FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

• Citation: 21 CFR Part 172
• Sections: 153

§ 172.5 General provisions for direct food additives.

(a) Regulations prescribing conditions under which food additive substances may be safely used predicate usage under conditions of good manufacturing practice. For the purposes of this part, good manufacturing practice shall be defined to include the following restrictions.

(1) The quantity of the substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritive, or other technical effect in food.

(2) Any substance intended for use in or on food is of appropriate food grade and is prepared and handled as a food ingredient.

(b) The existence of a regulation prescribing safe conditions of use for a food additive shall not be construed to relieve the use of the substance from compliance with any other provision of the Act.

(c) The existence of any regulation prescribing safe conditions of use for a nutrient substance does not constitute a finding that the substance is useful or required as a supplement to the diet of humans.

§ 172.105 Anoxomer.

Anoxomer as identified in this section may be safely used in accordance with the following conditions:

(a) Anoxomer is 1,4-benzenediol, 2-(1,1-dimethylethyl)-polymer with diethenylbenzene, 4-(1,1-dimethyl-ethyl)phenol, 4- methoxyphenol, 4,4′-(1-methylethylidene)bis(phenol) and 4-methylphenol (CAS Reg. No. 60837-57-2) prepared by condensation polymerization of divinylbenzene ( m - and p -) with tert -butylhydroquinone, tert -butylphenol, hydroxyanisole, p -cresol and 4,4′-isopropylidenediphenol.

(b) The polymeric antioxidant meets the following specifications:

(1) Polymer, not less than 98.0 percent as determined by an ultraviolet method entitled “Ultraviolet Assay, “1982, which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, 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.

(2) Molecular weight: Total monomers, dimers and trimers below 500 not more than 1 percent as determined by a method entitled “Low Molecular Weight Anoxomer Analysis,” 1982, which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, 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.

(3) Phenol content: Not less than 3.2 milliequivalent/gram and not more than 3.8 milliequivalent/gram as determined by a method entitled “Total Phenols,” 1982, which is incorporated by reference. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, 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.

(4) Heavy metals as lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million.

(c) Anoxomer may be safely used as an antioxidant in food at a level of not more than 5,000 parts per million based on fat and oil content of the food.

§ 172.110 BHA.

The food additive BHA (butylated hydroxyanisole) alone or in combination with other antioxidants permitted in food for human consumption in this subpart B may be safely used in or on specified foods, as follows:

(a) The BHA meets the following specification:

Assay (total BHA), 98.5 percent minimum. Melting point 48 °C minimum.

(b) The BHA is used alone or in combination with BHT, as an antioxidant in foods, as follows:

Food

Limitations (total BHA and BHT) parts per million

Dehydrated potato shreds

50

Active dry yeast

1 1,000

Beverages and desserts prepared from dry mixes

1 2

Dry breakfast cereals

50

Dry diced glazed fruit

1 32

Dry mixes for beverages and desserts

1 90

Emulsion stabilizers for shortenings

200

Potato flakes

50

Potato granules

10

Sweet potato flakes

50

1 BHA only.

(c) To assure safe use of the additive:

(1) The label of any market package of the additive shall bear, in addition to the other information required by the Act, the name of the additive.

(2) When the additive is marketed in a suitable carrier, in addition to meeting the requirement of paragraph (c)(1) of this section, the label shall declare the percentage of the additive in the mixture.

(3) The label or labeling of dry mixes for beverages and desserts shall bear adequate directions for use to provide that beverages and desserts prepared from the dry mixes contain no more than 2 parts per million BHA.

§ 172.115 BHT.

The food additive BHT (butylated hydroxytoluene), alone or in combination with other antioxidants permitted in this subpart B may be safely used in or on specified foods, as follows:

(a) The BHT meets the following specification: Assay (total BHT) 99 percent minimum.

(b) The BHT is used alone or in combination with BHA, as an antioxidant in foods, as follows:

Food

Limitations (total BHA and BHT) parts per million

Dehydrated potato shreds

50

Dry breakfast cereals

50

Emulsion stabilizers for shortenings

200

Potato flakes

50

Potato granules

10

Sweetpotato flakes

50

(c) To assure safe use of the additive:

(1) The label of any market package of the additive shall bear, in addition to the other information required by the Act, the name of the additive.

(2) When the additive is marketed in a suitable carrier, in addition to meeting the requirement of paragraph (c)(1) of this section, the label shall declare the percentage of the additive in the mixture.

§ 172.120 Calcium disodium EDTA.

The food additive calcium disodium EDTA (calcium disodium ethylene-diaminetetraacetate) may be safely used in designated foods for the purposes and in accordance with the conditions prescribed, as follows:

(a) The additive contains a minimum of 99 percent by weight of either the dihydrate C 10 H 12 O 8 N 2 CaNa 2 ·2H 2 O or the trihydrate C 10 H 12 O 8 N 2 CaNa 2 ·3H 2 O, or any mixture of the two.

(b) It is used or intended for use as follows:

(1) Alone, in the following foods at not to exceed the levels prescribed, calculated as the anhydrous compound:

Food

Limitation (parts per million)

Use

Cabbage, pickled

220

Promote color, flavor, and texture retention.

Canned carbonated soft drinks

33

Promote flavor retention.

Canned white potatoes

110

Promote color retention.

Clams (cooked canned)

340

Promote color retention.

Crabmeat (cooked canned)

275

Retard struvite formation; promote color retention.

Cucumbers pickled

220

Promote color, flavor, and texture retention.

Distilled alcoholic beverages

25

Promote stability of color, flavor, and/or product clarity.

Dressings, nonstandardized

75

Preservative.

Dried lima beans (cooked canned)

310

Promote color retention.

Egg product that is hard-cooked and consists, in a cylindrical shape, of egg white with an inner core of egg yolk

1 200

Preservative.

Fermented malt beverages

25

Antigushing agent.

French dressing

75

Preservative.

Legumes (all cooked canned, other than dried lima beans, pink beans, and red beans)

365

Promote color retention.

Mayonnaise

75

Do.

Mushrooms (cooked canned)

200

Promote color retention.

Oleomargarine

75

Preservative.

Pecan pie filling

100

Promote color retention.

Pink beans (cooked canned)

165

Promote color retention.

Potato salad

100

Preservative.

Processed dry pinto beans

800

Promote color retention.

Red beans (cooked canned)

165

Promote color retention.

Salad dressing

75

Preservative.

Sandwich spread

100

Do.

Sauces

75

Do.

Shrimp (cooked canned)

250

Retard struvite formation; promote color retention.

