[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR145.175]

[Page 424-427]
 
                        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. 145.175  Canned pears.

    (a) Identity--(1) Ingredients. Canned pears is the food prepared 
from one of the fresh or previously canned optional pear ingredients 
Pyrus communis or Pyrus sinensis specified in paragraph (a)(2) of this 
section which may be packed in one of the optional packing media 
specified in paragraph (a)(3) of this section. Such food may also 
contain one, or any combination of two or more, of the following safe 
and suitable optional ingredients.
    (i) Natural and artificial flavors.
    (ii) Spice.
    (iii) Vinegar, lemon juice, or organic acids.
    (iv) Artificial colors.


Such food is sealed in a container and before or after sealing is so 
processed by heat as to prevent spoilage.
    (2) Styles and forms of units. The optional pear styles and forms of 
units referred to in paragraph (a)(1) of this section are:
    (i) Whole--consisting of peeled or unpeeled pears with cores removed 
or left in.
    (ii) Halves--consisting of peeled or unpeeled pears with cores 
removed and cut into two approximately equal parts.
    (iii) Quarters--consisting of peeled pears with cores removed and 
cut into four approximately equal parts.
    (iv) Slices--consisting of peeled pears with cores removed and cut 
into wedge-shaped sectors.
    (v) Dice--consisting of peeled pears with cores removed and cut into 
cube-like parts.
    (vi) Pieces or irregular pieces--consisting of peeled pears with 
cores removed and cut into parts of irregular shapes and sizes.
    (vii) Chunky--consisting of peeled pears with cores removed and cut 
into parts 13 millimeters (0.51 inch) or greater in the smallest 
dimension and 44 millimeters (1.75 inches) or less in the largest 
dimension.
    (3) Packing media. (i) The optional packing media referred to in 
paragraph (a)(1) of this section, as defined in Sec. 145.3 are:
    (a) Water.
    (b) Fruit juice(s) and water.
    (c) Fruit juice(s).
    (d) Clarified juice.


Such packing media may be used as such or any one or any combination of 
two or more safe and suitable nutritive carbohydrate sweetener(s) may be 
added. Sweeteners defined in Sec. 145.3 shall be as defined therein, 
except that a nutritive carbohydrate sweetener for which a standard of 
identity has been established in part 168 of this chapter shall comply 
with such standard in lieu of any definition that may appear in 
Sec. 145.30.
    (ii) If the concentration of clarified juice is such that the 
packing medium forms to the density range for one of the sirups under 
paragraph (a)(3)(ii) (a), (b), (c), or (d) of this section, the 
concentrated clarified juice is considered to be light sirup, heavy 
sirup, or extra heavy sirup, as the case may be. When a sweetener is 
added as a part of any such liquid packing medium, the density range of 
the resulting packing medium expressed as percent by weight of sucrose 
(degrees Brix) as determined by the procedure in Sec. 145.3(m) shall be 
designated by the appropriate name for the respective density ranges, 
namely:

[[Page 425]]

