161 Part 317—Labeling, Marking Devices, And

Food Safety and Inspection Service, USDA Pt. 317

shall be plainly marked with the the carrier shall remove or obliterate phrase ‘‘For pharmaceutical purposes,’’ such label. ‘‘For organotherapeutic purposes’’ or ‘‘For technical purposes,’’ as appro- [53 FR 28634, July 29, 1988] priate, with no reference to inspection, § 316.15 Marking outside containers of and need not bear other markings oth- inedible grease, etc. erwise required under the regulations in this subchapter. (a) Outside containers of inedible (g) Stencils, box dies, labels, and grease, inedible tallow, or other ined- brands may be used on shipping con- ible animal fat, or mixture of any such tainers of properly labeled products articles, resulting from operations at and on such immediate containers, of any official establishment shall be properly marked products, as tierces, marked conspicuously with the word barrels, drums, boxes, crates, and ‘‘inedible’’ prior to removal from the large-size fiber-board containers, with- point of filling. Containers, such as out approval as provided for in § 317.3 of tierces, barrels, and half barrels shall this subchapter: Provided, That the have both ends painted white with du- stencils, box dies, labels, and brands rable paint, if necessary, to provide a are not false or misleading and are ap- contrasting background, and the word proved by the inspector in charge. The ‘‘inedible’’ shall be marked thereon in official inspection legend for use with letters not less than 2 inches high, such markings shall be approved by the while on tank cars and tank trucks the Administrator as provided for in part letters shall be not less than 4 inches 317 of this subchapter. high. (h) The outside containers of livers (b) Inspected rendered animal fat prepared as described in § 314.10(b), which is intended not to be used for shall be marked as prescribed in human food may also be marked ‘‘in- § 314.10(c) of this subchapter. edible’’ if handled as provided in para- (i) The outside containers of any graph (a) of this section and part 314 of equine product shall be marked to this subchapter. show the kinds of animals from which derived, when the products are sold, § 316.16 Custom prepared products to transported, offered for sale or trans- be marked ‘‘Not for Sale.’’ ported, or received for transportation in commerce. Carcasses and parts therefrom that are prepared on a custom basis under [35 FR 15577, Oct. 3, 1970, as amended at 43 FR § 303.1(a)(2) of this subchapter shall be 29268, July 7, 1978] marked at the time of preparation with the term ‘‘Not for Sale’’ in letters at § 316.14 Marking tank cars and tank trucks used in transportation of ed- least three-eighths inch in height, ex- ible products. cept that such products need not be so marked if in immediate containers Each tank car and each tank truck properly labeled in accordance with the carrying inspected and passed product regulations in § 317.16 of this sub- from an official establishment shall chapter. Ink used for marking such bear a label containing the name of the products must comply with the re- product in accordance with § 317.2 of quirements of § 316.5. this subchapter, the official inspection legend containing the number of the of- [35 FR 15577, Oct. 3, 1970, as amended at 38 FR ficial establishment and the words 29214, Oct. 23, 1973] ‘‘date of loading,’’ followed by a suit- able space in which the date the tank PART 317—LABELING, MARKING car or tank truck is loaded shall be in- DEVICES, AND CONTAINERS serted. The label shall be located conspicuously and shall be printed on ma- Subpart A—General terial of such character and so affixed as to preclude detachment or efface- Sec. ment upon exposure to the weather. 317.1 Labels required; supervision by Pro- Before the car or truck is removed gram employee. from the place where it is unloaded, 317.2 Labels: definition; required features.

161

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00171 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.1 9 CFR Ch. III (1–1–08 Edition)

317.3 Approval of abbreviations of marks of 317.354 Nutrient content claims for ‘‘good inspection; preparation of marking de- source,’’ ‘‘high,’’ and ‘‘more’’. vices bearing inspection legend without 317.355 [Reserved] advance approval prohibited; exception. 317.356 Nutrient content claims for ‘‘light’’ 317.4 Labeling approval. or ‘‘lite’’. 317.5 Generically approved labeling. 317.357–317.359 [Reserved] 317.6 Approved labels to be used only on 317.360 Nutrient content claims for calorie products to which they are applicable. content. 317.7 Products for foreign commerce; print- 317.361 Nutrient content claims for the so- ing labels in foreign language permis- dium content. sible; other deviations. 317.362 Nutrient content claims for fat, 317.8 False or misleading labeling or prac- fatty acids, and cholesterol content. tices generally; specific prohibitions and requirements for labels and containers. 317.363 Nutrient content claims for 317.9 Labeling of equine products. ‘‘healthy’’. 317.10 Reuse of official inspection marks; 317.364–317.368 [Reserved] reuse of containers bearing official 317.369 Labeling applications for nutrient marks, labels, etc. content claims. 317.11 Labeling, filling of containers, han- 317.370–317.379 [Reserved] dling of labeled products to be only in 317.380 Label statements relating to useful- compliance with regulations. ness in reducing or maintaining body 317.12 Relabeling products; requirements. weight. 317.13 Storage and distribution of labels and 317.381–317.399 [Reserved] containers bearing official marks. 317.400 Exemption from nutrition labeling. 317.14–317.15 [Reserved] 317.16 Labeling and containers of custom AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, prepared products. 2.53. 317.17 Interpretation and statement of la- SOURCE: 35 FR 15580, Oct. 3, 1970, unless beling policy for cured products; special otherwise noted. labeling requirements concerning nitrate and nitrite. 317.18 Quantity of contents labeling. Subpart A—General 317.19 Definitions and procedures for determining net weight compliance. § 317.1 Labels required; supervision by 317.20 Scale requirements for accurate Program employee. weights, repairs, adjustments, and re- (a) When, in an official establish- placement after inspection. 317.21 Scales: testing of. ment, any inspected and passed prod- 317.22 Handling of failed product. uct is placed in any receptacle or cov- 317.23 [Reserved] ering constituting an immediate con- 317.24 Packaging materials. tainer, there shall be affixed to such container a label as described in § 317.2 Subpart B—Nutrition Labeling except that the following do not have 317.300 Nutrition labeling of meat or meat to bear such a label. food products. (1) Wrappings of dressed carcasses 317.301 [Reserved] and primal parts in an unprocessed 317.302 Location of nutrition information. state, bearing the official inspection 317.303–317.307 [Reserved] legend, if such wrappings are intended 317.308 Labeling of meat or meat food prod- solely to protect the product against ucts with number of servings. soiling or excessive drying during 317.309 Nutrition label content. transportation or storage, and the 317.310–317.311 [Reserved] 317.312 Reference amounts customarily con- wrappings bear no information except sumed per eating occasion. company brand names, trade marks, or 317.313 Nutrient content claims; general code numbers which do not include any principles. information required by § 317.2; 317.314–317.342 [Reserved] (2) Uncolored transparent coverings, 317.343 Significant participation for vol- such as cellophane, which bear no writ- untary nutrition labeling. ten, printed, or graphic matter and 317.344 Identification of major cuts of meat which enclose any unpackaged or pack- products. 317.345 Guidelines for voluntary nutrition aged product bearing all markings relabeling of single-ingredient, raw prod- quired by part 316 of this subchapter ucts. which are clearly legible through such 317.346–317.353 [Reserved] coverings;

162

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00172 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.2

(3) Animal and transparent artificial customary conditions of purchase and casings bearing only the markings reuse. In order to meet this requirement, quired by part 316 of this subchapter; such information must appear on the (4) Stockinettes used as ‘‘operative principal display panel except as other- devices’’, such as those applied to cured wise permitted in this part. Except as meats in preparation for smoking, provided in § 317.7, all words, state- whether or not such stockinettes are ments, and other information required removed following completion of the by or under authority of the Act to ap- operations for which they were applied; pear on the label or labeling shall ap- (5) Containers such as boil-in bags, pear thereon in the English language: trays of frozen dinners, and pie pans Provided, however, That in the case of which bear no information except com- products distributed solely in Puerto pany brand names, trademarks, code Rico, Spanish may be substituted for numbers, directions for preparation English for all printed matter except and serving suggestions, and which are the USDA inspection legend. enclosed in a consumer size container (c) Labels of all products shall show that bears a label as described in § 317.2; the following information on the prin- (6) Containers of products passed for cipal display panel (except as otherwise cooking or refrigeration and moved permitted in this part), in accordance from an official establishment under with the requirements of this part or, § 311.1 of this subchapter. if applicable, part 319 of this sub- (b) Folders and similar coverings chapter: made of paper or similar materials, (1) The name of the product, which in whether or not they completely enclose the case of a product which purports to the product and which bear any writ- be or is represented as a product for ten, printed, or graphic matter, shall which a definition and standard of bear all features required on a label for identity or composition is prescribed in an immediate container. part 319 of this subchapter, shall be the (c) No covering or other container name of the food specified in the stand- which bears or is to bear a label shall ard, and in the case of any other prod- be filled, in whole or in part, except uct shall be the common or usual name with product which has been inspected of the food, if any there be, and if there and passed in compliance with the reg- is none, a truthful descriptive designa- ulations in this subchapter, which is tion, as prescribed in paragraph (e) of not adulterated and which is strictly in this section; accordance with the statements on the (2) If the product is fabricated from label. No such container shall be filled, two or more ingredients, the word ‘‘in- in whole or in part, and no label shall gredients’’ followed by a list of the in- be affixed thereto, except under super- gredients as prescribed in paragraph (f) vision of a Program employee. of this section; (3) The name and place of business of § 317.2 Labels: definition; required fea- the manufacturer, packer, or dis- tures. tributor for whom the product is pre- (a) A label within the meaning of this pared, as prescribed in paragraph (g) of part shall mean a display of any print- this section; ing, lithographing, embossing, stickers, (4) An accurate statement of the net seals, or other written, printed, or quantity of contents, as prescribed in graphic matter upon the immediate paragraph (h) of this section; container (not including package lin- (5) An official inspection legend and, ers) of any product. except as otherwise provided in para- (b) Any word, statement, or other in- graph (i) of this section, the number of formation required by this part to ap- the official establishment, in the form pear on the label must be prominently required by part 312 of this subchapter; placed thereon with such conspicuous- (6) Any other information required ness (as compared with other words, by the regulations in this part or part statements, designs, or devices, in the 319 of this subchapter. labeling) and in such terms as to (d) The principal display panel shall render it likely to be read and under- be the part of a label that is most like- stood by the ordinary individual under ly to be displayed, presented, shown, or

163

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00173 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.2 9 CFR Ch. III (1–1–08 Edition)

examined under customary conditions product was subjected to such prepara- of display for sale. Where packages tion. The unqualified terms ‘‘meat,’’ bear alternate principal display panels, ‘‘meat byproduct,’’ ‘‘meat food prod- information required to be placed on uct,’’ and terms common to the meat the principal display panel shall be du- industry but not common to consumers plicated on each principal display such as ‘‘picnic,’’ ‘‘butt,’’ ‘‘cala,’’ panel. The principal display panel shall ‘‘square,’’ ‘‘loaf,’’ ‘‘spread,’’ ‘‘delight,’’ be large enough to accommodate all ‘‘roll,’’ ‘‘plate,’’ ‘‘luncheon,’’ and the mandatory label information re- ‘‘daisy’’ shall not be used as names of a quired to be placed thereon by this part product unless accompanied with terms and part 319 of this subchapter with descriptive of the product or with a list clarity and conspicuousness and with- of ingredients, as deemed necessary in out obscuring of such information by any specific case by the Administrator designs or vignettes or crowding. In de- in order to assure that the label will termining the area of the principal dis- not be false or misleading. play panel, exclude tops, bottoms, (f)(1) The list of ingredients shall flanges at tops and bottoms of cans, show the common or usual names of and shoulders and necks of bottles or the ingredients arranged in the de- jars. The principal display panel shall scending order of predominance, except be: as otherwise provided in this para- (1) In the case of a rectangular pack- graph. age, one entire side, the area of which (i) The terms spice, natural flavor, is at least the product of the height natural flavoring, flavor and flavoring times the width of that side. may be used in the following manner: (2) In the case of a cylindrical or nearly cylindrical container: (A) The term ‘‘spice’’ means any aro- (i) An area that is 40 percent of the matic vegetable substance in the product of the height of the container whole, broken, or ground form, with times the circumference of the con- the exceptions of onions, garlic and tainer, or celery, whose primary function in food (ii) A panel, the width of which is is seasoning rather than nutritional one-third of the circumference and the and from which no portion of any vola- height of which is as high as the con- tile oil or other flavoring principle has tainer: Provided, however, That if there been removed. Spices include the spices is immediately to the right or left of listed in 21 CFR 182.10, and 184. such principal display panel, a panel (B) The term ‘‘natural flavor,’’ ‘‘nat- which has a width not greater than 20 ural flavoring,’’ ‘‘flavor’’ or ‘‘fla- percent of the circumference and a voring’’ means the essential oil, oleo- height as high as the container, and resin, essence or extractive, protein hy- which is reserved for information pre- drolysate, distillate, or any product or scribed in paragraphs (c) (2), (3), and roasting, heating or enzymolysis, (5), such panel shall be known as the which contains the flavoring constitu- ‘‘20 percent panel’’ and such informa- ents derived from a spice, fruit or fruit tion may be shown on that panel in juice, vegetable or vegetable juice, edi- lieu of showing it on the principal dis- ble yeast, herb, bark, bud, root, leaf or play panel. any other edible portion of a plant, (3) In the case of a container of any meat, seafood, poultry, eggs, dairy other shape, 40 percent of the total sur- products, or fermentation products face of the container. thereof, whose primary function in (e) Any descriptive designation used food is flavoring rather than nutri- as a product name for a product which tional. Natural flavors include the nat- has no common or usual name shall ural essence or extractives obtained clearly and completely identify the from plants listed in 21 CFR 182.10, product. Product which has been pre- 182.20, 182.40, 182.50 and 184, and the pared by salting, smoking, drying, substances listed in 21 CFR 172.510. The cooking, chopping, or otherwise shall term natural flavor, natural flavoring, be so described on the label unless the flavor or flavoring may also be used to name of the product implies, or the designate spices, powered onion, pow- manner of packaging shows that the dered garlic, and powdered celery.

164

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00174 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.2

(ii) The term ‘‘corn syrup’’ may be end of each component ingredients list- used to designate either corn syrup or ing. corn syrup solids. (B) Such ingredients may be adjusted (iii) The term ‘‘animal and vegetable in the product formulation without a fats’’ or ‘‘vegetable and animal fats’’ change being made in the ingredients may be used to designate the ingredi- statement on the labeling, provided ents of mixtures of such edible fats in that the adjusted amount complies product designated ‘‘compound’’ or with § 318.7(c)(4) and part 319 of this ‘‘shortening.’’ ‘‘Animal fats’’ as used subchapter, and does not exceed the herein means fat derived from in- amount shown in the quantifying spected and passed cattle, sheep, swine, statement. Any such adjustments to or goats. the formulation shall be provided to (iv) When a product is coated with the inspector-in-charge. pork fat, gelatin, or other approved (2) On containers of frozen dinners, substance and a specific declaration of entrees, pizzas, and similar consumer such coating appears contiguous to the packaged products in cartons the in- name of the product, the ingredient gredient statement may be placed on statement need not make reference to the front riser panel: Provided, That the ingredients of such coating. the words ‘‘see ingredients’’ followed (v) When two meat ingredients com- immediately by an arrow is placed on prise at least 70 percent of the meat the principal display panel imme- and meat byproduct ingredients of a diately above the location of such formula and when neither of the two statement without intervening print or meat ingredients is less than 30 percent designs. by weight of the total meat and meat (3) The ingredient statement may be byproducts used, such meat ingredients placed on the 20 percent panel adjacent may be interchanged in the formula to the principal display panel and re- without a change being made in the in- served for required information, in the gredients statement on labeling mate- case of a cylindrical or nearly cylin- rials: Provided, That the word ‘‘and’’ in drical container. lieu of a comma shall be shown be- (4) The ingredients statement may be tween the declaration of such meat in- placed on the information panel, ex- gredients in the statement of ingredi- cept as otherwise permitted in this ents. subchapter. (vi)(A) Product ingredients which are (g)(1) The name or trade name of the present in individual amounts of 2 per- person that prepared the product may cent or less by weight may be listed in appear as the name of the manufac- the ingredients statement in other turer or packer without qualification than descending order of predomi- on the label. Otherwise the name of the nance: Provided, That such ingredients distributor of the product shall be are listed by their common or usual shown with a phrase such as ‘‘Prepared names at the end of the ingredients for * * *’’. The place of business of the statement and preceded by a quanti- manufacturer, packer, or distributor fying statement, such as ‘‘Contains shall be shown on the label by city, lllll percent of lllll ,’’ ‘‘Less State, and postal ZIP code when such than lllllpercent of lllll .’’ business is listed in a telephone or city The percentage of the ingredient(s) directory, and if not listed in such di- shall be filled in with a threshold level rectory, then the place of business of 2 percent, 1.5 percent, 1.0 percent, or shall be shown by street address, city, 0.5 percent, as appropriate. No ingre- State, and postal ZIP code. dient to which the quantifying state- (2) The name and place of business of ment applies may be present in an the manufacturer, packer, or dis- amount greater than the stated thresh- tributor may be shown: old. Such a quantifying statement may (i) On the principal display panel, or also be utilized when an ingredients (ii) On the 20 percent panel adjacent statement contains a listing of ingredi- to the principal display panel and re- ents by individual components. Each served for required information, in the component listing may utilize the re- case of a cylindrical or nearly cylin- quired quantifying statement at the drical container, or

165

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00175 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.2 9 CFR Ch. III (1–1–08 Edition)

(iii) On the front riser panel of frozen as ‘‘Net Wt. 12 oz.’’ except as provided food cartons, or for in paragraph (h)(5) of this section (iv) On the information panel. for random weight packages; a declara- (h)(1) The statement of net quantity tion of 11⁄2 pounds avoirdupois weight of contents shall appear on the prin- shall be expressed as ‘‘Net Wt. 24 oz. (1 cipal display panel of all containers to lb. 8 oz.),’’ ‘‘Net Wt. 24 oz. (11⁄2 lb.),’’ or be sold at retail intact, in conspicuous ‘‘Net Wt. 24 oz. (1.5 lbs.).’’ and easily legible boldface print or (5) On packages containing 1 pound type in distinct contrast to other mat- or 1 pint and less than 4 pounds or 1 ter on the container, and shall be de- gallon, the statement shall be ex- clared in accordance with the provi- pressed as a dual declaration both in sions of this paragraph. ounces and (immediately thereafter in (2) The statement as it is shown on a parentheses) in pounds, with any relabel shall not be false or misleading mainder in terms of ounces or common and shall express an accurate state- or decimal fraction of the pound, or in ment of the quantity of contents of the container. Reasonable variations the case of liquid measure, in the larg- caused by loss or gain of moisture dur- est whole units with any remainder in ing the course of good distribution terms of fluid ounces or common or practices or by unavoidable deviations decimal fractions of the pint or quart, in good manufacturing practices will except that on random weight pack- be recognized. Variations from stated ages the statement shall be expressed quantity of contents shall be as pro- in terms of pounds and decimal frac- vided in § 317.19. The statement shall tions of the pound, for packages over 1 not include any term qualifying a unit pound, and for packages which do not of weight, measure, or count such as exceed 1 pound the statement may be ‘‘jumbo quart,’’ ‘‘full gallon,’’ ‘‘giant in decimal fractions of the pound in quart,’’ ‘‘when packed,’’ ‘‘minimum,’’ lieu of ounces. Paragraph (h)(9) of this or words of similar importance. section permits certain exceptions (3) The statement shall be placed on from the provisions of this paragraph the principal display panel within the for margarine packages, random bottom 30 percent of the area of the weight consumer size packages, and panel in lines generally parallel to the packages of less than 1⁄2 ounce net base: Provided, That on packages hav- weight. Pargraph (h)(12) of this section ing a principal display panel of 5 square permits certain exceptions from the inches or less, the requirement for provision of this paragraph for multi- placement within the bottom 30 per- unit packages. cent of the area of the label panel shall (6) The statement shall be in letters not apply when the statement meets and numerals in type size established the other requirements of this para- in relationship to the area of the prin- graph (h). In any case, the statement cipal display panel of the package and may appear in more than one line. The shall be uniform of all packages of sub- terms ‘‘net weight’’ or ‘‘net wt.’’ shall stantially the same size by complying be used when stating the net quantity with the following type specifications: of contents in terms of weight, and the term ‘‘net contents’’ or ‘‘content’’ (i) Not less than one-sixteenth inch when stating the net quantity of con- in height on packages, the principal tents in terms of fluid measure. display panel of which has an area of 5 (4) Except as provided in § 317.7, the square inches or less; statement shall be expressed in terms (ii) Not less than one-eighth inch in of avoirdupois weight or liquid meas- height on packages, the principal dis- ure. Where no general consumer usage play panel of which has an area of more to the contrary exists, the statement than 5 but not more than 25 square shall be in terms of liquid measure, if inches; the product is liquid, or in terms of (iii) Not less than three-sixteenths weight if the product is solid, semisolid inch in height on packages, the prin- viscous or a mixture of solid and liquid. cipal display panel of which has an For example, a declaration of 3⁄4-pound area of more than 25 but not more than avoirdupois weight shall be expressed 100 square inches;

166

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00176 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.2

(iv) Not less than one-quarter inch in the shipping container are exempt from height on packages, the principal dis- the type size, dual declaration, and play panel of which has an area of more placement requirements of this para- than 100 but not more than 400 square graph, if an accurate statement of net inches. weight is shown conspicuously on the (v) Not less than one-half inch in principal display panel of the shipping height on packages, the principal dis- container. The net weight also shall be play panel of which has an area of more applied directly to random weight con- than 400 square inches. sumer size packages prior to retail dis- (7) The ratio of height to width of let- play and sale. The net weight state- ters and numerals shall not exceed a ment on random weight consumer size differential of 3 units to 1 unit (no packages for retail sale shall be exempt more than 3 times as high as it is from the type size, dual declaration, wide). Heights pertain to upper case or and placement requirements of this capital letters. When upper and lower paragraph, if an accurate statement of case or all lower case letters are used, net weight is shown conspicuously on it is the lower case letter ‘‘o’’ or its the principal display panel of the pack- equivalent that shall meet the min- age. imum standards. When fractions are (ii) Individually wrapped and labeled used, each component numeral shall packages of less than 1⁄2 ounce net meet one-half the height standards. weight and random weight consumer (8) The statement shall appear as a size packages shall be exempt from the distinct item on the principal display requirements of this paragraph if they panel and shall be separated by a space are in a shipping container and the at least equal to the height of the let- statement of net quantity of contents tering used in the statement from on the shipping container meets the re- other printed label information appear- quirements of paragraph (h)(2) of this ing above or below the statement and section; by a space at least equal to twice the (iii) Individually wrapped and labeled width of the letter ‘‘N’’ of the style of packages of less than 1⁄2 ounce net type used in the quantity of contents weight bearing labels declaring net statement from other printed label in- weight, price per pound, and total formation appearing to the left or right price, shall be exempt from the type of the statement. It shall not include size, dual declaration, and placement any term qualifying a unit of weight, requirements of this paragraph, if an measure, or count such as, ‘‘jumbo accurate statement of net weight is quart,’’ ‘‘full gallon,’’ ‘‘giant quart,’’ shown conspicuously on the principal ‘‘when packed,’’ ‘‘Minimum’’ or words display panel of the package. of similar import. (iv) Margarine in 1 pound rectangular (9) The following exemptions from packages (except packages containing the requirements contained in this whipped or soft margarine or packages paragraph (h) are hereby established: that contain more than four sticks) is (i) Individually wrapped, random exempt from the requirements of para- weight consumer size packages shipped graphs (h) (3) and (5) of this section rein bulk containers (as specified in para- garding the placement of the state- graph (h)(11) of this section) and meat ment of the net quantity of contents products that are subject to shrinkage within the bottom 30 percent of the through moisture loss during good dis- principal display panel and that the tribution practices and are designated statement be expressed both in ounces as gray area type of products as defined and in pounds, if the statement appears under § 317.19 need not bear a net as ‘‘1 pound’’ or ‘‘one pound’’ in a con- weight statement when shipped from spicuous manner on the principal dis- an official establishment, provided play panel. that a net weight shipping statement (v) Sliced shingle packed bacon in which meets the requirements of para- rectangular packages is exempt from graph (h)(2) of this section is applied to the requirements of paragraphs (h)(3) their shipping container prior to ship- and (h)(5) of this section regarding the ping it from the official establishment. placement of the statement of the net Net weight statements so applied to quantity of contents within the bottom

167

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00177 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.2 9 CFR Ch. III (1–1–08 Edition)

30 percent of the principal display container or its labeling, e.g., the lid of panel, and that the statement be ex- a can, if shown in a prominent and leg- pressed both in ounces and in pounds, if ible manner in a size sufficient to in- the statement appears in a conspicuous sure easy visibility and recognition and manner on the principal display panel. accompanied by the prefix ‘‘EST’’; or (10) Labels for containers which bear (3) Off the exterior of the container, any representation as to the number of e.g., on a metal clip used to close cas- servings contained therein shall bear, ings or bags, or on the back of a paper contiguous to such representation, and label of a canned product, or on other in the same size type as is used for packaging or labeling material in the such representation, a statement of the container, e.g., on aluminum pans and net quantity of each such serving. trays placed within containers, when a (11) As used in this section, a ‘‘ran- statement of its location is printed dom weight consumer size package’’ is contiguous to the official inspection one which is one of a lot, shipment or legend, such as ‘‘EST. No. on Metal delivery of packages of the same prod- Clip’’ or ‘‘Est. No. on Pan’’, if shown in uct with varying weights and with no a prominent and legible manner in a fixed weight pattern. size sufficient to insure easy visibility (12) On a multiunit retail package, a and recognition; or statement of the net quantity of con- (4) On an insert label placed under a tents shall appear on the outside of the transparent covering if clearly visible package and shall include the number and legible and accompanied by the of individual units, the quantity of prefix ‘‘EST’’. each individual unit, and in paren- (j) Labels of any product within any theses, the total net quantity of con- of the following paragraphs shall show tents of the multiunit package in the information required by such para- terms of avoirdupois or fluid ounces, graph for such product: except that such declaration of total (1) A label for product which is an quantity need not be followed by an ad- imitation of another food shall bear ditional parenthetical declaration in the word ‘‘imitation’’ immediately pre- terms of the largest whole units and ceding the name of the food imitated subdivisions thereof, as required by and in the same size and style of let- paragraph (h)(5) of this section. For the tering as in that name and imme- purposes of this section, ‘‘multiunit re- diately thereafter the word ‘‘ingredi- tail package’’ means a package con- ents:’’ and the names of the ingredients taining two or more individually pack- arranged in the order of their predomi- aged units of the identical commodity nance. and in the same quantity, with the in- (2) If a product purports to be or is dividual packages intended to be sold represented for any special dietary use as part of the multiunit retail package by man, its label shall bear a state- but capable of being individually sold ment concerning its vitamin, mineral, in full compliance with all require- and other dietary properties upon ments of the regulations in this part. which the claim for such use is based in Open multiunit retail packages that do whole or in part and shall be in con- not obscure the number of units and formity with regulations (21 CFR part the labeling thereon are not subject to 125) established pursuant to sections this paragraph if the labeling of each 403, and 701 of the Federal Food, Drug, individual unit complies with the re- and Cosmetic Act (21 U.S.C. 343, 371). quirements of paragraphs (h) (2), (3), (3) When an artificial smoke fla- (6), and (8) of this section. voring or a smoke flavoring is added as (i) The official establishment number an ingredient in the formula of a meat of the official establishment in which food product, as permitted in part 318 the product was processed under in- of this subchapter, there shall appear spection shall be placed as follows: on the label, in prominent letters and (1) Within the official inspection leg- contiguous to the name of the product, end in the form required by part 312 of a statement such as ‘‘Artificial Smoke this subchapter; or Flavoring Added’’ or ‘‘Smoke Fla- (2) Outside the official inspection leg- voring Added,’’ as may be applicable, end elsewhere on the exterior of the and the ingredient statement shall

168

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00178 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.2

identify any artificial smoke flavoring statement identifying the officially ap- or smoke flavoring so added as an in- proved specific antioxidant by its com- gredient in the formula of the meat mon name or abbreviation thereof and food product. the purpose for which it is added, such (4) When any other artificial fla- as, ‘‘BHA, BHT, and Propylgallate voring is permitted under part 318 of added to help protect flavor.’’ this subchapter to be added to a prod- (11) Containers of meat packed in uct, the ingredient statement shall borax or other preservative for export identify it as ‘‘Artificial Flavoring.’’ to a foreign country which permits the (5) When artificial coloring is added use of such preservative shall, at the to edible fats as permitted under part time of packing, be marked ‘‘for ex- 318 of this subchapter such substance port,’’ followed on the next line by the shall be declared on the label in a words ‘‘packed in preservative,’’ or prominent manner and contiguous to such equivalent statement as may be the name of the product by the words approved for this purpose by the Ad- ‘‘Artificially colored’’ or ‘‘Artificial ministrator and directly beneath this coloring added’’ or ‘‘With added artifi- there shall appear the word ‘‘establish- cial coloring.’’ When natural coloring ment’’ or abbreviation thereof, fol- such as annatto is added to edible fats lowed by the number of the establish- as permitted under part 318 of this sub- ment at which the product is packed. chapter, such substance shall be de- The complete statement shall be ap- clared on the label in the same manner plied in a conspicuous location and in by a phrase such as ‘‘Colored with letters not less than 1 inch in height. annatto.’’ (12) Containers of other product (6) When product is placed in a casing packed in, bearing, or containing any to which artificial coloring is applied chemical preservative shall bear a as permitted under part 318 of this sub- label stating that fact. chapter, there shall appear on the (13)(i) On the label of any ‘‘Mechani- label, in a prominent manner and con- cally Separated (Species)’’ described in tiguous to the name of the product, the § 319.5(a) of this subchapter, the name words, ‘‘Artificially colored.’’ of such product shall be followed im- (7) If a casing is removed from prod- mediately by the phrase ‘‘for proc- uct at an official establishment and essing’’ unless such product has a pro- there is evidence of artificial coloring tein content of not less than 14 percent on the surface of the product, there and a fat content of not more than 30 shall appear on the label, in a promi- percent. nent manner and contiguous to the (ii) When any ‘‘Mechanically Sepa- name of product, the words ‘‘Artifi- rated (Species)’’ described in § 319.5 of cially colored.’’ this subchapter is used as an ingredient (8) When a casing is colored prior to in the preparation of a meat food prod- its use as a covering for product and uct and such ‘‘Mechanically Separated the color is not transferred to the prod- (Species)’’ contributes 20 mg or more of uct enclosed in the casing, no reference calcium to a serving of such meat food to color need appear on the label but product, the label of such meat food no such casing may be used if it is mis- product shall state the calcium content leading or deceptive with respect to of such meat food product, determined color, quality, or kind of product, or and expressed as the percentage of the otherwise. U.S. Recommended Daily Allowance (9) Product which bears or contains (U.S. RDA) in a serving in accordance any other artificial coloring, as per- with 21 CFR 101.9(b)(1), (c)(7) (i) and mitted under part 318 of this sub- (iv), and (e), as part of any nutrition chapter, shall bear a label stating that information included on such label, or fact on the immediate container or if if such meat food product does not bear there is none, on the product. nutrition labeling information, as part (10) When an antioxidant is added to of a prominent statement in immediate product as permitted under part 318 of conjunction with the list of ingredi- this subchapter, there shall appear on ents, as follows: ‘‘A lll serving con- the label in prominent letters and contains ll% of the U.S. RDA of cal- tiguous to the name of the product, a cium’’, with the blanks to be filled in,

169

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00179 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.2 9 CFR Ch. III (1–1–08 Edition)

respectively, with the quantity of such (1)(i) Safe handling instructions shall product that constitutes a serving and accompany every meat or meat prod- the amount of calcium provided by uct, specified in this paragraph (l) des- such serving: Provided, That, calcium tined for household consumers, hotels, content need not be stated where (a) restaurants, or similar institutions and the percent of the U.S. RDA of calcium shall appear on the label. The informa- to be declared would not differ from tion shall be in lettering no smaller the percent of the U.S. RDA that would than one-sixteenth of an inch in size be declared if the meat food product and shall be prominently placed with contained only hand deboned ingredi- such conspicuousness (as compared ents or (b) the calcium content of a with other words, statements, designs serving of the meat food product would or devices in the labeling) as to render be 20 percent of the U.S. RDA or more it likely to be read and understood by if the meat food product contained the ordinary individual under cus- only hand deboned ingredients. tomary conditions of purchase and use. (k) Packaged products which require (ii) The safe handling information special handling to maintain their shall be presented on the label under wholesome condition shall have promi- the heading ‘‘Safe Handling Instruc- nently displayed on the principal dis- tions’’ which shall be set in type size play panel of the label the statement: larger than the print size of the ration- ‘‘Keep Refrigerated,’’ ‘‘Keep Frozen,’’ ale statement and handling statements ‘‘Perishable Keep Under Refrigera- as discussed in paragraphs (l)(2) and tion,’’ or such similar statement as the (l)(3) of this section. The safe handling Administrator may approve in specific information shall be set off by a border cases. Products that are distributed and shall be one color type printed on frozen during distribution and thawed a single color contrasting background prior to or during display for sale at re- whenever practical. tail shall bear the statement on the (2) The labels of the meat and meat shipping container: ‘‘Keep Frozen.’’ products specified in this paragraph (l) The consumer-size containers for such shall include the following rationale products shall bear the statement statement as part of the safe handling ‘‘Previously Handled Frozen for Your instructions, ‘‘This product was pre- Protection, Refreeze or Keep Refrig- pared from inspected and passed meat erated.’’ For all perishable canned and/or poultry. Some food products products the statement shall be shown may contain bacteria that could cause in upper case letters one-fourth inch in illness if the product is mishandled or height for containers having a net cooked improperly. For your protec- weight of 3 pounds or less, and for con- tion, follow these safe handling in- tainers having a net weight over 3 structions.’’ This statement shall be pounds, the statement shall be in upper placed immediately after the heading case letters at least one-half inch in and before the safe handling state- height. ments. (l) Safe handling instructions shall be (3) Meat and meat products, specified provided for: All meat and meat prod- in this paragraph (l), shall bear the la- ucts of cattle, swine, sheep, goat, beling statements: horse, other equine that do not meet (i) Keep refrigerated or frozen. Thaw the requirements contained in § 318.17, in refrigerator or microwave. (Any por- or that have not undergone other proc- tion of this statement that is in con- essing that would render them ready- flict with the product’s specific han- to-eat; and all comminuted meat pat- dling instructions, may be omitted, ties not heat processed in a manner e.g., instructions to cook without that conforms to the time and tem- thawing.) (A graphic illustration of a perature combinations in the Table for refrigerator shall be displayed next to Permitted Heat-Processing Tempera- the statement.); ture/Time Combinations For Fully- (ii) Keep raw meat and poultry sepa- Cooked Patties in § 318.23, except as ex- rate from other foods. Wash working empted under paragraph (l)(4) of this surfaces (including cutting boards), section. utensils, and hands after touching raw

