General food standards (21 CFR 130.3-130.20)

373 Food and Drug Administration, HHS § 130.3 (g) Compliance procedures. A quality standard for bottled drinking water is established in § 165.110(b) of this chap ter. To assure that the plant’s produc tion of bottled drinking water complies with the applicable standards, laws, and regulations of the government agency or agencies having jurisdiction, the plant will analyze product samples as follows: (1) For bacteriological purposes, take and analyze at least once a week for total coliform a representative sample from a batch or segment of a contin uous production run for each type of bottled drinking water produced during a day’s production. The representative sample shall consist of primary con tainers of product or unit packages of product. If any coliform organisms are detected, follow-up testing must be conducted to determine whether any of the coliform organisms are E. coli. (2) For chemical, physical, and radio logical purposes, take and analyze at least annually a representative sample from a batch or segment of a contin uous production run for each type of bottled drinking water produced during a day’s production. The representtive sample(s) consists of primary con tainers of product of unit packages of product. (3) Analyze such samples by methods approved by the government agency or agencies having jurisdiction. The plant shall maintain records of date of sam pling, type of product sampled, produc tion code, and results of the analysis. (h) Record retention. All records re quired by §§ 129.1, 129.20, 129.35, 129.37, 129.40, and 129.80 shall be maintained at the plant for not less than 2 years. Plants shall also retain, on file at the plant, current certificates or notifica tions of approval issued by the govern ment agency or agencies approving the plant’s source and supply of product water and operations water. All re quired documents shall be available for official review at reasonable times. [42 FR 14355, Mar. 15, 1977, as amended at 44 FR 12175, Mar. 6, 1979; 60 FR 57124, Nov. 13, 1995; 74 FR 25665, May 29, 2009] PART 130—FOOD STANDARDS: GENERAL Subpart A—General Provisions Sec. 130.3 Definitions and interpretations. 130.5 Procedure for establishing a food standard. 130.6 Review of Codex Alimentarius food standards. 130.8 Conformity to definitions and stand ards of identity. 130.9 Sulfites in standardized food. 130.10 Requirements for foods named by use of a nutrient content claim and a stand ardized term. 130.11 Label designations of ingredients for standardized foods. 130.12 General methods for water capacity and fill of containers. 130.14 General statements of substandard quality and substandard fill of container. 130.17 Temporary permits for interstate shipment of experimental packs of food varying from the requirements of defini tions and standards of identity. 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. AUTHORITY: 21 U.S.C. 321, 336, 341, 343, 371. Subpart A—General Provisions § 130.3 Definitions and interpretations. (a) The definitions and interpreta tions 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 sec tion 401 of the act and the name there in specified for the food is used in any other regulation under section 401 or any other provision of the act, such name means the food which conforms to such definition and standard, except as otherwise specifically provided in such other regulation. (c) No provision of any regulation prescribing a definition and standard of identity or standard of quality or fill 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 VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00383 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 374 21 CFR Ch. I (4–1–15 Edition) § 130.5 regulations thereunder relating to adulteration and misbranding. For ex ample, 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 fla voring does not authorize such use under circumstances or in a manner whereby damage or inferiority is con cealed or whereby the food is made to appear better or of greater value than it is. (d) Safe and suitable means that the ingredient: (1) Performs an appropriate function in the food in which it is used. (2) Is used at a level no higher than necessary to achieve its intended pur pose in that food. (3) Is not a food additive or color ad ditive as defined in section 201 (s) or (t) of the Federal Food, Drug, and Cos metic Act as used in that food, or is a food additive or color additive as so de fined and is used in conformity with regulations established pursuant to section 409 or 721 of the act. (e) Section 403(i) of the act requires the listing of all ingredients in stand ardized foods. All ingredients must be listed in accordance with the require ments of part 101 of this chapter, ex cept that where a definition and stand ard of identity has specific labeling provisions for optional ingredients, op tional ingredients may be declared in accordance with those provisions. [42 FR 14357, Mar. 15, 1977, as amended at 58 FR 2876, Jan. 6, 1993] § 130.5 Procedure for establishing a food standard. (a) The procedure for establishing a food standard under section 401 of the act shall be governed by part 10 of this chapter. (b) Any petition for a food standard shall show that the proposal, if adopt ed, would promote honesty and fair dealing