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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2017]
[CITE: 21CFR172]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
 
PART 172FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
 

Subpart D--Special Dietary and Nutritional Additives

Sec. 172.310 Aluminum nicotinate.

Aluminum nicotinate may be safely used as a source of niacin in foods for special dietary use. A statement of the concentration of the additive, expressed as niacin, shall appear on the label of the food additive container or on that of any intermediate premix prepared therefrom.

Sec. 172.315 Nicotinamide-ascorbic acid complex.

Nicotinamide-ascorbic acid complex may be safely used in accordance with the following prescribed conditions:

(a) The additive is the product of the controlled reaction between ascorbic acid and nicotinamide, melting in the range 141 deg. C to 145 deg. C.

(b) It is used as a source of ascorbic acid and nicotinamide in multivitamin preparations.

Sec. 172.320 Amino acids.

The food additive amino acids may be safely used as nutrients added to foods in accordance with the following conditions:

(a) The food additive consists of one or more of the following individual amino acids in the free, hydrated, or anhydrous form, or as the hydrochloride, sodium, or potassium salts:

(1) L-Alanine

(2) L-Arginine

(3) L-Asparagine

(4) L-Aspartic acid

(5) L-Cysteine

(6) L-Cystine

(7) L-Glutamic acid

(8) L-Glutamine

(9) Aminoacetic acid (glycine)

(10) L-Histidine

(11) L-Isoleucine

(12) L-Leucine

(13) L-Lysine

(14) DL-Methionine (not for infant foods)

(15) L-Methionine

(16) L-Phenylalanine

(17) L-Proline

(18) L-Serine

(19) L-Threonine

(20) L-Tryptophan

(21) L-Tyrosine

(22) L-Valine

(b) The food additive meets the following specifications:

(1) As found in Food Chemicals Codex:

(i) L-Alanine, pages 28 and 29.

(ii) L-Arginine, pages 69 and 70.

(iii) L-Arginine Monohydrochloride, pages 70 and 71.

(iv) L-Cysteine Monohydrochloride, pages 269 and 270.

(v) L-Cystine, pages 270 and 271.

(vi) Aminoacetic acid (glycine), pages 457 and 458.

(vii) L-Leucine, pages 577 and 578.

(viii) DL-Methionine, pages 641 and 642.

(ix) L-Methionine, pages 642 and 643.

(x) L-Tryptophan, pages 1060 and 1061.

(xi) L-Phenylalanine, pages 794 and 795.

(xii) L-Proline, pages 864 and 865.

(xiii) L-Serine, pages 915 and 916.

(xiv) L-Threonine, pages 1031 and 1032.

(xv) L-Glutamic Acid Hydrochloride, page 440.

(xvi) L-Isoleucine, pages 544 and 545.

(xvii) L-Lysine Monohydrochloride, pages 598 and 599.

(xviii) Monopotassium L -glutamate, pages 697 and 698.

(xix) L-Tyrosine, page 1061.

(xx) L-Valine, pages 1072.

(2) As found in "Specifications and Criteria for Biochemical Compounds," NAS/NRC Publication, for the following:

(i) L-Asparagine

(ii) L-Aspartic acid

(iii) L-Glutamine

(iv) L-Histidine

(c) The additive(s) is used or intended for use to significantly improve the biological quality of the total protein in a food containing naturally occurring primarily intact protein that is considered a significant dietary protein source, provided that:

(1) A reasonable daily adult intake of the finished food furnishes at least 6.5 grams of naturally occurring primarily intact protein (based upon 10 percent of the daily allowance for the "reference" adult male recommended by the National Academy of Sciences in "Recommended Dietary Allowances," NAS Publication No. 1694.

(2) The additive(s) results in a protein efficiency ratio (PER) of protein in the finished ready-to-eat food equivalent to casein as determined by the method specified in paragraph (d) of this section.

(3) Each amino acid (or combination of the minimum number necessary to achieve a statistically significant increase) added results in a statistically significant increase in the PER as determined by the method described in paragraph (d) of this section. The minimum amount of the amino acid(s) to achieve the desired effect must be used and the increase in PER over the primarily intact naturally occurring protein in the food must be substantiated as a statistically significant difference with at least a probability (P) value of less than 0.05.