170

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00180 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.3

meat or poultry. (A graphic illustra- ents statement, is not divided and ap- tion of soapy hands under a faucet pears on the same panel. shall be displayed next to the state- (ii) All information appearing on the ment.); information panel pursuant to this sec- (iii) Cook thoroughly. (A graphic il- tion shall appear in one place without lustration of a skillet shall be dis- intervening material, such as designs played next to the statement.); and or vignettes. (iv) Keep hot foods hot. Refrigerate [35 FR 15580, Oct. 3, 1970] leftovers immediately or discard. (A graphic illustration of a thermometer EDITORIAL NOTE: For FEDERAL REGISTER ci- shall be displayed next to the state- tations affecting § 317.2, see the List of CFR ment.) Sections Affected, which appears in the Finding Aids section of the printed volume (4) Meat or meat products intended and on GPO Access. for further processing at another official establishment are exempt from the § 317.3 Approval of abbreviations of requirements prescribed in paragraphs marks of inspection; preparation of (l)(1) through (l)(3) of this section. marking devices bearing inspection (m)(1) The information panel is that legend without advance approval part of a label that is the first surface prohibited; exception. to the right of the principal display (a) The Administrator may approve panel as observed by an individual fac- and authorize the use of abbreviations ing the principal display panel, with of marks of inspection under the regu- the following exceptions: lations in this subchapter. Such abbre- (i) If the first surface to the right of viations shall have the same force and the principal display panel is too small effect as the respective marks for to accommodate the required informa- which they are authorized abbreviation or is otherwise unusable label tions. space, e.g., folded flaps, tear strips, (b) Except for the purposes of pre- opening flaps, heat-sealed flaps, the paring and submitting a sample or next panel to the right of this part of samples of the same to the Adminis- the label may be used. trator for approval, no brand manufac- (ii) If the package has one or more al- turer, printer, or other person shall ternate principal display panels, the in- cast, print, lithograph, or otherwise formation panel is to the right of any make any marking device containing principal display panel. any official mark or simulation there- (iii) If the top of the container is the of, or any label bearing any such mark principal display panel and the pack- or simulation, without the written au- age has no alternate principal display thority therefor of the Administrator. panel, the information panel is any However, when any such sample label, panel adjacent to the principal display or other marking device, is approved panel. by the Administrator, additional sup- (2) (i) Except as otherwise permitted plies of the approved label, or marking in this part, all information required to device, may be made for use in accord- appear on the principal display panel ance with the regulations in this sub- or permitted to appear on the informa- chapter, without further approval by tion panel shall appear on the same the Administrator. The provisions of panel unless there is insufficient space. this paragraph apply only to labels, or In determining the sufficiency of the other marking devices, bearing or con- available space, except as otherwise taining an official inspection legend prescribed in this part, any vignettes, shown in § 312.2(b), § 312.3(a) (only the designs, and any other nonmandatory legend appropriate for horse meat food information shall not be considered. If products) or § 312.3(b) (only the legend there is insufficient space for all re- appropriate for other (nonhorse) equine quired information to appear on a sin- meat food products), or any abbrevia- gle panel, it may be divided between tions, copy or representation thereof. the principal display panel and the in- (c) No brand manufacturer or other formation panel, provided that the in- person shall cast or otherwise make, formation required by any given provi- without an official certificate issued in sion of this part, such as the ingredi- quadruplicate by a Program employee,

171

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00181 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.4 9 CFR Ch. III (1–1–08 Edition)

a brand or other marking device con- § 317.4 Labeling approval. taining an official inspection legend, or (a) No final labeling shall be used on simulation thereof, shown in § 312.2(a), any product unless the sketch labeling § 312.3(a) (only the legend appropriate of such final labeling has been sub- for horse carcasses and parts of horse mitted for approval to the Food Label- carcasses), § 312.3(b) (only the legend ing Division, Regulatory Programs, appropriate for other equine (nonhorse) Food Safety and Inspection Service, carcasses and parts of other (nonhorse) and approved by such division, accom- equine carcasses) or § 312.7(a). panied by FSIS form, Application for (1) The certificate is a Food Safety Approval of Labels, Marking, and De- and Inspection Service form for signa- vices, except for generically approved ture by a Program employee and the labeling authorized for use in § 317.5(b). official establishment ordering the The management of the official estab- brand or other marking device, bearing lishment or establishment certified a certificate serial number and a let- under a foreign inspection system, in terhead and the seal of the United accordance with part 327 of this sub- States Department of Agriculture. The chapter, must maintain a copy of all certificate authorizes the making of labeling used, along with the product only the brands or other marking de- formulation and processing procedure, vices of the type and quantity listed on in accordance with part 320 of this sub- the certificate. chapter. Such records shall be made (2) After signing the certificate, the available to any duly authorized rep- Program employee and the establish- resentative of the Secretary upon re- ment shall each keep a copy, and the quest. remaining two copies shall be given to (b) The Food Labeling Division shall the brand or other marking device permit submission for approval of only manufacturer. sketch labeling, as defined in § 317.4(d), (3) The manufacturer of the brands or for all products, except as provided in other marking devices shall engrave or § 317.5(b) (2)–(9) and except for tem- otherwise mark each brand or other porary use of final labeling as pre- marking device with a permanent iden- scribed in paragraph (f) of this section. tifying serial number unique to it. The (c) All labeling required to be sub- manufacturer shall list on each of the mitted for approval as set forth in two copies of the certificate given to § 317.4(a) shall be submitted in dupli- the manufacturer the number of each cate to the Food Labeling Division, brand or other marking device author- Regulatory Programs, Food Safety and ized by the certificate. The manufac- Inspection Service, U.S. Department of turer shall retain one copy of the cer- Agriculture, Washington, DC 20250. A tificate for the manufacturer’s records parent company for a corporation may and return the remaining copy with submit only one labeling application the brands or other marking devices to (in duplicate form) for a product pro- the Program employee whose name and duced in other establishments that are address are given on the certificate as owned by the corporation. the recipient. (d) ‘‘Sketch’’ labeling is a printer’s (4) In order that all such brands or proof or equivalent which clearly other marking devices bear identifying shows all labeling features, size, loca- numbers, within one year after June 24, tion, and indication of final color, as 1985, an establishment shall either re- specified in § 317.2. FSIS will accept place each such brand or other mark- sketches that are hand drawn, com- ing device which does not bear an iden- puter generated or other reasonable tifying number, or, under the direction facsimiles that clearly reflect and of the inspector-in-charge, mark such project the final version of the label- brand or other marking device with a ing. Indication of final color may be permanent identifying number. met by: submission of a color sketch, (Recordkeeping requirements approved by submission of a sketch which indicates the Office of Management and Budget under by descriptive language the final col- control number 0583–0015) ors, or submission with the sketch of [35 FR 15580, Oct. 3, 1970, as amended at 50 FR previously approved final labeling that 21422, May 24, 1985] indicates the final colors.

172

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00182 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.5

(e) Inserts, tags, liners, pasters, and prominent manner as required in like devices containing printed or § 317.2, and is not otherwise false or graphic matter and for use on, or to be misleading in any particular. placed within, containers and coverings (2) The Food Safety and Inspection of product shall be submitted for ap- Service shall select samples of generi- proval in the same manner as provided cally approved labeling from the for labeling in § 317.4(a), except that records maintained by official estab- such devices which contain no ref- lishments and establishments certified erence to product and bear no mis- under foreign inspection systems, in leading feature shall be used without accordance with part 327 of this sub- submission for approval as prescribed chapter, as required in § 317.4, to deter- in § 317.5(b)(7). mine compliance with labeling require- (f)(1) Consistent with the requirements. Any finding of false or mis- ments of this section, temporary ap- leading labeling shall institute the pro- proval for the use of a final label or ceedings prescribed in § 335.12. other final labeling that may otherwise (b) Generically approved labeling is be deemed deficient in some particular labeling which complies with the fol- may be granted by the Food Labeling lowing: Division. Temporary approvals may be (1) Labeling for a product which has granted for a period not to exceed 180 a product standard as specified in part calendar days, under the following con- 319 of this subchapter or the Standards ditions: and Labeling Policy Book and which (i) The proposed labeling would not does not contain any special claims, misrepresent the product; such as quality claims, nutrient con- (ii) The use of the labeling would not tent claims, health claims, negative present any potential health, safety, or claims, geographical origin claims, or dietary problems to the consumer; guarantees, or which is not a domestic (iii) Denial of the request would cre- product labeled in a foreign language; ate undue economic hardship; and (2) Labeling for single-ingredient (iv) An unfair competitive advantage products (such as beef steak or lamb would not result from the granting of chops) which does not contain any spe- the temporary approval. cial claims, such as quality claims, nu- (2) Extensions of temporary approv- trient content claims, health claims, als may also be granted by the Food negative claims, geographical origin Labeling Division provided that the ap- claims, or guarantees, or which is not a plicant demonstrates that new cir- domestic product labeled with a for- cumstances, meeting the above cri- eign language; teria, have developed since the original (3) Labeling for containers of prod- temporary approval was granted. ucts sold under contract specifications (g) The inspector-in-charge shall ap- to Federal Government agencies, when prove meat carcass ink brands and such product is not offered for sale to meat food product ink and burning the general public, provided that the brands, which comply with parts 312 contract specifications include specific and 316 of this subchapter. requirements with respect to labeling, [60 FR 67454, Dec. 29, 1995] and are made available to the inspector-in-charge; § 317.5 Generically approved labeling. (4) Labeling for shipping containers (a)(1) An official establishment or an which contain fully labeled immediate establishment certified under a foreign containers, provided such labeling inspection system, in accordance with complies with § 316.13; part 327 of this subchapter, is author- (5) Labeling for products not in- ized to use generically approved label- tended for human food, provided they ing, as defined in paragraph (b) of this comply with part 325 of this subsection, without such labeling being chapter; submitted for approval to the Food (6) Meat inspection legends, which Safety and Inspection Service in Wash- comply with parts 312 and 316 of this ington or the field, provided the label- subchapter; ing is in accordance with this section (7) Inserts, tags, liners, pasters, and and shows all mandatory features in a like devices containing printed or

173

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00183 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.5 9 CFR Ch. III (1–1–08 Edition)

graphic matter and for use on, or to be (ix) The addition, deletion, or amend- placed within containers, and coverings ment of recipe suggestions for the of products, provided such devices con- product; tain no reference to product and bear (x) Any change in punctuation; no misleading feature; (xi) Newly assigned or revised estab- (8) Labeling for consumer test prod- lishment numbers for a particular es- ucts not intended for sale; and tablishment for which use of the label- (9) Labeling which was previously ap- ing has been approved by the Food La- proved by the Food Labeling Division beling Division, Regulatory Programs; as sketch labeling, and the final label- (xii) The addition or deletion of open ing was prepared without modification dating information; or with the following modifications: (xiii) A change in the type of pack- (i) All features of the labeling are aging material on which the label is proportionately enlarged or reduced, printed; provided that all minimum size re- (xiv) Brand name changes, provided quirements specified in applicable reg- that there are no design changes, the ulations are met and the labeling is brand name does not use a term that legible; connotes quality or other product char- (ii) The substitution of any unit of acteristics, the brand name has no geo- measurement with its abbreviation or graphic significance, and the brand the substitution of any abbreviation name does not affect the name of the with its unit of measurement, e.g., product; ‘‘lb.’’ for ‘‘pound,’’ or ‘‘oz.’’ for (xv) The deletion of the word ‘‘new’’ ‘‘ounce,’’ or of the word ‘‘pound’’ for on new product labeling; ‘‘lb.’’ or ‘‘ounce’’ for ‘‘oz.’’; (xvi) The addition, deletion, or (iii) A master or stock label has been amendment of special handling state- approved from which the name and ad- ments, provided that the change is con- dress of the distributor are omitted and sistent with § 317.2(k); such name and address are applied before being used (in such case, the words (xvii) The addition of safe handling ‘‘prepared for’’ or similar statement instructions as required by § 317.2(l); must be shown together with the blank (xviii) Changes reflecting a change in space reserved for the insertion of the the quantity of an ingredient shown in name and address when such labels are the formula without a change in the offered for approval); order of predominance shown on the (iv) Wrappers or other covers bearing label, provided that the change in pictorial designs, emblematic designs quantity of ingredients complies with or illustrations, e.g., floral arrange- any minimum or maximum limits for ments, illustrations of animals, fire- the use of such ingredients prescribed works, etc. are used with approved la- in parts 318 and 319 of this subchapter; beling (the use of such designs will not (xix) Changes in the color of the la- make necessary the application of labeling, provided that sufficient con- beling not otherwise required); trast and legibility remain; (v) A change in the language or the (xx) A change in the product vi- arrangement of directions pertaining gnette, provided that the change does to the opening of containers or the not affect mandatory labeling informa- serving of the product; tion or misrepresent the content of the (vi) The addition, deletion, or amend- package; ment of a dated or undated coupon, a (xxi) A change in the establishment cents-off statement, cooking instruc- number by a corporation or parent tions, packer product code informa- company for an establishment under tion, or UPC product code information; its ownership; (vii) Any change in the name or ad- (xxii) Changes in nutrition labeling dress of the packer, manufacturer or that only involve quantitative adjust- distributor that appears in the signa- ments to the nutrition labeling infor- ture line; mation, except for serving sizes, pro- (viii) Any change in the net weight, vided the nutrition labeling informa- provided the size of the net weight tion maintains its accuracy and con- statement complies with § 317.2; sistency;

174

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00184 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.8

(xxiii) Deletion of any claim, and the establishment number shall in all cases deletion of non-mandatory features or appear in English but in addition, may non-mandatory information; and appear literally translated in a foreign (xxiv) The addition or deletion of a language. direct translation of the English language into a foreign language for prod- § 317.8 False or misleading labeling or ucts marked ‘‘for export only.’’ practices generally; specific prohibitions and requirements for labels [60 FR 67455, Dec. 29, 1995] and containers. § 317.6 Approved labels to be used only (a) No product or any of its wrappers, on products to which they are ap- packaging, or other containers shall plicable. bear any false or misleading marking, Labels shall be used only on products label, or other labeling and no state- for which they are approved, and only ment, word, picture, design, or device if they have been approved for such which conveys any false impression or products in accordance with § 317.3: Pro- gives any false indication of origin or vided, That existing stocks of labels ap- quality or is otherwise false or mis- proved prior to the effective date of leading shall appear in any marking or this section and the quantity of which other labeling. No product shall be has been identified to the circuit super- wholly or partly enclosed in any wrap- visor as being in storage on said date per, packaging, or other container that at the official establishment or other is so made, formed, or filled as to be identified warehouse for the account of misleading. the operator of the official establish- (b) The labels and containers of prod- ment may be used until such stocks are uct shall comply with the following exhausted, but not later than 1 year provisions, as applicable: after the effective date of this section (1) Terms having geographical sig- unless such labels conform to all the nificance with reference to a locality requirements of this part and part 319 other than that in which the product is of this subchapter. The Administrator prepared may appear on the label only may upon the show of good cause grant when qualified by the word ‘‘style,’’ individual extension of time as he ‘‘type,’’ or ‘‘brand,’’ as the case may be, deems necessary. in the same size and style of lettering as in the geographical term, and ac- § 317.7 Products for foreign commerce; companied with a prominent qualifying printing labels in foreign language statement identifying the country, permissible; other deviations. State, Territory, or locality in which Labels to be affixed to packages of the product is prepared, using terms products for foreign commerce may be appropriate to effect the qualification. printed in a foreign language and may When the word ‘‘style’’ or ‘‘type’’ is show the statement of the quantity of used, there must be a recognized style contents in accordance with the usage or type of product identified with and of the country to which exported and peculiar to the area represented by the other deviations from the form of la- geographical term and the product beling required under this part may be must possess the characteristics of approved for such product by the Ad- such style or type, and the word ministrator in specific cases: Provided, ‘‘brand’’ shall not be used in such a (a) That the proposed labeling ac- way as to be false or misleading: Pro- cords to the specifications of the for- vided, That a geographical term which eign purchaser, has come into general usage as a trade (b) That it is not in conflict with the name and which has been approved by laws of the country to which the prod- the Administrator as being a generic uct is intended for export, and term may be used without the quali- (c) That the outside container is la- fications provided for in this para- beled to show that it is intended for ex- graph. The terms ‘‘frankfurter,’’ ‘‘vi- port; but if such product is sold or of- enna,’’ ‘‘bologna,’’ ‘‘lebanon bologna,’’ fered for sale in domestic commerce, ‘‘braunschweiger,’’ ‘‘thuringer,’’ all the requirements of this subchapter ‘‘genoa,’’ ‘‘leona,’’ ‘‘berliner,’’ ‘‘hol- apply. The inspection legend and the stein,’’ ‘‘goteborg,’’ ‘‘milan,’’ ‘‘polish,’’

175

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00185 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.8 9 CFR Ch. III (1–1–08 Edition)

‘‘italian,’’ and their modifications, as false impression of leanness of the applied to sausages, the terms ‘‘bruns- product. Transparent or wick’’ and ‘‘irish’’ as applied to stews semitransparent wrappers, casings, or and the term ‘‘boston’’ as applied to coverings for use in packaging cured, pork shoulder butts need not be accom- cured and smoked, or cured and cooked panied with the word ‘‘style,’’ ‘‘type,’’ sausage products, and sliced ready-to- or ‘‘brand,’’ or a statement identifying eat meat food products may be color the locality in which the product is tinted or bear red designs on 50 percent prepared. of such wrapper or covering: Provided, (2) Such terms as ‘‘farm’’ or ‘‘coun- That the transparent or try’’ shall not be used on labels in con- semitransparent portion of the prin- nection with products unless such cipal display panel is free of color tint- products are actually prepared on the ing and red designs: And provided fur- farm or in the country: Provided, That ther, That the principal display panel if the product is prepared in the same provides at least 20 percent unob- way as on the farm or in the country structed clear space, consolidated in these terms, if qualified by the word one area so that the true nature and ‘‘style’’ in the same size and style of color of the product is visible to the lettering, may be used: Provided fur- consumer. ther, That the term ‘‘farm’’ may be (ii) Packages for sliced bacon that used as part of a brand designation have a transparent opening shall be de- when qualified by the word ‘‘brand’’ in signed to expose, for viewing, the cut the same size and style of lettering, surface of a representative slice. Pack- and followed with a statement identi- ages for sliced bacon which meet the fying the locality in which the product following specifications will be accept- is prepared: And Provided further, That ed as meeting the requirements of this the provisions of this paragraph shall subparagraph provided the enclosed not apply to products prepared in ac- bacon is positioned so that the cut sur- cordance with § 319.106 of this sub- face of the representative slice can be chapter. Sausage containing cereal visually examined: shall not be labeled ‘‘farm style’’ or (a) For shingle-packed sliced bacon, ‘‘country style,’’ and lard not rendered the transparent window shall be de- in an open kettle shall not be des- signed to reveal at least 70 percent of ignated as ‘‘farm style’’ or ‘‘country the length (longest dimension) of the style.’’ representative slice, and this window (3) The requirement that the label shall be at least 11⁄2 inches wide. The shall contain the name and place of transparent window shall be located business of the manufacturer, packer, not more than five-eighths inch from or distributor shall not relieve any es- the top or bottom edge of a 1-pound or tablishment from the requirement that smaller package and not more than its label shall not be misleading in any three-fourths inch from either the top particular. or bottom edge of a package larger (4) The term ‘‘spring lamb’’ or ‘‘gen- than 1 pound. uine spring lamb’’ is applicable only to (b) For stack-packed sliced bacon, carcasses of new-crop lambs slaugh- the transparent window shall be de- tered during the period beginning in signed to reveal at least 70 percent of March and terminating not beyond the the length (longest dimension) of the close of the week containing the first representative slice and be at least 11⁄2 Monday in October. inches wide. (5)(i) Coverings shall not be of such (6) The word ‘‘fresh’’ shall not be color, design, or kind as to be mis- used on labels to designate product leading with respect to color, quality, which contains any sodium nitrate, so- or kind of product to which they are dium nitrite, potassium nitrate, or po- applied. For example, transparent or tassium nitrite, or which has been salt- semitransparent coverings for such ar- ed for preservation. ticles as sliced bacon or fresh (7)(i) No ingredient shall be des- (uncooked) meat and meat food prod- ignated on the label as a spice, fla- ucts shall not bear lines or other de- voring, or coloring unless it is a spice, signs of red or other color which give a flavoring, or coloring, as the case may

176

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00186 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.8

be. An ingredient that is both a spice Flame,’’ as the case may be, appearing and a coloring, or both a flavoring and as part of the product name. a coloring, shall be designated as (12) The term ‘‘meat’’ and the names ‘‘spice and coloring’’, or ‘‘flavoring and of particular kinds of meat, such as coloring’’, as the case may be, unless beef, veal, mutton, lamb, and pork, such ingredient is designated by its shall not be used in such manner as to common or usual name. be false or misleading. (ii) Any ingredient not designated in (13) The word ‘‘ham,’’ without any § 317.2(f)(1)(i) of this part whose func- prefix indicating the species of animal tion is flavoring, either in whole or in from which derived, shall be used in la- part, must be designated by its com- beling only in connection with the hind mon or usual name. Those ingredients legs of swine. Ham shanks as such or which are of livestock and poultry ori- ham shank meat as such or the trim- gin must be designated by names that mings accruing in the trimming and include the species and livestock and shaping of hams shall not be labeled poultry tissues from which the ingredi- ‘‘ham’’ or ‘‘ham meat’’ without quali- ents are derived. fication. When used in connection with (8) As used on labels of product, the a chopped product the term ‘‘ham’’ or term ‘‘gelatin’’ shall mean (i) the jelly ‘‘ham meat’’ shall not include the skin. prepared in official establishments by (14) The terms ‘‘shankless’’ and cooking pork skins, tendons, or con- ‘‘hockless’’ shall apply only to hams nective tissue from inspected and and pork shoulders from which the passed product, and (ii) dry commercial shank or hock has been completely re- gelatin or the jelly resulting from its moved, thus eliminating the entire use. tibia and fibula, or radius and ulna, re- (9) Product (other than canned prod- spectively, together with the overlying uct) labeled with the term ‘‘loaf’’ as muscle, skin, and other tissue. part of its name: (i) If distributed from the official es- (15) Such terms as ‘‘meat extract’’ or tablishment in consumer size con- ‘‘extract of beef’’ without qualification tainers may be in any shape; shall not be used on labels in connec- (ii) If distributed in a container of a tion with products prepared from or- size larger than that sold intact at re- gans or other parts of the carcass, tail the product shall be prepared in other than fresh meat. Extracts pre- rectangular form, or as in paragraph pared from any parts of the carcass (b)(9)(iii) of this section; other than fresh meat may be properly (iii) If labeled as an ‘‘Old Fashioned labeled as extracts with the true name Loaf’’ shall be prepared in a traditional of the parts from which prepared. In form, such as rectangular with rounded the case of extract in fluid form, the top or circular with flat bottom and word ‘‘fluid’’ shall also appear on the rounded top. label, as, for example, ‘‘fluid extract of (10) The term ‘‘baked’’ shall apply beef.’’ only to product which has been cooked (16) [Reserved] by the direct action of dry heat and for (17) When any product is enclosed in a sufficient time to permit the product a container along with a packing sub- to assume the characteristics of a stance such as brine, vinegar, or agar baked article, such as the formation of jelly, a declaration of the packing sub- a brown crust on the surface, rendering stance shall be printed prominently on out of surface fat, and the the label as part of the name of the caramelization of the sugar if applied. product, as for example, ‘‘frankfurts Baked loaves shall be heated to a tem- packed in brine,’’ ‘‘lamb tongue packed perature of at least 160 °F. and baked in vinegar,’’ or ‘‘beef tongue packed in pork cuts shall be heated to an internal agar jelly,’’ as the case may be. The temperature of at least 170 °F. packing substance shall not be used in (11) When products such as loaves are such a manner as will result in the con- browned by dipping in hot edible oil or tainer being so filled as to be mis- by a flame, the label shall state such leading. fact, e.g., by the words ‘‘Browned in (18) ‘‘Leaf lard’’ is lard prepared from Hot Cottonseed Oil’’ or ‘‘Browned by a fresh leaf fat.

177

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00187 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.8 9 CFR Ch. III (1–1–08 Edition)

(19) When lard or hardened lard is or colored oleomargarine (21 U.S.C. 347) mixed with rendered pork fat or hard- which are set forth herein as footnote. 1 ened rendered pork fat, the mixture shall be designated as ‘‘rendered pork 1 ‘‘Sec. 407(a) Colored oleomargarine or col- fat’’ or ‘‘hardened rendered pork fat,’’ ored margarine which is sold in the same as the case may be. State or Territory in which it is produced (20) Oil, stearin, or stock obtained shall be subject in the same manner and to the same extent to the provisions of this Act from beef or mutton fats rendered at a as if it had been introduced in interstate temperature above 170 °F. shall not be commerce. designated as ‘‘oleo oil,’’ ‘‘oleo ste- (b) No person shall sell, or offer for sale, arin,’’ or ‘‘oleo stock,’’ respectively. colored oleomargarine or colored margarine (21) When not more than 20 percent of unless— beef fat, mutton fat, oleo stearin, vege- (1) Such oleomargarine or margarine is packaged, table stearin, or hardened vegetable fat (2) The net weight of the contents of any is mixed with lard or with rendered package sold in a retail establishment is one pork fat, there shall appear on the pound or less, label, contiguous to and in the same (3) There appears on the label of the pack- size and style of lettering as the name age (A) The word ‘oleomargarine’ or ‘mar- of the product, the words ‘‘beef fat garine’ in type or lettering at least as large added,’’ ‘‘mutton fat added,’’ ‘‘oleo ste- as any other type or lettering on such label, and (B) A full and accurate statement of all arin added,’’ ‘‘vegetable stearin added,’’ the ingredients contained in such oleo- or ‘‘hardened vegetable fat added,’’ as margarine, or margarine, and the case may be. If more than 20 per- (4) Each part of the contents of the pack- cent is added, the product name shall age is contained in a wrapper which bears refer to the particular animal fat or the word ‘oleomargarine’ or ‘margarine’ in fats used, such as, ‘‘Lard and Beef type or lettering not smaller than 20-point Fat.’’ The designation ‘‘vegetable fat’’ type. The requirements of this subsection shall is applicable to vegetable oil, vegetable be in addition to and not in lieu of any of the stearin, or a combination of such oil other requirements of this Act. and stearin, whereas the designations (c) No person shall possess in a form ready ‘‘vegetable oil’’ and ‘‘vegetable ste- for serving colored oleomargarine or colored arin’’ shall be applicable only to the oil margarine at a public eating place unless a and the stearin respectively, when used notice that oleomargarine or margarine is in meat food products. served is displayed prominently and conspicuously in such place and in such manner (22) Cooked, cured, or pickled pigs as to render it likely to be read and under- feet, pigs knuckles, and similar prod- stood by the ordinary individual being served ucts, shall be labeled to show that the in such eating place or is printed or is other- bones remain in the product, if such is wise set forth on the menu in type or let- the case. The designation ‘‘semi- tering not smaller than that normally used boneless’’ shall not be used if less than to designate the serving of other food items. 50 percent of the total weight of bones No person shall serve colored oleomargarine has been removed. or colored margarine at a public eating place, whether or not any charge is made (23) When monoglycerides, therefor, unless (1) each separate serving diglycerides, and/or polyglycerol esters bears or is accompanied by labeling identi- of fatty acids are added to rendered fying it as oleomargarine or margarine, or animal fat or a combination of such fat (2) each separate serving thereof is tri- and vegetable fat, there shall appear on angular in shape. the label in a prominent manner and (d) Colored oleomargarine or colored mar- contiguous to the name of the product garine when served with meals at a public eating place shall at the time of such service a statement such as ‘‘With be exempt from the labeling requirements of Monoglycerides and Diglycerides section 343 of this Act (except subsection (a) Added,’’ or ‘‘With Diglycerides and and (f) of section 343 of this title) if it com- Monoglycerides,’’ or ‘‘With plies with the requirements of subsection (b) Polyglycerol Esters of Fatty Acids’’ as of this section. the case may be. (e) For the purpose of this section colored (24) Section 407 of the Federal Food, oleomargarine or colored margarine is oleomargarine or margarine having a tint or Drug, and Cosmetic Act contains provi- shade containing more than one and six sions with respect to colored margarine tenths degrees of yellow or of yellow and red

178

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00188 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.8

(25) When approved proteolytic en- ance with § 318.6(b)(8) of this subchapter zymes as permitted in part 318 of this shall be identified with product names subchapter are used on steaks or other that refer to such ingredients, as for raw meat cuts, there shall appear on instance, ‘‘Chitterling Loaf,’’ the label, in a prominent manner, con- ‘‘Chitterling Pie,’’ or ‘‘Calf Chitterlings tiguous to the product name, the state- and Gravy,’’ and shall be packed in ment, ‘‘Tenderized with [approved en- containers having a capacity of 3 zyme],’’ to indicate the use of such en- pounds or less and of a kind usually zymes. Any other approved substance sold at retail intact and bearing such which may be used in the solution shall other information as is required by this also be included in the statement. part. When approved inorganic chlorides as (31) Products that contain blood from permitted in part 318 of this subchapter livestock as permitted by part 318 of are used on steaks or other raw meat this subchapter shall be labeled with a cuts there shall appear on the label in name that includes the term ‘‘blood,’’ a prominent manner, contiguous to the and the specific kind of blood shall be product name, the statement, ‘‘Ten- declared in the ingredient statement, derized with (names of approved inor- e.g., ‘‘Swine blood,’’ in the manner re- ganic chloride(s))’’ to indicate the use quired by this part. of such inorganic chlorides. Any other (32) A calendar date may be shown on approved substance which may be in labeling when declared in accordance the solution shall also be included in with the provisions of this subpara- the statement. graph: (26) When dimethylpolysiloxan is (i) The calendar date shall express added as an antifoaming agent to ren- the month of the year and the day of dered fats, its presence shall be de- the month for all products and also the clared on the label contiguous to the year in the case of products hermeti- name of the product. Such declaration cally sealed in metal or glass con- shall read ‘‘Dimethylpolysiloxan tainers, dried or frozen products, or Added.’’ (27) When pizzas are formulated with any other products that the Adminis- crust containing calcium propionate or trator finds should be labeled with the sodium propionate, there shall appear year because the distribution and mar- on the label contiguous to the name of keting practices with respect to such the product the statement ‘‘llll products may cause a label without a added to retard spoilage of crust’’ pre- year identification to be misleading. ceded by the name of the preservative. (ii) Immediately adjacent to the cal- (28) Sausage of the dry varieties endar date shall be a phrase explaining treated with potassium sorbate or the meaning of such date, in terms of propylparaben (propyl p-hydroxy- ‘‘packing’’ date, ‘‘sell by’’ date, or ‘‘use benzoate) as permitted by part 318 of before’’ date, with or without a further this subchapter, shall be marked or la- qualifying phrase, e.g., ‘‘For Maximum beled with a statement disclosing such Freshness’’ or ‘‘For Best Quality’’, and treatment and the purpose thereof, such phrases shall be approved by the such as ‘‘dipped in a potassium sorbate Administrator as prescribed in § 317.4. solution to retard mold growth.’’ (33) [Reserved] (29) Meat of goats shall be identified (34) The terms ‘‘All,’’ ‘‘Pure,’’ as goat meat or chevon. ‘‘100%,’’ and terms of similar connota- (30) The term ‘‘Chitterlings’’ shall tion shall not be used on labels for apply to the large intestines of swine, products to identify ingredient con- or young bovine animals when preceded tent, unless the product is prepared with the word ‘‘Calf’’ or ‘‘Veal.’’ Meat solely from a single ingredient. food products that contain chitterlings (35) When agar-agar is used in canned or calf or veal chitterlings, in accord- jellied meat food products, as permitted in part 318 of this subchapter, collectively, but with an excess of yellow there shall appear on the label in a over red, measured in terms of Lovibond prominent manner, contiguous to the tintometer scale or its equivalent’’ (21 U.S.C. product name, a statement to indicate 347). the use of agar-agar.

