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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: 21CFR145.145]



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. 145.145 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 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 20deg. ) 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:

(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 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.

(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:

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
4,801-24,000213
24,001-48,000294
48,001-84,000486
84,001-144,000849
144,001-240,00012613
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
2,401-15,000213
15,001-24,000294
24,001-42,000486
42,001-72,000849
72,001-120,00012613
Over 120,00020019
net weight greater than 4.5 kg (10 lb)
600 or less132
601-2,000213
2,001-7,200294
7,201-15,000486
15,001-24,000849
24,001-42,00012613
Over 42,00020019

1n = number of primary containers in sample

2c = 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 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 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 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 17deg. to 20deg. 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 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 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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