deliver the acidic dressing to a user until at least 72 hours after such egg product is incorporated in such acidic dressing, and agrees to maintain for inspection adequate records covering such processing for 2 years after such processing.

(2) In addition to the caution statement referred to above, the container of such egg product shall also bear the statement "Unpasteurized for use in acidic dressings only," the blank being filled in with the applicable name of the eggs or egg product.

[29 F.R. 15285, Nov. 14, 1964, as amended at 31 F.R. 6491, Apr. 29, 1966]

§ 5.3 Conditions affecting expiration of exemptions.

(a) An exemption of a shipment or other delivery of a food under § 5.2(a) or (c) shall, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment become void ab initio if the food comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed.

(b) An exemption of a shipment or other delivery of a food under § 5.2(b) or (c) shall become void ab initio with respect to the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to make available for inspection a copy of the agreement, as required by § 5.2(b) or (c).

(c) An exemption of a shipment or other delivery of a food under § 5.2(b) or (c) shall expire:

(1) At the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment if the food comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed; or

(2) Upon refusal by the operator of the establishment where such food is to be processed, labeled, or repacked, to make available for inspection a copy of the agreement, as required by such paragraph.

[29 F.R. 15285, Nov. 14, 1964, as amended at 31 F.R. 6491, Apr. 29, 1966]

§ 5.4 Labeling of cheeses during curing and processing.

The word "processed" as used in this section shall include the holding of cheese in a suitable warehouse at a tem

perature of not less than 35° F. for the purpose of aging or curing to bring the cheese into compliance with requirements of an applicable definition and standard of identity. The exemptions provided for in § 5.2 shall apply to cheese which is, in accordance with the practice of the trade, shipped to a warehouse for aging or curing, on condition that the cheese is identified in the manner set forth in one of the applicable following paragraphs, and in such case the provisions of § 5.3 shall also apply:

(a) In the case of varieties of cheese for which definitions and standards of identity require a period of aging whether or not they are made from pasteurized milk, each such cheese shall bear on the cheese a legible mark showing the date at which the preliminary manufacturing process has been completed and at which date curing commences, and to each cheese, on its wrapper or immediate container, shall be affixed a removable tag bearing the statement "Uncured cheese for completion of curing and proper labeling," the blank being filled in with the applicable name of the variety of cheese. In the case of swiss cheese, the date at which the preliminary manufacturing process had been completed and at which date curing commences is the date on which the shaped curd is removed from immersion in saturated salt solution as provided in the definition and standard of identity for swiss cheese, and such cheese shall bear a removable tag reading, "To be cured and labeled as 'swiss cheese', but if eyes do not form to be labeled as 'swiss cheese for manufacturing.'"

(b) In the case of varieties of cheeses which when made from unpasteurized milk are required to be aged for not less than 60 days, each such cheese shall bear a legible mark on the cheese showing the date at which the preliminary manufacturing process has been completed and at which date curing commences, and to each such cheese or its wrapper or immediate container shall be affixed a removable tag reading,

66

cheese made from unpasteurized milk. For completion of curing and proper labeling," the blank being filled in with the applicable name of the variety of cheese.

(c) In the case of cheddar cheese,

ing," the blank being filled in with the applicable name of the variety of cheese. § 5.5 Certain foods with added artificial sweetener not intended for special dietary use.

(a) A food, or class of food, to which an artificial sweetener has been added and which does not purport to be and is not represented as a food, or class of food, for special dietary use including the diets of diabetics shall be exempt from the requirements of § 125.5 of this chapter if:

(1) It cannot be prepared in a way to achieve its intended characteristics without the addition of the artificial Sweetener as a substitute for sugar or other natural sweetener.

(2) As consumed, its caloric content is not less than 90 percent of the same food, or class of food, sweetened with natural substances only.

(3) Its label lists the nonnutritive artificial sweetener as an ingredient, and no other representations, direct or implied, are made for such food, or class of food, based on the nonnutritive value of the added artificial sweetener.

