cfr_sections
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:5.0.1.1.7.0.1.1 | 21 | Food and Drugs | I | D | 317 | PART 317—QUALIFYING PATHOGENS | § 317.1 [Reserved] | FDA | |||||||
| 21:21:5.0.1.1.7.0.1.2 | 21 | Food and Drugs | I | D | 317 | PART 317—QUALIFYING PATHOGENS | § 317.2 List of qualifying pathogens that have the potential to pose a serious threat to public health. | FDA | The term “qualifying pathogen” in section 505E(f) of the Federal Food, Drug, and Cosmetic Act is defined to mean any of the following: (a) Acinetobacter species. (b) Aspergillus species. (c) Burkholderia cepacia complex. (d) Campylobacter species. (e) Candida species. (f) Clostridium difficile. (g) Coccidioides species. (h) Cryptococcus species. (i) Enterobacteriaceae. (j) Enterococcus species. (k) Helicobacter pylori. (l) Mycobacterium tuberculosis complex. (m) Neisseria gonorrhoeae. (n) Neisseria meningitidis. (o) Non-tuberculous mycobacteria species. (p) Pseudomonas species. (q) Staphylococcus aureus. (r) Streptococcus agalactiae. (s) Streptococcus pneumoniae. (t) Streptococcus pyogenes. (u) Vibrio cholerae. | ||||||
| 9:9:2.0.2.1.18.1.7.1 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | § 317.1 Labels required; supervision by Program employee. | FSIS | (a) When, in an official establishment, any inspected and passed product is placed in any receptacle or covering constituting an immediate container, there shall be affixed to such container a label as described in § 317.2 except that the following do not have to bear such a label. (1) Wrappings of dressed carcasses and primal parts in an unprocessed state, bearing the official inspection legend, if such wrappings are intended solely to protect the product against soiling or excessive drying during transportation or storage, and the wrappings bear no information except company brand names, trade marks, or code numbers which do not include any information required by § 317.2; (2) Uncolored transparent coverings, such as cellophane, which bear no written, printed, or graphic matter and which enclose any unpackaged or packaged product bearing all markings required by part 316 of this subchapter which are clearly legible through such coverings; (3) Animal and transparent artificial casings bearing only the markings required by part 316 of this subchapter; (4) Stockinettes used as “operative devices”, such as those applied to cured meats in preparation for smoking, whether or not such stockinettes are removed following completion of the operations for which they were applied; (5) Containers such as boil-in bags, trays of frozen dinners, and pie pans which bear no information except company brand names, trademarks, code numbers, directions for preparation and serving suggestions, and which are enclosed in a consumer size container that bears a label as described in § 317.2; (6) Containers of products passed for cooking or refrigeration and moved from an official establishment under § 311.1 of this subchapter. (b) Folders and similar coverings made of paper or similar materials, whether or not they completely enclose the product and which bear any written, printed, or graphic matter, shall bear all features required on a label for an immediate container. (c) No covering or other container which bears or is to be… | ||||
| 9:9:2.0.2.1.18.1.7.10 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | § 317.11 Labeling, filling of containers, handling of labeled products to be only in compliance with regulations. | FSIS | (a) No person shall in any official establishment apply or affix, or cause to be applied or affixed, any label to any product prepared or received in such establishment, or to any container thereof, or fill any container at such an establishment, except in compliance with the regulations in this subchapter. (b) No covering or other container shall be filled, in whole or in part, at any official establishment with any product unless it has been inspected and passed in compliance with the regulations in this subchapter, is not adulterated, and is strictly in accordance with the statements on the label, and such filling is done under the supervision of a Program employee. (c) No person shall remove, or cause to be removed from an official establishment any product bearing a label unless such label is in compliance with the regulations in this subchapter, or any product not bearing a label required by such regulations. | ||||
| 9:9:2.0.2.1.18.1.7.11 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | § 317.12 Relabeling products; requirements. | FSIS | When it is claimed by an official establishment that any of its products which bore labels bearing official marks has been transported to a location other than an official establishment, and it is desired to relabel the product because the labels have become mutilated or otherwise damaged, a request for relabeling the product shall be sent to the Administrator, accompanied with a statement of the reasons therefor. Labeling material intended for relabeling inspected and passed product shall not be transported from an official establishment until permission has been received from the Administrator. The relabeling of inspected and passed product with labels bearing any official marks shall be done under the supervision of a Program inspector. The official establishment shall reimburse the Program, in accordance with the regulations of the Department, for any cost involved in supervising the relabeling of such product. | ||||
| 9:9:2.0.2.1.18.1.7.12 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | § 317.13 Storage and distribution of labels and containers bearing official marks. | FSIS | Labels, wrappers, and containers bearing any official marks, with or without the establishment number, may be transported from one official establishment to any other official establishment provided such shipments are made with the prior authorization of the inspector in charge at point of origin, who will notify the inspector in charge at destination concerning the date of shipment, quantity, and type of labeling material involved. No such material shall be used at the establishment to which it is shipped unless such use conforms with the requirements of this subchapter. | ||||
| 9:9:2.0.2.1.18.1.7.13 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | §§ 317.14-317.15 [Reserved] | FSIS | |||||
| 9:9:2.0.2.1.18.1.7.14 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | § 317.16 Labeling and containers of custom prepared products. | FSIS | [37 FR 4071, Feb. 26, 1972] | Products that are custom prepared under § 303.1(a)(2) of this subchapter must be packaged immediately after preparation and must be labeled (in lieu of information otherwise required by this part 317) with the words “Not For Sale” in lettering not less than three-eighth inch in height. Such exempted custom prepared products or their containers may bear additional labeling provided such labeling is not false or misleading. | |||
