Part 10—General Regulations Relating to Definitions and Standards for Food

(1)

156 A P P E N D I X [A-10]

F O O D A N D D R U G A D M I N I S T R A T I O N 21 C F R

Part 10—General Regulations Relating to Definitions and Standards for Food

Sec.

10.1 General regulation.

10.2 General methods for water capacity and fill of containers.

10.3 General statements of substandard quality and substandard fill of con

tainer.

AUTHORITY: §§ 10.1 to 10.3 issued under sec. 701, 52 Stat. 1055, as amended; 21 U. S. C.

371.

SOURCE: §§ 10.1 to 10.3 appear at 20 F. R.

9566, Dec. 20, 1955.

§ 10.1 General regulation, (a) The definitions and interpretations of terms contained in section 201 of the act shall be applicable also to such terms when used in regulations promulgated under the act.

(b) If a regulation prescribing a defi

nition and standard of identity for a food has been promulgated under section 401 of the act and the name therein specified for the food is used in any other regula

tion under section 401 or any other pro

vision of the act, such name means the food which conforms to such definition and standard, except as otherwise specif

ically provided in such other regulation.

(c) No provision of any regulation prescribing a definition and standard of identity or standard of quality or rill of container under section 401 of the act shall be construed as in any way affect

ing the concurrent applicability of the general provisions of the act and the regulations thereunder relating to adul

teration and misbranding. For exam

ple, all regulations under section 401 contemplate that the food and all arti

cles used as components or ingredients thereof shall not be poisonous or dele

terious and shall be clean, sound, and fit for food. A provision in such regula

tions for the use of coloring or flavoring does not authorize such use under cir

cumstances or in a manner whereby damage or inferiority is concealed or whereby the food is made to appear better or of greater value than it is.

§ 10.2 General methods for water ca

pacity and fill of containers. For the purposes of regulations promulgated under section 401 of the act:

(a) The term "general method for water capacity of containers" means the following method:

(1) In the case of a container with lid attached by double seam, cut out the lid without removing or altering the height of the double seam.

(2) Wash, dry, and weigh the empty container.

(3) Fill the container with distilled water at 68° Fahrenheit to «Ήο inch verti

cal distance below the top level of the container, and weigh the container thus filled.

(4) Subtract the weight found in sub

paragraph (2) from the weight found in subparagraph (3) of this paragraph.

The difference shall be considered to be the weight of water required to fill the container.

In the case of a container with lid at

tached otherwise than by double seam, remove the lid and proceed as directed in subparagraphs (2)-(4) of this para

graph (except that under subparagraph (3) fill the container to the level of the top thereof.

(b) The term "general method for fill of containers" m e a n s the following method:

(1) In the case of a container with lid attached by double seam, cut out the lid without removing or altering the height of the double seam.

(2) Measure the vertical distance from the top level of the container to the top level of the food.

(3) Remove the food from the con

tainer; wash, dry, and weigh the con

tainer.

(4) Fill the container with water to

•Yir, inch vertical distance below the top level of the container. Record the tem

perature of the water, weigh the con

tainer thus filled, and determine the weight of the water by substracting the weight of the container found in sub

paragraph (3) of this paragraph.

(5) Maintaining the water at the tem

perature recorded in subparagraph (4) of this paragraph, draw off water from the container as filled in subparagraph (4) to the level of the food found in sub

paragraph (2), weigh the container with remaining water, and determine the

(2)

[A-ll] FOOD AND DRUG ADMINISTRATION 157

weight of the remaining water by sub

tracting the weight of the container found in subparagraph (3) of this para

graph.

(6) Divide the weight of water found in subparagraph (5) by the weight of water found in subparagraph (4), and multiply by 100. The result shall be considered to be the percent of the total capacity of the container occupied by the food.

In the case of a container with lid at

tached otherwise than by double seam, remove the lid and proceed as directed in subparagraphs (2)-(6) of this para

graph, except that under subparagraph (4), fill the container to the level of the top thereof.

§ 10.3 General statements of sub

standard quality and substandard fill of container. For the purposes of regula

tions promulgated under section 401 of the act:

(a) The term "general statement of substandard quality" means the state

ment "Below Standard in Quality Good Food—Not High Grade" printed in two lines of Cheltenham bold condensed caps.

The words "Below Standard in Quality"

constitute the first line, and the second immediately follows. If the quantity of the contents of the container is less than 1 pound, the type of the first line is 12- point, and of the second, 8-point. If such quantity is 1 pound or more, the type of the first line is 14-point, and of the second, 10-point. Such statement is enclosed within lines, not less than 6 points in width, forming a rectangle.

Such statement, with enclosing lines, is on a strongly contrasting, uniform back

ground, and is so placed as to be easily seen when the name of the food or any pictorial representation thereof is viewed, wherever such name or repre

sentation appears so conspicuously as to be easily seen under customary condi

tions of purchase.

(b) The term "general statement of substandard fill" means the statement

"Below Standard in Fill" printed in Cheltenham bold condensed caps. If the quantity of the contents of the con

tainer is less than 1 pound, the state

ment is in 12-point type; if such quantity is 1 pound or more, the statement is in 14-point type. Such statement is en

closed within lines, not less than 6 points in width, forming a rectangle; but if the statement specified in paragraph (a) of this section is also used, both statements

(one following the other) may be en

closed within the same rectangle. Such statement or statements, with enclosing lines, are on a strongly contrasting, uni

form background, and are so placed as to be easily seen when the name of the food or any pictorial representation thereof is viewed, wherever such name or representation appears so conspicuously as to be easily seen under customary conditions of purchase.

Part 14—Cacao Products; Defini

tions and Standards of Iden

tity

Sec.

14.1 Cacao nibs, cocoa nibs, cracked cocoa;

identity; label statement of option

al ingredients.

14.2 Chocolate liquor, chocolate, baking chocolate, bitter chocolate, cooking chocolate, chocolate coating, bitter chocolate coating; identity; label statement of optional ingredients.

14.3 Breakfast cocoa, high fat cocoa; iden

tity; label statement of optional i n  gredients.

14.4 Cocoa, medium fat cocoa; identity;

label statement of optional in

gredients.

14.5 Low-fat cocoa; identity; label state

ment of optional ingredients.

14.6 Sweet chocolate, sweet chocolate coat

ing; identity; label statement of optional ingredients.