(4) An interested person desiring that such an exemption be made effective for such food, or class of food, has submitted an application for such an exemption to the Commissioner of Food and Drugs, supplying: Full information concerning the addition of the artificial sweetener; the proposed label and labeling for such food, or class of food; the reasons why he believes such food, or class of food, should be subject to this exemption; a sample of such food, or class of food; and, upon request, any other information concerning such food, or class of food, which the Commissioner deems necessary in order to reach a decision.

(5) Such an exemption has been made

effective by the Commissioner. When the Commissioner makes effective an exemption for food, or class of food, in accordance with the provisions of this section, such food, or class of food, will be listed in this section.

(b) The provisions of paragraph (a) (4) and (5) of this section shall not apply to a poultry product subject to the provisions of the Poultry Products Inspection Act or to a meat product subject to the provisions of the Meat Inspection Act, provided that authorization to produce and market such food has been granted by the U.S. Department of Agriculture.

[31 F.R. 8524, June 18, 1966]

NOTE: The provisions of § 5.5 were stayed at 31 F.R. 15730, Dec. 14, 1966.

The label declaration of a harmless marker used to identify a particular manufacturer's product may result in unfair competition through revealing a trade secret. Exemption from the label declaration of such a marker is granted, therefore, provided that the following conditions are met:

(a) The person desiring to use the marker without label declaration of its presence has submitted to the Commissioner of Food and Drugs full information concerning the proposed usage and the reasons why he believes label declaration of the marker should be subject to this exemption; and

(b) The person requesting the exemption has received from the Commissioner of Food and Drugs a finding that the marker is harmless and that the exemption has been granted.

§ 5.7 Wrapped fish fillets.

(a) Wrapped fish fillets of nonuniform weight intended to be unpacked and marked with the correct weight at the point of retail sale in an establishment other than that where originally packed shall be exempt from the requirement of section 403 (e) (2) of the act during introduction and movement in interstate commerce and while held for sale prior to weighing and marking: Provided, That:

(1) The outside container bears a label declaration of the total net weight; and (2) The individual packages bear a conspicuous statement "To be weighed

at time of sale” and a correct statement setting forth the weight of the wrapper; and

Provided further, That it is the practice of the retail establishment to weigh and mark the individual packages with a correct net-weight statement prior to or at the point of retail sale. A statement of the weight of the wrapper shall be set forth so as to be readily read and understood, using such term as "wrapper tare ounce," the blank being filled in with the correct average weight of the wrapper used.

(b) The act of delivering the wrapped fish fillets during the retail sale without the correct net-weight statement shall be deemed an act which results in the product's being misbranded while held for sale. Nothing in this section shall be construed as requiring net-weight statements for wrapped fish fillets delivered into institutional trade provided the outside container bears the required information.

§ 5.8 Bananas, wrapped clusters (consumer units).

(a) Wrapped clusters (consumer units) of bananas of nonuniform weight intended to be unpacked from a master carton or container and weighed at the point of retail sale in an establishment other than that where originally packed shall be exempt from the requirements of section 403 (e) (2) of the act during introduction and movement in interstate commerce and while held for sale prior to weighing: Provided, That:

(1) The master carton or container bears a label declaration of the total net weight; and

(2) The individual packages bear a conspicuous statement "To be weighed at the time of sale” and a correct statement setting forth the weight of the wrapper; and

Provided, further, That it is the practice of the retail establishment to weigh the individual packages either prior to or at the time of retail sale.

(b) The act of delivering the wrapped clusters (consumer units) during the retail sale without an accurate net weight statement or alternatively without weighing at the time of sale shall be deemed an act which results in the product's being misbranded while held for sale. Nothing in this paragraph shall be construed as requiring net-weight statements for clusters (consumer units)

delivered into institutional trade, provided that the master container or carton bears the required information.