in the interest of consumers. (c) Any petition for a food standard shall assert that the petitioner com mits himself to substantiate the infor mation in the petition by evidence in a public hearing, if such a hearing be comes necessary. (d) If a petitioner fails to appear, or to substantiate the information in his petition, at a public hearing on the matter, the Commissioner may either (1) withdraw the regulation and termi nate the proceeding or (2) if he con cludes that it is in accordance with the requirements of section 401 of the act, continue the proceeding and introduce evidence to substantiate such informa tion. [42 FR 14357, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977] § 130.6 Review of Codex Alimentarius food standards. (a) All food standards adopted by the Codex Alimentarius Commission will be reviewed by the Food and Drug Ad ministration and will be accepted with out change, accepted with change, or not accepted. (b) Review of Codex standards will be accomplished in one of the following three ways: (1) Any interested person may peti tion the Commissioner to adopt a Codex standard, with or without change, by proposing a new standard or an appropriate amendment of an exist ing standard, pursuant to section 401 of the act. Any such petition shall specify any deviations from the Codex stand ard, and the reasons for any such devi ations. The Commissioner shall publish such a petition in the FEDERAL REG ISTER as a proposal, with an oppor tunity for comment, if reasonable grounds are provided in the petition. Any published proposal shall state any deviations from the Codex standard and the stated reasons therefor. (2) The Commissioner may on his own initiative propose by publication in the FEDERAL REGISTER the adoption of a Codex standard, with or without change, through a new standard or an appropriate amendment to an existing standard, pursuant to section 401 of the act. Any such proposal shall specify any deviations from the Codex stand ard, and the reasons for any such devi ations. (3) Any Codex standard not handled under paragraph (b) (1) or (2) of this section may be published in the FED ERAL REGISTER for review and informal comment. Interested persons shall be VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00384 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 375 Food and Drug Administration, HHS § 130.10 requested to comment on the desir ability and need for the standard, on the specific provisions of the standard, on additional or different provisions that should be included in the stand ard, and on any other pertinent points. After reviewing all such comments, the Commissioner either shall publish a proposal to establish a food standard pursuant to section 401 of the act cov ering the food involved, or shall pub lish a notice terminating consideration of such a standard. (c) All interested persons are encour aged to confer with different interest groups (consumers, industry, the aca demic community, professional organi zations, and others) in formulating pe titions or comments pursuant to para graph (b) of this section. All such peti tions or comments are requested to in clude a statement of any meetings and discussions that have been held with other interest groups. Appropriate weight will be given by the Commis sioner to petitions or comments that reflect a consensus of different interest groups. § 130.8 Conformity to definitions and standards of identity. In the following conditions, among others, a food does not conform to the definition and standard of identity therefor: (a) If it contains an ingredient for which no provision is made in such def inition and standard, unless such ingre dient is an incidental additive intro duced at a nonfunctional and insignifi cant level as a result of its deliberate and purposeful addition to another in gredient permitted by the terms of the applicable standard and the presence of such incidental additive in unstandardized foods has been exempt ed from label declaration as provided in § 101.100 of this chapter. (b) If it fails to contain any one or more ingredients required by such defi nition and standard; (c) If the quantity of any ingredient or component fails to conform to the limitation, if any, prescribed therefor by such definition and standard. § 130.9 Sulfites in standardized food. (a) Any standardized food that con tains a sulfiting agent or combination of sulfiting agents that is functional and provided for in the applicable standard or that is present in the fin ished food at a detectable level is mis branded 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, ‘‘Sulfu rous 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 in corporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, and the refinements of the ‘‘Total Sul furous Acid’’ procedure in the ‘‘Monier Williams Procedure (with Modifica tions) 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 Ar chives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (b) Any standardized food that, as a result of actions that are consistent with current good manufacturing prac tice, 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 inci dental 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. [58 FR 2876, Jan. 6, 1993, as amended at 63 FR 14035, Mar. 24, 1998] § 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 VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00385 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 376 21 CFR Ch. I (4–1–15 Edition) § 130.10 of identity are those foods that sub stitute (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 con tent claim that has been defined by FDA regulation. The nutrient content claim shall comply with the require ments of § 101.13 of this chapter and with the requirements of the regula tions in part 101 of this chapter that define the particular nutrient content claim that is used. The food shall com ply with the relevant standard in all other respects except as provided in paragraphs (b), (c), and (d) of this sec tion. (b) Nutrient addition. Nutrients shall be added to the food to restore nutrient levels so that the product is not nutri tionally 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 ad dition of nutrients shall be reflected in the ingredient statement. (c) Performance characteristics. Devi ations from noningredient provisions of the standard of identity (e.g., moisture content, food solids content require ments, or processing conditions) are permitted in order that the substitute food possesses performance character istics similar to those of the standard ized food. Deviations from ingredient and noningredient provisions of the standard must be the minimum nec essary to qualify for the nutrient con tent 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 char acteristics (e.g., physical properties, flavor characteristics, functional prop erties, 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 mate rially limits the uses of the food com pared to the uses of the standardized food, the label shall include a state ment informing the consumer of such difference (e.g., if appropriate, ‘‘not recommended for cooking’’). Such statement shall comply with the re quirements 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. (d) Other ingredients. (1) Ingredients used in the product shall be those in gredients provided for by the standard as defined in parts 131 through 169 of this chapter and in paragraph (b) of this section, except that safe and suit able ingredients may be used to im prove texture, add flavor, prevent syn eresis, extend shelf life, improve ap pearance, or add sweetness so that the product is not inferior in performance characteristics to the standardized food defined in parts 131 through 169 of this chapter. (2) An ingredient or component of an ingredient that is specifically required by the standard (i.e., a mandatory in gredient) as defined in parts 131 through 169 of this chapter, shall not be replaced or exchanged with a similar ingredient from another source unless the standard, as defined in parts 131 through 169 of this chapter, provides for the addition of such ingredient (e.g., vegetable oil shall not replace milkfat in light sour cream). (3) An ingredient or component of an ingredient that is specifically prohib ited by the standard as defined in parts 131 through 169 of this chapter, shall not be added to a substitute food under this section. (4) An ingredient that is specifically required by the standard as defined in parts 131 through 169 of this chapter, shall be present in the product in a sig nificant amount. A significant amount of an ingredient or component of an in gredient is at least that amount that is required to achieve the technical effect of that ingredient in the food. (5) Water and fat analogs may be added to replace fat and calories in ac cordance with § 130.10(c), (d)(1), and (d)(2). (e) Nomenclature. The name of a sub stitute food that complies with all parts of this regulation is the appro priate expressed nutrient content claim and the applicable standardized term. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00386 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 377 Food and Drug Administration, HHS § 130.12 (f) Label declaration. (1) Each of the ingredients used in the food shall be de clared on the label as required by the applicable sections of part 101 of this chapter and part 130. (2) Ingredients not provided for, and ingredients used in excess of those lev els provided for, by the standard as de fined 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 prod uct as required in paragraph (b) of this section shall not be identified with an asterisk. The statement ‘‘*Ingredient(s) not in regular lll’’ (fill in name of the traditional stand ardized food) or ‘‘*Ingredient(s) in ex cess of amount permitted in regular lll’’ (fill in name of the traditional standardized food) or both as appro priate shall immediately follow the in gredient statement in the same type size. [58 FR 2446, Jan. 6, 1993] § 130.11 Label designations of ingredi ents for standardized foods. Some definitions and standards of identity for foods set forth below re quire that designated optional ingredi ents such as spices, flavorings, color ings, emulsifiers, flavor enhancers, sta bilizers, preservatives, and sweeteners be declared in a specified manner on the label wherever the name of the standardized food appears on the label so conspicuously as to be easily seen under customary conditions of pur chase. Such requirements shall apply to a manufacturer, packer, or dis tributor of a standardized food only if the words or statements on