14.7 Milk chocolate, sweet milk chocolate, milk chocolate coating, sweet milk chocolate coating; identity; label statement of optional ingredients.

14.8 Skim milk chocolate, sweet skim milk chocolate, skim milk chocolate coat

ing, sweet skim milk chocolate coating; identity; label statement of optional ingredients.

14.9 Buttermilk chocolate, buttermilk chocolate coating; identity; label statement of optional ingredients.

14.10 Mixed dairy product chocolates, mixed dairy product chocolate coatings;

identity; label statement of op

tional ingredients.

14.11 Sweet chocolate and vegetable fat (other than cacao fat) coating:

14.12 Sweet cocoa and vegetable fat (other than cacao fat) coating; identity;

label statement of optional in

gredients.

371. Interpret or apply sec. 401, 52 Stat. 1046, as amended; 21 U. S. C. 341.

9567, Dec. 20, 1955.

(3)

158 A P P E N D I X [A-12]

Part 15—Cereal Flours and Re

lated Products; Definitions and Standards of Identity

Subpart A—Wheat Flour and Related Products Sec.

15.1 Flour, white flour, wheat flour, plain flour; Identity; label statement of optional Ingredients.

15.10 Enriched flour; identity; label state

15.20 Bromated flour; identity; label state

15.30 Enriched bromated flour; identity;

label statement of optional ingre

dients.

15.40 Durum flour; identity.

15.50 Self-rising flour, self-rising white flour, self-rising wheat flour; iden

tity; label statement of optional ingredients.

15.60 Enriched self-rising flour; identity;

dients.

15.70 Phosphated flour, phosphated white flour, phosphated wheat flour;

tional Ingredients.

15.80 Whole wheat flour, graham flour, en

tire wheat flour; Identity; label statement of optional ingredients.

15.90 Bromated whole wheat flour; iden

tity; label statement of optional Ingredients.

15.100 Whole durum wheat flour; identity;

dients.

15.110 Crushed wheat, coarse ground wheat;

identity.

15.120 Cracked wheat; Identity.

15.130 Farina; identity.

15.140 Enriched farina; identity; label statement of optional Ingredients.

15.150 Semolina; identity.

Subpart Β—Corn Flour and Related Products 15.500 White corn meal; identity.

15.501 Yellow corn meal; identity.

15.502 Bolted white corn meal; identity.

15.503 Bolted yellow corn meal; identity.

15.504 Degerminated white corn meal, de- germed white corn meal; identity.

15.505 Degerminated yellow corn meal, de- germed yellow corn meal; identity.

15.506 Self-rising white corn meal; identity.

15.507 Self-rising yellow corn meal; iden

tity.

15.508 White corn flour; identity.

15.509 Yellow corn flour; identity.

15.510 Orits, corn grits, hominy grits; Iden

tity.

15.511 Yellow grits, yellow corn grits, yellow hominy grits; Identity.

15.512 Quick grits, quick cooking grits;

identity.

15.513 Enriched corn meals; identity.

15.514 Enriched corn grits; Identity.

Subpart C—Rice and Related Products 15.525 Enriched rice; identity; label state

AUTHORITY : §§ 15.1 to 15.514 issued under sec. 701, 52 Stat. 1055, as amended; 21 U.S.C.

371. Interpret or apply sec. 401, 52 Stat.

1046, as amended; 21 TJ.S.C. 341.

Part 16—Alimentary Pastes; Defi

nitions and Standards of Iden

tity

Sec.

16.1 Macaroni products; identity; label s t a t e m e n t of optional ingredients.

16.2 Milk macaroni products; identity; la

bel s t a t e m e n t of optional ingre

dients.

16.3 Whole w h e a t macaroni products; i d e n  tity; label s t a t e m e n t of optional ingredients.

16.4 Wheat and soy macaroni products;

identity; label s t a t e m e n t of optional ingredients.

16.5 Vegetable macaroni products; i d e n  tity; label s t a t e m e n t of optional ingredients.

16.6 Noodle products; identity; label s t a t e  m e n t of optional ingredients.

16.7 Wheat and soy noodle products; i d e n  tity; label s t a t e m e n t of optional i n  gredients.

16.8 Vegetable noodle products; identity;

label s t a t e m e n t of optional ingredi

ents.

16.9 Enriched macaroni products; identity;

label s t a t e m e n t of optional ingre

dients.

16.10 Enriched noodle products; identity;

label s t a t e m e n t of optional ingre

dients.

1046, as amended; 21 U. S. C. 341.

SOURCE: §§ 16.1 t o 16.10 appear at 20 F. R.

9575, Dec. 20, 1955.

(4)

FOOD AND DRUG ADMINISTRATION 159

[A-13]

Sec.

17.1 Bread, white bread, and rolls, white rolls, or buns, white buns; identity;

label statement of optional ingredi- ents.

17.2 Enriched bread and enriched rolls or enriched buns; identity; label state- ment of optional Ingredients.

17.3 Milk bread and milk rolls or milk buns;

identity; label statement of optional ingredients.

17.4 Raisin bread and raisin rolls or raisin buns; identity; label statement of optional ingredients.

17.5 Whole wheat bread, graham bread, en- tire wheat bread, and whole wheat rolls, graham rolls, entire wheat rolls, or whole wheat buns, graham buns, entire wheat buns; identity; label statement of optional ingredients.

A U T H O R I T Y : §§ 17.1 to 17.5 issued under sees. 401, 701, 52 Stat. 1046, as amended, 1055, as amended; 21 U.S.C. 341, 371.

Part 18—Milk and Cream; Defi- nitions and Standards of Iden- tity

Sec.

18.500 Cream class of food; identity.

18.501 Light cream, coffee cream, table cream; identity.

18.510 Whipping cream class of food; iden- tity.

18.511 Light whipping cream; identity.

18.515 Heavy cream, heavy whipping cream;

identity.

18.520 Evaporated milk; identity; label statement of optional ingredients.

18.525 Concentrated milk, plain condensed milk; identity; label statement of optional ingredients.

18.530 Sweetened condensed milk; identity.

18.535 Condensed milks which contain corn sirup; identity.

18.540 Dried skim milk, powdered skim milk, skim milk powder; identity.

AUTHORITY: §§ 18.500 to 18.540 issued under sec. 701, 52 Stat. 1055, as amended; 21 TJ. S . C.

1046, as amended; 21 U. S. C. 341.

