This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146]
[Page 436]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart A--General Provisions
Sec.
146.3 Definitions.
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
146.114 Lemon juice.
146.120 Frozen concentrate for lemonade.
146.121 Frozen concentrate for artificially sweetened lemonade.
146.126 Frozen concentrate for colored lemonade.
146.132 Grapefruit juice.
146.135 Orange juice.
146.137 Frozen orange juice.
146.140 Pasteurized orange juice.
146.141 Canned orange juice.
146.145 Orange juice from concentrate.
146.146 Frozen concentrated orange juice.
146.148 Reduced acid frozen concentrated orange juice.
146.150 Canned concentrated orange juice.
146.151 Orange juice for manufacturing.
146.152 Orange juice with preservative.
146.153 Concentrated orange juice for manufacturing.
146.154 Concentrated orange juice with preservative.
146.185 Pineapple juice.
146.187 Canned prune juice.
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Source: 42 FR 14433, Mar. 15, 1977, unless otherwise noted.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.3]
[Page 436-437]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart A--General Provisions
Sec. 146.3 Definitions.
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
[[Page 437]]
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.
(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) 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 (h) of this section, namely:
(1) 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.
(2) Fill of container. A lot shall be deemed to be in compliance for
fill of container when the number of defectives does not exceed the
acceptance number (c) in the sampling plans.
(h) 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 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.
[[Page 438]]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.114]
[Page 438-439]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.114 Lemon juice.
(a) Identity--(1) Description. Lemon juice is the unfermented juice,
obtained by mechanical process, from sound, mature lemons (Citrus limon
(L.) Burm. f.), from which seeds (except embryonic seeds and small
fragments of seed which cannot be separated by good manufacturing
practice) and excess pulp are removed. The juice may be adjusted by the
addition of the optional concentrated lemon juice ingredient specified
in paragraph (a)(2) of this section in such quantity so that the
increase in acidity, calculated as anhydrous citric acid, does not
exceed 15 percent of the acidity of the finished food. The lemon oil and
lemon essence (derived from lemons) content may be adjusted in
accordance with good manufacturing practice. The juice may have been
concentrated and later reconstituted. When prepared from concentrated
lemon juice, the finished food contains not less than 6 percent, by
weight, of soluble solids taken as the refractometric sucrose value (of
the filtrate), corrected to 20 deg.C, but uncorrected for acidity, in
accordance with the "International Scale of Refractive Indices of
Sucrose Solutions" in section 52.012 of "Official Methods of Analysis
of the Association of Official Analytical Chemists," 13th Ed. (1980),
which is incorporated by reference, and has a titratable acidity content
of not less than 4.5 percent, by weight, calculated as anhydrous citrus
acid. Copies of the incorporation by reference may be obtained from the
Association of Official Analytical Chemists International, 481 North
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be
examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC. The food may contain one or any
combination of the safe and suitable optional ingredients specified in
paragraph (a)(2) of this section. Lemon juice, as defined in this
paragraph, may be preserved by heat sterilization (canning),
refrigeration, freezing, or by the addition of safe and suitable
preservatives. When sealed in a container to be held at ambient
temperatures, it is preserved by the addition of safe and suitable
preservatives or so processed by heat, before or after sealing, as to
prevent spoilage.
(2) Optional ingredients. The optional safe and suitable ingredients
referred to in paragraph (a)(1) of this section are:
(i) Concentrated lemon juice (lemon juice from which part of the
water has been removed).
(ii) Water and/or lemon juice to reconstitute concentrated lemon
juice in the manufacture of lemon juice from concentrate.
(iii) Preservatives.
(3) Labeling. (i) The name of the food is:
(a) "Lemon juice" (1) if the food is prepared from unconcentrated,
undiluted liquid extracted from mature lemons; or (2) if the food is
prepared from unconcentrated, undiluted liquid extracted from mature
lemons to which concentrated lemon juice is added to adjust acidity as
provided for in paragraph (a)(1) of this section.
(b) "Lemon juice from concentrate" or "reconstituted lemon
juice" (1) if the food is prepared from concentrated lemon juice and
water and/or lemon juice; or (2) if the food is prepared from lemon
juice from concentrate and lemon juice. The words "from concentrate"
or "reconstituted" shall be shown in letters not less than one-half
the height of the letters in the word "lemon juice."
(ii) 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) [Reserved]
(c) Fill of container. (1) The standard of fill of container for
lemon juice, except when the food is frozen, is not less than 90 percent
of the total capacity of the container as determined by the general
method for fill of container prescribed in Sec. 130.12(b) of this
chapter, except (i) when the food is frozen or (ii) when the food is
packaged in individual serving-size packages, containing \1/2\ fluid
ounce or less, for use as described in Sec. 1.24(a)(3) of this chapter.
(2) Compliance is determined as specified in Sec. 146.3(g)(2).
[[Page 439]]
(3) If the lemon juice fails to meet the standard of fill as
prescribed in paragraph (c) (1) and (2) 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
prescribed.
[45 FR 7786, Feb. 5, 1980, as amended at 47 FR 11830, Mar. 19, 1982; 49
FR 10100, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2881, Jan. 6,
1993; 63 FR 14035, Mar. 24, 1998]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.120]
[Page 439]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.120 Frozen concentrate for lemonade.