179

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00189 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.9 9 CFR Ch. III (1–1–08 Edition)

(36) When sodium alginate, calcium portation or received for transpor- carbonate, and lactic acid and calcium tation in commerce. carbonate (or glucono delta-lactone) are used together in a dry binding ma- § 317.10 Reuse of official inspection trix in restructured, formed meat food marks; reuse of containers bearing products, as permitted in part 318 of official marks, labels, etc. this subchapter, there shall appear on (a) No official inspection legend or the label contiguous to the product other official mark which has been pre- name, a statement to indicate the use viously used shall be used again for the of sodium alginate, calcium carbonate identification of any product, except as and lactic acid and calcium carbonate provided for in paragraph (b) of this (or glucono delta-lactone). section. (37) The labels of sausages encased in (b) All stencils, marks, labels, or natural casings made from meat or other labeling on previously used con- poultry viscera shall identify the type tainers, whether relating to any prod- of meat or poultry from which the cas- uct or otherwise, shall be removed or ings were derived, if the casings are obliterated before such containers are from a different type of meat or poul- used for any product, unless such label- try than the encased meat or poultry. ing correctly indicates the product to The identity of the casing, if required, be packed therein and such containers may be placed on the principal display are refilled under the supervision of a panel or in the ingredient statement. Program employee. Establishments producing, manufacturing, or using natural sausage cas- § 317.11 Labeling, filling of containers, ings are to maintain records docu- handling of labeled products to be menting the meat or poultry source in only in compliance with regula- accordance with part 320 of this chap- tions. ter. (a) No person shall in any official es- (38) The labels of sausages encased in tablishment apply or affix, or cause to regenerated collagen casings shall dis- be applied or affixed, any label to any close this fact on the product label. product prepared or received in such The fact that the sausage is encased in establishment, or to any container collagen may be placed on the prin- thereof, or fill any container at such an cipal display panel or in the ingredient establishment, except in compliance statement. with the regulations in this sub- (39) When transglutaminase enzyme chapter. is used to bind pieces of meat to form (b) No covering or other container a cut of meat, or to reform a piece of shall be filled, in whole or in part, at meat from a multiple cuts, there shall any official establishment with any appear on the label, as part of the prod- product unless it has been inspected uct name, a statement that indicates and passed in compliance with the reg- that the product has been ‘‘formed’’ or ulations in this subchapter, is not adul- ‘‘reformed,’’ in addition to other prepa- terated, and is strictly in accordance ration steps, e.g., ‘‘Formed Beef Ten- with the statements on the label, and derloin’’ or ‘‘Reformed and Shaped Beef such filling is done under the super- Tenderloin.’’ vision of a Program employee. [35 FR 15580, Oct. 3, 1970] (c) No person shall remove, or cause to be removed from an official estab- EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 317.8, see the List of CFR lishment any product bearing a label Sections Affected, which appears in the unless such label is in compliance with Finding Aids section of the printed volume the regulations in this subchapter, or and on GPO Access. any product not bearing a label required by such regulations. § 317.9 Labeling of equine products. The immediate containers of any § 317.12 Relabeling products; require- equine products shall be labeled to ments. show the kinds of animals from which When it is claimed by an official es- derived when the products are sold, tablishment that any of its products transported, offered for sale or trans- which bore labels bearing official

180

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00190 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.17

marks has been transported to a loca- labeling provided such labeling is not tion other than an official establish- false or misleading. ment, and it is desired to relabel the [37 FR 4071, Feb. 26, 1972] product because the labels have become mutilated or otherwise damaged, § 317.17 Interpretation and statement a request for relabeling the product of labeling policy for cured prod- shall be sent to the Administrator, ac- ucts; special labeling requirements companied with a statement of the rea- concerning nitrate and nitrite. sons therefor. Labeling material in- (a) With respect to sections 1(n) (7), tended for relabeling inspected and (9), and (12) of the Act and § 317.2, any passed product shall not be transported substance mixed with another sub- from an official establishment until stance to cure a product must be iden- permission has been received from the Administrator. The relabeling of in- tified in the ingredients statement on spected and passed product with labels the label of such product. For example, bearing any official marks shall be curing mixtures composed of such in- done under the supervision of a Pro- gredients as water, salt, sugar, sodium gram inspector. The official establish- phosphate, sodium nitrate, and sodium ment shall reimburse the Program, in nitrite or other permitted substances accordance with the regulations of the which are added to any product, must Department, for any cost involved in be identified on the label of the prod- supervising the relabeling of such product by listing each such ingredient in uct. accordance with the provisions of § 317.2. § 317.13 Storage and distribution of la- (b) Any product, such as bacon and bels and containers bearing official pepperoni, which is required to be la- marks. beled by a common or usual name or Labels, wrappers, and containers descriptive name in accordance with bearing any official marks, with or § 317.2(c)(1) and to which nitrate or ni- without the establishment number, trite is permitted or required to be may be transported from one official added may be prepared without nitrate establishment to any other official es- or nitrite and labeled with such com- tablishment provided such shipments mon or usual name or descriptive name are made with the prior authorization when immediately preceded with the of the inspector in charge at point of term ‘‘Uncured’’ as part of the product origin, who will notify the inspector in name in the same size and style of let- charge at destination concerning the tering as the product name, provided date of shipment, quantity, and type of that the product is found by the Ad- labeling material involved. No such ministrator to be similar in size, fla- material shall be used at the establish- vor, consistency, and general appear- ment to which it is shipped unless such ance to such product as commonly pre- use conforms with the requirements of pared with nitrate or nitrite, or both. this subchapter. (c)(1) Products described in paragraph (b) of this section or § 319.2 of §§ 317.14–317.15 [Reserved] this subchapter, which contain no ni- § 317.16 Labeling and containers of trate or nitrite shall bear the state- custom prepared products. ment ‘‘No Nitrate or Nitrite Added.’’ This statement shall be adjacent to the Products that are custom prepared under § 303.1(a)(2) of this subchapter product name in lettering of easily must be packaged immediately after readable style and at least one-half the preparation and must be labeled (in size of the product name. lieu of information otherwise required (2) Products described in paragraph by this part 317) with the words ‘‘Not (b) of this section and § 319.2 of this For Sale’’ in lettering not less than subchapter shall bear, adjacent to the three-eighth inch in height. Such ex- product name in lettering of easily empted custom prepared products or readable style and at least one-half the their containers may bear additional

181

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00191 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.18 9 CFR Ch. III (1–1–08 Edition)

size of the product name, the state- Handbook cited herein will be pub- ment ‘‘Not Preserved—Keep Refrig- lished in the FEDERAL REGISTER. Copies erated Below 40 °F. At All Times’’ un- may be purchased from the Super- less they have been thermally proc- intendent of Documents, U.S. Govern- essed to Fo 3 or more; they have been ment Printing Office, Washington, DC fermented or pickled to pH of 4.6 or 20402. It is also available for inspection less; or they have been dried to a water at the National Archives and Records activity of 0.92 or less. Administration (NARA). For informa- (3) Products described in paragraph tion on the availability of this mate- (b) of this section and § 319.2 of this rial at NARA, call 202–741–6030, or go subchapter shall not be subject to the to: http://www.archives.gov/ labeling requirements of paragraphs (b) federallregister/ and (c) of this section if they contain codeloflfederallregulations/ an amount of salt sufficient to achieve ibrllocations.html. a brine concentration of 10 percent or (b) The following NBS Handbook 133 more. requirements are not incorporated by reference. [37 FR 16863, Aug. 22, 1972, as amended at 44 FR 48961, Aug. 21, 1979] Chapter 2—General Considerations § 317.18 Quantity of contents labeling. 2.13.1 Polyethylene Sheeting and Film 2.13.2 Textiles Sections 317.18 through 317.22 of this 2.13.3 Mulch part prescribe the procedures to be followed for determining net weight com- Chapter 3—Methods of Test for Packages Labeled by Weight pliance and prescribe the reasonable variations from the declared net 3.11. Aerosol Packages weight on the labels of immediate con- 3.14. Glazed Raw Seafood and Fish 3.15. Canned Coffee tainers of products in accordance with 3.16. Borax § 317.2(h) of this part. 3.17. Flour [55 FR 49834, Nov. 30, 1990] Chapter 4—Methods of Test for Packages Labeled by Volume § 317.19 Definitions and procedures for determining net weight compliance. 4.7. Milk 4.8. Mayonnaise and Salad Dressing (a) For the purpose of §§ 317.18 4.9. Paint, Varnish, and Lacquers—Nonaer- through 317.22 of this part, the reason- osol able variations allowed, definitions, 4.11. Peat Moss and procedures to be used in deter- 4.12. Bark Mulch mining net weight and net weight com- 4.15. Ice Cream Novelties pliance are described in the National Chapter 5—Methods of Test for Packages La- Institute of Standards and Technology beled by Count, Length, Area, Thickness, (NIST) Handbook 133, ‘‘Checking the or Combinations of Quantities Net Contents of Packaged Goods,’’ 5.4. Polyethylene Sheeting Third Edition, September 1988, and 5.5. Paper Plates Supplements 1, 2, 3, and 4 dated Sep- 5.6. Sanitary Paper Products tember 1990, October 1991, October 1992, 5.7. Pressed and Blown Glass Tumblers and and October 1994, respectively, which Stemware are incorporated by reference, with the Appendix D: Package Net Contents exception of the NIST Handbook 133 Regulations and Supplements 1, 3, and 4 requirements listed in paragraphs (b) and (c) D.1.1. U.S. Department of Health and Human Services, Food and Drug Adminis- of this section. Those provisions incor- tration porated by reference herein, are consid- D.1.2. Department of Agriculture, Food ered mandatory requirements. This in- Safety and Inspection Service corporation was approved by the Direc- D.1.3. Federal Trade Commission tor of the Federal Register in accord- D.1.4. Environmental Protection Agency ance with 5 U.S.C. 552(a) and 1 CFR D.1.5. U.S. Department of the Treasury, Bu- part 51. (These materials are incor- reau of Alcohol, Tobacco, and Firearms porated as they exist on the date of ap- (c) The following requirements of proval.) A notice of any change in the Supplement 1, dated September 1990,

182

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00192 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.21

Supplement 3, dated October 1992, and curate weights. Such scales shall meet Supplement 4, dated 1994, of NIST the applicable requirements contained Handbook 133 are not incorporated by in National Institute of Standards and reference. Technology Handbook 44, ‘‘Specifica- tions, Tolerances, and Other Technical Supplement 1 Requirements for Weighing and Meas- Chapter 2 General Considerations uring Devices’’, 1999 Edition, November 1998, which is incorporated by ref- 2.13.1. Polyethylene Sheeting and Film 2.13.2. Textiles erence. This incorporation was ap- 2.13.3. Mulch proved by the Director of the Federal Register in accordance with 5 U.S.C. Chapter 3 Methods of Test for Packages 552(a) and 1 CFR part 51. (These mate- Labeled by Weight rials are incorporated as they exist on 3.11.4. Exhausting the Aerosol Container the date of approval.) Copies may be purchased from the Superintendent of Chapter 4 Methods of Test for Packages Documents, U.S. Government Printing Labeled by Volume Office, Washington, DC 20402. It is also 4.6.4. Method D: Determining the Net Con- available for inspection at the National tents of Compressed Gas in Cylinders Archives and Records Administration 4.7. Milk (NARA). For information on the avail- 4.16. Fresh Oysters Labeled by Volume ability of this material at NARA, call Chapter 5 Methods of Test for Packages La- 202–741–6030, or go to: http:// beled by Count, Length, Area, Thickness, www.archives.gov/federallregister/ or Combinations of Quantities codeloflfederallregulations/ 5.4. Polyethylene Sheeting ibrllocations.html. (b) All scales used to weigh meat Supplement 3 products sold or otherwise distributed Chapter 3 Methods of Test for Packages in commerce or in States designated Labeled by Weight under section 301(c) of the Federal Meat Inspection Act, shall be of suffi- 3.17. Flour and Dry Pet Food cient capacity to weigh the entire unit Chapter 5 Methods of Test for Packages La- and/or package. beled by Count, Length, Area, Thickness, (c) No scale shall be used at a feder- or Combination of Quantities ally inspected establishment to weigh 5.4. Polyethylene Sheeting meat products unless it has been found 5.5. Paper Plates upon test and inspection, as specified 5.8. Baler Twine in NIST Handbook 44, to provide accu- Appendix A. Forms and Worksheets rate weight. If a scale is reinspected or retested and found to be inaccurate, or Supplement 4 if any repairs, adjustments or replace- 3.11 Aerosol Packages ments are made to a scale, it shall not 3.11.1 Equipment be used until it has been inspected and 3.11.2 Preparation for Test tested by a USDA official, or a State or 3.11.3 The Determination of Net Contents: local government weights and meas- Part 1 3.11.4 Exhausting the Aerosol Container ures official, or State registered or li- 3.11.5 The Determination of Net Contents: censed scale repair firm or person, and Part 2 it must meet all accuracy require- Appendix A. Report Forms ments as specified in NIST Handbook 44. If a USDA inspector has put a retain [55 FR 49834, Nov. 30, 1990, as amended at 60 FR 12884, March 9, 1995] tag on a scale it can only be removed by a USDA inspector. As long as the § 317.20 Scale requirements for accu- tag is on the scale, it shall not be used. rate weights, repairs, adjustments, [55 FR 49834, Nov. 30, 1990, as amended at 60 and replacement after inspection. FR 12884, Mar. 9, 1995; 64 FR 53187, Oct. 1, (a) All scales used to weigh meat 1999] products sold or otherwise distributed in commerce in federally inspected § 317.21 Scales: testing of. meat establishments shall be installed, (a) The operator of each official es- maintained and operated to insure ac- tablishment that weighs meat food

183

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00193 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.22 9 CFR Ch. III (1–1–08 Edition)

products shall cause such scales to be deleterious substances which may tested for accuracy, in accordance with render the contents adulterated or in- the technical requirements of NIST jurious to health. All packaging mate- Handbook 44, at least once during the rials must be safe for their intended calendar year. In cases where the use within the meaning of section 409 scales are found not to maintain accu- of the Federal Food, Drug, and Cos- racy between tests, more frequent tests metic Act, as amended (FFDCA). may be required and monitored by an (b) Packaging materials entering the authorized USDA program official. official establishment must be accom- (b) The operator of each official es- panied or covered by a guaranty, or tablishment shall display on or near statement of assurance, from the pack- each scale a valid certification of the aging supplier under whose brand name scale’s accuracy from a State or local and firm name the material is mar- government’s weights and measures keted to the official establishment. authority or from a State registered or The guaranty shall state that the ma- licensed scale repair firm or person, or shall have alternative documented pro- terial’s intended use complies with the cedures showing that the scale has FFDCA and all applicable food additive been tested for accuracy in accordance regulations. The guaranty must iden- with the requirements of NIST Hand- tify the material, e.g., by the distin- book 44. guishing brand name or code designation appearing on the packaging mate- [55 FR 49834, Nov. 30, 1990, as amended at 62 rial shipping container; must specify FR 45024, Aug. 25, 1997; 65 FR 34389, May 30, the applicable conditions of use, in- 2000; 66 FR 52486, Oct. 16, 2001] cluding temperature limits and any § 317.22 Handling of failed product. other pertinent limits specified under the FFDCA and food additive regula- Any lot of product which is found to be out of compliance with net weight tions; and must be signed by an author- requirements upon testing in accord- ized official of the supplying firm. The ance with § 317.19 shall be handled as guaranty may be limited to a specific follows: shipment of an article, in which case it (a) A lot tested in an official estab- may be part of or attached to the in- lishment and found not to comply with voice covering such shipment, or it net weight requirements may be re- may be general and continuing, in processed and must be reweighed and which case, in its application to any remarked to satisfy the net weight re- article or other shipment of an article, quirements of this section and be rein- it shall be considered to have been spected, in accordance with the re- given at the date such article was quirements of this part. shipped by the person who gives the (b) A lot tested outside of an official guaranty. Guaranties consistent with establishment and found not to comply the Food and Drug Administration’s with net weight requirements must be regulations regarding such guaranties reweighed and remarked with a proper (21 CFR 7.12 and 7.13) will be accept- net weight statement, provided that able. The management of the establish- such reweighing and remarking shall ment must maintain a file containing not deface, cover, or destroy any other guaranties for all food contact pack- marking or labeling required under aging materials in the establishment. this subchapter and the net quantity of The file shall be made available to Pro- contents is shown with the same prom- gram inspectors or other Department inence as the most conspicuous feature officials upon request. While in the of- of a label. ficial establishment, the identity of all [55 FR 49834, Nov. 30, 1990] packaging materials must be traceable to the applicable guaranty. § 317.23 [Reserved] (c) The guaranty by the packaging supplier will be accepted by Program § 317.24 Packaging materials. inspectors to establish that the use of (a) Edible products may not be pack- material complies with the FFDCA and aged in a container which is composed all applicable food additive regula- in whole or in part of any poisonous or tions.

184

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00194 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.302

(d) The Department will monitor the distinguishing brand name or code des- use of packaging material in official ignation, of packaging materials that establishments to assure that the re- have been reviewed and that fail to quirements of paragraph (a) of this sec- meet the requirements of paragraph (a) tion are met, and may question the of this section. Listed materials will basis for any guaranty described under not be permitted for use in official es- paragraph (b) of this section. Official tablishments. If a subsequent review of establishments and packaging sup- any material indicates that it meets pliers providing written guaranties to the requirements of paragraph (a), the those official establishments will be material will be deleted from the list- permitted an opportunity to provide ing. information tm designated Department (g) Nothing in this section shall af- officials as needed to verify the basis fect the authority of Program inspec- for any such guaranty. The required in- tors to refuse a specific material if he/ formation will include, but is not lim- she determines the material may ited to, manufacturing firm’s name, render products adulterated or inju- trade name or code designation for the rious to health. material, complete chemical composition, and use. Selection of a material [49 FR 2235, Jan. 19, 1984. Redesignated at 55 for review does not in itself affect a FR 49833, Nov. 30, 1990] material’s acceptability. Materials may continue to be used during the re- Subpart B—Nutrition Labeling view period. However, if information requested from the supplier is not pro- SOURCE: 58 FR 664, Jan. 6, 1993, unless oth- vided within the time indicated in the erwise noted. request—a minimum of 30 days—any applicable guaranty shall cease to be § 317.300 Nutrition labeling of meat or effective, and approval to continue meat food products. using the specified packaging material (a) Nutrition labeling shall be pro- in official establishments may be de- vided for all meat or meat food prod- nied. The Administrator may extend ucts intended for human consumption this time where reasonable grounds for and offered for sale, except single-in- extension are shown, as, for example, gredient, raw products, in accordance where data must be obtained from sup- with the requirements of § 317.309; ex- pliers. cept as exempted under § 317.400 of this (e) The Administrator may dis- subpart. approve for use in official establish- (b) Nutrition labeling may be pro- ments packaging materials whose use vided for single-ingredient, raw meat cannot be confirmed as complying with or meat food products in accordance FFDCA and applicable food additive with the requirements of §§ 317.309 and regulations. Before approval to use a 317.345. Significant participation in vol- packaging material is finally denied by untary nutrition labeling shall be the Administrator, the affected official measured by the Agency in accordance establishment and the supplier of the with §§ 317.343 and 317.344 of this sub- material shall be given notice and the part. opportunity to present their views to the Administrator. If the official estab- [58 FR 664, Jan. 6, 1993, as amended at 60 FR lishment and the supplier do not accept 176, Jan. 3, 1995] the Administrator’s determination, a hearing in accordance with applicable § 317.301 [Reserved] rules of practice will be held to resolve such dispute. Approval to use the ma- § 317.302 Location of nutrition infor- terials pending the outcome of the mation. presentation of views or hearing shall (a) Nutrition information on a label be denied if the Administrator deter- of a packaged meat or meat food prod- mines that such use may present an uct shall appear on the label’s principal imminent hazard to public health. display panel or on the information (f) Periodically, the Administrator panel, except as provided in paragraphs will issue to inspectors a listing, by (b) and (c) of this section.

185

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00195 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR §§ 317.303–317.307 9 CFR Ch. III (1–1–08 Edition)

(b) Nutrition information for gift (2) Except as provided in paragraphs packs may be shown at a location (b)(8), (b)(12), and (b)(14) of this section other than on the product label, pro- and for products that are intended for vided that the labels for these products weight control and are available only bear no nutrition claim. In lieu of on through a weight-control or weight- the product label, nutrition informa- maintenance program, serving size de- tion may be provided by alternate clared on a product label shall be deter- means such as product label inserts. mined from the ‘‘Reference Amounts (c) Meat or meat food products in Customarily Consumed Per Eating Oc- packages that have a total surface area casion—General Food Supply’’ (Ref- available to bear labeling greater than erence Amount(s)) that appear in 40 square inches but whose principal § 317.312(b) using the procedures de- display panel and information panel do scribed in this paragraph (b). For prod- not provide sufficient space to accom- ucts that are both intended for weight modate all required information may control and available only through a use any alternate panel that can be weight-control program, a manufac- readily seen by consumers for the nu- turer may determine the serving size trition information. In determining the that is consistent with the meal plan of sufficiency of available space for the the program. Such products must bear nutrition information, the space need- a statement, ‘‘for sale only through the ed for vignettes, designs, and other lll program’’ (fill in the blank with nonmandatory label information on the name of the appropriate weight- the principal display panel may be con- control program, e.g., Smith’s Weight sidered. Control), on the principal display [58 FR 664, Jan. 6, 1993, as amended at 59 FR panel. However, the Reference 40213, Aug. 8, 1994; 60 FR 176, Jan. 3, 1995] Amounts in § 317.312(b) shall be used for purposes of evaluating whether weight- §§ 317.303–317.307 [Reserved] control products that are available only through a weight-control program § 317.308 Labeling of meat or meat qualify for nutrition claims. food products with number of servings. (3) The declaration of nutrient and food component content shall be on the The label of any package of a meat or basis of the product ‘‘as packaged’’ for meat food product that bears a rep- all products, except that single-ingre- resentation as to the number of dient, raw products may be declared on servings contained in such package the basis of the product ‘‘as consumed’’ shall meet the requirements of as set forth in § 317.345(a)(1). In addition § 317.2(h)(10). to the required declaration on the basis [58 FR 664, Jan. 6, 1993, as amended at 60 FR of ‘‘as packaged’’ for products other 176, Jan. 3, 1995] than single-ingredient, raw products, the declaration may also be made on § 317.309 Nutrition label content. the basis of ‘‘as consumed,’’ provided (a) All nutrient and food component that preparation and cooking instruc- quantities shall be declared in relation tions are clearly stated. to a serving as defined in this section. (4) For products in discrete units (b)(1) The term ‘‘serving’’ or ‘‘serving (e.g., hot dogs, and individually pack- size’’ means an amount of food custom- aged products within a multi-serving arily consumed per eating occasion by package), and for products which con- persons 4 years of age or older, which is sist of two or more foods packaged and expressed in a common household presented to be consumed together measure that is appropriate to the where the ingredient represented as the product. When the product is specially main ingredient is in discrete units formulated or processed for use by in- (e.g., beef fritters and barbecue sauce), fants or by toddlers, a serving or serv- the serving size shall be declared as fol- ing size means an amount of food cus- lows: tomarily consumed per eating occasion (i) If a unit weighs 50 percent or less by infants up to 12 months of age or by of the Reference Amount, the serving children 1 through 3 years of age, re- size shall be the number of whole units spectively. that most closely approximates the

186

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00196 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.309

Reference Amount for the product cat- vided for consumption, the serving size egory. shall be the fractional slice of the (ii) If a unit weighs more than 50 per- ready-to-eat product (e.g., 1⁄8 quiche, 1⁄4 cent but less than 67 percent of the pizza) that most closely approximates Reference Amount, the manufacturer the Reference Amount for the product may declare one unit or two units as category. The serving size may be the the serving size. fraction of the package used to make (iii) If a unit weighs 67 percent or the Reference Amount for the unpre- more but less than 200 percent of the pared product determined in § 317.312(d) Reference Amount, the serving size or the fraction of the large discrete shall be one unit. unit represented as the main ingre- (iv) If a unit weighs 200 percent or dient plus proportioned minor ingredi- more of the Reference Amount, the ents used to make the Reference manufacturer may declare one unit as Amount of the combined product deter- the serving size if the whole unit can mined in § 317.312(c). In expressing the reasonably be consumed at a single fractional slice, manufacturers shall eating occasion. use 1⁄2, 1⁄3, 1⁄4, 1⁄5, 1⁄6, or smaller fractions (v) For products that have Reference that can be generated by further divi- Amounts of 100 grams (or milliliter) or sion by 2 or 3. larger and are individual units within a (6) For nondiscrete bulk products multi-serving package, if a unit con- (e.g., whole roast beef, marinated beef tains more than 150 percent but less tenderloin, large can of chili), and for than 200 percent of the Reference products which consist of two or more Amount, the manufacturer may decide foods packaged and presented to be whether to declare the individual unit consumed together where the ingre- as 1 or 2 servings. dient represented as the main ingre- (vi) For products which consist of dient is a bulk product (e.g., roast beef two or more foods packaged and pre- and gravy), the serving size shall be the sented to be consumed together where amount in household measure that the ingredient represented as the main most closely approximates the Ref- ingredient is in discrete units (e.g., erence Amount for the product cat- beef fritters and barbecue sauce), the egory and may be the amount of the serving size may be the number of dis- bulk product represented as the main crete units represented as the main in- ingredient plus proportioned minor ingredient plus proportioned minor ingredients used to make the Reference gredients used to make the Reference Amount for the combined product de- Amount for the combined product as termined in § 317.312(c). determined in § 317.312(c). (7) For labeling purposes, the term (vii) For packages containing several ‘‘common household measure’’ or individual single-serving containers, ‘‘common household unit’’ means cup, each of which is labeled with all re- tablespoon, teaspoon, piece, slice, frac- quired information including nutrition tion (e.g., 1⁄4 pizza), ounce (oz), or other labeling as specified in this section common household equipment used to (i.e., are labeled appropriately for indi- package food products (e.g., jar or vidual sale as single-serving con- tray). In expressing serving size in tainers), the serving size shall be 1 household measures, except as speci- unit. fied in paragraphs (b)(7)(iv), (v), and (5) For products in large discrete (vi) of this section, the following rules units that are usually divided for con- shall be used: sumption (e.g., pizza), for unprepared (i) Cups, tablespoons, or teaspoons products where the entire contents of shall be used wherever possible and ap- the package is used to prepare large propriate. Cups shall be expressed in 1⁄4- discrete units that are usually divided or 1⁄3-cup increments, tablespoons in for consumption (e.g. pizza kit), and for whole number of tablespoons for quan- products which consist of two or more tities less than 1⁄4 cup but greater than foods packaged and presented to be or equal to 2 tablespoons (tbsp), 1, 11⁄3, consumed together where the ingre- 11⁄2, or 1 2⁄3 tbsp for quantities less than dient represented as the main ingre- 2 tbsp but greater than or equal to 1 dient is a large discrete unit usually di- tbsp, and teaspoons in whole number of

187

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00197 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.309 9 CFR Ch. III (1–1–08 Edition)

teaspoons for quantities less than 1 be a single-serving container, and the tbsp but greater than or equal to 1 tea- entire content of the product shall be spoon (tsp), and in 1⁄4-tsp increments labeled as one serving, except for prod- for quantities less than 1 tsp. ucts that have Reference Amounts of (ii) If cups, tablespoons or teaspoons 100 g (or mL) or larger, manufacturers are not applicable, units such as piece, may decide whether a package that slice, tray, jar, and fraction shall be contains more than 150 percent but less used. than 200 percent of the Reference (iii) If cups, tablespoons and Amount is 1 or 2 servings. Packages teaspoons, or units such as piece, slice, sold individually that contain 200 per- tray, jar, or fraction are not applicable, cent or more of the applicable Ref- ounces may be used. Ounce measure- erence Amount may be labeled as a sin- ments shall be expressed in 0.5-ounce gle-serving if the entire content of the increments most closely approxi- package can reasonably be consumed mating the Reference Amount with at a single-eating occasion. rounding indicated by the use of the (9) A label statement regarding a term ‘‘about’’ (e.g., about 2.5 ounces). serving shall be the serving size ex- (iv) A description of the individual pressed in common household measures container or package shall be used for as set forth in paragraphs (b)(2) single-serving containers and for indi- through (b)(8) of this section and shall vidually packaged products within be followed by the equivalent metric multi-serving containers (e.g., can, quantity in parenthesis (fluids in milli- box, package, meal, or dinner). A de- liters and all other foods in grams), ex- scription of the individual unit shall be cept for single-serving containers. used for other products in discrete (i) For a single-serving container, the units (e.g., chop, slice, link, or patty). parenthetical metric quantity, which (v) For unprepared products where will be presented as part of the net the entire contents of the package is weight statement on the principal dis- used to prepare large discrete units play panel, is not required except that are usually divided for consump- where nutrition information is re- tion (e.g., pizza kit), the fraction or quired on a drained weight basis ac- portion of the package may be used. cording to paragraph (b)(11) of this sec- (vi) For products that consist of two tion. However, if a manufacturer vol- or more distinct ingredients or compo- untarily provides the metric quantity nents packaged and presented to be on products that can be sold as single- consumed together (e.g., ham with a servings, then the numerical value pro- glaze packet), the nutrition informa- vided as part of the serving size dec- tion may be declared for each compo- laration must be identical to the met- nent or as a composite. The serving ric quantity declaration provided as size may be provided in accordance part of the net quantity of contents with the provisions of paragraphs statement. (b)(4), (b)(5), and (b)(6) of this section. (ii) The gram or milliliter quantity (vii) For nutrition labeling purposes, equivalent to the household measure a teaspoon means 5 milliliters (mL), a should be rounded to the nearest whole tablespoon means 15 mL, a cup means number except for quantities that are 240 mL, and 1 oz in weight means 28 less than 5 g (mL). The gram (mL) grams (g). quantity between 2 and 5 g (mL) should (viii) When a serving size, determined be rounded to the nearest 0.5 g (mL) from the Reference Amount in and the g (mL) quantity less than 2 g § 317.312(b) and the procedures described (mL) should be expressed in 0.1-g (mL) in this section, falls exactly half way increments. between two serving sizes (e.g., 2.5 (iii) In addition, serving size may be tbsp), manufacturers shall round the declared in ounce, in parenthesis, fol- serving size up to the next incremental lowing the metric measure separated size. by a slash where other common house- (8) A product that is packaged and hold measures are used as the primary sold individually and that contains less unit for serving size, e.g., 1 slice (28 g/ than 200 percent of the applicable Ref- 1 oz) for sliced bologna. The ounce erence Amount shall be considered to quantity equivalent to the metric

188

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00198 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.309

quantity should be expressed in 0.1-oz basis of product as packaged or pur- increments. chased with the exception of products (iv) If a manufacturer elects to use that are packed or canned in water, abbreviations for units, the following brine, or oil but whose liquid packing abbreviations shall be used: tbsp for ta- medium is not customarily consumed. blespoon, tsp for teaspoon, g for gram, Declaration of the nutrient and food mL for milliliter, and oz for ounce. component content of products that (10) Determination of the number of are packed in liquid which is not cus- servings per container shall be based tomarily consumed shall be based on on the serving size of the product de- the drained solids. termined by following the procedures (12) The serving size for meal-type described in this section. products and main-dish products as de- (i) The number of servings shall be fined in § 317.313(l) and § 317.313(m) in rounded to the nearest whole number single-serving containers will be the except for the number of servings be- entire edible content of the package. tween 2 and 5 servings and random Serving size for meal-type products and weight products. The number of main-dish products in multi-serve con- servings between 2 and 5 servings shall tainers will be based on the reference be rounded to the nearest 0.5 serving. amount applicable to the product in Rounding should be indicated by the § 317.312(b) if the product is listed in use of the term ‘‘about’’ (e.g., about 2 § 317.312(b). Serving size for meal-type servings; about 3.5 servings). products and main-dish products in (ii) When the serving size is required multi-serve containers that are not to be expressed on a drained solids listed in § 317.312(b) will be based on the basis and the number of servings varies reference amount according to because of a natural variation in unit § 317.312(c), (d), and (e). size (e.g., pickled pigs feet), the manu- (13) Another column of figures may facturer may state the typical number be used to declare the nutrient and of servings per container (e.g., usually food component information in the 5 servings). same format as required by § 317.309(e), (iii) For random weight products, a (i) Per 100 grams, 100 milliliters, or 1 manufacturer may declare ‘‘varied’’ for ounce of the product as packaged or the number of servings per container purchased. provided the nutrition information is (ii) Per one unit if the serving size of based on the Reference Amount ex- a product in discrete units in a multi- pressed in ounces. The manufacturer serving container is more than one may provide the typical number of unit. servings in parenthesis following the (14) If a product consists of assort- ‘‘varied’’ statement (e.g., varied (ap- ments of meat or meat food products proximately 8 servings per pound)). (e.g., variety packs) in the same pack- (iv) For packages containing several age, nutrient content shall be ex- individual single-serving containers, pressed on the entire package contents each of which is labeled with all re- or on each individual product. quired information including nutrition (15) If a product is commonly com- labeling as specified in this section bined with other ingredients or is (i.e., are labeled appropriately for indi- cooked or otherwise prepared before vidual sale as single-serving con- eating, and directions for such com- tainers), the number of servings shall bination or preparations are provided, be the number of individual packages another column of figures may be used within the total package. to declare the nutrient contents on the (v) For packages containing several basis of the product as consumed for individually packaged multi-serving the product alone (e.g., a cream soup units, the number of servings shall be mix may be labeled with one set of determined by multiplying the number Daily Values for the dry mix (per serv- of individual multi-serving units in the ing), and another set for the serving of total package by the number of the final soup when prepared (e.g., per servings in each individual unit. serving of cream soup mix and 1 cup of (11) The declaration of nutrient and vitamin D fortified whole milk)): Pro- food component content shall be on the vided, That the type and quantity of

