[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: 21CFR145.145]
[Page 422-426]
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. 145.145 Canned grapefruit.
(a) Identity--(1) Product identification. Canned grapefruit is the
food prepared from one of the optional grapefruit ingredients specified
in paragraph (a)(2) of this section and one of the optional packing
media specified in paragraph (a)(3) of this section. Such food may also
contain one or more of the following safe and suitable optional
ingredients:
(i) Spices.
(ii) Natural and artificial flavoring.
(iii) Lemon juice.
(iv) Citric acid.
(v) Calcium chloride or calcium lactate or a mixture of the two
calcium salts in a quantity reasonably necessary to firm the grapefruit
sections, but in no case in a quantity such that the calcium contained
in such calcium salt or mixture is more than 0.035 percent by weight of
the finished food.
Such food is sealed in a container and, before or after sealing, is so
processed by heat as to prevent spoilage.
(2) Optional grapefruit ingredient. The optional grapefruit
ingredients referred to in paragraph (a)(1) of this section are prepared
from sound, mature grapefruit (Citrus paradisi Macfadyen) of the color
types white--produced from white-fleshed grapefruit, and pink--produced
from pink or red-fleshed grapefruit and are in the following forms of
units: Whole sections or broken sections. Each such form of units or a
mixture of such forms of units prepared from a single varietal group
(color type) is an optional grapefruit ingredient. The core, seeds, and
major portions of membrane of such ingredient are removed. For the
purpose of this section, a grapefruit section is considered whole when
the unit is intact or an intact portion of such unit is not less than 75
percent of its apparent
[[Page 423]]
original size and is not excessively trimmed.
(i) For the purpose of paragraph (a)(4) of this section, the name of
the optional grapefruit ingredient is:
(a) ``Section'' or ``segments'', if 50 percent or more of the
drained weight of the food consists of whole sections.
(b) ``Broken sections'' or ``broken segments'', if less than 50
percent of the drained weight of the food consists of whole sections.
(ii) The drained weight is determined by the method prescribed in
the standard of fill of container for canned grapefruit set forth in
paragraph (c)(2) of this section.
(3) Packing media. (i) The optional packing media referred to in
paragraph (a)(1) of this section are:
(a) Water.
(b) Grapefruit juice and water.
(c) Grapefruit juice.
(d) Slightly sweetened sirup or slightly sweetened water.
(e) Light sirup.
(f) Heavy sirup.
(g) Slightly sweetened grapefruit juice and water.
(h) Lightly sweetened grapefruit juice and water.
(i) Heavily sweetened grapefruit juice and water.
(j) Slightly sweetened grapefruit juice.
(k) Lightly sweetened grapefruit juice.
(l) Heavily sweetened grapefruit juice.
As used in paragraph (a)(3)(i) of this section, the optional packing
medium ``water'' means, in addition to water, any mixture of water and
grapefruit juice in which there is less than 50 percent grapefruit
juice; the optional packing medium ``grapefruit juice and water'' means
the liquid packing medium in which juice of mature grapefruit and water
are combined as a liquid packing medium with not less than 50 percent
grapefruit juice and the term ``grapefruit juice'' means single strength
expressed juice of sound, mature fruit. It may be fresh, canned, or made
from concentrate. However, if it is made from concentrate, the juice
shall be reconstituted with water to not less than the soluble solids
the grapefruit juice had before concentration.
(ii) Each of the packing media in paragraph (a)(3)(i) (d) to (l) of
this section is prepared with a liquid ingredient and one or more safe
and suitable nutritive carbohydrate sweeteners. Water is the liquid
ingredient from which packing media in paragraph (a)(3)(i) (d) to (f) of
this section are prepared. Grapefruit juice and water are the liquid
ingredients from which the packing media in paragraph (a)(3)(i) (g) to
(i) of this section are prepared. Grapefruit juice is the liquid
ingredient from which the packing media in paragraph (a)(3)(i) (j) to
(l) of this section are prepared. If one or more liquid nutritive
carbohydrate sweeteners and grapefruit juice are combined as a liquid
packing medium with not less than 50 percent grapefruit juice, the
packing medium is as set forth in paragraph (a)(3)(i) (g) to (i) of this
section.
