and with other information prescribed for marking products in this part.

(b) All equine carcasses and meat and other parts thereof shall be marked to show the kinds of animals from which they were derived, before the products are sold, transported, offered for sale or transportation, or received for transportation in commerce.

§316.13 Marking of outside containers.

(a) Except as otherwise provided in part 325 of this subchapter, when any inspected and passed product for domestic commerce is moved from an official establishment, the outside container shall bear an official inspection legend as prescribed in part 312 of this subchapter.

(b) When any product prepared in an official establishment for domestic commerce has been inspected and passed and is enclosed in a cloth or other wrapping, such wrapping shall bear the official inspection legend and official establishment number applied by the approved 21⁄2-inch rubber brand in the form prescribed in part 312 of this subchapter: Provided, That the rubber brand may be omitted if the official inspection legend and official establishment number on the product itself are clearly legible through the wrapping or the wrapping is labeled in accordance with part 317 of this subchapter: Provided further, That plain unprinted wrappings, such stockinettes, cheesecloth, paper, and crinkled paper bags, for properly marked products, which are used solely to protect the product against soiling or excessive drying during transportation or storage, need not bear the official inspection legend.

as

(c) The outside containers of products for export shall be marked in compliance with part 322 of this subchapter as well as this part.

(d) Slack barrels used as outside containers of products shall have a cloth or paper top covering bearing the official inspection legend containing the official establishment number. At the time of removal of the covering, the official inspection legend shall be destroyed.

(e) The outside containers of any product which has been inspected and passed for cooking, pork which has

been refrigerated as provided in §318.10(c) of this subchapter, and beef which has been inspected and passed for refrigeration shall bear the markings and tag prescribed in §325.7(b) of this subchapter.

(f) The outside containers of glands and organs which are not used for human food purposes, such as those described in §325.19 of this subchapter, shall be plainly marked with the phrase "For pharmaceutical purposes," "For organotherapeutic purposes" or "For technical purposes," as appropriate, with no reference to inspection, and need not bear other markings otherwise required under the regulations in this subchapter.

(g) Stencils, box dies, labels, and brands may be used on shipping containers of properly labeled products and on such immediate containers, of properly marked products, as tierces, barrels, drums, boxes, crates, and large-size fiber-board containers, without approval as provided for in § 317.3 of this subchapter: Provided, That the stencils, box dies, labels, and brands are not false or misleading and are approved by the inspector in charge. The official inspection legend for use with such markings shall be approved by the Administrator as provided for in part 317 of this subchapter.

(h) The outside containers of livers prepared as described in §314.10(b), shall be marked prescribed in §314.10(c) of this subchapter.

as

(i) The outside containers of any equine product shall be marked to show the kinds of animals from which derived, when the products are sold, transported, offered for sale or transported, or received for transportation in commerce.

[35 FR 15577, Oct. 3, 1970, as amended at 43 FR 29268, July 7, 1978]

§316.14 Marking tank cars and tank trucks used in transportation of edible products.

Each tank car and each tank truck carrying inspected and passed product from an official establishment shall bear a label containing the name of the product in accordance with §317.2 of this subchapter, the official inspection legend containing the number of the official establishment and the words

"date of loading," followed by a suitable space in which the date the tank car or tank truck is loaded shall be inserted. The label shall be located conspicuously and shall be printed on material of such character and so affixed as to preclude detachment or effacement upon exposure to the weather. Before the car or truck is removed from the place where it is unloaded, the carrier shall remove or obliterate such label.

[53 FR 28634, July 29, 1988]

§316.15 Marking outside containers of inedible grease, etc.

(a) Outside containers of inedible grease, inedible tallow, or other inedible animal fat, or mixture of any such articles, resulting from operations at any official establishment shall be marked conspicuously with the word "inedible" prior to removal from the point of filling. Containers, such as tierces, barrels, and half barrels shall have both ends painted white with durable paint, if necessary, to provide a contrasting background, and the word "inedible" shall be marked thereon in letters not less than 2 inches high, while on tank cars and tank trucks the letters shall be not less than 4 inches high.

(b) Inspected rendered animal fat which is intended not to be used for human food may also be marked "inedible" if handled as provided in paragraph (a) of this section and part 314 of this subchapter.

$316.16 Custom prepared products to be marked "Not for Sale."

Carcasses and parts therefrom that are prepared on a custom basis under §303.1(a)(2) of this subchapter shall be marked at the time of preparation with the term "Not for Sale" in letters at least three-eighths inch in height, except that such products need not be so marked if in immediate containers properly labeled in accordance with the regulations in §317.16 of this subchapter. Ink used for marking such products must comply with the requirements of § 316.5.