Spice extractives in soluble carriers

60

Promote color and flavor retention.

Spreads, artificially colored and lemon-flavored or orange-flavored

100

Promote color retention.

1 By weight of egg yolk portion.

(2) With disodium EDTA (disodium ethylenediaminetetraacetate) in the following foods at not to exceed, in combination, the levels prescribed, calculated as anhydrous C 10 H 12 O 8 N 2 CaNa 2 :

Food

Limitation (parts per million)

Use

Dressings, nonstandardized

75

Preservative.

French dressing

75

Do.

Mayonnaise

75

Do.

Salad dressing

75

Do.

Sandwich spread

100

Do.

Sauces

75

Do.

(c) To assure safe use of the additive:

(1) The label and labeling of the additive container shall bear, in addition to the other information required by the Act, the name of the additive.

(2) The label or labeling of the additive container shall bear adequate use directions to provide a final food product that complies with the limitations provided in paragraph (b) of this section.

(d) In the standardized foods listed in paragraph (b) of this section, the additives are used only in compliance with the applicable standards of identity for such foods.

§ 172.130 Dehydroacetic acid.

The food additive dehydroacetic acid and/or its sodium salt may be safely used in accordance with the following prescribed conditions:

(a) The food additive meets the following specifications:

Dehydroacetic acid: Melting point, 109 °C-111 °C; assay, minimum 98 percent (dry basis).

Sodium salt of dehydroacetic acid: Assay, minimum 98 percent (dry basis).

(b) It is used or intended for use as a preservative for cut or peeled squash, and is so used that no more than 65 parts per million expressed as dehydroacetic acid remains in or on the prepared squash.

(c) The label or labeling of any package of the additive intended for use in food shall bear adequate directions for use to insure compliance with this section.

§ 172.133 Dimethyl dicarbonate.

Dimethyl dicarbonate (CAS Reg. No. 4525-33-1) may be safely used in food in accordance with the following prescribed conditions:

(a) The additive meets the following specifications:

(1) The additive has a purity of not less than 99.8 percent as determined by the following titration method:

principles of method

Dimethyl dicarbonate (DMDC) is mixed with excess diisobutylamine with which it reacts quantitatively. The excess amine is backtitrated with acid.

apparatus

250-milliliter (mL) Beaker

100-mL Graduate cylinder

25-mL Pipette

10-mL Burette (automatic, e.g., Metrohm burette)

Stirrer

Device for potentiometric titration

Reference electrode

Glass electrode

reagents

Acetone, analytical-grade

Solution of 1 N diisobutylamine in chlorobenzene, distilled

1 N Acetic Acid

procedure

Accurately weigh in about 2 grams of the sample (W) and dissolve in 100 mL acetone. Add accurately 25 mL of the 1 N diisobutylamine solution by pipette and allow to stand for 5 minutes. Subsequently, titrate the reaction mixture potentiometrically with 1 N hydrochloric acid (consumption= a mL) while stirring. For determining the blank consumption, carry out the analysis without a sample (consumption= b mL).

calculation

Note:

For adding the diisobutylamine solution, always use the same pipette and wait for a further three drops to fall when the flow has stopped.

(2) The additive contains not more than 2,000 ppm (0.2 percent) dimethyl carbonate as determined by a method entitled “Gas Chromatography Method for Dimethyl Carbonate Impurity in Dimethyl Dicarbonate,” which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, 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.

(b) The additive is used or intended for use as a microbial control agent in the following beverages under normal circumstances of bottling, canning, or other forms of final packaging, where the viable microbial load has been reduced to 500 microorganisms per milliliter or less by current good manufacturing practices such as heat treatment, filtration, or other technologies prior to the use of dimethyl dicarbonate:

(1) In wine, dealcoholized wine, and low alcohol wine in an amount not to exceed 200 parts per million.

(2) In ready-to-drink teas in an amount not to exceed 250 parts per million.

(3) In carbonated or noncarbonated, nonjuice-containing (less than or equal to 1 percent juice), flavored or unflavored beverages containing added electrolytes (5-20 milliequivalents/liter sodium ion (Na + ) and 3-7 milliequivalents/liter potassium ion (K + )) in an amount not to exceed 250 parts per million.

(4) In carbonated, dilute beverages containing juice, fruit flavor, or both, with juice content not to exceed 50 percent, in an amount not to exceed 250 parts per million.

(c) To ensure the safe use of the food additive, the label of the package containing the additive shall bear, in addition to other information required by the Federal Food, Drug, and Cosmetic Act:

(1) The name of the additive “dimethyl dicarbonate.”

(2) The intended use of the additive.

(3) Adequate directions for use to ensure compliance with this section.

§ 172.135 Disodium EDTA.

The food additive disodium EDTA (disodium ethylenediaminetetraacetate) may be safely used in designated foods for the purposes and in accordance with the following prescribed conditions:

(a) The additive contains a minimum of 99 percent disodium ethylenedia-minetetraacetate dihydrate (C 10 H 14 O 8 N 2 Na 2 ·2H 2 O).

(b) It is used or intended for use as follows:

(1) Alone, in the following foods at not to exceed the levels prescribed, calculated as anhydrous calcium disodium EDTA:

Food

Limitation (parts per million)

Use

Aqueous multivitamin preparations

150

With iron salts as a stabilizer for vitamin B 12 in liquid multivitamin preparations.

Canned black-eyed peas

145

Promote color retention.

Canned kidney beans

165

Preservative.

Canned strawberry pie filling

500

Promote color retention.

Cooked sausage

36

As a cure accelerator with sodium ascorbate or ascorbic acid.

Dressings, nonstandardized

75

Preservative.

French dressing

75

Do.

Frozen white potatoes including cut potatoes

100

Promote color retention.

Gefilte fish balls or patties in packing medium

1 50

Inhibit discoloration.

Legumes (all cooked canned, other than black-eyed peas)

165

Promote color retention.

Mayonnaise

75

Preservative.

Ready-to-eat cereal products containing dried bananas

2 315

Promote color retention.

Salad dressing

75

Preservative.

Sandwich spread

100

Do.

Sauces

75

Do.

1 Based on total weight of finished product including packing medium.

2 In dried banana component of cereal product.

(2) With calcium disodium EDTA (calcium disodium ethylenediaminetetraacetate; calcium disodium (ethylenedinitrilo) tetraacetate), in the following foods at not to exceed, in combination, the levels prescribed, calculated as anhydrous C 10 H 12 O 8 N 2 CaNa 2 :

Food

Limitation (parts per million)

Use

Dressings, nonstandardized

75

Preservative.

French dressing

75

Do.