(4) The amount of the additive added for nutritive purposes plus the amount naturally present in free and combined (as protein) form does not exceed the following levels of amino acids expressed as percent by weight of the total protein of the finished food:

Percent by weight of total
protein (expressed as free
amino acid)
L-Alanine6.1
L-Arginine6.6
L-Aspartic acid (including L-asparagine)7.0
L-Cystine (including L-cysteine)2.3
L-Glutamic acid (including L-glutamine)12.4
Aminoacetic acid (glycine)3.5
L-Histidine2.4
L-Isoleucine6.6
L-Leucine8.8
L-Lysine6.4
L- and DL-Methionine3.1
L-Phenylalanine5.8
L-Proline4.2
L-Serine8.4
L-Threonine5.0
L-Tryptophan1.6
L-Tyrosine4.3
L-Valine7.4

(d) Compliance with the limitations concerning PER under paragraph (c) of this section shall be determined by the method described in sections 43.212-43.216, "Official Methods of Analysis of the Association of Official Analytical Chemists." Each manufacturer or person employing the additive(s) under the provisions of this section shall keep and maintain throughout the period of his use of the additive(s) and for a minimum of 3 years thereafter, records of the tests required by this paragraph and other records required to assure effectiveness and compliance with this regulation and shall make such records available upon request at all reasonable hours by any officer or employee of the Food and Drug Administration, or any other officer or employee acting on behalf of the Secretary of Health and Human Services and shall permit such officer or employee to conduct such inventories of raw and finished materials on hand as he deems necessary and otherwise to check the correctness of such records.

(e) To assure safe use of the additive, the label and labeling of the additive and any premix thereof shall bear, in addition to the other information required by the Act, the following:

(1) The name of the amino acid(s) contained therein including the specific optical and chemical form.

(2) The amounts of each amino acid contained in any mixture.

(3) Adequate directions for use to provide a finished food meeting the limitations prescribed by paragraph (c) of this section.

(f) The food additive amino acids added as nutrients to special dietary foods that are intended for use solely under medical supervision to meet nutritional requirements in specific medical conditions and comply with the requirements of part 105 of this chapter are exempt from the limitations in paragraphs (c) and (d) of this section and may be used in such foods at levels not to exceed good manufacturing practices.

(g) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(1) AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877:

(i) Sections 43.212-43.216, "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980).

(ii) [Reserved]

(2) National Academy of Sciences, available from the FDA Main Library, 10903 New Hampshire Ave., Silver Spring, MD 20993:

(i) "Recommended Dietary Allowances," NAS Publication No. 1694, 7th Ed. (1968).

(ii) "Specifications and Criteria for Biochemical Compounds," NAS/NRC Publication, 3rd Ed. (1972).

(3) United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ):

(i) Food Chemicals Codex, 7th ed. (2010), pages 28, 29, 69, 70, 71, 269, 270, 271, 440, 457, 458, 544, 545, 577, 578, 598, 599, 641, 642, 643, 697, 698, 794, 795, 864, 865, 915, 916, 1031, 1032, 1060, 1061, and 1072.

(ii) [Reserved]

[78 FR 71461, Nov. 29, 2013]

Sec. 172.325 Bakers yeast protein.

Bakers yeast protein may be safely used in food in accordance with the following conditions:

(a) Bakers yeast protein is the insoluble proteinaceous material remaining after the mechanical rupture of yeast cells of Saccharomyces cerevisiae and removal of whole cell walls by centrifugation and separation of soluble cellular materials.

(b) The additive meets the following specifications on a dry weight basis:

(1) Zinc salts less than 500 parts per million (ppm) as zinc.

(2) Nucleic acid less than 2 percent.

(3) Less than 0.3 ppm arsenic, 0.1 ppm cadmium, 0.4 ppm lead, 0.05 ppm mercury, and 0.3 ppm selenium.

(c) The viable microbial content of the finished ingredient is:

(1) Less than 10,000 organisms/gram by aerobic plate count.

(2) Less than 10 yeasts and molds/gram.

