Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=130&showFR=1
Timestamp: 2019-11-14 14:50:28
Document Index: 186386463

Matched Legal Cases: ['ART 130', 'art 51', 'art 101', 'arts 131', 'art 101', 'arts 131', 'arts 131', 'arts 131']

[CITE: 21CFR130]
PART 130 FOOD STANDARDS: GENERAL
Sec. 130.3 Definitions and interpretations.
Sec. 130.5 Procedure for establishing a food standard.
Sec. 130.8 Conformity to definitions and standards of identity.
(a) If it contains an ingredient for which no provision is made in such definition and standard, unless such ingredient is an incidental additive introduced at a nonfunctional and insignificant level as a result of its deliberate and purposeful addition to another ingredient permitted by the terms of the applicable standard and the presence of such incidental additive in unstandardized foods has been exempted from label declaration as provided in 101.100 of this chapter.
Sec. 130.9 Sulfites in standardized food.
(a) Any standardized food that contains a sulfiting agent or combination of sulfiting agents that is functional and provided for in the applicable standard or that is present in the finished food at a detectable level is misbranded unless the presence of the sulfiting agent or agents is declared on the label of the food. A detectable amount of sulfiting agent is 10 parts per million or more of the sulfite in the finished food. The level of sulfite in the finished food will be determined using sections 20.123 through 20.125, "Sulfurous Acid (Total) in Food Modified Monier-Williams Method Final Action" in "Official Methods of Analysis of the Association of Official Analytical Chemists," 14th ed. (1984), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, and the refinements of the "Total Sulfurous Acid" procedure in the "Monier-Williams Procedure (with Modifications) for Sulfites in Foods," which is appendix A to part 101 of this chapter. A copy of sections 20.123 through 20.125 of the "Official Methods of Analysis of the Association of Official Analytical Chemists" is available from AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877 , or available for at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federalregister/codeoffederalregulations/ibrlocations.html.
(b) Any standardized food that, as a result of actions that are consistent with current good manufacturing practice, contains an indirectly added sulfiting agent that has no functional effect in the food and that would, in the absence of 101.100(a)(4) of this chapter, be considered to be an incidental additive for purposes of 130.8, conforms to the applicable definition and standard of identity if the presence of the sulfiting agent is declared on the label of the food.
Sec. 130.10 Requirements for foods named by use of a nutrient content claim and a standardized term.
(a) Description. The foods prescribed by this general definition and standard of identity are those foods that substitute (see 101.13(d) of this chapter) for a standardized food defined in parts 131 through 169 of this chapter and that use the name of that standardized food in their statement of identity but that do not comply with the standard of identity because of a deviation that is described by an expressed nutrient content claim that has been defined by FDA regulation. The nutrient content claim shall comply with the requirements of 101.13 of this chapter and with the requirements of the regulations in part 101 of this chapter that define the particular nutrient content claim that is used. The food shall comply with the relevant standard in all other respects except as provided in paragraphs (b), (c), and (d) of this section.
(b) Nutrient addition. Nutrients shall be added to the food to restore nutrient levels so that the product is not nutritionally inferior, as defined in 101.3(e)(4) of this chapter, to the standardized food as defined in parts 131 through 169 of this chapter. The addition of nutrients shall be reflected in the ingredient statement.
(c) Performance characteristics. Deviations from noningredient provisions of the standard of identity (e.g., moisture content, food solids content requirements, or processing conditions) are permitted in order that the substitute food possesses performance characteristics similar to those of the standardized food. Deviations from ingredient and noningredient provisions of the standard must be the minimum necessary to qualify for the nutrient content claim while maintaining similar performance characteristics as the standardized food, or the food will be deemed to be adulterated under section 402(b) of the act. The performance characteristics (e.g., physical properties, flavor characteristics, functional properties, shelf life) of the food shall be similar to those of the standardized food as produced under parts 131 through 169 of this chapter, except that if there is a significant difference in performance characteristics that materially limits the uses of the food compared to the uses of the standardized food, the label shall include a statement informing the consumer of such difference (e.g., if appropriate, "not recommended for cooking"). Such statement shall comply with the requirements of 101.13(d) of this chapter. The modified product shall perform at least one of the principal functions of the standardized product substantially as well as the standardized product.
(5) Water and fat analogs may be added to replace fat and calories in accordance with 130.10(c), (d)(1), and (d)(2).
(2) Ingredients not provided for, and ingredients used in excess of those levels provided for, by the standard as defined in parts 131 through 169 of this chapter, shall be identified as such with an asterisk in the ingredient statement, except that ingredients added to restore nutrients to the product as required in paragraph (b) of this section shall not be identified with an asterisk. The statement "*Ingredient(s) not in regular ___" (fill in name of the traditional standardized food) or "*Ingredient(s) in excess of amount permitted in regular ___" (fill in name of the traditional standardized food) or both as appropriate shall immediately follow the ingredient statement in the same type size.
Sec. 130.11 Label designations of ingredients for standardized foods.
Sec. 130.12 General methods for water capacity and fill of containers.
(3) Fill the container with distilled water at 68 deg. F to 3/16 inch vertical distance below the top level of the container, and weigh the container thus filled.
(4) Fill the container with water to 3/16 inch vertical distance below the top level of the container. Record the temperature of the water, weigh the container thus filled, and determine the weight of the water by subtracting the weight of the container found in paragraph (b)(3) of this section.
Sec. 130.14 General statements of substandard quality and substandard fill of container.
(a) The term general statement of substandard quality means the statement "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 background, 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 representation appears so conspicuously as to be easily seen under customary conditions 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 container is less than 1 pound, the statement is in 12-point type; if such quantity is 1 pound or more, the statement is in 14-point type. Such statement is enclosed 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 enclosed within the same rectangle. Such statement or statements, with enclosing lines, are on a strongly contrasting, uniform 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.
Sec. 130.17 Temporary permits for interstate shipment of experimental packs of food varying from the requirements of definitions and standards of identity.
Subpart B--Food Additives in Standardized Foods
Sec. 130.20 Food additives proposed for use in foods for which definitions and standards of identity are established.