| 9:9:2.0.2.1.18.1.7.15 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | § 317.17 Interpretation and statement of labeling policy for cured products; special labeling requirements concerning nitrate and nitrite. | FSIS | [37 FR 16863, Aug. 22, 1972, as amended at 44 FR 48961, Aug. 21, 1979] | (a) With respect to sections 1(n) (7), (9), and (12) of the Act and § 317.2, any substance mixed with another substance to cure a product must be identified in the ingredients statement on the label of such product. For example, curing mixtures composed of such ingredients as water, salt, sugar, sodium phosphate, sodium nitrate, and sodium nitrite or other permitted substances which are added to any product, must be identified on the label of the product by listing each such ingredient in accordance with the provisions of § 317.2. (b) Any product, such as bacon and pepperoni, which is required to be labeled by a common or usual name or descriptive name in accordance with § 317.2(c)(1) and to which nitrate or nitrite is permitted or required to be added may be prepared without nitrate or nitrite and labeled with such common or usual name or descriptive name when immediately preceded with the term “Uncured” as part of the product name in the same size and style of lettering as the product name, provided that the product is found by the Administrator to be similar in size, flavor, consistency, and general appearance to such product as commonly prepared with nitrate or nitrite, or both. (c)(1) Products described in paragraph (b) of this section or § 319.2 of this subchapter, which contain no nitrate or nitrite shall bear the statement “No Nitrate or Nitrite Added.” This statement shall be adjacent to the product name in lettering of easily readable style and at least one-half the size of the product name. (2) Products described in paragraph (b) of this section and § 319.2 of this subchapter shall bear, adjacent to the product name in lettering of easily readable style and at least one-half the size of the product name, the statement “Not Preserved—Keep Refrigerated Below 40 °F. At All Times” unless they have been thermally processed to F o 3 or more; they have been fermented or pickled to pH of 4.6 or less; or they have been dried to a water activity of 0.92 or less. (3) Products described in paragraph (b) of th… | |||
| 9:9:2.0.2.1.18.1.7.16 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | §§ 317.18-317.23 [Reserved] | FSIS | |||||
| 9:9:2.0.2.1.18.1.7.17 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | § 317.24 Packaging materials. | FSIS | [49 FR 2235, Jan. 19, 1984. Redesignated at 55 FR 49833, Nov. 30, 1990] | (a) Edible products may not be packaged in a container which is composed in whole or in part of any poisonous or deleterious substances which may render the contents adulterated or injurious to health. All packaging materials must be safe for their intended use within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as amended (FFDCA). (b) Packaging materials entering the official establishment must be accompanied or covered by a guaranty, or statement of assurance, from the packaging supplier under whose brand name and firm name the material is marketed to the official establishment. The guaranty shall state that the material's intended use complies with the FFDCA and all applicable food additive regulations. The guaranty must identify the material, e.g., by the distinguishing brand name or code designation appearing on the packaging material shipping container; must specify the applicable conditions of use, including temperature limits and any other pertinent limits specified under the FFDCA and food additive regulations; and must be signed by an authorized official of the supplying firm. The guaranty may be limited to a specific shipment of an article, in which case it may be part of or attached to the invoice covering such shipment, or it may be general and continuing, in which case, in its application to any article or other shipment of an article, it shall be considered to have been given at the date such article was shipped by the person who gives the guaranty. Guaranties consistent with the Food and Drug Administration's regulations regarding such guaranties (21 CFR 7.12 and 7.13) will be acceptable. The management of the establishment must maintain a file containing guaranties for all food contact packaging materials in the establishment. The file shall be made available to Program inspectors or other Department officials upon request. While in the official establishment, the identity of all packaging materials must be traceable to the applicable guaranty. (c) The guaranty by the… | |||
| 9:9:2.0.2.1.18.1.7.2 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | § 317.2 Labels: definition; required features. | FSIS | [35 FR 15580, Oct. 3, 1970] | (a) A label within the meaning of this part shall mean a display of any printing, lithographing, embossing, stickers, seals, or other written, printed, or graphic matter upon the immediate container (not including package liners) of any product. (b) Any word, statement, or other information required by this part to appear on the label must be prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In order to meet this requirement, such information must appear on the principal display panel except as otherwise permitted in this part. Except as provided in § 317.7, all words, statements, and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of products distributed solely in Puerto Rico, Spanish may be substituted for English for all printed matter except the USDA inspection legend. (c) Labels of all products shall show the following information on the principal display panel (except as otherwise permitted in this part), in accordance with the requirements of this part or, if applicable, part 319 of this subchapter: (1) The name of the product, which in the case of a product which purports to be or is represented as a product for which a definition and standard of identity or composition is prescribed in part 319 of this subchapter, shall be the name of the food specified in the standard, and in the case of any other product shall be the common or usual name of the food, if any there be, and if there is none, a truthful descriptive designation, as prescribed in paragraph (e) of this section; (2) If the product is fabricated from two or more ingredients, the word “ingredients” followed by a list of the ingredients as prescribed in paragraph (f) of this section; (3) The… | |||