Mayonnaise

75

Do.

Salad dressing

75

Do.

Sandwich spread

100

Do.

Sauces

75

Do.

(3) Alone, as a sequestrant in the nonnutritive sweeteners that are listed in § 180.37 of this chapter and that, in addition, are designed for aqueous solution: Provided, That the amount of the additive, calculated as anhydrous calcium disodium EDTA, does not exceed 0.1 percent by weight of the dry nonnutritive sweetener.

(c) To assure the safe use of the additive:

(1) The label and labeling of the additive container shall bear, in addition to the other information required by the act, the name of the additive.

(2) The label or labeling of the additive container shall bear adequate use directions to provide a final food product that complies with the limitations provided in paragraph (b) of this section.

(d) In the standardized foods listed in paragraphs (b)(1) and (2) of this section the additives are used only in compliance with the applicable standards of identity for such foods.

§ 172.140 Ethoxyquin.

(a) Ethoxyquin (1,2-dihydro-6-ethoxy-2,2,4-trimethylquinoline) may be safely used as an antioxidant for preservation of color in the production of chili powder, paprika, and ground chili at levels not in excess of 100 parts per million.

(b) In order to provide for the safe use of the additive in feed prepared in accordance with §§ 573.380 and 573.400 of this chapter, tolerances are established for residues of ethoxyquin in or on edible products of animals as follows:

5 parts per million in or on the uncooked fat of meat from animals except poultry.

3 parts per million in or on the uncooked liver and fat of poultry.

0.5 part per million in or on the uncooked muscle meat of animals.

0.5 part per million in poultry eggs.

Zero in milk.

§ 172.145 Heptylparaben.

(a) The food additive heptylparaben is the chemical n -heptyl p -hydroxybenzoate.

(b) It may be safely used to inhibit microbiological spoilage in accordance with the following prescribed conditions:

(1) In fermented malt beverages in amounts not to exceed 12 parts per million.

(2) In noncarbonated soft drinks and fruit-based beverages in amounts not to exceed 20 parts per million, when standards of identity established under section 401 of the Act (21 U.S.C. 341) do not preclude such use.

§ 172.150 4-Hydroxymethyl-2,6-di- tert -butylphenol.

The food additive 4-hydroxymethyl-2,6-di- tert -butylphenol may be safely used in food in accordance with the following prescribed conditions:

(a) The additive has a solidification point of 140 °C-141 °C.

(b) The additive is used as an antioxidant alone or in combination with other permitted antioxidants.

(c) The total amount of all antioxidants added to such food shall not exceed 0.02 percent of the oil or fat content of the food, including the essential (volatile) oil content of the food.

§ 172.155 Natamycin (pimaricin).

(a) Natamycin (CAS Reg. No. 7681-93-8), also known as pimaricin, is a polyene macrolide antimycotic substance possessing an empirical formula of C 33 H 47 NO 13 and a molecular weight of 665.7.

(b) The additive shall conform to the following specifications:

Purity: 97 percent ±2 percent on an anhydrous basis.

Arsenic: Not more than 1 part per million.

Heavy metals (as Pb): Not more than 20 parts per million.

(c) The additive may be applied on cheese, as an antimycotic, in amounts not to exceed 20 milligrams per kilogram (20 parts per million) in the finished product as determined by International Dairy Federation (IDF) Standard 140A:1992, “Cheese and Cheese Rind-Determination of Natamycin Content-Method by Molecular Absorption Spectrometry and by High-Performance Liquid Chromatography,” 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. Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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.

§ 172.160 Potassium nitrate.

The food additive potassium nitrate may be safely used as a curing agent in the processing of cod roe, in an amount not to exceed 200 parts per million of the finished roe.

§ 172.165 Quaternary ammonium chloride combination.

The food additive, quaternary ammonium chloride combination, may be safely used in food in accordance with the following conditions:

(a) The additive contains the following compounds: n- dodecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 139-07-1); n- dodecyl dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-28-3); n- hexadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-18-9); n- octadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-19-0); n- tetradecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 139-08-2); n- tetradecyl dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-29-4).

(b) The additive meets the following specifications: pH (5 percent active solution) 7.0-8.0; total amines, maximum 1 percent as combined free amines and amine hydrochlorides.

(c) The additive is used as an antimicrobial agent, as defined in § 170.3(o)(2) of this chapter, in raw sugar cane juice. It is added prior to clarification when further processing of the sugar cane juice must be delayed.

(d) The additive is applied to the sugar juice in the following quantities, based on the weight of the raw cane:

Component

Parts per million

n- Dodecyl dimethyl benzyl ammonium chloride

0.25-1.0

n- Dodecyl dimethyl ethylbenzyl ammonium chloride

3.4-13.5

n- Hexadecyl dimethyl benzyl ammonium chloride

1.5-6.0

n- Octadecyl dimethyl benzyl ammonium chloride

0.25-1.0

n- Tetradecyl dimethyl benzyl ammonium chloride

3.0-12.0

n- Tetradecyl dimethyl ethylbenzyl ammonium chloride

1.6-6.5

§ 172.167 Silver nitrate and hydrogen peroxide solution.

An aqueous solution containing a mixture of silver nitrate and hydrogen peroxide may be safely used in accordance with the following prescribed conditions:

(a) The additive is used as an antimicrobial agent in bottled water.

(b) Hydrogen peroxide meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 496-497, 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 amount of silver added will not exceed 17 micrograms per kilogram in the treated bottled water, and the amount of hydrogen peroxide will not exceed 23 milligrams per kilogram in the treated bottled water. Analyses for silver and hydrogen peroxide shall be conducted on samples of treated bottled water at the site of bottling, using samples of the water intended for treatment for the blank determination.

(d)(1) The amount of silver in the treated bottled water is determined using the method for silver designated in 21 CFR 165.110(b)(4)(iii)(G)( 2 )( i ).

(2) The amount of hydrogen peroxide in the treated bottled water is determined using a Hydrogen Peroxide Test Kit from the HACH Co., or equivalent. The manual from the Hydrogen Peroxide Test Kit, Model HYP-1, Catalog Number 22917-00, 1991, is incorporated by reference. The Director 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 of the test kit manual from the HACH Co., P.O. Box 389, Loveland CO, 80359 (1-800-227-4224), Model HYP-1, Catalog Number 22917-00. Copies may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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.

(e) Substances generally recognized as safe in or on food may be used to stabilize the additive to ensure that the additive will perform its intended technical effect.

(f) The additive may not be added to bottled water that has been filtered or is intended to be filtered through a silver-containing water filter.

