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145.3 Definitions.

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[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR145.3]

[Page 396-399]
 
                        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 A_General Provisions
 
Sec.  145.3  Definitions.




                      Subpart A_General Provisions

Sec.
145.3 Definitions.

     Subpart B_Requirements for Specific Standardized Canned Fruits

145.110 Canned applesauce.
145.115 Canned apricots.
145.116 Artificially sweetened canned apricots.
145.120 Canned berries.
145.125 Canned cherries.
145.126 Artificially sweetened canned cherries.
145.130 Canned figs.
145.131 Artificially sweetened canned figs.
145.134 Canned preserved figs.
145.135 Canned fruit cocktail.
145.136 Artificially sweetened canned fruit cocktail.
145.140 Canned seedless grapes.
145.145 Canned grapefruit.
145.170 Canned peaches.
145.171 Artificially sweetened canned peaches.
145.175 Canned pears.
145.176 Artificially sweetened canned pears.
145.180 Canned pineapple.
145.181 Artificially sweetened canned pineapple.
145.185 Canned plums.
145.190 Canned prunes.

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.

    Source: 42 FR 14414, Mar. 15, 1977, unless otherwise noted.



    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.''

[[Page 397]]

    (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.\6\F011 (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)

[[Page 398]]

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 17[deg] to 20[deg] 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:

------------------------------------------------------------------------
                                                      Size in 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

[[Page 399]]


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.


[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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 145, Section 3


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