(3) Negative for Salmonella, E. coli, coagulase positive Staphylococci, Clostridium perfringens, Clostridium botulinum, or any other recognized microbial pathogen or any harmful microbial toxin.

(d) The ingredient is used in food as a nutrient supplement as defined in 170.3(o)(20) of this chapter.

Sec. 172.330 Calcium pantothenate, calcium chloride double salt.

The food additive calcium chloride double salt of calcium pantothenate may be safely used in foods for special dietary uses in accordance with good manufacturing practice and under the following prescribed conditions:

(a) The food additive is of the d (dextrorotatory) or the dl (racemic) form.

(b) To assure safe use of the additive, the label and labeling of the food additive container, or that of any intermediate premixes prepared therefrom, shall bear, in addition to the other information required by the Act, the following:

(1) The name of the additive "calcium chloride double salt of d- calcium pantothenate" or "calcium chloride double salt of dl- calcium pantothenate", whichever is appropriate.

(2) A statement of the appropriate concentration of the additive, expressed as pantothenic acid.

Sec. 172.335 D-Pantothenamide.

The food additive D-pantothenamide as a source of pantothenic acid activity, may be safely used in foods for special dietary use in an amount not in excess of that reasonably required to produce its intended effect.

Sec. 172.340 Fish protein isolate.

(a) The food additive fish protein isolate may be safely used as a food supplement in accordance with the following prescribed conditions:

(1) The additive shall consist principally of dried fish protein prepared from the edible portions of fish after removal of the heads, fins, tails, bones, scales, viscera, and intestinal contents.

(2) The additive shall be derived only from species of bony fish that are generally recognized by qualified scientists as safe for human consumption and that can be processed as prescribed to meet the required specifications.

(3) Only wholesome fresh fish otherwise suitable for human consumption may be used. The fish shall be handled expeditiously under sanitary conditions. These conditions shall be in accordance with recognized good manufacturing practice for fish to be used as human food.

(4) The additive shall be prepared by extraction with hexane and food-grade ethanol to remove fat and moisture. Solvent residues shall be reduced by drying.

(b) The food additive meets the following specifications: (Where methods of determination are specified, they are Association of Official Analytical Chemists Methods, 13th ed., 1980, which are incorporated by reference). 1

(1) Protein content, as N * 6.25, shall not be less than 90 percent by weight of the final product, as determined by the method described in section 2.057, Improved Kjeldahl Method for Nitrate-Free Samples (20)--Official Final Action.

(2) Moisture content shall not be more than 10 percent by weight of the final product, as determined by the method described in section 24.003, Air Drying (1)--Official First Action.

(3) Fat content shall not be more than 0.5 percent by weight of the final product, as determined by the method described in section 24.005, Crude Fat or Ether Extract--Official Final Action.

(4) Solvent residues in the final product shall not be more than 5 parts per million of hexane and 3.5 percent ethanol by weight.

1Copies are available from: AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

[46 FR 38072, July 24, 1981, as amended at 47 FR 53344, Nov. 26, 1982; 54 FR 24897, June 12, 1989]

Sec. 172.345 Folic acid (folacin).

Folic acid (CAS Reg. No. 59-30-3), also known as folacin or folate, may be safely used in food as a nutrient in accordance with the following prescribed conditions:

(a) Folic acid is the chemical N -[4-<(2-amino-1,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-L -glutamic acid.

(b) Folic acid meets the specifications of the Food Chemicals Codex, 9th ed., updated through Third Supplement, effective December 1, 2015, pp. 495-496, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) Folic acid may be added to foods subject to a standard of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act (the act) when the standard of identity specifically provides for the addition of folic acid.

(d) Folic acid may be added, at levels not to exceed 400 micrograms ([micro]g) per serving, to breakfast cereals, as defined under 170.3(n)(4) of this chapter, and to corn grits at a level such that each pound of corn grits contains not more than 1.0 milligram of folic acid.

(e) Folic acid may be added to infant formula in accordance with section 412(i)(1) of the act or with regulations issued under section 412(i)(2) of the act which are codified in 107.100 of this chapter.

(f) Folic acid may be added to a medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), at levels not to exceed the amount necessary to meet the distinctive nutritional requirements of the disease or condition for which the food is formulated.