(g) Bottled water must meet the quality standards for bottled water in § 165.110(b)(2) through (b)(5) of this chapter, including the limits specified for total silver and nitrate, unless the water bears a label statement of substandard quality, as provided for under § 165.110(c) of this chapter.

§ 172.170 Sodium nitrate.

The food additive sodium nitrate may be safely used in or on specified foods in accordance with the following prescribed conditions:

(a) It is used or intended for use as follows:

(1) As a preservative and color fixative, with or without sodium nitrite, in smoked, cured sablefish, smoked, cured salmon, and smoked, cured shad, so that the level of sodium nitrate does not exceed 500 parts per million and the level of sodium nitrite does not exceed 200 parts per million in the finished product.

(2) As a preservative and color fixative, with or without sodium nitrite, in meat-curing preparations for the home curing of meat and meat products (including poultry and wild game), with directions for use which limit the amount of sodium nitrate to not more than 500 parts per million in the finished meat product and the amount of sodium nitrite to not more than 200 parts per million in the finished meat product.

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

(1) The label of the additive or of a mixture containing the additive shall bear:

(i) The name of the additive.

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

(2) If in a retail package intended for household use, the label and labeling of the additive, or of a mixture containing the additive, shall bear adequate directions for use to provide a final food product that complies with the limitations prescribed in paragraph (a) of this section.

(3) If in a retail package intended for household use, the label of the additive or of a mixture containing the additive, shall bear the statement “Keep out of the reach of children”.

§ 172.175 Sodium nitrite.

The food additive sodium nitrite may be safely used in or on specified foods in accordance with the following prescribed conditions:

(a) It is used or intended for use as follows:

(1) As a color fixative in smoked cured tunafish products so that the level of sodium nitrite does not exceed 10 parts per million (0.001 percent) in the finished product.

(2) As a preservative and color fixative, with or without sodium nitrate, in smoked, cured sablefish, smoked, cured salmon, and smoked, cured shad so that the level of sodium nitrite does not exceed 200 parts per million and the level of sodium nitrate does not exceed 500 parts per million in the finished product.

(3) As a preservative and color fixative, with sodium nitrate, in meat-curing preparations for the home curing of meat and meat products (including poultry and wild game), with directions for use which limit the amount of sodium nitrite to not more than 200 parts per million in the finished meat product, and the amount of sodium nitrate to not more than 500 parts per million in the finished meat product.

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

(1) The label of the additive or of a mixture containing the additive shall bear:

(i) The name of the additive.

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

(2) If in a retail package intended for household use, the label and labeling of the additive, or of a mixture containing the additive, shall bear adequate directions for use to provide a final food product which complies with the limitations prescribed in paragraph (a) of this section.

(3) If in a retail package intended for household use, the label of the additive, or of a mixture containing the additive, shall bear the statement “Keep out of the reach of children”.

§ 172.177 Sodium nitrite used in processing smoked chub.

The food additive sodium nitrite may be safely used in combination with salt (NaCl) to aid in inhibiting the outgrowth and toxin formation from Clostridium botulinum type E in the commercial processing of smoked chub in accordance with the following prescribed conditions:

(a) All fish in smoking establishments shall be clean and wholesome and shall be expeditiously processed, packed, and stored under adequate sanitary conditions in accordance with good manufacturing practice.

(b) The brining procedure is controlled in such a manner that the water phase portion of the edible portion of the finished smoked product has a salt (NaCl) content of not less than 3.5 percent, as measured in the loin muscle, and the sodium nitrite content of the edible portion of the finished smoked product is not less than 100 parts per million and not greater than 200 parts per million, as measured in the loin muscle.

(c) Smoked chub shall be heated by a controlled heat process which provides a monitoring system positioned in as many strategic locations in the smokehouse as necessary to assure a continuous temperature throughout each fish of at least 160 °F for a minimum of 30 minutes.

(d) The finished product shall be cooled to a temperature of 50 °F or below within 3 hours after smoking and further cooled to a temperature of 38 °F or below within 12 hours after smoking. A temperature of 38 °F or below shall be maintained during all subsequent storage and distribution. All shipping containers, retail packages, and shipping records shall indicate with appropriate notice the perishable nature of the product and specify that the product shall be held under refrigeration (38 °F or below) until consumed.

(e) To assure safe use of the additive:

(1) The label and labeling of the additive container shall bear, in addition to the other information required by the Act, the name of the additive.

(2) The label or labeling of the additive container shall bear adequate directions to assure use in compliance with the provisions of this section.

§ 172.180 Stannous chloride.

The food additive stannous chloride may be safely used for color retention in asparagus packed in glass, with lids lined with an inert material, in an amount not to exceed 20 parts per million calculated as tin (Sn).

§ 172.185 TBHQ.

The food additive TBHQ, which is the chemical 2-(1,1-dimethylethyl)-1,4-benzenediol (Chemical Abstracts Service Registry Number 1948-33-0), also known as tertiary butylhydroquinone, may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive has a melting point of not less than 126.5 °C.

(b) The percentage of TBHQ in the food additive is not less than 99.0 percent when tested by the assay described in the Food Chemicals Codex, 9th ed. (2014), pp. 1192-1194, which is incorporated by reference, or an equivalent method. 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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) It is used as an antioxidant alone or in combination with BHA and/or BHT.

(d) The total antioxidant content of a food containing the additive will not exceed 0.02 percent of the oil or fat content of the food, including the essential (volatile) oil content of the food.

§ 172.190 THBP.

The food additive THBP (2,4,5-trihydroxybutyrophenone) may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive has a melting point of 149 °C-153 °C.

(b) It is used as an antioxidant alone or in combination with other permitted antioxidants.

(c) The total antioxidant content of a food containing the additive will not exceed 0.02 percent of the oil or fat content of the food, including the essential (volatile) oil content of the food.

§ 172.210 Coatings on fresh citrus fruit.

Coatings may be applied to fresh citrus fruit for protection of the fruit in accordance with the following conditions:

(a) The coating is applied in the minimum amount required to accomplish the intended effect.

(b) The coating may be formulated from the following components, each used in the minimum quantity required to accomplish the intended effect:

(1) Substances generally recognized as safe for the purpose or previously sanctioned for the purpose.

(2) One or more of the following:

Component

Limitations

Fatty acids

Complying with § 172.860.

Oleic acid derived from tall oil fatty acids

Complying with § 172.862.

Partially hydrogenated rosin

Catalytically hydrogenated to a maximum refractive index of 1.5012 at 100 °C. Color of WG or paler.

