(iv) Imported bottled water to which fluoride is added shall not contain fluoride in excess of 0.8 milligram per liter.

(e) Radiological quality. (1) Bottled water shall, when a composite of analytical units of equal volume from a sample is examined by the methods described in paragraph (e)(2) of this section, meet standards of radiological quality as follows:

(i) The bottled water shall not contain a combined radium-226 and radium-228 activity in excess of 5 picocuries per liter of water.

(ii) The bottled water shall not contain a gross alpha particle activity (including radium-226, but excluding radon and uranium) in excess of 15 picocuries per liter of water.

(iii) The bottled water shall not contain beta particle and photon radioactivity from manmade radionuclides in excess of that which would produce an annual dose equivalent to the total body or any internal organ of 4 millirems per year calculated on the basis of an intake of 2 liters of the water per day. If two or more beta or photonemitting radionuclides are present, the sum of their annual dose equivalent to the total body or to any internal organ shall not exceed 4 millirems per year.

(2) Analyses conducted to determine compliance with paragraph(e)(1) of this section shall be made in accordance with the methods described in the applicable sections of "Standard Methods for the Examination of Water and Wastewater," 14th Ed., 1975, and "Interim Radiochemical Methodology for Drinking Water," Environmental Monitoring and Support Laboratory, EPA-600/4-75-008 (Revised), March 1976, U.S. Environ

1

mental Protection Agency, both of which are incorporated by reference.

(f) Label statements. Bottled water. the quality of which is below that prescribed by this section, shall be labeled with a statement of substandard qual ity as follows:

(1) When the microbiological quality of bottled water is below that prescribed by paragraph (b) of this sec tion, the label shall bear the statement of substandard quality specified in § 103.5(b).

(2) When the physical, chemical and/or radiological quality of bottled water is below that prescribed by paragraphs (c) through (e) respectively of this section, the label shall bear the statement of substandard quality specified in § 103.5(b) except that, as ap propriate, instead of or in addition to the words "Contains Excessive Bacte ria" the following statement(s) shall be used:

(i) "Excessively Turbid", "Abnormal Color", and/or 'Abnormal Odor" if the bottled water fails to meet the re quirements of paragraph (c) (1), (2), and/or (3), respectively, of this sec tion.

(ii) "Contains Excessive Chemical Substances", if the bottled water fails to meet any of the requirements of paragraph (d) of this section. The spe cific chemical(s) may be declared in lieu of the words "Chemical Substances" in the statement "Contains Excessive Chemical Substances". When a specific chemical is declared, that name by which the chemical(s) is designated in paragraph (d) of this section shall be used. Example: "Contains Excessive Copper".

(iii) "Excessively Radioactive" if the bottled water fails to meet the requirements of paragraph (e) of this section.

(g) Adulteration. Bottled water containing a substance at a level considered injurious to health under section 402(a)(1) of the act is deemed to be adulterated, regardless of whether or not the bottled water bears a label statement of substandard quality prescribed by paragraph (f) of this section.

[42 FR 14325, Mar. 15, 1977, as amended at 44 FR 12172, Mar. 6, 1979]

'Copies are available from: National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22151.

a

§ 104.5 General principles.

(a) A nutritional quality guideline prescribes the minimum level or range of nutrient composition (nutritional quality) appropriate for a given class of food.

(b) Labeling for a product which complies with all of the requirements of the nutritional quality guideline esItablished for its class of food may state "This product provides nutrients in amounts appropriate for this class of food as determined by the U.S. Government," except that the words "this product" are optional. This statement, if used, shall be printed on the principal display panel, and may also be printed on the information panel, in letters not larger than twice the size of the minimum type required for the declaration of net quantity of contents by § 101.105 of this chapter. Labeling of noncomplying products may not include any such statement or otherwise represent, suggest, or imply the product as being, in whole or in part, in compliance with a guideline.

(c) A product bearing the statement provided for in paragraph (b) of this section, in addition to meeting the requirements of the applicable nutritional quality guideline, shall comply with the following requirements:

(1) The label of the product shall bear the common or usual name of the food in accordance with the provisions · of the guideline and §§ 101.3 and 102.5(a) of this chapter.

(2) The label of the product shall bear nutrition labeling in accordance with §§ 101.2 and 101.9 of this chapter and all other labeling required by applicable sections of Part 101 of this chapter.

(d) No claim or statement may be made on the label or in labeling representing, suggesting, or implying any nutritional or other differences between a product to which nutrient addition has or has not been made in order to meet the guideline, except that a nutrient addition shall be declared in the ingredient statement.

(e) Compliance with a nutrient level specified in a nutritional quality guideline shall be determined by the procedures and requirements established in § 101.9(e) of this chapter.

(f) A product within a class of food for which a nutritional quality guideline has been established and to which has been added a discrete nutrient either for which no minimum nutrient level or nutrient range or other allowance has been established as appropriate in the nutritional quality guideline, or at a level that exceeds any maximum established as appropriate in the guideline, shall be ineligible to bear the guideline statement provided for in paragraph (b) of this section, and such a product shall also be deemed to be misbranded under the act unless the label and all labeling bear the following prominent and conspicuous statement: "The addition of to (or "The addition of at the level contained in) this product has been determined by the U.S. Government to be unnecessary and inappropriate and does not increase the dietary value of the food," the blank to be filled in with the common or usual name of the nutrient(s) involved.

§ 104.19 Petitions.

