[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR146.3]
[Page 437-438]
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 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.
For the purposes of this part:
(a) The term corn sirup means a clarified, concentrated, aqueous
solution of the products obtained by the incomplete hydrolysis of
cornstarch, and includes dried corn sirup. The solids of corn sirup and
of dried corn sirup contain not less than 40 percent by weight of
reducing sugars calculated as anhydrous dextrose.
(b) The term dextrose means the hydrated or anhydrous, refined
monosaccharide obtained from hydrolyzed starch.
(c) The term dried glucose sirup means the product obtained by
drying glucose sirup.
(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:
[[Page 438]]
(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.
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