Pentaerythritol ester of maleic anhydride-modified wood rosin

Acid number of 134-145; drop-softening point of 127 °C-173 °C; saponification number of less than 280; and a color of M or paler.

Do

Acid number of 176-186; drop-softening point of 110 °C-118 °C; saponification number of less than 280; and a color of M or paler.

Polyethylene glycol

Complying with § 172.820. As a defoamer and dispersing adjuvant.

Polyhydric alcohol diesters of oxidatively refined (Gersthofen process) montan wax acids

Complying with § 178.3770 of this chapter and having a dropping point of 77 to 83 °C (170.6 to 181.4 °F), as determined by ASTM Method D566-76 (Reapproved 1982), “Standard Test Method for Dropping Point of Lubricating Grease,” which is incorporated by reference (Copies are available from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, 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. ) using as a solvent xylene-ethyl alcohol in a 2:1 ratio instead of toluene-ethyl alcohol in a 2:1 ratio.

Sodium lauryl sulfate

Complying with § 172.822. As a film former.

Wood rosin

Color of K or paler.

(3) In lieu of the components listed in paragraph (b)(2) and (4) of this section, the following copolymer and one or more of the listed adjuvants.

Component

Limitations

Vinyl chloride-vinylidene chloride copolymer

As an aqueous dispersion containing a minimum of 75 percent water when applied.

Polyethylene glycol

Complying with § 172.820. As a defoamer and dispersing adjuvant.

Polyvinylpyrrolidone

As an adjuvant.

Potassium persulfate

Do.

Propylene glycol alginate

Do.

Sodium decylbenzenesulfonate

Do.

(4) In lieu of the components listed in paragraph (b)(2) and (3) of this section, the following rosin derivative and either or both of the listed adjuvants:

Component

Limitations

Calcium salt of partially dimerized rosin

Having a maximum drop-softening point of 197 °C and a color of H or paler. It is prepared by reaction with not more than 7 parts hydrated lime per 100 parts of partially dimerized rosin. The partially dimerized rosin is rosin that has been dimerized by sulfuric acid catalyst to a drop-softening point of 95 °C to 105 °C and a color of WG or paler.

Petroleum naphtha

As adjuvant. Complying with § 172.250.

Sperm oil

As adjuvant.

§ 172.215 Coumarone-indene resin.

The food additive coumarone-indene resin may be safely used on grapefruit, lemons, limes, oranges, tangelos, and tangerines in accordance with the following prescribed conditions:

(a) The food additive is manufactured by the polymerization of a crude, heavy coal-tar solvent naphtha meeting the following specifications:

(1) It is a mixture of indene, indan (hydrindene), substituted benzenes, and related compounds.

(2) It contains no more than 0.25 percent tar bases.

(3) 95 percent distills in the range 167 °C-184 °C.

(b) The food additive meets the following specifications:

(1) Softening point, ring and ball: 126 °C minimum as determined by ASTM method E28-67 (Reapproved 1982), “Standard Test Method for Softening Point by Ring-and-Ball Apparatus,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, 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) Refractive index ( n

25 / D ) 1.63-1.64.

(c) It is used or intended for use as a protective coating for grapefruit, lemons, limes, oranges, tangelos, and tangerines whereby the maximum amount of the resin remaining on the fruit does not exceed 200 parts per million on a fresh-weight basis.

(d) To assure safe use of the additive:

(1) The label of the market package or any intermediate premix of the additive shall bear, in addition to the other information required by the act:

(i) The name of the additive, coumarone-indene resin.

(ii) A statement of the concentration of the additive therein.

(2) The label or accompanying labeling shall bear adequate directions that, if followed, will result in a finished food not in conflict with the requirements of this section.

§ 172.225 Methyl and ethyl esters of fatty acids produced from edible fats and oils.

Methyl esters and ethyl esters of fatty acids produced from edible fats and oils may be safely used in food, subject to the following prescribed conditions:

(a) The additive consists of a mixture of either methyl or ethyl esters of fatty acids produced from edible fats and oils and meets the following specifications:

(1) Not less than 90 percent methyl or ethyl esters of fatty acids.

(2) Not more than 1.5 percent unsaponifiable matter.

(b) The additive is used or intended for use at the level not to exceed 3 percent by weight in an aqueous emulsion in dehydrating grapes to produce raisins, whereby the residue of the additive on the raisins does not exceed 200 parts per million.

§ 172.230 Microcapsules for flavoring substances.

Microcapsules may be safely used for encapsulating discrete particles of flavoring substances that are generally recognized as safe for their intended use or are regulated under this part, in accordance with the following conditions:

(a) The microcapsules may be formulated from the following components, each used in the minimum quantity required to accomplish the intended effect:

(1) Substances generally recognized as safe for the purpose.

(2) One or more of the following components:

component and limitations

Succinylated gelatin—Not to exceed 15 percent by combined weight of the microcapsule and flavoring oil. Succinic acid content of the gelatin is 4.5 to 5.5 percent.

Arabinogalactan—Complying with § 172.610; as adjuvant.

Silicon dioxide—Complying with § 172.480; as adjuvant.

(3) In lieu of the components listed in paragraph (a)(2) of this section, the following components:

component and limitations

Glutaraldehyde—As cross-linking agent for insolubilizing a coacervate of gum arabic and gelatin.

n -Octyl alcohol—As a defoamer.

(4) In lieu of the components listed in paragraphs (a)(2) and (3) of this section, the following component:

component and limitations

Petroleum wax—Complying with § 172.886. Not to exceed 50 percent by combined weight of the microcapsule and spice-flavoring substance.

(b) The microcapsules produced from the components listed in paragraphs (a)(1), (2), and (3) of this section may be used for encapsulating authorized flavoring oils for use, in accordance with good manufacturing practice, in foods for which standards of identity established under section 401 of the Act do not preclude such use, except that microcapsules formulated from components listed in paragraph (a)(2) of this section may be used only for encapsulating lemon oil, distilled lime oil, orange oil, peppermint oil, and spearmint oil for use in dry mixes for puddings and gelatin desserts.

(c) The microcapsules produced from the components listed in paragraphs (a)(1) and (4) of this section may be used only for encapsulating authorized spice-flavoring substances for use, in accordance with good manufacturing practice, in frozen pizzas which are to be further processed by heat. Such pizzas shall bear labels or labeling including adequate directions for use to ensure heating to temperatures which will melt the wax to release the spice-flavoring substances.

§ 172.235 Morpholine.

Morpholine may be safely used as a component of food, subject to the following restrictions.

(a) It is used as the salt(s) of one or more of the fatty acids meeting the requirements of § 172.860, as a component of protective coatings applied to fresh fruits and vegetables.