    (a) When the density of the solution is less than 14 percent, the 
medium shall be designated as ``slightly sweetened water''; or ``extra 
light sirup''; ``slightly sweetened fruit juice(s) and water''; or 
``slightly sweetened fruit juice(s)'', as the case may be.
    (b) When the density of the solution is 14 percent or more but less 
than 18 percent, the medium shall be designated as ``light sirup''; 
``lightly sweetened fruit juice(s) and water''; or ``lightly sweetened 
fruit juice(s)'' as the case may be.
    (c) When the density of the solution is 18 percent or more but less 
than 22 percent, the medium shall be designated as ``heavy sirup''; 
``heavily sweetened fruit juice(s) and water''; or ``heavily sweetened 
fruit juice(s)'', as the case may be.
    (d) When the density of the solution is 22 percent or more but not 
more than 35 percent, the medium shall be designated as ``extra heavy 
sirup''; ``extra heavily sweetened fruit juice(s) and water''; or 
``extra heavily sweetened fruit juice(s)'', as the case may be.
    (4) Labeling requirements. (i) The name of the food is ``pears''. 
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, ``Spice added'', or in lieu of the word 
``Spice'', the common name of the spice, ``Seasoned with vinegar''. When 
two or more of the optional ingredients specified in paragraphs (a)(1) 
(ii) and (iii) of this section are used, such words may be combined as 
for example, ``Seasoned with cider vinegar, cloves, and cinnamon oil''.
    (ii) The style and forms of units of the pear ingredient as provided 
in paragraph (a)(2) of this section and the name of the packing medium 
specified in paragraph (a)(3) (i) and (ii) of this section, preceded by 
``In'' or ``Packed in'' or the words ``Solid pack'', where applicable, 
shall be included as part of the name or in close proximity to the name 
of the food, except that ``Halves'' may be alternatively designated as 
``Halved'', ``Quarters'' as ``Quartered'', ``Slices'' as ``Sliced'', and 
``Dice'' as ``Diced''. ``Pieces'' or ``Irregular pieces'' shall be 
designated as ``Pieces'', ``Irregular pieces'', or ``Mixed pieces of 
irregular sizes and shapes''. ``Chunky'' may be designated as 
``Chunks''. The style of the pear ingredient shall be preceded or 
followed by ``Unpeeled'' when the units are whole or halves and are 
unpeeled. When the packing medium is prepared with a sweetener(s) which 
imparts a taste, flavor or other characteristic to the finished food in 
addition to sweetness, the name of the packing medium shall be 
accompanied by the name of such sweetener(s), as for example in the case 
of a mixture of brown sugar and honey, an appropriate statement would be 
``______ sirup of brown sugar and honey'' the blank to be filled in with 
the word ``light'', ``heavy'', or ``extra heavy'', as the case may be. 
When the liquid portion of the packing media provided for in paragraphs 
(a)(3) (i) and (ii) of this section consists of fruit juice(s), such 
juice(s) shall be designated in the name of the packing medium as:
    (a) In the case of a single fruit juice, the name of the juice shall 
be used in lieu of the word ``fruit'';
    (b) In the case of a combination of two or more fruit juices, the 
names of the juices in the order of predominance by weight shall either 
be used in lieu of the word ``fruit'' in the name of the packing medium, 
or be declared on the label as specified in paragraph (a)(4)(iii) of 
this section; and
    (c) In the case of a single fruit juice or a combination of two or 
more fruit juices any of which are made from concentrate(s), the words 
``from concentrate(s)'' shall follow the word ``juice(s)'' in the name 
of the packing medium and in the name(s) of such juice(s) when declared 
as specified in paragraph (a)(4)(iii) of this section.
    (iii) Whenever the names of the fruit juices used do not appear in 
the name of the packing medium as provided in paragraph (a)(4)(ii)(b) of 
this section, such names and the words ``from concentrate'', as 
specified in paragraph (a)(4)(ii)(c) of this section, shall appear in an 
ingredient statement pursuant to the requirements of Sec. 101.3(d) of 
this chapter.
    (iv) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the

[[Page 426]]

applicable sections of parts 101 and 130 of this chapter.
    (b) Quality. (1) The standard of quality for canned pears is as 
follows:
    (i) Maturity. All units tested in accordance with the method 
prescribed in paragraph (b)(2) of this section are pierced by a weight 
of not more than 300 grams (10.6 ounces).
    (ii) Minimum size. In the case of halves and quarters styles, the 
weight of each unit is not less than 17 grams (0.6 ounce) and 8.5 grams 
(0.3 ounce), respectively.
    (iii) Uniformity of size--(a) Whole, halves, and quarters. In the 
case of whole, halves, and quarters styles, among those units comprising 
95 percent by count of those present in the container that are most 
uniform in size, the weight of the largest unit is not more than twice 
the weight of the smallest unit. In containers with fewer than 20 units, 
1 unit may be disregarded in making the determination. Where a unit has 
broken in the container, reassemble the broken pieces to approximate a 
single unit of the appropriate style.
    (b) Chunky. In the case of chunky style, not more than 25 percent of 
the drained weight of the contents of the container consists of units 
that will pass through an opening 13 millimeters (0.51 inch) wide or 
that are more than 44 millimeters (1.75 inches) along the longest cut 
edge.
    (iv) Peel (except unpeeled style). Not more than 10 square 
centimeters (1.6 square inches) of peel adhering to pears or loose in 
the container per kilogram (35.3 ounces) of net weight.
    (v) Blemished units. Not more than 20 percent by count of the units 
in the container are blemished with scab, hail injury, discoloration, or 
other abnormality aggregating the area of a circle more than 6.5 
millimeters (0.25 inch) in diameter; corky or hard spots on outer 
surfaces aggregating the area of a circle more than 13 millimeters (0.51 
inch) in diameter; or dark brown areas aggregating the area of a circle 
less than 6.5 millimeters (0.25 inch) in diameter which penetrate into 
the flesh or affect the appearance of the unit.
    (vi) Trimmed units. In the case of whole, halves, and quarters 
styles, all units are untrimmed or are so trimmed as to preserve normal 
shape of the unit.
    (vii) Crushed or broken units. In the case of whole, halves, 
quarter, slices, dice, and chunky styles, not more than 10 percent by 
count of the units in containers of 10 or more units and not more than 1 
unit in containers of less than 10 units are crushed or broken. A unit 
that lost its normal shape because of ripeness and bears no mark of 
crushing shall not be considered to be crushed or broken.
    (viii) Loose core material in all styles except uncored whole style. 
Not more than two units of loose core material per kilogram (35.3 
ounces) of net weight. A unit of such material is defined as a portion 
of loose core, with or without seeds, aggregating approximately one-half 
of a pear core.
    (ix) Partially cored units in all styles except uncored whole style. 
Not more than 40 percent by count partially cored units in halves, 
quarters, slices, and pieces or irregular pieces styles and not more 
than 5 percent by weight in dice style. A partially cored unit is a unit 
of pear that contains an attached portion of the seed cell cavity.
    (x) Seeds in all styles except whole uncored style. Not more than 8 
seeds or the equivalent in pieces of seeds per kilogram (35.3 ounces) of 
net weight. Seeds included as cored material in paragraph (b)(1) (viii) 
and (ix) of this section shall not be counted a second time.
    (2) Canned pears shall be tested by the following method to 
determine whether they meet the requirements of paragraph (b)(1)(i) of 
this section: So trim a test piece from the unit as to fit, with peel 
surface up, into a supporting receptacle. If the unit is of different 
firmness in different parts of its peel surface, trim the piece from the 
firmest part. If the piece is unpeeled, remove the peel. The top of the 
receptacle is circular in shape, of 28.6 millimeters (1.12 inches) 
inside diameter, with vertical sides; or rectangular in shape, 19 
millimeters (0.75 inch) by 25.4 millimeters (1 inch) inside 
measurements, with ends vertical and sides sloping downward and joining 
at the center at a vertical depth of 19 millimeters (0.75 inch). Use the 
circular receptacle for testing units of such size