[35 FR 15577, Oct. 3, 1970, as amended at 38 FR 29214, Oct. 23, 1973]

317.1 Labels required; supervision by Program employee.

317.2 Labels: definition; required features. 317.3 Approval of abbreviations of marks of inspection; preparation of marking devices bearing inspection legend without advance approval prohibited; exception. 317.4 Labeling approval.

317.5 Generically approved labeling. 317.6 Approved labels to be used only on products to which they are applicable. 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations.

317.8 False or misleading labeling or practices generally; specific prohibitions and requirements for labels and containers. 317.9 Labeling of equine products. 317.10 Reuse of official inspection marks; reuse of containers bearing official

marks, labels, etc. 317.11 Labeling, filling of containers, handling of labeled products to be only in compliance with regulations.

317.12 Relabeling products; requirements. 317.13 Storage and distribution of labels and containers bearing official marks. 317.14-317.15 [Reserved]

317.16 Labeling and containers of custom prepared products.

317.17 Interpretation and statement of labeling policy for cured products; special labeling requirements concerning nitrate and nitrite.

317.18 Quantity of contents labeling. 317.19 Definitions and procedures for determining net weight compliance. 317.20 Scale requirements for

accurate

Subpart A-General

$317.1 Labels required; supervision by Program employee.

(a) When, in an official establishment, any inspected and passed product is placed in any receptacle or covering constituting an immediate container, there shall be affixed to such container a label as described in §317.2 except that the following do not have to bear such a label.

(1) Wrappings of dressed carcasses and primal parts in an unprocessed state, bearing the official inspection legend, if such wrappings are intended solely to protect the product against soiling or excessive drying during transportation or storage, and the wrappings bear no information except company brand names, trade marks, or code numbers which do not include any information required by §317.2;

(2) Uncolored transparent coverings, such as cellophane, which bear no writ

ten, printed, or graphic matter and which enclose any unpackaged or packaged product bearing all markings required by part 316 of this subchapter which are clearly legible through such coverings;

(3) Animal and transparent artificial casings bearing only the markings required by part 316 of this subchapter;

(4) Stockinettes used as "operative devices", such as those applied to cured meats in preparation for smoking, whether or not such stockinettes are removed following completion of the operations for which they were applied; (5) Containers such as boil-in bags, trays of frozen dinners, and pie pans which bear no information except company brand names, trademarks, code numbers, directions for preparation and serving suggestions, and which are enclosed in a consumer size container that bears a label as described in §317.2;

(6) Containers of products passed for cooking or refrigeration and moved from an official establishment under §311.1 of this subchapter.

(b) Folders and similar coverings made of paper or similar materials, whether or not they completely enclose the product and which bear any written, printed, or graphic matter, shall bear all features required on a label for an immediate container.

(c) No covering or other container which bears or is to bear a label shall be filled, in whole or in part, except with product which has been inspected and passed in compliance with the regulations in this subchapter, which is not adulterated and which is strictly in accordance with the statements on the label. No such container shall be filled, in whole or in part, and no label shall be affixed thereto, except under supervision of a Program employee.

§317.2 Labels: definition; required features.

(a) A label within the meaning of this part shall mean a display of any printing, lithographing, embossing, stickers, seals, or other written, printed, or graphic matter upon the immediate container (not including package liners) of any product.

(b) Any word, statement, or other information required by this part to appear on the label must be prominently

placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In order to meet this requirement, such information must appear on the principal display panel except as otherwise permitted in this part. Except as provided in §317.7, all words, statements, and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of products distributed solely in Puerto Rico, Spanish may be substituted for English for all printed matter except the USDA inspection legend.

(c) Labels of all products shall show the following information on the principal display panel (except as otherwise permitted in this part), in accordance with the requirements of this part or, if applicable, part 319 of this subchapter:

(1) The name of the product, which in the case of a product which purports to be or is represented as a product for which a definition and standard of identity or composition is prescribed in part 319 of this subchapter, shall be the name of the food specified in the standard, and in the case of any other product shall be the common or usual name of the food, if any there be, and if there is none, a truthful descriptive designation, as prescribed in paragraph (e) of this section;

(2) If the product is fabricated from two or more ingredients, the word "ingredients" followed by a list of the ingredients as prescribed in paragraph (f) of this section;

(3) The name and place of business of the manufacturer, packer, or distributor for whom the product is prepared, as prescribed in paragraph (g) of this section;

(4) An accurate statement of the net quantity of contents, as prescribed in paragraph (h) of this section;

(5) An official inspection legend and, except as otherwise provided in paragraph (i) of this section, the number of the official establishment, in the form required by part 312 of this subchapter;

(6) Any other information required by the regulations in this part or part 319 of this subchapter.