the label of the standardized food significantly dif ferentiate between two or more foods that comply with the same standard by describing the optional forms or vari eties, the packing medium, or signifi cant characterizing ingredients present in the food. [58 FR 2876, Jan. 6, 1993] § 130.12 General methods for water ca pacity and fill of containers. For the purposes of regulations pro mulgated under section 401 of the act: (a) The term general method for water capacity of containers means the fol lowing 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 °F to 3⁄16 inch vertical dis tance below the top level of the con tainer, and weigh the container thus filled. (4) Subtract the weight found in paragraph (a)(2) of this section from the weight found in paragraph (a)(3) of this section. The difference shall be considered to be the weight of water re quired 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 paragraphs (a) (2) to (4) of this sec tion, except that under paragraph (a)(3) of this section, fill the container to the level of the top thereof. (b) The term general method for fill 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) 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 3⁄16 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 subtracting the weight of the container found in para graph (b)(3) of this section. (5) Maintaining the water at the tem perature recorded in paragraph (b)(4) of this section, draw off water from the container as filled in paragraph (b)(4) of this section to the level of the food found in paragraph (b)(2) of this sec tion, weigh the container with remain ing water, and determine the weight of the remaining water by subtracting the weight of the container found in para graph (b)(3) of this section. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00387 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 378 21 CFR Ch. I (4–1–15 Edition) § 130.14 (6) Divide the weight of water found in paragraph (b)(5) of this section by the weight of water found in paragraph (b)(4) of this section, 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 paragraphs (b) (2) to (6) of this sec tion, except that under paragraph (b)(4) of this section, fill the container to the level of the top thereof. § 130.14 General statements of sub standard quality and substandard fill of container. For the purposes of regulations pro mulgated under section 401 of the act: (a) The term general statement of sub standard 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 con tainer is less than 1 pound, the type of the first line is 12-point, and of the sec ond, 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 en closing lines, is on a strongly con trasting, uniform background, and is so placed as to be easily seen when the name of the food or any pictorial rep resentation thereof is viewed, wherever such name or representation appears so conspicuously as to be easily seen under customary conditions of pur chase. (b) The term general statement of sub standard 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 quan tity 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 para graph (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 rep resentation appears so conspicuously as to be easily seen under customary conditions of purchase. § 130.17 Temporary permits for inter state shipment of experimental packs of food varying from the re quirements of definitions and standards of identity. (a) The Food and Drug Administra tion recognizes that before petitions to amend food standards can be sub mitted, appropriate investigations of potential advances in food technology sometimes require tests in interstate markets of the advantages to and ac ceptance by consumers of experimental packs of food varying from applicable definitions and standards of identity prescribed under section 401 of the act. (b) It is the purpose of the Food and Drug Administration to permit such tests when it can be ascertained that the sole purpose of the tests is to ob tain data necessary for reasonable grounds in support of a petition to amend food standards, that the tests are necessary to the completion or con clusiveness of an otherwise adequate investigation, and that the interests of consumers are adequately safeguarded; permits for such tests shall normally be for a period not to exceed 15 months. The Food and Drug Administration, or good cause shown by the applicant, may provide for a longer test market period. The Food and Drug Administra tion will therefore refrain from recom mending regulatory proceedings under the act on the charge that a food does not conform to an applicable standard, if the person who introduces or causes the introduction of the food into inter state commerce holds an effective per mit from the Food and Drug Adminis tration providing specifically for those variations in respect to which the food fails to conform to the applicable defi nition and standard of identity. The test period will begin on the date the person holding an effective permit VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00388 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 379 Food and Drug Administration, HHS § 130.17 from the Food and Drug Administra tion introduces or causes the introduc tion of the food covered by the permit into interstate