(g) Folic acid may be added to food for special dietary use at levels not to exceed the amount necessary to meet the special dietary needs for which the food is formulated.

(h) Folic acid may be added to foods represented as meal-replacement products, in amounts not to exceed:

(1) Four hundred [micro]g per serving if the food is a meal-replacement that is represented for use once per day; or

(2) Two hundred [micro]g per serving if the food is a meal-replacement that is represented for use more than once per day.

(i) Folic acid may be added to corn masa flour at a level not to exceed 0.7 milligrams of folic acid per pound of corn masa flour.

[61 FR 8807, Mar. 5, 1996, as amended at 61 FR 27779, June 3, 1996; 64 FR 1758, Jan. 12, 1999; 78 FR 71463, Nov. 29, 2013; 81 FR 22183, Apr. 15, 2016]

Sec. 172.350 Fumaric acid and salts of fumaric acid.

Fumaric acid and its calcium, ferrous, magnesium, potassium, and sodium salts may be safely used in food in accordance with the following prescribed conditions:

(a) The additives meet the following specifications:

(1) Fumaric acid contains a minimum of 99.5 percent by weight of fumaric acid, calculated on the anhydrous basis.

(2) The calcium, magnesium, potassium, and sodium salts contain a minimum of 99 percent by weight of the respective salt, calculated on the anhydrous basis. Ferrous fumarate contains a minimum of 31.3 percent total iron and not more than 2 percent ferric iron.

(b) With the exception of ferrous fumarate, fumaric acid and the named salts are used singly or in combination in food at a level not in excess of the amount reasonably required to accomplish the intended effect.

(c) Ferrous fumarate is used as a source of iron in foods for special dietary use, when the use is consistent with good nutrition practice.

Sec. 172.365 Kelp.

Kelp may be safely added to a food as a source of the essential mineral iodine, provided the maximum intake of the food as may be consumed during a period of one day, or as directed for use in the case of a dietary supplement, will not result in daily ingestion of the additive so as to provide a total amount of iodine in excess of 225 micrograms for foods labeled without reference to age or physiological state; and when age or the conditions of pregnancy or lactation are specified, in excess of 45 micrograms for infants, 105 micrograms for children under 4 years of age, 225 micrograms for adults and children 4 or more years of age, and 300 micrograms for pregnant or lactating women. The food additive kelp is the dehydrated, ground product prepared from Macrocystis pyrifera, Laminaria digitata, Laminaria saccharina, and Laminaria cloustoni.

Sec. 172.370 Iron-choline citrate complex.

Iron-choline citrate complex made by reacting approximately equimolecular quantities of ferric hydroxide, choline, and citric acid may be safely used as a source of iron in foods for special dietary use.

Sec. 172.372 N-Acetyl-L-methionine.

The food additive N -acetyl-L-methionine may be safely added to food (except infant foods and foods containing added nitrites/nitrates) as a source of L-methionine for use as a nutrient in accordance with the following conditions:

(a) N- Acetyl-L-methionine (Chemical Abstracts Service Registry No. 65-82-7) is the derivative of the amino acid methionine formed by addition of an acetyl group to the alpha- amino group of methionine. It may be in the free, hydrated or anhydrous form, or as the sodium or potassium salts.

(b) The additive meets the following specifications:

(1) Purity assay, on a dry basis: Minimum 99 percent.

(2) Residue on ignition: Maximum 0.1 percent.

(3) Specific optical rotation [alpha] 20D: Between -19deg. and -23deg. .

(4) The additive may contain residues of not more than 500 ppm ethyl acetate; 50 ppm ethyl alcohol; 10 ppm methyl alcohol; and 10 ppm acetone, when used as processing solvents.

(c) The additive is used or intended for use as a source of L-methionine to improve significantly the biological quality of the total protein in a food containing naturally occurring primarily intact vegetable protein that is considered a significant dietary protein source, provided that:

(1) A reasonable daily adult intake of the finished food furnishes at least 6.5 grams of naturally occurring primarily intact vegetable protein.

(2) The additive results in a protein efficiency ratio (PER) of protein in the finished ready-to-eat food equivalent to casein as determined by the method specified in paragraph (d) of this section.

