[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR114.80]
[Page 257-258]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 114 ACIDIFIED FOODS--Table of Contents
Subpart E Production and Process Controls
Sec. 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
[[Page 258]]
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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