(a) Description. Yogurt is the food produced by culturing one or more of the basic dairy ingredients specified in paragraph (b) of this section and any of the optional dairy ingredients specified in paragraph (c) of this section with a characterizing bacterial culture that contains the lactic acid-producing bacteria, Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus. The ingredients specified in paragraphs (b) and (c) of this section may be homogenized and must be pasteurized or ultra-pasteurized before the addition of the characterizing bacterial culture. One or more of the other optional ingredients specified in paragraph (d) of this section may also be added. Yogurt, before the addition of bulky flavoring ingredients, contains not less than 3.25 percent milkfat and not less than 8.25 percent milk solids not fat and has either a titratable acidity of not less than 0.7 percent, expressed as lactic acid, or a pH of 4.6 or lower. To extend the shelf life of the food, yogurt may be treated after culturing to inactivate viable microorganisms.
(b) Basic dairy ingredients. Cream, milk, partially skimmed milk, skim milk, or the reconstituted versions of these ingredients may be used alone or in combination.
(c) Optional dairy ingredients. Other safe and suitable milk-derived ingredients may be used to increase the milk solids not fat content of the food above the minimum of 8.25 percent required in paragraph (a) of this section, provided that the ratio of protein to total nonfat solids of the food, and the protein efficiency ratio of all protein present must not be decreased as a result of adding such ingredients.
(d) Other optional ingredients. The following safe and suitable ingredients may be used:
(1) Cultures, in addition to the characterizing bacterial culture specified in paragraph (a) of this section.
(2) Nutritive carbohydrate sweeteners.
(3) Flavoring ingredients.
(4) Color additives.
(8) Vitamin addition (optional).
(i) If added, vitamin A must be present in such quantity that the food contains not less than 10 percent Daily Value per Reference Amount Commonly Consumed (RACC) thereof, within limits of current good manufacturing practice.
(ii) If added, vitamin D must be present in such quantity that the food contains not less than 25 percent Daily Value per Reference Amount Commonly Consumed (RACC) thereof, within limits of current good manufacturing practices.
(e) Methods of analysis -
(1) Milk -
(i) Milkfat content. As determined by the method prescribed in section 33.2.26, AOAC Official Method 989.05, Fat in Milk Modified Mojonnier Ether Extraction Method.
(ii) Milk solids not fat. Calculated by subtracting the milkfat content from the total solids content using the method prescribed in section 33.2.45, AOAC Official Method 990.21, Solids-Not-Fat in Milk by Difference between Total Solids and Fat Contents.
(iii) Titratable acidity. As determined by the method prescribed in section 33.2.06, AOAC Official Method 947.05, Acidity of Milk Titrimetric Method.
(2) pH. As determined by the potentiometric method described in § 114.90(a) of this chapter.
(3) Live and active cultures. As determined by the method described in ISO 7889:2003(E)/IDF 117:2003(E), Yogurt - Enumeration of Characteristic Microorganisms - Colony-Count Technique at 37 °C.
(f) Nomenclature. The name of the food is “yogurt.” The name of the food must be accompanied by a declaration indicating the presence of any characterizing flavoring as specified in § 101.22 of this chapter.
(1) The following term(s) must 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 word “sweetened” if a nutritive carbohydrate sweetener is added without the addition of characterizing flavor.
(ii) The phrase “does not contain live and active cultures” if the dairy ingredients have been treated after culturing to inactivate viable microorganisms.
(iii) 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”.
(2) The name of the food may be accompanied by the phrase “contains live and active cultures” or another appropriate descriptor if the food contains a minimum level of live and active cultures of 107 colony forming units per gram (CFU/g) at the time of manufacture with a reasonable expectation of 106 CFU/g through the manufacturer's assigned shelf life of the product.
(3) The term “homogenized” may appear on the label if the dairy ingredients used are homogenized.
(h) Incorporation by reference. The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, FDA must publish a document in the Federal Register, and the material must be available to the public. All approved material is available for inspection at the Food and Drug Administration's Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and is available from the sources indicated in this paragraph (h). It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email firstname.lastname@example.org or go to www.archives.gov/federal-register/cfr/ibr-locations.html.
(1) AOAC INTERNATIONAL, 2275 Research Blvd., Suite 300, Rockville, MD 20850-3250:
(i) AOAC Official Method 947.05, Acidity of Milk Titrimetric Method, Section 33.2.06, Official Methods of Analysis, 21st edition, 2019, Vol. 1.
(ii) AOAC Official Method 989.05, Fat in Milk Modified Mojonnier Ether Extraction Method, Section 33.2.26, Official Methods of Analysis, 21st edition, 2019, Vol. 1.
(iii) AOAC Official Method 990.21, Solids-Not-Fat in Milk by Difference between Total Solids and Fat Contents, Section 33.2.45, Official Methods of Analysis, 21st edition, 2019, Vol. 1.
(2) ISO, ISO Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland.
(i) ISO 7889:2003(E), Yogurt - Enumeration of Characteristic Microorganisms - Colony-Count Technique at 37 °C, First edition, 2003-02-01.
ISO 7889:2003(E) is co-published as IDF 117:2003(E).
[86 FR 31137, June 11, 2021]