(iii) The respective densities of packing media in paragraph
(a)(3)(i) (d) to (i) of this section as measured on the refractometer,
expressed as percent by weight sucrose (degrees Brix) with correction
for temperature to the equivalent at 20 [deg]C (68 [deg]F), 15 days or
more after the grapefruit are canned or the blended homogenized slurry
of the comminuted entire contents of the container if canned for less
than 15 days, according to the ``Official Methods of Analysis of the
Association of Official Analytical Chemists'' (AOAC), 13th Ed. (1980),
section 31.011 under ``Solids By Means of Refractometer--Official Final
Action,'' and Reference Tables, section 52.012 (Refractive indices (n)
of sucrose solutions at 20[deg]) and section 52.015 (Refractive indices
of invert sugar solutions), which is incorporated by reference (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), but without correction for invert
sugar or other substances, are as follows:
[[Page 424]]
(a) Packing media in paragraph (a)(3)(i) (d), (g), and (j) of this
section: Twelve percent or more but less than 16 percent.
(b) Packing media in paragraph (a)(3)(i) (e), (h), and (k) of this
section: Sixteen percent or more but less than 18 percent.
(c) Packing media in paragraph (a)(3)(i) (f), (i), and (l) of this
section: Eighteen percent or more. A lot shall be deemed to be in
compliance for packing medium density based on the average value for all
the samples analyzed according to paragraph (b)(2) of this section but
no container may have a value lower than that of the next lower category
or 2 percent by weight sucrose (degrees Brix) lower if no lower category
exists.
(4) Labeling requirements. (i) The name of the food is
``grapefruit'' or ``pink grapefruit'', as appropriate for the color type
of the grapefruit used. The name of the food shall also include a
declaration of any flavoring that characterizes the product as specified
in Sec. 101.22 of this chapter and a declaration of any spice or
seasoning that characterizes the product; for example, ``with added
spice''. Whenever the word ``sirup'' is used, it may be alternatively
spelled ``syrup''. When two or more of the optional ingredients
specified in paragraphs (a)(1) (i), (ii), and (iii) of this section are
used, such words may be combined; for example, ``with added cloves and
cinnamon oil''.
(ii) The form and style of the grapefruit ingredient as provided for
in paragraph (a)(2) of this section and the name of the packing medium
as used in paragraph (a)(3) of this section preceded by ``In'' or
``Packed in'' shall be included as part of the name. When the packing
medium is prepared from concentrated grapefruit juice, the words ``from
concentrate'' shall follow the words ``grapefruit juice'' in the name of
the packing medium.
(iii) 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.
(b) Quality. (1) The standard of quality for canned grapefruit is as
follows:
(i) The food is free from extraneous material such as leaves,
portions of leaves, and pieces of peel.
(ii) The finished food contains per 500 grams (17.6 ounces) not more
than:
(a) An aggregate area of 20 square centimeters (3.1 square inches)
of tough membrane or albedo on the units.
(b) Four developed seeds. A seed is considered a developed seed when
it measures more than 9.0 millimeters (0.35 inches) in any dimension.
(iii) Not more than 15 percent by weight of the drained grapefruit
may be blemished units. A blemished unit is a grapefruit section or any
portion thereof which is damaged by lye peeling, by discoloration, or by
other visible injury. The drained weight is determined by the method
prescribed in the standard of fill of container for canned grapefruit
set forth in paragraph (c)(2) of this section.
(2) Sampling and acceptance procedure. A lot is to be considered
acceptable when the number of ``defectives'' does not exceed the
acceptance number in the sampling plans given in paragraph (b)(2)(ii) of
this section.
(i) Definitions of terms to be used in the sampling plans in
paragraph (b)(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.