(d) The principal display panel shall be the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for sale. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part and part 319 of this subchapter with clarity and conspicuousness and without obscuring of such information by designs or vignettes or crowding. In determining the area of the principal display panel, exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and necks of bottles or jars. The principal display panel shall be:

(1) In the case of a rectangular package, one entire side, the area of which is at least the product of the height times the width of that side.

(2) In the case of a cylindrical or nearly cylindrical container:

(i) An area that is 40 percent of the product of the height of the container times the circumference of the container, or

(ii) A panel, the width of which is one-third of the circumference and the height of which is as high as the container: Provided, however, That if there is immediately to the right or left of such principal display panel, a panel which has a width not greater than 20 percent of the circumference and a height as high as the container, and which is reserved for information prescribed in paragraphs (c) (2), (3), and (5), such panel shall be known as the "20 percent panel" and such information may be shown on that panel in lieu of showing it on the principal display panel.

(3) In the case of a container of any other shape, 40 percent of the total surface of the container.

(e) Any descriptive designation used as a product name for a product which has no common or usual name shall clearly and completely identify the

product. Product which has been prepared by salting, smoking, drying, cooking, chopping, or otherwise shall be so described on the label unless the name of the product implies, or the manner of packaging shows that the product was subjected to such preparation. The unqualified terms "meat," "meat byproduct," "meat food product," and terms common to the meat industry but not common to consumers such as "picnic," "butt," "cala," "square," "loaf," "spread,' "delight," "roll," "plate," "luncheon," and "daisy" shall not be used as names of a product unless accompanied with terms descriptive of the product or with a list of ingredients, as deemed necessary in any specific case by the Administrator in order to assure that the label will not be false or misleading.

(f)(1) The list of ingredients shall show the common or usual names of the ingredients arranged in the descending order of predominance, except as otherwise provided in this paragraph.

(i) The terms spice, natural flavor, natural flavoring, flavor and flavoring may be used in the following manner:

(A) The term "spice" means any aromatic vegetable substance in the whole, broken, or ground form, with the exceptions of onions, garlic and celery, whose primary function in food is seasoning rather than nutritional and from which no portion of any volatile oil or other flavoring principle has been removed. Spices include the spices listed in 21 CFR 182.10, and 184.

(B) The term "natural flavor," "natural flavoring," "flavor" or "flavoring" means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product or roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or any other edible portion of a plant, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose primary function in food is flavoring rather than nutritional. Natural flavors include the natural essence or extractives obtained from plants listed in 21 CFR 182.10, 182.20, 182.40, 182.50 and 184, and the

substances listed in 21 CFR 172.510. The term natural flavor, natural flavoring, flavor or flavoring may also be used to designate spices, powered onion, powdered garlic, and powdered celery.

(ii) The term "corn syrup" may be used to designate either corn syrup or corn syrup solids.

(iii) The term "animal and vegetable fats" or "vegetable and animal fats" may be used to designate the ingredients of mixtures of such edible fats in product designated "compound" or "shortening.' "Animal fats" as used herein means fat derived from inspected and passed cattle, sheep, swine, or goats.

(iv) When a product is coated with pork fat, gelatin, or other approved substance and a specific declaration of such coating appears contiguous to the name of the product, the ingredient statement need not make reference to the ingredients of such coating.

(v) When two meat ingredients comprise at least 70 percent of the meat and meat byproduct ingredients of a formula and when neither of the two meat ingredients is less than 30 percent by weight of the total meat and meat byproducts used, such meat ingredients may be interchanged in the formula without a change being made in the ingredients statement on labeling materials: Provided, That the word "and" in lieu of a comma shall be shown between the declaration of such meat ingredients in the statement of ingredients.

(vi)(A) Product ingredients which are present in individual amounts of 2 percent or less by weight may be listed in the ingredients statement in other than descending order of predominance: Provided, That such ingredients are listed by their common or usual names at the end of the ingredients statement and preceded by a quantifying statement, such as "Contains percent of ""Less

than percent of The percentage of the ingredient(s) shall be filled in with a threshold level of 2 percent, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No ingredient to which the quantifying statement applies may be present in an amount greater than the stated threshold. Such a quantifying statement may