(a) Frozen concentrate for lemonade is the frozen food prepared from
one or both of the lemon juice ingredients specified in paragraph (b) of
this section together with one or any mixture of safe and suitable
nutritive carbohydrate sweeteners. The product contains not less than
48.0 percent by weight of soluble solids taken as the sucrose value
determined by refractometer and corrected for acidity prescribed in
"Official Methods of Analysis of the Association of Official Analytical
Chemists," 13th Ed. (1980), section 22.025, "Frozen Concentrate for
Lemonade (12)," under the heading "Soluble Solids by Refractometer--
Official First Action," which is incorporated by reference. Copies may
be obtained from the Association of Official Analytical Chemists
International, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877-2504, or may be examined at the Office of the Federal Register,
800 North Capitol Street, NW., suite 700, Washington, DC. When the
product is diluted according to directions for making lemonade which
shall appear on the label, the acidity of the lemonade, calculated as
anhydrous citric acid, shall be not less than 0.70 gram per 100
milliliters, and the soluble solids, measured as described for the
concentrate, shall be not less than 10.5 percent by weight.
(b) The lemon juice ingredients referred to in paragraph (a) of this
section are:
(1) Lemon juice or frozen lemon juice or a mixture of these.
(2) Concentrated lemon juice or frozen concentrated lemon juice or a
mixture of these.
For the purposes of this section, lemon juice is the undiluted juice
expressed from mature lemons of an acid variety; and concentrated lemon
juice is lemon juice from which part of the water has been removed. In
the preparation of the lemon juice ingredients, the lemon oil content
may be adjusted by the addition of lemon oil or concentrated lemon oil
in accordance with good manufacturing practice, and the lemon pulp in
the juice as expressed may be left in the juice or may be separated.
Lemon pulp that has been separated, which may have been preserved by
freezing, may be added in preparing frozen concentrate for lemonade,
provided that the amount of pulp added does not raise the proportion of
pulp in the finished food to a level in excess of that which would be
present by using lemon juice ingredients from which pulp has not been
separated. The lemon juice ingredients may be treated by heat, either
before or after the other ingredients are added, to reduce the enzymatic
activity and the number of viable microorganisms.
(c) 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.
[42 FR 14433, 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 2881, Jan.
6, 1993; 63 FR 14035, Mar. 24, 1998]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.121]
[Page 439-440]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.121 Frozen concentrate for artificially sweetened lemonade.
(a) Frozen concentrate for artificially sweetened lemonade conforms
to the definition and standard of identity prescribed for frozen
concentrate for lemonade by Sec. 146.120, except that in lieu of
nutritive sweeteners it is sweetened with one or more of the artificial
sweetening ingredients listed in and complying with the requirements of
parts 172, 180 or 184 of this chapter, and the soluble solids
specifications prescribed in Sec. 146.120(a) do not apply. When the
product is diluted according to directions which shall appear on the
label, the acidity of the artificially sweetened lemonade, calculated as
anhydrous citric acid, shall be not less than 0.70 gram per 100
milliliters. It may contain one or more safe and suitable dispersing
ingredients serving the function of distributing the lemon oil
[[Page 440]]
throughout the food. It may also contain one or more safe and suitable
thickening ingredients. Such dispersing and thickening ingredients are
not food additives as defined in section 201(s) of the Federal Food,
Drug, and Cosmetic Act; or if they are food additives as so defined,
they are used in conformity with regulations established pursuant to
section 409 of the act.
(b) [Reserved]
(c) The name of the food is "Frozen concentrate for artificially
sweetened lemonade". The words "artificially sweetened" shall be of
the same size and style of type as the word "lemonade".
(d) If an optional thickening or dispersing ingredient referred to
in paragraph (a) of this section is used, the label shall bear the
statement "------ added" or "with added ------", the blank being
filled in with the common name of the thickening or dispersing agent
used. Such statement shall be set forth on the label with such
prominence and conspicuousness as to render it likely to be read and
understood by the ordinary individual under customary conditions of
purchase.
(e) Frozen concentrate for artificially sweetened lemonade is
labeled to conform to the labeling requirements prescribed for foods
which purport to be or are represented for special dietary use by
regulations promulgated pursuant to section 403(j) of the act.
(f) 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.
[42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.126]
[Page 440]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.126 Frozen concentrate for colored lemonade.
(a) Frozen concentrate for colored lemonade conforms to the
definition and standard of identity prescribed for frozen concentrate
for lemonade by Sec. 146.120, except that it is colored with a safe and
suitable fruit juice, vegetable juice, or any such juice in concentrated
form, or with any other color additive ingredient suitable for use in
food, including artificial coloring, used in conformity with regulations
established pursuant to section 721 of the Federal Food, Drug, and
Cosmetic Act.
(b) The name of the food is "Frozen concentrate for ------
lemonade", the blank being filled in with the word describing the
color: for example, "Frozen concentrate for pink lemonade".
(c) 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.
[42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.132]
[Page 440-441]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.132 Grapefruit juice.