| 9:9:2.0.2.1.18.1.7.3 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | § 317.3 Approval of abbreviations of marks of inspection; preparation of marking devices bearing inspection legend without advance approval prohibited; exception. | FSIS | [35 FR 15580, Oct. 3, 1970, as amended at 50 FR 21422, May 24, 1985] | (a) The Administrator may approve and authorize the use of abbreviations of marks of inspection under the regulations in this subchapter. Such abbreviations shall have the same force and effect as the respective marks for which they are authorized abbreviations. (b) Except for the purposes of preparing and submitting a sample or samples of the same to the Administrator for approval, no brand manufacturer, printer, or other person shall cast, print, lithograph, or otherwise make any marking device containing any official mark or simulation thereof, or any label bearing any such mark or simulation, without the written authority therefor of the Administrator. However, when any such sample label, or other marking device, is approved by the Administrator, additional supplies of the approved label, or marking device, may be made for use in accordance with the regulations in this subchapter, without further approval by the Administrator. The provisions of this paragraph apply only to labels, or other marking devices, bearing or containing an official inspection legend shown in § 312.2(b), § 312.3(a) (only the legend appropriate for horse meat food products) or § 312.3(b) (only the legend appropriate for other (nonhorse) equine meat food products), or any abbreviations, copy or representation thereof. (c) No brand manufacturer or other person shall cast or otherwise make, without an official certificate issued in quadruplicate by a Program employee, a brand or other marking device containing an official inspection legend, or simulation thereof, shown in § 312.2(a), § 312.3(a) (only the legend appropriate for horse carcasses and parts of horse carcasses), § 312.3(b) (only the legend appropriate for other equine (nonhorse) carcasses and parts of other (nonhorse) equine carcasses) or § 312.7(a). (1) The certificate is a Food Safety and Inspection Service form for signature by a Program employee and the official establishment ordering the brand or other marking device, bearing a certificate serial number and a letterhead … | |||
| 9:9:2.0.2.1.18.1.7.4 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | §§ 317.4-317.5 [Reserved] | FSIS | |||||
| 9:9:2.0.2.1.18.1.7.5 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | § 317.6 Approved labels to be used only on products to which they are applicable. | FSIS | Labels shall be used only on products for which they are approved, and only if they have been approved for such products in accordance with § 317.3: Provided, That existing stocks of labels approved prior to the effective date of this section and the quantity of which has been identified to the circuit supervisor as being in storage on said date at the official establishment or other identified warehouse for the account of the operator of the official establishment may be used until such stocks are exhausted, but not later than 1 year after the effective date of this section unless such labels conform to all the requirements of this part and part 319 of this subchapter. The Administrator may upon the show of good cause grant individual extension of time as he deems necessary. | ||||
| 9:9:2.0.2.1.18.1.7.6 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | § 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations. | FSIS | Labels to be affixed to packages of products for foreign commerce may be printed in a foreign language and may show the statement of the quantity of contents in accordance with the usage of the country to which exported and other deviations from the form of labeling required under this part may be approved for such product by the Administrator in specific cases: Provided, (a) That the proposed labeling accords to the specifications of the foreign purchaser, (b) That it is not in conflict with the laws of the country to which the product is intended for export, and (c) That the outside container is labeled to show that it is intended for export; but if such product is sold or offered for sale in domestic commerce, all the requirements of this subchapter apply. The inspection legend and the establishment number shall in all cases appear in English but in addition, may appear literally translated in a foreign language. | ||||
| 9:9:2.0.2.1.18.1.7.7 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | § 317.8 False or misleading labeling or practices generally; specific prohibitions and requirements for labels and containers. | FSIS | [35 FR 15580, Oct. 3, 1970] | (a) No product or any of its wrappers, packaging, or other containers shall bear any false or misleading marking, label, or other labeling and no statement, word, picture, design, or device which conveys any false impression or gives any false indication of origin or quality or is otherwise false or misleading shall appear in any marking or other labeling. No product shall be wholly or partly enclosed in any wrapper, packaging, or other container that is so made, formed, or filled as to be misleading. (b) The labels and containers of product shall comply with the following provisions, as applicable: (1) Establishments may only use statements, words, pictures, designs, or devices on the label having geographical significance with reference to a locality other than where the animal from which the product was derived was born, raised, slaughtered, and processed if the statements, words, pictures, designs, or devices are qualified by the word “style,” “type,” or “brand,” as the case may be, in the same size and style of lettering as in the geographical statement, word, picture, design, or device, and accompanied with a prominent qualifying statement identifying the country, State, Territory, or locality, using terms appropriate to effect the qualification. When the word “style” or “type” is used, there must be a recognized style or type of product identified with and peculiar to the area represented by the geographical statement, word, picture, design, or device and the product must possess the characteristics of such style or type, and the word “brand” shall not be used in such a way as to be false or misleading: Provided, That a geographical statement, word, picture, design, or device which has come into general usage as a trade name and which has been approved by the Administrator as being a generic statement, word, picture, design, or device may be used without the qualifications provided for in this paragraph. The terms “frankfurter,” “vienna,” “bologna,” “lebanon bologna,” “braunschweiger,” “thuringer,” “geno… | |||
| 9:9:2.0.2.1.18.1.7.8 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | § 317.9 Labeling of equine products. | FSIS | The immediate containers of any equine products shall be labeled to show the kinds of animals from which derived when the products are sold, transported, offered for sale or transportation or received for transportation in commerce. | ||||
