Processing Shelf Stable Acidified Foods in Sealed Containers
*Disclaimer: If you manufacture and/or sell/market any other product(s) that contain cannabis as an ingredient, our lab cannot assist you even if that new product does not contain cannabis.*
Food products packaged in hermetically sealed (air tight) containers are subject to regulations equivalent to the Code of Federal Regulations, Title 21, Parts 108, 113, and/or 114 (21 CFR 108, 113, and/or 114). Of course, all food products also must comply with a number of other regulations including labeling, net contents, good manufacturing practices, etc.
Low acid foods have finished equilibrium pH greater than 4.6. Acid foods have a natural finished equilibrium pH of 4.6 or less. Acidified foods also have a finished equilibrium pH 4.6 or less but have a significant low acid component. Acidified foods include pickled vegetables, most salsas, and many other formulated products. Exceptions to the acidified foods regulations include carbonated beverages, alcoholic beverages, refrigerated and frozen products, and products with water activity 0.85 or less. Jams and jellies which meet the published standards of identity are exempt since their water activities are 0.85 or less.
A process authority (a person with expert knowledge in processing) determines the product classification and the processes for low acid and acidified foods. The rest of this document will address only acidified foods.
Copies of 21 CFR 108, 110, and 114 are attached for your information. It is our understanding that processors who are under the jurisdiction of the Washington State Department of Agriculture and the State Department of Health/local health departments are subject to these same regulations with a few modifications. There is substantial mandatory record keeping required for acidified foods, including (but not limited to) the following:
- Examination of raw materials, ingredients, and packaging materials.
- pH and/or acidity controls
- Processing and production records
- Product initial temperature
- Product fill temperatures
- Process temperature
- Process time
- Production date
- Product codes
- Container size
- Thermometer calibrations
- Container closure inspections
- Established process from process authority
- Examination of finished products, including pH
- Other critical factors prescribed by your process authority
- Process deviations, corrective actions taken, and product disposition
- Initial distribution of finished products by code
- Suppliers guarantees or certifications verifying regulatory compliance
- Recall plan
All mandatory records must be retained at a reasonably accessible location for at least 3 years from the date of manufacture.
In addition, every processing facility which processes low acid and/or acidified food products must be registered with the FDA (FDA Form 2541). The official process for each product x container combination must also be filed (FDA Form 2541a).
The regulations also include an education requirement. “All operators of processing and packaging systems for acidified food shall be under the operating supervision of a person who has attended a school approved by the Commissioner for giving instruction in food handling techniques, food protection principles, personal hygiene and plant sanitation, pH controls and critical factors in acidification, and who has been identified by that school as having satisfactorily completed the prescribed course of instruction (21 CFR 114.10).” WSU is an approved school and offers courses several times each year for as few as 6 students per time.
According to 21 CFR 114.80(a)(1) all acidified foods “. . . shall be thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of non-health significance capable of reproducing in the food under the conditions in which food is stored, distributed, retailed, and held by the user.”
Official processes for acidified foods include maximum pH as well as thermal processes. The thermal processes are often described as “hot fill/hold” or “hot water bath/steam bath” methods. Following are descriptions of each.
Hot fill hold process
- Product is filled into the finished containers at a temperature high enough to assure that the temperature of all product in the container is at or above the minimum prescribed when the closure (lid) is applied.
- Container is then inverted (turned upside down) for 3 minutes and then may be cooled.
- If the product cannot be pumped, the hot fill/hold process probably is not applicable.
- Critical factors may include head space (consult with process authority).
Hot water bath/steam bath process
- Product is filled into the finished container at convenient temperature and finished closure is applied. The higher the closing temperature, the better the finished vacuum.
- Filled, closed containers are then heated in a hot water bath or steam bath maintained at the prescribed minimum temperature for the prescribed time. This information is included in the process from your process authority. If you do not have that information, contact us immediately for assistance.
- Once the prescribed minimum process is completed, the containers of product may be cooled.
We strongly recommend that producers of acidified food products purchase and properly use a digital pH meter and appropriate accurate calibrated thermometers. Producers of jams, jellies, preserves, fruit butters, spreads, syrups, and other similar products are strongly advised to purchase and utilize appropriate refractometers. Many consider these instruments to be expensive, but we believe they are necessary for reasonable operation of a profitable food business.