(a) Identity--(1) Description. Grapefruit juice is the unfermented
juice, intended for direct consumption, obtained by mechanical process
from sound, mature grapefruit (Citrus paradisi Macfadyen) from which
seeds and peel (except embryonic seeds and small fragments of seeds and
peel which cannot be separated by good manufacturing practice) and
excess pulp are removed and to which may be added not more than 10
percent by volume of the unfermented juice obtained from mature hybrids
of grapefruit. The juice may be adjusted by the addition of the optional
concentrated grapefruit juice ingredients specified in paragraph (a)(2)
of this section, but the quantity of such concentrated grapefruit juice
ingredient added shall not contribute more than 15 percent of the
grapefruit juice soluble solids in the finished food. The grapefruit
pulp, grapefruit oil, and grapefuit essence (components derived from
grapefruit) content may be adjusted in accordance with good
manufacturing practice. The juice may have been concentrated and later
reconstituted with water suitable for the purpose of maintaining
essential composition and quality factors of the juice. It may be
sweetened with the dry nutritive sweeteners referred to in paragraph
(a)(2)(iii) of this section. If the grapefruit juice is prepared from
concentrate, such sweeteners, in liquid form, referred to in paragraph
(a)(2)(iii) of this section, also may be used. When prepared from
concentrated grapefruit juice, exclusive of added sweeteners, the
finished food contains not less than 10 percent, by weight, of soluble
solids taken as the refractometric sucrose
[[Page 441]]
value (of the filtrate), corrected to 20 deg.C, and corrected for
acidity by adding (0.012+0.193x-0.0004x\2\), where x equals the percent
anhydrous citric acid in the sample, to the refractometrically obtained
sucrose value by the first method prescribed in "Correction of
Refractometer Sucrose Readings for Citric Acid Content for Lemonade,"
by Yeatman, Senzel, and Springer, "Journal of the Association of
Official Analytical Chemists," vol. 59 p. 368 (1976). Copies are
available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite
500, Gaithersburg, MD 20877-2504, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC. The food may contain one or any combination of the
optional ingredients specified in paragraph (a)(2) of this section.
Grapefruit juice, as defined in this paragraph, may be preserved by heat
sterlization (canning), refrigeration, or freezing. When sealed in a
container to be held at ambient temperatures, it is so processed by
heat, before or after sealing, as to prevent spoilage.
(2) Optional ingredients. The optional ingredients referred to in
paragraph (a)(1) of this section are:
(i) Concentrated grapefruit juice (grapefruit juice from which part
of the water has been removed).
(ii) Water and/or grapefruit juice to reconstitute concentrated
grapefruit juice in the manufacture of grapefruit juice from
concentrate.
(iii) One or any combination of two or more of the dry or liquid
forms of sugar, invert sugar sirup, dextrose, glucose sirup, and
fructose. Sweeteners defined in part 168 of this chapter shall be as
defined therein.
(3) Labeling. (i) The name of the food is:
(a) "Grapefruit juice" (1) if the food is prepared from
unconcentrated, undiluted liquid extracted from mature grapefruit; or
(2) if the food is prepared from unconcentrated, undiluted liquid
extracted from mature grapefruit to which concentrated grapefruit juice
is added to adjust soluble solids as provided for in paragraph (a)(1) of
this section.
(b) "Grapefruit juice from concentrate" (1) if the food is
prepared from concentrated grapefruit juice and water and/or grapefruit
juice; or (2) if the food is prepared from grapefuit juice from
concentrate and grapefruit juice. The words "from concentrate" shall
be shown in letters not less than one-half the height of the letters in
the words "grapefruit juice."
(ii) If any nutritive sweetener is added, the principal display
panel of the label shall bear the statement "Sweetener added." If no
sweetener is added, the word "unsweetened" may immediately precede or
follow the words "Grapefruit Juice" or "Grapefruit Juice from
Concentrate."
(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) [Reserved]
(c) Fill of container. (1) The standard of fill of container for
grapefruit juice, except when the food is frozen, is not less than 90
percent of the total capacity of the container as determined by the
general method for fill of container prescribed in Sec. 130.12(b) of
this chapter.
(2) Compliance is determined as specified in Sec. 146.3(g)(2).
(3) If the grapefruit juice fails to meet the standard of fill as
prescribed in paragraphs (c) (1) and (2) 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
prescribed.
[46 FR 8464, Jan. 27, 1981; 46 FR 21359, Apr. 10, 1981; 46 FR 26300, May
12, 1981, as amended at 47 FR 11830, Mar. 19, 1982; 47 FR 24287, June 4,
1982; 47 FR 43364, Oct. 1, 1982; 58 FR 2881, Jan. 6, 1993; 66 FR 17359,
Mar. 30, 2001]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.135]
[Page 441-442]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.135 Orange juice.
(a) Orange juice is the unfermented juice obtained from mature
oranges of the species Citrus sinensis or of the citrus hybrid commonly
called "Ambersweet" (1/2 Citrus sinensis X 3/8 Citrus reticulata X 1/8
Citrus paradisi (USDA Selection:1-100-29: 1972 Whitmore Foundation
Farm)). Seeds (except embryonic seeds and small fragments of seeds that
cannot be separated by current good manufacturing practice) and excess
pulp are removed. The juice may be chilled, but it is not frozen.
[[Page 442]]
(b) The name of the food is "orange juice". The name "orange
juice" may be preceded on the label by the varietal name of the oranges
used, and if the oranges grew in a single State, the name of such State
may be included in the name, as for example, "California Valencia
orange juice".
[42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.137]
[Page 442]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.137 Frozen orange juice.
(a) Frozen orange juice is orange juice as defined in Sec. 146.135,
except that it is frozen.
(b) The name of the food is "Frozen orange juice". Such name may
be preceded on the label by the varietal name of the oranges used, and
if the oranges grew in a single State, the name of such State may be
included in the name, as for example, "California Valencia frozen
orange juice".
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.140]
[Page 442-443]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.140 Pasteurized orange juice.