commerce but not later than 3 months after notice of the issuance of the permit is published in the FEDERAL REGISTER. The Food and Drug Administration shall be notified in writing of the date on which the test period begins as soon as it is deter mined. (c) Any person desiring a permit may file with the Team Leader, Conven tional Foods Team, Division of Stand ards and Labeling Regulations, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS– 822), 5100 Paint Branch Pkwy., College Park, MD 20740, a written application in triplicate containing as part thereof the following: (1) Name and address of the appli cant. (2) A statement of whether or not the applicant is regularly engaged in pro ducing the food involved. (3) A reference to the applicable defi nition and standard of identity (citing applicable section of regulations). (4) A full description of the proposed variation from the standard. (5) The basis upon which the food so varying is believed to be wholesome and nondeleterious. (6) The amount of any new ingredient to be added; the amount of any ingre dient, required by the standard, to be eliminated; any change of concentra tion not contemplated by the standard; or any change in name that would more appropriately describe the new product under test. If such new ingre dient is not a commonly known food ingredient, a description of its prop erties and basis for concluding that it is not a deleterious substance. (7) The purpose of effecting the vari ation. (8) A statement of how the variation is of potential advantage to consumers. The statement shall include the rea sons why the applicant does not con sider the data obtained in any prior in vestigations which may have been con ducted sufficient to support a petition to amend the standard. (9) The proposed label (or an accurate draft) to be used on the food to be mar ket tested. The label shall conform in all respects to the general require ments of the act and shall provide a means whereby the consumer can dis tinguish between the food being tested and such food complying with the standard. (10) The period during which the ap plicant desires to introduce such food into interstate commerce, with a state ment of the reasons supporting the need for such period. If a period longer than 15 months is requested, a detailed explanation of why a 15-month period is inadequate shall be provided. (11) The probable amount of such food that will be distributed. The amount distributed should be limited to the smallest number of units reason ably required for a bona fide market test. Justification for the amount re quested shall be included. (12) The areas of distribution. (13) The address at which such food will be manufactured. (14) A statement of whether or not such food has been or is to be distrib uted in the State in which it was man ufactured. (15) If it has not been or is not to be so distributed, a statement showing why. (16) If it has been or is to be so dis tributed, a statement of why it is deemed necessary to distribute such food in other States. (d) The Food and Drug Administra tion may require the applicant to fur nish samples of the food varying from the standard and to furnish such addi tional information as may be deemed necessary for action on the application. (e) If the Food and Drug Administra tion concludes that the variation may be advantageous to consumers and will not result in failure of the food to con form to any provision of the act except section 403(g), a permit shall be issued to the applicant for interstate ship ment of such food. The terms and con ditions of the permit shall be those set forth in the application with such modifications, restrictions, or quali fications as the Food and Drug Admin istration may deem necessary and state in the permit. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00389 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 380 21 CFR Ch. I (4–1–15 Edition) § 130.20 (f) The terms and conditions of the permit may be modified at the discre tion of the Food and Drug Administra tion or upon application of the per mittee during the effective period of the permit. (g) The Food and Drug Administra tion may revoke a permit for cause, which shall include but not be limited to the following: (1) That the permittee has introduced a food into interstate commerce con trary to the terms and conditions of the permit. (2) That the application for a permit contains an untrue statement of a ma terial fact. (3) That the need therefor no longer exists. (h) During the period within which any permit is effective, it shall be deemed to be included within the terms of any guaranty or undertaking other wise effective pursuant to the provi sions of section 303(c) of the act. (i) If an application is made for an extension of the permit, it shall be ac companied by a description of experi ments conducted under the permit, tentative conclusions reached, and rea sons why further experimental ship ments 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 con cludes that it will be in the interest of consumers to issue an extension of the time period for the market test, a no tice will be published in the FEDERAL REGISTER stating that fact. The notice will include an invitation to all inter ested persons to participate in the mar ket test under the same conditions that applied