(3) The use of the additive results in a statistically significant increase in the PER as determined by the method described in paragraph (d) of this section. The minimum amount of the additive to achieve the desired effect must be used, and the increase in PER over the primarily intact naturally occurring vegetable protein in the food must be substantiated as a statistically significant difference with at least a probability (P) value of less than 0.05.

(4) The amount of the additive added for nutritive purpose shall not exceed the level that will provide a total of 3.1 percent L- and DL-methionine (expressed as the free amino acid) by weight of the total protein of the finished food, including the amount naturally present in free and combined (as protein) form.

(5) The additive shall not be added to infant foods or to foods containing added nitrites/nitrates.

(d) Compliance with the limitations concerning PER under paragraph (c) of the section shall be determined by the method described in sections 43.212-43.216, "Official Methods of Analysis of the Association of Official Analytical Chemists," 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Each manufacturer or person employing the additive under the provisions of this section shall keep and maintain throughout the period of use of the additive and for a minimum of 3 years thereafter, records of the tests required by this paragraph and other records required to assure effectiveness and compliance with this regulation. Those records shall be made available upon request at all reasonable hours by any officer or employee acting on behalf of the Secretary of Health and Human Services. Those officers or employees shall be permitted to conduct inventories of raw and finished materials on hand as are deemed necessary to verify the records.

(e) To assure safe use of the additive, the label and labeling of the additive and any premix thereof shall bear, in addition to the other information required by the Act, the following:

(1) The name of the additive contained therein.

(2) The amounts of additive and each amino acid contained in any mixture.

(3) Adequate directions for use to provide a finished food meeting the limitations prescribed by paragraph (c) of this section.

(f) When the food additive is added as a nutrient to special dietary foods that are intended for use solely under medical supervision to meet nutritional requirements in specific medical conditions and these foods comply with the requirements of part 105 of this chapter, the food additive is exempt from the limitations in paragraphs (c)(1) through (4) and (d) of this section and may be used in those foods at levels not to exceed good manufacturing practices.

[43 FR 27784, June 27, 1978, as amended at 46 FR 59968, Dec. 8, 1981; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]

Sec. 172.375 Potassium iodide.

The food additive potassium iodide may be safely used in accordance with the following prescribed conditions:

(a) Potassium iodide may be safely added to a food as a source of the essential mineral iodine, provided the maximum intake of the food as may be consumed during a period of one day, or as directed for use in the case of a dietary supplement, will not result in daily ingestion of the additive so as to provide a total amount of iodine in excess of 225 micrograms for foods labeled without reference to age or physiological state; and when age or the conditions of pregnancy or lactation are specified, in excess of 45 micrograms for infants, 105 micrograms for children under 4 years of age, 225 micrograms for adults and children 4 or more years of age, and 300 micrograms for pregnant or lactating women.

(b) To assure safe use of the additive, in addition to the other information required by the Act, the label of the additive shall bear:

(1) The name of the additive.

(2) A statement of the concentration of the additive in any mixture.

Sec. 172.379 Vitamin D[bdi2].

Vitamin D2 may be used safely in foods as a nutrient supplement defined under 170.3(o)(20) of this chapter in accordance with the following prescribed conditions:

(a) Vitamin D2, also known as ergocalciferol, is the chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. Vitamin D2 is produced by ultraviolet irradiation of ergosterol isolated from yeast and is purified by crystallization.

(b) Vitamin D2 meets the specifications of the 2015 Food Chemical Codex, 9th edition (through Third Supplement), effective December 1, 2015, pp. 1260-1261, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

(c) The additive may be used as follows:

Category of Food Maximum Levels in Food (as Served)
Edible plant-based beverages intended as milk alternatives84 IU/100 g.
Edible plant-based yogurt alternatives89 IU/100 g.
Soy beverage products89 IU/100 g
Soy-based butter substitute spreads330 IU/100 g
Soy-based cheese substitutes and soy-based cheese substitute products270 IU/100 g

[74 FR 11022, Mar. 16, 2009, as amended at 78 FR 71463, Nov. 29, 2013; 81 FR 46581, July 18, 2016]

Sec. 172.380 Vitamin D[bdi3].