(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 the examination or
testing as a single unit.
(e) Defective. Any sample unit shall be regarded as defective when
any of the defects or conditions specified in the quality standard
(paragraph (b)(1) of this section) and paragraph (c)(3)(i) of this
section for minimum fill of container are present in excess of the
stated tolerances.
[[Page 425]]
(f) Accepted 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 plans and acceptance procedure:
------------------------------------------------------------------------
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
4,801-24,000...................................... 21 3
24,001-48,000..................................... 29 4
48,001-84,000..................................... 48 6
84,001.144,000.................................... 84 9
144,001-240,000................................... 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
2,401.15,000...................................... 21 3
15,001-24,000..................................... 29 4
24,001-42,000..................................... 48 6
42,001-72,000..................................... 84 9
72,001.120,000.................................... 126 13
Over 120,000...................................... 200 19
------------------------------------------------------------------------
net weight greater than 4.5 kg (10 lb)
------------------------------------------------------------------------
600 or less....................................... 13 2
601-2,000......................................... 21 3
2,001-7,200....................................... 29 4
7,201.15,000...................................... 48 6
15,001-24,000..................................... 84 9
24,001-42,000..................................... 126 13
Over 42,000....................................... 200 19
------------------------------------------------------------------------
\1\ n=number of primary containers in sample
\2\ c=acceptance number
(3) If the quality of canned grapefruit falls below the standard
prescribed in paragraph (b)(1) of this section, the label shall bear the
general statement of substandard quality specified in Sec. 130.14(a) of
this chapter, in the manner and form therein specified; however, if the
quality of the canned grapefruit falls below standard with respect to
only one of the factors of quality specified by paragraph (b)(1) (i),
(ii), or (iii) of this section, there may be substituted for the second
line of such general statement of substandard quality, ``Good Food--Not
High Grade'', a new line as specified after the corresponding
designation of paragraph (b)(1) of this section which the canned
grapefruit fail to meet:
(i) ``Contains extraneous material''.
(ii)(a) ``Excessive tough membrane''.
(b) ``Excessive seeds''.
(iii) ``Excessive blemished units''.
(c) Fill of container.(1) The standard of fill of container for
canned grapefruit is:
(i) The fill of grapefruit and packing medium, as determined by the
general method for fill of container prescribed in Sec. 130.12(b) of
this chapter, is not less than 90 percent of the total capacity of the
container.
(ii) The drained weight of grapefruit ingredient is not less than 50
percent of the water capacity of the container, as determined by the
method prescribed in paragraph (c)(2) of this section and the general
method for water capacity of containers prescribed in Sec. 130.12(a) of
this chapter.
(2) Drained weight is determined by the following method: 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 that complies with the
specifications for the No. 8 sieve set forth in the ``Definitions of
Terms and Explanatory Notes'' of the AOAC, 13th Ed. (1980), Table 1,
which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (a)(3)(iii) of this
section. Without 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 grapefruit. The
weight so found, less the weight of the sieve, shall be considered to be
the weight of the drained grapefruit.
(3)(i) A container that falls below the requirement for minimum fill
prescribed in paragraph (c)(1)(i) of this section shall be considered a
``defective''. The food will be deemed to fall below the standard of
fill when the number of defectives exceeds the acceptance number (c) in
the sampling
[[Page 426]]
plans prescribed in paragraph (b)(2) of this section.
(ii) Canned grapefruit will be deemed to fall below the standard of
fill when the average drained weight of all containers analyzed when
sampled according to the sampling plans prescribed in paragraph (b)(2)
of this section is less than that prescribed in paragraph (c)(1)(ii) of
this section.
(4) If canned grapefruit falls below the standard of fill of
container prescribed in paragraph (c)(1) of this section, the label
shall bear the 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 11830, Mar. 19, 1982;
49 FR 10100, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2880, Jan.
6, 1993; 63 FR 14035, Mar. 24, 1998]
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