paragraph (1) of this paragraph, the label shall bear a statement of the quantity of such element in a specified quantity of such food. Except in the case of foods subject to § 125.9, the quantity of food specified as required in this section shall be the quantity customarily or usually consumed during a period of one day, or a quantity reasonably suitable for and practicable of consumption within such period. If the need in human nutrition for such element has not been established, the label shall also bear the statement "The need for in

human nutrition has not been established," the blank to be filled in with the name of such element.

(3) If a food purports to be or is represented for special dietary use by man by reason of its mineral property, and any such use is for treating any disease resulting from a dietary deficiency of any element, the label shall bear a statement of the quantity of such element in a specified quantity of such food. If the represented special dietary use of such food is solely for treating any such disease, such food shall be exempt from the labeling requirements of subparagraphs (1) and (2) of this paragraph when otherwise applicable.

(4) Compliance with the provisions of subparagraphs (2) and (3) of this paragraph shall not be construed as relieving any food which purports to be or is represented for special dietary use by reason of its mineral property from the application of sections 403 (a) and 201 (n) of the act, as in the case where the need for such element in human nutrition is not substantially supported by the opinion of experts qualified by scientific training and experience to determine such needs.

(b) For the purposes of the regulations in this section, the following are minimum daily requirements:

(1) For calcium (Ca), 750 milligrams for a child or an adult, except a pregnant or lactating woman in which case the minimum daily requirement is 1.5 grams.

(2) For phosphorus (P), 750 milligrams for a child or an adult, except a pregnant or lactating woman in which case the minimum daily requirement is 1.5 grams.

(3) For iron (Fe), 7.5 milligrams for a child less than six years old, 10 milligrams for a child six or more years old or for an adult, except a pregnant or

lactating woman in which case the minimum daily requirement is 15 milligrams. (4) For iodine (I), 0.1 milligram for a child or an adult.

§ 125.5 Label statements relating to infant food.

(a) If a food (other than a dietary supplement of vitamins and/or minerals alone) purports to be or is represented for special dietary use for infants, the label shall bear, if such food is fabricated from two or more ingredients, the common or usual name of each ingredient, including spices, flavoring, and coloring.

(b) If such food, or any ingredient thereof, consists in whole or in part of plant or animal matter and the name of such food or ingredient does not clearly reveal the specific plant or animal which is its source, such name shall be so qualified as to reveal clearly the specific plant or animal that is such source.

(c) If such use of the food is by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk, the label shall also bear:

(1) A statement of the percent by weight or weight per unit volume of moisture, protein, fat, available carbohydrate, ash, and crude fiber contained in such food.

(2) A statement of the number of available kilocalories (in the case of food label statements, a kilocalorie is represented by the word "Calorie") supplied by a specified quantity of such food as customarily or usually prepared for consumption.

(3) A statement of the amount of each vitamin-or mineral listed in subparagraph (5) of this paragraph and the amount of other added vitamin (s) and mineral(s) supplied by a specified quantity of such food as customarily or usually prepared for consumption.

(4) The statement "This product should not be used as the sole source of protein in the infant diet" if a quantity which supplies 100 available kilocalories of such food as customarily or usually prepared for consumption contains less than 1.8 grams of protein of a biological quality equivalent to that of casein, or if the amount and biological quality of protein per 100 available kilocalories of such food are such that the quality of protein expressed as a fraction of that of casein multiplied by the amount of protein in grams is less than 1.8, or if the biological

quality of protein is less than 70 percent of that of casein.

(i) For the purpose of this subparagraph, the method for determining biological quality of protein shall be the method prescribed on page 800 (secs. 39.166-39.170) under "Biological Evaluation of Protein Quality-Official, Final Action" of "Official Methods of Analysis of the Association of Official Analytical Chemists," 11th edition (1970).

(ii) For the purpose of this subparagraph, the method for determining the amount of protein is to multiply by 6.25 the total nitrogen content in grams, as determined by the method described on page 16 (sec. 2.051) under "Improved Kjeldahl Methods for Nitrate-Free Samples—Official, Final Action” of “Official Methods of Analysis of the Association of Official Analytical Chemists," 11th edition (1970).

(5) If a quantity which supplies 100 available kilocalories of such food as customarily or usually prepared for consumption contains less than the following amounts of vitamins and minerals, a statement that an additional quantity of such vitamin (s) or mineral(s), as the case may be, should be supplied from other sources:

amount of vitamin (s) and mineral(s) supplied and the amount required by this subparagraph, expressed on the same basis, must also appear in the same statement.

(6) If such food contains fat at a level supplying less than 15 percent of the total available kilocalories, or linoleic acid (present as a glyceride) at a level supplying less than 2 percent of the total available kilocalories, a statement that an additional quantity of fat or linoleic acid (linoleate), as the case may be, should be supplied from other sources. The requirement of this subparagraph shall not apply to such food which purports to be or is represented for special dietary use by reason of a need for regulating the intake of fat.