(a) Pasteurized orange juice is the food prepared from unfermented
juice obtained from mature oranges as specified in Sec. 146.135, to
which may be added not more that 10 percent by volume of the unfermented
juice obtained from mature oranges of the species Citrus reticulata or
Citrus reticulata hybrids (except that this limitation shall not apply
to the hybrid species described in Sec. 146.135). Seeds (except
embryonic seeds and small fragments of seeds that cannot be separated by
good manufacturing practice) are removed, and pulp and orange oil may be
adjusted in accordance with good manufacturing practice. If the
adjustment involves the addition of pulp, then such pulp shall not be of
the washed or spent type. The solids may be adjusted by the addition of
one or more of the optional concentrated orange juice ingredients
specified in paragraph (b) of this section. One or more of the optional
sweetening ingredients listed in paragraph (c) of this section may be
added in a quantity reasonably necessary to raise the Brix or the Brix-
acid ratio to any point within the normal range usually found in
unfermented juice obtained from mature oranges as specified in
Sec. 146.135. The orange juice is so treated by heat as to reduce
substantially the enzymatic activity and the number of viable
microorganisms. Either before or after such heat treatment, all or a
part of the product may be frozen. The finished pasteurized orange juice
contains not less than 10.5 percent by weight of orange juice soluble
solids, exclusive of the solids of any added optional sweetening
ingredients, and the ratio of the Brix hydrometer reading to the grams
of anhydrous citric acid per 100 milliliters of juice is not less than
10 to 1.
(b) The optional concentrated orange juice ingredients referred to
in paragraph (a) of this section are frozen concentrated orange juice as
specified in Sec. 146.146 and concentrated orange juice for
manufacturing as specified in Sec. 146.153 when made from mature
oranges; but the quantity of such concentrated orange juice ingredients
added shall not contribute more than one-fourth of the total orange
juice solids in the finished pasteurized orange juice.
(c) The optional sweetening ingredients referred to in paragraph (a)
of this section are sugar, invert sugar, dextrose, dried corn sirup,
dried glucose sirup.
(d)(1) The name of the food is "Pasteurized orange juice". If the
food is filled into containers and preserved by freezing, the label
shall bear the name "Frozen pasteurized orange juice". The words
"pasteurized" or "frozen pasteurized" shall be shown on labels in
letters not less than one-half the height of the letters in the words
"orange juice".
(2) If the pasteurized orange juice is filled into containers and
refrigerated, the label shall bear the name of the food, "chilled
pasteurized orange juice". If it does not purport to be either canned
orange juice or frozen pasteurized orange juice, the word "chilled"
may be omitted from the name. The words "pasteurized" or "chilled
pasteurized" shall be shown in letters not less than one-half the
height of the letters in the words "orange juice".
(e)(1) If a concentrated orange juice ingredient specified in
paragraph (b) of this section is used in adjusting the orange juice
solids of the pasteurized orange juice, the label shall bear the
[[Page 443]]
statement "prepared in part from concentrated orange juice" or "with
added concentrated orange juice" or "concentrated orange juice
added".
(2) If one or more of the sweetening ingredients specified in
paragraph (c) of this section are added to the pasteurized orange juice,
the label shall bear the statement "------ added", the blank being
filled in with the name or an appropriate combination of the names of
the sweetening ingredients used. However, for the purpose of this
section, the name "sweetener" may be used in lieu of the specific name
or names of the sweetening ingredients.
(f) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statements specified in this section for naming the
optional ingredients used shall immediately and conspicuously precede or
follow the name of the food, without intervening written, printed, or
graphic matter.
(g) 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.
[42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992; 58
FR 2881, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.141]
[Page 443-444]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.141 Canned orange juice.
(a) Canned orange juice is the food prepared from orange juice as
specified in Sec. 146.135 or frozen orange juice as specified in
Sec. 146.137, or a combination of both, to which may be added not more
than 10 percent by volume of the unfermented juice obtained from mature
oranges of the species Citrus reticulata or Citrus reticulata hybrids
(except that this limitation shall not apply to the hybrid species
described in Sec. 146.135). Seeds (except embryonic seeds and small
fragments of seeds that cannot be separated by good manufacturing
practice) are removed. Orange oil and pulp may be adjusted in accordance
with good manufacturing practice. The adjustment of pulp referred to in
this paragraph does not permit the addition of washed or spent pulp.
Liquid condensate recovered from the deoiling operation may be added
back. One or more of the optional sweetening ingredients named in
paragraph (b) of this section may be added, in a quantity reasonably
necessary to raise the Brix or the Brix-acid ratio to any point within
the normal range usually found in unfermented juice obtained from mature
oranges as specified in Sec. 146.135. The food is sealed in containers
and so processed by heat, either before or after sealing, as to prevent
spoilage. The finished canned orange juice tests not less than 10 deg.
Brix, and the ratio of the Brix hydrometer reading to the grams of
anhydrous citric acid per 100 milliliters of juice is not less than 9 to
1.
(b) The optional sweetening ingredients referred to in paragraph (a)
of this section are sugar, invert sugar, dextrose, dried corn sirup,
dried glucose sirup.
(c) The name of the food is "Canned orange juice". All the words
in the name shall appear in the same size, color, and style of type and
on the same color-contrasting background. If the food is not sold under
refrigeration and if it does not purport to be chilled pasteurized
orange juice or frozen pasteurized orange juice, the word "canned" may
be omitted from the name.
(d) If one or more of the sweetening ingredients specified in
paragraph (b) of this section are added to the canned orange juice, the
label shall bear the statement "------ added", the blank being filled
in with the name or an appropriate combination of the names of the
sweetening ingredients used. However, for the purpose of this section,
the name "sweetener" may be used in lieu of the specific name or names
of the sweetening ingredients.