| 9:9:2.0.2.1.18.1.7.9 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | A | Subpart A—General | § 317.10 Reuse of official inspection marks; reuse of containers bearing official marks, labels, etc. | FSIS | (a) No official inspection legend or other official mark which has been previously used shall be used again for the identification of any product, except as provided for in paragraph (b) of this section. (b) All stencils, marks, labels, or other labeling on previously used containers, whether relating to any product or otherwise, shall be removed or obliterated before such containers are used for any product, unless such labeling correctly indicates the product to be packed therein and such containers are refilled under the supervision of a Program employee. | ||||
| 9:9:2.0.2.1.18.2.7.1 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.300 Nutrition labeling of meat and meat food products. | FSIS | [75 FR 82164, Dec. 29, 2010] | (a) Nutrition labeling must be provided for all meat and meat food products intended for human consumption and offered for sale, except single-ingredient, raw meat products that are not ground or chopped meat products described in § 317.301 and are not major cuts of single-ingredient, raw meat products identified in § 317.344, unless the product is exempted under § 317.400 . Nutrition labeling must be provided for the major cuts of single-ingredient, raw meat products identified in § 317.344, either in accordance with the provisions of § 317.309 for nutrition labels, or in accordance with the provisions of § 317.345 for point-of-purchase materials, except as exempted under § 317.400. For all other products for which nutrition labeling is required, including ground or chopped meat products described in § 317.301, nutrition labeling must be provided in accordance with the provisions of § 317.309, except as exempted under § 317.400. (b) Nutrition labeling may be provided for single-ingredient, raw meat products that are not ground or chopped meat products described in § 317.301 and that are not major cuts of single-ingredient, raw meat products identified in § 317.344, either in accordance with the provisions of § 317.309 for nutrition labels, or in accordance with the provisions of § 317.345 for point-of-purchase materials. | |||
| 9:9:2.0.2.1.18.2.7.10 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | §§ 317.314-317.343 [Reserved] | FSIS | |||||
| 9:9:2.0.2.1.18.2.7.11 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.344 Identification of major cuts of meat products. | FSIS | [58 FR 664, Jan. 6, 1993, as amended at 59 FR 45196, Sept. 1, 1994; 75 FR 82165, Dec. 29, 2010] | The major cuts of single-ingredient, raw meat products are: Beef chuck blade roast, beef loin top loin steak, beef rib roast large end, beef round eye round steak, beef round top round steak, beef round tip roast, beef chuck arm pot roast, beef loin sirloin steak, beef round bottom round steak, beef brisket (whole, flat half, or point half), beef rib steak small end, beef loin tenderloin steak, pork loin chop, pork loin country style ribs, pork loin top loin chop boneless, pork loin rib chop, pork spareribs, pork loin tenderloin, pork loin sirloin roast, pork shoulder blade steak, pork loin top roast boneless, lamb shank, lamb shoulder arm chop, lamb shoulder blade chop, lamb rib roast, lamb loin chop, lamb leg (whole, sirloin half, or shank half), veal shoulder arm steak, veal shoulder blade steak, veal rib roast, veal loin chop, and veal cutlets. | |||
| 9:9:2.0.2.1.18.2.7.12 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.345 Nutrition labeling of single-ingredient, raw meat products that are not ground or chopped products described in § 317.301. | FSIS | [58 FR 664, Jan. 6, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 60 FR 189, Jan. 3, 1995; 75 FR 82165, Dec. 29, 2010] | (a)(1) Nutrition information on the major cuts of single-ingredient, raw meat products identified in § 317.344, including those that have been previously frozen, is required, either on their label or at their point-of-purchase, unless exempted under § 317.400. If nutrition information is presented on the label, it must be provided in accordance with § 317.309. If nutrition information is presented at the point-of-purchase, it must be provided in accordance with the provisions of this section. (2) Nutrition information on single-ingredient, raw meat products that are not ground or chopped meat products described in § 317.301 and are not major cuts of single-ingredient, raw meat products identified in § 317.344, including those that have been previously frozen, may be provided at their point-of-purchase in accordance with the provisions of this section or on their label, in accordance with the provisions of § 317.309. (3) A retailer may provide nutrition information at the point-of-purchase by various methods, such as by posting a sign or by making the information readily available in brochures, notebooks, or leaflet form in close proximity to the food. The nutrition labeling information may also be supplemented by a video, live demonstration, or other media. If a nutrition claim is made on point-of-purchase materials, all of the format and content requirements of § 317.309 apply. However, if only nutrition information—and not a nutrition claim—is supplied on point-of-purchase materials, the requirements of § 317.309 apply, provided, however: (i) The listing of percent of Daily Value for the nutrients (except vitamins and minerals specified in § 317.309(c)(8)) and footnote required by § 317.309(d)(9) may be omitted; and (ii) The point-of-purchase materials are not subject to any of the format requirements. (b) [Reserved] (c) For the point-of-purchase materials, the declaration of nutrition information may be presented in a simplified format as specified in § 317.309(f). (d) The nutrition label data for produ… | |||
| 9:9:2.0.2.1.18.2.7.13 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | §§ 317.346-317.353 [Reserved] | FSIS | |||||
