der "Fat-Official" on page 249 [Ed. note, 10th edition, 1965, p. 239, sec. 15.100] and the quantity of total milk solids is determined by the method prescribed under "Total Solids-Official" on page 248 [Ed. note, 10th edition, 1965, p. 239, sec. 15.098] of "Official Methods of Analysis of the Association of Official Agricultural Chemists," Seventh Edition, 1950.

(4) Vitamin D content may be increased by the application of radiant energy or by the addition of a concentrate of vitamin D (with any accompanying vitamin A when such vitamin D in such concentrate is obtained from natural sources) dissolved in a food oil; but if such oil is not milk fat the quantity thereof added is not more than 0.01 percent of the weight of the finished evaporated milk.

(5) The quantity of vitamin D is determined by the method prescribed in "Official Methods of Analysis of the Association of Official Agricultural Chemists," Seventh Edition, 1950, page 788 et seq. [Ed. note, 10th edition, 1965, p. 779, secs. 39.116-39.129], under the heading "Vitamin D in Milk-Official."

[20 FR. 9580, Dec. 20, 1955, as amended at 27 F.R. 3254, Apr. 5, 1962, 32 F.R. 1127, Feb. 1, 1967]

§ 18.525

Concentrated milk, plain condensed milk; identity; label statement of optional ingredients. Concentrated milk, plain condensed milk, conforms to the definition and standard of identity, and is subject to the requirements for label statement of optional ingredients, prescribed for evaporated milk by § 18.520, except that:

(a) It is not processed by heat; (b) Its container may be unsealed; and

(c) The optional ingredients listed in § 18.520 (a) (1) are not used.

[20 F.R. 9580, Dec. 20, 1955, as amended at 29 F.R. 15643, Nov. 21, 1964]

§ 18.530 Sweetened condensed milk; identity.

(a) Sweetened condensed milk is the liquid or semi-liquid food made by evaporating a mixture of sweet milk and refined sugar (sucrose) or any combination of refined sugar (sucrose) and refined corn sugar (dextrose) to such point that the finished sweetened condensed milk contains not less than 28.0 percent of total milk solids and not less than 8.5 percent of milk fat. The quantity of refined sugar (sucrose) or combination

of such sugar and refined corn sugar (dextrose) used is sufficient to prevent spoilage.

(b) For the purpose of this section: (1) The word "milk” means cow's milk.

(2) Such milk may be adjusted, before or after evaporation, by the addition or abstraction of cream or sweet skim milk, or the addition of concentrated sweet skim milk.

(3) Milk fat is determined by the method prescribed in "Official and Tentative Methods of Analysis of the Association of Official Agricultural Chemists," Fourth Edition, 1935, page 281 [Ed. note, 10th edition, 1965, p. 240, sec. 15.112] under "Fat-Official."

§ 18.535 Condensed milks which contain corn sirup; identity.

(a) Condensed milks which contain corn sirup are the foods each of which conforms to the definition and standard of identity prescribed for sweetened condensed milk by § 18.530 except that corn sirup or a mixture of corn sirup and sugar is used instead of sugar or a mixture of sugar and dextrose. For the purpose of this section the term "corn sirup" means a clarified and concentrated aqueous solution of the products obtained by the incomplete hydrolysis of cornstarch, and includes dried corn sirup; the solids of such corn sirup contain not less than 40 percent by weight of reducing sugars, calculated as anhydrous dextrose.

(b) The name of each such food is:

(1) "Corn sirup condensed milk," "condensed milk with corn sirup," or "condensed milk prepared with corn sirup," if corn sirup alone is used; or

(2) "

-% Corn sirup solids

-%

-% sugar condensed milk," "Condensed milk with % corn sirup solids -% sugar," or "Condensed milk prepared with --% corn sirup solids sugar," if a mixture of corn sirup and sugar is used, the blanks being filled in with the whole numbers nearest the actual percentages of corn sirup solids and sugar in such food; alternately % sugar" may precede % corn sirup solids" in such names.

