process (HPP) treatment to address pathogens for my refrigerated juices?
Shirin Abd:
"Yes, our laboratory has the capability to inoculate the juice product(s) with pertinent pathogenic organisms per Juice HACCP (21 CFR 120), HPP-treat the samples, and then test the samples over the desired refrigerated shelf life. The data generated from the studies will allow you to determine if the HPP treatment is adequate to achieve and maintain appropriate log reductions of the target organisms, and can be used in support of your food safety plan."
Q: Do I need to hot fill my high acid shelf stable sauce?
Martha Kimber:
"Not necessarily, but you need to make sure that you are addressing the risk of post-process contamination by acid tolerant pathogens and spoilage organisms which may be introduced after cooling, during filling, or from the non-sterile packaging. We can recommend conservative hot fill processes, or even cold-fill-hold processes, based upon data available in the literature and/or laboratory data."
Q: I am developing a refrigerated product, can you provide a thermal process recommendation?
Shirin Abd:
"Of course! We will start by gathering info about ingredients, finished product specifications, processing capabilities, packaging, desired shelf life, etc. We will then provide a conservative process recommendations based on scientific literature. Or, if you would like to use a non-standard process, we can perform process validation studies."
If you have a question for a process authority that is not answered here, let us know!