| 9:9:2.0.2.1.18.2.7.14 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.354 Nutrient content claims for “good source,” “high,” and “more.” | FSIS | [60 FR 189, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004] | (a) General requirements. Except as provided in paragraph (e) of this section, a claim about the level of a nutrient in a product in relation to the Reference Daily Intake (RDI) or Daily Reference Value (DRV) established for that nutrient (excluding total carbohydrate) in § 317.309(c), may only be made on the label or in labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term; (2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317.309. (b) “ High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l), and main-dish products as defined in § 317.313(m) provided that the product contains 20 percent or more of the RDI or the DRV per reference amount customarily consumed. (2) The terms defined in paragraph (b)(1) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l), and main-dish product as defined in § 317.313(m) provided that: (i) The product contains a food that meets the definition of “high” in paragraph (b)(1) of this section; and (ii) The label or labeling clearly identifies the food that is the subject of the claim (e.g., “the serving of broccoli in this meal is high in vitamin C”). (c) “ Good Source” claims. (1) The terms “good source,” “contains,” or “provides” may be used on the label or in labeling of products, except meal-type products as described in § 317.313(l), and main-dish products as defined in § 317.313(m) provided that the product contains 10 to 19 percent of the RDI or the DRV per reference amount customarily consumed. (2) The terms defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product as defined in § 317.313(l), and main-dish product as defined in § … | |||
| 9:9:2.0.2.1.18.2.7.15 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.355 [Reserved] | FSIS | |||||
| 9:9:2.0.2.1.18.2.7.16 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.356 Nutrient content claims for “light” or “lite.” | FSIS | [60 FR 189, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004] | (a) General requirements. A claim using the terms “light” or “lite” to describe a product may only be made on the label or in labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term; (2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317.309. (b) “Light” claims. The terms “light” or “lite” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), without further qualification, provided that: (1) If the product derives 50 percent or more of its calories from fat, its fat content is reduced by 50 percent or more per reference amount customarily consumed compared to an appropriate reference product as described in § 317.313(j)(1); or (2) If the product derives less than 50 percent of its calories from fat: (i) The number of calories is reduced by at least one-third (33 1/3 percent) per reference amount customarily consumed compared to an appropriate reference product as described in § 317.313(j)(1); or (ii) Its fat content is reduced by 50 percent or more per reference amount customarily consumed compared to the appropriate reference product as described in § 317.313(j)(1); and (3) As required in § 317.313(j)(2) for relative claims: (i) The identity of the reference product and the percent (or fraction) that the calories and the fat were reduced are declared in immediate proximity to the most prominent such claim (e.g., “ 1/3 fewer calories and 50 percent less fat than the market leader”); and (ii) Quantitative information comparing the level of calories and fat content in the product per labeled serving size with that of the reference product that it replaces is declared adjacent to the most prominent claim or to the nutrition information (e.g., “lite ‘this product’—200 calories, 4 gram… | |||
| 9:9:2.0.2.1.18.2.7.17 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | §§ 317.357-317.359 [Reserved] | FSIS | |||||
| 9:9:2.0.2.1.18.2.7.18 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.360 Nutrient content claims for calorie content. | FSIS | [60 FR 191, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004] | (a) General requirements. A claim about the calorie or sugar content of a product may only be made on the label or in labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term; (2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317.309. (b) Calorie content claims. (1) The terms “calorie free,” “free of calories,” “no calories,” “zero calories,” “without calories,” “trivial source of calories,” “negligible source of calories,” or “dietarily insignificant source of calories” may be used on the label or in labeling of products, provided that: (i) The product contains less than 5 calories per reference amount customarily consumed and per labeled serving size; and (ii) If the product meets this condition without the benefit of special processing, alteration, formulation, or reformulation to lower the caloric content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches. (2) The terms “low calorie,” “few calories,” “contains a small amount of calories,” “low source of calories,” or “low in calories” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that: (i)(A) The product has a reference amount customarily consumed greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and does not provide more than 40 calories per reference amount customarily consumed; or (B) The product has a reference amount customarily consumed of 30 g or less or 2 tbsp or less and does not provide more than 40 calories per reference amount customarily consumed and per 50 g (for dehydrated products that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in § 317.… | |||
| 9:9:2.0.2.1.18.2.7.19 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.361 Nutrient content claims for the sodium content. | FSIS | [60 FR 192, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004] | (a) General requirements. A claim about the level of sodium in a product may only be made on the label or in labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term; (2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317.309. (b) Sodium content claims. (1) The terms “sodium free,” “free of sodium,” “no sodium,” “zero sodium,” “without sodium,” “trivial source of sodium,” “negligible source of sodium,” or “dietarily insignificant source of sodium” may be used on the label or in labeling of products, provided that: (i) The product contains less than 5 milligrams (mg) of sodium per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product or a main-dish product, less than 5 mg of sodium per labeled serving size; (ii) The product contains no ingredient that is sodium chloride or is generally understood by consumers to contain sodium unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of sodium,” “adds a negligible amount of sodium” or “adds a dietarily insignificant amount of sodium”; and (iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches. (2) The terms “very low sodium” or “very low in sodium” may be used on the label or in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that: (i)(A) The product has a reference amount customarily consumed greater than 30 grams (g) or greater than 2 tablespoons … | |||