SOURCE: §§ 18.500 to 18.540 appear at 20 F. R. 9580, Dec. 20, 1955.

PART 1 9 — C H E E S E S ; PROCESSED CHEESES; CHEESE FOODS; CHEESE

SPREADS, A N D RELATED FOODS;

DEFINITIONS A N D STANDARDS OF IDENTITY [REVISED]

Sec.

19.500 Cheddar cheese, cheese; identity;

label statement of optional ingre- dients.

19.502 Cheddar cheese for manufacturing;

identity.

19.505 Washed curd cheese, soaked curd cheese; identity; label statement of optional ingredients.

19.507 Washed curd cheese for manufactur- ing; identity.

19.510 Colby cheese; identity; label state- ment of optional ingredients.

19.512 Colby cheese for manufacturing;

identity.

19.515 Cream cheese; identity; label state- ment of optional ingredients.

19.520 Neufchatel cheese; identity; label statement of optional ingredients.

19.525 Cottage cheese; identity.

19.530 Creamed cottage cheese; identity.

19.532 Ricotta cheese; identity. [Stayed]

19.533 Part-skim ricotta cheese; identity.

[Stayed]

19.535 Granular cheese, stirred curd cheese;

identity; label statement of op- tional ingredients.

19.537 Granular cheese for manufacturing;

identity.

19.540 Swiss cheese, emmentaler cheese;

19.542 Swiss cheese for manufacturing;

identity.

19.543 Gruyère cheese: identity; label state- ment of optional ingredients.

19.544 Samsoe cheese; identity.

19.545 Brick cheese; identity; label state- ment of optional ingredients.

19.547 Brick cheese for manufacturing;

identity.

19.550 Muenster cheese, munster cheese;

19.555 Edam cheese; identity.

19.560 Gouda cheese; identity.

19.565 Blue cheese; identity; label state- ment of optional ingredients.

Part 17—Bakery Products; Defi-

nitions and Standards of Iden-

tity

(5)

160 A P P E N D I X [A-14]

19.567 Gorgonzola cheese; identity; label statement of optional ingredients.

19.569 Nuworld cheese; identity.

19.570 Roquefort cheese, sheep's milk blue- mold cheese, blue-mold cheese from sheep's milk; identity.

19.575 Limburger cheese; identity.

19.580 Monterey cheese, monterey Jack cheese; identity; l a b e l state

19.585 High-moisture Jack cheese; identity;

label statement of optional In

gredients.

19.590 Provolone cheese, pasta fllata cheese;

19.591 Caciocavallo siciliano cheese; iden

19.595 Parmesan cheese, reggiano cheese;

identity; label s t a t e m e n t of o p  tional ingredients.

19.610 R o m a n o cheese; identity; label s t a t e  m e n t of optional ingredients.

19.615 Asiago fresh cheese, aslago soft cheese; identity; label statement of optional ingredients.

19.620 Asiago medium cheese; Identity.

19.625 Asiago old cheese; identity.

19.635 Cook cheese, koch kaese; identity.

19.637 Sap sago cheese; identity.

19.639 Gammelost cheese; identity.

19.650 Hard cheeses; identity.

19.655 Semisoft cheeses; identity; label statement of optional ingredients.

19.660 Semisoft part-skim cheeses; identity;

dients.

19.665 Soft ripened cheeses; identity; label statement of optional ingredients.

19.670 Spiced cheeses; identity; label state

19.675 Part-skim spiced cheeses; identity;

dients.

19.680 Hard grating cheeses; identity; label statement of optional ingredients.

19.685 Skim-milk cheese for manufactur

ing; identity.

19.750 Pasteurized process cheese; identity;

dients.

19.751 Pasteurized blended cheese; identity;

dients.

19.755 Pasteurized process cheese with fruits, vegetables, or meats; iden

19.760 Pasteurized process pimento cheese;

19.763 Pasteurized blended cheese with fruits, vegetables, or meats; iden

19.765 Pasteurized process cheese food;

Identity; label statement of op

19.770 Pasteurized process cheese food with fruits, vegetables, or meats; iden

19.775 Pasteurized process cheese spread;

19.776 Pasteurized cheese spread; identity, label statement of optional in

gredients.

19.780 Pasteurized process cheese spread with fruits, vegetables, or meats;

19.781 Pasteurized cheese spread with fruits, vegetables, or meats; identity;

dients.

19.782 Cream cheese with other foods; iden

19.783 Pasteurized neufchatel cheese spread with other foods; identity; label statement of optional ingredients.

19.785 Cold-pack cheese, club cheese, com

minuted cheese; identity; label statement of optional ingredients.

19.787 Cold-pack cheese food; identity;

dients.

19.788 Cold-pack cheese food with fruits, vegetables, or meats; identity; label statement of optional ingredients.

19.790 Grated American cheese food; iden

AUTHORITY: §§ 19.500 to 19.790 issued under sec. 701, 52 Stat. 1055, as amended; 21 U. S. C.

1046, as amended; 21 U. S. C. 341.

SOURCE: §§ 19.500 to 19.790 appear at 24 F.R. 6478, Aug. 12, 1959; 24 F.R. 6805, Aug.

21, 1959, except as otherwise noted.

Prior Amendments

NOTE : For FEDERAL REGISTER page numbers of all amendments to Part 19, see "List of Sections Affected" at the end of this supple

ment.

§ 19.500 Cheddar cheese, cheese; iden

tity; label statement of optional in

gredients.

(a> Cheddar cheese, cheese, is t h e food prepared from milk a n d other ingredients specified in this section, by

(6)

[A-15] F O O D A N D DRUG A D M I N I S T R A T I O N 161

the procedure set forth in paragraph (b) of this section, or by another procedure which produces a finished cheese having the same physical and chemical proper

ties as the cheese produced when the pro

cedure set forth in paragraph (b) of this section is used. It contains not more t h a n 39 percent of moisture, and its sol

ids contain not less t h a n 50 percent of milk fat, as determined by the methods prescribed in paragraph (c) of this sec

tion. If the milk used is not pasteurized, the cheese so made is cured at a t e m  perature of not less t h a n 35° P. for not less t h a n 60 days.

(b) Milk, which m a y be pasteurized or clarified or both, and which may be warmed, is subjected to the action of harmless lactic-acid-producing bacteria, present in such milk or added thereto.

