Code of Federal Regulations: Containing a Codification of Documents of ...

companied by a description of experiments conducted under the permit, tentative conclusions reached, and reasons why further experimental shipments are considered necessary. The application for an extension shall be filed not later than 3 months prior to the expiration date of the permit and shall be accompanied by a petition to amend the affected food standard. If the Food and Drug Administration concludes that it will be in the interest of consumers to issue an extension of the time period for the market test, a notice will be published in the FEDERAL REGISTER Stating that fact. The notice will include an invitation to all interested persons to participate in the market test under the same conditions that applied to the initial permit holder, including labeling and the amount to be distributed, except that the designated area of distribution shall not apply. The extended market test period shall not begin prior to the publication of a notice in the FEDERAL REGISTER granting the extension and shall terminate either on the effective date of an affirmative order ruling on the proposal or 30 days after a negative order ruling on the proposal, whichever the case may be. Any interested person who accepts the invitation to participate in the extended market test shall notify the Food and Drug Administration in writing of that fact, the amount to be distributed, and the area of distribution; and along with such notification, he shall submit the labeling under which the food is to be distributed.

(j) Notice of the granting or revocation of any permit shall be published in the FEDERAL REGISTER.

(k) All applications for a temporary permit, applications for an extension of a temporary permit, and related records are available for public disclosure when the notice of a permit or extension thereof is published in the FEDERAL REGISTER. Such disclosure shall be in accordance with the rules established in part 20 of this chapter. (1) Any person who contests denial, modification, or revocation of a temporary permit shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.

[42 FR 14357, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 46 FR 37500, July 21, 1981; 54 FR 24892, June 12, 1989]

Subpart B-Food Additives in Standardized Foods

§ 130.20 Food additives proposed for use in foods for which definitions and standards of identity are established. (a) Where a petition is received for the issuance or amendment of a regulation establishing a definition and standard of identity for a food under section 401 of the act, which proposes the inclusion of a food additive in such definition and standard of identity, the provisions of the regulations in part 171 of this chapter shall apply with respect to the information that must be submitted with respect to the food additive. Since section 409(b)(5) of the act requires that the Commissioner publish notice of a petition for the establishment of a food additive regulation within 30 days after filing, notice of a petition relating to a definition and standard of identity shall also be published within that time limitation if it includes a request, so designated, for the establishment of a regulation pertaining to a food additive.

(b) If a petition for a definition and standard of identity contains a proposal for a food additive regulation, and the petitioner fails to designate it as such, the Commissioner, upon determining that the petition includes a proposal for a food additive regulation, shall so notify the petitioner and shall thereafter proceed in accordance with the regulations in part 171 of this chapter.

(a) Cream means the liquid milk product high in fat separated from milk, which may have been adjusted by adding thereto: Milk, concentrated milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry milk. Cream contains not less than 18 percent milkfat.

(b) Pasteurized when used to describe a dairy product means that every particle of such product shall have been heated in properly operated equipment to one of the temperatures specified in the table of this paragraph and held continuously at or above that temperature for the specified time (or other time/temperature relationship which has been demonstrated to be equivalent thereto in microbial destruction):

0.01 second.

If the dairy ingredient has a fat content of 10 percent or more, or if it contains added sweeteners, the specified temperature shall be increased by 5°F.

(c) Ultra-pasteurized when used to describe a dairy product means that such product shall have been thermally processed at or above 280°F for at least 2 seconds, either before or after packaging, so as to produce a product which has an extended shelf life under refrigerated conditions.

§ 131.25 Whipped cream products containing flavoring or sweetening.

The unqualified name "whipped cream" should not be applied to any product other than one made by whipping the cream that complies with the standards of identity for whipping cream (§§ 131.150 and 131.157 of this chapter). If flavoring and/or sweetening is added, the resulting product is a flavored and/or sweetened whipped cream, and should be so identified.

Subpart B-Requirements for Specific Standardized Milk and Cream

§ 131.110 Milk.

(a) Description. Milk is the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows. Milk that is in final package form for beverage use shall have been pasteurized or ultrapasteurized, and shall contain not less than 84 percent milk solids not fat and not less than 34 percent milkfat. Milk may have been adjusted by separating part of the milkfat therefrom, or by adding thereto cream, concentrated milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry milk. Milk may be homogenized.