(e) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statement specified in this section for naming the
optional ingredients used shall immediately and conspicuously precede or
follow the name of the food, without intervening written, printed, or
graphic matter.
(f) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the
[[Page 444]]
applicable sections of parts 101 and 130 of this chapter.
[42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992; 58
FR 2881, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.145]
[Page 444]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.145 Orange juice from concentrate.
(a) Orange juice from concentrate is the food prepared by mixing
water with frozen concentrated orange juice as defined in Sec. 146.146
or with concentrated orange juice for manufacturing as defined in
Sec. 146.153 (when made from mature oranges), or both. To such mixture
may be added orange juice as defined in Sec. 146.135, frozen orange
juice as defined in Sec. 146.137, pasteurized orange juice as defined in
Sec. 146.140, orange juice for manufacturing as defined in Sec. 146.151
(when made from mature oranges and preserved by chilling or freezing but
not by canning), orange oil, orange pulp, and one or more of the
sweetening ingredients listed in paragraph (b) of this section. The
finished orange juice from concentrate contains not less than 11.8
percent orange juice soluble solids, exclusive of solids of any added
optional sweetening ingredients. It may be so treated by heat as to
reduce substantially the enzymatic activity and the number of viable
microorganisms.
(b) The sweetening ingredients referred to in paragraph (a) of this
section are sugar, sugar sirup, invert sugar, invert sugar sirup,
dextrose, corn sirup, dried corn sirup, glucose sirup, dried glucose
sirup.
(c) The name of the food is "Orange juice from concentrate". The
words "from concentrate" shall be shown in letters not less than one-
half the height of the letters in the words "orange juice".
(d) When orange juice from concentrate contains any optional
sweetening ingredient as listed in paragraph (b) of this section,
whether added directly as such or indirectly as an added ingredient of
any orange juice product used, the label shall bear the statement "----
-- added", the blank being filled in with the name or an appropriate
combination of the names of the sweetening ingredients added. However,
for the purposes of this section the name "sweetener" may be used in
lieu of the specific name or names of the sweetening ingredients.
(e) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statements specified in this section for naming the
optional ingredients used shall immediately and conspicuously precede or
follow the name of the food, without intervening written, printed, or
graphic matter.
(f) 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.
[42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.146]
[Page 444-445]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.146 Frozen concentrated orange juice.
(a) Frozen concentrated orange juice is the food prepared by
removing water from the juice of mature oranges as provided in
Sec. 146.135, to which may be added unfermented juice obtained from
mature oranges of the species Citrus reticulata, other Citrus reticulata
hybrids, or of Citrus aurantium, or both. However, in the unconcentrated
blend, the volume of juice from Citrus reticulata or Citrus reticulata
hybrids shall not exceed 10 percent (except that this limitation shall
not apply to the hybrid species described in Sec. 146.135) and from
Citrus aurantium shall not exceed 5 percent. The concentrate so obtained
is frozen. In its preparation, seeds (except embryonic seeds and small
fragments of seeds that cannot be separated by good manufacturing
practice) and excess pulp are removed, and a properly prepared water
extract of the excess pulp so removed may be added. Orange oil, orange
pulp, orange essence (obtained from orange juice), orange juice and
other orange juice concentrate as provided in this section or
concentrated orange juice for manufacturing provided in Sec. 146.153
(when made from mature oranges), water, and one or more of the optional
sweetening ingredients specified in paragraph (b) of this section may be
added to adjust the final composition. The juice of Citrus reticulata
and Citrus aurantium, as permitted by this paragraph, may be
[[Page 445]]
added in single strength or concentrated form prior to concentration of
the Citrus sinensis juice, or in concentrated form during adjustment of
the composition of the finished food. The addition of concentrated juice
from Citrus reticulata or Citrus aurantium, or both, shall not exceed,
on a single-strength basis, the 10 percent maximum for Citrus reticulata
and the 5 percent maximum for Citrus aurantium prescribed by this
paragraph. Any of the ingredients of the finished concentrate may have
been so treated by heat as to reduce substantially the enzymatic
activity and the number of viable microorganisms. The finished food is
of such concentration that when diluted according to label directions
the diluted article will contain not less than 11.8 percent by weight of
orange juice soluble solids, exclusive of the solids of any added
optional sweetening ingredients. The dilution ratio shall be not less
than 3 plus 1. For the purposes of this section and Sec. 146.150, the
term "dilution ratio" means the whole number of volumes of water per
volume of frozen concentrate required to produce orange juice from
concentrate having orange juice soluble solids of not less than 11.8
percent by weight exclusive of the solids of any added optional
sweetening ingredients.
(b) The optional sweetening ingredients referred to in paragraph (a)
of this section are sugar, sugar sirup, invert sugar, invert sugar
sirup, dextrose, corn sirup, dried corn sirup, glucose sirup, and dried
glucose sirup.
(c) If one or more of the sweetening ingredients specified in
paragraph (b) of this section are added to the frozen concentrated
orange juice, the label shall bear the statement "------ added", the
blank being filled in with the name or an appropriate combination of
names of the sweetening ingredients used. However, for the purpose of
this section, the name "sweetener" may be used in lieu of the specific
name or names of the sweetening ingredients.