Harmless artificial coloring may be added. Sufficient rennet (with or with

out purified calcium chloride in a quan

tity not more t h a n 0.02 percent, calcu

lated as anhydrous calcium chloride, of the weight of the milk) is added to set the milk to a semisolid mass. The mass is so cut, stirred, and heated with con

tinued stirring, as to promote and regu

late the separation of whey and curd.

The whey is drained off, and the curd is matted into a cohesive mass. The mass is cut into slabs, which are so piled and handled as to promote the drainage of whey and the development of acidity.

The slabs are t h e n cut into pieces, which may be rinsed by sprinkling or pouring water over them, with free and continu

ous drainage; but the duration of such rinsing is so limited t h a t only the whey on the surface of such pieces is removed.

The curd is salted, stirred, further drained, and pressed into forms. A harmless preparation of enzymes of ani

mal or plant origin capable of aiding in the curing or development of flavor of cheddar cheese m a y be added during t h e procedure, in such quantity t h a t the weight of the solids of such preparation is not more t h a n 0.1 percent of the weight of the milk used.

(c) Determine moisture by the m e t h o d prescribed on page 262 (15.124) [Ed.

note, 8th edition, 1955, p. 278, sec.

15.129], under "Moisture—Official," and milk fat by the method prescribed on page 263 (15.131) [Ed. note, 8th edition, 1955, p. 279, sec. 15.136], under " F a t - Official," of "Official Methods of Anal

ysis of the Association of Official Agri

cultural Chemists," Seventh Edition, 1950. Subtract the percent of moisture found from 100; divide the remainder into the percent milk fat found. T h e quotient, multiplied by 100, shall be considered to be the percent of milk fat contained in the solids.

(d) Cheddar cheese in the form of slices or cuts in consumer-sized packages may contain not more t h a n 0.2 percent by weight of sorbic acid.

(e) For the purposes of this section:

(1) T h e word "milk" means cow's milk, which may be adjusted by separat

ing part of the fat therefrom or by add

ing thereto one or more of the following : Cream, skim milk, concentrated skim milk, nonfat dry milk, water in a quan

tity sufficient to reconstitute any c o n  centrated skim milk or nonfat dry milk used.

PART 20—FROZEN DESSERTS; DEFI

NITIONS A N D STANDARDS OF IDENTITY

Sec.

20.1 Ice cream; identity; label s t a t e m e n t of optional ingredients.

20.2 Frozen custard, french ice cream, french custard ice cream; identity;

label s t a t e m e n t of optional ingredi

ents.

20.3 Ice milk; identity; label s t a t e m e n t of optional ingredients.

20.4 Fruit sherbets; identity; label s t a t e  m e n t of optional ingredients.

20.5 Water ices; identity; label s t a t e m e n t of optional ingredients.

AUTHORITY: §§ 20.1 to 20.5 issued under sec. 701, 52 Stat. 1055; 21 U.S.C. 371. Inter

pret or apply sec. 401, 52 Stat. 1046, as amended; 21 U.S.C. 341.

* CROSS-REFERENCES : For other regulatons in this chapter relating to ingredients permitted in frozen desserts, see also §§ 121.1008, 121.- 1009, and 121.1015. *

(7)

162 APPENDIX [A-16]

DEFINITIONS AND STANDARDS FOR FOOD

TITLE 21, PART 25—DRESSINGS FOR FOODS Definitions and Standards of Identity Sec.

25.1 Mayonnaise, mayonnaise dressing;

identity; label statement of optional ingredients.

25.2 French dressing; identity; label state

25.3 Salad dressing; identity; label state

AUTHORITY: §§ 25.1 to 25.3 issued under sees. 401, 701, 52 Stat. 1046, 1055; 21 U.S.C.

341,371.

§ 25.1 Mayonnaise, mayonnaise dress- ing; identity; label statement of optional ingredients, (a) Mayonnaise, mayon

naise dressing, is the emulsified semisolid food prepared from edible vegetable oil and one or both of the acidifying ingredi

ents specified in paragraph (b) of this section, and one or more of the egg-yolk- containing ingredients specified in para

graph (c) of this section. For the pur

poses of this section, the term "edible vegetable oil" includes salad oil that may contain not more than 0.125 percent by weight of oxystearin to inhibit crystal

lization as provided in the food additive regulation in § 121.1016 of this chapter.

Mayonnaise may be seasoned or flavored with one or more of the following in

gredients:

(1) Salt.

(2) Sugar, dextrose, corn sirup, invert sugar sirup, nondiastatic maltose sirup, glucose sirup, honey. The foregoing sweetening ingredients may be used in sirup or dried form.

(3) Mustard, paprika, other spice, or any spice oil or spice extract, except that no turmeric or saffron is used and no spice oil or spice extract is used which imparts to the mayonnaise a color simu

lating the color imparted by egg yolk.

(4) Monosodium glutamate.

(5) Any suitable, harmless food sea

soning or flavoring (other than imita

tions), provided it does not impart to the mayonnaise a color simulating the color imparted by egg yolk.

Mayonnaise may be mixed and packed in an atmosphere in which air is re

placed in whole or in part by carbon dioxide or nitrogen. Mayonnaise con

tains not less than 65 percent by weight of vegetable oil.

(b) The acidifying ingredients re

ferred to in paragraph (a) of this sec

tion are:

(1) Any vinegar or any vinegar di

luted with water to an acidity, calcu

lated as acetic acid, of not less than 2Y2 percent by weight, or any such vine

gar or diluted vinegar mixed with the additional optional acidifying ingredient citric acid, but in any such mixture the weight of citric acid is not greater than 25 percent of the weight of the acids of the vinegar or diluted vinegar calculated as acetic acid. For the purpose of this paragraph, any blend of two or more vinegars is considered to be a vinegar.

(2) Lemon juice or lime juice or both or any such juice in frozen, canned, concentrated, or dried form, or any one or more of these diluted with water to an acidity, calculated as citric acid, of not less than 2V2 percent by weight.

(c) The egg-yolk-containing ingre

dients referred to in paragraph (a) of this section are: Liquid egg yolks, frozen egg yolks, liquid whole eggs, frozen whole eggs, or any one or more of the foregoing with liquid egg white or frozen egg white.

(d) (1) When the additional optional acidifying ingredient as provided in paragraph (b) (1) of this section is used, the label shall bear the statement

"Citric acid added" or "With added citric acid."

