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any mention of the presence of egg in such a product.

(Sec. 602, 52 Stat. 1054; 21 U. S. C. 862) [23 F. R. 5380, July 16, 1958]

§ 3.652

Labeling of detergent substances, other than soap, intended for use in cleansing the body.

(a) In its definition of the term "cosmetic," the Federal Food, Drug, and Cosmetic Act specifically excludes soap. The term "soap" is nowhere defined in the act. In administering the act, the Food and Drug Administration interprets the term "soap” to apply only to articles that meet the following conditions:

(1) The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds; and

(2) The product is labeled, sold, and represented only as soap.

(b) Products intended for cleansing the human body and which are not "soap" as set out in paragraph (a) of this section are "cosmetics," and accordingly they are subject to the requirements of the act and the regulations thereunder. For example, such a product in bar form is subject to the requirement, among others, that it shall bear a label containing an accurate statement of the weight of the bar in avoirdupois pounds and ounces, this statement to be prominently and conspicuously displayed so as to be likely to be read under the customary conditions of purchase and

use.

(Secs. 201, 602, 52 Stat. 1041, 1054; 21 U.S.C. 321, 362) [23 FR. 7483, Sept. 26, 1958]

CAUSTIC POISON

§ 3.700 Definition of ammonia under Federal Caustic Poison Act.

For the purpose of determining whether an article containing ammonia is subject to the Federal Caustic Poison Act, the ammonia content is to be calculated as NH..

(Secs. 2, 9, 44 Stat. 1406, 1409; 15 U.S.C. 402, 409) [22 FR. 9594, Nov. 30, 1957]

PART 4 OFFICIAL RECORDS AND INFORMATION

§ 4.1 Disclosure of official records and information.

(a) No officer or employee of the Food and Drug Administration or of any other office or establishment in the Depart

ment of Health, Education, and Welfare, except as authorized by the Commissioner of Food and Drugs, and in the discharge of his official duties under the laws administered by the Food and Drug Administration, shall give any testimony before any tribunal pertaining to any function of the Food and Drug Administration or with respect to any information acquired from any record or otherwise acquired in the discharge of his official duties.

(b) Whenever a subpoena or a subpoena duces tecum, in appropriate form, has been lawfully served upon an officer or employee of the Food and Drug Administration commanding the production of any record or the giving of any testimony, such officer or employee will, unless otherwise authorized by the Commissioner of Food and Drugs, appear in response thereto and respectfully decline to produce the record or testify respecting the information specified therein, on the ground that disclosure of such record or information is prohibited by this section.

(c) A person who desires testimony from any employee, or the disclosure of information not specifically available under the Public Information Act (Public Law 90-23) and the Department of Health, Education, and Welfare's regulations thereunder (45 CFR Part 5), may make written request therefor, verified by oath, directed to the Commissioner of Food and Drugs, setting forth his interest in the matter sought to be disclosed and designating the use to which such information or testimony will be put in the event of compliance with such request: Provided, That a written request therefor made by a health, food, or drug officer, prosecuting attorney, or member of the judiciary of any State, Territory, or political subdivision thereof, acting in his official capacity, need not be verified by oath. If it is determined by the Commissioner, or any other officer or employee of the Food and Drug Administration whom he may designate to act on his behalf for the purpose, that such disclosure will not be incompatible with the public interest and with obligations of confidentiality and administrative necessity, the request may be granted. Where a request for testimony is granted, one or more employees of the Food and Drug Administration may be designated to appear, in response to a subpoena or a sub

poena duces tecum, and testify with respect thereto.

(d) A person who desires the disclosure of any record may make request therefor in accordance with the procedures set forth in 45 CFR Part 5.

(e) Requests for the disclosure of any record will be granted in accordance with the rules and principles set forth in 45 CFR Part 5.

Sec. 10, 29 Stat. 607, as amended, sec. 3, 44 Stat. 1102, sec. 9, 44 Stat. 1409. as amended, sec. 4, 49 Stat. 885, sec. 701(a), 52 Stat. 1055, sec. 10, 74 Stat. 378, sec. 5, 80 Stat. 1298; 15 U.S.C. 409, 1269, 1453, 21 U.S.C. 50, 64, 143, 371(a)) [32 F.R. 15709, Nov. 15, 1967]

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(a) An open container is a container of rigid or semirigid construction, which is not closed by lid, wrapper, or otherwise.

(b) An open container of a fresh fruit or fresh vegetable, the quantity of contents of which is not more than one dry quart, shall be exempt from the labeling requirements of subsections (e), (g) (2) (with respect to the name of the food specified in the definition and standard), and (1)(1) of section 403 of the act; but such exemption shall be on the condition that if two or more such containers are enclosed in a crate or other

shipping package, such crate or package shall bear labeling showing the number of such containers enclosed therein and the quantity of the contents of each. § 5.2 Repacked, reprocessed, and relabeled foods.

Except as provided by §§ 5.3 and 5.4, a shipment or other delivery of a food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling requirements of section 403 (c), (e), (g), (h), (i), (j) and (k) of the act if:

(a) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such food is to be processed, labeled, or repacked; or

(b) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post-office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case may be, of such food in such establishment as will insure, if such specifications are followed, that such food will not be adulterated or misbranded within the meaning of the act upon completion of such processing, labeling, or repacking. Such person and such operator shall each keep a copy of such agreement until 2 years after the final shipment or delivery of such food from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Department who requests them.

(c) The article is an egg product subject to a standard of identity promulgated in Part 42 of this chapter, is to be shipped under the conditions specified in paragraph (a) or (b) of this section and for the purpose of pasteurization or other treatment as required in such standard, and each container of such egg product bears a conspicuous tag or label reading "Caution-This egg product has not been pasteurized or otherwise treated to destroy viable Salmonella mirco-organisms." In addition to safe and suitable bactericidal processes designed specifi

cally for Salmonella destruction in egg products, the term "other treatment" in the first sentence of this paragraph shall include use in acidic dressings in the processing of which the pH is not above 4.1 and the acidity of the aqueous phase, expressed as acetic acid, is not less than 1.4 percent, subject also to the conditions that:

(1) The agreement required in paragraph (b) of this section shall also state that the operator agrees to utilize such unpasteurized egg products in the processing of acidic dressings according to the specifications for pH and acidity set forth in this paragraph, agrees not to 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 temperature 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.'

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(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 manufac

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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, washed curd cheese, colby cheese, granular cheese, and brick cheese made from unpasteurized milk, 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 cheese made from unpasteurized milk. For completion of curing and proper labeling, or for labeling cheese for manufactur

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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.

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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 inter

state 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]

§ 5.10 Labeling foods in the production of which dimethylpolysiloxane defoaming agents containing silica aerogel were used.

Silica aerogel added to dimethylpolysiloxane (defoaming agent complying with the provisions of § 121.1099 of this chapter) is deemed to be an incidental additive and is exempt from label declaration as an ingredient of fabricated foods in which such defoaming agent is used provided the silica aerogel complies with the provisions of § 121.101(d) (8) of this chapter and is present at a level not greater than necessary and at such level as to be quantitatively insignificant and nonfunctional in the finished fabricated

foods.

[35 F.R. 2584, Feb. 5, 1970]

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