(d) The name of the food concentrated to a dilution ratio of 3 plus
1 is "frozen concentrated orange juice" or "frozen orange juice
concentrate". The name of the food concentrated to a dilution ratio
greater than 3 plus 1 is "frozen concentrated orange juice, ------ plus
1" or "frozen orange juice concentrate, ------ plus 1", the blank
being filled in with the whole number showing the dilution ratio; for
example, "frozen orange juice concentrate, 4 plus 1". However, where
the label bears directions for making 1 quart of orange juice from
concentrate (or multiples of a quart), the blank in the name may be
filled in with a mixed number; for example, "frozen orange juice
concentrate, 4\1/3\ plus 1". For containers larger than 1 pint, the
dilution ratio in the name may be replaced by the concentration of
orange juice soluble solids in degrees Brix; for example, a 62 deg. Brix
concentrate in 3\1/2\-gallon cans may be named on the label "frozen
concentrated orange juice, 62 deg. Brix".
(e) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statements specified in this section for naming the
optional ingredients used shall immediately and conspicuously precede or
follow the name of the food, without intervening written, printed, or
graphic matter.
(f) Nothing in this section is intended to interfere with the
adoption and enforcement by any State, in regulating the production of
frozen concentrated orange juice in such State, of State standards,
consistent with this section, but which impose higher or more
restrictive requirements than those set forth in this section.
(g) 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.
[42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992; 58
FR 2881, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.148]
[Page 445-446]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.148 Reduced acid frozen concentrated orange juice.
(a) Reduced acid frozen concentrated orange juice is the food that
complies with the requirements for composition and label declaration of
ingredients prescribed for frozen concentrated orange juice by
Sec. 146.146, except that it may not contain any added sweetening
ingredient. A process involving the use of anionic ion-exchange resins
permitted by Sec. 173.25 of this chapter is used
[[Page 446]]
to reduce the acidity of the food so that the ratio of the Brix reading
to the grams of acid, expressed as anhydrous citric acid, per 100 grams
of juice is not less than 21 to 1 or more than 26 to 1.
(b) The name of the food is "Reduced acid frozen concentrated
orange juice".
[45 FR 12414, Feb. 26, 1980, as amended at 58 FR 2881, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.150]
[Page 446]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.150 Canned concentrated orange juice.
(a) Canned concentrated orange juice is the food that complies with
the requirements of composition, definition of dilution ratio, and
labeling of ingredients prescribed for frozen concentrated orange juice
by Sec. 146.146, except that it is not frozen and it is sealed in
containers and so processed by heat, either before or after sealing, so
as to prevent spoilage.
(b) The name of the food when concentrated to a dilution ratio of 3
plus 1 is "Canned concentrated orange juice" or "Canned orange juice
concentrate". The name of the food when concentrated to a dilution
ratio greater than 3 plus 1 is "Canned concentrated orange juice, ----
-- plus 1" or "Canned orange juice concentrate, ------ plus 1", the
blank being filled in with the whole number showing the dilution ratio;
for example, "Canned orange juice concentrate, 4 plus 1". However,
where the label bears directions for making 1 quart of single-strength
diluted product (or multiples of a quart) the blank in the name may be
filled in with a mixed number; for example, "Canned orange juice
concentrate, 4\1/3\ plus 1". For containers larger than 1 pint, the
dilution ratio in the name may be replaced by the concentration of
orange juice soluble solids in degrees Brix; for example, a 62 deg. Brix
concentrate in 1-gallon cans may be named on the label "canned
concentrated orange juice, 62 deg. Brix". If the food does not purport
to be frozen concentrated orange juice, the word "canned" may be
omitted from the name.
[42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.151]
[Page 446]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.151 Orange juice for manufacturing.
(a) Orange juice for manufacturing is the food prepared for further
manufacturing use. It is prepared from unfermented juice obtained from
oranges as provided in Sec. 146.135, except that the oranges may deviate
from the standards for maturity in that they are below the minimum for
Brix and Brix-acid ratio for such oranges, and to which juice may be
added not more than 10 percent by volume of the unfermented juice
obtained from oranges of the species Citrus reticulata or Citrus
reticulata hybrids (except that this limitation shall not apply to the
hybrid species described in Sec. 146.135). Seeds (except embryonic seeds
and small fragments of seeds that cannot be separated by good
manufacturing practice) are removed, and pulp and orange oil may be
adjusted in accordance with good manufacturing practice. If pulp is
added it shall be other than washed or spent pulp. The juice or portions
thereof may be so treated by heat as to reduce substantially the
enzymatic activity and number of viable microorganisms, and it may be
chilled or frozen, or it may be so treated by heat, either before or
after sealing in containers, as to prevent spoilage.
(b) The name of the food is "Orange juice for manufacturing".
[42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.152]
[Page 446-447]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.152 Orange juice with preservative.
(a) Orange juice with preservative is the food prepared for further
manufacturing use. It complies with the requirements for composition of
orange juice for manufacturing as provided for in Sec. 146.151, except
that a preservative is added to inhibit spoilage. It may be heat-treated
to reduce substantially the enzymatic activity and the number of viable
microorganisms.
(b) The preservatives referred to in paragraph (a) of this section
are any safe and suitable preservatives or combinations thereof.
(c) The name of the food is "Orange juice with preservative".
(d) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the
[[Page 447]]
applicable sections of parts 101 and 130 of this chapter. In addition,
the name of each preservative shall be proceeded by a statement of the
percent by weight of the preservative used. If the food is packed in
container sizes that are less than 19 liters (5 gallons), the label
shall bear a statement indicating that the food is for further
manufacturing use only.
(e) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statement specified in paragraph (d) of this section for
naming the preservative ingredient used shall immediately and
conspicuously precede or follow the name of the food, without
intervening written, printed, or graphic matter.