(2) Wherever the name "Mayonnaise"

or "Mayonnaise Dressing" appears on the label so conspicuously as to be easily seen under customary conditions of pur

chase, the statements specified in this paragraph, showing the optional ingre

dients present, shall immediately and conspicuously precede or follow such name, without intervening written, printed, or graphic matter.

§ 25.2 French dressing; identity; la

bel statement of optional ingredients.

(a) French dressing is the separable liq

uid food or the emulsified viscous fluid food prepared from edible vegetable oil and one or both of the acidifying ingre

dients specified in paragraph (b) of this section. For the purposes of this sec

tion, the term "edible vegetable oil" in

cludes salad oil that may contain not

* * * * * * * * * * * * * *

(8)

[A-17] FOOD AND DRUG ADMINISTRATION 163

PART 2 7 — C A N N E D FRUITS A N D CANNED FRUIT JUICES; DEFINI

TIONS A N D STANDARDS OF IDEN

TITY; QUALITY; A N D FILL OF CONTAINER [REVISED]

Sec.

27.1 Definitions.

27.2 Canned peaches; Identity; label state

27.3 -Canned peaches; quality; label state

ment of substandard quality.

27.4 Canned peaches; fill of container;

label statement of substandard fill.

27.5 Canned peaches with rum; identity;

label statement of optional ingredi

ents.

27.6 Artificially sweetened canned peaches;

27.10 Canned apricots; identity; label state

27.11 Canned apricots; quality; label state

27.12 Canned apricots; fill of container;

27.13 Canned apricots with rum; identity;

ents.

27.14 Artificially sweetened canned apricots;

27.15 Canned prunes; identity; label state

27.20 Canned pears; identity; label state

27.21 Canned pears; quality; label state

27.22 Canned pears; fill of container; label statement of substandard fill 27.23 Canned pears with rum; identity;

ents.

27.24 Artificially sweetened canned pears;

27.25 Canned seedless grapes; Identity; label statement of optional ingredients.

27.30 Canned cherries; identity; label state ment of optional ingredients.

27.31 Canned cherries; quality; label state

27.32 Canned cherries; fill of container;

27.33 Canned cherries with rum; identity;

ents.

27.34 Artificially sweetened canned cherries;

27.35 Canned berries; identity; label state

Sec.

27.40 Canned fruit cocktail, canned cocktail fruits, canned fruits for cocktail;

27.41 Canned fruit cocktail, canned cocktail fruits, canned fruits for cocktail;

quality; label statement of sub

standard quality.

27.42 Canned fruit cocktaiL canned cocktail fruits, canned fruits for cocktail;

fill of container; label statement of substandard fill.

27.43 Artificially sweetened canned fruit cocktail; Identity; label statement of optional ingredients.

27.45 Canned plums; identity; label state

27.50 Canned pineapple; identity; label statement of optional ingredients.

27.51 Canned pineapple; quality; label statement of substandard quality.

27.52 Canned crushed pineapple; fill of con

tainer; label statement of sub

standard fill.

27.54 Canned pineapple Juice; identity;

label statement of optional inr gredients.

27.55 Canned pineapple juice; quality;

label statement of substandard quality.

27.56 Canned pineapple juice; fill of con

standard fill.

27.57 Artificially sweetened canned pineap

ple; identity; label statement of optional ingredients.

27.60 Canned prune juice; identity; label statement of optional ingredients.

27.70 Canned figs; identity; label statement of optional ingredients.

27.73 Artificially sweetened canned figs;

27.101 Frozen concentrate for lemonade;

27.102 Frozen concentrate for colored lemon

ade; identity; label statement of optional ingredients.

27.106 Orange juice; identity.

27.107 Pasteurized orange juice; identity;

label statement of optional ingre- dents.

27.108 Canned orange juice; identity; label statement of optional ingredients.

27.109 Sweetened pasteurized orange juice;

27.110 Canned sweetened orange Juice; iden

tity; label identity; label statement of optional ingredients.

27.111 Concentrated orange Juice, orange Juice concentrate; identity; label statement of optional ingredients.

(9)

164 APPENDIX [A-18]

27.112 Sweetened concentrated orange Juice;

sweetened orange Juice concentrate;

27.113 Reconstituted orange Juice; orange Juice form concentrate; identity, label statement of optional ingre

dients.

27.114 Sweetened reconstituted orange Juice, sweetened orange juice from con

centrate; identity; label statement of optional ingredients.

AUTHORITY: §§27.1 to 27.114 issued under sec. 701, 52 Stat. 1055, as amended; 21 U.S.C.

1046, as amended; 21 U.S.C. 341.

SOURCE: §§ 27.1 to 27.114 appear at 24 F JR.

10663, Dec. 24, 1959, except as otherwise noted.

Part 29—Fruit Butters, Fruit Jel

lies, Fruit Preserves, and Re

lated Products; Definitions and Standards of Identity

Sec.

29.1 Fruit butter; identity; label statement of optional ingredients.

29.2 Fruit Jelly; identity; label statement of optional ingredients.

29.3 Preserves, Jams; identity; label state

29.4 Artificially sweetened fruit jelly; iden

tity; label statement of optional in

gredients. [Added]

29.5 Artificially sweetened fruit preserves, artificially sweetened fruit jams;

identity; label statement of optional ingredients. [Added]

AUTHORITY: §§ 29.1 to 29.3 Issued under sec.

701, 52 Stat. 1055, as amended; 21 U. S. C.

1046, as amended; 21 U. S. C. 341.

9609, Dec. 20, 1955.

(10)

[A-19] F O O D A N D DRUG A D M I N I S T R A T I O N 165

TITLE 21, PART 36—SHELLFISH Definitions and Standards of Identity;

Fill of Container

AUTHORITY: § § 3 6 . 3 to 3 6 . 2 0 issued under

sec. 701, 52 Stat. 1055, as amended; 2 1 U. S. C.

371. Interpret or apply sec. 4 0 1 , 5 2 Stat.

1046, as amended; 2 1 U . S. C. 341.

SOURCE: §§ 36.3 to 3 6 . 2 0 appear at 2 0 F. R.

9612, Dec. 2 0 , 1955.

CANNED SHRIMP

Sec.

36.3 Canned wet pack shrimp and canned dry pack shrimp in nontransparent containers; fill of container; label statement of substandard fill.

CANNED OYSTERS

Sec.

36.5 Canned oysters; identity; label state

36.6 Canned oysters; fill of container;

RAW OYSTERS

36.10 Oysters, raw oysters, shucked oysters;

identity.

