Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

(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 Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

(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.

[48 FR 18798, Apr. 26, 1983, as amended at 54 FR 24896, June 12, 1989]

(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.

(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.

Sandwich spread Sauces

(parts

Use

per mil

lion)

75 Preservative.

75

Do.

75

Do.

75

Do.

100

Do.

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.

[42 FR 14491, Mar. 15, 1977, as amended at 48 FR 10815, Mar. 15, 1983; 58 FR 52222, Oct. 7, 1993; 60 FR 33710, June 29, 1995; 65 FR 48379, Aug. 8, 2000]

§ 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, eg., 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).

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," whichis incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.

(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.

in

an

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

(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.

[42 FR 14491, Mar. 15, 1977, as amended at 65 FR 48379, Aug. 8, 2000]

$172.140 Ethoxyquin.

(a) Ethoxyquin (1,2-dihydro-6-ethoxy2,2,4-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-hydroxymethyl2,6-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. 7681-938), also known as pimaricin, is a polyene macrolide antimycotic substance possessing an empirical formula of C33H47NO13 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 Division of Product Policy (HFS-206), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition's Library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.

[47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1, 1998; 66 FR 13847, Mar. 8, 2001]

$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