Process Authority

Mérieux NutriSciences offers process authority services to support manufacturers of acidified foods.

Mérieux NutriSciences is qualified to issue a Process Authority Letter, which assesses submitted production process and formulation details, supplemented in some cases with literature review and other scientific substantiation. 

According to the FDA, an acidified food is defined as “a low acid food with added acid or acid food(s) to obtain a pH of 4.6 or below, and a water activity greater than 0.85.”  While acidified products have an outstanding safety record, recent outbreaks have shown that a number of pathogens can survive for extended periods. 

The Food and Drug Administration (FDA) now requires manufacturers of these products to register their facility and file scheduled processes for their products with the agency in accordance with 21 CFR 108 and 114. 

Support services include assistance in filing required FDA forms, process consultation, Process Authority Letters, and scientific studies to verify process performance.  Personal consultation on filing the required processing forms.  Process consultation can be conducted via telephone or during an on-site visit. 

Our key scientists have extensive educational backgrounds, personal experience, credentials as process control experts and numerous successful scientific studies in this field 

Wendy McMahon, General Manager

For the acidified foods requiring a scientific study, such as a challenge or preservative efficacy study, to verify log reduction or organism inactivation, the Mérieux NutriSciences team has the needed expertise and tools at their fingertips.  The facility houses a biosafety level 2 pilot plant, a large culture collection, and the personnel have years of experience in running challenge studies in accordance with NACMCF guidelines.