| 9:9:2.0.2.1.18.2.7.2 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.301 Required nutrition labeling of ground or chopped meat products. | FSIS | [75 FR 82165, Dec. 29, 2010] | (a) Nutrition labels must be provided for all ground or chopped products (livestock species) and hamburger with or without added seasonings (including, but not limited to, ground beef, ground beef patties, ground sirloin, ground pork, and ground lamb) that are intended for human consumption and offered for sale, in accordance with the provisions of § 317.309, except as exempted under § 317.400. (b) [Reserved] | |||
| 9:9:2.0.2.1.18.2.7.20 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. | FSIS | [60 FR 193, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004; 75 FR 82165, Dec. 29, 2010] | (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be made on the label or in labeling of products if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term; (2) The claim is made in accordance with the general requirements for nutrient content claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317.309. (b) Fat content claims. (1) The terms “fat free,” “free of fat,” “no fat,” “zero fat,” “without fat,” “nonfat,” “trivial source of fat,” “negligible source of fat,” or “dietarily insignificant source of fat” may be used on the label or in labeling of products, provided that: (i) The product contains less than 0.5 gram (g) of fat per reference amount customarily consumed and per labeled serving size or, in the case of a meal-type product or a main-dish product, less than 0.5 g of fat per labeled serving size; (ii) The product contains no added ingredient that is a fat or is generally understood by consumers to contain fat unless the listing of the ingredient in the ingredients statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: “Adds a trivial amount of fat,” “adds a negligible amount of fat,” or “adds a dietarily insignificant amount of fat”; and (iii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the fat content, it is labeled to clearly refer to all products of its type and not merely to the particular brand to which the label attaches. (2) The terms “low fat,” “low in fat,” “contains a small amount of fat,” “low source of fat,” or “little fat” may be used on the label and in labeling of products, except meal-type products as defined in § 317.313(l) and main-dish products as defined in § 317.313(m), provided that: (i)(A) The product has a reference amount customarily consumed greater than 30 g or gr… | |||
| 9:9:2.0.2.1.18.2.7.21 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.363 Nutrient content claims for “healthy.” | FSIS | [59 FR 24228, May 10, 1994, as amended at 60 FR 196, Jan. 3, 1995; 63 FR 7281, Feb. 13, 1998; 64 FR 72492, Dec. 28, 1999; 68 FR 463, Jan. 6, 2003; 69 FR 58802, Oct. 1, 2004; 71 FR 1686, Jan. 11, 2006] | (a) The term “healthy,” or any other derivative of the term “health,” may be used on the labeling of any meat or meat food product, provided that the product is labeled in accordance with § 317.309 and § 317.313. (b)(1) The product shall meet the requirements for “low fat” and “low saturated fat,” as defined in § 317.362, except that single-ingredient, raw products may meet the total fat and saturated fat criteria for “extra lean” in § 317.362. (2) The product shall not contain more than 60 milligrams (mg) of cholesterol per reference amount customarily consumed, per labeled serving size, and, only for foods with reference amounts customarily consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per 50 g, and, for dehydrated products that must be reconstituted with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients, the per-50-g criterion refers to the prepared form, except that: (i) A main-dish product, as defined in § 317.313(m), and a meal-type product, as defined in § 317.313(l), and including meal-type products that weigh more than 12 ounces (oz) per serving (container), shall not contain more than 90 mg of cholesterol per labeled serving size; and (ii) Single-ingredient, raw products may meet the cholesterol criterion for “extra lean”in § 317.362. (3) The product shall not contain more than 480 mg of sodium per reference amount customarily consumed, per labeled serving size, and, only for foods with reference amounts customarily consumed of 30 g or less or 2 tbsp or less, per 50 g, and, for dehydrated products that must be reconstituted with water or a diluent containing an insignificant amount, as defined in § 317.309(f)(1), of all nutrients, the per-50-g criterion refers to the prepared form, except that: (i) A main-dish product, as defined in § 317.313(m), and a meal-type product, as defined in § 317.313(l), and including meal-type products that weigh more than 12 oz per serving (container), shall not contain more than 600 mg of sodium… | |||
| 9:9:2.0.2.1.18.2.7.22 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | §§ 317.364-317.368 [Reserved] | FSIS | |||||
| 9:9:2.0.2.1.18.2.7.23 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.369 Labeling applications for nutrient content claims. | FSIS | [58 FR 664, Jan. 6, 1993, as amended at 59 FR 45196, Sept. 1, 1994; 60 FR 196, Jan. 3, 1995] | (a) This section pertains to labeling applications for claims, express or implied, that characterize the level of any nutrient required to be on the label or in labeling of product by this subpart. (b) Labeling applications included in this section are: (1) Labeling applications for a new (heretofore unauthorized) nutrient content claim, (2) Labeling applications for a synonymous term (i.e., one that is consistent with a term defined by regulation) for characterizing the level of a nutrient, and (3) Labeling applications for the use of an implied claim in a brand name. (c) Labeling applications and supporting documentation to be filed under this section shall be submitted in quadruplicate, except that the supporting documentation may be submitted on a computer disc copy. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The labeling application shall state the applicant's post office address. (d) Pertinent information will be considered as part of an application on the basis of specific reference to such information submitted to and retained in the files of the Food Safety and Inspection Service. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized (with the understanding that such information may in whole or part be subject to release to the public) in a written statement signed by the person who submitted it. Any reference to published information should be accompanied by reprints or photostatic copies of such references. (e) If nonclinical laboratory studies accompany a labeling application, the applicant shall include, with respect to each nonclinical study included with the application, either a statement that the study has been, or will be, conducted in compliance with the good laboratory practice regulations as set forth in part 58 of chapter 1, title 21, or, if any such study was not conducted in compli… | |||