(b) It is used at a level not in excess of that reasonably required to produce its intended effect.

§ 172.250 Petroleum naphtha.

Petroleum naphtha may be safely used in food in accordance with the following conditions:

(a) The additive is a mixture of liquid hydrocarbons, essentially paraffinic and naphthenic in nature obtained from petroleum,

(b) The additive is refined to meet the following specifications when subjected to the procedures described in this paragraph.

(1) Boiling-point range: 175 °F-300 °F.

(2) Nonvolatile residue: 0.002 gram per 100 milliliters maximum.

(3) Ultraviolet absorbance limits, as follows:

Wavelength (milli-microns)

Maximum absorbance per centimeter optical pathlength

280-289

0.15

290-299

.13

300-359

.08

360-400

.02

Analytical Specification for Petroleum Naphtha

general instructions

All glassware should be scrupulously cleaned to remove all organic matter such as oil, grease, detergent residues, etc. Examine all glassware, including stoppers and stopcocks, under ultraviolet light to detect any residual fluorescent contamination. As a precautionary measure, it is recommended practice to rinse all glassware with purified isooctane immediately before use. No grease is to be used on stopcocks or joints. Great care to avoid contamination of petroleum naphtha samples in handling and to assure absence of any extraneous material arising from inadequate packaging is essential. Because some of the polynuclear hydrocarbons sought in this test are very susceptible to photo-oxidation, the entire procedure is to be carried out under subdued light.

apparatus

Separatory funnels. 250-milliliter, and 2,000-milliliter capacity, equipped with tetrafluoroethylene polymer stopcocks.

Erlenmeyer flask. 125-milliliter with 24/40 standard taper neck.

Evaporation flask. 250-milliliter capacity all-glass flask equipped with 24/40 standard taper stopper having inlet and outlet tubes to permit passage of nitrogen across the surface of the container liquid to be evaporated.

Condenser. 24/40 joints, fitted with drying tube, length optional.

Spectrophotometric cells. Fused quartz cells, optical path length in the range of 5,000 centimeters ±0.005 centimeter; also for checking spectrophotometer performance only, optical path length in the range 1,000 centimeter ±0.005 centimeter. With distilled water in the cells, determine any absorbance difference.

Spectrophotometer. Spectral range 250-400 mµ with spectral slit width of 2 mµ or less; under instrument operating conditions for these absorbance measurements, the spectrophotometer shall also meet the following performance requirements:

Absorbance repeatability, ±0.01 at 0.4 absorbance.

Absorbance accuracy,

1

±0.05 at 0.4 absorbance.

1 As determined by procedure using potassium chromate for reference standard and described in National Bureau of Standards Circular 484, Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is to be determined by comparison with the standard values at 290, 345, and 400 millimicrons. The procedure is incorporated by reference. Copies of the material incorporated by reference are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or available for inspection 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.

Wavelength repeatability, ±0.2 millimicron.

Wavelength accuracy, ±1.0 millimicron.

Ultraviolet lamp. Long wavelength (3400-3800A°).

reagents

Isooctane ( 2,2,4-trimethylpentane ). Use 180 milliliters in a 250-milliliter Erlenmeyer flask, add 1 milliliter of purified n -hexadecane, insert the head assembly, allow nitrogen gas to flow into the inlet tube and connect the outlet tube to a solvent trap and vacuum line in such a way as to prevent any back flow of condensate into the flask. The contents of the flask are evaporated on a steam bath until 1 milliliter of residue remains. Dissolve the 1 milliliter of hexadecane residue in isooctane and make up to 25 milliliters. Determine the absorbance in a 5-centimeter path length cell compared to isooctane as reference. The absorbance should not exceed 0.01 per centimeter path length between 280-400 mµ. If necessary, isooctane may be purified by passage through a column of activated silica gel (Grade 12, Davidson Chemical Co., Baltimore, Md., or equivalent) or by distillation.

Methyl alcohol, A.C.S. reagent grade. Use 10 milliliters and proceed as with isooctane. The absorbance per centimeter of path length should be 0.00 between 280-400 mµ. Methyl alcohol may be purified by simple distillation or by refluxing in the presence of potassium hydroxide (10 grams/2 liters) and zinc dust (25 grams/2 liters) for 3 hours followed by distillation.

n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n- hexadecane to 25 milliliters with isooctane and determine the absorbance in a 5-centimeter cell compared to isooctane as reference between 280-400 mµ. The absorbance per centimeter path length shall not exceed 0.00 in this range. Purify, if necessary, by percolation through activated silica gel or by distillation.

Sodium borohydride. 98 percent.

Water. All distilled water must be extracted with isooctane before use. A series of three successive extracts of 1.5 liters of distilled water with 100-milliliter portions of isooctane is satisfactory.

procedure

Determination of ultraviolet absorbance. Add a 25-milliliter aliquot of the hydrocarbon solvent together with 1 milliliter of hexadecane to the 125-milliliter Erlenmeyer flask. While flushing with nitrogen, evaporate to 1 milliliter on a steam bath. Nitrogen is admitted through a 8±1-milliliter outer-diameter tube, drawn out into a 2±1-centimeter long and 1±0.5-millimeter inner-diameter capillary tip. This is positioned so that the capillary tip extends 4 centimeters into the flask. The nitrogen flow rate is such that the surface of the liquid is barely disturbed. After the volume is reduced to that of the 1 milliliter of hexadecane, the flask is left on the steam bath for 10 more minutes before removing. Add 10 milliliters of purified isooctane to the flask and reevaporate the solution to a 1-milliliter volume in the same manner as described above, except do not heat for an added 10 minutes. Repeat this operation twice more. Let the flask cool.

Add 10 milliliters of methyl alcohol and about 0.3 gram of sodium borohydride. (Minimize exposure of the borohydride to the atmosphere; a measuring dipper may be used.) Immediately fit a water-cooled condenser equipped with a 24/40 joint and with a drying tube into the flask, mix until the sodium borohydride is dissolved, and allow to stand for 30 minutes at room temperature, with intermittent swirling. At the end of this time, disconnect the flask and evaporate the methyl alcohol on the steam bath under nitrogen until sodium borohydride begins to drop out of solution. Remove the flask and let it cool.

Add 6 milliliters of isooctane to the flask and swirl to wash the crystalline slurry. Carefully transfer the isooctane extract to a 250-milliliter separatory funnel. Dissolve the crystals in the flask with about 25 milliliters of distilled water and pour this also into the separatory funnel. Adjust the water volume in the separatory funnel to about 100 milliliters and shake for 1 minute. After separation of the layers, draw off the aqueous layer into a second 250-milliliter separatory funnel. Transfer the hydrocarbon layer in the first funnel to a 25-milliliter volumetric flask.