(d) The provisions of paragraph (c) of this section shall not apply to whole milk (of cows) or evaporated milk except with respect to ascorbic acid, vitamin D, and iron under paragraph (c) (5) of this section.

(e) A food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk, and which complies with the provisions of this section, shall be exempt from the effective provisions of §§ 125.3, 125.4, and 125.6 of this Part 125. [36 F.R. 23555, Dec. 10, 1971; 36 F.R. 24792, Dec. 23, 1971]

EDITORIAL NOTE: The revision of § 125.5 appearing at 36 F.R. 23555, Dec. 10, 1971; 36 F.R. 24792, Dec. 23, 1971 becomes effective 90 days from the date of publication in the FEDERAL REGISTER. For the convenience of the user, the superseded text of § 125.5 appears below.

§ 125.5

Label statements relating to infant food.

If a food which purports to be or is represented for special dietary use is a food for infants, the label shall bear, in case such food is fabricated from two or more ingredients, the common or usual name of each such ingredient including spice, flavoring, and coloring; if such food, or any ingredient thereof in case it is fabricated from two or more ingredients, consists in whole or in part of plant or animal matter and the name of such food or ingredient does not clearly reveal the specific plant or animal which is its source, such name shall be so qualified as to reveal clearly the specific plant or animal which is such source. If such use of the food is by reason of its simulation of human milk or its suitability as a complete or partial

substitute for human milk, the label shall also bear:

(a) A statement of the percent by weight of moisture, protein, fat, available carbohydrate, crude fiber, calcium (Ca), phosphorus (P), and iron (Fe) contained in such food;

(b) A statement of the number of available calories and of U.S.P. units of vitamin A, vitamin B1 (thiamine), vitamin C (ascorbic acid), and vitamin D supplied by a specified quantity of such food; and

(c) If less than 30 U.S.P. units of vitamin C (ascorbic acid), less than 50 U.S.P. units of vitamin D, or less than 0.75 milligram of iron (Fe), is supplied by the quantity of such food which, as customarily or usually prepared for consumption, supplies 100 available calories, a statement that additional quantities of such vitamin or iron, as the case may be, should be supplied from other sources. The provisions of paragraphs (a) and (b) of this section shall not apply to cow's milk and evaporated milk. The provisions of paragraph (c) of this section with respect to vitamin D shall not apply to cow's milk or evaporated milk in which the vitamin D is increased by any means to not less than 135 U.S.P. units to each quart in the case of cow's milk and not less than 7.5 U.S.P. units to each avoirdupois ounce in the case of evaporated milk. § 125.6 Label statements relating to certain food used in control of body weight or in dietary management with respect to disease,

If a food purports to be or is represented for special dietary use by man by reason of its use as a means of regulating the intake of protein, fat, carbohydrate, or calories, for the purpose of controlling body weight, or for the purpose of dietary management with respect to disease, the label shall bear a statement of:

(a) The percent by weight of protein, fat, and available carbohydrates in such food; and

(b) The number of available calories supplied by a specified quantity of such food.

§ 125.7 Label statements relating to nonnutritive constituents.

If a food purports to be or is represented for special dietary use by man by reason of the presence of any constituent which is not utilized in normal metabolism, the label shall bear a statement of the percent by weight of such constituent, and, in juxtaposition with the name of such constituent, the word "nonnutritive". If such constituent is fibrous plant matter, it shall be considered to be crude fiber and its percent expressed as such. But if such constit

uent is saccharin or a saccharin salt, the label shall bear, in lieu of such statement and word, the statement "Contains saccharin (or saccharin salt, as the case may be), a nonnutritive, artificial sweetener which should be used only by persons who must restrict their intake of ordinary sweets," the blank to be filled in with the percent by weight of saccharin or saccharin salt in such food. The provisions of this section shall not be construed as authorizing the use of saccharin or its salts in any food other than one for use by persons who must restrict their intake of carbohydrates, or as relieving any food from compliance with any requirement of sections 402 (b) or (d), 403 (g), or other provisions of the act.

§ 125.8 Label statements relating to hypoallergenic food.

If a food purports to be or is represented for special dietary use by man by reason of the decrease or absence of any allergenic property, the label shall bear:

(a) The common or usual name and the quantity or proportion of each ingredient including spices, flavoring, and coloring, in case the food is fabricated from two or more ingredients;

(b) A qualification of the name of the food, or of the name of each ingredient thereof in case the food is fabricated from two or more ingredients, to reveal clearly the specific plant or animal which is the source of such food or of such ingredient, if such food or such ingredient consists in whole or in part of plant or animal matter and such name does not clearly reveal the specific plant or animal which is such source; and

(c) A statement indicating the nature and effect of any treatment or processing of the food or any ingredient thereof, if the changed allergenic property results from such treatment or processing.

§ 125.9 Label statements relating to certain foods used as a means of regulating the intake of sodium in dietary management.

