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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 2]
[CITE: 21CFR114]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION
 
PART 114ACIDIFIED FOODS
 

Subpart A - General Provisions

Sec. 114.3 Definitions.

For the purposes of this part, the following definitions apply.

(a) Acid foods means foods that have a natural pH of 4.6 or below.

(b) Acidified foods means low-acid foods to which acid(s) or acid food(s) are added; these foods include, but are not limited to, beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in any combination. They have a water activity (aw) greater than 0.85 and have a finished equilibrium pH of 4.6 or below. These foods may be called, or may purport to be, "pickles" or "pickled ______." Carbonated beverages, jams, jellies, preserves, acid foods (including such foods as standardized and nonstandardized food dressings and condiment sauces) that contain small amounts of low-acid food(s) and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, and foods that are stored, distributed, and retailed under refrigeration are excluded from the coverage of this part.

(c) Lot means the product produced during a period indicated by a specific code.

(d) Low-acid foods means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85. Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods.

(e) Scheduled process means 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.

(f) Shall is used to state mandatory requirements.

(g) Should is used to state recommended or advisory procedures or to identify recommended equipment.

(h) Water activity (aw) is a measure of the free moisture in a product and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

[44 FR 16235, Mar. 16, 1979, as amended at 61 FR 14245, Apr. 1, 1996]

Sec. 114.5 Current good manufacturing practice.

The criteria in §§ 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the criteria in parts 110 and 117 of this chapter, apply in determining whether an article of acidified food is adulterated:

(a) Within the meaning of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it has been manufactured under such conditions that it is unfit for food; or

(b) Within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

[80 FR 56144, Sept. 17, 2015]

Sec. 114.10 Personnel.

All operators of processing and packaging systems shall be under the operating supervisions 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 practices, pH controls and critical factors in acidification, and who has been identified by that school as having satisfactorily completed the prescribed course of instruction. The Commissioner will consider students who have satisfactorily completed the required portions of the courses presented under § 108.35 and part 113 of this chapter before March 16, 1979, to be in compliance with the requirement of this section.

Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.
Source: 44 FR 16235, Mar. 16, 1979, unless otherwise noted.

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