189

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00199 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.309 9 CFR Ch. III (1–1–08 Edition)

the other ingredients to be added to with 5 U.S.C. 552(a) and 1 CFR part 51. the product by the user and the specific It is available for inspection at the of- method of cooking and other prepara- fice of the FSIS Docket Clerk, Room tion shall be specified prominently on 3171, South Building, 14th and Inde- the label. pendence Avenue, SW., Washington, (c) The declaration of nutrition infor- DC, or at the National Archives and mation on the label or in labeling of a Records Administration (NARA). For meat or meat food product shall con- information on the availability of this tain information about the level of the material at NARA, call 202–741–6030, or following nutrients, except for those go to: http://www.archives.gov/ nutrients whose inclusion, and the dec- federallregister/ laration of amounts, is voluntary as codeloflfederallregulations/ set forth in this paragraph. No nutri- ibrllocations.html. Copies of the incor- ents or food components other than poration by reference are available those listed in this paragraph as either from the Product Assessment Division, mandatory or voluntary may be in- Regulatory Programs, Food Safety and cluded within the nutrition label. Ex- Inspection Service, U.S. Department of cept as provided for in paragraph (f) or Agriculture, Room 329, West End Court (g) of this section, nutrient informa- Building, Washington, DC 20250–3700; tion shall be presented using the nutri- (B) Using the general factors of 4, 4, ent names specified and in the fol- and 9 calories per gram for protein, lowing order in the formats specified in total carbohydrate, and total fat, re- paragraph (d) or (e) of this section. spectively, as described in USDA’s Ag- (1) ‘‘Calories, total,’’ ‘‘Total cal- riculture Handbook No. 74 (Slightly re- ories,’’ or ‘‘Calories’’: A statement of vised February 1973), pages 9–11, which the caloric content per serving, ex- is incorporated by reference. Pages 9– pressed to the nearest 5-calorie incre- 11, Agriculture Handbook No. 74 is in- ment up to and including 50 calories, corporated as it exists on the date of and 10-calorie increment above 50 cal- approval. This incorporation by ref- ories, except that amounts less than 5 erence was approved by the Director of calories may be expressed as zero. En- the Federal Register in accordance ergy content per serving may also be with 5 U.S.C. 552(a) and 1 CFR part 51. expressed in kilojoule units, added in (The availability of this incorporation parenthesis immediately following the by reference is given in paragraph statement of the caloric content. (c)(1)(i)(A) of this section.); (i) Caloric content may be calculated (C) Using the general factors of 4, 4, by the following methods. Where either and 9 calories per gram for protein, specific or general food factors are total carbohydrate less the amount of used, the factors shall be applied to the insoluble dietary fiber, and total fat, actual amount (i.e., before rounding) of respectively, as described in USDA’s food components (e.g., fat, carbo- Agriculture Handbook No. 74 (Slightly hydrate, protein, or ingredients with revised February 1973), pages 9–11, specific food factors) present per serv- which is incorporated by reference in ing. accordance with 5 U.S.C. 552(a) and 1 (A) Using specific Atwater factors CFR part 51. (The availability of this (i.e., the Atwater method) given in incorporation by reference is given in Table 13, page 25, ‘‘Energy Value of paragraph (c)(1)(i)(A) of this section.); Foods—Basis and Derivation,’’ by A. L. or Merrill and B. K. Watt, United States (D) Using data for specific food fac- Department of Agriculture (USDA), tors for particular foods or ingredients Agriculture Handbook No. 74 (Slightly approved by the Food and Drug Admin- revised February 1973), which is incor- istration (FDA) and provided in parts porated by reference. Table 13 of the 172 or 184 of 21 CFR, or by other means, ‘‘Energy Value of Foods—Basis and as appropriate. Derivation,’’ Agriculture Handbook No. (ii) ‘‘Calories from fat’’: A statement 74 is incorporated as it exists on the of the caloric content derived from date of approval. This incorporation by total fat as defined in paragraph (c)(2) reference was approved by the Director of this section per serving, expressed to of the Federal Register in accordance the nearest 5-calorie increment, up to

190

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00200 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.309

and including 50 calories, and the near- acid content shall be indented under est 10-calorie increment above 50 cal- saturated fat and expressed to the ories, except that label declaration of nearest 0.5 (1⁄2)-gram increment below 5 ‘‘calories from fat’’ is not required on grams and the nearest gram increment products that contain less than 0.5 above 5 grams. If the serving contains gram of fat per serving and amounts less than 0.5 gram, the content shall be less than 5 calories may be expressed as expressed as zero. zero. This statement shall be declared (B) [Reserved] as provided in paragraph (d)(5) of this (ii) ‘‘Polyunsaturated fat’’ or ‘‘Poly- section. unsaturated’’ (VOLUNTARY): A state- (iii) ‘‘Calories from saturated fat’’ or ment of the number of grams of poly- ‘‘Calories from saturated’’ (VOL- unsaturated fat per serving defined as UNTARY): A statement of the caloric cis,cis-methylene-interrupted poly- content derived from saturated fat as unsaturated fatty acids may be de- defined in paragraph (c)(2)(i) of this clared voluntarily, except that when section per serving may be declared monounsaturated fat is declared, or voluntarily, expressed to the nearest 5- when a claim about fatty acids or cho- calorie increment, up to and including lesterol is made on the label or in la- 50 calories, and the nearest 10-calorie beling of a product other than one that increment above 50 calories, except meets the criteria in § 317.362(b)(1) for a that amounts less than 5 calories may claim for ‘‘fat free,’’ label declaration be expressed as zero. This statement of polyunsaturated fat is required. shall be indented under the statement Polyunsaturated fat content shall be of calories from fat as provided in para- indented and expressed as grams per graph (d)(5) of this section. serving to the nearest 0.5 (1⁄2)-gram in- (2) ‘‘Fat, total’’ or ‘‘Total fat’’: A crement below 5 grams and to the near- statement of the number of grams of est gram increment above 5 grams. If total fat per serving defined as total the serving contains less than 0.5 gram, lipid fatty acids and expressed as the content shall be expressed as zero. triglycerides. Amounts shall be ex- (iii) ‘‘Monounsaturated fat’’ or pressed to the nearest 0.5 (1⁄2)-gram in- ‘‘Monounsaturated’’ (VOLUNTARY): A crement below 5 grams and to the near- statement of the number of grams of est gram increment above 5 grams. If monounsaturated fat per serving de- the serving contains less than 0.5 gram, fined as cis-monounsaturated fatty the content shall be expressed as zero. acids may be declared voluntarily, ex- (i) ‘‘Saturated fat’’ or ‘‘Saturated’’: A cept that when polyunsaturated fat is statement of the number of grams of declared, or when a claim about fatty saturated fat per serving defined as the acids or cholesterol is made on the sum of all fatty acids containing no label or in labeling of a product other double bonds, except that label dec- than one that meets the criteria in laration of saturated fat content infor- § 317.362(b)(1) for a claim for ‘‘fat free,’’ mation is not required for products label declaration of monounsaturated that contain less than 0.5 gram of total fat is required. Monounsaturated fat fat per serving if no claims are made content shall be indented and expressed about fat or cholesterol content, and if as grams per serving to the nearest 0.5 ‘‘calories from saturated fat’’ is not de- (1⁄2)-gram increment below 5 grams and clared. Saturated fat content shall be to the nearest gram increment above 5 indented and expressed as grams per grams. If the serving contains less than serving to the nearest 0.5 (1⁄2)-gram in- 0.5 gram, the content shall be expressed crement below 5 grams and to the near- as zero. est gram increment above 5 grams. If (3) ‘‘Cholesterol’’: A statement of the the serving contains less than 0.5 gram, cholesterol content per serving ex- the content shall be expressed as zero. pressed in milligrams to the nearest 5- (A) ‘‘Stearic Acid’’ (VOLUNTARY): A milligram increment, except that label statement of the number of grams of declaration of cholesterol information stearic acid per serving may be de- is not required for products that con- clared voluntarily, except that when a tain less than 2 milligrams of choles- claim is made about stearic acid, label terol per serving and make no claim declaration shall be required. Stearic about fat, fatty acids, or cholesterol

191

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00201 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.309 9 CFR Ch. III (1–1–08 Edition)

content, or such products may state (i) ‘‘Dietary fiber’’: A statement of the cholesterol content as zero. If the the number of grams of total dietary product contains 2 to 5 milligrams of fiber per serving, indented and ex- cholesterol per serving, the content pressed to the nearest gram, except may be stated as ‘‘less than 5 milli- that if a serving contains less than 1 grams.’’ gram, declaration of dietary fiber is (4) ‘‘Sodium’’: A statement of the not required, or, alternatively, the number of milligrams of sodium per statement ‘‘Contains less than 1 gram’’ serving expressed as zero when the or ‘‘less than 1 gram’’ may be used, and serving contains less than 5 milligrams if the serving contains less than 0.5 of sodium, to the nearest 5-milligram gram, the content may be expressed as increment when the serving contains 5 zero. to 140 milligrams of sodium, and to the (A) ‘‘Soluble fiber’’ (VOLUNTARY): nearest 10-milligram increment when A statement of the number of grams of the serving contains greater than 140 soluble dietary fiber per serving may milligrams. be declared voluntarily except when a (5) ‘‘Potassium’’ (VOLUNTARY): A claim is made on the label or in label- statement of the number of milligrams ing about soluble fiber, label declara- of potassium per serving may be de- tion shall be required. Soluble fiber clared voluntarily, except that when a content shall be indented under dietary claim is made about potassium con- fiber and expressed to the nearest tent, label declaration shall be re- gram, except that if a serving contains quired. Potassium content shall be ex- less than 1 gram, the statement ‘‘Con- pressed as zero when the serving contains less than 1 gram’’ or ‘‘less than 1 tains less than 5 milligrams of potas- gram’’ may be used as an alternative, sium, to the nearest 5-milligram incre- and if the serving contains less than 0.5 ment when the serving contains 5 to gram, the content may be expressed as 140 milligrams of potassium, and to the zero. nearest 10-milligram increment when (B) ‘‘Insoluble fiber’’ (VOLUNTARY): the serving contains greater than 140 A statement of the number of grams of milligrams. insoluble dietary fiber per serving may (6) ‘‘Carbohydrate, total’’ or ‘‘Total be declared voluntarily except when a carbohydrate’’: A statement of the claim is made on the label or in label- number of grams of total carbohydrate ing about insoluble fiber, label declara- per serving expressed to the nearest tion shall be required. Insoluble fiber gram, except that if a serving contains content shall be indented under dietary less than 1 gram, the statement ‘‘Con- fiber and expressed to the nearest tains less than 1 gram’’ or ‘‘less than 1 gram, except that if a serving contains gram’’ may be used as an alternative, less than 1 gram, the statement ‘‘Con- or, if the serving contains less than 0.5 tains less than 1 gram’’ or ‘‘less than 1 gram, the content may be expressed as gram’’ may be used as an alternative, zero. Total carbohydrate content shall and if the serving contains less than 0.5 be calculated by subtraction of the sum gram, the content may be expressed as of the crude protein, total fat, mois- zero. ture, and ash from the total weight of (ii) ‘‘Sugars’’: A statement of the the product. This calculation method is number of grams of sugars per serving, described in USDA’s Agriculture Hand- except that label declaration of sugars book No. 74 (Slightly revised February content is not required for products 1973), pages 2 and 3, which is incor- that contain less than 1 gram of sugars porated by reference. Pages 2 and 3, Ag- per serving if no claims are made about riculture Handbook No. 74 is incor- sweeteners, sugars, or sugar alcohol porated as it exists on the date of ap- content. Sugars shall be defined as the proval. This incorporation by reference sum of all free mono- and disaccharides was approved by the Director of the (such as glucose, fructose, lactose, and Federal Register in accordance with 5 sucrose). Sugars content shall be in- U.S.C. 552(a) and 1 CFR part 51. (The dented and expressed to the nearest availability of this incorporation by gram, except that if a serving contains reference is given in paragraph less than 1 gram, the statement ‘‘Con- (c)(1)(i)(A) of this section.) tains less than 1 gram’’ or ‘‘less than 1

192

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00202 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.309

gram’’ may be used as an alternative, gram, the statement ‘‘Contains less and if the serving contains less than 0.5 than 1 gram’’ or ‘‘less than 1 gram’’ gram, the content may be expressed as may be used as an alternative, and if zero. the serving contains less than 0.5 gram, (iii) ‘‘Sugar alcohol’’ (VOLUNTARY): the content may be expressed as zero. A statement of the number of grams of When the protein in products rep- sugar alcohols per serving may be de- resented or purported to be for adults clared voluntarily on the label, except and children 4 or more years of age has that when a claim is made on the label a protein quality value that is a pro- or in labeling about sugar alcohol or tein digestibility-corrected amino acid sugars when sugar alcohols are present score of less than 20 expressed as a per- in the product, sugar alcohol content cent, or when the protein in a product shall be declared. For nutrition label- represented or purported to be for chil- ing purposes, sugar alcohols are defined dren greater than 1 but less than 4 as the sum of saccharide derivatives in years of age has a protein quality value which a hydroxyl group replaces a ke- that is a protein digestibility-corrected tone or aldehyde group and whose use amino acid score of less than 40 ex- in the food is listed by FDA (e.g., pressed as a percent, either of the fol- mannitol or xylitol) or is generally rec- lowing shall be placed adjacent to the ognized as safe (e.g., sorbitol). In lieu declaration of protein content by of the term ‘‘sugar alcohol,’’ the name weight: The statement ‘‘not a signifi- of the specific sugar alcohol (e.g., cant source of protein,’’ or a listing ‘‘xylitol’’) present in the product may aligned under the column headed be used in the nutrition label, provided ‘‘Percent Daily Value’’ of the corrected that only one sugar alcohol is present amount of protein per serving, as de- in the product. Sugar alcohol content termined in paragraph (c)(7)(ii) of this shall be indented and expressed to the section, calculated as a percentage of nearest gram, except that if a serving the Daily Reference Value (DRV) or contains less than 1 gram, the state- Reference Daily Intake (RDI), as appro- ment ‘‘Contains less then 1 gram’’ or priate, for protein and expressed as per- ‘‘less than 1 gram’’ may be used as an cent of Daily Value. When the protein alternative, and if the serving contains quality in a product as measured by less than 0.5 gram, the content may be the Protein Efficiency Ratio (PER) is expressed as zero. less than 40 percent of the reference (iv) ‘‘Other carbohydrate’’ (VOL- standard (casein) for a product rep- UNTARY): A statement of the number resented or purported to be for infants, of grams of other carbohydrate per the statement ‘‘not a significant source serving may be declared voluntarily. of protein’’ shall be placed adjacent to Other carbohydrate shall be defined as the declaration of protein content. Pro- the difference between total carbo- tein content may be calculated on the hydrate and the sum of dietary fiber, basis of the factor of 6.25 times the ni- sugars, and sugar alcohol, except that trogen content of the food as deter- if sugar alcohol is not declared (even if mined by appropriate methods of anal- present), it shall be defined as the dif- ysis in accordance with § 317.309(h), ex- ference between total carbohydrate and cept when the procedure for a specific the sum of dietary fiber and sugars. food requires another factor. Other carbohydrate content shall be in- (i) A statement of the corrected dented and expressed to the nearest amount of protein per serving, as de- gram, except that if a serving contains termined in paragraph (c)(7)(ii) of this less than 1 gram, the statement ‘‘Con- section, calculated as a percentage of tains less than 1 gram’’ or ‘‘less than 1 the RDI or DRV for protein, as appro- gram’’ may be used as an alternative, priate, and expressed as percent of and if the serving contains less than 0.5 Daily Value, may be placed on the gram, the content may be expressed as label, except that such a statement zero. shall be given if a protein claim is (7) ‘‘Protein’’: A statement of the made for the product, or if the product number of grams of protein per serving is represented or purported to be for in- expressed to the nearest gram, except fants or children under 4 years of age. that if a serving contains less than 1 When such a declaration is provided, it

193

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00203 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.309 9 CFR Ch. III (1–1–08 Edition)

shall be placed on the label adjacent to to the actual amount of protein the statement of grams of protein and (grams) per serving multiplied by the aligned under the column headed relative protein quality value. The rel- ‘‘Percent Daily Value,’’ and expressed ative protein quality value shall be de- to the nearest whole percent. However, termined by dividing the subject prod- the percentage of the RDI for protein uct’s protein PER value by the PER shall not be declared if the product is value for casein. If the relative protein represented or purported to be for in- value is above 1.00, it shall be set at fants and the protein quality value is 1.00. less than 40 percent of the reference (iii) For the purpose of labeling with standard. a percent of the DRV or RDI, a value of (ii) The corrected amount of protein 50 grams of protein shall be the DRV (grams) per serving for products rep- for adults and children 4 or more years resented or purported to be for adults of age, and the RDI for protein for chil- and children 1 or more years of age is dren less than 4 years of age, infants, equal to the actual amount of protein pregnant women, and lactating women (grams) per serving multiplied by the shall be 16 grams, 14 grams, 60 grams, amino acid score corrected for protein and 65 grams, respectively. digestibility. If the corrected score is (8) Vitamins and minerals: A state- above 1.00, then it shall be set at 1.00. ment of the amount per serving of the The protein digestibility-corrected vitamins and minerals as described in amino acid score shall be determined this paragraph, calculated as a percent by methods given in sections 5.4.1, 7.2.1, of the RDI and expressed as percent of and 8 in ‘‘Protein Quality Evaluation, Daily Value. Report of the Joint FAO/WHO Expert (i) For purposes of declaration of per- Consultation on Protein Quality Eval- cent of Daily Value as provided for in uation,’’ Rome, 1990, which is incor- paragraphs (d) through (g) of this sec- porated by reference. Sections 5.4.1, tion, products represented or purported 7.2.1, and 8 of the ‘‘Report of the Joint to be for use by infants, children less FAO/WHO Expert Consultation on Pro- than 4 years of age, pregnant women, tein Quality Evaluation,’’ as published or lactating women shall use the RDI’s by the Food and Agriculture Organiza- that are specified for the intended tion of the United Nations/World group. For products represented or pur- Health Organization, is incorporated as ported to be for use by both infants and it exists on the date of approval. This children under 4 years of age, the per- incorporation by reference was ap- cent of Daily Value shall be presented proved by the Director of the Federal by separate declarations according to Register in accordance with 5 U.S.C. paragraph (e) of this section based on 552(a) and 1 CFR part 51. It is available the RDI values for infants from birth for inspection at the office of the FSIS to 12 months of age and for children Docket Clerk, Room 3171, South Build- under 4 years of age. Similarly, the ing, 14th and Independence Avenue, percent of Daily Value based on both SW., Washington, DC, or at the Na- the RDI values for pregnant women tional Archives and Records Adminis- and for lactating women shall be de- tration (NARA). For information on clared separately on products rep- the availability of this material at resented or purported to be for use by NARA, call 202–741–6030, or go to: http:// both pregnant and lactating women. www.archives.gov/federallregister/ When such dual declaration is used on codeloflfederallregulations/ any label, it shall be included in all la- ibrllocations.html. Copies of the incor- beling, and equal prominence shall be poration by reference are available given to both values in all such label- from the Product Assessment Division, ing. All other products shall use the Regulatory Programs, Food Safety and RDI for adults and children 4 or more Inspection Service, U.S. Department of years of age. Agriculture, Room 329, West End Court (ii) The declaration of vitamins and Building, Washington, DC 20250–3700. minerals as a percent of the RDI shall For products represented or purported include vitamin A, vitamin C, calcium, to be for infants, the corrected amount and iron, in that order, and shall in- of protein (grams) per serving is equal clude any of the other vitamins and

194

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00204 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.309

minerals listed in paragraph (c)(8)(iv) Vitamin C, 60 milligrams of this section when they are added, or Calcium, 1.0 gram when a claim is made about them. Iron, 18 milligrams Other vitamins and minerals need not Vitamin D, 400 International Units be declared if neither the nutrient nor Vitamin E, 30 International Units the component is otherwise referred to Thiamin, 1.5 milligrams on the label or in labeling or adver- Riboflavin, 1.7 milligrams tising and the vitamins and minerals Niacin, 20 milligrams are: Vitamin B6, 2.0 milligrams (A) Required or permitted in a stand- Folate, 0.4 milligram ardized food (e.g., thiamin, riboflavin, Vitamin B12, 6 micrograms and niacin in enriched flour) and that Biotin, 0.3 milligram standardized food is included as an in- Pantothenic acid, 10 milligrams gredient (i.e., component) in another Phosphorus, 1.0 gram product; or Iodine, 150 micrograms (B) Included in a product solely for Magnesium, 400 milligrams technological purposes and declared Zinc, 15 milligrams only in the ingredients statement. The Copper, 2.0 milligrams declaration may also include any of the (v) The following synonyms may be other vitamins and minerals listed in added in parenthesis immediately fol- paragraph (c)(8)(iv) of this section lowing the name of the nutrient or die- when they are naturally occurring in tary component: the food. The additional vitamins and Vitamin C—Ascorbic acid minerals shall be listed in the order es- Thiamin—Vitamin B tablished in paragraph (c)(8)(iv) of this 1 Riboflavin—Vitamin B section. 2 (iii) The percentages for vitamins Folate—Folacin and minerals shall be expressed to the Calories—Energy nearest 2-percent increment up to and (vi) A statement of the percent of vi- including the 10-percent level, the tamin A that is present as beta-caro- nearest 5-percent increment above 10 tene may be declared voluntarily. percent and up to and including the 50- When the vitamins and minerals are percent level, and the nearest 10-per- listed in a single column, the state- cent increment above the 50-percent ment shall be indented under the infor- level. Amounts of vitamins and min- mation on vitamin A. When vitamins erals present at less than 2 percent of and minerals are arrayed horizontally, the RDI are not required to be declared the statement of percent shall be pre- in nutrition labeling but may be de- sented in parenthesis following the dec- clared by a zero or by the use of an as- laration of vitamin A and the percent terisk (or other symbol) that refers to of Daily Value of vitamin A in the another asterisk (or symbol) that is product (e.g., ‘‘Percent Daily Value: placed at the bottom of the table and Vitamin A 50 (90 percent as beta-caro- that is followed by the statement tene)’’). When declared, the percent- ‘‘Contains less than 2 percent of the ages shall be expressed in the same in- Daily Value of this (these) nutrient crements as are provided for vitamins (nutrients).’’ Alternatively, if vitamin and minerals in paragraph (c)(8)(iii) of A, vitamin C, calcium, or iron is this section. present in amounts less than 2 percent (9) For the purpose of labeling with a of the RDI, label declaration of the nu- percent of the DRV, the following trient(s) is not required if the state- DRV’s are established for the following ment ‘‘Not a significant source of food components based on the reference lll (listing the vitamins or minerals caloric intake of 2,000 calories: omitted)’’ is placed at the bottom of Food component Unit of measurement DRV the table of nutrient values. (iv) The following RDI’s and nomen- Fat ...... grams (g) ...... 65 Saturated fatty acids ...... do ...... 20 clature are established for the fol- Cholesterol ...... milligrams (mg) ...... 300 lowing vitamins and minerals which Total carbohydrate ...... grams (g) ...... 300 are essential in human nutrition: Fiber ...... do ...... 25 Sodium ...... milligrams (mg) ...... 2,400 Vitamin A, 5,000 International Units Potassium ...... do ...... 3,500

195

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00205 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.309 9 CFR Ch. III (1–1–08 Edition)

Food component Unit of measurement DRV hydrate, and Protein), and the percentage amounts required by paragraph Protein ...... grams (g) ...... 50 (d)(7)(ii) of this section shall be high- (d)(1) Nutrient information specified lighted by bold or extra bold type or in paragraph (c) of this section shall be other highlighting (reverse printing is presented on products in the following not permitted as a form of high- format, except on products on which lighting) that prominently distin- dual columns of nutrition information guishes it from other information. No are declared as provided for in para- other information shall be highlighted. graph (e) of this section, on those prod- (v) A hairline rule that is centered ucts on which the simplified format is between the lines of text shall separate permitted to be used as provided for in ‘‘Amount Per Serving’’ from the cal- paragraph (f) of this section, on prod- orie statements required in paragraph ucts for infants and children less than (d)(5) of this section and shall separate 4 years of age as provided for in each nutrient and its corresponding § 317.400(c), and on products in packages percent of Daily Value required in that have a total surface area available paragraphs (d)(7)(i) and (d)(7)(ii) of this to bear labeling of 40 or less square section from the nutrient and percent inches as provided for in paragraph (g) of Daily Value above and below it. of this section. (2) The information shall be pre- (i) The nutrition information shall be sented under the identifying heading of set off in a box by use of hairlines and ‘‘Nutrition Facts’’ which shall be set in shall be all black or one color type, a type size larger than all other print printed on a white or other neutral size in the nutrition label and, except contrasting background whenever prac- for labels presented according to the tical. format provided for in paragraph (d)(11) (ii) All information within the nutri- of this section, unless impractical, tion label shall utilize: shall be set the full width of the infor- (A) A single easy-to-read type style, mation provided under paragraph (d)(7) (B) Upper and lower case letters, of this section. (C) At least one point leading (i.e., (3) Information on serving size shall space between two lines of text) except immediately follow the heading. Such that at least four points leading shall information shall include: be utilized for the information required (i) ‘‘Serving Size’’: A statement of by paragraphs (d)(7) and (d)(8) of this the serving size as specified in para- section, and graph (b)(9) of this section. (D) Letters should never touch. (ii) ‘‘Servings Per Container’’: The (iii) Information required in para- number of servings per container, ex- graphs (d)(3), (d)(5), (d)(7), and (d)(8) of cept that this statement is not re- this section shall be in type size no quired on single-serving containers as smaller than 8 point. Except for the defined in paragraph (b)(8) of this sec- heading ‘‘Nutrition Facts,’’ the infor- tion. mation required in paragraphs (d)(4), (4) A subheading ‘‘Amount Per Serv- (d)(6), and (d)(9) of this section and all ing’’ shall be separated from serving other information contained within the size information by a bar. nutrition label shall be in type size no (5) Information on calories shall im- smaller than 6 point. When provided, mediately follow the heading ‘‘Amount the information described in paragraph Per Serving’’ and shall be declared in (d)(10) of this section shall also be in one line, leaving sufficient space be- type no smaller than 6 point. tween the declaration of ‘‘Calories’’ (iv) The headings required by para- and ‘‘Calories from fat’’ to allow clear graphs (d)(2), (d)(4), and (d)(6) of this differentiation, or, if ‘‘Calories from section (i.e., ‘‘Nutrition Facts,’’ saturated fat’’ is declared, in a column ‘‘Amount per Serving,’’ and ‘‘% Daily with total ‘‘Calories’’ at the top, fol- Value*’’), the names of all nutrients lowed by ‘‘Calories from fat’’ (in- that are not indented according to re- dented), and ‘‘Calories from saturated quirements of paragraph (c) of this sec- fat’’ (indented). tion (i.e., Calories, Total fat, Choles- (6) The column heading ‘‘% Daily terol, Sodium, Potassium, Total carbo- Value,’’ followed by an asterisk (e.g.,

196

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00206 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.309

‘‘% Daily Value*’’), shall be separated vertically with percentages listed from information on calories by a bar. under the column headed ‘‘% Daily The position of this column heading Value.’’ shall allow for a list of nutrient names (9) A footnote, preceded by an aster- and amounts as described in paragraph isk, shall be placed beneath the list of (d)(7) of this section to be to the left of, vitamins and minerals and shall be sep- and below, this column heading. The arated from that list by a hairline. column headings ‘‘Percent Daily (i) The footnote shall state: Percent Value,’’ ‘‘Percent DV,’’ or ‘‘% DV’’ may Daily Values are based on a 2,000 cal- be substituted for ‘‘% Daily Value.’’ orie diet. Your daily values may be (7) Except as provided for in para- higher or lower depending on your cal- graph (g) of this section, and except as orie needs. permitted by § 317.400(d)(2), nutrient in- Calories: 2,000 2,500 formation for both mandatory and any voluntary nutrients listed in paragraph Total fat ...... Less than ..... 65 g ...... 80 g (c) of this section that are to be de- Saturated fat Less than ..... 20 g ...... 25 g Cholesterol ... Less than ..... 300 mg ...... 300 mg clared in the nutrition label, except vi- Sodium ...... Less than ..... 2,400 mg ..... 2,400 mg tamins and minerals, shall be declared Total carbo- ...... 300 g ...... 375 g as follows: hydrate. Dietary fiber ...... 25 g ...... 30 g (i) The name of each nutrient, as specified in paragraph (c) of this sec- (ii) If the percent of Daily Value is tion, shall be given in a column and given for protein in the Percent of followed immediately by the quan- Daily Value column as provided in titative amount by weight for that nu- paragraph (d)(7)(ii) of this section, pro- trient appended with a ‘‘g’’ for grams tein shall be listed under dietary fiber, or ‘‘mg’’ for milligrams. and a value of 50 g shall be inserted on (ii) A listing of the percent of the the same line in the column headed DRV as established in paragraphs ‘‘2,000’’ and value of 65 g in the column (c)(7)(iii) and (c)(9) of this section shall headed ‘‘2,500.’’ be given in a column aligned under the (iii) If potassium is declared in the heading ‘‘% Daily Value’’ established column described in paragraph (d)(7)(i) in paragraph (d)(6) of this section with of this section, potassium shall be list- the percent expressed to the nearest ed under sodium and the DRV estab- whole percent for each nutrient de- lished in paragraph (c)(9) of this sec- clared in the column described in para- tion shall be inserted on the same line graph (d)(7)(i) of this section for which in the numeric columns. a DRV has been established, except (iv) The abbreviations established in that the percent for protein may be paragraph (g)(2) of this section may be omitted as provided in paragraph (c)(7) used within the footnote. of this section. The percent shall be (10) Caloric conversion information calculated by dividing either the on a per-gram basis for fat, carbo- amount declared on the label for each hydrate, and protein may be presented nutrient or the actual amount of each beneath the information required in nutrient (i.e., before rounding) by the paragraph (d)(9), separated from that DRV for the nutrient, except that the information by a hairline. This infor- percent for protein shall be calculated mation may be presented horizontally as specified in paragraph (c)(7)(ii) of (i.e., ‘‘Calories per gram: Fat 9, Carbo- this section. The numerical value shall hydrate 4, Protein 4’’) or vertically in be followed by the symbol for percent columns. (i.e., %). (11)(i) If the space beneath the infor- (8) Nutrient information for vitamins mation on vitamins and minerals is not and minerals shall be separated from adequate to accommodate the informa- information on other nutrients by a tion required in paragraph (d)(9) of this bar and shall be arrayed horizontally section, the information required in (e.g., Vitamin A 4%, Vitamin C 2%, paragraph (d)(9) may be moved to the Calcium 15%, Iron 4%) or may be listed right of the column required in para- in two columns, except that when more graph (d)(7)(ii) of this section and set than four vitamins and minerals are off by a line that distinguishes it and declared, they may be declared sets it apart from the percent of Daily

197

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00207 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.309 9 CFR Ch. III (1–1–08 Edition)

Value information. The caloric conver- (iii) If there is not sufficient contin- sion information provided for in para- uous vertical space (i.e., approximately graph (d)(10) of this section may be pre- 3 inches) to accommodate the required sented beneath either side or along the components of the nutrition label up to full length of the nutrition label. and including the mandatory declara- (ii) If the space beneath the manda- tion of iron, the nutrition label may be tory declaration of iron is not adequate presented in a tabular display in which to accommodate any remaining vita- the footnote required by paragraph mins and minerals to be declared or the (d)(9) of the section is given to the far information required in paragraph right of the label, and additional vita- (d)(9) of this section, the remaining information may be moved to the right mins and minerals beyond the four and set off by a line that distinguishes that are required (i.e., vitamin A, vita- it and sets it apart from the percent of min C, calcium, and iron) are arrayed Daily Value information given to the horizontally following declarations of left. The caloric conversion informa- the required vitamins and minerals. tion provided for in paragraph (d)(10) of (12) The following sample label illus- this section may be presented beneath trates the provisions of paragraph (d) either side or along the full length of of this section: the nutrition label.

