[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: 21CFR145.110]
[Page 405-406]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 145 CANNED FRUITS--Table of Contents
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 Sec. 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
[[Page 406]]
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 Sec. 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
------------------------------------------------------------------------
Size of container
Lot size (primary containers) ---------------------
n \1\ c \2\
------------------------------------------------------------------------
net weight equal to or less than 1 kg (2.2 lb)
------------------------------------------------------------------------
4,800 or less..................................... 13 2
4,801 to 24,000................................... 21 3
24,001 to 48,000.................................. 29 4
48,001 to 84,000.................................. 48 6
84,001 to 144,000................................. 84 9
144,001 to 240,000................................ 126 13
Over 240,000...................................... 200 19
------------------------------------------------------------------------
net weight greater than 1 kg (2.2 lb) but not more than 4.5 kg (10 lb)
------------------------------------------------------------------------
2,400 or less..................................... 13 2
2,401 to 15,000................................... 21 3
15,001 to 24,000.................................. 29 4
24,001 to 42,000.................................. 48 6
42,001 to 72,000.................................. 84 9
72,001 to 120,000................................. 126 13
Over 120,000...................................... 200 19
------------------------------------------------------------------------
net weight greater than 4.5 kg (10 lb)
------------------------------------------------------------------------
600 or less....................................... 13 2
601 to 2,000...................................... 21 3
2,001 to 7,200.................................... 29 4
7,201 to 15,000................................... 48 6
15,001 to 24,000.................................. 84 9
24,001 to 42,000.................................. 126 13
Over 42,000....................................... 200 19
------------------------------------------------------------------------
\1\ n=number of primary containers in sample.
\2\ c=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 Sec.
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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