66

§ 18.540

66

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

Dried skim milk, powdered skim milk, skim milk powder, is the food made by drying sweet skim milk. It contains not

more than 5 percent of moisture, as determined by the method prescribed in "Official and Tentative Methods of Analysis of the Association of Official Agricultural Chemists," Fourth Edition, 1935, page 282 (Ed. note, 10th edition, 1965, p. 240, sec. 15.1191, under the caption "Moisture-Tentative." The term "skim milk" as used in this section, means cow's milk from which the milk fat has been separated.

NOTE: 70 Stat. 486, 21 U.S.C. 321c, provides a statutory definition for this food under the name "nonfat dry milk."

[20 F.R. 9582, Dec. 20, 1955, as amended at 21 FR. 6566, Aug. 31, 1956] § 18.545 Nonfat dry milk fortified with vitamins A and D; identity; label statement of optional ingredients.

(a) Nonfat dry milk fortified with vitamins A and D conforms to the definition and standard of identity prescribed for nonfat dry milk by Public Law 78244, March 2, 1944, Ch. 77, 58 Stat. 108, as amended by Public Law 84-646, July 2, 1956, Ch. 495, 70 Stat. 486; 21 U.S.C. 321c, except that:

(1) Vitamin A is added in such quantity that, when prepared according to label directions, 8 fluid ounces of the reconstituted product contains 500 U.S.P. units thereof.

(2) Vitamin D is added in such quantity that, when prepared according to label directions, 8 fluid ounces of the reconstituted product contains 100 U.S.P. units thereof.

(b) The requirements of paragraph (a) (1) and (2) of this section will be deemed to have been met if reasonable overages of the vitamins, within limits of good manufacturing practice, are present to insure that the required levels of the vitamins are maintained throughout the expected shelf life of the food under customary conditions of distribution. The vitamins may be added in a harmless carrier, such carrier being used only in the quantity reasonably necessary to effect an intimate and uniform admixture of such substances with the nonfat dry milk.

(c) The name of the food is "Nonfat dry milk fortified with vitamins A and D."

(d) Nonfat dry milk fortified with vitamins A and D is subject to the regulations for foods for special dietary uses promulgated under the provisions of sec

19.639 19.650

Gammelost cheese; identity. Hard cheeses; identity; label statement of optional ingredients. 19.655 Semisoft cheeses; identity; label statement of optional ingredients. 19.660 Semisoft part-skim cheeses; identity; label statement of optional ingredients. 19.665 Soft ripened cheeses; identity; label statement of optional ingredients. 19.670 Spiced cheeses; identity; label statement of optional ingredients.

19.675 Part-skim spiced cheeses; identity; label statement of optional ingredients.

19.680 Hard grating cheeses; identity; label statement of optional ingredients. 19.685 Skim milk cheese for manufacturing; identity.

19.750 Pasteurized process cheese; identity; label statement of optional ingredients.

Sec. 19.751

Pasteurized blended cheese; identity; label statement of optional ingredients.

19.755 Pasteurized

process

cheese with fruits, vegetables, or meats; identity; label statement of optional ingredients.

19.760 Pasteurized process pimento cheese; identity; label statement of optional ingredients.

19.763 Pasteurized blended cheese with fruits, vegetables, or meats; identity; label statement of optional ingredients.

19.765 Pasteurized process

cheese food; identity; label statement of optional ingredients.

19.770 Pasteurized process cheese food with fruits, vegetables, or meats; identity; label statement of optional ingredients.

19.775 Pasteurized process cheese spread; identity; label statement of optional ingredients.

19.776 Pasteurized cheese spread; identity, label statement of optional ingredients.

19.780 Pasteurized process cheese spread with fruits, vegetables, or meats; identity; label statement of optional ingredients.

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

label statement of optional ingredients.

19.782 Cream cheese with other foods; identity; label statement of optional ingredients.

19.785

19.783 Pasteurized neufchatel cheese spread with other foods; identity; label statement of optional ingredients. Cold-pack cheese, club cheese, comminuted cheese; identity; label statement of optional ingredients. 19.787 Cold-pack cheese food; identity; label statement of optional ingredients.

19.788 Cold-pack cheese food with fruits, vegetables, or meats; identity; label statement of optional ingredients. 19.790 Grated American cheese food; identity; label statement of optional ingredients.

19.791

Grated cheeses; identity; label statement of optional ingredients.

