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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 April 1 2018.

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]
[Revised as of April 1, 2018]
[CITE: 21CFR145]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
 
PART 145CANNED FRUITS
 

Subpart A--General Provisions

Sec. 145.3 Definitions.

For the purposes of this part:

(a) The term corn sirup means a clarified, concentrated aqueous solution of the products obtained by the incomplete hydrolysis of cornstarch, and includes dried corn sirup. The solids of corn sirup and of dried corn sirup contain not less than 40 percent by weight of reducing sugars calculated as anhydrous dextrose.

(b) The term dextrose means the hydrated or anhydrous, refined monosaccharide obtained from hydrolyzed starch.

(c) The term dried glucose sirup means the product obtained by drying "glucose sirup."

(d) The term glucose sirup means a clarified, concentrated, aqueous solution of the products obtained by the incomplete hydrolysis of any edible starch. The solids of glucose sirup contain not less than 40 percent by weight of reducing sugars calculated as anhydrous dextrose.

(e) The term invert sugar sirup means an aqueous solution of inverted or partly inverted, refined or partly refined sucrose, the solids of which contain not more than 0.3 percent by weight of ash, and which is colorless, odorless, and flavorless, except for sweetness.

(f) The term sugar means refined sucrose.

(g) The terms edible organic acid and edible organic salt refer to any edible organic acid and any edible organic salt added for the purpose of flavor enhancement that either is not a food additive as defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act or, if it is a food additive as so defined, is used in conformity with regulations established pursuant to section 409 of the act.

(h) The term water means, in addition to water, any mixture of water and fruit juice in which the fruit juice(s) is less than 50 percent of such mixture, including any water contributed by the use of liquid nutritive carbohydrate sweeteners.

(i) The term fruit juice(s) and water means any mixture of fruit juice as herein defined and water, including any water contributed by the use of liquid nutritive carbohydrate sweeteners, in which the fruit juice(s) is 50 percent, or more, of such mixture except that water used in preparing equivalent single strength juice(s) from concentrate(s) shall not be considered to be a mixture of fruit juice and water.

(j) The term fruit juice(s) means single strength expressed juice(s) of sound, mature fruit(s). It may be fresh, frozen, canned, or made from concentrate(s). However, if it is made from concentrate(s), the juice(s) shall be reconstituted with water to not less than the soluble solids that such fruit juice had before concentration. Fruit juice(s) may be used singly or in combination. If a fruit juice(s) is used which is regulated by a standard of identity of this chapter, it shall conform to the compositional requirements prescribed by such standard prior to the addition of any sweetener which may be used.

(k) The term clarified juice means the liquid expressed wholly or in part from fruit peelings, fruit shells, fruit cores, or from the fruit flesh or parts thereof, which is clarified and may be further refined or concentrated.

(l) The term solid pack means the product contains practically all fruit with only the very little free flowing liquid that is expressed from the fruit and to which no packing media have been added.

(m) The procedure for determining the densities of the packing media means the following: The density of the packing medium, when measured 15 days or more after packing, or the density of the blended homogenized slurry of the comminuted entire contents of the container, when measured less than 15 days after canning, is determined according to "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), which is incorporated by reference, section 31. 6F011 (Solids) "By Means of the Refractometer--Official Final Action" (and sections 52.012 and 52.015) with result expressed as percent by weight of sucrose (degrees Brix) with correction for temperature to the equivalent at 20 deg. C, but without correction for invert sugar or other substances. Copies of the material incorporated by reference may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(n) The procedure for determining drained weight is as follows: Tilt the opened container so as to distribute the contents evenly over the meshes of a circular sieve which has previously been weighed. The diameter of the sieve is 20.3 centimeters (8 inches) if the quantity of contents of the container is less than 1.4 kilograms (3 pounds) and 30.5 centimeters (12 inches) if such quantity is 1.4 kilograms (3 pounds) or more. The bottom of the sieve is woven-wire cloth which complies with the specifications for the No. 8 sieve set forth in the "Definitions of Terms and Explanatory Notes" of the "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (m) of this section. Carefully invert by hand all fruits having cups or cavities if they fall on the sieve with cups or cavities up. Cups or cavities in soft products may be drained by tilting sieve. Without further shifting the material on the sieve, incline the sieve at an angle of 17deg. to 20deg. to facilitate drainage. Two minutes after the drainage begins, weigh the sieve and drained fruit. The weight so found, less the weight of the sieve, shall be considered to be the weight of the drained fruit.

(o) Compliance means the following: Unless otherwise provided in a standard, a lot of canned fruits shall be deemed in compliance for the following factors, to be determined by the sampling and acceptance procedure as provided in paragraph (p) of this section, namely:

(1) Packing medium density. A lot shall be deemed to be in compliance for packing medium density based on the average sucrose value for all samples analyzed according to the sampling plans, but no container may have a sucrose value lower than that of the next lower category or 2 percent by weight sucrose (degrees Brix) lower if no lower category exists.

(2) Quality. The quality of a lot shall be considered acceptable when the number of defectives does not exceed the acceptance number in the sampling plans.

(3) Fill of container. A lot shall be deemed to be in compliance for fill of container (packing medium and fruit ingredient) when the number of defectives does not exceed the acceptance number (c) in the sampling plans.

(4) Drained weight. A lot shall be deemed to be in compliance for drained weight based on the average value of all samples analyzed according to the sampling plans. The sample unit shall be the entire contents of the container.

(p) The sampling and acceptance procedure means the following:

(1) Definitions --(i) Lot. A collection of primary containers or units of the same size, type, and style manufactured or packed under similar conditions and handled as a single unit of trade.

(ii) Lot size. The number of primary containers or units in the lot.

(iii) Sample size. The total number of sample units drawn for examination from a lot.

(iv) Sample unit. A container, a portion of the contents of a container, or a composite mixture of product from small containers that is sufficient for the examination or testing as a single unit.

(v) Defective. Any sample unit shall be regarded as defective when the sample unit does not meet the criteria set forth in the standards.

(vi) Acceptance number (c ). The maximum number of defective sample units permitted in the sample in order to consider the lot as meeting the specified requirements.

(vii) Acceptable quality level (AQL ). The maximum percent of defective sample units permitted in a lot that will be accepted approximately 95 percent of the time.

(2) Sampling plans:

Lot size (primary containers) Size in container
n 1 c 2
net weight equal to or less than 1 kg (2.2 lb)
4,800 or less132
4,801 to 24,000213
24,001 to 48,000294
48,001 to 84,000486
84,001 to 144,000849
144,001 to 240,00012613
Over 240,00020019
net weight greater than 1 kg (2.2 lb) but not more than 4.5 kg (10 lb)
2,400 or less132
2,401 to 15,000213
15,001 to 24,000294
24,001 to 42,000486
42,001 to 72,000849
72,001 to 120,00012613
Over 120,00020019
net weight greater than 4.5 kg (10 lb)
600 or less132
601 to 2,000213
2,001 to 7,200294
7,201 to 15,000486
15,001 to 24,000849
24,001 to 42,00012613
Over 42,00020019

1n = number of primary containers in sample.

2c = acceptance number.

[42 FR 14414, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19, 1982; 49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989; 63 FR 14035, Mar. 24, 1998]

Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Source: 42 FR 14414, Mar. 15, 1977, unless otherwise noted.

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