(b) Vitamin addition (Optional). (1) If added, vitamin A shall be present in such quantity that each quart of the food contains not less than 2000 International Units thereof within limits of good manufacturing practice.

(2) If added, vitamin D shall be present in such quantity that each quart of the food contains 400 International Units thereof within limits of good manufacturing practice.

(1) Carriers for vitamins A and D. (2) Characterizing flavoring ingredients (with or without coloring, nutritive sweetener, emulsifiers, and stabilizers) as follows:

(i) Fruit and fruit juice (including concentrated fruit and fruit juice).

(ii) Natural and artificial food flavorings.

(d) Methods of analysis. Referenced methods are from "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20001.

Final

(1) Milkfat content-"Fat, RoeseGottlieb Method-Official Action," section 16.059.

(2) Milk solids not fat content-Calculated by subtracting the milk fat content from the total solids content as determined by the method "Total Solids, Method I-Official Action," section 16.032.

Final

(3) Vitamin D content-"Vitamin D-Official Final Action," sections 43.195-43.208.

(e) Nomenclature. The name of the food is "milk”. The name of the food shall be accompanied on the label by a declaration indicating the presence of any characterizing flavoring, as specified in § 101.22 of this chapter.

(1) The following terms shall accompany the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half the height of the letters used in such name:

(i) If vitamins are added, the phrase "vitamin A" or "vitamin A added", or "vitamin D" or "vitamin D added", or "vitamin A and D" or "vitamins A and

D added", as is appropriate. The word "vitamin" may be abbreviated "vit.". (ii) The word “ultra-pasteurized" if the food has been ultra-pasteurized. (2) The following terms may appear on the label:

(i) The word "pasteurized" if the food has been pasteurized.

(ii) The word "homogenized" if the food has been homogenized.

(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 14360, Mar. 15, 1977, as amended at 47 FR 11822, Mar. 19, 1982; 49 FR 10090, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993]

EFFECTIVE DATE NOTE: At 58 FR 2890, Jan. 6, 1993 in § 131.110 paragraph (f) was revised, effective May 8, 1993. For the convenience of the reader, the superseded text appears below.

§ 131.110 Milk.

(f) Label declaration. When used in the food, each of the ingredients specified in paragraphs (b) and (c)(2) of this section shall be declared on the label as required by the applicable sections of part 101 of this chapter.

§ 131.111 Acidified milk.

(a) Description. Acidified milk is the food produced by souring one or more of the optional dairy ingredients specified in pargaph (c) of this section with one or more of the acidifying ingredients specified in paragraph (d) of this section, with or without the addition of characterizing microbial organisms. One or more of the other optional ingredients specified in paragraphs (b) and (e) of this section may also be added. When one or more of the ingredients specified in paragraph (e)(1) of this section are used, they shall be included in the souring process. All ingredients used are safe and suitable. Acidified milk contains not less than 3.25 percent milkfat and not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than 0.5 percent, expressed as lactic acid. The food may be homogenized and shall be pasteurized or ultra-pasteur

ized prior to the addition of the microbial culture and, when applicable, the addition of flakes or granules of butterfat or milkfat.

(b) Vitamin addition (optional). (1) If added, vitamin A shall be present in such quantity that each 946 milliliters (quart) of the food contains not less than 2,000 International Units thereof, within limits of good manufacturing practice.

(2) If added, vitamin D shall be present in such quantity that each 946 milliliters (quart) of the food contains 400 International Units thereof, within limits of good manufacturing practice.

(d) Optional acidifying ingredients. Acetic acid, adipic acid, citric acid, fumaric acid, glucono-delta-lactone, hydrochloric acid, lactic acid, malic acid, phosphoric acid, succinic acid, and tartaric acid.

(e) Other optional ingredients. (1) Concentrated skim milk, nonfat dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or whey modified by partial or complete removal of lactose and/or minerals, to increase the nonfat solids content of the food: Provided, That the ratio of protein to total nonfat solids of the food, and the protein efficiency ratio of all protein present, shall not be decreased as a result of adding such ingredients.

