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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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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[CITE: 21CFR113.3]



Subpart A - General Provisions

Sec. 113.3 Definitions.

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

(a) Aseptic processing and packaging means the filling of a commercially sterilized cooled product into presterilized containers, followed by aseptic hermetical sealing, with a presterilized closure, in an atmosphere free of microorganisms.

(b) Bleeders means openings used to remove air that enters with steam from retorts and steam chambers and to promote circulation of steam in such retorts and steam chambers. Bleeders may serve as a means of removing condensate.

(c) Come-up-time means the time which elapses between the introduction of steam into the closed retort and the time when the retort reaches the required processing temperature.

(d) Commercial processor includes any person engaged in commercial, custom, or institutional (church, school, penal, or other organization) processing of food, including pet food. Persons engaged in the production of foods that are to be used in market or consumer tests are also included.

(e) Commercial sterility: (1) "Commercial sterility" of thermally processed food means the condition achieved -

(i) By the application of heat which renders the food free of -

(a ) Microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution; and

(b ) Viable microorganisms (including spores) of public health significance; or

(ii) By the control of water activity and the application of heat, which renders the food free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.

(2) "Commercial sterility" of equipment and containers used for aseptic processing and packaging of food means the condition achieved by application of heat, chemical sterilant(s), or other appropriate treatment that renders the equipment and containers free of viable microorganisms having public health significance, as well as microorganisms of nonhealth significance, capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.

(f) Critical factor means any property, characteristic, condition, aspect, or other parameter, variation of which may affect the scheduled process and the attainment of commercial sterility.

(g) Flame sterilizer means an apparatus in which hermetically sealed containers are agitated at atmospheric pressure, by either continuous, discontinuous, or reciprocating movement, with impinging gas flames to achieve sterilization temperatures. A holding period in a heated section may follow the initial heating period.

(h) Headspace, gross is the vertical distance between the level of the product (generally the liquid surface) in an upright rigid container and the top edge of the container (the top of the double seam of a can or the top edge of a glass jar).

(i) Headspace, net of a container is the vertical distance between the level of the product (generally the liquid surface) in the upright rigid container and the inside surface of the lid.

(j) Hermetically sealed container means a container that is designed and intended to be secure against the entry of microorganisms and thereby to maintain the commercial sterility of its contents after processing.

(k) Incubation means the holding of a sample(s) at a specified temperature for a specified period of time for the purpose of permitting or stimulating the growth of microorganisms.

(l) Initial temperature means the average temperature of the contents of the coldest container to be processed at the time the thermal processing cycle begins, as determined after thorough stirring or shaking of the filled and sealed container.

(m) Lot means that amount of a product produced during a period of time indicated by a specific code.

(n) 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.

(o) Minimum thermal process means the application of heat to food, either before or after sealing in a hermetically sealed container, for a period of time and at a temperature scientifically determined to be adequate to ensure destruction of microorganisms of public health significance.

(p) Operating process means the process selected by the processor that equals or exceeds the minimum requirements set forth in the scheduled process.

(q) Retort means any closed vessel or other equipment used for the thermal processing of foods.

(r) Scheduled process means the process selected by the processor as adequate under the conditions of manufacture for a given product to achieve commercial sterility. This process may be in excess of that necessary to ensure destruction of microorganisms of public health significance, and shall be at least equivalent to the process established by a competent processing authority to achieve commercial sterility.

(s) Shall is used to state mandatory requirements.

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

(u) Vacuum-packed products means those products that are sealed in a container under the vacuum specified in the scheduled process, the maintenance of which vacuum is critical to the adequacy of the scheduled process.

(v) Vents means openings through the retort shell, controlled by gate, plug cock, or other adequate valves used for the elimination of air during the venting period.

(w) 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.