[42 FR 14414, Mar. 15, 1977, as amended at 44 FR 36378, June 22, 1979;
58 FR 2881, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.153]
[Page 447]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.153 Concentrated orange juice for manufacturing.
(a) Concentrated orange juice for manufacturing is the food that
complies with the requirements of composition and label declaration of
ingredients prescribed for frozen concentrated orange juice by
Sec. 146.146, except that it is either not frozen or is less
concentrated, or both, and the oranges from which the juice is obtained
may deviate from the standards for maturity in that they are below the
minimum Brix and Brix-acid ratio for such oranges: Provided, however,
that the concentration of orange juice soluble solids is not less than
20 deg. Brix.
(b) The name of the food is "Concentrated orange juice for
manufacturing, ------" or "------ orange juice concentrate for
manufacturing", the blank being filled in with the figure showing the
concentration of orange juice soluble solids in degrees Brix.
[42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.154]
[Page 447]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.154 Concentrated orange juice with preservative.
(a) Concentrated orange juice with preservative complies with the
requirements for composition and labeling of optional ingredients
prescribed for concentrated orange juice for manufacturing by
Sec. 146.153, except that a preservative is added to inhibit spoilage.
(b) The preservatives referred to in paragraph (a) of this section
are any safe and suitable preservatives or combinations thereof.
(c) The name of the food is "Concentrated orange juice with
preservative, ------", the blank being filled in with the figure
showing the concentration of orange juice soluble solids in degrees
Brix.
(d) 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. In addition, the name of each
preservative shall be preceded by a statement of the percent by weight
of the preservative used. If the food is packed in container sizes that
are less than 19 liters (5 gallons), the label shall bear a statement
indicating that the food is for further manufacturing use only.
(e) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statement specified in paragraph (d) of this section for
naming the preservative ingredient used shall immediately and
conspicuously precede or follow the name of the food, without
intervening written, printed, or graphic matter.
[42 FR 14414, Mar. 15, 1977, as amended at 44 FR 36378, June 22, 1979;
58 FR 2882, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.185]
[Page 447-449]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.185 Pineapple juice.
(a) Identity. (1) Pineapple juice is the juice, intended for direct
consumption, obtained by mechanical process from the flesh or parts
thereof, with or without core material, of sound, ripe pineapple (Ananas
comosus L. Merrill). The juice may have been concentrated and later
reconstituted with water suitable for the purpose of maintaining
essential composition and quality factors of the juice. Pineapple juice
may contain finely divided insoluble solids, but it does not contain
pieces of shell, seeds, or other coarse or hard substances or excess
pulp. It may be sweetened with any safe and suitable dry nutritive
carbohydrate sweetener. However, if the pineapple juice is prepared from
concentrate, such sweeteners, in liquid
[[Page 448]]
form, also may be used. It may contain added vitamin C in a quantity
such that the total vitamin C in each 4 fluid ounces of the finished
food amounts to not less than 30 milligrams and not more than 60
milligrams. In the processing of pineapple juice, dimethylpolysiloxane
complying with the requirements of Sec. 173.340 of this chapter may be
employed as a defoaming agent in an amount not greater than 10 parts per
million by weight of the finished food. Such food is prepared by heat
sterilization, refrigeration, or freezing. When sealed in a container to
be held at ambient temperatures, it is so processed by heat, before or
after sealing, as to prevent spoilage.
(2) The name of the food is "Pineapple juice" if the juice from
which it is prepared has not been concentrated and/or diluted with
water. The name of the food is "Pineapple juice from concentrate" if
the finished juice has been made from pineapple juice concentrate as
specified in paragraph (a) of this section. If a nutritive sweetener is
added, the label shall bear the statement "Sweetener added." If no
sweetener is added, the word "Unsweetened" may immediately precede or
follow the words "Pineapple juice" or "Pineapple juice from
concentrate."
(3) 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 pineapple juice is as
follows:
(i) The soluble solids content of pineapple juice (exclusive of
added sugars) without added water shall not be less than 10.5 deg. Brix
as determined by refractometer at 20 deg.C uncorrected for acidity and
read as degrees Brix on International Sucrose Scales. Where the juice
has been obtained using concentrated juice with addition of water, the
soluble pineapple juice solids content (exclusive of added sugars) shall
be not less than 12.8 deg. Brix, uncorrected for acidity and read as
degrees Brix on the International Sucrose Scales.
(ii) The acidity, as determined by the method prescribed in
paragraph (b)(2)(ii) of this section, is not more than 1.35 grams of
anhydrous citric acid per 100 milliliters of the juice.
(iii) The ratio of the degrees Brix to total acidity, as determined
by the method prescribed in paragraph (b)(2)(iii) of this section, is
not less than 12.
(iv) The quantity of finely divided "insoluble solids", as
determined by the method prescribed in paragraph (b)(2)(iv) of this
section, is not less than 5 percent nor more than 30 percent.
(2) The methods referred to in paragraph (b)(1) of this section are
as follows:
(i) Determine the degrees Brix of the pineapple juice by the method
prescribed in "Official Methods of Analysis of the Association of
Official Analytical Chemists," 13th Ed. (1980), section 31.009,
"Solids by Means of Spindle--Official Final Action," which is
incorporated by reference. Copies may be obtained from the Association
of Official Analytical Chemists International, 481 North Frederick Ave.,
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC.
(ii) Determine the total acidity of the pineapple juice by titration
by the method prescribed in Sec. 145.180(b)(2)(ix) of this chapter.