198

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00208 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.309

(13)(i) Nutrition labeling on the outer used interchangeably for the same type label of packages of meat or meat food of food (e.g., meat salad containers) products that contain two or more may use an aggregate display. products in the same packages (e.g., (ii) Aggregate displays shall comply variety packs) or of packages that are with format requirements of paragraph

199

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00209 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR EC11SE91.013 § 317.309 9 CFR Ch. III (1–1–08 Edition)

(d) of this section to the maximum ex- (d)(5) of this section with quantitative tent possible, except that the identity amounts declared in columns aligned of each food shall be specified to the under the column headings set forth in right of the ‘‘Nutrition Facts’’ title, paragraph (e)(1) of this section. and both the quantitative amount by (3) Quantitative information by weight (i.e., g/mg amounts) and the weight required in paragraph (d)(7)(i) of percent Daily Value for each nutrient this section shall be specified for the shall be listed in separate columns form of the product as packaged and under the name of each food. according to the label serving size (14) When nutrition labeling appears based on the Reference Amount in in a second language, the nutrition in- § 317.312(b). formation may be presented in a sepa- (i) Quantitative information by rate nutrition label for each language weight may be included for other forms or in one nutrition label with the infor- of the product represented by the addi- mation in the second language fol- tional column(s) either immediately lowing that in English. Numeric char- adjacent to the required quantitative acters that are identical in both lan- information by weight for the product guages need not be repeated (e.g., as packaged and according to the label ‘‘Protein/Proteinas 2 g’’). All required serving size based on the Reference information must be included in both Amount in § 317.312(b) or as a footnote. languages. (A) If such additional quantitative (e) Nutrition information may be pre- information is given immediately adja- sented for two or more forms of the cent to the required quantitative infor- same product (e.g., both ‘‘raw’’ and mation, it shall be declared for all nu- ‘‘cooked’’) or for common combina- trients listed and placed immediately tions of foods as provided for in para- following and differentiated from the graph (b) of this section, or for dif- required quantitative information ferent units (e.g., per 100 grams) as pro- (e.g., separated by a comma). Such in- vided for in paragraph (b) of this sec- formation shall not be put in a sepa- tion, or for two or more groups for which RDI’s are established (e.g., both rate column. infants and children less than 4 years (B) If such additional quantitative in- of age) as provided for in paragraph formation is given in a footnote, it (c)(8)(i) of this section. When such dual shall be declared in the same order as labeling is provided, equal prominence the nutrients are listed in the nutri- shall be given to both sets of values. tion label. The additional quantitative Information shall be presented in a for- information may state the total nutri- mat consistent with paragraph (d) of ent content of the product identified in this section, except that: the second column or the nutrient (1) Following the subheading of amounts added to the product as pack- ‘‘Amount Per Serving,’’ there shall be aged for only those nutrients that are two or more column headings accu- present in different amounts than the rately describing the forms of the same amounts declared in the required quan- product (e.g., ‘‘raw’’ and ‘‘roasted’’), titative information. The footnote the combinations of foods, the units, or shall clearly identify which amounts the RDI groups that are being declared. are declared. Any subcomponents de- The column representing the product clared shall be listed parenthetically as packaged and according to the label after principal components (e.g., 1⁄2 cup serving size based on the Reference skim milk contributes an additional 40 Amount in § 317.312(b) shall be to the calories, 65 mg sodium, 6 g total carbo- left of the numeric columns. hydrate (6 g sugars), and 4 g protein). (2) When the dual labeling is pre- (ii) Total fat and its quantitative sented for two or more forms of the amount by weight shall be followed by same product, for combinations of an asterisk (or other symbol) (e.g., foods, or for different units, total cal- ‘‘Total fat (2 g)*’’) referring to another ories and calories from fat (and cal- asterisk (or symbol) at the bottom of ories from saturated fat, when de- the nutrition label identifying the clared) shall be listed in a column and form(s) of the product for which quan- indented as specified in paragraph titative information is presented.

200

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00210 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.309

(4) Information required in para- headings set forth in paragraph (e)(1) of graphs (d)(7)(ii) and (d)(8) of this sec- this section. tion shall be presented under the sub- (5) The following sample label illus- heading ‘‘% DAILY VALUE’’ and in trates the provisions of paragraph (e) columns directly under the column of this section:

201

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00211 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.309 9 CFR Ch. III (1–1–08 Edition)

(f)(1) Nutrition information may be forth herein when any required nutri- presented in a simplified format as set ents, other than the core nutrients

202

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00212 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR EC11SE91.014 Food Safety and Inspection Service, USDA § 317.309

(i.e., calories, total fat, sodium, total are based on a 2,000 calorie diet’’ and, if carbohydrate, and protein), are present the term ‘‘Daily Value’’ is not spelled in insignificant amounts. An insignifi- out in the heading, a statement that cant amount shall be defined as that ‘‘DV’’ represents ‘‘Daily Value.’’ amount that may be rounded to zero in (g) Foods in packages that have a nutrition labeling, except that for total total surface area available to bear la- carbohydrate, dietary fiber, sugars and beling of 40 or less square inches may protein, it shall be an amount less than modify the requirements of paragraphs 1 gram. (c) through (f) of this section and (2) The simplified format shall in- § 317.302(a) by one or more of the fol- clude information on the following nu- lowing means: trients: (1)(i) Presenting the required nutri- (i) Total calories, total fat, total car- tion information in a tabular or linear bohydrate, sodium, and protein; (i.e., string) fashion, rather than in (ii) Any of the following that are vertical columns if the product has a present in more than insignificant total surface area available to bear la- amounts: Calories from fat, saturated beling of less than 12 square inches, or fat, cholesterol, dietary fiber, sugars, if the product has a total surface area vitamin A, vitamin C, calcium, and available to bear labeling of 40 or less iron; and square inches and the package shape or (iii) Any vitamins and minerals list- size cannot accommodate a standard ed in paragraph (c)(8)(iv) of this section vertical column or tabular display on when they are added in fortified or fab- any label panel. Nutrition information ricated foods. may be given in a linear fashion only if (3) Other nutrients that are naturally the package shape or size will not ac- present in the product in more than in- commodate a tabular display. significant amounts may be volun- (ii) When nutrition information is tarily declared as part of the simplified given in a linear display, the nutrition format. information shall be set off in a box by (4) Any required nutrient, other than the use of a hairline. The percent Daily a core nutrient, that is present in an Value is separated from the quan- insignificant amount may be omitted titative amount declaration by the use from the tabular listing, provided that of parenthesis, and all nutrients, both the following statement is included at principal components and subcompo- the bottom of the nutrition label, ‘‘Not nents, are treated similarly. Bolding is a significant source of llll.’’ The required only on the title ‘‘Nutrition blank shall be filled in with the appro- Facts’’ and is allowed for nutrient priate nutrient or food component. Al- names for ‘‘Calories,’’ ‘‘Total fat,’’ ternatively, amounts of vitamins and ‘‘Cholesterol,’’ ‘‘Sodium,’’ ‘‘Total car- minerals present in insignificant bohydrate,’’ and ‘‘Protein.’’ amounts may be declared by the use of (2) Using any of the following abbre- an asterisk (or symbol) that is placed viations: at the bottom of the table of nutrient Serving size—Serv size values and that is followed by the Servings per container—Servings statement ‘‘Contains less than 2 per- Calories from fat—Fat cal cent of the Daily Value of this (these) Calories from saturated fat—Sat fat cal nutrient (nutrients).’’ Saturated fat—Sat fat (5) Except as provided for in paragraph (g) of this section and in Monounsaturated fat—Monounsat fat § 317.400(c) and (d), nutrient informa- Polyunsaturated fat—Polyunsat fat tion declared in the simplified format Cholesterol—Cholest shall be presented in the same manner Total carbohydrate—Total carb as specified in paragraphs (d) or (e) of Dietary fiber—Fiber this section, except that the footnote Soluble fiber—Sol fiber required in paragraph (d)(9) of this sec- Insoluble fiber—Insol fiber tion is not required. When the footnote Sugar alcohol—Sugar alc is omitted, an asterisk shall be placed Other carbohydrate—Other carb at the bottom of the label followed by (3) Omitting the footnote required in the statement ‘‘Percent Daily Values paragraph (d)(9) of this section and

203

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00213 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.309 9 CFR Ch. III (1–1–08 Edition)

placing another asterisk at the bottom the Federal Register in accordance of the label followed by the statement with 5 U.S.C. 552(a) and 1 CFR part 51. ‘‘Percent Daily Values are based on a Copies may be purchased from the 2,000 calorie diet’’ and, if the term AOAC International, 2200 Wilson Blvd., ‘‘Daily Value’’ is not spelled out in the suite 400, Arlington, VA 22201. It is also heading, a statement that ‘‘DV’’ rep- available for inspection at the National resents ‘‘Daily Value.’’ Archives and Records Administration (4) Presenting the required nutrition (NARA). For information on the avail- information on any other label panel. ability of this material at NARA, call (h) Compliance with this section 202–741–6030, or go to: http:// shall be determined as follows: www.archives.gov/federallregister/ (1) A production lot is a set of food codeloflfederallregulations/ production consumer units that are ibrllocations.html. from one production shift. Alter- (3) Two classes of nutrients are de- natively, a collection of consumer fined for purposes of compliance: units of the same size, type, and style (i) Class I. Added nutrients in for- produced under conditions as nearly tified or fabricated foods; and uniform as possible, designated by a (ii) Class II. Naturally occurring (in- common container code or marking, digenous) nutrients. If any ingredient constitutes a production lot. which contains a naturally occurring (2) The sample for nutrient analysis (indigenous) nutrient is added to a shall consist of a composite of a min- food, the total amount of such nutrient imum of six consumer units, each from in the final food product is subject to a production lot. Alternatively, the Class II requirements unless the same sample for nutrient analysis shall con- nutrient is also added, which would sist of a composite of a minimum of six make the total amount of such nutri- consumer units, each randomly chosen ent subject to Class I requirements. to be representative of a production (4) A product with a label declaration lot. In each case, the units may be indi- of a vitamin, mineral, protein, total vidually analyzed and the results of the carbohydrate, dietary fiber, other car- analyses averaged, or the units would bohydrate, polyunsaturated or be composited and the composite ana- monounsaturated fat, or potassium lyzed. In both cases, the results, wheth- shall be deemed to be misbranded er an average or a single result from a under section 1(n) of the Federal Meat composite, will be considered by the Inspection Act (21 U.S.C. 601(n)(1)) un- Agency to be the nutrient content of a less it meets the following require- composite. All analyses shall be per- ments: formed by appropriate methods and (i) Class I vitamin, mineral, protein, procedures used by the Department for dietary fiber, or potassium. The nutri- each nutrient in accordance with the ent content of the composite is at least ‘‘Chemistry Laboratory Guidebook,’’ equal to the value for that nutrient de- or, if no USDA method is available and clared on the label. appropriate for the nutrient, by appro- (ii) Class II vitamin, mineral, propriate methods for the nutrient in ac- tein, total carbohydrate, dietary fiber, cordance with the 1990 edition of the other carbohydrate, polyunsaturated ‘‘Official Methods of Analysis’’ of the or monounsaturated fat, or potassium. AOAC International, formerly Associa- The nutrient content of the composite tion of Official Analytical Chemists, is at least equal to 80 percent of the 15th ed., which is incorporated by ref- value for that nutrient declared on the erence, unless a particular method of label; Provided, That no regulatory ac- analysis is specified in § 317.309(c), or, if tion will be based on a determination no USDA, AOAC, or specified method is of a nutrient value which falls below available and appropriate, by other re- this level by an amount less than the liable and appropriate analytical pro- variability generally recognized for the cedures as so determined by the Agen- analytical method used in that product cy. The ‘‘Official Methods of Analysis’’ at the level involved, and inherent nu- is incorporated as it exists on the date trient variation in a product. of approval. This incorporation by ref- (5) A product with a label declaration erence was approved by the Director of of calories, sugars, total fat, saturated

204

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00214 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.312

fat, cholesterol, or sodium shall be §§ 317.310–317.311 [Reserved] deemed to be misbranded under section 1(n) of the Federal Meat Inspection Act § 317.312 Reference amounts custom- (21 U.S.C. 601(n)(1)) if the nutrient con- arily consumed per eating occasion. tent of the composite is greater than 20 (a) The general principles followed in percent in excess of the value for that arriving at the reference amounts cus- nutrient declared on the label; Pro- tomarily consumed per eating occasion vided, That no regulatory action will be (Reference Amount(s)), as set forth in based on a determination of a nutrient paragraph (b) of this section, are: value which falls above this level by an (1) The Reference Amounts are cal- amount less than the variability gen- culated for persons 4 years of age or erally recognized for the analytical older to reflect the amount of food cus- method used in that product at the tomarily consumed per eating occasion level involved, and inherent nutrient by persons in this population group. variation in a product. These Reference Amounts are based on (6) The amount of a vitamin, mineral, data set forth in appropriate national protein, total carbohydrate, dietary food consumption surveys. fiber, other carbohydrate, polyunsat- (2) The Reference Amounts are cal- urated or monounsaturated fat, or po- culated for an infant or child under 4 tassium may vary over labeled years of age to reflect the amount of amounts within good manufacturing food customarily consumed per eating practice. The amount of calories, sug- occasion by infants up to 12 months of ars, total fat, saturated fat, choles- age or by children 1 through 3 years of terol, or sodium may vary under la- age, respectively. These Reference beled amounts within good manufac- Amounts are based on data set forth in turing practice. appropriate national food consumption (7) Compliance will be based on the surveys. Such Reference Amounts are metric measure specified in the label to be used only when the product is statement of serving size. specially formulated or processed for use by an infant or by a child under 4 (8) The management of the establish- years of age. ment must maintain records to support (3) An appropriate national food con- the validity of nutrient declarations sumption survey includes a large sam- contained on product labels. Such ple size representative of the demo- records shall be made available to the graphic and socioeconomic characteris- inspector or any duly authorized rep- tics of the relevant population group resentative of the Agency upon re- and must be based on consumption quest. data under actual conditions of use. (9) The compliance provisions set (4) To determine the amount of food forth in paragraph (h) (1) through (8) of customarily consumed per eating occa- this section shall not apply to single- sion, the mean, median, and mode of ingredient, raw meat (including ground the consumed amount per eating occa- beef) products, including those that sion were considered. have been previously frozen, when nu- (5) When survey data were insuffi- trition labeling is based on the most cient, FSIS took various other sources current representative data base values of information on serving sizes of food contained in USDA’s National Nutrient into consideration. These other sources Data Bank or its published form, the of information included: Agriculture Handbook No. 8 series (i) Serving sizes used in dietary guid- available from the Government Print- ance recommendations or rec- ing Office. ommended by other authoritative sys- (Paperwork requirements were approved by tems or organizations; the Office of Management and Budget under (ii) Serving sizes recommended in control number 0583–0088) comments; [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, (iii) Serving sizes used by manufac- 1993; 58 FR 47627, Sept. 10, 1993; 59 FR 45194, turers and grocers; and Sept. 1, 1994; 60 FR 176, Jan. 3, 1995; 69 FR (iv) Serving sizes used by other coun- 58801, Oct. 1, 2004] tries.

205

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00215 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.312 9 CFR Ch. III (1–1–08 Edition)

(6) Because they reflect the amount as the basis for determining serving customarily consumed, the Reference sizes for specific products: Amount and, in turn, the serving size declared on the product label are based TABLE 1—REFERENCE AMOUNTS CUSTOMARILY on only the edible portion of food, and CONSUMED PER EATING OCCASION—INFANT not bone, seed, shell, or other inedible AND TODDLER FOODS 1,2,3 components. Reference (7) The Reference Amount is based on Product category amount the major intended use of the product (e.g., a mixed dish measurable with a Infant & Toddler Foods: cup as a main dish and not as a side Dinner Dry Mix ...... 15 g dish). Dinner, ready-to-serve, strained type ...... 60 g Dinner, soups, ready-to-serve junior type ...... 110 g (8) The Reference Amounts for prod- Dinner, stew or soup ready-to-serve toddlers 170 g ucts that are consumed as an ingre- Plain meats and meat sticks, ready-to-serve .. 55 g dient of other products, but that may 1 These values represent the amount of food customarily also be consumed in the form in which consumed per eating occasion and were primarily derived they are purchased (e.g., ground beef), from the 1977–1978 and the 1987–1988 Nationwide Food Consumption Surveys conducted by the U.S. Department of are based on use in the form purchased. Agriculture. (9) FSIS sought to ensure that foods 2 Unless otherwise noted in the Reference Amount column, the Reference Amounts are for the ready-to-serve or almost that have similar dietary usage, prod- ready-to-serve form of the product (i.e., heat and serve). If not uct characteristics, and customarily listed separately, the Reference Amount for the unprepared form (e.g., dehydrated cereal) is the amount required to make consumed amounts have a uniform Ref- one Reference Amount of the prepared form. erence Amount. 3 Manufacturers are required to convert the Reference Amount to the label serving size in a household measure (b) The following Product Categories most appropriate to their specific product using the proce- and Reference Amounts shall be used dures established by regulation.

TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION—GENERAL FOOD SUPPLY 1,2,3,4,5

Reference Reference Product category amount amount Ready-to-serve Ready-to-cook

Egg mixtures, (western style omelet, souffle, egg foo young ...... 110 g n/a. Lard, margarine, shortening ...... 1 tbsp n/a. Salad and potato toppers; e.g., bacon bits ...... 7 g n/a. Bacon (bacon, beef breakfast strips, pork breakfast strips, pork rinds) ...... 15 g 54 g=bacon. 30 g = breakfast strips. Dried; e.g., jerky, dried beef, Parma ham sausage products with a moisture/protein ratio 30 g n/a. of less than 2:1; e.g., pepperoni. Snacks; e.g., meat snack food sticks ...... 30 g n/a. Luncheon meat, bologna, Canadian style bacon, pork pattie crumbles, beef pattie crum- 55 g n/a. bles, blood pudding, luncheon loaf, old fashioned loaf, berlinger, bangers, minced luncheon roll, thuringer, liver sausage, mortadella, uncured sausage (franks), ham and cheese loaf, P&P loaf, scrapple souse, head cheese, pizza loaf, olive loaf, pate, deviled ham, sandwich spread, teawurst, cervelet, Lebanon bologna, potted meat food product, taco fillings, meat pie fillings. Linked meat sausage products, Vienna sausage, frankfurters, pork sausage, imitation 55 g n/a. 75 frankfurters, bratwurst, kielbasa, Polish sausage, summer sausage, mettwurst, g=uncooked smoked country sausage, smoked sausage, smoked or pickled meat, pickled pigs feet. sausage. Entrees without sauce, cuts of meat including marinated, tenderized, injected cuts of 85 g 114 g. meat, beef patty, corn dog, croquettes, fritters, cured ham, dry cured ham, dry cured cappicola, corned beef, pastrami, country ham, pork shoulder picnic, meatballs, pu- reed adult foods. Canned meats, canned beef, canned pork. 4 ...... 55 g n/a. Entrees with sauce, barbecued meats in sauce ...... 140 g n/a. Mixed dishes NOT measurable with a cup; 5 e.g., burrito, egg roll, enchilada, pizza, 140 g (plus 55 g n/a. pizza roll, quiche, all types of sandwiches, cracker and meat lunch type packages, for products gyro, stromboli, burger on a bun, frank on a bun, calzone, taco, pockets stuffed with with sauce top- meat, foldovers, stuffed vegetables with meat, shish kabobs, empanada. pings) Mixed dishes measurable with a cup; e.g., meat casserole, macaroni and cheese with 1 cup n/a. meat, pot pie, spaghetti with sauce, meat chili, chili with beans, meat hash, creamed chipped beef, beef ravioli in sauce, beef stroganoff, Brunswick stew, goulash, meat stew, ragout, meat lasagna, meat filled pasta. Salads—pasta or potato, potato salad with bacon, macaroni and meat salad ...... 140 g n/a. Salads—all other meat, salads, ham salad ...... 100 g n/a. Soups—all varieties ...... 245 g n/a.

206

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00216 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.312

TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION—GENERAL FOOD SUPPLY 1,2,3,4,5—Continued

Reference Reference Product category amount amount Ready-to-serve Ready-to-cook

Major main entree type sauce; e.g., spaghetti sauce with meat, spaghetti sauce with 125 g n/a. meatballs. Minor main entree sauce; e.g., pizza sauce with meat, gravy ...... 1⁄4 cup n/a. Seasoning mixes dry, bases, extracts, dried broths and stock/juice, freeze dry trail mix products with meat.. As reconstituted: Amount to make one Reference Amount of the final dish; e.g., Gravy ...... 1⁄4 cup n/a. Major main entree type sauce ...... 125 g n/a. Soup ...... 245 g n/a. Entree measurable with a cup ...... 1 cup n/a. 1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the 1977–78 and the 1987–88 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture. 2 Manufacturers are required to convert the Reference Amounts to the label serving size in a household measure most appropriate to their specific product using the procedures established by regulation. 3 Examples listed under Product Category are not all inclusive or exclusive. Examples are provided to assist manufacturers in identifying appropriate product Reference Amount. 4 If packed or canned in liquid, the Reference Amount is for the drained solids, except for products in which both the solids and liquids are customarily consumed. 5 Pizza sauce is part of the pizza and is not considered to be sauce topping.

(c) For products that have no Ref- volumes should be used (e.g., grams of erence Amount listed in paragraph (b) one ingredient plus gram weight of ta- of this section for the unprepared or blespoons of a second ingredient). the prepared form of the product and (d) If a product requires further prep- that consist of two or more foods pack- aration, e.g., cooking or the addition of aged and presented to be consumed to- water or other ingredients, and if para- gether (e.g., lunch meat with cheese graph (b) of this section provides a Ref- and crackers), the Reference Amount erence Amount for the product in the for the combined product shall be de- prepared form, then the Reference termined using the following rules: Amount for the unprepared product (1) For bulk products, the Reference shall be determined using the following Amount for the combined product shall rules: be the Reference Amount, as estab- (1) Except as provided for in para- lished in paragraph (b) of this section, graph (d)(2) of this section, the Ref- for the ingredient that is represented erence Amount for the unprepared as the main ingredient plus propor- product shall be the amount of the un- tioned amounts of all minor ingredi- prepared product required to make the ents. (2) For products where the ingredient Reference Amount for the prepared represented as the main ingredient is product as established in paragraph (b) one or more discrete units, the Ref- of this section. erence Amount for the combined prod- (2) For products where the entire uct shall be either the number of small contents of the package is used to pre- discrete units or the fraction of the pare one large discrete unit usually di- large discrete unit that is represented vided for consumption, the Reference as the main ingredient that is closest Amount for the unprepared product to the Reference Amount for that in- shall be the amount of the unprepared gredient as established in paragraph (b) product required to make the fraction of this section plus proportioned of the large discrete unit closest to the amounts of all minor ingredients. Reference Amount for the prepared (3) If the Reference Amounts are in product as established in paragraph (b) compatible units, they shall be of this section. summed (e.g., ingredients in equal vol- (e) The Reference Amount for an imi- umes such as tablespoons). If the Ref- tation or substitute product or altered erence Amounts are in incompatible product as defined in § 317.313(d), such units, the weights of the appropriate as a ‘‘low calorie’’ version, shall be the

207

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00217 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.312 9 CFR Ch. III (1–1–08 Edition)

same as for the product for which it is with supporting documentation, sub- offered as a substitute. mitted to the Agency under this sec- (f) The Reference Amounts set forth tion will be governed by the rules spec- in paragraphs (b) through (e) of this ified in subchapter D, title 9. section shall be used in determining (4) Data accompanying the labeling whether a product meets the criteria application, such as food consumption for nutritional claims. If the serving data, shall be submitted on separate size declared on the product label dif- sheets, suitably identified. If such data fers from the Reference Amount, and has already been submitted with an the product meets the criteria for the earlier labeling application from the claim only on the basis of the Ref- applicant, the present labeling applica- erence Amount, the claim shall be fol- tion must provide the data. lowed by a statement that sets forth (5) The labeling application must be the basis on which the claim is made. signed by the applicant or by his or her That statement shall include the Ref- attorney or agent, or (if a corporation) erence Amount as it appears in para- by an authorized official. graph (b) of this section followed, in (6) The labeling application shall in- parentheses, by the amount in common clude a statement signed by the person household measure if the Reference responsible for the labeling applica- Amount is expressed in measures other tion, that to the best of his or her than common household measures. knowledge, it is a representative and (g) The Administrator, on his or her balanced submission that includes un- own initiative or on behalf of any in- favorable information, as well as favor- terested person who has submitted a able information, known to him or her labeling application, may issue a pro- pertinent to the evaluation of the la- posal to establish or amend a Product beling application. Category or Reference Amount identi- (7) Labeling applications for a new fied in paragraph (b) of this section. Reference Amount and/or Product Cat- (1) Labeling applications and sup- egory shall be accompanied by the fol- porting documentation to be filed lowing data which shall be submitted under this section shall be submitted in the following form to the Director, in quadruplicate, except that the sup- Food Labeling Division, Regulatory porting documentation may be sub- Programs, Food Safety and Inspection mitted on a computer disc copy. If any Service, Washington, DC 20250: part of the material submitted is in a foreign language, it shall be accom- llllllllllllllllllllllll panied by an accurate and complete (Date) English translation. The labeling appli- The undersigned, llllll submits this cation shall state the applicant’s post labeling application pursuant to 9 CFR office address. 317.312 with respect to Reference Amount (2) Pertinent information will be con- and/or Product Category. sidered as part of an application on the Attached hereto, in quadruplicate, or on a basis of specific reference to such infor- computer disc copy, and constituting a part of this labeling application, are the fol- mation submitted to and retained in lowing: the files of the Food Safety and Inspec- (i) A statement of the objective of the lation Service. However, any reference to beling application; unpublished information furnished by a (ii) A description of the product; person other than the applicant will (iii) A complete sample product label in- not be considered unless use of such including nutrition label, using the format es- formation is authorized (with the un- tablished by regulation; derstanding that such information may (iv) A description of the form in which the in whole or part be subject to release product will be marketed; to the public) in a written statement (v) The intended dietary uses of the prod- signed by the person who submitted it. uct with the major use identified (e.g., ham as a luncheon meat); Any reference to published information (vi) If the intended use is primarily as an should be accompanied by reprints or ingredient in other foods, list of foods or food photostatic copies of such references. categories in which the product will be used (3) The availability for public disclo- as an ingredient with information on the sure of labeling applications, along prioritization of the use;

208

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00218 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.312

(vii) The population group for which the (A) Sampled population selected should be product will be offered for use (e.g., infants, representative of the demographic and socio- children under 4 years of age); economic characteristics of the target popu- (viii) The names of the most closely-relation group for which the food is intended. lated products (or in the case of foods for (B) Sample size (i.e., number of eaters) special dietary use and imitation or sub- should be large enough to give reliable esti- stitute foods, the names of the products for mates for customarily consumed amounts. which they are offered as substitutes); (C) The study protocol should identify po- (ix) The suggested Reference Amount (the tential biases and describe how potential bi- amount of edible portion of food as con- ases are controlled for or, if not possible to sumed, excluding bone, skin or other inedible control, how they affect interpretation of re- components) for the population group for sults. which the product is intended with full de- (D) The methodology used to collect or scription of the methodology and procedures process data including study design, sam- that were used to determine the suggested pling procedures, materials used (e.g., ques- Reference Amount. In determining the Ref- tionnaire, interviewer’s manual), procedures erence Amount, general principles and fac- used to collect or process data, methods or tors in paragraph (a) of this section should procedures used to control for unbiased esti- be followed. mates, and procedures used to correct for (x) The suggested Reference Amount shall nonresponse, should be fully documented. be expressed in metric units. Reference (xiii) A statement concerning the feasi- Amounts for foods shall be expressed in bility of convening associations, corpora- grams except when common household units tions, consumers, and other interested par- such as cups, tablespoons, and teaspoons are ties to engage in negotiated rulemaking to more appropriate or are more likely to pro- develop a proposed rule. mote uniformity in serving sizes declared on product labels. For example, common house- Yours very truly, hold measures would be more appropriate if Applicant lllllllllllllll products within the same category differ By lllllllllllllllllll substantially in density such as mixed dishes measurable with a cup. (Indicate authority) (A) In expressing the Reference Amount in (8) Upon receipt of the labeling appli- grams, the following general rules shall be cation and supporting documentation, followed: the applicant shall be notified, in writ- (1) For quantities greater than 10 grams, the quantity shall be expressed in nearest 5 ing, of the date on which the labeling grams increment. application was received. Such notice (2) For quantities less than 10 grams, exact shall inform the applicant that the la- gram weights shall be used. beling application is undergoing Agen- (B) [Reserved] cy review and that the applicant shall (xi) A labeling application for a new sub- subsequently be notified of the Agen- category of food with its own Reference cy’s decision to consider for further re- Amount shall include the following addi- view or deny the labeling application. tional information: (A) Data that demonstrate that the new (9) Upon review of the labeling appli- subcategory of food will be consumed in cation and supporting documentation, amounts that differ enough from the Ref- the Agency shall notify the applicant, erence Amount for the parent category to in writing, that the labeling applica- warrant a separate Reference Amount. Data tion is either being considered for fur- must include sample size, and the mean, ther review or that it has been sum- standard deviation, median, and modal con- marily denied by the Administrator. sumed amount per eating occasion for the product identified in the labeling application (10) If the labeling application is and for other products in the category. All summarily denied by the Adminis- data must be derived from the same survey trator, the written notification shall data. state the reasons therefor, including (B) Documentation supporting the dif- why the Agency has determined that ference in dietary usage and product charac- the proposed Reference Amount and/or teristics that affect the consumption size Product Category is false or mis- that distinguishes the product identified in leading. The notification letter shall the labeling application from the rest of the inform the applicant that the applicant products in the category. (xii) In conducting research to collect or may submit a written statement by process food consumption data in support of way of answer to the notification, and the labeling application, the following gen- that the applicant shall have the right eral guidelines should be followed. to request a hearing with respect to

209

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00219 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.312 9 CFR Ch. III (1–1–08 Edition)

the merits or validity of the Adminis- ministrator, the Agency shall notify trator’s decision to deny the use of the the applicant, in writing, of the basis proposed Reference Amount and/or for the denial, including the reason Product Category. why the Reference Amount and/or (i) If the applicant fails to accept the Product Category on the labeling was determination of the Administrator determined by the Agency to be false and files an answer and requests a or misleading. The notification letter hearing, and the Administrator, after shall also inform the applicant that the review of the answer, determines the applicant may submit a written state- initial determination to be correct, the ment by way of answer to the notifica- Administrator shall file with the Hear- tion, and that the applicant shall have ing Clerk of the Department the notifi- the right to request a hearing with re- cation, answer, and the request for a spect to the merits or validity of the hearing, which shall constitute the complaint and answer in the pro- Administrator’s decision to deny the ceeding, which shall thereafter be con- use of the proposed Reference Amount ducted in accordance with the Depart- and/or Product Category. ment’s Uniform Rules of Practice. (A) If the applicant fails to accept (ii) The hearing shall be conducted the determination of the Adminis- before an administrative law judge trator and files an answer and requests with the opportunity for appeal to the a hearing, and the Administrator, after Department’s Judicial Officer, who review of an answer, determines the shall make the final determination for initial determination to be correct, the the Secretary. Any such determination Administrator shall file with the Hear- by the Secretary shall be conclusive ing Clerk of the Department the notifi- unless, within 30 days after receipt of cation, answer, and the request for a notice of such final determination, the hearing, which shall constitute the applicant appeals to the United States complaint and answer in the pro- Court of Appeals for the circuit in ceeding, which shall thereafter be con- which the applicant has its principal ducted in accordance with the Depart- place of business or to the United ment’s Uniform Rules of Practice. States Court of Appeals for the District (B) The hearing shall be conducted of Columbia Circuit. before an administrative law judge (11) If the labeling application is not with the opportunity for appeal to the summarily denied by the Adminis- Department’s Judicial Officer, who trator, the Administrator shall publish shall make the final determination for in the FEDERAL REGISTER a proposed rule to amend the regulations to au- the Secretary. Any such determination thorize the use of the Reference by the Secretary shall be conclusive Amount and/or Product Category. The unless, within 30 days after receipt of proposal shall also summarize the la- the notice of such final determination, beling application, including where the the applicant appeals to the United supporting documentation can be re- States Court of Appeals for the circuit viewed. The Administrator’s proposed in which the applicant has its principal rule shall seek comment from con- place of business or to the United sumers, the industry, consumer and in- States Court of Appeals for the District dustry groups, and other interested of Columbia Circuit. persons on the labeling application and (ii) If the Reference Amount and/or the use of the proposed Reference Product Category is approved, the Amount and/or Product Category. Agency shall notify the applicant, in After public comment has been re- writing, and shall also publish in the ceived and reviewed by the Agency, the FEDERAL REGISTER a final rule amend- Administrator shall make a determina- ing the regulations to authorize the tion on whether the proposed Reference Amount and/or Product Category shall be approved for use on the labeling of meat food products. (i) If the Reference Amount and/or Product Category is denied by the Ad-