AUTHORITY: The provisions of this Part 19 issued under secs. 401, 701, 52 Stat. 1046, as amended, 1055, as amended; 21 U.S.C. 841, 371.

CROSS REFERENCE: For other regulations in this chapter concerning cheese see §§ 3.19 and 5.4.

§ 19.499 Definitions.

For the purposes of this part, the phrase "safe and suitable" when used to describe ingredients of cheese or cheese

products means that such ingredients shall be functionally suitable substances that 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 shall be used in conformity with regulations established pursuant to section 409 of the act.

[32 F.R. 410, Jan. 14, 1967]

§ 19.500

Cheddar cheese, cheese; identity; label statement of optional ingredients.

(a) Cheddar cheese, cheese, is the food prepared from milk and other ingredients specified in this section, by 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 properties as the cheese produced when the procedure set forth in paragraph (b) of this section is used. It contains not more than 39 percent of moisture, and its solids contain not less than 50 percent of milk fat, as determined by the methods prescribed in paragraph (c) of this section. If the milk used is not pasteurized, the cheese so made is cured at a temperature of not less than 35° F. for not less than 60 days.

(b) Milk, which may 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, or other safe and suitable milk-clotting enzyme that produces equivalent curd formation, or both, with or without purified calcium chloride in a quantity not more than 0.02 percent (calculated 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 continued stirring, as to promote and regulate 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 then cut into pieces, which may be rinsed by sprinkling or pouring water over them, with free and continuous drainage; but the duration of such rinsing is so limited that 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 animal or plant origin capable of aiding in the curing or development of flavor of cheddar cheese may be added during the procedure, in such quantity that the weight of the solids of such preparation is not more than 0.1 percent of the weight of the milk used.

(c) Determine moisture by the method prescribed on page 262 (15.124) [Ed. note, 10th edition, 1965, p. 247, sec. 15.157], under "Moisture-Official," and milk fat by the method prescribed on page 263 (15.131) [Ed. note, 10th edition, 1965, p. 248, sec. 15.164], under "FatOfficial," of "Official Methods of Analysis of the Association of Official Agricultural Chemists," Seventh Edition, 1950. Subtract the percent of moisture found from 100; divide the remainder into the percent milk fat found. The 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 an optional mold-inhibiting ingredient consisting of sorbic acid, potassium sorbate, sodium sorbate, or any combination of two or more of these, in an amount not to exceed 0.3 percent by weight, calculated as sorbic acid.

(e) For the purposes of this section: (1) The word "milk" means cow's milk, which may be adjusted by separating part of the fat therefrom or by adding thereto one or more of the following: Cream, skim milk, concentrated skim milk, nonfat dry milk, water in a quantity sufficient to reconstitute any concentrated skim milk or nonfat dry milk used.

(2) Milk shall be deemed to have been pasteurized if it has been held at a temperature of not less than 143° F. for a period of not less than 30 minutes, or for a time and at a temperature equivalent thereto in phosphatase destruction. Cheddar cheese shall be deemed not to have been made from pasteurized milk if 0.25 gm. shows a phenol equivalent of more than 3 micrograms when tested by the method prescribed in paragraph (f) of this section.

(3) During the cheese-making process the milk may be treated with hydrogen peroxide solution followed by addition of a suitable catalase preparation to eliminate the hydrogen peroxide. The hydrogen peroxide solution shall comply with the specifications of the United

States Pharmacopeia, except that it may exceed the concentration specified therein and it does not contain added preservative. The amount of the hydrogen peroxide solution used shall be such that the weight of the hydrogen peroxide added thereby does not exceed 0.05 percent of the weight or the milk treated. The catalase preparation used shall be stable, and in potency, for eliminating added hydrogen peroxide from milk, it shall not be less than equivalent to livercatalase preparation testing 100 Keil units per gram. It shall be either a preparation that is not a food additive within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act, or a preparation that is a food additive but which is used in conformity with regulations promulgated pursuant to the authority of section 409 of the act. The amount of catalase preparation used shall be such that the weight of the catalase added thereby does not exceed 20 parts per million of the weight of the milk treated.