36.11 Extra large oysters, oysters counts (or plants), extra large raw oysters, raw oysters counts (or plants), ex

tra large shucked oysters, shucked oysters counts (or plants) ; identity.

36.12 Large oysters, oysters extra selects, large raw oysters, raw oysters extra selects, l a r g e shucked oysters, shucked oysters extra selects; iden

tity.

36.13 Medium oysters, oysters selects, me

dium raw oysters, raw oysters selects, medium shucked oysters, shucked oysters selects; identity.

36.14 Small oysters, oysters standards, small raw oysters, raw oysters standards, small shucked oysters, shucked oys

ters standards; identity.

36.15 Very small oysters, very small raw oysters, very small shucked oysters;

identity.

36.16 Olympia oysters, raw Olympia oysters, shucked Olympia oysters; identity.

Part 37—Fish; Definitions and Standards of Identity; Stand

ards of Fill of Container [Add

ed]

Sec.

37.1 Canned tuna; definition and standard of identity; label statement of op

"37.3 Canned tuna; fill of container; label statement of substandard fill.

AUTHORITY: § § 3 7 . 1 and 37.3 issued under sec. 701, 5 2 Stat. 1055 as amended; 2 1 U . S. C.

371. Interpret or apply ser. 4 0 1 , 5 2 Stat.

1046, as amended; 2 1 U . S. C. 3 4 1 .

SOURCE: § § 3 7 . 1 and 3 7 . 3 appear at 2 2 F. R.

892, Feb. 13, 1957; 2 2 F. R. 9 7 9 , Feb. 16, 1957;

22 F. R. 3106, May 2 , 1957. (See also note following § 3 7 . 1 . )

PACIFIC OYSTERS

36.17 Large Paciflc^oysters, large raw Pacific oysters, large shucked Pacific oys

ters; identity.

36.18 Medium Pacific oysters, medium raw Pacific oysters, medium shucked Pacific oysters; identity.

36.19 Small Pacific oysters, small raw Pacific oysters, small shucked Pacific oys

ters; identity.

36.20 Extra small Pacific oysters, extra small raw Pacific oysters, extra small shucked Pacific oysters; identity.

(11)

166 APPENDIX [A-20]

DEFINITIONS AND STANDARDS FOR FOOD

TITLE 21, PART 42—EGGS AND EGG PRODUCTS Definitions and Standards of Identity Sec.

42.1 Eggs.

42.10 Liquid eggs, mixed eggs, liquid whole eggs, mixed whole eggs;

Identity.

42.20 Frozen eggs, frozen whole eggs, frozen mixed eggs; Identity.

42.30 Dried eggs, dried whole eggs;

identity.

42.40 Egg yolks, liquid egg yolks, yolks, liquid yolks; Identity.

42.50 Frozen yolks, frozen egg yolks;

identity.

42.60 Dried egg yolks, dried yolks; iden

tity

AUTHORITY: §§ 42.1 to 42.60 issued under sec. 701, 52 Stat. 1055, as amended; 21 U. S. C. 371. Interpret or apply sec. 401, 52 Stat. 1046, as amended; 21 U. S. C. 341.

SOURCE: §§42.1 to 42.60 appear at 20 F.R.9614, Dec. 20, 1955.

§ 42.1 Eggs. N o r e g u l a t i o n s h a l l be p r o m u l g a t e d fixing a n d e s t a b l i s h i n g a r e a s o n a b l e definition a n d s t a n d a r d of i d e n t i t y for t h e food c o m m o n l y k n o w n a s eggs.

§ 42.10 Liquid eggs, mixed eggs, liq

uid whole eggs, mixed whole eggs;

identity. Liquid e g g s , m i x e d e g g s , l i q  uid w h o l e eggs, m i x e d w h o l e eggs, are e g g s of t h e d o m e s t i c h e n , b r o k e n f r o m t h e shells, a n d w i t h y o l k s a n d w h i t e s i n t h e i r n a t u r a l p r o p o r t i o n s a s so broken. T h e y m a y be m i x e d , or m i x e d a n d s t r a i n e d .

§ 42.20 Frozen eggs, frozen whole eggs, frozen mixed eggs; identity.

F r o z e n eggs, frozen w h o l e eggs, frozen m i x e d eggs, are t h e food prepared by freezing liquid eggs.

§ 42.30 Dried eggs, dried whole eggs;

identity. Dried eggs, dried w h o l e eggs, are t h e food p r e p a r e d by d r y i n g liquid

e g g s . T h e y m a y be p o w d e r e d . T h e y c o n t a i n n o t less t h a n 92 p e r c e n t t o t a l e g g solids, a s d e t e r m i n e d by t h e m e t h o d prescribed i n "Official a n d T e n t a t i v e M e t h o d s of A n a l y s i s of t h e A s s o c i a t i o n of Official Agricultural C h e m i s t s , " F o u r t h E d i t i o n , 1935, p a g e s 297 a n d 298 [Ed. n o t e , 9 t h edition, 1960, p. 220, sees. 16.002, 1 6 . 0 0 3 ] , u n d e r

"Total S o l i d s . "

§ 42.40 Egg yolks, liquid egg yolks, yolks, liquid yolks; identity. E g g yolks, liquid e g g yolks, yolks, liquid yolks, are yolks of e g g s of t h e d o m e s t i c h e n s o s e p a r a t e d f r o m t h e w h i t e s thereof as to c o n t a i n n o t less t h a n 43 p e r c e n t total egg solids, a s d e t e r m i n e d by t h e m e t h o d prescribed i n "Official a n d T e n t a t i v e M e t h o d s of A n a l y s i s of t h e A s s o c i a t i o n of Official Agricultural C h e m i s t s , " F o u r t h Edition, 1935, p a g e s 297 a n d 298 [Ed. n o t e , 9 t h edition, 1960, p. 220, s e e s . 16.002, 16.003], u n d e r "Total S o l i d s . " T h e y m a y be m i x e d , or m i x e d a n d s t r a i n e d .

§ 42.50 Frozen yolks, frozen egg yolks; identity. F r o z e n yolks, frozen e g g y e l k s , are t h e food prepared by freezing e g g yolks.