The Commissioner of Food and Drugs, on his own initiative, on the advice of the National Academy of Sciences or other experts, or on behalf of

(iv) Imported bottled water to which fluoride is added shall not contain fluoride in excess of 0.8 milligram per liter.

(e) Radiological quality. (1) Bottled water shall, when a composite of analytical units of equal volume from a sample is examined by the methods described in paragraph (e)(2) of this section, meet standards of radiological quality as follows:

(i) The bottled water shall not contain a combined radium-226 and radium-228 activity in excess of 5 picocuries per liter of water.

(ii) The bottled water shall not contain a gross alpha particle activity (including radium-226, but excluding radon and uranium) in excess of 15 picocuries per liter of water.

(iii) The bottled water shall not contain beta particle and photon radioactivity from manmade radionuclides in excess of that which would produce an annual dose equivalent to the total body or any internal organ of 4 millirems per year calculated on the basis of an intake of 2 liters of the water per day. If two or more beta or photonemitting radionuclides are present, the sum of their annual dose equivalent to the total body or to any internal organ shall not exceed 4 millirems per year.

(2) Analyses conducted to determine compliance with paragraph(e)(1) of this section shall be made in accordance with the methods described in the applicable sections of "Standard Methods for the Examination of Water and Wastewater," 14th Ed., 1975, and "Interim Radiochemical Methodology for Drinking Water," Environmental Monitoring and Support Laboratory, EPA-600/4-75-008 (Revised), March 1976, U.S. Environ

mental Protection Agency, both of which are incorporated by reference.

(f) Label statements. Bottled water, the quality of which is below that prescribed by this section, shall be labeled with a statement of substandard quality as follows:

(1) When the microbiological quality of bottled water is below that prescribed by paragraph (b) of this section, the label shall bear the statement of substandard quality specified in § 103.5(b).

(2) When the physical, chemical, and/or radiological quality of bottled water is below that prescribed by paragraphs (c) through (e) respectively of this section, the label shall bear the statement of substandard quality specified in § 103.5(b) except that, as appropriate, instead of or in addition to the words "Contains Excessive Bacteria" the following statement(s) shall be used:

(i) "Excessively Turbid", "Abnormal Color", and/or "Abnormal Odor" if the bottled water fails to meet the requirements of paragraph (c) (1), (2), and/or (3), respectively, of this section.

(ii) "Contains Excessive Chemical Substances", if the bottled water fails to meet any of the requirements of paragraph (d) of this section. The specific chemical(s) may be declared in lieu of the words "Chemical Substances" in the statement "Contains Excessive Chemical Substances". When a specific chemical is declared, that name by which the chemical(s) is designated in paragraph (d) of this section shall be used. Example: “Contains Excessive Copper".

(iii) "Excessively Radioactive" if the bottled water fails to meet the requirements of paragraph (e) of this section.

(g) Adulteration. Bottled water containing a substance at a level considered injurious to health under section 402(a)(1) of the act is deemed to be adulterated, regardless of whether or not the bottled water bears a label statement of substandard quality prescribed by paragraph (f) of this section.

[42 FR 14325, Mar. 15, 1977, as amended at 44 FR 12172, Mar. 6, 1979]

'Copies are available from: National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22151.

§ 104.5 General principles.

(a) A nutritional quality guideline prescribes the minimum level or range of nutrient composition (nutritional quality) appropriate for a given class of food.

(b) Labeling for a product which complies with all of the requirements of the nutritional quality guideline established for its class of food may state "This product provides nutrients in amounts appropriate for this class of food as determined by the U.S. Government," except that the words "this product" are optional. This statement, if used, shall be printed on the principal display panel, and may also be printed on the information panel, in letters not larger than twice the size of the minimum type required for the declaration of net quantity of contents by § 101.105 of this chapter. Labeling of noncomplying products may not include any such statement or otherwise represent, suggest, or imply the product as being, in whole or in part, in compliance with a guideline.

(1) The label of the product shall bear the common or usual name of the food in accordance with the provisions of the guideline and §§ 101.3 and 102.5(a) of this chapter.

(2) The label of the product shall bear nutrition labeling in accordance with §§ 101.2 and 101.9 of this chapter and all other labeling required by applicable sections of Part 101 of this chapter.

(d) No claim or statement may be made on the label or in labeling representing, suggesting, or implying any nutritional or other differences between a product to which nutrient addition has or has not been made in order to meet the guideline, except that a nutrient addition shall be declared in the ingredient statement.

(e) Compliance with a nutrient level specified in a nutritional quality guideline shall be determined by the procedures and requirements established in § 101.9(e) of this chapter.

(f) A product within a class of food for which a nutritional quality guideline has been established and to which has been added a discrete nutrient either for which no minimum nutrient level or nutrient range or other allowance has been established as appropriate in the nutritional quality guideline, or at a level that exceeds any maximum established as appropriate in the guideline, shall be ineligible to bear the guideline statement provided for in paragraph (b) of this section, and such a product shall also be deemed to be misbranded under the act unless the label and all labeling bear the following prominent and conspicuous statement: "The addition of

to (or "The addition of at the level contained in) this product has been determined by the U.S. Government to be unnecessary and inappropriate and does not increase the dietary value of the food," the blank to be filled in with the common or usual name of the nutrient(s) involved.

§ 104.19 Petitions.

The Commissioner of Food and Drugs, on his own initiative, on the advice of the National Academy of Sci