| 9:9:2.0.2.1.18.2.7.24 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | §§ 317.370-317.379 [Reserved] | FSIS | |||||
| 9:9:2.0.2.1.18.2.7.25 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.380 Label statements relating to usefulness in reducing or maintaining body weight. | FSIS | [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 58 FR 66075, Dec. 17, 1993; 60 FR 196, Jan. 3, 1995] | (a) General requirements. Any product that purports to be or is represented for special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition labeling in conformity with § 317.309 of this subpart, unless exempt under that section, and (2) A conspicuous statement of the basis upon which the product claims to be of special dietary usefulness. (b) Nonnutritive ingredients. (1) Any product subject to paragraph (a) of this section that achieves its special dietary usefulness by use of a nonnutritive ingredient (i.e., one not utilized in normal metabolism) shall bear on its label a statement that it contains a nonnutritive ingredient and the percentage by weight of the nonnutritive ingredient. (2) A special dietary product may contain a nonnutritive sweetener or other ingredient only if the ingredient is safe for use in the product under the applicable law and regulations of this chapter. Any product that achieves its special dietary usefulness in reducing or maintaining body weight through the use of a nonnutritive sweetener shall bear on its label the statement required by paragraph (b)(1) of this section, but need not state the percentage by weight of the nonnutritive sweetener. If a nutritive sweetener(s) as well as nonnutritive sweetener(s) is added, the statement shall indicate the presence of both types of sweetener; e.g., “Sweetened with nutritive sweetener(s) and nonnutritive sweetener(s).” (c) “Low calorie” foods. A product purporting to be “low calorie” must comply with the criteria set forth for such foods in § 317.360. (d) “Reduced calorie” foods and other comparative claims. A product purporting to be “reduced calorie” or otherwise containing fewer calories than a reference food must comply with the criteria set forth for such foods in § 317.360(b) (4) and (5). (e) “Label terms suggesting usefulness as low calorie or reduced calorie foods”. (1) Except as provided in paragraphs (e)(2) and (e)(3) of this section, a product may be labeled with terms such as “die… | |||
| 9:9:2.0.2.1.18.2.7.26 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | §§ 317.381-317.399 [Reserved] | FSIS | |||||
| 9:9:2.0.2.1.18.2.7.27 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.400 Exemption from nutrition labeling. | FSIS | [58 FR 664, Jan. 6, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 196, Jan. 3, 1995; 75 FR 82165, Dec. 29, 2010] | (a) The following meat or meat food products are exempt from nutrition labeling: (1) Food products produced by small businesses, other than the major cuts of single-ingredient, raw meat products identified in § 317.344 produced by small businesses, provided that the labels for these products bear no nutrition claims or nutrition information, and ground or chopped products described in § 317.301 produced by small businesses that bear a statement of the lean percentage and fat percentage on the label or in labeling in accordance with § 317.362(f), provided that labels or labeling for these products bear no other nutrition claims or nutrition information, (i) A food product, for the purposes of the small business exemption, is defined as a formulation, not including distinct flavors which do not significantly alter the nutritional profile, sold in any size package in commerce. (ii) For purposes of this paragraph, a small business is any single-plant facility, including a single retail store, or multi-plant company/firm, including a multi-retail store operation, that employs 500 or fewer people and produces no more than the following amounts of pounds of the product qualifying the firm for exemption from this subpart: (A) During the first year of implementation of nutrition labeling, from July 1994 to July 1995, 250,000 pounds or less, (B) During the second year of implementation of nutrition labeling, from July 1995 to July 1996, 175,000 pounds or less, and (C) During the third year of implementation and subsequent years thereafter, 100,000 pounds or less. (iii) For purposes of this paragraph, calculation of the amount of pounds shall be based on the most recent 2-year average of business activity. Where firms have been in business less than 2 years or where products have been produced for less than 2 years, reasonable estimates must indicate that the annual pounds produced will not exceed the amounts specified. (2) Products intended for further processing, provided that the labels for these products bear no… | |||
| 9:9:2.0.2.1.18.2.7.3 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.302 Location of nutrition information. | FSIS | [58 FR 664, Jan. 6, 1993, as amended at 59 FR 40213, Aug. 8, 1994; 60 FR 176, Jan. 3, 1995] | (a) Nutrition information on a label of a packaged meat or meat food product shall appear on the label's principal display panel or on the information panel, except as provided in paragraphs (b) and (c) of this section. (b) Nutrition information for gift packs may be shown at a location other than on the product label, provided that the labels for these products bear no nutrition claim. In lieu of on the product label, nutrition information may be provided by alternate means such as product label inserts. (c) Meat or meat food products in packages that have a total surface area available to bear labeling greater than 40 square inches but whose principal display panel and information panel do not provide sufficient space to accommodate all required information may use any alternate panel that can be readily seen by consumers for the nutrition information. In determining the sufficiency of available space for the nutrition information, the space needed for vignettes, designs, and other nonmandatory label information on the principal display panel may be considered. | |||
| 9:9:2.0.2.1.18.2.7.4 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | §§ 317.303-317.307 [Reserved] | FSIS | |||||
| 9:9:2.0.2.1.18.2.7.5 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.308 Labeling of meat or meat food products with number of servings. | FSIS | [58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995] | The label of any package of a meat or meat food product that bears a representation as to the number of servings contained in such package shall meet the requirements of § 317.2(h)(10). | |||