§ 5.9 Labeling of foods in which salt containing anticaking agents or other substances is an ingredient.

Anticaking agents and other substances added to salt for the purpose of improving the physical properties of such salt are deemed to be incidental additives and are exempt from label declaration as ingredients of foods fabricated from such salt and other ingredients when:

(a) The salt anticaking agents or substances added for otherwise improving the physical properties of salt are not food additives within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act, are present at a level not greater than necessary to accomplish their intended physical effect, or if food additives, are used in salt in accordance with section 409 of the act and regulations thereunder.

(b) The classes of substances named in paragraph (a) of this section are present at nonfunctional and insignificant levels and do not exert any effect on the fabricated food containing such salt. [30 F.R. 15292, Dec. 10, 1965]

Subpart A-Definitions and Procedural and Interpretative Regulations

SOURCE: The provisions of this Subpart A appear at 28 F.R. 6439, June 22, 1963, unless otherwise noted.

§ 8.1

Definitions and interpretations.

(a) "Secretary" means the Secretary of Health, Education, and Welfare.

(b) "Department" means the Department of Health, Education, and Welfare. (c) "Commissioner" means the Commissioner of Food and Drugs.

(d) "Act" means the Federal Food, Drug, and Cosmetic Act as amended.

(e) "Color Certification Branch" means the unit established within the Food and Drug Administration located in the Bureau of Science, charged with the responsibility for the mechanics of the certification procedure hereinafter described, and including the examination of samples of color additives subject to certification.

(f) A "color additive" is any material, not exempted under section 201(t) of the act, that is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source and that, when added or applied to a food, drug, or cosmetic or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting a color thereto. This includes all diluents. Substances capable of imparting a color to a container for foods, drugs, or cosmetics are not color additives unless the customary or reasonably foreseeable handling or use of the container may reasonably be expected to result in the color being transmitted to the contents of the package or any part thereof. Food ingredients such as cherries, green or red peppers, chocolate, and orange juice which contribute their own natural color when mixed with other foods are not regarded as "color additives"; but where a food substance such as beet juice is deliberately used as a color, as in pink lemonade, it is a "color additive." Food ingredients as authorized by a definition and standard of identity prescribed by regulations pursuant to section 401 of the act are "color additives," where the in

gredients are specifically designated in the definitions and standards of identity as permitted for use for coloring purposes. An ingredient of an animal feed whose intended function is to impart, through the biological processes of the animal, a color to the meat, milk, or eggs of the animal is a color additive and is not exempt from the requirements of the statute. This definition shall apply whether or not such ingredient has nutritive or other functions in addition to the property of imparting color. A substance that, when applied to the human body results in coloring, is a "color additive," unless the function of coloring is purely incidental to its intended use, such as in the case of deodorants. Lipstick, rouge, eye makeup colors, and related cosmetics intended for coloring the human body are "color additives." An ingested drug the intended function of which is to impart color to the human body is a "color additive." For the purposes of this part, the term "color" includes black, white, and intermediate grays, but substances including migrants from packaging materials which do not contribute any color apparent to the naked eye are not "color additives."

(g) For a material otherwise meeting the definition of "color additive" to be exempt from section 706 of the act, on the basis that it is used (or intended to be used) solely for a purpose or purposes other than coloring, the material must be used in a way that any color imparted is clearly unimportant insofar as the appearance, value, marketability, or consumer acceptability is concerned. (It is not enough to warrant exemption if conditions are such that the primary purpose of the material is other than to impart color.)

(h) The exemption that applies to a pesticide chemical, soil or plant nutrient, or other agricultural chemical, where its coloring effect results solely from its aiding, retarding, or otherwise affecting directly or indirectly, the growth or other natural physiological processes of produce of the soil, applies only to color developed in such product through natural physiological processes such as enzymatic action. If the pesticide chemical, soil or plant nutrient, or other agricultural chemical itself acts as a color or carries as an ingredient a color, and because of this property colors the prod