(iii) Divide the degrees Brix determined as prescribed in paragraph
(b)(2)(i) of this section by the grams of anhydrous citric acid per 100
milliliters of juice, determined as prescribed in paragraph (b)(2)(ii)
of this section, and report the results as ratio of degrees Brix to
total acidity.
(iv) Determine the quantity of "insoluble solids" in pineapple
juice as follows: Measure 50 milliliters of thoroughly stirred pineapple
juice into a cone-shaped graduated tube of the long-cone type, measuring
approximately 4\3/16\ inches from tip to top calibration and having a
capacity of 50 milliliters. Place the tube in a suitable centrifuge the
approximate speed of which is related to diameter of swing in accordance
with the table immediately below. The word "diameter" means the over-
all distance between the tips of opposing centrifuge tubes in operating
position.
[[Page 449]]
------------------------------------------------------------------------
Approximate
Diameter (inches) revolutions
per minute
------------------------------------------------------------------------
10......................................................... 1,609
10\1/2\.................................................... 1,570
11......................................................... 1,534
11\1/2\.................................................... 1,500
12......................................................... 1,468
12\1/2\.................................................... 1,438
13......................................................... 1,410
13\1/2\.................................................... 1,384
14......................................................... 1,359
14\1/2\.................................................... 1,336
15......................................................... 1,313
15\1/2\.................................................... 1,292
16......................................................... 1,271
16\1/2\.................................................... 1,252
17......................................................... 1,234
17\1/2\.................................................... 1,216
18......................................................... 1,199
18\1/2\.................................................... 1,182
19......................................................... 1,167
19\1/2\.................................................... 1,152
20......................................................... 1,137
------------------------------------------------------------------------
The milliliter reading at the top of the layer of "insoluble solids,"
after centrifuging 3 minutes, is multiplied by two to obtain the
percentage of "insoluble solids."
(3) If the quality of pineapple juice 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.
(c) Fill of container. (1) The standard of fill of container for
pineapple juice, except when the food is frozen, is not less than 90
percent of the total capacity of the container, as determined by the
general method for fill of container prescribed in Sec. 130.12(b) of
this chapter.
(2) If pineapple juice 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 14433, Mar. 15, 1977, as amended at 47 FR 11831, Mar. 19, 1982;
47 FR 52694, Nov. 23, 1982; 49 FR 10101, Mar. 19, 1984; 50 FR 19524, May
9, 1985; 54 FR 24895, June 12, 1989; 58 FR 2882, Jan. 6, 1993; 63 FR
14035, Mar. 24, 1998]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.187]
[Page 449-450]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 146--CANNED FRUIT JUICES--Table of Contents
Subpart B--Requirements for Specific Standardized Canned Fruit Juices
and Beverages
Sec. 146.187 Canned prune juice.
(a) Canned prune juice is the food prepared from a water extract of
dried prunes and contains not less than 18.5 percent by weight of water-
soluble solids extracted from dried prunes. The quantity of prune solids
may be adjusted by the concentration, dilution, or both, of the water
extract or extracts made. Such food may contain one or more of the
optional acidifying ingredients specified in paragraph (b)(1) of this
section, in a quantity sufficient to render the food slightly tart; it
may contain honey added within the quantitative limits prescribed by
paragraph (b)(2) of this section; and it may contain added vitamin C in
a quantity prescribed by paragraph (b)(3) of this section. Such food is
sealed in a container and so processed by heat, before or after sealing,
as to prevent spoilage.
(b) The optional ingredients referred to in paragraph (a) of this
section are:
(1) One or any combination of two or more of the following
acidifying ingredients:
(i) Lemon juice.
(ii) Lime juice.
(iii) Citric acid.
(2) Honey, in a quantity not less than 2 percent and not more than 3
percent by weight of the finished food.
(3) Vitamin C, in a quantity such that the total vitamin C in each 6
fluid ounces of the finished food amounts to not less than 30 milligrams
and not more than 50 milligrams.
(c)(1) The name of the food is "Prune juice--a water extract of
dried prunes". For the purposes of the Federal Food, Drug, and Cosmetic
Act concerning the label declaration of the name of the food, the
explanatory statement "A water extract of dried prunes" may appear
immediately below the words "prune juice", but there shall be no
intervening written, printed, or graphic matter, and the type used for
the words "A water extract of dried prunes" shall be of the same style
and not less than half the print size of the type used for the words
"prune juice".
(2)(i) When one or more of the acidifying ingredients specified in
paragraph (b)(1) of this section are used, the label shall bear the
statement "------ added" or "with added ------", the blank being
filled in with the name or names of the optional ingredients used.
(ii) When honey, as specified in paragraph (b)(2) of this section,
is used the label shall bear the statement "with ------ honey" or "--
---- honey added",
[[Page 450]]
the blank to be filled in with the percent by weight of the honey in the
finished food or with the statement "between 2 and 3%".
(iii) When one or more of the ingredients designated in paragraph
(b)(1) of this section and the ingredient designated in paragraph (b)(2)
of this section are used, the statements specified in paragraphs (c)(2)
(i) and (ii) of this section may be combined, as for example, "with
lemon juice and between 2 and 3% honey added".
(iv) When vitamin C is added as provided in paragraph (b)(3) of this
section, it shall be designated on the label as "vitamin C added" or
"with added vitamin C".
(3) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the words specified in this paragraph, showing the optional
ingredients used, shall immediately and conspicuously precede or follow
such name, without intervening written, printed, or graphic matter.
(d) 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.
[42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2882, Jan. 6, 1993]
