March 24, 2020
By Dr. Edward Richter, Certified Process Authority
Due to the recent events associated with the worldwide coronavirus (COVID-19) pandemic, food manufactures may experience supply chain disruptions that may require a change in one or more ingredients that impact how your product functions, and/or in the way in which you process food products. If your products include acidified foods or low acid canned food (LACF) and they have been registered (filed) with FDA, it is important to be aware of potential formulation changes which may constitute a regulatory deviation for a filed process.
What products require filing with FDA?
“Acidified foods” are low-acid foods to which acid(s) or acid food(s) are added; they have a
water activity greater than 0.85 and have a finished equilibrium pH of 4.6 or below (21 CFR
114.3(b)). The definition of acidified foods provides that carbonated beverages and foods that
are stored, distributed, and retailed under refrigeration are excluded from the coverage of 21 CFR part 114 (21 CFR 114.3(b)).
Acidified food requires the identification and verification of a scheduled process. The regulations in 21 CFR part 114 for acidified foods define a scheduled process as the process selected by a processor as adequate for use under the conditions of manufacture for a food in
achieving and maintaining a food that will not permit the growth of microorganisms having
public health significance. It includes control of pH and other critical factors equivalent to the
process established by a competent processing authority (21 CFR 114.3(e)).
Processors of acidified food are required to register their facility via FDA form 2541. FDA will register the facility and issue a Food Canning Establishment (FCE) number to the facility.
In addition, processors of acidified food are required to register their facility via FDA form 2541e in the following circumstances:
- When you manufacture, process, or pack a product in more than one container size or type, you are required to submit a separate Form FDA 2541e for each container size and type.
- You may report multiple product packing mediums on the same Form FDA 2541e provided that:
- Factors other than “product packing medium” (e.g., container type or size) do not require separate filing; and
- The process information you provide in Section I of Form FDA 2541e applies to each product variation. If the heat transfer rates are different for each product variation, the process for the slowest heating formulation of the product packing medium
must be filed. The comment section of the filing form should state which formulation packing medium heats the slowest.
- You may report multiple products with minor formulation changes on the same Form FDA 2541e provided that:
- Other factors (e.g., container type or size) do not require separate filing; and
- The process information you provide in Section I of Form FDA 2541e applies to each formulation of the product. If the heat transfer rates are different for each product formulation variation, the process for the slowest heating formulation of the product must be filed. The comment section of the filing form should state which formulation heats the slowest.
When Do I Need to Revisit My Filing?
An acidified food needs to be re-filed with the FDA if any critical factor has been changed. Critical Factors may include hydrogen ion activity (pH), water activity (aw), titratable acidity (TA), type of acid, thermal processing time or temperature, hot fill temperature, inversion time, container size, packaging material, etc.
If you have made changes to your acidified foods and/or microbiological control critical factors and would benefit from a Process Authority Review, please reach out to us here at Matrix Sciences Advisory Services. Matrix Sciences can review your formulations for microbiological risks and or regulatory compliance.
What We Need:
PROCESS AUTHORITY MICROBIOLOGICAL REVIEW
- Name of Company
- Name of product(s)
- Formula (in % by weight if possible)
- Any critical factors (if known) (pH, acid concentration, water activity, etc.)
- Process parameters (flow chart is acceptable)
- Packaging (dimensions)
- FCE Number if known
- Prior FDA Filing
- Copies of any correspondence from potential customers or regulators
- A unit (for verification of critical factors)
FOR ASSISTANCE PLEASE CONTACT US here: https://www.matrixsciences.com/contact/
Anon, Instructions for Paper Submission of Form FDA 2541e (Food Process Filing for Acidified Method), U.S. Department of Health and Human Services, Food and Drug Administration. Center for Food Safety and Applied Nutrition. January 2016
Anon, Guidance for Industry Acidified Foods. U.S. Department of Health and Human Services, Food and Drug Administration. Center for Food Safety and Applied Nutrition. September 2010