[[Page 427]]

that a test piece can be trimmed therefrom to fit it. Use the 
rectangular receptacle for testing other units. Test no unit from which 
a test piece with rectangular peel surface at least 13 millimeters (0.51 
inch) by 25.4 millimeters (1 inch) cannot be trimmed. Test the piece by 
means of a round metal rod 4 millimeters (0.16 inch) in diameter. To the 
upper end of the rod is affixed a device to which weight can be added. 
The rod is held vertically by the support through which it can freely 
move upward or downward. The lower end of the rod is a plane surface to 
which the vertical axis of the rod is perpendicular. Adjust the combined 
weight of the rod and device to 100 grams (3.5 ounces). Set the 
receptacle so that the surface of the test piece is held horizontally. 
Lower the end of the rod to the approximate center of such surface, and 
add weight to the device at a uniform, continuous rate of 12 grams (0.42 
ounce) per second until the rod pierces the test piece. Weigh the rod 
and weighted device. Test all units in containers of 50 units or less 
except those units too small for testing or too soft for trimming. Test 
at least 50 units, taken at random in containers of more than 50 units; 
but if less than 50 units are of sufficient size and firmness for 
testing, test those which are of sufficient size and firmness.
    (3) Determine compliance as specified in Sec. 145.3(o) except that a 
lot shall be deemed to be in compliance for peel in all styles except 
unpeeled styles and seeds in all styles except whole uncored style based 
on the average of all samples analyzed according to the sampling plans 
set out in Sec. 145.3(p).
    (4) If the quality of canned pears 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 pears falls below standard with respect to only 
one of the factors of quality specified in paragraph (b)(1) (i) through 
(x) 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 pears fail to meet, as 
follows:
    (i) ``Not tender'';
    (ii) ``Small halves'' or ``small quarters'', as the case may be;
    (iii)(a) ``Mixed sizes'';
    (b) ``Undersized and/or oversized pieces'';
    (iv) ``Excessive peel'';
    (v) ``Blemished'';
    (vi) ``Unevenly trimmed'';
    (vii) ``Partly crushed or broken'';
    (viii) ``Excessive core'';
    (ix) ``Excessive core'';
    (x) ``Excessive seeds''.


Such alternative statement shall immediately and conspicuously precede 
or follow, without intervening written, printed, or graphic matter, the 
name ``pears'' and any words and statements required or authorized to 
appear with such name by paragraph (a)(2) of this section.
    (c) Fill of container. (1) The standard of fill of container for 
canned pears is the maximum quantity of the optional pear ingredient 
that can be sealed in the container and processed by heat to prevent 
spoilage, without crushing or breaking such ingredient.
    (2) If canned pears fall 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 41528, 41530, Sept. 21, 
1982; 58 FR 2880, Jan. 6, 1993]