(f) The method referred to in paragraph (e) (2) of this section is as follows:

I. Reagents-1. Buffers—a. Barium boratehydroxide buffer. Dissolve 25.0 gm. of c. p. barium hydroxide (Ba(OH),:8H2O, fresh, not deteriorated) in distilled water and dilute to 500 ml. Dissolve, in another flask or cylinder, 11.0 gm. of c. p., boric acid (H,BO,) and dilute to 500 ml. Warm each to 50° C. (122° F.), mix the two together, stir, cool to approximately 20° C. (68° F.), filter, and stopper the filtrate tightly (pH approximately 10.8). The buffer prepared thus is designated as the 25-11 buffer, the figures indicating the grams per liter of each of the respective reagents.

b. Color-development buffer. Dissolve 6.0 gm. of sodium metaborate (NaBO2) and 20 gm. of sodium chloride in water and dilute to a liter with water (pH 9.8).

c. Color-dilution buffer. Dilute 100 ml. of color-development buffer 1-b to a liter with

water.

d. Standard borax buffer, 0.01-molar, for checking pH meter, pH 9.18 at 25° C.1 Dissolve 0.9544 gm. of pure borax (Bureau of Standards Sample 187) in distilled water (distilled recently or freshly boiled and cooled) and dilute to 250 ml. Keep stoppered tightly.

1All pH values reported herein were determined at 25° C. or corrected to that temperature.

2. Buffer substrates. Specify phenol-free crystalline disodium phenyl phosphate.

a. For evaluating pasteurization. Dissolve 0.10 gm. of the phenyl phosphate in 100 ml. of the appropriate (table 1) barium boratehydroxide buffer 1-a.

b. For quantitative results with raw-milk cheese. Dissolve 0.20 gm, of the phenyl phosphate in 100 ml. of the appropriate (table 1) barium borate-hydroxide buffer 1-8.

3. Protein precipitants—a. Zinc-copper precipitant for unripened cheese. Dissolve 6.0 gm. of zinc sulfate (ZnSO,·7H2O) and 0.1 gm. of copper sulfate (CuSO, 5H2O) in water and dilute to 100 ml. with water. The precipitant prepared thus is designated as the 6.0-0.1 precipitant.

b. Zinc precipitant for ripened cheese. Dissolve 6.0 gm. of zinc sulfate in water and dilute to 100 ml. with water. This precipitant is designated as the 6.0 precipitant. 4. BQC (2,6-dibromoquinone-chloroimine solution) (Gibbs' reagent): Dissolve 40 mg. of BQC powder in 10 ml. of absolute methyl alcohol and transfer to a dark-colored dropper bottle. This reagent remains stable for at least a month if kept in the ice tray of a refrigerator. Do not use it after it begins to turn brown.

5. Other reagents-a. Copper sulfate, 0.05 percent, for standards. Dissolve 0.05 gm. of copper sulfate in water and dilute to 100 ml. b. Butyl alcohol. Specify n-butyl alcohol, boiling point 116°-118° C. To adjust the pH, mix 50 ml. of the color-development buffer 1-b with a liter of the butyl alcohol.

6. Phenol standards-a. Stock solution. Weigh accurately 1.0 gm. of pure phenol, transfer to a liter volumetric flask, dilute to a liter with water, and mix. One ml. contains 1 mg. (0.001 gm.) of phenol. Use this stock solution to prepare standard solutions. It is stable for several months in the refrigerator.

b. Preparation of standards.

Dilute 10.0

ml. of the stock solution 6-a to a liter with water, and mix. One ml. contains 10 micrograms (0.00001 gm., 10 gammas, or 10 units) of phenol. Use this standard solution to prepare more dilute standard solutions; e. g., dilute 5, 10, 30, and 50 ml. to 100 ml. with water to prepare standard solutions containing 0.5, 1.0, 3.0, and 5.0 gammas or units of phenol per milliliter, respectively. Keep standard solutions in the refrigerator.

In a similar manner, prepare from the stock solution such more concentrated standard solutions as may be needed, containing, for example, 20, 30, and 40 units per milliliter.

Measure appropriate quantities of the phenol standard solution into a series of tubes (preferably graduated at 5.0 and 10.0 ml.) to provide a suitable range of standards as needed, containing 0 (control blank), 0.5, 1.0, 3.0, 5.0, 10.0, etc., to 30 or 40 units. To increase the brightness of the blue color