§ 42.60 Dried egg yolks, dried yolks, identity. Dried e g g yolks, dried yolks, are t h e food prepared by d r y i n g egg yolks. T h e y c o n t a i n n o t less t h a n 95 p e r c e n t t o t a l e g g solids, a s d e t e r m i n e d by t h e m e t h o d prescribed i n "Official a n d T e n t a t i v e M e t h o d s of A n a l y s i s of t h e A s s o c i a t i o n of Official Agricultural C h e m i s t s , " F o u r t h Edition, 1935, p a g e s 297 a n d 298 [Ed. n o t e , 9 t h edition, 1960, p. 220, sees. 16.002, 16.003 ] , u n d e r

"Total S o l i d s . "

(12)

FOOD AND DRUG ADMINISTRATION 167

TITLE 21, PART 45—OLEOMARGARINE, MARGARINE Definitions and Standards of Identity

§ 45.1 Oleomargarine, margarine;

identity; label statement of optional in

gredients, (a) Oleomargarine, marga

rine is the plastic food prepared with one or more of the optional fat ingredients named in subparagraph (1) (i), (ii), (iii). and (iv) of this paragraph, as follows :

(1) (i> The rendered fat or oil, or stearin derived therefrom (any or all of which may be hydrogenated), of-cattle, sheep, swine, or goats, or any combina

tion of two or more of such articles.

(ii) Any vegetable food fat or oil, or oil or stearin derived therefrom (any or all of which may be hydrogenated), or any combination of two or more of such articles.

(iii) Any combination of ingredients named in subdivisions i i ) and (ii) of this subparagraph, in such proportion that the weight of the ingredients named in subdivision (i) either equals the weight of the ingredients named in subdivision (ii), or exceeds such weight by a ratio of not greater than 9 to 1.

(iv) Any combination of ingredients named in subdivisions (i) and (ii) of this subparagraph, in such proportion that the weight of the ingredients named in subdivision (ii) exceeds the weight of the ingredients named in subdivision (i) by a ratio not greater than 9 to 1.

(2) One of the articles designated in subdivision (i), (ii), (iii), (iv), (v), or (vi) of this subparagraph is intimately mixed with the fat ingredient or ingredi

ents. The ingredients named in sub

divisions (i), (ii), (iii), <iv>, and (v) are pasteurized and then subjected to the action of harmless bacterial starters.

The term "milk" as used in this subpara

graph means cow's milk.

(i) Cream.

(ii) Milk.

(iii) Skim milk.

(iv) Any combination of nonfat dry milk and water, in which the weight of the nonfat dry milk is not less than 10 percent of the weight of the water. *

• CODIFICATION: In §45.1 (a) (2) (iv), the term "nonfat dry milk solids" was changed to "nonfat dry milk," 21 P. R. 6566, Aug. 31, 1959.

( v ) Any mixture of two or more of the articles named in subdivisions (i), (ii).

(iii), and (iv).

(vi) In case only of the fat ingredient designated in subparagraph (1) (ii) of this paragraph, any combination of finely ground soybeans and water, in which the weight of the finely ground soybeans is not less than 10 percent of the weight of the water. The finely ground soybeans are subjected to a heat treatment before or after mixing with the water. The soybeans may or may not be dehulled.

Congealing is effected, either with or without contact with water, and the con

gealed mixture may be worked.

(3) In the preparation of oleomarga

rine one or more of the following op

tional ingredients may also be used : (i) Artificial coloring. For the pur

poses of this subdivision provitamin A shall be deemed to be artificial coloring.

(ii) Sodium benzoate or benzoic acid or a combination of these, in a quantity not to exceed 0.1 percent of the weight of the finished product.

(iii) Vitamin A (with or without any accompanying vitamin D and with or without vitamin D concentrate), in such quantity that the finished oleomargarine contains not less than 15,000 United States Pharmacopeia units of vitamin A per pound, as determined by the method prescribed in the Pharmacopeia of the United States for total biological vitamin A activity. The vitamin A potency pre

scribed may be furnished by fish liver oil; by concentrates of vitamin A or its fatty acid esters from animal sources;

by synthetic vitamin A or its fatty acid esters; by mixtures of synthetic vitamin A or its fatty acid esters with harmless substances formed during the synthesis of the vitamin A, if the vitamin A or its fatty acid ester constitutes not less than 50 percent of the mixture; by provitamin A ; or by any combination of two or more of these. For the purposes of this subdi

vision the term "fatty acid" may include acetic acid.

(iv) The artificial flavoring diacetyl added as such or as starter distillate or produced during the preparation of the

(13)

168 APPENDIX [A-22]

product as a result of the addition of citric acid or harmless citrates.

(ν) (a) Lecithin, in an amount not ex

ceeding 0.5 percent of the weight of the finished oleomargarine; or

(b) Monoglycerides or diglycerides of fat-forming fatty acids, or a combina

tion of these, in an amount not exceeding 0.5 percent of the weight of the finished oleomargarine; or

(c) Such monoglycerides and diglyc

erides in combination with the sodium sulfo-acetate derivatives thereof, in a total amount not exceeding 0.5 percent of the weight of the finished oleomar

garine; or

(d) A combination of (a) and (b) of this subdivision, in which the amount of neither exceeds that above stated; or

(e) A combination of <a> and i o of this subdivision, in a total amount not exceeding 0.5 percent of the weight of the finished oleomargarine.

The weight of the diglycerides in each of ingredients (b). <c), <d , and (e) of this subdivision is calculated at one-half actual weight.

(vi) Butter.

(vii) Salt.

(viii) Citric acid incorporated in the fat or oil ingredient used.

(ix) Isopropyl citrates incorporated in the fat or oil ingredient used, in an amount not to exceed 0.02 percent by weight of the finished oleomargarine.

(x) Stearyl citrate incorporated in the fat or oil ingredient used, in an amount not to exceed 0.15 percent by weight of the finished oleomargarine.

The finished oleomargarine contains not less than 80 percent fat, as determined by the method prescribed in 'Officiai Methods of Analysis of the Association of Official Agricultural Chemists," 7th Edition, page 259 under "Indirect Method," section 15.111. [Ed. note, 9th edition, 1960, p. 205, sec. 15.115.]

(b) (1) When any ingredient named under one of the following specified sub

paragraphs of paragraph (a) of this section is used, the label shall, except as provided in this paragraph, bear the statement set forth below after the num

ber of such subparagraph:

Subparagraph (1) (1)—"Prepared from Animal Pat" or "Made from Animal Fat."