Carefully wash the Erlenmeyer flask with an additional 6 milliliters of isooctane, swirl, and transfer to the second separatory funnel. Shake the funnel for 1 minute. After separation of the layers, draw off the aqueous layer into the first separatory funnel. Transfer the isooctane in the second funnel to the volumetric flask. Again wash the Erlenmeyer flask with an additional 6 milliliters of isooctane, swirl, and transfer to the first separatory funnel. Shake the funnel for 1 minute. After separation of the layers, draw off the aqueous layer and discard. Transfer the isooctane layer to the volumetric flask and adjust the volume to 25 milliliters of isooctane. Mix the contents well, then transfer to the first separatory funnel and wash twice with 50-milliliter portions of distilled water. Discard the aqueous layers after each wash.

Determine the ultraviolet absorbance of the isooctane extract in 5-centimeter path length cells compared to isooctane as reference between 280-400 mµ. Determine a reagent blank concurrently with the sample, using 25 milliliters of purified isooctane instead of a solvent sample and measuring the ultraviolet absorbance of the blank between 280-400mµ.

The reagent blank absorbance should not exceed 0.04 per centimeter path length between 280-289 mµ; 0.020 between 290-359 mµ; and 0.010 between 360-400 mµ.

Determination of boiling-point range. Use ASTM method D86-82, “Standard Method for Distillation of Petroleum Products,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, 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.

Determination of nonvolatile residue. For hydrocarbons boiling below 121 °C, determine the nonvolatile residue by ASTM method D1353-78, “Standard Test Method for Nonvolatile Matter in Volatile Solvents for Use in Paint, Varnish, Lacquer, and Related Products;” for those boiling above 121 °C, use ASTM method D381-80, “Standard Test Method for Existent Gum in Fuels by Jet Evaporation,” which methods are incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, 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.

(c) Petroleum naphtha containing antioxidants shall meet the specified ultraviolet absorbance limits after correction for any absorbance due to the antioxidants. Petroleum naphtha may contain antioxidants authorized for use in food in an amount not to exceed that reasonably required to accomplish the intended effect or to exceed any prescribed limitations.

(d) Petroleum naphtha is used or intended for use as a solvent in protective coatings on fresh citrus fruit in compliance with § 172.210.

§ 172.255 Polyacrylamide.

Polyacrylamide containing not more than 0.2 percent of acrylamide monomer may be safely used as a film former in the imprinting of soft-shell gelatin capsules when the amount used is not in excess of the minimum required to produce the intended effect.

§ 172.260 Oxidized polyethylene.

Oxidized polyethylene may be safely used as a component of food, subject to the following restrictions:

(a) Oxidized polyethylene is the basic resin produced by the mild air oxidation of polyethylene. The polyethylene used in the oxidation process conforms to the density, maximum n- hexane extractable fraction, and maximum xylene soluble fraction specifications prescribed in item 2.3 of the table in § 177.1520(c) of this chapter. The oxidized polyethylene has a minimum number average molecular weight of 1,200, as determined by high temperature vapor pressure osmometry; contains a maximum of 5 percent by weight of total oxygen; and has an acid value of 9 to 19.

(b) The additive is used or intended for use as a protective coating or component of protective coatings for fresh avocados, bananas, beets, coconuts, eggplant, garlic, grapefruit, lemons, limes, mango, muskmelons, onions, oranges, papaya, peas (in pods), pineapple, plantain, pumpkin, rutabaga, squash (acorn), sweetpotatoes, tangerines, turnips, watermelon, Brazil nuts, chestnuts, filberts, hazelnuts, pecans, and walnuts (all nuts in shells).

(c) The additive is used in accordance with good manufacturing practice and in an amount not to exceed that required to produce the intended effect.

§ 172.270 Sulfated butyl oleate.

Sulfate butyl oleate may be safely used in food, subject to the following prescribed conditions:

(a) The additive is prepared by sulfation, using concentrated sulfuric acid, of a mixture of butyl esters produced by transesterification of an edible vegetable oil using 1-butanol. Following sulfation, the reaction mixture is washed with water and neutralized with aqueous sodium or potassium hydroxide. Prior to sulfation, the butyl oleate reaction mixture meets the following specifications:

(1) Not less than 90 percent butyl oleate.

(2) Not more than 1.5 percent unsaponifiable matter.

(b) The additive is used or intended for use at a level not to exceed 2 percent by weight in an aqueous emulsion in dehydrating grapes to produce raisins, whereby the residue of the additive on the raisins does not exceed 100 parts per million.

§ 172.275 Synthetic paraffin and succinic derivatives.

Synthetic paraffin and succinic derivatives identified in this section may be safely used as a component of food, subject to the following restrictions:

(a) The additive is prepared with 50 percent Fischer-Tropsch process synthetic paraffin, meeting the definition and specifications of § 172.615, and 50 percent of such synthetic paraffin to which is bonded succinic anhydride and succinic acid derivatives of isopropyl alcohol, polyethylene glycol, and polypropylene glycol. It consists of a mixture of the Fischer-Tropsch process paraffin (alkane), alkyl succinic anhydride, alkyl succinic anhydride isopropyl half ester, dialkyl succinic anhydride polyethylene glycol half ester, and dialkyl succinic anhydride polypropylene glycol half ester, where the alkane (alkyl) has a chain length of 30-70 carbon atoms and the polyethylene and polypropylene glycols have molecular weights of 600 and 260, respectively.

(b) The additive meets the following specifications: Molecular weight, 880-930; melting point, 215°-217 °F; acid number, 43-47; and saponification number, 75-78.

(c) It is used or intended for use as a protective coating or component of protective coatings for fresh grapefruit, lemons, limes, muskmelons, oranges, sweetpotatoes, and tangerines.

(d) It is used in an amount not to exceed that required to produce the intended effect.

§ 172.280 Terpene resin.

The food additive terpene resin may be safely used in accordance with the following prescribed conditions:

(a) The food additive is the betapinene polymer obtained by polymerizing terpene hydrocarbons derived from wood. It has a softening point of 112 °C-118 °C, as determined by ASTM method E28-67 (Reapproved 1982), “Standard Test Method for Softening Point By Ring-and-Ball Apparatus,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, 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.

(b) It is used or intended for use as follows:

(1) As a moisture barrier on soft gelatin capsules in an amount not to exceed 0.07 percent of the weight of the capsule.

