21 CFR 114.80 - Processes and controls.

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§ 114.80 Processes and controls.

(a) Processing operations. The manufacturer shall employ appropriate quality control procedures to ensure that finished foods do not present a health hazard.

(1) Acidified foods shall be so manufactured, processed, and packaged that a finished equilibrium pH value of 4.6 or lower is achieved within the time designated in the scheduled process and maintained in all finished foods. Manufacturing shall be in accordance with the scheduled process. 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 nonhealth significance capable of reproducing in the food under the conditions in which the food is stored, distributed, retailed and held by the user. Permitted preservatives may be used to inhibit reproduction of microorganisms of nonhealth significance (in lieu of thermal processing).

(2) Sufficient control, including frequent testing and recording of results, shall be exercised so that the finished equilibrium pH values for acidified foods are not higher than 4.6. Measurement of acidity of foods in-process may be made by potentiometric methods, titratable acidity, or colorimetric methods. If the finished equilibrium pH of the food is above 4.0, the measurement of the finished equilibrium pH shall be by a potentiometric method, and the in-process measurements by titration or colorimetry shall be related to the finished equilibrium pH. If the finished equilibrium pH is 4.0 or below, then the measurement of acidity of the final product may be made by any suitable method. Special care should be taken when food ingredients have been subjected to lye, lime, or similar high pH materials.

(3) Procedures for acidification to attain acceptable equilibrium pH levels in the final food include, but are not limited to, the following:

(i) Blanching of the food ingredients in acidified aqueous solutions.

(ii) Immersion of the blanched food in acid solutions. Although immersion of food in an acid solution is a satisfactory method for acidification, care must be taken to ensure that the acid concentration is properly maintained.

(iii) Direct batch acidification, which can be achieved by adding a known amount of an acid solution to a specified amount of food during acidification.

(iv) Direct addition of a predetermined amount of acid to individual containers during production. Liquid acids are generally more effective than solid or pelleted acids. Care must be taken to ensure that the proper amount of acid is added to each container.

(v) Addition of acid foods to low-acid foods in controlled proportions to conform to specific formulations.

(4) Testing and examinations of containers shall occur often enough to ensure that the container suitably protects the food from leakage or contamination.

(b) Coding. Each container or product shall be marked with an identifying code permanently visible to the naked eye. If the container does not permit the code to be embossed or inked, the label may be legibly perforated or otherwise marked, as long as the label is securely affixed to the product container. The required identification shall specify in code the establishment where the product was packed, the product contained therein, and the year, day, and period during which it was packed. The packing period code shall be changed often enough to enable ready identification of lots during their sale and distribution. Codes may be changed periodically on one of the following bases: intervals of 4 to 5 hours; personnel shift changes; or batches, as long as the containers constituting the batch do not represent those processed during more than one personnel shift.

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 114 after this date.

  • 2015-11-18; vol. 80 # 222 - Wednesday, November 18, 2015
    1. 80 FR 71934 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; clarification of compliance date for certain food establishments.
      The compliance date under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (published on September 17, 2015 at 80 FR 55908) for grade “A” milk and milk products covered by NCIMS under the PMO is September 17, 2018.
      21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211