Vitamin D3 may be used safely in foods as a nutrient supplement defined under 170.3(o)(20) of this chapter in accordance with the following prescribed conditions:

(a) Vitamin D3, also known as cholecalciferol, is the chemical 9,10-seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. Vitamin D3 occurs in and is isolated from fish liver oils. It also is manufactured by ultraviolet irradiation of 7-dehydrocholesterol produced from cholesterol and is purified by crystallization.

(b) Vitamin D3 meets the specifications of the 2015 Food Chemical Codex, 9th edition (through Third Supplement), effective December 1, 2015, pp. 1261-1262, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) The additive may be used as follows:

(1) At levels not to exceed 100 International Units (IU) per 240 milliliters (mL) in 100 percent fruit juices (as defined under 170.3(n)(35) of this chapter) that are fortified with greater than or equal to 33 percent of the reference daily intake (RDI) of calcium per 240 mL, excluding fruit juices that are specially formulated or processed for infants.

(2) At levels not to exceed 100 IU per 240 mL in fruit juice drinks (as defined under 170.3(n)(35) of this chapter) that are fortified with greater than or equal to 10 percent of the RDI of calcium per 240 mL, excluding fruit juice drinks that are specially formulated or processed for infants.

(3) At levels not to exceed 140 IU per 240 mL (prepared beverage) in soy-protein based meal replacement beverages (powder or liquid) that are represented for special dietary use in reducing or maintaining body weight in accordance with 105.66 of this chapter.

(4) At levels not to exceed 100 IU per 40 grams in meal replacement bars or other-type bars that are represented for special dietary use in reducing or maintaining body weight in accordance with 105.66 of this chapter.

(5) At levels not to exceed 81 IU per 30 grams in cheese and cheese products as defined under 170.3(n)(5) of this chapter, excluding cottage cheese, ricotta cheese, and hard grating cheeses such as Parmesan and Romano as defined in 133.165 and 133.183 of this chapter, and those defined by standard of identity in 133.148 of this chapter.

(6) At levels not to exceed 500 IU per 240 mL (prepared beverage) in meal replacement beverages that are not intended for special dietary use in reducing or maintaining body weight and that are represented for use such that the total amount of Vitamin D3 provided by the product does not exceed 1,000 IU per day.

(7) At levels not to exceed 1.0 IU per kilocalorie in foods represented for use as a sole source of nutrition for enteral feeding.

(8) At levels not to exceed 84 IU per 100 g (800 IU/quart) in milk that contains more than 42 IU vitamin D per 100 g (400 IU/quart) and that meets the requirements for foods named by use of a nutrient content claim and a standardized term in accordance with 130.10 of this chapter.

[68 FR 9003, Feb. 27, 2003, as amended at 70 FR 36025, June 22, 2005; 70 FR 37257, June 29, 2005; 70 FR 69438, Nov. 16, 2005; 78 FR 71463, Nov. 29, 2013; 79 FR 46996, Aug. 12, 2014; 81 FR 46582, July 18, 2016]

Sec. 172.381 Vitamin D[bdi2] bakers yeast.

Vitamin D2 bakers yeast may be used safely in foods as a source of vitamin D2 and as a leavening agent in accordance with the following prescribed conditions:

(a) Vitamin D2 bakers yeast is the substance produced by exposing bakers yeast (Saccharomyces cerevisiae ) to ultraviolet light, resulting in the photochemical conversion of endogenous ergosterol in bakers yeast to vitamin D2 (also known as ergocalciferol or (9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol)).

(b) Vitamin D2 bakers yeast may be used alone as an active dry yeast concentrate or in combination with conventional bakers yeast.

(c) The additive may be used in yeast-leavened baked goods and baking mixes and yeast-leavened baked snack foods at levels not to exceed 400 International Units of vitamin D2 per 100 grams in the finished food.

(d) To assure safe use of the additive, the label or labeling of the food additive container shall bear, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions for use to provide a final product that complies with the limitations prescribed in paragraph (c) of this section.

(e) Labels of manufactured food products containing the additive shall bear, in the ingredient statement, the name of the additive, "vitamin D2 bakers yeast," in the proper order of decreasing predominance in the finished food.