| 9:9:2.0.2.1.18.2.7.6 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.309 Nutrition label content. | FSIS | [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993; 58 FR 47627, Sept. 10, 1993; 59 FR 45194, Sept. 1, 1994; 60 FR 176, Jan. 3, 1995; 69 FR 58801, Oct. 1, 2004; 75 FR 82165, Dec. 29, 2010] | (a) All nutrient and food component quantities shall be declared in relation to a serving as defined in this section. (b)(1) The term “serving” or “serving size” means an amount of food customarily consumed per eating occasion by persons 4 years of age or older, which is expressed in a common household measure that is appropriate to the product. When the product is specially formulated or processed for use by infants or by toddlers, a serving or serving size means an amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively. (2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14) of this section and for products that are intended for weight control and are available only through a weight-control or weight-maintenance program, serving size declared on a product label shall be determined from the “Reference Amounts Customarily Consumed Per Eating Occasion—General Food Supply” (Reference Amount(s)) that appear in § 317.312(b) using the procedures described in this paragraph (b). For products that are both intended for weight control and available only through a weight-control program, a manufacturer may determine the serving size that is consistent with the meal plan of the program. Such products must bear a statement, “for sale only through the ______ program” (fill in the blank with the name of the appropriate weight-control program, e.g., Smith's Weight Control), on the principal display panel. However, the Reference Amounts in § 317.312(b) shall be used for purposes of evaluating whether weight-control products that are available only through a weight-control program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be on the basis of the product “as packaged” for all products, except that single-ingredient, raw products that are not ground or chopped meat products described in § 317.301 may be declared on the basis of the product “as consumed”. For single-ingredient, ra… | |||
| 9:9:2.0.2.1.18.2.7.7 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | §§ 317.310-317.311 [Reserved] | FSIS | |||||
| 9:9:2.0.2.1.18.2.7.8 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.312 Reference amounts customarily consumed per eating occasion. | FSIS | [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 186, Jan. 3, 1995] | (a) The general principles followed in arriving at the reference amounts customarily consumed per eating occasion (Reference Amount(s)), as set forth in paragraph (b) of this section, are: (1) The Reference Amounts are calculated for persons 4 years of age or older to reflect the amount of food customarily consumed per eating occasion by persons in this population group. These Reference Amounts are based on data set forth in appropriate national food consumption surveys. (2) The Reference Amounts are calculated for an infant or child under 4 years of age to reflect the amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively. These Reference Amounts are based on data set forth in appropriate national food consumption surveys. Such Reference Amounts are to be used only when the product is specially formulated or processed for use by an infant or by a child under 4 years of age. (3) An appropriate national food consumption survey includes a large sample size representative of the demographic and socioeconomic characteristics of the relevant population group and must be based on consumption data under actual conditions of use. (4) To determine the amount of food customarily consumed per eating occasion, the mean, median, and mode of the consumed amount per eating occasion were considered. (5) When survey data were insufficient, FSIS took various other sources of information on serving sizes of food into consideration. These other sources of information included: (i) Serving sizes used in dietary guidance recommendations or recommended by other authoritative systems or organizations; (ii) Serving sizes recommended in comments; (iii) Serving sizes used by manufacturers and grocers; and (iv) Serving sizes used by other countries. (6) Because they reflect the amount customarily consumed, the Reference Amount and, in turn, the serving size declared on the product label are based on only the edible portion of food, and not bon… | |||
| 9:9:2.0.2.1.18.2.7.9 | 9 | Animals and Animal Products | III | A | 317 | PART 317—LABELING, MARKING DEVICES, AND CONTAINERS | B | Subpart B—Nutrition Labeling | § 317.313 Nutrient content claims; general principles. | FSIS | [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 59 FR 40213, Aug. 8, 1994; 59 FR 45196, Sept. 1, 1994; 60 FR 187, Jan. 3, 1995; 69 FR 58801, Oct. 1, 2004] | (a) This section applies to meat or meat food products that are intended for human consumption and that are offered for sale. (b) A claim which, expressly or by implication, characterizes the level of a nutrient (nutrient content claim) of the type required in nutrition labeling pursuant to § 317.309, may not be made on a label or in labeling of that product unless the claim is made in accordance with the applicable provisions in this subpart. (1) An expressed nutrient content claim is any direct statement about the level (or range) of a nutrient in the product, e.g., “low sodium” or “contains 100 calories.” (2) An implied nutrient content claim is any claim that: (i) Describes the product or an ingredient therein in a manner that suggests that a nutrient is absent or present in a certain amount (e.g., “high in oat bran”); or (ii) Suggests that the product, because of its nutrient content, may be useful in maintaining healthy dietary practices and is made in association with an explicit claim or statement about a nutrient (e.g., “healthy, contains 3 grams (g) of fat”). (3) Except for claims regarding vitamins and minerals described in paragraph (q)(3) of this section, no nutrient content claims may be made on products intended specifically for use by infants and children less than 2 years of age unless the claim is specifically provided for in subpart B of this part. (4) Reasonable variations in the spelling of the terms defined in applicable provisions in this subpart and their synonyms are permitted provided these variations are not misleading (e.g., “hi” or “lo”). (c) Information that is required or permitted by § 317.309 to be declared in nutrition labeling, and that appears as part of the nutrition label, is not a nutrient content claim and is not subject to the requirements of this section. If such information is declared elsewhere on the label or in labeling, it is a nutrient content claim and is subject to the requirements for nutrient content claims. (d) A “substitute” product is one that may be… |
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