to the initial permit hold er, including labeling and the amount to be distributed, except that the des ignated 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 termi nate either on the effective date of an affirmative order ruling on the pro posal or 30 days after a negative order ruling on the proposal, whichever the case may be. Any interested person who accepts the invitation to partici pate in the extended market test shall notify the Food and Drug Administra tion in writing of that fact, the amount to be distributed, and the area of dis tribution; and along with such notifica tion, he shall submit the labeling under which the food is to be distributed. (j) Notice of the granting or revoca tion 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 disclo sure when the notice of a permit or ex tension thereof is published in the FED ERAL REGISTER. Such disclosure shall be in accordance with the rules estab lished in part 20 of this chapter. (l) Any person who contests denial, modification, or revocation of a tem porary permit shall have an oppor tunity for a regulatory hearing before the Food and Drug Administration pur suant 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; 59 FR 15051, Mar. 31, 1994; 66 FR 17359, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001] Subpart B—Food Additives in Standardized Foods § 130.20 Food additives proposed for use in foods for which definitions and standards of identity are estab lished. (a) Where a petition is received for the issuance or amendment of a regula tion 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 sub mitted with respect to the food addi tive. Since section 409(b)(5) of the act requires that the Commissioner publish notice of a petition for the establish ment 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 pub lished within that time limitation if it includes a request, so designated, for VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00390 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 381 Food and Drug Administration, HHS § 131.110 the establishment of a regulation per taining to a food additive. (b) If a petition for a definition and standard of identity contains a pro posal for a food additive regulation, and the petitioner fails to designate it as such, the Commissioner, upon deter mining 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 chap ter. PART 131—MILK AND CREAM Subpart A—General Provisions Sec. 131.3 Definitions. 131.25 Whipped cream products containing flavoring or sweetening. Subpart B—Requirements for Specific Standardized Milk and Cream 131.110 Milk. 131.111 Acidified milk. 131.112 Cultured milk. 131.115 Concentrated milk. 131.120 Sweetened condensed milk. 131.125 Nonfat dry milk. 131.127 Nonfat dry milk fortified with vita mins A and D. 131.130 Evaporated milk. 131.147 Dry whole milk. 131.149 Dry cream. 131.150 Heavy cream. 131.155 Light cream. 131.157 Light whipping cream. 131.160 Sour cream. 131.162 Acidified sour cream. 131.170 Eggnog. 131.180 Half-and-half. 131.200 Yogurt. 131.203 Lowfat yogurt. 131.206 Nonfat yogurt. AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, 379e. SOURCE: 42 FR 14360, Mar. 15, 1977, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 131 appear at 63 FR 14035, Mar. 24, 1998. Subpart A—General Provisions § 131.3 Definitions. (a) Cream means the liquid milk prod uct high in fat separated from milk, which may have been adjusted by add ing thereto: Milk, concentrated milk, dry whole milk, skim milk, con centrated 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 par ticle 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 tempera ture for the specified time (or other time/temperature relationship which has been demonstrated to be equivalent thereto in microbial destruction): Temperature Time 145 °F 1 ..................................................... 30 minutes 161 °F 1 ..................................................... 15 seconds 191 °F ....................................................... 1 second 204 °F ....................................................... 0.05 second 212 °F ....................................................... 0.01 second 1 If the dairy ingredient has a fat content of 10 percent or more, or if it contains added sweeteners, the specified tem perature shall be increased by 5 °F. (c) Ultra-pasteurized when used to de scribe 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 pack aging, so as to produce a product which has an extended shelf life under refrig erated conditions. § 131.25 Whipped cream products con taining flavoring or sweetening. The unqualified name ‘‘whipped cream’’ should not be applied to any product other than one made by whip ping 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 fla vored and/or sweetened whipped cream, and should be so identified. Subpart B—Requirements for Spe cific Standardized Milk and Cream § 131.110 Milk. (a) Description. Milk is the lacteal se cretion, practically free from colos trum, obtained by the complete milk ing of one or more healthy cows. Milk that is in final package form for bev erage use shall have been pasteurized or ultrapasteurized, and shall contain not less than 81⁄4 percent milk solids VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00391 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B