[77 FR 52231, Aug. 29, 2012]

Sec. 172.385 Whole fish protein concentrate.

The food additive whole fish protein concentrate may be safely used as a food supplement in accordance with the following prescribed conditions:

(a) The additive is derived from whole, wholesome hake and hakelike fish, herring of the genera Clupea, menhaden, and anchovy of the species Engraulis mordax, handled expeditiously and under sanitary conditions in accordance with good manufacturing practices recognized as proper for fish that are used in other forms for human food.

(b) The additive consists essentially of a dried fish protein processed from the whole fish without removal of heads, fins, tails, viscera, or intestinal contents. It is prepared by solvent extraction of fat and moisture with isopropyl alcohol or with ethylene dichloride followed by isopropyl alcohol, except that the additive derived from herring, menhaden and anchovy is prepared by solvent extraction with isopropyl alcohol alone. Solvent residues are reduced by conventional heat drying and/or microwave radiation and there is a partial removal of bone.

(c) The food additive meets the following specifications:

(1) Protein content (N * 6.25) shall not be less than 75 percent by weight of the final product, as determined by the method described in section 2.057 in "Official Methods of Analysis of the Association of Official Analytical Chemists" (AOAC), 13th Ed. (1980). Protein quality shall not be less than 100, as determined by the method described in sections 43.212-43.216 of the AOAC. The 13th Ed. is incorporated by reference, and copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(2) Moisture content shall not exceed 10 percent by weight of the final product, as determined by the method described in section 24.003 of the AOAC. See paragraph (c)(1) of this section for availability of the material incorporated by reference.

(3) Fat content shall not exceed 0.5 percent by weight of the final product, as determined by the method described in section 24.005 of the AOAC. See paragraph (c)(1) of the this section for availability of the material incorporated by reference.

(4) The additive may contain residues of isopropyl alcohol and ethylene dichloride not in excess of 250 parts per million and 5 parts per million, respectively, when used as solvents in the extraction process.

(5) Microwave radiation meeting the requirements of 179.30 of this chapter may be used to reduce residues of the solvents used in the extraction process.

(6) The additive shall contain not in excess of 100 parts per million fluorides (expressed as F).

(7) The additive shall be free of Escherichia coli and pathogenic organisms, including Salmonella, and shall have a total bacterial plate count of not more than 10,000 per gram.

(8) The additive shall have no more than a faint characteristic fish odor and taste.

(d) When the additive is used or intended for use in the household as a protein supplement in food for regular consumption by children up to 8 years of age, the amount of the additive from this source shall not exceed 20 grams per day (about one heaping tablespoon).

(e) When the additive is used as a protein supplement in manufactured food, the total fluoride content (expressed as F) of the finished food shall not exceed 8 ppm based on the dry weight of the food product.

(f) To assure safe use of the additive, in addition to the other information required by the Act:

(1) The label of consumer-sized or bulk containers of the additive shall bear the name "whole fish protein concentrate".

(2) The label or labeling of containers of the additive shall bear adequate directions for use to comply with the limitations prescribed by paragraphs (d) and (e) of this section.

(3) Labels of manufactured foods containing the additive shall bear, in the ingredient statement, the name of the additive, "whole fish protein concentrate" in the proper order of decreasing predominance in the finished food.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]

Sec. 172.395 Xylitol.

Xylitol may be safely used in foods for special dietary uses, provided the amount used is not greater than that required to produce its intended effect.

Sec. 172.399 Zinc methionine sulfate.

Zinc methionine sulfate, CAS Reg. No. 56329-42-1, may be safely used in accordance with the following prescribed conditions:

(a) The additive is the product of the reaction between equimolar amounts of zinc sulfate and DL-methionine in purified water.

(b) The additive meets the following specifications:

Zinc content--19 to 22 percent.

C5H11NO2S "DL-methionine"--46 to 50 percent.

Cadmium--not more than 0.05 part per million.

(c) The additive is used in tablet form as a source of dietary zinc.

[46 FR 58297, Dec. 1, 1981]

Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
Source: 42 FR 14491, Mar. 15, 1977, unless otherwise noted.

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