Subparagraph (1) (ii)—"Vegetable** or

"Prepared from Vegetable Fat" or "Made from Vegetable Fat."

Subparagraph (2) (vi)—In lieu of label

statement prescribed for Ingredients desig

nated in subparagraph (1) (ii), "Prepared from Vegetable Fat, Water and Finely Ground Soybeans" or "Made from Vegetable Fat, Water and Finely Ground Soybeans."

Subparagraph (1) (iii)—"Prepared from Animal and Vegetable Fats" or "Made from Animal and Vegetable Fats."

Subparagraph (1) (iv)—"Prepared from Vegetable and Animal Fats" or "Made from Vegetable and Animal Fats."

Subparagraph (3) (i)—"Artificially Col

ored" or "Artificial Coloring Added" or "With Added Artificial Coloring."

Subparagraph (3) (ii)—"Sodium Benzoate (or, as the case may be. "Benzoic Acid" or

"Sodium Benzoate and Benzoic Acid") Added as a Preservative" or "With Added Sodium Benzoate (or. as the case may be, "Benzoic Acid" or "Sodium Benzoate and Benzoic Acid") as a Preservative."

Subparagraph (3) (ill)—"Vitamin A Added" or "With Added Vitamin A."

Subparagraph (3) (iv)—"Artificially Flav

ored" or "Artificial Flavoring Added" or

"With Added Artificial Flavoring."

Subparagraph (3) ( viii )—"Citric Acid Added to Protect Flavor" or "Citric Acid Added as a Preservative."

Subparagraph (3) (ix)—"Isopropyl Citrate Added to Protect Flavor" or "Isopropyl Ci

trate Added as a Preservative."

Subparagraph (3) (χ)—"Stearyl Citrate Added to Protect Flavor" or "Stearyl Citrate.

Added as a Preservative."

Where oil is used, the word "oil" may be substituted for "fat" in the label state

ment. In lieu of the word "animal" or

"vegetable" in any such statement, the common or usual name of the fat in

gredient may be used. If two or more of the optional ingredients named in para

graph (a) (3) (i), (ii), (iii), (iv), (viii), (ix), and (x) of this section are used, the words "added" or "with added" need ap

pear only once, either at the beginning or end of the list of such ingredients de

clared. The declaration of vitamin A may include the number of United States Pharmacopeia units present in the fin

ished oleomargarine.

(2) Wherever the name "oleomarga

rine" or "margarine" appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the words and statements prescribed in this section, showing the ingredients used, shall immediately and conspicu

ously precede or follow, or in part pre

cede and in part follow, such name, without intervening written, printed, or other graphic matter.

(14)

[A-23]

FOOD AND DRUG ADMINISTRATION 169

TITLE 21, PARTS 51 AND 53—CANNED VEGETABLES Definitions and Standards of Identity; Quality; and Fill of Container

Sec. Sec.

51.1 Canned peas; identity; label state- 51.32 ment of optional ingredients.

51.2 Canned peas; quality; label state

51.3 Canned peas; fill of container; label statement of substandard fill.

51.10 Canned green beans; identity; label 51.503 statement of optional ingredients.

51.11 Canned green beans; quality; label

statement of substandard quality. 51.990 51.15 Canned wax beans; identity; label

statement of optional ingredients.

51.16 Canned wax beans; quality; label statement of substandard quality. 53.1 51.20 Canned corn, canned sweet corn, 53.5 canned sugar corn: identity; label 53.10 statement of optional ingredients.

51.21 Canned corn, canned sweet corn,

canned sugar corn; quality; label 53.20 statement of substandard quality.

51.22 Canned corn, canned sweet corn,

canned sugar corn where the corn 53.30 ingredient is in one of the forms

known as fritter corn, ground corn, 53.40 or cream-style corn; fill of con

tainer; label statement of substand- 63.41 ard fill.

51.30 Canned field corn; identity; label 53.42 statement of optional ingredients,

Canned field corn where the corn in

gredient is in one of the forms known as fritter field corn, ground field corn, or cream-style field corn;

fill of containers; label statement of substandard fill.

Canned mushrooms; fill of con

standard fill.

Canned vegetables oxner than those specifically regulated; identity:

dients.

Tomato Juice; identity.

Yellow tomato juice; identity.

Catsup, ketchup, catchup; identity;

label statement of optional ingredU ents.

Tomato puree, tomato pulp; Identity;

ents.

Tomato paste; identity; label state

Canned tomatoes; identity; label statement of optional ingredients.

Canned tomatoes; quality; label state

Canned tomatoes; fill of container; la^

bel statement of substandard fill.

AUTHORITY: Issued under sec. 701, 52 Stat. 1055, us amended: 21 Ij. S. C. 371.

apply sec. 401, 52 Stat. 1046. as amended : 21 Γ. S. C. 341. Interpret or

SUBCHAPTER E—REGULATIONS UNDER SPECIFIC ACTS OF CON

GRESS OTHER THAN THE FOOD, DRUG, AND COSMETIC ACT

PART 281—ENFORCEMENT OF THE TEA IMPORTATION ACT Sec.

281.19 Tea standards. [Amended!

§ 281.19 Tea standards.

(a) Samples for standards of the fol

lowing teas, prepared, identified, and submitted by the Board of Tea Experts on February 16, 1961, are hereby fixed and established as the standards of purity, quality, and fitness for consump

tion under the Tea Importation Act for the year beginning May 1, 1961, and e n d  ing April 30, 1962:

(1) Formosa Oolong.

(2) Ceylon Black (all black tea except Formosa and Japan Black and Congou t y p e ) .

(3) Formosa Black (Formosa Black and Congou t y p e ) .

(4) Japan Black.

(5) Japan Green.

(6) Canton type (all Canton type teas including scented Canton and Canton Oolong t y p e s ) .

These standards apply to tea shipped from abroad on or after May 1, 1961.

Tea shipped prior to May 1, 1961, will be governed by the standards which became effective May 1, 1960 (25 F.R.

1820).

[Paragraph (a) amended, 26 F.R. 2230, Mar.

16,1961]

Prior Amendments 1956: 21 F. R. 1317, Feb. 29.

1957: 22 F. R. 1037, Feb. 20.

1958: 23F.R. 1171. Feb. 25.

1959: 24 F.R. 1862, Mar. 14.

1960: 25 F.R. 1820, Mar. 2.

Part 10—General Regulations Relating to Definitions and Standards for Food