If a food purports to be or is represented for special dietary use by man by reason of its use as a means of regulating the intake of sodium or salt (sodium chloride), the label shall bear a statement of the number of milligrams of sodium in 100 grams of the food and a statement of the number of milligrams

The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act are applicable to such terms when used in this part. The following definitions shall also apply:

(a) "Adequate" means that which is needed to accomplish the intended purpose in keeping with good public health practice.

(b) "Plant" means the building or buildings or parts thereof, used for or in connection with the manufacturing, processing, packaging, labeling, or holding of human food.

(c) "Sanitize" means adequate treatment of surfaces by a process that is effective in destroying vegetative cells of pathogenic bacteria and in substantially reducing other micro-organisms. Such treatment shall not adversely affect the product and shall be safe for the consumer.

(a) Grounds. The grounds about a food plant under the control of the operator shall be free from conditions which may result in the contamination of food including, but not limited to, the following:

(1) Improperly stored equipment, litter, waste, refuse, and uncut weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for rodents, insects, and other pests.

(2) Excessively dusty roads, yards, or parking lots that may constitute a source of contamination in areas where food is exposed.

(3) Inadequately drained areas that may contribute contamination to food products through seepage or foot-borne filth and by providing a breeding place for insects or micro-organisms.

If the plant grounds are bordered by grounds not under the operator's control of the kind described in subparagraphs (1) through (3) of this paragraph, care must be exercised in the plant by inspection, extermination, or other means to effect exclusion of pests, dirt, and other filth that may be a source of food contamination.

(b) Plant construction and design. Plant buildings and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-processing purposes. The plant and facilities shall:

(1) Provide sufficient space for such placement of equipment and storage of materials as is necessary for sanitary operations and production of safe food. Floors, walls, and ceilings in the plant shall be of such construction as to be adequately cleanable and shall be kept clean and in good repair. Fixtures, ducts,

and pipes shall not be so suspended over working areas that drip or condensate may contaminate foods, raw materials, or food-contact surfaces. Aisles or working spaces between equipment and between equipment and walls shall be unobstructed and of sufficient width to permit employees to perform their duties without contamination of food or foodcontact surfaces with clothing or personal contact.

(2) Provide separation by partition, location, or other effective means for those operations which may cause contamination of food products with undesirable micro-organisms, chemicals, filth, or other extraneous material.

(3) Provide adequate lighting to hand-washing areas, dressing and locker rooms, and toilet rooms and to all areas where food or food ingredients are examined, processed, or stored and where equipment and utensils are cleaned. Light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation shall be of the safety type or otherwise protected to prevent food contamination in case of breakage.

(4) Provide adequate ventilation or control equipment to minimize odors and noxious fumes or vapors (including steam) in areas where they may contaminate food. Such ventilation or control equipment shall not create conditions that may contribute to food contamination by airborne contaminants.

(5) Provide, where necessary, effective screening or other protection against birds, animals, and vermin (including, but not limited to, insects and rodents). § 128.4 Equipment and utensils.

All plant equipment and utensils should be (a) suitable for their intended use, (b) so designed and of such material and workmanship as to be adequately cleanable, and (c) properly maintained. The design, construction, and use of such equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces.

§ 128.5 Sanitary facilities and controls. Each plant shall be equipped with adequate sanitary facilities and accommo

dations including, but not limited to, the following:

(a) Water supply. The water supply shall be sufficient for the operations intended and shall be derived from an adequate source. Any water that contacts foods or food-contact surfaces shall be safe and of adequate sanitary quality. Running water at a suitable temperature and under pressure as needed shall be provided in all areas where the processing of food, the cleaning of equipment, utensils, or containers, or employee sanitary facilities require.

(b) Sewage disposal. Sewage disposal shall be made into an adequate sewerage system or disposed of through other adequate means.

(c) Plumbing. Plumbing shall be of adequate size and design and adequately installed and maintained to:

(1) Carry sufficient quantities of water to required locations throughout the plant.

(2) Properly convey sewage and liquid disposable waste from the plant.

(3) Not constitute a source of contamination to foods, food products or ingredients, water supplies, equipment, or utensils or create an insanitary condition.

(4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor.

(d) Toilet facilities. Each plant shall provide its employees with adequate toilet and associated hand-washing facilities within the plant. Toilet rooms shall be furnished with toilet tissue. The facilities shall be maintained in a sanitary condition and kept in good repair at all times. Doors to toilet rooms shall be self-closing and shall not open directly into areas where food is exposed to airborne contamination, except where alternate means have been taken to prevent such contamination (such as double doors, positive air-flow systems, etc.). Signs shall be posted directing employees to wash their hands with cleaning soap or detergents after using toilet.

(e) Hand-washing facilities. Adequate and convenient facilities for hand washing and, where appropriate, hand sanitizing shall be provided at each location in the plant where good sanitary practices require employees to wash or sanitize and dry their hands. Such facilities