210

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00220 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.313

use of the Reference Amount and/or (c) Information that is required or Product Category. permitted by § 317.309 to be declared in nutrition labeling, and that appears as (Paperwork requirements were approved by part of the nutrition label, is not a nu- the Office of Management and Budget under control number 0583–0088) trient content claim and is not subject to the requirements of this section. If [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, such information is declared elsewhere 1993 as amended at 58 FR 47627, Sept. 10, 1993; on the label or in labeling, it is a nutri- 59 FR 45196, Sept. 1, 1994; 60 FR 186, Jan. 3, 1995] ent content claim and is subject to the requirements for nutrient content § 317.313 Nutrient content claims; gen- claims. eral principles. (d) A ‘‘substitute’’ product is one that may be used interchangeably with (a) This section applies to meat or another product that it resembles, i.e., meat food products that are intended that it is organoleptically, physically, for human consumption and that are and functionally (including shelf life) offered for sale. similar to, and that it is not nutrition- (b) A claim which, expressly or by ally inferior to unless it is labeled as implication, characterizes the level of an ‘‘imitation.’’ a nutrient (nutrient content claim) of (1) If there is a difference in perform- the type required in nutrition labeling ance characteristics that materially pursuant to § 317.309, may not be made limits the use of the product, the prod- on a label or in labeling of that product uct may still be considered a substitute unless the claim is made in accordance if the label includes a disclaimer adja- with the applicable provisions in this cent to the most prominent claim as subpart. defined in paragraph (j)(2)(iii) of this (1) An expressed nutrient content section, informing the consumer of claim is any direct statement about such difference (e.g., ‘‘not rec- the level (or range) of a nutrient in the ommended for frying’’). product, e.g., ‘‘low sodium’’ or ‘‘con- (2) This disclaimer shall be in easily tains 100 calories.’’ legible print or type and in a size no (2) An implied nutrient content claim less than that required by § 317.2(h) for is any claim that: the net quantity of contents state- (i) Describes the product or an ingre- ment, except where the size of the dient therein in a manner that sug- claim is less than two times the re- gests that a nutrient is absent or quired size of the net quantity of con- present in a certain amount (e.g., tents statement, in which case the dis- ‘‘high in oat bran’’); or claimer statement shall be no less than (ii) Suggests that the product, be- one-half the size of the claim but no cause of its nutrient content, may be smaller than 1⁄16-inch minimum height, useful in maintaining healthy dietary except as permitted by § 317.400(d)(2). practices and is made in association (e)(1) Because the use of a ‘‘free’’ or with an explicit claim or statement ‘‘low’’ claim before the name of a prod- about a nutrient (e.g., ‘‘healthy, con- uct implies that the product differs tains 3 grams (g) of fat’’). from other products of the same type (3) Except for claims regarding vita- by virtue of its having a lower amount mins and minerals described in para- of the nutrient, only products that graph (q)(3) of this section, no nutrient have been specially processed, altered, content claims may be made on prod- formulated, or reformulated so as to ucts intended specifically for use by in- lower the amount of the nutrient in fants and children less than 2 years of the product, remove the nutrient from age unless the claim is specifically pro- the product, or not include the nutri- vided for in subpart B of this part. ent in the product, may bear such a (4) Reasonable variations in the spell- claim (e.g., ‘‘low sodium beef noodle ing of the terms defined in applicable soup’’). provisions in this subpart and their (2) Any claim for the absence of a nu- synonyms are permitted provided these trient in a product, or that a product is variations are not misleading (e.g., low in a nutrient when the product has ‘‘hi’’ or ‘‘lo’’). not been specially processed, altered,

211

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00221 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.313 9 CFR Ch. III (1–1–08 Edition)

formulated, or reformulated to qualify the nutrient in the product and it is for that claim shall indicate that the not false or misleading in any respect product inherently meets the criteria (e.g., ‘‘100 calories’’ or ‘‘5 grams of and shall clearly refer to all products fat’’), in which case no disclaimer is re- of that type and not merely to the par- quired. ticular brand to which the labeling at- (4) ‘‘Percent fat free’’ claims are not taches (e.g., ‘‘lard, a sodium free authorized by this paragraph. Such food’’). claims shall comply with § 317.362(b)(6). (f) A nutrient content claim shall be (j) A product may bear a statement in type size and style no larger than that compares the level of a nutrient in two times that of the statement of the product with the level of a nutrient identity and shall not be unduly promi- in a reference product. These state- nent in type style compared to the ments shall be known as ‘‘relative statement of identity. claims’’ and include ‘‘light,’’ ‘‘re- (g) Labeling information required in duced,’’ ‘‘less’’ (or ‘‘fewer’’), and §§ 317.313, 317.354, 317.356, 317.360, 317.361, ‘‘more’’ claims. 317.362, and 317.380, whose type size is (1) To bear a relative claim about the not otherwise specified, is required to level of a nutrient, the amount of that be in letters and/or numbers no less nutrient in the product must be com- than 1⁄16 inch in height, except as per- pared to an amount of nutrient in an mitted by § 317.400(d)(2). appropriate reference product as speci- (h) [Reserved] fied in this paragraph (j). (i) Except as provided in § 317.309 or in (i)(A) For ‘‘less’’ (or ‘‘fewer’’) and paragraph (q)(3) of this section, the ‘‘more’’ claims, the reference product label or labeling of a product may con- may be a dissimilar product within a tain a statement about the amount or product category that can generally be percentage of a nutrient if: substituted for one another in the diet (1) The use of the statement on the or a similar product. product implicitly characterizes the (B) For ‘‘light,’’ ‘‘reduced,’’ and level of the nutrient in the product and ‘‘added’’ claims, the reference product is consistent with a definition for a shall be a similar product, and claim, as provided in subpart B of this (ii)(A) For ‘‘light’’ claims, the ref- part, for the nutrient that the label ad- erence product shall be representative dresses. Such a claim might be, ‘‘less of the type of product that includes the than 10 g of fat per serving;’’ product that bears the claim. The nu- (2) The use of the statement on the trient value for the reference product product implicitly characterizes the shall be representative of a broad base level of the nutrient in the product and of products of that type; e.g., a value in is not consistent with such a defini- a representative, valid data base; an tion, but the label carries a disclaimer average value determined from the top adjacent to the statement that the three national (or regional) brands, a product is not ‘‘low’’ in or a ‘‘good market basket norm; or, where its nu- source’’ of the nutrient, such as ‘‘only trient value is representative of the 200 milligrams (mg) sodium per serv- product type, a market leader. Firms ing, not a low sodium product.’’ The using such a reference nutrient value disclaimer must be in easily legible as a basis for a claim, are required to print or type and in a size no less than provide specific information upon required by § 317.2(h) for the net quan- which the nutrient value was derived, tity of contents, except where the size on request, to consumers and appro- of the claim is less than two times the priate regulatory officials. required size of the net quantity of (B) For relative claims other than contents statement, in which case the ‘‘light,’’ including ‘‘less’’ and ‘‘more’’ disclaimer statement shall be no less claims, the reference product may be than one-half the size of the claim but the same as that provided for ‘‘light’’ no smaller than 1⁄16-inch minimum in paragraph (j)(1)(ii)(A) of this section height, except as permitted by or it may be the manufacturer’s reg- § 317.400(d)(2); ular product, or that of another manu- (3) The statement does not in any facturer, that has been offered for sale way implicitly characterize the level of to the public on a regular basis for a

212

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00222 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.313

substantial period of time in the same (C) A claim on the information panel; geographic area by the same business or entity or by one entitled to use its (D) A claim elsewhere on the label or trade name, provided the name of the labeling. competitor is not used on the labeling (iv) The label or labeling must also of the product. The nutrient values bear: used to determine the claim when com- (A) Clear and concise quantitative in- paring a single manufacturer’s product formation comparing the amount of to the labeled product shall be either the subject nutrient in the product per the values declared in nutrition label- labeled serving size with that in the ing or the actual nutrient values, pro- reference product; and vided that the resulting labeling is in- (B) This statement shall appear adja- ternally consistent (i.e., that the val- cent to the most prominent claim or to ues stated in the nutrition informa- the nutrition information. tion, the nutrient values in the accom- (3) A relative claim for decreased lev- panying information, and the declara- els of a nutrient may not be made on tion of the percentage of nutrient by the label or in labeling of a product if which the product has been modified the nutrient content of the reference are consistent and will not cause con- product meets the requirement for a sumer confusion when compared), and ‘‘low’’ claim for that nutrient. that the actual modification is at least equal to the percentage specified in the (k) The term ‘‘modified’’ may be used definition of the claim. in the statement of identity of a product that bears a relative claim that (2) For products bearing relative claims: complies with the requirements of this part, followed immediately by the (i) The label or labeling must state name of the nutrient whose content the identity of the reference product has been altered (e.g., ‘‘modified fat and the percent (or fraction) of the ‘product’ ’’). This statement of identity amount of the nutrient in the reference must be immediately followed by the product by which the nutrient has been comparative statement such as ‘‘con- modified, (e.g., ‘‘50 percent less fat tains 35 percent less fat than ‘reference than ‘reference product’ ’’ or ‘‘1⁄3 fewer product’ ’’ The label or labeling must calories than ‘reference product’ ’’); and also bear the information required by (ii) This information shall be imme- paragraph (j)(2) of this section in the diately adjacent to the most prominent manner prescribed. claim in easily legible boldface print or (l) For purposes of making a claim, a type, in distinct contrast to other ‘‘meal-type’’ product will be defined as printed or graphic matter, that is no a product that: less than that required by § 317.2(h) for net quantity of contents, except where (1) Makes a major contribution to the the size of the claim is less than two diet by: times the required size of the net quan- (i) Weighing at least 10 ounces per la- tity of contents statement, in which beled serving; and case the referral statement shall be no (ii) Containing not less than three 40 less than one-half the size of the claim, gram portions of food, or combinations but no smaller than 1⁄16-inch minimum of foods, from two or more of the fol- height, except as permitted by lowing four food groups, except as § 317.400(d)(2). noted in paragraph (l)(1)(ii)(E) of this (iii) The determination of which use section: of the claim is in the most prominent (A) Bread, cereal, rice, and pasta; location on the label or labeling will be (B) Fruits and vegetables; made based on the following factors, (C) Milk, yogurt, and cheese; considered in order: (D) Meat, poultry, fish, dry beans, (A) A claim on the principal display eggs, and nuts; except that: panel adjacent to the statement of (E) These foods will not be sauces identity; (except for foods in the four food (B) A claim elsewhere on the prin- groups in paragraph (l)(1)(ii)(A) cipal display panel; through (D) of this section, that are in

213

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00223 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.313 9 CFR Ch. III (1–1–08 Edition)

the sauces), gravies, condiments, rel- § 317.312(f) (e.g., ‘‘very low sodium, 35 ishes, pickles, olives, jams, jellies, syr- mg or less per 55 grams’’). ups, breadings, or garnishes; and (2) The criteria for the claim shall be (2) Is represented as, or is in the form immediately adjacent to the most commonly understood to be, a break- prominent claim in easily legible print fast, lunch, dinner, meal, or entre. or type and in a size that is no less Such representations may be made by than that required by § 317.2(h) for net statements, photographs, or vignettes. quantity of contents, except where the (m) For purposes of making a claim, size of the claim is less than two times a main-dish product will be defined as the required size of the net quantity of a food that: contents statement, in which case the (1) Makes a major contribution to the criteria statement shall be no less than meal by: one-half the size of the claim but no (i) Weighing at least 6 ounces per la- smaller than 1⁄16-inch minimum height, beled serving; and except as permitted by § 317.400(d)(2). (ii) Containing not less than 40 grams (q) The following exemptions apply: of food, or combinations of foods, from (1) Nutrient content claims that have two or more of the following four food not been defined by regulation and that groups, except as noted in paragraph appear as part of a brand name that (m)(1)(ii)(E) of this section. was in use prior to November 27, 1991, (A) Bread, cereal, rice, and pasta; may continue to be used as part of that (B) Fruits and vegetables; brand name, provided they are not (C) Milk, yogurt, and cheese; false or misleading under section 1(n) (D) Meat, poultry, fish, dry beans, of the Act (21 U.S.C. 601(n)(1)). eggs, and nuts; except that: (2) [Reserved] (E) These foods will not be sauces (3) A statement that describes the (except for foods in the four food percentage of a vitamin or mineral in groups in paragraph (m)(l)(ii)(A) the food, including foods intended spe- through (D) of this section, that are in cifically for use by infants and children the sauces), gravies, condiments, rel- less than 2 years of age, in relation to ishes, pickles, olives, jams, jellies, syr- a Reference Daily Intake (RDI) as de- ups, breadings, or garnishes; and fined in § 317.309 may be made on the (3) Is represented as, or is in a form label or in the labeling of a food with- commonly understood to be, a main out a regulation authorizing such a dish (e.g., not a beverage or dessert). claim for a specific vitamin or mineral. Such representations may be made by (4) The requirements of this section statements, photographs, or vignettes. do not apply to infant formulas and (n) Nutrition labeling in accordance medical foods, as described in 21 CFR with § 317.309, shall be provided for any 101.13(q)(4). food for which a nutrient content claim (5) [Reserved] is made. (6) Nutrient content claims that were (o) Compliance with requirements for part of the name of a product that was nutrient content claims shall be in ac- subject to a standard of identity as of cordance with § 317.309(h). November 27, 1991, are not subject to (p)(1) Unless otherwise specified, the the requirements of paragraph (b) of reference amount customarily con- this section whether or not they meet sumed set forth in § 317.312(b) through the definition of the descriptive term. (e) shall be used in determining wheth- (7) Implied nutrient content claims er a product meets the criteria for a may be used as part of a brand name, nutrient content claim. If the serving provided that the use of the claim has size declared on the product label dif- been authorized by FSIS. Labeling ap- fers from the reference amount cus- plications requesting approval of such tomarily consumed, and the amount of a claim may be submitted pursuant to the nutrient contained in the labeled § 317.369. serving does not meet the maximum or [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, minimum amount criterion in the defi- 1993, as amended at 58 FR 47627, Sept. 10, nition for the descriptor for that nutri- 1993; 59 FR 40213, Aug. 8, 1994; 59 FR 45196, ent, the claim shall be followed by the Sept. 1, 1994; 60 FR 187, Jan. 3, 1995; 69 FR criteria for the claim as required by 58801, Oct. 1, 2004]

214

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00224 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.345

§§ 317.314–317.342 [Reserved] loin chop boneless, pork loin rib chop, pork spareribs, pork loin tenderloin, § 317.343 Significant participation for pork loin sirloin roast, pork shoulder voluntary nutrition labeling. blade steak, pork loin top roast (a) In evaluating significant partici- boneless, ground pork, lamb shank, pation for voluntary nutrition labeling, lamb shoulder arm chop, lamb shoulder FSIS will consider only the major cuts blade chop, lamb rib roast, lamb loin of single-ingredient, raw meat prod- chop, lamb leg (whole, sirloin half, or ucts, as identified in § 317.344, including shank half), veal shoulder arm steak, those that have been previously frozen. veal shoulder blade steak, veal rib (b) FSIS will judge a food retailer to roast, veal loin chop, and veal cutlets. be participating at a significant level if the retailer provides nutrition labeling [58 FR 664, Jan. 6, 1993, as amended at 59 FR 45196, Sept. 1, 1994] information for at least 90 percent of the major cuts of single-ingredient, § 317.345 Guidelines for voluntary nu- raw meat products, listed in § 317.344, trition labeling of single-ingredient, that it sells, and if the nutrition label raw products. is consistent in content and format with the mandatory program, or nutri- (a) Nutrition information on the cuts tion information is displayed at point- of single-ingredient, raw meat prod- of-purchase in an approriate manner. ucts, including those that have been (c) To determine whether there is sig- previously frozen, shall be provided in nificant participation by retailers the following manner: under the voluntary nutrition labeling (1) If a retailer or manufacturer guidelines, FSIS will select a rep- chooses to provide nutrition informa- resentative sample of companies allo- tion on the label of these products, cated by type and size. these products shall be subject to all (d) FSIS will find that significant requirements of the mandatory nutri- participation by food retailers exists if tion labeling program, except that nu- at least 60 percent of all companies trition labeling may be declared on the that are evaluated are participating in basis of either ‘‘as consumed’’ or ‘‘as accordance with the guidelines. packaged.’’ In addition, the declaration (e) FSIS will evaluate significant of the number of servings per container participation of the voluntary program need not be included in nutrition label- every 2 years beginning in May 1995. ing of single-ingredient, raw meat (1) If significant participation is products (including ground beef), in- found, the voluntary nutrition labeling cluding those that have been pre- guidelines shall remain in effect. viously frozen. (2) If significant participation is not (2) A retailer may choose to provide found, FSIS shall initiate rulemaking nutrition information at the point-of- to require nutrition labeling on those purchase, such as by posting a sign, or products under the voluntary program. by making the information readily available in brochures, notebooks, or § 317.344 Identification of major cuts leaflet form in close proximity to the of meat products. food. The nutrition labeling informa- The major cuts of single-ingredient, tion may also be supplemented by a raw meat products are: Beef chuck video, live demonstration, or other blade roast, beef loin top loin steak, media. If a nutrition claim is made on beef rib roast large end, beef round eye point-of-purchase materials all of the round steak, beef round top round requirements of the mandatory nutri- steak, beef round tip roast, beef chuck tion labeling program apply. However, arm pot roast, beef loin sirloin steak, if only nutrition information—and not beef round bottom round steak, beef a nutrition claim—is supplied on point- brisket (whole, flat half, or point half), of-purchase materials: beef rib steak small end, beef loin ten- (i) The requirements of the manda- derloin steak, ground beef regular tory nutrition labeling program apply, without added seasonings, ground beef but the nutrition information may be about 17% fat, pork loin chop, pork supplied on an ‘‘as packaged’’ or ‘‘as loin country style ribs, pork loin top consumed,’’ basis;

215

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00225 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR §§ 317.346–317.353 9 CFR Ch. III (1–1–08 Edition)

(ii) The listing of percent of Daily (g) Retailers may use data bases that Value for the nutrients (except vita- they believe reflect the nutrient con- mins and minerals specified in tent of single-ingredient, raw meat § 317.309(c)(8)) and footnote required by products (including ground beef), in- § 317.309(d)(9) may be omitted; and cluding those that have been pre- (iii) The point-of-purchase materials viously frozen; however, such labeling are not subject to any of the format re- shall be subject to the compliance pro- quirements. cedures of paragraph (e) of this section (b) [Reserved] and the requirements specified in this (c) The declaration of nutrition infor- subpart for the mandatory nutrition mation may be presented in a sim- labeling program. plified format as specified in § 317.309(f) for the mandatory nutrition labeling [58 FR 664, Jan. 6, 1993, as amended at 58 FR 47627, Sept. 10, 1993; 60 FR 189, Jan. 3, 1995] program. (d) The nutrition label data should be §§ 317.346–317.353 [Reserved] based on either the raw or cooked edible portions of meat cuts with external § 317.354 Nutrient content claims for cover fat at trim levels reflecting cur- ‘‘good source,’’ ‘‘high,’’ and ‘‘more.’’ rent marketing practices. If data are (a) General requirements. Except as based on cooked portions, the methods provided in paragraph (e) of this sec- used to cook the products must be tion, a claim about the level of a nutri- specified and should be those which do ent in a product in relation to the Ref- not add nutrients from other ingredi- erence Daily Intake (RDI) or Daily Ref- ents such as flour, breading, and salt. erence Value (DRV) established for Additional nutritional data may be that nutrient (excluding total carbo- presented on an optional basis for the hydrate) in § 317.309(c), may only be raw or cooked edible portions of the made on the label or in labeling of the separable lean of meat cuts. product if: (e) Nutrient data that are the most (1) The claim uses one of the terms current representative data base values defined in this section in accordance contained in USDA’s National Nutrient with the definition for that term; Data Bank or its published form, the Agriculture Handbook No. 8 series, (2) The claim is made in accordance may be used for nutrition labeling of with the general requirements for nu- single-ingredient, raw meat products trient content claims in § 317.313; and (including ground beef), including (3) The product for which the claim is those that have been previously frozen. made is labeled in accordance with These data may be composite data that § 317.309. reflect different quality grades of beef (b) ‘‘High’’ claims. (1) The terms or other variables affecting nutrient ‘‘high,’’ ‘‘rich in,’’ or ‘‘excellent source content. Alternatively, data that re- of’’ may be used on the label or in la- flect specific grades or other variables beling of products, except meal-type may be used, except that if data are products as defined in § 317.313(l), and used on labels attached to a product main-dish products as defined in which is labeled as to grade of meat or § 317.313(m) provided that the product other variables, the data must rep- contains 20 percent or more of the RDI resent the product in the package when or the DRV per reference amount cus- such data are contained in the rep- tomarily consumed. resentative data base. When data are (2) The terms defined in paragraph used on labels attached to a product, (b)(1) of this section may be used on the data must represent the edible the label or in labeling of a meal-type meat tissues present in the package. product as defined in § 317.313(l), and (f) If the nutrition information is in main-dish product as defined in accordance with paragraph (e) of this § 317.313(m) provided that: section, a nutrition label or labeling (i) The product contains a food that will not be subject to the Agency com- meets the definition of ‘‘high’’ in para- pliance review under § 317.309(h), unless graph (b)(1) of this section; and a nutrition claim is made on the basis (ii) The label or labeling clearly iden- of the representative data base values. tifies the food that is the subject of the

216

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00226 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.354

claim (e.g., ‘‘the serving of broccoli in appropriate reference product as de- this meal is high in vitamin C’’). scribed in § 317.313(j)(1); and (c) ‘‘Good Source’’ claims. (1) The (ii) As required in § 317.313(j)(2) for terms ‘‘good source,’’ ‘‘contains,’’ or relative claims: ‘‘provides’’ may be used on the label or (A) The identity of the reference in labeling of products, except meal- product and the percent (or fraction) type products as described in that the nutrient is greater relative to § 317.313(l), and main-dish products as the RDI or DRV are declared in imme- defined in § 317.313(m) provided that the diate proximity to the most prominent product contains 10 to 19 percent of the such claim (e.g., ‘‘contains 10 percent RDI or the DRV per reference amount more of the Daily Value for fiber than customarily consumed. (2) The terms defined in paragraph ‘reference product’ ’’); and (c)(1) of this section may be used on the (B) Quantitative information com- label or in labeling of a meal-type paring the level of the nutrient in the product as defined in § 317.313(l), and product per labeled serving size with main-dish product as defined in that of the reference product that it re- § 317.313(m) provided that: places is declared adjacent to the most (i) The product contains a food that prominent claim or to the nutrition in- meets the definition of ‘‘good source’’ formation (e.g., ‘‘fiber content of ‘ref- in paragraph (c)(1) of this section; and erence product’ is 1 g per serving; ‘this (ii) The label or labeling clearly iden- product’ contains 4 g per serving’’). tifies the food that is the subject of the (2) A relative claim using the terms claim (e.g., ‘‘the serving of sweet pota- ‘‘more’’ and ‘‘added’’ may be used on toes in this meal is a good source of the label or in labeling to describe the fiber’’). level of protein, vitamins, minerals, di- (d) Fiber claims. (1) If a nutrient con- etary fiber, or potassium in meal-type tent claim is made with respect to the products as defined in § 317.313(l), and level of dietary fiber, i.e., that the main-dish products as defined in product is high in fiber, a good source § 317.313(m) provided that: of fiber, or that the product contains (i) The product contains at least 10 ‘‘more’’ fiber, and the product is not percent more of the RDI or the DRV ‘‘low’’ in total fat as defined in § 317.362(b)(2) or, in the case of a meal- for protein, vitamins, minerals, dietary type product or a main-dish product, is fiber, or potassium (expressed as a per- not ‘‘low’’ in total fat as defined in cent of the Daily Value) per 100 g of § 317.362(b)(3), then the labeling shall product than an appropriate reference disclose the level of total fat per la- product as described in § 317.313(j)(1); beled serving size (e.g., ‘‘contains 12 and grams (g) of fat per serving’’); and (ii) As required in § 317.313(j)(2) for (2) The disclosure shall appear in im- relative claims: mediate proximity to such claim and (A) The identity of the reference be in a type size no less than one-half product and the percent (or fraction) the size of the claim. that the nutrient is greater relative to (e) ‘‘More’’ claims. (1) A relative claim the RDI or DRV are declared in imme- using the terms ‘‘more’’ and ‘‘added’’ diate proximity to the most prominent may be used on the label or in labeling such claim (e.g., ‘‘contains 10 percent to describe the level of protein, vita- more of the Daily Value for fiber per 3 mins, minerals, dietary fiber, or potas- ounces (oz) than does ‘reference prod- sium in a product, except meal-type uct’ ’’), and products as defined in § 317.313(l), and (B) Quantitative information com- main-dish products as defined in paring the level of the nutrient in the § 317.313(m) provided that: (i) The product contains at least 10 meal-type product or a main-dish prod- percent more of the RDI or the DRV uct per specified weight with that of for protein, vitamins, minerals, dietary the reference product that it replaces fiber, or potassium (expressed as a per- is declared adjacent to the most promi- cent of the Daily Value) per reference nent claim or to the nutrition informa- amount customarily consumed than an tion (e.g., ‘‘fiber content of ‘reference

217

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00227 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.355 9 CFR Ch. III (1–1–08 Edition)

product’ is 2 g per 3 oz; ‘this product’ (ii) Quantitative information com- contains 5 g per 3 oz’’). paring the level of calories and fat content in the product per labeled serving [60 FR 189, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004] size with that of the reference product that it replaces is declared adjacent to § 317.355 [Reserved] the most prominent claim or to the nutrition information (e.g., ‘‘lite ‘this § 317.356 Nutrient content claims for product’—200 calories, 4 grams (g) fat; ‘‘light’’ or ‘‘lite.’’ regular ‘reference product’—300 cal- (a) General requirements. A claim ories, 8 g fat per serving’’); and using the terms ‘‘light’’ or ‘‘lite’’ to de- (iii) If the labeled product contains scribe a product may only be made on less than 40 calories or less than 3 g fat the label or in labeling of the product per reference amount customarily con- if: sumed, the percentage reduction for (1) The claim uses one of the terms that nutrient need not be declared. defined in this section in accordance (4) A ‘‘light’’ claim may not be made with the definition for that term; on a product for which the reference (2) The claim is made in accordance product meets the definition of ‘‘low with the general requirements for nu- fat’’ and ‘‘low calorie.’’ trient content claims in § 317.313; and (c)(1)(i) A product for which the ref- (3) The product for which the claim is erence product contains 40 calories or made is labeled in accordance with less and 3 g fat or less per reference § 317.309. amount customarily consumed may (b) ‘‘Light’’ claims. The terms ‘‘light’’ use the terms ‘‘light’’ or ‘‘lite’’ without or ‘‘lite’’ may be used on the label or in further qualification if it is reduced by labeling of products, except meal-type 50 percent or more in sodium content products as defined in § 317.313(l) and compared to the reference product; and main-dish products as defined in § 317.313(m), without further qualifica- (ii) As required in § 317.313(j)(2) for tion, provided that: relative claims: (1) If the product derives 50 percent (A) The identity of the reference or more of its calories from fat, its fat product and the percent (or fraction) content is reduced by 50 percent or that the sodium was reduced are de- more per reference amount custom- clared in immediate proximity to the arily consumed compared to an appro- most prominent such claim (e.g., ‘‘50 priate reference product as described in percent less sodium than the market § 317.313(j)(1); or leader’’); and (2) If the product derives less than 50 (B) Quantitative information com- percent of its calories from fat: paring the level of sodium per labeled (i) The number of calories is reduced serving size with that of the reference by at least one-third (331⁄3 percent) per product it replaces is declared adjacent reference amount customarily con- to the most prominent claim or to the sumed compared to an appropriate ref- nutrition information (e.g., ‘‘lite ‘this erence product as described in product’—500 milligrams (mg) sodium § 317.313(j)(1); or per serving; regular ‘reference prod- (ii) Its fat content is reduced by 50 uct’—1,000 mg sodium per serving’’). percent or more per reference amount (2)(i) A product for which the ref- customarily consumed compared to the erence product contains more than 40 appropriate reference product as de- calories or more than 3 g fat per ref- scribed in § 317.313(j)(1); and erence amount customarily consumed (3) As required in § 317.313(j)(2) for rel- may use the terms ‘‘light in sodium’’ ative claims: or ‘‘lite in sodium’’ if it is reduced by (i) The identity of the reference prod- 50 percent or more in sodium content uct and the percent (or fraction) that compared to the reference product, pro- the calories and the fat were reduced vided that ‘‘light’’ or ‘‘lite’’ is pre- are declared in immediate proximity to sented in immediate proximity with the most prominent such claim (e.g., ‘‘in sodium’’ and the entire term is pre- ‘‘1⁄3 fewer calories and 50 percent less sented in uniform type size, style, fat than the market leader’’); and color, and prominence; and

218

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00228 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.356

(ii) As required in § 317.313(j)(2) for describe the sodium content, provided relative claims: that: (A) The identity of the reference (i) The product is reduced by 50 per- product and the percent (or fraction) cent or more in sodium content com- that the sodium was reduced are de- pared to the reference product; clared in immediate proximity to the (ii) A statement specifically stating most prominent such claim (e.g., ‘‘50 that the product is ‘‘light in sodium’’ percent less sodium than the market or ‘‘lite in sodium’’ appears: leader’’); and (A) Contiguous to the brand name; (B) Quantitative information com- and paring the level of sodium per labeled (B) In uniform type size, style, color, serving size with that of the reference and prominence as the product name; product it replaces is declared adjacent and to the most prominent claim or to the (iii) As required in § 317.313(j)(2) for nutrition information (e.g., or ‘‘lite relative claims: ‘this product’—170 mg sodium per serv- (A) The identity of the reference ing; regular ‘reference product’—350 mg product and the percent (or fraction) per serving’’). that the sodium was reduced are de- (3) Except for meal-type products as clared in immediate proximity to the defined in § 317.313(l) and main-dish most prominent such claim; and products as defined in § 317.313(m), a (B) Quantitative information com- ‘‘light in sodium’’ claim may not be paring the level of sodium per labeled made on a product for which the ref- serving size with that of the reference erence product meets the definition of product it replaces is declared adjacent ‘‘low in sodium.’’ to the most prominent claim or to the (d)(1) The terms ‘‘light’’ or ‘‘lite’’ nutrition information. may be used on the label or in labeling (e) Except as provided in paragraphs of a meal-type product as defined in (b) through (d) of this section, the § 317.313(l) and main-dish product as de- terms ‘‘light’’ or ‘‘lite’’ may not be fined in § 317.313(m), provided that: used to refer to a product that is not (i) The product meets the definition reduced in fat by 50 percent, or, if ap- of: plicable, in calories by 1⁄3 or, when (A) ‘‘Low in calories’’ as defined in properly qualified, in sodium by 50 per- § 317.360(b)(3); or cent unless: (B) ‘‘Low in fat’’ as defined in (1) It describes some physical or § 317.362(b)(3); and organoleptic attribute of the product (ii)(A) A statement appears on the such as texture or color and the infor- principal display panel that explains mation (e.g., ‘‘light in color’’ or ‘‘light whether ‘‘light’’ is used to mean ‘‘low in texture’’) so stated, clearly conveys fat,’’ ‘‘low calories,’’ or both (e.g., the nature of the product; and ‘‘Light Delight, a low fat meal’’); and (2) The attribute (e.g., ‘‘color’’ or (B) The accompanying statement is ‘‘texture’’) is in the same style, color, no less than one-half the type size of and at least one-half the type size as the ‘‘light’’ or ‘‘lite’’ claim. the word ‘‘light’’ and in immediate (2)(i) The terms ‘‘light in sodium’’ or proximity thereto. ‘‘lite in sodium’’ may be used on the (f) If a manufacturer can dem- label or in labeling of a meal-type onstrate that the word ‘‘light’’ has product as defined in § 317.313(l) and been associated, through common use, main-dish product as defined in with a particular product to reflect a § 317.313(m), provided that the product physical or organoleptic attribute to meets the definition of ‘‘low in so- the point where it has become part of dium’’ as defined in § 317.361(b)(5)(i); the statement of identity, such use of and the term ‘‘light’’ shall not be consid- (ii) ‘‘Light’’ or ‘‘lite’’ and ‘‘in so- ered a nutrient content claim subject dium’’ are presented in uniform type to the requirements in this part. size, style, color, and prominence. (g) The term ‘‘lightly salted’’ may be (3) The term ‘‘light’’ or ‘‘lite’’ may be used on a product to which has been used in the brand name of a product to added 50 percent less sodium than is

219

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00229 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR §§ 317.357–317.359 9 CFR Ch. III (1–1–08 Edition)

normally added to the reference prod- (i)(A) The product has a reference uct as described in § 317.313(j)(1)(i)(B) amount customarily consumed greater and (j)(1)(ii)(B), provided that if the than 30 grams (g) or greater than 2 ta- product is not ‘‘low in sodium’’ as de- blespoons (tbsp) and does not provide fined in § 317.361(b)(4), the statement more than 40 calories per reference ‘‘not a low sodium food,’’ shall appear amount customarily consumed; or adjacent to the nutrition information (B) The product has a reference and the information required to accom- amount customarily consumed of 30 g pany a relative claim shall appear on or less or 2 tbsp or less and does not the label or labeling as specified in provide more than 40 calories per ref- § 317.313(j)(2). erence amount customarily consumed and per 50 g (for dehydrated products [60 FR 189, Jan. 3, 1995, as amended at 69 FR 58802, Oct. 1, 2004] that must be reconstituted before typical consumption with water or a dil- §§ 317.357–317.359 [Reserved] uent containing an insignificant amount, as defined in § 317.309(f)(1), of § 317.360 Nutrient content claims for all nutrients per reference amount cus- calorie content. tomarily consumed, the per-50-g cri- (a) General requirements. A claim terion refers to the ‘‘as prepared’’ about the calorie or sugar content of a form). product may only be made on the label (ii) If the product meets these condi- or in labeling of the product if: tions without the benefit of special (1) The claim uses one of the terms processing, alteration, formulation, or defined in this section in accordance reformulation to lower the caloric con- with the definition for that term; tent, it is labeled to clearly refer to all (2) The claim is made in accordance products of its type and not merely to with the general requirements for nu- the particular brand to which the label trient content claims in § 317.313; and attaches. (3) The product for which the claim is (3) The terms defined in paragraph made is labeled in accordance with (b)(2) of this section may be used on § 317.309. the label or in labeling of a meal-type (b) Calorie content claims. (1) The product as defined in § 317.313(l) and terms ‘‘calorie free,’’ ‘‘free of calories,’’ main-dish product as defined in ‘‘no calories,’’ ‘‘zero calories,’’ ‘‘with- § 317.313(m), provided that: out calories,’’ ‘‘trivial source of cal- (i) The product contains 120 calories ories,’’ ‘‘negligible source of calories,’’ or less per 100 g of product; and or ‘‘dietarily insignificant source of (ii) If the product meets this condi- calories’’ may be used on the label or tion without the benefit of special in labeling of products, provided that: processing, alteration, formulation, or (i) The product contains less than 5 reformulation to lower the calorie con- calories per reference amount custom- tent, it is labeled to clearly refer to all arily consumed and per labeled serving products of its type and not merely to size; and the particular brand to which it at- (ii) If the product meets this condi- taches. tion without the benefit of special (4) The terms ‘‘reduced calorie,’’ ‘‘re- processing, alteration, formulation, or duced in calories,’’ ‘‘calorie reduced,’’ reformulation to lower the caloric con- ‘‘fewer calories,’’ ‘‘lower calorie,’’ or tent, it is labeled to clearly refer to all ‘‘lower in calories’’ may be used on the products of its type and not merely to label or in labeling of products, except the particular brand to which the label meal-type products as defined in attaches. § 317.313(l) and main-dish products as (2) The terms ‘‘low calorie,’’ ‘‘few cal- defined in § 317.313(m), provided that: ories,’’ ‘‘contains a small amount of (i) The product contains at least 25 calories,’’ ‘‘low source of calories,’’ or percent fewer calories per reference ‘‘low in calories’’ may be used on the amount customarily consumed than an label or in labeling of products, except appropriate reference product as de- meal-type products as defined in scribed in § 317.313(j)(1); and § 317.313(l) and main-dish products as (ii) As required in § 317.313(j)(2) for defined in § 317.313(m), provided that: relative claims:

220

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00230 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.360

(A) The identity of the reference sugar,’’ ‘‘sugarless,’’ ‘‘trivial source of product and the percent (or fraction) sugar,’’ ‘‘negligible source of sugar,’’ or that the calories differ between the two ‘‘dietarily insignificant source of products are declared in immediate sugar’’ may reasonably be expected to proximity to the most prominent such be regarded by consumers as terms claim (e.g., lower calorie ‘product’— that represent that the product con- ‘‘331⁄3 percent fewer calories than our tains no sugars or sweeteners, e.g., regular ‘product’ ’’); and ‘‘sugar free,’’ or ‘‘no sugar,’’ as indi- (B) Quantitative information com- cating a product which is low in cal- paring the level of calories in the prod- ories or significantly reduced in cal- uct per labeled serving size with that of ories. Consequently, except as provided the reference product that it replaces in paragraph (c)(2) of this section, a is declared adjacent to the most promi- product may not be labeled with such nent claim or to the nutrition informa- terms unless: tion (e.g., ‘‘calorie content has been re- (i) The product contains less than 0.5 duced from 150 to 100 calories per serv- g of sugars, as defined in ing’’). § 317.309(c)(6)(ii), per reference amount (iii) Claims described in paragraph customarily consumed and per labeled (b)(4) of this section may not be made serving size or, in the case of a meal- on the label or in labeling of products type product or a main-dish product, if the reference product meets the defi- less than 0.5 g of sugars per labeled nition for ‘‘low calorie.’’ serving size; (5) The terms defined in paragraph (ii) The product contains no ingre- (b)(4) of this section may be used on dient that is a sugar or that is gen- the label or in labeling of a meal-type erally understood by consumers to con- product as defined in § 317.313(l) and tain sugars unless the listing of the in- main-dish product as defined in gredient in the ingredients statement § 317.313(m), provided that: is followed by an asterisk that refers to (i) The product contains at least 25 the statement below the list of ingredi- percent fewer calories per 100 g of prod- ents, which states: ‘‘Adds a trivial uct than an appropriate reference prod- amount of sugar,’’ ‘‘adds a negligible uct as described in § 317.313(j)(1); and amount of sugar,’’ or ‘‘adds a dietarily (ii) As required in § 317.313(j)(2) for insignificant amount of sugar;’’ and relative claims: (iii)(A) It is labeled ‘‘low calorie’’ or (A) The identity of the reference ‘‘reduced calorie’’ or bears a relative product and the percent (or fraction) claim of special dietary usefulness la- that the calories differ between the two beled in compliance with paragraphs products are declared in immediate (b)(2), (b)(3), (b)(4), or (b)(5) of this sec- proximity to the most prominent such tion; or claim (e.g., ‘‘calorie reduced ‘product’, (B) Such term is immediately accom- 25% less calories per ounce (oz) (or 3 oz) panied, each time it is used, by either than our regular ‘product’ ’’); and the statement ‘‘not a reduced calorie (B) Quantitative information com- product,’’ ‘‘not a low calorie product,’’ paring the level of calories in the prod- or ‘‘not for weight control.’’ uct per specified weight with that of (2) The terms ‘‘no added sugar,’’ the reference product that it replaces ‘‘without added sugar,’’ or ‘‘no sugar is declared adjacent to the most promi- added’’ may be used only if: nent claim or to the nutrition informa- (i) No amount of sugars, as defined in tion (e.g., ‘‘calorie content has been re- § 317.309(c)(6)(ii), or any other ingre- duced from 110 calories per 3 oz to 80 dient that contains sugars that func- calories per 3 oz’’). tionally substitute for added sugars is (iii) Claims described in paragraph added during processing or packaging; (b)(5) of this section may not be made (ii) The product does not contain an on the label or in labeling of products ingredient containing added sugars if the reference product meets the defi- such as jam, jelly, or concentrated nition for ‘‘low calorie.’’ fruit juice; (c) Sugar content claims. (1) Terms (iii) The sugars content has not been such as ‘‘sugar free,’’ ‘‘free of sugar,’’ increased above the amount present in ‘‘no sugar,’’ ‘‘zero sugar,’’ ‘‘without the ingredients by some means such as

221

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00231 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.361 9 CFR Ch. III (1–1–08 Edition)

the use of enzymes, except where the label or in labeling of a meal-type intended functional effect of the proc- product as defined in § 317.313(l) and ess is not to increase the sugars con- main-dish product as defined in tent of a product, and a functionally § 317.313(m), provided that: insignificant increase in sugars results; (i) The product contains at least 25 (iv) The product that it resembles percent less sugars per 100 g of product and for which it substitutes normally than an appropriate reference product contains added sugars; and as described in § 317.313(j)(1); and (v) The product bears a statement (ii) As required in § 317.313(j)(2) for that the product is not ‘‘low calorie’’ relative claims: or ‘‘calorie reduced’’ (unless the prod- (A) The identity of the reference uct meets the requirements for a ‘‘low’’ product and the percent (or fraction) or ‘‘reduced calorie’’ product) and that that the sugars differ between the two directs consumers’ attention to the nu- products are declared in immediate trition panel for further information proximity to the most prominent such on sugar and calorie content. claim (e.g., ‘‘reduced sugar ‘product’— (3) Paragraph (c)(1) of this section 25% less sugar than our regular ‘prod- shall not apply to a factual statement uct’ ’’); and that a product, including products in- (B) Quantitative information com- tended specifically for infants and chil- paring the level of the nutrient in the dren less than 2 years of age, is un- product per specified weight with that sweetened or contains no added sweet- of the reference product that it re- eners in the case of a product that con- places is declared adjacent to the most tains apparent substantial inherent prominent claim or to the nutrition in- sugar content, e.g., juices. formation (e.g., ‘‘sugar content has (4) The terms ‘‘reduced sugar,’’ ‘‘re- been reduced from 17 g per 3 oz to 13 g duced in sugar,’’ ‘‘sugar reduced,’’ ‘‘less per 3 oz’’). sugar,’’ ‘‘lower sugar,’’ or ‘‘lower in sugar’’ may be used on the label or in [60 FR 191, Jan. 3, 1995, as amended at 69 FR labeling of products, except meal-type 58802, Oct. 1, 2004] products as defined in § 317.313(l) and § 317.361 Nutrient content claims for main-dish products as defined in the sodium content. § 317.313(m), provided that: (i) The product contains at least 25 (a) General requirements. A claim percent less sugars per reference about the level of sodium in a product amount customarily consumed than an may only be made on the label or in la- appropriate reference product as de- beling of the product if: scribed in § 317.313(j)(1); and (1) The claim uses one of the terms (ii) As required in § 317.313(j)(2) for defined in this section in accordance relative claims: with the definition for that term; (A) The identity of the reference (2) The claim is made in accordance product and the percent (or fraction) with the general requirements for nu- that the sugars differ between the two trient content claims in § 317.313; and products are declared in immediate (3) The product for which the claim is proximity to the most prominent such made is labeled in accordance with claim (e.g., ‘‘this product contains 25 § 317.309. percent less sugar than our regular (b) Sodium content claims. (1) The product’’); and terms ‘‘sodium free,’’ ‘‘free of sodium,’’ (B) Quantitative information com- ‘‘no sodium,’’ ‘‘zero sodium,’’ ‘‘without paring the level of the sugar in the sodium,’’ ‘‘trivial source of sodium,’’ product per labeled serving size with ‘‘negligible source of sodium,’’ or that of the reference product that it re- ‘‘dietarily insignificant source of so- places is declared adjacent to the most dium’’ may be used on the label or in prominent claim or to the nutrition in- labeling of products, provided that: formation (e.g., ‘‘sugar content has (i) The product contains less than 5 been lowered from 8 g to 6 g per serv- milligrams (mg) of sodium per ref- ing’’). erence amount customarily consumed (5) The terms defined in paragraph and per labeled serving size or, in the (c)(4) of this section may be used on the case of a meal-type product or a main-

222

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00232 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.361

dish product, less than 5 mg of sodium main-dish product as defined in per labeled serving size; § 317.313(m), provided that: (ii) The product contains no ingre- (i) The product contains 35 mg or less dient that is sodium chloride or is gen- of sodium per 100 g of product; and erally understood by consumers to con- (ii) If the product meets this condi- tain sodium unless the listing of the in- tion without the benefit of special gredient in the ingredients statement processing, alteration, formulation, or is followed by an asterisk that refers to reformulation to lower the sodium con- the statement below the list of ingredi- tent, it is labeled to clearly refer to all ents, which states: ‘‘Adds a trivial products of its type and not merely to amount of sodium,’’ ‘‘adds a negligible the particular brand to which the label amount of sodium’’ or ‘‘adds a dietarily attaches. insignificant amount of sodium’’; and (4) The terms ‘‘low sodium,’’ ‘‘low in (iii) If the product meets these condi- sodium,’’ ‘‘little sodium,’’ ‘‘contains a tions without the benefit of special small amount of sodium,’’ or ‘‘low processing, alteration, formulation, or source of sodium’’ may be used on the reformulation to lower the sodium con- label and in labeling of products, extent, it is labeled to clearly refer to all cept meal-type products as defined in products of its type and not merely to § 317.313(l) and main-dish products as the particular brand to which the label defined in § 317.313(m), provided that: attaches. (i)(A) The product has a reference (2) The terms ‘‘very low sodium’’ or amount customarily consumed greater ‘‘very low in sodium’’ may be used on than 30 g or greater than 2 tbsp and the label or in labeling of products, ex- contains 140 mg or less sodium per ref- cept meal-type products as defined in erence amount customarily consumed; § 317.313(l) and main-dish products as or defined in § 317.313(m), provided that: (B) The product has a reference (i)(A) The product has a reference amount customarily consumed of 30 g amount customarily consumed greater or less or 2 tbsp or less and contains 140 than 30 grams (g) or greater than 2 ta- mg or less sodium per reference blespoons (tbsp) and contains 35 mg or amount customarily consumed and per less sodium per reference amount cus- 50 g (for dehydrated products that must tomarily consumed; or be reconstituted before typical con- (B) The product has a reference sumption with water or a diluent con- amount customarily consumed of 30 g taining an insignificant amount, as de- or less or 2 tbsp or less and contains 35 fined in § 317.309(f)(1), of all nutrients mg or less sodium per reference per reference amount customarily con- amount customarily consumed and per sumed, the per-50-g criterion refers to 50 g (for dehydrated products that must the ‘‘as prepared’’ form); and be reconstituted before typical con- (ii) If the product meets these condi- sumption with water or a diluent con- tions without the benefit of special taining an insignificant amount, as de- processing, alteration, formulation, or fined in § 317.309(f)(1), of all nutrients reformulation to lower the sodium con- per reference amount customarily content, it is labeled to clearly refer to all sumed, the per-50-g criterion refers to products of its type and not merely to the ‘‘as prepared’’ form); and the particular brand to which the label (ii) If the product meets these condi- attaches. tions without the benefit of special (5) The terms defined in paragraph processing, alteration, formulation, or (b)(4) of this section may be used on reformulation to lower the sodium con- the label or in labeling of a meal-type tent, it is labeled to clearly refer to all product as defined in § 317.313(l) and products of its type and not merely to main-dish product as defined in the particular brand to which the label § 317.313(m), provided that: attaches. (i) The product contains 140 mg or (3) The terms defined in paragraph less sodium per 100 g of product; and (b)(2) of this section may be used on (ii) If the product meets these condi- the label or in labeling of a meal-type tions without the benefit of special product as defined in § 317.313(l) and processing, alteration, formulation, or

223

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00233 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.361 9 CFR Ch. III (1–1–08 Edition)

reformulation to lower the sodium con- two products are declared in imme- tent, it is labeled to clearly refer to all diate proximity to the most prominent products of its type and not merely to such claim (e.g., ‘‘reduced sodium the particular brand to which the label ‘product’—30% less sodium per 3 oz attaches. than our ‘regular product’ ’’); and (6) The terms ‘‘reduced sodium,’’ (B) Quantitative information com- ‘‘reduced in sodium,’’ ‘‘sodium re- paring the level of sodium in the prod- duced,’’ ‘‘less sodium,’’ ‘‘lower so- uct per specified weight with that of dium,’’ or ‘‘lower in sodium’’ may be the reference product that it replaces used on the label or in labeling of prod- is declared adjacent to the most promi- ucts, except meal-type products as de- nent claim or to the nutrition informa- fined in § 317.313(l) and main-dish prod- tion (e.g., ‘‘sodium content has been re- ucts as defined in § 317.313(m), provided that: duced from 220 mg per 3 oz to 150 mg (i) The product contains at least 25 per 3 oz’’). percent less sodium per reference (iii) Claims described in paragraph amount customarily consumed than an (b)(7) of this section may not be made appropriate reference product as de- on the label or in labeling of products scribed in § 317.313(j)(1); and if the nutrient content of the reference (ii) As required in § 317.313(j)(2) for product meets the definition for ‘‘low relative claims: sodium.’’ (A) The identity of the reference (c) The term ‘‘salt’’ is not synony- product and the percent (or fraction) mous with ‘‘sodium.’’ Salt refers to so- that the sodium differs between the dium chloride. However, references to two products are declared in imme- salt content such as ‘‘unsalted,’’ ‘‘no diate proximity to the most prominent salt,’’ ‘‘no salt added’’ are potentially such claim (e.g., ‘‘reduced sodium misleading. ‘product’, 50 percent less sodium than (1) The term ‘‘salt free’’ may be used regular ‘product’ ’’); and on the label or in labeling of products (B) Quantitative information com- only if the product is ‘‘sodium free’’ as paring the level of sodium in the prod- defined in paragraph (b)(1) of this sec- uct per labeled serving size with that of tion. the reference product that it replaces is declared adjacent to the most promi- (2) The terms ‘‘unsalted,’’ ‘‘without nent claim or to the nutrition informa- added salt,’’ and ‘‘no salt added’’ may tion (e.g., ‘‘sodium content has been be used on the label or in labeling of lowered from 300 to 150 mg per serv- products only if: ing’’). (i) No salt is added during processing; (iii) Claims described in paragraph (ii) The product that it resembles and (b)(6) of this section may not be made for which it substitutes is normally on the label or in labeling of a product processed with salt; and if the nutrient content of the reference (iii) If the product is not sodium free, product meets the definition for ‘‘low the statement, ‘‘not a sodium free sodium.’’ product’’ or ‘‘not for control of sodium (7) The terms defined in paragraph in the diet’’ appears adjacent to the nu- (b)(6) of this section may be used on trition information of the product the label or in labeling of a meal-type bearing the claim. product as defined in § 317.313(l) and (3) Paragraph (c)(2) of this section main-dish product as defined in shall not apply to a factual statement § 317.313(m), provided that: that a product intended specifically for (i) The product contains at least 25 infants and children less than 2 years percent less sodium per 100 g of product than an appropriate reference product of age is unsalted, provided such state- as described in § 317.313(j)(1); and ment refers to the taste of the product (ii) As required in § 317.313(j)(2) for and is not false or otherwise mis- relative claims: leading. (A) The identity of the reference [60 FR 192, Jan. 3, 1995, as amended at 69 FR product and the percent (or fraction) 58802, Oct. 1, 2004] that the sodium differs between the

224

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00234 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.362

§ 317.362 Nutrient content claims for (i)(A) The product has a reference fat, fatty acids, and cholesterol con- amount customarily consumed greater tent. than 30 g or greater than 2 tablespoons (a) General requirements. A claim (tbsp) and contains 3 g or less of fat per about the level of fat, fatty acid, and reference amount customarily con- cholesterol in a product may only be sumed; or made on the label or in labeling of (B) The product has a reference products if: amount customarily consumed of 30 g (1) The claim uses one of the terms or less or 2 tbsp or less and contains 3 defined in this section in accordance g or less of fat per reference amount with the definition for that term; customarily consumed and per 50 g (for (2) The claim is made in accordance dehydrated products that must be re- with the general requirements for nu- constituted before typical consumption trient content claims in § 317.313; and with water or a diluent containing an (3) The product for which the claim is insignificant amount, as defined in made is labeled in accordance with § 317.309(f)(1), of all nutrients per ref- § 317.309. erence amount customarily consumed, (b) Fat content claims. (1) The terms the per-50-g criterion refers to the ‘‘as ‘‘fat free,’’ ‘‘free of fat,’’ ‘‘no fat,’’ prepared’’ form). ‘‘zero fat,’’ ‘‘without fat,’’ ‘‘nonfat,’’ (ii) If the product meets these condi- ‘‘trivial source of fat,’’ ‘‘negligible tions without the benefit of special source of fat,’’ or ‘‘dietarily insignifi- processing, alteration, formulation, or cant source of fat’’ may be used on the reformulation to lower the fat content, label or in labeling of products, pro- it is labeled to clearly refer to all prod- vided that: ucts of its type and not merely to the (i) The product contains less than 0.5 particular brand to which the label at- gram (g) of fat per reference amount taches. customarily consumed and per labeled (3) The terms defined in paragraph serving size or, in the case of a meal- (b)(2) of this section may be used on type product or a main-dish product, the label or in labeling of a meal-type less than 0.5 g of fat per labeled serving product as defined in § 317.313(l) and size; main-dish product as defined in (ii) The product contains no added in- § 317.313(m), provided that: gredient that is a fat or is generally understood by consumers to contain (i) The product contains 3 g or less of fat unless the listing of the ingredient total fat per 100 g of product and not in the ingredients statement is fol- more than 30 percent of calories from lowed by an asterisk that refers to the fat; and statement below the list of ingredients, (ii) If the product meets these condi- which states: ‘‘Adds a trivial amount of tions without the benefit of special fat,’’ ‘‘adds a negligible amount of fat,’’ processing, alteration, formulation, or or ‘‘adds a dietarily insignificant reformulation to lower the fat content, amount of fat’’; and it is labeled to clearly refer to all prod- (iii) If the product meets these condi- ucts of its type and not merely to the tions without the benefit of special particular brand to which the label at- processing, alteration, formulation, or taches. reformulation to lower the fat content, (4) The terms ‘‘reduced fat,’’ ‘‘re- it is labeled to clearly refer to all prod- duced in fat,’’ ‘‘fat reduced,’’ ‘‘less fat,’’ ucts of its type and not merely to the ‘‘lower fat,’’ or ‘‘lower in fat’’ may be particular brand to which the label at- used on the label or in labeling of prod- taches. ucts, except meal-type products as de- (2) The terms ‘‘low fat,’’ ‘‘low in fat,’’ fined in § 317.313(l) and main-dish prod- ‘‘contains a small amount of fat,’’ ‘‘low ucts as defined in § 317.313(m), provided source of fat,’’ or ‘‘little fat’’ may be that: used on the label and in labeling of (i) The product contains at least 25 products, except meal-type products as percent less fat per reference amount defined in § 317.313(l) and main-dish customarily consumed than an appro- products as defined in § 317.313(m), propriate reference product as described in vided that: § 317.313(j)(1); and

225

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00235 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.362 9 CFR Ch. III (1–1–08 Edition)

(ii) As required in § 317.313(j)(2) for (6) The term ‘‘lll percent fat free’’ relative claims: may be used on the label or in labeling (A) The identity of the reference of products, provided that: product and the percent (or fraction) (i) The product meets the criteria for that the fat differs between the two ‘‘low fat’’ in paragraph (b)(2) or (b)(3) of products are declared in immediate this section; proximity to the most prominent such (ii) The percent declared and the claim (e.g., ‘‘reduced fat—50 percent words ‘‘fat free’’ are in uniform type less fat than our regular ‘product’ ’’); size; and and (iii) A ‘‘100 percent fat free’’ claim (B) Quantitative information com- may be made only on products that paring the level of fat in the product meet the criteria for ‘‘fat free’’ in para- per labeled serving size with that of the graph (b)(1) of this section, that con- reference product that it replaces is de- tain less than 0.5 g of fat per 100 g, and clared adjacent to the most prominent that contain no added fat. claim or to the nutrition information (iv) A synonym for ‘‘lll percent (e.g., ‘‘fat content has been reduced fat free’’ is ‘‘lll percent lean.’’ from 8 g to 4 g per serving’’). (c) Fatty acid content claims. (1) The (iii) Claims described in paragraph terms ‘‘saturated fat free,’’ ‘‘free of (b)(4) of this section may not be made saturated fat,’’ ‘‘no saturated fat,’’ ‘‘zero saturated fat,’’ ‘‘without satu- on the label or in labeling of a product rated fat,’’ ‘‘trivial source of saturated if the nutrient content of the reference fat,’’ ‘‘negligible source of saturated product meets the definition for ‘‘low fat,’’ or ‘‘dietarily insignificant source fat.’’ of saturated fat’’ may be used on the (5) The terms defined in paragraph label or in labeling of products, pro- (b)(4) of this section may be used on vided that: the label or in labeling of a meal-type (i) The product contains less than 0.5 product as defined in § 317.313(l) and g of saturated fat and less than 0.5 g main-dish product as defined in trans fatty acids per reference amount § 317.313(m), provided that: customarily consumed and per labeled (i) The product contains at least 25 serving size or, in the case of a meal- percent less fat per 100 g of product type product or a main-dish product, than an appropriate reference product less than 0.5 g of saturated fat and less as described in § 317.313(j)(1); and than 0.5 g trans fatty acids per labeled (ii) As required in § 317.313(j)(2) for serving size; relative claims: (ii) The product contains no ingre- (A) The identity of the reference dient that is generally understood by product and the percent (or fraction) consumers to contain saturated fat un- that the fat differs between the two less the listing of the ingredient in the products are declared in immediate ingredients statement is followed by an proximity to the most prominent such asterisk that refers to the statement claim (e.g., ‘‘reduced fat ‘product’, 33 below the list of ingredients, which percent less fat per 3 oz than our reg- states: ‘‘Adds a trivial amount of satu- ular ‘product’ ’’); and rated fat,’’ ‘‘adds a negligible amount (B) Quantitative information com- of saturated fat,’’ or ‘‘adds a dietarily paring the level of fat in the product insignificant amount of saturated fat;’’ per specified weight with that of the and reference product that it replaces is de- (iii) If the product meets these condi- clared adjacent to the most prominent tions without the benefit of special such claim or to the nutrition informa- processing, alteration, formulation, or tion (e.g., ‘‘fat content has been re- reformulation to lower saturated fat duced from 8 g per 3 oz to 5 g per 3 oz’’). content, it is labeled to clearly refer to (iii) Claims described in paragraph all products of its type and not merely (b)(5) of this section may not be made to the particular brand to which the on the label or in labeling of a product label attaches. if the nutrient content of the reference (2) The terms ‘‘low in saturated fat,’’ product meets the definition for ‘‘low ‘‘low saturated fat,’’ ‘‘contains a small fat.’’ amount of saturated fat,’’ ‘‘low source

226

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00236 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.362

of saturated fat,’’ or ‘‘a little saturated ‘product’, contains 50 percent less satu- fat’’ may be used on the label or in la- rated fat than the national average for beling of products, except meal-type ‘product’ ’’); and products as defined in § 317.313(l) and (B) Quantitative information com- main-dish products as defined in paring the level of saturated fat in the § 317.313(m), provided that: product per labeled serving size with (i) The product contains 1 g or less of that of the reference product that it re- saturated fat per reference amount cus- places is declared adjacent to the most tomarily consumed and not more than prominent claim or to the nutrition in- 15 percent of calories from saturated formation (e.g., ‘‘saturated fat reduced fat; and from 3 g to 1.5 g per serving’’). (ii) If the product meets these condi- (iii) Claims described in paragraph tions without benefit of special proc- (c)(4) of this section may not be made essing, alteration, formulation, or re- on the label or in labeling of a product formulation to lower saturated fat con- if the nutrient content of the reference tent, it is labeled to clearly refer to all product meets the definition for ‘‘low products of its type and not merely to saturated fat.’’ the particular brand to which the label (5) The terms defined in paragraph attaches. (c)(4) of this section may be used on the (3) The terms defined in paragraph label or in labeling of a meal-type (c)(2) of this section may be used on the product as defined in § 317.313(l) and label or in labeling of a meal-type main-dish product as defined in product as defined in § 317.313(l) and § 317.313(m), provided that: main-dish product as defined in § 317.313(m), provided that: (i) The product contains at least 25 (i) The product contains 1 g or less of percent less saturated fat per 100 g of saturated fat per 100 g and less than 10 product than an appropriate reference percent calories from saturated fat; product as described in § 317.313(j)(1); and and (ii) If the product meets these condi- (ii) As required in § 317.313(j)(2) for tions without the benefit of special relative claims: processing, alteration, formulation, or (A) The identity of the reference reformulation to lower saturated fat product and the percent (or fraction) content, it is labeled to clearly refer to that the saturated fat differs between all products of its type and not merely the two products are declared in imme- to the particular brand to which the diate proximity to the most prominent label attaches. such claim (e.g., ‘‘reduced saturated fat (4) The terms ‘‘reduced saturated ‘product’,’’ ‘‘50 percent less saturated fat,’’ ‘‘reduced in saturated fat,’’ fat than our regular ‘product’ ’’); and ‘‘saturated fat reduced,’’ ‘‘less satu- (B) Quantitative information com- rated fat,’’ ‘‘lower saturated fat,’’ or paring the level of saturated fat in the ‘‘lower in saturated fat’’ may be used product per specified weight with that on the label or in labeling of products, of the reference product that it re- except meal-type products as defined in places is declared adjacent to the most § 317.313(l) and main-dish products as prominent claim or to the nutrition in- defined in § 317.313(m), provided that: formation (e.g., ‘‘saturated fat content (i) The product contains at least 25 has been reduced from 2.5 g per 3 oz to percent less saturated fat per reference 1.5 g per 3 oz’’). amount customarily consumed than an (iii) Claims described in paragraph appropriate reference product as de- (c)(5) of this section may not be made scribed in § 317.313(j)(1); and on the label or in labeling of a product (ii) As required in § 317.313(j)(2) for if the nutrient content of the reference relative claims: product meets the definition for ‘‘low (A) The identity of the reference saturated fat.’’ product and the percent (or fraction) (d) Cholesterol content claims. (1) The that the saturated fat differs between terms ‘‘cholesterol free,’’ ‘‘free of cho- the two products are declared in imme- lesterol,’’ ‘‘zero cholesterol,’’ ‘‘without diate proximity to the most prominent cholesterol,’’ ‘‘no cholesterol,’’ ‘‘trivial such claim (e.g., ‘‘reduced saturated fat source of cholesterol,’’ ‘‘negligible

227

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00237 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.362 9 CFR Ch. III (1–1–08 Edition)

source of cholesterol,’’ or ‘‘dietarily in- (B) Quantitative information com- significant source of cholesterol’’ may paring the level of cholesterol in the be used on the label or in labeling of product per labeled serving size with products, provided that: that of the reference product that it re- (i) The product contains less than 2 places is declared adjacent to the most milligrams (mg) of cholesterol per ref- prominent claim or to the nutrition in- erence amount customarily consumed formation (e.g., ‘‘contains no choles- and per labeled serving size or, in the terol compared with 30 mg in one serv- case of a meal-type product as defined ing of ‘reference product’ ’’). in § 317.313(l) and main-dish product as (2) The terms ‘‘low in cholesterol,’’ defined in § 317.313(m), less than 2 mg of ‘‘low cholesterol,’’ ‘‘contains a small cholesterol per labeled serving size; amount of cholesterol,’’ ‘‘low source of (ii) The product contains no ingre- cholesterol,’’ or ‘‘little cholesterol’’ dient that is generally understood by may be used on the label or in labeling consumers to contain cholesterol, un- of products, except meal-type products less the listing of the ingredient in the as defined in § 317.313(l) and main-dish ingredients statement is followed by an products as defined in § 317.313(m), pro- asterisk that refers to the statement vided that: below the list of ingredients, which (i)(A) If the product has a reference states: ‘‘Adds a trivial amount of cho- amount customarily consumed greater lesterol,’’ ‘‘adds a negligible amount of than 30 g or greater than 2 tbsp: cholesterol,’’ or ‘‘adds a dietarily insig- (1) The product contains 20 mg or less nificant amount of cholesterol’’; of cholesterol per reference amount customarily consumed; and (iii) The product contains 2 g or less (2) The product contains 2 g or less of of saturated fat per reference amount saturated fat per reference amount cus- customarily consumed or, in the case tomarily consumed; or of a meal-type product as defined in (B) If the product has a reference § 317.313(l) and main-dish product as de- amount customarily consumed of 30 g fined in § 317.313(m), 2 g or less of satu- or less or 2 tbsp or less: rated fat per labeled serving size; and (1) The product contains 20 mg or less (iv) If the product meets these condi- of cholesterol per reference amount tions without the benefit of special customarily consumed and per 50 g (for processing, alteration, formulation, or dehydrated products that must be re- reformulation to lower cholesterol con- constituted before typical consumption tent, it is labeled to clearly refer to all with water or a diluent containing an products of its type and not merely to insignificant amount, as defined in the particular brand to which it at- § 317.309(f)(1), of all nutrients per ref- taches; or erence amount customarily consumed, (v) If the product meets these condi- the per-50-g criterion refers to the ‘‘as tions only as a result of special proc- prepared’’ form); and essing, alteration, formulation, or re- (2) The product contains 2 g or less of formulation, the amount of cholesterol saturated fat per reference amount cus- is reduced by 25 percent or more from tomarily consumed. the reference product it replaces as de- (ii) If the product meets these condi- scribed in § 317.313(j)(1) and for which it tions without the benefit of special substitutes as described in § 317.313(d) processing, alteration, formulation, or that has a significant (e.g., 5 percent or reformulation to lower cholesterol con- more of a national or regional market) tent, it is labeled to clearly refer to all market share. As required in products of its type and not merely to § 317.313(j)(2) for relative claims: the particular brand to which the label (A) The identity of the reference attaches; or product and the percent (or fraction) (iii) If the product contains 20 mg or that the cholesterol was reduced are less of cholesterol only as a result of declared in immediate proximity to the special processing, alteration, formula- most prominent such claim (e.g., ‘‘cho- tion, or reformulation, the amount of lesterol free ‘product’, contains 100 per- cholesterol is reduced by 25 percent or cent less cholesterol than ‘reference more from the reference product it re- product’ ’’); and places as described in § 317.313(j)(1) and

228

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00238 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.362

for which it substitutes as described in percent or more of a national or re- § 317.313(d) that has a significant (e.g., 5 gional market) market share; percent or more of a national or re- (ii) The product contains 2 g or less gional market) market share. As re- of saturated fat per reference amount quired in § 317.313(j)(2) for relative customarily consumed; and claims: (iii) As required in § 317.313(j)(2) for (A) The identity of the reference relative claims: product and the percent (or fraction) (A) The identity of the reference that the cholesterol has been reduced product and the percent (or fraction) are declared in immediate proximity to that the cholesterol has been reduced the most prominent such claim (e.g., are declared in immediate proximity to ‘‘low cholesterol ‘product’, contains 85 the most prominent such claim (e.g., percent less cholesterol than our reg- ‘‘25 percent less cholesterol than ‘ref- ular ‘product’ ’’); and erence product’ ’’); and (B) Quantitative information com- (B) Quantitative information comparing the level of cholesterol in the paring the level of cholesterol in the product per labeled serving size with product per labeled serving size with that of the reference product that it re- that of the reference product that it replaces is declared adjacent to the most places is declared adjacent to the most prominent claim or to the nutrition in- prominent claim or to the nutrition information (e.g., ‘‘cholesterol lowered formation (e.g., ‘‘cholesterol lowered from 30 mg to 5 mg per serving’’). from 55 mg to 30 mg per serving’’). (3) The terms defined in paragraph (iv) Claims described in paragraph (d)(2) of this section may be used on (d)(4) of this section may not be made the label or in labeling of a meal-type on the label or in labeling of a product product as defined in § 317.313(l) and if the nutrient content of the reference main-dish product as defined in product meets the definition for ‘‘low § 317.313(m), provided that: cholesterol.’’ (i) The product contains 20 mg or less of cholesterol per 100 g of product; (5) The terms defined in paragraph (ii) The product contains 2 g or less (d)(4) of this section may be used on of saturated fat per 100 g of product; the label or in labeling of a meal-type and product as defined in § 317.313(l) and (iii) If the product meets these condi- main-dish product as defined in tions without the benefit of special § 317.313(m), provided that: processing, alteration, formulation, or (i) The product has been specifically reformulation to lower cholesterol con- formulated, altered, or processed to re- tent, it is labeled to clearly refer to all duce its cholesterol by 25 percent or products of its type and not merely to more from the reference product it re- the particular brand to which the label places as described in § 317.313(j)(1) and attaches. for which it substitutes as described in (4) The terms ‘‘reduced cholesterol,’’ § 317.313(d) that has a significant (e.g., 5 ‘‘reduced in cholesterol,’’ ‘‘cholesterol percent or more of a national or re- reduced,’’ ‘‘less cholesterol,’’ ‘‘lower gional market) market share; cholesterol,’’ or ‘‘lower in cholesterol’’ (ii) The product contains 2 g or less may be used on the label or in labeling of saturated fat per 100 g of product; of products or products that substitute and for those products as specified in (iii) As required in § 317.313(j)(2) for § 317.313(d), excluding meal-type prod- relative claims: ucts as defined in § 317.313(l) and main- (A) The identity of the reference dish products as defined in § 317.313(m), product and the percent (or fraction) provided that: that the cholesterol has been reduced (i) The product has been specifically are declared in immediate proximity to formulated, altered, or processed to re- the most prominent such claim (e.g., duce its cholesterol by 25 percent or ‘‘25% less cholesterol than ‘reference more from the reference product it re- product’ ’’); and places as described in § 317.313(j)(1) and (B) Quantitative information com- for which it substitutes as described in paring the level of cholesterol in the § 317.313(d) that has a significant (e.g., 5 product per specified weight with that