For further information and assistance with any of the above please contact:
Dr. Girish Ganjyal, Extension Food Processing Specialist
Washington State University
1945 Ferdinand’s Lane
106 FSHN Bldg
P.O. Box 646376
Pullman, WA 99164-6376
**Disclaimer: If you manufacture and/or sell/market any other product(s) that contain cannabis as an ingredient, our lab cannot assist you even if that new product does not contain cannabis.**
For safety evaluation of your acidified product, please follow the directions below:
- Mail or deliver to Dr. Girish Ganjyal at the address provided above.
- Download required excel spreadsheet template for product evaluation.
- Please type out your spreadsheet and keep a copy for yourself. You can use Google Sheets (free) or Microsoft Excel.
- We ask that you fill out the spreadsheet, fully.
- You must convert your recipe to either all ounces or all grams, and no mixing of two different weights.
- If any information is not filled out or incorrect, it may delay the evaluation process.
- The jar size that will be sold.
- Recipe amounts in weights and percentages preferred before volume (we keep all recipes and processes strictly confidential) and label for your product.
- Please send the amount for indicated services provided. If you send a check, please make the check out to Washington State University.
- When shipping, please pack each jar with bubble wrap and avoid having the glass jars touch each other during shipping. This will decrease chances of breakage during shipping.
- Any paperwork and check needs to be placed in a plastic sleeve or bag in case the product leaks or breaks.
Product evaluation for potential safety issues, process classification, potential quality problems which might be associated with the product, etc.
Timeline: Dr. Ganjyal will contact your within 5 weeks to discuss your results, after which a process authority letter will be mailed out to you. If you do not have the correct information, like filling out the recipe spreadsheet completely, it will delay the process.
For these types of products (using hot fill hold process) we ask that 2 jars of product, packed in the jar size that will be sold be sent into our lab:
- Jams, Jellies, Fruit Butter, Salsa, Salad Dressing, Garlic Spread, BBQ Sauce,Hot Sauce, Teas, and Mustard. These must have acid ingredient like citric acid, vinegar, lime juice, and etc.
- Baked Goods, Seasonings, Granola, Spices, and Cookies for water activity only, and no PA letter.
- We do not analyze any fermented products or products which have not been thermally processed.
- Please note that we can only accept up to 5 different products/recipes for testing at a time.
- If you water bath or steam, you must submit using water bath/steam fees.
Hot Fill Hold Fees – 2 jars per recipe:
- $150.00 each product/recipe in-state (WA/ID/MT).
- $200.00 each product/recipe out-of-state.
For example, if you want to test a blueberry jam, strawberry jam, and blackberry jam, they are three different products thus we ask you send a $450 or $600.
Another example, if you have a strawberry jam and you want to test pint glass jar, quart glass jar, and half gallon glass jar. Those are considered three different recipes due to the processing, and we would ask you send a $450 or $600.
Process determination with specified pH, process times/temperatures, and critical factors.
For these types of products we ask that 6 jars of product, packed in the jar size that will be sold be sent into our lab. These must have acid ingredient like citric acid, vinegar, lime juice, and etc.:
- Whole or spears pickles
- Spears of asparagus
- Whole jalapenos
- Any whole pickle vegetable or fruit
- Sliced veggies that are tightly packed, like salsa or chutney.
- Jams and Jellies processed with water bath
- Please note that we can only accept up to 3 different products/recipes for heat penetration testing at a time.
Heat Penetration/Hot Water Bath/ Steam Fees – 6 jars per recipe:
- $250.00 each product/recipe for in-state (WA/ID/MT).
- $275.00 each product/recipe for out-of-state.
Example, if you have a salsa and you want to test the mild salsa, medium salsa, and extremely spicy salsa. Those are considered three different recipes and we would ask you send a $750 or $825.
Another example, if you have a salsa and you want to test pint glass jar, quart glass jar, and half gallon glass jar. Those are considered three different recipes, due to the processing, and we would ask you send a $750 or $850.
For basic microbiological testing, please visit Washington Animal Disease Diagnostic Laboratory website.
For non-traditional microbiological testing, please email Dr. Stephanie Smith.