(2) As a moisture barrier on powders of ascorbic acid or its salts in an amount not to exceed 7 percent of the weight of the powder.

§ 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.

§ 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 °C to 145 °C.

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

§ 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-Alanine

6.1

L-Arginine

6.6

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-Histidine

2.4

L-Isoleucine

6.6

L-Leucine

8.8

L-Lysine

6.4

L- and DL-Methionine

3.1

L-Phenylalanine

5.8

L-Proline

4.2

L-Serine

8.4

L-Threonine

5.0

L-Tryptophan

1.6

L-Tyrosine

4.3

L-Valine

7.4

(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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday:

(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]

§ 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.

§ 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.

§ 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.

§ 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 Copies 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.

(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.

§ 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 (µg) 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 µg per serving if the food is a meal-replacement that is represented for use once per day; or

(2) Two hundred µg 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.

§ 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.

§ 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.

§ 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.

§ 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]

20 D : Between −19° and −23°.

(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.

§ 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.

§ 172.379 Vitamin D 2 .

Vitamin D 2 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 D 2 , also known as ergocalciferol, is the chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. Vitamin D 2 is produced by ultraviolet irradiation of ergosterol isolated from yeast and is purified by crystallization.

(b) Vitamin D 2 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 Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, 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 alternatives

84 IU/100 g.

Edible plant-based yogurt alternatives

89 IU/100 g.

Soy beverage products

89 IU/100 g

Soy-based butter substitute spreads

330 IU/100 g

Soy-based cheese substitutes and soy-based cheese substitute products

270 IU/100 g

§ 172.380 Vitamin D 3 .

Vitamin D 3 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 D 3 , also known as cholecalciferol, is the chemical 9,10-seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. Vitamin D 3 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 D 3 meets the specifications of Vitamin D 3 , Food Chemicals Codex, 14th edition, effective June 1, 2024, which is incorporated by reference into this section. The Director of the Federal Register approved this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration (FDA) and at the National Archives and Records Administration (NARA). Contact FDA at: the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday; phone: [phone]; email: [email protected]. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. This material may be obtained from the U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852; phone [phone]; email [email protected]; website: https://www.usp.org.

(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 330 milligrams (mg) 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 100 mg 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 D 3 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.

(9) At levels not to exceed 560 IU per 100 g in breakfast cereals (as defined under § 170.3(n)(4) of this chapter).

(10) At levels not to exceed 400 IU per 100 g in grain-based bars (e.g., breakfast bars, granola bars, rice cereal bars).

(11) At levels not to exceed 178 IU per 100 g in yogurt under § 131.200 of this chapter, and lower fat yogurt under § 130.10 of this chapter, and other cultured dairy products fermented with Lactobacillus delbrueckii, subsp. bulgaricus, and Streptococcus thermophilus.

§ 172.381 Vitamin D 2 bakers yeast.

Vitamin D 2 bakers yeast may be used safely in foods as a source of vitamin D 2 and as a leavening agent in accordance with the following prescribed conditions:

(a) Vitamin D 2 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 D 2 (also known as ergocalciferol or (9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol)).

(b) Vitamin D 2 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 D 2 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 D 2 bakers yeast,” in the proper order of decreasing predominance in the finished food.

§ 172.382 Vitamin D 2 mushroom powder.

Vitamin D 2 mushroom powder may be used safely in foods as a source of vitamin D 2 in accordance with the following prescribed conditions:

(a) Vitamin D 2 mushroom powder is the substance produced by exposing an aqueous homogenate of edible cultivars of Agaricus bisporus mushrooms to ultraviolet (UV) light, resulting in the photochemical conversion of endogenous ergosterol in the mushrooms to vitamin D 2 (also known as ergocalciferol or [9,10-Seco(5Z,7E,22E)-5,7,10(19),22- ergostatetraen-3-ol]).

(b) The total dose of UV light applied to the mushroom homogenate shall not exceed 12 Joules/square centimeter (J/cm

2 ).

(c) Vitamin D 2 mushroom powder meets the following specifications:

(1) Moisture, not more than 10 percent.

(2) Negative for Salmonella, Staphylococcus aureus, and Listeria monocytogenes, and any other recognized microbial pathogen or any harmful microbial toxin.

(3) Standard plate count, not more than 5,000 colony forming units per gram (CFU/g).

(4) Yeasts and molds, not more than 100 CFU/g.

(5) Lead, not more than 0.5 milligrams per kilogram (mg/kg).

(6) Arsenic, not more than 0.3 mg/kg.

(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 (f) of this section.

(e) Labels of manufactured food products containing the additive shall bear, in the ingredient statement, the name of the additive “vitamin D 2 mushroom powder,” in the proper order of decreasing predominance in the finished food.

(f) Vitamin D 2 mushroom powder may be used as a source of vitamin D 2 in food as follows:

Table 1 to Paragraph ( f )

Category of food

Maximum level of vitamin D 2

Breakfast cereals

350 IU/100 g.

Edible plant-based beverages marketed as milk alternatives

84 IU/100 g.

Edible plant-based products marketed as yogurt alternatives

89 IU/100 g.

Extruded vegetable snacks

80 IU/28 g.

Fruit smoothies

100 IU/240 mL.

100% fruit juices that are fortified with greater than or equal to 330 mg of calcium per 240 mL, excluding fruit juices that are specially formulated or processed for infants

100 IU/240 mL.

Fruit juice drinks that are fortified with greater than or equal to 100 mg of calcium per 240 mL, excluding fruit juice drinks that are specially formulated or processed for infants

100 IU/240 mL.

Grain products and pastas

90 IU/100 g.

Meal replacement bars or other-type bars that are represented for special dietary use in reducing or maintaining body weight

100 IU/40 g.

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 D provided by the product does not exceed 1,000 IU per day

500 IU/240 mL.

Plant protein products

80 IU/85 g.

Soups and soup mixes, except for soup and soup mixes containing meat or poultry that are subject to regulation by the U.S. Department of Agriculture under the Federal Meat Inspection Act or the Poultry Products Inspection Act

100 IU/245 mL.

Soy-based spreads marketed as butter alternatives

330 IU/100 g.

Soy-based products marketed as cheese and cheese-product alternatives

270 IU/100 g.

Soy beverage products

89 IU/100 g.

Soy-protein based meal replacement beverages (powder or liquid) that are represented for special dietary use in reducing or maintaining body weight

140 IU/240 mL.

Vegetable juices

100 IU/240 mL.

Yeast-leavened baked goods and baking mixes and yeast-leavened baked snack foods

400 IU/100 g.

§ 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.