229

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00239 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.363 9 CFR Ch. III (1–1–08 Edition)

of the reference product that it re- size, and, only for foods with reference places is declared adjacent to the most amounts customarily consumed of 30 prominent claim or to the nutrition in- grams (g) or less or 2 tablespoons (tbsp) formation (e.g., ‘‘cholesterol content or less, per 50 g, and, for dehydrated has been reduced from 35 mg per 3 oz to products that must be reconstituted 25 mg per 3 oz). with water or a diluent containing an (iv) Claims described in paragraph insignificant amount, as defined in (d)(5) of this section may not be made § 317.309(f)(1), of all nutrients, the per- on the label or in labeling of a product 50-g criterion refers to the prepared if the nutrient content of the reference form, except that: product meets the definition for ‘‘low (i) A main-dish product, as defined in cholesterol.’’ § 317.313(m), and a meal-type product, (e) ‘‘Lean’’ and ‘‘Extra Lean’’ claims. as defined in § 317.313(l), and including (1) The term ‘‘lean’’ may be used on the meal-type products that weigh more label or in labeling of a product, provided that the product contains less than 12 ounces (oz) per serving (con- than 10 g of fat, 4.5 g or less of satu- tainer), shall not contain more than 90 rated fat, and less than 95 mg of choles- mg of cholesterol per labeled serving terol per 100 g of product and per ref- size; and erence amount customarily consumed (ii) Single-ingredient, raw products for individual foods, and per 100 g of may meet the cholesterol criterion for product and per labeled serving size for ‘‘extra lean’’in § 317.362. meal-type products as defined in (3) The product shall not contain § 317.313(l) and main-dish products as more than 480 mg of sodium per ref- defined in § 317.313(m). erence amount customarily consumed, (2) The term ‘‘extra lean’’ may be per labeled serving size, and, only for used on the label or in labeling of a foods with reference amounts custom- product, provided that the product con- arily consumed of 30 g or less or 2 tbsp tains less than 5 g of fat, less than 2 g or less, per 50 g, and, for dehydrated of saturated fat, and less than 95 mg of products that must be reconstituted cholesterol per 100 g of product and per with water or a diluent containing an reference amount customarily con- insignificant amount, as defined in sumed for individual foods, and per 100 § 317.309(f)(1), of all nutrients, the per- g of product and per labeled serving 50-g criterion refers to the prepared size for meal-type products as defined form, except that: in § 317.313(l) and main-dish products as (i) A main-dish product, as defined in defined in § 317.313(m). § 317.313(m), and a meal-type product, [60 FR 193, Jan. 3, 1995, as amended at 69 FR as defined in § 317.313(l), and including 58802, Oct. 1, 2004] meal-type products that weigh more than 12 oz per serving (container), shall § 317.363 Nutrient content claims for not contain more than 600 mg of so- ‘‘healthy.’’ dium per labeled serving size;1 and (a) The term ‘‘healthy,’’ or any other (ii) The requirements of this para- derivative of the term ‘‘health,’’ may graph (b)(3) do not apply to single-in- be used on the labeling of any meat or gredient, raw products. meat food product, provided that the product is labeled in accordance with 1 This regulation previously provided that, § 317.309 and § 317.313. after January 1, 2006, individual meat prod- (b)(1) The product shall meet the re- ucts bearing the claim ‘‘healthy’’ (or any de- quirements for ‘‘low fat’’ and ‘‘low rivative of the term ‘‘health’’) must contain saturated fat,’’ as defined in § 317.362, no more than 360 mg of sodium and that except that single-ingredient, raw meal-type products bearing the claim products may meet the total fat and ‘‘healthy’’ (or any other derivative of the saturated fat criteria for ‘‘extra lean’’ term ‘‘health’’) must contain no more than in § 317.362. 600 mg of sodium. Implementation of these sodium level requirements for products bear- (2) The product shall not contain ing the claim ‘‘healthy’’ (or any derivative of more than 60 milligrams (mg) of cho- the term ‘‘health’’) has been deferred indefi- lesterol per reference amount custom- nitely due to technological barriers and con- arily consumed, per labeled serving sumer preferences.

230

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00240 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.369

(4) The product shall contain 10 per- the basis of specific reference to such cent or more of the Reference Daily In- information submitted to and retained take or Daily Reference Value as de- in the files of the Food Safety and In- fined in § 317.309 for vitamin A, vitamin spection Service. However, any ref- C, iron, calcium, protein, or fiber per erence to unpublished information fur- reference amount customarily con- nished by a person other than the ap- sumed prior to any nutrient addition, plicant will not be considered unless except that: use of such information is authorized (i) A main-dish product, as defined in (with the understanding that such in- § 317.313(m), and including main-dish formation may in whole or part be sub- products that weigh less than 10 oz per ject to release to the public) in a writ- serving (container), shall meet the ten statement signed by the person level for two of the nutrients per la- who submitted it. Any reference to beled serving size; and published information should be ac- (ii) A meal-type product, as defined companied by reprints or photostatic in § 317.313(l), shall meet the level for copies of such references. three of the nutrients per labeled serv- (e) If nonclinical laboratory studies ing size. accompany a labeling application, the applicant shall include, with respect to [59 FR 24228, May 10, 1994, as amended at 60 FR 196, Jan. 3, 1995; 63 FR 7281, Feb. 13, 1998; each nonclinical study included with 64 FR 72492, Dec. 28, 1999; 68 FR 463, Jan. 6, the application, either a statement 2003; 69 FR 58802, Oct. 1, 2004; 71 FR 1686, Jan. that the study has been, or will be, 11, 2006] conducted in compliance with the good laboratory practice regulations as set §§ 317.364–317.368 [Reserved] forth in part 58 of chapter 1, title 21, or, if any such study was not conducted in § 317.369 Labeling applications for nu- compliance with such regulations, a trient content claims. brief statement of the reason for the (a) This section pertains to labeling noncompliance. applications for claims, express or im- (f) If clinical investigations accom- plied, that characterize the level of any pany a labeling application, the appli- nutrient required to be on the label or cant shall include, with respect to each in labeling of product by this subpart. clinical investigation included with the (b) Labeling applications included in application, either a statement that this section are: the investigation was conducted in (1) Labeling applications for a new compliance with the requirements for (heretofore unauthorized) nutrient con- institutional review set forth in part 56 tent claim, of chapter 1, title 21, or was not subject (2) Labeling applications for a syn- to such requirements in accordance onymous term (i.e., one that is con- with § 56.194 or § 56.105, and that it was sistent with a term defined by regula- conducted in compliance with the re- tion) for characterizing the level of a quirements for informed consents set nutrient, and forth in part 50 of chapter 1, title 21. (3) Labeling applications for the use (g) The availability for public disclo- of an implied claim in a brand name. sure of labeling applications, along (c) Labeling applications and sup- with supporting documentation, sub- porting documentation to be filed mitted to the Agency under this sec- under this section shall be submitted tion will be governed by the rules spec- in quadruplicate, except that the sup- ified in subchapter D, title 9. porting documentation may be sub- (h) The data specified under this sec- mitted on a computer disc copy. If any tion to accompany a labeling applica- part of the material submitted is in a tion shall be submitted on separate foreign language, it shall be accom- sheets, suitably identified. If such data panied by an accurate and complete has already been submitted with an English translation. The labeling appli- earlier labeling application from the cation shall state the applicant’s post applicant, the present labeling applica- office address. tion must provide the data. (d) Pertinent information will be (i) The labeling application must be considered as part of an application on signed by the applicant or by his or her

231

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00241 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.369 9 CFR Ch. III (1–1–08 Edition)

attorney or agent, or (if a corporation) pected to understand the meaning of the by an authorized official. term under the proposed conditions of use. (j) The labeling application shall in- (iii) Analytical data that demonstrates the amount of the nutrient that is present in the clude a statement signed by the person products for which the claim is intended. responsible for the labeling applica- The assays should be performed on rep- tion, that to the best of his or her resentative samples in accordance with knowledge, it is a representative and 317.309(h). If no USDA or AOAC methods are balanced submission that includes un- available, the applicant shall submit the favorable information, as well as favor- assay method used, and data establishing the able information, known to him or her validity of the method for assaying the nu- pertinent to the evaluation of the la- trient in the particular food. The validation data shall include a statistical analysis of beling application. the analytical and product variability. (k)(1) Labeling applications for a new (iv) A detailed analysis of the potential ef- nutrient content claim shall be accom- fect of the use of the proposed claim on food panied by the following data which consumption, and any corresponding changes shall be submitted in the following in nutrient intake. The analysis shall spe- form to the Director, Food Labeling cifically address the intake of nutrients that Division, Regulatory Programs, Food have beneficial and negative consequences in the total diet. If the claim is intended for a Safety and Inspection Service, Wash- specific group within the population, the ington, DC 20250. analysis shall specifically address the dietary practices of such group, and shall in- llllllllllllllllllllllll clude data sufficient to demonstrate that the (Date) dietary analysis is representative of such The undersigned, lllll, submits this group. labeling application pursuant to 9 CFR Yours very truly, 317.369 with respect to (statement of the claim and its proposed use). Applicant lllllllllllllll Attached hereto, in quadruplicate, or on a By lllllllllllllllllll computer disc copy, and constituting a part (Indicate authority) of this labeling application, are the fol- (2) Upon receipt of the labeling appli- lowing: (i) A statement identifying the nutrient cation and supporting documentation, content claim and the nutrient that the the applicant shall be notified, in writ- term is intended to characterize with respect ing, of the date on which the labeling to the level of such nutrient. The statement application was received. Such notice shall address why the use of the term as pro- shall inform the applicant that the la- posed will not be misleading. The statement beling application is undergoing Agen- shall provide examples of the nutrient con- cy review and that the applicant shall tent claim as it will be used on labels or la- subsequently be notified of the Agen- beling, as well as the types of products on cy’s decision to consider for further re- which the claim will be used. The statement shall also specify the level at which the nu- view or deny the labeling application. trient must be present or what other condi- (3) Upon review of the labeling appli- tions concerning the product must be met cation and supporting documentation, for the appropriate use of the term in labels the Agency shall notify the applicant, or labeling, as well as any factors that would in writing, that the labeling applica- make the use of the term inappropriate. tion is either being considered for fur- (ii) A detailed explanation supported by ther review or that it has been sum- any necessary data of why use of the food marily denied by the Administrator. component characterized by the claim is of (4) If the labeling application is sum- importance in human nutrition by virtue of its presence or absence at the levels that marily denied by the Administrator, such claim would describe. This explanation the written notification shall state the shall also state what nutritional benefit to reasons therefor, including why the the public will derive from use of the claim Agency has determined that the pro- as proposed and why such benefit is not posed nutrient content claim is false or available through the use of existing terms misleading. The notification letter defined by regulation. If the claim is in- shall inform the applicant that the ap- tended for a specific group within the popu- plicant may submit a written state- lation, the analysis shall specifically address nutritional needs of such group, and sci- ment by way of answer to the notifica- entific data sufficient for such purpose, and tion, and that the applicant shall have data and information to the extent necessary the right to request a hearing with re- to demonstrate that consumers can be ex- spect to the merits or validity of the

232

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00242 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.369

Administrator’s decision to deny the termined by the Agency to be false or use of the proposed nutrient content misleading. The notification letter claim. shall also inform the applicant that the (i) If the applicant fails to accept the applicant may submit a written state- determination of the Administrator ment by way of answer to the notifica- and files an answer and requests a tion, and that the applicant shall have hearing, and the Administrator, after the right to request a hearing with re- review of the answer, determines the spect to the merits or validity of the initial determination to be correct, the Administrator’s decision to deny the Administrator shall file with the Hear- use of the proposed nutrient content ing Clerk of the Department the notifi- claim. cation, answer, and the request for a (A) If the applicant fails to accept hearing, which shall constitute the the determination of the Adminis- complaint and answer in the pro- trator and files an answer and requests ceeding, which shall thereafter be con- a hearing, and the Administrator, after ducted in accordance with the Depart- review of the answer, determines the ment’s Uniform Rules of Practice. initial determination to be correct, the (ii) The hearing shall be conducted Administrator shall file with the Hear- before an administrative law judge ing Clerk of the Department the notifi- with the opportunity for appeal to the cation, answer, and the request for a Department’s Judicial Officer, who hearing, which shall constitute the shall make the final determination for complaint and answer in the pro- the Secretary. Any such determination ceeding, which shall thereafter be con- by the Secretary shall be conclusive unless, within 30 days after receipt of ducted in accordance with the Depart- notice of such final determination, the ment’s Uniform Rules of Practice. applicant appeals to the United States (B) The hearing shall be conducted Court of Appeals for the circuit in before an administrative law judge which the applicant has its principal with the opportunity for appeal to the place of business or to the United Department’s Judicial Officer, who States Court of Appeals for the District shall make final determination for the of Columbia Circuit. Secretary. Any such determination by (5) If the labeling application is not the Secretary shall be conclusive un- summarily denied by the Adminis- less, within 30 days after receipt of the trator, the Administrator shall publish notice of such final determination, the in the FEDERAL REGISTER a proposed applicant appeals to the United States rule to amend the regulations to au- Court of Appeals for the circuit in thorize the use of the nutrient content which the applicant has its principal claim. The proposal shall also summa- place of business or to the United rize the labeling application, including States Court of Appeals for the District where the supporting documentation of Columbia Circuit. can be reviewed. The Administrator’s (ii) If the claim is approved, the proposed rule shall seek comment from Agency shall notify the applicant, in consumers, the industry, consumer and writing, and shall also publish in the industry groups, and other interested FEDERAL REGISTER a final rule amend- persons on the labeling application and ing the regulations to authorize the the use of the proposed nutrient con- use of the claim. tent claim. After public comment has (l)(1) Labeling applications for a syn- been received and reviewed by the onymous term shall be accompanied by Agency, the Administrator shall make the following data which shall be sub- a determination on whether the pro- mitted in the following form to the Di- posed nutrient content claim shall be rector, Food Labeling Division, Regu- approved for use on the labeling of latory Programs, Food Safety and In- meat and meat food products. spection Service, Washington, DC 20250: (i) If the claim is denied by the Ad- ministrator, the Agency shall notify llllllllllllllllllllllll the applicant, in writing, of the basis (Date) for the denial, including the reason The undersigned, llllll submits this why the claim on the labeling was de- labeling application pursuant to 9 CFR

233

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00243 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR § 317.369 9 CFR Ch. III (1–1–08 Edition)

317.369 with respect to (statement of the syn- ther review or that it has been sum- onymous term and its proposed use in a nu- marily denied by the Administrator. trient content claim that is consistent with (4) If the labeling application is sum- an existing term that has been defined under subpart B of part 317). marily denied by the Administrator, Attached hereto, in quadruplicate, or on a the written notification shall state the computer disc copy, and constituting a part reasons therefor, including why the of this labeling application, are the fol- Agency has determined that the pro- lowing: posed synonymous term is false or mis- (i) A statement identifying the synony- leading. The notification letter shall mous term, the existing term defined by a inform the applicant that the applicant regulation with which the synonymous term is claimed to be consistent, and the nutrient may submit a written statement by that the term is intended to characterize the way of answer to the notification, and level of. The statement shall address why the that the applicant shall have the right use of the synonymous term as proposed will to request a hearing with respect to not be misleading. The statement shall pro- the merits or validity of the Adminis- vide examples of the nutrient content claim trator’s decision to deny the use of the as it will be used on labels or labeling, as proposed synonymous term. well as the types of products on which the (i) If the applicant fails to accept the claim will be used. The statement shall also specify whether any limitations not applica- determination of the Administrator ble to the use of the defined term are in- and files an answer and requests a tended to apply to the use of the synony- hearing, and the Administrator, after mous term. review of the answer, determines the (ii) A detailed explanation supported by initial determination to be correct, the any necessary data of why use of the pro- Administrator shall file with the Hear- posed term is requested, including whether ing Clerk of the Department the notifi- the existing defined term is inadequate for the purpose of effectively characterizing the cation, answer, and the request for a level of a nutrient. This explanation shall hearing, which shall constitute the also state what nutritional benefit to the complaint and answer in the pro- public will derive from use of the claim as ceeding, which shall thereafter be con- proposed, and why such benefit is not avail- ducted in accordance with the Depart- able through the use of existing terms de- ment’s Uniform Rules of Practice. fined by regulation. If the claim is intended (ii) The hearing shall be conducted for a specific group within the population, the analysis shall specifically address nutri- before an administrative law judge tional needs of such group, scientific data with the opportunity for appeal to the sufficient for such purpose, and data and in- Department’s Judicial Officer, who formation to the extent necessary to dem- shall make the final determination for onstrate that consumers can be expected to the Secretary. Any such determination understand the meaning of the term under by the Secretary shall be conclusive the proposed conditions of use. unless, within 30 days after receipt of Yours very truly, notice of such final determination, the Applicant lllllllllllllll applicant appeals to the United States By lllllllllllllllllll Court of Appeals for the circuit in (Indicate authority) which the applicant has its principal (2) Upon receipt of the labeling appli- place of business or to the United cation and supporting documentation, States Court of Appeals for the District the applicant shall be notified, in writ- of Columbia Circuit. ing, of the date on which the labeling (5) If the claim is approved, the Agen- application was received. Such notice cy shall notify the applicant, in writ- shall inform the applicant that the la- ing, and shall publish in the FEDERAL beling application is undergoing Agen- REGISTER a notice informing the public cy review and that the applicant shall that the synonymous term has been ap- subsequently be notified of the Agen- proved for use. cy’s decision to consider for further re- (m)(1) Labeling applications for the view or deny the labeling application. use of an implied nutrient content (3) Upon review of the labeling appli- claim in a brand name shall be accom- cation and supporting documentation, panied by the following data which the Agency shall notify the applicant, shall be submitted in the following in writing, that the labeling applica- form to the Director, Food Labeling tion is either being considered for fur- Division, Regulatory Programs, Food

234

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00244 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.369

Safety and Inspection Service, Wash- tion is either being considered for fur- ington, DC 20250: ther review or that it has been sum- llllllllllllllllllllllll marily denied by the Administrator. (Date) (4) If the labeling application is sum- The undersigned, llllll submits this marily denied by the Administrator, labeling application pursuant to 9 CFR the written notification shall state the 317.369 with respect to (statement of the im- reasons therefor, including why the plied nutrient content claim and its proposed Agency has determined that the pro- use in a brand name). posed implied nutrient content claim is Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part false or misleading. The notification of this labeling application, are the fol- letter shall inform the applicant that lowing: the applicant may submit a written (i) A statement identifying the implied nu- statement by way of answer to the no- trient content claim, the nutrient the claim tification, and that the applicant shall is intended to characterize, the cor- have the right to request a hearing responding term for characterizing the level of such nutrient as defined by a regulation, with respect to the merits or validity and the brand name of which the implied of the Administrator’s decision to deny claim is intended to be a part. The statement the use of the proposed implied nutri- shall address why the use of the brand-name ent content claim. as proposed will not be misleading. The (i) If the applicant fails to accept the statement shall provide examples of the determination of the Administrator types of products on which the brand name will appear. It shall also include data show- and files an answer and requests a ing that the actual level of the nutrient in hearing, and the Administrator, after the food would qualify the label of the prod- review of the answer, determines the uct to bear the corresponding term defined initial determination to be correct, the by regulation. Assay methods used to deter- Administrator shall file with the Hear- mine the level of a nutrient shall meet the requirements stated under labeling applica- ing Clerk of the Department the notifi- tion format in paragraph (k)(1)(iii) of this cation, answer, and the request for a section. hearing, which shall constitute the (ii) A detailed explanation supported by complaint and answer in the pro- any necessary data of why use of the pro- ceeding, which shall thereafter be con- posed brand name is requested. This expla- ducted in accordance with the Depart- nation shall also state what nutritional benefit to the public will derive from use of the ment’s Uniform Rules of Practice. brand name as proposed. If the branded prod- (ii) The hearing shall be conducted uct is intended for a specific group within before an administrative law judge the population, the analysis shall specifi- with the opportunity for appeal to the cally address nutritional needs of such group Department’s Judicial Officer, who and scientific data sufficient for such purpose. shall make the final determination for the Secretary. Any such determination Yours very truly, by the Secretary shall be conclusive Applicant lllllllllllllll unless, within 30 days after receipt of By lllllllllllllllllll notice of such final determination, the (2) Upon receipt of the labeling appli- applicant appeals to the United States cation and supporting documentation, Court of Appeals for the circuit in the applicant shall be notified, in writ- which the applicant has its principal ing, of the date on which the labeling place of business or to the United application was received. Such notice States Court of Appeals for the District shall inform the applicant that the la- of Columbia Circuit. beling application is undergoing Agen- (5) If the labeling application is not cy review and that the applicant shall summarily denied by the Adminis- subsequently be notified of the Agen- trator, the Administrator shall publish cy’s decision to consider for further re- a notice of the labeling application in view or deny the labeling application. the FEDERAL REGISTER seeking com- (3) Upon review of the labeling appli- ment on the use of the implied nutrient cation and supporting documentation, the Agency shall notify the applicant, content claim. The notice shall also in writing, that the labeling applica-

235

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00245 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR §§ 317.370–317.379 9 CFR Ch. III (1–1–08 Edition)

summarize the labeling application, in- (ii) If the claim is approved, the cluding where the supporting docu- Agency shall notify the applicant, in mentation can be reviewed. The Ad- writing, and shall also publish in the ministrator’s notice shall seek com- FEDERAL REGISTER a notice informing ment from consumers, the industry, the public that the implied nutrient consumer and industry groups, and content claim has been approved for other interested persons on the label- use. ing application and the use of the im- (Paperwork requirements were approved by plied nutrient content claim. After the Office of Management and Budget under public comment has been received and control number 0583–0088) reviewed by the Agency, the Adminis- trator shall make a determination on [58 FR 664, Jan. 6, 1993, as amended at 59 FR 45196, Sept. 1, 1994; 60 FR 196, Jan. 3, 1995] whether the implied nutrient content claim shall be approved for use on the §§ 317.370–317.379 [Reserved] labeling of meat food products. (i) If the claim is denied by the Ad- § 317.380 Label statements relating to ministrator, the Agency shall notify usefulness in reducing or maintain- the applicant, in writing, of the basis ing body weight. for the denial, including the reason (a) General requirements. Any product why the claim on the labeling was de- that purports to be or is represented termined by the Agency to be false or for special dietary use because of use- misleading. The notification letter fulness in reducing body weight shall shall also inform the applicant that the bear: applicant may submit a written state- (1) Nutrition labeling in conformity ment by way of answer to the notifica- with § 317.309 of this subpart, unless ex- tion, and that the applicant shall have empt under that section, and the right to request a hearing with re- (2) A conspicuous statement of the spect to the merits or validity of the basis upon which the product claims to Administrator’s decision to deny the be of special dietary usefulness. use of the proposed implied nutrient (b) Nonnutritive ingredients. (1) Any content claim. product subject to paragraph (a) of this (A) If the applicant fails to accept section that achieves its special die- the determination of the Adminis- tary usefulness by use of a nonnutri- trator and files an answer and requests tive ingredient (i.e., one not utilized in a hearing, and the Administrator, after normal metabolism) shall bear on its review of the answer, determines the label a statement that it contains a initial determination to be correct, the nonnutritive ingredient and the per- Administrator shall file with the Hear- centage by weight of the nonnutritive ing Clerk of the Department the notifi- ingredient. cation, answer, and the request for a (2) A special dietary product may hearing, which shall thereafter be con- contain a nonnutritive sweetener or ducted in accordance with the Depart- other ingredient only if the ingredient ment’s Uniform Rules of Practice. is safe for use in the product under the (B) The hearing shall be conducted applicable law and regulations of this before an administrative law judge chapter. Any product that achieves its with the opportunity for appeal to the special dietary usefulness in reducing Department’s Judicial Officer, who or maintaining body weight through shall make the final determination for the use of a nonnutritive sweetener the Secretary. Any such determination shall bear on its label the statement by the Secretary shall be conclusive required by paragraph (b)(1) of this sec- unless, within 30 days after receipt of tion, but need not state the percentage the notice of such final determination, by weight of the nonnutritive sweet- the applicant appeals to the United ener. If a nutritive sweetener(s) as well States Court of Appeals for the circuit as nonnutritive sweetener(s) is added, in which the applicant has its principal the statement shall indicate the pres- place of business or to the United ence of both types of sweetener; e.g., States Court of Appeals for the District ‘‘Sweetened with nutritive sweetener(s) of Columbia Circuit. and nonnutritive sweetener(s).’’

236

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00246 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Food Safety and Inspection Service, USDA § 317.400

(c) ‘‘Low calorie’’ foods. A product (1) Food products produced by small purporting to be ‘‘low calorie’’ must businesses provided that the labels for comply with the criteria set forth for these products bear no nutrition claims such foods in § 317.360. or nutrition information, (d) ‘‘Reduced calorie’’ foods and other (i) A food product, for the purposes of comparative claims. A product pur- the small business exemption, is de- porting to be ‘‘reduced calorie’’ or oth- fined as a formulation, not including erwise containing fewer calories than a distinct flavors which do not signifi- reference food must comply with the cantly alter the nutritional profile, criteria set forth for such foods in sold in any size package in commerce. § 317.360(b) (4) and (5). (ii) For purposes of this paragraph, a (e) ‘‘Label terms suggesting usefulness small business is any single-plant facil- as low calorie or reduced calorie foods’’. ity or multi-plant company/firm that (1) Except as provided in paragraphs employs 500 or fewer people and pro- (e)(2) and (e)(3) of this section, a prod- duces no more than the following uct may be labeled with terms such as amounts of pounds of the product ‘‘diet,’’ ‘‘dietetic,’’ ‘‘artificially sweet- qualifying the firm for exemption from ened,’’ or ‘‘sweetened with nonnutri- this subpart: tive sweetener’’ only if the claim is not (A) During the first year of imple- false or misleading, and the product is mentation of nutrition labeling, from labeled ‘‘low calorie’’ or ‘‘reduced cal- July 1994 to July 1995, 250,000 pounds or orie’’ or bears another comparative cal- less, orie claim in compliance with the ap- (B) During the second year of imple- plicable provisions in this subpart. mentation of nutrition labeling, from July 1995 to July 1996, 175,000 pounds or (2) Paragraph (e)(1) of this section less, and shall not apply to any use of such (C) During the third year of imple- terms that is specifically authorized by mentation and subsequent years there- regulation governing a particular food, after, 100,000 pounds or less. or, unless otherwise restricted by regu- (iii) For purposes of this paragraph, lation, to any use of the term ‘‘diet’’ calculation of the amount of pounds that clearly shows that the product is shall be based on the most recent 2- offered solely for a dietary use other year average of business activity. than regulating body weight, e.g., ‘‘for Where firms have been in business less low sodium diets.’’ than 2 years or where products have (3) Paragraph (e)(1) of this section been produced for less than 2 years, shall not apply to any use of such reasonable estimates must indicate terms on a formulated meal replace- that the annual pounds produced will ment or other product that is rep- not exceed the amounts specified. resented to be of special dietary use as (2) Products intended for further a whole meal, pending the issuance of a processing, provided that the labels for regulation governing the use of such these products bear no nutrition claim terms on foods. or nutrition information, (f) ‘‘Sugar free’’ and ‘‘no added sugar’’. (3) Products that are not for sale to Criteria for the use of the terms ‘‘sugar consumers, provided that the labels for free’’ and ‘‘no added sugar’’ are pro- these products bear no nutrition claims vided for in § 317.360(c). or nutrition information, [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, (4) Products in small packages that 1993, as amended at 58 FR 47627, Sept. 10, are individually wrapped packages of 1993; 58 FR 66075, Dec. 17, 1993; 60 FR 196, Jan. less than 1⁄2 ounce net weight, provided 3, 1995] that the labels for these products bear no nutrition claims or nutrition infor- §§ 317.381–317.399 [Reserved] mation, (5) Products custom slaughtered or § 317.400 Exemption from nutrition la- prepared, beling. (6) Products intended for export, and (a) The following meat or meat food (7) The following products prepared products are exempt from nutrition la- and served or sold at retail provided beling: that the labels or the labeling of these

237

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00247 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR Pt. 318 9 CFR Ch. III (1–1–08 Edition)

products bear no nutrition claims or (2) When such products bear nutri- nutrition information: tion labeling, either voluntarily or be- (i) Ready-to-eat products that are cause nutrition claims or other nutri- packaged or portioned at a retail store tion information is provided, all re- or similar retail-type establishment; quired information shall be in a type and size no smaller than 6 point or all (ii) Multi-ingredient products (e.g., upper case type of 1⁄16-inch minimum sausage) processed at a retail store or height, except that individual serving- similar retail-type establishment. size packages of meat products that (b) Restaurant menus generally do have a total area available to bear la- not constitute labeling or fall within beling of 3 square inches or less may the scope of these regulations. provide all required information in a (c)(1) Foods represented to be specifi- type size no smaller than 1⁄32-inch min- cally for infants and children less than imum height. 2 years of age shall bear nutrition la- [58 FR 664, Jan. 6, 1993, as amended at 58 FR beling as provided in paragraph (c)(2) of 47627, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; this section, except such labeling shall 60 FR 196, Jan. 3, 1995] not include calories from fat, calories from saturated fat, saturated fat, stearic acid, polyunsaturated fat, PART 318—ENTRY INTO OFFICIAL monounsaturated fat, and cholesterol. ESTABLISHMENTS; REINSPECTION (2) Foods represented or purported to AND PREPARATION OF PROD- be specifically for infants and children UCTS less than 4 years of age shall bear nutrition labeling except that: Subpart A—General (i) Such labeling shall not include Sec. declarations of percent of Daily Value 318.1 Products and other articles entering for total fat, saturated fat, cholesterol, official establishments. sodium, potassium, total carbohydrate, 318.2 Reinspection, retention, and disposal and dietary fiber; of meat and poultry products at official (ii) Nutrient names and quantitative establishments. amounts by weight shall be presented 318.3 Designation of places of receipt of in two separate columns; products and other articles for reinspec- (iii) The heading ‘‘Percent Daily tion. Value’’ required in § 317.309(d)(6) shall 318.4 Preparation of products to be offi- be placed immediately below the quan- cially supervised; responsibilities of official establishments; plant operated qual- titative information by weight for pro- ity control. tein; 318.5 Requirements concerning procedures. (iv) The percent of the Daily Value 318.6 Requirements concerning ingredients for protein, vitamins, and minerals and other articles used in preparation of shall be listed immediately below the products. heading ‘‘Percent Daily Value’’; and 318.8 Preservatives and other substances (v) Such labeling shall not include permitted in product for export only; the footnote specified in § 317.309(d)(9). handling; such product not to be used for (d)(1) Products in packages that have domestic food purposes. 318.9 Samples of products, water, dyes, a total surface area available to bear chemicals, etc., to be taken for examina- labeling of less than 12 square inches tion. are exempt from nutrition labeling, 318.10 Prescribed treatment of pork and provided that the labeling for these products containing pork to destroy products bear no nutrition claims or trichinae. other nutrition information. The man- 318.11 [Reserved] ufacturer, packer, or distributor shall 318.12 Manufacture of dog food or similar provide, on the label of packages that uninspected article at official establish- qualify for and use this exemption, an ments. 318.13 Mixtures containing product but not address or telephone number that a amendable to the Act. consumer can use to obtain the re- 318.14 Adulteration of product by polluted quired nutrition information (e.g., water; procedure for handling. ‘‘For nutrition information call 1–800– 318.15 Tagging chemicals, preservatives, ce- 123–4567’’). reals, spices, etc., ‘‘U.S. retained.’’

238

VerDate Aug<31>2005 10:21 Jan 31, 2008 Jkt 214029 PO 00000 Frm 00248 Fmt 8010 Sfmt 8010 Y:\SGML\214029.XXX 214029 yshivers on PROD1PC62 with CFR