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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: 21CFR145.110]



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

PART 145 -- CANNED FRUITS

Subpart B--Requirements for Specific Standardized Canned Fruits

Sec. 145.110 Canned applesauce.

(a) Identity --(1) Definition. Canned applesauce is the food prepared from comminuted or chopped apples (Malus domestica Borkhausen), which may or may not be peeled and cored, and which may have added thereto one or more of the optional ingredients specified in paragraph (a)(2) of this section. The apple ingredient is heated and, in accordance with good manufacturing practices, bruised apple particles, peel, seed, core material, carpel tissue, and other coarse, hard, or extraneous materials are removed. The food is sealed in containers. It is so processed by heat, either before or after sealing, as to prevent spoilage. The soluble solids content, measured by refractometer and expressed as percent sucrose (degrees Brix) with correction for temperature to the equivalent at 20 deg. C (68 deg. F), is not less than 9 percent (exclusive of the solids of any added optional nutritive carbohydrate sweeteners) as determined by the method prescribed in "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), section 22.024, "Soluble Solids by Refractometer in Fresh and Canned Fruits, Jams, Marmalades, and Preserves--Official First Action," which is incorporated by reference, but without correction for invert sugar or other substances. Copies 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.

(2) Optional ingredients. The following safe and suitable optional ingredients may be used:

(i) Water.

(ii) Apple juice.

(iii) Salt.

(iv) Any organic acid added for the purpose of acidification. (Organic acids generally recognized as having a preservative effect are not permitted in applesauce except as provided for in paragraph (a)(2)(viii) of this section.)

(v) Nutritive carbohydrate sweeteners.

(vi) Spices.

(vii) Natural and artificial flavoring.

(viii) Either of the following:

(a ) Erythorbic acid or ascorbic acid as an antioxidant preservative in an amount not to exceed 150 parts per million; or

(b ) Ascorbic acid (vitamin C) in a quantity such that the total vitamin C in each 113 g (4 ounces) by weight of the finished food amounts to 60 mg. This requirement will be deemed to have been met if a reasonable overage of the vitamin, within limits of good manufacturing practice, is present to insure that the required level is maintained throughout the expected shelf life of the food under customary conditions of distribution.

(ix) Color additives in such quantity as to distinctly characterize the food unless such addition conceals damage or inferiority or makes the finished food appear better or of greater value than it is.

(3) Nomenclature. The name of the food is "applesauce". The name of the food shall include a declaration indicating the presence of any flavoring that characterizes the product as specified in 101.22 of this chapter and a declaration of any spice that characterizes the product. If a nutritive sweetener as provided for in paragraph (a)(2)(v) of this section is added and the soluble solids content of the finished food is not less than 16.5 percent as determined by the method referred to in paragraph (a)(1) of this section, the name may include the word "sweetened". If no such sweetener is added, the name may include the word "unsweetened".

(4) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter. However, when ascorbic acid (vitamin C) is added as provided for in paragraph (a)(2)(viii)(b ) of this section, after the application of heat to the apples, preservative labeling requirements do not apply.

(b) [Reserved]

(c) Fill of container. (1) The standard of fill of container for canned applesauce is a fill of not less than 90 percent of the total capacity of the container, as determined by the general method for fill of containers prescribed in 130.12(b) of this chapter; except that in the case of glass containers having a total capacity of 192 ml (6 1/2 fluid ounces) or less, the fill is not less than 85 percent.

(2) Sampling and acceptance procedure: A lot will be deemed to fall below the standard of fill when the number of "defectives" exceeds the acceptance number "c" in the sampling plans prescribed in paragraph (c)(2)(ii) of this section.

(i) Definitions of terms to be used in the sampling plans in paragraph (c)(2)(ii) of this section are as follows:

(a ) 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.

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

(c ) Sample size "n." The total number of sample units drawn for examination from a lot as indicated in paragraph (c)(2)(ii) of this section.

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

(e ) Defective. A container that falls below the requirement for minimum fill prescribed in paragraph (c)(1) of this section is considered a "defective."

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

(g ) 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.

(ii) Sampling and acceptance:

Acceptable quality level (AQL) 6.5

Lot size (primary containers) Size of 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.

(3) If canned applesauce falls below the standard of fill of container prescribed in paragraph (c)(1) of this section, the label shall bear the general statement of substandard fill specified in 130.14(b) of this chapter, in the manner and form therein specified.

[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; 58 FR 2879, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998]

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