(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or cane; invert sugar (in paste or sirup form); brown sugar; refiner's sirup; molasses (other than blackstrap); high fructose corn sirup; fructose; fructose sirup; maltose; maltose sirup, dried maltose sirup; malt extract, dried malt extract; malt sirup, dried malt sirup; honey; maple sugar; or any of the sweeteners listed in part 168 of this chapter, except table sirup.

(3) Flavoring ingredients.

(4) Color additives that do not impart a color simulalting that of milkfat or butterfat.

(5) Stabilizers.

(6) Butterfat or milkfat, which may or may not contain color additives, in the form of flakes or granules.

(7) Aroma- and flavor-producing microbial culture.

(8) Salt.

(9) Citric acid, in a maximum amount of 0.15 percent by weight of the milk used, or an equivalent amount of sodium citrate, as a flavor precursor.

(f) Methods of analysis. The following referenced methods of analysis are from "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), which is incorporated by reference. Copies are available from the Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 222013301, or available for inspection at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC 20001.

(1) Milkfat content-As determined by the method prescribed in section 16.059, "Roese-Gottlieb Method (Reference Method) (11)-Official Final Action," under the heading "Fat."

(2) Milk solids not fat content-Calculated by subtracting the milkfat content from the total solids content as determined by the method prescribed in section 16.032, "Method IOfficial Final Action," under the heading "Total Solids."

(3) Titratable acidity-As determined by the method prescribed in section 16.023, "Acidity (2)-Official Final Action," or by an equivalent potentiometric method.

(g) Nomenclature. The name of the food is "acidified milk". The full name of the food shall appear on the principal display panel of the label in type of uniform size, style, and color. The name of the food shall be accompanied by a declaration indicating the presence of any characterizing flavoring as specified in § 101.22 of this chapter, and may be accompanied by a declaration such as a traditional name of the food or the generic name of the organisms used, thereby indicating the presence of the characterizing microbial organisms or ingredients when used, e.g., "acidified kefir milk”, "acidified acidophilus milk", or when characterizing ingredients such as those in paragraphs (e) (6), (7), (8), and (9) of this section are used, the

food may be named "acidified buttermilk".

(1) The following terms shall accompany the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half of the height of the letters used in such name:

(i) The phrase "vitamin A” or “vitamin A added”, or “vitamin D" or "vitamin D added", or "vitamins A and D added", as appropriate. The word "vitamin" may be abbreviated "vit.".

(ii) The word "sweetened" if nutritive carbohydrate sweetener is added without the addition of characterizing flavoring.

(2) The term "homogenized" may appear on the label if the dairy ingredients used are homogenized.

(h) 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.

[46 FR 9934, Jan. 30, 1981, as amended at 47 FR 11822, Mar. 19, 1982; 47 FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993)

EFFECTIVE DATE NOTE: At 58 FR 2890, Jan. 6. 1993 in § 131.111 paragraph (h) was revised, effective May 8, 1993. For the convenience of the reader, the superseded text appears below.

(a) Description. Cultured milk is the food produced by culturing one or more of the optional dairy ingredients specified in paragraph (c) of this section with characterizing microbial organisms. One or more of the other optional ingredients specified in paragraphs (b) and (d) of this section may also be added. When one or more of the ingredients specified in paragraph (d)(1) of this section are used, they shall be included in the culturing process. All ingredients used are safe and suitable. Cultured milk contains not

less than 3.25 percent milkfat and not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than 0.5 percent, expressed as lactic acid. The food may be homogenized and shall be pasteurized or ultra-pasteurized prior to the addition to the microbial culture, and when applicable, the addition of flakes or granules of butterfat or milkfat.

(2) If added, vitamin D shall be present in such quantity that each 946 milliliters (quart) of the food contains 400 International Units thereof, within limits of good manufacturing practice.

(d) Other optional ingredients. (1) Concentrated skim milk, nonfat dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or whey modified by partial or complete removal of lactose and/or minerals, to increase the nonfat solids content of the food: Provided, That the ratio of protein to total nonfat solids of the food, and the protein efficiency ratio of all protein present, shall not be decreased as a result of adding such ingredients.

(3) Flavoring ingredients.

(4) Color additives that do not impart a color simulating that of milkfat or butterfat.

(5) Stabilizers.

(6) Butterfat or milkfat, which may or may not contain color additives, in the form of flakes or granules.

341-067 0-93-9

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