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Food and drug branch (fdb)

Food Safety Program

How to Complete the Request for Official Sterilization Process Form for Low-Acid Canned Foods

The purpose of this webpage is to assist you in properly completing the Request for Official Sterilization Process (PDF) form in order to provide the University of California Laboratory for Research in Food Preservation (UCLRFP) with the best available information about your product and process.

Please fill out a separate form for each product.

Filling out the Form

Canner

The name of the company or person who will be manufacturing the product. This can be the name of a co-packer who will be manufacturing the product. If you plan to manufacture the product yourself, but do not yet have a company name, put your own name in this box.

Mailing Address/City/Zip Code

Include the complete address where the canner receives mail. The canner will be notified of the outcome of the process evaluation via letter, so it is important to provide a valid, accurate mailing address.

Product

The name of your product, as it will appear on the finished packaged product label.

Formula

An alphanumeric code unique to this formulation of the product. For example, Vegetarian Refried Beans might be called VRB-01. Note: if you ever change the formulation for this product, the new formula number would be changed sequentially. In the example above, the new formula for the product would be VRB-02.

Telephone and/or E-mail address

Sometimes, UCLRFP has questions during the evaluation process. Provide a telephone number and/or E-mail address where the responsible individual can be reached to answer questions.

Sample Source

Use this box if you are submitting a sample of the product. If the sample was made in the production facility where you intend to make the product for commercial production, check the ā€œProductionā€ box. If the sample was made in a laboratory or test kitchen, check the ā€œLaboratoryā€ box.

New Product

If the product has never been previously submitted to UCLFRP, check the ā€œYesā€ box. If the product has previously been submitted to UCLFRP (perhaps under a different formula number), check the ā€œNoā€ box. This is a reformulation.

Reformulation

If the product has been previously submitted to UCLFRP and this submittal is for a new formula number, check the ā€œYesā€ box. Or if you are changing the container and/or the process or processing equipment, provide details about the changes you are making. If the product has never previously been submitted to UCLFRP, leave this section blank.

Container Size(s)

Describe the container (can, pouch, glass jar, plastic tub, etc.), complete with dimensions. List all that apply.

Existing S-Number and/or Date of Existing Process Letter

If the product has been previously submitted to UCLFRP, what is the S number and date from the previous process letter?

Type of Retort/Cooker Speed Desired/Hold Tube Length

Provide information about the equipment used to manufacture the product. Here are examples of necessary information.

For Aseptic Canning:

  • Process system
  • Does the system use heat? If yes, direct heat or indirect heat?
  • Hold tube length?
  • Hold tube identification
  • Flow rate
  • Packaging System
For Conventional Canning (Retort):
  • Still Retorts
  • Container Position Agitating Retorts
  • Cooker Speed Desired: RPM
  • Gross Headspace (Provide information in the designated box)
  • Consistency (Provide information in the designated box)

Fill Weight

Identify the fill weight.

Net Weight

Identify the net weight.

Product pH

Identify the pH of the product.

Syrup Brix (if applicable)

Identify the Brix of the syrup.

Other

Use this space if you wish to include additional processing parameters not identified above.

Ingredients

Identify each ingredient used in the product and the amount of each ingredient. Use consistent units of measure (ounces, pounds, grams, etc.). Amount of ingredients is a key consideration when UCLFRP is evaluating the process. If you use inconsistent measurements (cups, TBSP, tsp), UCLFRP will have to make calculations to determine how much of each ingredient is in the product, and this determination may have an impact on the final evaluation of the process and/or the critical factors that are determined. If you can calculate the percentage values accurately for each ingredient, please do so. If not, just submit the weight/measure.

Desired Process Temperature(s)

Identify the temperature(s) the processor plans to use.

Desired Initial Temperature(s)

Identify the initial temperature(s) the processor plans to use. If the product is heated in advance of filling, and/or if hot brine is added, include those temperatures.

Details of Product Preparation

This section is where the canner explains exactly how the product will be made. How are the ingredients combined? What goes in first, second, etc...? Are the ingredients chopped, blended, cooked, peeled, etc...? Use additional paper, if necessary. The better information you provide regarding product preparation, the more accurate the evaluation

Signature/Printed Name/Title

The signature, title and printed name of the person who prepared the form.

Date

The date the form was completed.

Please refer to the webpage Steps for Submission of Low-Acid Canned Food (LACF) Products for additional information regarding the evaluation process.

Important Notes

The product formulation is protected under the law. Specifically, California Health and Safety Code Section 110165 states that it is unlawful for any person to use to his own advantage, or to reveal to any person other than to the director or officers or employees of this department, or to the courts when relevant to any judicial proceeding under this division, any information acquired under authority of this division concerning any method or process which as a trade secret is entitled to protection.

Submittal of this form is like entering into a contract. The information provided needs to be factual, and the official process determination is based upon the information provided on this form. If any changes are made to the formulation, container and/or process the product needs to be re-submitted for evaluation to determine whether the official process determination has changed.

Food and Drug Branch

1-800-495-3232

FDBfood@cdph.ca.govā€‹

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